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 .
Status of Claims
Claims 1-4, 6, 8-18, 21, 25-26, 28 are pending and under examination.
Claims 5, 7, 19, 20, 22-24, 27, 29-39 are cancelled.
Priority
The instant application does not claim the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to any prior applications. Accordingly, the effective priority date for the instant application is the filing date of 08/07/2020.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted 02/07/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Objections
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See at least page(s) 26. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Additionally, the specification (on pages 26) recites a section entitled “REFERENCES”. Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and MPEP § 609.04(a), subsection I. states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Accordingly, the specification is objected to as it contains non-standard section headings. See 37 CFR 1.77(b). This objection may be overcome by amending section headings to comply with 37 CFR 1.77(b).
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 1-4, 6, 8-18, 21, 25-26, 28 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.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and ‘as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355).
Guidance: Step 1.
Under the broadest reasonable interpretation, the claimed invention (claim 1 being representative) is directed to a method for performing a process and therefore falls within one of the four statutory categories.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. In this case, the following steps encompass an abstract idea for the reasons set forth below:
extrapolating a post-surgical kinetic condition of the patient based on the first and second condition data and the planned surgical intervention; (mental process, mathematical concept)
calculating a surgical plan optimized for the post-surgical kinetic condition of the patient; (mental process, mathematical concept)
Mental Processes
With regards to extrapolating, this step is recited at a high level of generality (without any technological details directed to how it is performed) and does not explicitly require a computer. In addition, human brains routinely perform extrapolation (i.e. estimation). As such, this step encompasses a mental process of observing data and making a judgement. MPEP 2106.04(a)(2), section III.
With regards to calculating, this step is recited at a high level of generality (without any technological details or rules directed to how it is performed) and does not explicitly require a computer. In addition, doctors routinely perform calculations during surgical planning. As such, this step encompasses a mental process of observing data, performing analysis, and making a judgement. MPEP 2106.04(a)(2), section III.
It is important to note that a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). [Step 2A, Prong 1: YES].
Mathematical Concept
With regards extrapolating, this step is recited at a high level of generality (without any technological details or rules directed to how it is performed) and does not explicitly require a computer. A review of the specification teaches extrapolation performed “using an extrapolation function whose parameters are determined by a trained model based on a training data set; implementing a parameterized dynamic model of the patient, calculating pre-operative parameters of the first and second condition, calculating a trend in the parameters…” [0076]. Accordingly, when read in light of the specification, this step also encompasses a mathematical concept of manipulating information through mathematical correlations or calculations. MPEP 2106.04(a)(2) Section I.
With regards to calculating, this step is recited at a high level of generality (without any technological details or rules directed to how it is performed) and does not explicitly require a computer. A review of the specification teaches “calculating: a confidence metric of the extrapolated post-surgical condition, or an uncertainty metric of the extrapolated post-surgical condition...” [0083]. Accordingly, when read in light of the specification, this step also encompasses a mathematical concept of manipulating information through mathematical correlations or calculations. MPEP 2106.04(a)(2) Section I.
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). See also Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014)[Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
Having made that determination, under the 2019 Guidance, the examiner next determines whether there are additional elements beyond the recited abstract idea(s) that integrate them into a practical application. In this case, the additional steps/elements that are not part of the abstract idea are as follows:
receiving from a prehabilitation system first and second condition data, wherein the first condition data and second condition data comprising kinetic information about how the patient moves from two different time points; wherein the kinetic information is derived from spatial measurements of the patient's movement…;
providing the plan for display.
With regards to receiving, this step is recited at a high level of generality and results in gathering data for use by the abstract idea. Accordingly, this step amounts to insignificant extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g).
With regards to providing, this this limitation is recited at a high level of generality and amounts to outputting data. Accordingly, this step amounts to insignificant extra-solution activity and is not indicative of an integration into a practical application. See MPEP 2106.05(g).
With regards to the additional elements directed to a processing unit and storage device (claim 28), these are nothing more than generic computer components being used as a tool to perform generic computer functions or the abstract idea. See MPEP 2106.05(b).
