Ex Parte Wu et alDownload PDFPatent Trial and Appeal BoardOct 18, 201713974464 (P.T.A.B. Oct. 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. 13/974,464 08/23/2013 Yongjian Wu A13P3011 1309 24473 7590 Theresa Raymer Pacesetter, Inc. 3200 Lakeside Drive Bldg. B, 3rd Floor, M/S 314 Santa Clara, CA 95054 EXAMINER PORTER, JR, GARY A ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 10/20/2017 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): tray mer @ sj m. com jnewell@sjm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YONGIJAN WU, ERIC HUSKY, DAVID DOUDNA, CHAO-WEN YOUNG, MIN YANG, ROBERT ROMANO, TOMMY AKKILA, GORAN, BUDGIFVARS, and EDUARDO SERRANO Appeal 2016-006693 Application 13/974,4641 Technology Center 3700 Before TAWEN CHANG, TIMOTHY G. MAJORS, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to an implantable medical device (IMD) and a method of operating an IMD, which have been rejected as anticipated or obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant is the Applicant, Pacesetter, Inc., which, according to the Brief, is the Real Party in Interest. (Br. 3.) Appeal 2016-006693 Application 13/974,464 STATEMENT OF THE CASE Various IMDs are known that “are programmed and monitored by an external programmer or external home-based patient care system.” (Spec. 13.) “For example, a patient may have an IMD that communicates with a base station within the patient’s home or a programmer that is used by physicians to change settings within the IMD and/or retrieve data from the IMD.” (Id.) “Conventional external programmers and base stations employ inductive communication techniques that facilitate communication between the IMD and a telemetry wand that is operatively connected to the base station.” (Id. 14.) Appellant’s invention is directed to IMDs that communicate with an external device through radio frequency (RF) signals. (Spec. 11.) Claims 1—24 are on appeal. Claim 1 is representative and reads as follows: 1. An implantable medical device (IMD) configured to be implanted within a patient and communicate with an external device remote from the patient, the IMD comprising: a communication module configured to wirelessly communicate over an RF link with the external device; a therapy control module configured to deliver therapy to the patient, the therapy control module including a reprogrammable therapy logic circuit configured to operate the therapy control module in a reprogrammable mode of operation, and a base- therapy state machine (BTSM) logic circuit configured to operate the therapy control module in a base therapy mode of operation; a firmware control module including a central processing unit (CPU) and a memory; and 2 Appeal 2016-006693 Application 13/974,464 a service application stored in the memory, the firmware control module configured to launch the service application during which the BTSM logic circuit provides a base level of sensing and pacing therapy while the communications module in parallel maintains the RF link with the external device. (Appeal Br. 27—28.) The following grounds of rejection by the Examiner are before us on review: Claims 1—10, 12—15, and 17—24 under 35 U.S.C. § 102(b) as anticipated by Petersen.2 Claim 11 under 35 U.S.C. § 103 as unpatentable over Petersen and Masoud.3 Claim 16 under 35 U.S.C. § 103 as unpatentable over Petersen and Rueter.4 DISCUSSION Anticipation The Examiner finds Petersen discloses an IMD that includes a communication module that initiates a programming session, a therapy control module, and a processor that is programmed to operate the therapy control module in fail-safe mode when a programming or operational error is detected. (Final Action 6; Ans. 3.) The Examiner further finds that Petersen discloses IMD operation during fail-safe mode in which an RF link is maintained in parallel with the pre-programmed therapy instructions (i.e., 2 Petersen et al., US 2005/0049656 Al, published Mar. 3, 2005. 3 Masoud et al., US 2007/0239229 Al, published Oct. 11, 2007. 4 Rueter et al., US 2005/0021095 Al, published Jan. 27, 2005. 3 Appeal 2016-006693 Application 13/974,464 default therapy and sensing parameters stored in memory) being executed. (Final Action 6; Ans. 3 and 8—9.) According to the Examiner, Petersen teaches this link is maintained to enable (1) user notification by an external programmer, (2) receiving new programming instruction, and (3) fixing of the programming and/or operational error. (Id.) The Examiner explains that Petersen indicates that “the notification device 22 can be located in the IMD 12 or the [external] programmer 14 (par. [0034]).” (Ans. 11.) Thus, the Examiner concludes that, as to paragraph 37 of Petersen, when “the notification device 22 is indicated as capable of communicating via a wireless network, it is understood that device 22 is capable of the type of communication regardless of whether it is associated with [external] programmer 14 or IMD 12.” (Id. at 12.) The Examiner asserts that the last claim limitation does not [require] that a notification is provided at the same time that the IMD provides a base level of sensing and pacing therapy as presently claimed (emphasis added). Maintaining in parallel, as required by the claim, only requires that the RF link be usable while the IMD is operating according [to] base