DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted November 12, 2025. Claims 1, 15, and 25 are amended. Claims 2 – 4, 6, 10, 12, 14, 18, and 20 were previously cancelled. Claims 1, 5, 7 – 9, 11, 13, 15 – 17, 19, and 21 – 29 are pending.
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 .
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, 7 – 9, 11, 13, 15 – 17, 19, and 21 – 29 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.
Step One
Claims 1, 5, 7 – 9, 11, 13, 15 – 17, 19, and 21 – 29 are drawn to a system and method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1 and 15 recite receiving an input related to a position of an implant model relative to a bone model within a surgical planning environment; and preoperatively calculate a deviation between a planned postoperative implant center of rotation of the implant model and a preoperative native anatomy center of rotation of the bone model; wherein the deviation is calculated preoperatively without using any physical implant or interoperative image, wherein the preoperative native anatomy center of rotation is the native center of rotation about which a joint mechanics of a joint associated with the bone model will revolve, wherein the preoperative native anatomy center of rotation is derived from an original, non- deteriorated anatomy of a patient associated with the bone model, wherein the planned postoperative implant center of rotation is a value associated with an implant associated with the implant model.
Independent claim 25 recites providing a preoperative planning input, wherein the preoperative planning input includes a position of an implant model relative to a bone model of a subject patient; receiving an identification of a planned postoperative implant center of rotation of an implant of the implant model relative to the bone model; receiving a delta distance between the planned postoperative implant center of rotation and a preoperative native anatomy center of rotation of a bone of the bone model, wherein the delta distance is calculated preoperatively; adjusting the position of the implant model relative to the bone model until a desired delta distance between the planned postoperative implant center of rotation and the preoperative native anatomy center of rotation is achieved; and performing a surgical procedure on the subject patient according to the surgical plan.
The respective dependent claims 5, 7 – 9, 11, 13, 16 – 17, 19, 21 – 24, 26 – 29, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the disclosure “relates to improved surgical planning systems and methods” (paragraph 4 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “surgical planning system”, “memory device configured to store computer executable instructions”, “a processor operably coupled to the memory device and configured to execute the computer executable instructions”, “virtual”
Claims 5, 19: “surgical planning system”, “virtual”
Claims 7, 16, 21, 28, 29: “surgical planning system”
Claim 8: “surgical planning system”, “processor”, “user interface”
Claims 9, 27: “surgical planning system”, “user interface”
Claim 11: “surgical planning system”, “the processor is further configured to query a database”, “the database is an anatomical makeup classification database that stores a plurality of anatomical makeup classifications”
Claim 13: “surgical planning system”, “the processor is further configured to command that a user be prompted to assess a probability of a successful surgical outcome based on the records having the similar center of rotation characteristics”
Claim 15: “surgical planning system”, “memory device configured to store computer executable instructions”, “a processor operably coupled to the memory device and configured to execute the computer executable instructions to execute a surgical planning environment that includes a display module, a spatial module, and a comparison module”, “display window of a graphical user interface”, “virtual”
Claim 17: “surgical planning system”, “display window”
Claims 22 – 24: “surgical planning system”, “processor”, “display window”
Claim 25: “surgical planning system”, “saving a surgical plan that includes the desired delta distance”
Claim 26: “virtually displayed in the graphical user interface”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0045] The system 10 may include, among other things, at least one host computer 12, one or more client computers 14, one or more imaging devices 16, a cloud-based storage system 18, and a network 20. The system 10 may include a greater or fewer number of subsystems within the scope of this disclosure.
[0047] The host computer 12 may be operable to communicate with the network 20, which itself may include one or more computing devices. The network 20 may be a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network, for example.
[0048] The host computer 12 and each client computer 14 may include one or more of a computer processor, memory, storage means, network devices and input and/or output devices and/or interfaces. The input devices may include a keyboard, mouse, etc. The output devices may include a monitor, speakers, printers, etc. The memory may, for example, include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, a hard drive, or other computer readable medium that may store data and/or other information relating to the surgical planning and implementation techniques disclosed herein. The host computer 12 and each client computer 14 may be a desktop computer, laptop computer, smart phone, tablet, virtual machine, or any other computing device. The interfaces may facilitate communication with the other systems and/or components of the network 20.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 5, 7 – 9, 11, 13, 16 – 17, 19, 21 – 24, 26 – 29 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
The rejection of Claim(s) 1, 7, 15, and 22 – 24 under 35 U.S.C. 103 as being unpatentable over de Souza et al., herein after de Souza (U.S. Publication Number 2020/0188026 A1) in view of Willowick et al., herein after Willowick (U.S. Publication Number 2024/0245375 A1) are withdrawn based upon the amendment submitted November 12, 2025.
