Garnet BioTherapeutics Response Brief

Case: 16-2116 Document: 25 Page: 1 Filed: 11/23/2016
2016-2116
UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT
ABT HOLDING COMPANY
and
REGENTS OF THE UNIVERSITY OF MINNESOTA,

Appellants,
v.
GARNET BIOTHERAPEUTICS, INC.,
Appellee.
Appeal from the United States Patent and Trademark Office,

Patent Trial and Appeal Board in Interference No. 105,953.
CORRECTED RESPONSE BRIEF OF APPELLEE

GARNET BIOTHERAPEUTICS, INC.
_____________________________________________________________
Cynthia M. Bouchez Matthew J. Dowd

Medler Ferro Woodhouse & Dowd PLLC
Mills PLLC 1717 Pennsylvania Avenue, NW
8201 Greensboro Drive Suite 1025
Suite 1060 Washington, D.C. 20006
McLean, VA 22102 (202) 573-3853
cbouchez@medlerferro.com mjdowd@dowdpllc.com
Counsel for Appellee

Garnet BioTherapeutics, Inc.
CERTIFICATE OF INTEREST
Counsel for Appellee Garnet BioTherapeutics, Inc. certifies the

following:
1. The full name of every party or amicus represented by me is:
Garnet BioTherapeutics, Inc.
2. The name of the real party in interest (if the party named in the
caption is not the real party in interest) represented by me is:
Not Applicable
3. All parent corporations and any publicly held companies that own
10 percent or more of the stock of the party or amicus curiae
represented by me are:
Not Applicable
4. The names of all law firms and the partners or associates that
appeared for the party or amicus now represented by me in the trial
court or agency or are expected to appear in this court are:
Matthew J. Dowd, Dowd PLLC, 1717 Pennsylvania Avenue,

NW, Suite 1025, Washington, D.C. 20006;
Cynthia M. Bouchez, Medler Ferro Woodhouse & Mills PLLC,
8201 Greensboro Drive, Suite 1060, McLean, VA 22102
Date: November 22, 2016 /s/ Matthew J. Dowd

Signature of counsel
Matthew J. Dowd
Printed name of counsel
TABLE OF CONTENTS
Page
STATEMENT OF RELATED CASES ....................................................... 1
STATEMENT OF THE ISSUES ................................................................ 1
STATEMENT OF THE CASE AND FACTUAL BACKGROUND ........... 1
I. Procedural Background ..................................................................... 1
II. Factual Background .......................................................................... 3
A. The Basics of Stem Cell Technology ........................................ 4
B. Multipotent Progenitor Cells Are Characterized by

Particular Physical Features and the Methods Used to
Isolate and Culture the Cells ................................................... 7
C. The Isolation and Culturing of Multipotent Progenitor

Cells are Difficult and Depend on the Tissue Source
and the Methods Used............................................................ 10
D. Dr. Verfaille and Colleagues Report on the Isolation of

a Multipotent Adult Progenitor Cell (“MAPC”), But
They Later Retract One Publication Due To Falsified
Data ......................................................................................... 15
E. Notwithstanding the Falsified Data, Verfaille and Her

Fellow Furcht Inventors Sought Broad Claims
Covering Their MAPCs .......................................................... 18
F. Ho and His Colleagues File Patent Applications

Directed to a Different Stem Cell Population Co-
Expressing CD49c and CD90 ................................................. 20
G. After Repeated Attempts by Furcht, the Board

Declares an Interference Between Ho and Furcht ............... 21
H. The Board Rules in Favor of Ho on the Motions of No

Interference-in-Fact and Lack of Written Description ......... 23
- ii -
SUMMARY OF THE ARGUMENT ......................................................... 28
ARGUMENT ............................................................................................. 30
I. Standard Of Review......................................................................... 30
II. The Board Did Not Adopt Or Rely On An “Improper”

Definition Of The Level Of Ordinary Skill In The Art .................. 31
III. The Board Did Not Err In Crediting The Testimony of Ho’s
Experts Over Furcht’s Experts ....................................................... 34
IV. The Board Correctly Found That Stem Cell Technology Was
Unpredictable in 1999-2000 ............................................................ 39
V. Substantial Evidence Supports The Board’s Finding That

The Furcht ‘037 Claims Are Not “Inherently” Described In
The Furcht Specification ................................................................. 43
A. Legal Standard for the Written Description

Requirement ........................................................................... 44
B. The Board Correctly Identified Significant Differences

Between the Methods Used in the Deans Experiments
and the Method Used in the Furcht Application .................. 46
C. The Board Did Not Misconstrue the Definition of “Co-

Express” .................................................................................. 53
VI. Substantial Evidence Supports The Board’s Finding That

The Furcht ‘118 Claims Do Not Satisfy The Written
Description Requirement ................................................................ 61
A. The Furcht Disclosure Does Not Demonstrate

Possession of the Broadly Claimed Cells .............................. 62
B. This Court’s Precedent Supports the Board’s Decision ........ 64
C. The Court Did Not Err Concerning the “Two Facts”

Identified by ABT ................................................................... 67
- iii -
VII. ABT’s Challenge To The Board’s Decision On The Furcht

‘256 Claims Repeats Its Factual Challenges And Should Be
Rejected For The Same Reasons ..................................................... 69
VIII. The Board Correctly Held That No Interference-In-Fact

Existed Between Any Furcht Claim And Any Ho Claim ............... 71
A. Legal Standard ....................................................................... 71
B. ABT’s Argument is Entirely Based on the Same

Arguments Concerning Written Description ........................ 72
IX. If The Court Remands, The Board Should Rule That The
Furcht Claims Are Not Enabled ..................................................... 73
X. Conclusion ........................................................................................ 73
CERTIFICATE OF COMPLIANCE
CERTIFICATE OF SERVICE
- iv -
TABLE OF AUTHORITIES
Page(s)
Cases
AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc.,

759 F.3d 1285 (Fed. Cir. 2014) ...................................................... 66, 67
Agilent Technologies, Inc. v. Affymetrix, Inc.,

567 F.3d 1366 (Fed. Cir. 2009) ...................................................... 53, 58
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co.,

598 F.3d 1336 (Fed. Cir. 2010) (en banc) ...................................... 64, 66
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,

776 F.2d 281 (Fed. Cir. 1985) .............................................................. 39
Bamberg v. Dalvey,
815 F.3d 793 (Fed. Cir. 2016) .............................................................. 31
Biogen Idec, Inc. v. GlaxoSmithKline LLC,

713 F.3d 1090 (Fed. Cir. 2013) ............................................................ 54
Biogen MA, Inc. v. Japanese Foundation for Cancer Research,

785 F.3d 648 (Fed. Cir. 2015) ................................................................ 3
Capon v. Eshhar,
418 F.3d 1349 (Fed. Cir. 2005) ............................................................ 65
Carnegie Mellon University v. Hoffmann-La Roche, Inc.,

541 F.3d 1115 (Fed. Cir. 2008) ................................................ 44, 65, 66
Chen v. Bouchard,
347 F.3d 1299 (Fed. Cir. 2003) ............................................................ 31
Consolidated Edison Co. v. NLRB,

305 U.S. 197 (1938) .............................................................................. 31
Consolo v. Federal Maritime Commission,

383 U.S. 607 (1966) ........................................................................ 31, 40
-v-
DeGeorge v. Bernier,
768 F.2d 1318 (Fed. Cir. 1985) ............................................................ 43
Dystar Textilfarben GmbH v. C.H. Patrick Co.,

464 F.3d 1356 (Fed. Cir. 2006) ............................................................ 32
Eli Lilly v. Board of Regents of the Univeristy of Washington,

334 F.3d 1264 (Fed. Cir. 2003) ............................................................ 72
Enzo Biochem, Inc. v. Calgene, Inc.,

188 F.3d 1362 (Fed. Cir. 1999) ............................................................ 42
Enzo Biochem, Inc. v. Gen-Probe Inc.,

323 F.3d 956 (Fed. Cir. 2002) .............................................................. 45
Fenner Investments, Ltd. v. Cellco Partnership,

778 F.3d 1320 (Fed. Cir. 2015) ............................................................ 54
Graham v John Deere Co.,

383 U.S. 1 (1966) .................................................................................. 32
Harari v. Lee,
656 F.3d 1331 (Fed. Cir. 2011) ...................................................... 31, 53
Hyatt v. Boone,
146 F.3d 1348 (Fed. Cir. 1998) ............................................................ 43
In re Alton,
76 F.3d 1168 (Fed. Cir. 1996) .............................................................. 45
In re Fisher,
427 F.2d 833 (C.C.P.A. 1970) ............................................................... 65
In re Gartside,
203 F.3d 1305 (Fed. Cir. 2000) ...................................................... 30, 32
In re Jolley,
308 F.3d 1317 (Fed. Cir. 2002) ............................................................ 31
In re Spina,
975 F.2d 854 (Fed. Cir. 1992) ........................................................ 53, 58
- vi -
Martin v. Mayer,
823 F.2d 500 (Fed. Cir. 1987) .............................................................. 43
Medichem, S.A. v. Rolabo, S.L.,

437 F3d 1157 (Fed. Cir. 2006) ............................................................. 72
Medichem, S.A. v. Rolabo, S.L.,

353 F.3d 928 (Fed. Cir. 2003) .............................................................. 72
Microsoft Corp. v. Proxyconn, Inc.,

789 F.3d 1292 (Fed. Cir. 2015) ............................................................ 54
Newell Cos., Inc. v. Kenney Manufacturing Co.,

864 F.2d 757 (Fed. Cir. 1988) .............................................................. 35
O’Reilly v. Morse,
56 U.S. (15 How.) 62 (1853) ................................................................. 44
Regents of the University of California v. Eli Lilly & Co.,

119 F.3d 1559 (Fed. Cir. 1997) ............................................................ 67
Sage Products, Inc. v. Devon Industries, Inc.,

126 F.3d 1420 (Fed. Cir. 1997) ............................................................ 38
University of Rochester v. G.D. Searle & Co.,

358 F.3d 916 (Fed. Cir. 2004) .............................................................. 45
Velander v. Garner,
348 F. 3d 1359 (Fed. Cir. 2003) ..................................................... 39, 47
Statutes
28 U.S.C. § 1631 .......................................................................................... 3
35 U.S.C. § 112 .................................................................................. passim
28 U.S.C. § 146 ............................................................................................ 3
Regulations
37 C.F.R. § 41.203(a) ................................................................................. 72
- vii -
Other Authorities
The Guidelines for Examination of Patent Applications under the 35

U.S.C. § 112, ¶ 1, “Written Description” Requirement,
66 Fed. Reg. 1099 (Jan. 5, 2001) .......................................................... 65
- viii -
STATEMENT OF RELATED CASES
Pursuant to Fed. Cir. R. 47.5, there are no related appeals, and
counsel is unaware of any cases that may be affected by this appeal.
STATEMENT OF THE ISSUES
1. Whether substantial evidence supports the Board’s
determination that the involved Furcht claims are not patentable
because the Furcht claims did not satisfy the written description
requirement of 35 U.S.C. § 112.
2. Whether the Board correctly decided that there was no
interference-in-fact when substantial evidence supports (a) the finding
that at least one Furcht claim does not anticipate at least one Ho claim
and (b) the legal conclusion that at least one Furcht claim does not
render at least one Ho claim obvious.
STATEMENT OF THE CASE

