DETAILED ACTION
Response to Arguments
Applicant's arguments filed 12/29/25 have been fully considered but they are not fully persuasive.
Regarding the 112 rejections, the amendments resolve some of the issues. Regarding claims 4, 14, 18, the rejection is maintained. Examiner suggests perhaps reciting wherein the trained computer model “comprises” a physics-based virtual heart computer model, or similar phrasing. Regarding claims 12-13, the rejection (and previous suggestions) are maintained. Claim 12 recites “the comparing” (line 3), which finds antecedent in claim 11, not claim 10. Claim 13 recites “the abnormality” (line 1), which finds antecedent in claim 12, not claim 10. See also claims 6-8 for comparison.
Regarding the 101, the rejection is maintained. Examiner suggests moving the “configured to be” to recite the fabric is configured to be in contact with the patient.
Regarding Darbari, Applicant asserts that since Darbari uses audio sensors to monitor each heart valve, Darbari does not disclose the plurality of sensors for detecting sound and vibration as recited. However, as noted below, sound and vibration are two ways to describe the same physical phenomenon (i.e. acoustic waves). The audio sensors of Darbari read on the recited sensors for detecting sound and vibration.
Claim Objections
Claims objected to because of the following informalities:
Claim 1, line 5: “configured produce” should be “configured to produce”.
Claim 10, line 6: Same issue as above.
Claim 19, line 4: “sensors increase signal” should be “sensors to increase a signal”.
Claim 20, lines 4-5: “ two dimensional” should be “two dimensions”.
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 19 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 19 recites the trained computer model comprises a computational-based signal model “using” a gradient flow adaptive beamforming algorithm. This does not appear to be supported by the original specification, because the specification describes that the analysis uses results from the computer model together with results from a gradient flow algorithm (Paragraph 74), not that the computer model itself uses the algorithm. The claim also recites combining signals to increase an SNR on the signals. This does not appear to be supported, because the specification describes combining signals from the sensors with the highest SNR (Paragraph 74), not increasing the SNR of the existing signals themselves.
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.
Claims 1-20 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.
Claims 1, 10, 15: It is unclear to recite detecting sound and also vibration, since sound and vibration are two ways to describe the same physical phenomenon (i.e. acoustic waves).
Claims 4, 14, 18: It is unclear to recite the trained computer model is trained using a computer model, since this appears to be a circular definition.
Claims 12-13: Wrong dependency. For sake of examination, claim 12 is interpreted to depend from claim 11, claim 13 is interpreted to depend from claim 12.
Claim 19: Unclear for reasons noted above.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 9 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 9 recites the device includes a fabric that is in physical contact with the patient, which would require the patient in the scope of the claim. Examiner suggest reciting a fabric “configured to be” in physical contact with the patient.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Darbari (US 2018/0116626).
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Regarding claims 1, 10, 15, Darbari discloses the same invention as claimed (Figure 14 shown above for example), including a system for monitoring blood flow (abstract) comprising a plurality of spatially separated sensors configured to detect sound produced by one or more locations of a thorax of a patient and vibration based on motion of a valve of a heart of the patient and configured to produce sound and vibration signals representative of the sound and the vibration that are detected (Figures 1, 14; abstract), a hardware processor and a non-transitory computer-readable medium that stores a trained computer model for modeling a function of a healthy heart for analyzing the sound and vibration signals (Figure 2: 24, 25, 26; Figure 5; Paragraphs 49, 56), and a transmitter that transmits the sound and vibration signals from the plurality of spatially separated sensors (Figure 2: 20, 21; abstract: mobile device; Paragraph 33; transmitter is a broad term and could include wired transmission).
Regarding claims 2, 10, 16, Darbari discloses ECG sensors as recited (Paragraphs 32, 37).
Regarding claims 3, 17, Darbari discloses analyzing includes ECG as recited (Figures 2, 3).
Regarding claims 4, 14, 18, Darbari discloses a trained computer model as recited (Paragraphs 43, 49, 56; physics-based heart model as recited is broad since any practical training data would be based on a physical and physiological functioning of the heart; training data is considered representative of the physical and physiological functioning of the heart).
Regarding claims 5-7, 11, 12, Darbari discloses using a baseline of known healthy signals (e.g. Figure 10, lower middle section: check for abnormality/normality).
Regarding claims 8, 13, Darbari discloses monitoring abnormality of at least an artificial valve (abstract; Paragraph 53).
Regarding claims 9, 10, Darbari discloses the sensors are part of a fabric as recited (Figure 14).
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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darbari (US 2018/0116626) in view of Mittal (US 2016/0004837).
Regarding claim 19, Darbari shows analyzing blood flow in the heart to optimize the signal (Paragraph 35; claim 15). Darbari does not disclose using a gradient flow beamforming algorithm as recited. However, Mittal teaches ViCar3D is a known tool, in order to analyze the flow dynamics of the heart. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Darbari as taught by Mittal to include using ViCar3D, in order to analyze the flow dynamics of the heart. Examiner notes Applicant’s specification discloses that ViCar3D is a known tool that uses the gradient flow solver (Paragraph 53).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darbari (US 2018/0116626) in view of Kale (US 2017/0188862).
Regarding claim 20, Darbari does not disclose using a four dimensional map as recited. However, Kale teaches using a four dimensional map (Paragraph 28, end) including two dimensions in the spatial domain (e.g. relations among channels), one dimension in the time domain (relative times), and one dimension in the frequency domain (spectral information), in order to localize sources in the heart. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Darbari as taught by Kale to include using a four dimensional map as recited, in order to localize sources in the heart.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chang (US 2008/0009754), Chen (US 2018/0028144), Krimsky (US 2014/0378849), Nallathambi (US 2020/0077951) show using acoustic and ECG sensors.
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 Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3796
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