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 .
Preliminary Amendment
Applicant’s preliminary amendment of the claims and specification, filed 08/01/2023, has been entered and considered in full.
Status of Claims
Claims 1-18, 20-21 are currently under examination. Claim 19 is cancelled, claim 21 is a new claim.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 01/11/2024, 03/26/2024, 06/18/2024, 07/12/2024,08/20/2024, 09/17/2024, 01/08/2025, 06/23/2025, 08/13/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Priority
The instant application is a national stage entry under §371 of the international application PCT/US2022/014192 which was filed on 01/28/2022.
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) to provisional application 63/146,278, filed 02/05/2021, are acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18, 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims depending directly or indirectly from claims 1, 20 are rejected due to their dependency from claims 1, 20.
Claims 1 and 20 recites the limitations “the surgeon preference parameters”. “the surgical parameters”, "the surgical options" and “the positioning parameters the disclosure does not provide a full description or definition of these “parameters” and “options”. Therefore the claims contain subject matters lacking description in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 2, 11 and 21 recite also “trial vectors”. The disclosure does not provide a full description or definition of what “trial vectors” are. Therefore the claims contain subject matters lacking description in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 2, 11 and 21 recite also “cost value”. The disclosure does not describe in sufficient details how these cost values are determined as no sufficient details are provided within the disclosure as how the cost value is defined for any “trial vectors”, which appears to be only related to a determination from mental assessments. Therefore the claims contain subject matters lacking description in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
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 1-18, 20-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims depending directly or indirectly from claims 1, 20 are rejected due to their dependency from claims 1, 20.
Claims 1 and 20 recites the limitations “the surgeon preference parameters”. “the surgical parameters”, "the surgical options" and “the positioning parameters”. There is insufficient antecedent basis for these limitations in the claims. Additionally, it is unclear as what are specifically the “parameters” since the disclosure does not provide a clear description or definition of these parameters especially regarding the “surgeon preference parameters”. Clarification are requested via amendments.
Claims 2, 11 and 21 recite also “trial vectors”. The disclosure does not provide a clear description or definition of what “trial vectors” are. Therefore it is unclear what limitation is intended with these terms “trial vectors” since the claim appears to define the “trial vector” as one of the suggested surgical options. Clarifications are requested via amendments.
Claims 2, 11 and 21 recite also “cost value”. It is unclear in what way the “cost value” is determined especially for the “input values” as based for the “trial vector”. Clarifications are requested via amendments.
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 1-18 and 20-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding independent claim 1,
Step 1: Statutory Category: YES - The claim recites a method.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the limitations “obtaining, by a computing system, one or more surgeon preference parameters that specify values of one or more surgical parameters, wherein the surgical parameters include one or more positioning parameters for a glenoid implant to be attached to a glenoid fossa of a patient during a surgery”, “determining, by the computing system, based on one or more anatomic parameters of the patient and the surgeon preference parameters, one or more suggested surgical options, each of the surgical options corresponding to a different combination of the positioning parameters for the glenoid implant and types of the glenoid implant”, “outputting, by the computing system, the one or more suggested surgical options” which are of accessing data/parameters related to the geometrical position for the glenoid implant to be attached to the patient glenoid fossa/implantation, and determining the optimum glenoid implant for fitting it the anatomical characteristic of the patient implantation region, and providing the surgical path to take for the implantation. These limitations, as drafted, are steps of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components as recited “by a computing system” in a generic description and with the limitations which are nothing more than the mental knowledge of a practitioner to identify and compare geometrical data of implants and of the implantation region to determine the type of implant and surgical protocol to be performed as for generically planning a surgical implantation.
That is, other than reciting “computer system” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computer system” language, the claim encompasses a user simply taking implant geometrical parameters to fit different implants within the implantation region with known characteristics and deciding patient optimal surgical implantation protocol. The mere nominal recitation of a generic computer system appliance with a generic machine learning algorithm does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not recite additional elements beside the “computer system” which is recited at a high level of generality (i.e., as a general means of storing data), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The computer system that performs the above recited steps is also recited at a high level of generality, and merely automates the different steps. Therefore, the additional limitations are no more than mere instructions to apply the exception using a generic computer component (the computer system with machine learning algorithm).
