Lawrence J. Gerrans et al.

Patent Trials and Appeals BoardAug 31, 2020

2018007012 (P.T.A.B. Aug. 31, 2020)

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. 14/748,810 06/24/2015 Lawrence J. Gerrans 04530-P0013D 6195 151971 7590 08/31/2020 Forge IP, PLLC 1077 Bridgeport Ave Suite 301 Shelton, CT 06484 EXAMINER LALONDE, ALEXANDRA ELIZABETH ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 08/31/2020 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): patent@forge-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte LAWRENCE J. GERRANS and ERHAN H. GUNDAY ____________ Appeal 2018-007012 Application 14/748,810 Technology Center 3700 ____________ Before ANNETTE R. REIMERS, BRANDON J. WARNER, and BRENT M. DOUGAL, Administrative Patent Judges. WARNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–23, which are all the pending claims. Appeal Br. 1, 2. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Sanovas Intellectual Property, LLC. Appeal Br. 2. Appeal 2018-007012 Application 14/748,810 2 CLAIMED SUBJECT MATTER Appellant’s disclosed invention “relates to methods and systems for delivering therapeutic and/or diagnostic agents to specific cellular locations within and adjacent to bodily tissues and cavities,” and more specifically “relates to a method and system of localized delivery of diagnostic and/or therapeutic agents to nasal cavities and tissues via a nested balloon catheter.” Spec. ¶ 1. Claim 1, reproduced below with emphasis added, is the sole independent claim and is representative of the subject matter on appeal. 1. A method of localized delivery of a therapeutic and/or diagnostic agent to nasal tissue or cavities, comprising the steps of: inserting a catheter into a nasal cavity, said catheter comprising an outer balloon having a wall with at least one opening therethrough and an inner surface; and an inner balloon at least partially disposed in said outer balloon, said inner balloon at least partially enclosing an inflation chamber and having an outer surface defining a space between the outer surface of said inner balloon and the inner surface of said outer balloon; supplying the therapeutic and/or diagnostic agent to the space between the outer surface of said inner balloon and the inner surface of said outer balloon via a first lumen of said catheter; and inflating said inner balloon by supplying fluid to the inflation chamber via a second lumen of said catheter to urge the therapeutic and/or diagnostic agent out of the at least one opening in the wall of said outer balloon and into nasal tissue. Appeal 2018-007012 Application 14/748,810 3 EVIDENCE The Examiner relies on the following evidence in rejecting the claims on appeal: Vigil US 5,336,234 Aug. 9, 1994 Shah US 2005/0015047 A1 Jan. 20, 2005 Willard US 2005/0107741 A1 May 19, 2005 Chang US 2006/0004323 A1 Jan. 5, 2006 Zadno-Azizi US 2006/0200074 A1 Sept. 7, 2006 Schon US 2007/0198047 A1 Aug. 23, 2007 Broker US 2009/0054922 A1 Feb. 26, 2009 Makower US 2009/0187098 A1 July 23, 2009 Rahimsobhani US 2009/0240199 A1 Sept. 24, 2009 Boatman US 2009/0254064 A1 Oct. 8, 2009 Diamant US 2011/0082483 A1 Apr. 7, 2011 Ogle US 2011/0218517 A1 Sept. 8, 2011 Thielen US 2011/0264039 A1 Oct. 27, 2011 Gerrans US 9,186,485 B2 Nov. 17, 2015 REJECTIONS The following rejections are before us for review: I. Claims 1, 2, 9, 12–14, and 18–22 stand rejected on the basis of obviousness-type double patenting as being unpatentable over claims 34–43 of Gerrans in view of Shah. Final Act. 4–11. II. Claims 1, 2, 7, 8, 13, 14, and 18 stand rejected under 35 U.S.C. § 103 as being unpatentable over Boatman and Shah. Id. at 12–18. Appeal 2018-007012 Application 14/748,810 4 III. Claim 3 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Rahimsobhani. Id. at 18–19. IV. Claims 4–6, and 11 stand rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Chang. Id. at 19–22. V. Claim 9 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Broker. Id. at 22. VI. Claims 10 and 19 stand rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Makower. Id. at 22–24. VII. Claim 12 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Schon. Id. at 24–25. VIII. Claims 15 and 16 stand rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Willard. Id. at 26–27. IX. Claim 17 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Vigil. Id. at 28. X. Claim 20 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Zadno-Azizi. Id. at 28–31. XI. Claim 21 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Thielen. Id. at 31–32. XII. Claim 22 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, Thielen, and Diamant. Id. at 32. XIII. Claim 23 stands rejected under 35 U.S.C. § 103 as being unpatentable over Boatman, Shah, and Ogle. Id. at 32–33. Appeal 2018-007012 Application 14/748,810 5 ANALYSIS Rejection I – Double Patenting Appellant does not address the double patenting rejection in the Appeal Brief. See Appeal Br. 6–12; see also id. at 3–6 (omitting this rejection from the grounds listed to be reviewed on appeal). Therefore, we summarily sustain the obviousness-type double patenting rejection of claims 1, 2, 9, 12–14, and 18–22. See MPEP § 1205.02 (An appellant may, of course, choose not to present arguments or rely upon particular evidence as to certain claim rejections; however, such arguments and evidence are waived for purposes of the appeal and the Board may summarily sustain any grounds of rejections not argued.); see also In re Berger, 279 F.3d 975 (Fed. Cir. 2002) (confirming same). Rejections II–XIII – Obviousness over Cited Prior Art All the claims recite a “method of localized delivery of a therapeutic and/or diagnostic agent to nasal tissue or cavities” that includes the steps of “inserting a catheter into a nasal cavity,” where the catheter has a perforated outer balloon, an inner balloon, and a space therebetween, “supplying the therapeutic and/or diagnostic agent to [that] space,” and “inflating [the] inner balloon . . . to urge the therapeutic and/or diagnostic agent out of the at least one opening in the wall of said outer balloon and into nasal tissue.” Appeal Br., Claims App. (emphasis added). In other words, as highlighted by these emphasized limitations, the claims are directed to a particular method of delivering an agent to an area of the body using a catheter; they are not directed solely to the structure of the catheter itself. See Appeal Br. 7–9. Appeal 2018-007012 Application 14/748,810 6 For all the obviousness rejections on appeal, the Examiner relies on a base combination of Boatman and Shah to render obvious the claimed method. See Final Act. 12–33. In particular, the Examiner finds that Boatman discloses a multiple-balloon catheter having a perforated outer balloon, referred to as a “weeping balloon catheter,” which includes the recited catheter structure, but which is disclosed for use in a method of delivering an agent into a body vessel (described in Boatman as being any body passage lumen that conducts fluid, such as blood vessels, esophageal, intestinal, biliary, urethral, and ureteral passages). Final Act. 12–14 (citing Boatman ¶¶ 2, 33, Fig. 7A). Critically, with respect to the method claimed, the Examiner acknowledges that Boatman “fails to specifically disclose a method of localized delivery of a therapeutic and/or diagnostic agent to nasal tissue or cavities.” Final Act. 14 (emphasis added). The Examiner then turns to Shah, which teaches an inflatable dual- balloon catheter for applying pressure to a body cavity as a way to control bleeding or hemorrhage therein.2 Final Act. 14 (citing Shah, ¶¶ 8, 10, 34). Shah’s pressure-applying catheter is admittedly broadly disclosed as being useful for controlling bleeding in various body cavities, including a nasal cavity. See Appeal Br. 10–11; Shaw ¶ 10. From these teachings, all the 2 Although the Examiner accurately notes that Shah mentions delivery of an agent to a body cavity (see Final Act. 14; Ans. 3), Appellant is correct that Shah does so only in the context of coating or covering the external surface of the outer balloon (see Appeal Br. 10–11 (citing Shah, ¶ 34)) rather than by passing any agent through the wall of the outer balloon as required in the claimed method, as Shah’s wall would need to contain the pressure acting against the body cavity. In other words, we agree with Appellant that Shah teaches locations and uses of a