DETAILED ACTION
Notice of 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 .
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 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.
Withdrawal of Objections and Rejections
Applicant's response, filed 02/09/2026, has been fully considered.
In view of the amendment and remarks from 02/09/2026, the objection to claims 11, 14 and 24 are withdrawn.
The following rejections and/or objections are either maintained or newly applied for claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Non-Final Rejection of 11/05/2025.
Status of the Claims
Claims 6-7, 10, 12, 19-20, 23 and 25 are canceled.
Claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 are pending.
Claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 are rejected.
Priority
This application is a 371 of PCT/US2020/020866 (03/04/2020) which claims priority from Application No. 62/813,491 (03/04/2019) as reflected in the filing receipt mailed on 02/08/2022. As detailed on the 02/08/2022 filing receipt, the application claims priority as early as 03/04/2019. The claims to the benefit of priority are acknowledged. The effective filing date of claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 is 03/04/2019.
Claim Rejections - 35 USC § 112(b)
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.
Claims 4 and 17 are rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. Any newly recited portions are necessitated by claim amendment. The following issues cause the respective claims to be rejected under 112(b) as indefinite:
In claims 4 and 17, the recited “the sensor” has unclear antecedent basis because there are sensors recited in the independent claims 1 and 14 and "a sensor" recited in claims 3 and 16. It is unclear which of these sensors “the sensor" in claims 4 and 17 refers to.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 15 are rejected under 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend. MPEP 608.01(n).III pertains. Any newly recited portions are necessitated by claim amendment. Due to the amendments in claim 1 (i.e. patient monitoring system having sensors), it is not clear that the recitations in claim 2 and 15 differ in scope from claim 1. MPEP 2111.02 pertains. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). Any newly recited portions are necessitated by claim amendment.
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 1-5, 8-9, 11 and 13), and a system (claim 14-18, 21-22, 24 and 26), each of which falls within one of the categories of statutory subject matter.
[Step 1: claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows.
Mathematical concepts (in particular mathematical relationships and formulas) include:
• "calculating/calculate … at least one of joint loading data or gait mechanics data based on the patient-specific biomechanical simulation" (independent claims 1 and 14); and
• "calculating/calculate … a net joint damage index based on the joint loading data compared to the historical data, wherein the net joint damage index comprises a net measure of potential joint damage suffered by a patient" (independent claims 1 and 14).
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation. Without further detail as to the methodology involved in "calculating a net joint damage index after the joint load has been compare to the historical data", under the BRI, one may simply, for example, use pen and paper to perform mathematical steps to arrive at a calculated net joint damage index. Further support for the mathematical techniques used in the claims is provided in the specification at [0044-0045], which describes calculating a net joint damage index after the joint load has been compare to the historical data; and [0051] which describes that he biomechanical simulation may be used to calculate the net joint damage. Thus, the recited terms correspond to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words 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). MPEP 2106.04(a)(2) pertains.
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include:
• "generate kinematic data and anthropometric data based on the physical characteristics" (independent claims 1 and 14);
• "comparing/compare … at least one of the joint loading data or the gait mechanics data to historical data, wherein the historical data comprises a plurality of previously created biomechanical simulations of patients" (independent claims 1 and 14); and
• "determining/determine … a treatment strategy based on the comparison, wherein the treatment strategy comprises one or more of operative, non-operative, and postoperative interventions; wherein the determined treatment strategy is further based on the net joint damage index; and providing, by the computer system, the determined treatment strategy to a clinician" (independent claims 1 and 14).
Under the Broadest Reasonable Interpretation, the recited limitations are mental processes because a human mind is also sufficiently capable of generating kinematic data and anthropometric data based on the physical characteristics (i.e. which constitutes data evaluation), comparing data available and making a decision based on a comparison and determining a treatment strategy based on the comparison a data value.
