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 § 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.
Claims 3, 4, 6, 7, 10 and 11 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.
In regards to claims 3 and 10, the two instances of “if” are vague. It is unclear whether the claim requires a condition of meeting the stability criterion in response to determining the recited calculations, or whether the claim merely requires that the stability criterion can be met in combination with the “if” conditions being met (i.e., the stability criterion is met “if” the conditions are met, but also can be met “if” they are not). In other words, it is unclear whether the claim requires the stability criterion to be met conditionally on the “if” parameters, or merely permissive “if” the parameters are met.
In regards to claims 4 and 11, “the first time period” and “the second time period” lack antecedent basis. It appears that this claim should depend from claim 3.
In regards to claim 6, similar to claim 3, it is unclear whether the “if” limitations are conditional for the “transitions” or merely permissive.
Claim 7 recites that “the pacemaker works in the VDD mode.” This limitation is vague because it lacks antecedent basis and it is unclear if or how this limits any of the structural features set forth in the apparatus claim 1 from which it depends. It is unclear whether this is some sort of intended use of the apparatus or whether some element or elements have been specifically programmed to provide a VDD mode.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the broadest reasonable interpretation of a “computer program product” or “computer readable data carrier” include within their scope software per se (e.g., a computer program product including an “app” or other purely software product not embodied on a tangible medium, or a signal per se (e.g., a “data carrier” can be a signal carrying information disembodied from any tangible medium).
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 13-15 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 (as best understood), 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 (as best understood), 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 (as best understood), 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 claims 14 and 15, 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 works in the VDD mode.
However, Sheldon in the same field of endeavor of cardiac pacing teaches providing a pacemaker that works in the VDD mode (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 works in the VDD mode 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yoon et al. (US 2022/0072316) is another example of motion-responsive pacing.
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