AND FACTUAL BACKGROUND
I. Procedural Background
This is an appeal from the final decision of the Patent Trial and
Appeal Board (“Board”), dated September 26, 2014, between senior
party Furcht and junior party Ho. Appx1-64. The Board’s final
judgment was entered the same day. Appx47-50.
-1-
The Board decided two of the three motions filed by Ho.1 First, Ho
filed a motion asserting that no interference-in-fact existed between any
Furcht claim and any Ho claim. Appx866-897. Second, Ho filed a
motion that all of Furcht’s involved claims were not patentable because
they failed to satisfy the written description and enablement
requirements of 35 U.S.C. § 112. Appx719-754. Furcht opposed the
motions but did not file any motions of its own. Appx907-988. Ho filed
replies. Appx1240-1342. Oral argument on the motions occurred on
July 30, 2014. Appx1387-1425.
On September 26, 2014, the Board ruled in favor of Ho on two
motions, finding that the Furcht claims were not supported by the
written description and that there was no interference-in-fact.
Appx1-50. The Board entered judgment against senior party Furcht
and ordered that the involved claims of the Furcht patents and
applications be cancelled or refused. Appx1-50. The Board did not rule
on whether the Furcht claims were adequately enabled under § 112.
Appx45.
1The Board dismissed as moot Ho Motion 3 seeking an order denying

priority benefit of the two Furcht provisional applications. Appx7.
-2-
After the final judgment, the senior party, ABT Holding Company
and Regents of the University of Minnesota (collectively “ABT”) filed a
civil action, pursuant to 35 U.S.C. § 146, in the United States District
Court for the District of Delaware. Appx1448. While that action was
pending, this Court decided Biogen MA, Inc. v. Japanese Foundation for
Cancer Research, 785 F.3d 648 (Fed. Cir. 2015), cert. denied, 136 S. Ct.
1450 (2016), which held that a civil action under 35 U.S.C. § 146 is not
available for an interference proceeding declared after September 15,
2012. After the Supreme Court declined to review Biogen, the trial
court granted Garnet BioTherapeutics, Inc.’s motion to dismiss. The
trial court transferred the case to this Court pursuant to 28 U.S.C.
§ 1631.
II. Factual Background
Garnet provides a concise counterstatement of the facts. ABT’s
opening Statement of the Facts contains assertions lacking citation to
the record and non-factual assertions that constitute attorney
argument. See, e.g., Appellant Br. 13 (“The Board erred in finding for
Ho.”).
-3-
A. The Basics of Stem Cell Technology
The present appeal relates to what are commonly referred to as
“stem cells.” Appx9-12; Appx2032-2977; Appx3493; Appx3602-3606.
The quintessential stem cell is the “embryonic stem cell,” which can
differentiate into every type of cell in the body, such as a skin cell,
muscle cell, or nerve cell, and in particular, cells of the three different
basic germ layers: ectoderm, endoderm, and mesoderm. Appx2970-
2972. Embryonic stem cells are isolated from an embryo during the
first few days of development. Appx3493. “As stem cells within a
developing human embryo differentiate in vivo, their capacity to
diversify generally becomes more limited and their ability to generate
many differentiated cell types generally becomes more restricted.”
Appx3493-3494.
Even in adulthood, the body contains adult “stem” cells of various
degrees of “pluripotency” or “multipotency.”2 Appx3402; Appx3605.
While the terminology used to describe stem cells is often imprecise,
under one definition, “[p]luripotent stems cells are capable to
differentiate into the three somatic germ layers that comprise an
2 Adult stem cells can also be referred to as adult progenitor cells.
-4-
organism: mesoderm (muscle, bone, etc.), ectoderm (neurons, skin, etc.),
and endoderm (hepatocytes, pancreatic beta cells, etc.), whereas
multipotent cells can differentiate only into cells of one tissue or germ
layer.” Appx3402; see also Appx3605; Appx3644-3645.
For example, a multipotent blood stem cell, called a hematopoietic
stem cell, can differentiate into various blood cells, such as red blood
cells and white blood cells, but not into brain cells, bone cells, or other
types of cells. Appx3022-3027; Appx3037-3043. Similarly,
mesenchymal stem cells (“MSCs”) are isolated from bone marrow and
can differentiate into bone cells (osteoblasts), cartilage cells
(chondrocytes), muscles cells (myocytes), and fat cells (adipocytes).
Appx1588; Appx2911-2922; Appx3015-3021.
-5-
Appx3016.
The various adult stem cells generally exist in the body in a
tissue-specific manner. In other words, an adult stem cell, such as a
mesenchymal stem cell (“MSC”), can be isolated from the bone marrow
and can differentiate into muscle cells but cannot differentiate into
brain or skin cells. Appx3022-3027; Appx3037-3107; Appx3274-3284.
Stem cells and multipotent progenitor cells have enormous
potential for scientific and medical uses. Appx108; Appx1549-1553;
Appx3028-3036. That greatest potential resides with embryonic stem
-6-
cells because they can differentiate into any type of adult cell.
Appx3492-3496.
The use of embryonic stem cells presents thorny ethical issues,
however. Appx2979-2988. In August 2001, President Bush addressed
the nation and restricted funding to established embryonic stem cell
lines. Appx3487-3489. That development increased the need for an
alternative to embryonic stem cells, and one alternative sought was an
adult cell capable of differentiating into multiple cell lines. In the years
preceding the President’s decision, researchers had been advancing
their efforts to identify the so-called “Holy Grail” of stem cells: non-
embryonic, or adult, stems cells, i.e., adult cells that had the same
differentiating ability as embryonic stem cells. Appx2945-2947.
B. Multipotent Progenitor Cells Are Characterized by

Particular Physical Features and the Methods Used to
Isolate and Culture the Cells
Multipotent stem cells are not characterized simply by observing
the cell features under a microscope, unlike other cells, such as muscle
or skin cells. Appx3016. Instead, multipotent progenitor cells are
characterized based on certain phenotypic characteristics, the methods
used to prepare the stem cell cultures, and the tissue source of the cells.
-7-
One important phenotypic characteristic is the identity of the
cellular proteins expressed by the particular cell population. Appx1528-
1529; Appx1603-1613; Appx3085. As Furcht points out in its opening
brief, the type of “stem cell” is reflected in the cell’s gene expression,
which in turn is often but not always reflected in the differential
expression of various proteins on a cell. Appellant Br. 6; see also
Appx1603-1613. The marker proteins (or epitopes) are designated
using various monikers such as CD34, CD44, CF45, HLA Class I,
CD49c, Muc18, and others. E.g., Appx214; Appx3085. Two marker
proteins of particular importance in this case are CD49c and CD90.
Appx52-56; Appx2369-2382.
While the precise roles of the various protein markers are not
always fully understood, Appx2921, it is understood that individual cell
populations having different protein expression profiles are not
identical cell populations. Appx2416-2438. For example, a cell
population in which 90 percent of cells express CD49c is different than
a cell population in which only 10 percent express CD49c. Appx2416-
2438.
-8-
A stem cell population is also characterized by the doubling rate of
the population. Appx2004-2005; Appx2423-2433. The doubling rate of
a cell population describes the time necessary for the population to
double in number, or size, and is expressed in hours. Appx1972-1981;
Appx2416-2438. The lower the doubling rate, the faster the particular
stem cells grow and divide. Appx2416-2438. The doubling rate is
important because stem cell populations that have different doubling
rates are likely expressing different proteins and are likely at different
stages of differentiation. Appx2911 (“[A]s cultures of the cells are
expanded under standard conditions, they lose their proliferative
capacity and their potential to differentiate into lineages such as
adipocytes and chrondocytes.”); Appx1973 (Dr. Phinney explaining that
“modifying the doubling rate of cells” can alter “the properties of the
cells themselves”).
In addition to protein expression profiles and doubling rate, adult
stem cells are often described according to the tissue source of the cells
and the methods used to isolate and culture the cells. As explained
below, the tissue source and the methods used will alter the identity of
the isolated and cultured stem cell population.
-9-
C. The Isolation and Culturing of Multipotent Progenitor Cells

are Difficult and Depend on the Tissue Source and the
Methods Used
Around 1999 to 2000, multipotent stem, or progenitor, cells were
notoriously difficult to characterize, isolate, and maintain in cell
culture. Appx2921 (noting “[t]he difficulties in expanding human MSCs
in culture are compounded by the fact that there is no consensus as to
the characteristic surface epitopes that can be used to identify the
cells”); Appx4030 (Dr. Deans agreeing with previous statement);
Appx2947-2948; Appx3077-3091.
The identity of the isolated cell population depends on the
particular conditions, protocols, and equipment used. Appx1984;
Appx3091 (“Basal nutrients, cell density, spatial organization and
mechanical forces, as well as growth factors and cytokines, appear to
have profound influences on differentiation of hMSCs.”); Appx3277;
Appx3607-3617; Appx4043. Indeed, “the methods used to isolate cells
reflect unique properties of the cell’s biology.” Appx1984; see also
Appx3391 (“Differences in the properties of MSCs also depend on the
site of tissue harvest, phenotypic and genotypic characteristics of the
- 10 -
donor and the isolation, and storage and expansions methods used.”);
Appx3274-3284.
Relevant parameters affecting the stem cell population include:
(1) oxygen content; (2) the cell culture medium; (3) the steps used to
process the cell tissue, including immunodepletion and centrifugation
step; (4) the type of vessel used to culture the cells; (5) cell density; and
(6) the tissue source of the cells. See Appx3936; Appx3607-3617.
The first important parameter is the oxygen content. Under
normal atmospheric conditions, oxygen is approximately 21% of the air.
Appx2422-2423; Appx2437. In contrast, stem cells in their native
environment may experience much lower levels of oxygen, such as 5%
oxygen. Appx1664. The difference in oxygen content is significant
because prolonged exposure to atmospheric oxygen can promote cell
damage, negatively affect growth and survival, and influence the
identity of the stem cell population that is isolated and cultured.
Appx1675-1677; Appx2437; Appx2926-2939. If a research publication is
silent on oxygen content, then the default condition is atmospheric
oxygen, or normoxia (21%), as opposed to 5% oxygen (“hypoxia”).
Appx4028.
- 11 -
The cell culture medium also affects the identity of the stem cell
population. Appx1675-1677; Appx2422-2423; Appx3391. When stem
cells are isolated and cultured outside the body, they are grown in a cell
culture medium that supplies the necessary nutrients and growth
factors. Appx2437; Appx2883-2910; Appx2925 (discussing growth
factors); Appx3123. The composition of the cell culture medium affects
the fate of the stem cells, similar to when stem cells develop in the
human body. Appx2925. In other words, stem cells grown in one
medium or exposed to one environment may become different than cells
grown in or exposed to a different medium or environment. Appx3607-
3617.
A third factor affecting the stem cell population is the method
used to harvest and process the tissue culture before isolating and
expanding the stem cells. Appx17-18; Appx2070-2073; Appx2422-2423;
Appx2369-2382. When bone marrow is used as a source for potential
stem cells, the biological material consists primarily of red blood cells,
not stem cells. Appx2435-2436; Appx3607. Processing steps, such as
Ficoll-Paque density gradient or ammonium chloride lysis, are used to
remove red blood cells and other unwanted material. Appx18;
- 12 -
Appx2070-2075. Immunodepletion can also remove cells of certain
known phenotypes. Appx18; Appx2960-2961. For instance, cells
expressing a specific protein marker, such as CD45, can be selectively
removed from the extract. Appx2960. These various steps are not
always used, and they lead to different results with different stem cell
populations. Appx18; Appx2070-2075; Appx2434-2436.
Fifth, the type of vessel in which stem cells are cultured can affect
the identity of the stem cell population obtained. Appx2422-2423. Two
common vessels used to isolate and culture stem cells are (1) the 96-well
plate and (2) the tissue culture flask. Appx2416. The two differ in
shape, size and surface area, which affect the type of cells grown and
isolated. Appx2416. Tissue culture flasks are generally used to grow a
large number of cells. Appx2416. The 96-well plate, in contrast, is
typically used to isolate a smaller number of specific cell
subpopulations. Appx2416.
A sixth factor affecting the stem cell culture is the cell culture
density. Appx4326. Cell culture density refers to the number of cells
that are initially added to a culture vessel with a defined surface area,
which determines whether the cells are densely packed or spread apart.
- 13 -
This parameter is very cell-type specific, as some cells thrive when they
are in close proximity to other cells, while others thrive with more
space. Cells grown at a density other than what is recommended can
alter their phenotype. Appx4318-4323 (discussing Appx3402-3417). It
is “common knowledge” that cells grown at different cell culture
densities will develop into different cell populations. Appx4116. This
occurs because stem cells are affected by proximity to other cells in
culture, and the secretion of factors by the cell population as a whole.
For example, one method for triggering multipotent cells to differentiate
and become another phenotype is to culture them at a much higher
density than used for growing or expanding them. Appx1554-1559.
Finally, the source of the tissue affects the types of stem cells
obtained. Appx2963; Appx3121-3139; Appx3141-3144. For example,
mesenchymal stem cells (MSCs) are generally obtained from bone
marrow but not from neuronal tissue. Appx3391 (“Difference in the
properties of MSCs also depend on the site of tissue harvest . . . .”).
In sum, a range of factors materially affect the isolation and
culturing of stem cells. Appx2941-2968. For this reason, stem cell
scientists describe stem cell populations in terms of both certain
- 14 -
physical features, such as protein markers and doubling rates, and the
conditions used to isolate and culture the cells. Appx3085.
D. Dr. Verfaille and Colleagues Report on the Isolation of a