[Step 2A Prong One: claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26: Yes ]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Instant claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 recite additional elements that are not abstract ideas:
• "tracking, by a patient monitoring system having sensors on or directed toward a patient, physical characteristics of the patient's body while the patient performs a plurality of activities" (independent claims 1 and 14);
• " creating/create, by the computer system, a patient-specific biomechanical simulation based on the patient data" (independent claims 1 and 14);
• "receiving, by a computer system, in communication with the patient monitoring system, patient data comprising the kinematic data and the anthropometric data" (independent claim 14);
• " providing, by the computer system, the determined treatment strategy to a clinician" (independent claims 1 and 14);
• "simulating/simulate, by the computer system, a plurality of different treatment strategies using the patient-specific biomechanical simulation, wherein the determined treatment strategy is determined from the plurality of simulated different treatment strategies" (claims 8 and 21);
• "transmitting/transmit, by the computer system, the patient-specific biomechanical simulation to at least one of a computer-assisted surgical system or a clinician computer system" (claims 9 and 22);
• "computer system" (claims 1, 8-9, 14-18, 21-22, 24 and 26);
• "computer-assisted surgical system" (claims 9 and 22); and
• "computer-implemented" (claims 1-5, 8-9, 11 and 13).
Dependent claims 2-5 and 15-18 recite further details about the patient data received. Dependent claims 11, 13, 24 and 26 recite further details about the treatment strategies determined.
Considerations under Step 2A, Prong Two
The recited limitations in 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 are interpreted as requiring the use of a computer. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions or instructions to implement on a generic computer. Further steps directed to additional non-abstract elements of a computing device/computer do not describe any specific computational steps by which the "computer parts" perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. The instant claims state nothing more than that a generic computer performs the functions that constitute the abstract idea (MPEP 2106.05(f)).
Limitations of claims 1 and 14 are considered to perform the claimed abstract idea with a computer, which is not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and merely performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
The recited "tracking physical characteristics of the patient's body while the patient performs a plurality of activities", "creating a simulation" and "simulating treatment strategies" read on data gathering activity because the simulations are utilized to gather information that is used as input to the judicial exceptions; not amounting to a practical application. The type of data doesn’t change that it is mere data gathering or conventional computer receiving means.
Claims directed to "receiving/transmitting" read on receiving or transmitting data over a network -Symantec, 838 F.3d at 1321 - MPEP 2106.05(a) pertains; which constitutes just necessary data gathering and therefore correspond to insignificant extra-solution activity.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claims do not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)).
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In this Step 2A, Prong Two immediately above claim steps and/or elements were identified as part of one or more additional elements. Additional elements are further discussed in Step 2B below.
Here in Step 2A, Prong Two, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
[Step 2A Prong Two: claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during examination that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
Claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Further, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versa ta 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, as discussed in MPEP 2106.05(d)(Il)(i)).
Claims directed to the simulation of treatment strategies by a computer system recite steps known in the art as conventional as discussed in the instant specification: “As would be understood by a person of ordinary skill in the art, there are a number of computational tools that may be used to create the simulation including, but not limited to, LifeModeler by LifeModeler, Inc., AnyBody Modeling System by AnyBody Technology, and OpenSimulator, which is an open-10-source multi-platform” [0042]. As discussed above regarding the treatment limitations cannot integrate a judicial exception as mere data gathering activity.
With respect to the instant claims, the prior art review to Vaughan (“A review of virtual reality based training simulators for orthopaedic surgery” Medical Engineering and Physics 38:59–71 (2016); cited in the 02/07/2025 PTO 892) discloses a simulator for hip injuries in human bodies using a wireless electromagnetic motion (i.e. kinematic data) tracking system is routine, well-understood and conventional in the art. Said portions of the prior art are, for example,( pg. 64 col. 1 para. 5).
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h).
The instant claims constitute insignificant extra solution activity, and when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(g)). Hence, these elements, when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(d)).
