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 .
Priority
Claims 1-20 are deemed to have an effective filing date of June 26, 2023.
Claim Objections
Claim 11 is objected to because of the following informalities: The word “to” is missing in line 2. “configured receive symptom” should be --configured to receive symptom--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2-4 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.
Claim 2 recites “the stenosis detector” in line 4; but, claim 1 refers to “a stenosis detector circuit” in line 4. It is unclear if the recitation in line 4 of claim 2 refers to the circuit in line 4 of claim, or, if another stenosis detector is being claimed.
Claim 3 recites “the stenosis detector” in line 2; but, claim 1 refers to “a stenosis detector circuit” in line 4. It is unclear if the recitation in line 2 of claim 3 refers to the circuit in line 4 of claim, or, if another stenosis detector is being claimed.
Claim 4 is rejected because it depends from an indefinite claim, and because it also recites “stenosis detector” in line 1.
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 1-5, 10-12, 13-16, and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-12 claim a system (apparatus) and claims 13-20 claim a method (process). Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Independent claims 1 and 13 recite detecting heart sound components from the received heart sound information, determining a change in aortic valve surface area using detected sounds; and generating an aortic stenosis indicator based at least in part of the determined change in surface area. Dependent claims 2-5, 10-12, 14-16, and 19-20 add generating/calculating steps (claims 2-4, 10-12, 14-15, and 19-20). The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitations in the mind except for the recitation of “controller circuit” (claim 1) and “a stenosis detector circuit” (claims 1 and 13). That is, other than reciting that a controller circuit with a stenosis detector circuit is performing these tasks, nothing in the claims precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper, to be an abstract idea. In this case, aside from the recitation of the “controller circuit” and a stenosis detector circuit”, claims encompass a user observing the clinical data and making a judgement as to the presence of aortic stenosis. It is further noted that limitations, “a user” and “a process executable by the medical-device system” are associated with outputting the results of the abstract idea and are not involved in performing any of the detecting, determining, and generating/calculating steps. Thus, the claims are directed to an abstract idea.
Step 2A, Prong 2:
Claims 1 and 13 recite “data receiver circuit” or “receiving heart sounds from a patient”, “a controller circuit”, and “a stenosis detector circuit” to perform abstract idea steps. The specification discloses that the controller circuit and the stenosis detector circuit are performed by software (see paragraph [0090]: any medium that is capable of providing instructions for execution by the machine to perform any one or more of the techniques of the present disclosure). As such, these components read on a computer implemented system and are recited at a high level of generality, i.e., as a generic controller, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
With respect to the “data receiver circuit” or “receiving heart sounds from a patient”, this element or step is an insignificant extra-solution activity of data gathering.
Step 2B:
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in [0062] and [0090] does not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Thus, the above-identified claims are directed to the judicial exception and ineligible since there is no inventive concept in the claims.
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.
Claims 1, 3-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2020/0289057 to An et al (hereinafter referred to as “An”) in view of US Patent Application Publication No. 2021/0022624 to Lin and US Patent No. 6,149,595 to Seitz et al. (hereinafter referred to as “Seitz”).
Regarding claims 1 and 13, An discloses a medical-device system for and a method of managing a valvular heart disease (title and abstract), comprising: a data receiver circuit configured to receive heart sound information sensed from a patient (e.g., paragraphs [0061]-[0064]: PHV monitoring system 200 can be used to monitor chronic cardiac function; system 200 may include one or more of a data receiver circuit 210; and data receiving circuit 210 may include a heart sound (HS) sensor circuit 212 to receive HS information); and a controller circuit (e.g., Fig. 2, 220), comprising a stenosis detector circuit (e.g., paragraph [0046]: Another aspect of the present invention relates to risk stratification of patients with stenosed heart valves as the ambulatory HS monitoring via the systems and methods discussed in this document can be used to screen aortic stenosis) configured to: detect heart sound components including S1 sound and S2 sound from the received heart sound information (e.g., paragraphs [0065]: control circuit 220 may reconstruct heart sounds from the HS signal data sensed by circuit 212; [0067]: HS metric 222 of control circuit 220 may detect one or more HS components including a first (S1) heart sound