DETAILED ACTION
The Applicant’s response, received 21 January 2026, has 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.
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 the Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Claims 2, 4, 5, 6, 11, 12, 13, 18, 19, and 20 are objected to.
Priority
The Applicant’s claim for the benefit of a prior-filed application:
U.S. Non-Provisional Application No. 17/351,157, filed 17 June 2021 and U.S. Provisional Application 63/041,627, filed 19 June 2020; and
U.S. Provisional Application 63/082,822, filed 24 September 2020; under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c), is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 17/351,157, filed 17 June 2021 and U.S. Provisional Application 63/041,627, filed 19 June 2020; fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Instant independent claims 1, 8, and 15 recite “wherein the machine-learned model is trained using a training dataset of historical sensor data collected from a population of users, each entry of the training data comprising historical sensor data collected for a joint and labeled with an identifier of the joint and a known movement of the joint” and “categorizing, based on the predicted performance of the joint, a risk level for biomechanical compromise of the joint.” Application No. ‘627 does not appear to provide support for these particular characteristics of a machine-learned model.
Instant claims 2, 9, and 16 recite “wherein the machine-learned model is iteratively re-trained as the training dataset is updated with new sensor data collected from new users beginning to wear a plyowrap and existing users continuing to wear a plyowrap.” Application Nos. ‘157 and ‘627 do not appear to disclose a process for iteratively re-training a model using updated sensor data from new and existing users.
The disclosure of the prior-filed applications, Provisional Application No. 63/082,822, filed 24 September 2020; fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Instant claims 2, 9, and 16 recite “wherein the machine-learned model is iteratively re-trained as the training dataset is updated with new sensor data collected from new users beginning to wear a plyowrap and existing users continuing to wear a plyowrap.” Application No. ‘822 does not appear to disclose a process for iteratively re-training a model using updated sensor data from new and existing users.
Therefore, the effective filing date of claims 2, 9, and 16 is 24 September 2021.
The effective filing date of claims 1, 3-8, 10-15, and 17-20 is 17 June 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 January 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings received 21 January 2026 are objected to because of the reasons noted below.
The drawings are objected to for failing to comply with 37 C.F.R. 1.84(t) because the sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, and the number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking. (MPEP 608.02 Section V).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment to the Specification received 21 January 2026 has been entered.
There were two 58-page substitute specifications received 21 January 2026. These Specifications are objected to, because both documents show marked-up revisions, and accordingly, the application file does not have a clean version of the substitute Specification.
Appropriate correction is required.
Claim Interpretation
The claim interpretations in the Office action mailed 28 October 2025 are maintained in view of the amendment received 21 January 2026.
Claim 1 recites the limitation “wherein the machine learning model is trained using…” at line seven. This limitation is interpreted to recite a product-by-process limitation with the product being the machine learning model, and further interpreted to not recite the process of performing active steps of training the machine learning model (e.g., data collection; pre-processing raw data; model selection; optimization; validation; and testing).
Claims 4-7, 11-14, and 18-20 recite the limitation “generate/generating instructions to/for…” This limitation is interpreted to mean creating a sequence of commands or steps that tell a system or a device how to perform a specific task, however the action(s) and/or effects that would result from the instructions (e.g., the subsequent wherein clauses) are interpreted as an intended use and/or intended result of the generated instructions.
The claim interpretations under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, in the Office action mailed 28 October 2025 are maintained with modification in view of the amendment received 21 January 2026.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a joint performance evaluator configured to…” in claim 15; and
“a joint support module configured to…” in claim 15.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The written description discloses a corresponding structure for:
“a joint performance evaluator” (computer system 1000 within which program code, e.g., software for causing the machine to perform…) at para. [00126]; and e.g., at paras. [00105] - [00107] and FIG. 8; e.g., “a prediction generated by joint performance evaluator 810 using a machine-learned model may also characterize a risk…” (para. [00107]). The program code may be comprised of instructions (reference # 1024 in FIG. 10) executable by one or more processors (reference # 1002 in FIG. 10).
“a joint support module” (computer system 1000 within which program code, e.g., software for causing the machine to perform…) at para. [00126]; and e.g., at paras. [00105], [00111] and FIG. 8; e.g., “the joint support module 820 may generate instructions for…” (para. [00111]). The program code may be comprised of instructions (reference # 1024 in FIG. 10) executable by one or more processors (reference # 1002 in FIG. 10).
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
The objection to claim 19 in the Office action mailed 28 October 2025 is withdrawn in view of the amendment received 21 January 2026.
The amendment received 21 January 2026 has been fully considered, however after further consideration, the objections to claims 4, 5, 6, 11, 12, 13, 18, 19, and 20 in the Office action mailed 28 October 2025 are maintained in view of the amendment, as noted below.
