Gynesonics, Inc.Download PDFPatent Trials and Appeals BoardDec 18, 20202020003453 (P.T.A.B. Dec. 18, 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. 15/597,511 05/17/2017 Michael MUNROW 31992-709.304 9447 21971 7590 12/18/2020 WILSON SONSINI GOODRICH & ROSATI 650 PAGE MILL ROAD PALO ALTO, CA 94304-1050 EXAMINER MEHL, PATRICK M ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 12/18/2020 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@wsgr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MICHAEL MUNROW, JORDAN BAJOR, and MALCOLM G. MUNRO Appeal 2020-003453 Application 15/597,511 Technology Center 3700 ____________ Before MICHAEL L. HOELTER, WILLIAM A. CAPP, and LEE L. STEPINA, Administrative Patent Judges. HOELTER, 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 1–8, 16, 18–30, and 32–36, which constitute all the claims pending in this application. See Appeal Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM the Examiner’s rejections of these claims. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Gynesonics, Inc.” Appeal Br. 3. Appeal 2020-003453 Application 15/597,511 2 CLAIMED SUBJECT MATTER The disclosed subject matter “relates to methods and systems for controlling the deployment of needles using visual feedback from an ultrasonic or other image.” Spec. ¶ 2. Method claims 1 and 16 are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. A method for facilitating treatment of uterine anatomy, the method comprising: positioning a probe proximate to the uterine anatomy; using the probe to provide an image of the uterine anatomy; overlaying the image with a projected treatment boundary and a safety boundary based on an estimated or actual position of a tissue treatment device, wherein the projected treatment boundary defines a projected treatment region therewithin that includes at least a portion of uterine anatomy to be treated by the tissue treatment device, wherein tissue between the treatment and safety boundaries is at risk of tissue damage by the tissue treatment device, and wherein tissue outside the safety boundary will likely not be damaged by the tissue treatment device; and aligning the projected treatment boundary on the image so that the projected treatment region includes at least a portion of the uterine anatomy to be treated by the treatment device and so that a sensitive anatomical structure is outside of the safety boundary. Appeal 2020-003453 Application 15/597,511 3 EVIDENCE Name Reference Date Zvuloni et al. (“Zvuloni”) US 2002/0040220 A1 Apr. 4, 2002 Vaezy et al. (“Vaezy ’867”) US 6,425,867 B1 July 30, 2002 Vaezy et al. (“Vaezy ’399”)2 US 2005/0203399 A1 Sept. 15, 2005 Christopherson et al. (“Christopherson”) US 2006/0089636 A1 Apr. 27, 2006 Grossman US 2006/0189972 A1 Aug. 24, 2006 Chopra et al. (“Chopra”) US 2007/0239062 A1 Oct. 11, 2007 REJECTIONS Claims 1–7, 16, 18–23, 25, 27, 28, 30, and 32–36, are rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Vaezy ’399, Vaezy ’867, Christopherson, Chopra, and Zvuloni. Claims 8, 24, 26, and 29 are rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Vaezy ’399, Vaezy ’867, Christopherson, Chopra, Zvuloni, and Grossman. ANALYSIS Unpatentability of claims 1–7, 16, 18–23, 25, 27, 28, 30, and 32–36 over Vaezy ’399, Vaezy ’867, Christopherson, Chopra, and Zvuloni Appellant argues all these claims together. See Appeal Br. 8–12. We select claim 1 for review, with the remaining claims standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv). 2 Vaezy ’399 is “a division of” Vaezy ’867. The Examiner refers only to “Vaezy,” but the cited figures and paragraphs correlate to Vaezy ’399. See Final Act. 3–4. The Examiner also states that Vaezy ’867 is employed as an “evidentiary reference.” Final Act. 3. Appellant acknowledges the primary use of Vaezy ’399 and the evidentiary use of Vaezy ’867. See Appeal Br. 8, 9. Appeal 2020-003453 Application 15/597,511 4 Claim 1 is directed to a medical procedure using a “probe to provide an image of the uterine anatomy.” Claim 1 also recites “overlaying the image with a projected treatment boundary and a safety boundary.” Within the inner “treatment boundary” is a “treatment region” and “outside the safety boundary” is an area that “will likely not be damaged by the tissue treatment device.” Claim 1 also addresses “tissue between the treatment and safety boundaries.” The Examiner primarily relies on Vaezy ’399 for disclosing a probe that provides an image, and overlaying the image with a boundary thereby defining the recited “treatment boundary” and its associated “treatment region.” See Final Act. 3–4; see also Vaezy ’399 Fig. 