DETAILED ACTION
Response to Arguments
Applicant’s arguments, see page 9, filed on 3/05/2026, with respect to the drawing objections have been fully considered and are persuasive. The previous drawing objections have been withdrawn.
Applicant’s arguments, see page 10, filed on 3/05/2026, with respect to the specification objections have been fully considered and are persuasive. The previous specification objections have been withdrawn.
Applicant’s arguments, see pages 10-12, filed on 3/05/2026, with respect to the 35 U.S.C. 103 rejections of claims 11, 13-14, and 16-17 under Berlin in view of Sharma have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejections for claims 11, 13-14, and 16-17 are made in view of Ostroff et al. (AU 2010201351) due to a new search that was necessitated by the amendments.
Applicant’s arguments, see pages 10-12, filed on 3/05/2026, with respect to the 35 U.S.C. 103 rejections of claims 15 and 18-20 under Berlin in view of Sharma and Mischler have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection for claim 15 is made in view of Ostroff et al. (AU 2010201351) due to a new search that was necessitated by the amendments. Also, upon further consideration, new grounds of rejections for claims 18-20 are made in view of Patel et al. (U.S. PGPub No. 2012/0108994) due to a new search that was necessitated by the amendments.
Claim Rejections - 35 USC § 112
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.
Claim 19 is 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 19 recites “the one or more processors, in response to determining that the correlation scores of the plurality of recent beats form more than one cluster, is further configured to declare that oversensing is not occurring.” However, this is contradictory to the Applicant’s specification. The specification states that “if more than one cluster is identified, oversensing is occurring” (Paragraph 0041, lines 18-19). Therefore, it is unclear what the scope of the instant claim is. For examining purposes, claim 19 is being interpreted as “the plurality of beats form more than one cluster, is further configured to declare that oversensing is occurring” (per the specification).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Berlin et al. (WIPO Pub. No. 2024/089501) in view of Sharma et al. (U.S. PGPub No. 2017/0043173) (both cited previously) and Ostroff et al. (AU 2010201351).
Regarding claim 11, Berlin teaches a system (Paragraph 0028, line 1), comprising: electrodes (Paragraph 0028, line 4); an implantable medical device (IMD) (Paragraph 0028, line 3) coupled to the electrodes (Paragraph 0028, lines 3-4), the IMD including sensing circuitry (Paragraph 0049, line 5), and a pulse generator (Paragraph 0032, line 7) configured to deliver shock therapy (Paragraph 0032, lines 8-9) to a patient (Paragraph 0028, line 5) via the electrodes (Paragraph 0046, lines 1-2), the IMD configured to sense far field (FF) signals (Paragraph 0069, line 14), utilizing the sensing circuitry, between the electrodes (Paragraph 0069, lines 11-13); memory (Paragraph 0032, line 1) to store the FF signals (Paragraph 0100, lines 6-7) and to store program instructions (Paragraph 0034, line 1), the memory further storing a template (Paragraph 0095, line 9) associated with a set of the electrodes (Paragraph 0069, lines 14-15); and one or more processors (Paragraph 0032, line 1) that, when executing the program instructions (Paragraph 0034, line 1), are configured to detect tachyarrhythmia (Paragraph 0063, line 13).
Berlin doesn’t teach that the template is a sinus QRS template. Berlin also does not teach a system that declares an MVT diagnosis based on:
i) a first comparison of a plurality of recent beats to a sinus QRS template by aligning the plurality of recent beats to the sinus QRS template and performing a cross-correlation to determine correlation scores for the plurality of recent beats;
ii) a second comparison of the correlation scores of the plurality of recent beats to a correlation threshold, wherein the recent beats are based on the FF signals sensed between the electrodes in the set; and
iii) a variability of the correlation scores of the plurality of recent beats being less than a correlation variability threshold, wherein the one or more processors are configured to direct the pulse generator to postpone delivery of the shock therapy responsive to declaring the MVT diagnosis.
