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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 16, 2024; December 17, 2024; September 15, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on September 09, 2024 are accepted.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 31-41, 43-44 and 47-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bharmi et al. (US 2021/0020294 A1) (“Bharmi”).
Regarding claims 31 and 50, Bharmi discloses A method/device for evaluating the response to and/or the effectiveness of a cardiovascular medication administration program (CMAP), the method comprising (Abstract and entire document):
providing a wearable device comprising a pressure sensor array ([0013], [0132], [0140], [0151] wearables, pap sensors);
a processor in communication with a non-transitory computer-readable storage medium, the storage medium has stored thereon one or more program codes executable by the processor to (abstract and [0166] – [0167]):
receiving at least one first signal associated with a first arterial pressure waveform of the patient obtained prior to the change in CMAP (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness);
receiving at least one second signal associated with a second arterial pressure waveform of the patient obtained after (or during) the change in CMAP (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness);
comparing the at least one first and second signals, thereby identifying differences between the first and second arterial pressure waveforms (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness); and
displaying the identified differences between the first and second arterial pressure waveforms (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness; see at least [0228]).
Regarding claim 32, Bharmi discloses The method according to claim 31, wherein displaying comprises one or more visual representation techniques (FIG. 6I).
Regarding claim 33, Bharmi discloses The method according to claim 31, wherein the visual representation techniques are selected from: a two dimensional attractor, graphs of waveform signals, graphs of the difference in the signals, attractor reconstruction, Hilbert-Huang spectrum analysis with empirical mode decomposition (EMD), and the difference between waveform characteristics (FIG. 6I).
Regarding claim 34, Bharmi discloses The method according to claim 31, wherein the type of change in cardiovascular medication administration program comprises any one or more of: beginning a new treatment, change in type of medication, change in dosage of a medication, change in timing of a medication, changing an administration regime, changing at least a portion of the CMAP, maintaining at least a portion of the CMAP, or any combination thereof (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness; see at least [0232] discussing change in dosage).
Regarding claim 35, Bharmi discloses The method according to claim 31, further comprising outputting a recommendation for a CMAP based, at least in part, on the comparison of the at least one first signal and the at least one second signal, wherein the recommendation comprises at least one of maintaining at least a portion of the CMAP and changing at least a portion of the CMAP, wherein changing at least a portion of the CMAP comprises a recommendation for a specific change in the CMAP regime (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness; see at least [0232] discussing change in dosage).
Regarding claim 36, Bharmi discloses The method according to claim 31, wherein the at least one first signal and/or the at least one second signal is continuous ([0159]).
Regarding claim 37, Bharmi discloses The method according to claim 31, further comprising analyzing the at least one signal via frequency domain and/or time (pulse) domain (FIG. 6I).
Regarding claim 38, Bharmi discloses The method according to claim 31, further comprising preprocessing the at least one first signal and/or the at least one second signal, and wherein the preprocessing comprises dividing at least a portion of the least one first and/or second signals into a plurality of segments, wherein each segment comprises a heart cycle ([0194]).
Regarding claim 39, Bharmi discloses The method according to claim 31, further comprising preprocessing the at least one first signal and/or the at least one second signal, and wherein the preprocessing comprises: calculating the blood pressure from the at least one first signal and/or the at least one second signal; and/or calculating the continuous blood pressure from the at least one first signal and/or the at least one second signal ([0218 – 0220], pap pressure).
Regarding claim 40, Bharmi discloses The method of claim 31, further comprising: dividing at least a portion of the pulses of the least one first signal into a plurality of segments, dividing at least a portion of the pulses of the least one second signal into a plurality of segments, and wherein comparing between the at least one first and second signals comprises comparing between one or more values associated with the plurality of segments of the at least one first signal and one or more values associated with the plurality of segments of the at least one second signal ([0194]).
Regarding claim 41, Bharmi discloses The method of claim 40, wherein the plurality of segments comprises at least three segments, or wherein the plurality of segments is equivalent sets or subset of pulses ([0194]).
Regarding claim 43, Bharmi discloses The method of claim 31, wherein comparing the at least one first and second signals comprises assessing at least one feature of the at least one first and/or second signals (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness).
Regarding claim 44, Bharmi discloses The method of claim 43, wherein the at least one feature comprises any one or more of at least one maximum value, at least one minimum value, a difference between at least one maximum value and at least one minimum value, an average between at least one maximum value and at least one minimum value, number of peaks, slopes between two or more extrema points, time of pulse, time between two or more extrema points, ratio between times of two or more extrema points, energy, and/or any combination thereof (FIG. 6A-6I and associated paragraphs, PAP levels and trends, monitoring before during and after medication to monitor effectiveness and see [0331 – 0332]).
