14641435 - (D) (P.T.A.B. Jul. 8, 2020)

ThermiGen, LLC

Patent Trials and Appeals BoardJul 8, 2020

14641435 - (D) (P.T.A.B. Jul. 8, 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. 14/641,435 03/09/2015 Red Alinsod TGL-01-USN1 2591 50446 7590 07/08/2020 HOXIE & ASSOCIATES LLC 75 MAIN STREET SUITE 203 MILLBURN, NJ 07041 EXAMINER WONG, ALBERT KANG ART UNIT PAPER NUMBER 3649 NOTIFICATION DATE DELIVERY MODE 07/08/2020 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): HoxiePatentMail@gmail.com HoxiePatentMail@hoxpat.com file@hoxpat.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte RED ALINSOD, PAUL R. HERCHMAN JR., and KEVIN D. O’BRIEN ____________ Appeal 2020-000408 Application 14/641,435 Technology Center 3600 ____________ Before JENNIFER D. BAHR, BRANDON J. WARNER, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the rejection of claims 1, 3, 8–13, and 15–18. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies TheremiGen, LLC, which is a wholly owned subsidiary of Celling Biosciences, as the real party in interest. Appeal Br. 2. Appeal 2020-000408 Application 14/641,435 2 THE INVENTION Appellant’s invention relates to “systems and methods for treating vaginal laxity and, more specifically, to treating vaginal laxity by inducing collagen growth.” Spec. ¶ 2. Claims 1, 11, and 12 are the independent claims on appeal. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A treatment probe comprising: a. a curved, rounded treatment tip designed to accommodate vaginal anatomy, wherein the treatment tip is elongate and configured to be advanced 4-12 cm into the vaginal cavity; b. an electrode coupled to the treatment tip, wherein the electrode coupled to the treatment tip is configured to transfer radiofrequency energy to specific vaginal structures; c. a thermocouple coupled to the electrode assembly, wherein the thermocouple coupled to the electrode assembly is configured to monitor and regulate electrode and skin temperature; d. a connector configured to connect the treatment tip to a radiofrequency generator, wherein the treatment probe is configured to heat vaginal mucosal tissue, and wherein the tissue includes the surface of vaginal mucosal tissue. THE REJECTIONS2 The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Parmer US 8,961,511 B2 Feb. 24, 2015 Galen US 2016/0296278 A1 Oct. 13, 2016 2 The Examiner’s rejection of claims 1, 3, and 8–11 under 35 U.S.C. 112(b) has been withdrawn. Ans. 3; Final Act. 2. Appeal 2020-000408 Application 14/641,435 3 The following rejections are before us for review: I. Claims 1, 3, and 8–11 stand rejected under 35 U.S.C. § 103 as unpatentable over Galen. II. Claims 12, 13, and 15–18 stand rejected under 35 U.S.C. § 103 as unpatentable over Galen and Parmer. OPINION Rejection I Appellants argue claims 1, 3, and 8–11 as a group. Appeal Br. 5–9. We select independent claim 1 as representative, and claims 3 and 8–11 stand or fall therewith. See 37 C.F.R. § 41.37(c)(1)(iv). Regarding independent claim 1, the Examiner finds that Galen discloses an electrode assembly (i.e., energy delivery elements 4) coupled to a treatment tip 1 and configured to heat the surface of vaginal mucosal tissue, as claimed. Final Act. 3 (citing Galen ¶ 77). The Examiner finds that Galen does not expressly disclose configuring the treatment tip 1 to be advanced 4–12 cm into the vaginal cavity, as claimed, but reasons that because the dimensions of a vagina are known, “it would have been obvious to make the tip of such a length to reach all areas of the vagina.” Id. Appellant argues that claim 1 requires the treatment probe to be configured to heat the surface of vaginal mucosal tissue, and that this claim limitation is “not disclosed or made obvious by Galen alone or in combination with Parmer.” Appeal Br. 5. Appellant submits that “Galen discloses specifically treating ‘target tissue’ defined as tissue residing below mucosal tissue, and specifically cautions against heating muscosal tissue.” Id. (citing Galen ¶¶ 16, 43). Appellant also submits that “Galen does not teach any alternative embodiments in which the surface tissue is not actively Appeal 2020-000408 Application 14/641,435 4 cooled while the underlying tissue is heated.” Id. at 6 (citing Galen ¶¶ 37, 56–58, 105). We are not persuaded by Appellant’s arguments. “A reference must be considered for everything that it teaches, not simply the described invention or a preferred embodiment.” In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012); see also In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006) (“the teaching of [a reference] is not limited to the specific invention disclosed”). Here, although Galen