9; Ans. 4–6, 9. The Examiner finds that this boundary in Vaezy ’399 is “so that a sensitive anatomical structure (bladder) is outside of the treatment region [ . . . the safety boundary . . .].” Final Act. 4; see also Ans. 5. However, the Examiner acknowledges that this reference “does not explicitly disclose “tissue between the treatment and safety boundaries.” Final Act. 4; see also Ans. 5. Regarding Vaezy ’867, the Examiner states that this reference is relied upon “to only support the teaching of a combined imaging and treatment probe as an evidentiary reference to Vaezy ’399 allowing for an ultrasound image-guided treatment for tissue ablation.” Ans. 5. The Examiner relies on Christopherson for teaching “treatment boundary #70A” and another boundary (“#76”) “considered as the safety boundary” disclosing a “region in between.” Final Act. 5 (referencing Christopherson Fig. 3A); see also Ans. 5–6. Likewise, the Examiner relies on Chopra for teaching “treatment boundary ([0065]) and “also a safety boundary beyond which a surrounding tissue . . . should not be damaged.” Appeal 2020-003453 Application 15/597,511 5 Final Act. 5 (referencing Chopra Fig. 2); see also Ans. 8. Overlapping such teachings above, the Examiner further relies on Zvuloni, which “describes the definition of two boundaries” with (a) the “treatment region” being within the small-radius circle; (b) the region beyond the large-radius circle “corresponding to a 0% destruction therefore a safety region;” and (c) “the region in between the two boundaries being producing destruction between 0 and 100%.” Final Act. 6 (referencing Zvuloni Figs. 1a and b); see also Ans. 6–7 (and the Examiner’s annotations of Zvuloni Figures 1a, 1b), 9. The Examiner thereafter provides reasons for the combination of these references. See Final Act. 7; see also Ans. 6, 8–9. Addressing Vaezy ’399, Appellant states that this reference fails to “show any two separate treatment and safety boundaries” and also that this reference does not show such “boundaries that are overlaid on the images.” Appeal Br. 9; see also Reply Br. 2. Appellant makes similar arguments regarding Vaezy ’867. See Appeal Br. 9; Reply Br. 2. First, the Examiner acknowledges that “Vaezy does not explicitly disclose details regarding the treatment boundary and the safety boundary” as recited. Final Act. 4. The Examiner relies on the other references for more explicit teachings of the two boundaries. See Final Act. 4 (“Vaezy does not explicitly disclose . . .”). As such, Appellant’s contention on this point is not persuasive of Examiner error. Regarding an overlay, the Examiner specifically addresses Figure 9 of Vaezy ’399 for such teachings. See Ans. 4–5 (citing Vaezy ’399 ¶¶ 76, 77); see also Final Act. 4, Ans. 6, 9. Paragraph 77 of Vaezy ’399 clearly states that “FIG. 9 is a composite ultrasound image” that has been annotated to “illustrate[] an area of potential treatment 250.” It is this added item 250 Appeal 2020-003453 Application 15/597,511 6 that the Examiner has identified as “defining a boundary for the treatment region.” Final Act. 4. In view of such teachings, Appellant does not make clear how Vaezy ’399’s annotation of the probe’s image fails to correspond to Appellant’s step of “overlaying the image with a projected treatment boundary.” Regarding the teachings of Christopherson, Appellant contends that the referenced “Figure 3A” fails to disclose an overlaid image. Appeal Br. 10; see also Reply Br. 2. However, Figure 3A of Christopherson was not relied upon for teaching such an overlaid image, Vaezy ’399 was. See above.3 Additionally, Appellant contends that Christopherson does not disclose “an image of anatomy taken by the probe.” Appeal Br. 10; see also Reply Br. 2. However, the Examiner relied on Vaezy ’399 and Vaezy ’867 for such probe teachings, not Christopherson. See Final Act. 3; Ans. 5. Appellant also contends that Christopherson’s “prostate lobe 76 is fixed and not dependent on” location. Appeal Br. 10. However, whether Christopherson’s outer (“safety”) boundary 76 is fixed or not does not detract from the fact that the treatment is to have no effect on the region beyond this boundary, consistent with claim 1. Appellant also contends that the two boundaries disclosed in Christopherson, i.e., 70A and 76, “would not divide the image into the claimed Regions.” Appeal Br. 10. However, Appellant does not explain how the two boundaries fail to disclose a first region within the inner boundary, a second region beyond the outer 3 The Examiner also states that “Appellant’s arguments were presented against the references individually with