Claims 4, 11, and 18 are objected to because of the following informalities: The limitation reciting “identifying a subset of fluid chambers of the plyowrap based on a model of properly performing joint” should have the word “a” inserted between the word “of” and the word “properly.”
Claims 4, 11, and 18 are further objected to because of the following informalities: The limitation reciting “wherein the generated instructions activate electroactive gels in the subset of fluid chambers to movement of the joint” has improper grammar, e.g., syntax, with regard to the phrase “…of fluid chambers to movement of the joint.”
Claims 5, 12, and 19 are objected to because of the following informalities: The limitation reciting “identifying a subset of fluid chambers of the plyowrap based on a model of properly performing joint” should have the word “a” inserted between the word “of” and the word “properly.”
Claims 6, 13, and 20 are objected to because of the following informalities: The limitation reciting “wherein the instructions activate a fluid chamber of plyowrap to” should have the word “the” inserted between the word “of” and the word “plyowrap.”
Claims 6, 13, and 20 are further objected to because of the following informalities: The limitation reciting “generating instructions for improving performance of joint by dispensing” should have the word “the” inserted between the word “of” and the word “joint.”
Appropriate correction is required.
The amendment received 21 January 2026 has been fully considered, however after further consideration, new grounds of objection are raised in view of the amendment, as noted below.
Claim 2 is objected to because of the following informalities: The word “from” should be inserted between the word “collected” and the word “a” in lines three and four.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 15-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the Office action mailed 28 October 2025 is withdrawn in view of the amendment received 21 January 2026.
The amendment received 21 January 2026 has been fully considered, however after further consideration, new grounds of rejection are raised under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in view of the amendment.
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 1-20 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 1 and 8 recite the limitation “wherein the machine learning model is trained using a training dataset of historical sensor data collected from a population of users, each entry of the training data comprising historical sensor data collected for a specified joint and labeled with an identifier (a) specifying a joint type and laterality, and (b) specifying a predefined movement type performed by the specified joint,” however the Specification does not contain the terms “laterality” or “predefined.” Therefore, this limitation appears to be a new scope not contemplated nor supported by the present Specification.
Claims 2-7 and 9-14 are rejected for depending from either claim 1 or claim 8 and for failing to remedy the indefiniteness of the claim from which they depend.
Claim 15 recites the limitation “wherein the machine learning model is trained using a training dataset of historical sensor data collected from a population of users, each entry of the training data comprising historical sensor data collected for a specified joint and annotated with an identifier (a) specifying a joint type and laterality, and (b) specifying a predefined movement type performed by the specified joint,” however the Specification does not contain the terms “annotated,” “laterality” or “predefined.” Therefore, this limitation appears to be a new scope not contemplated nor supported by the present Specification.
Claims 16-20 are rejected for depending from claim 15 and for failing to remedy the indefiniteness of claim 15.
The rejection of claims 1-11, 13, and 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 28 October 2025 is withdrawn in view of the amendment received 21 January 2026.
The amendment received 21 January 2026 has been fully considered, however after further consideration, the rejection of claims 12 and 15-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 28 October 2025 is maintained in view of the amendment.
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 12 and 15-20 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.
Claim 12 is indefinite for reciting the “non-transitory computer readable medium of claim 8, wherein determining adjustment parameters for the joint further causes the processor to: detect, by a tension sensor of the tension sensor array, an external impact to the joint” because it is not clear as to whether the detecting is performed by the processor (i.e. receiving data from the sensor), or if the stored instructions cause a tension sensor to perform the function of detecting. This claim is interpreted to be limited to analyzing sensor data to detect an impact, and not requiring an active step of actually using a tension sensor to generate the data.
Claim 15 is indefinite for reciting the preamble “A brace feedback system” because the claim does not recite any tangible, physical hardware components. The limitations reciting “a joint performance evaluator” and “a joint support module” do not have support in the Specification for being hardware components, but do have support for being interpreted as software.
Claims 16-20 are indefinite for depending from claim 15 and for failing to remedy the indefiniteness of claim 15.
Claim 19 is indefinite for reciting “wherein generating instructions… cause the joint support module to: detect, by a tension sensor of the tension sensor array…” because the system of independent claim 15 does not include a tension sensor of a tension sensor array, and therefore it is not clear as to whether the system is supposed to include the tension sensor array for performing the detecting step, or else if the joint support module performs the function of a tension sensor for detecting an external impact to the joint. This claim is interpreted to be limited to analyzing sensor data to detect an impact, and not requiring an active step of actually using a tension sensor to generate the data.
