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 .
Status of Claims
This action is in reply to the claims filed on 21 January 2026. Claims 1 and 10 were amended. Claims 2-3 were previously canceled. Claims 1 and 4-10 are currently pending and have been examined.
Subject Matter Free of Prior Art
Claims 1 and 4-10 are considered to be subject matter free of prior art. The following is a statement of reasons for the indication of allowable subject matter: Applicant’s claims are directed to a system and method for advanced neuro-rehabilitation. This includes the categorization of a patient into at least one of brain injury rehabilitation stages or spinal cord injury rehabilitation stages. Claims 1 and 10 recites further detail about the spinal cord injury stages including that there are 4 stages and 10 levels. The closest prior art of record is understood to be the prior art of record. This includes the Irving reference and the Nas reference. Irving discloses a system and method of categorizing stages of brain injury rehabilitation but is silent concerning spinal cord injury rehabilitation. Nas teaches the use of 4 stages/phases of spinal cord rehabilitation (acute, subacute, and chronic) but is silent as to the different levels of rehabilitation and does not mention 10 levels of rehabilitation within the 4 stages/phases. Therefore, the prior art does not teach or fairly suggest a combination of elements that arrive at the specific combination of elements described in claims 1 and 4-10. Therefore, claims 1 and 4-10 are considered to be free of prior art.
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 and 4-10 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 1 and 4-10 fall within one or more statutory categories. Claims 1 and 4-9 fall within the category of a machine. Claim 10 falls within the category of a process.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 and 4-10 recite an abstract idea. Representative claim 1 recites:
… clinically evaluate a user of a plurality of users and compute a clinical evaluation data, wherein the computed clinical evaluation data comprises at least one medical condition of the user of the plurality of users;
present a set of questions to the user …, wherein the set of questions is associated with the at least one medical condition of the user, wherein the set of questions are referred as Self Evaluation of Functional Abilities (SEFA); and
receive user input data comprising a set of answers corresponding to the set of questions …;
… receive the computed clinical evaluation data, associated with the user, from the health care person; and
at least one of a plurality of Brain Injury Rehabilitation (BIR) stages and a plurality of Spinal cord Injury Rehabilitation (SCIR) stages; and
generate a first set of data based on the received user input data associated with the at least medical condition of the user;
categorize … the first set of data into at least one of the plurality of BIR stages and the plurality of SCIR stages,
wherein the categorization is based on the stored historical data associated with at least one medical condition of the one of the plurality of the users,
the first set of data pertains to C2C levels associated with BIR & SCIR injuries of the user, wherein the first set of data comprises a plurality of data sets under specific categories coded for both BIR & SCIR,
the plurality of BIR & SCIR stages include C2C BIR stages 1-4 and C2C SCIR stages 1-4,
the plurality of BIR & SCIR stages further includes at least four stages of both BIR & SCIR and at least ten levels each of both BIR or SCIR, and
each level in BIR & SCIR stages describes specific patterns of functional disabilities of patient in brain or spinal cord injuries;
perform a first verification by matching a C2C level obtained from the SEFA with stored historical data associated with at least one medical condition of the one of the plurality of the users;
determine objective assessment of at least one of the plurality of BIR stages and the plurality of SCIR stages based on the plurality of data sets and the computed clinical evaluation data, wherein the determined objective assessment indicates a current functional condition of the user who had been subjected to brain or spinal cord injuries, wherein the objective assessment corresponds to Clinical Evaluation of Functional Abilities (CEFA);
perform a second verification by matching the C2C level obtained from the CEFA with the C2C level obtained from the SEFA to confirm user's rehabilitation stage within the plurality of BIR or SCIR stage of the user;
generate … based on the objective assessment, a type of diagnosis, a time of diagnosis, a rehabilitation index and a detailed report, that indicates a median probability of functional improvements possible for the user,
wherein the detailed report further indicates the type of diagnosis, time of diagnosis, rehabilitation time, C2C scores, and predictability of reaching the outcome C2C score, and Progress & Prognosis Prediction;
wherein progress and prognosis prediction is performed by computing the rehabilitation index and an initial C2C level (irC2C) attainable by the user,
wherein the rehabilitation index is computed based on received inputs from the user through the SEFA questionnaire and the CEFA and duration between onset of injury to a rehab consultation;
compute an optimal value of C2C level (erC2C) based on the rehabilitation index;
[provide] the erC2C to the clinician;
analyze the detailed report based on novel treatment protocols that are guided by a Clinical, Anatomical, Radiological, Etio-Pathological and Rehabilitation (CAREPa-Re) Framework;
map dynamics of the CAREPa-Re Framework with rehabilitation, wherein mapping provides understanding areas of the brain affected, wherein the CAREPa framework captures initial clinical findings at ictus, the subsequent worsening due to the progress of the disease, and related and unrelated complications, wherein the related and unrelated complications includes raised ICP, brain surgery, electrolyte disturbances, effective control of hypertension and diabetes, infections, speed of improvement, areas of the brain affected, the type of etio-pathology;
determine, based on the mapping, subtle and complex neurological disabilities, wherein the subtle and complex neurological disabilities include apraxias, agnosias, visuo-spatial issues; and
provide a customized plan of treatment with specific goals for the treatment based on the determined subtle and complex neurological disabilities.
