DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed November 21, 2025 has been entered. Claims 1-2, 5-6, 11, 15-16, 18, 25 have been amended. Currently, claims 1-25 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed November 21, 2025, with respect to the rejection(s) of claim(s) 1-25 under 35 U.S.C. 102 and/or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gunderson et al. (US 2014/0350621).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 9, 15-17, 20 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Gunderson et al. (US 2014/0350621).
Regarding claims 1 and 15, Gunderson et al. discloses a method and an implantable medical device (IMD) 10 configured to be coupled to at least one implantable medical lead 14, 16, 18 (fig. 1), wherein the IMD comprises: sensing circuitry 102 configured to sense an electrogram (EGM) signal of a patient via at least one electrode 20-42 of the implantable medical lead (fig. 2); impedance measurement circuitry 105 to measure impedance via the implantable medical lead ([0038]); and a processor 112 configured, in response to coupling of the IMD to the at least one implantable medical lead, to initiate a device test sequence comprising a plurality of qualification tests over an evaluation period in which the processor: (1) controls the impedance measurement circuitry to measure an impedance 808 (fig. 11) for at least one electrical path that includes the at least one electrode to determine a connection status of the IMD to the at least one electrode ([0038]); and (2) in response to a determination that the connection status indicates the IMD is connected to the at least one electrode (“a lead impedance measurement performed at block 808 may trigger lead monitoring” [0111]), compares amplitudes of the EGM signal over an EGM test period against a predetermined threshold 812 (fig. 11; [0112-0114]).
Regarding claims 2 and 16, Gunderson et al. discloses wherein the processor controls the sensing circuitry to measure current of injury (COI) parameters in the EGM signal ([0059], [0062], [0112-0114], [0116]) in response to a determination that the connection status indicates the IMD is connected to the at least one electrode ([0038], [0111]).
Regarding claims 3 and 17, Gunderson et al. discloses wherein the current of injury (COI) parameters include one or more of a maximum amplitude of an ST segment, an amplitude of the ST segment 80 milliseconds from a beginning of the segment, an area under a wave curve from an R-wave starting to the end of the ST segment, an area under the ST segment, an amplitude at a start of the ST segment, median and quartile amplitudes of the EGM following the ST segment, an amplitude of the R-wave ([0116]), a duration of the ST segment, a duration of the signal (QT), a ratio of the amplitude of the R-wave to maximum amplitude of ST segment, or a ratio of the amplitude of the R-wave to amplitude of ST segment 80 ms from start.
Regarding claim 4, Gunderson et al. discloses wherein the processor controls the sensing circuitry to measure the COI parameters in parallel with qualification test (2) ([0059], [0062], [0112-0114], [0116]).
Regarding claims 9 and 20, Gunderson et al. discloses the device test sequence further comprises a qualification test (3) in which the processor controls the signal generator and the sensing circuitry to determine whether a pacing capture threshold (PCT) satisfies one or more criterial ([0038]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5-6, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Swerdlow et al. (US 2012/0191153).
Regarding claims 5, 18, Gunderson et al. does not expressly disclose the processor automatically initiates the device test sequence, without input from an external programmer, in response to connection of the at least one implantable lead is connected to the IMD. Swerdlow et al. teaches it is known in the art for an IMD to automatically determine and differentiate between types of lead problems ([0025]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the IMD of Gunderson et al. to automatically initiate the determination of lead integrity as taught by Swerdlow et al. as it is a known technique in the art, would have been reasonably predictable, and would enable the IMD independent functionality for determining lead problems.
Regarding claim 6, Gunderson et al. does not expressly disclose the evaluation period is about 2 minutes to about 1 hour following attachment of the at least one implantable medical lead to the IMD. Swerdlow et al. teaches an evaluation period (“interval”) for determining lead integrity may occur soon after leads 18, 20, 22 are connected to IMD 16 ([0080-0082]) as doing so allows for detection of an issue compared to a baseline value ([0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to enable an evaluation period soon after attachment of the at least one lead to the IMD as taught by Swerdlow et al. as it is a known period of time to initiate lead integrity tests, and would allow for comparing a detected issue to a baseline value. Furthermore the specific values of 2 minutes to about 1 hour following attachment of the at least one lead would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Kuehn (US 5,201,865).
Regarding claim 7, Gunderson et al. discloses a signal generator 104 (fig. 2) configured to deliver pacing pulses via the implantable medical lead, wherein the processor 112 controls the signal generator to deliver pacing pulses in a demand pacing mode (“alter a therapy vector” [0097]; “adjusting a therapy delivery vector selection” [0115])) during performance of the qualification test (2) ([0115]) but does not expressly disclose delivering pacing pulses in an asynchronous mode during qualification test (1). Kuehn discloses impedance testing may be performed by initiating a temporary asynchronous pacing mode so that the testing does not have any effect on the patient (col. 6, lines 22-44). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to use asynchronous mode pacing pulses during qualification test (1) as taught by Kuehn to ensure that impedance testing does not have any effect on the patient (col. 6, lines 22-44).
Claim(s) 8, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Demmer et al. (US 2020/0254262).