Response to Arguments
The Applicant’s arguments/remarks received 21 January 2026 have been fully considered, but are not persuasive.
The Applicant states on page 18 (middle) of the Remarks the claims identified in the Office action and other claims have been amended to now recite appropriate antecedent basis, and that reconsideration and withdrawal of the rejection is requested.
This argument is persuasive in part, to the extent that the rejection has been partially withdrawn, as noted above, and not persuasive in part, to the extent that the rejection has been partially maintained, as noted above.
Claim Rejections - 35 USC § 101
The amendment received 21 January 2026 has been fully considered, however after further consideration, the rejection of claims 1-20 under 35 U.S.C. 101 in the Office action mailed 28 October 2025 is maintained with modification in view of the amendment.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mental processes, i.e., concepts performed in the human mind (e.g., observation, evaluation, judgement, opinion); and (b) mathematical concepts (e.g., mathematical relationships, formulas or equations, mathematical calculations).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1-7 are directed to a method (i.e., a process); claims 8-14 are directed to a non-transitory computer-readable medium (i.e., a machine or manufacture); and claims 15-20 are directed to a system (i.e., a machine or manufacture).
Therefore, the claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under Step 1.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claims 1, 8, and 15 recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
inputting the received sensor data to a machine learning model to generate a prediction of the performance of the joint, wherein the machine learning model is trained using a training dataset of historical sensor data collected from a population of users, each entry of the training data comprising historical sensor data collected for a specified joint and labeled with an identifier (a) specifying a joint type and laterality, and (b) specifying a predefined movement type performed by the specified joint (i.e., mental processes and mathematical concepts) (claims 1, 8, and 15);
categorizing, based on the predicted performance of the joint, a risk level for biomechanical compromise of the joint (i.e., mental processes) (claims 1, 8, and 15); and
determining adjustment parameters for the plyowrap based on the categorized risk level for biomechanical compromise of the joint (i.e., mental processes) (claims 1, 8, and 15).
Dependent claims 2-7, 9-14, and 16-20 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claims 2, 9, and 16 further recite:
iteratively training the machine learning model as the training dataset is updated with new sensor data collected from a plyowrap of a new user and a plyowrap of an existing user (i.e., mental processes and mathematical concepts).
Dependent claims 3, 10, and 17 further recite:
wherein a predicted performance output by the model for the joint is a predicted range of motion of the joint (i.e., mental processes);
comparing the predicted range of motion of the joint to an expected range of motion of the joint (i.e., mental processes); and
determining, responsive to the predicted range of motion differing from the expected range of motion by more than a threshold deviation, that the categorization of the risk level of the joint satisfies a threshold for potential biomechanical compromise (i.e., mental processes).
Dependent claims 4, 11, and 18 further recite:
identifying a subset of fluid chambers of the plyowrap based on a model of properly performing joint and a model of an improperly performing joint (i.e., mental processes and mathematical concepts);
generating instructions to adjust structural properties of the plyowrap, wherein the generated instructions activate electroactive gels in the subset of fluid chambers to movement of the joint (i.e., mental processes).
Dependent claims 5, 12, and 19 further recite:
detect an external impact to the joint by analyzing sensor data of a tension sensor of the tension sensor array (i.e., mental processes (claims 12 and 19));
identifying a subset of fluid chambers of the plyowrap based on a model of properly performing joint and a model of an improperly performing joint (i.e., mental processes and mathematical concepts); and
generating instructions to adjust structural properties of the plyowrap, wherein the generated instructions activate electroactive gels in the subset of fluid chambers to support the joint against the detected external impact (i.e., mental processes).
Dependent claims 6 and 13 further recite:
generating instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions activate a fluid chamber of plyowrap to deliver a substance to the user (i.e., mental processes); or
generating instructions for improving performance of joint by dispensing nutrients to the user, wherein the instructions activate a nutrition chamber of the plyowrap to deliver a nutrient supplement to the user (i.e., mental processes).
Dependent claims 7, 14, and 19 further recite:
generating instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions actuate a delivery pump coupled to the plyowrap to deliver the substance to the user (i.e., mental processes).
