DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on October 29, 2025 were received and fully considered. Claims 44, 63, and 64 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 112B
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 44-50 and 52-64 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 44, and all dependent claims thereof, recites “the signals” in line 16, which lacks antecedent basis.
Similar indefiniteness is exhibited in independent claims 63 and 64.
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 44-50, and 52-64 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 44 follows.
Regarding claim 44, the claim recites a method for non-invasively assessing presence, non-presence, severity and/or localization of significant coronary artery disease of a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“...performing, by the one or more processors, a statistical assessment of phase relations between periods of the first and second photoplethysmographic signals and the cardiac signal in a manner that preserves phase space information; determining, by the one or more processors, one or more landmarks defined between the first photoplethysmographic signal, the second photoplethysmographic signal, and the cardiac signal based on the phase relations between the signals; determining, by the one or more processors utilizing at least a portion of the first and second biophysical signal data sets and based on the one or more landmarks, one or more values associated with one or more synchronicity features, including a first value associated with a first synchronicity feature and a second value associated with a second synchronicity feature, wherein the first and second synchronicity features each characterizes one or more non-linear dynamical properties relating to chaoticity of the subject’s heart between the first photoplethysmographic signal, the second photoplethysmographic, and the cardiac signal; determining, by the one or more processors, an estimated value for the presence, non- presence, severity and/or localization of the coronary artery disease based on the one or more values associated with the first synchronicity feature and the second synchronicity feature...”
These limitations describe a mathematical calculation. Moreover, the limitations describe a mental process as the skilled artisan is capable of looking at biophysical signal data sets and making a mental assessment thereafter. Furthermore, nothing from the claims suggest that the above limitations cannot be practically performed mentally, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“...obtaining, by one or more processors, a first biophysical signal data set associated with a first photoplethysmographic signal and a second photoplethysmographic signal, wherein the first photoplethysmographic signal and the second photoplethysmographic signal have been acquired over multiple cardiac cycles of the subject; obtaining, by the one or more processors, a second biophysical signal data set associated with a cardiac signal, wherein the cardiac signal has been acquired over the multiple cardiac cycles, and wherein the first photoplethysmographic signal, the second photoplethysmographic signal, and the cardiac signal are acquired via surface sensors placed on the subject... outputting, via a report and/or display, the estimated value for the presence, non- presence, severity and/or localization of the significant coronary artery disease, wherein the output is made available to a healthcare provider to determine a diagnosis or surgical, therapeutic, or pharmacologic treatment of the coronary artery disease.”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the judicial exception and/or outputting a result fail to integrate the claims into a practical application. See MPEP 2106.05(g).
Furthermore, the additional limitations do not add significantly more to the judicial exception as they pertain to implementing the judicial exception on a generically claimed processor, utilizing conventional sensors to obtain widely known types of physiological data, and outputting the result on a generically recited display. Moreover, obtaining photoplethysmographic signals and cardiac signals for various diagnostic purposes is conventional, as evidence by art applied in current and/or previous office actions.
Independent claims 63 and 64 are also not patent eligible for substantially similar reasons.
Dependent claims 45-50 and 52-62 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite additional limitations that do not integrate the judicial exception into a practical application for substantially similar reasons as set forth above, and/or recite additional limitations that do not amount to significantly more than the judicial exception for substantially similar reasons as set forth above.
Therefore, claims 44-50 and 52-64 are not patent eligible under 35 USC 101.
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.
The factual inquiries 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.
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 44-50 and 52-64 are rejected under 35 U.S.C. 103 as being unpatentable over Banerjee et al. (US PG Pub. No. 2018/0228444 A1) (hereinafter “Banjeree”), Lee (US PG Pub. No. 2016/0029967 A1), and Dekker (US Patent No. 6896661 B2).
Banjeree and Lee were applied in the previous office action.
