BPAI outlines requirements for prima facie rejection of claims under 35 U.S.C. §112, first paragraph, for a genus where specification describes at least one species of the genus
In an appeal from a final rejection, the Board of Patent Appeals and Interferences reversed rejections based on both the written description and enablement requirements of 35 U.S.C. § 112, first paragraph, and entered a new ground of rejection under 35 U.S.C. § 112, second paragraph for one of the claims. The Board found that the claims were directed to a naturally occurring amino acid (or polynucleotide) sequence at least 95% identical to the disclosed amino acid (or polynucleotide) sequence and met the written description requirement. The Examiner has rejected claims for failing to comply with the written description requirement, asserting that the specification provides only a single representative species – the polynucleotide of SEQ ID NO: 2, and fails to disclose any structure-function relationship in this species. The Examiner also rejected the claims for failing to comply with the enablement requirement, asserting that because the specification does not teach the specific amino acids and structural motifs in the proteins encoded by the claimed polynucleotides that are essential for protein activity (specifically, malate dehydrogenase activity), the amount of experimentation required to make the claimed polynucleotides was undue. In response, the Appellants contended that because the claims at issue recite polynucleotides having a naturally occurring polynucleotide sequence, or that encode a polypeptide having a naturally occurring amino acid sequence, “through the process of natural selection, nature will have determined the appropriate amino acid sequences.”
On appeal, the Board sided with the Appellants on whether the claims were supported by the specification for the purposes of 35 U.S.C. §112, first paragraph. Specifically, on the issue of written description, the Board noted that “[t]he written description requirement . . . does not require a description of the complete structure of every species with a chemical genus.” While the Examiner asserted that the disclosure of the single disclosed species does not disclose the structure sufficient to support a genus, the Board found there was insufficient evidence to maintain a rejection under 35 U.S.C. §112, first paragraph, for lack of written description since “the examiner has not adequately explained and/or provided evidence to support that assertion.”
Similarly, with regard to the enablement rejection, the Board disagreed with the Examiner’s assertion that in order to satisfy this requirement, the specification must provide guidance regarding the specific amino acid residues that are tolerant to change without affecting malate dehydrogenase activity. Instead, the Board deemed persuasive the Appellants’ argument that because the claims were limited to naturally occurring sequences, nature will have determined the amino acid residues that are tolerant to change (i.e., naturally occurring variants will presumably retain malate dehydrogenase activity). In particular, in reversing the Examiner’s enablement rejection, the Board determined that the Examiner had not provided sufficient evidence that a naturally occurring polypeptide that is at least 95% identical to the amino acid sequence of SEQ ID NO: 1 or a polypeptide encoded by a naturally occurring polynucleotide sequence that is at least 95% identical to the polynucleotide sequence of SEQ ID NO: 2 would not retain malate dehydrogenase activity. As such, for the purposes of satisfying 35 U.S.C. §112, the disclosure of a natural sequence in and of itself is generally sufficient for disclosing a variance for that sequence, and the Examiner is required to provide evidence that such disclosure is insufficient in order to maintain a prima facie case of failure to comply with 35 U.S.C. §112, first paragraph. Ex parte Bandman, Appeal No. 2004-2319 (BPAI January 6, 2005) (non-precedential).
BPAI interprets closed transition phrase for method claims
In a case involving processes for preparing an organic electroluminescent element, the patent examiner issued a rejection for indefiniteness under 35 USC 112, second paragraph. The examiner indicated that the claimed language of “consisting essentially of” is accepted as “excluding any further steps which materially affect the process.” The examiner further stated that since dependent claims 43, 44, 55 and 56 require the further step of forming a sealing membrane which would affect the claimed process, therefore, these claims contradict “two mutually exclusive limitations.” On appeal at the Board of Patent Appeals and Interferences (BPAI), the Board reversed the examiner. In a non-precedential opinion, the Board held that the phrase “consisting essentially of” does not “limit the claim to only those steps recited in the claim,” Ex parte Hoffman, 12 USPQ2d 1061, 1063 (BPAI 1989), as would a phrase such as “consisting solely of.” In fact, according to the Board, the phrase, “consisting essentially of” does not necessarily limit the claims so as to exclude other things when the specification clearly indicates that other constituents may be present. The Board found that limitations described in the dependent claims were disclosed in the specification. As such, the Board concluded that those elements cannot contradict the basic characteristics of the invention as suggested by the Examiner. Ex parte Ueda, Appeal No. 2004-1584 (BPAI