Dependent claim 20 further recites:
generate instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions activate a fluid chamber of the plyowrap to deliver a substance to the user (i.e., mental processes);
generate instructions for improving performance of joint by dispensing nutrients to the user, wherein the instructions activate a nutrition chamber of the plyowrap to deliver a nutrient supplement to the user (i.e., mental processes); or
generate instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions actuate a delivery pump coupled to the plyowrap to deliver the substance to the user (i.e., mental processes).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., inputting data into a machine learning model and using the model to generate a prediction require manipulating data according to an algorithm; categorizing a risk level requires organizing/ranking data; and determining adjustment parameters requires setting values according to the risk level that correlate with in an intended effect, e.g., stiffening of the plyowrap), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., generating a prediction using a machine learning model requires mathematical calculations using equations) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-20 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
Dependent claims 2-4, 6, 7, 9, and 16 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements in independent claims 1, 8, and 15 include:
receiving, at a remote server, sensor data describing movement of a joint of a user covered by a plyowrap, wherein the sensor data is collected by an array of tension sensors embedded into the plyowrap across one or more horizontal axes and one or more vertical axes (i.e., receiving data) (claims 1, 8, and 15);
transmitting, to a local controller coupled to the plyowrap, instructions to adjust structural properties of the plyowrap based on the determined adjustment parameters, wherein the instructions activate electroactive gels in fluid chambers of the plyowrap to adjust a pliability of the plyowrap (i.e., transmitting data) (claims 1, 8, and 15);
a non-transitory computer readable storage medium (claim 8);
at least one processor (claim 8);
a joint performance evaluator (i.e., one or more processors for executing algorithms) (claim 15); and
a joint support module (i.e., one or more processors for executing algorithms) (claim 15).
The additional elements in dependent claims 5, 10-14, and 17-20 include:
detecting, by a tension sensor of the tension sensor array, an external impact to the joint (claim 5);
at least one processor (claims 10, 11, 12, 13, and 14);
the joint performance evaluator (claim 17);
the joint support module (claim 18);
the joint support module (claims 19 and 20).
The additional elements of a non-transitory computer readable storage medium (claim 8); and at least one processor (claims 8, 10, 11, 12, 13, and 14) and one or more processors (claims 17-20) invoke a computer and/or computer-related components merely as tools for use in the claimed process, such that they amount to no more than mere instructions to apply the exceptions using a generic computer (MPEP 2106.05(f)), and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(1)).
The additional elements of receiving data (claims 1, 8, and 15); and transmitting data (claims 1, 8, and 15); are merely pre-solution or post-solution activities – nominal or tangential additions to the claims that do not meaningfully limit the claims, and therefore do not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)). Furthermore, at the transmitting step, the limitations “to a local controller coupled to the plyowrap, instructions to adjust…wherein the instructions activate…to adjust the pliability of the plyowrap” are an intended use of the transmitted data, and are not actually controlling anything (i.e., the claims do not include the physical components of a controller coupled to a plyowrap (e.g., brace)). Further still, these limitations are mere instructions to apply the exception since the instructions to adjust are based on parameters that are determined based on the categorized risk level (MPEP 2106.05(f)).
The additional element of detecting, by a tension sensor of the tension sensor array, an external impact to the joint (claim 5); is a step of gathering data for use in the claimed process, and thus merely a pre-solution activity – a nominal or tangential addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and as such, when all limitations in claims 1-20 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-20 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Dependent claims 2-4, 6, 7, 9, and 16 do not recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 1, 8, and 15 and dependent claims 5, 10-14, and 17-20 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of a non-transitory computer readable storage medium (claim 8); and at least one processor (claims 8, 10, 11, 12, 13, and 14); one or more processors (claims 17-20); receiving data (claims 1, 8, and 15); and transmitting data (claims 1, 8, and 15); are conventional computer components and/or functions (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional element of detecting, by a tension sensor of the tension sensor array, an external impact to the joint (claim 5); is conventional. Evidence for the conventionality is shown by:
Lou et al. (Advanced Materials Technologies, 2018, Vol. 3, No. 12, (1800444), pp. 1-17, as cited in the Office action mailed 28 October 2025).
Lou et al. reviews recent advances in smart wearable sensing systems (Title; and Abstract); and shows that the wearable technology can detect various stimuli relevant to biological species or specific environments (Abstract); and further shows physical sensing devices with mechanical sensors including pressure and strain that enable capabilities to detect physiological changes such as subtle deformations caused by physical activity, such as respiration and blood flow, and large deformations associated with physical movement, such as finger and knee bending (page 8, col. 1, para. 2 and col. 2, para. 1). Lou et al. further shows a flexible integrated sensing array (FISA) on a subject’s wrist (Figure 7(a)). Additionally, Lou et al. shows a stretchable wearable sensing system with strain sensors that provide input to feedback controllers that activate movement of a robot arm (page 13, col. 1, para. 2 and col. 2, para. 1; and Figure 10).
Therefore, when taken alone, all additional elements in claims 1-20 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-20 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
Response to Arguments
The Applicant’s arguments/remarks received 21 January 2026 have been fully considered, but are not persuasive.
