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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casey US 2020/0170802.
Regarding Claim 1, Casey discloses an implant system comprising:
an intervertebral implant (“cage” paragraph 7, 21) configured for implantation in a patient, the intervertebral implant including a superior patient-specific surface, an inferior patient-specific surface (“cage” paragraph 7 would inherently have superior and inferior surfaces, paragraph 7, 21 where the whole implant including the superior and inferior surfaces are patient specific, where the size and/or shape of the surfaces are patient specific and does not utilize standard sizes and shapes where the top and bottom surfaces of the implant are “designed for optimal fit in the negative space created by removal of anatomy”), and a main body configured to receive material configured to promote spinal fusion (paragraph 7 is able to hold material in the “cage” in order to promote bone growth);
a first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy (end of paragraph 49, as seen in Fig 6-8, paragraph 64) associated with a first surgical procedure and including a first set of predicted post-operative spinal metrics (paragraph 48-49 where the metrics are based on patient data and/or surgeon input data, see also Fig 6-8, paragraph 64); and
a second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy (paragraph 50-51, “this process can be repeated until the design and/or treatment protocol are approved” where one is able to revise and/or reject the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy to provide a second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy, end of paragraph 49, as seen in Fig 6-8, paragraph 64) associated with a second surgical procedure and including a second set of predicted post-operative spinal metrics (paragraph 48-49 where the metrics are based on patient data and/or surgeon input data, see also Fig 6-8, paragraph 64 similar to that of the first procedure),
wherein the intervertebral implant is configured to be implanted in conjunction with either the first surgical procedure or the second surgical procedure, and wherein the intervertebral implant is designed based at least in part on the corresponding predicted post-operative three-dimensional representation and/or virtual model (paragraph 51 where the implant manufactured and implanted based on the approved second surgical procedure).
Regarding Claim 2, Casey discloses wherein the superior patient-specific surface of the intervertebral implant matches a first vertebral surface of the corresponding post-operative three-dimensional representation and/or virtual model, and the inferior patient-specific surface of the intervertebral implant matches a second vertebral surface of the corresponding post-operative three-dimensional representation and/or virtual model (paragraph 7, 21 where the superior and inferior surfaces of the “cage” are patient specific, for example the size and/or shape of the surfaces are patient specific and does not utilize standard sizes and shapes where the top and bottom surfaces of the implant are “designed for optimal fit in the negative space created by removal of anatomy”).
Regarding Claim 3, Casey discloses further comprising one or more implants configured to be implanted in conjunction with the intervertebral implant, wherein the one or more implants are designed based at least in part on the corresponding post-operative three-dimensional representation and/or virtual model (paragraph 48 where there can be at least one additional implant designed using the steps as the implant in claim 1).
Regarding Claim 4, Casey discloses the first predicted post-operative three-dimensional representation or virtual model is linked to an interactive surgical planner configured to receive at least one physician post-operative metric (paragraph 49 “The surgical team can review, revise, and approve, via healthcare portal, or the treatment protocol”), wherein the first predicted post-operative three-dimensional representation or virtual model is configured to be modified to meet the at least one physician post-operative metric and to be measured for obtaining a modified first set of predicted post-operative spinal metrics based on the modified post-operative three-dimensional representation or virtual model (paragraph 49 “The surgical team can review, revise, and approve, via healthcare portal, or the treatment protocol” where the first predicted post-operative three-dimensional representation or virtual model is able to be modified based on one reviewing and revising the procedure which is then able to be measured, see also paragraph 80).
Regarding Claim 5, Casey discloses the first predicted post-operative three-dimensional representation or virtual model is linked to an account for the patient (as seen in Fig 4, paragraph 57) and configured for post-operative metric measuring (paragraph 21, 80 measurements are provided in order to construct a custom implant ), wherein the account includes simulated post-operative metrics for at least the first surgical procedure and the second surgical procedure (end of paragraph 50, paragraph 51 the account can include predicted information).
