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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on October 13, 2025. Claims 31-50 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 10/13/2025 amending claims 31, 33 and 41 to clarify the language the 112(b) rejections made against the claims in the office action of 6/11/2025 have been withdrawn.
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.
Claims 31-50 are 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. MPEP 2161.01(I) states “claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” MPEP 2161.01(J). “It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015),”. Claims 31 and 41 recite "use the modified biophysical signal data set in a machine learning operation to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease or significant ischemic heart disease", however the original disclosure (original claims, description and drawings) does not provide support for the claim language. The specification recites using experimental results, see para. [0185]-[0190] but does not disclose how the claimed “modified biophysiological signal data set” is used in a machine learning operation to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease or ischemic heart disease. The original disclosure does not disclose how the claimed modified biophysiological signal is used in a machine learning operation to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease. Further, how is the modified biophysical-signal data used in a “machine learning operation” to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease or ischemic heart disease? How is the machine learning operation used to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease or ischemic heart disease? There is not enough detail of how the machine learning operation would create a useful output from the inputted biophysical-signal data set. The specification does not describe how the claimed “modified biophysiological signal” is used to within a machine learning operation to estimate a value indicative of a presence or non-presence of coronary artery disease or ischemic heart disease or steps/procedure taken to perform the function with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. Therefore, the limitation "use the modified biophysical signal data set in a machine learning operation to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease or significant ischemic heart disease", lacks written description. Claims 32-40 and 42-50 directly or indirectly depend from claims 31 and 41 and are also rejected to for the reasons stated above regarding claims 31 and 41. As best understood, for the purpose of examination, the claims have been interpreted to include using the modified biophysical-signal data within any machine learning operation including generic machine learning algorithms performed by a computer to determine presence of coronary artery disease or ischemic heart disease.
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 31-50 are rejected under 35 U.S.C. 101 because the claimed invention is
directed to an abstract idea without significantly more.
Step 1
Claims 31-50 are directed to “computer readable medium” and “an system” which describe one of the four statutory categories of patentable subject matter, i.e., a machine (Step 1, Yes)
Step 2A. Prong One
Regarding claims 31 and 41, the limitations of "receive the biophysical-signal data…", "determine at least one template-signal vector…", "apply the at least one template-signal vector set to one or more denoising vector data….", “generate a modified biophysical-signal data set..” and “use the modified biophysical-signal data set in…is used to non-invasively diagnose..” are processes that under broadest reasonable interpretation standard, covers performance of these limitations in human mind. There is nothing in the claims precludes the receiving, determining, applying, generating and using steps from practically being performed in human mind. The method steps themselves can be carried out in the mind and/or by pen and paper.
The reasons that the limitations is/are considered an abstract idea is/are the following: The limitations of “receive”, “determine”, “apply”, “generate”, and “use” is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the use of generic computer components including “by a processor” (claim 31), “by the processor causes the processor to” (Claim 41) and a generic “machine learning operation” nothing in the claim precludes the steps from practically being performed in the mind. For example the “receive” language in the context of the claim encompasses the user being handed a biophysical-signal data set, e.g. a sheet of paper or strip containing the biophysical-signal data set, the “determine” language in the context of the claim encompasses the user manually determining at least one template-signal vector data set based on the detected quasi-periodic cycles in the received biophysical-signal data set, the “apply” language in the context of the claim encompasses the user applying the template-signal vector data to one or more denoising vector data sets, the “generate” language in the context of the claim encompasses the user generating a modified biophysical-signal data set by merging the portion of the biophysical-signal data set and the at least one or more denoising vector data sets and the “use” language in the context of the claim encompasses using the modified biophysical-signal data to estimate a value indicative of a presence or non-presence of coronary artery disease or ischemic heart disease that is used to diagnose coronary artery disease or ischemic heart disease. There is nothing to suggest an undue level of complexity in the steps of “receive”, “determine”, “apply”, “generate”, and “use”. If a claim limitations, under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls with the “Mental Processes” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to the concepts that have been identified as abstract by the courts, such as: collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016), selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP America Inc. v. Investpic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed Cir. 2018). See MPEP 2106.04(a)(2)(111). (Step 2A: Prong One YES).
Step 2A. Prong Two
The judicial exception is not integrated into a practical application. Analyzing the claim as whole for an inventive concept, the claims do not include additional elements/steps that integrate the judicial exception into a practical application. Claims 31 and 41 do not include additional elements that integrate the mental process into a practical application. The additionally recited element(s) appended to the abstract idea include: “a processor”, “a non-transitory computer readable medium”, “in a machine learning operation”, “a memory having instruction stored thereon” and “obtaining…a biophysical-signal data set…”. The additional elements reciting “obtaining…a biophysical-signal data set” merely: add insignificant extra-solution activity and are recited is at a high level of generality (i.e. as a general means of gathering biophysical-signal data) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity), all uses of the recited judicial exception require the pre-solution activity of data gathering. As discussed above with respect to integration of abstract idea into a practical application, the additional element of “a processor”, “a non-transitory computer readable medium”, “a machine learning operation” and “a memory having instruction stored thereon” amount to no more than mere instruction to apply the exception using generic computer components. The “a processor”, “a non-transitory computer readable medium”, “a machine learning operation” and “a memory having instruction stored thereon” are purely general-purpose computer components recited as carrying out the general-purpose computer functions of processing data and displaying to enable the abstract process. The disclosed “a processor”, “a non-transitory computer readable medium”, “a machine learning operation” and “a memory having instruction stored thereon” are recited at a high level of generality as a processor that is running a machine learning operation and outputting the results (see specification, para. [0207]). The additional elements of a processor, a non transitory computer readable medium, and a memory amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application, see MPEP 2106.04(d)(I) and 2106.05(f). Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application (Step 2A, Prong Two, NO).
