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BPAI Refuses to Consider Secondary Considerations of Nonobviousness in Obviousness-Type Double Patenting Determination
Practical Law Legal Update 9-516-9616 (Approx. 3 pages)
BPAI Refuses to Consider Secondary Considerations of Nonobviousness in Obviousness-Type Double Patenting Determination
by PLC Intellectual Property & Technology
| Published on 20 Dec 2011 • USA (National/Federal) |
The BPAI refuses to consider the secondary considerations of nonobviousness in affirming the examiner's obviousness-type double patenting rejection of certain pending patent claims even though it reversed the patent examiner's obviousness rejection of those claims based on the secondary considerations.
Key Litigated Issues
In Ex Parte Francis Y.F. Lee, the USPTO Board of Patent Appeals and Interferences (BPAI) reviewed the examiner's rejection of certain pending patent claims based on both:
- Obviousness.
- Nonstatutory, obviousness-type double patenting.
In its decision, the BPAI determined whether:
- The prior art cited by the examiner in its obviousness rejection supported the conclusion that the claimed invention is prima facie obvious and, if so, whether the patent applicant's evidence of the claimed invention's unexpected results outweighs the evidence supporting the prima face case of obviousness.
- Unexpected results used to overcome an obviousness rejection under Section 103 of the Patent Act can be used to overcome an obviousness-type double patenting rejection of the same claims.
Background
The claims of the patent application in Ex Parte Francis Y.F. Lee involve a method of treating pancreatic or lung cancer by administering a combination of:
- Compound (1), also known as ixabepilone, C-15-Aza-EpoB, 15-Aza-EpoB or BMS 247550.
- Antibody C225, also known as cetuximab.
The examiner rejected the claims:
- As obvious in view of the combination of multiple prior art references, some of which teach ixabepilone for treating cancer, and another reference which teaches treatment of cancer using cetuximab (35 USC § 103(a)(2011)).
- For obviousness-type double patenting because:
- the examiner believed that the patent applicant's claimed invention was not patentably distinguishable from claims in the patent applicant's previous reissue patent since the prior art reference teaches the treatment of cancer using cetuximab and the patent applicant's previous reissue patent teaches a method of using ixabepilone to treat cancer; and
- the patent applicant did not file a terminal disclaimer to overcome the double patenting rejection.
The patent applicant then appealed to the BPAI.
Outcome
The majority's December 14, 2011, opinion reversed the examiner's obviousness rejection based on evidence that the claimed invention provided unexpected results. Specifically, the patent applicant submitted a declaration providing data comparing the results of treating cancer with a combination of ixabepilone and cetuximab to the results of treatment using either ixabepilone or cetuximab alone. This data showed the claimed method of treating cancer with the combination of compounds was more effective in treating cancer than treatment with either compound alone.
The Board noted that the patent applicant demonstrated substantially improved results and that the results were unexpected while the examiner did not provide any evidence or technical reasoning to support a conclusion that the data did not show unexpected results over the entire scope of the claims.
However, the majority affirmed the nonstatutory, obviounsess-type double patenting rejection. It cited Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F3d 989 (Fed. Cir. 2009) and Geneva Phams. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003) to support its position that evidence of unexpected results could not be used to rebut an obviousness-type double patent rejection.
Practical Implications
This opinion may be appealed. In the meantime, patent applicants faced with an obviousness-type double patenting rejection should continue to consider filing a terminal disclaimer rather than relying solely on any secondary considerations of nonobviousness.