Ex parte JACQUES DUMAS (Bayer Corporation)
Appeal 2008-3379
Application 09/838,286
Technology Center 1600
Decided: February 10, 2009
Claim at issue:
50. A method of treating a disease mediated by p38 within a host, said method comprising administering to said host a compound of Formula I.
The Examiner rejected claims 50 and 52-56 under 35 U.S.C. § 112, first paragraph as enabled for treating rheumatoid arthritis, osteoarthritis and septic arthritis with the compound of formula I but not reasonably enabled for “a method of treating a disease mediated by p38 within a host” with the compound of formula I.
Appellants contend “[n]o evidence has been presented which even suggests that any compounds of this invention, as inhibitors of p38, would not be effective in treating the diseases defined by the functional language. Furthermore, no evidence has been presented of the ‘undue experimentation,’ allegedly necessary to practice the invention commensurate in scope with the claims” (App. Br. 3). Appellants contend that “one of ordinary skill in the art, by performing the same or similar tests, can, by routine experimentation, determine the activity levels of each of the claimed compounds in treating various p38 mediated diseases”
The Board found that "The art cited by the Examiner provides extensive evidence of the unpredictability of p38 inhibitors in treating diseases, including diseases expressly listed in the Specification" and affirmed the holding that the claims were not enabled for the entire scope. The Board affirmed the Examiner stating: "The Specification only teaches methods of making the compounds of formula I with no teaching or examples of specific diseases on which the compounds are predicted to function (FF 1-4)." The found that there was significant unpredictability in the art.
“If mere plausibility were the test for enablement under section 112, applicants would obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.” Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318. The Appellants argued that they did not have to enable every species but the Board stated "while a claim may encompass some inoperable subject matter, it must encompass some operable matter."--Almost seeming to indicate that any method isn't enabled but they did defer to the Examiner on the 3 conditions that are mentioned above.
Case can be found here
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