[Step 2B: claims 1-5, 8-9, 11, 13-18, 21-22, 24 and 26: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For the reasons above, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept not clearly anything significantly more.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 101
The Remarks of 02/09/2026 have been fully considered but are not persuasive for the reasons below:
Applicant asserts in pg. 8 para. 5:
With regard to Step 2A Prong Two, Applicant respectfully submits that the patient monitoring system comprising sensors on or directed toward a patient, and the tracking by the patient monitoring system while the patient performs a plurality of activities as claimed in amended claims 1 and 14 more clearly claims the judicial exception integrated into a practical application. The patient monitoring system including sensors on or directed toward the patient are more than mere data gathering/outputting components of a computer system. Moreover, the patient monitoring system as claimed generates kinematic data and anthropometric data particular way by tracking the patient during activities. This tracking and data generating more clearly integrates the judicial exception into a practical application.
It is respectfully submitted that this is not persuasive because, despite the fact that the tracking step – using a monitoring system - has been identified as an additional element, it appears to constitute data gathering activity. As such, the limitations indicated by Applicant do not integrate the recited judicial exceptions into a practical application at Step 2A, Prong 2, or provide significantly more at Step 2B. In this case, the identified additional element do not provide sufficient evidence to ensure that the claim as a whole amounts to significantly more than the judicial exception itself.
Applicant asserts in pg. 9 para. 2:
With regard to Step 2B, Applicant respectfully submits that the claims as amended including tracking a patient by a computer monitoring system having sensors on or directed toward a patient, and the claimed generation of patient data by the computer monitoring system impose meaningful limitations on the judicial exception. Moreover, the claimed steps/computer instructions cannot be performed without the particularly claimed computer and monitoring system.
It is respectfully submitted that this is not persuasive. MPEP 2106.05(d) sets forth that, at Step 2B, it is the additional elements which are examined to determine whether they are well-understood, routine, conventional activities previously known to the industry. The analysis at Step 2A, Prong 2, considers the claims as a whole, i.e., the additional elements in combination with the judicial exceptions (see MPEP 2106.05(a)), although the integration or improvement provided in the claim must flow from the additional elements and not the judicial exceptions to be considered persuasive. However, Step 2B instructs that an inventive concept cannot be provided the by judicial exception. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself (Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)). The argued "tracking a patient's physical characteristics" pointed to be Applicant are considered to recite a judicial exception as described above and are therefore not considered at Step 2B.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A. Claims 1-5, 11, 13-18, 24 and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hicks (“Is My Model Good Enough? Best Practices for Verification and Validation of Musculoskeletal Models and Simulations of Movement” J. Biomech. Eng. 137(2):020905 (2015)) in view of Stanczyk ("Modelling of heat transfer in biomechanics–a review. Part II. Orthopaedics." Acta of Bioengineering and Biomechanics 4(2):3-31 (2002)), as cited on the attached Form PTO-892. Any newly recited portions are necessitated by claim amendment.
Claims 1 and 14 recite:
tracking, by a patient monitoring system having sensors on or directed toward a patient, physical characteristics of the patient's body while the patient performs a plurality of activities;
generating kinematic data and anthropometric data by the patient monitoring system based on the physical characteristics:
creating, by the computer system, a patient-specific biomechanical simulation based on the patient data;
calculating, by the computer system, at least one of joint loading data or gait mechanics data based on the patient-specific biomechanical simulation;
comparing, by the computer system, at least one of the joint loading data or the gait mechanics data to historical data, wherein the historical data comprises a plurality of previously created biomechanical simulations of patients;
calculating, by the computer system, a net joint damage index based on the joint loading data compared to the historical data, wherein the net joint damage index comprises a net measure of potential joint damage suffered by a patient:
determining, by the computer system, a treatment strategy based on the comparison, wherein the treatment strategy comprises one or more of operative, non-operative, and postoperative interventions; wherein the determined treatment strategy is further based on the net joint damage index; and providing, by the computer system, the determined treatment strategy to a clinician.
