Medtronic, Inc.Download PDFPatent Trials and Appeals BoardSep 15, 20212020003892 (P.T.A.B. Sep. 15, 2021) 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. 14/920,363 10/22/2015 Xin Su 4944.358US01 8764 145379 7590 09/15/2021 PATTERSON THUENTE PEDERSEN, P.A. 80 South Eighth Street 4800 IDS Center Minneapolis, MN 55402 EXAMINER MELHUS, BENJAMIN S ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 09/15/2021 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): efsuspto@ptslaw.com rs.patents.two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte XIN SU, TIMOTHY J. DENISON, and BRETT KNAPPE ____________ Appeal 2020-003892 Application 14/920,363 Technology Center 3700 ____________ Before PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and TARA L. HUTCHINGS, Administrative Patent Judges. HUTCHINGS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s rejection of claims 11–28, which are all of the pending claims.2 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Medtronic, Inc. as the real party in interest. Appeal Br. 2. 2 Claims 1–10 have been withdrawn from consideration. See Appeal Br. 25– 27 (Claims Appendix). Appeal 2020-003892 Application 14/920,363 2 CLAIMED INVENTON Appellant’s invention “is directed to acoustic sensing.” Spec. ¶ 2. In particular, Appellant’s invention monitors one or more acoustic signals to detect a medical condition and tracks the status or progression of a patient disease state. Id. ¶ 4. The manner in which the system monitors the one or more acoustic signals is configured based on a patient prescription established by a caregiver. Id. Claims 11 and 23 are the independent claims on appeal. Claim 11, reproduced below, is representative of the claimed subject matter: 11. A medical device system comprising: an implantable telemetry module configured to receive a patient prescription comprising information related to a selection of at least one acoustic sensing program to be performed for a patient based on a disease state of the patient; an acoustic sensor configured to sense an acoustic signal; and a processor configured to: select the at least one acoustic sensing program from a plurality of acoustic sensing programs based upon the information regarding the disease state of the patient as received in the patient prescription, each selected at least one acoustic sensing program of the plurality of acoustic sensing programs associated with detection of at least one characteristic of the sensed acoustic signal associated with the disease state of the patient; set at least one patient specific threshold for the at least one characteristic of the sensed acoustic signal based on the patient prescription, wherein the patient specific threshold corresponds to a change in the disease state of the patient; receive the sensed acoustic signal from the acoustic sensor; Appeal 2020-003892 Application 14/920,363 3 analyze the sensed acoustic signal using the selected acoustic sensing program to detect a presence of the at least one characteristic in the sensed acoustic signal; and generate an indication associated with the disease state of the patient based on a comparison of the at least one characteristic of the sensed acoustic signal and the patient specific threshold. Appeal Br. 27–28 (Claims Appendix). REJECTION Claims 11–27 are rejected under 35 U.S.C. § 103 as unpatentable over Thompson (US 2008/0294209 A1, pub. Nov. 27, 2008) and Thiagarajan (US 2008/0273709 A1, pub. Nov. 6, 2008). Claim 28 is rejected under 35 U.S.C. § 103 as unpatentable over Thompson, Thiagarajan, Gerber (US 2008/0300651 A1, pub. Dec. 4, 2008) and Huiku (US 2010/0081942 A1, pub. Apr. 1, 2010). ANALYSIS We are persuaded that the Examiner erred in rejecting claims 11 and 23 under 35 U.S.C. § 103, at least because the combination of Thompson and Thiagarajan does not teach or suggest a processor configured to select the at least one acoustic sensing program from a plurality of acoustic sensing programs based upon the information regarding the disease state of the patient as received in the patient prescription, each selected at least one acoustic sensing program of the plurality of acoustic sensing programs associated with detection of at least one characteristic of the sensed acoustic signal associated with the disease state of the patient[,] as recited in claim 11, and similarly recited in claim 23. Appeal Br. 17–22; see also Reply Br. 3–5. In rejecting independent claims 11 and 23 under 35 Appeal 2020-003892 Application 14/920,363 4 U.S.C. § 103, the Examiner relies primarily on Thompson as teaching the claimed controller functionality. See Final Act. 4–6, 8–10. Thompson relates to using sensor data acquired from an implantable medical device to determine if a target level of therapy benefit has been achieved. Thompson ¶ 1. A heart failure patient’s response to decongestive therapy is assessed to