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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the online analysis platform, multiple data streams, snippets and single composite data stream must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 15: the claim recites “wherein when the data transferred from the wearable device comprises multiple data streams, the online analysis platform is operable to: break each of the data streams into a plurality of snippets, each snippet recorded in a different recording period; calculate a SNR for each of the plurality of snippets of each data stream; select the snippet having the highest SNR in every recording period; and concatenate all the selected snippets to generate a single composite data stream.” This language is directed towards data processing and/or a computer implemented method which is considered to be a computer implemented function. When examining computer implemented functions it must be determined if an algorithm (steps and/or flow charts) are described in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor had possession of the claimed invention. In this case the algorithm to perform this function is missing entirely. There is a high level discussion found on pages 25-26 but this in no way provides detail as to how the methods are performed. It is not disclosed as to how the snippets are all concatenated to form a single composite data stream. This language will not be rejected under prior art.
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 1-12 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.
Regarding claims 2-12: the claims are directed towards what appears to be methods steps (see claim 3 in particular). Claim 1 is directed towards “A wearable device”. The claims are therefore indefinite in that the language appears to be mainly functional in language without further limiting the claimed structure of the wearable device. In these claims the processor is operable to preform these steps without detailing in any way how the structure of the device, outside of the processor, or the structure of the processor can perform this function. The claims are therefore indefinite.
Regarding claim 2: the claim recites “wherein to determine the electrode pair for data recording”; this appears to lack proper antecedent basis to claim 1 which recites “determine an electrode pair”. This should likely recite “wherein the determining of the electrode pair for the data recording”.
Regarding claim 3: the claim recites “repetitively perform calculating, identifying and selecting steps”. These processes are not identified as steps in claim 1 or in claim 2. It is unclear if this is to be a method claim or a device claim.
Regarding claim 4: the claim recites “wherein the processor unit is operable to end data recording for the selected electrode pair when its SNR drops below the SNR threshold.” It is unclear when SNR is calculated to enable this step. It is further unclear how this language further limits the device structure.
Regarding claim 5: the claim recites “wherein the processor unit is operable to select another electrode pair for data recording and determine that there is no change in the selected electrode pair”. It is unclear which electrode pair is selected.
Regarding claim 6: the claim recites “the newly selected electrode pair”, the language lacks proper antecedent basis and it is unclear how this language further limits the structure of the previous claims.
Regarding claim 7: the claim recites “operable to append the voltage signal data measured”, this language is not understood and will not be addressed with prior art.
Regarding claim 8: the claim recites “wherein the processor unit is operable to begin recording voltage signal data from all of the electrode pairs when none of the electrode pairs have a SNR equal to or higher than the SNR threshold”. This language is indefinite in that it is unclear when and how SNR is determined.
The remainder of the claims are also rejected in that they depend from previously rejected claims.
Claim Rejections - 35 USC § 102
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, 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weisel US 2019/0298200.
Regarding claim 1 : Weisel disclose a wearable device (figures 1-2) for detecting heart rhythm abnormalities (“atrial fibrillation”, abstract), comprising:
a pulse oximeter 14/16 (figure 2, paragraph 0037 and “plethysmography”, paragraph 0057) which inherently senses peak-to-peak pulse timings (see figures 3-4 which include a pulse waveform from a plethysmograph);
an ECG sensor 36 (figure 22 and paragraphs 0051, 0053-54), it is inherent and known in the art that in order to conduct ECG measurements there are pairs of electrodes which measure voltage, the electrodes are considered to be dry electrodes; and
a processor 32 (figure 2) which uses pulse beats to initially determine Afib (paragraph 0049), the processor checks for irregularities in the pulse beats, if Afib is present then an ECG is initiated (paragraph 0050), the pulse beats are obtained by plethysmography and/or a light source (paragraphs 0057-59). Weisel further discloses the processor analyzes signals from each pair of electrodes and selects the pair of electrodes with the largest amplitude and least noise, which is a high signal to noise amplitude (paragraph 0053). This indicates that each electrode pair is measured/polled periodically after there is an indication of Afib and all of the pairs are measured indicating sequentially activating the electrode pairs. The signals are recorded and stored (paragraphs 0070 and 0073).
Regarding claim 13: Weisel discloses the wearable device on a users arm (figure 8), the electrodes are on the band where the fingers are positioned and also on the back of the watch face (figure 8).
