Minerva Surgical, Inc.

Patent Trials and Appeals Board

Mar 2, 2022

2021002285 (P.T.A.B. Mar. 2, 2022)

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. 16/247,265 01/14/2019 Dominique Filloux 37646-726.301 4774 21971 7590 03/02/2022 WILSON SONSINI GOODRICH & ROSATI 650 PAGE MILL ROAD PALO ALTO, CA 94304-1050 EXAMINER TOWA, RENE T ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 03/02/2022 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 DOMINIQUE FILLOUX, DAVE CLAPPER, AKOS TOTH, SEAN DARBY, TEJAS N. MAZMUDAR, and ESTELA HILARIO ____________ Appeal 2021-002285 Application 16/247,265 Technology Center 3700 ____________ Before JOHN C. KERINS, CHARLES N. GREENHUT, and BRANDON J. WARNER, 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 1-30, which are all the pending claims. Appeal Br. 3.2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 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 Minerva Surgical, Inc. Appeal Br. 3. 2 We note that references herein to “Appeal Br.” refer to the Corrected Appeal Brief filed October 20, 2020. Appeal 2021-002285 Application 16/247,265 2 CLAIMED SUBJECT MATTER Appellant’s disclosed invention “relates to systems and methods for global endometrial ablation in a treatment of menorrhagia,” and particularly, “a subsystem using gas flows and a controller to test whether a patient’s uterine cavity has a wall that is perforated or whether the uterus is intact, wherein such a test should be performed before proceeding with an ablation procedure.” Spec. ¶ 2. Claims 1 and 19 are independent. Claim 1, reproduced below with emphasis added, is illustrative of the subject matter on appeal. 1. A method for detecting perforations in a uterus, comprising: providing a probe assembly including a deployable energy applicator at a distal end thereof, said deployable energy applicator having a contracted state and an expanded state, wherein the contracted shape is configured for trans-cervical introduction and the expanded shape has a triangular form with an exterior surface configured for positioning proximate walls of a uterine cavity; and trans-cervically inserting the probe assembly into the uterine cavity; delivering a fluid flow through a plurality of flow pathways having outlets along a length of the energy applicator including an outlet in a distal tip of the energy applicator, wherein the fluid flow comprises a gas; and monitoring a parameter of said fluid flow to detect a perforation in the uterus. Appeal 2021-002285 Application 16/247,265 3 EVIDENCE The Examiner relies on the following evidence in rejecting the claims on appeal: Sampson US 2005/0143728 A1 June 30, 2005 Freed US 2010/0228239 A1 Sept. 9, 2010 Toth US 8,394,037 B2 Mar. 12, 2013 REJECTIONS The following rejections are before us for review:3 I. Claims 1-14 and 19-28 stand rejected under 35 U.S.C. § 103 as being unpatentable over Toth and Freed. Final Act. 6-15. II. Claims 15-18, 29, and 30 stand rejected under 35 U.S.C. § 103 as being unpatentable over Toth, Freed, and Sampson. Id. at 15-19. ANALYSIS Independent claims 1 and 19 are both directed to a method for detecting perforations in a uterus and require, among other things, providing a probe having an energy applicator (where the energy applicator includes fluid passages with multiple outlets therealong), delivering fluid flow through those passages and outlets, and monitoring a parameter of the fluid flow to detect the perforation. See Appeal Br., Claims App. More 3 We note that a rejection of claims 1-30 on the ground of nonstatutory obviousness-type double patenting has been withdrawn by the Examiner, in light of the filing of a terminal disclaimer, and therefore is not before us for review as part of the instant appeal. Ans. 3; see Final Act. 3-5. Appeal 2021-002285 Application 16/247,265 4 specifically, claim 1 recites “a plurality of flow pathways having outlets along a length of the energy applicator,” with the outlets including “an outlet in a distal tip of the energy applicator.” Id. Claim 19 similarly recites “at least one flow channel” extending through a shaft of the energy applicator, with “at least one flow outlet proximate a distal end of the shaft” and “at least one terminal outlet at a distal tip of the energy applicator.” Id. From a review of Appellant’s disclosure of the invention, one of skill in the art will appreciate that it is the recited disposition of these multiple flow outlets that allows the claimed methods to detect a perforation more accurately, by avoiding possible mischaracterization in certain situations, relative to prior art methods. See, e.g., Spec. ¶¶ 47-50. In rejecting the claims, the Examiner relies primarily on Toth for disclosing most of the recited method steps and most of the structures required of the probe provided in the method. See Final Act. 6, 11-12. But the Examiner acknowledges that Toth lacks a teaching of flow outlets disposed as in the claims, for which the Examiner turns to Freed. Id. at 6-8, 12-13. Specifically, the Examiner relies on Freed’s lumen 410 as being a fluid passage, and on elements 400, 700 as being flow outlets thereof disposed as claimed. Id. at 8 (citing Figs. 4, 7; ¶¶ 32-34, 42), 13 (citing same); see also Ans. 4-6 (reiterating same findings). After a thorough review of the evidence relied upon, we agree with Appellant that Freed’s elements 400, 700 are not sufficient to teach flow outlets disposed as in the claims. See Appeal Br. 12-13; Reply Br. 2-3. Initially, we note that Freed teaches an ablation device that includes a feature for removing steam during the procedure, specifically via suction device 420 communicating through open channels 400 defined by ridges 402 protruding Appeal 2021-002285 Application 16/247,265 5 from surface 404. See, e.g., Freed ¶¶ 2-4, 32-33; Figs. 4, 5, 7-9. In the context of Freed’s device, one of skill in the art would understand that these channels are open to tissue, as opposed to being discrete outlets from an otherwise closed fluid passage. This understanding would hold whether the open channels are being used to draw out fluid, such as steam, via vacuum (see Freed ¶¶ 32-33) or alternatively to deliver fluid, such as saline or a drug, to the ablation site (see Freed ¶ 34). With respect to identified elements 400, these are open channels without discrete flow outlets, let alone outlets that would be disposed as claimed. See Freed ¶¶ 32-34; Figs. 4, 7 (as relied on by the Examiner). With respect to identified elements 700, these are spaced apart protrusions that define and maintain the open channels therebetween, but are likewise not discrete flow outlets. See Freed ¶ 42; Fig. 7 (as relied on by the Examiner). Based on this shortcoming in the findings relied upon, the rejections are in error in that they are premised on an unsupported finding from Freed. Accordingly, we do not sustain the rejections. DECISION We REVERSE the Examiner’s decision rejecting claims 1-14 and 19-28 under 35 U.S.C. § 103 as being unpatentable over Toth and Freed. We REVERSE the Examiner’s decision rejecting claims 15-18, 29, and 30 under 35 U.S.C. § 103 as being unpatentable over Toth, Freed, and Sampson. Appeal 2021-002285 Application 16/247,265 6 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-14, 19-28 103 Toth, Freed 1-14, 19-28 15-18, 29, 30 103 Toth, Freed, Sampson 15-18, 29, 30 Overall Outcome 1-30 REVERSED