Ex Parte Goldenberg et alDownload PDFPatent Trial and Appeal BoardMar 14, 201713037784 (P.T.A.B. Mar. 14, 2017) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/037,784 03/01/2011 David M. GOLDENBERG IMMU-0022US1A 7553 37013 7590 03/16/2017 Rossi, Kimms & McDowell LLP 20609 Gordon Park Square Suite 150 Ashburn, VA 20147 EXAMINER SCHWADRON, RONALD B ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 03/16/2017 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): mail@rkmllp.com EOfficeAction@rkmllp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID M. GOLDENBERG, CHIEN-HSING CHANG, and HANS J. HANSEN Appeal 2016-000145 Application 13/037,7841 Technology Center 1600 Before JOHN G. NEW, ELIZABETH A. LaVIER, and DAVID COTTA, Administrative Patent Judges. LaVIER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the Examiner’s rejections of claims 2—5, 7—16, and 28—32. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons of record and those set forth below, we AFFIRM. BACKGROUND The Specification relates to “structural variants of anti-CD20 antibodies and/or antigen binding fragments thereof, preferably involving the amino acid sequences of complementarity-determining regions (CDRs), 1 Appellants state the real party in interest is Immunomedics, Inc. Br. 2. Appeal 2016-000145 Application 13/037,784 with improved therapeutic characteristics.” Spec. 12. Claim 2 is illustrative: 2. A method of treating a disease in a human subject comprising: obtaining a substituted chimeric, humanized or human anti- CD20 antibody or antigen binding fragment thereof which binds to human CD20 and which is made by substituting the third complementarity determining region (CDR) sequence of the heavy chain of a chimeric, humanized or human anti-CD20 antibody or antigen binding fragment thereof at position 101 to make a substituted antibody or antigen binding fragment thereof; improving by the substitution at least one characteristic selected from the group consisting of a slower off-rate, slower antigen dissociation rate, higher CDC activity, higher ADCC activity, higher apoptotic activity, greater ability to induce cell death in vitro in the absence of cross-linking and greater ability to kill or inhibit the growth of CD20-positive cells in vivo when administered to a human subject with CD20-positive cells; administering the substituted anti-CD20 antibody or fragment thereof to a subject; and treating the disease in the human subject, wherein the disease is selected from the group consisting of B-cell mediated immune disease, autoimmune disease, B-cell lymphoma and leukemia, graft-versus-host disease, organ transplant rejection, immune hemolytic anemia, alio sensitization, and cryoglobulinemia. Br. 18 (Claims Appendix). REJECTIONS MAINTAINED ON APPEAL 1. Claims 2—5, 16, and 28—30 stand rejected under 35 U.S.C. § 102(b) as anticipated by Hansen ’433.2 Ans. 6. 2 Hansen et al., US 2003/0219433 Al, published Nov. 27, 2003. 2 Appeal 2016-000145 Application 13/037,784 2. Claims 2—5, 7—14, 16, 28—30, and 32 stand rejected under 35 U.S.C. § 102(b) as anticipated by Hansen ’259.3 Ans. 9. 3. Claims 2—5, 15, and 16 stand rejected under 35 U.S.C. § 102(b) as anticipated by Tahir,4 as evidenced by Hansen ’433. Ans. 9. 4. Claims 2—5, 7—9, 11, 12, 15, and 16 stand rejected under 35 U.S.C. § 102(b) as anticipated by Morschhauser,5 as evidenced by Hansen ’433. Ans. 10. 5. Claims 2—5, 7—14, 16, 28—30, and 32 stand rejected under 35 U.S.C. § 102(b) as anticipated by Smith.6 Ans. 10. 6. Claims 2—5, 7—16, and 28—32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Hansen ’259, Tahir, and Morschhauser. Ans. 11—12; see also Final Action 7. DISCUSSION We agree with, and adopt, the Examiner’s reasoning and conclusions that the claims are anticipated and/or obvious over the cited prior art references cited by the Examiner. We address Appellants’ arguments below. 3 Hansen et al., US 2007/0020259 Al, published Jan. 25, 2007. 4 Tahir et al., Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Severe Resistant Systemic Lupus Erythematosus in a Patient with Antibodies against Rituximab (Letter to the Editor), 44 Rheumatology 561 (2005). 5 Morschhauser et al., Low Doses of Humanized Anti-CD20 Antibody, IMMU- 106 (hA20), in Refractory or Recurrent NHL: Phase //// Results (Meeting Abstract), 25 J. Clinical Oncology (2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition) 8032 (2007). 6 Smith et al., US 2008/0089885 Al, published Apr. 17, 2008. 3 Appeal 2016-000145 Application 13/037,784 A. Rejection 1 As relevant to exemplary claim 2, the Examiner finds that Hansen ’433 teaches the use of veltuzumab for the treatment of rheumatoid arthritis (RA). Final Action 3. Veltuzumab, the Examiner explains, is a “hA20 humanized antibody[,] wherein said antibody is a substituted antibody of claim 2 as per claim 15.” Id. The Examiner further finds that “hA20 inherently has the functional attributes recited in the claims because it is the antibody recited in claim 15.” Id. Appellants note that the rejected claims are drawn to a method, not a product or composition (see Br. 3—4, 5), and rely on this distinction to argue that: A method as recited in claim 2 is not disclosed in Hansen ’433. Therefore, the subject matter of claim 2 is novel over Hansen ’433. It does not matter whether a possible product of such method, namely veltuzumab, is already known in the art. The mere existence of a product which can be obtained by the claimed method does not disclose