In summary, the claimed invention does not provide any objective evidence of an improvement to the technology, nor does the specification explain the details of an unconventional technical solution expressed in the claim, or identify technical improvements realized by the claim over the prior art. See MPEP 2106.04(d)(1) and MPEP 2106.05(a). Therefore, even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity. Moreover, Nawana et al. (US20140081659A) teaches, inter alia, a computer processor programmed for receiving treatment plan data regarding a plurality of patients and providing the suggested plan to a user. In addition, with regards to the claimed processor and storage device, as discussed above, these are generically recited, routine and conventional elements, and the courts have explained that the use of generic computer elements do not alone transform an otherwise abstract idea into patent-eligible subject matter. See DDR Holdings (Fed. Cir. 2014). Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements/steps. See MPEP 2106.05(d)(Part II). Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
Dependent Claims
Dependent claims 2-4, 6, 8-18, 21, 25-26, have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claims 2-4, 6, 8-18, 21, 25-26, these claims further limit the specificity of the abstract idea or the nature of the data being used and therefore are not patent eligible for reasons set forth above (Step 2A, prong 1). Therefore, the claims as a whole are not patent eligible.
Claim rejections - 35 USC § 112, 2nd Paragraph
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 1-4, 6, 8-18, 21, 25-26, 28 are 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 are also rejected due to said dependency.
Claims 1 and 28 recite “receiving from a prehabilitation system…”. It is unclear as to the metes and bounds of a “prehabilitation system” such that the artisan would recognize what structural limitation is intended. A review of the specification does not provide any limiting definition that would serve to clarify the scope. Clarification is requested via amendment.
Claims 1 and 28 recite “extrapolating a post-surgical kinetic condition...based on the first and second condition data and the planned surgical intervention.” It is unclear as to the metes and bounds of said “extrapolating”. Such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed function. A review of the specification teaches extrapolation performed “using an extrapolation function whose parameters are determined by a trained model based on a training data set; implementing a parameterized dynamic model of the patient, calculating pre-operative parameters of the first and second condition, calculating a trend in the parameters…” [0076]. However, examples are not limiting definitions and it is improper to import narrowing limitations into the claims. MPEP 2111.01. As a result, it is unclear what computational techniques are included or excluded by the claim language such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
Claims 1 and 28 recite “based on…the planned surgical intervention.” There is no previous step for providing (or even mentioning) a “planned intervention” such that is can be used in said extrapolation. Accordingly, there is lack of antecedent basis for this limitation. Correction is requested via amendment.
Claims 1 and 28 recite “calculating a surgical plan optimized for the post-surgical kinetic condition....”. It is unclear as to the metes and bounds of said “calculating”. Such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed function A review of the specification teaches “calculating: a confidence metric of the extrapolated post-surgical condition, or an uncertainty metric of the extrapolated post-surgical condition...” [0083]. However, examples are not limiting definitions and it is improper to import narrowing limitations into the claims. MPEP 2111.01. As a result, it is unclear what computational techniques are included or excluded by the claim language such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
Claim 8 recites “an extrapolation function whose parameters are determined by a trained model based on a training data set.” It is unclear as to the metes and bounds of the claimed “extrapolation function” and “trained model” such that the artisan would recognize what internal structures are intended, i.e. what is scope of the claimed function and in what way has the model been trained. For example, the artisan would recognize that “training” a model generally requires feature selection, adjusting model parameters, optimizing loss functions, etc. However, the instant claims do not define the model in terms of parameters nor do they set forth any steps involved in the method/process of training. As a result, it is unclear what method/process applicant is intending to encompass to achieve the claimed function. Clarification is requested via amendment.
Claim 8 recites “implementing a parameterized dynamic model of the patient, calculating preoperative parameters of the first and second condition, calculating a trend in the parameters, calculating updated parameters of the dynamic model based on the surgical intervention and the trend; and using an optimization method and a generalized patient model.” Firstly, it is unclear as to the metes and bounds of the claimed “parameterized dynamic model of the patient” such that the artisan would recognize what internal structure is intended, i.e. what is the scope of the claimed function. Stated differently, applicant has essentially chosen to claim a black box ‘models’ a critical aspect of the invention (without defining them). As such, by claiming a method for performing such a specialized function in a computer system without disclosing the internal structure of that system/processor in the form of an algorithm, the claim is indefinite. Clarification is again requested via amendment.
Secondly, with regards to “…using an optimization methods and a generalized patient model”, it is unclear as to the metes and bounds of the claimed “methods” and “generalized patient model” such that the artisan would recognize what operations and internal structures are intended, respectively. The instant claim does not define the model in terms of parameters nor do they set forth any steps involved in the method/process of using. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP § 2173.05(q). Stated differently, applicant has essentially chosen to claim a black box ‘models’ a critical aspect of the invention (without defining them). As such, by claiming a method for performing such a specialized function in a computer system without disclosing the internal structure of that system/processor in the form of an algorithm, the claim is indefinite. Clarification is again requested via amendment.
