Ex Parte Simard et alDownload PDFPatent Trial and Appeal BoardApr 30, 201411067159 (P.T.A.B. Apr. 30, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte JOHN J. L. SIMARD, DAVID C. DIAMOND, and ZHENG LIU1 __________ Appeal 2012-006800 Application 11/067,159 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC GRIMES, and JOHN G. NEW, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a nucleic acid encoding part of a tumor-associated antigen, which have been rejected for anticipation, obviousness, and double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Party in Interest as MannKind Corporation (App. Br. 3). Appeal 2012-006800 Application 11/067,159 2 STATEMENT OF THE CASE The Specification states that “[f]or a T cell to respond to an antigen, it requires the antigen to be processed to peptides which are then bound to a presenting structure encoded in the major histocompatibility complex (MHC)” (Spec. 3, ¶ 11). “MHC proteins have a peptide binding cleft on their external portions. It is in this cleft that small fragments of proteins, endogenous or foreign, are bound and presented to the extracellular environment” (id. at 4, ¶ 12). The Specification states that the “invention relates to an epitope cluster, the cluster being derived from an antigen associated with a target, the cluster including or encoding at least two sequences having a known or predicted affinity for an MHC receptor peptide binding cleft, wherein the cluster is an incomplete fragment of the antigen” (id. at 8, ¶ 27). Claims 1-5, 9-12, 14-16, 18, and 20-24 are on appeal. Claims 1 and 21 are the only independent claims and read as follows: 1. An isolated nucleic acid comprising a reading frame comprising a first sequence, wherein said first sequence encodes one or more segments of tumor-associated antigen PRAME (SEQ ID NO: 77), wherein the first sequence does not encode the complete PRAME antigen, and each segment comprises an epitope cluster, said cluster comprising at least two amino acid sequences having a known or predicted affinity for a same MHC receptor peptide binding cleft, and wherein said reading frame is operably linked to a promoter. 21. An expression vector comprising a promoter operably linked to means for encoding an amino acid sequence comprising at least one PRAME epitope cluster, wherein said means do not encode the complete PRAME antigen. Appeal 2012-006800 Application 11/067,159 3 The claims stand rejected as follows: • Claim 21 on the basis that the Specification does not explicitly disclose the structures corresponding to the recited “means for encoding an amino acid sequence comprising at least one PRAME epitope cluster” (Ans. 5); • Claims 1, 3, 4, 14-16, 18, 20, 21, and 23 under 35 U.S.C. § 102(a) as anticipated by Chiang2 (Ans. 7); • Claims 1-5, 9-12, 14-16, 18, and 20-24 under 35 U.S.C. § 103(a) as obvious based on Chiang and Simard3 (Ans. 8). • Claims 1, 3, 4, 5, 9, 10, 14-16, 18, 20, 21, and 23 (provisionally) for obviousness-type double patenting based on claims 17-19, 22-34, and 36-43 of application 10/292,4134 in view of Chiang (Ans. 13); and • Claims 2, 11, 12, 22, and 24 (provisionally) for obviousness-type double patenting based on claims 17-19, 22-34, and 36-43 of application 10/292,413 in view of Chiang and Simard (Ans. 16-17). I. The Examiner has rejected claim 21 on the basis that it includes a means-plus-function limitation but the “written description only implicitly or inherently sets forth the corresponding structure, material or acts that perform the claimed function, without explicitly disclosing which structures 2 Chiang, WO 2004/112825 A2, Dec. 29, 2004. 3 Simard, WO 02/081646 A2, Oct. 17, 2002. 4 The ʼ413 application issued Jan. 28, 2014 as U.S. Patent 8,637,305. Appeal 2012-006800 Application 11/067,159 4 correspond to the ‘means’” (Ans. 5).5 The Examiner concludes that (a) claim 21 must be amended so that it is not in means-plus-function format, or (b) the Specification must be amended to expressly recite the structure corresponding to the means, or (c) Appellants must state on the record what the corresponding structure is (id. at 6-7). Appellants argue that the MPEP only requires that the Specification adequately associates particular structure with the function or “it is clear based on the facts of the application that one skilled in the art would have known what structure, material, or acts perform the function recited” (App. Br. 19). Appellants argue that the Examiner acknowledges that the structure corresponding to the means is “implicitly or inherently set forth” in the Specification and, Appellants argue, those skilled in the art would understand the structure that performs the recited function (id. at 19-20). We agree with Appellants that the Examiner has not established that claim 21 fails