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 .
The present Office Action is in response to the Request for Continued Examination dated 11 June 2026.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 June 2026 has been entered.
DETAILED ACTION
In the RCE filed 11 June 2026:
Claims 1-3,21-22 are amended
Claims 1-3,21-22 are pending
Subject Matter Free of Prior Art
Claim(s) 1-3,21-22 recite subject matter that is free of prior art. In particular, the cited prior art of record fails to teach or suggest the combination of:
Claim 1, 21-22 describe(s) a graphical user interface for interacting with the surgical planning system for use in correcting a spinal deformity of the patient, the graphical user interface configured to simultaneously display a 3D model of the deformed spine of the patient in one portion, a quantitative listing of the spinal alignment parameters in a second portion, and a coronal image and a sagittal image on a third portion along with a display of a selection of the spinal alignment parameters on the displayed coronal and sagittal images, wherein the indication of the spine alignment parameters associated with the anatomical feature is transmitted to a robotic assisted surgery system, wherein the surgical planning system is configured to provide instructions to guide movement of a surgical robot.
Claims 2-13 are dependent on Claim 1 and are therefore also subject matter free of prior art.
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 1-3,21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 21, 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a system, which are within a statutory category.
Step 2A1
The limitations of:
Claims 1, 21, 22 (Claim 21 being representative)
provide a surgical plan to assist a user during surgery;
determine the pose of the spine of the defined- patient relative to a pose by an operator;
obtain the spinal surgery plan and determine a target pose of the surgical instrument based on the spinal surgery plan indicating where a surgical procedure is to be performed on the spine of the defined-patient and based on the pose of the spine of the defined-patient, and generate steering information based on comparison of the target pose of the surgical instrument and the pose of the surgical instrument;
obtain postoperative feedback data provided regarding surgical outcomes for a plurality of patients;
and obtain preoperative data characterizing a defined-patient, generate a spinal surgery plan for the defined-patient based on processing the preoperative data;
obtain images of the anatomical feature of the deformed spine of a patient;
receiving the image of the anatomical feature;
automatically detecting a landmark associated with the anatomical feature of the deformed spine within the image;
determining spine alignment parameters associated with the anatomical feature based on the landmark;
interacting to for use in correcting a spinal deformity of the patient, simultaneously display a 3D model of the deformed spine of the patient in one portion, a quantitative listing of the spinal alignment parameters in a second portion, and a coronal image and a sagittal image on a third portion along with a display of a selection of the spinal alignment parameters on the displayed coronal and sagittal images,
wherein the indication of the spine alignment parameters associated with the anatomical feature is transmitted,
provides is configured to provide instructions to guide movement,
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “providing, determining, obtaining, receiving, detecting, interacting,” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The Examiner notes that the training of a machine learning model is recited in the claim. The type of training utilized by the claimed invention is not described by the Applicant. As such the Examiner is required to analyze the training step given the broadest reasonable interpretation. The step(s) performed to train step(s) of the model/algorithm is/are considered to be part of the abstract idea because it/they fall(s) under data manipulations that humans perform (i.e., fitting a model to data) and thus are interpreted to be part of the abstraction--the rules or instructions that fall under Certain Methods of Organizing Human Activity. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 12 (Fed. Cir. April 18, 2025) (finding that “[i]terative training using selected training material…are incident to the very nature of machine learning.”). As such, the training of the machine learning model represents a mathematical concept that is interpreted to be part of the identified abstract idea, supra. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a surgical system, surgical navigation system, camera tracking system, imaging system, distributed networked computers, processing circuitry, memory and robotic assisted surgery system that implement the identified abstract idea. The surgical system, surgical navigation system, camera tracking system, imaging system, distributed networked computers, processing circuitry, memory and robotic assisted surgery system are not described by the applicant and is recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional element of using a trained machine learning model to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). Alternatively, or in addition, the implementation of the trained machine learning model to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine merely confines the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use and thus fails to add an inventive concept to the claims.
The claims further recite the additional elements of distributed network computers, robotic assisted surgery system, surgical robot, display device, imaging device, and surgical instrument. The distributed network computers, robotic assisted surgery system, surgical robot, display device, imaging device, and surgical instrument merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
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, the additional elements of using a surgical system, surgical navigation system, camera tracking system, imaging system, distributed networked computers, processing circuitry, memory and robotic assisted surgery system to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using the trained machine learning model to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine was found to represent mere instructions to implement the abstract idea on a generic computer and/or confine the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and determined to be insufficient to provide significantly more. MPEP 2106.05(I) indicates that mere instructions to implement the abstract idea on a generic computer and/or confining the use of the abstract idea to a particular technological environment or field of use cannot provide significantly more. See also Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 17 (Fed. Cir. April 18, 2025) (finding that applying machine learning to an abstract idea does not transform a claim into something significantly more).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of distributed network computers, robotic assisted surgery system, surgical robot, display device, imaging device, and surgical instrument were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claim is not patent eligible.
