DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 6 February 2026. The Examiner acknowledges the amendments to claims 1, 5, and 9. Claims 1-20 are pending, with claims 12-20 standing as previously withdrawn.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 5-6 is/are objected to because of the following informalities:
Claim 5 should read “a plurality of sensors” [lines 1-2].
Claim 6 should read “wherein the plurality of sensors are” [line 1].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 1 [representing all independent claims] recite(s):
A method to evaluate knee stiffness, the method comprising the steps of:
releasing a subject's leg from an extension position to allow the leg to oscillate under gravity;
tracking a knee angle and at least one joint motion characteristic during the oscillation using at least one sensor;
determining a knee joint torque and a knee gravitational moment from the knee angle and the joint motion characteristic;
computing a net knee moment from the knee joint torque and the knee gravitational movement; and
determining a knee stiffness by calculating a slope of net knee moment versus the knee angle.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) Error! Reference source not found. recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“releasing a subject's leg from an extension position to allow the leg to oscillate under gravity” – may be considered a method of organizing human activity [managing interactions between people (including teaching, following rules or instructions) (see MPEP § 2106.04(a)(2)(II))], based at least on the broadest reasonable interpretation of the identified limitation requiring physical interaction between an operator and a subject [In a first step 102, an operator performs a knee oscillation test such as a pendulum knee drop test (“PKD”) on a patient’s knee. The oscillation test is performed by positioning the patient’s leg in near full extension, and releasing the leg… While an operator facilitates the performance of the oscillation test in this embodiment, the oscillation test can be performed by the patient with no assistance (Applicant’s Specification ¶0023)]
“determining a knee joint torque and a knee gravitational moment from the knee angle and the joint motion characteristic” – may be performed by merely applying known or derived mathematical equations, formulae, or processes to known or previously collected data, for at least a limited amount of data, under no particular time constraints [Applicant’s Specification ¶¶0024-0025]
“computing a net knee moment from the knee joint torque and the knee gravitational movement” – may be performed by merely applying known or derived mathematical equations, formulae, or processes to known or previously collected data, for at least a limited amount of data, under no particular time constraints [Applicant’s Specification ¶¶0026-0027]
“determining a knee stiffness by calculating a slope of net knee moment versus the knee angle” – may be performed by merely applying known or derived mathematical equations, formulae, or processes to known or previously collected data, for at least a limited amount of data, under no particular time constraints [Applicant’s Specification ¶¶0026-0027]
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “determining a knee joint torque and a knee gravitational moment from the knee angle and the joint motion characteristic”, “computing a net knee moment from the knee joint torque and the knee gravitational movement”, “determining a knee stiffness by calculating a slope of net knee moment versus the knee angle”] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment of field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim Error! Reference source not found. only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [data gathering] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 2, 7-11 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 3-4 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claim(s) 1 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., data gathering] and/or generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring, storing, filtering, signals related to data gathered using generically recited sensors] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
Claim 1 recites the limitation “tracking a knee angle and at least one joint motion characteristic during oscillation using at least one sensor”; claim 5 recites wherein the knee angle is tracked using “a plurality sensors”; and claim 6 further limits the “sensors” to refer to “any of a camera, a location sensor, an orientation sensor, a movement sensor, a proximity sensor, and a magnetic sensor”. Such a “sensor” is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed “sensor”, and recites the “sensor” at a high level of generality [Various sensors such as tracking cameras, location sensors, orientation sensors, movement sensors, proximity sensors, load sensors, magnetic sensor, inertial measurement units ("IMUs"), etc. can be used to track and record the knee oscillation. The tracking and recording can be performed continuously or at multiple regular or irregular intervals. Sensors can be remote (such as cameras), internal (placed in implants, trials, or joint tensioners), or external (such as wearables) to collect joint motion characteristics such as knee angle, knee angular velocity, force between the tibia and femur, number of oscillations, oscillation time, etc. (Applicant’s Specification ¶0023)]. 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 medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of motion tracking. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is 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, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Strausser (US-20150045703-A1, previously presented) [Inertial measurement units (IMUs) could be coupled to the leg support 212. An inertial measurement unit is generally composed of an accelerometer and a gyroscope and sometimes a magnetometer as well; in many modern sensors these devices are MEMS (Mico electromechanical systems) that have measurement in all three orthogonal axes on one or more microchips. The behavior of IMUs is well understood in the art (IMUs being used for applications from missile guidance to robotics to cell phones to hobbyist toys); they typically provide measurement of angular orientation with respect to gravity, as well as measurement of angular velocity with respect to earth and linear acceleration, all in three axes (Strausser ¶0025)]
Yang (US-20070103471-A1, previously presented) [Motion capture data 210 may be acquired by a variety of conventional techniques. In one embodiment, a subject wears a special suit with markers and performs motions captured by a video camera or similar device. Further, motion capture data 210 may be two dimensional or three dimensional (Yang ¶0031)]
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 9-10 recite subject matter regarding “wherein the method is performed prep-operatively to determine a pre-operative knee stiffness” and “wherein the method is performed post-operatively to determine a post-operative knee stiffness” [respectively], which the Examiner notes is not considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
Subject Matter Not Taught By Prior Art
Regarding claim 1, the closest prior art of record is Vodovnik et al. (“Dynamics of spastic knee joint”, previously presented), hereinafter Vodovnik, and Lin et al. (“A Quantitative Analysis of Pendular Motion of the Lower Leg in Spastic Human Subjects”, previously presented), hereinafter Lin.
