BiotechnologyChemicalPharmaceutical Customer Partnership Meeting October 8, 2002

1
Biotechnology/Chemical/Pharmaceutical Customer
Partnership Meeting October 8, 2002

• William F. Smith
• Administrative Patent Judge
• Board of Patent Appeals and Interferences

2
Biotechnology DivisionEx parte Administrative
Patent Judges

• Donald Adams Lora Green
• Eric Grimes Demetra Mills
• Toni Scheiner William Smith
• Sherman Winters

3
Biotechnology DivisionSupport Team

• Dianne Maggard, Paralegal Specialist
• Phone Number 703 305-4673
• Dionne Murphy and JoAnne Burke, Legal Technicians
• Lisa Bean and Marrilyn Johnson, Legal Instrument
  Examiners
• Facsimile Number 703 308-6200

4

• The Boards goal is to have no more than a six
  month inventory of ex parte appeals pending
  decision by September 30, 2003.
• The Biotechnology Division is on track to meet
  that goal.

5
Case Load

• As of October 1, 2002, all pre-2001-XXXX
  biotechnology appeals available for decision have
  been decided.
• As of October 1, 2002, the Biotechnology Division
  had 324 cases on APJs dockets awaiting decision
  (on brief and cases which have been heard and
  awaiting decision) and 85 cases waiting to be
  heard.

6
Hearings

• Hearing notices will be mailed 3-5 months ahead
  of date
• After confirmations/waivers are received in
  initial set of cases, notices will be mailed in a
  second set of cases
• Goal is to have at least 3 cases confirmed for
  each session

7
Hearings

• Special hearings will be scheduled as needed and
  are normally scheduled by way of telephone.
• Requests for rescheduling hearings should be made
  with an earlier date in mind.

8
Role of the Board

• The Board shall, on written appeal of an
  applicant, review adverse decisions of examiners
  upon applications for patents 35 U.S.C.
  6(b)(emphasis added)
• In other words, the Board serves as a board of
  review, not as a de novo examination tribunal.

9
How can you assist in preparing a record which
will facilitate a meaningful review of the
examiners decision?

• Has prosecution/examination been conducted on the
  basis of determining the patentability of
  individual claims?
• Or have the examiners actions and your
  responses been based upon The invention,
  Applicants invention, The instant invention
  etc.

10
Record

• Focus must begin and remain on the claims
• The name of the game is the claim. In re
  Hiniker Co., 47 USPQ2d 1523, 1529 (Fed. Cir.
  1998)
• The sooner counsel and the examiner are
  discussing the patentability of individual
  claims, the sooner the patentability issues will
  be resolved.

11
Record contd

• Remember claim construction in the USPTO differs
  from claim construction in an enforcement action.
• As an initial matter the PTO applies to the
  verbiage of the proposed claims the broadest
  reasonable meaning of the words in their ordinary
  usage as they would be understood by one of
  ordinary skill in the art, taking into account
  whatever enlightenment by way of definitions or
  otherwise that may be afforded by the written
  description contained the applicants
  specification.
• In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d
  1023, 1027 (Fed. Cir. 1997)

12
Record contd

• Has prosecution/examination been based upon the
  most complete set of facts available?
• Are abstracts and/or untranslated documents
  relied upon by you or the examiner?
• Rely upon source documents, translated if needed,
  at the earliest point in the examination process.

13
Record contd

• Have formal matters been completed?
• All petitions been decided?
• Do you have a clear understanding of the status
  of all claims and the entry of all amendments
  after final rejection?

14
Record contd

• Has all prior art of record been properly
  evaluated by you and the examiner?
• The majority of panel remands to examiners and
  new rejections under 37 CFR 1.196(b) involve
  prior art of record.

15
Record contd

• Has all the evidence you intend to rely upon in
  the appeal been entered and considered by the
  examiner?
• Affidavits, declarations, or exhibits submitted
  after the case has been appealed will not be
  admitted without a showing of good and sufficient
  reasons why they were not earlier presented.
• 37 CFR 1. 195

16
Appeal Brief

• The formal requirements of the Appeal Brief are
  set forth in 37 CFR 1.192. See also MPEP
  Chapter 1200.
• In preparing your Appeal Brief be aware that a
  mandatory appeal conference will be held in the
  Technical Center before an Examiners Answer is
  authorized.

17
Appeal Brief

• Brief must contain your complete position.
• Any arguments or authorities not included in
  the brief will be refused consideration by the
  Board of Patent Appeals and Interferences, unless
  good cause is shown.
• 37 CFR 1.192(a)
• Remember requirements of 37 CFR 1.195

18
Appeal Brief Summary of Invention

• Focus on the requirements of individual claims.
  Be specific with references to specification and
  drawings to aid the reader in understanding the
  claims.

19
Appeal BriefSeparate argument of claims

• Separate argument of claims
• 1. If appropriate, simply state Claims do not
  stand or fall together.
• 2. For every rejection, use headings in
  Argument section of brief to highlight
  argument.

20
Appeal BriefSeparate argument of claims, contd

• For example in the Argument section a series of
  headings such as these can be used for each
  rejection
• I. Arguments in response to enablement
  rejection.
• A. Separate argument for claim 1.
• B. Claims 2-3 are patentable for the
  reasons claim 1 is patentable.
• C. Separate argument for claim 4.

21
Reply Brief

• Two reasons to file
• Point to arguments set forth in the Appeal Brief
  which the examiner overlooked.
• Respond to new points of argument made in the
  Examiners Answer.
• Remember the requirements of 37 CFR 1.195

22
Do you know where your case is?

• Know where your case is located in the PTO after
  the briefing is concluded by using PAIR. The
  case should be forwarded to the Board within two
  months of the Reply Brief being acknowledged or
  the Examiners Answer being mailed if no Reply
  Brief is timely filed. MPEP 1210.

23
Summary

• Make sure your case is ready for a decision on
  appeal.
• Briefing should be focused on individual claims.
• Make sure all evidence you need to prove your
  case is entered and considered by the examiner
  before the appeal.
• Remember that the Board serves as a Board of
  review not as a de novo examination tribunal.