Ex Parte SIMARDDownload PDFPatent Trial and Appeal BoardAug 24, 201813215464 (P.T.A.B. Aug. 24, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/215,464 08/23/2011 88684 7590 08/28/2018 XBiotech, Inc. 5425 Park Central Court Suite 111 Naples, FL 34109 FIRST NAMED INVENTOR John SIMARD 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. 5407-0093 2259 EXAMINER PAK, MICHAEL D ART UNIT PAPER NUMBER 1646 NOTIFICATION DATE DELIVERY MODE 08/28/2018 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): sakptomail@iplawpro.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN SIMARD 1 Appeal2017-009028 Application 13/215,464 Technology Center 1600 Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of reducing the size of a cancerous tumor in a human subject having cancer. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE Claims on Appeal Claims 1---6, 14, 16, and 17 are on appeal. 2 (Claims Appendix, Br. 16.) Claim 1 is illustrative and reads as follows: 1 According to Appellant, the real party in interest is XBiotech, Inc. (Br. 3.) 2 Claims 7-13 and 15 are cancelled. (Final Office Action dated March 11, 2016 ("Final Act."), at 2.) Appeal2017-009028 Application 13/215,464 A method of reducing the size of a cancerous tumor in a human subject having cancer, the method comprising the step of administering to the subject a pharmaceutical composition comprising a pharmaceutically acceptable carrier and an amount of an anti-IL- I a antibody (Ab) effective to reduce the size of the cancerous tumor in the subject, wherein the size of the tumor in the subject is reduced. Examiner's Rejections 1. Claims 1-3, 6, and 14 stand rejected under pre-AIA 35 U.S.C. § I02(b) as anticipated by Simard. 3 (Final Act. 3--4; Ans. 2-3.) 2. Claims 1---6, 14, 16, and 17 stand rejected under pre-AIA 35 U.S.C. § I03(a) as unpatentable over Simard, Salcedo, 4 and Oriuchi. 5 (Final Act. 7-8; Ans. 3--4.) DISCUSSION We adopt the Examiner's findings, analysis, and conclusions regarding the anticipation of claims 1-3, 6, and 14 by Simard, as set forth in the Final Action and Answer. We discern no error in the rejection of those claims as anticipated under pre-AIA 35 U.S.C. § 102(b ). We adopt the Examiner's findings, analysis, and conclusions as set forth in the Final Action and Answer, including with regard to the scope and content of and motivation to combine the prior art, regarding the rejection of claims 1-3, 6, 14, 16, and 17 under pre-AIA 35 U.S.C. § I03(a). We discern no error in the rejections of those claims as obvious. 3 Simard, WO 2007/135546 A2, published Nov. 29, 2007 ("Simard"). 4 Salcedo et al., US 2005/0129699 Al, published June 16, 2005 ("Salcedo"). 5 N. Oriuchi et al., Current status of cancer therapy with radiolabeled monoclonal antibody, ANNALS OF NUCLEAR MEDICINE 19 (5), 355---65 (2005) ("Oriuchi"). 2 Appeal2017-009028 Application 13/215,464 Because the Examiner does not explain any basis for rejecting claims 4 and 5 as obvious, the rejection of claims 4 and 5 under pre-AIA 35 U.S.C. § 103(a) is reversed. Rejection No. 1 Issue Whether a preponderance of evidence of record supports the Examiner's finding that claims 1-3, 6, and 14 are anticipated by Simard. Principles of Law A claim is anticipated if a prior art reference discloses every limitation of the claimed invention, either explicitly or inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). In considering the disclosure of a reference for anticipation, "it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826 (CCPA 1968). "[ A ]nticipation does not require actual performance of suggestions in a disclosure. Rather, anticipation only requires that those suggestions be enabling to one of skill in the art." Bristol-Myers Squibb Co. v. Ben Venue Labs. Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001). Analysis We limit our consideration to claim 1 because the claims subject to this rejection were not argued separately. The Examiner's anticipation finding is supported by detailed findings regarding the teachings of Simard that show that every limitation of claim 1 is disclosed in Simard, explicitly or inherently. (See Final Act. 3--4; Ans. 2- 3, 5-6.) 