AEGEA MEDICAL INC.Download PDFPatent Trials and Appeals BoardJun 18, 20212020006512 (P.T.A.B. Jun. 18, 2021) 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. 16/224,287 12/18/2018 Hugh R. Sharkey 19671-0555006 1258 26161 7590 06/18/2021 FISH & RICHARDSON P.C. (BO) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER BOSWORTH, KAMI A ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 06/18/2021 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): PATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HUGH R. SHARKEY, RAMIRO REYES, and KURT D. SPARKS Appeal 2020-006512 Application 16/224,287 Technology Center 3700 Before MURRIEL E. CRAWFORD, MICHAEL L. WOODS, and MATTHEW S. MEYERS, Administrative Patent Judges. WOODS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the Examiner’s Final rejection of claims 1–14.1 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Aegea Medical Inc. as the real party in interest. Appeal Br. 2. Appeal 2020-006512 Application 16/224,287 2 CLAIMED SUBJECT MATTER The claims are directed to a method of providing therapy to a patient’s uterus. Spec. ¶ 11. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of providing heat therapy to a patient’s uterus comprising: inserting a uterine heat therapy system through a cervix and a cervical canal into the uterus; creating a seal between an exterior surface of the uterine heat therapy system and the cervical canal; delivering heat therapy through the uterine heat therapy system into the uterus; and condensing vapor on tissue within the uterus. Appeal Br. 6 (Claims App.). REFERENCES2 The prior art relied upon by the Examiner is: Name Reference Date Nobles US 2002/0013601 A1 Jan. 31, 2002 Mulier US 2002/0177846 A1 Nov. 28, 2002 Weng US 6,626,855 B1 Sept. 30, 2003 Hua Xiao US 2004/0002698 A1 Jan. 1, 2004 Barry ’233 US 2006/0161233 A1 July 20, 2006 Barry US 8,585,645 B2 Nov. 19, 2013 2 We refer only to the first named inventor, and as to the two Barry references, additional identifiers distinguish the two references with the same inventor. Appeal 2020-006512 Application 16/224,287 3 REJECTIONS Claims 1, 3–10, 13, and 14 are rejected under 35 U.S.C. § 103(a) as unpatentable over Hua Xiao, Barry, and Mulier. Final Act. 3–7. Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hua Xiao, Barry, Mulier, and Nobles. Final Act. 7. Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hua Xiao, Barry, Mulier, and Barry ’233. Final Act. 7–8. Claim 12 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hua Xiao, Barry, Mulier, and Weng. Final Act. 8–9. OPINION The Examiner finds that Hua Xiao teaches all the limitations of claim 1, except for the final limitation of “condensing vapor on tissue within the uterus.” Final Act. 3. As to that limitation, the Examiner finds that Barry teaches heat therapy using vapor, and that Barry “discloses that various other energy modalities could be used to achieve the end result of tissue ablation, such as . . . a resistive heating source.” Id. at 3 (citing Barry, 9:25–31). The Examiner reasons that: Since Hua Xiao’s device and method is directed to thermal ablation (Para 1) using a resistive heating source (Para 7), it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hua Xiao to use vapor as the heat therapy, as taught by Barry, since the heat ablation systems of both Hua Xiao and Barry achieve the same result (and Barry even admits that) and thus were art-recognized equivalents at the time the invention was made; therefore, it would have been obvious to one of ordinary skill in the art to substitute Barry’s vapor heat therapy system in place of Hua Xiao’s resistive heat therapy system since it has been held that substituting parts of an invention involves only routine skill in the art. Appeal 2020-006512 Application 16/224,287 4 Id. at 3–4. To summarize, the Examiner finds Hua Xiao’s instrument is used for heat therapy in a uterus using radiant heat, finds Barry’s instrument is used for heat therapy in the lungs using vapor, contends Barry teaches that radiant heat and vapor heat are “art-recognized equivalents,” and concludes the combination would have been obvious, because using Barry’s vapor in place of Hua Xiao’s radiant heat is a substitution that “involves only routine skill in the art.” See Final Act. 3–4. Appellant argues the Examiner relied on impermissible hindsight in the proposed combination, because “Barry’s use of vapor addresses a problem in the lung that [heating]3 devices did not have in the uterus. A skilled artisan would therefore not look to Barry’s lung therapy method to make any modifications to the [heating] system of Xiao.” Appeal Br. 4; see also Reply Br. 2. We agree with Appellant. A statement that modifications of the prior art to meet the claimed invention would have been “well within the ordinary skill of the art at the time the claimed invention was made,” because the references relied upon teach that all aspects of the claimed invention were individually known in the art, is not sufficient to establish a prima facie case of obviousness without some objective reason to combine the teachings of the references. Ex parte Levengood, 28 USPQ 2d 1300 (Bd. Pat. App. & Inter. 1993). 3 Appellant asserts the Examiner relies on the “RF” energy source of Hua Xiao. Appeal Br. 4. This is noted by the Examiner as incorrect, because instead the rejection relies on the “radiant” heat embodiment of Barry. See Answer 4; see also Final Act. 3. Appeal 2020-006512 Application 16/224,287 5 Further, the Federal Circuit has stated that “rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). We see two errors in the Examiner’s reasoning. First, the finding that vapor and radiant heating “achieve the same result” and “were art-recognized equivalents” is not supported by the evidence of record. For example, no citation to evidence behind the conclusion appears in the Final Action. See Final Act. 3–4. We assume the Examiner relies on Barry’s teaching that “other energy modalities could be used.” Final Act. 3 (citing Barry at 9:25–31). But this does not support a finding that radiant heat and vapor heat are recognized in the art as equivalents. Barry’s disclosure lacks sufficient detail about how to implement the alternative heat sources. See, generally, Barry col. 1–9. The second problem is that the rejection fails to adequately reason why the ordinary artisan, reading Hua Xiao and Barry, would have been led to modify the process of Hua Xiao to use Barry’s lung-treatment vapor as a heat source in the uterus. For example, no problem with Hua Xiao’s method appears in the rejection that would have led the artisan to make the proposed substitution. Although the Examiner states that “Barry[] does not teach away from using vapor to treat other body tissue,” this reasoning is insufficient for the artisan to undertake the proposed substitution. Ans. 4. We also do not discern any discussion in these references, or from the Examiner, that would indicate doing so would yield predictable results, given the differing nature of the uterus and lungs. Appeal 2020-006512 Application 16/224,287 6 The stated motivation to modify Hua Xiao, therefore, lacks sufficient “rational underpinning to support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988. For this reason, we do not sustain the rejection of claim 1, or the dependent claims rejected along with it. Because the Examiner has not shown that either Nobles, Barry ’233, or Weng remedies this shortcoming, we also do not sustain the rejections additionally relying on these references. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–10, 13, 14 103(a) Hua Xiao, Barry, Mulier 1, 3–10, 13, 14 2 103(a) Hua Xiao, Barry, Mulier, Nobles 2 11 103(a) Hua Xiao, Barry, Mulier, Barry ’233 11 12 103(a) Hua Xiao, Barry, Mulier, Weng 12 Overall Outcome 1–14 REVERSED Copy with citationCopy as parenthetical citation