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 .
This office action is in response to communication filed on 2/24/2026.
Claims 1-14 and 22-23 are presented for examination.
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 1-14 and 22-23 are rejected under 35 U.S.C. 101 because the claimed invention are directed to non-statutory subject matter.
Claim 1 recites the following limitations:
generating, based on imaging data of a femur and a tibia of a patient, at least a portion of the femur and the tibia;
identifying, based on imaging data of the portion of femur-and the tibia of a patient, a plurality of medial femoral condyle control points on a medial femoral condyle of the femur, wherein the plurality of medial femoral condyle control points are distributed on an active flexion range on articular features of the femur, the identifying comprising:
identifying, one or more contact points between the femur and the tibia at various degrees of flexion, or identifying, one or more locations tangent to a contact plane;
determining, based on the plurality of medial femoral condyle control points, a first medial femoral condyle curve, the determining comprising:
fitting at least a portion of a curve to the plurality of medial femoral condyle control points, wherein the first femoral medial condyle curve corresponds to at least the portion of the fitted curve;
determining comparing the plurality of medial femoral condyle control points to the first medial femoral condyle curve to determine whether a deviation of any of the plurality of medial femoral condyle control points exceed a threshold deviation from the first medial femoral condyle curve, the determining comprising:
comparing the plurality of medial femoral condyle control points to the first medial femoral condyle curve;
identifying, based on the comparison of the plurality of medial femoral condyle control points to the first medial femoral condyle curve, a deviation value;
comparing the deviation value to a threshold deviation value; and
determining, when the deviation value exceeds the threshold deviation value, the deviation;
determining, based on the determined deviation, a resulting medial femoral condyle curve;
identifying, based on the resulting medial femoral condyle curve comparison, at least one of a resection location or the patient specific articular implant, wherein the at least one of the resection location or the patient specific articular implant is configured to recreate pre-operative or pre-injury function of the first medial femoral condyle curve; and
providing an indication of the at least one of the resection location or the patient specific articular implant.
Claim 23 recites the following limitations:
identifying, based on imaging data of a femur of a patient, a plurality of medial femoral condyle control points on a medial femoral condyle of the femur, wherein the plurality of medial femoral condyle control points are distributed on an active flexion range on articular features of the femur;
determining, based on the plurality of medial femoral condyle control points, a first medial femoral condyle curve; comparing the plurality of medial femoral condyle control points to the first medial femoral condyle curve to determine whether any of the plurality of medial femoral condyle control points exceed a threshold deviation from the first medial femoral condyle curve;
identifying one or more medial femoral condyle control points that exceed the threshold deviation from the first medial condyle curve as irregular; when a first medial femoral condyle control point of the plurality of medial femoral condyle control points is identified as irregular,
determining a second medial femoral condyle curve to the plurality of medial femoral condyle control points with less weight is given to the first medial femoral condyle control point; identifying, based on the comparison, at least one of a resection location or the patient specific articular implant, wherein the at least one of the resection location or the patient specific articular implant is configured to recreate pre-operative or pre-injury function of the first medial femoral condyle curve; selecting a tibial resection angle measured in a coronal plane, wherein:
a tibial resection depth and angle are selected from within a tibial resection depth range and a tibial resection angle range, respectively, in view of a location and diameter of a partial- circular portion of the second medial femoral condyle curve between a subchondral surface of the medial femoral condyle and a medial femoral condyle cartilage surface, and
a lower end of the tibial resection depth range and a lower end of the tibial resection angle range correspond to alignment of the partial-circular portion of the second medial femoral condyle curve with the subchondral surface of the medial femoral condyle, and
an upper end of the tibial resection depth range and the upper end of the tibial resection angle range correspond to alignment of the partial-circular portion of the second medial femoral condyle curve with the medial femoral condyle cartilage surface; and
providing an indication of the at least one of the resection location or the patient specific articular implant.
The above limitations recite fitting a medial femoral condyle curve and determining whether any of the plurality of medial femoral condyle control points exceed a threshold deviation from the first medial femoral condyle curve. These limitations, under their broadest reasonable interpretation, fall within the “Mathematical Concepts” and “Mental Processes” grouping of abstract ideas in that they recite mathematical relationships because analyzing geometric shapes and data are mental and mathematical analysis. Accordingly, under Prong One of Step 2A.
Under Prong Two of Step 2A of the Alice/Mayo test, claim 1 recites the additional elements of a generated three dimensional model using generic computer components, such that thy are no more than a tool to perform the abstract idea. As such, under Prong Two of Step 2A of the Alice/Mayo test, when considered both individually and as a whole, the limitations of claim 1 does not indicative of integration into a practical application and claim 23 doesn’t recite any additional elements indicative of integration into a practical application (Step 2A, Prong Two: NO).
