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 .
Election/Restrictions
Claims 12-14, 16-20, 23, 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 23rd, 2026.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 23rd, 2026.
Applicant's election with traverse of the species election requirement in the reply filed on April 23rd, 2026 is acknowledged. The traversal is on the grounds that “the species are not mutually exclusive or independent”. Examiner respectfully disagrees. This is not found persuasive because the species are described as mutually independent in the claims within which they appear. For example, claim 1 requires “one or more physical intensity measures and/or one or more stability measures”. The use of the word “or” does not link the species and allows for the species to work independently from one another. The same reasoning appears in claims 2, 3, and 5 which also include mutually independent species.
The traversal is also on the grounds “improper deconstruction of the inventive concept” as the special technical feature requires “the transformation of a multi-dimensional subject data set”. This is not persuasive because a multi-dimensional subject data set is not claimed. Claim 1 requires “one or more physical intensity measures and/or one or more stability measures from the subject to produce a subject data set”. Under broadest reasonable interpretation, the subject data set only requires physical intensity measures or stability measures. Thus, the special technical feature as written does not include a multi-dimensional subject data set.
The traversal is also on the grounds that “the generic claims link the species” and that Mirelman (US 2021/0161430) “does not disclose the specific application of a computational model of temporal and spatial data—particularly one utilizing Floquet theory (as in Claim 9)—to a multi-parameter data set to identify a substantial match for a neurological condition”. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” filed on April 9th, 2026, Mirelman discloses a computational model of temporal and spatial data (Mirelman: [0224]: “an algorithm for detecting falls” that uses data such as “precise location” and “the speed at which the patient was walking” yields a computational model of temporal and spatial data). The generic claim does not require the use of Floquet theory or that the data set be a multi-parameter data set as discussed above.
The traversal is also on the grounds “the burden of examining the claims as written—reflecting the multi-parameter nature of the invention—is not undue”. This is not persuasive because the sub-species physical intensity measures and stability measures would require separate search terms. In the example the Applicant provided, Examiner would have to search with the search terms “heart rate variability” and conduct a search with the search terms “postural stability”. As explained above, the invention as described in the claims does not require multiple parameters. In applications where only generic claims are presented, restrictions are permitted when the generic claims recite or encompass a multiplicity of species that an unduly extensive and burdensome search would be necessary to search the entire scope of the claim (see MPEP § 803.02 and § 809.02(a)).
Since none of the arguments were found persuasive, the requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 6 is objected to because of the following informalities:
In re claim 6, the limitation “The method of claim 1, comprising receiving the physical intensity measures…” should say further comprising. Appropriate correction is required.
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.
Claim 1-2, 5-9 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 re claim 1, the limitation “a computational model of temporal and spatial indicative of the neurological and/or physical condition to the subject data set to identify a substantial match between at least a subset of the subject data set and the computational model of temporal and spatial data” is unclear. “a computational model of temporal and spatial” indicates that the model was developed only with temporal and spatial data, however, the model seemingly requires physical intensity data in order to find a match to the subject data set. For purposes of examination, the limitation will be interpreted to mean the model is built off of data that has a time and a location/motion.
In re claim 7, the limitation “wherein a wearable device worn by the subject comprises that sensor” is unclear. Claim 6, from which claim 7 depends, discloses “at least one sensor” and so it is unclear which of these sensors “that sensor” refers to. For purposes of examination, the limitation will be interpreted as best understood to mean wherein a wearable device worn by the subject comprises the at least one sensor.
In re claim 9, the limitation “comprising: repeating the receiving and applying steps at multiple time points; adjusting one or more baseline measures in the subject data set; or, using one or more elements of Floquet theory to generate the computational model of temporal and spatial data indicative of the neurological and/or physical condition” is unclear because of the use of the word “or”. Under broadest reasonable interpretation, the limitation only requires one of the steps. For purposes of examination, the limitation will be understood under broadest reasonable interpretation as only requiring one of these steps and the limitation of “using one or more elements of Floquet theory to generate the computational model of temporal and spatial data indicative of the neurological and/or physical condition” will not be examined.
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, 5-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-2, 5-9 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Step 1: Claim 1 is drawn to a method.
Step 2A – Prong 1:
Claim 1 is drawn to an abstract idea, that under its broadest reasonable interpretation, covers a mental process but for the recitation of generic computer components to collecting and processing data. In particular, claim 1 recites the following limitations:
a method of detecting a neurological and/or physical condition in a subject using a computer, the method comprising:
receiving, by the computer, one or more physical intensity measures and/or one or more stability measures (non-elected) from the subject to produce a subject data set; and,
applying, by the computer, a computational model of temporal and spatial indicative of the neurological and/or physical condition to the subject data set to identify a substantial match between at least a subset of the subject data set and the computational model of temporal and spatial data, thereby detecting the neurological and/or physical condition in the subject using the computer.
