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 I (medical treatment system) in the reply filed on 12/18/2025 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the one or more radiographic markers (claim 9), and camera (Claim 10) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statement filed 2/18/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. NPL reference #4 has not been provided.
The information disclosure statement filed 2/18/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Foreign document #6 does not have an English abstract or explanation.
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, 3-8, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reglos (US Publication No. 2023/0414374 A1) in view of Casey et al. (US Publication No. 2022/0160518 A1).
Regarding Claim 1, Reglos discloses a medical treatment system for treating a patient, the system comprising:
an interbody implant (cage 12, Fig. 2A) having at least one implant surface (18, 20) designed to mate with a first corresponding surface of a first vertebral body of the patient when the interbody implant is implanted at a first predetermined target location between the first vertebral body and an adjacent second vertebral body of the patient [0086] (Fig. 2A, 22A-B);
an inserter instrument (200, see figure below) having an elongated shaft (214) extending between a proximal complex (202) and a distal end region (216), wherein the distal end region (216) is sized and shaped to be coupled to the interbody implant (12) (threads 216 are screwed into threaded opening on the cage, [0093] Fig. 21D); and
a positioning guide (210+206+230, shown in figure below) configured to be coupled to the elongated shaft (214) proximate the interbody implant (12, shown in Fig. 21D), wherein the positioning guide includes one or more contoured surfaces (232) designed to mate with a second corresponding surface of the first vertebral body and/or the second vertebral body when the positioning guide is implanted at a second predetermined target location (“distal surface 232 located on one side of the forked distal end of the main body so that the distal surface may contact against one of the upper or lower vertebral bodies”, [0093]),
wherein, when the positioning guide and the interbody implant are coupled to the elongated shaft (214) , placing the positioning guide at the second predetermined target location automatically places the interbody implant at the first predetermined target location (“When the distal surface 232 of stop 230 abuts the vertebral bone, user will have an indication of final positioning of the cage in the disc space.”, [0100] Fig. 22B).
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However, Reglos is silent to the implant 12 being a “patient-specific” implant or the positioning guide being a “patient-specific” positioning guide. (Applicant defines “patient-specific” in [0026] of the specification referring to an implant that has one or more properties specifically designed for a particular patient.)
Casey discloses patient specific intervertebral implants in the same field of endeavor [0022]. Casey discloses the interbody implant (110) has patient specific topography/contouring/shape designed to mate with the patient’s anatomy [0029] which optimizes the benefit and/or minimizes the side effects of the implant [0023]. Further, Casey describes the positioning feature (plate) which abuts the outside of the vertebrae to assist in placement of the implant as also having a patient-specific geometry [0030] in order to align the proper placement of the implant to maximize fit and benefit of the implant [0020, 0031].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Reglos to have patient specific topography/contouring/shape designed to mate with the patient’s anatomy as taught by Casey in order to maximize the contact between the implant and the vertebrae to optimize the benefit and/or minimize the side effects of the implant. Further, it would have been obvious to modify the contoured surface of the positioning guide of Reglos (surface 232, Reglos) which is designed to abut the outside of the vertebrae to have a patient specific geometry as taught by Casey in order to better align the placement of the implant.
Regarding Claim 3, the second corresponding surface (outer surface of vertebrae engaged by surface 232 taught by Reglos) is at an anterior, lateral, or posterior margin of the first and/or second vertebral body (anterior margin shown in Fig. 22C, Reglos).
Regarding Claim 4, the patient-specific positioning guide includes: a body (230, Reglos) having the one or more contoured surfaces (surface 232 Reglos, as modified to be patient specific as taught by Casey); a depth stop (distal end of 210 protruding past 230, see figure below) extending from the body; and a lumen extending through the body and the depth stop (lumen contains shaft 214 with threaded end 216, see figure of Reglos below).
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Regarding Claim 5, wherein a length of the depth stop (distal end of 210, Reglos) is based at least in part on a distance between the second predetermined target position and the first predetermined target position (“When the distal surface 232 of stop 230 abuts the vertebral bone, user will have an indication of final positioning of the cage in the disc space.”, [0100] Fig. 22B Reglos).
Regarding Claim 6, the depth stop (distal end of 210, Reglos) has a height less than a distance between the first vertebral body and the second vertebral body (distal end of 210 is sized to engage the cage and fit between the vertebrae as shown in Fig. 22B, Reglos).
Regarding Claim 7, the patient-specific positioning guide is configured to control a distance between an entry point and the patient-specific interbody implant (“When the distal surface 232 of stop 230 abuts the vertebral bone, user will have an indication of final positioning of the cage in the disc space.”, [0100] Fig. 22B Reglos).
Regarding Claim 8, Casey discloses using a virtual model showing the first vertebral body, the second vertebral body, a virtual patient-specific interbody implanted at the first predetermined target location, and a virtual positioning guide implanted at the second predetermined target location in order to assist in designing and planning the procedure/tools [0093, Casey]. It would have been obvious to use a virtual model showing the system components as taught by Casey in order for the surgeon to plan the procedure.