Regarding claims 8, 19, Gunderson et al. does not expressly disclose wherein for the qualification test (2), the processor is configured to: determine that a threshold number of R-waves have not been sensed; and reduce a rate of the pacing pulses based on the determination. Demmer et al. teaches it is known in the art to reduce the pacing rate when intrinsic R-waves are absent in a patient ([0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to reduce the rate of pacing pulses based on a determination that a threshold number of R-waves have not been sensed as taught by Demmer et al. in order to provide a more effective pacing rate that invokes R-waves in the patient, thus providing more effective therapy and more effective means to determine lead integrity.
Claim(s) 10-11, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621).
Regarding claims 10, 21, Gunderson et al. does not expressly disclose the order of performing the qualification tests, such as qualification tests (2)-(3) follow qualification test (1). The specific limitation of the order of the qualification tests does not appear to have any specific criticality (“In the device test sequence according to some examples, processor 80 causes IMD 126 to conduct, in series or in parallel, the following qualification tests:” [0038] of the published application), is not dependent on each other, and the resultant device test sequence in a different order would have yielded the same determination. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to select any order of performing the steps, such as (2)-(3) follow (1), in the absence of new or unexpected results. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Regarding claim 11, Gunderson et al. does not expressly disclose the order of performing the qualification tests, such as measuring current of injury (COI) parameters in the EGM after qualification test (3). The specific limitation of the order of the qualification tests does not appear to have any specific criticality (“In the device test sequence according to some examples, processor 80 causes IMD 126 to conduct, in series or in parallel, the following qualification tests:” [0038] of the published application), is not dependent on each other, and the resultant device test sequence in a different order would have yielded the same determination. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to select any order of performing the steps, such measuring current of injury (COI) parameters in the EGM after qualification test (3), in the absence of new or unexpected results. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Claim(s) 12, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Gessman (US 4,637,404).
Regarding claims 12, 22, Gunderson et al. does not expressly disclose pacing capture is observable by a clinician via an electrocardiogram monitor as an indication of device test sequence success. Gessman teaches it is known in the art to display cardiac pacing capture on an electrocardiogram monitor (col. 4, lines 52-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to display the pacing capture on an electrocardiogram monitor observable by a clinician as an indication of device test sequence success as taught by Gessman as it is a known technique to another known similar device to yield predictable results. Gunderson also does not expressly disclose the processor controls performance of qualification test (3) at the end of the device test sequence. The specific limitation of the order of the qualification tests does not appear to have any specific criticality (“In the device test sequence according to some examples, processor 80 causes IMD 126 to conduct, in series or in parallel, the following qualification tests:” [0038] of the published application), is not dependent on each other, and the resultant device test sequence in a different order would have yielded the same determination. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to select any order of performing the steps, such performance of qualification test (3) at the end of the device test sequence, in the absence of new or unexpected results. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Claim(s) 13-14, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Katz et al. (US 5,549,646).
Regarding claims 13-14, 23-24, Gunderson et al. discloses a signal generator 104 but does not expressly the processor controls the IMD to generate a confirmation signal in response to success of the device test sequence; the signal generator delivering pacing pulses via the implantable medical lead, wherein the confirmation signal comprises the delivery of pacing pulses. Katz et al. teaches it is known in the art for a signal generator of an IMD to alert a patient by emitting a sound or generating a low energy shock in response to success of a device test sequence of determining lead integrity tests (col. 8, lines 9-44). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. and provide a detectable notification signal such as delivered pacing pulse to the patient in response to success of a device test sequence as taught by Katz et al. in order to more effectively notify the patient of a device status.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Demmer et al. (US 2020/0038664).
Regarding claim 25, Gunderson et al. discloses an implantable medical device (IMD) 10 comprising: a housing configured for implantation within a patient (fig. 1); a plurality of electrodes 20-42 (fig. 2); sensing circuitry 102 within the housing, the sensing circuitry configured to sense an electrogram (EGM) signal of a patient via the electrodes 20-42 (fig. 2); impedance measurement circuitry 105 within the housing, the impedance measurement circuitry configured to measure impedance via the electrodes ([0038]); and a processor 112 configured to detect placement of the IMD into the patient and, in response to placement of the IMD into the patient, to initiate a device test sequence comprising a plurality of qualification tests over an evaluation period in which the processor: (1) controls the impedance measurement circuitry to measure an impedance 808 (fig. 11) for at least one electrical path that includes the at least one electrode to determine a connection status of the IMD to the at least one electrode ([0038]); and (2) in response to a determination that the connection status indicates the IMD is connected to the at least one electrode (“a lead impedance measurement performed at block 808 may trigger lead monitoring” [0111]), compares amplitudes of the EGM signal over an EGM test period against a predetermined threshold 812 (fig. 11; [0112-0114]). Gunderson et al. does not expressly disclose the IMD is a leadless IMD with the plurality of electrodes on the housing. Demmer et al. teaches IMD embodiments where the device can comprise an implantable lead 165 with electrodes (fig. 2b-c) similar to Gunderson et al. or be leadless with electrodes on the housing (fig. 2a), both configured for implanting within a patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try substituting a leadless implantable medical device where the plurality of electrodes are on the housing as taught by Demmer et al., for the leaded IMD of Gunderson et al. as the two IMDS are equivalent structures known in the art for the same purpose of providing cardiac therapy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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