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 Arguments
There are new 35 USC 112 rejections in view of the amendments.
Applicant’s arguments, see Remarks page 8, filed 07/06/2026, with respect to the claim objection to claim 20 has been fully considered and is persuasive. The applicant has amended the claim to resolve the objection. The claim objection to claim 20 has been withdrawn.
Applicant's arguments, see Remarks pages 9-11, filed 07/06/2026, with respect to the 35 US 101 rejection of claims 15-25 and 28-33 have been fully considered but they are not persuasive.
In response to the applicant’s argument that amended treatment step is now a particular treatment, the examiner respectfully disagrees. As mentioned during the interview, the examiner still contends the “treatment” appears to be an attempt at organizing human activity by removing an individual from activity after observations are made.
In response to the applicant’s argument that the applicant’s claim structure is analogous to the eligible claims in USPTO Subject Matter Eligibility Example 43 and 49, the examiner respectfully disagrees. As mentioned above, the examiner maintains the contention that the “treatment” appears to be an attempt at organizing human activity by removing an individual from activity after observations are made.
Therefore, the 35 USC 101 rejection of claims 15-25 and 28-33 is maintained.
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 15-25 and 28-35 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 15 recites “…the sensor unit continues to monitor and transmit updated impact metrics and Post Impact Concussion Score of the subject until the subject is further treated for the cognitive impairment, neurological injury, or concussion”], which the examiner notes has been amended into the claims and does not appear to be described in the specification.
Claim 55 recites “…the sensor unit continues to monitor and transmit updated impact metrics and Post Impact Concussion Score of the subject until the subject is further treated for the cognitive impairment, neurological injury, or concussion”, which the examiner notes has been amended into the claims and does not appear to be described in the specification.
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 15-25 and 28-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 15 recites:
A method for improved real-time assessment of a cognitive impairment, neurological injury, or concussion for a subject experiencing an impact, the method comprising:
a) determining for the subject any two or more impact metrics selected from:
i) Impact Force;
ii) Stun Time;
iii) Sway Time;
iv) Slow Time;
v) Sway Score; and
vi) Trismus,
b) assigning a numerical weighting to all impact metrics, respectively; and
c) summing or calculating a weighted average from the weighted metrics to provide a Post Impact Concussion Score and wherein upon the Post Impact Concussion Score being above a predetermined threshold value, an alert is generated and sent to a designated person to indicate that the subject is cognitively impaired, has sustained the neurological injury, or has the concussion and requires treatment for the cognitive impairment, the neurological injury, or the concussion,
…
wherein the x-axis is a horizontal axis parallel to the ground directed forward of the subject's body; the y-axis is a horizontal axis parallel to the ground directed laterally of the subject's body; and the z-axis is a vertical axis perpendicular to the ground,
wherein the sensor unit is associated with a mouthguard, helmet, headgear, or apparel, and wherein the method further comprises:
d) upon the Post Impact Concussion Score being above the predetermined threshold value, (i) the sensor unit generates the alert to the designated person and the designated person treats the subject by removing the subject from athletic, recreational, or occupational activity for clinical neurological evaluation and to prevent further neurological injury, and (ii) the sensor unit continues to monitor and transmit updated impact metrics and Post Impact Concussion Score of the subject until the subject is further treated for the cognitive impairment, neurological injury, or concussion.
Independent Claim 25 recites:
A method for determining a Post Impact Concussion Score for a subject experiencing an impact in real time, the method comprising:
a) determining for the subject any two or more impact metrics selected from:
i) Impact Force;
ii) Stun Time;
iii) Sway Time;
iv) Slow Time;
v) Sway Score; and
vi) Trismus,
b) assigning a numerical weighting to all impact metrics, respectively; and
c) summing or calculating a weighted average from the weighted metrics to provide the Post Impact Concussion Score and wherein upon the Post Impact Concussion Score being above a predetermined threshold value, an alert is generated and sent to a designated person to indicate that the subject is cognitively impaired, has sustained a neurological injury, or has a concussion and requires treatment for the cognitive impairment, neurological injury, or concussion;
…
wherein the x-axis is a horizontal axis parallel to the ground directed forward of the subject's body; the y-axis is a horizontal axis parallel to the ground directed laterally of the subject's body; and the z-axis is a vertical axis perpendicular to the ground,
wherein the sensor unit is associated with a mouthguard, helmet, headgear, or apparel, and wherein the method further comprises:
d) upon the Post Impact Concussion Score being above the predetermined threshold value, (i) the sensor unit generates the alert to the designated person and the designated person treats the subject by removing the subject from athletic, recreational, or occupational activity for clinical neurological evaluation and to prevent further neurological injury, and (ii) the sensor unit continues to monitor and transmit updated impact metrics and Post Impact Concussion Score of the subject until the subject is further treated for the cognitive impairment, neurological injury, or concussion.
Step 1:
The examiner finds claims 15 and 25 are drawn to methods.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of determining, assigning, summing, and calculating recite a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The examiner notes the steps of “monitoring”, “transmitting”, and “alerting” are being interpreted as insignificant extra-solution activities that amount to necessary data gathering/data output.
The step of “determining for the subject any two or more impact metrics” in independent Claims 15 and 25 is an example of using mathematical processes to analyze data. The steps of “assigning a numerical weighting to each impact metric” in independent Claims 15 and 25 is a mathematical calculation to assign a quantitative hierarchy of each metric for the purpose of optimized patient diagnosis. The step of “summing or calculating a weighted average from the weighted metrics to provide the Post Impact Concussion Score” in claims 15 and 25 is an example of using mathematical processes to analyze data.
The claimed steps of determining, assigning, summing, and calculating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 16-24 and 28-35, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 15-25 and 28-35 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for determining, assigning, summing, and calculating merely invoke a computer as a tool.
• The data-gathering steps (monitoring) and the data-output step (treating, transmitting) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for collecting, aggregating, analyzing, and correlating.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for collecting, aggregating, analyzing, and correlating. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: a gyroscope, a magnetometer, an accelerometer, a sensor unit, an indicator, a helmet, and a processor.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s specification (e.g. page 14 lns 33-34) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. determining, assigning, summing, and calculating) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Applicant’s specification (e.g. page 9, lines 9-15) which discloses that accelerometers, gyroscopes, and magnetometers in wearables are commonly known;
Ritchey (US 20200218767 A1) which discloses that helmets are a conventional means to carry sensors [0094];
• Applicant’s Background in the specification.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer. A gyroscope, a magnetometer, and an accelerometer that are wearable are commonly or conventionally known data gathering tools.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Conclusion
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 JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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