With respect to claims 44, 63, and 64, Banerjee teaches a method for non-invasively assessing presence, non-presence, severity and/or localization of coronary artery disease of a subject (abstract “detection of… CAD”), the method comprising: obtaining, by one or more processors, a first biophysical signal data set associated with a first photoplethysmographic signal, wherein the first photoplethysmographic signal has been acquired over multiple cardiac cycles of the subject (par.0013 “sample PPG signal captured from a person”; pulse oximeter 120 in Fig. 1); obtaining, by the one or more processors, a second biophysical signal data set associated with a cardiac signal, wherein the cardiac signal has been acquired over the multiple cardiac cycles (par.0025 “plurality of physiological sensors 112… using PCG… PPG… for the detection CAD”; digital stethoscope 118 in Fig. 1); determining, by the one or more processors, one or more landmarks defined between the first photoplethysmographic signal and the cardiac signal (feature extraction module 110 in Fig. 1); determining, by the one or more processors utilizing at least a portion of the first and second biophysical signal data sets, one or more values associated with one or more synchronicity features, including a first value associated with a first synchronicity feature and a second value associated with a second synchronicity feature, wherein the first and second synchronicity features each characterizes one or more non-linear dynamical properties relating to chaoticity of the subject’s heart between the first and second biophysical signal data sets (classification module 112 in Fig. 1; par.0032+ “non-linear SVM… produces the optimal performance”; par.0033 “fusion module 114 is configured to fuse the output of the PPG classifier and the PCG classifier”; par.0042 “feature level fusion was also performed”); determining, by the one or more processors, an estimated value for the presence, non-presence, severity and/or localization of the coronary artery disease based on the one or more values associated with the first synchronicity feature and the second synchronicity feature (par.0034+ “detection module 116 configured to detect the person if he is a CAD or non-CAD person”; par.0036+ “time domain features, frequency domain features, time-frequency domain features and statistical features are extracted from each of the processed physiological signals”); outputting, via a report and/or display, the estimated value for the presence, non-presence, severity and/or localization of the coronary artery disease, wherein the output is made available to a healthcare provide to determine a diagnosis or surgical, therapeutic, or pharmacologic treatment of the coronary artery disease (par.0037 “the presence of coronary artery disease is detected in the person using the fused output of the physiological signal classifiers based on a predefined criteria”; see also Figs. 5A-5B, which shows a detailed outcome of the fusion technique including distance values).
Although Banerjee does not explicitly teach the first photoplethysmographic signal and the cardiac signal are acquired via surface sensors placed on the subject, such a modification of Banerjee would have been obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed because as it is widely known to position PPG and PCG sensors in direct contact with the patient (wrist, forearm, abdomen, etc.). Moreover, Banerjee teaches collecting physiological data non-invasively, via fingertip, etc. (see par.0023, 0026), thereby providing additional motivation for PHOSITA to utilize surface sensors placed on the subject.
However, Banjeree does not teach a second photoplethysmographic signal acquired over multiple cardiac cycles of the subject; the second photoplethysmographic signal is acquired via surface sensor placed on the subject; performing, by the one or more processors, a statistical assessment of phase relations between periods of the first and second photoplethysmographic signals and the cardiac signal in a manner that preserves phase space information; determining, by the one or more processors, one or more landmarks defined between the first photoplethysmographic signal and the second photoplethysmographic signal, and the cardiac signal based on the phase relations between the signals.
Lee teaches a second photoplethysmographic signal acquired over multiple cardiac cycles of the subject; the second photoplethysmographic signal is acquired via surface sensor placed on the subject; and determining one or more landmarks defined between the first photoplethysmographic signal and the second photoplethysmographic signal (par.0026 “second optical sensor 42… skin surface”; par.0031-32 “second signals transmitted by the second optical sensor 42 include a second variation of photoplethysmography… comparing the first signal-to-noise ratio of the first optical sensor 32 with the second signal-to-noise ratio of the second optical sensor 42 or comparing the first performance index of the first optical sensor 32 with the second performance index of the second optical sensor 42. Thereby the processor module 11 chooses the better variation of photoplethysmography to calculate the physiological information which includes heart rates, the oxygen contents of blood, heart rate variabilities and so on”).
