Kirk P. SewardDownload PDFPatent Trials and Appeals BoardMay 14, 202013656413 - (D) (P.T.A.B. May. 14, 2020) 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. 13/656,413 10/19/2012 Kirk P. SEWARD 34634-726.201 1023 21971 7590 05/14/2020 WILSON, SONSINI, GOODRICH & ROSATI 650 PAGE MILL ROAD PALO ALTO, CA 94304-1050 EXAMINER PHAN, DOAN THI-THUC ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 05/14/2020 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): patentdocket@wsgr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KIRK P. SEWARD Appeal 2018-008779 Application 13/656,413 Technology Center 1600 ____________ Before ULRIKE W. JENKS, TAWEN CHANG, and JAMIE WISZ, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims directed to a method of modulating local tissue physiology as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Mercator Medsystems, Inc. Appeal Br. 3. We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appeal 2018-008779 Application 13/656,413 2 STATEMENT OF THE CASE According to the Specification, it was known “that pH differences may alter drug effects in cell culture assays, the localized or regionalized modification of pH within the body to enable more rapid drug uptake, more rapid clearance, or improved effect has not been attempted.” Spec. ¶ 3. The Specification describes methods for “the modulation of local tonicity or osmolarity [in the body] to achieve enhanced cellular uptake of pharmaceutical agents in formulation with or delivered before or after the agents that modulate local tonicity or osmolarity.” Id. ¶ 14. Claims 17, 20, 21, 24, and 59–77 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 17 is representative of the claims on appeal, and reads as follows: 17. A method for modulating local tissue physiology comprising: injecting a preparation comprising a liquid, gel, or semisolid into the tissue of a perivascular space beyond an external elastic lamina of a blood vessel; buffering the local tissue physiology by raising or lowering the pH of the local tissue with the injected preparation, wherein the preparation comprises a therapeutic agent that has its index effect at a physiological condition modulated by the injection of such preparation, but not having an index effect at a neutral physiological condition; and enhancing uptake of the therapeutic agent by the local tissue by the raising or lowering of the pH of the local tissue. Appeal Br. 14 (Claims Appendix) (emphasis added). Appeal 2018-008779 Application 13/656,413 3 REFERENCE(S) The prior art relied upon by Examiner is: Name Reference Date Rosenthal et al. (“Rosenthal”) US 6,524,274 B1 Feb. 25, 2003 Goodson et al. (“Goodson”) US 2005/0267010 A1 Dec. 1, 2005 Seward et al. (“Seward”) US 2007/0100318 A1 May 3, 2007 Vyavahare et al. (“Vyavahare”) US 2007/0281026 A1 Dec. 6, 2007 Blaskovich et al. (“Blaskovich”) US 2011/0091549 A1 Apr. 21, 2011 REJECTION(S) The claims stand rejected as follows: I. Claims 17, 20, 21, 24, 61, 63–67, and 70–77 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Rosenthal, Vyavahare, and Seward. II. Claims 21, 24, 59, and 60 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Rosenthal, Vyavahare, Seward, and Blaskovich. III. Claims 62, 68, and 69 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Rosenthal, Vyavahare, Seward, and Goodson. I. Obviousness over Rosenthal, Vyavahare, and Seward Does the preponderance of evidence of record relied upon by Examiner supports the conclusion of obviousness? Appeal 2018-008779 Application 13/656,413 4 A. Findings of Fact (FF) FF1 Rosenthal teaches delivering a drug associated with a hydrogel to a desired location. Rosenthal Abstract; see id. at 1:62–2:10. Rosenthal teaches maneuvering “a catheter constructed for insertion in the body, a portion of which carries a hydrogel having the capacity to incorporate a predetermined substantial amount of a drug,” to the point of desired drug application. Id. at 1:51–55. FF2 Rosenthal teaches that the drug is “immobilized in the hydrogel until released by a triggering agent or condition which is different from ambient physiological conditions.” Id. at 2:2– 4; see also id. at 2:43–44 (“the drug released by a change in pH”); see also id. at 3:35–39 (“The immobilized drug to be delivered to a body tissue may also be released from the hydrogel by contacting the hydrogel with a solution having a pH which induces a volume phase transition of hydrogel.”); see also id. at 6:42–43 (“Contact of the triggering agent with the hydrogel 55 induces the release of drug carried by the hydrogel.”); see also id. at 8:59–62 (“Upon contact with a triggering agent, the hydrogel reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue in a burst or over a desired time frame.”). FF3 Vyavahare teaches the use of hydrogels for the sustained delivery of drugs. Vyavahare ¶¶ 10, 52. Vyavahare teaches that “the disclosed compounds can be delivered to the connective Appeal 2018-008779 Application 13/656,413 5 tissue of a blood vessel wall via intravenous delivery.” Id. ¶ 11, see id. ¶ 56. FF4 Vyavahare teaches that the hydrogels can polymerize via self-assembly, or they can be induced to polymerize by any known method, such as for example by the presence of an initiator. Id. ¶ 63. “[T]he hydrogel can self-assemble upon contact of the various components or upon contact in conjunction with the presence of particular environmental conditions (such as temperature or pH).” Id. FF5 Seward teaches that “[t]he perivascular region is defined as the region beyond external elastic lamina of an artery or beyond the tunica media of a vein.” Seward ¶ 16, see also id. ¶ 41 (“[T]he perivascular space will be considered anything lying beyond the external elastic lamina EEL, including regions within the adventitia and beyond.”). Seward teaches delivering “pharmaceutical agents to the adventitia surrounding a blood vessel utilize a catheter having a microneedle.” Id. Abstract, see id. ¶¶ 14, 40, 41. FF6 Examiner finds that the trigger solution [of Rosenthal] intrinsically