Ex Parte Norman et alDownload PDFPatent Trial and Appeal BoardJul 28, 201611788808 (P.T.A.B. Jul. 28, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111788,808 0412012007 Andrew B. Norman 24256 7590 07/29/2016 DINSMORE & SHOHL LLP 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. 10738-90 5708 EXAMINER 255 East Fifth Street, Suite 1900 DUTT, ADITI CINCINNATI, OH 45202 ART UNIT PAPER NUMBER 1649 MAILDATE DELIVERY MODE 07/29/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANDREW B. NORMAN and WILLIAM J. BALL JR.1 Appeal2013-005634 Application 11/788,808 Technology Center 1600 Before JEFFREYN. FREDMAN, RICHARD J. SMITH, and TA WEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) involving claims to a monoclonal antibody, which have been rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. STATEMENT OF THE CASE "Cocaine is a powerful addictive stimulant that directly affects the brain." (Spec. i-f 3.) According to the Specification, 1 Appellants identify the Real Party in Interest as the University of Cincinnati. (Appeal Br. 1.) 1 Appeal2013-005634 Application 11/788,808 [a]s the site of action of cocaine is in the brain, decreasing the concentrations [of cocaine] reaching the brain would be expected to decrease the probability of [cocaine] dependence, addiction, overdose, and relapse. Antibodies with high affinity and specificity for cocaine would be expected to act as pharmacokinetic antagonists by sequestering cocaine in the peripheral circulation and preventing its entry to the brain. (Id. at iT 18.) Further according to the Specification, antibodies may be obtained from hybridomas, which are hybrid cells generated by fusing mouse tumor cells with spleenocytes of transgenic mice immunized with the appropriate antigens. (Id. at iT 41.) The Specification explains that "the present invention is directed toward a monoclonal [anti-cocaine] antibody comprising a human gamma heavy chain and a murine [lambda] light chain." (Id. at iT 8.) Claims 16-18, 23, and 24 are on appeal. Claim 16 is representative and reproduced belov,r: 16. A monoclonal antibody compnsmg a human gamma heavy chain and a murine lambda light chain, wherein the antibody specifically binds cocaine and is generated by immunizing a HCo7 /Ko5 mouse with an antigen comprising a conjugate of benzoylecgonine and an immunogenic carrier protein, wherein the murine lambda light chain comprises SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6 and wherein the human gamma heavy chain comprises SEQ ID NO: 7, SEQ ID NO: 8, and SEQ ID NO: 9. 2 Appeal2013-005634 Application 11/788,808 Issue DISCUSSION The Examiner rejected claims 16-18, 23, and 24 under 35 U.S.C. § 102(b) as being anticipated by Paula.2 (Ans. 3.) The Examiner finds that Paula teaches a monoclonal antibody 2E2, "[which] is the same antibody that is generated from the same hybridoma cell line obtained from the same mouse strain HCo7 /Ko5, by immunizing with the same antigen as recited in the instant claim 16, and described in the instant specification." (Id. 4.) The Examiner further finds that, "[a]lthough the prior art reference does not teach sequences of the heavy and light chains, these would be inherent, as a consequence of corresponding to an identical monoclonal antibody and an identical hybridoma." (Id.) Appellants do not dispute that they are co-authors of Paula or that Paula is directed to the monoclonal antibody of the instant claims. (Appeal Br. 6.) However, Appellants contend that, because Paula does not disclose the actual sequences of the variable regions of the antibody or any distinguishing details of the hybridoma other than an arbitrary lab-assigned name, Paula does not provide sufficient disclosure to be enabling reference for the claims on appeal. (Id. at 6-10.) In particular, Appellants contend that, while Paula discloses how the monoclonal antibody E2E was made, the process for making antibodies is so variable that "it is virtually a statistical impossibility that one of ordinary 2 Stefan Paula et al., Three-Dimensional Quantitative Structure-Activity Relationship Modeling of Cocaine Binding by a Novel Human Monoclonal Antibody, 47 J. Medicinal Chemistry 133 (2004). 