The Applicant states on page 21 (para. 2) of the Remarks that as amended, the claims are directed to patent-eligible subject matter because they are integrated into a specific practical application in the medical device field and recite significantly more than the alleged abstract ideas. The Applicant further states (para. 3) that regarding Step 2A Prong One, under the broadest reasonable interpretation in light of the specification, the amended claims are not directed to mere mental steps or disembodied mathematics. The Applicant further states that the claims now recite technical particularity with machine learning model and certain categorization steps, and further states (para. 4) that the dual-label data architecture as now recited in the claims is a concrete, anatomical data structure that is directly tied to physical-world sensors embedded “across one or more horizontal axes and one or more vertical axes” of a “plyowrap” worn on a joint. The Applicant further states that the model’s inputs and outputs cannot be performed in the human mind as they originate from tension sensors embedded in a physical brace and are used to generate joint-specific actuation instructions for electroactive gels in fluid chambers of that brace.
These arguments are not persuasive, because first, a claim can recite mental processes even if they are claimed as being performed on (or with) a physical entity, e.g., a computer (MPEP 2106.04(a)(2)(III)(C)). Second, the limitations reciting training and using a machine learning model to perform computational analyses on data comprise the judicial exceptions identified at Step 2A Prong One, regardless of where the data originated from (e.g., a sensor).
The Applicant states on page 22 (para. 1) of the Remarks that turning to Step 2A Prong Two, the claims now recite integration into a practical application, and that even assuming, arguendo, that limitations could be characterized as reciting a judicial exception, the claims, when viewed as a whole, integrate that exception into a practical application. The Applicant further states that the sensor array and anatomical laterality labeling require a specific physical configuration and is not generic data collection, and further states that the dual-label training dataset improves the technological process by enabling accurate differentiation between movements performed by different joints/sides, which in turn improves model precision for real-time brace actuation. The Applicant further states that the predicted risk level and adjustment parameters are used to control electroactive gels in fluid chambers of a physical plyowrap to change its pliability and structural support in real time, providing for a concrete modification to a medical device worn by a user of the plyowrap. The Applicant further states (para. 2) that moreover, as now recited, the claimed invention is analogous to Thales Visionix Inc. v. U.S. (Fed. Cir. 2017) (improved inertial tracking via a unique sensor arrangement) and CardioNet, LLC v. Infobionic, Inc. (955 F.3d 1358) (specific processing of physiologic signals improving medical device accuracy). The Applicant further states that the claims apply any abstract mathematical element in service of a specific improvement in a wearable medical apparatus.
These arguments are not persuasive, because first, a claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, however independent claims 1, 8, and 15 do not recite any additional elements that actually apply, rely on, or use the judicial exception, because the claims recite a final step of transmitting instructions (i.e., data) that does not affirmatively recite an actual step of using the data. Second, the dual-label training dataset is a limitation that is identified as a judicial exception at Step 2A Prong One, thus when the claims are considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Third, the fact pattern differs between Thales Visionix (a system for tracking the motion of an object relative to a moving reference frame) and the instant application (a wearable system for evaluating joint performance and function) and also the claims in Thales Visionix specified a particular configuration of inertial sensors (i.e., additional elements) that used the raw data from the sensors to more accurately calculate the position and orientation of an object on a moving platform (i.e., the claim was determined to recite an additional element that applied, relied on, or used the judicial exception in a manner that imposed a meaningful limit on the judicial exception). Fourth, the fact pattern differs between CardioNet (specific processing of physiologic signals improving medical device accuracy) and the instant claims (a wearable system for evaluating joint performance and function), at least because in CardioNet the improvement was found in an additional element (i.e., the cardiac monitoring device) that applied, relied on, or used the judicial exception (i.e., analyzing the variability in the beat-to-beat timing for atrial fibrillation and atrial flutter in light of the variability in the beat-to-beat timing caused by ventricular beats identified by the ventricular beat detector) to more accurately detect the occurrence of atrial fibrillation and atrial flutter, as distinct from V-TACH and other arrythmias, whereas in contrast to CardioNet, the instant claims do not recite an additional element that actually applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exceptions, as noted in the above rejection.
The Applicant states on page 22 (para. 3) of the Remarks that under Step 2B, the claims recite significantly more than an abstract idea because the additional elements are not well-understood, routine, or conventional in the field. The Applicant further states that the claims recite a structured dataset with dual labels of joint type and laterality along with movement type, and that this is a novel, non-conventional data architecture in joint rehabilitation devices, absent from the cited prior art. The Applicant further states that the linkage between that dataset and specific anatomical tension-sensor placement and brace actuation via electroactive gels produces a tangible, physical change to the mechanical support for a joint, and further states that the improvement is in the operation of the brace itself, which enables joint-specific, side-specific actuation based on learned movement patterns, rather than in abstract data analysis.