Claims 2-13 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2-3 merely describe(s) method of detecting landmarks, which further defines the abstract idea.
Claim(s) 4 merely describe(s) what the landmarks include, which further defines the abstract idea.
Claim(s) 5 merely describe(s) the use of a 3-d imaging modality and processing of imaging modality data, which further defines the abstract idea.
Claim(s) 6 merely describe(s) the imaging modalities that can be used, which further defines the abstract idea.
Claim(s) 7 merely describe(s) what is being displayed in the indication output, which further defines the abstract idea.
Claim(s) 8 merely describe(s) the parameters obtained from the spine, which further defines the abstract idea.
Claim(s) 9 merely describe(s) what outputting an indication includes, which further defines the abstract idea.
Claim(s) 10-11 merely describe(s) what the images include, which further defines the abstract idea.
Claim(s) 12 merely describe(s) processing the landmarks and anatomical features of the images, which further defines the abstract idea.
Claim(s) 13 merely describe(s) the perspectives of the models and images, which further defines the abstract idea.
Response to Arguments
Claim Objections
Regarding the objection(s) to Claims 22, the Applicant has amended the claims to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-3,21-22, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
The Examiner believes that the claims are directed to an abstract idea without any practical applications. Applicant respectfully submits that the system does have a practical application, which is to allow a physician to plan a corrective surgery for a deformed spine. This is a highly complex operation requiring precision and landmark extraction that can only be performed with the assistance of a computerized planning system. For example, a natural person cannot see through a patient to figure out how to attach screws and rods to a deformed spine, let along determine where the landmarks are. Thus, applicant submits that the claimed invention does have a practical application of allowing the physician to plan a corrective surgery to a deformed spine.
Regarding (a), the Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions for a person or persons, with or without the aid of a computer, to follow to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine. The Examiner notes that Applicant’s Background describes measuring and obtaining spinal alignment measurements (see Spec. Para. 0022) as a human task. Furthermore, the Examiner submits that healthcare itself is inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions for a person or persons to follow to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine, the claimed invention is directed to an abstract idea.
Regarding Applicant’s assertion that a practical application is present, the Examiner submits that none of the tests for a practical application are met by Applicant’s claim. The tests to determine whether a practical application (an improvement) is present are described in MPEP 2106.05(d):
Whether an improvement to the computer is present.
Whether a technological solution to a technological problem, i.e., a problem caused by the technological environment to which the claim is confined, is present.
Whether a particular treatment/prophylaxis is present.
Whether a particular machine is claimed.
Whether a transformation is present.
Whether the claims do more than generally linking the abstraction to a particular technological environment.
Applying the most applicable of these tests to the independent claims, the is no indication that the computer is physically improved, there is no technological problem described, there is no other technology that is improved, and there is no particular treatment claimed. The additional elements present in the dependent claims also do not provide a practical application as described in the basis of rejection. Because none of the tests for a practical application are satisfied, an improvement to technology (and thus a “solution to a problem”) is not present and the claims are ineligible.
To make this feature clearer, applicant has amended claim 1 (claims 21 and 22 also) to recite "A surgical system configured to automatically determine a spine alignment parameter associated with an anatomical feature of a deformed spine" and "a graphical user interface for interacting with the surgical planning system to for use in correcting a spinal deformity of the patient, the graphical user interface configured to ..." Thus, applicant requests the Examiner to remove the Section 101 rejection.
Regarding (b), the Examiner respectfully disagrees. The limitations merely equate to data analysis and output, which is the abstraction. Furthermore, the Specification does not describe any technological problem associated with the technological environment to which the abstraction is confined (a general-purpose computer). If a technical problem cannot be found, a practical application cannot be found based on this test.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1-3,21-22, the Examiner has considered the Applicant’s arguments in view of the present amendments and finds the arguments persuasive. The prior art of record does not reasonably teach the claimed invention. Therefore, Examiner withdraws the rejection.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
KANG et al (Foreign Publication KR-101124144-B1) discloses a system for measuring spinal deformity.
Herrmann et al (US Publication No. 20200107883) discloses a system for high precision measurement of the spine.
School et al (US Publication No. 20160242857) discloses systems and methods related to the planning, performing, and assessing of surgical correction to the spine during a spinal surgical procedure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272 - 6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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