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 statements (IDS) submitted on November 27, 2024, January 20, 2025, November 20, 2025, and December 30, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections
Claims 3-5 and 8-10 are objected to because of the following informalities: “The method of claims 1” should read “The method of claim 1” (line 1). Appropriate correction is required.
Claims 15-16 are objected to because of the following informalities: “The method of claims 13” should read “The method of claim 13” (line 1). 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 4, 6, 9-17 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 4 recites the limitation "the sum of the forces" in line 2 and line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the entire knee compartment" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the time" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the step" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “determining a percentage of the load passing through the meniscus of the knee joint is determined while the knee joint moves through a range of motion”. It is unclear whether “a percentage of the load” is meant to be the same percentage described in claim 1 (line 4), or if claim 14 is reciting a different percentage of the load being determined. Additionally, it is unclear if “a range of motion” is meant to be the same range of motion described in claim 1 (lines 5-6) of if claim 14 is reciting a different range of motion. Further clarification is required.
Claim 15 recites “determining a percentage of the load” in lines 1-2. It is unclear whether “a percentage of the load” is meant to be the same percentage described in claim 1 (line 4), or if claim 15 is reciting a different percentage of the load being determined. Further clarification is required.
Claim 16 recites “a load on a meniscus” in line 2. It is unclear if this is meant to the same “load” and “meniscus” recited in claim 1, or if these are intended to be different elements from claim 1. Further clarification is required.
Claim 17 recites “determining a percentage of the load through the meniscus of the knee is measured by the sensor while the knee moves through a defined range of motion”. It is unclear whether “a percentage of the load” is meant to be the same percentage described in claim 1 (line 4), or if claim 17 is reciting a different percentage of the load being determined. Additionally, it is unclear if “a range of motion” is meant to be the same range of motion described in claim 1 (lines 5-6) of if claim 17 is reciting a different range of motion. Further clarification is required.
Claim 17 recites the limitation "the steps" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites “a knee” in lines 1-2. It is unclear if this is meant to be the same knee as recited in claim 1, or if this is a different knee.
Claim 17 recites the limitation "the sum of the forces" in line 5 and line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the entire knee compartment" in line 6. There is insufficient antecedent basis for this limitation in the claim.
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 1-17 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. Claims 1-17 are directed to a method of phenotyping a knee using a computational algorithm, which is an abstract idea. Claims 1-17 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “determining a percentage of the load through a meniscus of the knee through a defined range of motion”; and
[B1] – “assigning the knee to a predetermined classification based on the determined percentage of the load through the meniscus of the knee.”
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “applying a load to the knee”.
These elements [A2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the element [B2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation [A2] does not qualify as significantly more because this limitation merely describes the nature of the procedure performed on the knee to gather data and does not incorporate any particular machine for applying load as part of the claimed invention.
Claims 2-17 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 10-12 and 16-17: “sensor”
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 10-12 and 16-17 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, sensor is not defined by the claims, and therefore does not qualify as a particular machine. Also, this limitation from claims 10-12 and 16-17 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 12, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Function of the medial meniscus in force transmission and stability” (Walker et al.).
Regarding claim 1, Walker teaches a method of phenotyping a knee, the method comprising: applying a load to the knee (Page 1384 – Methods and materials: “A sequence of loads was then applied, each for a full range of flexion from 5 degrees hyperextension to 135 degrees flexion, or as close to that as the knee would allow.”);
determining a percentage of the load through a meniscus of the knee through a defined range of motion (Page 1385 – Statistical analysis: “In order to evaluate differences of percentages of load in repeated measurements between meniscal regions, different flexion angles, and different force types, a multi-variate linear mixed-effect model was used”, Page 1387 – Discussion: “the percentage of load carried by the meniscus remained relatively constant throughout flexion, although the load distributions between the 3 regions did change with flexion angle and loading conditions … meniscal/total force ratio for their range of flexion.”); and
assigning the knee to a predetermined classification based on the determined percentage of the load through the meniscus of the knee (Page 1386 – Results: “The overall average for meniscal load-bearing for the 3 loading conditions was 58%. However, there was considerable variation in the pressure patterns and forces between knees. Examples of 3 Tekscan patterns for specific cases are shown in Fig. 5. A typical average case is shown; a case with a pressure bias towards the posterior horn; and a single case with minimal pressure on the central body”).
Regarding claim 2, Walker teaches the method of claim 1, wherein the predetermined classifications consist essentially of cluster 1 or cluster 2 (Page 1386 – Results: “The overall average for meniscal load-bearing for the 3 loading conditions was 58%. However, there was considerable variation in the pressure patterns and forces between knees. Examples of 3 Tekscan patterns for specific cases are shown in Fig. 5. A typical average case is shown; a case with a pressure bias towards the posterior horn; and a single case with minimal pressure on the central body”).
