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 1-20 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 claim 1, line 8, “including at least two electrodes…” is vague as this term has been previously used in line 5 and it is unclear if they are the same element or different elements. If they are the same element, then line 8 should use “including the at least two electrodes”.
In claim 3, “the other medical device is configured to be implanted…” and “the at least two electrodes…comprise dry electrodes” are vague as the other medical device and electrodes have not been positively recited/claimed but have only been set forth as intended/functional use recitations. If the claim is meant to limit these elements, it is suggested to first state the system “further comprises” these elements before they are being limited. If they are meant as function recitations, then it is suggested to claim their function in regards to a positively recited element, such as the medical device.
In claim 5, “based on an average value…” is vague and makes the claim incomplete for omitting an element to determine the average value in order for the baseline to be “based on” the average value. It is suggested to first set forth an element that determines the average value. Similarly, in claim 6, “based on a peak value” is vague and makes the claim incomplete.
In claim 11, lines 5, 9, and 10, “that is sensed”, “sensed”, and “is sensed” is vague and in the passive voice. It is unclear if the claim is positively reciting method steps to sensing the signals, or if the claim and/or prior art must only be capable of using a signal that is the same/similar to the sensed signal through two electrodes. It is suggested to use active voice, such as “sensing using a sensing vector including at …” to positively recite the sensing.
Similarly, in claims 14-18, the use of passive voice—“amplified”, “filtered”, “based on”, “produced”, “performed”, etc.—is vague. It is suggested to use active voice to positively recite these method steps.
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.).
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.); 7-8, 17-18, 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 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
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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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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/George R Evanisko/Primary Examiner, Art Unit 3792 6/11/26
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