These limitations of claim 1 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps merely comprised of mental processes.
Step 2A – Prong Two:
Claim 1 recites the following emphasized (indicated in bold) additional elements that are beyond the judicial exception:
a method of detecting a neurological and/or physical condition in a subject using a computer, the method comprising:
receiving, by the computer, one or more physical intensity measures and/or one or more stability measures (non-elected) from the subject to produce a subject data set; and,
applying, by the computer, a computational model of temporal and spatial indicative of the neurological and/or physical condition to the subject data set to identify a substantial match between at least a subset of the subject data set and the computational model of temporal and spatial data, thereby detecting the neurological and/or physical condition in the subject using the computer.
The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. The computer system is a computer that carries out abstract steps described in claim 1 (see 2106.05(g) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field. The alleged improvement made by the claimed invention as argued by the application above sets forth the improvement in a conclusory manner and the claim does not include the components or steps of the invention that the improvement described.
Step 2B:
Claim 14 does not recite additional elements that amount to significantly more than the judicial exception itself. Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well understood, routine, conventional activity. The computer system is a computer that carries out abstract steps described in claim 1. All uses of the recited abstract idea require the pre-solution data gathering.
Claims 2 and 5-9 recite the same abstract idea as their respective parent claims. Furthermore, these claims only contain recitations that further limit the abstract idea.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McEwen (US 20210113140).
In re claim 1, McEwen discloses method of detecting a neurological and/or physical condition in a subject using a computer (Fig. 3: 300; abstract), the method comprising:
receiving, by the computer, one or more physical intensity measures (310; [0036-0037]: heart rate variability is a physical intensity measure) and/or one or more stability measures (non-elected) from the subject to produce a subject data set (312; [0038]); and,
applying, by the computer (Fig. 1: 108), a computational model of temporal and spatial (210 and 314; [0039]: “HRV algorithm”; [0043-0044]: an algorithm developed with data tracking the physical activity of the subject over time is a computational model of temporal and spatial data) indicative of the neurological and/or physical condition to the subject data set to identify a substantial match between at least a subset of the subject data set and the computational model of temporal and spatial data, thereby detecting the neurological and/or physical condition in the subject using the computer (302; [0040-0043]).
In re claim 2, McEwen discloses wherein the physical intensity measures comprise a heart rate intensity measure (non-elected), a heart rate variability measure (310, [0016]), a heart rate interval measure (non-elected), cardiac stability index (CSI) (non-elected), and/or an electrocardiogram (ECG) measure (non-elected).
In re claim 5, McEwen discloses wherein the neurological and/or physical condition comprises a concussion [0016], mental fatigue, physical fatigue, bodily injury, traumatic brain injury, and/or frailty.
In re claim 6, McEwen discloses receiving the physical intensity measures and/or the stability measures from at least one sensor (Fig. 1: 102; [0026-0027]: “The HRV monitor 102 can include an electrocardiogram (ECG) or use photoplethysmography (PPG) technology”) within communication of at least one target location of the subject ([0027]: “The HRV monitor 102 can be worn on the wrist, chest, arm, finger, feet or ear”).
In re claim 7, McEwen discloses wherein a wearable device worn by the subject comprises that sensor ([0027, 0029]: “The individual engages in all the physical activities they normally would and wears the HRV monitor 102 during these activities”).
In re claim 9, McEwen discloses:
Repeating the receiving and applying steps at multiple time points ([0043]: repeating measurements and analysis throughout the year; Fig. 3: arrow from 312 to 308 shows repetition of collecting data; [0038]);
Adjusting one or more baseline measures in the subject data ([0040]: “dynamically adjusted threshold”); or,
Using one or more elements of Floquet theory to generate the computational model of temporal and spatial data indicative of the neurological and/or physical condition.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McEwen (US 20210113140) in view of Herman (US 20160051179).
In re claim 8, McEwen lacks:
wherein the receiving and applying steps are performed in substantially real-time.
Herman discloses a method for detecting a brain injury, for example a concussion (i.e. a neurological and/or physiological condition), that like the method disclosed by McEwen monitors heart rate variability [0013], wherein the reception of data, application of algorithm (i.e. model), and assessment are performed in real-time [0012, 0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method disclosed by McEwen to provide wherein the receiving and applying steps of the method are performed in real time as taught by Herman because this would allow for accurate detection of neurological and/physical conditions, like concussions, sooner in the case of patients who could be masking their symptoms or deceiving other concussion assessments (Herman: [0005]).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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