different type of dual-balloon catheter than in Boatman. See Reply Br. 2–3. Appeal 2018-007012 Application 14/748,810 7 Examiner’s art rejections are premised on modifying Boatman’s method of delivering an agent via a weeping balloon catheter “to specifically nasal tissue or cavities, as taught by Shah, for the purpose of applying pressure in the cavity to reduce or eliminate bleeding.” Final Act. 14 (emphasis added). Appellant persuasively argues that the Examiner’s rejections do not provide an adequately supported reason why a person of ordinary skill in the art would have modified Boatman in view of Shah to arrive at the method of the claimed invention. See Appeal Br. 6, 8–11; Reply Br. 2–3. We agree that the Examiner’s stated reason—to apply pressure in the nasal cavity (Final Act. 14; Ans. 3)—lacks a rational underpinning in that Shah’s teaching of use in a nasal cavity is only in the context of a pressure-applying catheter; it does not provide any relevant teaching that would suggest using another type of catheter in the nasal cavity, much less a weeping balloon catheter as in Boatman.3 Moreover, we question whether the Examiner’s stated rejections, all premised on a combination of Boatman and Shah, would achieve the claimed method—by using a multi-balloon catheter to “apply pressure,” such as to reduce bleeding, it is unclear how an agent could also be urged out of at least one opening in the wall of the outer balloon as the claims require. 3 We note that the Examiner’s ultimate conclusion of obviousness (essentially that Boatman’s method of delivering an agent via a weeping balloon catheter could be used to deliver an agent to nasal tissue) may find objective support somewhere, but it is not from Shah. As we limit our review to the rejections presented on appeal, we leave it to the Examiner to reconsider whether there would have been an objective reason in the art to apply Boatman’s teachings for such an application to nasal tissue. Appeal 2018-007012 Application 14/748,810 8 Rejections based on obviousness must rest on a factual basis; in making such a rejection, the Examiner has the initial burden of supplying the requisite factual basis and may not, because of doubts that the invention is patentable, resort to speculation, unfounded assumptions, or hindsight reconstruction to supply deficiencies in the factual basis. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). Here, absent improper hindsight reconstruction, we do not see a sufficiently articulated explanation, based on an objective rational underpinning, as to why one of ordinary skill in the art would have been led to modify the location of Boatman’s weeping balloon catheter application to treat the nasal cavity by applying pressure, as stated in the rejections. No adequate reason for such modification is otherwise evident from the record. The Examiner’s reliance on the remaining references of record is for teaching additional claimed features, but not in a way that would cure the fundamental deficiency in the base combination of Boatman and Shah discussed above. See Final Act. 18–33. Accordingly, based on the record before us, the Examiner has not met the burden of establishing a proper case of obviousness. Thus, we do not sustain the obviousness rejections of claims 1–23. DECISION We AFFIRM the Examiner’s uncontested double patenting rejection of claims 1, 2, 9, 12–14, and 18–22. We REVERSE the Examiner’s obviousness rejections of claims 1–23 based on the cited art. Appeal 2018-007012 Application 14/748,810 9 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 9, 12–14, 18–22 Obviousness-Type Double Patenting 1, 2, 9, 12–14, 18–22 1, 2, 7, 8, 13, 14, 18 103 Boatman, Shah 1, 2, 7, 8, 13, 14, 18 3 103 Boatman, Shah, Rahimsobhani 3 4–6, 11 103 Boatman, Shah, Chang 4–6, 11 9 103 Boatman, Shah, Broker 9 10, 19 103 Boatman, Shah, Makower 10, 19 12 103 Boatman, Shah, Schon 12 15, 16 103 Boatman, Shah, Willard 15, 16 17 103 Boatman, Shah, Vigil 17 20 103 Boatman, Shah, Zadno-Azizi 20 21 103 Boatman, Shah, Thielen 21 22 103 Boatman, Shah, Thielen, Diamant 22 23 103 Boatman, Shah, Ogle 23 Overall Outcome 1, 2, 9, 12–14, 18–22 3–8, 10, 11, 15–17, 23 AFFIRMED IN PART