Regarding claim 3, Walker teaches the method of claims 1, wherein the predetermined classifications consist essentially of cluster 1, cluster 2, cluster 3, and cluster 4 (Page 1386 – Fig. 5, “A typical average case is shown; a case with a pressure bias towards the posterior horn; and a single case with minimal pressure on the central body. In all cases, there was pressure on the tibial surface not covered by the meniscus. Data of the anterior–posterior stability analysis is shown in Fig. 6. The measure of stability was the net anterior or posterior shear force carried by the meniscus, in relation to the applied shear force.”; The knee can be classified as experiencing typical average, posterior loading, no central body loading, and anterior loading)
Regarding claim 4, Walker teaches the method of claim 1, wherein the percentage of the load through the meniscus is equal to the sum of the forces through a meniscus region divided by the sum of the forces through the entire knee compartment (Page 1385 – Statistical analysis: “In order to evaluate differences of percentages of load in repeated measurements between meniscal regions, different flexion angles, and different force types, a multi-variate linear mixed-effect model was used”, Page 1387 – Discussion: “the percentage of load carried by the meniscus remained relatively constant throughout flexion, although the load distributions between the 3 regions did change with flexion angle and loading conditions … meniscal/total force ratio for their range of flexion.”).
Regarding claim 5, Walker teaches the method of claims 1, further comprising moving the knee though the defined range of motion at a predefined frequency (Page 1384 – Methods and materials: “each for a full range of flexion from 5 degrees hyperextension to 135 degrees flexion, or as close to that as the knee would allow.”).
Regarding claim 6, Walker teaches the method of claim 4, wherein the predefined frequency is about 0.1-0.3 Hz (Page 1384 – Table 1: “Tekscan load time 10–15 sec”; 10 sec load cycles is equivalent to 0.1 Hz) at about 0 to 60 percent gait cycle (Page 1384 – Table 1: “14% gait max at posterior region, 45% gait at central region”)..
Regarding claim 7, Walker teaches the method of claim 5, wherein the defined range of motion is 0 to 60 percent gait cycle (Page 1384 – Table 1: “14% gait max at posterior region, 45% gait at central region”).
Regarding claim 8, Walker teaches the method of claims 1, wherein the load is about 175-2250N (Page 1384 – Methods and materials: “A sequence of loads was then applied, each for a full range of flexion from 5 degrees hyperextension to 135 degrees flexion, or as close to that as the knee would allow. Tekscan data was obtained for the following sequences of loading: 500 N compressive vertical load, 500 N + 100 N anterior shear (an anterior force on the femur applied simultaneously to the compressive load), 500 N + 100 N posterior shear.”).
Regarding claim 9, Walker teaches the method of claims 1, wherein the time the load is applied is greater than 20 seconds (Page 1384 – Table 1: “120 s load time”).
Regarding claim 10, Walker teaches the method of claims 1, further comprising the step of securing a sensor to the knee (Page 1384 – Methods and materials: “Tekscan sensor (500 N sensor, 4011 N, Tekscan Inc, Boston MA) was inserted between the medial meniscus and the cartilage surface through an anterior incision, and sutured posteriorly (Fig. 2).”).
Regarding claim 12, Walker teaches the method of claim 10, wherein the sensor is secured to an anterior cruciate ligament or a posterior capsule of the knee (Page 1384 – Methods and materials: “The sensor covered all of the cartilage under the meniscus and the central uncovered cartilage, but did not include the slope of the tibial spine.”).
