Ex Parte Brinkley et al

Patent Trial and Appeal BoardMar 22, 2016

12769335 (P.T.A.B. Mar. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 121769,335 04/28/2010 Paul Andrew Brinkley 26158 7590 03/24/2016 WOMBLE CARLYLE SANDRIDGE & RICE, LLP ATTN: IP DOCKETING P.O. BOX 7037 ATLANTA, GA 30357-0037 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. N64138 1010.1 7397 EXAMINER AHMED, HASAN SYED ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 03/24/2016 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): IPDocketing@WCSR. COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PAUL ANDREW BRINKLEY and AUGUST JOSEPH BORSCHKE Appeal2014-002527 Application 12/769,335 Technology Center 1600 Before DONALD E. ADAMS, DEMETRA J. MILLS, and JEFFREY N. FREDMAN, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. Â§ 6(b). WE AFFIRM. Appeal2014-002527 Application 12/769,335 STATEMENT OF CASE The following claim is representative. 1. A nicotine-containing pharmaceutical composition, compnsmg: at least two nicotinic compounds comprising nicotine levulinate and at least one compound selected from the group consisting of nicotine in free base form, a nicotine salt other than nicotine levulinate, a nicotine complex, and a nicotine solvate, wherein a levulinate moiety of the nicotine levulinate, determined as levulinate anion, is present in an amount of at least about 10 percent by weight based on the total weight of nicotine calculated as nicotine base, wherein the composition is in a pharmaceutically acceptable form adapted for oral or nasal delivery of the composition. Cited References Lawson Hansson Rabinoff us 4,830,028 US 2004/0191322 Al US 2007/0134169 Al May 16, 1989 Sept. 30, 2004 Jun. 14,2007 Grounds of Rejection Claims 1, 8-10, 12-23, and 29--47 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Hansson in view of Rabinoff and Lawson. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Answer at pages 3---6. 2 Appeal2014-002527 Application 12/769,335 PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "In rejecting claims under 35 U.S.C. Â§ 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and ( 4) objective evidence of nonobviousness, if present. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). The test for non-analogous art is first whether the art is within the field of the inventor's endeavor and, if not, whether it is "reasonably pertinent to the particular problem with which the inventor was involved." In re Wood, 599 F.2d 1032, 1036 (CCPA 1979). "A reference is reasonably pertinent if, even though it may be in a different field" of endeavor, it logically would have commended itself to an inventor's attention in considering his problem "because of the matter with which it deals." In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). 3 Appeal2014-002527 Application 12/769,335 Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In re Klein, 647 F.3d 1343, 1348 (2011) ANALYSIS We agree with the Examiner's fact finding, statement of the rejection and responses to Appellants' arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. We provide the following additional comment to the Examiner's argument set forth in the Final Rejection and Answer. Appellants argue that there is no motivation to combine the cited references, particularly Lawson with the two primary references, and that Lawson is non-analogous art to the claimed invention. We are not persuaded. Rabinoff states that Other agents possibly enhancing addiction in cigarettes, and which can be used in smoking cessation patches, include levulinic acid (4- oxopentanoic acid)+nicotine and nicotine levulinate to enhance binding of nicotinic receptors (low nanomolar ranges); and also the possible use of 4-pentenoic acid, omega-pentadecalactone, 2,3- pentanedione, 2-pentanone, 2-pentylpyridine (other known cigarette additives). Other chemicals that can possibly enhance addiction, and which can be used in smoking cessation patches, are chemicals that were shown by cigarette companies or other research, either by subjective testing measures, or objective measures (such as CNS PI-N2 amplitudes, but including other measures, but not limited to, behavioral, neurological, biochemical, gene or protein sequence or expression product scientific 4 Appeal2014-002527 Application 12/769,335 measures/markers) to increase "impact" or addiction: for instance, tobacco industry research showed PI-N2 amplitudes, an objective measure of "impact", were increased by pyrazine (already mentioned), vanillin and propylene glycol. Thus, these chemicals could also be added to a patch (or other method of delivery) to decrease "impact", and which might help the smoker, as a replacement therapy, to cease smoking, or to switch to/substitute with use of a reduced harm or non- harmful replacement for cigarettes. Rabinoffi-fi-120, 21; Ans. 12, emphasis added. Thus, Rabinoffteaches agents and chemicals known to enhance addiction can be incorporated into smoking cessation or alcohol cessation pharmaceutical gums or patches. Rabinoff provides clear evidence that one of ordinary skill in the art would look to smoking products such as cigarettes for a suggestion of these addictive chemicals and amounts of these chemicals, such as amounts of levulinate, known to enhance cigarette addiction. Hannson also specifically states that nicotine patches deliver the nicotine intake equivalent of consuming 15-25 cigarettes a day. Hannson i-fl8. Rabinofftherefore demonstrates that cigarettes and smoking cessation products are in the same field of endeavor for purposes of identifying chemical compounds associated with addiction. Moreover, Rabinoff also evidences that dosing of nicotine and other chemicals in cigarettes is relevant and reasonably pertinent to dosing of nicotine in smoking cessation drugs, patches and gums by expressly suggesting that the ordinary artisan would look to cigarettes for agents to use in smoking cessation products. See Rabinoff i1i1 20, 21. Appellants have provided no evidence that the amounts of levulinate moiety disclosed in Lawson would not be relevant to a smoking cessation pharmaceutical composition or other nicotine-containing pharmaceutical composition. Appellants also recognized that Lawson discloses that 5 Appeal2014-002527 Application 12/769,335 nicotinic levulinate provides a smooth and palatable flavor. Br. 8, 19. One of ordinary skill in the art desiring to make a smoking cessation product with a palatable flavor would incorporate a nicotinic levulinate as suggested by Rabinoff into a smoking cessation pharmaceutical product. In KSR, the Supreme Court stated that When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR Int'! v. Teleflex Inc., 550 U.S. 398, 421 (2007). We, therefore, agree with the Examiner that it would have been obvious to one of ordinary skill in the art at the time of the invention, and a person of ordinary skill in the art would have been directly motivated by Rabinoff to look to the pertinent analogous art of Lawson for amounts of levulinate moiety to be incorporated into a nicotine-containing pharmaceutical composition, and that Lawson is reasonably pertinent to formulation of a pharmaceutical compositions for smoking cessation. Appellants argue Lawson's cigarettes are heated and burned and therefore are not relevant to a pharmaceutical composition. Br. 11. However, as discussed herein, notwithstanding that cigarettes are burned, Rabinoff specifically states that "agents possibly enhancing addiction in cigarettes, and which can be used in smoking cessation patches, include levulinic acid ( 4-oxopentanoic acid)+nicotine and nicotine levulinate to enhance binding of nicotinic receptors." Rabinoffi-f 20. 6 Appeal2014-002527 Application 12/769,335 We find that the Examiner has established a prima facie case of obviousness which has not been rebutted by Appellants by the weight of the evidence. CONCLUSION OF LAW The cited references support the Examiner's obviousness rejections, which are affirmed for the reasons of record. All pending rejected claims fall. AFFIRMED 7