DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 14-19, 23, and 24 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 now calls for the processing unit to “temporally align at least a portion of the proximal pressure measurement signals with at least a portion of the distal pressure measurement”; it is unclear if the intent is to align the proximal signals themselves with one single measurement from the distal measurements, or to select some plurality of the distal measurements to be considered a portion of the distal measurement[s], or if equivalent signals should be aligned with signals, or measurements should be aligned with measurements. It is entirely unclear whether the intent is to involve signals, measurements derived from signals, or both in the step. For the purposes of examination the claim will be treated as though calling for aligning the signals. 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 14-19, 23, and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 14-19, 23, and 24 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”, “temporally align at least a portion of the… signals”, “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 and a pressure-sensing instrument configured to obtain the pressure measurement signals. However, these elements are not “significantly more”; the processing unit is 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. The “pressure-sensing instrument” is recited at a high level of generality and only for the purpose of insignificant, extrasolution data gathering - see MPEP 2106.05(d), where 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. 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) 15-19, 23, and 24 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 23, 24, 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) 14-19, 23, and 24 is/are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 101, Applicant initially argues that the recitation of an unspecified “pressure-sensing instrument” for the purposes of obtaining data renders the identified abstract idea as not a mental process; the abstract idea itself is clearly identified both in the previous Office Action and again above. The nonspecific “instrument” is recited at a high level of generality and only for the purpose of insignificant extrasolution data gathering, and does not alter the analysis of the actual abstract idea itself.
Applicant next argues that the recitation of “temporal alignment” of data signals cannot be part of a mental process because it is possible to perform this task via hardware, software, cross-correlation, matching features or timestamps; the Examiner notes that the disclosure of the instant application explicitly defines that the process of “temporal alignment” of data signals can be accomplished by “ alignment is performed by a software user where adjustments are made to the delay time of at least one of the proximal and distal pressures until the cardiac cycles are visually aligned to the user” (paragraph [00112] as filed), a mental process which can nominally include a nonspecific computing device to provide a technological environment for its execution, such that this argument is entirely unpersuasive in light of Applicant’s own disclosures. In the absence of any specific positive recitation of a particular process of “temporal alignment” that actually could not be a mental process, this is entirely unpersuasive.
The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all claims are rejected under 101 and 112 above they are not presently allowable.
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.
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/KAREN E TOTH/Examiner, Art Unit 3791
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