discloses “energy delivery elements for simultaneous cooling of the vaginal epithelium and transmission of energy for heating the tissues underneath the epithelium” (Galen, Abstract), wherein cooling is advantageous, Galen teaches that cooling is an alternative: “[t]he control may allow the user to apply energy to the energy delivery elements, to apply coolant, or both” (Galen ¶ 59 (emphasis added)), wherein application of energy to the energy delivery elements only (without applying coolant) results in a treatment probe configured to heat the surface of vaginal mucosal tissue, as claimed. See id. ¶¶ 90, 91 (characterizing coolants as “supplementary materials” that may be “started or stopped” during treatment; id., claim 21 (reciting a device having a surface comprising energy delivery elements, wherein “said elements have an internal surface and an epithelium-contacting surface,” without requiring any cooling means). In other words, we do not agree with Appellant that “while Galen teaches that the energy delivery electrodes could potentially be turned off, the reference make[s] no such teaching as to the cooling mechanism.” Reply Br. 3. Rather, Galen discloses that the device may apply energy (i.e., heat), or coolant, or both heat and coolant. Appeal 2020-000408 Application 14/641,435 5 Moreover, Galen discloses that “[k]nown systems and devices for treating the vagina are less than optimal, including those using radiant energy,” and that “[i]n particular, known systems are not optimized for . . . the cooling of the treated tissue.” Galen ¶ 4. In other words, Galen discloses to a person of ordinary skill in the art that known treatment devices are configured to heat vaginal tissue (i.e., the surface of vaginal mucosal tissue) without cooling. See Ans. 6 (determining that Galen recognizes “excessive heating of the surface layer is a known problem,” and finding that “[t]he recognition of this problem suggests that a system without cooling was known to the people of ordinary skill in the art”); cf. Reply Br. 3 (acknowledging, with reference to Galen’s paragraph 5, that “Galen sought to solve this issue by creating a system that provides ‘simultaneous cooling of the vaginal epithelium,’” wherein the issue is that “known system are not optimized for . . . cooling of the treated tissue” (emphasis omitted)). To the extent Appellant argues that because Galen discloses that it is advantageous to cool the surface of vaginal mucosal tissue while simultaneously heating underlying tissue, Galen teaches away from the claimed invention (Appeal Br. 5), Appellant’s argument is misplaced. The Examiner is not proposing any modification to Galen to result in a treatment probe configured to heat the surface of vaginal mucosal tissue, as claimed. As stated supra, Galen may be relied upon for disclosing that it was known to configure treatment probes to heat the surface of vaginal mucosal tissue, as claimed, notwithstanding Galen’s disclosure that including cooling is advantageous and solves a problem recognized in the prior art, namely, excessive heating of the surface of vaginal mucosal tissue. Appeal 2020-000408 Application 14/641,435 6 Appellant also argues that the Examiner’s interpretation of Galen is contrary to a federal district court’s interpretation of claims in the Parmer reference, and Appellant argues that the Board should apply the court’s claim construction relative to Parmer to Galen. Appeal Br. 8–9. In particular, Appellant submits that the claim language “heating the target tissue” means “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” Id. at 8. Even assuming that the “specific vaginal structures” of claim 1 corresponds to “target tissue,” such a claim construction is not contrary to the discussions supra, wherein Galen discloses heating of the surface of vaginal mucosal tissue by Galen’s device, and further, Galen recognizes that prior art devices heat the surface of vaginal mucosal tissue, without cooling. Accordingly, we sustain the Examiner’s rejection of independent claim 1 and claims 3 and 8–11 fall therewith. Rejection II Appellant chose not to present arguments for the patentability of claims 12, 13, and 15–18 apart from the arguments presented supra for the patentability of claim 1, and therefore, for essentially the same reasons as stated supra, we sustain the Examiner’s rejection of claims 12, 13, and 15– 18. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s) Affirmed Reversed 1, 3, 8–11 103 Galen 1, 3, 8–11 12, 13, 15–18 103 Galen, Parmer 12, 13, 15–18 Overall Outcome 1, 3, 8–13, 15–18 Appeal 2020-000408 Application 14/641,435 7 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). AFFIRMED