apparent circular arguments regarding the claim limitations.” Ans. 3; see also Ans. 9. There is merit to this comment. Appeal 2020-003453 Application 15/597,511 7 boundary, and a third region between the two boundaries. Accordingly, Appellant’s contentions regarding Christopherson are not persuasive that the Examiner erred when relying on this reference. Regarding Chopra, Appellant contends that both of the disclosed boundaries (i.e., items 201 and 202) “should be considered treatment boundaries” because “the region between boundaries 201, 202 is intended to be treated.” Appeal Br. 11. To be clear, claim 1 describes this intermediate region as being “at risk of tissue damage by the tissue treatment device.” In other words, claim 1 acknowledges that tissue within this intermediate region is at risk of being effected (i.e., treated). Appellant is not persuasive that there is a discrepancy between that which Chopra teaches and that which is recited. Appellant also contends that “Chopra does not disclose overlaying any image” (Appeal Br. 11; see also Reply Br. 2), but as noted above, the Examiner relies on Vaezy ’399 for such teaching. Further, similar to Christopherson above, Appellant contends that “Chopra is not even an image of the anatomy taken by a probe.” Appeal Br. 11; see also Reply Br. 3. However, as above, the Examiner relied on Vaezy ’399 and Vaezy ’867 for such probe teachings, not Chopra. See Final Act. 3; Ans. 5. Accordingly, Appellant’s contentions regarding Chopra are not persuasive the Examiner erred when relying on this reference. Regarding Zvuloni, Appellant contends that this reference does not teach overlaying a probe’s image, or the display thereof. See Appeal Br. 12. However, as noted above, the Examiner relies on Vaezy ’399 for such teachings. See Final Act. 3–4. Accordingly, Appellant’s arguments regarding Zvuloni are not persuasive the Examiner erred when relying on this reference. Appeal 2020-003453 Application 15/597,511 8 In Appellant’s Reply Brief, Appellant “reiterates that many of the cited references are in different fields of art and cannot be reasonably combined.” Reply Br. 3. As support, Appellant contends that both Vaezy ’399 and Vaezy ’867 disclose use of a probe “for vaginal use” whereas Christopherson, Chopra, and Zvuloni are directed to treatment of the “prostrate.” Reply Br. 4. As such, Appellant contends that a skilled person would not use the teachings of Christopherson, Chopra, and Zvuloni to modify the teachings of Vaezy ’399 and Vaezy ’867. See Reply Br. 4. To be clear, claim 1 recites a method “for facilitating treatment of uterine anatomy.” Appellant does not dispute that Vaezy ’399 and Vaezy ’867 relate to such treatment. See Vaezy ’399 and Vaezy ’867 generally. However, Appellant does not explain how the treatment boundaries taught by Christopherson, Chopra, and Zvuloni cannot also be applied to address the difficulty of treating “uterine anatomy” in order “to improve the control of the thermal treatment while sparing sensitive and critical tissues surrounding the targeted abnormalities,” as expressed by the Examiner. Final Act. 7; see also Ans. 6, 8–9. Thus, based on the record presented, we sustain the Examiner’s rejection of claims 1–7, 16, 18–23, 25, 27, 28, 30, and 32–36, as unpatentable over Vaezy ’399, Vaezy ’867, Christopherson, Chopra, and Zvuloni. The rejection of claims 8, 24, 26, and 29 as unpatentable over Vaezy ’399, Vaezy ’867, Christopherson, Chopra, Zvuloni, and Grossman Each of these claims depend directly from either independent claim 1 or independent claim 16. The Examiner relies on the additional reference to Grossman as teachings their additional limitations. See Final Act. 12–14. Appeal 2020-003453 Application 15/597,511 9 Appellant does not dispute the teaching of these additional limitations, but instead contends that there is no showing of “where Grossman has been shown to cure the above discussed deficiencies of Vaezy ’399, Vaezy ’867, Chopra, Christopherson, and Zvuloni.” Appeal Br. 13. Appellant’s contention is not persuasive of Examiner error. We sustain the Examiner’s rejection of claims 8, 24, 26, and 29 as unpatentable over Vaezy ’399, Vaezy ’867, Christopherson, Chopra, Zvuloni, and Grossman. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–7, 16, 18– 23, 25, 27, 28, 30, 32– 36 103(a) Vaezy ’399, Vaezy ’867, Christopherson, Chopra, Zvuloni 1–7, 16, 18– 23, 25, 27, 28, 30, 32– 36 8, 24, 26, 29 103(a) Vaezy ‘399, Vaezy ’867, Christopherson, Chopra, Zvuloni, Grossman 8, 24, 26, 29 Overall Outcome 1–8, 16, 18– 30, 32–36 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation