Ex Parte Verard et alDownload PDFPatent Trial and Appeal BoardSep 18, 201711068342 (P.T.A.B. Sep. 18, 2017) 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. 11/068,342 02/28/2005 Laurent Verard 5074A-000059/US/COA 2174 132492 7590 09/20/2017 Harness, Dickey, & Pierce, PLLC (Medtronic Surgical Technologies) 5445 Corporate Drive Suite 200 Troy, MI 48098 EXAMINER PENG, BO JOSEPH ART UNIT PAPER NUMBER 3786 NOTIFICATION DATE DELIVERY MODE 09/20/2017 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): troymailroom @hdp. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LAURENT VERARD, PAUL KESSMAN, and MARK HUNTER Appeal 2015-007023 Application 11/068,342 Technology Center 3700 Before BRETT C. MARTIN, THOMAS F. SMEGAL, and JEFFREY A. STEPHENS, Administrative Patent Judges. STEPHENS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants1 seek our review under 35 U.S.C. § 134(a) from the Examiner’s Final Office Action (“Final Act.”) rejecting claims 1—7, 9, 12, 14—24, 26, 28-41, 43—45, 48—51, and 55—58, which are all the claims pending in the application.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The real party in interest is identified as Medtronic Navigation, Inc. App. Br. 4. 2 The Final Action is supplemented by a first Advisory Action (mailed Feb. 21, 2014) and a second Advisory Action (mailed Mar. 18, 2014) (entering Amendment filed Feb. 5, 2014). Appeal 2015-007023 Application 11/068,342 Claimed Subject Matter Claims 1,21, and 35 are independent. The claimed subject matter relates to a surgical navigation system, and specifically to reporting an error indicating that a surgical instrument has potentially punctured a vessel within the body. See App. Br. 31—32 (Claims. Appendix); Spec. para. 32. Claim 1, reproduced below, is illustrative. 1. A navigation system comprising: a tracking system configured to capture position data indicative of a first position of a surgical instrument subsequent to acquisition of scan image data, wherein the scan image data is representative of a region of interest of a patient; a data processor adapted to receive the scan image data and the position data from the tracking system, wherein the data processor is configured to render an image of the region of interest from the scan image data, compensate for an inaccuracy in the first position caused by an anatomical shift of a first anatomical member of the patient that occurred subsequent to the acquisition of the scan image data, wherein the data processor is configured to, while compensating for the inaccuracy, determine a most likely position of the surgical instrument based on the first position, determine whether the first position is greater than or equal to a predetermined distance away from the most likely position, generate a trajectory error if the first position is greater than or equal to the predetermined distance away from the most likely position, and determine a second position of the surgical instrument based on the most likely position, and report the trajectory error of the surgical instrument if the first position is indicative that the surgical instrument has potentially punctured the 2 Appeal 2015-007023 Application 11/068,342 first anatomical member or a second anatomical member; and a display operable to display the image and the second position of the surgical instrument relative to the image of the region of interest. Rejections3 I. Claims 1, 6, 7, 9, 14, 15, 17-19, 20-22, 24, 26, 28, 29, 32-36, 38—44, and 48—50 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tenhoff (US 5,830,145, issued Nov. 3, 1998), Watkins et al. (US 6,175,757 Bl, issued Jan. 16, 2001) (“Watkins”), Martinelli et al. (US 4,821,731, issued Apr. 18, 1989) (“Martinelli”), Teo et al. (US 5,885,218, issued Mar. 23, 1999) (“Teo”), Shahidi (US 2001/0007919 Al, published July 12, 2001), andNishiki et al. (US 5,345,938, issued Sept. 13, 1994) (“Nishiki”). Final Act. 7-14.4 II. Claims 2—5, 12, 23, and 45 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, and Rex (US 6,038,468, issued Mar. 14, 2000). Final Act. 14—17.5 3 The Examiner withdraws all rejections under 35 U.S.C. § 112 in the Answer. Ans. 19; see Final Act. 2—6. 4 We note the summary of the rejection omits reference to Teo and Nishiki, Final Act. 7, which are used in rejecting the claims, see, e.g., Final Act. 10, 12. Because these references are used in rejecting the independent claims, we include these references in each listed rejection of the claims. We have also included independent claim 21 as rejected with independent claim 35, based on (1) claim 21 ’s similarity to claim 35, (2) the Examiner’s reference to claim 21 being rejected with claim 35, Final Act. 13, and (3) Appellants arguing claims 21 and 35 together with claim 1, App. Br. 25. 