Ex Parte SunDownload PDFPatent Trial and Appeal BoardJun 9, 201713656395 (P.T.A.B. Jun. 9, 2017) Copy Citation United States Patent and Trademark Office 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. 13/656,395 10/19/2012 Thomas Sun 7946-87599-03 2851 74839 7590 Klarquist Sparkman, LLP 121 SW Salmon St Suite 1600 Portland, OR 97204 06/13/2017 EXAMINER PAGONAKIS, ANNA ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 06/13/2017 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): docketing @klarquist.com AS CChair @klarquist. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS SUN1 Appeal 2016-008564 Application 13/656,395 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and RACHEL H. TOWNSEND, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a device for administering a drug composition, which have been rejected as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification describes a device for delivering a xinafoate salt. Spec. 8. The device may be an inhaler such as a dry powder inhaler. Id. Claims 1, 4, and 16—18 are on appeal. Claim 1 is representative of the rejected claims and reads as follows: 1 Appellant identifies the Real Party in Interest as Rigel Pharmaceuticals, Incorporated. Appeal Br. 2. Appeal 2016-008564 Application 13/656,395 1. A device, comprising: a housing defining a chamber that houses an excipient- free, dry powder xinafoate salt-of N4-[(2,2-difluoro-4H- benzo[l,4]oxazin-3-one)-6-yl]-5-fluoro-N2-[3- (methylaminocarbonylmethyleneoxy)phenyl]-2,4- pyrimidinediamine, wherein the xinafoate salt is formulated for administration to the patient via inhalation using the device through a patient interface; and an advancement mechanism capable of distributing the xinafoate salt to the chamber. The claims stand rejected as follows: Clams 1,4, and 16—18 have been rejected under 35 U.S.C. § 102(b) as anticipated by Taylor2 as evidenced by Islam.3 Claims 1, 4, and 16—18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Taylor in view of Hodson.4 ANTICIPATION Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the claims are anticipated by Taylor. The Examiner finds that Taylor teaches a drug formulation comprising the recited xinafoate salt as a dry powder with or without an excipient. Final Act. 3. The Examiner finds that the drug formulation can 2 Taylor at al., WO 2009/031011 A2 (publ. Mar. 12, 2009) (“Taylor”). 3 Nazrul Islam & Ellen Gladki, Dry powder inhalers (DPIs)—A review of device reliability and innovation, 360 Inf 1 J. Pharm. 1—11 (2008) (“Islam”). 4 Hodson et al., US 5,619,984 (iss. Apr. 15, 1997) (“Hodson”). 2 Appeal 2016-008564 Application 13/656,395 be administered intranasally or by inhalation using a dry powder inhaler. Id. The Examiner finds that Islam evidences the structure of the inhalers referenced in Taylor and that inhalers shown in Islam consist of a housing chamber and an advancement mechanism capable of distributing the drug to the chamber. Final Act. 3^4. Appellant contends that Tylor does not disclose a housing defining a chamber that houses the xinafoate salt. Appeal Br. 3^4. Appellant also argues that Taylor does not teach using a xinafoate salt that is free of excipients. Appeal Br. 4. Principles of Law “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). A gap in an otherwise anticipating reference may be closed by reference to extrinsic evidence. The evidence must make clear though that the missing descriptive matter is necessarily present in the other reference. Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003). Analysis We find that Appellant has the better argument. Taylor broadly mentions the use of a dry powder inhaler (Taylor p. 16,11. 26—35), Taylor is silent as to the structure of the inhaler. Thus, Taylor does not anticipate the pending claims. The Examiner points to Islam as evidencing the structure of the standard dry powder inhalers referenced in Taylor. Ans. 6. While this may 3 Appeal 2016-008564 Application 13/656,395 be true, Islam does not teach that all “standard dry powder inhalers” taught in Taylor to be devices for use with the disclosed xinafoate salt necessarily have a chamber that houses an active as an excipient free, dry powder, and an advancement mechanism capable of distributing the active ingredient to the chamber as required by the claim. Thus, the Examiner has failed to show that the claimed structure is “necessarily present.” Id. Conclusion of Law We conclude that a preponderance of the evidence does not support the Examiner’s conclusion that the present claims are anticipated by Taylor as evidenced by Islam. OBVIOUSNESS Issue The issue with respect to this rejection is whether a preponderance of the evidence support the Examiner’s conclusion that the rejected claims would have been obvious over Taylor combined with Hodson. The Examiner finds that Taylor teaches a drug formulation comprising the recited xinafoate salt as a dry powder with or without an excipient. Final Act. 4—5. The Examiner finds that Taylor teaches the drug formulation can be administered intranasally or by inhalation using a dry powder inhaler. Final Act. 5. While the Examiner finds that