Tuesday, February 10, 2009

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