or suggest such method claim if the method as such is novel and based on an inventive step. Id. at 6. Appellants are correct that a known product can be the subject of a patentable method claim. However, as the Examiner points out (see Ans. 7), the inherency doctrine applies to method claims as well as product claims. In affirming a district court’s judgment that a method claim was invalid, the Federal Circuit explained inherency thusly: a prior art reference may anticipate when the claim limitation or limitations not expressly found in that reference are nonetheless inherent in it. See In re Oelrich, 666 F.2d [578, 581 (CCPA 1981)]; Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628, 630, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). Under the principles of inherency, if the prior art necessarily functions in 4 Appeal 2016-000145 Application 13/037,784 accordance with, or includes, the claimed limitations, it anticipates. See In re King, 801 F.2d 1324, 1326, 231 USPQ 136, 138 (Fed. Cir. 1986). Inherency is not necessarily coterminous with the knowledge of those of ordinary skill in the art. Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. See id., 801 F.2d at 1326. MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). Here, the Examiner finds that Hansen ’433 teaches the use of a substituted antibody within the scope of claim 2 (i.e., veltuzumab) to treat a disease within the scope of claim 2 (i.e., rheumatoid arthritis). The “improving . . . [of] at least one characteristic ...” step of claim 2 would have flowed necessarily from the claimed substitution; it is immaterial whether one of ordinary skill in the art at the time of the invention would have recognized the improvement. Appellants’ assertions of surprising results (see Br. 6—7) are not germane to a § 102 rejection. See, e.g., In re Malagari, 499 F.2d 1297, 1302 (CCPA 1974) (citing In re Wiggins, 488 F.2d 538 (CCPA 1973)). Accordingly, the Examiner did not err in rejecting claim 2 as anticipated by Hansen ’433. Claims 3—5, 16, and 28—30, which are not argued separately, fall with claim 2. See 37 C.F.R. § 41.37(c)(l)(iv) (2014). We affirm Rejection 1. B. Rejections 2—4 Appellants repeat substantially the same arguments regarding Rejections 2-4 as they advance regarding Rejection 1. Compare Br. 7—10 with Br. 4—7. These arguments are unpersuasive as applied to each of Hansen ’259, Tahir, and Morschhauser for the reasons discussed with 5 Appeal 2016-000145 Application 13/037,784 respect to Hansen ’433. See Final Action 4—6; see also Ans. 9-10. Accordingly, we affirm Rejections 2-4. C. Rejection 5 As applicable to exemplary claim 2, the Examiner finds: Smith et al. teach a CDR3 substituted anti CD20 antibody [as] recited in the claims (see [0124],[0357]) wherein the substituted Asn in CDR3 is at position 101 of said antibody (aka the same position in CDR3)). The antibody has the properties recited in the claims (see [0106]). Smith et al. teach use of said antibody to treat RA in combination with methotrexate (see [0269]). Final Action 6. Appellants compare SEQ ID NO:4 of Smith, which is discussed in the passages cited by the Examiner, with the amino acid sequence for veltuzumab. See Br. 11. According to Appellants, the number and nature of the differences between SEQ ID NO:4 and veltuzumab mean that Smith does not anticipate because (1) there are too many differences (Smith 1124 discloses sequences with “at least 85% sequence identity” with SEQ ID NO:4) and (2) bridging the differences would require non-conservative substitutions (contrary to the conservative amino acid substitutions discussed in Smith 1124). See id. at 11—14. The Examiner responds that the claims subject to Rejection 5 do not specifically recite veltuzumab (i.e., claim 15 is not included in Rejection 5), rendering Appellants’ veltuzumab-specific arguments beside the point, and further notes that the claims do not “define the nature of the substituted amino acid.” Ans. 11. We agree. 6 Appeal 2016-000145 Application 13/037,784 As we are unpersuaded by Appellants’ arguments, we affirm the Examiner’s rejection of claim 2 as anticipated by Smith. Claims 3—5, 7—14, 16, 28—30, and 32, which are not argued separately, fall with claim 2. D. Rejection 6 1. Arguments Applicable to All Rejected Claims In regard to claims 2—5, 7—16, and 28—32 generally, Appellants argue solely by reference to their arguments presented for the § 102 rejections over each of the Hansen references, Tahir, and Morschhauser, noting, inter alia, that because Hansen ’259 (cited for this rejection) is a continuation application based on Hansen ’433 (not cited for this rejection), “its disclosure is identical.” Br. 15. We have already dispensed with these arguments in the context of the §102 rejections, as discussed above. Accordingly, we need not recite the particulars of the § 103 rejection generally, except to state that we adopt the Examiner’s findings and analysis as set forth on pages 7—9 of the Final Action and as further explained in pages 11—13 of the Answer. However, within Appellants’ discussion of the § 102 rejections, we discern two arguments that are relevant primarily to the § 103 rejection (though Appellants do not flag them as such or expressly reiterate them in discussing Rejection 6). Neither is persuasive. Accordingly, for the reasons of record and as explained further below, we affirm the Examiner’s § 103 rejection of claim 2. Claims 3—5, 7—16, 28—30, and 32, which are not argued separately, fall with claim 2. We address claim 31, which Appellants argue separately, following this more general analysis. 