Ex Parte WOLF et alDownload PDFPatent Trial and Appeal BoardSep 19, 201813429383 (P.T.A.B. Sep. 19, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/429,383 03/25/2012 IdoWOLF 35938 7590 09/21/2018 Acuity Law Group, P.C. 12707 High Bluff Drive Suite 200 San Diego, CA 92130-2037 UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. GUR-0005-US2 1394 EXAMINER AULT, ADDISON D ART UNIT PAPER NUMBER 1636 NOTIFICATION DATE DELIVERY MODE 09/21/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing© acuity lg. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte IDO WOLF, TAMAR RUBINEK, BELLA KAUFMAN, and LILACH ABRAMOVITCH 1 Appeal2017-001846 Application 13/429,383 Technology Center 1600 Before RICHARD J. SMITH, TA WEN CHANG, and TIMOTHY G. MAJORS, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of treatment comprising administering an isolated polypeptide that includes a claimed amino acid sequence, which have been rejected as indefinite and anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE According to the Specification, "[t]he present invention relates to the field of therapeutics, and more specifically to the use of the klotho protein 1 Appellants identify the Real Party in Interest as Tel Hashomer Medical Research Infrastructure and Services Ltd. (Appeal Br. 4.) Appeal2017-001846 Application 13/429,383 and related compounds for the treatment and diagnosis of cancer, such as breast cancer and pancreatic cancer as well as other IGF-1 dependent cancers." (Spec. 1:16-18.) Claims 1-3, 5, and 9 are on appeal. Claim 1 is illustrative and reproduced below: 1. A method of treatment, comprising administering to a subject in need thereof a pharmaceutically effective amount of a composition comprising an isolated polypeptide including an amino acid sequence having at least 80% homology to the amino acid sequence represented by SEQ ID NO: 2, or a DNA encoding therefor. (Appeal Br. 8 (Claims App.).) The Examiner rejects claims 1-3, 5, and 9 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. (Ans. 2.) The Examiner rejects claims 1-3, 5, and 9 under 35 U.S.C. § I02(b) as being anticipated by Nemoto, 2 as evidenced by Hanai. 3 (Ans. 3.) Oral argument for this appeal took place on September 11, 2018. I. Issue The Examiner has rejected claims 1-3, 5, and 9 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. Claim 1 recites "an amino acid sequence having at least 80% homology to the amino acid sequence represented by SEQ ID NO: 2," and the Examiner concludes that "[t]he term 'represented by' renders the claim 2 Nemoto et al., US 2005/0208015 Al, published Sept. 22, 2005. 3 Hanai et al., WO 00/27885, published May 18, 2000. 2 Appeal2017-001846 Application 13/429,383 indefinite because it is unclear how or if one amino acid sequence may be 'represented by' another amino acid sequence." (Ans. 2.) Appellants contend that [ t ]he plain meaning of "representation" is "something (such as a picture or symbol) that stands for something else." There can be no doubt to one of skill in the art that SEQ ID NO: 2 is not a polypeptide sequence per se, but rather a textual representation of the amino acid sequence of a polypeptide. Thus, stating that a polypeptide has homology to the amino acid sequence represented by SEQ ID NO: 2 is completely unambiguous. (Appeal Br. 5.) The issue with respect to this rejection is whether a preponderance of the evidence of record support the Examiner's conclusion that the phrase "the amino acid sequence represented by SEQ ID NO: 2" is indefinite. Analysis "[A] claim is indefinite when it contains words or phrases whose meaning is unclear." In re Packard, 751 F.3d 1310, 1314 (Fed. Cir. 2014). In this case, we find Appellants to have the better argument. In particular, we agree with Appellants that a skilled artisan reading the claims in light of the Specification would understand that "the amino acid sequence represented by SEQ ID NO: 2" to refer to the single, entire amino acid sequence described or set forth in SEQ ID NO: 2, rather than some other amino acid sequence or group of amino acid sequences. (Appeal Br. 8, Claim 1 ). Accordingly, we reverse the Examiner's rejection of claims 1-3, 5, and 9 as indefinite. 3 Appeal2017-001846 Application 13/429,383 II. Issue The Examiner has rejected claims 1-3, 5, and 9 under 35 U.S.C. § 102(b) as being anticipated by N emoto, as evidenced by Hanai. The Examiner concludes that, based on Guidance dated Dec. 29, 2005, regarding "PTO policy as it relates to [interpretation of] the words 'a' or 'the' [ when referring] to sequences identified by SEQ ID Nos.," a prior art polypeptide "only require[ s] two or more amino acids or homology with the polypeptide set forth in Seq ID No. 2 in order to anticipate" the limitation in claim 1 relating to "sequence having at least 80% homology to ... SEQ ID NO: 2." (Id. at 4.) The Examiner concludes that, "[b ]ased on this claim interpretation, the 80% limitation ... is moot, as any dipeptide of sequence homology will meet the 80% limitation." (Id.) The Examiner then finds that Nemoto teaches administration of a pharmaceutically effective amount of klotho protein ( which is the protein encoded by Seq ID No. 2) to a subject in need thereof . . . . Regarding the specified level of homology (i.e. at least two amino acids), Nemoto does not explicitly teach the klotho sequence, and thus Hanai is relied upon to teach that Nemoto, by teaching administration ofklotho protein, inherently teaches proteins in which at least two amino acids are in common with the sequence set forth in Seq ID No.2. (Id. at 5.) More specifically, the Examiner finds that "[a]n alignment of Hanai's Seq ID No. 2 against Applicant's Seq ID No. 2" shows that "[t]he two sequences are nearly 100% identical." (Id.) The Examiner explains that, "based on the evidence provided in Hanai, any protein described as klotho would have at least two amino acids of homology with Applicant's Seq ID No. 2, and thus would meet the 4 Appeal2017-001846 Application 