5 The Final Action’s reference, on pages 14 and 17, to claim 44 instead of claim 45 appears to be a typographical error. 3 Appeal 2015-007023 Application 11/068,342 III. Claims 16, 31, and 51 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, and Morris et al. (US 5,923,001, issued July 13, 1999). Final Act. 17—18. IV. Claims 30 and 37 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, and a second Shahidi reference (US 2001/0007919 Al, published July 12, 2001) (“Shahidi’919”). Final Act. 18-19. V. Claims 55 and 57 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, and Lorigo (Liana M. Lorigo et al., Codimension-Two Geodesic Active Contours for the Segmentation of Tubular Structures, Computer Vision and Pattern Recognition IEEE Conference Proceedings 444-451 (2000)). Final Act. 19— 20. VI. Claims 56 and 58 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, Lorigo, and Von Teichert (US 6,436,073 Bl, issued Aug. 20, 2002) (“Teichert”). Final Act. 20—22. DISCUSSION Rejection I Appellants argue Tenhoff, Watkins, Martinelli, and Shahidi fail to teach several limitations recited in claim 1. App. Br. 22. Appellants’ arguments, however, primarily address each of the references separately, and Appellants do not persuasively address the Examiner’s findings that one of ordinary skill in the art would have modified the combination of references to make the determinations and report the trajectory error claimed. 4 Appeal 2015-007023 Application 11/068,342 Appellants argue it is irrelevant that Watkins teaches determining a radial distance between a lumen wall and a catheter because Watkins “is simply directed to determining the position of the catheter,” and “the claimed navigation system is trajectory based.” App. Br. 22. Appellants’ arguments do not persuasively challenge the Examiner’s finding, with which we agree, that Watkins “teaches a catheter insertion tracking within a lumen of a body and acquiring a luminal image with tracking system and determining radial distance between the lumen wall and the probe and creating a 3D image map.” Final Act. 7. Appellants assert that “[n]one of the relied upon references disclose determining whether and/or reporting that a surgical instrument has punctured an anatomical member.” Id. at 23. We note, however, that claim 1 recites, in relevant part: “generate a trajectory error if the first position is greater than or equal to the predetermined distance away from the most likely position,” and “report the trajectory error of the surgical instrument if the first position is indicative that the surgical instrument has potentially punctured the first anatomical member or a second anatomical member.” Thus, claim 1 does not require determining and/or reporting that a surgical instrument has actually punctured an anatomical member. The Examiner finds “it would be obvious to any clinician that puncturing the wall of [a lumen] or vessel should be avoided, and tracking and real time imaging of the instrument insertion are for such purpose to avoid puncturing the wall.” Final Act. 9. We agree with this finding. Although perhaps not stated explicitly, one of ordinary skill in the art considering references such as Watkins would have understood that part of the purpose of mapping the walls of a lumen and tracking an invasive probe 5 Appeal 2015-007023 Application 11/068,342 in real time is to aid the clinician in avoiding puncturing the vessel wall. And although we agree with Appellants that Shahidi does not teach reporting this particular type of potential error, see App. Br. 23, Shahidi relates to assisting a surgeon to perform an endoscopic surgical procedure, and the passages relied upon by the Examiner provide evidence that one of ordinary sill in the art would have wanted to provide visual display of errors, see Final Act. 11—12; Ans. 24—25, 28. Appellants contend that whether or not it would have been obvious to determine a center of a vessel based on the position information provided by Watkins, “determining a center point does not render obvious the claimed trajectory based limitations of claim 1, as determining the center point alone does not provide a trajectory of the catheter and/or a trajectory error of the catheter.” App. Br. 23. Appellants also argue Teo and Shahidi do not teach determining a trajectory of