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 arguments filed 7/22/26 have been fully considered but they are not persuasive. The argument that Schmidt teaches a very different approach to determine an edge detection threshold may be correct, however Schmidt still reads on the broad claim limitations. Schmidt senses noise signals, such as peaks, to find a noise baseline in order to increase the threshold over that noise baseline (e.g. paras. 93-94, 85, 91, etc.) and starts the sensing of the noise based on an R wave (e.g. para. 86, etc.), not using/during a frame or advertisement sequence. It is also noted that Schmidt does not discuss frames or advertisement sequences, and the claim is an open-ended “comprising” claim and does not preclude determining the noise baseline also from times/signals when there are frames or advertising sequences—i.e. the claims do not state that no signals are used from periods of advertisement sequences or frames to determine the noise baseline.
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.
Claims 1-4, 6-9, 11-12, 14, and 16-19 are rejected under 35 U.S.C. 102a1 as being anticipated by Schmidt et al (2017/0054516). Schmidt discloses the claimed limitations as follows:
--a medical device (e.g. figures 1-3, paras. 68-71, etc. where the device can be internal or external)
--sense circuitry configured to use a sensing vector of two electrodes (e.g. elements 106, 206, etc.)
--a controller to determine a noise baseline (e.g. elements 110, 210, etc.) where the noise baseline is determined (e.g. paras. 107, 93, 85, etc.) and edge detection threshold is set above the noise baseline (e.g. element 505, paras. 107, 93, 85, etc.), and
--comparator circuitry by comparing further sensed signals to produce edge detections (e.g. paras. 81, 93, etc.).
As to the newly amended claims and arguments about the amended limitation of obtaining a plurality of sensed amplitude values when the sensed signal includes neither an advertisement sequence nor a frame, and determining a noise baseline from the obtained signals, as seen in figure 5, the noise 504 is sensed neither during an advertisement sequence nor a frame (e.g. at element 502/503), or when a frame is not being conductively communicated. It is also noted that:
--Schmidt does not discuss frames or advertisement sequences,
--Schmidt does sense the amplitude of noise signals (e.g. paras. 91, 93, 85, etc.) and starts the sensing window based on a cardiac R wave (e.g. para. 86, etc.), not using/during a frame or advertisement sequence, and/or
-- the claim is an open-ended “comprising” claim and does not preclude determining the noise baseline also from times/signals when there are frames or advertising sequences.
For claim(s): 2, decode a message (paras. 12-16, 50, etc.); 3, external MD (e.g. para. 71, with internal device and skin electrodes—note that the dry electrodes have not been positively recited—in the alternative, see the 103 rejection below); 4, amplified and filtered signal to determine the noise baseline (e.g. paras. 81, 107, 93, 85, etc.); 6, as the system senses the peak values of the noise, the noise baseline will be based on the peaks (e.g. paras. 107, 93, 85, etc.); for claim 7 and 17, using a threshold equal to noise baseline plus an offset (e.g. paras. 93-94, 85, etc.; an offset above the peak/maximum values); 8 and 18, as seen in figure 5, the noise 504 is sensed neither during an advertisement sequence, nor a frame (e.g. at element 502/503), or when a frame is not being conductively communicated.
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 3, 5, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. Schmidt discloses the claimed invention and attachment of the electrodes to the skin, but does not specifically call them dry electrodes, and using the noise signal to find the noise baseline, but not the use of averaging the noise signal for determining the baseline. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Schmidt, with the use of dry electrodes on the skin and averaging the noise amplitude values to determine the noise baseline, as is well known and common knowledge in the art, since it would provide the predictable results of allowing faster setup of attachment of the electrodes to the skin without requiring cleanup of gel from gel electrodes and are better for sensitive skin, and providing a better representation of the noise that gets rid of random noise or spikes and that is easier to analyze and determine the value of the noise.
Allowable Subject Matter
Claims 10 and 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 10/2/26