These arguments are not persuasive, because first, the conclusion of whether a claim is eligible at Step 2B requires that only the additional elements identified at Step 2A Prong Two are carried over to Step 2B for further evaluation, thus limitations identified as judicial exceptions at Step 2A Prong One are excluded from the Step 2B analysis. Therefore, the “structured dataset with dual labels of joint type and laterality along with movement type” as argued, is not a limitation carried over to Step 2B because the limitation comprises the judicial exceptions. Second, regarding the Applicant’s argument that the improvement is in the operation of the brace itself, it is noted that the claims as a whole do not amount to significantly more than the exception itself (i.e., there is no inventive concept in the claim), because the additional elements are conventional, as noted in the above rejection.
Claim Rejections - 35 USC § 103
The amendment received 21 January 2026 has been fully considered, however after further consideration, the rejection of claims 1-4, 8-11, and 15-18 under 35 U.S.C. 103 as being unpatentable over Howard et al. in view of Ishikawa et al. in the Office action mailed 28 October 2025, is maintained in view of the amendment.
The amendment received 21 January 2026 has been fully considered, however after further consideration, the rejection of claims 5, 12, and 19 under 35 U.S.C. 103 as being unpatentable over Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, and further in view of Bettin et al. in the Office action mailed 28 October 2025, is maintained in view of the amendment.
The amendment received 21 January 2026 has been fully considered, however after further consideration, the rejection of claims 6-7, 13-14, and 20 under 35 U.S.C. 103 as being unpatentable over Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, and further in view of Hyde et al. in the Office action mailed 28 October 2025, is maintained in view of the amendment.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 1-4, 8-11, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (US 2019/0117156, as cited in the Office action mailed 28 October 2025) in view of Ishikawa et al. (US 2016/0120733, as cited in the Office action mailed 28 October 2025).
Regarding claims 1, 8, and 15, Howard et al. shows:
a non-invasive wearable biomechanical and physiology monitor for injury prevention and rehabilitation (Title) that is a wearable device that measures, tracks, and monitors a wearer’s physiological conditions during a rehabilitation period (Abstract); and a patient joint monitoring system which can detect swelling, infection, and/or blood clots and track body movements to ensure proper joint use (para. [0016]);
a wearable may collect physiological and medical data and in real time transmit that data in unprocessed or processed form to remote devices (para. [0069]);
a plurality of sensors, a processor with decision making logic for processing and extracting useful information from the sensor data, and output mechanisms for instructing, alerting, or otherwise communicating with a user (para. [0048]);
groups of sensors may be configured together as one or more sensor arrays (para. [0051]; and Figure 1B reference #109);
a machine learning algorithm which uses collected patient data to improve rehabilitation procedures and outcomes and further uses data from groups of patients correlated with outcomes (para. [0082]); and the device may be configured to perform or assist in performing a noninvasive method of monitoring joint rehabilitation by utilizing unique sensors and a learning algorithm (para. [0013]);
data from the sensors is processed and interpreted to determine, e.g., joint kinematics, misalignment, impact, range of motion, joint deviations, etc. (para. [0053]); providing an alert system for users by which users are alerted to a risk or presence of a medical condition requiring attention based on the monitoring of a part of the body such as a joint (para. [0011]);
instructing adjustment of wearable position (para. [0012]);
improve patient outcome in terms of joint mobility and range of motion while reducing recover time following a knee injury or knee surgery (para. [0019]).
Regarding claims 1, 8, and 15, Howard et al. does not show tension sensors, or transmitting, to a local controller coupled to the plyowrap, instructions to adjust structural properties of the plyowrap based on the determined adjustment parameters, wherein the instructions activate electroactive gels in fluid chambers of the plyowrap to adjust a pliability of the plyowrap.
Regarding claims 1, 8, and 15, Ishikawa et al. shows:
that the one or more sensors for detecting movement or physiologic characteristics of the subject may be a tension sensor (paras. [0051] & [0067]);
the flexible compression garment can include one or more discrete, air-tight chambers extending circumferentially or longitudinally, and being fluidly connected (paras. [0087] & [0088]);
responsive to receiving sensing data of tension beyond a threshold level, the control electrical circuitry can direct one or more actuators to cause the flexible compression garment to selectively constrict, or selectively dilate (para. [0067]); and
the one or more actuators may be electroactive polymer actuators (paras. [0080] & [0081]).
Regarding claims 2, 9, and 16, Howard et al. further shows using a neural network trained on data obtained from similar subjects that perform the one or more exercises (page 11, claim 17).