Sharma, however, teaches an IMD system that declares an MVT diagnosis (Paragraph 0023, line 3) from a plurality of recent beats (Paragraph 0081, line 3). Sharma teaches that the IMD system postpones shock delivery (Paragraph 0035, lines 12-16) following an MVT diagnosis (Paragraph 0023, line 3) if the VT has been successfully reverted by anti-tachycardia pacing (ATP) therapy.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of
Sharma to include a system that is configured to postpone shock delivery based on an
MVT diagnosis. Doing so would ensure that a shock is not delivered when the device
declares an MVT diagnosis, and instead use anti-tachycardia pacing to minimize patient discomfort (Paragraph 0026), as recognized by Sharma.
Ostroff, however, teaches a method for discriminating between ventricular and supraventricular arrythmias that declares an MVT diagnosis (Page 23, lines 28-29) by using a sinus QRS template (Fig. 3, Page 10, lines 7-10). Furthermore, Ostroff teaches that an MVT diagnosis is detected based on: a first comparison of a plurality of recent beats to a sinus QRS template (Page 13, lines 15-16) by aligning the plurality of recent beats to the sinus QRS template (Page 10, lines 17-19) and performing a cross-correlation to determine correlation scores for the plurality of recent beats (Page 13, lines 11-14); a second comparison of the correlation scores of the plurality of recent beats to a correlation threshold (Page 37, lines 6-9), wherein the recent beats are based on the FF signals sensed between the electrodes in the set (Page 30, lines 4-8); and a variability of the correlation scores of the plurality of recent beats (Page 14, lines 27-30) being less than a correlation variability threshold (Page 19, lines 18-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Berlin to incorporate the teachings of Ostroff to include that the system declares an MVT diagnosis based on: a first comparison of a plurality of recent beats to a sinus QRS template and determining correlation scores, a second comparison between the correlation scores and a correlation threshold, and a variability of the correlation scores being less than a correlation variability threshold. Doing so would ensure that MVT can be properly diagnosed in order to postpone shock delivery (Page 19), as recognized by Ostroff.
Regarding claim 13, Berlin teaches the system (Paragraph 0028, line 1) of claim
11 that includes the processor (Paragraph 0032, line 1). Berlin does not teach that the MVT diagnosis is a first MVT diagnosis and, in response to the one or more processors declaring a second MVT diagnosis within a predetermined time of the first MVT diagnosis, the one or more processors are further configured to postpone delivery of shock therapy a second time.
Sharma, however, teaches a system that declares a first MVT diagnosis (Paragraph
0023, line 3), and a second MVT diagnosis (Paragraph 0093, lines 4-5) within a predetermined time (Paragraph 0093, line 7) of the first MVT diagnosis. Sharma also teaches that this system is configured to postpone shock delivery a second time (Paragraph 0093, lines 4-9).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of Sharma to include a system that declares a second MVT diagnosis within a predetermined time of the MVT diagnosis, and postpones shock delivery a second time. Doing so would ensure that the system continues to detect and/or declare an MVT diagnosis periodically, that a shock is not delivered when the device declares an MVT diagnosis, and that proper therapy such as anti-tachycardia pacing is delivered instead (Paragraph 0093), as recognized by Sharma.
Regarding claim 14, Berlin in view of Sharma and Ostroff discloses the claimed
invention of claim 11. Berlin further discloses the system (Paragraph 0028, line 1) of claim 11, wherein the one or more processors (Paragraph 0032, line 1) are further configured to declare the MVT diagnosis based on a comparison of (Paragraph 0095, lines 8-9) R-wave peak amplitudes (Paragraph 0118, line 5) of the plurality of recent beats to an R-wave peak amplitude associated with the template (Paragraph 0095, line 9).
Regarding claim 16, Berlin teaches the system (Paragraph 0028, line 1) of claim
11, wherein the one or more processors (Paragraph 0032, line 1) are further configured to declare the MVT diagnosis based on i) a comparison of (Paragraph 0095, lines 8-9) durations of QRS complexes (Paragraph 0118, line 5) associated with the plurality of recent beats to a duration of a QRS complex associated with the template.
Berlin does not teach a system that declares an MVT diagnosis based on a
comparison of duration of QRS complexes associated with the plurality of recent beats,
and a stability of the durations of the QRS complexes associated with the plurality of
recent beats. Sharma, however, teaches an IMD system that declares an MVT diagnosis
(Paragraph 0023, line 3) from a plurality of recent beats (Paragraph 0081, line 3).
