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 Arguments
Applicant’s amendment and arguments filed 4/6/2026, with respect to the 35 USC 112b rejections have been fully considered and are persuasive. The 35 USC 112b rejections have been withdrawn.
Applicant's amendments and arguments filed 4/6/2026 regarding the 35 USC 102 and 103 rejections have been fully considered but they are not persuasive. Applicant argues “Zhang and Haefner at best disclose a reduction criterion for reducing the sense threshold for a current cycle is fulfilled if not atrial events have been detected in the current cycle.” The Examiner respectfully disagrees. Regarding Zhang, a cycle is monitored for atrial activity. If no atrial activity is identified in that cycle (e.g. once the cycle ends and there is so atrial activity), a detection threshold is adjusted. This adjustment occurs after the end of the previous cycle (no atrial events in the previous cycle cannot be ascertained until that cycle is concluded) and thus would occur in the next cycle, as required by the current claim. The same can be said with respect to Haefner. The adjustments are made after the sensed cycle fails to produce a sensed event.
Applicant has not provided any specific arguments regarding the 35 USC 102 rejections of the claims with respect to Sheldon. The rejections are maintained.
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.
Claims 1-3, 6 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (2008/0262559).
In claims 1-3 and 15, regarding the “reduction criterion is fulfilled if in X1 out of Y1 cycles…”, Applicant defines X1 as “a natural number equal or larger than 1” and Y1 “being a natural number equal or larger than X1”. Therefore, the X1 and Y1 can both be interpreted as 1 thus making the criterion “1 out of 1”. Zhang discloses an implantable medical device comprising a body (lead 14 connectable to generator 38, Fig. 1); a sensor arrangement (electrodes 16, 18, 20, 22, 24) arranged on the body 14 and configured to receive cardiac sense signals (at sense amplifier 12, Fig. 1, par. [0020]); and processing circuitry 28 operatively connected to the sensor arrangement (see Fig. 1), wherein the processing circuitry is configured to process cardiac sense signals received using the sensor arrangement. Zhang further discloses detecting if a cardiac cycle (1 out of 1) does not include an atrial event and lowering the sense threshold if no event is detected (par. [0009], “If no depolarization event has been detected in a sensing channel during the current cardiac cycle, it may be surmised that either no such event actually occurred, or that an event occurred but was undersensed. Because of the latter possibility, it would be desirable to adjust the sensing threshold downward (i.e., decrease the threshold) for a sensing channel after a cardiac cycle in which no depolarization event was detected.”) More specifically with respect to Zhang, a cycle is monitored for atrial activity and, if no atrial activity is identified in that cycle (e.g. once the cycle ends and there is so atrial activity), a detection threshold is adjusted. This adjustment occurs after the end of the previous cycle (no atrial events in the previous cycle cannot be ascertained until that cycle is concluded) and thus would occur in the next cycle, as required by the current claim.
With regard to Claim 6, Zhang discloses reducing the threshold by a reduction factor represented by the last equation in p. [0046]).
Claims 1-3, 6, 7, 9, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Haefner et al. (EP 2108400 A1).
In claims 1-3 and 15, regarding the “reduction criterion is fulfilled if in X1 out of Y1 cycles…”, Applicant defines X1 as “a natural number equal or larger than 1” and Y1 “being a natural number equal or larger than X1”. Therefore, the X1 and Y1 can both be interpreted as 1 thus making the criterion “1 out of 1”. Haefner discloses an implantable medical device 105 comprising a body (leads 115 or 120 connectable to generator 205A, B, Fig. 1, 2; par. [0017]); a sensor arrangement (electrodes 125A, B; 135 A, B, etc., Fig. 1; par. [0017]) arranged on the body 115 or 120 and configured to receive cardiac sense signals (at terminals 200A, B, Fig. 2, par. [0018]); and processing circuitry 230 operatively connected to the sensor arrangement (see Fig. 2), wherein the processing circuitry is configured to process cardiac sense signals received using the sensor arrangement. Haefner further discloses detecting if a cardiac cycle (1 out of 1) does not include an atrial event and lowering the sense threshold if no event is detected (see steps 315 to 310 B; Fig. 3). More specifically with respect to Haefner, a cycle is monitored for atrial activity and, if no atrial activity is identified in that cycle (e.g. once the cycle ends and there is so atrial activity), a detection threshold is adjusted. This adjustment occurs after the end of the previous cycle (no atrial events in the previous cycle cannot be ascertained until that cycle is concluded) and thus would occur in the next cycle, as required by the current claim
With regard to Claim 6, Haefner discloses reducing the threshold by a reduction factor (see reduction between t1 and t2 in Fig. 4).