Regarding claims 3, 10, and 17, Howard et al. further shows the range of motion (ROM) for a subject wearing the sleeve calibrated to flexion/extension angles of the knee (paras. [0041] & [0093]; and FIG. 13).
Regarding claims 4, 11, and 18, Howard et al. further shows a graphical interface that compares real-time data to the historical record of the joint for easy analysis and understanding of progress, and that shows real-time changes in the data falling out of expected ranges compared to historical data (para. [0081]); and progress toward rehabilitation may be computed based on sensor data from a subject’s wearable and reference data, where data retrieved from the wearable’s sensors may be compared with reference data in a databank which specifies parameter threshold corresponding with rehabilitation progress levels (para. [0084]).
Regarding claims 4, 11, and 18, Howard et al. does not show identifying a subset of fluid chambers of the plyowrap and generating instructions to adjust structural properties of the plyowrap, wherein the generated instructions activate electroactive gels in the subset of fluid chambers to movement of the joint.
Regarding claims 4, 11, and 18, Ishikawa et al. shows the flexible compression garment can include one or more discrete, air-tight chambers extending circumferentially or longitudinally, and being fluidly connected (paras. [0087] & [0088]); responsive to receiving sensing data of tension beyond a threshold level, the control electrical circuitry can direct one or more actuators to cause the flexible compression garment to selectively constrict, or selectively dilate (para. [0067]); and the one or more actuators may be electroactive polymer actuators (paras. [0080] & [0081]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Howard et al. by incorporating methods for selectively constrict or selectively dilate the flexible compression garment, as shown by Ishikawa et al., and discussed above. One of ordinary skill in the art would have been motivated to combined the methods of Howard et al. with the methods of Ishikawa et al. because Ishikawa et al. shows methods for using tension sensors in a flexible wearable compression sleeve to detect or measure tension on a body part of the subject, such as one or more muscles, tendons, or ligaments, and responsive to receiving sensing data of tension beyond a threshold level on a body part, causing the flexible compression garment to selectively constrict or dilate. This modification would have had a reasonable expectation of success given that both Howard et al. and Ishikawa et al. disclose flexible compression garments for improved muscle and/or joint functioning.
Claims 5, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, and further in view of Bettin et al. (US 2007/0107778, as cited in the Office action mailed 28 October 2025).
Regarding claims 5, 12, and 19, Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, further shows using sensor data from a subject’s wearable device in comparison to reference data (i.e., normal or baseline measurements) (Howard et al., para. [0084]).
Regarding claims 5, 12, and 19, Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, does not show detecting, by a tension sensor of the tension sensor array, an external impact to the joint; and generating instructions to adjust structural properties of the plyowrap, wherein the generated instructions activate electroactive gels in the subset of fluid chambers to support the joint against the detected external impact.
Regarding claims 5, 12, and 19, Bettin et al. shows an active controlled energy absorber using responsive fluids that may be used in protective body armor, medical devices such as splints and casts, vehicle safety absorbers, and many other products which benefit from ability to control the stiffness of the energy absorber (Title; and Abstract); and an impact mode where the device responds to imposed stress and therefore imposed strain rate which activate the dilatant fluid so that it responds to small deformations or larger impacts by undergoing a transition to high viscosity and high dampening state upon impact (para. [0059]); and the device (i.e., actuator or transducer) that converts one form of energy to another (para. [0061]) may be an electroactive polymer (para. [0067]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods shown by Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, by incorporating an impact (i.e., energy) absorber and methods for controlling the stiffness of the energy absorber, as shown by Bettin et al., and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, with the methods of Bettin et al. because Bettin et al. shows that the impact (i.e., energy) absorber may take a shaped or flexible form that can be worn on the body as protective, impact absorbing body armor (paras. [0011] – [0012]). This modification would have had a reasonable expectation of success given that Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, discloses wearable devices comprising physiological sensors for monitoring joints, and Bettin et al. discloses that the protective energy absorber may be used in medical devices such as splints and casts (para. [0050]).
Claims 6-7, 13-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, and further in view of Hyde et al. (US 2017/0258995, as cited in the Office action mailed 28 October 2025).
Regarding claims 6-7, 13-14, and 20, Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, does not show generating instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions activate a fluid chamber of plyowrap to deliver a substance to the user; or generating instructions for improving performance of joint by dispensing nutrients to the user, wherein the instructions activate a nutrition chamber of the plyowrap to deliver a nutrient supplement to the user (claims 6, 13, and 20); generating instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions actuate a delivery pump coupled to the wearable brace to deliver the substance to the user (claims 7, 14, and 20); and generate instructions for improving performance of the joint by applying a substance at the joint, wherein the instructions actuate a delivery pump coupled to the plyowrap to deliver the substance to the user (claim 20).