the catheter and/or whether a trajectory error has occurred. Id. Claim 1 requires a data processor that determines whether a “first position” of a surgical instrument “is greater than or equal to a predetermined distance away from the most likely position,” and generates a trajectory error if that condition is met. The Examiner finds Tenhoff and Watkins teach determining the current position of a catheter within a lumen, including the distance from the wall of the vessel, and finds Martinelli teaches determining a most likely position based on a previously measured first position. Final Act. 7—9. The Examiner finds one of ordinary skill in the art would have used Teo’s centerline location to calculate the distance from the centerline to the catheter instead of the distance to the wall as taught in Watkins “in order to provide user the distance information of how 6 Appeal 2015-007023 Application 11/068,342 far the catheter is away from the center of the vessel which is the optimal location for catheter placement within the vessel.” Final Act. 11; see also Ans. 24. Appellants argue the term “optimal” cannot be found in Teo. Reply Br. 9. The Examiner’s use of the term “optimal,” however, forms part of the articulated reasons for why one of ordinary skill in the art would have used Teo’s centerline measurement to modify Tenhoff, Watkins, and Martinelli— namely in order to ensure that the catheter stays near the centerline, which is plainly the optimal location furthest away from the walls of the lumen. To the extent this is one of the “several limitations of claim 1 ” of which Appellants argue the Examiner improperly takes Official Notice, App. Br. 24—25, we agree with the Examiner that Official Notice was not relied upon, Ans. 27. Rather, Appellants have not persuasively challenged the reasoning of the Examiner, with which we agree, as to why one of ordinary skill would have modified the combination of references in the manner claimed. Deviation from an initial detection of a catheter at the centerline of a vessel (i.e., the claimed “first position”) to a current position (i.e., the claimed “most likely position”), which is determined based on the initial position and movement of the anatomical feature, and reporting such a condition, meets the limitations of claim 1 disputed by Appellants. For the reasons discussed, we agree with the Examiner that the combined teachings and modifications of the references meet these limitations, and Appellants have not identified error in the findings or reasoning of the Examiner. Accordingly, for the reasons discussed above and by the Examiner, we are not informed of error in the Examiner’s rejection of claim 1 under 35 7 Appeal 2015-007023 Application 11/068,342 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, and Nishiki. Thus, we sustain the rejection of claim 1. Appellants argue the Examiner errs in rejecting claims 6, 7, 9, 14, 15, 17—19, 20—22, 24, 26, 28, 29, 32—36, 38-44, and 48—50 for “at least similar reasons as claim 1.” App. Br. 25. Thus, these claims fall with representative claim 1, see 37 C.F.R. § 41.37(c)(l)(iv), and we do not sustain the rejection of claims 6, 7, 9, 14, 15, 17-19, 20-22, 24, 26, 28, 29, 32-36, 38-44, and 48—50 under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, and Nishiki.6 Rejection II Claim 23 depends from claim 22, which depends from claim 21, and recites, in part, “the tracking system is operable to track both the first position and an orientation of the surgical instrument to allow the data processor to render the image of the region of interest from a point of view of the surgical instrument.” Appellants argue Shahidi “does not disclose a processor configured to, based on a first position and an orientation of a surgical instrument and scan image data of a region of interest of a patient, render an image of the region of interest from a point of view of a surgical instrument,” and to do this “without generating an endoscopic image.” App. Br. 26. Appellants assert Tenhoff, Watkins, Martinelli, Teo, and Rex do not make up for the deficiencies of Shahidi. Id. 6 Appellants offer additional arguments specific to claims 21 and 35 in the Reply Brief, pages 11—13, but do not show good cause why these arguments could not have been presented in the Appeal Brief. Thus, we consider these arguments waived. 37 C.F.R. § 41.41(b)(2). 