Ex Parte GundersonDownload PDFPatent Trial and Appeal BoardMay 25, 201612180911 (P.T.A.B. May. 25, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/180,911 07/28/2008 27581 7590 05/27/2016 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 FIRST NAMED INVENTOR Bruce D. Gunderson 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. P0021112.00/llll-040US01 1962 EXAMINER BERTRAM, ERIC D ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 05/27/2016 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): medtronic_crdm_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRUCE D. GUNDERSON Appeal2014-002747 Application 12/180,911 Technology Center 3700 Before STEFAN STAICOVICI, GEORGE R. HOSKINS, and BRANDON J. WARNER, Administrative Patent Judges. HOSKINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Bruce D. Gunderson ("Appellant")1 appeals under 35 U.S.C. § 134 from the Examiner's final decision rejecting, under 35 U.S.C. § 103(a), claims 11-13 and 15-23 as unpatentable over Schuelke (US 5,755,742, iss. May 26, 1998) and Gunderson (US 5, 776,168, iss. July 7, 1998), and claim 14 as unpatentable over Schuelke, Gunderson, and Krause (US 2008/0300497 Al, pub. Dec. 4, 2008). The Board has jurisdiction over the appeal under 35 U.S.C. § 6(b). 1 The Appeal Brief identifies Medtronic, Inc. as the real party in interest. Appeal Br. 3. Appeal2014-002747 Application 12/180,911 SUMMARY OF DECISION We AFFIRM-IN-PART and designate the affirmance as a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). CLAIMED SUBJECT MATTER Claim 11 is the sole independent claim, and it recites: 11. A system comprising: an implantable medical lead comprising one or more electrodes; an implantable medical device (IMD) coupled to the lead that senses a physiological signal of a patient via the electrodes; and a processor configured to: detect saturation of the signal; and control the IMD to perform a lead impedance measurement of the implantable medical lead in response to the detection. Appeal Br. 14 (Claims App.). ANALYSIS A. Unpatentability based on Schuelke and Gunderson Claims 11-13, 16, and 19-23 Appellant argues for the patentability of claims 11-13, 16, and 19-23 together in one group. Appeal Br. 5-8. We select claim 11 to decide the appeal as to the rejection of these claims, with the other claims standing or failing with claim 11. 37 C.F.R. § 41.37(c)(l)(iv). Concerning claim 11, the Examiner finds Schuelke discloses an IMD coupled to a lead of electrodes and sensing a physiological signal of a patient 2 Appeal2014-002747 Application 12/180,911 via the electrodes. Final Act. 3--4. The Examiner further finds Schuelke discloses a processor to perform a lead impedance measurement in response to a programmed interval, to detect and/or prevent possible lead fractures. Id. at 4. However, the Examiner finds "Schuelke is silent as to detecting saturation of the physiological signal" from the lead, and performing a lead impedance measurement in response to the detected saturation, as recited in claim 11. Id. The Examiner finds Gunderson discloses "saturation of a cardiac electrogram signal may occur from artifacts generated by movement of a fracture in a pacing lead," which can be detected when the signal crosses a threshold. Final Act. 4 (citing Gunderson, Fig. 1 ); Ans. 3--4 (citing Gunderson, 2:40-67). The Examiner determines it would have been obvious to program Schuelke to perform lead integrity tests in response to saturation detection, to help ensure detection of lead fractures. Final Act. 4. According to the Examiner, this combination would have predictably resulted in an improved device for detecting and/ or preventing lead fractures, thus protecting the patient. Id. Appellant traverses the Examiner's rejection on the basis that Schuelke discloses initiating lead integrity tests only "at a specified time each day or other interval or upon receipt of a programmed-in command," or "on a regular basis." Appeal Br. 6-7 (quoting Schuelke, 19:43-52, 4:35- 41 ). Appellant relatedly asserts Schuelke does not teach the lead impedance testing interval being something other than a predetermined interval, or initiating lead impedance testing in response to a detected event such as signal saturation. Id. at 7. 3 Appeal2014-002747 Application 12/180,911 These arguments are not persuasive of Examiner error, because the rejection is premised on Schuelke failing to disclose what Appellant argues Schuelke does not disclose. Ans. 5. That is, the Examiner does not find Schuelke discloses initiating lead impedance testing in response to a detected event, such as signal saturation. Final Act. 3--4; Ans. 5. Rather, the Examiner determines it would have been obvious to modify Schuelke' s system to do that, in light of Gunderson. Final Act. 4; Ans. 5. Appellant also argues "nothing in either reference suggests that there would be any benefit from or reason for measuring impedance when signal saturation occurs." Appeal Br. 7 (emphasis added); Reply Br. 2-3. Appellant particularly contends "neither Schuelke nor Gunderson suggests that measuring impedance in response to signal saturation would facilitate detection of lead fracture." Appeal Br. 7 (emphasis added). Therefore, according to Appellant, a person of ordinary skill in the art would not modify Schuelke' s predetermined interval testing to be based on detection of saturated lead signals, in light of Gunderson. These arguments are not convincing because they attack Schuelke and Gunderson individually, rather than in combination. Nonobviousness cannot be established by attacking the references individually when the rejection is predicated upon a combination of prior art disclosures. