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 Group II, Species 3 in the reply filed on 03/04/2026 is acknowledged.
Claims 11-13 and 83-109 are pending. Claims 12 and 13 have been withdrawn by applicant.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required claims 103 and 104 reference “meeting an acceptable outcome threshold.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 94, 103 and 104 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 94 recites the limitation "the planned surgical approach" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 103 and 104 references “meeting an acceptable outcome threshold.” It is unclear what applicant is attempting to claim. The Specification fails to define, mention or elaborate on “an acceptable outcome threshold.”
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 11, 83, 84, 91, 93 and 109 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultz et al. (U.S. 11, 298,244 B2).
Concerning claim 11, Schultz et al. disclose a method of implanting an intervertebral implant, the method comprising: delivering the intervertebral implant (see Figs. 25-30) rigidly coupled to an inserter instrument into an intervertebral disc space of a patient such that the intervertebral implant is positioned at the intervertebral disc space while a longitudinal axis of the inserter instrument is angled away from the intervertebral disc space (see col. 15, lines 10-30); and separating the inserter instrument from the intervertebral implant at the intervertebral disc space.
Concerning claim 83, wherein an angled coupling element (see Fig. 25, element 545) of the intervertebral implant is configured to detachably receive the inserter instrument such that the longitudinal axis of the inserter instrument is angled away from a transverse plane of the intervertebral implant.
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Concerning claim 84, Schultz et al. disclose method comprising: obtaining a planned surgical approach for a target anatomical correction to a subject using an approach-specific intervertebral implant configured based on the target anatomical correction and the planned surgical approach (see col. 15, lines 10-30); detachably coupling the approach-specific intervertebral implant to an insertion instrument (see Fig. 25, element 545); positioning the approach-specific intervertebral implant at an intervertebral disc space in the subject while the approach-specific intervertebral implant is angled away from a longitudinal axis of the insertion instrument and the insertion instrument is positioned along a delivery path for the planned surgical approach; and separating the insertion instrument from the approach-specific intervertebral implant located at the intervertebral disc space.
Concerning claim 91, wherein the longitudinal axis of the insertion instrument is angled away from a transverse plane of the approach-specific intervertebral implant when the insertion instrument is coupled to the approach-specific intervertebral implant (see Fig. 30 above).
Concerning claim 93, wherein the approach-specific intervertebral implant includes an angled coupling element (see Fig. 25, element 545) including an internally threaded hole configured to receive a threaded distal end of the insertion instrument.
Concerning claim 109, wherein the approach-specific intervertebral implant includes an internally threaded hole (see Fig. 25, element 545) configured to couple to the insertion instrument, and wherein a longitudinal axis of the internally threaded hole is angled with respect to a transverse plane of the approach-specific intervertebral implant (see Fig. 30 above).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 85-87, 90, 92, 100-102 and 108 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (U.S. 11, 298,244 B2) in view of McAfee et al. (U.S. 12,178,516 B2).
Schultz et al. disclose the invention substantially as described above. However, Schultz et al. do not explicitly disclose the method steps of viewing a pre-operatively generated design of the approach-specific intervertebral implant, and wherein the pre-operatively generated design is based on an implant footprint obtained from an implant footprint database.
McAfee et al. teach a method comprising viewing a pre-operatively generated design of an approach-specific intervertebral implant, and wherein the pre-operatively generated design is based on an implant footprint obtained from an implant footprint database (see col. 9, line 15 – col. 11, lines 46; and Fig. 25A) in the same field of endeavor for the purpose of tailoring an implant and insertion method to the specific patient.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schultz’s method by viewing a pre-operatively generated design of a approach-specific intervertebral implant, and wherein the pre-operatively generated design is based on an implant footprint obtained from an implant footprint database, as disclosed by McAfee et al, in order to provide a better anatomical fit and endplate coverage thereby distributing compressive loads more evenly across the cortical rim and reducing the chance of subsidence.
Concerning claim 86, wherein the implant footprint includes one or more dimensional design constraints (see Fig. 25A).
Concerning claim 87, wherein the implant footprint includes a shape for a surgical approach-specific design (see Fig. 25A – inserter implant connection point).
Concerning claim 90, further comprising: viewing a target location (see Fig. 18B) for the approach-specific intervertebral implant predicted to achieve the target anatomical correction; and viewing a design of the approach-specific intervertebral implant for delivery to the target location (see col. 22, lines 6-15).