Regarding Claim 12, the patient-specific positioning guide is configured to remain coupled to the inserter instrument after the patient-specific interbody implant is released from the inserter instrument at the first predetermined target location [0094, Reglos].
Claim(s) 2, 28-30, 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reglos (US Publication No. 2023/0414374 A1) in view of Casey et al. (US Publication No. 2022/0160518 A1) in further view of Geisert et al. (US Publication No. 2009/0216330 A1).
Regarding Claim 2, the system of Reglos in view of Casey is described above with regards to the rejection of claim 1, the patient-specific positioning guide including a first contoured surface (232) designed to mate with the second corresponding surface [0093, Reglos]. Reglos describes that the contoured surface can engage the superior vertebrae or the inferior vertebrae [0094, Reglos] and Casey describes that the plate which ensures positioning of the interbody device [0020, Casey] can also be designed to contact both the superior and inferior vertebrae (Fig. 2A, [0063, Casey]). Reglos and Casey are silent to the guide having a second contoured surface designed to mate with a third corresponding surface on the second vertebral body such that the patient-specific positioning guide is configured to contact both the first vertebral body and the second vertebral body.
Geisert discloses a positioning guide in the same field of endeavor which has both upper and lower contact surfaces (17, Fig. 48) for simultaneously abutting both superior and inferior vertebrae adjacent the intervertebral space during placement of the implant and acting as a depth stop ([0369], Fig. 48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the depth control feature (230) of Reglos in view of Casey to have a second contour surface to also abut the other adjacent vertebra as taught by Geisert in order to use a known technique (abutting both vertebrae simultaneously) to provide stopping surfaces for intervertebral implant placement.
Regarding Claim 28, Reglos discloses a medical treatment system for treating a patient, the system comprising:
an interbody implant (cage 12, fig. 2A) designed to be implanted at a target position between a first vertebral body and a second vertebral body of the patient (Fig. 22A-B);
an inserter instrument (200, see figure below) having an elongated shaft (214) extending between a proximal complex (202) and a distal end region (216), wherein the distal end region (216) is sized and shaped to be coupled to the interbody implant (12) (threads 216 are screwed into threaded opening on the cage, [0093] Fig. 21D); and
a positioning guide (210+206+230, shown in figure below), the positioning guide including: a first contoured surface (232) designed to mate with a first surface of the first vertebral body, the first surface being at a lateral, anterior, or posterior margin of the first vertebral body (anterior margin shown in Fig. 22B, [0093]), and
a connection mechanism (lumen within elements 210 and 230 and pin 228, [0093] Fig. 20A) for connecting the positioning guide to the distal end region (216) of the inserter instrument at a predetermined orientation such that, when the first contoured surface mates with the first surface, the interbody implant is directed to the target position (“When the distal surface 232 of stop 230 abuts the vertebral bone, user will have an indication of final positioning of the cage in the disc space.”, [0100] Fig. 22B).
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However, Reglos is silent to the implant 12 being a “patient-specific” implant or the positioning guide being a “patient-specific” positioning guide. (Applicant defines “patient-specific” in [0026] of the specification referring to an implant that has one or more properties specifically designed for a particular patient.)
Casey discloses patient specific intervertebral implants in the same field of endeavor [0022]. Casey discloses the interbody implant (110) has patient specific topography/contouring/shape designed to mate with the patient’s anatomy [0029] which optimizes the benefit and/or minimizes the side effects of the implant [0023]. Further, Casey describes the positioning feature (plate) which abuts the outside of the vertebrae to assist in placement of the implant as also having a patient-specific geometry [0020, 0030] in order to align the proper placement of the implant to maximize fit and benefit of the implant [0020,0031].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Reglos to have patient specific topography/contouring/shape designed to mate with the patient’s anatomy as taught by Casey in order to maximize the contact between the implant and the vertebrae to optimize the benefit and/or minimize the side effects of the implant. Further, it would have been obvious to modify the contoured surface of the positioning guide of Reglos (surface 232, Reglos) which is designed to abut the outside of the vertebrae to have a patient specific geometry as taught by Casey in order to better align the placement of the implant.
Reglos describes that the contoured surface can engage the superior vertebrae or the inferior vertebrae [0094, Reglos] and Casey describes that the plate which ensures positioning of the interbody device [0020, Casey] can also be designed to contact both the superior and inferior vertebrae (Fig. 2A, [0063, Casey]). Reglos and Casey are silent to the guide having a second contoured surface designed to mate with a third corresponding surface on the second vertebral body such that the patient-specific positioning guide is configured to contact both the first vertebral body and the second vertebral body.
Geisert discloses a positioning guide in the same field of endeavor which has both upper and lower contact surfaces (17, Fig. 48) for simultaneously abutting both superior and inferior vertebrae adjacent the intervertebral space during placement of the implant and acting as a depth stop ([0369], Fig. 48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the depth control feature (230) of Reglos in view of Casey to have a second contour surface to also abut the other adjacent vertebra as taught by Geisert in order to use a known technique (abutting both vertebrae simultaneously) to provide stopping surfaces for intervertebral implant placement. The modification would result in both the contour surfaces contacting the anterior margins of their respective vertebrae.
