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 .
Election/Restrictions
Applicant’s election without traverse of election/restriction in the reply filed on July 1, 2026 is acknowledged.
Applicant has elected Group I: Claims 1-8, drawn to a method of evaluating spinal stiffness for a spine of a patient.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 1, 2026.
Claims 1-20 are presently pending in this application.
Examiner’s Note
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Spine Journal titled “The effect of neighboring segments on the measurement of segmental stiffness in the intact lumbar spine” by Susanne J.P.M. van Engelen, MSc, Amo Bisschop, BSc (Hons), Theo H. Smit, PhD, Barend J. van Royen, MD, PhD, Jaap H. van Dieen, PhD, and in view of Murray et al. (US 2022/0160428), herein referred to as Murray.
Regarding claim 1, The Spinal Journal discloses a method of evaluating spinal stiffness for a spine of a patient (title and Abstract), the method comprising (a) providing a database model (e.g. data analysis, page 1304) based on existing patient data with normalized spine stiffness data (Abstract), (b) measuring segmental stiffness of a motion segment between two vertebrae of the spine of the patient intraoperatively (e.g. introduction, pages 1302-1303), (c) comparing the measured segmental stiffness to the database model (e.g. data analysis, page 1304) and estimating how much the vertebrae will move based on the model (e.g. statistical analysis and simulation of bending tests, pages 1304-1305).
Yet, The Spinal Journal lacks (d) performing a surgical task based on guidance from the database model to adjust the spinal stiffness.
However, Murray teaches a navigation system that uses pre-operative and intra-operative data to define the placement and nature of recommended osteotomies (¶102). Thus, Murray teaches the step of performing a surgical task (e.g. osteotomy, ¶102) based on guidance from a database model (¶8) to adjust the spinal stiffness (¶8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide The Spinal Journal’s method with the step of performing a surgical task based on guidance from the database model to adjust the spinal stiffness as taught by Murray, since such a step would raise the standard of care for patients (¶8) and wherein robotic technologies have the ability to provide enhanced safety and improved efficiency for surgeons during deformity correction in spinal surgeries (¶9).
Thus, the modified The Spinal Journal’s method has measuring segmental stiffness after the surgical task (e.g. osteotomy, ¶102 of Murray) and updating the database model with each reading on segmental stiffness in real time (e.g. real time feedback, ¶9, ¶75 of Murray), wherein steps (b)-(e) are repeated for each level until targeted stiffness values are reached based on the database model (e.g. procedure was repeated, Appendix, page 1309 of The Spinal Journal).
Regarding claim 2, the modified The Spinal Journal’s method has wherein the guidance from the database model includes expected values for the patient in their current condition (e.g. pre-operative, ¶75-¶77 of Murray) and expected values for the patient after correction (e.g. post-operative, ¶75-¶77 of Murray).
Regarding claim 3, the modified The Spinal Journal’s method has wherein the database model provides the normalized spine stiffness data for each level and global stiffness values (pages 1302-1309 of The Spinal Journal).
Regarding claim 4, the modified The Spinal Journal’s method has wherein each level of the spine has its own segmental stiffness value (Abstract of The Spinal Journal), which is variable depending on the patient (¶97 of Murray).
Regarding claim 5, the modified The Spinal Journal’s method has wherein the surgical task includes an osteotomy (¶102 of Murray) or ligament release to decrease segmental stiffness.
Regarding claim 6, the modified The Spinal Journal’s method has wherein the database model identifies how and where osteotomies are needed including the number and size of the osteotomies (¶102 of Murray).
Regarding claim 7, the modified The Spinal Journal’s method has wherein the database model incorporates artificial intelligence to enhance database functionality, data analysis, and predictions (¶8 of Murray).
Regarding claim 8, the modified The Spinal Journal’s method has wherein the database model is incorporated into software of an on-board computer (figure 3 of Murray) for a surgical robotic and navigation system (¶9 of Murray).
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775
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