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 .
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to claims 34-54 in the reply filed on June 12, 2026 is acknowledged.
Applicant has added new claims 55-67. Examiner contends that these claims are drawn to non-elected Group I, as set forth in the Requirement for Restriction/Election of March 10, 2026, specifically the “designing at least one patient-specific instrument configured to access the target tissue and perform a decompression step on the target tissue.” Group II is drawn towards “determining a surgical plan with one or more spinal corrections for the patient's pre- operative spine for achieving a target corrected spinal configuration based on the patient data.” Claims 55-67 include the tissue removal instruments and kit, as opposed to the creation of the surgical plan of claims 34-54. Claims 55-67 will be treated as withdrawn.
Allowable Subject Matter
Claims 38 and 51 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose wherein predicting and compensating for the post-operative nerve compression includes simulating the one or more spinal corrections by moving features of a three-dimensional virtual model of the patient's anatomy, identifying compression of nerve tissue caused by the movement of the features of the three-dimensional virtual model, and modifying the surgical plan to reduce the identified compression of nerve tissue.
The prior art fails to teach or disclose further comprising predicting a first pain reduction score for removing tissue associated with nerve compression according to the surgical plan, and predicting a second pain reduction score for implantation of at least one implant according to the surgical plan.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 34-37, 39-50, and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0038109 to Steinberg in view of U.S. Patent Pub. No. 2021/0068863 to Choi et al.
As to Claim 34, Steinberg discloses a computer-implemented method [0018, 0052, 0056]. The method comprises receiving patient data for a patient [0058], the patient data including one or more images of anatomy of the patient [0059-0060], determining a surgical plan with one or more spinal corrections for the patient's pre-operative spine for achieving a target corrected spinal configuration based on the patient data [0077], and predicting and compensating for post-operative outcomes associated with the one or more spinal corrections [0081]. Nerve compression is discussed in [0005].
As to Claim 35, Steinberg discloses a computer-implemented method wherein predicting and compensating for the post-operative nerve compression includes: comparing a pre-operative configuration of the patient's vertebrae to a post- operative target configuration of the vertebrae (described in [0066]).
As to Claim 37, Steinberg discloses a computer-implemented method further comprising generating a personalized surgical plan for implanting one or more patient-specific interbody devices for achieving the target corrected spinal configuration for a segment of patient's spine [0077].
As to Claim 43, Steinberg discloses a computer-implemented method further comprising predicting and compensating for one or more additional post-operative adverse effects by at least one of modifying the surgical plan or generating additional surgical steps [0069, 0072, 0074].
As to Claim 45, Steinberg discloses a computer-implemented method further comprising collecting post-operative pain data for training a machine-learning model that was used to predict the post-operative outcome [0054, 0071-0072].
As to Claim 47, Steinberg discloses a computer-implemented method further comprising determining a level-by-level nerve score for the surgical plan for display to a user [0070, 0072].
As to Claim 50, Steinberg discloses a computer-implemented method further comprising predicting a pain reduction score for the procedure [0070, 0072].
As to Claims 34-, Steinberg discloses the claimed invention except for predicting and compensating for post-operative nerve compression associated with the one or more spinal corrections, predicting post-operative nerve compression that is caused by the one or more spinal corrections and exceeds a threshold level based on the comparison, and generating a decompression plan to compensate for the predicted post-operative nerve compression, designing at least one patient-specific instrument configured to perform one or more decompression steps based on the predicted nerve compression, virtually simulating nerve compression caused by the one or more spinal corrections further comprising designing a set of patient-specific decompression instruments based on the surgical plan or pre-operative spinal configuration of the patient, wherein the surgical kit includes one or more instruments and one or more implants, wherein the one or more instruments are designed based on the one or more implants, and the one or more implants are designed based on the one or more instruments, determining, based on the predicted intra-operative and/or the post-operative nerve compression, whether to modify the surgical plan, recommend a decompression procedure, or both, further comprising in response to receiving user approval of a decompression procedure of the surgical plan, designing one or more patient-specific decompression instruments, identifying pre-operative nerve compression causing pain and/or discomfort based on pain data of the patient, and predicting that the nerve compression will remain post-operatively when the one or more spinal corrections do not cause significant reduction of the nerve compression, further comprising generating a decompression plan for substantially eliminated targeted nerve compression, identifying targeted tissue that can be removed from the patient to achieve the elimination of the targeted nerve compression, and sending instructions to manufacture the kit and validating that the manufactured kit is complete.
Choi discloses a computer-implemented surgical method [0030, 0088] including predicting and compensating for post-operative nerve compression associated with the one or more spinal corrections [0090]. The method includes predicting post-operative nerve compression that is caused by the one or more spinal corrections and exceeds a threshold level based on the comparison (data obtained in [0090]) and generating a decompression plan to compensate for the predicted post-operative nerve compression [0090, 0092-0093]. The method includes designing at least one patient-specific instrument (1200) configured to perform one or more decompression steps based on the predicted nerve compression [0100-0101, 0103-0104]. The method includes virtually simulating nerve compression caused by the one or more spinal corrections [0090]. The method includes designing a set of patient-specific decompression instruments (1200) based on the surgical plan or pre-operative spinal configuration of the patient [0101-0104], wherein the surgical kit includes one or more instruments and one or more implants [0101-0104] wherein the one or more instruments are designed based on the one or more implants [0101-0104], and the one or more implants are designed based on the one or more instruments [0101-0104]. The method includes determining, based on the predicted intra-operative and/or the post-operative nerve compression, whether to modify the surgical plan, recommend a decompression procedure, or both [0089-0090, 0092]. The method includes, in response to receiving user approval of a decompression procedure of the surgical plan, designing one or more patient-specific decompression instruments (physician input [0090], [0104]). The method includes identifying pre-operative nerve compression causing pain and/or discomfort based on pain data of the patient [0088] and predicting that the nerve compression will remain post-operatively when the one or more spinal corrections do not cause significant reduction of the nerve compression [0090]. The method includes generating a decompression plan for substantially eliminated targeted nerve compression [0090, 0092-0093]. The method includes identifying targeted tissue that can be removed from the patient to achieve the elimination of the targeted nerve compression [0084]. The method includes sending instructions to manufacture the kit and validating that the manufactured kit is complete [0104] in order to allow for a surgical plan to be formulated with optimal post-operative outcomes for the patient [0030, 0090].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the computer-implemented method of Steinberg with the nerve compression modification of Choi in order to allow for a surgical plan to be formulated with optimal post-operative outcomes for the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
Prosecution Insights