TARIS Biomedical LLCDownload PDFPatent Trials and Appeals BoardNov 20, 20202020003340 (P.T.A.B. Nov. 20, 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. 14/224,256 03/25/2014 Michael J. Cima 29449-0126 9174 29052 7590 11/20/2020 EVERSHEDS SUTHERLAND (US) LLP 999 PEACHTREE STREET, N.E. SUITE 2300 ATLANTA, GA 30309 EXAMINER OSINSKI, BRADLEY JAMES ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 11/20/2020 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@eversheds-sutherland.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL J. CIMA and HEEJIN LEE Appeal 2020-003340 Application 14/224,256 Technology Center 3700 Before DANIEL S. SONG, STEFAN STAICOVICI, and ANNETTE R. REIMERS, Administrative Patent Judges. SONG, 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 1–21, 24–31, 35, 36, and 38–41.2 We have jurisdiction under 35 U.S.C. § 6(b). In addition to its Appeal Brief and 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). The Appellant identifies the real party in interest as Taris Biomedical LLC. Appeal Br. 2. 2 The Appellant appeals claims 1–21 and 24–41, claims 22 and 23 having been canceled by the Appellant. Appeal Br. 3. However, the double patenting rejection of claims 32, 33, 34, and 37 has been withdrawn by the Examiner, and these claims are not subject to another rejection. Ans. 15; Reply Br. 3. Appeal 2020-003340 Application 14/224,256 2 Reply Brief, the Appellant also relies on a declaration filed under 37 C.F.R. § 1.132 by Christopher J. Cutie, M.D. A telephonic oral hearing was conducted with the Appellant’s representative on November 10, 2020, a transcript of which will be entered into the electronic record in due course. We REVERSE. CLAIMED SUBJECT MATTER The claims are directed to an implantable device with intravesical tolerability and methods of treatment. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A drug delivery device for deployment within the bladder of a human patient which is well tolerated by the patient, comprising: an elongated elastic body comprising a first end, an opposed second end, an annular portion disposed between the first end and the second end, and a drug reservoir lumen defined at least in part by the annular portion; and a drug formulation loaded in the drug reservoir lumen, the drug formulation comprising a drug, wherein the device has a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the device from entering the orifices of the ureters, wherein the retention shape has a maximum dimension in any dimension of 6 cm or less when in an uncompressed state, and wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm. Appeal 2020-003340 Application 14/224,256 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Matsuura US 6,171,298 B1 Jan. 9, 2001 Yachia US 6,398,718 B1 June 4, 2002 Friedman US 2004/0260272 A1 Dec. 23, 2004 Rahe US 2006/0105010 A1 May 18, 2006 Lee US 2007/0202151 A1 Aug. 30, 2007 Cima US 9,586,035 B2 Mar. 7, 2017 REJECTIONS3 The Examiner rejects various claims under 35 U.S.C. § 103(a) as follows: 1. Claims 1, 3, 5–11, 13–21, and 24–30 as unpatentable over Lee.4 Final Act. 3. 2. Claim 4 as unpatentable over Lee in view of Friedman. Final Act. 10. 3. Claims 2 and 12 as unpatentable over Lee in view of Matsuura. Final Act. 10. 4. Claims 31, 35, 36, 38, and 39 as unpatentable over Lee in view of Rahe. Final Act. 11. 5. Claims 40 and 41 as unpatentable over Lee in view of Matsuura and Yachia. Final Act. 12. 3 As noted, the Examiner’s non-statutory double patenting rejection of claims 1–21 and 24–41 has been withdrawn. Ans. 15. The Examiner does not further reject claims 32, 33, 34, and 37. 4 As noted, claims 22 and 23 have been canceled by the Appellant. Appeal Br. 3. Appeal 2020-003340 Application 14/224,256 4 OPINION Rejection 1: Claims 1, 3, 5–11, 13–21, and 24–30 The Examiner rejects claims 1, 3, 5–11, 13–21, and 24–30 as unpatentable over Lee. Final Act. 3. As to independent claim 1, the Examiner finds that Lee discloses a drug delivery device substantially as claimed, but fails to disclose dimensions that allow for intravesical mobility but prevents voiding through the urethra or entering the ureters, and further fails to disclose the limitation maximum dimension in any dimension of 6 cm or less when in an uncompressed state, and wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm. Final Act. 4. However, the Examiner finds that Lee discloses, inter alia, that the retention device should be buoyant, avoid irritation of the trigone region of the bladder, have a small size within 1–10 cm, and that “one skilled in the art can select appropriate materials of construction and an appropriate structure design for the device.” Final Act. 4, citing Lee ¶¶ 53–54, 95–96; quoting Lee ¶ 54. Based on these findings, the Examiner concludes that it would have been obvious to one of ordinary skill in the art to have modified the device of Lee to have the claimed properties, including the dimensions as claimed “since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.” Final Act. 5. The Appellant disagrees with the rejection of claim 1 and argues that “[t]he Examiner’s reliance on the doctrine of routine optimization is improper because Lee does not recognize acting force as being a variable Appeal 2020-003340 Application 14/224,256 5 that affects a result of tolerability.” Appeal Br. 7 (emphasis omitted); see also Appeal Br. 11. According to the Appellant, “[f]or purposes of determining obviousness with respect to a claimed range of a particular parameter, the parameter must be recognized as a result-effective variable for achieving a particular result,” and that “[t]he Examiner has not established that Lee even recognizes or discusses any particular variable as affecting a particular result of tolerability.” Appeal Br. 9–10 (emphasis omitted); see also Reply Br. 6. To the extent that the Appellant is asserting that result effective variable must be explicitly disclosed in the prior art of record, we disagree. A person of ordinary skill understands the art of which the applied reference is representative, and such understanding is not limited to the four corners of the document applied. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962) (an artisan must be presumed to know something about the art apart from what the references disclose); Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (“The person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art.”). In that regard, we also disagree with the Appellant’s rebuttal assertion that general physics or other general knowledge cannot be relied upon to support the conclusion of obviousness based on result effective variable analysis. See Reply Br. 4. Substantively, we agree with the Examiner that the device of Lee “has to have acting force” because it requires the device to move reversibly between both states (compressed and uncompressed) and to move the device from the uncompressed state to the compressed state (to allow for delivery, such as via a catheter or needle) the user has exert a Appeal 2020-003340 Application 14/224,256 6 force which overcomes the acting force, meaning too high of an acting force and the user won’t be able to move the device from the uncompressed state to the compressed state. Ans. 16. Nonetheless, we ultimately agree with the Appellant that “mere recognition that a device that can return to an initial shape from a deployment shape may exert a restoring force is not sufficient.” Appeal Br. 9. Although the Examiner concludes that “discovering the optimum workable range of Lee [is] routine as Lee would not function (due to a lack of retainment in the intended location) without a sufficient acting force (not be too pliable so as to be voided),” there is insufficient basis that such an optimum workable range of Lee would have encompassed the dimensions or the acting force claimed. Ans. 17. Whereas Lee does disclose an implant of 1–10 cm, it is silent as to the magnitude of the force required to implant the device or retain the device in the bladder, and is silent as to the magnitude of any such force during the course of compression within any given range of dimensions, much less the 6 cm to 3 cm explicitly recited in claim 1. The Examiner also finds that the workable range for restoring the device to an uncompressed state, “at its lower end, will thus overlap with Applicant’s claimed less than 1 N since Appellant is claiming all of the workable range less than 1 N,” this finding is not dispositive. Ans. 16. The recited force in claim 1 is that of compression force, and is not restoring the device to an uncompressed state, and is explicitly for a range of dimensions, i.e., from 6 cm to 3 cm. Ans. 16. Indeed, as the Appellant points out, the claims “recite the maximum acting force (which is a threshold for the acting force, and is different from an instantaneous value of the acting force itself)” and “relate this threshold-the maximum acting force-to compression of the Appeal 2020-003340 Application 14/224,256 7 device from a maximum dimension associated with an uncompressed state to a dimension associated with a compressed state.” Reply Br. 4–5 (emphasis omitted); see also Reply Br. 6 (“Instead of analyzing the threshold (maximum acting force) in the context of the compressed and uncompressed dimensions, the Examiner discusses ‘forces’ in isolation.”). In summary, the Examiner’s reasoning based on the real need for the device of Lee to be implanted and retained in the bladder, and be tolerable, does not adequately account for the recited maximum acting force of 1 N when the device is compressed from the retention shape of 6 cm to a shape having a maximum dimension of 3 cm. Accordingly, we also generally agree with the Appellant that the rejection appears to be based on impermissible hindsight reconstruction. Appeal Br. 14; Reply Br. 10. Therefore, in view of the above considerations, we reverse the Examiner’s rejection of independent claim 1 and of claims 3, 5–11, 13–21, and 24–30 that either ultimately depend therefrom, or recite substantively the same limitations at issue. The Appellant’s remaining arguments based on expectation of success is moot. Appeal Br. 14. Rejections 2 and 3: Claims 2, 4, and 12 Claims 2, 4, and 12 depend from independent claim 1. The Appellant, inter alia, relies on dependency on claim 1 for patentability of these claims, and correctly argues that the Examiner’s application of Friedman or Matsuura does not address the above noted deficiency of Lee. Appeal Br. 17–18. Accordingly, we reverse these rejections as well. Rejection 4: Claims 31, 35, 36, 38, and 39 Claims 31, 35, 36, 38, and 39 depend from independent claim 30. The Appellant, inter alia, relies on dependency on claim 30 for patentability of Appeal 2020-003340 Application 14/224,256 8 these claims, and correctly argues that the Examiner’s application of Rahe does not address the above noted deficiency of Lee. Appeal Br. 19. Accordingly, we reverse these rejections as well. Rejection 5: Claims 40 and 41 The Appellant relies on substantively the same arguments submitted relative to claim 1 in support of patentability of claim 40, which recites substantively the same limitations at issue, and relies on dependency for patentability of claim 41. Appeal Br. 20–23. Indeed, the Examiner’s application of Matsuura and Yachia does not address the above noted deficiency of Lee. Accordingly, we reverse this rejection of claims 40 and 41 as well. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 5–11, 13–21, 24– 30 103(a) Lee 1, 3, 5–11, 13–21, 24– 30 4 103(a) Lee, Friedman 4 2, 12 103(a) Lee, Matsuura 2, 12 31, 35, 36, 38, 39 103(a) Lee, Rahe 31, 35, 36, 38, 39 40, 41 103(a) Lee, Matsuura, Yachia 40, 41 Overall Outcome 1–21, 24– 31, 35, 36, 38–41 Appeal 2020-003340 Application 14/224,256 9 REVERSED Copy with citationCopy as parenthetical citation