Next, under Step 2B, the claims are analyzed to determine if there are additional claim limitations that individually, or as an ordered combination, ensure that the claim amounts to significantly more than the abstract idea. As discussed above with respect to Prong Two of Step 2A, the claims do not recite any additional elements beyond the abstract idea to show an improvement in computer-functionality (see MPEP 2106.05(a)()). Furthermore, as discussed above with respect to Prong Two of Step 2A, claim 1 the abstract idea of mathematically fitting a medial femoral condyle curve and there are no additional limitations in Alice Corp., the Court considered the additional elements “as an ordered combination,” an determined that “the computer components...‘[a]dd nothing. ..that is not already present when the steps are considered separately’ and simply recite intermediated settlement as performed by a generic computer.” Id. (citing Mayo, 566 U.S. at 79, 101 USPQ2d at 1972). Similarly, viewed as a whole, claims 1 and 23 are abstract idea itself facilitated by generic computing components. Therefore, under Step 2B of the Alice/Mayo test, there are no meaningful limitations in claims 1 and 23 that transforms the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception itself (Step 2B: NO).
Dependent claims 2-14 and 22 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend. There’re no additional elements that transform the recited abstract idea into a patent eligible invention because these claims merely recite further abstract limitations that provide no more than simply narrowing the recited abstract idea.
Allowable Subject Matter
Claims 1-14 and 22-23 are allowable over prior art of record.
The closes prior art of record: McKinnon (11,997,817) teaches on Figure 16 image of the patient’s anatomy, step 104 for creating virtual resection/position on the patient’s bone/femur, steps 114 and 116 describe random point sets around the peripheries of the implant models. Mckinnon is comparing the position of the implant model to the anatomical model and not on the femur itself. Mckinnon points are randomly generated points and are not equivalent to :”a plurality of medial femoral condyle control points on a medial femoral condyle of the femur, wherein the plurality of the medial femoral condyle control points are distributed on an active flexion range on articular features of the femur ” nor are the randomly generated points are equivalent to “the first medial femoral curve” , which was determined based on the plurality of femoral condyle control points, as shown on Figures 3A and 3B.
Pavlovskaia (2019/0239926) teaches determining femoral condyle vectors and tibial plateau vectors based on image data of the knee, a computer-implemented method of preoperatively planning a surgical procedure on a knee of a patient including determining femoral condyle vectors and tibial plateau vectors based on image data of the knee. Pavlovskaia doesn’t teach the control points of the femur“a plurality of medial femoral condyle control points on a medial femoral condyle of the femur, wherein the plurality of the medial femoral condyle control points are distributed on an active flexion range on articular features of the femur”.
Response to Arguments
Applicant argues that the claims as amended solves a technical problem and thereby provides a practical application. The Examiner disagrees with Applicant because The Examiner disagrees with Appellant because the claims pertain to a pre-operative planning techniques to optimize implant size and placement in a joint by . fitting at least a portion of a curve to the plurality of medial femoral condyle control points, wherein the first femoral medial condyle curve corresponds to at least the portion of the fitted curve. According to MPEP 2106.04 (a)(2) “ It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea). In this case, the claim limitations of “determining whether any of the plurality of medial femoral condyle control points exceed a threshold deviation from the first medial femoral condyle curve”, is making a mathematical relationship determination/connection association of the femoral control points to deviation to a curve, which are process of organizing information through mathematical correlations and are considered abstract ideas and fall under “Mathematical Concepts” and also example of concepts performed in the human mind as mathematical ideas and mental processes.
Applicant argues that the claims do not merely recite the idea of a solution and that the claims as amended are specific concrete implementation of pre-operatively identifying patient specific implants and/or resection locations and, or more specifically, characterization of the joint, selection of an implant, and resection planning. The examiner wants to point out that pre-operatively identifying patient specific implants and/or resection locations and, or more specifically, characterization of the joint, selection of an implant, and resection planning are all part of the abstract idea of identifying patients, implants and/or resection locations, selection of implant and resection planning data mimic human though processes of observation, evaluation and planning, perhaps with a paper and pencil and are part of the abstract idea, where the data interpretation is perceptible in the human mind and an abstract idea under 2A, prong one.
With respect to features of dependent claims 3 and 5, of how “the data representing a curve from control points” and “comparing data representing the curve to the control points” are part of the abstract idea, and not additional technical elements under 2A, prong two.
With respect to the features of depend claim 14, the “indication of the at least one of the reconstruction location or the patient specific articular implant” is part of the abstract idea, and not additional technical elements under 2A, prong two.
With respect to claims 21-22, “wherein the contact plane is defined by a rotation of a femoral distal tangent plane within a sagittal plane along a surface of a medial femoral condyle”, is part of the abstract idea, and not additional technical elements under 2A, prong two.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAQUEL ALVAREZ whose telephone number is (571)272-6715. The examiner can normally be reached Mondays thru Thursdays 8:30-6:30.
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/RAQUEL ALVAREZ/ Primary Examiner, Art Unit 3622