Furthermore, Sharma teaches a system that determines a stability of the durations of QRS
complexes (Paragraph 0025, lines 1-4) associated with the plurality of recent beats.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of Sharma to include a system that declares an MVT diagnosis based on a comparison of durations of QRS complexes associated with the plurality of recent beats to a duration of a QRS complex associated with the template, and a stability of the durations of the QRS complexes associated with the plurality of recent beats. Doing so would ensure that an MVT diagnosis is properly detected by using comparisons and stability analyses of QRS complex durations from a plurality of recent beats (Paragraph 0025), as recognized by Sharma.
Regarding claim 17, Berlin in view of Sharma and Ostroff discloses the claimed
invention of claim 11. Berlin further discloses the system (Paragraph 0028, line 1) of claim 11, wherein the set of electrodes is a first set of electrodes (Paragraph 0069, lines 14-15), and further comprising: wherein the IMD (Paragraph 0028, line 3) is further configured to sense the FF signals (Paragraph 0069, line 14), utilizing the sensing circuitry (Paragraph 0049, line 5), between a second set of the electrodes (Paragraph 0069, lines 16-17), wherein at least one of the electrodes (Paragraph 0028, line 4) within the second set of the electrodes is different (Paragraph 0069, lines 14-18) from one of the electrodes within the first set of the electrodes; and wherein the memory (Paragraph 0032, line 1) is further configured to store a second template (Paragraph 0135, line 17) associated with the second set of the electrodes.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Berlin et al. (WIPO Pub. No. 2024/089501) in view of Sharma et al. (U.S. PGPub No. 2017/0043173) and Ostroff et al. (AU 2010201351) according to claim 11, and in further view of Mischler et al. (U.S. Patent No. 11,931,585) (cited previously).
Regarding claim 15, Berlin teaches the system (Paragraph 0028, line 1) of claim
11 that includes the one or more processors (Paragraph 0032, line 1). Berlin does not teach a system that declares an MVT diagnosis based on heart rate stability associated with a plurality of recent beats. Sharma, however, teaches an IMD system that declares an MVT diagnosis (Paragraph 0023, line 3) from a plurality of recent beats (Paragraph 0081, line 3). Mischler also teaches an IMD that determines heart rate stability (Col. 7, lines 47-51).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of Sharma and Mischler to declare an MVT diagnosis based on a heart rate stability associated with a plurality of recent beats. Doing so would ensure that patient heart rate is analyzed from recent heart beats and that the device properly detects MVT, as recognized by Sharma (Paragraph 0023) and Mischler (Col. 7).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Berlin et al. (WIPO Pub. No. 2024/089501) in view of Sharma et al. (U.S. PGPub No. 2017/0043173), Patel et al. (U.S. PGPub No. 2012/0108994), and Mischler et al. (U.S. Patent No. 11,931,585).
Regarding claim 18, Berlin teaches a system (Paragraph 0028, line 1), comprising: implantable electrodes (Paragraph 0028, lines 4-6); an implantable medical device (IMD) (Paragraph 0028, line 3) coupled to the electrodes, the IMD including sensing circuitry (Paragraph 0049, line 5) and a pulse generator (Paragraph 0032, line 7), the IMD configured to sense far field (FF) signals (Paragraph 0069, line 14), utilizing the sensing circuitry, between the electrodes (Paragraph 0069, lines 11-13); memory (Paragraph 0032, line 1) to store the FF signals (Paragraph 0100, lines 6-7) and to store program instructions (Paragraph 0034, line 1), the memory further storing a template (Paragraph 0095, line 9) associated with a set of the electrodes (Paragraph 0069, lines 14-15); and one or more processors (Paragraph 0032, line 1) that, when executing the program instructions (Paragraph 0034, line 1) make: iii) a determination of amplitudes of sensed R-waves (Paragraph 0118, line 5); iv) a determination of peak RR intervals (Paragraph 0118, line 9); v) a determination of sense-to-peak durations (Paragraph 0118, lines 6-8).