Regarding claims 6-7, 13-14, and 20, Hyde et al. shows systems and methods of dispensing one or more medicaments to a subject utilizing at least one flexible compression garment having one or more medicament dispensers therein (Title; and Abstract). Hyde et al. further shows the systems include one or more sensors and one or more actuators that operate responsive to one or more signals from the one or more sensors to selectively deliver one or more medicaments that can provide timely relief from certain physical symptoms, improve performance, stop or alleviate potentially dangerous medical conditions, or improve muscle or joint functioning (para. [0030]); the one or more medicaments can include a nutrient and can be dispensed as a fluid (para. [0033]); and the medicament dispenser can include an actuator configured to pump the medicament from a reservoir (para. [0098]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above, by incorporating systems and methods for dispensing medicaments to a subject utilizing a flexible compression garment, as shown by Hyde et al. and discussed above. One of ordinary skill in the art would have been motivated to combined the methods of Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above with the methods of Hyde et al. because Hyde et al. shows that compression garments such as joint sleeves can provide support and reduce time taken for muscles to repair themselves (paras. [0006] – [0008]), and that selective delivery of medicaments via utilization of a wearable flexible compression garment can provide timely relief from certain physical symptoms, improve performance, stop or alleviate potentially dangerous medical conditions, or improve muscle or joint functioning (para. [0030]). This modification would have had a reasonable expectation of success given that both Howard et al. in view of Ishikawa et al. as applied to claims 1-4, 8-11, and 15-18 above and Hyde et al. disclose methods for using wearable flexible sleeves using elastic compression wraps for joint rehabilitation.
Response to Arguments
The Applicant’s arguments/remarks received 21 January 2026 have been fully considered, however they are not persuasive.
The Applicant states on page 18 (bottom) of the Remarks that claim 1 has been amended to further define the machine-learned model training requirements, and further states on page 19 (para. 1) that this claim now recites explicit structural and organizational requirements on the training dataset, specifically, as not presented, the claims recite a machine learning model in which the data corresponds to a specified joint, each entry is labeled with an identifier specifying the joint type and laterality, and each entry is further labeled with a predefined movement type performed by the specific joint, and further that the labels for joint type with laterality information and movement type information is part of the dataset used to train the model. The Applicant points to the cited Howard reference, and further states (para. 2) that the invention as now claimed is not disclosed or suggested in the cited art, and in particular, no disclosure exists of a per-entry labeling scheme with both a joint identifier specifying type and laterality and a predefined movement type label, and further states that Howard’s dataset description is generic and does not identify or impose the claimed dual-annotation requirement, nor does it require laterality tags or provide any teaching or suggestion of it. The Applicant further points (para. 3) to the cited Howard reference and states that the reference provides a generic description for using sensors and a learning algorithm, without any detail on how the model is trained, what the dataset structure is, or what labels are applied to the data. The Applicant further states on page 20 (para. 1) that Howard does not explicitly teach, nor does it inherently require, the claimed dataset architecture. The Applicant further states (para. 2) that the cited Ishikawa reference does not address the shortcomings of the Howard reference, and states further still (para. 3) that there is not any motivation, teaching, or suggestion to combine Howard and Ishikawa as is claimed, because the claimed invention recites a structured, standardized dataset for training, designed to isolate movement signatures by joint type and laterality, which improves model discrimination and prediction accuracy, however neither of the cited references recognizes the need for this anatomical side-specific labeling in a machine learning trained model, and thus there is no teaching that would motivate one of ordinary skill to introduce this particular dataset schema into Howard’s system. The Applicant further states (para. 4) that accordingly, the claimed invention is distinguishable over the combination of Howard and Ishikawa both individually and in combination.
These arguments are not persuasive, because first, Howard shows a machine learning algorithm which uses collected data to improve rehabilitation procedures and outcomes (para. [0036]) and that exemplary systems will improve patient outcomes in terms of joint mobility and range of motion while reducing recovery time (para. [0019]). Furthermore, Howard shows a wearable with lateral, anterior, and medial flex sensors (Figure 1A), which at least suggests a structured dataset for training that comprises multidimensional data (e.g., different axes). Second, one of skill would have been motivated to combine Howard with Ishikawa at least because it would have been advantageous to combine the machine learning methods of Howard with the methods to selectively constrict or selectively dilate the flexible compression garment, as shown by Ishikawa et al., and discussed in the above rejection and motivation statement.
Conclusion
No claims are allowed.
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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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687
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