Dekker teaches performing, by the one or more processors, a statistical assessment of phase relations between periods of the first and second photoplethysmographic signals and the cardiac signal in a manner that preserves phase space information (col. 8, lines 54-63 “The Mayer Wave and respiration wave can also be distinguished based on differing phase relationships of associated parameters”; col. 9, lines 24-46 “an effect of interest can be identified based on appropriate processing, e.g., mathematical or spectral analysis of the pleth…Analysis of these waveforms with regard to the phase relationships therebetween yields information as to whether the effect under analysis is associated with the Mayer Wave or the respiration wave”; col. 9 line 63 – col. 10 line 21 “Using the resulting blood pressure and heart rate signals, an analysis is performed (612) to identify a phase relationship associated with the pleth component of interest. The pleth component of interest is thereby identified (614) as relating to the respiration wave or the Mayer Wave based on the phase relationship”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Banjeree to further incorporate a second PPG signal in order to allow for comparison between landmarks/noise in first and second PPG signals, thereby choosing the better variation of the two PPG signal to calculate various types of physiological information thereafter (e.g. heart rate variability), as evidence by Lee (par.0032). Moreover, Banjeree provides added motivation to incorporate Lee’s second PPG sensor as Banjeree teaches that detection of coronary artery disease is possible from different physiological signals, the most commonly being heart rate variability (par.0004). Lastly, PHOSITA would have had predictable success modifying Banjeree and Lee to incorporate a statistical assessment of phase relations in the manner recited in order to yield information as to whether the effect under analysis is associated with the Mayer Wave or the respiration wave, as suggested by Dekker (col. 8, lines 54-63; col. 9 line 24- col. 10 line 21).
With respect to claim 45, Banerjee teaches the first value associated with the first synchronicity feature is determined from an analysis selected from the group consisting of: a statistical analysis or a dynamical analysis of values of the cardiac signal at a landmark defined by both the first photoplethysmographic signal and the second photoplethysmographic signal over the multiple cardiac cycles; a statistical analysis or a dynamical analysis of values of one of the first or second photoplethysmographic signals at a landmark defined in the cardiac signal over the multiple cardiac cycles; a statistical analysis or a dynamical analysis of time interval values between a) a first set of landmarks defined between the first and second photoplethysmographic signals and b) a second set of landmarks defined in the cardiac signal over the multiple cardiac cycles; and a statistical analysis or a dynamical analysis of phase relation values between i) periods of one of the first or second photoplethysmographic signals and ii) periods of the cardiac signal over the multiple cardiac cycles (par.0031, 0036).
With respect to claim 46, Banerjee teaches the second value associated with the second synchronicity feature is determined from the statistical analysis or the dynamical analysis of the values of the cardiac signal at the landmark defined by both the first and second photoplethysmographic signals over the multiple cardiac cycles, wherein the landmark defined by both the first and second photoplethysmographic signals is defined at a time when the values of the first and second photoplethysmographic signals intersect (par.0031, 0036).
With respect to claim 47, Banerjee teaches second value associated with the second synchronicity feature is determined from the statistical analysis or the dynamical analysis of the values of one of the first and second photoplethysmographic signals at the landmark defined in the cardiac signal (par.0031, 0036).
With respect to claim 48, Banerjee teaches the landmark defined in the cardiac signal includes a peak associated with ventricular depolarization (Fig. 2).
With respect to claim 49, Banerjee teaches the landmark defined in the cardiac signal includes a peak associated with ventricular repolarization or atrial depolarization (Fig. 2).
With respect to claim 50, Banerjee teaches the second value associated with the second synchronicity feature is determined from the statistical analysis or the dynamical analysis of the time interval values between i) the first set of landmarks defined between the first photoplethysmographic signal and the second photoplethysmographic signal and ii) the second set of landmarks defined in the cardiac signal (par.0031, 0036).
With respect to claim 51, Banerjee teaches the first and second biophysical signal data sets are obtained and analyzed to investigate complex, non-linear dynamical properties of the heart (par.0028, 0031-32).
With respect to claim 52, Banerjee teaches the second set of landmarks defined in the cardiac signal includes peaks in the cardiac signal associated with ventricular repolarization or atrial depolarization (Fig. 2).
With respect to claim 53, Lee teaches the first set of landmarks defined by both the first and second photoplethysmographic signals are defined at times when the values of the first and second photoplethysmographic signals signal intersect (par.0032). Therefore, PHOSITA would have had predictable success modifying Banjeree with Lee in the manner recited in order to choose the better variation of the two PPG signals to calculate HRV, which can be used to derive CAD, as evidence by Lee and Banjeree.