modulate the local tissue physiology by raising or lowering the pH of the local tissue (for example: if sodium bicarbonate is used as the triggering solution, the sodium bicarbonate will raise the pH of the local tissue above 7.5 because sodium bicarbonate is an alkaline), the raising or lowering of the pH of the local tissue would lead to enhancing the uptake of the drug by the local tissue. Final Act. 11–12; Ans. 20; see id. at 6. Appeal 2018-008779 Application 13/656,413 6 B. Analysis Based on the combination of Rosenthal, Vyavahare, and Seward, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to formulate a drug into a hydrogel and release the drug in the perivascular tissue environment. See Final Act. 3–8, 11–12; see Ans. 4–13, 20; see FF1–FF5. Examiner acknowledges that Rosenthal alone does not teach injecting a composition into the tissue of the perivascular space, or injecting the composition beyond an external elastic lamina of a blood vessel and therefore looks to Vyavahare and Seward for teaching these elements. See Final Act. 6; see Ans. 8. Examiner, therefore, is relying on Rosenthal for teaching the claimed preparation comprising a therapeutic agent, wherein the preparation can modulate local tissue physiology by raising and lowering the pH level. See Final Act. 11–12; see Ans. 20; FF6. Appellant contends that combination of references “does not teach or reasonably suggest the step of ‘buffering the local tissue physiology by raising or lowering the pH of the local tissue with the injected preparation’ as recited by claim 17.” Appeal Br. 8; see also Reply Br. 4 (“[T]he Rosenthal [reference teaches that] (i) hydrogel immobilized with drug and (ii) the triggering agent introduced into the space between the coating and the housing seem to be two separate elements rather than a ‘single composite.’”). On this record, we find that Appellant has the better position. “[T]he [E]xaminer bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Appeal 2018-008779 Application 13/656,413 7 We agree with Appellant that the claim as written requires a “preparation” that not only modulates the pH at the local tissue level but also contains a drug of interest. See Appeal Br. 8; see Reply Br. 4. Examiner, however, has not identified such a preparation in the combined references. Indeed, Examiner relies on a triggering solution to release the drug from the hydrogel disclosed in Rosenthal, and in addition relies on this triggering solution as altering the pH at the local tissue level. FF6. We find that Examiner has not identified a preparation that both holds the drug and alters the pH at the local tissue level as recited in the claim. Examiner in the Answer tries to rectify this shortcoming by identifying a “preparation” as encompassing “the balloon catheter that contained the hydrogel immobilized drug and the triggering agent is a single composite.” Ans. 23. We agree with Appellant, and find that Examiner interpretation of “a preparation comprising a liquid, gel, or semisolid” as encompassing a catheter containing a gel and liquid is unreasonable. We note that the claim language reciting the conjunction “or” indicates that the selection is between the three listed options, and not a combination of these options. We do not discern, and Examiner has not directed us to, any disclosure in the Specification that would indicate such an interpretation is necessary. Accordingly, we are not persuaded by Examiner’s interpretation in the Answer that a “preparation” reasonably encompasses a catheter and a combination of a liquid triggering solution and a gel containing a drug. On this record, Examiner failed to meet the initial burden of presenting a prima facie case of unpatentability. In re Oetiker, 977 F.2d at 1445. Accordingly, we are compelled to reverse the rejection of record. Appeal 2018-008779 Application 13/656,413 8 C. Conclusion The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 17, 20, 21, 24, 61, 63–67, and 70–77 under 35 U.S.C. § 103(a) as unpatentable over the combination of Rosenthal, Vyavahare, and Seward is reversed. II. Obviousness over Rosenthal, Vyavahare, Seward, and Blaskovich The rejection of claims 21, 24, 59, and 60 relies upon the underlying rejection of claim 17, where Blaskovich is relied upon to teach an alkaline hydrogel and the use of a contrast medium. See Ans. 13. Because this rejection does not address the underlying issue with respect to claim 17 as discussed above (see I.B), the combination with Blaskovich still fails to teach a preparation that both holds a drug of interest and modulates the pH of the local tissue environment. Therefore, having reversed the underlying rejection over Rosenthal, Vyavahare, and Seward, we also reverse this rejection for the same reasons. III. Obviousness over Rosenthal, Vyavahare, Seward, and Goodson The rejection of claims 62, 68, and 69 relies upon the underlying rejection of claim 17, where Goodson is relied upon to address the additional claim element that the generated plume diffuses to reach local tissue. See Ans. 16 (“Rosenthal, Vyavahare and Seward do not expressly teach the limitations of claims 62, 68 and 69 of the instant invention.”). Because this rejection does not address the underlying issue with respect to claim 17 as discussed above (see I.B), the combination with Goodson still fails to teach a preparation that both holds a drug of interest and modulates the pH of the Appeal 2018-008779 Application 13/656,413 9 local tissue environment. Therefore, having reversed the underlying rejection over Rosenthal, Vyavahare, and Seward, we also reverse this rejection for the same reasons. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 17, 20, 21, 24, 61, 63−67, 70−77 103(a) Rosenthal, Vyavahare, Seward 17, 20, 21, 24, 61, 63−67, 70−77 21, 24, 59, 60 103(a) Rosenthal, Vyavahare, Seward, Blaskovich 21, 24, 59, 60 62, 68, 69 103(a) Rosenthal, Vyavahare, Seward, Goodson 62, 68, 69 Overall Outcome 17, 20, 21, 24, 59–77 REVERSED Copy with citationCopy as parenthetical citation