Regarding Claim 6, Casey discloses an account (as seen in Fig 4, paragraph 57) for the patient is linked to a surgical procedure being performed on the patient to enable real-time intra-operative viewing of simulated post-operative metrics for the surgical procedure (paragraph 30, 31, 34, 57 users, such as the physicians are able to view the patients account and once accessed, able to view in real time data of the patient including simulated metrics as discussed in claim 1 above ).
Regarding Claim 7, Casey discloses the first predicted post-operative three-dimensional representation and/or virtual model and the second predicted post-operative three-dimensional representation and/or virtual model include repositionable spinal anatomical elements (paragraph 21 “adjustment of the relative positions of bony anatomy” and “Modifying the spatial relationship between adjacent vertebrae..” .
Regarding Claim 8, Casey discloses the first predicted post-operative three-dimensional representation and/or virtual model includes first model data for measuring the first set of predicted post-operative spinal metrics in a first predicted post-operative configuration associated with performance of the first surgical procedure (end of paragraph 49 “post-treatment images illustrating the predicted post-treatment position of anatomical features”), and the second predicted post-operative three-dimensional representation and/or virtual model includes second model data for measuring the second set of predicted post-operative spinal metrics in a second predicted post-operative configuration associated with performance of the second surgical procedure (paragraph 50-51, one is able to revise and/or reject the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy to provide a second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy, end of paragraph 49 “post-treatment images illustrating the predicted post-treatment position of anatomical features”).
Regarding Claim 9, Casey discloses the first model data and/or the second model data include surface rendering data, measured patient metrics, and/or image data from images of the patient (paragraph 35 image data from the patient is used).
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 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Casey US 2020/0170802.
Casey discloses the claimed invention as discussed above in claim 1 with an interactive surgical plan containing the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the first set of predicted post-operative spinal metrics; and the second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the second set of predicted post-operative spinal metrics (paragraph 49 “The surgical team can review, revise, and approve, via healthcare portal, or the treatment protocol” and “The post-treatment images can be included in the treatment protocol or can be included in a post-treatment report”) but does not disclose the interactive surgical plan is configured to concurrently display the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the first set of predicted post-operative spinal metrics; and the second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the second set of predicted post-operative spinal metrics.
However, Casey discloses that the system is able to save and interact with the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the first set of predicted post-operative spinal metrics; and the second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the second set of predicted post-operative spinal metrics (end of paragraph 49 where the first and second representations/models can be reviewed and revised) and that system includes a display (#330, paragraph 98) to display text, models, virtual procedures, surgical plans, implants, and graphics (paragraph 98) and where the surgeon analyzes the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the first set of predicted post-operative spinal metrics; and the second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the second set of predicted post-operative spinal metrics until the plan is approved (paragraph 49-51).
As such, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system such that the display is able to concurrently display the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the first set of predicted post-operative spinal metrics; and the second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the second set of predicted post-operative spinal metrics in order to aid the surgeon in analyzing the date before final approval (for example comparing the first representation/model against the second representation/model). Examiner notes that it is common in the art to have software that utilizes “windows” or “tabs” where each window/tab can be viewed individually or side-by-side where each window/tab can display the first predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the first set of predicted post-operative spinal metrics; and the second predicted post-operative three-dimensional representation and/or virtual model of patient anatomy and the second set of predicted post-operative spinal metrics.
Regarding Claim 11, Casey discloses an interactive surgical plan configured to receive user input (paragraph 49-51 where the plan is interactive allowing for user input to revise the surgical plans) and to display dynamic comparisons of the first surgical procedure and the second surgical procedure based on user input (as discussed above in claim 10, paragraph 49-51, the surgical plans are able to be viewed concurrently or individually as well as revised and updated accordingly).
Regarding Claim 12, Casey discloses an interactive surgical planner visually comparing multiple surgical plans with predicted outcome data (as discussed above in claim 10, paragraph 49-51 where at least the first and second procedures are able to be visually compared on a display).
Conclusion
See PTO-892 for art of cited interest, in particular other references that deal with custom implants and surgical planning. Examiner also notes applicant cited reference Casey US 2021/0059822 which also discusses custom implants and surgical planning.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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