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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 7, 2026 has been entered.
Response to Amendment
The amendment filed March 11, 2026 has been entered. Claims 1, 3, 15, 17 have been amended. Currently, claims 1-25 are pending for examination.
Response to Arguments
Applicant's arguments filed March 11, 2026 with respect to the 35 U.S.C. 102 of claim 1 and the 35 U.S.C. 103 rejection of claim 25 have been fully considered but they are not persuasive. With regard to claim 1, applicant argues (p. 7-8) that Gunderson et al. (US 2014/0350621) “does not recite a processor that, ‘upon implantation and in response to coupling of the IMD to the at least one implantable medical lead’, ‘controls the impedance measurement circuitry to measure an impedance 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.’”. Claim 1 is directed to an apparatus. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The limitation of, “upon implantation and in response to coupling of the IMD to the at least one implantable medical lead” is regarded as a recitation with respect to the manner in which the processor is intended to be employed, and does not add additional structure to the claimed apparatus. Furthermore, Gunderson et al. states Fig. 11 is a method of detecting a short circuit (SC) condition due to changes of a medical electrical lead within a patient’s body ([0107]) regarded as, “coupling of the IMD to the at least one implantable medical lead”. With regard to claim 25, applicant argues (p. 8-9) that Gunderson et al. in view of Demmer et al. (US 2020/0038664) “does not disclose a processor that, ‘in response to placement of the IMD into the patient… initiate[s] a device test sequence… in which the processing: (1) controls the impedance measurement circuitry to measure an impedance.’”. Claim 25 is directed to an apparatus. Similar to claim 1, the limitation of, “in response to placement of the IMD into the patient…” is regarded as a recitation with respect to the manner in which the processor is intended to be employed, and does not add additional structure to the claimed apparatus. Furthermore, Gunderson et al. states Fig. 11 is a method of detecting a short circuit (SC) condition due to changes of a medical electrical lead within a patient’s body ([0107]) regarded as, “placement of the IMD into the patient”.
Applicant’s arguments, see pages 7-8, filed March 11, 2026, with respect to the rejection(s) of claim(s) 15 under 35 U.S.C. 102 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 Bobgan et al. (US 2012/0004699) and Eick et al. (US 2006/0116747).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 now recites, “upon implantation and in response to coupling of the IMD to the at least one implantable medical device,”. In light of the Applicant Remarks dated March 11, 2026 where the applicant stresses this limitation must be considered in claim 1 to evaluate the limitation of, “a processor configured… to initiate a device test sequence”, it appears the applicant is claiming a limitation not supported by the specification. For example, Example L in paragraph [0103] of the applicant’s published application states, “the evaluation period is about 2 minutes to about 1 hour following attachment of the at least one lead to the IMD” but the standard definition of “upon” as defined by dictionary.com is “immediately or very soon after” (https://www.dictionary.com/browse/upon). Even if applicant argues the short end of the range of “about 2 minutes” can be regarded as “upon implantation”, this is not equivalent to “immediately or very soon after”.
Claims 2-14 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
Claim 15 now recites, “upon implantation and based on the detection of the attachment to the IMD of the at least one medical lead,”. Support is not provided for the limitation, “upon implantation” given the specifics as recited above for claim 1.
Claims 16-24 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 15.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, “sensing circuitry configured to sense an electrogram (EGM) signal of a patient via at least one electrode of the implantable medical lead” and later recites, “compares amplitudes of the EGM signal over an EGM test period against a predetermined threshold”, but does not recite the active step of sensing any EGM. It is unclear if the sensing of the EGM signal over the EGM test period occurs: (1) “in response to a determination that the connection status indicates the IMD is connected to the at least one electrode”, (2) constantly occurring even during the measurement of the impedance, or (3) some other period of time.
Claim 2 references “the EGM signal” but similar to claim 1, this EGM signal has not actively been sensed.
Claim 6 recites, “wherein the evaluation period is about 2 minutes to about 1 hour following attachment of the at least one implantable medical lead to the IMD”. This limitation is indefinite in light of the Applicant Remarks dated March 11, 2026. Applicant stresses the limitation, “upon implantation and in response to coupling of the IMD to the at least one implantable medical lead” must be considered in claim 1 to evaluate the limitation of, “a processor configured… to initiate a device test sequence”. The standard definition of “upon” as defined by dictionary.com is “immediately or very soon after” (https://www.dictionary.com/browse/upon). However claim 6 requires a broad range of 2 minutes to about 1 hour following attachment of the at least one implantable medical lead to the IMD. One of ordinary skill in the art would find it indefinite to consider the time period of “2 minutes to an about 1 hour” equivalent to “upon implantation”.