Taylor does not teach “a housing defining chamber that houses the xinafoate salt and an advancement mechanism capable of distributing the xinafoate salt to the chamber and is loaded on an elongate carrier,” Hodson teaches such a structure. Id. The Examiner concludes that 4 Appeal 2016-008564 Application 13/656,395 One of ordinary skill in the art would have found it prima facie obvious at the time of the invention to administer the dry powder formulation comprising the claimed xinafoate salt of Taylor et al. ion [sic] the dry powder inhalation device of Hodson et al. One would have been motivated to do so as the device of Taylor et al. is a known effective dry powder inhalation [device] and the formulation of Taylor et al. is intended for administration via a dry powder inhaler. As such, one would have a reasonable expectation of success that the formulation of Taylor et al. would be therapeutically effective when administered in the dry powder inhalation device of Hodson et al. Final Act. 6. Appellant contends that the Examiner has failed to establish a prima facie case of obviousness in that neither of the references teaches the use of the xinafoate salt without an excipient. Appeal Br. 8. Appellant argues that Taylor mandates the use of an excipient thereby teaching away from the present invention. Id. Appellant also argues that the present invention provides superior results. Appeal Br. 7. Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Office Action and Answer regarding this rejection. We find the Examiner has established that the claims would have been obvious to one of ordinary skill in the art over Taylor combined with Hodson. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have 5 Appeal 2016-008564 Application 13/656,395 identified claim 1 as representative; therefore, all claims fall with claim 1. We address Appellant’s arguments below. Appellant contends that Taylor does not teach the use of the xinafoate salt without an excipient. Appeal Br. 6. We are unpersuaded. Taylor specifically teaches that the xinafoate salt can be used alone. Taylor p. 12, 11. 15-19, p. 16,11. 26-35. Appellant argues that Taylor teaches away from using the xinafoate salt without excipients. Appeal Br. 8. Again we are unpersuaded. We have reviewed the sections of Taylor cited by Appellant and find that they do not rise to the level of a teaching away in that they do not “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). For example, Appellant cites to Taylor where it states that “[compatibility with conventional excipients such as lactose and starch is a further mandatory requirement” (emphasis omitted) as mandating the use of excipients. Appeal Br. 4. We do not agree. The cited passage relates to the properties of the xinafoate salt and does not mandate the inclusion of excipients. Similarly, while the other cited passages teach the use of the xinafoate salt with an excipient, they do not mandate the use of excipients. Moreover, as discussed above, Taylor specifically teaches that the salt can be used without an excipient. Appellant argues that the claimed invention exhibits superior results and that this shows nonobviousness. Appeal Br. 7. We are unpersuaded. “To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of 6 Appeal 2016-008564 Application 13/656,395 ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). “[I]t is well settled that unexpected results must be established by factual evidence. ‘Mere argument or conclusory statements in the specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)). Appellant has pointed to nothing in the record which supports the conclusion that the results achieved by the claimed invention are unexpected. Appellant has only offered arguments that the results are superior not that they are unexpected. Appeal Br. 7, Reply Br. 7—8. The superiority is asserted to be related to the advantage of administration without an excipient: for example, “such as ameliorating concomitant lung irritation associated with inhaling compositions comprising excipient.” Reply Br. 8. However, there is no evidence that this benefit is “unexpected” in light of Taylor’s specific teaching that the xinafoate salt can be used alone, Taylor p. 12,11. 15—19, p. 16,11. 26—35, i.e., without excipients. In addition, Appellant’s arguments regarding the alleged superior results are premised on Appellant’s contention that Taylor mandates the use of an excipient. Appeal Br. 7. As discussed above, we do not read Taylor as mandating the use of excipients. Conclusion of Law We conclude that a preponderance of the evidence supports the Examiner’s conclusion that claim 1 would have been obvious over Taylor combined with Hodson under 35 U.S.C. § 103(a). 7 Appeal 2016-008564 Application 13/656,395 Claims 4 and 16—18 have not been argued separately and, therefore, fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY We reverse the rejection of claims 1,4, and 16—18 under 35 U.S.C. § 102(b). We affirm the rejection of claims 1, 4, and 16—18 under 35 U.S.C. § 103(a). 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 8 Copy with citationCopy as parenthetical citation