and a second (S2) heart sound; and [0078]: patient monitoring system 500 monitors and assesses patient natural valve function using a control circuit 520 with a HS metric circuit 522 to identify patients at risk of a valvular disease (e.g., stenosis), Fig. 5); and generate an aortic stenosis indicator (e.g., paragraphs [0068]: PHV monitor circuit 224 may generate an indicator of PHV function and be presented during post-operative recovery using one or more of the HS metrics [0078]-[0079]: valvular disease risk stratifier can identify patients at risk using heart sounds and Fig. 5, 524), wherein the controller circuit is configured to provide the aortic stenosis indicator to a user or a process executable by the medical-device system (e.g., paragraphs [0068] and [0079]: risk indicator of valvular disease may be output to a user interface 230). An differs from the claimed invention in that it does not expressly disclose 1) determining a change in aortic valve surface from a baseline stenosis-free state using the detected S1 and S2 sounds and that the indicator is based at least in part on the determined change in aortic valve surface area. However, Lin, in a related art: multifunctional measuring device for obtaining the degree of carotid stenosis (e.g., paragraph [0045] of Lin, teaches that heart sound (S1) at the beginning of the systole and heart sound (S2) at the beginning of a diastole can be converted into heartbeat signals to shed light on the cardiac cycle and their irregular sound from the cardiac valve area can help diagnose valvular heart disease such as aortic stenosis (e.g., paragraphs [0067] and [0076] of Lin). Seitz, in a related art: noninvasive apparatus and method for the determination of cardiac valve function, teaches that aortic and mitral valve areas can be obtained noninvasively along with stroke volume and pressure gradients by obtaining mechanical cardiac event data and estimating those parameters using the obtained data (e.g., abstract of Seitz), and that quantifying the degree of stenosis in terms of valvular area using Gorlin’s formula was known (column 2, lines 1-12 and 29-43 of Seitz), and further teaches a noninvasive method for calculating cardiac valvular area to assess cardiac valvular stenosis using echocardiographic estimation (e.g., column 4, lines 60-63, claims 2 and 9-14 of Seitz) by modifying the Gorlin formula for aortic valve area in conditions of stenosis of A=V(44.5t)-1(dP)-1/2 where A is the aortic valve area, V is stroke volume, t is the systolic ejection period, and dP is the average aortic valve pressure gradient was modified to A=7SV/(HFt)2 where SV is stroke volume, HF is heart frequency or heart rate (determined by S1 and S2 as per Lin), and t is the systolic ejection period (column 5, lines 23-35, column 29, lines 55-67 and column 32, lines 28-33 and claims 2 and 9-14 of Seitz). Accordingly, one of ordinary skill in the art would have recognized the benefits of using sound information including S1and S2 to determine a change in the aortic valve surface area in view of the teachings of Lin and Seitz that calculating cardiac valvular area was a well-known protocol in the cardiac art to assess aortic stenosis noninvasively, and because the combination would have yielded a predictable result.
With respect to claims 3 and 15, An in view of Lin and Seitz teaches the medical-device system of claim 1 and method of 13, wherein to determine the change in aortic valve surface area, the stenosis detector is configured to: generate an estimate of a left ventricular ejection time using a time interval between the detected S1 and S2 sounds (e.g., paragraph [0067] of An: HS metric circuit 222 may generate HS metrics including a left-ventricular ejection time measured between detected S1 and S2), and an estimate of an aorta-to-left ventricular pressure gradient using an intensity of the S2 sound (e.g., An paragraphs [0044] and [0073] of An: S2 intensity is correlated with a pressure gradient across the aortic valve at the time of aortic valve closure and S2 intensity indicates a pressure gradient from the aorta to the left ventricle); and determine the aortic valve surface area based on the estimate of the aorta-to-left ventricular pressure gradient and the estimate of the left ventricular ejection time (e.g., column 2, lines 21-43 of Seitz: a quantification of the degree of aortic stenosis can be achieved stroke volume, aortic valve pressure gradient and left ventricular ejection period/time; and column 29, lines 55-67: the Gorlin formula for aortic valve area in conditions of stenosis of A=V(44.5t)-1(dP)-1/2 where A is the aortic valve area, V is stroke volume, t is the systolic ejection period, and dP is the average aortic valve pressure gradient). Accordingly, one of ordinary skill in the art would have recognized the benefits of left ventricular ejection time and aorta to left ventricular pressure gradient to determine the surface area of the aortic valve in view of the teachings of Seitz. Consequently, one of ordinary skill in the art would have modified the system and method of An in view of Lin and Seitz to determine the aortic valve surface area based on the estimate of the aorta to ventricular pressure gradient and the estimate of the left ventricular ejection time in view of the teachings of Seitz, and because the combination would have yielded a predictable result.
