DETAILED ACTION
This action is in response to the submission filed on 5/14/2026. Claims 1-7, 9, 11-18, 20 are presented for examination.
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 .
Response to Arguments- 35 USC § 101
Applicant's arguments filed 5/14/2023 have been fully considered but they are not persuasive.
The claims have been amended to “control a surgical robot to navigate along the planned path to access the intervertebral disc space of the space of the subject and remove the planned minimal amount of vertebral bone”. However the amended limitation is merely further intended effect of the robot navigation and is mere result-oriented “apply it” language. See MPEP 2106.05(f)(1) – the claim recites the idea of a solution or outcome without reciting any detail on how it is accomplished. The claim itself makes no attempt to explain what robot navigation is performed or how. It is entirely result-oriented and coverts "any attempt to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result”. The rejection is updated to reflect the claim 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 1-7, 9, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. To determine if a claim is directed to patent ineligible subject matter, the Court has guided the Office to apply the Alice/Mayo test, which requires:
1. Determining if the claim falls within a statutory category;
2A. Determining if the claim is directed to a patent ineligible judicial exception consisting of a law of
nature, a natural phenomenon, or abstract idea; and
2B. If the claim is directed to a judicial exception, determining if the claim recites limitations or elements
that amount to significantly more than the judicial exception.(See MPEP 2106).
Step 1: With respect to claims 1-7, 9, and 11, applying step 1, the preamble of independent claim 1 claims a system. As such these claims fall within the statutory categories of machine.
Step 2A, prong one: In order to apply step 2A, a recitation of claim 1 is copied below. The limitations of the claim that describe an abstract idea are bolded.
A system of planning and performing surgical access to an 1. intervertebral disc space of a subject for robotic insertion of prosthetic hardware to create a bone-hardware assembly, the system comprising:
at least one processor executing instructions stored on at least one non-transitory storage medium, to cause the at least one processor to:
analyze collected clinical data on the subject to detect conditions that may affect either spine strength or an expected useful lifetime of the bone-hardware assembly (mental process – observation, evaluation, judgement, opinion);
use a path-finding algorithm to plan a path for the surgical access using a virtual representation of the prosthetic hardware superimposed on a three-dimensional preoperative image set of a region of the intervertebral disc space of the subject (mental process – observation, evaluation, judgement, opinion);
use any of the detected conditions and the planned path to plan a minimal amount of vertebral bone to be removed to allow (a) removal of an intervertebral disc and (b) the robotic insertion of the prosthetic hardware along the planned path, such that an increase is achieved in at least one of a likelihood of a favorable clinical outcome or the expected useful lifetime of the bone-hardware assembly wherein planning the minimal amount of vertebral bone to be removed takes into account protection of vertebral end plates and avoidance of structures susceptible to damage (mental process – observation, evaluation, judgement, opinion); and
control a surgical robot to navigate along the planned path to access the intervertebral disc space of the space of the subject and remove the planned minimal amount of vertebral bone.
The limitations as analyzed include concepts directed to the "mental process" groupings of abstract ideas performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III). The claim involves analyzing, planning and determining. The steps are simple enough/broadly claimed that they could be performed mentally or with pen and paper. Thus, limitations noted above also fall into the "mental process" groupings of abstract ideas.
Step 2A, prong two: Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present generic computing components and result oriented “apply it” language. In particular, the claim recites the additional limitations: “A system of planning and performing surgical access to an intervertebral disc space of a subject for robotic insertion of prosthetic hardware to create a bone-hardware assembly” (generic computing components merely carrying out the abstract idea - see MPEP § 2106.05(f) and (b)), “at least one processor executing instructions stored on at least one non-transitory storage medium, to cause the at least one processor to” (generic computing components merely carrying out the abstract idea - see MPEP § 2106.05(f) and (b)), “use a path-finding algorithm to plan a path” (generic computing components merely carrying out the abstract idea - see MPEP § 2106.05(f) and (b)), “control a surgical robot to navigate along the planned path to access the intervertebral disc space of the space of the subject and remove the planned minimal amount of vertebral bone” (result oriented “apply it” language – MPE 2106.05(f)(1)).
When viewed in combination or as a whole, the recited additional elements do no more than automate the mental process using the computer components as a tooI. Accordingly, 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.
Step 2B: Moving on to step 2B of the analysis, the Examiner must consider whether each claim limitation individually or as an ordered combination amounts to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as "apply it" or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations is considered directed towards generic computer components carrying out the abstract idea and result oriented “apply it” language. See MPEP 2106.04(d) referencing MPEP 2106.05(h).
For the foregoing reasons, claim 1 is directed to an abstract idea without significantly more, and is rejected as not patent eligible under 35 U.S.C. 101.
Claims 2-7, 9, 11 are directed to the "mental process" groupings of abstract ideas performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III). The claim involves analyzing, planning and determining. The steps are simple enough/broadly claimed that they could be performed mentally or with pen and paper. Thus, limitations noted above also fall into the "mental process" groupings of abstract ideas. This judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present generic computing components. The recited additional elements do no more than automate the mental process using the computer components as a tooI. Accordingly, 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 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations is considered directed towards generic computer components carrying out the abstract idea.
Allowable Subject Matter
Claims 1-7, 9, 11-18, and 20 contain allowable subject matter.
Lang, Kostrzewski, Anderson, Steines and Brooks teach methods for optimizing surgical outcomes. However, these references and the remaining prior art of record, alone or in combination, fails to disclose or suggest
(claim 1)
“wherein planning the minimal amount of vertebral bone to be removed takes into account protection of the vertebral end plates and avoidance of structures susceptible to damage”,
(claims 12, 16)
“wherein at least one of the artificial intelligence algorithms is trained using training data on outcomes of previous surgical procedures using the available artificial disc prostheses”,
in combination with the remaining elements and features of the claimed invention. It is for these reasons that the applicant’s invention defines over the prior art of record.
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 NITHYA J. MOLL whose telephone number is (571)270-1003. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/NITHYA J. MOLL/Primary Examiner, Art Unit 2189
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