Multipotent Adult Progenitor Cell (“MAPC”), But They Later
Retract One Publication Due To Falsified Data
Prior to 2002, adult stem (or progenitor) cells were understood to
have only limited ability to grow in culture and differentiate.
Appx2946. No one had identified an adult progenitor cell (or adult stem
cell) that could be grown and differentiated into cells of each of the
three germ layers. Appx2946 (Dr. Phinney describing the “Holy Grail”
of stem cell technology).
In 2002, Dr. Catherine Verfaille and her colleagues3 at the
University of Minnesota published a paper in Nature describing what
they termed “multipotent adult progenitor cells,” or “MAPCs” for short.4
Appx1644-1652. The Nature paper was among other Verfaille
publications, including reports in Blood and Experimental Hematology,
3Catherine Verfaille is one of the named inventors of the involved

Furcht patents and applications. Appx191.
4 MAPCs are also referred to as “multipotent adult stem cells,” or
“MASCs.” Appx4096-4097. Note that a MASC (or MAPC) is not the
same as a MSC (mesenchymal stem cell).
- 15 -
detailing their work on MAPCs. Appx1635-1643; Appx1653-1663;
Appx3206-3212.
Verfaille reported specific conditions for isolating the MAPCs.
Appx1635-1643. Verfaille also characterized the cells based on the
protein expression, such as specifying CD45 negative, but did not
identify CD49c or CD90 as potential protein markers. Appx1635-1643.
Verfaille’s other publications did not identify the MAPCs as co-
expressing greater than 91% of both CD49c and CD90. See Appx1635-
1663.
Not long after Verfaille’s publications, questions arose about the
accuracy and reproducibility of Verfaille’s research on MAPCs.
Appx1620-1634. Other scientists were having significant difficulty
reproducing the Verfaille’s research results. E.g., Appx1623 (“Everyone
can agree on one thing about Catherine Verfaille’s stem cells, known as
MAPCs: they are fiendishly difficult to work with.”); Appx3359
(observing that MAPCs “have proven difficult to isolate and culture”).
In addition to the lack of reproducibility, it was subsequently
learned that several figures and data in the publications had been
falsified or misrepresented. Appx1620-1629; Appx1997-1998;
- 16 -
Appx2412-2415; Appx2535-2540; Appx2955-2957; Appx3213-3229;
Appx3470-3472. As a consequence, the Nature paper was “corrected,”
and the Blood paper was retracted—a “significant event” for a scientist.
Appx1626; Appx3212; Appx4252.
Years later, Verfaille and her colleagues published additional
research that described different methods and conditions for isolating
the MAPCs. Appx3340-3365; Appx3418-3446. In one publication,
Verfaille explained that, “[s]ince 2003, culture conditions under which
rodent MAPCs are isolated have changed, including isolation and
maintenance at 5% oxygen, use of a different serum and maintenance at
higher cell densities for the first 4 weeks in culture, compared with the
previously described MAPCs.” Appx3341. In another article, Verfaille
reported using “low oxygen (O2) conditions,” different from their original
method. Appx3349 (“Since the initial description of MAPCs, we
improved MAPC isolation and expansion conditions.”). In 2001,
Verfaille further explained:
Major factors that play a role in successful maintenance of

MAPC include cell density, CO2 concentration and pH of the
medium, lot of fetal calf serum that is used, and even the
type of culture plastic that is used. Control of cell density
appears to be species specific . . . . The reason why MAPC
- 17 -
tend to differentiate to the default MSC lineage when

maintained at higher densities is not known.
Appx3788.
While the falsification of data was certainly extraordinary, the
events associated with Verfaille’s disclosure and subsequent
modification of the procedures were representative of the general
unpredictability in the field at the time. Appx2001-2002; Appx2947-
2948; Appx2955-2957; Appx4030. Scientists were “eager to isolate a
phenotypically well-defined cell population with broad plasticity, but
there were no standard protocols, and no guidance existing regarding
how to obtain this goal.” Appx2948. The data-falsification incident
involving Verfaille’s work contributed to the substantial
unpredictability in the field. Appx4348. A 2007 report concluded that
“[t]he discovery of more duplicated data is again casting a shadow over
‘versatile’ adult stem cells.” Appx1622.
E. Notwithstanding the Falsified Data, Verfaille and Her

Fellow Furcht Inventors Sought Broad Claims Covering
Their MAPCs
Notwithstanding the reproducibility issues and data falsification,
Verfaille and colleagues filed several patent applications directed to
their MAPCs. Appx191-447. Two applications eventually issued as the
- 18 -
Furcht ‘037 and ‘118 patents. Appx191-244; Appx393-447. The Furcht
specification provides a single example of isolating and culturing the
MAPCs. Appx220-221; Appx2948-2963. The Furcht method uses a cell
culture medium that requires supplemental growth factors for
maintaining proliferation of the stem cells derived from bone marrow.
Appx220, col. 17, table1. The Furcht specification further describes a
single method for isolating the claimed cells under standard, i.e.,
atmospheric, oxygen conditions. Appx2948-2955; Appx2958-2963.
“Standard conditions,” as explained above, means that the oxygen
content was approximately 21% (i.e., normoxia). Appx4028; Appx4109.
The Furcht specification also identifies the MAPCs according to
typical characteristics. The Furcht cells, after 10-12 cell doublings,
“stained positive with antibodies against CD10, CD13, CD49b, CDw90,
and Flk1.” Appx2953; Appx214, col.5, ll.60-67. Furcht also specified
that the cell population “has a doubling rate of about 36 hours.”
Appx243. Furcht’s cell population grows poorly and dies when seeded
at less than 500 cells/cm2. Appx219, col.15, ll.58-59.
- 19 -
F. Ho and His Colleagues File Patent Applications Directed to a

Different Stem Cell Population Co-Expressing CD49c and
CD90
Around the same time the Furcht patent family was filed, Tony
Ho and his colleagues at Neuronyx, Inc., later renamed Garnet
BioTherapeutics, Inc., filed applications (the ‘244 and ‘685 applications)
directed to a different adult stem cell population isolated from bone
marrow. Appx51-190. The stem cell populations described and claimed
in the Ho applications co-express greater than 91% CD49c and CD90.
Appx88-101.
The Ho applications provided detailed examples of how the
claimed cells are isolated and cultured. Appx75-88; Appx144-165. The
cells are described as being (a) negative for surface marker CD10, and
(b) positive for surface markers CD44, HLA-class 1 and beta
2-microglobulin. Appx2541-2573. Ho’s cells are cultured at 30 cells/cm2
and thrive. Appx77-78; Appx2437.
Unlike the Furcht specification, the Ho applications describe cells
that are grown without the use of supplemental growth factors.
Appx2422-2423. Also in contrast to the Furcht specification, the
- 20 -
method for growing the Ho cells uses 5% oxygen, whereas Furcht uses
21% oxygen. Appx2422-2423; Appx2437.
G. After Repeated Attempts by Furcht, the Board Declares an

Interference Between Ho and Furcht
Although the specifications and the claims of Ho’s applications
differed from Furcht’s applications and claims, Furcht repeatedly
attempted to initiate an interference between the parties. Appx2593-
2605; Appx2660-2661; Appx3222-3229. For instance, after Ho paid the
‘244 application’s issue fee in February 2005, Furcht amended its claims
in the application that later issued as the ‘037 patent to include the new
limitation that the cells co-express CD49c and CD90, even though the
limitation is not described in Furcht’s specification. Appx2423-2437.
Simultaneously, Furcht requested an interference with Ho’s ’244
application. Appx2593-2605. The PTO declined to declare the
interference and instead allowed the ‘037 patent to issue, continuing
examination of Ho’s ‘244 application. Appx2662-2674.
Ho’s ‘244 application subsequently overcame anticipation and
obviousness rejections based on Furcht’s ‘037 patent. Appx2606-2661.
The examiner ultimately concluded that the claimed CD49c/CD90 stem
- 21 -
cell population in Ho’s application was not anticipated or obvious in
view of Furcht’s ‘037 patent. Appx2606-2661.
Ho appealed to the Board separate rejections in the ’244
application (along with rejections in Ho’s ‘685 application). Appx2606-
2661. The Board reversed the rejections, the claims were soon in
condition for allowance, but the examiner withheld the issuance after
communications from Furcht’s representatives. Appx2660-2661. A
notice of allowance subsequently issued in each of Ho’s applications.
Appx2662-2674; see also Appx2587-2592.
Before issuance, however, Furcht filed a notice of interfering
subject matter in its ‘256 application. Appx2593-2605. Along with each
interference request, Furcht included a declaration from Robert J.
Deans. Appx2459-2496 (collectively “the Deans Declarations”). The
Deans Declarations described two sets of experiments (“the Deans
Experiments”) which purported to demonstrate that the stem cell
population made according to the single method in the Furcht
specification is the same as the cell stem population claimed in Ho’s
applications. Appx2459-2496. Although Dr. Deans (or his colleagues)
had made stem cells according to the Furcht method, the Deans
- 22 -
Declarations do not include those results. Appx2459-2496; Appx 4116-
4117. Instead, the Deans Declaration used different methods.
Appx2959-2961. Dr. Deans later contended that “[i]t was not necessary
or logical to” include results based on the Furcht method, even though
the purpose of the Deans Declarations was to prove that the Furcht
cells were the same as the Ho cells. Appx 4116-4117.
In response to the Deans Declarations, Ho filed a declaration (“the
Kopen Declaration”) from Dr. Gene Kopen, one of the inventors of the
Ho applications. Appx2541-2573. Dr. Kopen provided a detailed
explanation of why the cells in the ‘244 application are not the same as
the cells in the Furcht ‘037 patent. Appx2543-2564. After Furcht’s
second attempt, the PTO instituted the interference proceeding that is
the basis of the present appeal. Appx456-463.
H. The Board Rules in Favor of Ho on the Motions of No

