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 .
Election/Restrictions
Applicant’s election without traverse of Invention II (claim 7) in the reply filed on 06/30/2025 is acknowledged.
Claims 1-6 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2025.
Drawings
The drawings are objected to because Figs. 1-7 use words that are pixelated and are hard to read due to the use of small font size. 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 Objections
Claim 7 is objected to because of the following informalities: the phrase “Method for multimodal biological feedback” of line one should recite “A method for multimodal biological feedback”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase “enabling it to monitor” of line 6 should recite “enabling the set of sensors to monitor”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase "the sensors" in line 6 should recite “the motion sensors”. Appropriate correction is required.
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 7 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.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted).It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Claim 7 fails to sufficiently describe the usage of the machine learning algorithms and digital twins in enough detail for one skilled in the art to understand how the inventor has possession of the claimed invention. The mere statement and recitation of the usage of models such as deep learning neural network model of the instant specification provides insufficient detail to the type of data that is used to train the model and the algorithm used to determine the anomalies. Further, the instant specification fails to detail the way in which the machine learning model pre-trains the data, how/what the pre-trained data is classified as, what ways are the sensors calibrated in their respective manners, and how/what within the data is looked at to make the determination of an anomaly. It is further unknown what within the EMG, EEG, and ECG data’s combined would help reach a state of anomaly and what is this anomaly relating to. It is further unknow what “digital twins” are and how they are used to process the data. One skilled in the art would not know how the instant application uses the “digital twins” and the application to the instant invention and is merely naming its use. Therefore, claim 7 does not provide sufficient detail for one to replicate and understand the intended function that’s being performed as Applicant has failed to show possession of the invention. The mere statement and recitation of the human pose tracking technology and digital twins in the instant specification provides insufficient detail as to what this human pose tracking technology composes.
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.
Regarding claim 7 line 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites the limitation "the form" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the measured parameters" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the current state" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 7 recites a step detecting any changes or anomalies in the user's vitals… interpreting the user's vitals and providing feedback, comparing the current state with historical data, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements, determining values, and detecting anomalies do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and detecting anomalies, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 7 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claim 7, the following step is an abstract idea:
“detecting any changes or anomalies in the user's vitals… interpreting the user's vitals and providing feedback, comparing the current state with historical data”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze and interpret vital signs and detect anomalies.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 7, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a processor and memory [would presumably be required as it is not claimed]” to are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
It is noted that the machine learning algorithms and digital twins are by definition automating the human thinking process with a computer.
- “set of sensors and tracking devices”, “motion sensors” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “physiological and biomechanical, “current state”, “historical data”, “vital signals”, “ECG”, “EMG”, “EEG”, “anomalies”, and “biological feedback /auditory, visual, or tactile stimuli” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “human pose tracking technology” is generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a processor and memory [would presumably be required as it is not claimed]” to are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
It is noted that the machine learning algorithms and digital twins are by definition automating the human thinking process with a computer.
- “set of sensors and tracking devices”, “motion sensors” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “physiological and biomechanical, “current state”, “historical data”, “vital signals”, “ECG”, “EMG”, “EEG”, “anomalies”, and “biological feedback /auditory, visual, or tactile stimuli” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “human pose tracking technology” is generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
The additional elements of claim 7, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the implantable medical device, processing circuitry, and storage devices, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor, EKG sensor, accelerometer or an acoustic sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]) and Roovers et al (US 20170007166) teaches an accelerometer for detecting motion signals ([0008]).
In summary, claims 7 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mi et al. (US 20200129099) (Hereinafter Mi) in view of Miller et al. (US 20150289820)(Hereinafter Miller) and Aloqaily et al. (US 20240127384)(Hereinafter Aloqaily).
Regarding claim 7, Mi teaches Method for multimodal biological feedback measurement ([0008] “The physiologic information may include cardiac electrical information, cardiac mechanical information (e.g., heart sounds information), bioimpedance information, patient autonomic response, blood pressure information, or respiration information.”), comprising:
- providing a user with a set of sensors and tracking devices configured to measure various physiological and biomechanical signals, such as electroencephalography (EEG) signals, electromyography (EMG) signals, and electrocardiography (ECG) signals ([0068] “The cardiac sensor 210 can be configured to receive cardiac electrical information, such as an electrocardiograph (ECG), a subcutaneous ECG, or an intracardiac electrogram (EGM).”);
- providing motion sensors and human pose tracking technology ([0066] “The heart sound sensor 206 may take a form of an accelerometer [motion sensor]” [0064] “a posture sensor 214 [human pose tracking technology]”);
- using machine learning algorithms to automatically calibrate the sensors, enabling it to monitor the user's vitals more accurately ([0076] “the calibration circuit 308 can be configured to adjust sensor operations (e.g., sensor configuration, timing, sampling rate, duration) for collecting physiologic information, such as one or more of the sensors 204-216. Additionally or alternatively, based on the glucose concentration measurement, the calibration circuit 308 can be configured to adjust an algorithm used by the glucose index generator 305 to determine the glucose index, such as by adjusting the weights for individual sensors, or the method of combining the sensor measurements to generate a composite risk score.”);
- detecting any changes or anomalies in the user's vitals and alerting both the user and their doctor ([0094] “an alert or notification may be generated and provided to user (e.g., a patient, a clinician, or a caregiver) about the determined abnormality in patient glucose level.” [0075] “The alert or notification may include audio, text, graph, animation, or other visual or audiovisual formats.”);
- providing biological feedback to the user in the form of auditory, visual, or tactile stimuli designed to help the user improve their performance ([0075] “The alert or notification may include audio, text, graph, animation, or other visual or audiovisual formats.”);
determining appropriate feedback to provide to the user ([0094] “an alert or notification may be generated and provided to user (e.g., a patient, a clinician, or a caregiver) about the determined abnormality in patient glucose level.”);
- interpreting the user's vitals and providing feedback ([0060] “an increase in one or more of the Q-T, R-T, or R-S2 interval can be indicative of an increase in Q-T prolongation, which can be indicative of arrhythmia, or a decrease in cardiac output, etc.), which can be indicative of an increased likelihood of abnormal blood glucose level.”).
However, Mi does not teach the comparison of the current state with historical data. Miller, in the same field of endeavor, teaches a medical device for calibrating a measurement sensor for physiological signals (Abstract), and further teaches - interpreting the user's vitals and providing feedback, comparing the current state with historical data ([0135] “the historical trending data can be averaged or compared to other historical trending data or current measurement data and each data set can be given weighting values.”) to optimally calibrate the sensors ([0136]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Mi, with the comparison of the current state with historical data of Miller, because such a modification would allow to optimally calibrate the sensors.
However, Mi does not teach using digital twins to interpret measured parameters. Aloqaily, in the same field of endeavor, teaches predicting abnormalities from sensors that obtain physiological parameters and sensing feedback (Abstract), and further teaches - processing using digital twins to interpret the measured parameters relevant to the biological feedback ([0122]-[0123]) to improve the models' accuracy ([0122]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Mi, with the digital twins to interpret measured parameters of Aloqaily, because such a modification would allow to improve the models' accuracy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796