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
In light of the amendments received the Drawing objections and 35 USC § 112 rejections have been withdrawn.
Applicant’s arguments, see Applicants Response, filed 6/25/2026, with respect to the rejections of claims 1, 13 and 16 under Weisel US 2019/0298200 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Luna et al. US 2015/0057506.
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 19 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 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. Claim 19 recites “A wearable device as claimed in claim 1, wherein the processor unit is further configured to operate in a simultaneous recording mode wherein voltage signal data is recorded and stored from all of the two or more electrode pairs simultaneously”. Within the specification, page 8 lines 20-26 recite “In an embodiment, the ECG sensor 301(b) may be configured such that it can be switched between two operating modes, i.e. an idling mode and an active mode. When in the idling mode, the ECG sensor 301(b) may not measure electrical voltages from multiple pairs of electrodes and thus generate no electrical voltage signals. Whereas, when in the active mode, the ECG sensor 301(b) may continuously measure the electrical voltage between one or more pairs of electrodes at a given sampling rate, such as the sampling rate set for the multi-channel pulse oximeter 301(a), as described above.” Page 10, lines 9-24 recite sleep, active modes and inactive modes. However, nowhere within the specification is there a recitation of a simultaneous recording mode in which voltage signals are recorded and stored from all of the electrode pairs simultaneously. Therefore this is considered to be new matter which was not previously disclosed.
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.
Claim 7 is 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.
Claim 7 recites “A wearable device as claimed in claim 6, wherein the processor unit is operable configured to append the voltage signal data measured through the newly selected electrode pair to that measured through the previously selected electrode pair so as to form a single data stream.” The definition of the word “append” is: “to add something to the end of a piece of writing” i. It is not clear what applicant intends the language to mean, it is unclear how a voltage signal can be or is appended which would be to add something, it is not clear what is added. This claim will not be addressed using prior art in that it is not clear what is intended.
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.
Claims 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Weisel US 2019/0298200 previously cited in view of Luna et al. US 2015/0057506.
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).
Weisel therefore discloses the claimed invention including the wearable device attached to a user’s arm (figure 8), which is a single arm. However, Weisel does not disclose that the ECG sensors are attached to an inner surface of the armband and positioned so that dry electrode pairs are on opposite sides of the single arm facing each other and the ECG voltage is measured across one electrode pair between two locations on a single arm.
Luna however teaches of a wearable device (abstract, title) which can be worn on a single wrist or arm (paragraphs 0009, 0019, 0038-0039 “electrodes adjacent an arm portion of a wearer”, figure 2 demonstrates a single arm). Luna further teaches that multiple electrodes 110a-110d (figure 1A, there are 17 electrodes shown in figure 1A) are attached to an inner surface of band 170 (figure 1D, paragraph 0018 “In some embodiments, array 101 and physiological information generator 120 are disposed in a wearable device, such as a wearable data-capable band 170”), this is a concentric arrangement of electrodes around the band. The electrodes of Luna couple capacitively (paragraph 0028) and are considered to be dry electrodes because they do not require electrode gel. Luna further teaches separating the electrodes into pairs 205/207 (“subsets”, figure 2), pairs can be on opposite sides of the band. Luna further that the device is configured to measure electrocardiogram (ECG) signals, ECG signals are signals that include voltage signals and therefore read on the claim language. 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 a single band with multiple dry electrodes, separated in pairs, concentrically spaced around the interior region of the band facing the skin so that there are electrodes facing each other and measuring ECG signals, which include voltage measurements.
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).
Luna however teaches of a wearable device (abstract, title) which can be worn on a single wrist or arm (paragraphs 0009, 0019, 0038-0039 “electrodes adjacent an arm portion of a wearer”, figure 2 demonstrates a single arm). Luna further teaches that multiple electrodes 110a-110d (figure 1A, there are 17 electrodes shown in figure 1A) are attached to an inner surface of band 170 (figure 1D, paragraph 0018 “In some embodiments, array 101 and physiological information generator 120 are disposed in a wearable device, such as a wearable data-capable band 170”), this is a concentric arrangement of electrodes around the band. The electrodes of Luna couple capacitively (paragraph 0028) and are considered to be dry electrodes because they do not require electrode gel. Luna further teaches separating the electrodes into pairs 205/207 (“subsets”, figure 2), pairs can be on opposite sides of the band. Luna further that the device is configured to measure electrocardiogram (ECG) signals, ECG signals are signals that include voltage signals and therefore read on the claim language. 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 a single band with multiple dry electrodes, separated in pairs, concentrically spaced around the interior region of the band facing the skin so that there are electrodes facing each other and measuring ECG signals, which include voltage measurements.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Weisel US 2019/0298200previously cited in view of Luna et al. US 2015/0057506 and further in view of in view of Xue et al. US 2019/0133483 previously cited.
Regarding claim 2: Weisel/Luna 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/Luna 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/Luna to include the use of a SNR threshold, as taught by Xue, in order to evaluate the ECG signal for quality.
Regarding claim 3: Weisel/Luna discloses the claimed invention, Weisel further discloses that the processor 32 (figure 2) 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 2019/0298200previously cited in view of Luna et al. US 2015/0057506 and further in view of Xue et al. US2019/0133483 previously cited and further in view of Jain et al. US 2016/0287128 previously cited.
Regarding claim 4: Weisel/Luna/Xue discloses the claimed invention. However Weisel/Luna/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 re-run 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/Luna/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: Weisel/Luna/Xue discloses the claimed invention, Weisel further discloses that the processor selects electrode pairs (paragraphs 0052-53).
Regarding claim 6: Weisel/Luna/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: Weisel/Luna/Xue discloses the claimed invention, Weisel further discloses that each electrode pair can be recorded from (paragraphs 0020, 0030-31), this would include whether or not their SNR is higher or lower than a threshold.
Regarding claim 9: Weisel/Luna/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: Weisel/Luna/Xue discloses the claimed invention, Weisel further discloses recording ECG signals, this would inherently also include stopping the recording.
Regarding claim 11: Weisel/Luna/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: Weisel/Luna/Xue discloses the claimed invention, Weisel further discloses selecting electrode pairs and recording signals this would include for new pairs of electrodes.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Weisel US 2019/0298200 previously cited in view of Luna et al. US 2015/0057506 and further in view of Oz et al. US 2016/0270675.
Regarding claim 19: Weisel/Luna discloses the claimed invention however Weisel/Luna does not specifically disclose a simultaneous mode where the signals are recorded from all of the pairs of electrodes simultaneously. Oz however teaches of a system for recording and detecting fetal cardiac electrically activity data in which the electrodes are divided into pairs of electrodes and the data is recorded simultaneously from all of the channels (paragraph 0100). It therefore would have been obvious at the time the invention was filed to modify Weisel/Luna to include simultaneously recording from all of the channels of the paired electrodes, as taught by Oz, in order to analyze electrical activity data.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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, Benjamin Klein can be reached at 571-272-5213. 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
i APPEND | English meaning - Cambridge Dictionary https://dictionary.cambridge.org/dictionary/english/append#google_vignette
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