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Applicant’s amendments appear to correct the minor informalities and therefore the claim objections are withdrawn.
With respect to claim interpretation under 35 U.S.C. § 112(f), Applicant does not persuasively argue or provide evidence for why the three-prong test for interpretation would not apply in the instant claims. Therefore, the claims are nevertheless interpreted under 35 U.S.C. § 112(f).
Applicant’s arguments with respect to the pending claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: processor unit and memory unit in claims 1 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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.
Claim(s) 1-4, 5, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao et al. (U.S. Patent Application Publication No. 2018/0279891) hereinafter referred to as Miao; in view of Bruinsma et al. (U.S. Patent No. 11,026,628) hereinafter referred to as Bruinsma; in view of Lisogurski et al. (U.S. Patent Application Publication No. 2016/0135692) hereinafter referred to as Lisogurski; in view of Gill et al. (U.S. Patent Application Publication No. 2019/0336083) hereinafter referred to as Gill.
Regarding claim 1, Miao teaches a wearable device (Fig. 1a-b) for long-term monitoring of heart rhythm waveforms (¶[0007]), comprising:
a sensor unit (¶[0036]) comprising at least one pulse oximeter (¶[0039]) and an ECG sensor (¶[0078] ECG co-located with PPG sensor) having at least one pair of dry electrodes configured to be in contact with a body surface (Fig. 1a, sensors 152, 156 configured to be in contact with body, ¶[0039]);
a processor unit (¶¶[0042-0043]);
a memory unit (¶[0044]); and
a power unit comprising a battery and configured to disseminate battery power amongst various components of the wearable device (¶[0036] battery);
wherein, the at least one pulse oximeter is configured to measure optically a bloodstream at a sampling rate (¶[0044]) and output first oximetry data (¶[0029]);
wherein, the processor unit is configured to process the first oximetry data and determine a time to automatically start a single continuous recording of the processed first oximetry data (¶[0035]);
wherein the ECG sensor is configured to measure one or more voltage signals in relation to heart rhythm activity (¶[0052]), and
output second ECG data comprising the one or more voltage signals (¶[0077]),
wherein the time for the automatic recording of the processed first oximetry data is determined when one or more voltage signals of the ECG sensor exceed a voltage threshold (¶[0077] ECG signals used for threshold beat detection adjustment),
wherein the processor unit is configured to analyze the processed first oximetry data to determine whether there is any irregularity in peak-to-peak pulse timings (¶[0079] PPG based arrhythmia detection), and
wherein, when an irregularity in peak-to-peak pulse timings is determined, the processor unit is configured to activate the ECG sensor and record the second ECG data in the memory unit (¶[0078]).
Miao does not teach the ECG sensor having at least one pair of dry electrodes, or wherein, the processor unit is configured to dynamically adjust the sampling rate of the at least one pulse oximeter based on a predetermined event; or that the processor is configured to automatically activate the ECG sensor.
Attention is drawn to the Bruinsma reference, which teaches the ECG sensor having at least one pair of dry electrodes (col. 2, lines 1-6, col. 3, lines 47-52 plurality of electrodes).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable device of Miao to use dry electrodes, as taught by Bruinsma, because they do not require additional components such as electrolytic gel (Bruinsma, col. 3, lines 47-52).
Miao as modified does not teach wherein, the processor unit is configured to dynamically adjust the sampling rate of the at least one pulse oximeter based on a predetermined event; or that the processor is configured to automatically activate the ECG sensor.
Attention is brought to the Lisogurski reference, which teaches wherein a processor unit is configured to dynamically adjust the sampling rate of the at least one pulse oximeter based on a predetermined event (¶[0063]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable device PPG sensor of Miao as modified to include dynamic sampling rate adjustment, as taught by Lisogurski, because it provides power usage optimization (Lisogurski, Abstract).
Miao as modified does not teach the processor is configured to automatically activate the ECG sensor.