Claims 2-14 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
Claim 15 recites, “comparing amplitudes of an electrogram (EGM) signal over an EGM test period against a predetermined threshold”, but does not recite the active step of sensing any EGM. It is unclear if the sensing of the EGM signal over the EGM test period occurs: (1) “in response to a determination that the connection status indicates the IMD is connected to the at least one electrode”, (2) constantly occurring even during the measurement of the impedance, or (3) some other period of time.
Claim 16 references “the EGM signal” but similar to claim 1, this EGM signal has not actively been sensed.
Claims 16-24 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 15.
Claim 25 recites, “sensing circuitry within the housing, the sensing circuitry configured to sense an electrogram (EGM) signal of a patient via the electrodes” and later recites, “compares amplitudes of the EGM signal over an EGM test period against a predetermined threshold”, but does not recite the active step of sensing any EGM. It is unclear if the sensing of the EGM signal over the EGM test period occurs: (1) “in response to a determination that the connection status indicates the IMD is connected to the at least one electrode”, (2) constantly occurring even during the measurement of the impedance, or (3) some other period of time.
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 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 claim 1, Gunderson et al. discloses 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, upon implantation (A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).) and in response to coupling of the IMD to the at least one implantable medical lead (Gunderson et al. states Fig. 11 is a method of detecting a short circuit (SC) condition due to changes of a medical electrical lead within a patient’s body ([0107]) and includes other lead monitoring tests ([0117]) regarded as “coupling of the IMD to 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 claim 2, 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 claim 3, 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 claim 9, 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 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 claim 5, 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 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 claim 8, 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621).
Regarding claim 10, 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) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
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) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Claim(s) 12 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 claim 12, 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) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Claim(s) 13-14 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, 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) 15-17, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Bobgan et al. (US 2012/0004699) and Eick et al. (US 2006/0116747).
Regarding claim 15, Gunderson et al. discloses a method comprising: detecting, by an implantable medical device (IMD) 10, attachment to the IMD ([0038]) of at least one implantable medical lead 14, 16, 18 (fig. 1), wherein the at least one implantable medical lead comprises at least one electrode 20-42 (fig. 2); triggering by the IMD 10, based on the detecting of the attachment to the IMD of the at least one medical lead (Gunderson et al. states Fig. 11 is a method of detecting a short circuit (SC) condition due to changes of a medical electrical lead within a patient’s body ([0107]) and discusses other lead monitoring tests ([0117]) regarded as, “detecting of the attachment to the IMD of the at least one medical lead”), a device test sequence in which the IMD performs the following qualification tests over an evaluation period: (1) detecting 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]), comparing 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 triggering of the IMD to perform the device test sequence occurs upon implantation. Bobgan et al. teaches that a measured impedance to determine a lead related condition requires a comparison of the measured impedance against a baseline measurement “taken at or shortly after implant of the lead” ([0008]). To further emphasize, Eick et al. teaches that a baseline EGM, determined “at the time of implantation of a medical device”, is derived and stored for later reference ([0047]). Even though Gunderson et al. only states that impedance monitoring occurs on a periodic scheduled basis ([0111]), it does not preclude the prior art from initiating the impedance and EGM test sequence from occurring at other times, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initiate the device test sequence upon implantation as taught by Bobgan et al. and Eick et al. as determining impedance and EGM signal values shortly after implantation to use as a comparison for later measurements would be advantageous when the integrity of the connection between the lead and the IMD connection is best and before fractured conductors or insulation failures occur (Bobgan et al. [0007]).
Regarding claim 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 claim 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 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]).
Regarding claim 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) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Bobgan et al. (US 2012/0004699) and Eick et al. (US 2006/0116747) and further in view of Swerdlow et al. (US 2012/0191153).
Regarding claim 18, Gunderson et al. does not expressly disclose wherein triggering the device test sequence comprises automatically initiating 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.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Bobgan et al. (US 2012/0004699) and Eick et al. (US 2006/0116747) and further in view of Demmer et al. (US 2020/0254262).
Regarding claim 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) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Bobgan et al. (US 2012/0004699) and Eick et al. (US 2006/0116747) and further in view of Gessman (US 4,637,404).
Regarding claim 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) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2014/0350621) in view of Bobgan et al. (US 2012/0004699) and Eick et al. (US 2006/0116747) and further in view of Katz et al. (US 5,549,646).
Regarding claims 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 (Gunderson et al. states Fig. 11 is a method of detecting a short circuit (SC) condition due to changes of a medical electrical lead within a patient’s body ([0107]) and includes other lead monitoring tests ([0117]) regarded as “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
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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