MINERVA SURGICAL, INC.Download PDFPatent Trials and Appeals BoardAug 18, 20212021000281 (P.T.A.B. Aug. 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. 15/245,586 08/24/2016 Aaron Germain 1495.3907101 8671 28075 7590 08/18/2021 SEAGER, TUFTE & WICKHEM, LLP 100 SOUTH 5TH STREET SUITE 600 MINNEAPOLIS, MN 55402 EXAMINER BLAISE, BRADFORD CHRISTOPHER ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 08/18/2021 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): GEN.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AARON GERMAIN, MICHAEL D. WALKER, JACOB ROLAND, and JAN ECHEVERRY Appeal 2021-000281 Application 15/245,586 Technology Center 3700 Before DANIEL S. SONG, STEFAN STAICOVICI, and JEREMY M. PLENZLER, Administrative Patent Judges. PLENZLER, 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 1–15 and 17–22. 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(a). Appellant identifies the real party in interest as Boston Scientific Scimed, Inc. Appeal Br. 4. Appeal 2021-000281 Application 15/245,586 2 CLAIMED SUBJECT MATTER The claims are directed to a tissue resecting device. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A tissue resecting device for resecting uterine polyps comprising: an elongated structure having a longitudinal axis, the elongated structure comprising an outer sleeve with a distal window configured to receive uterine polyp tissue and an inner sleeve configured to move between a proximal position and a distal position relative to the window; an active electrode element coupled to the inner sleeve; and an insulative layer covering at least a portion of the inner sleeve; wherein the tissue resecting device is configured to fail when used to resect uterine tissue within a uterus during a medical procedure, wherein the uterine tissue is more fibrous than uterine polyp tissue. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Germain US 2013/0231652 A1 Sept. 5, 2013 Medical Applications of Stainless Steel 304 (UNS S30400), AZO Materials, pp. 1–5 (August 30, 2012), https://www.azom.com/article.aspx?ArticleID=6641 (last viewed November 7, 2018) (hereafter “Azom”). REJECTIONS Claims 1–6, 8–15, and 17–22 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Germain. Claim 7 is rejected under 35 U.S.C. § 103 as being unpatentable over Germain and Azom. Appeal 2021-000281 Application 15/245,586 3 OPINION Claim 1 The main dispute surrounding claim 1 is whether Germain’s “tissue resecting device is configured to fail when used to resect uterine tissue within a uterus during a medical procedure, wherein the uterine tissue is more fibrous than uterine polyp tissue” as required by claim 1. See Appeal Br. 8–11. The Examiner finds that “Germain discloses an insulative layer that is made of the same material as Applicant’s insulative layer, has the same thickness as Applicant’s insulative layer, and is part of a device having the same structure as the claimed device,” and “would therefore fail in the same manner as the claimed device.” Final Act. 5. Specifically, the Examiner finds that “Germain discloses an insulative layer made of the same material as Applicant’s insulative layer (compare ¶[0070] of Germain with pg. 13, ll. 1-5 of Applicant’s Specification), and having the same thickness as Applicant’s insulative layer (compare, e.g., claims 30-31 of Germain with pg. 11, ll. 7–11 of Applicant’s Specification).” Id. at 4–5. Appellant does not dispute the Examiner’s findings that Germain discloses the same structure as that disclosed in its Specification. Rather, Appellant faults the Examiner because “[t]he device of Germain is designed and intended for use in resecting uterine fibroids (see for example, [0003- 0006], [0039-0040], [0047], [0051]).” Appeal Br. 10. Without identifying any structure missing from Germain in connection with claim 1, Appellant does not apprise us of Examiner error, particularly where the Examiner presents undisputed findings that Germain and Appellant’s Specification disclose the same structure. Appeal 2021-000281 Application 15/245,586 4 Appellant’s contentions are problematic. Initially, we note that Germain lists two of the same inventors as the instant application, with the first named inventor, Aaron Germain, being the same on both applications.2 If Appellant does not dispute that Germain and the instant application have the same structure, as noted above, then we do not see why and how the disclosure of the present application satisfies the enablement requirement of 35 U.S.C. § 112(a). That is, if the