The combination of the additional elements is no more than mere instructions to apply the exception using a generic computer component (the computer system). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the initial value accessing step and analyzing/identifying/determining steps were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processing circuitry and storage is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the collecting and analyzing/identifying/determining steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus claim 1 is ineligible.
Regarding claims 2-9, claims 2-9 are directed to try defining “trial vector” or a list of essential values for essential parameters defining the implant characteristics and its presentation to the implantation site in order to define a surgical option and estimate the associated cost using different cost estimation approaches, which are considered as common processes for planning the surgical procedure and its associated medical bill in generic approaches. The determination of the cost appears as an mental assessment of the cost based on the “input value” representing the “trial vector” without any definite description or definition of the “trial vectors” as corresponding to the “parameters” not fully described within the disclosure. Therefore, the limitations are part of the mental activity associated to the generic surgical planning and therefore does not change the eligibility status of the claims. Claims 2-9 are rejected under 35 U.S.C. 101.
Regarding independent claim 10, claim 10 is directed to a computing system with a memory and a processor to execute the method of claim 1. Since the processor and memory are recited as generic elements and as discussed above the same conclusion applies directly mutatis mutandis to the subject matter of claim 10 therefore places the claim 10 in the same eligibility status than the claim 1. Claim 10 is rejected under 35 U.S.C. 101.
Regarding claims 11-18, claims 11-18 are considered as directed to try defining “trial vector” or a list of essential values for essential parameters defining the implant characteristics and its presentation to the implantation site in order to define a surgical option and estimate the associated cost using different cost estimation approaches, which are considered as common processes for planning the surgical procedure and its associated medical bill in generic approaches. The determination of the cost appears as an mental assessment of the cost based on the “input value” representing the “trial vector” without any definite description or definition of the “trial vectors” as corresponding to the “parameters” not fully described within the disclosure. Therefore, the limitations are part of the mental activity associated to the generic surgical planning and therefore does not change the eligibility status of the claims. Claims 11-18 are rejected under 35 U.S.C. 101.
Regarding independent claim 20, claim 20 is directed to a non-transitory computer-readable storage medium having instructions stored thereon to execute the method of claim 1. Since the processor and memory are recited as generic elements and as discussed above the same conclusion applies directly mutatis mutandis to the subject matter of claim 20 therefore places the claim 20 in the same eligibility status than the claim 1. Claim 20 is rejected under 35 U.S.C. 101.
Regarding claim 21, claim 21 are directed to defining “trial vector” or a list of essential values for essential parameters defining the implant characteristics and its presentation to the implantation site in order to define a surgical protocol and estimate the associated cost using different cost estimation approaches, which are considered as common processes for planning the surgical procedure and its associated medical bill in generic approaches. Therefore, the limitations are part of the mental activity associated to the generic surgical planning and therefore does not change the eligibility status of the claim. Claim 21 is rejected under 35 U.S.C. 101.
Examiner’s Comment on Prior Art
In view of the lack of written description based on the disclosure of the instant application at the time of filing as well as the indefiniteness of the instant claims as set forth above in the 35 U.S.C. 112(a) and (b) rejections, the scope of the claims is additionally unclear. There is tension between the breadth of the claims and lack of corresponding breadth of the specification, making determining the scope of the claim problematic. Reading the language of claims 2, 11 and 21 with the determination of the “cost value” in isolation suggests a broad scope with the value of the medical procedure being directed to how the procedure is performed while reading the language in light of the corresponding portions of the specification does not suggest any limitations since not definite description is provided. The scope of the claims cannot be reasonably understood without resorting to a high amount of speculation directed to assessing a money cost to each kind of parameters as relevant to mental activity and business directives without any descriptive basis. No prior art rejections were provided for claims 2, 11 and 21.
Since the claims 3-9, 12-18 are also dependent from claims 2 and 11, no prior art rejections were provided for these claims 3-9 and 12-18 due to their dependency from claims 2 and 11.
