St. Jude Medical, Atrial Fibrillation Division, Inc.Download PDFPatent Trials and Appeals BoardMar 31, 202014151273 - (D) (P.T.A.B. Mar. 31, 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. 14/151,273 01/09/2014 Riki Thao 0B-0479USC20/065513001365 4326 67337 7590 03/31/2020 DYKEMA GOSSETT PLLC (STJ) 4000 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402 EXAMINER ZINK, AMANDA L ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 03/31/2020 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): ASJM_Patents@abbott.com MN-IPMail@dykema.com Patents@dykema.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RIKI THAO and SAURAV PAUL Appeal 2019-005092 Application 14/151,273 Technology Center 3700 Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. STEPINA, 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 27–46. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 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 St. Jude Medical, Atrial Fibrillation Division, Inc. Appeal Br. 4. Appeal 2019-005092 Application 14/151,273 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to a system for assessing tissue contact for flexible tip devices. Claims 27, 41, and 46 are independent. Claim 27, reproduced below, is illustrative of the claimed subject matter: 27. A tissue contact sensing system comprising: a plurality of sensors extending in a direction coaxial to a central longitudinal axis of a shaft and offset within a tip of the shaft; and a signal processing device electrically connected to the sensors, the signal processing device configured to receive electrical signals from the plurality of sensors which are generated in response to contact stress of the tip, and assesses a direction of tissue contact on the tip based on the received electrical signals. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Wuchinich US 5,176,677 Jan. 5, 1993 Shapiro US 5,645,065 July 8, 1997 Fleischman US 6,241,724 B1 June 5, 2001 Jain US 2002/0123749 Al Sept. 5, 2002 REJECTIONS I. Claims 27, 32, 33, 35–41, 44 and 45 are rejected under 35 U.S.C. § 103(a) as unpatentable over Jain and Shapiro. II. Claims 28–31, 42, and 46 are rejected under 35 U.S.C. § 103(a) as unpatentable over Jain, Fleischman, and Shapiro. III. Claims 34 and 43 are rejected under 35 U.S.C. § 103(a) as unpatentable over Jain, Shapiro, and Wuchinich. Appeal 2019-005092 Application 14/151,273 3 OPINION Rejection I, Claims 27, 32, 33, 35–41, 44 and 45 The Examiner finds that Jain discloses a tissue contact sensing system having a plurality of sensors and a signal processing device that receives electrical signals from the sensors, but that Jain’s signal processing device does not assess a direction of tissue contact on the tip. Final Act. 2–3. The Examiner finds that Shapiro discloses a system that can determined the orientation and position of a catheter. Id. at 3. The Examiner considers that it would have been obvious to modify Jain to use “an additional system of determining direction of the catheter when in tissue as taught by Shapiro.” Id. The Examiner concludes that the modified Jain “would allow for accurate placement of a catheter without the use of external imaging such as x rays which expose the physician needlessly to added radiation.” Id. Appellant argues, inter alia, that “Shapiro generally teaches a catheter localization system which relies-upon magnetic signals to determine a position of a catheter tip within space.” Appeal Br. 8. According to Appellant, “Shapiro does not appear to provide any teaching as to how these magnetic signals, which are entirely unrelated to a (non-)contact state between the tissue and catheter tip, could be used to determine tissue contact, let alone direction of tissue contact, as claimed.” Id. at 8–9. In response, the Examiner disagrees with Appellant’s assertion and states that Jain’s system “can determine which electrodes are in contact with tissue along the length of the distal tip and can deduce information regarding the direction by knowing which electrodes are in contact and which electrodes lack contact, and as broadly claimed by the appellant, could assess a direction of tissue contact.” Ans. 9. The Examiner states that Appeal 2019-005092 Application 14/151,273 4 Shapiro teaches using sensors to indicate the direction or orientation of a catheter, and that the combined teachings of Jain and Shapiro would “meet the limitation of ‘assesses a direction of tissue contact on the tip based on the received signals.’” Ans. 10. Appellant replies that the Examiner does not explain how Shapiro’s “sensing the orientation of the device” is the same as the claimed “assess[ing] a direction of tissue contact on the tip.” Reply Br. 4. Appellant contends that, although Shapiro senses, for example, a vertical orientation of the device, it does not determine whether the vertically orientated device is in contact with tissue, or a direction of tissue contact. Id. Appellant has the better position. Claim 27 requires that electrical signals from the plurality of sensors, generated in response to contact stress of the tip, are used to determine a direction of tissue contact on the tip. The Specification discloses that “piezoelectric sensors 320a-c respond to mechanical stresses by generating electrical energy (e.g., a voltage),” i.e., the claimed electrical signal. Spec. ¶ 65. “In addition to detecting tissue contact, the relative magnitude and direction of the signal obtained from each of the separate piezoelectric sensors 320a-c may be used to determine the direction and plane of contact of the flexible tip device 310.” Id. Thus, the signal from the sensor itself determines “a direction of tissue contact.” As the Examiner correctly notes, Jain’s signal processing device “can analyze the signals received by the sensors in order to determine a degree of confidence of tissue contact along the length of the catheter. The system of Jain can determine which electrodes are in contact with tissue along the length of the distal tip.” Ans. 9. Specifically, in Jain, a linear array of electrodes A–F are used, beginning “with electrode A and continuing in Appeal 2019-005092 Application 14/151,273 5 sequence though electrode F, the pressure exerted on each electrode 50 is measured and compared to the reference pressure to assess electrode/tissue contact adequacy.” Jain ¶ 74. The Examiner does not explain, however, how using such a system, Jain “can deduce information regarding the direction by knowing which electrodes are in contact and which electrodes lack contact, and as broadly claimed by the appellant, could assess a direction of tissue contact.” Indeed, the Examiner’s reasoning to use Shapiro is to “allow for accurate placement of a catheter without the use of external imaging.” Final Act. 3. If Jain’s system were able to “deduce information regarding the direction” and “could assess a direction of tissue contact,” Jain would be anticipatory and would not require external imaging. Nor does the Examiner explain adequately how the addition of Shapiro cures Jain’s inability to assess direction. As Appellant correctly notes, “Shapiro generally teaches a catheter localization system which relies- upon magnetic signals to determine a position of a catheter tip within space.” Appeal Br. 8. Notwithstanding that Shapiro’s system requires an external magnetic system as opposed to an external imaging system, the Examiner does not explain adequately how the combined teachings of the references would assess a direction of tissue contact on the tip based on the received signals. An exemplary external sensing system of Shapiro is depicted in Figure 4A, reproduced below. Appeal 2019-005092 Application 14/151,273 6 Figure 4A is a cross sectional, schematic view of a catheter and one embodiment of the external probe of this invention that uses a vertically- oriented output coil. Shapiro, 5:46–48. As seen in Figure 4A, Shapiro’s “[s]ystem 10 includes an external probe which includes pair 12 of perpendicular electromagnetic output coils … moved over skin 7 to detect the depth of, and angular orientation of, inductive sensor coil 30 carried by and proximate the distal end of catheter 9 located under skin 7.” Id. at 6:29–36. In Shapiro, “electromagnetic fields generated from coil pair 12 penetrate skin 7 and induce voltages in sensor coil 30. These induced signals are … digitized by analog-to-digital (AID) converter 48. Id. at 6:44–50. “The digitized signals are provided to microprocessor 50, which determines from these signals, and the drive Appeal 2019-005092 Application 14/151,273 7 signals provided to coil drive voltage generator 2 … the direction D (called the ‘true direction’) in which the distal end of catheter 9 is pointing.” Id. at 6:51–56. Thus, although we appreciate that Jain determines contact and Shapiro determines direction, we agree with Appellant that this is not the same as “assessing a direction of tissue contact on the tip based on the received electrical signals.” Reply Br. 4. The Examiner does not explain sufficiently how the combination would allow a signal from Jain’s sensors to determine direction of tissue contact. Specifically, the combined teachings of Jain and Shapiro separately determine whether there is contact, using the sensors on the distal end of Jain’s catheter, and then separately determine which direction the distal end is pointing using Shapiro’s external probe. Such a combination requires a signal indicating contact and a separate induced signal indicating direction. By contrast, claim 27 assesses a direction of tissue contact on the tip based on the received electrical signals generated in response to contact stress of the tip. Accordingly, Appellant's argument on this point is persuasive, and we do not sustain the rejection of claim 27 and associated dependent claims 32, 33, and 35–40 as unpatentable over Jain and Shapiro. We do not sustain the rejection of independent claim 41, and claims 44 and 45, which depend from claim 41, as unpatentable over Jain and Shapiro for the same reasons. Rejection II; Claims 28–31, 42, and 46 Claims 28–31 depend from claim 27, and claim 42 depends from claim 41. The Examiner does not rely on Fleischman in any way that would remedy the deficiency in Rejection I discussed above. See Final Act. 6–7. Appeal 2019-005092 Application 14/151,273 8 Accordingly, we do not sustain the rejection of claims 28–31 and 42 as unpatentable over Jain, Fleischman, and Shapiro for the same reasons. Similar to claim 27, independent claim 46 requires a “plurality of sensors generating electrical signals generated in response to contact stress of the tip to detect at least one of axial stress, angular stress, and radial stress indicative of a direction of tissue contact on the tip.” See Appeal Br. 21 (Claims App.). The Examiner makes the same findings as to Jain and Shapiro, and relies on the reasoning that the combined teachings of Jain and Shapiro would determine a direction of tissue contact. Final Act. 7. The Examiner does not rely on Fleischman in any way that would remedy the deficiency of the combination of Jain and Shapiro, discussed above. For the same reasons as discussed in Rejection I, we do not sustain the rejection of claim 46 as unpatentable over Jain, Fleischman, and Shapiro. Rejection III; Claims 34 and 43 The Examiner does not rely on Wuchinich in any way that would remedy the deficiency in Rejection I discussed above. See Final Act. 7–8. Accordingly, we do not sustain the rejection of claims 34 and 43 as unpatentable over Jain, Shapiro, and Wuchinich for the same reasons. Appeal 2019-005092 Application 14/151,273 9 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 27, 32, 33, 35–41, 44, 45 103(a) Jain, Shapiro 27, 32, 33, 35–41, 44, 45 28–31, 42, 46 103(a) Jain, Fleischman, Shapiro 28–31, 42, 46 34, 43 103(a) Jain, Shapiro, Wuchinich 34, 43 Overall Outcome: 27–46 REVERSED Copy with citationCopy as parenthetical citation