Concerning claim 92, Applicant’s attention is directed to col. 20, lines 6-10 of McAfee et al. It is noted that obtaining a digital surgical plan for the planned surgical approach, and wherein an angle between an axis of an angled coupling element configured to couple to the insertion instrument and an imaginary reference plane of the approach-specific intervertebral implant (see Fig. 30 above) is viewable in the digital surgical plan would be an obvious step to those of ordinary skill in the art. The personalization of the method would take into account the implant and the specific insertion tool used for implantation.
Concerning claims 100-102, it is noted that Schultz et al. disclose a main body, and multiple connections features. The separate connection features are for insertion along different approaches to the spine so that the insertion instrument does not contact the vertebrae or other sensitive spinal structures during implantation. Accordingly, a patient specific implant would take into account the insertion path and insertion tool connection feature as disclosed by Schultz et al.
Regarding claim 108, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to base the planned surgical approach on both the anatomical correction and the insertion instrument (length, diameter, angulation capability, and handle orientation) which both define a physical region in which the surgeon must operate. If the planned correction required a trajectory that the instrument physically cannot achieve then the plan is inexecutable. It is well known in the art that the delivery instrument is a geometric constraint that shapes the surgical approach. Accordingly, the planned surgical approach must be based on the target anatomical correction and the insertion instrument.
Claim(s) 94, 105-107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (U.S. 11, 298,244 B2) in view of Shannon et al. (U.S. 2023/0360768 A1).
Schultz et al. disclose the invention substantially as described above. However, Schultz et al. do not explicitly disclose a planned surgical approach obtained from a machine learning module trained to generate delivery paths based on historical data.
Shannon et al. teach the concept of utilizing historical data from patient’s to plan an optimal procedure on a patient’s spine (see par. 0017).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schultz’s method to include the step of utilizing a planned surgical approach obtained from a machine learning module trained to generate delivery paths based on historical data, the concept of which is disclosed by Shannon et al., in order to reduce risk and improve the final outcome. By analyzing outcomes from prior surgeries – including complication rates, implant positioning, alignment measures, and revision rates – a surgeon can identify patterns that correlate with success or failure, permitting a tailored approach to the specific patient. Data-driven planning helps anticipate intraoperative challenges before they arise.
Regarding claim 105, the concept of communicating with a design platform to simulate one or more surgical procedures on the subject to determine the planned surgical approach falls within the teaching of Shannon et al.
Regarding claim 106, Shannon et al. disclose the concept of a machine learning module to utilize historical patient data, then inputting patient image data into the module, and planning a surgical approach and selecting an implant from the module (see abstract and pars. 0041-0043). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schultz’s method to incorporate the training and inputting of image data into a machine learning module, as disclosed by Shannon et al., in order to provide a better surgical outcome for the patient by taking into account factors that determine the success of a particular surgery.
Regarding claim 107, it would have been an obvious modification to the disclosed method to include historical patient data related to a specific surgeon in order to reduce intraoperative deviation from the surgical plan. Different surgeons have preferred approaches, hand dominance, and instrument handling styles. A platform that accounts for these can optimize implant positioning that aligns with how the specific surgeon naturally operates.
Claim(s) 95 and 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (U.S. 11, 298,244 B2) in view of Casey et al. (U.S. 2022/0160518 A1).
Schultz et al. disclose the invention substantially as described above. However, Schultz et al. do not explicitly disclose viewing a plurality of delivery paths each to a respective level along a spine of the subject; and providing a plurality of implants each configured for delivery along a respective one of the plurality of delivery paths.
Casey et al. disclose the viewing of a delivery path and the step of providing an implant configured for delivery along the path (see par. 0108) in the same field of endeavor for the purpose of providing patient-specific vertebral implants.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to view a plurality of delivery paths and to provide a plurality of implants configured for delivery along the path, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ
Concerning claim 96, Casey et al. also disclose that the planned surgical approach is obtained by a user device of a physician (see par. 0109).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize numerous visualization and computing devices to plan the surgical approach, as disclosed by Casey et al., in order to precisely tailor the patient-specific vertebral implant to the patient.
Allowable Subject Matter
Claims 88, 89 and 97-99 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Implants with varying articulation and angulation with respect to a longitudinal axis of the inserter are disclosed. For example, see Fig. 11D of US 2003/0139813 A1 below; and Fig. 7 of US 2022/0023063 A1.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773