DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 January 2026 has been entered.
Claim Rejections - 35 USC § 112
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 14-22 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.
Claim 14 calls for the pressure ratio to be calculated based on “a plurality of distal pressure measurements obtained during a parallel portion, less than all, of each respective cardiac cycle and a plurality of proximal pressure measurements obtained during the parallel portion”. There is no description in the disclosure whatsoever of use of a “parallel portion” of a cycle or any suggestion of any aspect that might be considered to be “parallel”. At no point does the disclosure convey possession of use of measurements obtained during a “parallel portion” of a cardiac cycle at the time the invention was filed.
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 14-22 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 14 calls for the pressure ratio to be calculated based on “a plurality of distal pressure measurements obtained during a parallel portion, less than all, of each respective cardiac cycle and a plurality of proximal pressure measurements obtained during the parallel portion”. There is no description in the disclosure whatsoever of what a “parallel portion” of a cycle might be or any suggestion of any aspect that might be considered to be “parallel” or any information as to how this may be identified or what this refers to, whether this might describe a physical shape of a trace of a cycle or referring to measurements occurring simultaneously or some other aspect of the cycle which somehow aligns/is parallel with some unidentified standard, nor is this a standard term in the art. As such, it is unclear what data should be used as the scope of what is considered to be a “parallel portion” of a cycle might be. Clarification is required.
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 14-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 14-22 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 14 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive proximal pressure measurements”, “receive distal pressure measurements”, “calculate… a pressure ratio”, and “output… a pressure ratio indicator”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter; at best the recited “processing unit” merely links the use of the judicial exception to a particular technological environment or field of use. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are that the system includes “a processing unit” configured to perform the abstract idea. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 14 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 15-22 fail to cure the deficiencies of independent claim 14 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited, or reciting additional elements used only for the insignificant extrasolution activity of data gathering (see claims 20-22, where MPEP 2106.05(d) holds that determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional). Thus, claim(s) 14-22 is/are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant’s arguments filed 9 December 2025, with respect to the rejections of the claims under 112b regarding the pressure ratio indicator, have been fully considered and are persuasive in light of the amendment to the claims. This rejection has been withdrawn.
The remainder of Applicant's arguments filed 9 December 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 101, Applicant argues that the use of “measurements obtained during a parallel portion of each cardiac cycle” results in an improvement in accuracy by avoiding dramatic fluctuations; as noted above, use of measurements during a “parallel portion” has not been disclosed in the specification of the instant invention, such that there is no clear showing whatsoever how this could result in avoiding dramatic fluctuations or be at all related to this theoretical improvement. At best, Applicant’s arguments imply that the measurements which are compared are obtained during similar portions of a cycle, which is an inherent aspect of performing calculations between cycles so as to allow comparison of equivalent data, such that this still does not provide any showing of how data occurring during similar stages of a cycle would thus inherently avoid “dramatic fluctuations” that could occur during a cycle and affect accuracy, such that this argument of use of “parallel portions” provides some sort of improvement in accuracy is entirely unpersuasive.
Regarding the double patenting rejections, due to the indefinite nature of the claims raised by the term “parallel portion”, these rejections have been withdrawn as the scope of the current claims is too indefinite to allow comparison, but these double patenting rejections will be revisited upon resolution of the indefiniteness if still applicable.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791