IPR in Biotechnology (BTX-402)

B.Tech Biotechnology (8th Sem)

Course coordinator:
Harmanpreet Meehnian
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Topic: The Legal Decision-Making

Process
Lecture-5
 THE PATENT APPLICATION PROCESS
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 All U.S. patents are issued by the PTO, an agency within the U.S.
Department of Commerce.

 The PTO is located in Arlington, Virginia, just outside of Washington, DC.

 The PTO examines all U.S. patent applications, issues all U.S. patents,
and conducts certain proceedings relating to patents already issued.
 Patent Examiners
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 The PTO employs approximately 1900 patent examiners, who are

responsible for examining each patent application that is filed. In 1991
alone, approximately 178,000 patent applications were filed

 All patent examiners have one or more college degrees in the various
technical areas and, in some cases, the law.

 Many of the biotechnology examiners have advanced degrees and even

postdoctoral experience. Regardless of their legal training or experience, all
patent examiners are required to attend an eight-week training course on
patent law and procedure during their first year on the job .

 The course covers all aspects of the PTO's patent application process,
from filing to examination to the issuance of U.S. patents.
 Patent Examiners
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 Besides the training, the PTO offers examiners the opportunity to take
advanced courses covering specialized areas of patent law throughout their
tenure in the PTO.

 Many examiners also attend law school in the evenings at one of the
universities in the Washington, DC, area.

 Part of an examiner's training, of course, occurs on the job. In the

beginning, an examiner's work is closely watched by a supervisory primary
examiner (SPE), who must review and sign all of the examiner's work.

 As an examiner gains experience, he or she is allowed more autonomy.

The ultimate goal is to give each examiner the authority to make decisions
concerning patent applications with only minimum supervision.
 Patent Examiners
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 In order to gain this autonomy, the examiner must complete two separate
review programs.

In the first, or "partial signatory authority" program, the examiner is given
the authority to make preliminary decisions on the merits of patent
applications for six months without supervisory approval.

The SPEs within each Examining Group and the group director oversee
this program.

 After the review period ends, the cases the examiner acted on during the
review period are gone over.

If minimum standards for quality and quantity are met, the examiner's
partial signatory authority is made permanent.
 Patent Examiners
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Two years after completing the partial signatory program, the examiner
may enter the "full signatory authority" program.

In this, the examiner is allowed to make final decisions concerning patent
applications without prior supervisory approval.

At the end of the review period, again six months, the cases he or she
acted on are evaluated against minimum quality and quantity standards.

If these standards are met, the examiner's full signatory authority is made
permanent.

Examiners earning full signatory authority are called "primary

examiners.“ are met, the examiner's partial signatory authority is made
permanent.
 Patent Filings
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 All patent applications filed in the PTO are reviewed by a series of

"divisions" or "groups" within the PTO.

First the applications go to the Application Division, where they are

reviewed for compliance with a number of formal filing requirements.

Next, applications are classified, based on their technical content,

according to the PTO's classification system.

Then they are assigned to the Examining Group responsible for the
particular technologies that they cover.
 Patent Filings
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 When the technology is sensitive in nature or may affect national security,

applications are assigned to the Security Group, or Group 220, for
examination.

 Security applications are examined like any other applications. However,

unless the security designation is removed later, these applications are never
allowed to enter the public domain.

 This means that such applications, even when patentable, are never
allowed to issue as U.S. patents and are never included in any interference
proceeding
 Patent Filings
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 A goal of the classification process is to ensure that applications are

assigned to an examiner who has the relevant technical expertise.

 Although the PTO's classification system may make little sense to the
average layperson, its sophistication and detail provide a degree of
consistency and quality to the examination process.

 People who understand the classification system often know ahead of

time what Examining Group, if not which examiner, will be assigned a given
application.

Biotechnology applications most frequently go to Group 180.

 The Examination Process
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Before the Examiner.

 The heart of the PTO operation is the examination process. In this stage
of the patent application process, technically and legally trained examiners
again review the application for matters of form and also examine the
application on its merits to determine the patentability of the inventions
claimed.

 Once in the Examining Group, the applications are assigned to a Group

Art Unit where they are further assigned to an examiner based on internal
classification procedures.

 Once assigned to a particular examiner, the applications generally are

examined n order of filing date, although in practice each examiner has
some limited discretion to study the applications as he or she wishes for
expediency and as a matter of personal preference
 The Examination Process
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Before the Examiner.

 An examiner's discretion in picking and choosing among the applications

is limited by the requirement that all applications be examined within
controlled time periods.

To help examiners and their supervisors in this and other processes, the
PTO has a computerized system to track each application at each stage of
the application process.

Each examiner and supervisor is provided with a series of periodic reports

that update and document the progression of the individual dockets.

Supervisors also receive a report on the overall docket of the Art Unit and
Examining Group.
 The Examination Process
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Before the Examiner.

 Most of the examination process involves reviewing applications for

patentability according to the patent statutes and regulations.

These statutes and regulations provide the standards against which all
applications are measured for patentability.

For the most part, examiners judge the patentability of application claims
according to 35 U.S.C. 101-103 and 112.

The first step in judging the patentability of an application is to identify

what constitutes prior art to a given application. This process focuses
primarily on the date the application was filed but it is governed by section
102, as well as by various decisions from the U.S. Supreme Court, the U.S.
Court of Appeals for the Federal Court, and the Board of Patent Appeals and
Interferences.
 The Examination Process
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Before the Examiner.

 After identifying what constitutes prior art to a given application, the

examiner must search for the specific prior art that is relevant.

This searching process is the most time-consuming part of the

examination process and usually takes up the majority of an examiner's
workday.

The examiner searches for relevant prior art throughout the process. In
practical terms, however, the search mostly is performed before the
examiner makes the initial "office action" on the application.

To assist the examiner, copies of previously issued U.S. patents and
selected foreign patents and technical articles are classified in "shoes," or
files, located within the examiner's Art Unit
Thanks

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