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 .
Applicant filed a response dated 12/9/2025 in which claims 1, 8-9, 11, 13-15, and 19 have been amended, new claim 20 has been added. Thus, the claims 1-20 are pending in the application.
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 1-20 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.
In claim 1 (and elsewhere, where applicable), lines 6-9, Examiner interprets “parametrizing a mathematical model to the heart tissue sample” to include assigning a parameter to the model. Examiner is unclear how to assign a parameter to the model based on heart tissue sample. The heart tissue sample is just a sample in which the protein quantities have been quantified in limitation 1b). Calculating a maximal activity Vmax of said subject does not clearly identify which activity of the subject is calculated. The maximal activity is represented by Vmax, however, it is unclear as to how to identify maximal activity unless the calculations have been carried out multiple times to determine which output is maximal. Moreover, calculating a maximal activity Vmax of said subject by applying information about the protein quantities from step b) to said mathematical model is confusing. It is unclear if applying protein quantities to the mathematical model should be interpreted as parametrizing a mathematical model since parametrizing involves heart tissue sample? The mathematical model is not defined with any specificity and it is unclear how one can calculate maximal activity Vmax of said subject from protein quantities. Thus, the scope of the limitation c) is unclear and hence the claim is indefinite.
With regard to claims 1 and 15, the Examiner believes that the text of MPEP §2173.06 is relevant:
When making a rejection over prior art in these circumstances, it is important for the examiner to point out how the claim is being interpreted. Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of determining an individual metabolic cardiac profile of a subject without significantly more.
Claim 1 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 recites a series of steps, e.g., providing a heart tissue sample from said subject, quantifying proteins in said sample to obtain protein quantities of the heart tissue sample, and parametrizing a mathematical model to the heart tissue sample of said subject by calculating a maximal activity Vmax of said subject by applying information about the protein quantities b) to said mathematical model. These limitations describe an abstract idea of determining an individual metabolic cardiac profile of a subject which correspond to a certain method of organizing human activity. The use of a mathematical model to calculate a maximal activity may correspond to an abstract idea of mathematical concepts. The claim 1 does not recite additional elements. Thus, the claim 1 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the claim 1 does not recite additional elements. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO and Step 2B: NO). Thus, the claim 1 is not patent eligible.
Claim 15 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 15 recites a series of steps, e.g., a) receiving protein quantities from a heart tissue sample of a subject, and b) parameterizing a mathematical model to the heart tissue sample of said subject by calculating a maximal activity Vmax of said subject by applying the protein quantities to said model; wherein said method is performed via a computer program which is written in a programming language selected from the group consisting of Fortran, C#, C/C++, High Level Shading Language, and Python. These limitations (with the exception of italicized limitations) describe an abstract idea of determining an individual metabolic cardiac profile of a subject which correspond to a certain method of organizing human activity. The use of a mathematical model to calculate a maximal activity may correspond to an abstract idea of mathematical concepts. The additional elements of a computer program, a programming language, and Fortran, C#, C/C++, High Level Shading Language, and Python do not restrict the claim from reciting an abstract idea. Thus, the claim 15 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional elements of a computer program, a programming language, and Fortran, C#, C/C++, High Level Shading Language, and Python result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a computer program, a programming language, and Fortran, C#, C/C++, High Level Shading Language, and Python are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 15 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 15 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a computer program, a programming language, and Fortran, C#, C/C++, High Level Shading Language, and Python are recited at a high level of generality in that it result in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these limitations provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 15 is not patent eligible.
Dependent claims 2-14 and 16-20 further define the abstract idea that is present in their respective independent claims 1 and 15, thus correspond to a Certain Methods of Organizing Human Activity, and hence are abstract in nature for the reason presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 1-20 are not patent-eligible.
Response to Arguments
Examiner withdraws previously cited 35 U.S.C. 112(b) rejection of in view of the amendment/argument.
Applicant's arguments filed dated 12/9/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-19 under 35 U.S.C. 101, Applicant states that the subject matter of claim 1 does not fall into any of these enumerated subgroupings and is also not a “tentative abstract idea.” The claims recite additional elements that integrate the judicial exception into a practical application. The method transforms protein quantity data from a physical tissue sample into a specific parameter (Vmax), which is then used to parameterize a physiological kinetic model of cardiac metabolism. The claimed method provides a practical application by creating a specific, parameterized computational model that assesses the energetic capacity of heart tissue, a technical problem that, as stated in the application, could not be solved by prior art methods. Any computer used to implement the method is not merely used as a generic tool; it is integral to the claimed process of kinetic modeling and parameterization. Finally, the claimed steps, when taken as a whole, also amount to “significantly more” than the abstract idea of data analysis.
Examiner respectfully disagrees and notes that the claim recites the steps of providing, quantifying and parametrizing a mathematical model. These steps are clearly abstract idea and support Examiner’s conclusion that the claim recites an abstract idea of determining an individual metabolic cardiac profile of a subject. The preamble of the claim states that it is a computer-implemented method, however, the body of the claim does not mention use of a computer to carry out the method steps. The method steps are recited at a high level of generality and makes use of a mathematical model to calculate a maximal activity. These are all abstract steps and the claim does not recite additional elements. Thus, the claim is directed to an abstract idea.
With respect to claim 15, Applicant states that the claim 15 has been significantly amended to integrate elements previously presented in claim 1. Thus, applicant’s above analysis re claim 1 also applies in the context of claim 15.
Examiner respectfully disagrees and relies on the response presented above for claim 1 for maintaining the rejection. The additional elements present in claim 15 are recited at a high level of generality in that it simply amounts to applying the abstract idea without providing any technical improvement. Thus, the additional elements do not integrate the abstract idea into a practical application or amount to add significantly more.
With respect to the 35 U.S.C. 103 rejection of claims 1, 3-6, and 13-19, Applicant’s arguments are moot in view of the new ground of rejection based on 35 U.S.C. 112(b) presented above in this office action.
With regard to Applicant traversing Official Notice taken in the previous office action for claims 2 and 11, Examiner relies on Yeghiazarians et al., US Patent Application No. 2014/0120066 for disclosing the limitation of claim 2, e.g., Yeghiazarians discloses wherein said heart tissue sample is a left ventricle, a right ventricle, a septum, a left atrium, and/or a right atrium heart tissue sample obtained from said subject during a myocardium examination or cardiac surgery ([0089]). For claim 11, Examiner relies on Makriyannis et al., US Patent Application No. 2012/0172339 for disclosing wherein a plurality of said mathematical models are used in computations for the heart at physiological state, and for the heart at pathological state ([0010]). Examiner has withdrawn the rejection of claims 10 and 12 in view of the argument.
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 RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684