to meet the statutory requirements of patentability. The Examiner relies on 37 C.F.R. § 1.75(d) and MPEP §§ 608.01(o) and 2181 (Ans. 6). MPEP § 2181, however, expressly states that “[t]he disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what 5 The Examiner does not identify any section of Title 35 of the United States Code that claim 21 fails to comply with. We presume that the rejection is based on either a lack of descriptive support under 35 U.S.C. § 112, first paragraph, or indefiniteness under 35 U.S.C. § 112, second paragraph. Appeal 2012-006800 Application 11/067,159 5 structure (or material or acts) corresponds to the means (or step)-plus- function claim limitation.” MPEP § 2181(II)(A).6 Those skilled in the art are aware that the structure that carries out the function of encoding an amino acid sequence is a nucleic acid (DNA or RNA) sequence. The Examiner’s acknowledgement that the Specification “implicitly or inherently sets forth the corresponding structure” (Ans. 5), coupled with the knowledge of those skilled in the art that the structure corresponding to the function is a nucleic acid made up of codons specifying, via the genetic code, a sequence of amino acids from the PRAME antigen, leads us to the conclude that the Examiner has not persuasively shown that claim 21 is unpatentable because of its means-plus- function limitation. II. The Examiner has rejected claims 1, 3, 4, 14-16, 18, 20, 21, and 23 as anticipated by Chiang, and has rejected all of the claims on appeal as obvious based on Chiang and Simard. The same issue is dispositive with respect to both rejections. The Examiner finds that Chiang discloses all of the limitations of most of the claims on appeal (Ans. 7-8) and concludes that its combination with Simard would have made obvious the remaining claims (id. at 8-12). The Examiner concludes that Chiang and Simard are available as prior art because, even though the instant application claims the benefit of application 6 The provisions of 37 C.F.R. § 1.75(d) and MPEP §§ 608.01(o) simply require that terms in a claim are adequately defined in the corresponding specification; they are not specific to the sixth paragraph of 35 U.S.C. § 112. Appeal 2012-006800 Application 11/067,159 6 10/117,937, filed April 4, 2002, the instant claims are not entitled to the earlier effective filing date (id. at 20-22). Appellants argue that the instant claims are adequately supported by the ʼ937 application and, therefore, have an effective filing date that is earlier than the date of either Chiang or Simard (App. Br. 6, 18). Appellants point specifically to the ʼ937 application’s Example 16 and its Tables 55 and 56 (id. at 7-10). We agree with Appellants that the Examiner has not established that Chiang and Simard qualify as prior art with respect to the instant claims. “In the prosecution of a patent, the initial burden falls on the PTO to set forth the basis of any rejection, i.e., a prima facie case.” Hyatt v. Dudas, 492 F.3d 1365, 1369 (Fed. Cir. 2007). “In the context of the written description requirement, an adequate prima facie case must . . . sufficiently explain to the applicant what, in the examiner’s view, is missing from the written description.” Id. at 1370. Here, the Examiner argues that the instant claims are not adequately supported by the disclosure of the parent ʼ937 application for several reasons (Ans. 19-22). First, “[h]undreds of MHC receptor molecules exist just for humans alone,” in addition to MHC receptors for other animals, and thus, “the genus of epitopes with a known or predicted affinity for a MHC receptor is so large as to be considered almost infinitely large, as the MHC receptors may be any MHC receptor from any animal that has such receptors” (Ans. 20). Second, the claims do not recite an upper limit for the number of MHC receptor epitopes encoded by the claimed nucleic acids and the “examples in ‘937 are not representative of an open-upper limit on the Appeal 2012-006800 Application 11/067,159 7 number of sequences having a known or predicted affinity for a same MHC receptor peptide binding cleft” (id. at 21). Third, the Examiner finds that the limitation of “at least two amino acid sequences have a known or predicted affinity for a same MHC receptor peptide binding cleft . . . does not appear in the disclosure of the parent application” (id. at 22). We conclude that the Examiner has not provided an adequate basis for denying the instant claims the benefit of the filing date of the ʼ937 application. The standard for written description is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Here, the claimed subject matter is a nucleic acid encoding a portion of the PRAME antigen (SEQ ID NO: 77), where the portion includes at least two epitopes having affinity (known or predicted) for