Ex Parte Luck et alDownload PDFPatent Trials and Appeals BoardFeb 12, 201912155897 - (D) (P.T.A.B. Feb. 12, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/155,897 06/11/2008 90679 7590 02/14/2019 Finnegan/Perring, B.V. 901 New York A venue, N.W. Washington, DC 20001 FIRST NAMED INVENTOR Martin Luck 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. 13214.0029-00 6986 EXAMINER RAWLINGS, STEPHEN L ART UNIT PAPER NUMBER 1643 NOTIFICATION DATE DELIVERY MODE 02/14/2019 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): regional-desk@finnegan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARTIN LUCK and PIERRE BROQUA 1 Appeal2017-007506 Application 12/155,897 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision under 35 U.S.C. § 134(a) involving claims directed to an injectable pharmaceutical composition. Claims 76, 77, 79--82, 84--86, and 88-97 are on appeal as rejected under 35 U.S.C. § 112, first paragraph, and§ 103. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 Appellants identify the Real Party in Interest as "Perring B.V." Appeal Br. 3. Oral argument was heard on February 7, 2019; a transcript of which will be made a part of the record on appeal. Appeal2017-007506 Application 12/155,897 STATEMENT OF THE CASE Independent claim 76 is representative and is reproduced below: 7 6. An injectable pharmaceutical compos1t10n comprising a pharmaceutically acceptable solvent and a GnRH antagonist peptide according to formula 1 or a pharmaceutically acceptable salt thereof Ac-DNal-Dcpa-Dpal-Ser-Aph(X1)- DAph(X2)-Leu-Lys(iPr)-Pro-DAla-NH2 1 wherein X1 is L-Hor and X2 is CONH2, wherein the composition does not form a gel depot within 30 minutes of formation of the composition and the concentration of the peptide or salt thereof in the solvent is: (1) 20 mg/ml, provided that it is administered to a patient within 24 hours of formation of the composition; (2) 40 mg/ml, provided that it is administered to a patient within 24 hours of formation of the composition; (3) 60 mg/ml, provided that it is administered to a patient within 8 hours of formation of the composition; or ( 4) 80 mg/ml, provided that it is administered to a patient within 1 hour of formation of the composition, wherein the composition achieves a gel depot upon administration to a patient for release of the peptide or salt thereof over a period of at least two weeks. Appeal Br. 26 (Claims Appendix). The following rejections are appealed: Claims 76, 77, 79--82, 84--86, 88, and 89 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Final Action 7. 2 Appeal2017-007506 Application 12/155,897 Claims 76, 77, 79--82, 84--86, 88, and 89-97 stand rejected under 35 U.S.C. § 103(a) over Jiang. 2 Id. at 11. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision; arguments not so- presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). I. WRITTEN DESCRIPTION A description adequate to satisfy 35 U.S.C. § 112, first paragraph, must "clearly allow persons of ordinary skill in the art to recognize that [ the inventor] invented what is claimed." In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) ( en bane) ( citation omitted, alteration in original). "[T]he written description requirement does not demand either examples or an actual reduction to 2 Guangcheng Jiang et al., GnRH Antagonists: A New Generation of Long Acting Analogues Incorporating p-Ureido-phenylalanines at Positions 5 and 6, 44 J. MED. CHEM. 453---67 (2001) ("Jiang"). 3 Appeal2017-007506 Application 12/155,897 practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement." Id. at 1352; see also Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). "The 'written description' requirement must be applied in the context of the particular invention and the state of the knowledge." Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). "It is not necessary that every permutation within a generally operable invention be effective in order for an inventor to obtain a generic claim, provided that the effect is sufficiently demonstrated to characterize a generic invention." Id. at 1359. The Examiner determined: Water is the only solvent that is described that can be used to formulate stable solutions of the peptide or salt thereof, which lack the observed propensity to form gels when the concentration of the peptide in the solvent exceeds 0.25 mg/ml. Inasmuch as the claims are not limited to solutions comprising water, it would appear the specification fails to adequately describe with the requisite clarity and particularity the claimed genus of solvents that can be used to make the claimed injectable pharmaceutical composition comprising the solution of the peptide at the requisite concentrations. Final Action 10. The Examiner explained in the Answer the differences in types of solvents; it is the Examiner's position that, without providing evidence to support that the various solvents listed in Appellants' Specification will dissolve or re-suspend FE200486 (the claimed active compound), the skilled artisan would not recognize a disclosure of the solvent limitation (without further testing examples) because the only solvent described as working was water. Answer 34--45. 4 Appeal2017-007506 Application 12/155,897 Appellants argue the claims' solvent limitation is described in the Specification at page 6, where it states: The peptide or pharmaceutically acceptable salt is preferably comprised in a solution in a pharmaceutically acceptable solvent. Examples of such pharmaceutically acceptable solvents are water, an alcohol (for example ethanol), N-methylpyrrolidone or dimethylsulfoxide. In a preferred embodiment of the invention the solvent is water or a mixture of water and a second solvent, such as alcohol, N-methylpyrrolidone or dimethylsulfoxide, such that the water constitutes at least 90% by weight of the solvent mixture. Appeal Br. 14 ( emphasis original). Further, Appellants point to the Specification's Examples 2---6, which include water and 5% mannitol as a solvent, thus, describing working solvents that were not only water. Id. at 15. Appellants also argue that the term "pharmaceutically acceptable solvent" is a common term used in the art. The Office does not argue, and cannot argue, that a person of ordinary skill would not be led to a known class of solvents by the term "pharmaceutically acceptable solvent" or that Appellants' specification does not provide enough guidance to the class of solvents encompassed by the term. Reply Br. 6. We conclude that the balance of evidence favors Appellants' position. Appellants have not identified only a single solvent for their invention, but have listed several specifically and described a class of solvents for consideration-those that are pharmaceutically acceptable. Here, this is a sufficient disclosure to apprise the skilled artisan of what type of solvent component is included in the claimed invention. "A patent need not teach, and preferably omits, what is well known in the art." Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1534 (Fed. Cir. 1987). The Examiner's 5 Appeal2017-007506 Application 12/155,897 explanation of solvent types and properties provided in the Answer at pages 3 6-3 7, which does not cite any particular source, is not merely informative, but appears to be illustrative of the kind of basic knowledge the skilled artisan would have had when considering solvents for the claimed invention ( e.g., no sources were cited for such information by the Examiner, hence we understand such to be common knowledge). For these reasons, the written description rejection is reversed. IL OBVIOUSNESS "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). "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under§ 103." Id. at 419. "[T]he question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) ( citation omitted). The Examiner determined the claimed invention would have been obvious over Jiang. Final Action 11-21. Specifically, the Examiner determined Jiang taught or suggested the compound "FE200486," which is a synthetic peptide having the same structure as that claimed. Id. at 12. Further, the Examiner determined that Jiang disclosed a composition having 6 Appeal2017-007506 Application 12/155,897 a 50 mg/mL concentration of FE200486 (which Jiang called compound 31) in water, or water and 5% mannitol, as a solvent, which provided an initially-clear and free-flowing liquid and presented no gel formation initially (but, upon storage at ambient temperature, had signs of turbidity at 24 hours and some sediment at 1 week). Id. at 12-13; see also Jiang 460 (Table 2). Further, the Examiner determined Jiang taught and suggested injecting such a composition into a subject (rat). Final Action 12-13. Further, the Examiner determined that Jiang suggests that, after administration to a subject (rat), the injected FE200486 composition formed a gel depot because Jiang disclosed an extended duration of action following such administration, consistent with such gel formation. Final Action 13; Answer 23-24; see also Jiang 461 ("results strongly suggest that the very long duration of action of 31 ... after sc administration ... is the result of the peptide's bioavailability at, and distribution from, the injection site rather than one of stability in the circulation."). We discern no error in the Examiner's determinations. We address Appellants' arguments below. Appellants argue "Jiang fails to teach a composition of an injectable pharmaceutical composition according to Appellants' claim 7 6." Appeal Br. 17. This argument is not persuasive. It is clear from Jiang that its aqueous formulations including the compound FE200486, which Appellants do not contest is the claimed compound, were injected into rats. Moreover, the formulations disclosed by Jiang's Table 2 fall within the scope of the claims and would have been injectable, particularly within 24 hours of their preparation, i.e., before the appearance of any turbidity. 7 Appeal2017-007506 Application 12/155,897 Appellants argue Jiang teaches away from the claimed invention because the reference notes that increasing dosage of FE200486 increases the drug's duration of action, which is different from Appellants' discovery that concentration is the key variable relating to the active compound's duration of action. Appeal Br. 19. This argument is also not persuasive. Appellants' claims do not require controlling a pharmaceutical formulation's duration of action by manipulating its drug concentration. In any event, Jiang expressly states that the duration of action of its disclosed GnRH antagonist formulations was both concentration-dependent and dose- dependent See Jiang 461. Jiang' s focus on dosage is not a teaching away of the importance of concentration. Appellants argue Jiang teaches away from gel depot formation ( after injection) because "[t]here is no teaching in Jiang that [its] solutions form a gel depot upon administration" and the skilled artisan "would consider Jiang to teach that gel formation is an adverse quality for GnRH antagonist peptides." Appeal Br. 21. This argument is also not persuasive. Jiang does not teach away from post-injection gel formation of its compositions. As discussed above, Jiang implies that such gel formation inherently occurs because its formulations exhibit a very long duration of action because the active agent does not enter the subject's circulation, but maintains its bioavailability at the injection site. Jiang 461. Moreover, "[p ]roducts of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Appellants argue Jiang does not teach a GnRH antagonist peptide composition that releases over a period of at least two weeks and Jiang fails 8 Appeal2017-007506 Application 12/155,897 to teach the claimed administration of injectable composition within the time intervals after composition formation, as claimed. Appeal Br. 23. This argument is also not persuasive. Jiang discloses that its formulations exhibit a very long duration of action. For example, Jiang states: in rats injected sc with FE200486 (2 mg/kg), plasmatic concentrations of FE200486 remained above 5 ng/mL until day 41, and the time after which they dropped below 3 ng/mL and plasma LH levels started rising until full recovery was reached at day 84 with levels of FE200486 hovering around 1 ng/mL. Jiang 453. This far exceeds the claimed two-week period. Moreover, as discussed above, Jiang teaches that its 50 mg/mL FE200486 formulations, whether in just water or a 5% mannitol solution as solvent, were initially not gels, but were clear and either slightly viscous or free-flowing, but exhibited some signs of turbidity at 24 hours. Jiang 460 (Table 2). This suggests that injection can and should be performed with such formulations before 24 hours after preparation, as claimed, so that a non-turbid formulation is used for injection. For the reasons set forth above, we are unpersuaded that the Examiner erred in presenting a prima facie case for obviousness. The balance of evidence on appeal favors the Examiner's position and we affirm the rejection. 9 Appeal2017-007506 Application 12/155,897 SUMMARY The rejection for lack of written description rejection under 35 U.S.C. § 112 is reversed. The obviousness rejection under 35 U.S.C. § 103 is affirmed. 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)(l )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation