Cotera, Inc.Download PDFPatent Trials and Appeals BoardAug 4, 20202020000533 (P.T.A.B. Aug. 4, 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. 15/295,560 10/17/2016 Vivek Shenoy 14151-012USC1 3045 21918 7590 08/04/2020 DOWNS RACHLIN MARTIN PLLC 199 MAIN STREET P O BOX 190 BURLINGTON, VT 05402-0190 EXAMINER CARTER, TARA ROSE E ART UNIT PAPER NUMBER 3773 NOTIFICATION DATE DELIVERY MODE 08/04/2020 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): USPTO@dockettrak.com patip@drm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VIVEK SHENOY, HANSON S. GIFFORD III, and MARK DEEM Appeal 2020-000533 Application 15/295,560 Technology Center 3700 Before KEVIN F. TURNER, BRETT C. MARTIN, and BRANDON J. WARNER, Administrative Patent Judges. MARTIN, 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 1−23. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real parties in interest as Foundry, LLC and Moximed, Inc. Appeal Br. 1. Appeal 2020-000533 Application 15/295,560 2 CLAIMED SUBJECT MATTER The claims are “directed to an interventional technique and an implant for altering biomechanics of the spine to provide a therapeutic effect.” Spec. ¶ 2. Claim 6 (and claim 1 from which it depends), reproduced below, is illustrative of the claimed subject matter: 1. A method of treating the spine to reduce loading in a targeted region of the spine, comprising: selecting at least one of the muscles or connective tissues extending posteriorly along the spine as target tissue for treatment; guiding a prosthesis over a guidewire to a fixation position along the spine in engagement with the target tissue; fixing the prosthesis at said fixation position in engagement with the target tissue without cutting bone; and displacing, without cutting bone, said target tissue with said prosthesis sufficiently to alter the location, angle or magnitude of forces exerted by the target tissue thereby reducing loading in said targeted region. 6. The method of claim 1, wherein said displacing comprises displacing said target tissue posteriorly by between about 10 mm and to about 30 mm relative to the natural path of said target tissue to redistribute a load through the intervertebral disk. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Kim Peterman Lee McCormack Bennett Butler US 2006/0085069 A1 US 2006/0235387 A1 US 2008/0033552 A1 US 2008/0208341 A1 US 2008/0262549 A1 US 2009/0082808 A1 Apr. 20, 2006 Oct. 19, 2006 Feb. 7, 2008 Aug. 28, 2008 Oct. 23, 2008 Mar. 26, 2009 Appeal 2020-000533 Application 15/295,560 3 REJECTIONS I. Claims 1–3, 5, 6, 13, and 14 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Bennett. Final Act. 2. II. Claims 1, 2, 4, 7, 8, and 10–13 stand rejected under 35 U.S.C. § 102(b) as being anticipated by McCormack. Final Act. 5. III. Claims 1, 2, and 7–9 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Kim. Final Act. 7. IV. Claim 20 stands rejected under 35 U.S.C. § 102(b) as being anticipated by Butler. Final Act. 9. V. Claims 15–18 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over McCormack. Final Act. 11. VI. Claims 15 and 19 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Peterman and Lee. Final Act. 12. VII. Claims 21–23 stand rejected under 35 U.S.C. 103(a) as being unpatentable over Butler and McCormack. Final Act. 15. OPINION Unargued Rejections Appellant does not argue rejections II–IV and VII, above. Appeal Br. 4. Accordingly, we summarily affirm these rejections. In addition, Appellant only argues claim 62 of rejection I and so we summarily affirm this rejection as to claims 1–3, 5, 13, and 14. Id. 2 We address the language of claim 1, infra, only to the extent that claim 6 contains its recitations by virtue of its dependence on claim 1. Appeal 2020-000533 Application 15/295,560 4 Bennett Claim 6 Appellant first argues that Bennett does not select tissue as “target tissue for treatment” as recited in claim 1. Appeal Br. 6. Appellant argues that Bennett discloses tethers that “run around two spinous processes, but otherwise extend only in the cranial-caudal direction primarily to treat degenerative disc disease by restricting flexion of the treated spinal segment.” Appeal Br. 5 (citing Bennett ¶ 66). Thus, according to Appellant, Bennett does not target the claimed tissue for treatment because the purpose of Bennett’s tether is not to work on the claimed muscles or connective tissue, but rather to connect to and restrict flexion of adjacent vertebrae, i.e., bone. Appellant next asserts that Bennett does not perform the “displacing” step found in base claim 1 because any “incidental displacement of a posterior-extending tissue incidental to the placement of the Bennett device does not mean that the displacing is sufficient to alter one of the parameters of the forces exerted by the target tissues so as to reduce loading as recited.” Appeal Br. 6. More specifically, with regard to claim 6, Appellant asserts that “[n]othing in the cited references discloses or suggests such a posteriorly directed displacement as recited in claim 6.” Appeal Br. 7 (emphasis added). We agree with Appellant that, although there may be incidental displacement as recited in claim 1, such displacement would not occur posteriorly as claimed. At best, Bennett teaches restriction of flexion in the cranial-caudal direction, but this is not displacement of any targeted tissue in the posterior direction as found in claim 6. Accordingly, we do not sustain the rejection of claim 6. Appeal 2020-000533 Application 15/295,560 5 McCormack Claims 15–18 Appellant first argues that McCormack fails to anticipate claim 15 because it does not “posteriorly displace the connective tissue by a specific amount to achieve a stated effect.” Appeal Br. 9. We note, however, that, although claim 6 recites such posterior displacement, claim 15 is silent regarding any particular direction, stating only that the implant is “dimensioned so as to displace said connective tissue from a pre-treatment anatomical path by a displacement distance of more than about 10 mm.” Accordingly, we find this argument unpersuasive as it is not commensurate with the scope of claim 15. Appellant also argues “that in McCormack there is no teaching to purposefully displace a posteriorly positioned muscle or connective tissue as recited.” Appeal Br. 10. As the Examiner points out, however, McCormack teaches that “the space between the facets is increased (see figure 4 []) and, thus, the capsular ligament is also displaced/moved.” Ans. 10 (citing McCormack ¶ 54). This particular capsule/capsular ligament is located posteriorly as claimed and because it is stretched, it is therefore moved from its natural position. Lastly, Appellant argues that the rejection is improper as to the magnitude of displacement “[w]ithout first establishing that the prior art explicitly recognized this parameter as a critical parameter.” Reply Br. 6. The Examiner counters, however, that McCormack does recognize this as a result-effective variable in that McCormack discloses that the increase in space between the facets, and thus lengthening of the capsular ligament, can be from about 1mm to over 3mm. Ans. 12. McCormack also “contemplates that the devices and methods may also be used to increase foraminal Appeal 2020-000533 Application 15/295,560 6 dimension in other regions of the spine, e.g., thoracic, lumbar, etc.” Id. (citing McCormack ¶ 75). Thus, the Examiner concludes that “[t]he displacement dimensions could be changed to achieve the desired stability to the facet joint” by increasing to the claimed 10mm displacement. Appellant does not argue that this is not possible in the cervical facet joint or in the other disclosed locations such as the thoracic or lumbar regions. Accordingly, we are not persuaded of error in the Examiner’s rejection of claims 15–18 as obvious over McCormack and we sustain this rejection. Peterman/Lee Claims 15 and 19 As with McCormack, Appellant asserts that Peterman is deficient because “[t]here is no teaching in Peterman to displace posterior connective tissue further posteriorly.” Appeal Br. 10 (emphasis added). As noted above, claim 15 does not require posterior displacement, merely displacement. We agree with the Examiner that, as with McCormack, Peterman’s device is intended to increase the facet space so as to provide decompression in the space between vertebrae. Ans. 10. Any increase in the facet height also increases the length of “any posterior muscle or ligament group” associated with the facet at issue and thus displacement from its natural position occurs, which would also affect the forces exerted by any such muscle or ligament group in the targeted region as claimed. Final Act. 13. Appellant further argues that the Examiner’s rejection “relies on a theory of optimization without first establishing the parameter as being recognized by the prior art.” Reply Br. 6. As with McCormack, however, the Examiner does point out that the facet height is specifically targeted for decompression/increased height. Despite Lee being directed to lordosis, the Appeal 2020-000533 Application 15/295,560 7 Examiner is correct that “Lee further provides a formula used to determine the displacement (length) of the extensor muscle to adjust the load (force) on this posterior tissue which will affect the load on the facet joint and other tissues of the posterior spine.” Ans. 17. Thus, the Examiner has identified a result-effective variable and we agree that “[t]he displacement dimensions could be changed to achieve the desired stability to the facet joint and posterior spine segment.” Id. In general, with respect to both rejections of claim 15, Appellant relies on posterior displacement, which is not claimed. The only requirement of claim 15 is displacement of posterior tissue and we agree with the Examiner that lengthening of posterior connective tissue by decompression of the facet joint as taught in the devices of McCormack, Peterman, and Lee is sufficient to teach the claimed displacement. Accordingly, we likewise sustain this rejection. CONCLUSION The Examiner’s rejections are AFFIRMED IN PART. More specifically, DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5, 6, 13, 14 102(b) Bennett 1–3, 5, 13, 14 6 1, 2, 4, 7, 8, 10–13 102(b) McCormack 1, 2, 4, 7, 8, 10–13 1, 2, 7–9 102(b) Kim 1, 2, 7–9 20 102(b) Butler 20 15–18 103(a) McCormack 15–18 15, 19 103(a) Peterman, Lee 15, 19 Appeal 2020-000533 Application 15/295,560 8 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 21–23 103(a) Butler, McCormack 21–23 Overall Outcome: 1–5, 7– 23 6 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 IN PART Copy with citationCopy as parenthetical citation