**BY E-MAIL TO:** <BPAI.Rules@uspto.gov>

September 28, 2007![](media/image1.png){width="1.0361111111111112in"
height="0.6458333333333334in"}

The Honorable Jon Dudas

Under Secretary of Commerce for Intellectual Property and

Director of the United States Patent and Trademark Office

Mail Stop Comments

P.O. Box 1450

Alexandria, VA 22313-1450

Re: **[Proposed Changes to Rules of Practice Before The Board of Patent
Appeals and Interferences in Ex Parte Appeals]{.underline}**

Dear Under Secretary Dudas:

Wyeth appreciates the opportunity to provide comments on the U.S. Patent
and Trademark Office ("PTO") proposed rules directed to changes to rules
of practice before the Board of Patent Appeals and Interferences in Ex
Parte Appeals published at 72 Fed. Reg. 145 (July 30, 2007).

Wyeth is one of the world's largest research based pharmaceutical and
health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals,
biotechnology products, vaccines and non-prescription medicines that
improve the quality of life for people worldwide. Wyeth's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and
Fort Dodge Animal Health.

Wyeth understands the critical importance of discovering and developing
valuable new therapies and vaccines to help millions of people around
the world. Cutting-edge pharmaceutical research and development is more
challenging, more complex and more critical than ever. At the same time,
the need for treatments for unmet medical needs is expanding greatly,
even as regulatory hurdles increase and costs grow. Novel candidates and
new mechanisms of action are central to Wyeth's pipeline, which pipeline
includes small molecules, biopharmaceuticals and vaccines. The cost of
developing a new drug is more than \$800 million, on average, and can
take up to 15 years. The patents granted on Wyeth's inventions enable
Wyeth to continue to invest in developing the therapies and vaccines of
the future to improve the lives of people and lead the way to a
healthier world.

The PTO has proposed major changes to the rules of practice before the
Board of Patent Appeals and Interferences in Ex Parte Appeals. The
stated rationale of the PTO is to permit the Board to handle an
increasing number of appeals in a timely manner; the stated intention of
the proposed rules is to provide Examiners and Office reviewers with a
clear and complete statement of an appellant's position at the time of
filing an appeal brief so as to enhance the likelihood that appealed
claims will be allowed without the necessity of further proceeding with
the appeal, minimize the pendency of appeals before the office, minimize
the need for lengthy patent term adjustments in cases where claims
become allowable by the Board in an appeal, provide uniform treatment of
requests for an extension of time filed after an appeal brief is filed,
and make the decision making process more efficient.

Wyeth supports the PTO's goals stated above, and particularly the goals
of handling appeals in a timely manner, enhancing the likelihood that
appealed claims will be allowed without the necessity of further
proceeding with the appeal, minimizing the pendency of appeals before
the office, and making the decision making process more efficient.

However, Wyeth believes that the changes being proposed will not enhance
the likelihood that appealed claims will be allowed without the
necessity of further proceeding with the appeal, or make the decision
making process more efficient. Rather, the proposed rules will burden
Appellants with having to supply unnecessary information, and will
prejudice Appellants ability to fully discuss the issues on appeal.

**[The 25-page Limit is Arbitrary and Insufficient]{.underline}**

If enacted, the rules will limit the jurisdictional statement, statement
of facts, argument, status of claims, status of amendments, and
rejections to be reviewed sections combined to a total of 25 pages,
double-spaced with 14-point type. This will often not be sufficient,
especially where there are multiple rejections or many references to
discuss. It is unreasonable to set an arbitrary limit applicable to all
appeals, since circumstances vary greatly among cases on appeal.

In addition, Appellants typically have little control over the length of
the jurisdictional statement, status of claims, status of amendments,
and rejections to be reviewed sections, which will depend on the facts
and circumstances of the case. Indeed, the length of the facts and
arguments section alone will depend in large part on how many references
are cited by the Examiner and how many grounds for rejection must be
appealed. Because Appellants have no control over many such variables
that determine the length of the brief, it will be highly prejudicial to
have an arbitrary page limit, particularly when there is no such page
limit for any of the Examiner's papers.

Furthermore, Appellants right to argue various claims separately will be
compromised by the page limit in many instances, since each separate
argument will require more pages. The proposed rule is also prejudicial
for the additional reason that it forces Appellants to choose between
arguing claims separately and grouping them together merely to have
enough room to make a full and fair argument.

Additionally, the proposed rules do not provide any criteria for
allowing a petition requesting permission to file a longer brief, and it
is completely unclear whether such petitions will ever be granted.

**[The Proposed Additional Descriptive Sections of Should Not Be
Required in All Instances]{.underline}**

The proposed requirement for additional sections of the Appeal Brief
describing claims support, drawing analysis and means/step plus function
analysis should be limited to disclosures on which the Appellant wishes
to rely in arguing the case on appeal. Requiring these analyses for
elements of the claim that are not being argued or disputed on appeal
burdens Appellants for no reason, particularly where a claim is lengthy
and complex (as are many pharmaceutical claims), or where many claims
are argued separately.

**[The Criteria for Imposition of Sanctions are Vague, and They Should
Be Limited to Instances Where Willfulness is Shown]{.underline}**

The proposed rules impose sanctions for failure to comply with an order
entered in the appeal or an applicable rule; advancing or maintaining a
misleading or frivolous request for relief or argument; or engaging in
dilatory tactics. However, it is completely unclear what constitutes a
"frivolous request for relief or argument" or "dilatory tactics."
Appellants should not be sanctioned for pursuing arguments made in good
faith, just because the PTO may consider them to have little merit.
Moreover, the imposition of sanctions should be limited to cases where
intent or willfulness is shown, and Appellants should be provided an
opportunity to argue against any sanction prior to its imposition.

\* \* \* \* \*

The PTO is on record stating that the proposed revisions to the rules of
practice before the Board of Patent Appeals and Interferences in Ex
Parte Appeals have been put forward, at least in part, to meet the
increase in appeals expected as a result of the recent implementation of
the new rules governing the claim examination process and continued
examination practice. However, denying Appellants a full opportunity to
present their arguments by imposing an arbitrary page limit on appeal
briefs, requiring the inclusion of descriptive disclosures that do not
relate to issues on appeal, and creating the threat of vague sanctions
to be imposed without an opportunity to be heard will not achieve the
goals set forth by the PTO. Rather, the proposed rules will overburden
Appellants, and adversely impact Appellants' ability to secure patent
protection for their inventions, thereby stifling innovation and
commercial development.

Wyeth thanks the PTO for the opportunity to provide comments.

Very truly yours,

*Joseph M.Mazzarese*

Joseph M. Mazzarese

Michael P. Straher

Michael P. Straher