8 Appeal 2015-007023 Application 11/068,342 The Examiner explains that Shahidi is not relied on for this teaching, and that Nishiki and Rex are relied on. Ans. 29. Based on the Examiner’s rejection at pages 15—16 of the Final Action, we agree with the Examiner. Thus, Appellants’ arguments do not address the Examiner’s rejection. Accordingly, for the reasons discussed above and by the Examiner, we are not informed of error in the Examiner’s rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, and Rex. Thus, we sustain the rejection of claim 23, and, for the same reasons, the rejection of claims 2—5, 12, and 45, which are not argued separately. App. Br. 26. Rejections III—V Appellants argue Rejections III through V are in error for the same reasons argued in support of independent claims 1,21, and 35. App. Br. 26— 28. Thus, for the same reasons that we sustain the rejection of claims 1,21, and 35 as set forth in Rejection I, we sustain the rejections of claims 16, 31, and 51, claims 30 and 37, and claims 55 and 57, as set forth in Rejections III-V. Rejection VI Appellants argue claims 56 and 58 as a group. App. Br. 28—29. We select claim 56 as representative. 37 C.F.R. § 41.37(c)(l)(iv). Claim 56 depends from claim 21 and recites “wherein the data processor is configured to determine (i) whether the surgical instrument is the predetermined distance from the most likely position, and (ii) whether the angle between the trajectory of the surgical instrument and the centerline of the region of interest is greater than the predetermined angle.” Thus, 9 Appeal 2015-007023 Application 11/068,342 claim 56 requires the same determination in claim 1, as well as an additional determination related to the angle of the surgical instrument relative to the centerline of a region of interest, such as an anatomical vessel. Appellants contend “Teichert does not disclose determining an angle between a trajectory and a centerline of a region of interest and/or determining whether an angle between a trajectory of the surgical instrument and a centerline of a region of interest is greater than the predetermined angle.” App. Br. 29. Appellants state that Teichert instead teaches a butterfly anchor that prevents a catheter 52 from resting against or puncturing a vein. Id.', see also Reply Br. 17—18. The Examiner finds Teichert “teaches to control an angle at which the catheter is maintained within the vein of a patient, as to prevent accidental puncturing of the vein wall (col. 2, lines 10—13).” Final Act. 21. The Examiner finds that, based on this teaching, “one of ordinary skill in the art would know that at a certain angle a catheter will puncture the vein wall and hence, one of ordinary skill in the art when moving catheter in the vein should avoid such angle.” Ans. 31. The Examiner acknowledges “Teichert is not directed to determining, monitoring, and reporting an error of a trajectory of a surgical instrument,” and relies on the references discussed above for these features. Id. Teichert, then, is specifically relied on to explain why one of ordinary skill in the art would modify the combination of other references to also determine, monitor, and report a deviation from the angle of the centerline of a vessel, in order to avoid puncturing the vessel wall. See Ans. 31—32. Thus, although we agree with Appellants that Teichert does not teach determining “whether the angle between the trajectory of the surgical 10 Appeal 2015-007023 Application 11/068,342 instrument and the centerline of the region of interest is greater than the predetermined angle,” as recited in claim 56, this argument does not address the Examiner’s rejection. We agree with the Examiner that Teichert’s recognition of the importance of the angle of a catheter with respect to a vessel so as to prevent accidental puncturing of the vessel wall supports the finding that one of ordinary skill in the art would have been motivated to determine this angle and report a deviation from it in addition to determining that the catheter has deviated from the centerline of the vessel, as recited in claim 21. Accordingly, for the reasons discussed above and by the Examiner, we are not informed of error in the Examiner’s rejection of claim 56 under 35 U.S.C. § 103(a) as unpatentable over Tenhoff, Watkins, Martinelli, Teo, Shahidi, Nishiki, Lorigo, and Teichert. Thus, we sustain the rejection of claim 56, and, for the same reasons, the rejection of claim 58. See 37 C.F.R. § 41.37(c)(l)(iv). DECISION We affirm the Examiner’s rejection of claims 1—7, 9, 12, 14—24, 26, 28-41, 43—45, 48-51, and 55-58. 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)(l)(iv). AFFIRMED 11 Copy with citationCopy as parenthetical citation