Ex Parte ENDO et alDownload PDFPatent Trial and Appeal BoardJun 27, 201412125569 (P.T.A.B. Jun. 27, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte HIROFUMI ENDO, YOSHIYUKI YONETANI, HIROSHI MIZOGUCHI, SHIN-ICHI HASHIMOTO, and AKIO OZAKI, ____________ Appeal1 2012-009421 Application2 12/125,569 Technology Center 1600 ____________ Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a process of producing a compound using host cells transformed with the nucleotide sequence set out in SEQ ID NO:2. The Examiner has rejected the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The record contains an Oral Hearing Transcript of the hearing held June 12, 2014. 2 Appellants identify Kyowa Hakko Bio Co., Ltd. as the Real Party in Interest. (App. Br. 3.) Appeal 2012-009421 Application 12/125,569 2 STATEMENT OF THE CASE Claims 1-12 are on appeal, and are reproduced in the Claims Appendix of the Appeal Brief. The Examiner has rejected claims 1-12 under 35 U.S.C. § 102(b) as anticipated by Endo WO 00/44886.3 The Issue The Examiner takes the position that the present application is not entitled to the benefit of priority to Endo ’1114 and ultimately to the International Application Endo WO 00/44886 because “SEQ ID NO: 2 as disclosed in the instant application is not [identical to] SEQ ID NO: 2 as disclosed in U.S. Application No. 09/869,334 [now Endo ’111].” (Ans. 7 (emphasis omitted).) “SEQ ID NO: 2 in U.S. Application No. 09/869,334 [Endo ’111] differs from SEQ ID NO: 2 of the instant application by one nucleotide at position 462.” (Id.) The issue with respect to this rejection is whether Appellants have established that the Examiner erred in (i) determining that the claims are not entitled to a benefit date of January 29, 1999, and (ii) applying WO 00/44886 as prior art? Findings of Fact FF1. The Specification provides a hydroxylase protein, “[a] protein having the amino acid sequence shown by SEQ ID NO: 1.” (Spec. 9.) 3 Endo et al., WO 00/44886 filed Jan. 28, 2000, which claims benefit to the Japanese Application 11-21707, filed Jan. 29, 1999. 4 Endo et al., U.S. Application No. 09/869,334, now Patent No. US 7,049,111. Appeal 2012-009421 Application 12/125,569 3 FF2. The Specification provides “[t]he DNA fragment amplified by PCR with a combination of primers of SEQ ID NO:27 and 28 above, contained the nucleotide sequence shown by SEQ ID NO:2; and said nucleotide sequence contained a nucleotide sequence encoding a protein having the amino acid sequence shown by SEQ ID NO:1.” (Spec. 41.) Analysis Appellants contend [t]he Sequence Listing of the ‘111 patent also discloses the protein encoded by SEQ ID NO: 2, which protein is designated SEQ ID NO: l. Appellant submits that SEQ ID NOS: 1 and 2 of the ‘111 patent, and that SEQ ID NOS: 1 and 2 as disclosed in the “CRF Sequence Listing File” in the Image File Wrapper of the ‘334 application with mail room date October 4, 2001 both indicate that SEQ ID NO: 2 encodes the protein of SEQ ID NO: 1. Further, both documents indicate that nucleotides 460- 462 of SEQ ID NO: 2 code for a histidine (His) residue at position 154 of SEQ ID NO: l. However, incorrect substitution of a “g” at position 462 would result in a corresponding glutamine (Gln) residue, not His. Accordingly, one of ordinary skill in the art would have immediately known that substitution of a “g” at position 462 of SEQ ID NO: 2 was incorrect in view of the other disclosure in the ‘111 patent and in view of the ‘334 application papers as filed. (App. Br. 23; see also Reply Br. 15; see also Oral Hearing Transcript 10.) Although we find the Examiner’s position is well-reasoned, given the particular facts presented in the prosecution history of the present Specification, we find that the totality of the evidence weighs in favor of Appellants. Specifically, the Specification discloses that SEQ ID NO: 2 encodes the amino acid sequence set out in SEQ ID NO:1 (FF 1 & 2). As pointed out by Appellants, the substitution of “g” instead of “t” at position 462 of SEQ ID NO:2 would results in a change in the amino acid sequence Appeal 2012-009421 Application 12/125,569 4 from the correct amino acid histidine to a glutamine in the amino acid sequence of SEQ ID NO:1. However, a review of the Specification and all listed benefit applications, each shows that SEQ ID NO:1 at all times contained the correct amino acid His at that critical position. Here, the benefit application resulting in Endo ’111 shows that SEQ ID NO: 2 as disclosed in the sequence listing associated with Endo ’111 could not encode for SEQ ID NO:1 as described in the Specification. The nucleotide sequence listened in SEQ ID NO: 2 of Endo ’111 would result in a change of the amino acid from His to Gln in the associated amino acid sequence. Appellants contend that SEQ ID NO: 2 was correct in the sequence listing as originally filed in Endo ’111 (App. Br. 21, see also 23, 25). Indeed, a review of the file wrapper associated with the prosecution history of Endo ’111 shows that the sequence listing of Oct. 4, 2001, contains SEQ ID NO:2 with the correct sequence while the sequence submitted on Dec 28, 2001 contains the typographical error at position 462 changing the “t” to a “g.” Because SEQ ID NO: 2 encodes for the amino acid of SEQ ID NO:1, we agree with Appellants position that a typographical error was inadvertently introduced into the record of Endo ’111.5 Based on the totality of the evidence of this record, we find that 5 We note that during oral argument, Appellants acknowledge that there were two viable alternatives for correcting the typographical errors in the sequence in Patent No. US 7,049,111, either by filing a reissue or by filing a continuation application. Either route would have introduced more prosecution into the application, and Appellants indicated that due to the way amendments are introduced in reissue cases “it made a whole lot more practical sense and expediency to go the more familiar route” of filing a continuation (Oral Hearing Transcript 6). Appeal 2012-009421 Application 12/125,569 5 there is no break in the chain of continuity of the benefit applications; as such, the present application is entitled to the earliest benefit date. Because the present application is entitled to the earliest benefit date, Endo WO 00/4486 is not available as prior art under 35 U.S.C. § 102(b). We reverse the rejection of claims 1-12 as anticipated by Endo WO 00/44886. SUMMARY We reverse the rejection of claims 1-12. REVERSED lp Copy with citationCopy as parenthetical citation