programming parameters. (Ans. 10; see also id. at 13.) The Examiner contends that this limitation is met because Petersen discloses changing therapy parameters in addition to sending out notifications via an RF link (par. [0040, 0043]). Petersen further discloses that the IMD can be further monitored once the new parameters are established (par. [0068], wherein the ways in which the IMD is monitored via RF telemetry are highlighted in par. [0037, 0050, 0053]. One example of note is found in par. [0050] in which IMD notes in a failure log an occurrence of a failure and then sends the log to a remote programmer, which can only be achieved via an RF 4 Appeal 2016-006693 Application 13/974,464 telemetry link since there is no direct connection between a device in the body and an external device outside of the body. (Ans. 10.; see also id. at 9 (noting Petersen teaches (a) the IMD can send electronic messages over a wireless network after a programming error (citing Petersen || 36, 37), (b) “in addition to sending Tsuchl a notification,” the IMD is instructed after the programming failure by a local programmer “to revert to a set of default parameters” (citing Petersen 140), and (c) the IMD “may be monitored again to detect an adverse event” (citing Petersen 1 68) (emphasis in the original)). Regarding the claimed logic circuits, the Examiner states that “one would understand that the processor 36 of Petersen, by virtue of the functions it performs according [to] the instructions stored therein, necessarily has the claimed hardware ‘circuits’, i.e. the control module, the reprogrammable logic circuit, the BTSM logic circuit and the service application.” (Final Action 3.) The Examiner explains further that “a processor is not a single circuit but a combination of circuits,” and that the “various substructures of a processor combine to execute instructions stored in memory, and in particular separate memory locations.” (Ans. at 13—14.) The Examiner finds that Petersen discloses that the IMD is reprogrammable with default and new value parameters and can operate in a default sensing and therapy mode, which functions are implemented via the processor. {Id.; see also Final Action 6 (“since the processor is programmed with instructions to perform the claimed functions, the processor necessarily has the hardware circuits for storing and implementing said instructions.”).) According to the Examiner, “[t]he combination of components in Fig. 3 of Petersen are tangible circuits that perform the claimed functions and 5 Appeal 2016-006693 Application 13/974,464 therefore anticipate the claimed invention.” (Ans. at 14.) In particular, the Examiner explains that In the Petersen reference, the execution of default program parameters stored in location 50 require separate circuit pathways than those required to execute new parameters in location 48 (Fig. 3). Therefore, location 50 can be considered part of the BTSM logic circuit since it contains the configuration to operate the IMD 12 in a default, i.e. base, therapy mode of operation as required by the claim. Likewise, location 48 can be considered part of the reprogrammable therapy logic circuit since it is a circuit component configured to operate the IMD in a reprogrammable mode of operation. {Id. at 14.) We agree with the Examiner’s factual findings and determination that claim 1 is anticipated. a) an IMD that provides a base level of sensing and pacing therapy while a communications module in parallel maintains an RF link In its Appeal Brief, Appellant acknowledges that “Peterson discloses that, in response to a programming session failure, a notification may be sent to an external device and the processor may load default programming parameters.” (Br. 17; see also Br. 19.) However, Appellant contends that the Examiner’s rejection is in error because the portions of Petersen relied upon by the Examiner do not disclose that “the notification is provided at the same time that the IMD provides a base level of sensing and pacing therapy.” {Id. at 17 (emphasis in the original).) According to Appellant, paragraphs 35—37 of Petersen “merely state that notification is provided in response to a programming failure. Such notification may be at a time before the IMD switches programming parameters.” {Id.; see also Br. 20 (“the notification may be provided and then the IMD may revert to default 6 Appeal 2016-006693 Application 13/974,464 parameters.”).) In other words, “the cited paragraphs do not teach or suggest an implantable medical device (IMD) that provides a base level of sensing and pacing therapy while a communications module of the IMD in parallel maintains the RF link with the external device.” (Id. at 19 (emphasis in the original).) Appellant argues that paragraphs 40 and 44 also fail to teach the foregoing. (Id. at 20-21.) Regarding paragraph 40, Appellant contends that Petersen does not state when IMD 12 actually reverts to a set of default parameters. Local programmer/monitor 14 may communicate instructions to IMD 12 to revert to a set of default parameters and a notification signal may be sent prior to IMD 12 reverting to a set of default parameters. Thus paragraph [0040] does not inherently or otherwise teach the claim limitations. (Id. at 21.) Regarding paragraph 44, Appellant agrees that “Petersen teaches . . . that local programmer/monitor 14 may be configured to deliver a therapy in response to an adverse event associated with remote programming and that delivering therapy to a patient may include therapy delivered via an IMD 12.” (Id.) However, Appellant contends Petersen does not disclose in paragraph [0044] that the therapy “provides a base level of sensing and pacing therapy.” Petersen teaches, for example, that local programmer/monitor 14 may provide defibrillation therapy via other devices—which is clearly not a base level of sensing and pacing therapy. Moreover, paragraph [0044] of Petersen does not disclose maintaining an RF link between the local programmer/monitor 14 and IMD 12 to deliver therapy—as opposed [to] an inductive link or other form of communication. Indeed, local programmer/monitor 14 may be communicating with IMD 12 through inductive telemetry, through a wand, and not an RF link. (Id. at 21—22 (emphasis in the original).) Moreover, argues Appellant, 7 Appeal 2016-006693 Application 13/974,464 paragraph [0044] of Petersen does not disclose that programmer/monitor 14 interrogates IMD 12, using an RF link or otherwise. Instead, paragraph [0044] teaches monitoring patient data, such as the patient’s electrocardiogram (ECG), using an automated external defibrillator (AED) 24 to determine whether IMD 12 is providing adequate therapy. Thus Petersen discloses that programmer/monitor 14 uses the patient’s ECG collected by the AED 24 to determine whether IMD 12 is working properly, and if not using the AED 24 to deliver the therapy. {Id. at 22.) Regarding paragraphs 50, 53, and 57, Appellant agrees that “Petersen states that default programming parameters are loaded if failure of the remote programming session is detected, and that notification of the programming failure may be sent,” and “failure log logs information concerning detection of adverse events associated with remote programming sessions.” {Id. at 18—19.) However, Appellant argues that Petersen “does not disclose or suggest a BTSM logic circuit that provides a base level of sensing and pacing therapy while the communications module in parallel maintains the RF link with the external device” because Petersen does not state that (1) “notification is provided at the same time that the IMD provides a base level of sensing and pacing therapy;” or (2) “the failure log is sent at a time when the IMD is providing a base level of sensing and pacing therapy.” {Id. (emphasis in the original).) Regarding the latter point, Appellant notes that “the failure log may be sent after, for example, inductive telemetry is used to reactivate communication, and the processor of the IMD is reset.” {Id. at 19.) Thus, Appellant contends that Peterson does not disclose that the 8 Appeal 2016-006693 Application 13/974,464 firmware control module is configured to launch the service application during the time the base-therapy state machine logic circuit of the therapy control module provides a base level of sensing and pacing therapy while the communications module in parallel maintains the RF link with the external device, as required by claim 1. We do not find Appellant’s arguments persuasive. We agree with the Examiner (Ans. 8—9) that Petersen discloses (1) at least through paragraphs 36 and 37, that IMD 12 contains a notification device 22 and that the notification device is able to send electronic messages via RF communication over a wireless network to external programmer 14 after a programming error; (2) that the RF telemetry link is maintained in parallel after the programming failure in light of Petersen’s teaching at paragraph 40 that, “in addition to” notification process, the local programmer 14 instructs the IMD 12 programming to revert to default parameters; and, (3) Petersen discloses at paragraph 68 that “monitoring the IMD for programming errors is an iterative process. . .,” which when read in conjunction with paragraph 40, provides that “the telemetry link used by the external programmer 14 is established with IMD 12 while IMD 12 is programmed with and operating according to stored program parameters” (Ans. 9). We also agree with the Examiner (Ans. 10) that “[mjaintaining in parallel, as required by the claim, only requires that the RF link be usable while the IMD is operating according to base programming parameters.” Thus, we also agree with the Examiner (Ans. 13) that “the determination of exactly when an active communication is sent in relation to the delivery of therapy is moot as the claims do not require such a feature. One can ‘maintain’ an RF link without actively communicating on said link.” 9 Appeal 2016-006693 Application 13/974,464 As the Examiner notes, Petersen highlights in paragraphs 37, 50 and 53, ways in which IMD is monitored via RF telemetry. The Examiner points out (Ans. 10-11), and we agree, Petersen does not disclose a “direct connection between a device in the body and an external device outside of the body,” but discloses that the “IMD notes in a failure log an occurrence of a failure and then sends the log to a remote programmer.” Accordingly, a skilled artisan would understand that the noting and sending process discussed above is achieved via an RF telemetry link. Appellant did not respond to the foregoing findings by the Examiner; that is, Appellant