3 Appeal2013-005634 Application 11/788,808 skill in the art, following the process exactly as outlined in Paula, would spontaneously generate the same hybridoma/monoclonal antibody as that produced by the Paula authors/Appellants." (Id. at 7-8.) Appellants further contend that the preliminary research published in Paula mischaracterized the E2E antibody as containing a human rather than murine lambda light chain. (Id. at 8.) Thus, Appellants argue that, if a skilled artisan tried to screen for the E2E antibody by following Paula's disclosure, such efforts would have been unsuccessful because Paula's mischaracterization of the E2E antibody would have led the skilled artisan to screen incorrectly for an antibody having a human lambda light chain. (Id. at 9.) The Examiner counters that neither the variability of the antibody production process nor Paula's mischaracterization of the antibody obviates the anticipation rejection, because Paula's publication placed both the claimed antibody and the antibody-producing hybridoma in the public domain. (Ans. 8.) In making this argument, the Examiner relies on ACS Publications' "Ethical Guidelines to Publication of Chemical Research" ("Ethical Guidelines"), which states in part that, [ w ]hen requested, the authors should make every reasonable effort to provide ... samples of unusual materials unavailable elsewhere, such as ... antibodies, etc. to other researchers. (Reply Br. 3.) Appellants dispute the Examiner's interpretation of Paula authors' obligation to share materials under the Ethical Guidelines, and further state that Appellants have never provided another investigator access 4 Appeal2013-005634 Application 11/788,808 to either the hybridoma or the monoclonal antibody discussed in Paula. (Ball/Norman Decl.3 i-f 7 .) The issues with respect to this rejection are whether Paula's publication placed the 2E2 antibody and/or the hybridoma producing the antibody in the public domain in view of the Ethical Guidelines, and, if not, whether the Paula reference itself is nonetheless enabling prior art. Principles of Law "A prior art reference cannot anticipate a claimed invention 'if the allegedly anticipatory disclosures cited as prior art are not enabled."' In re Antor Media Corp., 689 F.3d 1282, 1287 (Fed. Cir. 2012 (citation omitted)). "Enablement of prior art requires that the reference teach a skilled artisan to make or carry out what it discloses in relation to the claimed invention." Id. at 1290. [D]uring patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under§ 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement. Id. at 1289. "Once an applicant makes a non-frivolous argument that cited prior art is not enabling, however, the examiner must address that challenge." In re Morsa, 713 F.3d at 104, 110 (Fed. Cir. 2013). Analysis On balance, we agree with the Appellants that ACS' s Ethical Guidelines does not require Appellants to place the Paula antibody and 3 Declaration of William J. Ball, Jr. and Andrew B. Norman Under 37 C.F.R. § 1.132 (Jan. 27, 2012). 5 Appeal2013-005634 Application 11/788,808 hybridoma in the public domain as a condition of publishing the Paula paper. As Appellants point out, the Ethical Guidelines state that authors of papers should make "reasonable" efforts to provide materials unavailable elsewhere, such as antibodies, but also takes into account "the legitimate interests of the authors." (Reply Br. 3.) Thus, we do not find that the Appellants agreed to place Paula antibody and hybridoma in the public domain through publication of the Paula reference. Given our conclusion above, and given Appellants' declaration that they have not otherwise publicly shared either the Paula hybridoma or the antibody it produces (Ball/Normal Deel. i-fi-17, 9; Reply Br. 3), we next tum to the issue of whether the Paula reference itself anticipates the claims on appeal. We agree with Appellants that it does not. "A prior art reference cannot anticipate a claimed invention 'if the allegedly anticipatory disclosures cited as prior art are not enabled."' In re Antor Media Corp., 689 F.3d at 1287. Although prior art publications cited by an Examiner are presumed enabling during prosecution, in this case we find that Appellants have submitted persuasive evidence that Paula does not teach a skilled artisan to make an antibody with the claimed sequences. Id. at 1290 (holding that to be enabling the prior art reference must "teach a skilled artisan to make or carry out what it discloses in relation to the claimed invention"). In particular, Appellants have explained in a declaration why it is "extremely unlikely" for a skilled artisan to generate a monoclonal antibody that is identical to E2E based on Paula's disclosures. (Ball/Norman Deel. i-fi-1 5, 6, 8, 9.) Neither has the Examiner disputed the variable nature of making monoclonal antibodies or provided other evidence that disclosures contained 6 Appeal2013-005634 Application 11/788,808 within the Paula reference itself enables a skilled artisan to generate an antibody with the claimed sequences. (Ans. 7-8.) Accordingly, we find that the evidence of record does not support the Examiner's conclusion that Paula anticipates the claims on appeal. SUMMARY For the reasons above, we reverse the Examiner's decision rejecting claims 16-18, 23, and 24. REVERSED 7 Copy with citationCopy as parenthetical citation