Interference-in-Fact and Lack of Written Description
The Board instituted the interference proceeding based on one
count, which was an alternative of claim 1 of the Furcht ‘118 patent,
claim 124 of the Furcht ‘256 application, claim 1 of the Furcht ‘037
patent, claim 1 of the Ho ‘685 application, or claim 14 of Ho ‘244
application. Appx456-463. These claims read as follows:
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Claim 1 (Furcht ‘118 patent): A cell culture comprising

isolated expanded human multipotent, nonembryonic, non-
germ cells that can differentiate into at least one cell type of
each of the endodermal, ectodermal, and mesodermal
embryonic lineages and express telomerase, said cells having
undergone at least 10-40 cell doublings in culture.
Claim 124 (Furcht ‘256 application): A human cell

population that has undergone 22 cell doublings in culture
that expresses CD90 and CD49c and one or more of sox-9,
sox-11, hox-A5, and MSX-1.
Claim 1 (Furcht ‘037 patent): An isolated cell population

derived from human bone marrow, wherein the cells of the
cell population co-express CD49c and CD90, and wherein the
cell population has a doubling rate of about 36 hours.
Claim 1 (Ho ‘685 application): An isolated cell population

induced to express at least one cardiac-related transcription
factor, wherein the cell population is derived from bone
marrow, wherein greater than about 91% of the cells of the
cell population co-express CD49c and CD90, and wherein the
cell population is capable of maintaining a doubling rate of
less than about 30 hours after 30 cell doublings.
Claim 14 (Ho ‘244 application): An isolated cell population

derived from human bone marrow, wherein greater than
about 91% of the cells of the cell population co-express
CD49c and CD90, and wherein the cell population maintains
a doubling rate of less than about 30 hours after 30 cell
doublings.
Appx4-6.
During the interference proceeding, each party presented
testimony from expert witnesses, which the Board fully considered. See
Appx9-12. Ho filed two declarations from Dr. Donald Phinney.
- 24 -
Appx2416-2438; Appx2940-2968. Furcht submitted one declaration
from Dr. Armand Keating. Appx2383-2411. The parties also relied on
the Deans Declarations and the Kopen Declaration. Appx2459-2496;
Appx2541-2573. Each witness was subject to cross-examination.
Appx1834-1862 (Phinney); Appx1863-2032 (Kopen); Appx3925-4161
(Deans); Appx4162-4434 (Keating).
After briefing and oral hearing, the Board ruled that the Furcht
claims were not patentable because they were not adequately supported
under 35 U.S.C. § 112. Appx25-33. The Board also ruled that there
was no interference-in-fact. Appx33-44. The Board did not reach the
issues of whether the Furcht claims were enabled under § 112 and the
issue of doubling rate. Appx47-50.
The Board ruled that Furcht had failed to demonstrate that over
91% of the cells of the Furcht specification co-express CD49c and CD90.
Appx16. The Deans Declarations—offered as proof of interfering
subject matter—did did not provide evidence of the stem cells disclosed
in the Furcht application and thus did not establish written description
support for the CD49c/CD90 limitation. Appx16-24.
- 25 -
The Board first recognized that the Furcht specification does not
“explicitly describe[] a product wherein greater than about 91% of the
cells of the cell population co-express CD49c and CD90.” Appx22.
Thus, there was no express written description to support the Furcht
‘037 claims. Appx22. Next, the Board turned to whether the Furcht
disclosure inherently described cells that co-express CD49c and CD90
over 91%. Id. The Board concluded in the negative. Id.
Here, the Board considered the detailed testimony of the expert
witnesses. The Board found the “testimony by Dr. Phinney and Dr.
Kopen (albeit a named inventor) to be highly credible.” Appx22. The
Board also determined that the Deans Experiments were not
representative of the cells described in the Furcht specification because
there were at least five differences, or variations, between the Deans
Experiments and the Furcht example. Appx22-24.
The Board found that there was a “different means . . . used to
remove the red blood cells.” Id. There was also “a difference in medium
used to culture cells,” and the Board had “not been told why use of
medium ‘one’ in place of medium ‘two’ would produce the same results.”
Id. (emphasis in original). The Board also noted that there was a
- 26 -
difference in oxygen content, observing that Furcht had not established
that “a test at 5% oxygen will yield the same result as a test at ~20%
oxygen.” Appx23. The Board also agreed that the differences in the
immunodepletion step and the type of culturing vessel were significant
for the reasons given by Ho’s witnesses. Appx24. In view of the
material differences, the Board ruled that the evidence did not
demonstrate that the cells described in the Furcht application actually
express both CD49c and CD90 over 91%. Appx16.
The Board also ruled that the claims of the Furcht ‘118 patent
were not adequately supported by the written description. Appx28-33.
The Board held that “Furcht ‘118 claim 1 is broad enough to include cell
cultures isolated from” marrow, liver, or brain, and that the
specification did not provide adequate working examples to support
such a broad claim in stem cell technology, which “was in its infancy
and was highly unpredictable.” Appx29-30.
The Board also found that claim 124 of the Furcht ‘256 application
lacks a written description. Appx33. The Board observed that Furcht’s
opposition was “essentially the same as its opposition with respect to
- 27 -
Furcht ‘037 claim 1” and thus ruled in favor of Ho for the same reasons.
Appx33.
Finally, the Board held that there was no interference-in-fact
between any Furcht claim and any Ho claim. Appx33-44. The Board
again detailed the substantial differences between the claimed subject
matter, as well as the deficiencies in Furcht’s evidence. Appx33-44.
SUMMARY OF THE ARGUMENT
ABT rests its appeal primarily on challenges to the Board’s fact
findings. ABT’s challenges should be rejected because, based on the
extensive evidentiary record, substantial evidence supports the Board’s
decision.
First, substantial evidence supports the Board’s decision about the
level of skill in the art. The Board found little difference between the
definitions offered by Dr. Phinney and Dr. Keating. Even if there were
a difference, ABT never explains how the purported “critical” error
demonstrates reversible error.
Second, substantial evidence supports the Board’s finding that
stem cell technology was an unpredictable art during the relevant time.
Dr. Phinney’s testimony directly addressed the unpredictability.
- 28 -
Numerous references describe the uncertainty about the techniques
used for stem cell isolation and culturing. Even publications by
Furcht’s inventors and experts evince the unpredictability. The
incident concerning falsified data epitomized the need for detailed
guidance due to the uncertainty in stem cell science at the time.
Third, substantial evidence supports the Board’s decision to give
more credit to the testimony of Garnet’s experts over ABT’s experts.
ABT’s expert Dr. Keating acknowledged a lack of unfamiliarity with
important facts relating to the issues. Additionally, his declaration was
conclusory and lacked documentary support.
Fourth, substantial evidence supports the Board’s decision that
the claims of the Furcht ‘037 patent are not adequately described.
During the interference, ABT attempted to establish inherent written
description for a stem cell population co-expressing CD49c and CD90 by
relying on the Deans Experiments. As the Board found, however, the
stem cells produced by Deans Experiments were not representative of
the stem cells disclosed in the Furcht specification.
Fifth, substantial evidence supports the Board’s decision that the
broad generic claims of the Furcht ‘118 patent are not adequately
- 29 -
described. The ‘118 patent attempts to claim a stem cell population
that can be obtained from almost any type of human cell and that has
the ability to differentiate into almost any type of human cell. The
Board correctly found that the single example provided in the ‘037
specification was not an adequate written description under 35 U.S.C.
§ 112. The extensive factual record includes substantial evidence to
support the Board’s finding.
Sixth, ABT’s challenge regarding the Furcht ‘256 application
merely repeats its earlier disagreements with the Board’s factual
findings. ABT’s challenge should be rejected for the same reasons.
Finally, ABT’s appeal of the Board’s decision concerning no
interference-in-fact is entirely dependent on ABT’s arguments
concerning written description. The Board’s decision therefore should
be affirmed for the same reasons.
ARGUMENT
I. Standard Of Review
The Board’s factual findings are reviewed under the deferential
substantial evidence standard. In re Gartside, 203 F.3d 1305, 1311
(Fed. Cir. 2000). Whether the written description requirement is met is
- 30 -
a question of fact, reviewed by this Court for substantial evidence.
Bamberg v. Dalvey, 815 F.3d 793, 797 (Fed. Cir. 2016); Harari v. Lee,
656 F.3d 1331, 1340 (Fed. Cir. 2011); Chen v. Bouchard, 347 F.3d 1299,
1304 (Fed. Cir. 2003).
Substantial evidence “means such relevant evidence as a
reasonable mind might accept as adequate to support a conclusion.”
Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). “[T]he
possibility of drawing two inconsistent conclusions from the evidence”
will not render the Board’s findings unsupported by substantial
evidence. See Consolo v. Fed. Mar. Comm’n, 383 U.S. 607, 620 (1966).
If the evidence supports more than one reasonable but contradictory
conclusion, the Board’s decision will not be overturned merely because
the Board opted for one reasonable finding over a different reasonable
finding. In re Jolley, 308 F.3d 1317, 1320 (Fed. Cir. 2002).
II. The Board Did Not Adopt Or Rely On An “Improper” Definition Of

The Level Of Ordinary Skill In The Art
On appeal, ABT first contends that the Board adopted an
“improper” definition of the level of ordinary skill in the art. Appellant
Br. 25-26. ABT’s arguments are misplaced, and they offer no basis for
reversal.
- 31 -
First, the question of the level of ordinary skill in the art is a
question of fact. See, e.g., Graham v John Deere Co., 383 U.S. 1, 17
(1966); Dystar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356,
1360 (Fed. Cir. 2006). Thus, the Board’s finding must be sustained if
the record contains substantial evidence. Gartside, 203 F.3d at 1311.
In its brief, ABT does not state that the Board’s factual
determination on the level of ordinary skill is unsupported by
substantial evidence. See Appellant Br. 25-26. ABT merely argues that
“Furcht’s experts submitted that the level of skill in the art was quite
high, whilst Ho’s experts argued that the level of skill was rather low.”
Appellant Br. 16. Furcht further contends there was a “more
appropriate definition of one or ordinary skill in the art.” Appellant Br.
26. The existence of an alternative, “more appropriate” fact-finding
does not mean the Board’s factual conclusion lacks substantial evidence.
Importantly, there is no meaningful distinction between the two
definitions. The two experts’ definitions, in the Board’s view, did not
“differ all that much when defining the level of skill in the art.”
Appx13. Both Dr. Phinney and Dr. Keating required the person of
ordinary skill in the art to have a Ph.D. in biology or a related
- 32 -
discipline. Appx12. Both experts required the person of ordinary skill
to have advanced technical knowledge about culturing stem cells and
experience characterizing stem cells. Appx12.
ABT is incorrect when it argues that Dr. Phinney’s definition does
“not even requir[e] experience with stem cell cultures.” Appellant Br.
26. The Board expressly rejected this argument. Appx13 (“Dr. Phinney
includes within the skill of the art an ability to perform routine [tasks]
based on the knowledge that existed with respect to culturing stem
cells.”). Dr. Phinney required that the person of ordinary skill “would
have been able to perform routine trouble shooting tasks based on the
knowledge that existed at the time with respect to culturing stem cells
or other primary mammalian cells, and have a basic understanding of
[the] method used to characterize the physical and biological properties
of mammalian stem cells.” Appx12. Dr. Phinney’s extensive experience
with stem cells gives him significant familiarity with what a person of
ordinary skill in the art would know. See Appx2439-2458.
Even if there were a meaningful difference between the two
definitions, ABT does not demonstrate any harmful error based on the
purported incorrect level of skill in the art. ABT only generally claims
- 33 -
that “[t]he Board’s erroneous finding regarding the skill in the art
tainted all of its subsequent findings as to written description and
interference-in-fact.” Appellant Br. 18. ABT does not explain with any
specificity how any purported difference between the definitions of the
level of skill caused the Board to reach an incorrect legal decision or an
unsupported factual finding. ABT’s generalized complaint is not
sufficient to demonstrate a reversible error in the Board’s factual
findings or legal holding. The Board explained that, in the experts’
testimony, “reference is made to scientific documents supporting their
respective positions” and “[t]hose document[s] facially provide sufficient
evidence revealing what one skilled in the art would have known.”
Appx13.
In sum, while ABT asserts that “[t]he level of ordinary skill in the
art is critical to the case,” Appellant Br. 25, ABT does not articulate the
alleged criticality. The Board’s decision concerning level of skill in the
art is correct and is supported by substantial evidence.
III. The Board Did Not Err In Crediting The Testimony of Ho’s
Experts Over Furcht’s Experts
Furcht next argues that the Board credited the testimony of Ho’s
experts over that of Furcht’s experts. See, e.g., Appellant Br. 14, 16-17.
- 34 -
To the extent the Board weighed the expert testimony, the Board did
not err. See Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 787-88
(Fed. Cir. 1988) (“Determining the weight and credibility of the
evidence is the special province of the trier of fact.”) Furcht also does
not explain how any purported error here requires reversal.
Cross-examination of Furcht’s primary expert witness, Dr.
Armand Keating, revealed significant weaknesses in his testimony. See
Appx3925-4162. Dr. Keating exhibited limited knowledge about the
subject matter of the Furcht patent, which are purportedly MAPCs:
Q. Getting back to the topic of MAPCs, do you know whether