In regard to Claim 7, the multiple step reductions between t1-t2 and t3-t4 can be considered the claimed step factor (Fig. 4).
Regarding Claim 9, Haefner discloses reducing the threshold a second time with a second reduction factor (see reduction between t3-t4 in Fig. 4.
With regard to Claim 10, Haefner discloses not allowing the threshold to stay below a steady state value (see 310A, B; Fig. 3; see also A1 in Fig. 4).
Claims 1, 4, 6, 8 and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sheldon et al. (2021/0236826).
Regarding Claims 1 and 4, Sheldon discloses a leadless pacing device 14 having a body; a sensor arrangement 162, 164 on the body (Fig. 2; par. [0046]) and processing circuitry 244 connected to the sensor arrangement (Fig. 3). Sheldon discloses detecting whether a threshold number A3 events (windows or crossings) occur over N cycles and discloses reducing the sensing threshold if too few are sensed (see par. [0189-0190]; Fi. 13, ref. 776, 778). More specifically with respect to Sheldon, a cycle or group of cycles is monitored for atrial activity and, if no atrial activity is identified in that cycle or group of cycles (e.g. once the cycle(s) ends and there is so atrial activity), a detection threshold is adjusted. This adjustment occurs after the end of the previous cycle(s) (no atrial events in the previous cycle(s) cannot be ascertained until that cycle(s) is concluded) and thus would occur in the next cycle, as required by the current claim.
In regards to Claim 6, Sheldon discloses decreasing the threshold by an amount (a reduction factor), see par. [0190].
With regard to Claims 8 and 9, Sheldon discloses a second criteria in which a threshold number of A4 events need to be detected over N cycles, wherein the threshold is reduced if the threshold is not met (par. [0191]; Fig. 13, steps 775, 777).
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.
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.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (2008/0262559) in view of Bornzin et al. (2021/0345900). Zhang discloses all of the claimed invention except for adjusting a sensing threshold based on an average reference. However, in the same field of endeavor of P-wave detection, Bornzin discloses setting a detection threshold as an average of P-wave peaks over time (par. [0096] for the purpose of providing a high-quality template that is not corrupted by noise (par. [0085]). Therefore 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 device in the Zhang reference to include setting a detection threshold as an average of P-wave peaks over time, as taught and suggested by Bornzin, for the purpose of providing a high-quality template that is not corrupted by noise.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Haefner et al. (EP 2108400 A1) in view of Pei et al. (7,668,593). Haefner discloses two sensing channels ( a ventricular sensing channel 225B and an atrial sensing channel 225A) and discloses that each channel has a gain associated with it (par. [0020-0021]). However, Haefner does not disclose the relative values of the atrial channel gain to the ventricular channel gain. However, in the same field of endeavor of cardiac activity sensing, Pei discloses setting the atrial channel gain to a value higher than the ventricular channel gain since the atrial signal (a P-wave) is much smaller and harder to detect than the larger QRS complex representative of a ventricular contraction (col. 5, lines 35-40). Therefore 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 device in the Haefner reference to include a higher atrial channel gain than a ventricular channel gain, as taught and suggested by Pei, for the purpose of achieving optimal settings to detect atrial events (a P-wave), which is much smaller and harder to detect than the larger QRS complex representative of a ventricular contraction .
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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