7 Appeal 2016-000145 Application 13/037,784 a. Motivation to Combine First, Appellants argue that Hansen ’433 (which, as noted above, has the same disclosure as Hansen ’259) “provides no suggestion or reasonable expectation” to the skilled artisan that the residue substitution at position 101 “would result in the functional changes recited in the claimed method.” Br. 5. Although inherency is more circumscribed in the context of obviousness than anticipation, a disclosure is inherent for obviousness purposes if it is “sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” PAR Pharm., Inc. v. TWIPharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). As discussed above, here the “improving . . . [of] at least one characteristic . . .” step of claim 2 would have flowed naturally from the use of veltuzumab to treat rheumatoid arthritis described in Hansen ’433, whether the ordinarily skilled artisan would have appreciated it or not. b. Surprising Results Second, Appellants address data regarding several hA20 variants in their Specification, asserting that “it was surprisingly determined that especially substitution at position 101 was of major importance for the claimed method step of ‘improving by [substitution at position 101 of CDR3] at least one characteristic ....’” Br. 6—7 (discussing Spec. ^fl[ 148, 255—274). To the extent Appellants are arguing that unexpected results overcome the Examiner’s prima facie case of obviousness, this is not persuasive because Appellants’ alleged surprising results relate to the inherent characteristics or functioning of known prior art compositions. Moreover, the burden of analyzing and explaining data to support 8 Appeal 2016-000145 Application 13/037,784 nonobviousness rests with the Appellant. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Appellants have failed to meet this burden. Appellants include no convincing analysis or explanation of the data in their Brief that establishes that the claimed invention provides unexpected results. Of the paragraphs of the Specification flflf 148, 255—274) cited by Appellants, only paragraph 148 discusses hA20 variants that differ from one another at position 101. Appellants have not explained how paragraph 148 supports the “surprising[]” importance of substitution at position 101, nor have they directed us to any additional support. 2. Claim 31 Finally, Appellants present additional arguments regarding claim 31 specifically. Claim 31 is ultimately dependent on claim 2, and through its multiple dependencies, “recites subcutaneous administration to treat rheumatoid arthritis, wherein the human subject is refractory to rituximab, and the therapeutic agent is methotrexate.” Br. 16. In rejecting claim 31, the Examiner relies, inter alia, on Tahir and Morschhauser, as teaching the use of veltuzumab in patients refractory to rituximab for the treatment of SLE7 (in Tahir) and NHL8 (Morschhauser). See Final Action 8. Appellants assert that the Examiner’s position in the obviousness rejection, in relying on references that discuss treatment of SLE and NHL, contradicts the Examiner’s position taken in regard to the restriction requirement imposed earlier during prosecution of this application, which required Appellants to elect “a specific disease.” See Br. 16; Restriction Requirement (Dec. 2, 2011) 5. Appellants’ original claim 3 recited diseases 7 Systemic lupus erythematosus. Tahir 561. 8 Non-Hodgkin lymphoma. Spec. 147. 9 Appeal 2016-000145 Application 13/037,784 including, inter alia, rheumatoid arthritis, SLE, and NHL. See Reply to Requirement for Restriction and Election of Species (Jan. 3, 2012) 2—3. Appellants elected rheumatoid arthritis. See id. at 6. Appellants now argue: The basis given [in the restriction requirement] was that the “these species are not obvious variants of each other based on the current record.” Thus, it has been established on the record that each of the diseases in applicant’s claims is a distinct variant which would not have been obvious based on any of the other diseases. Br. 16. This argument fails for two reasons. First, as the Examiner points out, the restriction requirement was entered before the present prior art rejection. Ans. 12. Accordingly, the cited references were not part of “the current record” on which the restriction requirement was based, not the present record; we discern no logical contradiction between the two. Second, the Examiner’s rejection does not rely on SLE and NHL being obvious variants of, or indistinct from, rheumatoid arthritis. Rather, the Examiner’s obviousness analysis acknowledges that the diseases treated in Tahir and Morschhauser (SLE and NHL, respectively) are “unrelated.” Final Action 8. Indeed, the Examiner uses the fact of this unrelatedness as part of the rationale for treating “any disease wherein use of anti CD 20 antibody treatment of said disease was known in the art (aka RA) and wherein some of the treated patients were refractory to treatment with rituximab.” Id. As Appellants offer no other arguments or evidence for the unpatentability of claim 31 specifically, we are unpersuaded the Examiner erred in rejecting claim 31. 10 Appeal 2016-000145 Application 13/037,784 CONCLUSION The rejections of claims 2—5, 7—16, and 28—32 are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 11 Copy with citationCopy as parenthetical citation