Written Description Requires Specification to be Read as a Whole (BPAI)

Ex parte FREDERICK KHACHIK (BPAI)
Appeal 2009-25571
Application 11/702,486
Technology Center 1600
Decided: February 20, 2009

21. A lutein composition suitable for human consumption which
comprises:
(a) at least about 90% lutein having been extracted and purified from plant extracts which contain 10% or less of non-lutein carotenoids,

(b) no traces of toxic chemicals that would render the lutein composition unsuitable for human consumption, and
(c) significantly less than about 10% of non-lutein carotenoids obtained by purification of said plant extracts.

The examiner rejected the claim for lacking written description. The Examiner alleges that the specification would be understood to only include a limitation of at least 97%, not 90%. The patent disclosed two statements that are relevant:

1. "after recrystallization, the purity of “the resulting lutein is usually greater than 90%, most often greater than 97%." with two working examples of greater than 97%.

2. The specification also disclosed “[w]hile 70% pure lutein may be acceptable for use in animal feed, further purification of this compound may be employed to produce lutein with purity greater than 97% for human consumption”

The examiner relied upon the second to state that specification only described greater than 97% while ignoring the first statement. The Board disagreed finding that read as a whole the specification adequately described the 90% limitation. The Board stated that the second phrase only says that further purification may be employed, "but [the specification] does not say that only lutein compositions with 97% purity are suitable for human consumption." Therefore, the claim satisfied the written description requirement.

Case can be found here

Enablement requires both how to use and how to make-BPAI

Ex parte SAMUELSON (BPAI)
Appeal 2008-5927
Application 10/958,452
Technology Center 1600
Decided: February 10, 2009

16. A method of modulating the conformation of DNA (deoxyribonucleotides) double helix which is bound to polyaniline in a complex, comprising changing the oxidation state of the polyaniline.

The claim was rejected for not being enabled. The Examiner did not reject it on how to make but rather on "how to use." The Examiner found that it would require undue experimentation to use the invention. The Board looked to the specification for the uses and agreed. Therefore, although the "use" was not in the claim it was read into the claim for purposes of determining whether the claim was enabled.

The Examiner reasoned "the specification does not provide any example or other form of enabling guidance as to how the changes in oxidation state of polyaniline-dsDNA is to be used in a method that has utility, and no declaration has been filed which would show that appellants have been able to use the invention in the manner disclosed, using the guidance provided. This lack of showing, and the teachings of Zhang et al., some 9 years post effective filing date, all point to the instant disclosure as not being enabling for the claimed invention."

The Board summarized the law as follows:
The Court has explained that “‘the how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention.’” In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999), quoting In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). “Patent protection is granted in return for an enabling disclosure . . . , not for vague intimations of general ideas that may or may not be workable.”

The Board held: Balancing the Wands factors, we agree with the Examiner that undue experimentation would have been required to use the claimed invention. With a Specification that only teaches methods of making the DNA-polyaniline complex (FF 2-8), with no guidance as to how modulating the DNA-polyaniline complexes results in a practical, real world use, such as use as a biosensor (FF 9-11), the significant experimentation required for use the polyaniline-DNA complex in the claimed method, and the unpredictibilty of the prior art, we conclude that it would require an undue amount of experimentation to use the polyaniline-DNA complex in a method of modulating conformation as set forth in the claim 16.

Case can be found here

Enablement requires more than "mere plausibility'--BPAI

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