• Hicks teaches the computational modeling and simulation of the human neuromusculoskeletal system for improving the diagnosis and treatment of the many conditions that limit human mobility (i.e. directed toward a patient, physical characteristics of the patient's body while the patient performs a plurality of activities) (pg. 020905-1 col. 1 para. 3), essential for applications like designing assistive devices, planning rehabilitative treatment (i.e. determining, by the computer system, a treatment strategy) (pg. 020905-1 col. 2 para. 1), and understanding the fundamental principles of human locomotion. comprising datasets of comprehensive set of anthropometric and motion data (i.e. kinematic data and the anthropometric data) (pg. 020905-20 col. 2 para. 3); wherein anthropometry of bodies could also be estimated on a subject-specific basis (pg. 020905-9 col. 2 para. 2) and the mathematical formulation of the physical system—the equations of motion—that enables the modeler to calculate accelerations, velocities, and positions over time (pg. 020905-7 col. 1 para. 1); wherein a multibody dynamics engine is used to calculate motions and forces for the system of interest (pg. 020905-9 col. 2 para. 5); wherein model formulations can provide net internal joint moments (i.e. calculating net joint index, the joint loading data or the gait mechanics data – which refers to the forces and moments applied to joints during activities) (pg. 020905-7 col. 2 para. 6); wherein the validation of the computational modeling and simulation of the human neuromusculoskeletal system can be done by comparison of the present model to the many walking simulations available in the literature (i.e. historical data of previously created biomechanical simulations of patients) (pg. 020905-5 col. 2 para. 2); wherein clinicians can adopt simulations to evaluate the accuracy and credibility of modeling studies (pg. 020905-1 para. 1); wherein the outputs of a musculoskeletal model are compared to experimental moment arms and passive and active net joint moments (pg. 020905-11 col. 1 para. 2); wherein anthropometry varies by age, sex, pathology and natural variation (i.e., pathology and natural variation both read on damages) (pg. 020905-10 col. 2 para. 4).
• Hicks does not teach “a net joint damage index .. wherein the net joint damage index comprises a net measure of potential joint damage suffered by a patient …wherein the determined treatment strategy is further based on the net joint damage index”. Hicks teaches that the simulated contact forces and moments take into account the friction of the motion (pg. 020905-20 Table 3); which is classified as a dissipative component (pg. 020905-7 col. 2 para. 4). However, Stanczyk teaches that dissipative energy occurs in the form of heat generation and dissipation that takes place every time the joint is used leading to potential thermal damage (i.e. which reads on analysis of joint damage) (pg. 25 para. 7).
Claim 1 recites:
receiving, by a computer system, in communication with the patient monitoring system, patient data comprising the kinematic data and the anthropometric data;
• Hicks teaches motion capture experiments for obtaining kinematic data with the use of sensors (pg. 020905-9 col. 1 para. 1).
Claim 2 recites:
wherein the patient data is at least partially sensed via a patient monitoring system
Claim 15 recites:
wherein the patient data is at least partially sensed via a patient monitoring system to which the computer system is communicably coupled
Claims 5 and 18 recites:
wherein the patient monitoring system comprises a camera configured to detect the kinematic data associated with a patient, the kinematic data comprising motion capture data
• Hicks teaches a model for computational simulations where the physical model system is the human or animal neural and/or muscular system acting on a rigid multibody skeletal structure, possibly in interaction with external devices (i.e. monitoring system) (pg. 020905-2 col. 1 para 2); wherein the sources for subject-specific data for the described computational modeling include data from a typical motion capture analysis like optical marker (i.e. comprising camera sensors) trajectories, ground reaction forces, and electromyography signals, along with data collected from imaging or cadaver studies to help define musculoskeletal dynamics and geometry (pg. 020905-5 col. 2 para. 1); including case-studies involving running activities for human subjects (i.e. monitoring system) (pg. 020905-17 Fig. 10).
Claims 3 and 16 recites:
wherein the patient monitoring system comprises a sensor configured to detect the kinematic data associated with a patient
• Hicks teaches that in a motion capture experiment, kinematic data (obtained from optical markers (i.e., sensors) or inertial measurement units) are measured (pg. 020905-8 col. 2 para. 1); where the physical model system is the human or animal neural and/or muscular system (pg. 020905-2 col. 1 para 2).
