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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/27/2026 has been entered. Claims 31-50 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 5/27/2026 amending claims 31 and 41 to clarify the language the 112(a) rejections made against the claims in the office action of 2/27/2026 have been withdrawn.
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..”, “non-invasively estimate…a value of a presence or non-presence of coronary artery disease…using the modified biophysical data set”, and “responsive to determining that the subject has coronary artery disease…determine a treatment for the subject based…on the determined value.., wherein the treatment comprises surgery or administering a pharmacological substance” 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, non-invasively measuring, and determining 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”, “non-invasively measure” and “determine” 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 trained “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 “non-invasively estimate” 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, and the “determine” language in the context of the claim encompasses the user determining, based on the determined value, whether surgery or a pharmacologic substance should be provided to the subject. There is nothing to suggest an undue level of complexity in the steps of “receive”, “determine”, “apply”, “generate”, “non-invasively estimate” and “determine”. 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”, “via a machine learning operation…trained using biophysical-signal data paired with classification results…from a patient population”, “a memory having instruction stored thereon”, “obtaining…a biophysical-signal data set…” and “treat the subject for the coronary artery disease..”. 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. The additional element reciting “treat the subject for the coronary artery disease..” merely: add insignificant extra-solution activity and is recited is at a high level of generality (i.e. insignificant application) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to insignificant application, which is a form of insignificant extra-solution activity. The step of “treat the subject for the coronary artery disease..” appear to amount to an application of the exception as a generic prophylaxis which is not particular because there is no particular prophylaxis being administered, see MPEP 2106.04(d)(2). 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”, “via a machine learning operation…trained using biophysical-signal data paired with classification results…from a patient population” 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”, “via a machine learning operation…trained using biophysical-signal data paired with classification results…from a patient population” 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”, via a machine learning operation…trained using biophysical-signal data paired with classification results…from a patient population” and “a memory having instruction stored thereon” are recited at a high level of generality as a processor that is running a trained machine learning operation and outputting the results (see specification, para. [0204], [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, previously cited. 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)
Applicant's arguments filed 5/27/2026, regarding the 112(a) rejections have been fully considered and are persuasive in view of the claim amendments. It is noted that the 112(a) rejections have been withdrawn in view of the claim amendments.
Rejections under 35 USC 101
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 5/27/2026. 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 “determine a treatment for the subject based, at least in part, on the determined value”, which includes a user simply using the value to aid in determining a treatment to provide to the subject which includes a surgery or administering a pharmacologic substance. The treatment that is determined is not 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).” Further MPEP 2106.04(d)(2) recites “The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s).” and “Examiners should keep in mind that in order to qualify as a “treatment” or “prophylaxis” limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” The claims recite “treat the subject for the coronary artery disease or significant ischemic heart disease”, which are “merely instructions to “apply” the exception in a generic way” and do not “affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition”. The “treat the subject for the coronary artery disease or significant ischemic heart disease” step has been determined to be a generic prophylaxis because there is no particular prophylaxis being administered. Therefore, the recited “treat” is not a particular treatment of prophylaxis for a disease or medical condition and the claims do not include a limitation that affirmatively recite an action that effects a particular treatment, see MPEP 2106.02(d)(2). It is suggested to affirmatively recite providing a particular treatment of prophylaxis for a disease or medical condition, assuming support is found within the original disclosure, in accordance with MPEP 2106.02(d)(2) to aid in providing “significantly more” than the abstract idea.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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