10186186 (B.P.A.I. Dec. 23, 2009)

Ex Parte Logtenberg

Board of Patent Appeals and InterferencesDec 23, 2009

10186186 (B.P.A.I. Dec. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte TON LOGTENBERG __________ Appeal 2009-009549 Application 10/186,186 Technology Center 1600 __________ Decided: December 23, 2009 __________ Before TONI R. SCHEINER, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 from the rejection of claims 17, 21, 46-48, 52, 55, and 58-60, directed to molecules that bind Ep-CAM (epithelial cell adhesion molecule). The claims have been rejected as failing to comply with the written description requirement (new matter). We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2009-009549 Application 10/186,186 2 STATEMENT OF THE CASE Claims 16, 17, 19-21, 44-48, and 51-76 are pending, but only claims 17, 21, 46-48, 52, 55, and 58-60 are on appeal as claims 61-76 have been withdrawn from consideration (Ans. 2), and the Examiner has indicated claims 16, 19, 20, 44, 45, 51, 53, 54, 56, and 57 allowable (id.).1 Allowable independent claim 16 is reproduced for clarity, and reads as follows: 16. A molecule that binds to Ep-CAM, said molecule comprising a human heavy chain variable CDR3 region consisting of the amino acid sequence DPFLHY (SEQ ID NO: 6). Claims 17, 46, and 47 are representative of the subject matter on appeal: 17. The molecule of claim 16, further comprising a human light chain variable CDR3 region, the CDR3 region consisting of the amino acid sequence MQALQTFTF (SEQ ID NO: 7). 46. The molecule of claim 16, further comprising a human heavy chain variable region consisting of the amino acid sequence of SEQ ID NO: 10. 47. A molecule that binds to Ep-CAM, comprising a human heavy chain variable region comprising a CDR3 region consisting of the amino acid sequence DPFLHY (SEQ ID NO: 6) and a human light chain variable region comprising a CDR1 region consisting of an amino acid sequence of RASQTISNNYLA (SEQ ID NO: 12) or RASQSVSSSYLA (SEQ ID NO: 13). 1 The Examiner indicated that “rejections under 35 USC 103 . . . 35 USC 112, second paragraph and 35 USC 112, first paragraph (new matter) for claims 16, 19-20, 44-45, 51, 53-54 and 56-57 have been withdrawn and are no longer issues to be reviewed on Appeal” (Ans. 3). Appeal 2009-009549 Application 10/186,186 3 The sole rejection on appeal is the rejection of claims 17, 21, 46-48, 52, 55, and 58-60 under 35 U.S.C. § 12, first paragraph, as failing to comply with the written description requirement. We reverse. ISSUE Figure 2 of the Specification as originally filed shows the amino acid sequences of the anti-Ep-CAM antibody UBS-54 and two higher affinity mutant antibodies, A37 and C52 (Spec. 26: 11-12). Claims 17, 21, 46-48, 52, 55, and 58-60 are directed to molecules comprising discrete regions (designated SEQ ID NOS: 7-13) of the amino acid sequences shown in Figure 2. SEQ ID NOS: 7-13 were first included in a sequence listing filed after the filing date of the instant application. The Examiner’s position is that Figure 2 “disclose[s] the entire or whole sequence of the antibody” (Ans. 4), but the regions designated SEQ ID NOS: 7-13 weren’t “carved out from the whole, specific antibody” until after the present application was filed (id.). Appellant contends that SEQ ID NOS: 7-13 correspond to various domains of the antibody, which are “identified in FIG. 2 by their common names and it is well known in the art that the common names shown in FIG. 2 indicate functional regions of the antibody sequence” (App. Br. 9). The issue raised by this rejection is whether Appellant’s disclosure, as originally filed, conveys with reasonable clarity to those skilled in the art that Appellant was in possession of Ep-CAM binding molecules comprising regions consisting of the amino acid sequences of SEQ ID NOS: 7-13. Appeal 2009-009549 Application 10/186,186 4 FINDINGS OF FACT The Invention FF1 Figure 2 of the Specification as originally filed, shows the amino acid sequences of the anti-Ep-CAM antibody UBS-54 and two higher affinity mutant antibodies, A37 and C52, separated into various functional domains, labeled CDR1, CDR2, etc. (Spec. 26: 11-12). Figure 2 is reproduced immediately below: FF2 A Sequence Listing was filed on September 9, 2004 (after the filing date of the instant application), which included new SEQ ID NOS: 7- 13, corresponding to several functional domains of the molecules shown in Figure 2. FF3 The Examiner rejected claims 17, 21, 46-48, 52, 55, and 58-60, directed to molecules comprising portions of the larger amino acid sequences shown in Figure 2 (i.e., the portions designated SEQ ID NOS: 7- 13), as lacking written descriptive support in the Specification as originally filed. FF4 Claim 17 is directed to an Ep-CAM binding molecule comprising a human light chain variable CDR3 region consisting of the Appeal 2009-009549 Application 10/186,186 5 amino acid sequence MQALQTFTF, which corresponds to SEQ ID NO: 7. The sequence MQALQTFTF, labeled CDR3, is shown as a subsection of the sequence shown in Figure 2. FF5 Similarly, claim 21 is directed to an Ep-CAM binding molecule comprising a human heavy chain variable CDR2 region consisting of the amino acid sequence IPIFGT, which corresponds to SEQ ID NO: 8, and a human heavy chain variable CDR1 region consisting of the amino acid sequence GGTFSSY, which corresponds to SEQ ID NO: 9. The sequence IPIFGT, labeled CDR2, and the sequence GGTFSSY, labeled CDR1, are shown as subsections of the sequence shown in Figure 2. FF6 SEQ ID NOS: 10 and 11, the variable heavy and light chains of the UBS-54 antibody, respectively, are shown separately in Figure 2. FF7 SEQ ID NOS: 12 and 13, the CDR1 regions of the mutant antibodies A37 and C52, respectively, are also labeled and shown as subsections of the sequence shown in Figure 2. PRINCIPLES OF LAW “The purpose of the written description requirement is to prevent an applicant from later asserting that he invented that which he did not.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003). “In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. See id. Appeal 2009-009549 Application 10/186,186 6 ANALYSIS There is no dispute that the molecules shown in Figure 2 of the Specification include all of the subsequences designated SEQ ID NOS: 7-13. Moreover, the subsequences are actually shown as separate, functional domains of the whole molecules. That is, the spaces inserted between the different domain subsequences in Figure 2 are present solely to permit immediate identification of which amino acids belong to which subsequences and their corresponding domains. Therefore, we don’t agree with the Examiner that “[n]othing in the original claims or specification provides any blaze marks . . . leading from the full length polypeptide” to the fragments of SEQ ID NOS: 7-13 (Ans. 5). CONCLUSIONS OF LAW Appellant’s disclosure, as originally filed, conveys with reasonable clarity to those skilled in the art that Appellant was in possession of Ep- CAM binding molecules comprising regions consisting of the amino acid sequences of SEQ ID NOS: 7-13. The rejection of claims 17, 21, 46-48, 52, 55, and 58-60 under 35 U.S.C. § 112, first paragraph, is reversed. REVERSED clj TRASKBRITT, P.C. P.O. BOX 2550 SALT LAKE CITY, UT 84110