Attention is drawn to the Gill reference, which teaches automatically activating an ECG based sensor to confirm a cardiac arrhythmia (¶¶[0069-0070]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cardiac monitoring of Miao as modified to include automatic activation of ECG sensing, as taught by Gill, because it provides improved sensing and confirmation during/of arrhythmia episodes (Gill, ¶[0152]).
Regarding claim 2, Miao as modified teaches the wearable device as claimed in claim 1.
Lisogurski further teaches wherein the predetermined event is one or more of: a battery charge level of the wearable device, a detected physical activity level, and quality of one or more detected sensor signals (¶[0173]).
Regarding claim 3, Miao as modified teaches the wearable device as claimed in claim 2.
Lisogurski further teaches wherein the dynamic adjustment of the sampling rate of the at least one pulse oximeter is such that the sampling rate is reduced as the battery charge level of the wearable device drops (¶[0173], it is noted that battery charge level drops as the device is powered on over time, therefore any reduction in sampling rate meets the requirement of occurring as the battery charge level is dropping).
Regarding claim 4, Miao as modified teaches the wearable device as claimed in claim 2.
Miao further teaches wherein the sensor unit further comprises a tri-axis accelerometer (¶[0043]) configured to track motion of the wearable device (¶[0035]) at the same sampling rate as that of the at least one pulse oximeter, the tracked motion being used to determine the detected physical activity level (¶[0043]).
Regarding claim 6, Miao as modified teaches the wearable device as claimed in claim 1.
Gill further teaches wherein the sampling rate is adjustable in a range approximately between 215 Hz and 1000 Hz (¶[0157] 128, 512 Hz is within this range).
Regarding claim 13, Miao as modified teaches the wearable device as claimed in claim 12.
Gill further teaches wherein the processor unit is configured to end the recording of the second ECG data when any of the following two conditions is met:
a fixed duration of recording time is reached (¶[0095])
Regarding claim 14, Miao as modified teaches the wearable device as claimed in claim 13.
Miao as modified does not teach wherein upon ending of the recording of the second ECG data, the processor unit is configured to analyze the second ECG data so as to select ECG data with the best signal to noise ratio
Gill further teaches wherein upon ending of the recording of the second data, the processor unit is configured to analyze the second data so as to select ECG data with the best signal to noise ratio (¶[0108]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the data analysis of Miao as modified to include selection based on signal to noise ratio, as taught by Hughes, for improving the sensitivity level of signal analysis (Hughes ¶[0108]).
Claim(s) 5, 15, 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao, Bruinsma, Lisogurski, and Gill as applied to claim 1 above, and further in view of Panteloupos et al. (U.S. Patent Application Publication No. 2017/0209055) hereinafter referred to as Panteloupos.
Regarding claim 5, Miao as modified teaches the wearable device as claimed in claim 4.
Miao as modified does not teach wherein the further dynamic adjustment of the sampling rate is such that the sampling rate is increased as the tracked motion intensifies.
Attention is brought to the Panteloupos reference, which teaches wherein the further dynamic adjustment of the sampling rate is such that the sampling rate is increased as the tracked motion intensifies (¶[0172]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sampling rate adjustment of Miao as modified to include adjustment based on motion data, as taught by Panteloupos, because it improves robustness of sensor data to motion artifact (Panteloupos ¶[0172]).
Regarding claims 15, 23, and 25, Miao as modified teaches the wearable device as claimed in claim 14.
Miao as modified does not teach further comprising a cellular module wherein the processor unit is configured to activate the cellular module so as to transmit the selected ECG data to a remote server via a mobile network without affecting the recording of the first data
Attention is brought to the Panteloupos reference, which teaches further comprising a cellular module wherein the processor unit is configured to activate the cellular module so as to transmit the selected ECG data to a remote server via a mobile network without affecting the recording of the first data (¶[0184], ¶[0304]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the analysis of Miao as modified to use selective and automated transmission of selected data, as taught by Panteloupos, because it allows for additional biometric or physiological quantities to be calculated that are difficult or inaccurate to calculate otherwise (Panteloupos ¶[0252]).
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792