Step 2B
Analyzing the claim as whole for an inventive concept, the claims do not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception. Claims 31 and 41 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all elements are directed to insignificant extra-solution activity which merely facilitate the abstract idea and/or purely general-purpose computer components recited as carrying out the general-purpose computer function of processing data and displaying to enable the abstract process. The recited additional elements are well-understood, routine, conventional activity including receiving or transmitting data over a network, performing repetitive calculations and storing or retrieving information in memory, see MPEP 2106.05(d). As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a non-transitory computer readable medium, a processor and a memory amount to no more than mere pre solution activity of data gathering, which does not amount to an inventive concept. Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225,110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer ( a non-transitory computer readable medium, a processor and a memory) are being used to implement abstract idea of processing biophysical signal data. These elements are recited at a high-level of generality that are well-known in basic biophysical signal processing arts (Gupta et al US2013/0096394) and the added limitation of a non-invasive measurement system, a set of electrodes are elements that are recited at a high-level of generality that are well-known in basic biophysical signal processing arts (Grouchy et al US2019/0200893) and amount to nothing more than a mere pre-solution activity of data gathering. The additional elements of a processor, a non transitory computer readable medium and a memory amount to nothing more than parts of a generic computer. (Step 2B: NO). Therefore, the claims do not appear to be patent eligible.
Claim(s) 32-40 and 42-50 depend directly or indirectly from claim(s) 31 and 41. Therefore, the dependent claims rely upon the same abstract idea as the independent claim(s), as set forth above. Additionally, the dependent claims do nothing more than further limiting the abstract idea while failing to qualify as "significantly more", and the specificity of an abstract idea does not make it any "less abstract" as it is still directed to concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work subject matter. Regarding claims 32-38,42-48 the limitations in these claims further limit how the biophysical signal data is measured and used. As such, the claims are not patent eligible for the same reason provided above in claims 31 and 41. Regarding claims 39 and 49, the limitation of "a 12-lead surface potential sensing electrode system, an intracardiac electrocardiogram, a Halter electrocardiogram, a 6-lead differential surface potential sensing electrode system, a 3-lead orthogonal surface potential sensing electrode system, and a single lead potential sensing electrode system" further limits the sensing biophysical signal data. However, these limitations amount to no more than mere pre-solution activity of data gathering as set forth above for claims 31 and 41. Further, this pre solution activity of data gathering of using the sensors is well-understood, routine, and convention in the field of biophysical signal processing as shown in (fig.1 [0037,0079,0086]) of Gupta et al US2013/0096394 reference. Regarding claims 40 and 50, the limitation of "a plurality of surface electrode placed on surfaces of a body in proximity to heart" further limits the sensing biophysical signal data by placing the electrode at a specific location of the patient. However, this limitation amounts to no more than mere pre-solution activity of data gathering as set forth above for claims 31 and 41. Further, this pre-solution activity of data gathering using electrodes placed on body surface of the patient is well-understood, routine, and convention in the field of biophysical signal processing as shown in fig.1of Gupta et al US2013/0096394 reference. Therefore, the dependent claim(s) are also not patent eligible for the reasons discussed above.
The instantly rejected claim(s) are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. In the interest of advancing prosecution, the examiner suggests: providing evidence, for example, delineating how the abstract idea and/or additional elements appended to the abstract idea results in an improvement to the technology/technical field, which can show eligibility and/or adding a practical application of the claimed method outside of the computer. See MPEP § 716.01(c) for examples of providing evidence supported by an appropriate affidavit or declaration. For additional guidance, applicant is directed generally to MPEP § 2106.
Response to Arguments
Rejections under 35 USC 112(a) and 112(b)
Applicant's arguments filed 10/13/2025, regarding the 112(a) rejections have been fully considered but they are not persuasive. It is noted that the 112(a) rejections have been updated in view of the claim amendments. Applicant states that the 112(a) rejections are moot in light of the amendments, see pg. 8 of response filed 10/13/2025, however even with the amendments several 112(a) rejections remain regarding using the modified biophysical-signal data set in a machine learning operation to non-invasively estimate a value indicative of a presence or non- presence of coronary artery disease or significant ischemic heart disease, see claim rejections above.
As stated above, in view of the amendment filed on 10/13/2025 amending claims 31, 33 and 41 to clarify the language the 112(b) rejections made against the claims in the office action of 6/11/2025 have been withdrawn.
