DETAILED ACTION
Applicant’s arguments, filed 02/27/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 02/27/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-5 and 7-43 are pending and hereby under examination.
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 .
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 1-5 and 7-43 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.
Regarding claims 1, 16, and 30, the claims are directed to treating the subject by “causing” the subject to carry out targeted exercise and training in response to the comparison of the baseline limb excursion data to the post-injury limb excursion data. How does the system of inertial measurement sensors cause the subject to perform exercise or training? Per Applicant’s specification paragraph 0042, the present invention “assist with exercise and treatment prescription, enhance performance and to reduce the risk injuries” and the “ability to quantify the impairment and guide rehabilitative treatment” (Paragraph 0096). There is no support or disclosure of “causing” the subject to perform any exercise found within the specification, rather the disclosure suggests rehabilitation exercises. Claims 2-5, 7-15, 17-29, and 31-43 are also rejected due to their dependence on claims 1, 16, and 30.
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 1-5 and 7-43 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.
Regarding claims 1, 16, and 30, it is unclear as to what is required regarding “causing” the subject to carry out targeted exercises and training. How does the system of inertial measurement sensors or method of diagnosis “cause” the subject to perform an action? It appears that the treatment prescription is providing a suggestion to the subject of exercises they should perform, but they do not necessarily have to perform the exercise nor does the system cause (i.e., require/force) the subject to do so. For examination purposes, “providing a treatment prescription to the subject and cause the subject to carry out target exercises and training” will be interpreted as a suggestion for the subject to perform said exercises and training. Claims 2-5, 7-15, 17-29, and 31-43 are also rejected due to their dependence on claims 1, 16, and 30.
Regarding claim 30, the preamble and determination step are directed to determining a diagnosis of a concussion; however, the limitation of “treating the subject for the condition or disorder ” is not directed towards a concussion. It is unclear how the narrow determination of a concussion leads to the treatment for a broader condition or disorder. It appears Applicant intends to claim that condition or disorder is a concussion. For examination purposes, that is how the claim will be interpreted.
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 1-5 and 7-43 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.
Analysis of independent claims 1, 16, and 30:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1, 16, and 30 are directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 16, and 30 recite an abstract idea. In particular, the claims generally recite
the following:
Determining a diagnosis or a condition as a function of a comparison; and
Determining transition start and transition end for a change in direction of movement of subject on a graph; and
calculating the area under the curve between the transitions.
These elements recited in claims 1, 16, and 30 are drawn to an abstract idea since they are directed towards:
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I);
2) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“determining a diagnosis or a condition as a function of a comparison” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person of ordinary skill in the art could reasonably view baseline data and post-injury data, compare the two, and determine a generic diagnosis or condition. There is nothing to suggest an undue level of complexity in “determining a diagnosis or a condition as a function of a comparison”.
“determining transition start and end times for a change in direction of movement” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person of ordinary skill in the art could reasonably view a graph or data, and determine start and end times for a change in direction of movement. There is nothing to suggest an undue level of complexity in “determining transition start and end times for a change in direction of movement”.
“calculating an area under the curve” is drawn towards an abstract idea since it is a mathematical concept because taking the area under the curve (i.e., an integral) is a well-known mathematical equation to determine a variable or number.
Prong Two: Claims 1, 16, and 30 do not recite additional elements that integrate the exception
into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional
elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., “placing two or more inertial measurement sensors on a left limb of the subject and two or more inertial measurement sensors on a right limb of the subject” (claims 1, 16, and 30), "acquiring baseline limb excursion data from the inertial measurement sensors while a subject is performing at least one of a static balance activity by tracking the relative displacement of the respective two or more inertial measurement sensors on the left limb and the right limb, and a dynamic balance activity by tracking the relative displacement of the respective two or more inertial measurement sensors" (claims 1, 16, and 30), “acquiring post-injury limb excursion data after a concussion injury from the inertial measurement sensors while a subject is performing at least one of the static balance activity by tracking the relative displacement of the respective two or more inertial measurement sensors and the dynamic balance activity by tracking the relative displacement of the respective two or more inertial measurement sensors” (claims 1, 16, and 30), and “executing a two-phase signal processing alignment procedure to establish a known relationship between the four relevant reference frames: a sensor frame, a joint frame, a body frame, and a global frame” (claim 1)); the post-solution activity of; (e.g., “treating the subject for the condition or disorder using the comparison of the baseline limb excursion data to the post-injury limb excursion data; the step of treating including providing a treatment prescription to the subject and causing the subject to carry out targeted exercises and training in response to the comparison of the baseline limb excursion data to the post-injury limb excursion data” (claims 1, 16, and 30)).
As a whole, the additional elements merely serve to gather information to be used by the
abstract idea, while generically implementing it on a computer. There is no practical application because
the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed
remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the
technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the
abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and
conventional. For example, “an inertial measurement sensor” as disclosed in the Applicant’s specification on page 9, lines 4-8, “While reference is made to the term inertial measurement units (IMU), it is noted that other such wearable motion capture sensors, or inertial measurement sensors, can be used in place of an IMU and are understood to be comparable”.
An inertial measurement unit does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d
1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an
abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP
Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a
practical application and do not amount to significantly more than the above-judicial exception (the
abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing
that is not already present when looking at the elements taking individually. There is no indication that
the combination of elements improves the functioning of a computer, for example, or improves any
other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of
elements include a particular solution to a computer-based problem or a particular way to achieve a
desired computer-based outcome. Rather, the collective functions of the claimed invention merely
provide conventional computer implementation, i.e., the computer is simply a tool to perform the
process.