there are different types of MAPCs?
A. I do not know the answer to whether or not there are

different types of MAPCs.
Appx4191-4192. He also did not know significant details about the
development of MAPCs:
Q. Okay. I’m not an expert in this area, so I might be using

the wrong terminology, but does a does an embryonic stem
cell turn directly into a MAPC?
A. I do not know the answer to if an embryonic stem cell

turns into a MAPC.
Appx4191-4192.
- 35 -
Dr. Keating acknowledged that he read only “[o]ccasional articles
with respect to MAPC research,” he never published articles directed to
MAPCs, and he had never grown or isolated MAPCs in his lab.
Appx4259; Appx4193; Appx4265 (“no personal experience” with
MAPCs). He did not know whether MAPCs “exist in the human body
and are isolated through a particular process.” Appx4272.
Dr. Keating also stated that he was “not aware of any literature
that addresses the issue of atmosphere on cell surface antigen
expression, cell surface protein expression.” Appx4196. Yet, numerous
articles in the field detailed the effect of oxygen content in the
atmosphere to the effect on protein expression, even his own. See
Appx3396 (article listing Dr. Keating and Dr. Deans as authors:
“[m]aintaining a hypoxic environment” is an important parameter for
culturing stem cells); Appx3374 (article by Dr. Keating identifying
“oxygen tension” as one of several factors affecting the stem cell
manufacturing process); see also Appx4273-4299.
Dr. Keating’s cross-examination revealed significant gaps in his
knowledge about the cell surface proteins that are purportedly
indicative of MAPCs.
- 36 -
Q. Right. Okay. Do you know what CD13 does? It’s listed in

the “Cell surface phenotype.”
A. I would have to familiarize myself with CD13.
Q. Do you know what CD73 does?
A. I’m familiar with CD73, but I not sure I really understand

its role.
Q. Okay. And can you tell me anything about CD146 with

respect to MAPCs?
A. I’m not sure that I’m able to do that. It is considered a

marker of stromal cells.
Appx4257. He did not know whether CD90w is the same as CD90.
Appx4325. These proteins were identified as potential markers for
various stem cells. See Appx2955.
Dr. Keating was also unaware that Verfaille’s Blood paper had
been retracted due to the falsified data. Appx4249; Appx4357-4363.5
He did not know whether any other scientific group was able to
replicate Dr. Verfaille’s research. Appx4261-4262. His lack of
knowledge is important because it directly addresses the question of
whether a person of ordinary skill in the art would view stem cell
technology as unpredictable. Dr. Keating was simply unaware of key
5 The copy of the Blood article Furcht submitted as an exhibit,

Appx1653-1663, omits the notice of retraction, which is in the copy
submitted by Ho, Appx3200-3212.
- 37 -
information that corroborated the high level of unpredictability in the
stem cell field.
Similarly, Dr. Deans, who testified on behalf of Furcht, was
evasive in response to numerous questions. Appx4045 (being unable to
explain what he meant by “reasonably expected”); Appx4036-4040;
Appx4092-4093. Dr. Deans appeared insufficiently prepared for his
cross-examination; he stated that he had not reviewed “in scientific
detail” certain of cited exhibits prior to his cross-examination.
Appx4050; Appx4096 (responding that it would take Dr. Deans a
“significant block of time” to read the ‘037 patent and determine
whether the Furcht method uses a T75 flask).
Finally, in its opening brief, ABT offers no reason to discredit the
testimony of Garnet’s experts. The testimony of Dr. Phinney and Dr.
Kopen was highly credible, and ABT cannot challenge their testimony
for the first time in its reply brief. See, e.g., Sage Prods., Inc. v. Devon
Indus., Inc., 126 F.3d 1420, 1426 (Fed. Cir. 1997) (“With a few notable
exceptions, such as some jurisdictional matters, appellate courts do not
consider a party’s new theories, lodged first on appeal.”).
- 38 -
Based on the testimony as a whole, the Board acted well within its
discretion to credit the testimony of Garnet’s experts over ABT’s
experts. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003)
(“In giving more weight to prior publications than to subsequent
conclusory statements by experts, the Board acted well within that
discretion.”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776
F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert
opinion going to factual determinations, however, may render the
testimony of little probative value in a validity determination.”).
IV. The Board Correctly Found That Stem Cell Technology Was
Unpredictable in 1999-2000
ABT next advances general disputes about the Board’s findings on
the state of the art. See Appellant Br. 26-28, 41-44. ABT’s complaints
are linked to its challenge to both the written description and no
interference-in-fact issues. ABT’s complaints have no merit because the
evidence demonstrates unpredictability.
ABT’s primary argument on appeal is that the Board purportedly
made “erroneous findings regarding the state of the art.” Appellant
Br. 41. As ABT notes, the Board found that the “state of the art of the
claimed inventions was ‘a rapidly evolving field full of uncertainties,’
- 39 -
and ‘in its infancy and . . . highly unpredictable.’” Appellant Br. 42
(citing Appx29-30).
ABT expressly reverses the correct inquiry. ABT argues that,
“despite substantial evidence to the contrary,” the Board found
unpredictability with the mouse model. Appellant Br. 42 (citing
Appx31). The existence of “substantial evidence to the contrary” is not
dispositive. The pertinent question is whether substantial evidence
supports the Board’s findings. ABT can prevail only by showing a lack
of substantial evidence supporting those findings. See Consolo, 383
U.S. at 620. For the most part, ABT simply fails to contend that the
Board’s findings lack substantial evidence support.
Importantly, the record is replete with evidence about the
unpredictability of stem cell research during the relevant time period of
1999-2000 and beyond. Dr. Phinney explained that the state of the art
at the relevant time period was extremely unpredictable. Appx2945
(“In 1999 and 2000 stem cell research was a rapidly evolving field with
many uncertainties that gave rise to intense debate among scientists.”);
Appx2948 (“[C]ell culture methods were highly unpredictable in the
hands of an ordinarily skilled artisan.”); Appx2947 (“In 1999 and 2000
- 40 -
MSCs were not well defined with regard to phenotype and function.”).
Even a 2014 article co-authored by Furcht’s experts Dr. Keating and
Dr. Dean explains that “[p]ersistent issues include the definition of a
MSC and comparability between MSC preparations.” Appx3391. ABT
does not address this evidence on appeal.
Dr. Keating’s testimony is not to the contrary. If anything, Dr.
Keating’s uncertainty in answering many questions during his cross-
examination only underscores the unpredictability in the art. He did
not know, for example, that Dr. Verfaille had to change experimental
conditions over the years in order to isolate the MAPCs. Appx4254-
4255.
ABT also makes little reference to the data falsification associated
with Verfaille’s MAPC work. The data falsification and the errors
associated with publications and patent applications illustrate the
uncertainty in the stem cell field. Appx2957 (“Those working in the
field in 1999-2000 would consider such falsification to significantly
harm the credibility of the inventors with regard to the reproducibility
and validity of the experiments, Examples and supporting figures set
forth in the ‘037 patent.”). ABT’s expert Dr. Keating acknowledged
- 41 -
that, because of the falsification of data, “there might be additional
skepticism” by a stem cell scientist. Appx4348. The continued
problems experienced by Verfaille and others in isolating the MAPCs,
which are the cells in the Furcht specification, constitute substantial
evidence that the field was unpredictable in 1999. See Enzo Biochem,
Inc. v. Calgene, Inc., 188 F.3d 1362, 1372 (Fed. Cir. 1999).
ABT also argues that the unpredictability in the art was limited to
“the culture conditions required to cause the stem cells to differentiate
into various downstream lineages, and not to the culture conditions
required to obtain the stem cells.” Appellant Br. 42. ABT does not
support its contention with any citation to the record evidence. See id.
Regardless, it is not correct because the evidence demonstrates general
unpredictability.
The only specific argument ABT asserts—again without any
citation to record evidence—is that the Board’s reliance on a 1997
article by Brewer, Appx3108-3120, is not reflective of the state of the
art two years later, in 1999. See Appellant Br. 43. The two-year
difference is of no consequence because the evidence of record shows
significant unpredictability both before and after the relevant time
- 42 -
period. Appx2945-2950 (citing Appx3108-3172); Appx3044-3107;
Appx3793 (Verfaille in 2004: “Currently we do not fully understand the
mechanism(s) underlying the culture selection of MAPC.”).
Accordingly, the Board’s finding that stem cell technology was
unpredictable in 1999 finds support in substantial evidence, and ABT
does not identify any basis to disturb this finding.
V. Substantial Evidence Supports The Board’s Finding That The

Furcht ‘037 Claims Are Not “Inherently” Described In The Furcht
Specification
The specification of Furcht’s 037 patent does not expressly
describe the limitation that the stem cells co-express greater than 91%
CD49c and CD90. Thus, the issue in dispute is whether Furcht has met
its burden in proving that its specification inherently describes the “co-
express” limitation Furcht copied from the Ho applications. Hyatt v.
Boone, 146 F.3d 1348, 1353-54 (Fed. Cir. 1998); Martin v. Mayer, 823
F.2d 500, 505 (Fed. Cir. 1987); DeGeorge v. Bernier, 768 F.2d 1318,
1321 (Fed. Cir. 1985) (“[T]he party copying the claims . . . had the
burden of persuasion on the right to make the counts which had to be
met before an interference could properly be declared.”).
- 43 -
ABT advances four general arguments as to why the Board’s
decision on “inherent written description” of the ’037 patent claims is
allegedly erroneous. Appellant Br. 23-41. First, ABT argues that the
Board erred concerning the level of skill in the art. Id. at 25-26.
Second, ABT argues that the Board’s decision concerning the
unpredictability in the art is wrong. Id. at 26-28. Third, ABT argues
the Board misconstrued the meaning of “co-express.” Id. at 28-34.
Fourth, ABT disagrees with the Board’s findings concerning the
differences between the Deans Experiments and the Furcht application
method. Id. at 35-41. The first two arguments should be rejected for
the reasons presented above. The second two arguments should be
rejected for the reasons presented below.
A. Legal Standard for the Written Description Requirement
“The basic function of a patent specification is to disclose an
invention.” Carnegie Mellon Univ. v. Hoffmann-La Roche, Inc., 541
F.3d 1115, 1122 (Fed. Cir. 2008). A patentee “can lawfully claim only
what he has invented and described, and if he claims more his patent is
void.” O’Reilly v. Morse, 56 U.S. (15 How.) 62, 121 (1853).
- 44 -
The written description’s purpose is to serve as a quid pro quo
through “which the public is given ‘meaningful disclosure in exchange
for being excluded from practicing the invention for a limited period of
time.’” Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922
(Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d
956, 970 (Fed. Cir. 2002)).
A patent “does not have to utilize any particular form of disclosure
to describe the subject matter claimed, but the description must clearly
allow persons of ordinary skill in the art to recognize that he or she
invented what is claimed.” In re Alton, 76 F.3d 1168, 1172 (Fed. Cir.
1996) (quotations omitted). The applicant must “convey with
reasonable clarity to those skilled in the art that, as of the filing date
sought, he or she was in possession of the invention.” Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1564 (Fed. Cir. 1991); Univ. of Rochester, 358
F.3d at 926 (“The specification must teach the invention by describing
it.”).
In sum, the written description requirement ensures that the
inventor has actually invented what he or she has claimed. When broad
claims are presented in unpredictable arts, such as stem cell
- 45 -
technology, the claims must be supported by adequate examples—not a
single example—in order to satisfy the written description requirement.
B. The Board Correctly Identified Significant Differences

