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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/11/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “and normalizes” should be amended to “and normalize” to be in the same verb tense as the previously recited “extract a walking waveform”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 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, 5, 6, 10 and 11, the recitations of “a/the sign variables” render the claims indefinite. The claims introduce “a sign variable” (singular) twice, then recites “to estimate at least one of the sign variables” and “perform a PCA on the estimated at least one of the sign variables”. It is unclear what each of the claimed sign variables are related to, and how many sign variables exist. For purposes of examination the indefinite limitation has been deemed to claim a single sign variable.
Regarding Claims 1 and 2, the limitations “in a future” is grammatically nonstandard and it is unclear about the timeframe of knee pain in the future. For purposes of examination the indefinite limitation has been deemed to claim a future medical examination related to knee pain.
Regarding Claim 2, the claim recites the limitation “output” twice in the claim making the claim grammatically broken. The claim is indefinite because it cannot be determined whether model outputs the index, or whether the index is “output” by some other mechanism. For purposes of examination the indefinite limitation has been deemed to claim that the output is knee pain.
Regarding Claim 2, the claim limitation “five years” renders the claim indefinite. It is unclear from when the “five years” starts. For purposes of examination the indefinite limitation has been deemed to claim “within five years” of the time of measurement.
Regarding Claim 3, the limitation “a possibility of having a medical examination” renders the claim indefinite, because the claim previous recites (Claim 1) “a risk of having a medical examination”. It is unclear the difference between the possibility and risk of having a medical examination. For purposes of examination the indefinite limitation has been deemed to claim that a risk/possibility are synonymous.
The term “cost” in claims 5 and 6 is a relative term which renders the claim indefinite. The term “cost” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation “cost” is not a term of art for smoothness. For purposes of examination the indefinite limitation has been deemed to claim angular jerk cost as set forth in the specification.
The term “smoothness” in claims 5 and 6 is a relative term which renders the claim indefinite. The term “smoothness” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim that smoothness means integral of squared angular jerk over a phase window as set forth in the specification.
Regarding Claim 6, the limitation “for estimating each of a plurality of the sign variables” and the limitation “a plurality of models for estimating the sign variable” renders the claim indefinite, because there is an inconsistency regarding the number of sign variables. For purposes of examination the indefinite limitation has been deemed to claim “a plurality of models for estimating the plurality of the sign variables”.
The term “optimized” in claim 7 is a relative term which renders the claim indefinite. The term “optimized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 8 and 9, the limitation “system” in the preamble renders the claim indefinite, because the claims they depend from are apparatus type claims. For purposes of examination the indefinite limitation has been deemed to claim apparatus type claims.
The term “browsable” in claim 9 is a relative term which renders the claim indefinite. The term “browsable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1-11 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.
Each of Claims 1-11 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-11 recites at least one step or instruction for estimating knee pain, which is grouped as a mental process under the 2019 PEG. Accordingly, each of Claims 1-11 recites an abstract idea.
Specifically, Claim 1 recite collecting foot-sensor walking data, inputting the data through a trained model to get intermediate biomechanical variables, run PCA on those variables, run the PCA scores through a second trained model, and output a knee-pain risk score(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Further, dependent Claims 2-9 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1, 10 and 11 (and their respective dependent Claims 2-9) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 10 1and 11), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: memory, processor and measurement device (Claim 8) are generically recited computer elements in independent Claims 1, 10 and 11 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims1, 10 and 11 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., memory, processor and measurement device (Claim 8) as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 10 and 11 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 10 and 11 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-11 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: memory, processor and measurement device (Claim 8).
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
In light of Applicant’s specification, the claimed term memory, processor and measurement device is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the memory, processor and measurement device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-11 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and methods of Claims 1-11 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-11 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 10 and 11 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-11 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-11 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-11 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Method for Estimating Temporal Gait Parameters Concerning Bilateral Lower Limbs of Healthy Subjects Using a Single In-Shoe Motion Sensor through a Gait Event Detection Approach” to Huang et al. disclose an in-shoe sensor on a foot that captures one walking stride from heel strike to heel strike, performs normalization and computes features from time windows within stride, but fails to disclose the use of machine learning, PCA, or second models and instead uses threshold rules instead.
“Estimation of Gait Mechanics Based on Simulated and Measured IMU Data Using an Artificial Neural Network” to Mundt et al. disclose using inertial sensor data and feeding it into a train neural network to provide knee/hip/ankle joint angles out as the model’s predication, but does not disclose PCA on joint angles, second models after the joint angle output, risk indexes – joint angles are the end product, not an intermediate step.
“Baseline Gait Muscle Activation Patterns Differ for Osteoarthritis Patients Who Undergo Total Knee Arthroplasty Five to Eight Years Later From Those Who Do Not” to Hatfield et al. disclose taking baseline gait waveforms from individuals with knee OA and running PCA on the gait waveforms, however, these inputs come from lab motion capture and EMG, not an in-shoe IMU. Furthermore, the waveforms are directly recorded and not outputs of a prior machine learning model.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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