Claims 4 and 17 recites:
wherein the sensor comprises at least one of an accelerometer or a piezoelectric device configured to be coupled to the patient
• Hicks teaches a model for computational simulations where the physical model system is the human or animal neural and/or muscular system acting on a rigid multibody skeletal structure, possibly in interaction with external devices (pg. 020905-2 col. 1 para 2) involving comparison of the acceleration computed from kinematic data to the acceleration generated by measured ground reaction forces (pg. 020905-10 col. 2 para. 4).
Claims 11 and 24 recites:
wherein the non-operative intervention comprises a recommendation for at least one of physical therapy of using a brace
Claims 13 and 26 recites:
wherein the operative intervention comprises a total or partial joint replacement surgery
• Hicks teaches a computational modeling that can be used as a tool for planning musculoskeletal surgery designing training programs to reduce sports injuries, and prototyping powered prosthesis that aid locomotion (i.e. plurality of treatment strategies including operative represented by “surgery” as in claims 13 and 26 – and non-operative represented by “prototyping powered prosthesis that aid locomotion” as in claims 11 and 24) (pg. 020905-22 col. 1 para. 2); wherein instrumented knee replacements aid the validation of the presented method (i.e. total or partial joint replacement surgery) (pg. 020905-5 col. 2 para. 1).
Rationale for combining (MPEP §2142-2143)
Regarding claims 1-5, 11, 13-18, 24 and 26, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Hicks in view of Stanczyk because all references disclose methods for modeling and investigating musculoskeletal systems. The motivation would have been to incorporate the criteria of thermal/chemical damage to the bone tissue in computed calculations (pg. 17 para. 6 Stanczyk).
Therefore it would have been obvious to one of ordinary skill in the art to substitute modeling musculoskeletal method of Hicks to the methods by Stanczyk because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for modeling and investigating musculoskeletal systems.
B. Claims 8 and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hicks and Stanczyk as applied to claims 1 and 14 above further in view of Seth (“OpenSim: a musculoskeletal modeling and simulation framework for in silico investigations and exchange” Procedia IUTAM 2:212–232 (2011)), as cited on the attached Form PTO-892. Any newly recited portions are necessitated by claim amendment.
Claims 8 and 21 recite:
wherein the memory further stores instructions that, when executed by the processor, cause the computer system to: simulate a plurality of different treatment strategies using the patient-specific biomechanical simulation, wherein the determined treatment strategy is further based on the plurality of simulated different treatment strategies
• Hicks and Stanczyk do not teach the recited limitation above. However, Seth teaches a musculoskeletal modeling and simulation software framework that builds musculoskeletal models, simulate movement, and analyze resulting behaviors to be used for predicting effective surgical and rehabilitation treatments (pg. 213 para. 1).
Rationale for combining (MPEP §2142-2143)
Regarding claims 8 and 21, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Hicks and Stanczyk in view of Seth because all references disclose methods for modeling and investigating musculoskeletal systems. The motivation would have been to reach the ultimate goal of musculoskeletal modeling and simulation which is the prediction of outcome due to treatment or intervention (pg. 230 para. 2 Seth).
Therefore it would have been obvious to one of ordinary skill in the art to substitute modeling musculoskeletal method of Hicks and Stanczyk to the methods by Seth because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for modeling and investigating musculoskeletal systems.
C. Claims 9 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hicks and Stanczyk as applied to claims 1 and 14 above further in view of Vaughan (“A review of virtual reality based training simulators for orthopaedic surgery” Medical Engineering and Physics 38:59–71 (2016)), as cited on the attached Form PTO-892. Any newly recited portions are necessitated by claim amendment.