structure disclosed in Germain, which is the same as that disclosed in the application before us, does not fail when used to resect uterine tissue that is more fibrous than uterine polyp tissue, then there is disclosure missing from the application before us that causes the recited failure. Rather than enter a new ground of rejection, we assume, for purposes of this appeal, that the structure disclosed in Appellant’s Specification provides the recited functionality. Appellant’s Specification explains, for example, that “[i]n some additional embodiments, insulative layer 202 may be comprised of a material that may be less wear-resistant or degrade relatively more easily than other materials,” and “[f]or instance, insulative layer 202 may comprise [fluorinated ethylenepropylene (FEP)].” Spec. 13:25–27. The Specification further explains that “[i]n some embodiments, tissue-resecting device 100 may be configured to be used only for particular procedures, such as for resecting uterine polyps,” which “may be generally less fibrous or mechanically rigid than uterine fibroids.” Id. at 13:29–14:1. The 2 Appellant provides a declaration under 37 C.F.R. § 1.132 from Aaron Germain, which is unpersuasive because even Mr. Germain fails to identify any structural differences between the device of Germain and that of the instant application. Appeal 2021-000281 Application 15/245,586 5 Specification explains that “the materials of tissue-resecting device 100 configured for uterine polyp resection may not need to be as highly wear- resistant or stand up to a higher level of forces that may be present during resection of uterine fibroids,” and provides the example that “insulative layer 202 may be comprised of FEP as opposed to more durable materials.” Id. at 14:3–8. The Specification provides example dimensions of insulative layers, explaining that “[i]n general, insulative layers 200 and 202 may have a thickness between about 0.0005” (0.0127 mm) to about 0.0015” (0.038 mm), and in some specific embodiments about 0.001” (0.025 mm).” Id. at 11:7–9. Paragraph 46 of Germain, for example, discloses materials similar to those in Appellant’s Specification. Claims 30 and 31 in Germain, for example, recite similar material thickness to that in Appellant’s Specification. The Examiner notes these similarities between Appellant’s disclosure and that of Germain and concisely lays out these findings in the Answer. See Ans. 8–9. Again, Appellant does not dispute these findings. Rather than address these findings, Appellant simply alleges that this same structure in Germain would not function as recited in the claim. As the Examiner explains: It is not clear how Appellant can maintain that the uterine polyp resection device of the instant application is configured to fail when used to resect uterine fibroids (or other abnormal tissue that is more fibrous than uterine polyps), yet an identical prior art device possessing the same exact structure [i.e., the insulative layer and its attributes (material, thickness)] that Appellant describes as being responsible for the failure, would somehow behave differently. Ans. 9. Appeal 2021-000281 Application 15/245,586 6 Here, where the Examiner “shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990); see also In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). We are not apprised of Examiner error in the rejection of claim 1 because Germain discloses the same structure as that in Appellant’s Specification and Appellant offers no persuasive explanation, let alone evidence, as to why the devices would function in a manner different from one another. Claims 2, 9, 10, and 18 Claim 2 depends from claim 1 and recites that “when the tissue resecting device fails, a portion of the insulative layer wears away from an outer surface of the inner sleeve to expose the outer surface of the inner sleeve proximal of the active electrode element.” Claim 9 also depends from claim 1 and recites that “the insulative layer is configured to separate from the active electrode element after a predetermined period of activation of the tissue resecting device.” Claims 10 and 18 are independent and recite similar features. Similar to claim 1, the Examiner’s rejection of these claims is based on findings that Germain provides the recited function because it has the same structure as that disclosed in Appellant’s Specification. Final Act. 5–8, Appeal 2021-000281 Application 15/245,586 7 10–11. Again, Appellant does not dispute the Examiner’s findings that Germain has the