Between the Methods Used in the Deans Experiments and
the Method Used in the Furcht Application
The Board found five significant differences between the methods
used in the Deans Experiments and the method used in the Furcht ‘037
patent to produce the respective stem cell populations. Appx15-24.
Because of these differences, the stem cell populations produced by the
Deans Experiments was not the same as described and made in the
Furcht specification. Appx25-28; Appx2961. These findings are fully
supported, and ABT has not shown the absence of substantial evidence.
First, the Board correctly found that removing red blood cells from
the culture by Ficoll-Paque, as used in Furcht Example 1, is
significantly different than using an ammonium chloride process, as
described in the Ho applications. Appx17-18. The record evidence
confirms that the identity, e.g., protein expression, of the stem cell
population is highly dependent on whether and how red blood cells are
removed. Appx2960; Appx2949-2954. Dr. Phinney’s testimony detailed
the difference between the Deans Experiments and the Furcht example,
- 46 -
explaining that the Deans Declarations were silent on this step.
Appx2960 (“omitting the negative selection step, which removes 99.90-
99.95% of the original bone marrow cells”). Thus, “[a]ny conclusions
regarding the co-expression of CD49c and CD90 on the cells made by
the methods of the Deans Declaration or the second Deans Declaration .
. . would have no bearing on whether the cells made using the methods
disclosed in the ‘037 patent claims had such expression.” Appx2961.
In contrast, Dr. Keating’s testimony was conclusory and without
explanation. He merely stated in his declaration: “Removing red blood
cells from the culture: The choice of using Ficoll-Paque gradient
centrifugation, Histopaque separation or lysis (ammonium chloride)
would not be expected to produce significantly different results.”
Appx2395. An expert’s bare statement cannot overcome the weight of
the evidence demonstrating that the method of removing blood cells will
significantly affect the stem cell population. See Velander, 348 F.3d at
1371 (“In giving more weight to prior publications than to subsequent
conclusory statements by experts, the Board acted well within that
discretion.”).
- 47 -
Second, the Board correctly found that removing CD45-positive
cells, as described in the Furcht Example 1, is significantly different
than what was done in the Deans Experiments. Appx18. Again,
Dr. Phinney detailed this particular difference. Appx2422-2423;
Appx2961. He also explained the importance of this difference during
his cross-examination. Appx1984-1985.
ABT alleges only that “the Board failed to consider Dr. Keating’s
reference to a publication by Baddoo.” Appellant Br. 36 (citing
Appx1588-1602). Nothing indicates that the Board ignored the
testimony or the cited reference. Dr. Keating’s testimony adds little, as
he merely referred to Baddoo in a single sentence, stating that Badoo
“shows that all of immunodepletion, ammonium chloride lysis and Ficoll
gradient separation can be used to enrich CFU-F and deplete
hematopoietic progenitors.” Appx2395. The issue is not whether the
three procedures can be used but whether the three procedures yield
different results. ABT does not contend that Dr. Keating testified that
the methods are equivalent.
Third, the Board correctly concluded that the composition of the
cell culture medium would significantly affect the identity of the stem
- 48 -
cell population. Appx19. Dr. Phinney explained that the composition of
the cell culture medium is important and that the cell culture media
differed significantly between the Deans Experiments and the Furcht
example. Appx2960-2961; Appx1985-1985; Appx4102-4108. In the
second Deans Declaration, Dr. Deans used a cell culture medium of
unknown composition. Appx2960; Appx4099-4102.
Numerous references detail the effect of cell culture medium on
the identify of progenitor cell populations. E.g., Appx2958-2963. ABT
does not address this evidence in its brief.
Fourth, the Board correctly found that there was a significant
difference between the 5%-oxygen condition used in the Deans
Declarations and the 21%-oxygen used in Furcht Example 1. The
record is replete with testimony and documents establishing that the
difference in oxygen content for culturing stem cells will significantly
affect the identity and protein makeup of the cell. See, e.g., Appx3287;
Appx4273-4299 (discussing Appx1664-1670, Appx1684-1692, Appx1703-
1714, Appx1721-1739). ABT again does not address the multiple
references supporting the finding that oxygen levels affect the identity
of the stem cells and the expression of cellular proteins.
- 49 -
ABT’s misplaced argument is revealed by its statement: “Dr.
Deans showed that when the Furcht cells were grown under low oxygen
conditions . . . .” Appellant Br. 38. ABT’s statement reveals its error;
Dr. Deans never grew the Furcht cells because it used a different
oxygen level. During his cross-examination, Dr. Deans acknowledged
that oxygen content can change protein expression on stem cells.
Appx4023; see also Appx4047-4049; Appx-4056-4065 (discussing
Appx1684-1692 and Appx1703-1714); Appx4067-4076 (discussing
Appx1715-1752); Appx4083-4085 (discussing Appx1797-1810);
Appx4087-4092 (discussing Appx3285-3296). The evidence establishes
that oxygen levels alter a stem cell’s expression of cellular proteins,
including CD49c and CD90. Appx22-23.
Fifth, the Board correctly found that significant differences
existed because the Deans Experiments used a T75 flask, while the
Furcht Example 1 used a 96-well plate. Appx21; Appx24. The evidence
described the significant differences one would expect in stem cell
populations based on the type of vessel used. Appx2960-2961.
Dr. Phinney testified about these differences during his cross-
examination. Appx1984-1985. He detailed how the method used in the
- 50 -
Ho application uses a T75 flask and that “this is a large culture vessel
and so that typically indicates that the cells are not as sensitive to the
microenvironment with respect to the growth because you add large
amounts of media and would dilute out any growth factors produced by
the cells themselves and that speaks to the different biological
properties of the cells.” Appx1984-1985. He further explained that, in
contrast, the Furcht application used 96-well plates having a “small
surface area” and that “one would use that approach when trying to
isolate a rare cell because that small volume well provides a
microenvironment where the rare cell can condition its own media and
that’s usually thought to promote the survival and eventual expansion
of that cell.” Appx1985. ABT overlooks this testimony on appeal.
ABT’s expert Dr. Keating offered only a single conclusory
statement on whether the type of vessel would affect the type of cell
obtained, without any consideration of the cited technical documents.
Appx2395. While he stated that “[o]ne would not expect a significant
difference in cells grown in six well plates or T-75 flasks,” he did not
explain why and he did not support his conclusion with any
documentary evidence. Dr. Deans, on the other hand, acknowledged
- 51 -
that “[t]he relationship of seeding density to surface area can be a
variable in establishing the culture” and that “Furcht teaches the
criticality of cell density in plating and retention of the MAPC
phenotype.” Appx4098-4099.
Finally, ABT contends that “[t]he Board essentially ignored the
data in the Deans declaration.” Appellant Br. 35. That complaint has
no basis. The Board carefully considered the evidence but rejected
ABT’s view of the evidence. ABT’s narrow factual challenges on appeal
do not establish the absence of substantial evidence.
In sum, ABT has not identified a single fact finding for which
substantial evidence is lacking. ABT instead asks this Court to reweigh
the evidence and make factual findings anew. Substantial evidence
supports the Board’s findings that there were significant differences
between the method used in the Deans Declarations and the method in
the Furcht specification. Therefore, there is substantial evidence that
the Deans Experiments do not accurately reflect the cells described in
the Furcht ‘037 patent and therefore Furcht has not shown “inherent
written description” of the “co-expressing CD49c and CD90” claim
limitation.
- 52 -
C. The Board Did Not Misconstrue the Definition of “Co-

Express”
ABT also contends that the Board misconstrued the proper scope
of the term “co-express.” Contrary to ABT’s argument, the Board’s
claim construction is correct, and the fact findings supporting the
Board’s construction rest on substantial evidence.
With respect to the ‘037 patent, Furcht copied Ho’s claims in this
interference. Appx2593-2605 (stating the new claims were “substantial
copies of pending claim 14 of the Ho’ 244 application”). The claims are
thus given their broadest reasonable construction in light of the ‘244
specification. Harari, 656 F.3d at 1340; see also Agilent Techs., Inc. v.
Affymetrix, Inc., 567 F.3d 1366, 1375 (Fed. Cir. 2009) (“[W]hen a party
challenges written description support for an interference count or the
copied claim in an interference, the originating disclosure provides the
meaning of the pertinent claim language."); In re Spina, 975 F.2d 854,
856 (Fed. Cir. 1992) (“When interpretation is required of a claim that is
copied for interference purposes, the copied claim is viewed in the
context of the patent from which it was copied.”).
“[U]nder the broadest reasonable interpretation, the Board’s
construction cannot be divorced from the specification and the record
- 53 -
evidence, and must be consistent with the one that those skilled in the
art would reach.” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292,
1298 (Fed. Cir. 2015) (internal quotations and citations omitted).
“The terms used in patent claims are not construed in the
abstract, but in the context in which the term was presented and used
by the patentee, as it would have been understood by a person of
ordinary skill in the field of the invention on reading the patent
documents.” Fenner Invs., Ltd. v. Cellco P’ship, 778 F.3d 1320, 1322-23
(Fed. Cir. 2015); see also Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713
F.3d 1090, 1095 (Fed. Cir. 2013) (“[A] term’s ordinary meaning must be
considered in the context of all the intrinsic evidence, including the
claims, specification, and prosecution history.”).
Here, the Board correctly construed the term “co-express” when
considering the evidence as a whole. Ho’s expert Dr. Phinney testified
that “co-express” has a “well-defined” meaning for scientists working in
the stem cell field. Appx1969-1971.
Q. If you recall from earlier today, Mr. Huntington was

asking you about the meaning of co-express as it is used in
the Ho applications. Do you recall that?
A. Yes.
- 54 -
Q. Is the term co-express something that’s well-defined in

the art of stem cell research?
A. Yes.
Q. And what’s the general understanding of that term?
A. Particularly as it applies to flow cytometric analysis using

cluster designation antigens, it’s typically interpreted as it is
in the Ho [application], which is a single cell simultaneously
expresses or co-expresses two proteins.
Q. So if there is a description that the cell co-expresses