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The Examiner cites Schuelke as disclosing the testing of IMD electrode lead impedance, at predetermined regular intervals, to determine whether a lead integrity failure has occurred. Final Act. 3--4; Schuelke, Abstract, 13:66-14:5, 19:43--46. The Examiner cites Gunderson as disclosing a saturated electrode lead signal, illustrated in Gunderson's Figure 1, which may be "generated by 4 Appeal2014-002747 Application 12/180,911 movement of a fracture in a pacing lead." Final Act. 4; Ans. 6; Gunderson, Fig. 1, 7:23-57. We agree with the Examiner's determination that the combination of these disclosures would have led a person of ordinary skill in the art to modify Schuelke to monitor for signal saturation and, in response to detecting signal saturation, perform an electrode lead impedance test to determine whether a lead integrity failure caused the detected signal saturation. "A person of ordinary skill is also a person of ordinary creativity, not an automaton." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Further, Appellant's suggestion that the cited prior art must itself provide a teaching, suggestion, or motivation to combine the prior art has been rejected by the Supreme Court. Id. at 407, 415 (rejecting "rigid" TSM test in favor of "an expansive and flexible approach"). Appellant further argues Gunderson teaches away from using electrode lead impedance tests as a means of determining lead integrity in response to signal saturation. Appeal Br. 7-8 (citing Gunderson, 2:29- 3:39). According to Appellant, Gunderson indicates lead impedance testing should be performed at regular intervals independent of pacing events, in order to avoid missing a test due to suspension of pacing activity during an oversense event. Id. (citing Gunderson, 3 :27-39). Further according to Appellant, Gunderson states lead impedance testing may prove inconclusive in determining the existence of a lead integrity failure, due to sense amplifier problems and response to electromagnetic interference as possible other causes of oversense events. Id. at 8 (citing Gunderson, 4:6-7, 4:33-36). Appellant moreover asserts Gunderson discloses a method of lead integrity testing that is "alternative" to lead impedance testing. Id. 5 Appeal2014-002747 Application 12/180,911 We are not persuaded Gunderson teaches away from the invention of claim 11. To teach away, a reference must actually criticize, discredit, or otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). At most, Gunderson suggests there are conditions under which lead impedance testing may prove inconclusive (Gunderson, 4:6-7, 4:33-36), but that suggestion does not criticize or discourage using electrode lead impedance measurements when such conditions are not present. Indeed, Gunderson discloses lead impedance testing can in some cases be advantageous. See Gunderson, 3:28-39 (stating it is "preferred" to conduct lead integrity tests "at regular intervals"). For the foregoing reasons, we sustain the rejection of claims 11-13, 16, and 19-23 as unpatentable over Schuelke and Gunderson. Claim 15 Appellant argues for the patentability of claim 15 separately from its parent claim 11. Appeal Br. 8-10. Claim 15 recites "the processor is configured to determine whether the signal is saturated for at least one of a threshold duration or a threshold number of samples." Id. at 15 (Claims App.). Appellant argues the Examiner errs in finding Gunderson discloses that subject matter. Id. at 9. This argument is persuasive. The Final Office Action groups claim 15 together with several other claims, and fails to address the specific subject matter of claim 15. Final Act. 3--4. The Answer adds "in order for saturation to be detected, there must inherently be an occurrence of saturation that occurs for a duration of time." Ans. 6. While factually accurate, that statement fails to address the claim requirement for "determin[ing] whether the signal is saturated for ... 