the same MHC receptor. The ʼ937 application discloses the PRAME protein having the sequence shown in SEQ ID NO: 77 (ʼ937 application 16 (Table 1B); 45:17-24). It also discloses that “the invention relate[s] to isolated epitopes, and antigens or polypeptides that comprise the epitopes . . . . Other embodiments can include an epitope cluster comprising a polypeptide from Table 1.” (Id. at 6:24-27.) The ʼ937 application states that [t]he epitope, cluster, or polypeptide comprising the same can have affinity to an HLA-A2 molecule. The affinity can be determined by an assay of binding, by an assay of restriction of epitope recognition, by a prediction algorithm, and the like. The epitope, cluster, or polypeptide comprising the same can have affinity to an HLA-B7, HLA-B51 molecule, and the like. (Id. at 7:7-10.) Appeal 2012-006800 Application 11/067,159 8 The ʼ937 application discloses that “[i]n pursuing the development of epitope vaccines others have generated lists of predicted epitopes based on MHC binding motifs” (id. at 29:10-11), and identifies algorithms for epitope cluster region prediction (id. at 53:8-13). Finally, the ʼ937 application includes an example describing “9-mer epitopes predicted for HLA-A2 binding using both the SYFPEITHI and NIH algorithms” (id. at 128:1-2) for the PRAME antigen (id. at 145-147). As noted by Appellants, the algorithms identified portions of PRAME predicted to include between two and twenty-one HLA-A2 epitopes. The Examiner has not persuasively explained why the disclosure of the ʼ937 application would not have “reasonably convey[ed] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351. The Examiner notes that there are a lot of different MHC receptors (Ans. 20), but has not explained why the algorithms discussed in the Specification would not have effectively put those of skill in the art in possession of predicted epitopes for those receptors, in the same way that the algorithms were used to predict HLA-A2 epitopes. The Examiner also notes that the claims do not recite an upper limit for the number of epitopes present on the encoded PRAME fragment (id. at 21), but has not provided a reasoned explanation of why the ʼ937 application’s disclosure of fragments having up to twenty-one predicted epitopes would not have been recognized as showing possession of the claimed group of nucleic acids encoding PRAME fragments that include at least two epitopes. Finally, the Examiner finds that the limitation of “at least Appeal 2012-006800 Application 11/067,159 9 two amino acid sequences have a known or predicted affinity for a same MHC receptor peptide binding cleft . . . does not appear in the disclosure of the parent application” (id. at 22). The test for adequate descriptive support, however, is not whether the precise words of the claim appear in the disclosure, but whether the disclosure conveys possession of the invention to those of skill in the art. We conclude that the ʼ937 application reasonably appears to describe the instantly claimed invention, and the Examiner has not carried the burden of showing that it does not. The Examiner therefore has not shown that Chiang and Simard are prior art with respect to the instant claims. III. The Examiner has rejected claims 1, 3, 4, 5, 9, 10, 14-16, 18, 20, 21, and 23 for obviousness-type double patenting based on the claims of application 10/292,413 in view of Chiang. The Examiner has also rejected claims 2, 11, 12, 22, and 24 for obviousness-type double patenting based on the claims of the ʼ413 application in view of Chiang and Simard. Appellants state that they “are prepared to address these rejections when they are the only remaining rejections in at least one of the applications, including by filing a Terminal Disclaimer or amending the claims in the appropriate application if required in view of the allowable claim language” (App. Br. 21). We decline to reach the merits of the obviousness-type double patenting rejections because Appellants have waived any arguments directed to these rejections. We leave it to the Examiner to determine whether the double patenting rejections are still appropriate based on the claims in U.S. Appeal 2012-006800 Application 11/067,159 10 Patent 8,637,305, which issued from the ʼ413 application, and to Appellants to determine how best to address any remaining concerns the Examiner may have in this regard. SUMMARY We reverse the rejection of claim 21 based on its means-plus-function limitation, the rejection of claims 1, 3, 4, 14-16, 18, 20, 21, and 23 as anticipated by Chiang, and the rejection of claims 1-5, 9-12, 14-16, 18, and 20-24 as obvious based on Chiang and Simard. We do not reach the merits of the obviousness-type double patenting rejections. REVERSED lp Copy with citationCopy as parenthetical citation