SKGF_Advisory_USPTO Bio-Chem-Pharma Customer Partnership Meeting_2006

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SKGF_Advisory_USPTO Bio-Chem-Pharma Customer Partnership Meeting_2006

  1. 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. 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. Sterne, Kessler, Goldstein & Fox P.L.L.C. : 1100 New York Avenue, NW, Washington, DC 20005 : 202.371.2600 : www.skgf.com
  3. 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

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