Regarding claim 17, Walker teaches the method of claim 1 further comprising the steps of securing a sensor to a knee (Page 1384 – Methods and materials: “Tekscan sensor (500 N sensor, 4011 N, Tekscan Inc, Boston MA) was inserted between the medial meniscus and the cartilage surface through an anterior incision, and sutured posteriorly (Fig. 2).”).; wherein the step of determining a percentage of the load through the meniscus of the knee is measured by the sensor while the knee moves through a defined range of motion of about 0 to 60 percent gait cycle (Page 1384 – Methods and materials: “A sequence of loads was then applied, each for a full range of flexion from 5 degrees hyperextension to 135 degrees flexion”; Page 1385 – Statistical analysis: “In order to evaluate differences of percentages of load in repeated measurements between meniscal regions, different flexion angles, and different force types, a multi-variate linear mixed-effect model was used”; Page 1384 – Table 1: “14% gait max at posterior region, 45% gait at central region”) at a predefined frequency of about 0.1-0.3 Hz (Page 1384 – Table 1: “Tekscan load time 10–15 sec”; 10 sec load cycles is equivalent to 0.1 Hz), wherein the percentage of the load through the meniscus is equal to the sum of the forces through a meniscus region divided by the sum of the forces through the entire knee compartment (Page 1385 – Statistical analysis: “In order to evaluate differences of percentages of load in repeated measurements between meniscal regions, different flexion angles, and different force types, a multi-variate linear mixed-effect model was used”, Page 1387 – Discussion: “the percentage of load carried by the meniscus remained relatively constant throughout flexion, although the load distributions between the 3 regions did change with flexion angle and loading conditions … meniscal/total force ratio for their range of flexion.”), and wherein the predetermined classification consists essentially of cluster 1 and cluster 2 (Page 1386 – Results: “The overall average for meniscal load-bearing for the 3 loading conditions was 58%. However, there was considerable variation in the pressure patterns and forces between knees. Examples of 3 Tekscan patterns for specific cases are shown in Fig. 5. A typical average case is shown; a case with a pressure bias towards the posterior horn; and a single case with minimal pressure on the central body”).
Claim Rejections - 35 USC § 103
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over “Function of the medial meniscus in force transmission and stability” (Walker et al.) in view of US 20230032821 A1 (Georgeson et al.).
Regarding claim 11, Walker teaches the method of claim 10.
Walker does not explicitly teach wherein the sensor has a diameter of approximately 0.008”-0.01” or a thickness of approximately 0.001-0.006”.
However,
Georgeson teaches wherein the sensor has a diameter of approximately 0.008”-0.01” or a thickness of approximately 0.001-0.006” ([0060] “0.25 millimeter”; 0.25 mm is approximately 0.01”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Walker to include sensor dimensions approximately 0.01”. Walker describes that the sensor is inserted between the medial meniscus and the cartilage surface (Walker – Methods and materials), which is an area in the magnitude of 0.01”. One would have been motivated to make this modification because these dimensions can be used in an ergonomically improvement system for a sensor in the knee, as suggested by Georgeson ([0003, 0034]).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over “Function of the medial meniscus in force transmission and stability” (Walker et al.) in view of US 20130211259 A1 (Komistek et al.).
Regarding claim 13, Walker teaches a method of treating a partial meniscectomy of the knee joint according to the method of claim 1 (Page 1383 – Introduction: “the importance of the medial meniscus when the tibia was loaded anteriorly. The stability data by Arno et al. (2012) after partial meniscectomy experiments is consistent with these studies.”).
Walker does not explicitly teach further comprising the step of determining a course of medical treatment of the knee based on the assigned classification of the knee.
However,
Komistek teaches and further comprising the step of determining a course of medical treatment of the knee based on the assigned classification of the knee ([0004] “Depending on the type and nature of the joint damage, different treatment modalities can be pursued.”; [0100] “the diagnostic information page 210 may provide the joint information in a unique and comprehensive manner that is invaluable for treatment planning.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the metho taught by Walker to include determining a course of medical treatment. One would have been motivated to make this modification because gathering contact location maps, such as Fig. 5 of Walker, provides information to diagnose and determine a proper course of treatment and could eliminate the need for imaging modalities with harmful radiation, as suggested by Komistek ([0100-0101]).
Regarding claim 14, Walker teaches the method of claim 13, wherein the determining a percentage of the load passing through the meniscus of the knee joint is determined while the knee joint moves through a range of motion (Page 1384 – Introduction: “This would include both compressive and shear forces over different flexion ranges, using input data from instrumented total knees (Heinlein et al., 2009, 2009; D'Lima et al., 2011). Motion should also be continuous over the flexion range rather than the tests being conducted under static conditions.”; Page 1384 – Methods and materials: “each for a full range of flexion from 5 degrees hyperextension to 135 degrees flexion, or as close to that as the knee would allow.”).
Regarding claim 15, Walker teaches the method of claims 13, wherein the determining a percentage of the load passing through the meniscus of the knee joint is determined while the knee joint moves at a predefined frequency (Page 1384 – Methods and materials: “each for a full range of flexion from 5 degrees hyperextension to 135 degrees flexion, or as close to that as the knee would allow.”).
Regarding claim 16, Walker teaches the method of claims 13, further comprising applying a sensor to the knee joint to measure a load on a meniscus of the knee joint (Page 1384 – Methods and materials: “Tekscan sensor (500 N sensor, 4011 N, Tekscan Inc, Boston MA) was inserted between the medial meniscus and the cartilage surface through an anterior incision, and sutured posteriorly (Fig. 2).”).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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