The rejection of Claim(s) 5, 8 – 9, 11, 13, 16 – 17, 19, 21, 25 – 27, and 29 under 35 U.S.C. 103 as being unpatentable over de Souza et al., herein after de Souza (U.S. Publication Number 2020/0188026 A1) in view of Wollowick (U.S. Patent Number 12,109,120 B2) further in view of Morvan et al., herein after Morvan (U.S. Publication Number 2021/0093385 A1) are withdrawn based upon the amendment submitted November 12, 2025.
Response to Arguments
Applicant's arguments filed November 12, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections - 35 USC § 101
The Applicant argues the claimed limitations do not recite a judicial exception, and the claims are not directed to methods of organizing human activity. The Examiner disagrees. Under its broadest reasonable interpretation, the Applicant’s claims are an abstract idea that falls into the grouping of “Certain Methods of Organizing Human Activity” which covers fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Examiner respectfully submits that the MPEP 2106.04(a)(2) recites that “Certain Methods of Organizing Human Activity” include managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The present claims recite the abstract idea of surgical planning of an orthopedic procedure by assessing both an anatomical and an implant model center of rotation. The present claims recite receiving an input related to a position of an implant model relative to a bone model within a surgical planning environment; and calculate a deviation between a planned postoperative implant center of rotation of the implant model and a preoperative native anatomy center of rotation of the bone model; wherein the preoperative native anatomy center of rotation is the native center of rotation about which a joint mechanics of a joint associated with the bone model will revolve, wherein the preoperative native anatomy center of rotation is derived from an original, non- deteriorated anatomy of a patient associated with the bone model, wherein the planned postoperative implant center of rotation is a value associated with an implant associated with the implant model. The present specification recites “One or more surgeons and/or other staff users may be presented with the planning environment 28 via the client computers 14 and may simultaneously access each image 26, bone model 30, implant model 32, transfer model 34, and surgical plan 36 stored in the database(s) 38. Each user may interact with the planning environment 28 to create, view, refine, and/or modify various aspects of the surgical plan 36.” (paragraph 62) indicating personal behavior or relationships or interactions between people. In addition, “…. the system 10 may receive approval of the preoperative surgical plan from the user.” (paragraph 120) indicating organizing the surgical procedure of a patient. These features describe interactions with people, thus “Certain Methods of Organizing Human Activity”. Thus, if a claim limitation, under its broadest reasonable interpretation, covers interactions with people, but for the recitation of generic components, then it is still in the “Certain Methods of Organizing Human Activity” grouping.
The Applicant argues the claims amount to a practical application of the abstract idea, citing Berkheimer. The Examiner respectfully disagrees. The Berkheimer memo discloses “a citation to an express statement in the specification or to a statement made by applicant during prosecution that demonstrates the well-understood, routine, conventional nature of additional elements.” The Examiner submits the Applicant’s own published specification supports this conclusion and recites:
[0045] The system 10 may include, among other things, at least one host computer 12, one or more client computers 14, one or more imaging devices 16, a cloud-based storage system 18, and a network 20. The system 10 may include a greater or fewer number of subsystems within the scope of this disclosure.
[0047] The host computer 12 may be operable to communicate with the network 20, which itself may include one or more computing devices. The network 20 may be a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network, for example.
[0048] The host computer 12 and each client computer 14 may include one or more of a computer processor, memory, storage means, network devices and input and/or output devices and/or interfaces. The input devices may include a keyboard, mouse, etc. The output devices may include a monitor, speakers, printers, etc. The memory may, for example, include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, a hard drive, or other computer readable medium that may store data and/or other information relating to the surgical planning and implementation techniques disclosed herein. The host computer 12 and each client computer 14 may be a desktop computer, laptop computer, smart phone, tablet, virtual machine, or any other computing device. The interfaces may facilitate communication with the other systems and/or components of the network 20.
The Examiner submits the Berkheimer memo requires factual support on the record, which is shown in the 101 rejection above, as well as in the response to the Applicant’s 101 argument. The Applicant’s published specification supports the elements in the claims are “well-understood, routine, and conventional”. The Berkheimer memo recites “In a step 2B analysis, an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds, and expressly supports a rejection in writing with, one or more of the following: 1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element.” The Examiner has cited multiple paragraphs in the Applicant’s published specification (see above) which are directed to well-understood, routine or conventional elements.
In addition, the additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, 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) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682