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A Reference That Lists Every Fifteen-Base Sense Oligodeoxynucleotide in a Known Nucleic Acid Sequence Anticipates Claims to Specific Antisense Sequences Having Particular Properties

March 26, 2009

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Last Month at the Federal Circuit - April 2009

Judges: Michel, Prost (author), Moore

[Appealed from: Board]

In In re Gleave, No. 08-1453 (Fed. Cir. Mar. 26, 2009), the Federal Circuit affirmed the Board’s rejection of specific claims of a patent application under 35 U.S.C. § 102(b).

The patent application at issue, U.S. Patent Application No. 10/346,493 (“the ’493 application”), filed by Martin Gleave and Maxim Signaevsky (collectively “Gleave”), was directed to an antisense oligodeoxynucleotide, which can simultaneously bind to and prevent the translation of mRNA into two types of human Insulin-Dependent Growth Factor Binding Protein (“IGFBP”), methods of making pharmaceutical compounds containing the oligodeoxynucleotides, and methods of treating endocrine-regulated cancers by using the oligodeoxynucleotides to prevent the formation of IGFBP-2 and IGFBP-5.

The examiner rejected claims 1, 4, 15, and 18-21, all of which were composition claims directed to antisense oligodeoxynucleotides, as indefinite under 35 U.S.C. § 112, ¶ 2, and as anticipated or obvious under 35 U.S.C. §§ 102(b) and 103(a). The claims were rejected over the published PCT application 00/78341 of Wraight et al. (“Wraight”). In Wraight, the applicants listed every fifteen-base sense oligodeoxynucleotide in the IGFBP-2 gene. The list included more than 1400 sequences.

The Board reversed the examiner’s § 112, ¶ 2 rejection and affirmed the § 102(b)/103(a) rejections. Gleave appealed the § 102/103 rejections. The issue presented on appeal was whether a reference that lists every fifteen-base sense oligodeoxynucleotide in a known nucleic acid sequence anticipates or renders obvious claims to specific antisense sequences having particular properties. Gleave argued that Wraight did not describe any particular antisense species because Wraight merely listed the oligodeoxynucleotide sequences without inventive thought, without guidance to make particular selections, and without understanding of which of the targets would be useful.

The Federal Circuit first noted that a reference need not disclose independent use or utility to anticipate a claim under § 102. The Federal Circuit made clear that where a method claim was at issue, the “make” requirement becomes, in effect, a “use” requirement; the only way one can show that a reference enables the method is to show that a person of ordinary skill would know how to use the method in light of the reference. This did not mean, however, that the prior art reference must demonstrate the invention’s utility.

Because Gleave’s claims were to compositions of matter—oligonucleotides—a reference satisfied the enablement requirement of § 102(b) by showing that one of skill in the art would know how to make the relevant sequences disclosed in Wraight. Gleave admitted that it was within the skill of an ordinary person in the art to make any oligodeoxynucleotide sequence, and as such, Wraight was an enabling disclosure.

The Federal Circuit next addressed Gleave’s policy argument that where there is no basis in the art for selecting some individual members of the listing over others, what is actually described and what is actually disclosed to the public is no more than the generic concept underlying the list. The Court distinguished In re Wiggins, 488 F.2d 538 (C.C.P.A. 1973), saying in that case, no evidence existed that a person of ordinary skill in the art could make the compounds disclosed in the allegedly anticipatory reference at the time of disclosure. The Court read Wiggins as standing for the proposition that the mere naming of a theoretical compound, without more, cannot constitute a description under § 102(b).

Finally, the Court addressed Gleave’s argument that Wraight did not show that sequences antisense to any of the sequences in the application were actually made and tried. Citing In re Donohue, 766 F.2d 531 (Fed. Cir. 1985), the Court again made clear that it was not necessary that an invention disclosed in a publication have actually been made in order to satisfy the enablement requirement.

The Court stated that the discovery of a new property or use of a previously known composition cannot impart patentability to claims to the known composition. If the use is new, Gleave could patent the method of use of the compound but not the previously discovered compound itself. The Court therefore affirmed the Board’s rejection of claims 1, 4, 15, and 18-21 of the ’493 application under § 102(b). The Court did not address the § 103 obviousness rejection.