3 Appeal2017-009028 Application 13/215,464 Appellant argues that the rejection is in error because "Simard does not describe that any experiments were performed on a human subject, nor does it expressly assert that an anti-IL-la antibody can reduce the size of a cancerous tumor in a human subject having cancer." (Br. 8.) Thus, according to Appellant, Simard does not teach each and every element as set forth in claim 1. (Id. at 8-9.) We are not persuaded. As the Examiner explains, Simard expressly teaches treating human patients. (Ans. 5, citing Simard ,r,r 10 and 44--45.) That disclosure is sufficient because a finding of anticipation does not require actual treatment of human patients. See Bristol-Myers Squibb, 246 F.3d at 1379. Appellant argues that Simard does not state reducing the size of a tumor, only that human and non-human patients can be treated, and that the experimental results in Simard "indicate that only the rate of growth of the metastatic lesions was retarded." (Br. 9.) We are not persuaded. As the Examiner explains, "[t]he effective dosage cited by Simard in paragraphs 19-20 of [0.25] 6 mg/Kg to 50 mg/Kg is the same as the effective dosage cited in [Appellant's] specification," and that "[t]hus the administration of antibody in the effective amount would inherently reduce the size of the tumor."7 (Ans. 6; compare Simard ,r,r 19-20 with Spec. ,r 31.) Appellant argues that Simard does not inherently teach the subject matter of claim 1 because Simard indicates "that it was unknown whether 6 The Examiner states "5 mg/Kg," but both 0.25 mg/Kg and 5 mg/Kg lie within the range set forth in the Specification. 7 Although dependent claim 14 was not separately agued, a similar analysis applies to "a decrease in edema in the subject." (See Ans. 5-6.) 4 Appeal2017-009028 Application 13/215,464 the antibody used in the described mouse experiments caused direct tumor cytotoxicity," and because Simard states that "[t]he mechanism of action is not yet clear." (Br. 9-10.) We are not persuaded. A finding of inherent anticipation does not require recognition in the prior art, and newly discovered results of known processes are not patentable because they are inherent in the known process. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir. 2007); Bristol-Myers Squibb, 246 F.3d at 1376. When a claimed product appears to be substantially identical to a product disclosed by the prior art, the burden is on the patent applicant to prove that the product of the prior art does not necessarily or inherently possess characteristics or properties attributed to the claimed product. In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977). Appellant has not met this burden on the record before us. Accordingly, for the reasons of record and as set forth above, we affirm the rejection of claim 1 as anticipated by Simard. Claims 2, 3, 6, and 14 fall with claim 1. Rejection No. 2 Issue Whether a preponderance of evidence of record supports the Examiner's rejection under pre-AIA 35 U.S.C. § 103(a). Analysis The Examiner's statement of rejection restates the findings regarding Simard set forth in connection with the anticipation rejection, and further states that "Simard does not teach a human subject is one whose cancer has progressed after treatment with chemotherapy, radiotherapy or biologic 5 Appeal2017-009028 Application 13/215,464 agents. Simard does not [teach] the human antibody." (Final Act. 7-8.) The Examiner relies on Oriuchi and Salcedo for those teachings. (Id. at 8.) Appellant argues that "the examiner focuses only on claims 16 and 17" in the Final Office Action, and that the examiner provides "no analysis or clear articulation of the reasons for the 103 rejection[] made with respect to the rejection of claims 1-6 and 14." (Br. 11.) Appellant also states that "at least with respect to claims 1---6 and 14, the examiner has failed to establish a primafacie case of obviousness." (Id.) Appellant also advances arguments as to why the rejection of claims 1---6 and 14 "is substantively erroneous." (Id. at 11-14.) Claims 4 and 5 are directed to an antibody comprising a complementarity determining region of MABp 1 and the MABp 1 antibody itself. 8 We agree with Appellant that the Examiner did not address these claims and therefore does not set forth a prima facie case of obviousness as to claims 4 and 5, and reverse the rejection as to those claims. However, because claims 1-3, 6, and 14 are anticipated by Simard, they are also obvious in view of Simard. See In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (finding that "anticipation is the epitome of obviousness") ( citations omitted). Appellant nevertheless argues that claims 1-3, 6, and 14 are nonobvious (see Br. 12-14), and the Examiner persuasively addresses those arguments (see Ans. 7-10). Claim 16 Claim 16 recites the method of claim 1 "wherein the human subject is one whose cancer has progressed after treatment with chemotherapy, 8 The Specification discloses that MABpl is disclosed in U.S. Pat. Appl. No. 12/455,458 (Spec. ,r 19) which is now U.S. Pat. No. 8,034,337. 