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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
1617
01/26/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
stl.uspatents@stinson.com
Appeal 2020-003411
Application 14/415,434
Technology Center 1600
__________
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a dosage
form comprising a crosslinked cation-binding polymer comprising
carboxylate groups and pKa decreasing groups and a base. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1
We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Vifor
(International) Ltd. (see Appeal Br. 2). We have considered the
Specification of Jan. 16, 2015 (“Spec.”); Final Office Action of Jan. 4, 2019
(“Final Action”); Appeal Brief of Aug. 6, 2019 (“Appeal Br.”); and
Examiner’s Answer of Dec. 16, 2019 (“Ans.”).
Appeal 2020-003411
Application 14/415,434
2
We note that claims 85, 87–89, 130 and 131 were withdrawn by the
Examiner in the Non-Final action mailed October 31, 2016 and as indicated
in the Amendment filed May 1, 2017.
2
Appeal 2020-003411
Application 14/415,434
The issues
A. The Examiner rejected claims 60, 62–68, 74–76, 127–129, 132, and
133 under 35 U.S.C. § 103(a) as obvious over Mansky,3 Reddy,4 Albrecht,5
and Strickland6 (Final Act. 4–12).
B. The Examiner rejected claims 60 and 63–68 on the ground of
provisional nonstatutory obviousness-type double patenting as being
unpatentable over claims 54, 59, 60, 64–66, and 76–78 of copending
application 14/415,409 (Final Act. 17–19).
3
Mansky et al., US 2010/0104527 A1, published Apr. 29, 2010.
4
Reddy et al., WO 2010/132662 A1, published Nov. 18, 2010.
5
Albrecht et al., US 2010/0111891 A1, published May 6, 2010.
6
Strickland et al., WO 2009/029829 A1, published Mar. 5, 2009.
3
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4
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does not disclose wherein the calcium cations are from about
5% to about 75% of the carboxylate group.
(Final Act. 5).
8. Reddy teaches a “crosslinked potassium-binding polymer” with
units where “the carboxylic acid is preferably in the salt form (i.e., balanced
with a counterion such as Ca2+, Mg2+, Na+, NH4+, and the like). Preferably,
the carboxylic acid is in the salt form and balanced with a Ca2+ counterion”
(Reddy ¶ 17).
9. Reddy teaches “the powder formulation includes an
antimicrobial agent . . . . Suitable antimicrobial agents include . . . sodium
benzoate . . . in a concentration ranging from about 0 wt.% to about 1.5
wt.%” (Reddy ¶ 43).
10. Reddy teaches agents like calcium carbonate “can be present in
a concentration ranging from about 0 wt.% to about 0.1 wt.%” (Reddy ¶ 46).
11. Albrecht teaches “compositions of a stabilizing linear polyol
and a salt of a crosslinked cation exchange polymer comprising a fluoro
group and an acid group. These compositions are useful to bind potassium in
the gastrointestinal tract” (Albrecht ¶ 2).
12. Albrecht teaches “a pharmaceutical composition comprising a
crosslinked cation exchange polymer salt and from about 10 wt. % to about
40 wt. % of a linear polyol based on the total weight of the composition”
(Albrecht ¶ 8).
13. Albrecht teaches the “percent calcium in the composition is
tested after extraction with an appropriate acid . . . the amount of calcium in
the polymer is in the range of from about 8 wt. % to about 25 wt. %”
(Albrecht ¶ 59). The Examiner calculates that this would result in a range
5
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Application 14/415,434
6
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7
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8
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suggestion of the amount of base nor a reason to use the recited amount of
base is present in this case.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that Mansky, Reddy, Albrecht, and Strickland render
claim 60 obvious.
B. Provisional obviousness-type double patenting over US 14/415,409
We decline to reach the provisional rejection. The rejection is
provisional and US Application No. 14/415,409 remains copending and not
allowed. The Examiner should process the obviousness-type double-
patenting rejection consistent with MPEP 804. See, e.g., MPEP
804(B)(1)(b)(ii); In re Moncla, 95 USPQ2d 1884, 1885 (BPAI 2010)
(precedential).
DECISION SUMMARY
In summary:
Claims 35 U.S.C. Reference(s)/Basis Affirmed Reversed
Rejected §
60, 62–68, 103 Mansky, Reddy, 60, 62–68,
74–76, 127– Albrecht, Strickland 74–76, 127–
129, 132, 129, 132, 133
133
60, 63–68 Provisional
Nonstatutory Double
Patenting
Overall 60, 62–68,
Outcome 74–76, 127–
129, 132, 133
REVERSED