CD49c and CD90, how would one of ordinary skill in the art
interpret that?
A. One would interpret it to mean that if you did double

staining on a population of cells, at least some measurable
number would co-express both antigens.
Q. Are you aware of any articles that use co-express in a

manner contrary to the definition as it’s understood in the
field?
A. Not based on my recollection at this time.
Q. Now, if you read an article or even patent application, and

it defined co-express differently, would you require any
additional information to believe that different meaning of
the term co-express?
A. Yes. It would have to demonstrate that their definition is

valid in the sense you can have a measurable outcome.
Q. And by measurable -- measurable outcome, what do you

mean?
A. That they can demonstrate or illustrate their definition of

co-express.
Q. And how would one do that?
- 55 -
A. Through some experimentation.
Q. And which experimentation specifically?
A. Typically, as we noted, surface expression of proteins is

determined using flow cytometry.
Appx1969-1971. ABT does not address this testimony on appeal, and
the testimony supports the Board’s construction.
ABT’s argument rests on language in the Ho ’685 application
which ABT believes expands the art-accepted definition of “co-express.”
See Appellant Br. 28-30. Contrary to ABT’s argument, the wording in
the ‘685 application does not change how a person of ordinary skill in
the art would understand the term “co-express.” ABT does not identify
any additional disclosure in the specification indicating the inventors
intended to expand the definition of “co-express.” See Appellant Br. 29-
30.
In a footnote, ABT cites a portion of Dr. Phinney’s testimony, but
his complete testimony confirms the Board’s construction. Dr. Phinney
expressly confirmed the Board’s construction:
Q. Wouldn’t saying alternatively on or in a collection of cells

would allow for CD49c to be on certain cells and CD90 to be
on others?
A. Not when the term co-express is used and defined as such.
- 56 -
Q. So what does the phrase alternatively on or in a collection

of cells add to the rest of the definition?
A. My interpretation is it means it can be more than one cell

so that you could simultaneously detect both proteins on a
single cell or more than a single cell in a collection of cells.
Appx1914-1915. ABT overlooks this testimony on appeal, and ABT is
incorrect when asserting that Dr. Phinney “admitt[ed] that the
definitions in the two Ho applications conflicted.” See Appellant Br. 29
n.7.
Similarly, Dr. Keating’s conclusory testimony does not support
ABT’s argument. Dr. Keating offered only a single paragraph in which
he merely “disagree[d]” with Dr. Phinney’s view. Appx2394. He cited
only one of the Deans Declarations, but that document does not explain
how the term “co-express” is to be understood. The Board observed that
“Deans does not explain in his declarations how [the figure depicting
the data] supports his opinion that well over 91% of the tested cells
expressed both CD49c and CD90.” Appx16. Beyond that, Dr. Keating
identified no document or technical article to support for his position.
Finally, ABT’s reliance on the ‘685 application is misplaced
because claim 1 of the Furcht ‘037 patent copied the “co-express”
limitation from the Ho ‘244 application. Appx2597. Therefore, the ‘244
- 57 -
application serves as the specification for interpreting the claim. See
Agilent Techs., 567 F.3d at 1375 (“[W]hen a party challenges written
description support for an interference count or the copied claim in an
interference, the originating disclosure provides the meaning of the
pertinent claim language.”); Spina, 975 F.2d at 856 (“When
interpretation is required of a claim that is copied for interference
purposes, the copied claim is viewed in the context of the patent from
which it was copied.”). Thus, even if the evidence supported ABT’s
interpretation—which it does not—it would be irrelevant because the
specification of the Ho ‘244 application controls.
ABT also urges that the Board erred by finding the Furcht ‘037
patent to describe only the presence of mRNA encoding CD49c, and not
the co-expression of the CD49c protein. See Appellant Br. 32-34. The
Board expressly rejected ABT’s argument, Appx27-28, and the finding is
supported by substantial evidence.
The Board relied on a scientific article which explained that the
presence of mRNA does not necessarily mean that the corresponding
protein is expressed in the cell. Appx28 (citing Appx3418-3429). This
- 58 -
reference by itself is substantial evidence to support the Board’s
decision, and ABT does not address it.
Further, in testimony not cited by ABT, Dr. Keating admitted that
measuring mRNA expression is “not exactly equivalent” to protein
expression, and that he was “not certain” whether a protein is expressed
in a cell when mRNA expression is detected:
Q. So in your view, with respect to this sentence, just

measuring the mRNA expression levels isn’t sufficient to tell
you whether the protein is actually expressed in the cell?
A. Well, it could be.
Q. It could be, but --
A. Yeah.
Q. But you’re not certain?
A. It’s not exactly equivalent.
Q So are you -- with respect to this, are you certain as to

whether the protein is expressed by measuring the mRNA?
A. I’m not certain.
Q. Not certain. Okay.
Appx4271.
Furcht also points to the Ho ‘244 application, but that disclosure
in fact confirms the Board’s finding. The Ho ‘244 application provides
an express definition:
- 59 -
“Co-express,” as used herein, refers to the simultaneous

detection of two or more molecules, e.g., CD49c and CD90, on
or in a single cell. Techniques to detect co-expression of
CD49c and CD90 in cells (e.g., bone marrow stromal cells)
are well established. For example, co-expression of CD49c
and CD90 on a cell can be detected by multiple color
cytometric analysis. CD49c can be detected employing a
fluorescein labeled probe and CD90 can be detected
employing a Texas red probe. The CD49c and CD90 cell
surface antigens can be visualized with the aid of a flow
cytometer equipped with multiple filters capable of detecting
the multiple colors.
Appx57. The specification then includes the general statement that
“molecules of interest” can be detected by ELISA, RIA,
immunofluorescence microscopy, and quantitative PCR, but it does not
state that CD49c and CD90 can be detected by using all of those
techniques. Id. Nor does the specification provide an example of
detecting CD49c and CD90 using a PCR method.
Even with the mention of PCR, the description is clearly directed
to identifying the CD49c and CD90 proteins themselves, not the mRNA.
To adopt ABT’s reasoning, any cell that has mRNA or DNA encoding
the proteins would be considered a cell “expressing” the proteins, but
Furcht’s own expert Dr. Keating acknowledged that the presence of
mRNA does not “really address the issue of the presence of proteins
themselves.” Appx4293.
- 60 -
Finally, ABT’s argument regarding Dr. Kopen’s analysis is
erroneous. See Appellant Br. 33-34. ABT cites five pages of Dr. Kopen’s
declaration, but none of those pages addresses mRNA. Appx2544-2549.
That portion of Dr. Kopen’s declaration focuses specifically on expressed
proteins using FACS analysis to identify proteins—similar to the Ho
‘244 and ‘685 applications. Id.
In short, ABT’s argument regarding “co-express” is contrary to the
evidence underlying the Board’s decision. The Board’s claim
construction of “co-express” is legally correct, and substantial evidence
supports the relevant fact findings.
VI. Substantial Evidence Supports The Board’s Finding That The

Furcht ‘118 Claims Do Not Satisfy The Written Description
Requirement
ABT next disputes several factual findings supporting the Board’s
determination that the Furcht ‘118 claims are not adequately described.
Appellant Br. 44-51. One ABT challenge targets the Board’s finding
that the stem cell field was highly unpredictable at the relevant time.
This should be rejected for the reasons detailed above. ABT’s remaining
factual challenges should be rejected for the reasons set forth below.
- 61 -
A. The Furcht Disclosure Does Not Demonstrate Possession of

the Broadly Claimed Cells
Furcht ‘118 claim 1 reads as follows:
A cell culture comprising isolated expanded human

multipotent, non-embryonic, non-germ cells that can
differentiate into at least one cell type of each of the
endodermal, ectodermal, and mesodermal embryonic
lineages and express telomerase, said cells having
undergone at least 10-40 cell doublings in culture.
Appx28. The Board understood claim 1 of the ‘118 patent to be “broad
enough to include cell cultures isolated from” any organ in the human
body. Appx30-31. On appeal, ABT does not dispute the Board’s
understanding. See Appellant Br. 44-51.
As the Board recognized, claim 1 of the ‘118 patent attempts to
cover cells isolated “from a fetus, newborn, child or adult” and that
“[t]he cell may be derived from an organ, such as from marrow, liver or
brain.” Appx29-30; Appx416; Appx2962. Claim 1 further requires such
isolated cells to be capable of differentiating into at “least one cell type
of each of the endodermal, ectodermal, and mesodermal.” Appx445.
The ‘118 patent therefore attempts to claim a stem cell population that
can be obtained from almost any type of human cell and that has the
ability to differentiate into almost any type of human cell. Id.
- 62 -
There is no evidence that Furcht invented so broad an invention,
and the single example in the Furcht ‘118 patent does not provide
legally sufficient written description of such a broad claim in the
unpredictable stem cell field. Appx30 (“[T]his case involves a relatively
new and highly unpredictable field where an applicant has described
one species of a rather large genus.”). The patent specification did not
demonstrate possession of an invention in which the claimed cells can
be derived from a fetus, a newborn, or a child. Appx30-33; Appx2962-
2963. The only example disclosed in the Furcht ‘118 patent is the use of
adult bone marrow mononuclear cells to obtain the stem cell culture.
Appx435-436. The inventors provided no other working examples of
isolating cells from a different tissue source.
The Board also noted that claim 1 of the Furcht ‘118 patent is
broad enough to cover a stem cell population derived from any organ
and any cell in the human body—meaning from the approximately 78
human organs and even more types of cells. See, e.g., Appx3143 (listing
“210 varieties of cells” in the human body); Appx2949 (“Bone marrow
contains at least 20 different cells types.” (citing Appx3121-3139)).
Nothing in the specification supports a conclusion that the single
- 63 -
example is representative of stem cells that could possibly be obtained
from other organs and other cell types. Appx2962-2963.
Dr. Phinney explained in detail why “[i]solation and culture of
cells from bone marrow, brain and liver would require significantly
different procedures and protocols.” Appx2949. Dr. Phinney further
explained that “[s]upporting an assertion that MASCs could be isolated
from each of bone marrow, brain and liver, requires a significant
amount of guidance to establish that cells from all of these sources could
be isolated and could in fact differentiate as asserted” in the Furcht
specification. Appx2949. The Board properly credited this evidence.
B. This Court’s Precedent Supports the Board’s Decision
ABT also takes issue with the Board’s reliance on three specific
cases from this Court’s jurisprudence concerning the written description
requirement as applied to biotechnology inventions. Each case cited by
the Board supports the Board’s fact findings.
As a first point, ABT cannot reasonably dispute that, in an
unpredictable technology area such as stem cell science, a more detailed
disclosure is required to support broad, generic claims. See Ariad
Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)
- 64 -
(“[T]he level of detail required to satisfy the written description
requirement varies depending on the nature and scope of the claims and
on the complexity and predictability of the relevant technology.”);
Capon v. Fisher, 418 F.3d 1349, 1360 (Fed. Cir. 2005) (“The
predictability or unpredictability of the science is relevant to deciding
how much experimental support is required to adequately describe the
scope of an invention.”); In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970)
(“In cases involving unpredictable factors, such as most chemical
reactions and physiological activity, the scope of enablement obviously
varies inversely with the degree of unpredictability of the factors
involved.”); The Guidelines for Examination of Patent Applications
under the 35 U.S.C. § 112, ¶ 1, “Written Description” Requirement,
66 Fed. Reg. 1099 (Jan. 5, 2001) (“For inventions in an unpredictable
art, adequate written description of a genus which embraces widely
variant species cannot be achieved by disclosing only one species within
the genus.”), cited with approval by Carnegie Mellon University v.
Hoffmann-La Roche, Inc., 541 F.3d 1115, 1124 (Fed. Cir. 2008).
Second, the Board correctly analogized Furcht’s broad,
unsupported claims to the broad, unsupported claims in the cited three
- 65 -
cases. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc.,
759 F.3d 1285, 1300 (Fed. Cir. 2014), the Court held that “the jury
heard ample evidence that AbbVie’s patents only describe one type of
structurally similar antibodies and that those antibodies are not
representative of the full variety or scope of the genus.” In Ariad, the
Court held that, as a matter of law, the broad generic method claims for
modifying gene expression were not adequately described. 598 F.3d at
1354-58. Similarly, in Carnegie Mellon University, 541 F.3d at 1123-
24, the Court affirmed the invalidity of claims to “recombinant plasmids
that contain a DNA coding sequence that is broadly defined, and only
by its function.” In each instance, broad biotechnology claims were
invalidated under the written description requirement because the
specification lacked sufficient working examples.
The ultimate deficiency with the Furcht ‘118 claims is best
captured by this Court’s explanation of the written description
requirement:
With the written description of a genus, however, merely

drawing a fence around a perceived genus is not a
description of the genus. One needs to show that one has
truly invented the genus, i.e., that one has conceived and
described sufficient representative species encompassing the
breadth of the genus. Otherwise, one has only a research
- 66 -
plan, leaving it to others to explore the unknown contours of

the claimed genus.
AbbVie, 759 F.3d at 1300. The Furcht ‘118 patent attempts to draw a
fence around a wide swath of stem cell technology—stem cells defined
entirely by function—without disclosing adequate working examples.
See Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568
(Fed. Cir. 1997) (holding that “[a] description of rat insulin cDNA is not
a description of the broad classes of vertebrate or mammalian insulin
cDNA”).
C. The Court Did Not Err Concerning the “Two Facts”