balance the therapeutic need for fluid removal during acute decongestion against the potential risks associated with over-diuresis. Id. ¶ 26. Specifically, Thompson uses a relationship between sensor data and a threshold to determine whether a target level of patient diuresis is achieved. Id. ¶ 36. The physiological sensor data includes data developed using a wide range of sensors, such as implantable device-based sensors and sensors for obtaining heart sounds. Id. ¶ 38. Physiologic sensor data is monitored to determine if a threshold representing an optimal or desirable level of therapy has been met. Id. ¶ 39. Data from multiple sensors of different types may be monitored. Id. ¶ 40; see also id. ¶ 61 (describing the use of a motion sensor for sensing patient activity and respiration and cardiac related conditions). Signals indicative of a patient’s heart failure status and diuresis may take several forms, including electrical, electromagnetic, optical, or acoustic signals. Id. ¶ 44. The Examiner acknowledges that Thompson does not teach the argued limitation, and relies on Thiagarajan to cure the deficiency. See id. Final Act. 5–6 (citing Thiagarajan ¶¶ 9–16, 50–77), 10. Thiagarajan relates to tuning, analyzing, and displaying heart sounds. Thiagarajan ¶ 9. A heart sounds transducer of a tunable auscultation system senses heart sounds from a chest location of a patient. Id. ¶ 10. The heart sounds pass through a Appeal 2020-003892 Application 14/920,363 5 preconditioning circuit and then to an analysis tool, which filters frequencies of the heart sounds to extract segments of interest. See id. ¶¶ 10–14. For example, a traditional, acoustic Bell/Diaphragm head stethoscope has two opposing sensors, a Bell-side sensor and a Diaphragm-side sensor. Id. ¶¶ 51, 57. In one embodiment, device 100 asks a user whether device 100 should sense in Bell mode, Diaphragm mode, or another filter preset mode. Id. ¶ 64. In another embodiment, rather than a user selecting a mode, device 100 selects a default mode by sensing whether a Bell side sensor or Diaphragm side sensor of the Bell/Diaphragm head stethoscope is touching the chest wall of the patient. Id. ¶ 57; see also id. ¶ 55 (describing that decomposition of heart sound signals using a Diaphragm mode captures heart sound signals in the complete range of Diaphragm frequencies; whereas, decomposition of heart sound signals using a Bell mode captures heart sound signals in the complete range of Bell frequencies). The Examiner finds that selecting an acoustic sensing mode from a plurality of modes based upon a user’s input commands, as disclosed by Thiagarajan, teaches the claimed selecting step, as recited in claim 11, and similarly recited in claim 23. Final Act. 6, 10. Further, the Examiner reasons that it would have been obvious to an ordinarily skilled artisan to modify Thompson’s telemetry module to incorporate Thiagarajan’s sensing mode selection “to help distinguish sounds of interest from signal noise” and to “include multiple modes of operation (i.e. sensing programs) familiar to physicians (i.e. Bell mode and Diaphragm mode).” Id. at 6 (citing Thiagarajan ¶¶3, 51), 10. Yet, Thiagarajan does not teach or suggest that the selection of a Bell mode or Diaphragm mode is “based upon the information regarding the disease state of the patient as received in the patient Appeal 2020-003892 Application 14/920,363 6 prescription” or that each selected mode is “associated with detection of at least one characteristic of the sensed acoustic signal associated with the disease state of the patient,” as required by claim 11, and similarly required by claim 23. Further, it is unclear why or how Thiagarajan’s disclosure of operating a Bell/Diaphragm stethoscope by selecting a Bell or Diaphragm mode would teach or suggest one of ordinary skill in the art to modify Thompson’s method for assessing a heart failure patient’s response to therapy by configuring the processor to arrive at these missing claim limitations. For at least the above reasons, we do not sustain the rejection of claims 11 and 23, and dependent claims 12–22 and 24–27 under 35 U.S.C. § 103 as unpatentable over Thompson and Thiagarajan. The Examiner’s rejection of claim 28 under 35 U.S.C. § 103 as unpatentable over Thompson, Thiagarajan, Gerber, and Huiku does not cure the deficiency in the Examiner’s rejection of independent claim 11 under 35 U.S.C. § 103. See Final Act. 11–12. Therefore, we do not sustain the rejection of claim 28 under 35 U.S.C. § 103 for the same reasons set forth above with respect to independent claim 11. Appeal 2020-003892 Application 14/920,363 7 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Basis/References Affirmed Reversed 11–27 103 Thompson, Thiagarajan 11–27 28 103 Thompson, Thiagarajan, Gerber, Huiku 28 Overall Outcome 11–28 REVERSED Copy with citationCopy as parenthetical citation