same structure as that disclosed in Appellant’s Specification. See Appeal Br. 11–12, 14–18, 20–24. As discussed with respect to claim 1 above, the Examiner shows sound basis for believing that the products of Appellant and the prior art are the same. Again, we are not apprised of Examiner error in the rejection of claims 2, 9, 10, and 18 because Germain discloses the same structure as that in Appellant’s Specification and Appellant offers no persuasive explanation, let alone evidence, as to why the devices would function in a manner different from one another. Claims 3, 12, and 19 Claim 3 depends from claim 1 and further recites that “the insulative layer is bonded directly to the active electrode element.” Claim 12 depends from claim 10 and further recites that “the insulative material is attached to the active electrode element.” Claim 19 depends from claim 18 and further recites that “the insulative layer is attached to at least a portion of the active electrode element.” The Examiner finds that Germain’s Figure 14 and corresponding description, for example, disclose these features. Final Act. 6 (“Regarding claim 3, Germain further discloses wherein the insulative layer [insulative layer (202)] is bonded directly to the active electrode element [electrode sleeve element (195)] [see FIG. 14].”) (alterations in original) (emphasis omitted), 9 (“Regarding claim 12, Germain further discloses wherein the insulative material [insulative layer (202)] is attached to the active electrode element [¶’s [0043], [0045], [0046]; FIGS. 5 & 14].”) (alterations in original) (emphasis omitted), 11 (“Regarding claim 19, Germain further Appeal 2021-000281 Application 15/245,586 8 discloses wherein the insulative layer [insulative layer (202)] is attached to at least a portion of the active electrode element [¶’s [0043], [0045], [0046]; FIGS. 5 & 14].”) (alterations in original) (emphasis omitted). The Examiner’s rejection relies on a finding that Germain’s “FIG. 14 shows inner sleeve (175) and sleeve element (195) as being integrally formed.” Ans. 12; see also id. at 13–14. Germain’s Figure 14 is reproduced below. Germain’s “FIG. 14 is a sectional view of the working end of [its tissue cutting device] showing an interior chamber and a variation of a projecting element.” Germain ¶ 31. Based on the continuous cross hatching in Figure 14, inner sleeve 175 and electrode sleeve element 195 are illustrated as a single piece. Appeal 2021-000281 Application 15/245,586 9 Appellant contends that “[n]owhere does Germain teach that the two pieces are ‘integrally formed’, as set forth in the Examiner’s Answer, such that the Examiner’s interpretation of the insulative layer (202) of Germain being bonded directly to or attached to the active electrode element (195) can be considered proper.” Reply Br. 2. Appellant appears to acknowledge that if Germain’s inner sleeve 175 and electrode sleeve element 195 form an integral part, then the claim limitations of claims 3, 12, and 19 are disclosed by Germain’s Figure 14. Although Appellant “disagree[s] with the [Examiner’s] characterization of Germain,” Appellant provides no persuasive explanation as to why one skilled in the art would not understand Germain’s Figure 14 as disclosing the integral structure stated in the Examiner’s findings. Id. It has long been the case that “[d]escription for the purposes of anticipation can be by drawings alone as well as by words.” In re Bager, 47 F.2d 951, 953 (CCPA 1931). A drawing is evaluated on the basis of what it reasonably discloses and suggests to a person of ordinary skill in the art. In re Aslanian, 590 F.2d 911, 914 (CCPA 1979). “[A] drawing in a utility patent can be cited against the claims of a utility patent application even though the feature shown in the drawing was unintended or unexplained in the specification of the reference patent.” Id. We are not apprised of Examiner error in the rejection of claims 3, 12, and 19 because it is not necessary that what is clearly shown in the drawings has corresponding explanation in the Specification. Claims 5 and 14 Claim 5 depends from claim 1 and recites that “the distal window has a longitudinal length of about 8 mm.” Claim 14 depends from claim 10 and Appeal 2021-000281 Application 15/245,586 10 similarly recites that “tissue-receiving window has a longitudinal length of about 8 mm.” The Examiner finds that Germain discloses “about 8mm” via its example of 10 mm. Final Act. 6, 9. The Examiner explains that this comports with the meaning of “about” set forth in Appellant’s Specification because there is not “any evidence that this 2mm difference would result in a different function or result.” Ans. 12 (referencing the explanation of the term “about” in Appellant’s Specification). Although noting that “[i]n many instances, the term[] ‘about’ may include numbers that are rounded to the nearest significant figure,” Appellant’s Specification makes clear that “[t]he term ‘about’ generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result).” Spec. 5:25–28. Other than alleging, without explanation or citation to evidence, that 10 mm is not “about” 8 mm, Appellant offers no response to the Examiner’s findings. See Appeal Br. 13, 19–20; Reply Br. 3. Indeed, Appellant does not even allege any difference in function or result would exist. For at least these reasons, we are not apprised of error in the rejection of claims 5 and 14. Claim 11 Claim 11 depends from claim 10 and recites that “the active electrode element comprises at least a portion of the inner sleeve.” The Examiner finds that “Germain further discloses wherein the active electrode element [electrode sleeve element (195)] comprises at least a portion of the inner sleeve [¶[0045]; FIG. 5]. Final Act. 9 (alterations in original). Appeal 2021-000281 Application 15/245,586 11 Appellant “respectfully disagree[s] with the [Examiner’s] characterization of Germain” and contends that “Paragraph [0045] of Germain teaches an electrode sleeve element 195 is attached (e.g., welded or press fit) to the inner sleeve 175” and “does not teach that the cited electrode sleeve element 195 comprises at least a portion of the inner sleeve 175.” Appeal Br. 18. As the Examiner explains, however, ¶[0045] of Germain clearly discloses that the active electrode element [electrode sleeve element (195)] comprises at least a portion of the inner sleeve [(175)] as broadly as claimed [see ¶[0045] (“inner sleeve 175 has a first diameter portion 190A that extends from the handle 142 (FIG. 1) to a distal region 192 of the sleeve 175 wherein the tissue extraction lumen transitions to a smaller second diameter lumen 190B with a reduced diameter indicated at B which is defined by the electrode sleeve element 195 that provides cutting electrode edge 180”)]. Ans. 13. Without further explanation from Appellant, we are not apprised of error in the Examiner’s finding.3 Claims 21 and 22 Claim 21 depends from claim 18 and recites that “the altered electrical pathway prevents plasma formation at the tissue resection edge of the active electrode element.” Claim 22 depends from claim 10 and recites that “the altered electrical pathway prevents plasma formation at the distal edge of the active electrode element.” 3 Appellant chose not to address the additional explanation from the Examiner’s Answer in its Reply Brief. Appeal 2021-000281 Application 15/245,586 12 Similar to claims 10 and 18, the Examiner’s rejection of these claims is based on findings that Germain provides the recited function because it has the same structure as that disclosed in Appellant’s Specification. Final Act. 11–12. Again, Appellant does not dispute the Examiner’s findings that Germain has the same structure as that disclosed in Appellant’s Specification. See Appeal Br. 25–26. As discussed above, the Examiner shows sound basis for believing that the products of Appellant and the prior art are the same. Again, we are not apprised of Examiner error in the rejection of claims 21 and 22 because Germain discloses the same structure as that in Appellant’s Specification and Appellant offers no persuasive explanation, let alone evidence, as to why the devices would function in a manner different from one another. Claims 4, 6–8, 13, 15, 17, and 20 Claims 4 and 6–8 depend from claim 1. Claims 13, 15, and 17 depend from claim 10. Claim 20 depends from claim 18. Appellant relies on the arguments presented with respect to claims 1, 10, and 18 for the patentability of claims 4, 6–8, 13, 15, 17, and 20. Because Appellant’s contentions regarding claims 1, 10, and 18 are not persuasive, we are also not apprised of error in the rejection of claims 4, 6–8, 13, 15, 17, and 20. CONCLUSION The Examiner’s rejections are affirmed. Appeal 2021-000281 Application 15/245,586 13 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–6, 8–15, 17–22 102(a)(1) Germain 1–6, 8–15, 17–22 7 103 Germain, Azom 7 Overall Outcome 1–15, 17–22 TIME PERIOD FOR RESPONSE 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 Copy with citationCopy as parenthetical citation