Regarding claim 47, Bharmi discloses The method of claim 31, wherein the medication associated with the cardiovascular medication administration program comprises any one or more of one or more artery dilators (Vasodilators), beta blockers, Alpha blockers, Calcium channel blockers, Diuretics, Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin receptor blockers (ARBs), Central Agonists, or any combination thereof ([0262]).
Regarding claim 48, Bharmi discloses The method of claim 31, wherein the at least one of the first and/or second signals are recorded for one or more seconds, minutes and/or days ([0159], [0293]).
Regarding claim 49, Bharmi discloses The method of claim 31, wherein comparing the at least one first and second signals comprises applying at least a portion of the at least one first and second signals to a machine learning algorithm configured to identify the differences between the first and second arterial pressure waveforms ([0155], [0207], [0280]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Bharmi in view of Ghodrati (US 2022/0351852 A1) (“Ghodrati”).
Regarding claim 42, Bharmi discloses The method of claim 31, Bharmi fails to disclose further comprising normalizing the at least one first and/or second signal and/or the plurality of segments of the at least one signal using a decomposition of triangular logarithmic, and/or gaussian waveforms, thereby generating at least one normalized first and/or second signal and wherein comparing the at least one first and second signals comprises assessing at least one feature of the at least one normalized first and/or second signal.
However, in the same field of endeavor, Ghodrati teaches further comprising normalizing the at least one first and/or second signal and/or the plurality of segments of the at least one signal using a decomposition of triangular logarithmic, and/or gaussian waveforms, thereby generating at least one normalized first and/or second signal and wherein comparing the at least one first and second signals comprises assessing at least one feature of the at least one normalized first and/or second signal ([0171]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Bharmi to include further comprising normalizing the at least one first and/or second signal and/or the plurality of segments of the at least one signal using a decomposition of triangular logarithmic, and/or gaussian waveforms, thereby generating at least one normalized first and/or second signal and wherein comparing the at least one first and second signals comprises assessing at least one feature of the at least one normalized first and/or second signal as taught by Ghodrati to increase reliability ([0171]).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Bharmi in view of Lange et al. (US 2023/0055617 A1) (“Lange”).
Regarding claim 45, Bharmi discloses The method of claim 31, Bharmi fails to disclose wherein comparing the at least one first and second signals comprises one or more of: transforming the at least one first and/or second signals to a first and/or second frequency domain, respectively, and assessing at least one feature of the first and/or second frequency domains; comparing the change in one or more statistical attributes between pulses, such as average and/or variability, of at least one or more features of the at least first and/or second signals over time; comparing change between each pulse waveform and/or one or more features thereof before and after the change in cardiovascular medication administration program.
However, in the same field of endeavor, Lange teaches wherein comparing the at least one first and second signals comprises one or more of: transforming the at least one first and/or second signals to a first and/or second frequency domain, respectively, and assessing at least one feature of the first and/or second frequency domains; comparing the change in one or more statistical attributes between pulses, such as average and/or variability, of at least one or more features of the at least first and/or second signals over time; comparing change between each pulse waveform and/or one or more features thereof before and after the change in cardiovascular medication administration program ([0008], [0035] [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Bharmi to include wherein comparing the at least one first and second signals comprises one or more of: transforming the at least one first and/or second signals to a first and/or second frequency domain, respectively, and assessing at least one feature of the first and/or second frequency domains; comparing the change in one or more statistical attributes between pulses, such as average and/or variability, of at least one or more features of the at least first and/or second signals over time; comparing change between each pulse waveform and/or one or more features thereof before and after the change in cardiovascular medication administration program as taught by Lange to identify presence of changing condition ([0008]).
Regarding claim 46, Bharmi discloses The method of claim 31, Bharmi fails to disclose wherein the at least one feature of the first and/or second frequency domains comprises at least one of a maximum frequency, an energy of specific frequency, a peak amplitude, a peak time position, a half width, at least one peak time interval, and at least one amplitude ratio, or any combination thereof.
However, in the same field of endeavor, Lange teaches wherein the at least one feature of the first and/or second frequency domains comprises at least one of a maximum frequency, an energy of specific frequency, a peak amplitude, a peak time position, a half width, at least one peak time interval, and at least one amplitude ratio, or any combination thereof ([0008], [0035] [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Bharmi to include wherein the at least one feature of the first and/or second frequency domains comprises at least one of a maximum frequency, an energy of specific frequency, a peak amplitude, a peak time position, a half width, at least one peak time interval, and at least one amplitude ratio, or any combination thereof as taught by Lange to identify presence of changing condition ([0008]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nakajima et al. (US 2019/0125252 A1) (“Nakajima”) discloses a similar device/method utilizing a wearable device comprising a pressure sensor array and monitoring the effectiveness of CMAP by comparing waveforms before and after administration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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