Rejections under 35 USC 101
Applicant's arguments filed 10/13/2025, regarding the 101 rejections have been fully considered but they are not persuasive. It is noted that the 101 rejections have been updated in view of the claim amendments. Applicant argues that independent claim 31 includes additional elements demonstrating that the claims as a whole integrates the alleged abstract idea into a practical application, i.e. an improvement to technology in accordance with MPEP 2106.04(d)(1), see pgs. 9-10 of response filed 10/13/2025. The present claims do not recite a combination of additional elements that provide a specific improvement over prior systems. MPEP 2106.04(d) discloses limitations that have been found by the courts to be indicative that an additional element may have integrated the exception into a practical application and include an improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). MPEP 2106.05(a) recites “the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art....During examination, the examiner should analyze the ‘improvements’ consideration by evaluating the specification and the claims to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement.” Applicant alleges that the specification discloses an improvement over prior art system. Applicant states the specification describes such technological improvements by employing biophysical signals acquired non-invasive and “analyzing such signals using advanced processing operations to generate a modified/denoised biophysical-signal data set for subsequent analysis”. However, applicant fails to include sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement such as a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. Acquiring biophysical signals non-invasively from surface sensors is a well-known technique for acquiring data that is used to determine cardiac conditions, see rejection above. It is unclear what “additional elements” applicant is pointing to within the claim that provide “significantly more” as several of the analysis steps are part of the abstract idea. As stated within MPEP 2106.04 II “(eligibility “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.”). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must “transform the nature of the claim” into a patent-eligible application of the judicial exception”. Therefore, it is the “additional elements” not the steps which are part of the abstract idea which may provide “significantly more” to aid in determining a patent-eligible application. As discussed above, the additional elements recited within the claims do not include any limitations found by the courts to be indicative that an additional element may have integrated the exception into a practical application and merely recite the words “apply it” and add insignificant extra-solution activity to the judicial exception, see 101 analysis above, therefore the recited additional elements within the claims do not integrate the judicial exception into a practical application.
Applicant argues “Instant claim 31 is analogous to the patent eligible claims in Thales Visionix Inc. V. United States, 850 F.3d. 1343, 121 USPQ2d 1898 (Fed. Cir. 2017), and Diamond V. Diehr. 881 F.3d 1354 (Fed. Cir. 2018); 450 U.S. 175, 177 (1981)…..In providing a solution which implements an asynchronous contamination removal operation to normalize signals acquired from multiple and different acquisition platforms in a manner that improves the output of subsequent machine learning analysis or training, the instant claims improve the operation of a computer, thus providing a technological improvement in a manner similar to the claims at issue in Diehr and Thales Visionix. See also, Specification, paragraphs [0100] and [0182].”, see pgs. 11-12 of response filed 10/13/2025. As stated above, the present claims do not recite a combination of additional elements that provide a specific improvement over prior systems. The limitations which applicant is arguing for showing technological improvement including "apply the at least one template-signal vector data set to one or more denoising vector data sets, wherein the one or more denoising vector data sets have a vector length corresponding to a vector length of a portion of the received biophysical-signal data set to be filtered; generate a modified biophysical-signal data set of the biophysical-signal data set, or a portion thereof, by merging the portion of the received biophysical-signal data set to be filtered and the at least one or more denoising vector data sets; and use the modified biophysical-signal data set in a machine learning operation to non-invasively estimate a value indicative of a presence or non-presence of coronary artery disease or significant ischemic heart disease." are part of the abstract idea and are not “additional elements”. Regarding the machine learning operation, as discussed above, the additional element of “a processor”, “a non-transitory computer readable medium”, “a machine learning operation” and “a memory having instruction stored thereon” amount to no more than mere instruction to apply the exception using generic computer components. The disclosed “a processor”, “a non-transitory computer readable medium”, “a machine learning operation” and “a memory having instruction stored thereon” are recited at a high level of generality as a processor that is running a machine learning operation and outputting the results (see specification, para. [0207]). Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application, see MPEP 2106.04(d)(I) and 2106.05(f).
Applicant argues the claimed invention “applies or uses a judicial exception to effect a particular treatment of prophylaxis for a disease or medical condition, see pg. 10-11 of response filed 10/13/2025. Applicant alleges the claimed invention provides a particular treatment of prophylaxis for a disease or medical condition, however the claims do not recite any treatment being provided to the patient since the claims only state “wherein the estimated value for the presence or non-presence of coronary artery disease or significant ischemic heart disease is used to non-invasively diagnose or to direct treatment of the coronary artery disease or significant ischemic heart disease.”, which includes a user simply using the value to aid in diagnosis of the patient or to instruct that treatment should be provided to the patient. No actual treatment is currently recited as being provided to the patient within the claims. As stated in MPEP 2106.04(d)(2) “Examples of “treatment” and prophylaxis” limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011).” The claims do not recite any treatment being provided to the patient and do not include a limitation that affirmatively recite an action that effects a particular treatment, see MPEP 2106.02(d)(2).
Conclusion
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 JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796