Claim 10 recites “calculating a psychological profile…based on the condition data, and wherein the extrapolating is based in part on the psychological profile.” It is unclear in what way the claimed profile is “based on the condition data”. A review of the specification does not describe, to any appreciable extent, any algorithms, equations, or prose equivalent that correspond to the claimed function. As a result, it is unclear what computational techniques are included or excluded by the claim language such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 8-18, 21, 25-26, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Nawana et al. (US20140081659A).
Regarding claim(s) 1 and 28, Nawana teaches methods and systems for surgical and interventional planning, support, post-operative follow-up, and functional recovery tracking
In particular, Nawana teaches a computer processor configured to: receive treatment plan data regarding a plurality of patients, wherein the data includes a plurality of different types of data including treatments plans and patient conditions [ref. claims 1, 46, 0005, 0156, 0159, 0200, 0202, and Figure 1]. Nawana teaches that the treatment planning data can additionally include patient-specific factors including one or more of mobility, gait, walking speed, and range of motion, pain [0031, 0159], which the artisan would recognize includes kinetic information, as well as information directed to changes in movement and spatial positioning [0034, 0210, 0243, 0258]. Nawana does not specifically teach using kinetic information about how the patient moves from two different time points. However, Nawana makes obvious this limitation by additionally teaching the use of temporal parameters from different time points [0267, and 0159, e.g. "every sixty minutes, every twenty-four hours”], and evaluating changes over time [0128], which the artisan would recognize as being obvious for determining changes kinetic conditions. Moreover, the choice of kinetic data is nothing more than a design consideration that does not change the function of the claimed process steps, as claimed, and Applicant has not disclosed that this particular feature provides an advantage, is used for a particular purpose, or solves a stated problem.
Nawana teaches performing simulations (i.e. extrapolations) for determining the effectiveness of planned interventions [ref. claim 1]; analyzing the procedure for projected results, e.g., potential healing, potential increase in patient mobility after "X" amount of time, amount of correction, etc. [0124]; determining a suggested plan of medical treatment for a patient based on the determined effectiveness [ref. claim 1, 0143, 0156, 0170, 215], which broadly reads on calculating an optimized surgical plan. Nawana additionally teaches providing the suggested plan to a user [ref. claim 1, 0233].
Regarding claim(s) 2, 3, Nawana teaches that the condition data further comprises demographic information [0031, 0120, 0159], as well as gait, walking speed, and range of motion, pain level [0031, 0159]. Regarding claim(s) 4, Nawana teaches receiving data from a plurality of sensors, e.g., a smartphone camera [0031]. Regarding claim(s) 6, Nawana teaches functionality for calculating optimized surgical plans [0140, 143, 156, 157, 159, 170] and for updating surgical plans [0223].
Regarding claim(s) 9, 11, Nawana teaches surgical planning that includes implant positioning and movement (i.e. kinetics) [0242, 0034, 0210, 0243, 0258] and can be based on future interventions [0169, 0179]. Regarding claim(s) 12, 13, Nawana teaches the use of robotic systems [0261, 0269] and implants [0291, 0314]. Regarding claim(s) 14, 18, Nawana teaches a treatment compliance module for calculating compliance metrics [0315]. Regarding claim(s) 15, 16, 17, Nawana teaches surgical plans that additionally include lifestyle behaviors (e.g., smoking, exercise, etc.), scans of images (e.g., MRI, CT, x-ray, etc.), and positional registration information [0143, 0217, 0232, 0238, 0240]. Regarding claim(s) 21, Nawana teaches using patient-specific factors that additionally include flexibility, muscular strength [0031] and provides instrumentation for measuring force [0272]. Regarding claim(s) 25, 26, Nawana teaches using planning information including logistics and surgery dates [0101, 0165, 0197, 0291 and Figure 2]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed methods.
Cited Prior Art
The following prior art made of record and not presently relied upon is considered pertinent to applicant' s disclosure.
Wu et al. (The Journal of Arthroplasty, 2017, 32, pp. 2214-2218) teaches a multivariate regression model for predicting surgical time for total hip arthroplasty.
Singh et al. (J. Clin. Med. 2021, 10, 5655, pp.1-18) teaches a review of virtual surgical planning methods using digital clinical data for diagnostic, procedure selection and treatment planning purposes, including the forecast of potential outcomes.
Jean et al. (WO/2020123709) teaches a surgical planning system for use in surgical procedures to repair an anatomy of interest includes a preplanning system to generate a virtual surgical plan and a mixed reality system that includes a visualization device wearable by a user to view the virtual surgical plan projected in a real environment. The virtual surgical plan includes a 3D virtual model of the anatomy of interest.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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