The Examiner notes that while Vodovnik as evidenced by Lin is considered to teach almost each and every limitation of claim 1 as previously presented [see p. 10-11 of Non-Final Rejection dated 10 November 2025] and the amended limitations regarding the use of sensors [Vodovnik p. 64, wherein a goniometer is considered to be a type of orientation sensor] and “computing a net knee moment from the knee joint torque and the knee gravitational moment [see Vodovnik Eq 1-2, wherein the Examiner notes that the equations depicting summing elasticity, damping, and knee gravitational moment (see Examiner’s analysis above) is considered to read on the claimed limitation], the Examiner notes that Vodovnik fails to explicitly disclose the amended limitation of “determining a knee stiffness by calculating a slope of net knee moment versus the knee angle”. Lin also fails to explicitly disclose “determining a knee stiffness by calculating a slope of net knee moment versus the knee angle”. As such, it would not have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Vodovnik or Lin, alone or in combination, to have employed the step of “determining a knee stiffness by calculating a slope of net knee moment versus the knee angle” without the benefit of hindsight.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 6 February 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for reference characters not in the specification have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection to claim 9 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 6-8, with respect to the previously presented rejections under § 101 have been fully considered but they are not persuasive.
Regarding the limitation “releasing a subject’s leg…” and corresponding analysis by the Office Action that the identified limitation may be performed by hand and is directed to a judicial exception, the Applicant disagrees and asserts that the act of physically manipulating a patient’s limb to initiate a gravitational oscillation is a tangible, physical exertion that cannot be performed in the human mind. However, while the Examiner acknowledges that the step of “releasing a subject’s leg…” cannot be performed in the mind, the Examiner notes that the argued limitation is still considered to fall under the abstract idea grouping of at least “methods of organizing human activity” for reasons at least outlined below.
The Applicant further asserts that the “releasing” step is an essential physical component of the overall technical process to enabling collecting biomechanical data and subsequent “computing” and “determining” steps. However, the Examiner notes that the argued “releasing” step is not considered to integrate the data gathering and limitations identified as being directed towards abstract ideas, as the “releasing” step is performed in order to gather data for the steps identified as abstract ideas, and is a necessary precursor for all uses of any recited abstract idea. The “releasing” step is considered extra-solution activity and does not integrate the abstract idea into a practical application.
The Applicant also directs attention to MPEP § 2106.04(a)(2)(II) as defining “managing interactions between people” in the context of commercial, legal, or social interactions, such as agreements, insurance, hedging, advertising, or social networking, does not fit in the enumerated sub-grouping or examples [budgeting, voting, game rules, social activities, teaching/following instructions], and does not manage interactions between people, as the step requires tangible gravitational force on anatomy. However, the Examiner disagrees with the Applicant’s argument. The Examiner notes that the broadest reasonable interpretation of the limitation “releasing a subject’s leg…” based on the Applicant’s Specification requires a human operator to interact with the subject to perform the claimed function or the subject by themselves moving into a position [In a first step 102, an operator performs a knee oscillation test such as a pendulum knee drop test (“PKD”) on a patient’s knee. The oscillation test is performed by positioning the patient’s leg in near full extension, and releasing the leg… While an operator facilitates the performance of the oscillation test in this embodiment, the oscillation test can be performed by the patient with no assistance (Applicant’s Specification ¶0023)]. The Examiner further notes that the examples as provided by the MPEP are considered exemplary and non-limiting, such that based on the broadest reasonable interpretation of the argued limitation [Applicant’s Specification ¶0023], “releasing a subject’s leg…” is understood to be performed as an interaction between an operator and a subject. The Examiner further acknowledges the Applicant’s arguments regarding the releasing step requiring tangible gravitational force on anatomy, however the Examiner notes that this specific argument is only considered to highlight the natural correlation between a law of nature [gravity] and the effect of the law of nature on the human body [MPEP § 2106.04(b)(I)], wherein based on the Examiner’s responses above regarding the “releasing” step being a necessary precursor for data gathering and steps identified as abstract ideas, the correlation pointed out by the Applicant fails to integrate the abstract idea into a practical application.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously presented rejections of claims 1 and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. The rejections of claims 1 and those dependent therefrom under § 102 and § 103 have been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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