As to claim 4, An in view of Lin and Seitz teaches the medical-device system of claim 3, wherein the stenosis detector is configured to determine the aortic valve surface area to be inversely proportional to the estimate of the left ventricular ejection time, and inversely proportional to a square root of the estimate of the aorta-to-left ventricular pressure gradient (e.g., column 29, lines 55-67 of Seitz teaches that the Gorlin formula for aortic valve area is A=V(44.5t)-1(dP)-1/2 and the negative exponent rule of mathematics: negative sign indicates the reciprocal of the base raised to the positive version of the power – A=V/44.5t(dP)-1/2 and the rational exponent rule of mathematics: an exponent of ½ is the equivalent of taking the square root of the base – A=V/ (44.5t√dP) ). Accordingly, one of ordinary skill in the art would have recognized the benefits of the aortic valve surface area being calculated by the Gorlin formula in view of the teachings of Seitz. Consequently, one of ordinary skill in the art would have modified the system and method of An in view of Lin and Seitz to determine the aortic valve surface area to be inversely proportional to the estimate of the left ventricular ejection time and inversely proportional to the square root of the aorta to ventricular pressure gradient in view of the teachings of Seitz that such was the well-known formula for calculating aortic valve surface area, and because the combination would have yielded a predictable result.
With respect to claims 5 and 16, An in view of Lin and Seitz teaches the medical-device system of claim 1, wherein the controller circuit is configured to generate an alert to the user in response to the aortic stenosis indicator indicating a presence of aortic stenosis (e.g., abstract of An: an alert of PHV dysfunction can be presented to a system user and [0086] of An: HS metric generated at 620 and the PHV indicator generated at 630 may be provided to a user or a process and at 642 an alert can be generated if a temporal changed in the HS metric fails below a predetermined threshold when the HS metric identifies patients at risk of stenosis [0078] of An).
As to claims 6 and 17, An in view of Lin and Seitz teaches the medical-device system of claim 1, wherein the controller circuit is configured to, in response to the aortic stenosis indicator indicating a presence of aortic stenosis: trigger the data receiver circuit to receive symptom or physiological information of the patient indicative of functional deterioration associated with the presence of aortic stenosis (e.g., paragraphs [0045] and [0069] of An: physiologic event detector circuit 226 detects a target physiologic event using HS information, among other physiologic information acquired from the patient to generate a cardiac function indicator that may indicate worsening heart failure attributable to a dysfunctional PHV – functional deterioration); and categorize a stenosis severity level based on the aortic stenosis indicator and the received symptom or physiological information (e.g., abstract of An: the system can generate a risk indicator indicating patient natural valve function and a need for heart valve repair or replacement; paragraphs [0004] of An: some patients are aortic stenosis patients are treated with medication and patients with severe aortic stenosis often require surgical placement of a prosthetic heart valve (PHV); [0068] of An: HS metrics may include PEP/LVET ratio, STI/DTI ratio … and other composite metrics; and [0074], [0078]-[0079] of An: the valvular risk stratifier circuit 524 can stratify valvular disease using a composite HS metric such as a ratio of S1 intensity to S2 intensity, which may indicate deterioration of cardiac hemodynamics during arrhythmia [0069]).
With respect to claim 7, An in view of Lin and Seitz teaches the medical-device system of claim 6, comprising a user interface coupled to data receiver circuit (e.g., paragraph [0062] and Figs. 2 or 5, 230 of An), the user interface is capable of receiving a user input of symptom in response to the indication of the presence of aortic stenosis (e.g., paragraph [0070] of An: user interface 230 may include an input unit where the user input can program the data receiver circuit and may include a keyboard).
As to claim 8, An in view of Lin and Seitz teaches the medical-device system of claim 6, wherein the triggered received physiological information includes an intensity of S1 sound indicative of cardiac contractility (e.g., paragraphs [0011], [0042], and [0069] of An: S1 intensity can be received where a reduction in S1 intensity may be indicative of reduced cardiac contractility).
With respect to claims 9 and 18, An in view of Lin and Seitz teaches the medical-device system of claim 6, comprising one or more sensors coupled to data receiver circuit and configured to sense physiological information in response to the indication of the presence of aortic stenosis, the one or more sensors including at least one of a physical activity sensor, a respiration sensor, a heart rate sensor, or an electrocardiogram sensor (e.g., paragraph [0051] of An).