13/429,383 limitations of Claim 1." (Id.) In the alternative, the Examiner finds that "[t]he Klotho sequence taught by Hanai has higher than 80% sequence identity to SEQ ID NO: 2" and, "given the breadth of Applicant's claim language and the indefiniteness issues, a case of inherency may be made that Nemoto teaches Applicant's claimed method." (Id. at 9.) Appellants contend that the Examiner describes the cited PTO Guidance as stating that "claims referring to 'comprising f! nucleotide sequence of SEQ ID NO: X' could be any dinucleotide or larger, but that claims referring to 'comprising the nucleotide sequence of SEQ ID NO: X' could only be satisfied by the full length of the SEQ ID." (Appeal Br. 6.) Appellants contend that, since the claims refer to "an isolated polypeptide including an amino acid sequence having at least 80% homology to the amino acid sequence represented by SEQ ID No: 2," the claims should be read as requiring an "isolated polypeptide ... hav[ing] 80% homology to the full length of SEQ ID N0:2" in accordance with the Guidance. (Id. at 7 .) Appellants do not separately argue the claims. Accordingly, we limit our analysis to claim 1 as representative. The issue with respect to this rejection is whether Nemoto, as evidenced by Hanai, anticipates claim 1. Analysis We begin our analysis with claim interpretation. We agree with Appellants that "an isolated polypeptide including an amino acid sequence having at least 80% homology to the amino acid sequence represented by SEQ ID NO: 2" requires an amino acid sequence at least 80% homologous to the full length of SEQ ID NO: 2. (Appeal Br. 8, Claim 1 (emphasis added).) 5 Appeal2017-001846 Application 13/429,383 The Guidance cited by the Examiner states that the limitation, "[a] nucleic acid comprising a nucleotide sequence of SEQ ID NO: 1," encompasses "nucleic acids that comprise ... any portion of SEQ ID NO: 1," whereas the limitation, "[a] nucleic acid comprising the nucleic acid of SEQ ID NO: 1," claims "only nucleic acids that comprise the full length of SEQ ID NO: 1, with or without additional nucleotides at either or both ends." (Ans. 4 (emphasis added).) In this case claim 1 recites an amino acid sequence having at least 80% homology to "the" amino acid sequence represented by SEQ ID NO: 2. Thus, pursuant to the Guidance cited by the Examiner, claim 1 requires an amino acid sequence having at least 80% homology to the full length of SEQ ID NO: 2. The Examiner argues that "'an amino acid sequence' having 80% homology to a second sequence may or may not comprise the entirety of the second sequence." (Ans. 12.) In particular, the Examiner argues that "[i]f the claims set forth a step of administering 'an isolated polypeptide having 80% homology to the amino acid sequence of SEQ ID NO: 2 ', the claim could be interpreted as setting forth administration of a peptide encompassing the full length ( or at least 80% of the full length) of SEQ ID NO: 2." (Id.) The Examiner argues, however, that "an isolated polypeptide 'including a sequence having 80% homology' to another sequence 'represented by' a sequence identifier is not as clear, and thus the claim language chose by Applicant leaves the claim open to other interpretations." (Id.) We are not persuaded. To the extent the Examiner's proposed claim construction is based on the alleged indefiniteness of "represented by SEQ ID: NO. 2," we find that the phase is not indefinite for the reasons already 6 Appeal2017-001846 Application 13/429,383 discussed above. To the extent the Examiner's construction is predicated on the phrase "an isolated polypeptide 'including a sequence having [ at least] 80% homology' to [an amino acid] sequence 'represented by' [SEQ ID NO: 2 ]" ( Ans. 12 ( emphasis added)), we find this phrase to be analogous to the phrase "[a] nucleic acid comprising the nucleotide sequence of SEQ ID NO: 1" that is discussed in the Dec. 29, 2005 Guidance, and construe the phrase to mean that the isolated polypeptide may include additional amino acids at either or both ends of the sequence having at least 80% homology with the full length of SEQ ID NO: 2. While we disagree with the Examiner's construction of the claims, however, the Examiner also provides an alternative basis for finding the claims to be anticipated by Nemoto as evidenced by Hanai. As discussed above, the Examiner finds that Nemoto teaches administration of a klotho protein. (Ans. 8.) The Examiner further finds that the amount administered in Nemoto must be inherently "pharmaceutically effective" and finds that Hanai discloses an active domain of a klotho protein that has higher than 80% sequence identity to the full sequence of SEQ ID NO: 2. (Id. at 8-9.) Given the above, the Examiner finds that "a case of inherency may be made that Nemoto teaches Applicant's claimed method." (Id. at 9.) Accordingly, the anticipation rejection over Nemoto as evidenced by Hanai does not depend on adoption of the Examiner's claim construction position, because the Examiner finds that the prior art discloses an amino acid sequence that is at least 80% homologous with the full length of SEQ ID NO: 2. "[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 708 (Fed. 7 Appeal2017-001846 Application 13/429,383 Cir. 1990). The Examiner has articulated a reasonable basis for finding N emoto to inherently anticipate claim 1 in light of Hanai, and Appellants did not file a Reply Brief disputing the Examiner's inherency findings. Given this, we affirm the Examiner's rejection of claim 1 as anticipated by Nemoto as evidenced by Hanai. Claims 2-3, 5, and 9, which are not separately argued, fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv). SUMMARY For the reasons above, we reverse the Examiner's rejection of claims 1-3, 5, and 9 as indefinite and affirm the Examiner's rejection of claims 1-3, 5, and 9 as anticipated by Nemoto as evidenced by Hanai. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 8 Copy with citationCopy as parenthetical citation