BIOTECHNOLOGY/CHEMICAL/PHARMACEUTICAL CUSTOMER PARTNERSHIP MEETING

6 June 2012

Suzannah K. Sundby Smith, Gambrell & Russell, LLP

Copies of the handouts from this meeting and from prior meeting can be obtained at http://www.cabic.com/bcp/. Copies of materials from this meeting and prior meetings are also available at the American Intellectual Property Law Association (AIPLA) Biotechnology Committee web page.

George Elliott opened the meeting by noting various directors and specialists in Technology Center 1600. See the handout for a list of names, art units and telephone numbers for TC1600 management.

Susan Wolski, PCT Legal, gave a presentation on the proposed transition to the XML standard, i.e. ST.26, for sequence listings in order to set forth a “standardized” formate that is accepted by most, if not all, patent offices. She indicated that if the XML standard is implemented, software will be made available. Comments on the XML standard and its implementation are due 16 July 2012. The AIPLA Biotechnology Committee requests that all members review the proposed XML standard and complete the survey so that the Committee may provide comments and recommendations which represent the majority of its members.

***Recommendations on implementation of the XML standard and applicability are strongly encouraged. Specifically, the USPTO proposes a "clean" transition date in which ALL applications (including continuing applications) must comply with the new standard. It should also be noted that under the XML standard, the file size as well as the printed XML code is expected to be 5-10 times larger than the current standard. Thus, the Committee would appreciate specific comments on whether Applicants should be permitted to file a paper/image copy of the sequences in any format (e.g., the ST.25 standard or simply provide the sequences with written descriptions of any variants), which may be fully relied upon for support and/or correction of the XML format Sequence Listing if needed, without incurring any application size or other fees. Finally, the proposed XML standard will require that variant sequences specifically mentioned in the specification are set forth in the Sequence Listing as individual sequences having their own SEQ ID NOs and that all sequence variants that are disclosed only by reference to a primary sequence in the Sequence Listing (e.g., deletions, additions, or substitutions) are set forth in the Sequence Listing as individual sequences having their own SEQ ID NOs or by annotation of the primary sequence as features/qualifiers. Thus, the Committee would appreciate specific comments on whether these requirements are reasonable or unduly burdensome.

Janet Gongola, Patent Reform Coordinator, gave a presentation on AIA implementation. She noted that in view of the comments on the proposed fees, the final rules on the fees will be modified such that the costs of applications and prosecution are back-loaded in the maintenance fees. The final rules on the first rules packages (Oath/Dec, Preissuance, Supplemental Exam, Citation of Prior Art, IPR, PGR, Derivation) are expected to be published sometime in July-August 2012 and will be effective 16 September 2012. She also indicated that the final rules for the oath/declaration provisions are expected to be significantly different from the proposed rules due to comments that the proposed rules do not adequately reflect the AIA provision and intent. The First-to-File proposed rules package and guidance materials are expected to be published in June-July 2012, and after comment period, the final rules will be published by 16 February 2013 with an effective date of 16 March 2013. She also indicated that the proposed rules for micro-entity status are published and public comments are due 30 July 2012.

Jerry Lorengo, SPE, TC1700, gave a presentation on the Cooperative Patent Classification (CPC, i.e. EPO and USPTO bilateral classification system). The final stage of CPC will be implemented in 2015. The CPC general website is at http://www.CPCinfo.org.

Jeffrey Lundgren, SPE, TC1629, gave a presentation on claim interpretation. The presentation provided guidance on whether or not a preamble will likely be limiting. The construction of terms that are not explicitly defined in the specification was also covered. Finally, the patentability of product-by-process claims were discussed.

Roberte Makowski of Connolly Bove Lodge & Hutz, LLP and Hans Sauer, Associate General Counsel for BIO presented on Mayo v. Prometheus, subsequent cases and practice tips.

Jean Witz, QAS, TC1600, gave a thoughtful presentation on legal trends regarding ranges and anticipation. The issues and cases she covered relate to the fine line between overlapping ranges that anticipate and those that suggest a claimed range.

Future Meeting – The next BCP meeting is 5 September 2012. If there are any issues or topics that you wish to hear, please let the biotechnology committee know about them or send your ideas to Cecilia Tsang (571-272-0562 or [email protected]) or to the Group Directors.

Happy Hour – A few of us who attend the BCP meeting in person have begun an informal happy hour tradition at the Trademark Bar after the BCP meeting. Come join us after the next BCP meeting for and lively discussions having little to do with patent law.