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.
Claims 1, 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McGuan et al. (For. WO 2020163358 A1; Pub.Date 08/13/2020; Fil.Date 02/04/2020) in view of
Regarding independent claim 1, McGuan teaches a method (a method for arthroplasty replacement procedure for knee and applicable to shoulder (Title, abstract and [0002])) comprising:
obtaining, by a computing system (Title computer-assisted arthroplasty system), one or more surgeon preference parameters that specify values of one or more surgical parameters, wherein the surgical parameters include one or more positioning parameters for a glenoid implant to be attached to a glenoid fossa of a patient during a surgery ([0005] providing a set of proposed implant positions and implant type wherein one of ordinary skill in the art would recognize as obvious to apply the same method as described by McGuan in different embodiments for [0155] the implant as directed to parameters regarding the glenoid version and inclination or reverse condition for fitting the glenoid implant to the glenoid fossa);
determining, by the computing system, based on one or more anatomic parameters of the patient and the surgeon preference parameters, one or more suggested surgical options, each of the surgical options corresponding to a different combination of the positioning parameters for the glenoid implant and types of the glenoid implant ([0007] performing pre-operative simulations to optimized the implantation and implant performance ([0108]-[0109], [0144]) as applied to the shoulder ([0155]-[0157]); and
outputting, by the computing system, the one or more suggested surgical options ([0144] notification of results for optimization provided by the system display).
Regarding independent claim 10, McGuan teaches a computing system (a system for method for arthroplasty replacement procedure for knee and applicable to shoulder (Title, abstract and [0002])) comprising:
a memory configured to store one or more surgeon preference parameters that specify values of one or more surgical parameters ([0289] host memory), wherein the surgical parameters include one or more positioning parameters for a glenoid implant to be attached to a glenoid fossa of a patient during a surgery ([0005] providing a set of proposed implant positions and implant type wherein one of ordinary skill in the art would recognize as obvious to apply the same method as described by McGuan in different embodiments for [0155] the implant as directed to parameters regarding the glenoid version and inclination or reverse condition for fitting the glenoid implant to the glenoid fossa);
one or more processors implemented in circuitry, the one or more processors configured to ([0289] parallel processing platform): determine, by the computing system, based on one or more anatomic parameters of the patient and the surgeon preference parameters, one or more suggested surgical options, each of the surgical options corresponding to a different combination of the positioning parameters for the glenoid implant and types of the glenoid implant ([0007] performing pre-operative simulations to optimized the implantation and implant performance ([0108]-[0109], [0144]) as applied to the shoulder ([0155]-[0157]); and
output, for display, the one or more suggested surgical options ([0144] notification of results for optimization provided by the system display).
Regarding independent claim 20, McGuan teaches a computing system and processors ([0289]) with a non-transitory computer-readable storage medium having instructions stored thereon that when executed cause one or more processors of a computing system to (a system for method for arthroplasty replacement procedure for knee and applicable to shoulder (Title, abstract and [0002]) with a ([0289]) host memory),):
obtain one or more surgeon preference parameters that specify values of one or more surgical parameters, wherein the surgical parameters include one or more positioning parameters for a glenoid implant to be attached to a glenoid fossa of a patient during a surgery (Title computer-assisted arthroplasty system, [0005] providing a set of proposed implant positions and implant type wherein one of ordinary skill in the art would recognize as obvious to apply the same method as described by McGuan in different embodiments for [0155] the implant as directed to parameters regarding the glenoid version and inclination or reverse condition for fitting the glenoid implant to the glenoid fossa);
determine, based on one or more anatomic parameters of the patient and the surgeon preference parameters, one or more suggested surgical options, each of the surgical options corresponding to a different combination of the positioning parameters for the glenoid implant and types of the glenoid implant ([0007] performing pre-operative simulations to optimized the implantation and implant performance ([0108]-[0109], [0144]) as applied to the shoulder ([0155]-[0157]); and
output the one or more suggested surgical options ([0144] notification of results for optimization provided by the system display).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK M MEHL/ Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798