DETAILED ACTION
This action is responsive to the “RESPONSE TO NON-FINAL OFFICE ACTION” filed 27 January 2026. The Examiner acknowledges the amendments to claims 15 and 29. Claims 15-20, 23, and 29 are pending.
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) 29 is/are objected to because of the following informalities:
Claim 29 should read “The method of claim 15, further comprise comprising:” [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) 15-20, 23, and 29 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) 15 [representing all independent claims] recite(s):
A method of planning and assessing insertion of an implant component to a joint of a patient, the method comprising:
collecting, by a sleeve configured to be worn by the patient, biomechanical information related to movement of a joint, the biomechanical information comprising at least one of ligament movement information and muscle movement information;
receiving, by one or more processors, a first set of the biomechanical information associated with a pre-operative activity of the joint from the sleeve;
determining, by the one or more processors, clinical measurement information related to the joint;
generating, by the one or more processors, a first musculoskeletal simulation for the joint based upon the first set of biomechanical information and the clinical measurement information, wherein the first musculoskeletal simulation simulates one or more forces related to the joint in a pre-operative state;
determining, by the one or more processors using an algorithm configured to modify an estimated force environment in the joint, one or more surgical parameters for the patient based upon the first musculoskeletal simulation, wherein the one or more surgical parameters are selected from one or more implant placement parameters, an amount of bone to be removed, a bone cut angle, and a placement of a cut guide;
determining, by the one or more processors, at least one of a position and an orientation of the implant component to be inserted into the joint based upon the one or more surgical parameters;
receiving, by the one or more processors, a second set of the biomechanical information associated with a post-operative activity of the joint from the sleeve;
generating, by the one or more processors, a second musculoskeletal simulation for the joint based upon the second set of biomechanical information and the clinical measurement information, wherein the second musculoskeletal simulation simulates the one or more forces related to the joint in a post-operative state;
comparing, by the one or more processors, the one or more forces related to the joint in the post-operative state to the pre-operative state to assess the post-operative state of the joint;
refining the algorithm based on the assessed post-operative state of the joint, wherein refining the algorithm comprises one of: (i) reinforcing the determined one or more surgical parameters based on the post-operative state of the joint, and (ii) modifying the determined one or more surgical parameters based on the post-operative state of the joint; and
resecting a bone of a next patient based on the reinforced or the modified one or more surgical parameters.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 15 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“receiving… a first set of the biomechanical information associated with a pre-operative activity of the joint from the sleeve” – may be performed by merely observing known or collected data or information [Applicant’s Specification ¶0047]
“determining… clinical measurement information related to the joint” – may be performed by merely observing known or collected data or information [Applicant’s Specification ¶0074]
“generating… a first musculoskeletal simulation for the joint based upon the first set of biomechanical information and the clinical measurement information, wherein the first musculoskeletal simulation simulates one or more forces related to the joint in a pre-operative state” – may be performed by merely drawing out a freebody diagram of known or estimated forces acting on the joint based on known information of the joint, using at least a limited amount of data [Applicant’s Specification ¶0076]
“determining… using an algorithm configured to modify an estimated force environment in the joint, one or more surgical parameters for the patient based upon the first musculoskeletal simulation, wherein the one or more surgical parameters are selected from one or more implant placement parameters, an amount of bone to be removed, a bone cut angle, and a placement of a cut guide” – may be performed by observing known or determined information and drawing mental conclusions therefrom based on known or determined mathematical procedures [Applicant’s Specification ¶0081]
“determining… at least one of a position and an orientation of the implant component to be inserted into the joint based upon the one or more surgical parameters” – may be performed by observing known or determined information and drawing mental conclusions therefrom based on known or determined mathematical procedures [Applicant’s Specification ¶0081]
“receiving… a second set of the biomechanical information associated with a post-operative activity of the joint from the sleeve” – may be performed by merely observing known or collected data or information [Applicant’s Specification ¶0047]
“generating… a second musculoskeletal simulation for the joint based upon the second set of biomechanical information and the clinical measurement information, wherein the second musculoskeletal simulation simulates the one or more forces related to the joint in a post-operative state” – may be performed by merely drawing out a freebody diagram of known or estimated forces acting on the joint based on known information of the joint [clinical measurement information], using at least a limited amount of data [Applicant’s Specification ¶0076]
“comparing… the one or more forces related to the joint in the post-operative state to the pre-operative state to assess the post-operative state of the joint” – may be performed by merely observing known or determined data/information and drawing mental conclusions therefrom [Applicant’s Specification ¶0079]
“refining the algorithm based on the assessed post-operative state of the joint, wherein refining the algorithm comprises one of: (i) reinforcing the determined one or more surgical parameters based on the post-operative state of the joint, and (ii) modifying the determined one or more surgical parameters based on the post-operative state of the joint” – may be performed by observing known or determined information and drawing mental conclusions therefrom based on known or determined mathematical procedures [Applicant’s Specification ¶0081]
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., “generating… a first musculoskeletal simulation for the joint based upon the first set of biomechanical information and the clinical measurement information, wherein the first musculoskeletal simulation simulates one or more forces related to the joint in a pre-operative state”, “generating… a second musculoskeletal simulation for the joint based upon the second set of biomechanical information and the clinical measurement information, wherein the second musculoskeletal simulation simulates the one or more forces related to the joint in a post-operative state”] 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. applying known mathematical concepts (claims 16-17), further limiting parameters in determination steps (claims 18-20), additional limitations relating to data gathered which are entirely embodied in the mental process (claims 23, 29 particularly the limitation regarding ”tracking…”)] and amount to no more than generally linking the use of the abstract idea to pre-operative and post-operative assessment of a joint 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 15 only recites additional elements of extra-solutionary activity – in particular, mere 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 data gathering, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 16-20, 23, and 29 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 steps which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 29 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, etc.] 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 claims 15 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 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 of receiving signals/data as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [one or more processors and functions thereof recited at a high level of generality], 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.
