Biotechnology/Chemical/Pharmaceutical 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 Board’s goal is to have no more than a six month inventory of exparte 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 APJ’s 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 denovo examination tribunal.

9. How can you assist in preparing a record which will facilitate a meaningful review of the examiner’s decision? Has prosecution/examination been conducted on the basis of determining the patentability of individual claims? Or have the examiner’s actions and your responses been based upon “The invention,” “Applicant’s invention,” “The instant invention” etc.

10. Record Focus must begin and remain on the claims “[T]he 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 cont’d Remember claim construction in the USPTO differs from claim construction in an enforcement action. “[A]s 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 applicant’s specification.” In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997)

12. Record cont’d 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 cont’d 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 cont’d 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 cont’d 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 Examiner’s 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 toaid 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, cont’d 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 Examiner’s 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 Examiner’s 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 denovo examination tribunal.