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, see pages 14-16, filed on 12/22/2025, with respect to the pending 35 USC 101 rejection of claim 8 have been fully considered and are persuasive. The 35 USC 101 rejection of claim 8 has been withdrawn.
Claim Objections
Claims 8 and 29 are objected to because of the following informalities:
Claim 8, Pg. 2, line 4 recites “…communication prototcol…”. Examiner suggests amending the claim to recite, “….communication protocol…”
Claim 29 depends from canceled claim 1. Examiner suggests amending the claim to depend from claim 8. In order to further advance prosecution, Examiner will be interpreting the claim as depending from claim 8 for examination purposes.
Appropriate correction is respectfully requested.
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: “consumer grade non-invasive wearables” in claim 8. For examination purposes, “consumer grade non-invasive wearables” will be interpreted as a smart watch, wristwatch, or a vital patch as supported by [0013] and [0089] of the disclosure (as published).
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 § 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.
Claims 8, 14, 16, and 28-44 are 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. Claim 8 now requires “consumer grade non-invasive wearables”, “consumer grade mobile devices”, and a “consumer grade mobile edge-computing device” which is not described in the specification. There is no support in the disclosure for using consumer grade devices to carry out the method recited in claim 8. A review of the disclosure ([0089] as published) teaches the use of wearables, mobile devices, and edge computing devices, but fails to teach consumer grade non-invasive wearables, consumer grade mobile devices, or a consumer grade mobile edge-computing device. Therefore, it appears Applicant is adding new matter requiring the method of claim 8 to be executed using consumer grade non-invasive wearables, consumer grade mobile devices, and a consumer grade mobile edge-computing device.
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 8, 14, 16, and 28-44 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.
The term “problematic signal noise” in claim 8 is a relative term which renders the claim indefinite. The term “problematic signal noise” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear if the claim can only be executed when a certain type of noise, or if the method can be used with any type of noise. Dependent claims inherit the same deficiencies.
Regarding claim 8, the recitation of “consumer grade non-invasive wearables”, “consumer grade mobile devices”, and a “consumer grade mobile edge-computing device” renders the claim unclear. The term “consumer grade” in claim 8 is a relative term which renders the claim indefinite. The term “consumer grade” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In order to further advance prosecution, Examiner is interpreting a “consumer grade” non-invasive wearable, mobile device, or mobile edge-computing device to be any non-invasive wearable device, mobile device, or mobile edge-computing device that is considered to be well-known, routine, and conventional in the art. Dependent claims inherit the same deficiencies.
Examiner’s Note
Examiner notes that claims 8, 14, 16, and 28-44 are rejected under 35 USC 112, however no prior art rejections have been made. Examiner has not found any prior art that teaches or suggests all of the limitations recited in claim 8.
Rossi et al (US Publication 2017/0340292) hereinafter Rossi discloses:
by one or more biosensors embodied among one or more wearable devices worn by a mobile patient: (i) measuring a biosignal of the mobile patient and performing real- time conversion thereof into a digital biosignal, in which there is embodied noise that is of detrimental relation to accurate measurement of the physiological parameter and includes motion artifacts ([0005] detecting a beat in a heartbeat signal; associating a heart rate and an energy of acceleration with the detected beat)
(ii) converting said noisy digital biosignal into a digitally compressed noisy signal comprising sparse vector data representative of both the physiological parameter and said noise ([0005] generating, using the set of detected beats as a set of training data, a dictionary of a sparse approximation model);
in concurrent relation to step (a), and by one or more motion sensors embodied among said one or more wearable devices worn by the mobile patient, capturing motion data representative of body motion of the mobile patient during capture of the measured biosignal ([0094] he ECG data stream and the accelerometer data are synchronized or assumed to be synchronized. For each heartbeat the energy of the acceleration (EE) of the associated accelerometer data is measured).
However, Rossi fails to disclose a method of overcoming problematic signal noise in measurement and wireless transmission of electrocardiogram (ECG) and photoplethysmography (PPG) biosignals of actively mobile subjects using consumer grade non-invasive wearables for transmission to consumer grade mobile devices over low power wireless communication to enable real-time evaluation and continuous monitoring of multiple physiological parameters of said actively mobile subjects, the method comprising:
by non-invasive ECG and PPG sensors embodied among one or more consumer grade wearable devices worn by an actively mobile patient:
(i) measuring a ECG and PPG biosignals of the mobile patient and performing real-time conversion thereof into digital ECG and PPG signals, in which there is embodied noise that is of detrimental relation to accurate measurement of the physiological parameters and includes both motion artifacts and electromagnetic interference;
(ii) converting said noisy digital ECG and PPG signals into digitally compressed ECG and PPG signals by performing, in real-time, inverse discrete cosine transformation of said noisy digital ECG and PPG signals and quantization of the transformed noisy digital ECG and PPG signals to derive vector representations thereof composed of frequency components and associated coefficients, and discarding a subset of said frequency components whose associated coefficients fall below a threshold such that the digitally compressed ECG and PPG signals comprise sparse vector data representative of both the ECG and PPG biosignals and said noise, and transmitting, via a low power wireless communication protocol, said digitally compressed noisy signals from the one or more wearable devices;
(b) in concurrent relation to step (a), and by one or more motion sensors embodied among said one or more consumer grade wearable devices worn by the actively mobile patient, capturing motion data representative of body motion of the actively mobile patient during capture of the measured ECG and PPG biosignals and transmitting, via a low power wireless communication protocol, said motion data from the one or more consumer grade wearable devices;
(c) by a consumer grade mobile edge-computing device borne by the actively mobile patient, receiving via said low power wireless communication protocol, of both the digitally compressed ECG and PPG signals and the motion data from the one or more consumer grade wearable devices;
(d) by said consumer grade mobile edge-computing device of the actively mobile subject, and through execution thereby of a machine learning algorithm trained to detect and classify patterns between sparse ECG and PPG signals and noise factors including at least said motion artifacts and said electromagnetic interference, using the digitally compressed ECG and PPG signals and the motion data from the one or more wearable devices as combined input to the machine learning algorithm to calculate, in real-time, estimated noiseless sparse vector ECG and PPG signals from which said motion artifacts are filtered out during classification using said motion data;
(e) by said consumer grade mobile edge-computing device, decompressing said estimated noiseless sparse ECG and PPG signals, in real-time, to reconstruct source ECG and PPG biosignals therefrom;
(f) by said consumer grade mobile edge-computing device, applying a multi-linear regression algorithm to features extracted from the reconstructed source ECG and PPG biosignals to calculate, in real-time, estimated noiseless quantifications of the physiological parameter;
(g) outputting, in real time and by said mobile consumer grade edge- computing device, said estimated noiseless quantifications of the physiological parameters; and
(h) continuously repeating steps (a) through (g) for continuous real-time monitoring of the physiological parameters;
wherein the multiple physiological parameters comprise at least a plurality of skin temperature, oxygen saturation, blood pressure, heart rate and respiration rate, and the machine learning algorithm comprises a classifier trained using random initial guesses of weights and biases of neurons in a deep neural network, through which training samples were fed through layers thereof to calculate predicted sparse vector ECG-PPG signals to find a class label for ECG-PPG signals and noise interference, and a cost function used to measure difference between the predicted sparse vector ECG-PPG signals and desired outputs, with application of gradient descent and backpropagation over multiple training samples to minimize the cost function through adjustment of the weights and biases, arriving at weights that configure the classifier to eliminate the motion artifacts, and accurately derive the estimated noiseless sparse vector ECG and PPG signals, in step (d).
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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792