did not address the Examiner’s identification as to the interplay of paragraph 68 and the occurrence of base level sensing and pacing being carried on while the RF link is maintained and capable of being used for communication during that base level sensing and pacing. We agree with Appellant that anticipation requires the reference to disclose the claimed limitations as arranged in the claim. (Br. 10 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)).) However, in light of the unrebutted finding by the Examiner as to the interplay of the teaching of paragraph 68 of Petersen being an iterative process, and thus, the RF telemetry link being established while IMD 12 is programmed with and operating according to stored programming parameters, e.g., a base level, we find the Examiner has established Petersen teaches the requirement of claim 1 that an IMD includes a firmware control module configured to launch a service application stored in the memory during which the BTSM logic circuit provides a base level of sensing and pacing therapy “while a communications module of the IMD in parallel [with that activity] maintains the RF link with the external device.” 10 Appeal 2016-006693 Application 13/974,464 b) reprogrammable therapy logic and the base-therapy state machine logic circuit Appellant argues that “[t]he disclosure of processor 36 plus software would not be understood by a person of skill in the art to be ‘a reprogrammable logic circuit’ and a ‘base-therapy state machine logic circuit’ even if their functions could be integrated in a single module and combined in a single device, such as a single integrated circuit chip (as argued by the Examiner at pars. 8 and 9 of the final Office Action, dated March 24, 2015).” (Br. 24—25.) The Examiner, however, addresses Appellant’s argument finding that “when specification instructions are performed by the processor, a different combination of circuit components within said processor are used to implement the instruction, beginning with the unique memory location, which is made of a memory circuit called a register.” (Ans. 14.) The Examiner also notes “Appellant has not defined any specific or particular components that compose the claimed circuits and instead only describes them functionally. Therefore, the prior art need only disclose some form of circuit that performs the claimed function.” (Id.) The Examiner finds “[t]he combination of components in Fig. 3 of Petersen are tangible circuits that perform the claimed functions and therefore anticipate the claimed invention.” (Id.) In particular, the Examiner points out the execution of default program parameters stored in location 50 require separate circuit pathways than those required to execute new parameters in location 48 (Fig. 3). Therefore, location 50 can be considered part of the BTSM logic circuit since it contains the configuration to operate the IMD 12 in a default, i.e. base, therapy mode of operation as required by the claim. Likewise, location 48 can be considered part of the reprogrammable therapy logic circuit since it is a circuit 11 Appeal 2016-006693 Application 13/974,464 component configured to operate the IMD in a reprogrammable mode of operation. (Id. ) Appellant did not provide persuasive argument or evidence to the contrary. We accordingly agree with the Examiner’s finding that Petersen teaches the claimed circuitry. Thus, for the foregoing reasons, we affirm the Examiner’s rejection of claim 1 as being anticipated by Petersen. The Appellant’s arguments as to Examiner error with respect to claim 17 are the same as those for claim 1. (See, e.g., Br. 14 (“Petersen does not disclose an IMP that provides a base level of sensing and pacing therapy while a communications module in parallel maintains an RE link recited in claims 1 and 17”).) For the reasons discussed, we also affirm the Examiner’s rejection of claim 17 as being anticipated by Petersen. Claims 2—10, 12—15, and 18—24 have not been argued separately and therefore fall with claims 1 and 17. 37 C.F.R. § 41.37(c)(l)(iv). Obviousness The Examiner relies on Masoud for the limitations found in dependent claim 11 and Rueter for the limitations found in dependent claim 16. (Final Action 10—11.) Appellant does not dispute the Examiner’s findings with regard to Masoud or Rueter or the Examiner’s rationale for finding claim 11 obvious in light of the teachings of Petersen and Masoud and claim 16 obvious in light of the teachings of Petersen and Rueter. Rather, Appellant contends “[i[t is believed that the addition of Masoud and Rueter does not remedy the deficiency of rejection of independent claim 1.” (Br. 25.) Because we do not agree with Appellant that the Examiner’s anticipation 12 Appeal 2016-006693 Application 13/974,464 rejection is deficient, we also affirm the Examiner’s obviousness rejections of claims 11 and 16. SUMMARY We affirm the Examiner’s rejection of claims 1—10, 12—15, and 17—24 under 35 U.S.C. § 102(b) as anticipated by Petersen. We affirm the Examiner’s rejection of claim 11 under 35 U.S.C. § 103 as unpatentable over Petersen and Masoud. We affirm the Examiner’s rejection of claim 16 under 35 U.S.C. § 103 as unpatentable over Petersen and Rueter. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 13 Copy with citationCopy as parenthetical citation