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 .
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 1-4, 6, 8-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Bornzin et al. (US 5,514,162, hereinafter “Bornzin”).
In regards to claims 1 and 8, Bornzin discloses a pacemaker and method of operating a pacemaker for a patient's heart (Fig. 1), comprising
a processing unit (Fig. 1, elements 26 and 30),
a detector (elements 22 and 24), and
a pacing signal generator (element 28),
wherein the processing unit, the detector and the pacing signal generator are electrically interconnected (Fig. 1),
wherein the detector is configured to determine activity signals of the patient and to provide the activity signals to the processing unit (col. 7, line 53 to col. 8, line 8),
wherein the processing unit is configured to determine a pacing rate based on the currently received activity signals of the detector and on a gain value (col. 8, line 66 to col. 9, line 34; the gain being based on the “transfer function”) in an adaption mode or in a stabilized mode (col. 9, lines 31-35; “adaptation mode” being when the slope is automatically adjusted and the “stabilized mode” being between these adjustments),
wherein the processing unit is configured to produce a pace control signal based on the determined pacing rate and to provide it to the pacing signal generator (col. 8, lines 55-65),
wherein in the adaption mode the processing unit is configured to adapt the gain value to the specific patient (col. 9, lines 43-65; adapting the transfer function to a particular patient’s activity history),
wherein the processing unit is configured to stay in the adaption mode as long as at least one stability criterion is not met and to transition in the stabilized mode if the processing unit identifies that the at least one stability criterion is met (col. 13, lines 19-24 and col. 13, line 65 to col. 14, line 8); the slope adjustment is not performed if the “stability criterion” (i.e., low activity levels) is met and adjustment is performed if the stability criterion is not met),
wherein in the stabilized mode the processing unit is configured to use a locked gain value determined based on the most recently adapted gain values for determining the pacing rate (col. 13, line 65 to col. 14, line 8; slope adjustment is inhibited).
In regards to claims 2 and 9, the gain value is a 1-dimensional or multidimensional value (e.g., Fig. 2; example gain transfer function showing single dimensional gain over intervals and multi-dimensional gain over the range of activity levels).
In regards to claims 3 and 10, the stability criterion is met if an absolute value of a difference of a first average value of the adapted gain values determined within a first time period and a second average value of the adapted gain values determined within a second time period is less than a pre-determined stability threshold value and/or if the pacing rate is determined in the adaption mode during a pre-defined adaption time period (col. 13, line 65 to col. 14, line 8; the stability criterion has been met due to determination that the median of the activity deviation histogram is less than about 2.5 times the mode, and “continue[s] to use a slope that was set after a week of relatively normal activity,” and so uses a “pacing rate [] determined in the adaption mode during a pre-defined adaption time period”).
In regards to claims 4 and 11, the first time period and the second time period are directly adjacent, most recently assessed time periods (claim 3 recites alternative bases for the stability criterion to be met. The rejection of claim 3 depends on the second basis, and this claim further limits the first basis, and so Bornzin still anticipates the claimed subject matter).
In regards to claims 6 and 13, the processing unit transitions from the stabilized mode into the adaption mode if the processing unit receives a respective request (Fig. 6, element 130; a request from the algorithm in response to the median being less than about 2.5 times the mode) and/or if a pre-defined third time period is expired since the transition into the stabilized mode.
In regards to claim 14, Bornzin discloses a computer program product (the control algorithm) comprising instructions which, when executed by a processing unit, cause the processing unit to perform the steps of the method, and a computer readable data carrier (the memory) storing a computer program product (col. 4, lines 19-43).
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.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bornzin in view of Kane et al. (US 2017/0056664, hereinafter “Kane”).
Bornzin discloses the essential features of the claimed invention, including multi-chamber demand pacing (col. 8, lines 32-46), but does not expressly disclose wherein in the stabilized mode the processing unit is configured to interrupt or reduce detecting the activity signals by the detector, wherein the processing unit is configured to determine a motion signal from the reduced activity signals.
However, Kane in the same field of endeavor of cardiac pacing teaches providing a pacing device wherein in the stabilized (low activity) mode the processing unit is configured to interrupt or reduce detecting the activity signals by the detector, wherein the processing unit is configured to determine a motion signal from the reduced activity signals (pars. 0109-0111) to provide the predictable results of saving battery power when the more accurate sensing it is not needed (e.g. during patient inactive time periods) (par. 0109).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bornzin by providing a pacing device wherein in the stabilized (low activity) mode the processing unit is configured to interrupt or reduce detecting the activity signals by the detector, wherein the processing unit is configured to determine a motion signal from the reduced activity signals to provide the predictable results of saving battery power when the more accurate sensing it is not needed (e.g. during patient inactive time periods).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bornzin in view of Sheldon et al. (US 2020/0147396, hereinafter “Sheldon”).
Bornzin discloses the essential features of the claimed invention, including providing pacing in a multi-chamber demand mode (col. 8, lines 32-54), but does not expressly disclose that the pacemaker is configured to generate pacing signals based on atrial activity and atrial- ventricle conduction.
However, Sheldon in the same field of endeavor of cardiac pacing teaches providing a pacemaker that is configured to generate pacing signals based on atrial activity and atrial- ventricle conduction (par. 0027) to provide the predictable results of a pacing in a manner that promotes synchrony between atrial systole and ventricular systole, e.g., by maintaining a target atrioventricular (AV) interval between a sensed atrial systolic event and ventricular pacing pulse while operating in an atrial synchronous ventricular pacing mode (par. 0027).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bornzin by providing a pacemaker that is configured to generate pacing signals based on atrial activity and atrial- ventricle conduction to provide the predictable results of a pacing in a manner that promotes synchrony between atrial systole and ventricular systole, e.g., by maintaining a target atrioventricular (AV) interval between a sensed atrial systolic event and ventricular pacing pulse while operating in an atrial synchronous ventricular pacing mode.
Response to Arguments
Applicant's arguments filed 5/15/2026 have been fully considered but they are moot in part and not persuasive in part. The amendments to the claims have overcome the rejections under sections 112 and 101. In regards to the prior art rejections, Applicant argued that Bornzin fails to disclose a stabilized mode in which a locked gain value is used, but instead uses a predetermined slope value only once in one slope adjustment step, since the most recently determined slope value is determined to be not reliable. However, the examiner respectfully maintains the rejection for the reasons above. Column 13, lines 6-64 generally describes the claimed “adaption mode,” where the slope (claimed “gain”) is adjusted in the normal or default situation. In “remarks,” Applicant cites column 13, line 65 to column 14, line 8 describing Bornzin’s algorithm for the claimed “stabilized mode.” Here, Bornzin describes that, when a stability criterion is met (i.e., the patient is in a “stable” or inactive state as indicated by the activity deviation histogram), “control is returned to the main program of Fig. 4, without an update of the slope of the transfer function. Thus, in accordance with the principles of the present invention, slope adjustments are advantageously inhibited when the patient has been unusually inactive. The pacemaker 20 (FIG. 1) may continue to use a slope that was set after a week of relatively normal activity.” The examiner’s position is that this un-updated slope (“gain”) fairly reads on “a locked gain value determined based on the most recently adapted gain values for determining the pacing rate” because the gain value is “locked” to the previously-determined value because updating the slope is inhibited. Bornzin notes that “[t]he pacemaker 20 (FIG. 1) may continue to use a slope that was set after a week of relatively normal activity” (i.e., locked to the slope/gain values that were previously determined before the lack of patient activity initiated the “stabilized mode”). Accordingly, the examiner respectfully maintains the previous grounds of rejection in view of Bornzin.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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