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 .
Remarks
Claims 1-20, filed 02/18/2025, are currently pending and are under consideration.
Claim Objections
Claims 1, 3, and 16 are objected to because of the following informalities:
Claims 1 and 16 recite “HCM”. The first instance should include the full name and should read “hypertrophic cardiomyopathy (HCM)”.
Claim 3, line 3, “includes to detect” should read “includes detecting”.
Appropriate correction is required.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system and method for determining a change in HCM condition. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a system and claim 16 is directed to a method, and thus meets the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 and 16 recite a system and method for determining a change in HCM condition, comprising receiving physiologic information of a user including heart sounds, receiving an indication of HCM for a user, determining a change in HCM condition using the received heart sound information, and provide an indication to a user of the determined change. The limitation of a system and method for determining a change in HCM condition as drafted in claims 1-20, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components.
For example, determining a change in HCM condition in the context of this claim encompasses a user gathering heart sound data, receiving an indication of HCM for the patient, determining a change in HCM condition using the heart sound data, and notifying the user of the determined change. Nothing in the elements of the claim precludes the step from practically being performed in the mind or using generic computing components.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The steps of receiving physiologic information of a user including heart sounds and receiving an indication of HCM for a user are considered to be data gathering steps. The step of determining a change in HCM condition using the received heart sound information is considered to be a data processing step, and the step of providing an indication to a user of the determined change is considered to be a data output step.
The additional elements of a signal receiver circuit and assessment circuit are recited at a high level of generality (i.e. as generic computer components to acquire, process, and analyze data; See MPEP 2106.05(h)) such that they amount to no more than mere instructions to apply the exception using generic computer components.
Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of an optical sensor, light emitting diodes, detectors, a display, and a processor amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-15 and 17-20 depend on claims 1 and 16 and recite the same abstract idea as claims 1 and 16 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2 and 17 (i.e. defining the parameters measured) is simply further defining the data gathered. The additional limitations recited in claims 3-15 and 18-20 (i.e. providing additional details about the data analysis performed) is simply further describing the data analysis performed. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
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 (i.e., changing from AIA to pre-AIA ) 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 1-3, 8-11, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thakur et al. (US Patent Application Publication 2015/0343223), hereinafter Thakur.
Regarding claims 1 and 16, Thakur discloses a system and method, comprising: a signal receiver circuit configured to receive physiologic information of a patient, including S4 heart sound information (e.g. Par. [0074]; Par. [0076]); and an assessment circuit configured to: receive an indication of HCM for the patient (e.g. Par. [0012]: hypertrophic cardiomyopathy); determine a change in an HCM condition using the received S4 heart sound information by comparing S4 heart sound information over a first time period with an S4 heart sound reference, the first time period comprising one or more days (e.g. Pars. [0077]-[0078]: determining changes in the heart sound signals); and provide an indication to a user or process based on the determined change in the HCM condition crossing an alert threshold (e.g. Par. [0068]; Par. [0077]).
Regarding claims 2 and 17, Thakur further discloses wherein the S4 heart sound reference includes S4 heart sound information over a second time period shorter than the first time period (e.g. Par. [0071]; Pars. [0076]-[0078]: different time periods used).
Regarding claims 3 and 18, Thakur further discloses wherein the S4 heart sound reference includes a static S4 threshold value, and wherein to determine the change in the HCM condition includes to detect one or more cardiac cycles below the static S4 threshold value (e.g. Par. [0071]).
Regarding claim 8, Thakur further discloses wherein the assessment circuit is configured to control a sample rate of the S4 heart sound information based on the determined change in the HCM condition (e.g. Par. [0097]).
Regarding claim 9, Thakur further discloses wherein the assessment circuit is configured to adjust a physical activity program based on the determined change in the HCM condition and to provide the adjusted physical activity program to the patient or a user or process (e.g. Fig. 6; Par. [0102]: providing updated therapy).
Regarding claim 10, Thakur further discloses wherein the assessment circuit is configured to receive an indication of respiration, and to provide the adjusted physical activity program to the patient or a user or process based on the determined change in the HCM condition and the indication of respiration (e.g. Par. [0048]: respiration can be measured; Fig. 6; Par. [0102]: providing updated therapy).
Regarding claim 11, Thakur further discloses wherein indication of respiration includes respiration rate (RR) or rapid shallow breathing index (RSBI) (e.g. Par. [0048]: respiration can be measured; Fig. 6; Par. [0102]: providing updated therapy).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US Patent Application Publication 2015/0343223), hereinafter Thakur, as applied to claim 1 above, and further in view of Thakur et al. (US Patent Application Publication 2019/0274655), hereinafter Thakur’655.
Regarding claim 4, Thakur fails to disclose wherein the static S4 threshold value includes a statistical population-based threshold value. Thakur’655, in a similar field of endeavor, is directed towards monitoring of conditions using heart sounds. Thakur’655 discloses using a population-based threshold value (e.g. Par. [0087]: threshold can be population based).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Thakur to include the population-based threshold value as taught by Thakur’655 because doing so would allow better detection of health conditions.
Regarding claim 5, Thakur fails to disclose wherein the S4 heart sound reference includes an S4 loss threshold, and wherein to determine the change in the HCM condition includes to detect one or more cardiac cycles below the S4 loss threshold. Thakur’655, in a similar field of endeavor, is directed towards monitoring of conditions using heart sounds. Thakur’655 discloses determining changes in the condition when the signals are below the threshold (e.g. Par. [0078]: when the heat sounds are greater than the threshold they are ignored).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Thakur to include determining changed in a condition by detecting signals below a threshold as taught by Thakur’655 because doing so would allow better detection of health conditions.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US Patent Application Publication 2015/0343223), hereinafter Thakur, as applied to claim 1 above, and further in view of Shute et al. (US Patent Application Publication 2022/0354384), hereinafter Shute.
Regarding claim 12, Thakur further discloses wherein the signal receiver circuit is configured to receive impedance information of the patient (e.g. Par. [0011]; Par. [0048]); and wherein the assessment circuit is configured to determine an indication of patient parameters of the patient using the determined change in the HCM condition and the received impedance information and to provide the determined indication of patient parameters to the patient or a user or process (e.g. Pars. [0077]-[0078]). However, Thakur fails to disclose determining an indication of dehydration. Shute is directed towards patient monitoring. Shute discloses determining an indication of dehydration (e.g. Par. [0072]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Thakur to include the determination of dehydration as taught by Shute because doing so would allow better detection of heart conditions.
While there are no prior art rejections for claims 6, 7, 13-15, 19, and 20, they are not indicated as allowable due to the rejection of the claims under 35 U.S.C. 101, as explained above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bao (US 2024/0115202) is directed towards a smart watch that can be used for patient monitoring.
Ahmed et al. (US 2021/0369196) is directed towards monitoring of cardiovascular patients.
Min et al. (US 2020/0046312) is directed towards detecting heart sounds to monitor cardiac function.
Thakur et al. (US 2017/0347969) is directed towards detecting respiratory diseases.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights