This document summarizes a USPTO Bio/Chem/Pharma Customer Partnership meeting in September 2006. About 100 people attended in person and 40 attended virtually. Key topics discussed included recent changes to restriction practice, data on restriction petition outcomes, new accelerated examination rules, the examination of bioinformatics cases, and upcoming proposed rule changes regarding claims, continuations, IDS practice and Markush claims. Speakers from various technology centers and art units provided updates in their areas. Attendees engaged in discussion and questions.

1. USPTO Bio/Chem/Pharma Customer Partnership Meeting
September 2006
PREPARED BY MICHAEL V. MESSINGER, ESQ.
AND CHRISTOPHER J. WALSH, PH.D., ESQ.
Wednesday, September 13, 2006
Here is a summary of the USPTO Bio/Chem/Pharma Customer Partnership
meeting held today at the USPTO. This partnership meeting is an quarterly event hosted
by the USPTO – Tech Center 1600. Companies, inventors and patent practitioners active
in the Bio/Chem/Pharma area are invited. This quarter, about 100 people attended in-
person, and according to the USPTO, about 40 people attended via the Internet.
Key USPTO Speakers included: John LeGuyader, Bruce Kisliuk and George
Elliot, Directors of TC 1600, Andrew Faile, Director of TC 2600, Julie Burke SPRE of
TC 1600 and Deborah Reynolds, tQAS of TC 1600.
Other USPTO Speakers included: Kathleen Kerr, SPE, Art Unit 1656 (Data
Processing and Modeling), Mike Hartley, SPE, Art Unit 1618 (Organic Compounds),
Peter Paras, SPE, Art Unit 1635/1639 (Molecular Biology/Microbiology), Andrew Wang,
SPE, Art Unit 1631 (Bioinformatics), Christina Chan, SPE, Art Unit 1644 (Vaccines) and
Ram Shukla, SPE Art Unit 1632/1634 (Living Organisms).
Highlights
Restriction Practice in TC 1600
Kathleen Kerr, Mike Hartley, Peter Paras and Deborah Reynolds spoke on this
important topic. The revisions to Chapter 800 of the M.P.E.P. were particularly
emphasized. Deborah stood out as a good speaker, while the others were more
mechanical.
The revisions seemed mixed for applicants. Peter mentioned that, as part of the
revisions, examiner burden must be shown for all restrictions. He recognized that
TC 1600 is having problems with examiners making restrictions in which the Groups
improperly overlap in scope.
Deborah emphasized the new definition for linking claims and revisions to
rejoinder practice. She stressed that there must be an allowable linking or generic claim
in order to have a number of allowable species. However, the species may be restricted if
they are distinct. The revision to rejoinder practice requires that all claims in a Group be

2. USPTO Bio/Chem/Pharma Customer Partnership Meeting
September 2006
allowable for rejoinder, whereas the old rules stated only “at least one claim” needed to
be allowable.
Deborah stressed that if applicants disagree with the examiner's restriction, then
they should follow up with the SPE, SPRE, and Director.
The presentation generated many questions and strong comments from the
audience. In particular, the audience stressed that the Office needs to develop examples
for both applicants and examiners that are specific to TC 1600. Currently, they only
present mechanical examples. John LeGuyader stated they are currently working on
examples for TC 1600, and they will hopefully be approved soon, but they will be
affected by the new Markush rules that will be proposed later this year.
Survey of Restriction Petitions
Julie Burke presented informative data compiled from studying the past three
years of restriction petitions in TC 1600:
TC 1600 mails out 28,000 first actions on the merits each year and about
12,000 restriction requirements (this number is low because it does not
include telephone restrictions where an election was made and confirmed
only in a first action on the merits).
Only about 75 petitions are filed each year out of the 12,000 restrictions
mailed.
21% of TC 1600 cases are filed under § 371, yet they account for ~30% of
all petitions.
There is an average of 91-days for turnaround of petitions.
Many of the petitions are granted; in FY2005, 17 petitions were granted
out of 28 filed in work group 1620, and in FY2006 11 out of 20 have been
granted in work group 1620.
Markush restrictions receive the majority of petitions.
Julie stressed to the audience that applicants should petition restrictions. The
Office is aware of problems with examiner compliance with restriction practice
guidelines and suggested that the petition process would help solve these problems.
John LeGuyader stated that TC 1600 is actively:
• training examiners in Markush practice with the hopes of reducing the number
of petitions in Markush practice; and
• seeking to reduce the turnaround time for petitions below the current 91-day
average.
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3. USPTO Bio/Chem/Pharma Customer Partnership Meeting
September 2006
Accelerated Examination
Andrew Faile presented the new rules for accelerated examination. He confirmed
that the Office is asking applicants to do what examiners do, and examine their own
application. In terms of the Examination Support Documents, the Office is not
looking to waste time on administrative compliance and will generally accept what
applicants file, unless it appears that they are obviously deficient. All petitions to
make special will be decided by the SPRE. Rejoinder practice will be allowed under
the new Accelerated Examination rules.
Bioinformatics
According to John LeGuyader and Andrew Wang, all Bioinformatics cases are
being examined in work group 1631.
Andrew is the SPE for work group 1631. Offline, Andrew stated that almost all
the examiners in this work group are trained as research chemists and biologists, and
that only a few of their examiners have primarily computer-focused technical
experience. Andrew said they are actively recruiting examiners with greater
computer-related experience, but will still look for individuals with chemical and
biology research backgrounds.
Andrew gave a talk that focused on the new guidelines for subject matter
eligibility under 35 U.S.C. § 101. He stated this is becoming the biggest area of
concern for bioinformatics applications. The presentation tracked closely to the
proposed guidelines, showing that the Office has changed little, in light of the
comments received from the public.
New Proposed Rules
John LeGuyader stated he has no information on when the proposed changes to
claims and continuations practice would become effective. He stated the Office is
still reviewing comments submitted by the public.
On the proposed changes to Information Disclosure Statement practice, John
suggested that they may become effective in a couple months, although he could not
give an exact date.
John also mentioned that a Notice of Proposed Rule Making (NPRM) would be
published by the end of 2006 regarding Markush practice before the Office. John
Doll has formed a team that is currently developing the new rules and NPRM.
Finally, John mentioned the Office is “considering” whether to issue a NPRM
requiring applicants to search their invention before filing an application.
Sterne, Kessler, Goldstein & Fox P.L.L.C. : 1100 New York Avenue, NW, Washington, DC 20005 : 202.371.2600 : www.skgf.com