Berlin does not teach that the system postpones shock delivery. Berlin doesn’t teach that the template is a sinus QRS template. Berlin also does not teach that the system postpones shock delivery based on:
i) a first comparison of a plurality of recent beats to a sinus QRS template by aligning the recent beats to the sinus QRS template and performing a cross-correlation to determine correlation scores for the recent beats;
ii) a determination that the correlation scores of the plurality of recent beats form more than one cluster, wherein the recent beats are associated with the FF signals sensed between the electrodes in the set.
Sharma, however, teaches an IMD system that declares an MVT diagnosis (Paragraph 0023, line 3) from a plurality of recent beats (Paragraph 0081, line 3). Sharma teaches that the IMD system postpones shock delivery (Paragraph 0035, lines 12-16) following an MVT diagnosis (Paragraph 0023, line 3) if the VT has been successfully reverted by anti-tachycardia pacing (ATP) therapy.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of
Sharma to include a system that is configured to postpone shock delivery based on an
MVT diagnosis. Doing so would ensure that a shock is not delivered when the device
declares an MVT diagnosis, and instead use anti-tachycardia pacing to minimize patient discomfort (Paragraph 0026), as recognized by Sharma.
Ostroff, however, teaches a method for discriminating between ventricular and supraventricular arrythmias that declares an MVT diagnosis (Page 23, lines 28-29) by using a sinus QRS template (Fig. 3, Page 10, lines 7-10). Furthermore, Ostroff teaches that postponing shock delivery is based on: a first comparison of a plurality of recent beats to a sinus QRS template (Page 13, lines 15-16) by aligning the plurality of recent beats to the sinus QRS template (Page 10, lines 17-19) and performing a cross-correlation to determine correlation scores for the plurality of recent beats (Page 13, lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Berlin to incorporate the teachings of Ostroff to include that the system declares an MVT diagnosis based on: a first comparison of a plurality of recent beats to a sinus QRS template and determining correlation scores. Doing so would ensure that MVT can be properly diagnosed in order to postpone shock delivery (Page 19), as recognized by Ostroff.
Patel, however, teaches a method and apparatus for morphology change detection for cardiac analysis that calculates correlation values (Paragraph 0096, line 11) by aligning the recent beats to the template beats (Paragraph 0096, lines 10-15) by performing cross-correlation (Paragraph 0096, line 9). Furthermore, Patel teaches that it can be determined that the correlation scores form more than one cluster (Paragraph 0106, lines 11-12). Patel teaches that, by grouping beats, this can help prevent false identifications of morphology changes (Paragraph 0107, lines 1-3), which are also known as false positives or oversensing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Berlin to incorporate the teachings of Patel to include that a first comparison of a plurality of recent beats to a sinus QRS template is made in order to determine correlation scores, and then a determination is made that the correlation scores form more than one cluster. Doing so would ensure that false positives are prevented and that the groups can smooth inherent inconsistencies over time (Paragraph 0107), as recognized by Patel.
Berlin also does not teach that postponing shock delivery is based on: a determination that amplitudes of sensed R-waves within the plurality of recent beats form more than one cluster; a determination that peak RR intervals form more than one cluster; or that a determination that sense-to-peak durations form more than one cluster. Mischler, however, teaches an IMD that determines (Col. 21, line 60) if cardiac event oversensing is occurring based on signal feature data forming more than one cluster (Col. 22, lines 4-7). Mischler teaches that if oversensing is detected, shock delivery can be postponed (Col. 22, lines 64-67).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of
Sharma and Mischler to postpone shock delivery based on determinations that QRS
morphology metrics form more than one cluster within a plurality of recent beats. Doing
so would ensure that a shock is not delivered when the device oversenses a cardiac event,
and that proper therapy such as anti-tachycardia pacing is delivered instead (Col. 22 and 23), as recognized by Mischler.
Regarding claim 19, Berlin teaches the system (Paragraph 0028, line 1) of claim 18 that includes the one or more processors (Paragraph 0032, line 1). Berlin does not teach that, in response to determining that the correlation scores of the plurality of recent beats form more than one cluster, is further configured to declare that oversensing is occurring.