Analysis of the dependent claims:
Claims 2-5, 7-15, 17-29, and 31-43 depend from the independent claims. Dependent claims 2-5, 7-15, 17-29, and 31-43 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“wherein the determining step is calculated as a function of a Symmetry Index” (claims 3, 9, 18, 23, 32, and 38), “determining one of when the Symmetry Index is greater than a first threshold value, allowing the subject to return to regular activities; when the Symmetry Index is less than the first threshold value, and more or than or equal to a second threshold value allowing the subject to return to supervised activities, or when the Symmetry Index is less than the second threshold value, restricting the subject from participating in regular activities, wherein the first threshold value is greater than the second threshold value” (claims 4, 10, 19, 24, 33, and 39), “obtaining shank sagittal angular velocity data for one or more shanks of the subject during a predefined activity with one of the two or more inertial measurement sensors place on the one or more shanks of the subject, determine transition start and transition end for a change in direction of movement of the subject respectively on a graph of the shank sagittal angular velocity data, and calculate an area under the curve by integrating a line joining at all transitions” (claims 7 and 36), “wherein the determining step is calculated as a function of a Symmetry Index” (claims 9, 23, and 38), and “wherein the injury or condition is a concussion (claims 11 and 25)),
Further describe the pre-solution activity (“wherein the post-injury limb excursion data is a region of limb stability for the respective limb and is calculated by each segment's medio-lateral and anterior-posterior excursions within the horizontal plane and combining the maximum excursions into an excursion square area for each of the left and right limbs” (claims 2, 17, and 31), “a processing alignment procedure to establish and capture a rotation matrix of the subject performing a stand-still step and a linear gait step, calculating a known relationship for the processing alignment of one of the inertial measurement sensors roll, pitch, and yaw as a function of a fixed time-invariant rotation from one of the inertial measurement sensors frame of reference from a limb joint frame of reference” (claims 5, 20, and 34), “executing a two-phase signal processing alignment procedure to establish a known relationship between four relevant reference frames: a sensor frame, a joint frame, a body frame, and a global frame” (claims 21 and 35), “combining shank sagittal angular velocity of one or more shanks of the subject with the sagittal plane angular velocity of the thigh and coronal plane velocities thereof to quantify motion of the knee joint” (claims 8, 22, and 37), “wherein the two or more inertial measurement sensors on the left limb of the subject are fixed to a left limb sleeve and two or more inertial measurement sensors on the right limb are fixed to a right limb sleeve” (claims 12, 26, and 40), “wherein two or more inertial measurement sensors on the left limb are placed below the knee joint line at the medial tibial flare on a left shank of the subject and above a left knee joint line, along with the distal iliotibial band on a left thigh of the subject, and wherein two or more inertial measurement sensors on the right limb are placed below the knee joint line at the medial tibial flare on a right shank of the subject and above a right knee joint line, along with the distal iliotibial band on a right thigh of the subject.” (claims 13, 27, and 41), “further comprising placing an additional inertial measurement sensor at the center of the sacrum of the subject” (claims 14, 28, and 42), and “wherein the additional inertial measurement sensor confirms a change in direction of the subject” (claims 15, 29, and 43), and
Taken alone or in combination, the additional elements do not integrate the judicial exception
into a practical application at least because the abstract idea is not applied, relied on, or used in a
meaningful way. The additional elements do not add anything significantly more than the abstract idea.
The collective functions of the additional elements merely provide computer/electronic implementation
and processing, and no additional elements beyond those of the abstract idea. There is no indication
that the combination of elements permits automation of specific tasks that previously could not be
automated. There is no indication that the combination of elements improves the functioning of a
computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform
different.
Therefore, claims 1-5 and 7-43 are rejected as being directed to non-statutory subjection matter.
Response to Arguments
Applicant’s arguments, see page 18, filed 02/27/2026, with respect to the claim objections claim rejections have been fully considered and are persuasive. Applicant amended the claims per the suggestion of the Examiner. The objection of the claims has been withdrawn.
Applicant’s arguments, see page 18, filed 02/27/2026, with respect to the 35 U.S.C. §112(b) claim rejections have been fully considered and are persuasive. Applicant amended the claims per the suggestion of the Examiner. The rejection of the claims has been withdrawn. However, new rejections have been applied.
Applicant's arguments, see pages 19-21, filed 02/27/2026, with respect to the 35 U.S.C. §101 claim rejections have been fully considered but they are not persuasive.
Applicant argues that by amending the claims to incorporate that the method uses the outputted resultant data to “treat” the subject for the condition/disorder, which includes providing a treatment prescription to the subject and the subject carrying out targeted exercise and training, the judicial exception is integrated into a practical application. Examiner respectfully disagrees.
Per the claim interpretation of “causing” as described in the 112(b) rejection above, the “providing a prescription” and “causing the subject to carry out targeted exercises and training” is merely insignificant post-solution activity. The prescription and recommended exercises is merely another form of output of the resultant data, and the subject does not necessarily have to perform the exercises prescribed to them. Thus, the claims remain rejected.
Applicant further argues that the treatment and targeted exercise cannot be carried out in the mind, and Examiner agrees. However, as stated above, this step is directed to insignificant post-solution activity of the abstract idea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bunn (US 20140024971) teaches a mobility assessment of a subject for concussion detection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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