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 September 2, 2026 were received and fully considered. Claims 1, 4, and 7 were amended. Claims 10 and 11 were cancelled. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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, 2, 4, 5, 7, and 8 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 1 follows.
Regarding claim 1, the claim recites a processor implemented method. Thus, the claim is directed to a method/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:
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These limitations describe and/or expressly recite a mathematical calculation(s). Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, 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:
“…and providing an output… and generating a cardiac rehabilitation monitoring aid for the subject based on the estimated blood pressure, wherein the cardiac rehabilitation monitoring aid is provided for the subject if the subject is suffering from heart disease based on the estimated blood pressure.”
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 outputting/displaying does not integrate the judicial exception into a practical application. MPEP 2106.05(g). Moreover, “generating a cardiac rehabilitation monitoring aid” is recited at a high level of generality and does not constitute a particular treatment. See MPEP 2106.04(d).
The additional limitations also do not add significantly more to the identified judicial exception because they relate to mere extra-solution activity recited at a high level of generality.
Independent claims 4 and 7 are also not patent eligible for substantially similar reasons.
Dependent claims 2, 5, and 8 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1, 2, 4, 5, 7, and 8 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant raises the following main arguments:
“The claim is directed to operation of an ECG-driven in-silico cardiovascular hemodynamic model that dynamically reproduces physiological chamber activation and blood-pressure behavior of a subject. The mathematical relationships merely form part of the technological framework used to operate the cardiovascular model” (remarks, pgs. 12-13);
“amended claims 1-2, 4-5, 7-8 are patent eligible as they effect an improvement to other technology or technical field… in terms of generating a cardiac rehabilitation monitoring aid for the subject based on the estimated blood pressure” (remarks, pg. 13);
“the claim applies alleged mathematical concepts within a specifically recited cardiovascular simulation system to achieve a practical medical-monitoring objective rather than merely calculation information for display” (remarks, pg. 13);
“the amended claim recites operations that cannot be practically performed in the human mind” (remarks, pgs. 14+);
The instant claims are similar to USPTO Example 47 (remarks, pgs. 16+); and
“The ordered combination… constitutes an unconventional arrangement directed to operation of a cardiovascular digital-twin simulation system and not merely to performance of mathematical calculations… together achieve robust blood-pressure estimation using ECG data even where ECG signals are missing or noisy” (remarks, pg. 17).
Examiner respectfully disagrees. When given their broadest reasonable interpretation in light of the specification, the claimed cardiovascular hemodynamic model corresponds to mathematical calculations. Moreover, the plain meaning of a model (adaptive or not) that is being implemented on a generic processor is a series of mathematical calculations. The instant claims further expressly recite mathematical equations, thereby further demonstrating the mathematical nature of the claims. As the claims are entirely mathematical, it follows that any purported improvement lies within the mathematical calculations. However, it is important to note that “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). As the claims fail to recite any additional limitations that integrate the claims into a practical application, Examiner maintains that the recited model/calculation(s) is not patent eligible. Additionally, Examiner argues that nothing from the claims suggests that the skilled artisan would not be able to perform the recited calculations mentally, aided with simple pen/paper. For at least these reasons, the 35 USC 101 rejections are maintained.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Previously cited:
US PG Pub. No. 2024/0188874 A1, see par. 69, 87, 95, 112, 114
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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