6 Appeal2017-009028 Application 13/215,464 radiotherapy, or biologic agents." (Br. 16.) The Examiner relies on Oriuchi' s teachings of the method of radiotherapy treatment of tumors, and that "future studies should focus on the new strategies of targeting, locoregional application, and combination therapy" (Oriuchi 363), to conclude that: It would have been obvious to one of ordinary skill in the art at the time of the invention to use the method of treatment of Simard in patients whose cancer has progressed after treatment with radiotherapy or chemotherapy or biologic agents because of motivation provided by Oriuchi [] that combination therapy may be a good strategy. (Final Act. 8.) Appellant argues that "[r]egarding Oriuchi as applied to claim 16 ... this reference does not teach or suggest treating a human subject whose cancer has progressed after treatment with chemotherapy, radiotherapy, or biologic agents." (Br. 14--15.) Appellant further argues that the statement from Oriuchi ( quoted above) "does not directly state or inferentially suggest the claim limitation at issue." (Id. at 15.) The Examiner's position is supported by preponderance of the evidence. As explained by the Examiner, the rejection is based on the combination of Simard and Oriuchi. (Ans. 10.) See In re Keller, 642 F.2d 413,425 (CCPA 1981) (the test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art"). Furthermore, "'a reference must be considered not only for what it expressly teaches, but also for what it fairly suggests."' In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994) (quoting In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979)). 7 Appeal2017-009028 Application 13/215,464 Here, Oriuchi suggests radiotherapy treatment of tumors in combination with another tumor therapy. The combined teachings of Oriuchi and Simard thus fairly suggest the use of the method of claim 1 after a human subject has been treated with radiotherapy, and the class of human subjects would reasonably be expected to include patients whose cancer has progressed after treatment with radiotherapy. Claim 17 Claim 1 7 recites the method of claim 1 "wherein the anti-IL- I a Ab is a human mAb that specifically binds IL-la." (Br. 16.) The Examiner relies on Salcedo's teaching of the method of using IL-I antibody, and the method of humanizing antibodies, to conclude that: It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate the humanizing technique of Salcedo [] to Simard [] antibody. One of ordinary skill in the art would be motivated by the desire to treat human patient[ s] and humanized antibody would be more efficacious. (Final Act. 8, citing Salcedo ,r,r 239, 244, 689, and claims.) Appellant argues that "the proposed modification of the antibodies disclosed in Simard by humanization according to Salcedo' s methods would result in a chimeric antibody that would still retain non-human sequences. Thus, unlike the antibody described in the current application, the modified antibody as proposed by the examiner would not be 'human."' (Br. 14.) Appellant also argues that it was well known in the art at the time of the invention that "making human anti-human antibodies specific for a selected target antigen was a very challenging and unpredictable process." (Id.) We agree with the Examiner that the term "human" as used in claim 17 includes Salcedo's humanized antibody. (Ans. 10.) Appellant appears to be arguing that the claim requires a "fully human mAb." While such 8 Appeal2017-009028 Application 13/215,464 embodiment is described in the Specification (i1 19), the claims do not use this language. Moreover, while Salcedo refers to "humanization" of the mouse immune system, it also expressly states that such strategy could provide "fully human monoclonal antibodies." (Salcedo ,r 239.) Regarding the alleged difficulty of making human antibodies, the Examiner further explains that "Salcedo teaches the making of human antibodies." (Id.) Accordingly, for the reasons of record and as set forth above, we affirm the rejections of claims 1-3, 6, 14, 16, and 17 under pre-AIA 35 U.S.C. § 103(a), and reverse the obviousness rejection of claims 4--5. Conclusions A preponderance of evidence of record supports the Examiner's rejection of claims 1-3, 6, and 14 under pre-AIA 35 U.S.C. § 102(b) and the Examiner's rejection of claims 1-3, 6, 14, 16, and 17 under pre-AIA 35 U.S.C. § 103(a), but fails to support the Examiner's rejection of claims 4 and 5 under pre-AIA 35 U.S.C. § 103(a). SUMMARY We affirm the rejections of claims 1-3, 6, 14, 16, and 17. We reverse the rejection of claims 4 and 5. 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-IN-PART 9 Copy with citationCopy as parenthetical citation