Accordingly, the one or more processors, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim 15 recites the limitation “collecting, by a sleeve configured to be worn by the patient, biomechanical information related to movement of a joint, the biomechanical information comprising at least one of ligament movement information and muscle movement information” and claim 20 recites “wherein the biomechanical information comprises bone position information and other soft tissue information for the joint as collected by the sleeve”. Such a “sleeve” 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 sleeve, and recites that the sleeve may merely comprise: an opening to allow for the sleeve to be worn [In an embodiment, the sleeve 205 may include an opening 207 configured to receive a portion of the joint, thereby allowing the joint to move while the sleeve is worn by the patient. In addition, the opening 207 may enable a user to determine a proper position for the sleeve 205. In an alternate embodiment, the sleeve 205 may be substantially tubular (i.e., without an opening). A tubular sleeve 205 may be used, in particular, for a sleeve that is not be positioned in proximity to a portion of a patient’s extremity (Applicant’s Specification ¶0043)], and one or more sensors recited at a high level of generality [the one or more sensors can include one or more inertial measurement units (IMUs) that include, for example, one or more accelerometers, gyroscopes, and magnetometers (Applicant’s Specification ¶0046); an infrared camera that identifies the location of position trackers… In certain embodiments, the tracking device 305 can detect tracking spheres on the position trackers 210 in order to gather location data regarding a patient’s femur, tibia, or other bone (Applicant’s Specification ¶0049)]. 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 pre-operative and post-operative joint assessment. 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].
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 15 recite(s) subject matter regarding “resecting a bone of a next patient based on the reinforced or the modified one or more surgical parameters” and 29 recite(s) subject matter regarding “resecting a first bone of the patient based on the one or more surgical parameters; and tracking the resection over an area of the first bone of the patient”, 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 [the Examiner notes that the recited “resecting a first bone of the patient based on the one or more surgical parameters” / “resecting a bone of a next patient based on the reinforced or the modified one or more surgical parameters” may be considered to refer to general treatment performed by hand, and “tracking the resection over an area of the first bone of the patient” may be considered to refer to a mental activity of merely observing known or collected data or information. Furthermore, the limitation “resecting a first bone of the patient based on the one or more surgical parameters” / “resecting a bone of a next patient based on the reinforced or the modified one or more surgical parameters” is considered to be a treatment/prophylaxis, but is not considered to be particular, as the resection is not particularly defined in light of any of the determined one or more surgical parameters and is thus merely instructions to “apply” the resection in a generic way; and the limitation of “resecting a first bone of the patient based on the one or more surgical parameters” of claim 29 is also considered to be a treatment/prophylaxis that does not impose meaningful limits on the identified judicial exception(s), as the resection is considered to be performed in order to gather data (as noted in the Step 2A Prong 2 analysis above) for the identified mental analyses steps regarding post-operative activity of the joint, and is thus a necessary precursor for all uses of the identified mental analyses steps regarding post-operative activity of the joint] [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
Examiner’s Note Regarding Prior Art
The following is a statement of reasons for the indication of subject matter not taught by the prior art:
The previously applied art references of Berend (US-20160278868-A1, previously presented), Otto (US-20100076563-A1, previously presented), Meere (US-20180160977-A1, previously presented), and Mahfouz (WO-2016007936-A2, previously presented) each fail to teach each and every limitation of independent claim 15 [see previous Non-Final Office Action dated 8 February 2024 for limitations considered to be taught by the modified Berend in view of Otto, Meere, and Mahfouz], alone or in combination, as the modified Berend in view of Otto, Meere, and Mahfouz [see previous Non-Final Office Action dated 8 February 2024] fails to teach the limitations of “refining the algorithm based on the assessed post-operative state of the joint, wherein refining the machine learning algorithm comprises one of: (i) reinforcing the determined one or more surgical parameters based on the post-operative state of the joint, and (ii) modifying the determined one or more surgical parameters based on the post-operative state of the joint” and “resecting a bone of a next patient based on the reinforced or the modified one or more surgical parameters”, such that without the benefit of hindsight, it would not have been obvious to one of ordinary skill in the art to have modified Berend in view of Otto, Meere, and Mahfouz in order to incorporate the limitation not taught.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 5, filed 27 January 2026, with respect to the previously applied rejection(s) under § 112(b) have been fully considered and are persuasive. The § 112(b) rejection of claim 29 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 5-7, with respect to the previously applied rejection(s) under § 101 have been fully considered but they are not persuasive.
The Applicant asserts that the amended limitation of claim 15 of “resecting a bone of a next patient based on the reinforced or the modified one or more surgical parameters” integrates the entire claim into a practical solution, as the post-operative feedback collected from the first patient is used as an input when resecting the bone of the next patient. However, the Examiner disagrees with the Applicant’s argument for reasons similar to the previously applied § 101 rejection, particularly the Step 2B Particular Treatment or Prophylaxis analysis, as the Examiner notes that the broad language of “based on the reinforced or the modified one or more surgical parameters” is considered similar to the previously analyzed limitation of claim 29 “resecting a bone of the patient based on the one or more surgical parameters”. The argued limitation is not considered to allow the claim as a whole to amount to significantly more and is considered to refer to general treatment performed by hand as a treatment/prophylaxis, but is not considered to be particular, as the resection is not particularly defined in light of the any of the reinforced or the modified one or more surgical parameters and is thus merely instructions to “apply” the resection in a generic way, as being “based on” the reinforced or the modified one or more surgical parameters is considered to broadly refer to the surgical parameters without referencing how the reinforced or the modified one or more surgical parameters may affect the resection.
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.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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