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 .
Response to Amendment
Claims 1-9 are currently pending. Claims 1-3 have been amended. Claims 4-9 have been added. Claim 2 has been amended to overcome the claim objections and claim 1 has been amended to overcome the 35 U.S.C. 112(b) rejections set forth in the Non-Final Office Action mailed on 19 August 2025.
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 1 and 9 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. Claims 2-8 are further rejected due to their dependency to claim 1.
Claim 1 recites “variability indices HV1 and HV2” in lines 21-22. However, the filed specification does not have support for two hemodynamic variabilities. It is noted that [0024] of the PGPUB mentions “cerebral oxygenation variability (OV) and hemodynamic variability (HV).” It is unclear if HV1 and HV2 are directed to OV and HV. Clarification is requested.
Claim 9 recites “wherein the predetermined threshold for diagnosing vascular aging is derived from a reference database of subjects aged 50 years or older.” The filed specification does not have support for this limitation. [0032] of the PGPUB mentions studying participations from age 20 to 88.
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 and 4-8 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. Claims 2, 3, and 9 are further rejected due to their dependency to claim 1.
Claim 1 recites the limitation “the indices” in line 22. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is referring to “variability indices” as mentioned in lines 21-22. Clarification is requested.
Claim 1 recites “variability indices HV1 and HV2” in lines 21-22. It is unclear what “HV1” and HV2” stand for. It is noted that “HV” stands for “hemodynamic variability,” as mentioned in [0024] of the PGPUB. Examiner suggests to amend “HV1” and “HV2” to read as “hemodynamic variability 1 (HV1)” and “hemodynamic variability 2 (HV2).”
Claims 4-8 recite what each of the variability indices are. However, claim 1 recites that the variability indices represent amplitudes of hemodynamic fluctuations in lines 22-23. It is unclear if the variability indices should only be the amplitudes of hemodynamic fluctuations or if the variability indices are the amplitudes or hemodynamic fluctuations and a root mean square, standard deviation, variance, range, or interquartile range. Clarification is requested.
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 1-9 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.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including a placing a fNIRS optical detector on the subject’s frontal region while the subject is seated with one hand resting on a table. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
placing a functional near-infrared spectroscopy (fNIRS) optical detector on the subject’s frontal region while the subject is seated with one hand resting on a table;
establishing a baseline;
activating a pacer during a 30-second rest phase preceding a handgrip test;
instructing the subject to perform a series of ten handgrips at maximal voluntary effort, one handgrip every three seconds, during a 30-second grip phase;
instructing the subject to relax during a 30-second recovery phase;
repeating the baseline, rest, grip, and recovery phase after a three-minute interval; and
processing the recorded signals to compute variability indices HV1 and HV2, respectively, of the rest and grip phases, the indices representing amplitudes of hemodynamic fluctuations
set forth a judicial exception. The placing, establishing, activating, instructing, and repeating steps describe a concept of organizing human activity. Thus, the claim is drawn to Organizing Human Activity, which is an Abstract Idea. The processing and computing steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is also drawn to a Mental Process, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites diagnosing the subject as having advanced vascular aging when the variability indices HV1 and HV2 exceed a predetermined threshold, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The diagnosing of the subject does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the diagnosed subject, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
recording cerebral hemoglobin signals for at least 30 seconds while the subject is relaxed;
simultaneously recording cerebral hemoglobin signals; and
continuing to record cerebral hemoglobin signals
The recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claim 2 merely recites recording cerebral hemoglobin signals at a frequency greater than 1 Hz, which is pre-solution activity of data gathering. Claims 3-8 recite how variability analysis is performed or what the variability indices are, which adds to the Abstract Idea as claims 3-8 recite mathematical concepts. Claim 9 recites wherein the predetermined threshold for diagnosing vascular aging is derived from a reference database, which is a mental process and a generic output of data. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Response to Arguments
Applicant argues that the claims are directed to a practical application. Examiner respectfully disagrees, as the placing step is a step of organizing human activity, which is an Abstract Idea. It is noted that section 2106.05(a) II. of the MPEP states that “…it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” Regarding the diagnosing step, this step merely outputs a data point. There is no practical application or technical improvement to outputting a data pint (whether or not the subject has advanced vascular aging).
Applicant argues the claim applies the relationship between hemodynamic variability and vascular aging through non-routine data acquisition and signal processing steps involving fNIRS instrumentation and defined experimental timing. Examiner respectfully disagrees, as Wriessnegger et al. teaches similar steps, as previously mentioned in the Non-Final Office Action mailed on 19 August 2025. Furthermore, the fNIRS sensor is a generic and well-understood sensor known to those skilled in the art.
Applicant argues that the claimed method improves the technical field of non-invasive diagnostics by introduce new variability-based indices that enhance sensitive. However, claim 1 merely recites steps that are Abstract Ideas. As previously mentioned, section 2106.05(a) II. of the MPEP states that “…it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” As such, the arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections have been fully considered and are persuasive. The 35 U.S.C. 103 rejections of claims 1-9 have been withdrawn. Although it was found that Iconaru et al. (“Hand grip strength as a physical biomarker of aging from the perspective of a Fibonacci mathematical model” – 2018) teaches that hand grip strength can be used to determine the aging process, Iconaru et al. does not teach using the steps of claim 1 to determine the aging process. There is no reason to combine Inconaru et al. with Wriessnegger et al. and Jung et al. ‘481.
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.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791