With respect to claim 54, Banerjee teaches the second value associated with the second synchronicity feature is determined from the statistical analysis or the dynamical analysis of the phase values between the periods of one of the first or second photoplethysmographic signals and the periods of the cardiac signal (par.0031, 0036).
With respect to claim 55, Banerjee teaches causing, by the one or more processors, generation of a visualization of the estimated value for the presence, non-presence, severity and/or localization of the significant coronary artery disease, wherein the generated visualization is rendered and displayed at a display of a computing device and/or presented in a report (Figs. 4-5).
With respect to claim 56, Banerjee teaches the first value associated with the first synchronicity feature is determined by: determining, by the one or more processors, a histogram having one or more distribution of the synchronicity properties of the first and second biophysical signal data sets; and determining a value of a first statistical parameter of the histogram, wherein the first statistical parameter of the histogram is selected from the group consisting of mean, mode, median, skew, kurtosis, and standard deviation of one or more distributions defined in the histogram, and wherein the first statistical parameter is used in the determining of the estimated value for the presence, non-presence, severity and/or localization of the significant coronary artery disease (Figs. 4-5).
With respect to claim 57, Banerjee teaches the first value associated with the first synchronicity feature are determined by: determining, by the one or more processors, a map of the values of the cardiac signal, the values of the one or second photoplethysmographic signal, the time interval values, or the phase relation values determined from the analysis; and determining a value of a geometric parameter a shape fitted to a cluster defined in the map, wherein the value of the geometric parameter is used in the determining of the estimated value for the presence, non-presence, severity and/or localization of the significant coronary artery disease (Figs. 4-5). Although Banerjee does not explicitly teach a Poincare map, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as a simple substitution as it is widely known to utilize Poincare maps in medical diagnostics.
With respect to claim 58, Banerjee teaches the map is generated by iteratively plotting i) in an x-axis, at a first index x-1 and a second index x, values of the cardiac signal, the values of one of the first or second photoplethysmographic signal, the time interval values, or the phase relation values and ii) in a y-axis, at the second index x and a third index x+1, values of the cardiac signal, the values of one of the first or second photoplethysmographic signal, the time interval values, or the phase relation values determined from the analysis (Figs. 4-5). Although Banerjee does not explicitly teach a Poincare map, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as a simple substitution as it is widely known to utilize Poincare maps in medical diagnostics.
With respect to claim 59, Banerjee teaches the time interval value is defined between the second set of landmarks of the cardiac signal and the first set of landmarks defined at a crossover between the first and second photoplethysmographic signals (par.0028 “overlapping windows”).
With respect to claim 60, Banerjee teaches the values of the cardiac signal are amplitude signal values of the cardiac signal at a crossover landmark defined between the first and second photoplethysmographic signals (par.0031, 0036).
With respect to claim 61, Banerjee teaches the values of one of the first or second photoplethysmographic signals are amplitude signal values of a at a respective landmark defined in the cardiac signal (par.0031, 0036).
With respect to claim 62, Banerjee teaches determining, by the one or more processors, the one or more synchronicity features as one or more candidate features in a machine learning model (par.0032).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 44-50 and 52-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,291,379. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 101 rejections raised in the previous office action were fully considered, but they were not persuasive. Examiner maintains that the claims, as amended, recite an abstract idea (mathematical calculations and/or mental process) that (1) is not integrated into a practical application; and (2) the additional limitations do not recite significantly more. Moreover, the current amendment merely further limits the abstract idea such that it does not overcome the patent eligibility rejections. Furthermore, applicant’s “improvement” argument is not persuasive as the purported improvement appears to lie within the judicial exception itself1. Please see corresponding rejection heading above for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but are moot in view of the current combination of rejections that were necessitated by amendment. Please see prior art section above for more detail, updated citations (new secondary reference, Dekker), and updated obviousness rationale.
Applicant’s arguments filed with respect to the double patenting rejections raised in the previous office action were fully considered, but they were not persuasive. Examiner maintains that the instant claims, even as amended, are not patentably distinct over claims 1-21 of US Patent No. 11,291,379 for the reasons set forth in the double patenting rejection section above.
Conclusion
No claim is allowed.
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.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 “the judicial exception alone cannot provide the improvement.” See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981).