6 Appeal2014-002747 Application 12/180,911 a threshold duration" (emphasis added). Therefore, we do not sustain the rejection of claim 15 as unpatentable over Schuelke and Gunderson. Claim 17 Appellant argues for the patentability of claim 17 separately from its parent claim 11. Appeal Br. 10-11. Claim 1 7 recites "wherein the IMD comprises a clamp circuit that clamps the signal and provides an indication when the signal is clamped, and wherein the processor is configured to detect saturation of the signal based on the indication." Id. at 15 (Claims App.). Appellant argues the Examiner errs in finding Gunderson's Figure 1 discloses that subject matter. Appeal Br. 10. This argument is persuasive. The Examiner finds Gunderson's Figure 1 "clearly shows an indication of voltage clamped at a max voltage, i.e., where the signal maxes and levels off." Ans. 6. The Examiner also finds "the processing circuitry of Gunderson is necessarily clamping the displayed voltage at that level, and is properly classified as 'clamping circuitry'" as claimed. Id. Further according to the Examiner, Gunderson's circuitry "provides an indication when the signal is clamped," as claimed, as "indicated by the flat part of the signal in the EGM display in" Figure 1. Id. The Examiner apparently relies on the flat-line peaks and troughs in the "Near-Field EGM" signal illustrated in Gunderson's Figure 1 as necessarily being caused by a clamping of that signal by a clamping circuit. However, even if that finding of inherency is correct, claim 17 further requires that the processor is "configured to detect" signal saturations "based on" an indication that a signal has been clamped. Merely displaying the results of a clamped signal does not disclose that claim requirement. 7 Appeal2014-002747 Application 12/180,911 Therefore, we do not sustain the rejection of claim 17 as unpatentable over Schuelke and Gunderson. Claim 18 Appellant argues for the patentability of claim 18 separately from its parent claim 11. Appeal Br. 11-12. Claim 18 recites "wherein the processor is configured to control the IMD to perform the integrity test during the saturation of the signal." Id. at 15 (Claims App.). Appellant argues neither Schuelke nor Gunderson "suggest[ s] that measuring impedance during signal saturation would facilitate detection of lead fracture, e.g., the impedance values measured during signal saturation would be indicative of lead fracture or would allow lead fracture to be discerned." Appeal Br. 11. Appellant also contends "the Examiner failed to assert" either Schuelke or Gunderson "discloses or suggests performing the integrity test during the saturation of the signal, or how such a test would be [performed]." Id. Further, in Appellant's view, "any discussion regarding claim 18 in the Examiner's Answer would constitute a new rejection." Id. The Final Office Action groups claim 18 together with several other claims, and fails to address the specific subject matter of claim 18. Final Act. 3--4. However, the Answer adds "it would have at least been obvious to perform the integrity test during saturation, since saturation is the indicator of a lead integrity problem," and "[t]esting while the signal is not saturated would not make sense, as the lack of saturation is not an indicator of lead fracture." Ans. 6-7. We agree with the analysis provided in the Answer, which Appellant fails to address in the Reply Brief. Based on the Answer's analysis, we sustain the rejection of claim 18 as unpatentable over Schuelke and 8 Appeal2014-002747 Application 12/180,911 Gunderson. However, we agree with Appellant that the Answer's analysis constitutes a new ground of rejection, so we denominate our affirmance as a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). B. Unpatentability based on Schuelke, Gunderson, and Krause Appellant argues claim 14 is distinguished from Schuelke, Gunderson, and Krause by reciting an analog-to-digital converter that digitizes the signal, wherein the processor is configured to compare an amplitude of the digitized signal to a threshold to detect saturation of the signal. Appeal Br. 12. Appellant then summarizes the Examiner's rejection, and states simply that Appellant "disagrees." Id. The rejection of claim 14 finds Krause "discloses that detecting an over range signal (of which saturation is, by definition) can be done by comparing an amplitude from an ADC to a threshold (see claim 24)." Final Act. 5; see also Krause, Fig. 5, i-f 42 (discussing AID converter 37). The Examiner determines it would have been obvious "to substitute the saturation detection method of Krause for that of Schuelke and Gunderson to achieve the predictable result of detecting saturation of a signal." Final Act. 5. The conclusory nature of Appellant's argument fails to apprise us of error in the Examiner's findings of fact and conclusions of law as to the obviousness of claim 14. Therefore, we sustain the rejection of claim 14 as unpatentable over Schuelke, Gunderson, and Krause. DECISION The rejection of claims 11-13 and 15-23 as unpatentable over Schuelke and Gunderson is affirmed as to claims 11-13, 16, and 18-23, and reversed as to claims 15 and 1 7. For the reasons discussed above, we 9 Appeal2014-002747 Application 12/180,911 denominate our atlirmance of claim 18 as a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure§ 1214.01. The rejection of claim 14 as unpatentable over Schuelke, Gunderson, and Krause is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b) 10 Copy with citationCopy as parenthetical citation