Patel, however, teaches a method and apparatus for morphology change detection for cardiac analysis that calculates correlation values (Paragraph 0096, line 11). Patel also teaches that it can be determined that the correlation scores form more than one cluster (Paragraph 0106, lines 11-12). Patel teaches that, by grouping beats, this can help prevent false identifications of morphology changes (Paragraph 0107, lines 1-3), which are also known as false positives or oversensing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Berlin to incorporate the teachings of Patel to include that a first comparison of a plurality of recent beats to a sinus QRS template is made in order to determine correlation scores, and then a determination is made that the correlation scores form more than one cluster. Doing so would ensure that false positives are prevented and that the groups can smooth inherent inconsistencies over time (Paragraph 0107), as recognized by Patel.
Regarding claim 20, Berlin teaches the system (Paragraph 0028, line 1) of claim 19. Berlin does not teach a system that determines if cardiac event oversensing is occurring, wherein the oversensing is P-wave oversensing, T-wave oversensing, or QRS-wave oversensing. Mischler, however, teaches an IMD that determines if cardiac event oversensing is occurring (Col. 21, lines 15-17), wherein the oversensing is P-wave oversensing (Col. 11, lines 39-40), T-wave oversensing (Col. 38, lines 5-6), or QRS-wave oversensing (Col. 4, lines 44-48).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Berlin to incorporate the teachings of
Mischler to have an IMD that can determine cardiac event oversensing, wherein the
oversensing is P-wave oversensing, T-wave oversensing, or QRS-wave oversensing.
Doing so would ensure that a shock is not delivered when the device oversenses a cardiac event, and that proper therapy such as anti-tachycardia pacing is delivered instead (Col. 22 and 23), as recognized by Mischler. While Mischler does not explicitly list that QRS-wave oversensing could be performed with their device, it would be obvious to try this as QRS-waves are also a key component of QRS morphology, which could help further determine if oversensing is occurring or not.
Allowable Subject Matter
Claims 21-22 are allowed.
Claim 21 is allowable for disclosing a system, comprising: electrodes; an
implantable medical device (IMD) coupled to the electrodes, the IMD including sensing circuitry and a pulse generator, the IMD configured to sense far field (FF) signals and near field (NF) signals, utilizing the sensing circuitry, between the electrodes; memory to store the FF signals and the NF signals and to store program instructions; and a processor that, when executing the program instructions, is configured to postpone shock delivery, by the pulse generator, based on the FF signals or the NF signals, wherein the postponing the shock delivery is further based on:
i) a comparison of a mean of absolute peak amplitudes of QRS-wave peaks of a plurality of recent beats to a first voltage threshold;
ii) a comparison of absolute peak amplitudes of the QRS-wave peaks of the plurality of recent beats to a second voltage threshold;
iii) a comparison of a mean of an absolute difference of beat-to-beat peak amplitudes of the QRS-wave peaks of the plurality of recent beats to a third voltage threshold;
iv) a comparison of an absolute difference of the beat-to-beat peak amplitudes of the QRS-wave peaks of the plurality of recent beats to an amplitude stability threshold;
v) a comparison of beat-to-beat RR intervals of the plurality of recent beats to a heart rate threshold;
vi) a comparison of a range of RR intervals to a heart rate range stability threshold, the range of the RR intervals based on the plurality of recent beats and excluding at least one of a highest value and a lowest value;
vii) a comparison of a largest absolute beat-to-beat interval difference of the beat-to-beat RR intervals of the plurality of recent beats to the heart rate range stability threshold; or
viii) a determination of a percentage of the RR intervals, of the plurality of recent beats, with an absolute difference less than a heart stability threshold, wherein the percentage is compared to a predetermined percentage.
Neither Berlin, Sharma, Ostroff, or Mischler disclose a system that postpones shock delivery based on a comparison of a range of RR intervals to a heart rate range stability threshold, the range of the RR intervals based on the plurality of recent beats, and excluding at least one of a highest value and a lowest value.
Claim 22 would be allowable because it depends on claim 21.
Conclusion
Applicant's amendment necessitated the new grounds 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.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796