Regarding claim 16 : Weisel disclose detecting heart rhythm abnormalities (“atrial fibrillation”, abstract), comprising: a pulse oximeter 14/16 (figure 2, paragraph 0037 and “plethysmography”, paragraph 0057) which inherently senses peak-to-peak pulse timings (see figures 3-4 which include a pulse waveform from a plethysmograph);
an ECG sensor 36 (figure 22 and paragraphs 0051, 0053-54); and a processor 32 (figure 2) which uses pulse beats to initially determine Afib (paragraph 0049), the processor checks for irregularities in the pulse beats, if Afib is present then an ECG is initiated (paragraph 0050), the pulse beats are obtained by plethysmography and/or a light source (paragraphs 0057-59). Weisel further discloses the processor analyzes signals from each pair of electrodes and selects the pair of electrodes with the largest amplitude and least noise, which is a high signal to noise amplitude (paragraph 0053). This indicates that each electrode pair is measured/polled periodically after there is an indication of Afib and all of the pairs are measured indicating sequentially activating the electrode pairs. The signals are recorded and stored (paragraphs 0070 and 0073).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Weisel US 2019/0298200 in view of Xue et al. US 2019/0133483.
Regarding claim 2 as understood: Weisel disclose that the processor calculates the largest amplitude ECG signal with the least noise which is considered to be the pair with the highest signal-to-noise ratio, this calculation is performed on each electrode pair (paragraph 0053); as is inherent and known in the art with respect to ECG signals, the voltage is measured between the pairs. Weisel further discloses that the pair with the largest amplitude and least noise (i.e. highest SNR) is selected. However, Weisel does not disclose using a SNR threshold. Xue however teaches of ECG recordings in which a signal-to-noise threshold is used to determine if reliable information regarding the patient is within the ECG signal prior to recording. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisel to include the use of a SNR threshold, as taught by Xue, in order to evaluate the ECG signal for quality.
Regarding claim 3 as understood: Weisel discloses the claimed invention including the which processor 32 (figure 2) which calculates the SNR, identifies the electrode pairs with the highest signal and selects the electrode pair with the highest signal to noise ratio (paragraphs 0052-0053) as well a recording (paragraph 0020), the ECG and pulse are recorded concurrently which is considered to be in parallel (paragraph 0011).
Claim 4-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Weisel US 2019/0298200 in view of Xue et al. US2019/0133483 and further in view of Jain et al. US 2016/0287128.
Regarding claim 4 as understood: Weisel/Xue discloses the claimed invention. However Weisel/Xue does not disclose the end of recording when the pair dops below the SNR threshold. Jain hover teaches of contactless ECG sensors which measure signal quality, which could be SNR, once the quality drops below a threshold a separate sensor is used (paragraph 0039) and to rerun the selection algorithm (paragraph 0077). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisel/Xue to include removing the electrode from recording if the signal quality drops below a threshold, as taught by Jain, in order to attain the highest quality signals.
Regarding claim 5 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses that the processor selects electrode pairs (paragraphs 0052-53).
Regarding claim 6 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses that the processor records from the pairs (paragraph 0020) therefore Weisel discloses recording from any pair which would necessarily and inherently include new pairs.
Regarding claim 8 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses that each electrode pair can be recorded from (paragraphs 0020, 0030-31), this would include weather or not their SNR is higher or lower than a threshold.
Regarding claim 9 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses that each electrode pair can be recorded from (paragraphs 0020, 0030-31), this would include the capability of recording and storing multiple data streams.
Regarding claim 10 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses recording ECG signals, this would inherently also include stopping the recording.
Regarding claim 11 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses selecting electrode pairs and recording signals this would include if there is no change (paragraphs 0052-53).
Regarding claim 12 as understood: Weisel/Xue discloses the claimed invention, Weisel further discloses selecting electrode pairs and recording signals this would include for new pairs of electrodes.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Weisel US 2019/0298200 in view of Lange US 2016/0360986.
Regarding claim 14 as understood: Weisel discloses the claimed invention however Weisel does not disclose online analysis which processes and analyzes the ECG. Lange however teaches of a similar device which includes a cloud-based computing resource with server farms, the sensor data which includes ECG data is sent to the cloud for analysis (paragraph 0034). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisel to include cloud based signal analysis, as taught by Lange, in order to remotely analyze the data (paragraph 0049).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796