As to claims 10 and 19, An in view of Lin and Seitz teaches the medical-device system of claim 1, wherein the controller circuit is configured to generate an indicator of patient candidacy for aortic valve replacement procedure based at least in part on the aortic stenosis indicator (e.g., paragraphs [0023], [0031], [0046] and [0078]-[0079] of An: the ambulatory medical device can screen for early signs of aortic stenosis and is further configured to determine patient candidacy for heart valve repair or replacement).
With respect to claim 11, An in view of Lin and Seitz teaches the medical-device system of claim 10, wherein the controller circuit is configured [to] receive symptom or physiological information of the patient indicative of functional deterioration associated with the aortic stenosis (e.g., paragraphs [0045]-[0046] of An: Ambulatory HS monitoring screens patients for aortic stenosis using physiological information obtained by physiologic sensors of [0041] and [0051] and can provide therapy to correct or slow down deteriorated cardiac function), and to generate the indicator of patient candidacy for aortic valve replacement further based on the received symptom or physiological information (e.g., paragraph [0046] of An: Ambulatory HS monitoring via the systems and methods discussed in this document can further identify candidates for heart valve replacement).
As to claims 12 and 20, An in view of Lin and Seitz teaches the medical-device system of claim 1, wherein the controller circuit comprises a heart failure detector circuit configured to detect worsening heart failure (WHF) using physiological information received from the data receiver circuit (e.g., paragraphs [0019], [0045] of An: any of examples 1-12 optionally include a heart failure detector circuit), and in response to the aortic stenosis indicator indicating a presence of aortic stenosis (e.g., paragraph [0020] of An: the heart failure detector circuit can be configured to detect WHF attributable to PHV dysfunction in response to an increase in S3 intensity and a decrease in S2 intensity from their respective baselines), the controller circuit is configured to: generate a diagnosis of WHF secondary to aortic stenosis (e.g., paragraphs [0041]: AMD can detect cardiac arrhythmia or heart failure events indicative of worsening heart failure); and generate a recommendation to titrate therapy based on the diagnosis of WHF secondary to aortic stenosis (e.g., paragraphs [0041] of An: the AMD may deliver electrostimulation therapy to the heart or other tissue to restore or improve cardiac performance or to correct cardiac arrhythmia).
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over An in view of Lin and Seitz as applied to claim 1 above, and further in view of US Patent Application Publication No. 2022/014712 to Sanchez Fernandez et al. (EFD: at least 01/30/2020 and hereinafter referred to as “Sanchez Fernandez”).
An in view of Lin and Seitz teaches the medical-device system of claim 1 and the method of claim 13, but does not expressly teach that determining the change in aortic valve surface area includes detecting a decrease in aortic valve surface area from the baseline stenosis-free state, wherein the stenosis detector is configured to generate the aortic stenosis indicator indicating a presence of aortic stenosis in response to the decrease in aortic value surface area exceeding a threshold. However, Sanchez Fernandez, in a related art: aortic stenosis echocardiographic follow-up system, teaches that aortic stenosis (AS) was known to use Aortic Valve Area (cm2) to determine the grade of AS; in particular, mild AS >1.5, moderate AS is in the range of 1-1.5, and severe AS <1 (e.g., Table 1 between paragraphs [0019] and [0020] of Sanchez Fernandez). Accordingly, one of ordinary skill in the art would have recognized that the aortic valve area measurement decreases as the AS becomes worse where the threshold could be 0.5 cm2 to determine severe AS from moderate AS in view of the teachings of Sanchez Fernandez. Consequently, one of ordinary skill in the art would have modified the system and method of An in view of Lin and Seitz to determine the change in aortic surface area by detecting a decrease in the aortic valve surface area from the baseline stenosis-free state, and generating the AS indicator in response to a decrease in change exceeding a threshold in view of the teachings of Sanchez Fernandez that such was a known medical protocol for determining AS, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application NO. 2016/0354053 to Tsai et al. is directed to method and system for recognizing physiological sound and teaches that it was known in the art that many heart diseases (such as heart valve dysfunction) could be effectively diagnosed through auscultation using S1 and S2 (e.g., paragraphs [0003] and [0088]).
US Patent Application Publication No. 2023/0165474 to Brown et al. (EFDA: at least 02/25/2022) is directed to methods to simulate metrics of vascular function from clinical data where a patient is assessed for aortic valve replacement via echocardiographic data comprising a heart rate value, a peak velocity through aortic valve value, an aortic valve area value, and a stroke volume value (e.g., paragraph [0089]).
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792