Claims 9 and 22 recite:
wherein the memory further stores instructions that, when executed by the processor, cause the computer system to: transmit the patient-specific biomechanical simulation to at least one of a computer- assisted surgical system or a clinician computer system
• Hicks and Stanczyk do not teach the recited limitation above. However, Vaughan teaches a computer-assisted surgery system (HipNav) that includes kinematic joint models and tools for predicting femoral range of motion, bone motion, and optimal alignment based on implant placement for use in-vivo, the data and preoperative plans are transferred to a computer station in the operating room for interactive in-vivo surgical navigation (pg. 62 col. 1 para. 1)
Rationale for combining (MPEP §2142-2143)
Regarding claims 9 and 22, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Hicks and Stanczyk in view of Vaughan because all references disclose methods for simulation of orthopaedic motion for improving treatment strategies. The motivation would have been to reduce the learning curve during the in-vivo procedure and design customized surgical guides (pg. 69 col. 1 para. 2 Vaughan).
Therefore it would have been obvious to one of ordinary skill in the art to substitute simulation of orthopaedic motion for improving treatment method of Hicks and Stanczyk to the methods by Vaughan because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for simulation of orthopaedic motion for improving treatment strategies.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 103
The Remarks of 02/09/2026 have been fully considered but are not persuasive for the reasons below:
Applicant asserts in pg. 9 para. 6:
Applicant respectfully submits that this assertion is incorrect for at least the reason that Stanczyk does not cure the deficiencies of Hicks. Applicant submits that no combination of Hicks and Stanczyk teaches a "NET" joint damage which is calculated based on the joint loading data compared to historical data, wherein the historical data comprises a plurality of previously created biomechanical simulations, wherein the net joint damage index comprises a net measure of potential joint damage suffered by the patient. Stanczyk investigates the problem of temperature distribution in an artificial joint when the joint is being used to establish whether thermal damage can take place. Stanczyk' s discussion of criteria for thermal damage when there is thermal loading resulting in thermal bone damage accumulation doesn't teach anything about applicant's net joint damage index, or any index based on joint loading data compared to historical data as particularly claimed. The Office Action also asserts that "Hicks teaches that validation of the computational modeling and simulation of the human neuromusculoskeletal system can be done by comparison of the present model to the many walking simulation available in the literature (i.e. historical data of previously created biomechanical simulations of patients) ... " Office Action, p. 17. Applicant respectfully submits that Hicks' description of comparing a present model to the many walking simulations available in the literature does not teach or suggest applicant's claimed "net joint damage index." The claimed "net joint damage index" is fundamentally different from the prior art because the net joint damage index as particularly claimed is determined by a comparison between the joint loading data and the historical data. Neither Hicks nor Stanczyk teach or suggest that exact comparison.
It is respectfully submitted that this is not persuasive. Hicks teaches mathematical formulation of the physical system—the equations of motion—that enables the modeler to calculate accelerations, velocities, and positions over time (pg. 020905-7 col. 1 para. 1); wherein a multibody dynamics engine is used to calculate motions and forces for the system of interest (pg. 020905-9 col. 2 para. 5); wherein model formulations can provide net internal joint moments (i.e. calculating net joint index, the joint loading data or the gait mechanics data – which refers to the forces and moments applied to joints during activities) (pg. 020905-7 col. 2 para. 6); wherein anthropometry of bodies could also be estimated on a subject-specific basis (pg. 020905-9 col. 2 para. 2) wherein the validation of the computational modeling and simulation of the human neuromusculoskeletal system can be done by comparison of the present model to the many walking simulations available in the literature (i.e. historical data of previously created biomechanical simulations of patients) (pg. 020905-5 col. 2 para. 2); wherein the simulated contact forces and moments take into account the friction of the motion (pg. 020905-20 Table 3); which is classified as a dissipative component (pg. 020905-7 col. 2 para. 4).
Stanczyk art is used to teach that the "dissipative energy via friction" as taught by Hicks reads on the recited damage to the joint in question which occurs in the form of heat generation and dissipation that takes place every time the joint is used leading to potential thermal damage (pg. 25 para. 7 Stanczyk). Thus there is no gap in the teachings as argued. Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). One of ordinary skill in the art would be motivated to calculate the "NET" joint damage which is calculated based on the joint loading data to incorporate the criteria of thermal/chemical damage to the bone tissue in computed calculations (pg. 17 para. 6 Stanczyk).
Conclusion
No claims are allowed.
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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/F.F.L./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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