Therefore, the claim as a whole is directed to “diagnosis and categorization of injury” which is an abstract idea because it is a method of organizing human activity. “Diagnosis and categorization of injury” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claims include the interaction between a clinician and patient during diagnosis and treatment.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the following additional element(s):
a clinical evaluation apparatus, wherein the clinical evaluation apparatus comprises at least one of a Magnetic Resonance Imaging (MRI) scanner, a computerized Tomography (CT) scanner or an X-ray detector;
a first portable device associated with the user of the plurality of users, configured to [perform part of the method described above] … through a display unit of the first portable device … [and] through an input unit of the first portable device;
a second portable device associated with a health care person;
a server;
a memory;
an Artificial Intelligence (AI) unit configured to store historical data associated with at least one medical condition of one of the plurality of the users, [the AI unit is also used to perform parts of the above described method];
circuitry coupled with the memory.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional elements merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s), individually and in combination, merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, claim 1 is ineligible.
Dependent claim 4 recites the method of claim 1, wherein:
the C2C BIR stage 1 corresponds to: the state of the user when the user is in altered sensorium/coma, and a patient whose condition corresponds a 100% bedridden completely dependent or support of ventilator (either invasive or CPAP), and
the C2C SCIR stage 1 corresponds to: the state of the user when the user is in one of 100% bedridden condition, completely dependent on a ventilator.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 4 is considered to be ineligible.
Dependent claim 5 recites the method of claim 1, wherein:
the C2C BIR stage 2 correspond to: the state of the user in which the user progresses from a state of basic consciousness (GCS 1OT/15 or 14/15), to becoming oriented and aware to all that is happening to the user internally as well as in the external environment around the user and to appropriately respond to a specific stimuli, and a patient whose condition corresponds to mobile on wheel chair but with maximum/ moderate dependence, or limited ambulation with walker or crutches or calipers, and
the C2C SCIR stage 2 corresponds to: the state of the user in which the user is movable on a wheel chair (WC) inside home - but with one of a maximum dependence to a moderate dependence, or a limited ambulation with walker, crutches, or calipers.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 5 is considered to be ineligible.
Dependent claim 6 recites the method of claim 1, wherein:
the C2C stage 3 correspond to: a stage in which the user predominantly attempts to restore cognitive, motor planning, programming & execution as well as the speech/ language and swallowing capabilities closer to the premorbid levels of functioning, and a patient whose condition corresponds to being mobile or ambulant outside home and in the community; and
the C2C SCIR stage 3 corresponds to: a stage in which the user predominantly is movable outside home in a community with or without the support of assistive devices.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 6 is considered to be ineligible.
Dependent claim 7 recites the method of claim 1, wherein:
the C2C stage 4 correspond to: a state in which the user have overcome the neurological disabilities and have achieved normal levels of functioning when compared to their premorbid levels, and a patient whose condition corresponds to 100% reintegration into the community, and
the C2C SCIR stage 4 corresponds to: a state in which the user has overcome the neurological disabilities and has achieved normal levels of functioning when compared to their premorbid levels.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 7 is considered to be ineligible.
Dependent claim 8 recites the method of claim 1, wherein:
the set of questions and set of answers are in any specific language.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 8 is considered to be ineligible.
Dependent claim 9 recites the method of claim 1, wherein:
the user input configured to receive input from input via input unit based on written answers of the user or voice/ video input of the user.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 9 is considered to be ineligible.
Claim 10 is parallel in nature to claims 1 and 4-9. Accordingly claims 10 is rejected as being directed towards ineligible subject matter based upon the same analysis above.
Response to Arguments
Applicant's arguments filed 21 January 2026, with respect to the 35 U.S.C. §101 rejection of the claims have been fully considered but they are not persuasive. First, Applicant argues that the claims cannot be directed to a mental process (see Applicant remarks pages 10-11). The claims are not currently rejected as being directed to a mental process so this argument moot. Similarly, Applicant argues that the claims do not recite a method of organizing human activity because the method is machine implemented (see Applicant Remarks pages 11-12). This is not persuasive. The mere inclusion of machine/computer components does not preclude a finding under Step 2A Prong One that the claims recite a method of organizing human activity. The broadest reasonable interpretation includes the interaction between a healthcare provider and a patient. Any additional elements, including implementing the method using machine/computer components, are considered under step 2A Prong Two and Step 2B.
Next, Applicant argues that the abstract idea recited in the claims is integrated into a practical application because it is an automatic process following an algorithm, and provides a “technical improvements” (see Applicant remarks pages 12-13). This is not persuasive. Any improvement is provided by the use of general purpose computing hardware and functions, including the broadly recited use of “AI-driven” technology. Merely adding generic computer components to perform the method is not sufficient. The claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology (see MPEP 2106.05(a)(II)). Further, there is no improvement to technology recited in the claims, as considered in MPEP 2106.04(d)(1). If any improvement is recited, it is the improvement inherit in the use of generic computing technology on an abstract idea, because the claims merely recite the use of generic computer systems and functions to aid in performing the abstract idea, that of diagnosis and categorization of injury. In other words, the additional elements merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). This is not enough to integrate the abstract idea into a practical application or be considered significantly more than the judicial exception. Therefore, the claims do not include a technical solution that integrates the abstract idea into a practical application.
Finally, Applicant argues that the claims include significantly more than an abstract idea (see Applicant Remarks page 13). This is not persuasive. The claims recite that the abstract idea is performed by computer components and functions that are recited at a high level of generality. The claims do not include additional elements, considered individually or in combination, that are sufficient to amount to significantly more than the judicial exception. Similar to the discussion above with respect to integration of the abstract idea into a practical application, the additional element(s), individually and in combination, merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, the claims remain rejected as being directed to ineligible subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Leshem et al. (U.S. 2019/0258701) discloses a system for managing rehabilitation.
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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/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684