Identified by ABT
ABT also contends that “[t]he Board erred fundamentally in
presuming two facts not found in evidence” regarding the written
description of the ‘118 patent. Appellant Br. 49-51. The record does not
support ABT’s position.
First, the subject matter of the ‘118 claims covers a broad number
of different cells and cell populations, contrary to ABT’s argument. See
Appellant Br. 49-50. There are hundreds of types of cells included in
the genus covered by the claims of the ‘118 patent. Appx2949;
- 67 -
Appx2963; Appx3121-3139; Appx3141-3144. ABT does not cite any
evidence to the contrary. See Appellant Br. 49-50.
The ‘118 patent claims themselves belie ABT’s argument that the
‘118 patent is directed to “a single product.” Specifically, claim 2
narrows claim 1 by specifying that the cells are “obtained by culture of
non-embryonic, non-germ tissue.” Appx445. Thus, claim 1
encompasses these cell types and others, namely, those “obtained by
culture” of different types of tissue. Accordingly, the plain language
and structure of the claims establish that the ‘118 patent is not directed
to “a single product,” as ABT contends.
Second, the Board correctly found that cells isolated from different
sources are generally of different cell types. The general understanding
in the stem cell field was that stem cells retain differentiation potential
associated with the tissue from which the cells are isolated. Appx2962-
2963 (“To be achievable, a significant amount of detailed disclosure
demonstrating that cells from all sources encompassed by the claims
had been isolated and could in fact differentiate into one cell type of
each of endodermal, ectodermal, and mesodermal embryonic lineages,
would be required.”).
- 68 -
In sum, the broad claims of the ‘118 patent are not adequately
described and supported by the specification. Indeed, Verfaille and the
other Furcht inventors needed years of additional research to identify
conditions for isolating some of the claimed cells, and there is no
evidence that the full scope of the ‘118 claims has ever been invented.
The Board’s decision is accordingly supported by substantial evidence.
VII. ABT’s Challenge To The Board’s Decision On The Furcht ‘256

Claims Repeats Its Factual Challenges And Should Be Rejected
For The Same Reasons
ABT challenges the Board’s decision that the claims of the Furcht
‘256 application were not adequately described under 35 U.S.C. § 112.
See Appellant Br. 51-54. ABT does not provide a legally sufficient
reason why the Board’s decisions should be overturned.
ABT first asserts that the Board erred by providing a “one
sentence analysis,” but the Board fully considered the issues raised and
detailed its factual findings concerning the lack of examples to support
a broad generic claim. Appx33. Contrary to ABT’s implication, the
Board is not required to reiterate factual findings that it fully set forth
in its decision. The Board noted the similarity of the issues presented
for the Furcht ‘037 patent and agreed that the claims of the ‘256
- 69 -
application lacked an adequate written description “for the reasons
given above.” Appx33. ABT implicitly acknowledges the propriety of
using an “incorporation-by-reference” approach when it does the same
in its brief. See Appellant Br. 54 (“[T]he Board erred for all the reasons
discussed above regarding the ‘118 claims.”).
Second, ABT argues, without factual support or citation to the
record, that the claims of the ‘256 application “do not refer to a ‘rather
large genus.’” Appellant Br. 54. ABT merely recites certain limitations
of the ‘256 claims without explaining the significance.
Beyond those two general contentions, ABT does not provide any
basis to conclude that there was no substantial evidence supporting the
Board’s decision. ABT does not address the evidence supporting the
Board’s decision. Dr. Phinney testified that, “[a]t most, Applicants of
the ‘256 application have allegedly provided evidence of a single
example, of a single, extremely rare cell population isolated from
human bone marrow (on average, one cell out of every 2-3 million cells
isolated from a bone marrow sample).” Appx2963; see also Appx245-
392. Dr. Phinney further explained that there was “[n]o actual isolation
- 70 -
of any cell types from liver or brain, are provided in the ’256
application.” Appx2963; see also Appx245-392.
This evidence, together with the evidence detailed above,
constitutes substantial evidence supporting the Board’s factual
determination that the Furcht ‘256 application does not provide
adequate written description support for the broad claims.
VIII. The Board Correctly Held That No Interference-In-Fact Existed

Between Any Furcht Claim And Any Ho Claim
The Board held that there was no interference-in-fact. On appeal,
ABT’s challenge to the Board’s decision is based entirely on its
arguments presented in the context of the written description issues.
See Appellant Br. 55-58. For the above reasons, the Board’s decision
should be affirmed.
Further, ABT challenges the interference-in-fact ruling with
respect to only the Furcht ‘037 patent. ABT does not challenge the
Board’s decision that there is no interference-in-fact for its ‘118 patent
and ‘256 application.
A. Legal Standard
“An interference exists if the subject matter of a claim of one party
would, if prior art, have anticipated or rendered obvious the subject
- 71 -
matter of a claim of the opposing party and vice versa.” 37 C.F.R.
§ 41.203(a); Eli Lilly v. Bd. of Regents of the Univ. of Wash., 334 F.3d
1264, 1267 (Fed. Cir. 2003). The Board applies the two-way test in
determining whether there is an interference-in-fact. Lilly, 334 F.3d at
1268. Here, the Board correctly held that no interference-in-fact existed
between any Furcht claim and any Ho claim.
In reviewing the Board’s application of the two-way test, this
Court “reviews, where necessary, both the subsidiary findings of
anticipation and/or obviousness as they relate to the application of the
test. See Medichem, S.A. v. Rolabo, S.L., 437 F3d 1157, 1164 (Fed. Cir.
2006) (citing Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928, 932 (Fed.
Cir. 2003)).
B. ABT’s Argument is Entirely Based on the Same Arguments

Concerning Written Description
As noted above, ABT disputes the Board’s decision only on the
basis of the same reasons presented for challenging the Board’s decision
concerning written description. ABT recites those seven points on
pages 57-58 of its brief. Those seven factual disputes are fully
addressed above. ABT’s challenge should be rejected for the same
reasons set forth above.
- 72 -
Further, Dr. Phinney provided detailed reasons supported by
evidence and testimony of why the claims of the Furcht ‘037 patent are
not anticipated or obvious in view of the Ho claims. Appx2420-2429.
ABT does not challenge that testimony on appeal.
IX. If The Court Remands, The Board Should Rule That The Furcht
Claims Are Not Enabled
During the interference proceeding, Ho sought judgment that the
Furcht claims are not enabled. Appx732-744; Appx2943-2958. While
the Board found many facts which establish the non-enablement of the
claims, the Board did not reach the issue of enablement. Appx45. If the
Court were to remand this case for any reason, the Board should be
instructed to rule on Ho’s motion that the Furcht claims are not enabled
under 35 U.S.C. § 112.
X. Conclusion
For the above reasons, the Board’s decision should be affirmed. In
the event the Board’s decision is not affirmed, the Board should be
instructed to address Ho’s motion that the Furcht claims are not
enabled under 35 U.S.C. § 112, and to decide the doubling rate,
inventorship, and inequitable conduct issues.
- 73 -
Date: November 22, 2016 Respectfully submitted,
/s/ Matthew J. Dowd

Matthew J. Dowd
Dowd PLLC
1717 Pennsylvania Avenue, NW
Suite 1025
Washington, D.C. 20006
mjdowd@dowdpllc.com
Cynthia M. Bouchez
Medler Ferro Woodhouse & Mills
PLLC
8201 Greensboro Drive, Suite 1060
McLean, VA 22102
cbouchez@medlerferro.com
- 74 -
CERTIFICATE OF COMPLIANCE
This brief complies with the word-length limitation of Federal
Rule of Appellate Procedure 28(e)(2)(A)(i). This brief contains
13,448 words, excluding the portions set forth in FRAP 32(a)(7)(B)(iii)
and Federal Circuit Rule 32(b). This brief complies with the typeface
requirements of Federal Rule of Appellate Procedure 32(a)(5) and the
type style requirements of Federal Rule of Appellate Procedure 32(a)(6).
The brief has been prepared in a proportionally spaced typeface using
Microsoft® Word and 14-point Century type.
/s/ Matthew J. Dowd

Matthew J. Dowd
Dowd PLLC
Suite 1025
mjdowd@dowdpllc.com
Dated: November 22, 2016

CERTIFICATE OF SERVICE
I hereby certify that on this day, November 23, 2016, the foregoing
was electronically filed and therefore served electronically via the
court’s ECF/CM system on all counsel of record.
/s/ Matthew J. Dowd

Matthew J. Dowd
Dowd PLLC
Suite 1025
mjdowd@dowdpllc.com
Dated: November 23, 2016

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Case: 16-2116 Document: 25 Page: 1 Filed: 11/23/2016

UNITED STATES COURT OF APPEALS

ABT HOLDING COMPANY

REGENTS OF THE UNIVERSITY OF MINNESOTA,

Appeal from the United States Patent and Trademark Office,

CORRECTED RESPONSE BRIEF OF APPELLEE

Cynthia M. Bouchez Matthew J. Dowd

Counsel for Appellee

Counsel for Appellee Garnet BioTherapeutics, Inc. certifies the

1. The full name of every party or amicus represented by me is:

Garnet BioTherapeutics, Inc.

Matthew J. Dowd, Dowd PLLC, 1717 Pennsylvania Avenue,

Date: November 22, 2016 /s/ Matthew J. Dowd

STATEMENT OF RELATED CASES ....................................................... 1

STATEMENT OF THE ISSUES ................................................................ 1

STATEMENT OF THE CASE AND FACTUAL BACKGROUND ........... 1

I. Procedural Background ..................................................................... 1

II. Factual Background .......................................................................... 3

A. The Basics of Stem Cell Technology ........................................ 4

B. Multipotent Progenitor Cells Are Characterized by

C. The Isolation and Culturing of Multipotent Progenitor

D. Dr. Verfaille and Colleagues Report on the Isolation of

E. Notwithstanding the Falsified Data, Verfaille and Her

F. Ho and His Colleagues File Patent Applications

G. After Repeated Attempts by Furcht, the Board

H. The Board Rules in Favor of Ho on the Motions of No

SUMMARY OF THE ARGUMENT ......................................................... 28

II. The Board Did Not Adopt Or Rely On An “Improper”

V. Substantial Evidence Supports The Board’s Finding That

A. Legal Standard for the Written Description

B. The Board Correctly Identified Significant Differences

C. The Board Did Not Misconstrue the Definition of “Co-

VI. Substantial Evidence Supports The Board’s Finding That

A. The Furcht Disclosure Does Not Demonstrate

B. This Court’s Precedent Supports the Board’s Decision ........ 64

C. The Court Did Not Err Concerning the “Two Facts”

VII. ABT’s Challenge To The Board’s Decision On The Furcht

VIII. The Board Correctly Held That No Interference-In-Fact

A. Legal Standard ....................................................................... 71

B. ABT’s Argument is Entirely Based on the Same

AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc.,

Agilent Technologies, Inc. v. Affymetrix, Inc.,

Ariad Pharmaceuticals Inc. v. Eli Lilly & Co.,

Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,

Biogen Idec, Inc. v. GlaxoSmithKline LLC,

Biogen MA, Inc. v. Japanese Foundation for Cancer Research,

Carnegie Mellon University v. Hoffmann-La Roche, Inc.,

Consolidated Edison Co. v. NLRB,

Consolo v. Federal Maritime Commission,

Dystar Textilfarben GmbH v. C.H. Patrick Co.,

Eli Lilly v. Board of Regents of the Univeristy of Washington,

Enzo Biochem, Inc. v. Calgene, Inc.,

Enzo Biochem, Inc. v. Gen-Probe Inc.,

Fenner Investments, Ltd. v. Cellco Partnership,

Graham v John Deere Co.,

Medichem, S.A. v. Rolabo, S.L.,

Medichem, S.A. v. Rolabo, S.L.,

Microsoft Corp. v. Proxyconn, Inc.,

Newell Cos., Inc. v. Kenney Manufacturing Co.,

Regents of the University of California v. Eli Lilly & Co.,

Sage Products, Inc. v. Devon Industries, Inc.,