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 § 103
1. 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 40-42 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over BIRD et al. US 20230094575 (hereinafter Bird) in view of Frey et al. US 20140350614(hereinafter Frey).
Regarding claim 40, Bird provides for obtaining patient data including image data of one or more regions of a patient's spine in a native anatomical configuration ( [0085] Method 1200 includes measuring a patient for a spinal implant to determine one or more measurements, at 1210. For example, a computer or health care professional may image a patient's spine to determine a measurement or may read a previously acquired image”); determining a target anatomical configuration for the one or more regions, wherein the target anatomical configuration is different than the native anatomical configuration ( see [0085], see “ To illustrate, an X-ray or CT image may be used to determine a spinal implant dimension, such as a vertebral spacing or thickness”); and designing a plurality of separately implantable patient-specific devices that cooperate to achieve the target anatomical configuration (see “[0086] Method 1200 also includes modifying at least one base dimension of the spinal implant based on the one or more measurements, at 1212”).
Bird does not provide for, wherein at least one of the implantable patient-specific devices is expandable to position the patient's spine in the target anatomical configuration. Frey teaches the above missing limitation of Bird, see [0233] of Frey see “ In the context of a spinal implant, the implant may further specify a desired angle of lordosis or coronal defect correction, specify a patient-specific height of the implant or (desired height following disc height restoration), specify a degree of expansion permitted (for expandable implants), and may be unidirectional or multi-directional depending on the surgery and the surgeon preference”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine the teaching of Frey with the system and method of Bird, in order to obtain the claimed invention, via the expandable implants, a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (MPEP 2143).
Regarding claim 41, Bird does provide for, wherein the at least one implantable patient-specific devices is an expandable interbody device and another of the patient-specific devices is a fusion rod system([0056], see “For example, the fasteners 146 may include screws, pins, rods”, further see [0059] “ spinal implant 102 may enable better and quicker fusion of the spinal implant and reduce non-union and subsidence”).
Regarding claim 42, Bird does not provide for, wherein the target anatomical configuration includes restoration disk heights at multiple levels along the patient's spine, wherein the at least one of the implantable patient-specific devices are designed to achieve the restoration disk heights. Frey teaches the above missing limitation of Bird, see [0233] of Frey see “ In the context of a spinal implant, the implant may further specify a desired angle of lordosis or coronal defect correction, specify a patient-specific height of the implant or (desired height following disc height restoration), specify a degree of expansion permitted (for expandable implants), and may be unidirectional or multi-directional depending on the surgery and the surgeon preference”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine the teaching of Frey with the system and method of Bird, in order to obtain the claimed invention, via the expandable implants, a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (MPEP 2143).
Regarding claim 44, Bird does not provide for, wherein the target anatomical configuration includes one or more target disk heights and an acceptable spinal curvature of the spine. Frey teaches the above missing limitation of Bird, see [0233] of Frey see “ In the context of a spinal implant, the implant may further specify a desired angle of lordosis or coronal defect correction, specify a patient-specific height of the implant or (desired height following disc height restoration), specify a degree of expansion permitted (for expandable implants), further see [0311] of Frey teaches “the plurality of guides may receive a plurality of elongated shafts or "indicators" to assist the user in visualizing the location, orientation, curvature and/or deformity associated with the patient's underlying anatomy”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine the teaching of Frey with the system and method of Bird, in order to obtain the claimed invention, via the expandable implants and "indicators" to assist the user in visualizing the location, orientation, curvature and/or deformity associated with the patient's underlying anatomy , a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (MPEP 2143).
Allowable Subject Matter
2. Claim 43 is 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: the prior arts of over BIRD et al. US 20230094575 in view of Frey et al. US 20140350614, either alone or combined failed to teach or suggest for designing auxiliary implantable devices based on the target anatomical configuration achieved by the plurality of interbody devices. As cited in claim 43.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowed Claims
3. Claims 30-39 are allowed.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: the prior arts of over BIRD et al. US 20230094575 in view of Frey et al. US 20140350614, either alone or combined failed to teach or suggest for determining a treatment plan for a target spinal correction of the patient's spine based on the obtained patient data, the target spinal correction including increasing a spacing between adjacent vertebral bodies; and designing an expandable interbody device according to the treatment plan such that the expandable interbody device (i) has a topological feature configured to the identified at least one anatomical feature, and (ii) is transitionable between a collapsed configuration and an expanded configuration, wherein the dimensions of the device in the expanded configuration are set to induce the increased spacing associated with the target spinal correction. As cited in independent claim 30.
Further the prior arts of over BIRD et al. US 20230094575 in view of Frey et al. US 20140350614, either alone or combined failed to teach or suggest for “designing an adjustable patient-specific implant based at least in part on the target anatomical configuration and the topography of the inferior surface, wherein, when the adjustable patient-specific implant is implanted in the patient, the patient-specific implant is configured to be adjusted to bias the patient's spine toward the target anatomical configuration”. As cited in independent claim 34.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ali US 2 0190117266, is cited because the reference teaches “[0009] According to some embodiments, the passage created through the first vertebra is generally linear. In some embodiments, the method is performed minimally invasively. In some embodiments, the implant comprises an expandable implant (e.g., a coiled implant, an inflatable implant, etc.).
Sungarian et al. US 20130158669, is cited because the reference teaches “Such implants are used to correct degenerative conditions and facilitate spinal fusion while stabilizing and strengthening the spine. Spinal fusion is the joining of adjacent vertebrae through shared bone”, in [0006].
Butler et al. US 8444697 is cited because the reference teaches “The mass of the moveable block(s) forces the hinged top(s) of the interbody spacer to expand upward. Similarly, the hinged bottom expand downwards. The upward expansion of the hinged top and, or downward expansion of the hinged bottom will force the adjacent vertebra to move. The expansion of the hinged top(s) and, or bottom may be used to restore normal balance, tilt and disc height of the vertebrae. See summery.
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/ALI BAYAT/ Primary Examiner, Art Unit 2677
