Ex Parte Manzke et al

Patent Trials and Appeals BoardMar 28, 2019

13817263 - (D) (P.T.A.B. Mar. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/817,263 02/15/2013 Robert Manzke 24737 7590 04/01/2019 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus A venue Suite 340 Valhalla, NY 10595 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 201 OP00809WOUS 1047 EXAMINER MCDONALD, KATHERINE M ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 04/01/2019 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): patti. demichele@Philips.com marianne.fox@philips.com katelyn.mulroy@philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ROBERT MANZKE, RAYMOND EMMANUEL CHAN, ADRIEN DESJARDINS, GERT WIM 'T HOOFT, and SZABOLCS DELADI Appeal2018-004905 Application 13/817,263 Technology Center 3700 Before JENNIFER D. BAHR, JAMES P. CALVE, and NATHAN A. ENGELS, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Robert Manzke et al. (Appellants) 1 appeal under 35 U.S.C. Â§ 134(a) from the Examiner's decision rejecting claims 1-15. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM-IN-PART. 1 Appellants identify Koninklijke Philips N V as the real party in interest. App. Br. 3. Appeal2018-004905 Application 13/817,263 THE CLAIMED SUBJECT MATTER Appellants' invention is directed to "medical imaging, and more particularly to systems and methods for mapping internal volumes using a combination of shape sensing and images during medical procedures." Spec. 1. Claims 1 and 7 are independent. Appeal Br. 19-21 (Claims App.) Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. A system for mapping intraluminal structures, comprising: an elongated flexible instrument; an optical shape sensing device that is separate and discrete from the elongated flexible instrument, said optical shape sensing device being disposed within the flexible instrument and configured to determine a shape of an elongated portion of the flexible instrument over an extended length from a distal end of the flexible instrument relative to a reference, the optical shape sensing device configured to collect anatomical information concerning an intraluminal structure based on a configuration of the elongated portion of the flexible instrument to generate an electroanatomic volumetric map of a three- dimensional region of the intraluminal structure during a procedure; and an imaging enabled ablation device mounted at or near the distal end of the flexible instrument. REJECTIONS I. Claims 1-3, 5-9, and 11-15 stand rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Froggatt et al. (US 7,772,541 B2, issued Aug. 10, 2010, hereinafter "Froggatt"), Barley et al. (US 2012/0105480 Al, published May 3, 2012, hereinafter "Barley"), and Ramamurthy et al. (US 2009/0137952 Al, published May 28, 2009, hereinafter "Ramamurthy"). Ans. 2- 7. 2 Appeal2018-004905 Application 13/817,263 II. Claims 4 and 10 stand rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Froggatt, Barley, Ramamurthy, and Laby et al. (US 2010/0099951 Al, published Apr. 22, 2010, hereinafter "Laby"). Ans. 7-8. DISCUSSION Rejection I Claims 1-3, 5, 6, 14, and 15 The Examiner's findings and reasoning in rejecting claim 1 is set forth on pages 2-6 of the Answer. In relevant part, the Examiner finds that Froggatt is silent with regard to generating an electroanatomic volumetric map of the intraluminal structure and an imaging enabled ablation device mounted at or near the end of the flexible instrument. Ans. 4 (reading the optical shape sensing device on multicore fiber 20, fiber Bragg gratings 50, and single core optical fibers 55, 57). The Examiner relies on Barley for these features. See Ans. 3--4. Froggatt discloses that optical fiber 20 "may be physically associated with an object[, such as a flexible medical instrument ( e.g., catheter),] e.g., it can be inserted into, affixed to, aligned with, conformed to or otherwise follow the object." Froggatt 10:21-25, 53-55; 14:59-15:5. However, to the extent that this disclosure may not be sufficient to establish that the optical sensing device (Froggatt's fiber 20 with fiber Bragg gratings 50) "is separate and discrete from the elongated flexible instrument," as recited in claim 1, the Examiner relies on the additional teachings of Ramamurthy. See Ans. 5. The Examiner determines that it would have been obvious to modify Froggatt' s apparatus to provide the optical fiber and the elongate flexible 3 Appeal2018-004905 Application 13/817,263 instrument (e.g., catheter) as separate and distinct elements in order to position the instrument to diagnose, treat, or ablate tissue and to provide accurate shape and/or position data of the elongate instrument, as taught by Ramamurthy. Id. at 5---6. Appellants argue that Froggatt is silent with respect to the optical fiber "being configured to collect anatomical information concerning an intraluminal structure based on a configuration of the elongated portion of the flexible instrument." Appeal Br. 9. Appellants contend that "Froggatt solely discloses determining the shape of the object that the optical fiber is physically associated with and not anatomical information concerning an intraluminal structure." Id. Appellants argue that the shape sensing device being configured to collect anatomical information concerning an intraluminal structure involves structural features which permit the device to collect anatomical information concerning an intraluminal structure based on a configuration of the elongated portion of the flexible instrument. These structural features include the optical shape sensing device being configured to be disposed within an elongated flexible instrument and the system including a structure which allows the elongated flexible instrument having an optical shape sensing device to be inserted into an intraluminal structure during the procedure and manipulated in a manner which determines anatomical information concerning the intraluminal structure based on the configuration of the elongated portion of the flexible instrument. Id. at 10-11. Froggatt' s optical sensing fiber 20 is