Ex Parte Carper et al

Patent Trial and Appeal BoardSep 19, 2012

11731297 (P.T.A.B. Sep. 19, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/731,297 03/30/2007 Stephen Carper 777.011US1 7281 7590 09/20/2012 Mark A. Litman, Technology Transfer Officer Office of Economic Development University of Nevada, Las Vegas 4505 S. Maryland Parkway - Box 451092 FDH Room 314 Las Vegas, NV 89154-1092 EXAMINER BREDEFELD, RACHAEL EVA ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 09/20/2012 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 STEPHEN CARPER and SUSAN MEACHAM __________ Appeal 2011-006851 Application 11/731,297 Technology Center 1600 __________ Before DEMETRA J. MILLS, JEFFREY N. FREDMAN and STEPHEN WALSH, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2011-006851 Application 11/731,297 2 STATEMENT OF CASE 1. A method for treatment of cancer in tissue within the prostate, breast or cervix comprising the ingestion, injection, infusion or application of an ingredient comprising a pharmaceutically active phenyl boric acid or salts of a phenyl boric acid to treat the affected tissue. 4. The method of claim 3 wherein the treatment is with an amount of ingredient that inhibits the growth of at least one cancer cell line for cancer of the prostate, breast or cervix. Cited References Zhuo et al., Synthesis and Biological Evaluation of Boron-Containing Polyamines as Potential Agents for Neutron Capture Therapy of Brain Tumors, 42 J. Med. Chem. 1282-1292 (1999). Grounds of Rejection Claims 1-24 are rejected under 35 U.S.C. § 112, first paragraph, for lack of enablement. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 3- 7. Discussion ISSUE The Examiner concludes that Claims 1-24 are rejected under 35 U.S.C. § 112, first paragraph, because i.) the specification, while being enabling for a method of treating prostate, breast, and cervix cancer by administering unsubstituted phenyl boric acid or a salt of phenyl boric acid, does not reasonably provide enablement for prevention of cancer; and ii.) the specification, while being Appeal 2011-006851 Application 11/731,297 3 enabling for a method of treating prostate, breast, and cervix cancer by administering unsubstituted phenyl boric acid or a salt of phenyl boric acid, does not reasonably provide enablement for administering an ingredient comprising an active phenyl boric acid or salts of a phenyl boric acid (i.e., derivatives of active phenyl boric acid or salts thereof). (Ans. 3.) Appellants argue that Applicants have previously limited all claims to treatment of the specific forms of cancer that the PTO has identified as being enabled - PROSTATE, BREAST AND CERVIX. All claims are limited to those three regions for the presence of cancer. (Br.10.) The present application has provided clear statements of utility and provided in vitro clinical evidence of actual performance as evidenced by Figures 1, 2 and 3. The attacks on the enablement of the present specification are based solely on case law without any substantive basis of analysis of the actual disclosure in the present specification. (Br. 12.) The dispositive issue is: Has the Examiner met the burden of showing a prima facie case of lack of enablement? PRINCIPLES OF LAW “[A]s part of the quid pro quo of the patent bargain, the applicant's specification must enable one of ordinary skill in the art to practice the full scope of the claimed invention. That is not to say that the specification itself must necessarily describe how to make and use every possible variant of the claimed invention, for the artisan's knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability Appeal 2011-006851 Application 11/731,297 4 of the art.” AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, (Fed. Cir. 2003) (citation omitted). “When rejecting a claim under the enablement requirement of section 112, the PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application; this includes, of course, providing sufficient reasons for doubting any assertions in the specification as to the scope of enablement. If the PTO meets this burden, the burden then shifts to the applicant to provide suitable proofs indicating that the specification is indeed enabling.” In re Wright, 999 F.2d 1557, 1561- 62, (Fed. Cir. 1993). “[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support.” In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971), (emphasis in original). “The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of a patent enable any person skilled in the art to which it pertains to make and use the claimed invention. Although the statute does not say so, enablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, (Fed. Cir. 1991) (emphasis in original). Enablement is a question of law based on underlying factual inquiries. Enzo Biochem Inc. v. Calgene Inc., 188 F.3d 1362, 1370 (Fed. Cir. 1999). Appeal 2011-006851 Application 11/731,297 5 Wands factors (predictability, amount of direction, etc.) are factual inquiries underlying the enablement conclusion. Enzo Biochem Inc. v. Calgene Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999). ANALYSIS The Examiner finds that a review of the Wands factors (Ans. 4-7) supports a conclusion of lack of enablement. More particularly, the Examiner relies on Zhuo (Zhuo et al., Synthesis and Biological Evaluation of Boron-Containing Polyamines as Potential Agents for Neutron Capture Therapy of Brain Tumors, J. Med. Chem. 42 1282-1292 (1999)) for teaching that the … [disclosed] boron-containing compound, which is a single [amine] substituted phenyl boric acid, is not considered as an appropriate BNCT agent in spite of the fact that it has been shown to have low in vitro toxicity and comparable DNA binding affinity to SPD (page 1284, col. 2, Scheme 3; and page 1286, col. 1, first full para., last five lines). (Ans. 5.) In other words, the Examiner finds that Zhuo suggests that an amine substituted phenyl boric acid would not be useful to treat brain tumors. The Examiner's apparent position that the Specification cannot teach how to use the claimed method unless it teaches all possible usable phenyl boric acid species for treating all prostate, breast or cervical cancers. This position is contrary to controlling case law. See, e.g., In re Brana, 51 F.3d 1560, 1568 (Fed. Cir. 1995). We do not find that the Examiner has provided sufficient evidence to support a prima facie case of lack of enablement on the record before us. Appeal 2011-006851 Application 11/731,297 6 “[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support.” In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971), emphasis in original. The claims before us are limited to “A method for treatment of cancer in tissue within the prostate, breast or cervix.” The Specification’s Figs. 1-3 evidence treatment of tumor cells (prostate, breast and cervix) with phenyl boric acid. The Examiner has not explained with solid reasoning how the Zhou publication, dealing with the treatment of brain tumors with boron neutron capture therapy is relevant to the enablement of treatment of cancers unrelated to brain tumors, i.e., prostate, breast and cervical cancers with pharmaceutically active phenyl boric acid or its salts to the affected tissues. In view of the above, the rejection of the claims for lack of enablement is reversed. CONCLUSION OF LAW The Examiner has not met the burden of showing a prima facie case of lack of enablement in the first instance. REVERSED dm