Regarding Claim 29, as modified above in the rejection of claim 28, the patient-specific positioning guide includes a body (modified element 230 of Reglos) and a depth stop extending from the body (distal section of 210 shown below of Reglos), wherein the body (as modified by Casey and Geisert) has the first contoured surface and the second contoured surface (see rejection of claim 28 above).
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Regarding Claim 30, the body and the depth stop include a lumen extending therethrough (lumen accommodates shaft 214, shown above), wherein the lumen is sized and shaped to rotatably receive an inner shaft (214, Reglos) of the inserter instrument [0094, Reglos].
Regarding Claim 32, the connection mechanism is configured to remain coupled to the inserter instrument following deployment of the patient-specific interbody implant (all the connections of the guide and inserter of Reglos remain intact after the implant is released therefrom).
Regarding Claims 33-34, the patient-specific positioning guide is designed to control (a) an insertion depth of the patient-specific interbody implant, and/or (b) an insertion angle of the patient-specific interbody implant and an axial angle and/or a lateral angle of the patient-specific interbody implant. The guide is designed to place the implant in the final resting place [0093, Reglos] and therefore all orientations of the implant are controlled.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reglos (US Publication No. 2023/0414374 A1) in view of Casey et al. (US Publication No. 2022/0160518 A1) in further view of Biscup (US Publication No. 2003/0216737 A1).
Regarding Claim 10, the system of Reglos in view of Casey is described above with regards to the rejection of claim 1. Reglos and Casey are silent to a camera configured to be coupled to the distal end region of the elongated shaft to provide real-time image and/or video feedback of a position of the patient-specific positioning guide and/or the patient-specific interbody implant.
Biscup discloses an intervertebral implant inserter tool. Biscup teaches that the tool can include one or more passageways which can be used to insert a camera into the posterior end portion during surgery in order to facilitate guiding an/or position the implant into the intervertebral space [0031]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a passage through to the posterior end portion of the tool as taught by Biscup in order to insert a camera to assist with visualizing the procedure.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reglos (US Publication No. 2023/0414374 A1) in view of Casey et al. (US Publication No. 2022/0160518 A1) in further view of Hes et al. (US Publication No. 2010/0298941 A1).
Regarding Claim 11, the system of Reglos in view of Casey is described above with regards to the rejection of claim 1. Reglos and Casey are silent to the materials the implant or the guide are composed of.
Hes discloses intervertebral implants and insertion tools and discloses suitable materials for the implant can be titanium alloy [0047] and suitable material for the inserter instrument can be polymers such as PEEK, PEKK [0047]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the implant from titanium alloy as taught by Hes in order to use a material known in the art suitable to create interbody implants It would have been obvious to one having ordinary skill in the art to make the positioning guide from plastic (polymer) since Hes teaches this is a material suitable for making spinal positioning/insertion tools.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reglos (US Publication No. 2023/0414374 A1) in view of Casey et al. (US Publication No. 2022/0160518 A1) in further view of Geisert et al. (US Publication No. 2009/0216330 A1), in further view of Hes et al. (US Publication No. 2010/0298941 A1).
Regarding Claim 31, the system of Reglos in view of Casey in further view of Geisert is described above with regards to the rejection of claim 28. Reglos, Geisert and Casey are silent to the materials the implant or the guide are composed of.
Hes discloses intervertebral implants and insertion tools and discloses suitable materials for the implant can be titanium alloy [0047] and suitable material for the inserter instrument can be polymers such as PEEK, PEKK [0047]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the implant from titanium alloy as taught by Hes in order to use a material known in the art suitable to create interbody implants It would have been obvious to one having ordinary skill in the art to make the positioning guide from plastic (polymer) since Hes teaches this is a material suitable for making spinal positioning/insertion tools.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reglos (US Publication No. 2023/0414374 A1) in view of Casey et al. (US Publication No. 2022/0160518 A1) in further view of Josse et al. (US Publication No. 2022/0387184 A1).
Regarding Claim 9, the system of Reglos in view of Casey is described above with regards to the rejection of claim 8. Reglos and Casey are silent to the guide includes one or more radiographic markers that can be imaged and compared to the virtual model to determine whether the patient-specific positioning guide is at the second predetermined target location and/or that the patient-specific interbody implant is at the first predetermined target location.
Josse discloses intervertebral implants and insertion tools and discloses the ends of the insertion tool (400, 500) may include markers at the tip portion thereof to permit them to be seen on fluoroscopy while advancing into the patient [0191].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include radiographic markers in the tip of the parts of the tool as taught by Josse in order to permit the tool to be seen on fluoroscopy while advancing into the patient. The markers would be fully capable of being imaged and compared to the virtual model to determine whether the patient-specific positioning guide is at the second predetermined target location and/or that the patient-specific interbody implant is at the first predetermined target location.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773