provided with strain sensors (fiber Bragg gratings 50) that generate strain measurements, which are received by computer 90 from frequency domain reflectometer 70 and correlated into local bend measurements, which are then integrated into a 4 Appeal2018-004905 Application 13/817,263 position or shape to determine the shape of the flexible instrument (e.g., catheter) into which fiber 20 is inserted or which fiber 20 is conformed to follow. Froggatt 8:16-31; 10:8-55; 14:52-15:16. Further, the flexible instrument (e.g., catheter), with optical fiber 20 disposed therein, is designed to be inserted into an intraluminal structure, such as a colon, and can be manipulated within the intraluminal structure while strain measurements are collected and integrated into position and shape information. See id. 14:52- 15: 16. Thus, Froggatt's optical fiber 20, with strain sensing fiber Bragg gratings 50, appears to comprise all the structure required to satisfy the limitations of the "optical shape sensing device" recited in claim 1. Moreover, Froggatt's optical fiber 20, with fiber Bragg gratings 50, is substantially similar to the structure of Appellant's optical shape sensing device. See Spec. 4, 7 ( describing an "optical shape sensing setup" comprising optical fibers 152 configured with sensors 154, such as Fiber Bragg Gratings (FBGs)). Appellants argue that claim 1 "requires the system to 'generate an electroanatomic volumetric map of a three-dimensional region of the intraluminal structure during a procedure' based upon" the anatomical information "collected 'based on a configuration of an elongated portion of the flexible instrument."' Appeal Br. 12-13. We do not construe claim 1 as requiring that the system actually generate an electroanatomic volumetric map from the information collected, nor does claim 1 positively recite structure for actually performing this function. Rather, we construe claim 1 as requiring a shape sensing device for collecting the shape information that could then be used to generate the map. Claim 1 does not recite a processor for processing the shape information to generate the map. Compare Appeal 5 Appeal2018-004905 Application 13/817,263 Br. 19 (Claims App.) (claim 1), with id. at 20-21 (claim 7, reciting, in pertinent part, "an optical sensing device" and "a shape sensing module configured to receive the information collected by the shape sensing device and generate an electroanatomic volumetric map"). For the above reasons, Appellants do not apprise us of error in the rejection of claim 1, or claims 2, 3, 5, 6, 14, and 15, which depend from claim 1 and for which Appellants do not present any separate arguments. Claims 7-9 and 11-13 The Examiner's findings and reasoning in rejecting claim 7 are the same as those for claim 1. See Ans. 2---6. However, unlike claim 1, in addition to an optical shape sensing device configured to determine shape of an elongated portion of a flexible instrument and collect anatomical information based on a configuration of the elongated portion of the flexible instrument, claim 7 also recites "a shape sensing module configured to receive the information collected by the shape sensing device and generate an electroanatomic volumetric map of a three-dimensional region of the intraluminal structure." Appeal Br. 20-21 (Claims App.). Appellants argue that claim 7 "clearly positively recite[ s] the structural elements concerning generation of an electroanatomic volumetric map," and "[t]hese features are neither taught nor suggested by the cited references." Appeal Br. 16. The Examiner does not explicitly identify the structure in the cited references that corresponds to the claimed "shape sensing module," namely, structure configured to both receive the information collected by the shape sensing device and generate an electroanatomic volumetric map as claimed. The Examiner finds that Barley's "system would be at least capable of 6 Appeal2018-004905 Application 13/817,263 collecting the anatomical information based on the shape sensing to generate the electroanatomic map" and determines it would have been obvious to include in Froggatt "the generation of electroanatomic volumetric map" as taught by Barley. Ans. 3--4 ( citing Barley ,r 1 O); see also Barley ,r,r 4, 7-10 (teaching measuring electrical properties on an object to which energy is to be applied for generating an electroanatomic map of the object). However, the Examiner does not explicitly propose modifying the structure of Froggatt to configure it to receive the information collected by the shape sensing device of Froggatt and generate the map therefrom, much less explain why it would have been obvious to a person of ordinary skill in the art to do so, and it is not clear whether this is what the Examiner intends. Thus, the Examiner does not articulate with sufficient clarity the necessary findings and reasoning to establish that the subject matter of claim 7 would have been obvious. Accordingly, we do not sustain the rejection of claim 7 or claims 8, 9, and 11-13, which depend from claim 7. Rejection II Claim 4 In contesting the rejection of claim 4, Appellants rely on the arguments presented for claim 1, and assert that the Examiner's application of Laby does not cure the deficiencies in the rejection of claim 1. Appeal Br. 16-17. Appellants' arguments in contesting claim 1 fail to apprise us of error in the rejection of claim 1 and, likewise, fail to apprise us of error in the rejection of claim 4. Accordingly, we sustain the rejection of claim 4. 7 Appeal2018-004905 Application 13/817,263 Claim 10 The Examiner does not articulate any additional findings or reasoning in rejecting claim 10 to make up for the aforementioned deficiency in the findings and reasoning in regard to claim 7. See Ans. 7-8. Thus, we do not sustain the rejection of claim 10, which depends from claim 7. Appeal Br. 21 (Claims App.). DECISION The Examiner's decision rejecting claims 1---6, 14, and 15 is AFFIRMED. The Examiner's decision rejecting claims 7-13 is REVERSED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED-IN-PART 8