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 .
Specification
Amendment to the specification filed 9/5/2025 has been entered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neo et al. (US Publication No. 2018/0161075 A1).
Regarding Claim 1, Neo discloses an apparatus (Fig. 7), comprising: a stabilizing bridge (702) comprising: a first attachment (portion of cured material directly engaging one of the vertebrae) configured to be directly attached in a form-fit with a first vertebra [0060] (Fig. 7); and a second attachment (portion of cured material directly engaging a directly adjacent vertebrae) configured to be directly attached in a form-fit with a second vertebra [0060] (Fig. 7); wherein the first attachment (348) and the second attachment are fixed in position relative to each other (all portions of the bridge 702 attaching to the vertebrae are fixed relative to one another as it is a cured material, described in [0060]). The first attachment (portion of cured material directly engaging one of the vertebrae) comprises a size and shape that is a reverse of a 3D representation of an actual size and shape of a first vertebra to which the first attachment will be attached. Since the portion over the first vertebra is molded over the first vertebra, it takes on the exact shape of the first vertebra and therefore has identical structural features to a 3D representation of an actual size and shape of the first vertebra.
Regarding Claim 2, Neo discloses the first attachment comprises a C1 attachment, wherein the second attachment comprises a C2 attachment, wherein the first vertebra comprises a C1 vertebra, and wherein the second vertebra comprises a C2 vertebra (Neo discloses that the bridge can be attached to the skull, to the cervical, thoracic, lumbar, and/or sacral regions of the spine, to the hips, to the shoulders, or to any combination thereof [0024] and the curable material bridge 702 shown in Fig. 7 is fully capable of being attached to the C1-C2 vertebrae).
Regarding Claim 18, the stabilizing bridge (702) comprises a plastic material (“thermoplastics”, [0060]).
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) 17, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neo et al. (US Publication No. 2018/0161075 A1) in view of Couture et al. (US Publication No. 2004/0039396 A1).
Regarding Claim 17, Neo discloses the apparatus of claims 1-2 as described above. Neo disclose that the bridge 702 is attached to a reference array 704 with an arm structure to secure a navigation reference array of a neurosurgical navigation system in a fixed position relative to the stabilizing bridge and fully capable of placing the navigation reference array in a position superior to a location of the C1 vertebra and the C2 vertebra. (Neo in [0027] discloses the reference array can be located anywhere along the length or the width of the bridge and the array can extend outward from the bridge.)
However, Neo is silent to the attachment between the navigation marker and the bridge being an arc.
Couture discloses a reference array attachment in the analogous art of orthopedic surgical navigation systems. Couture discloses that the arm structure attaching the bridge (10) to the reference array (16) is an arc (19) (Fig. 1). 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 arm structure shown in Neo Fig.7 to be arc shaped as shown in Couture Fig. 1 since this would be a substitution of one shaped attachment arm for another known in the art which would predictably secure the reference array to the bridge structure.
Regarding Claim 19, further comprising the navigation reference array (markers 704 shown in Fig. 7, Neo) securable by the apparatus in the fixed position relative to the stabilizing bridge and suitable for use with a 3D image surgical guidance system [0028-0031, Neo].
Regarding Claim 20, further comprising the neurosurgical navigation system (101, [0031], Neo), the neurosurgical navigation system comprising: an imaging system configured to register the navigation reference array in a 3D space [0031], Neo; fully capable of determining a position of the C1 vertebra and a position of the C2 vertebra in the 3D space (if the bridge is attached to the C1 and C2 vertebrae, that is the position that the system will determine); and fully capable of registering a position of a tool (“instrument”) relative to the position of the C1 vertebra and the position of C2 vertebra in the 3D space ([0031], Neo).
Claim(s) 1-3, 6-16, 18, 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montello et al. (US Publication No. 2015/0012039 A1) in view of Sperling (US Publication NO. 2020/0163703 A1).
Regarding Claim 1, Montello discloses an apparatus (Fig. 33A-B), comprising: a stabilizing bridge (32v) comprising: a first attachment (348) configured to be directly attached in a form-fit with a first vertebra [0131] (Fig. 33B); and a second attachment (352+354) configured to be directly attached in a form-fit with a second vertebra [0132] (Fig. 33B); wherein the first attachment (348) and the second attachment (352+354) are fixed in position relative to each other (via solid connection at 344 shown in Fig. 33A).
Although Montello discloses that the first attachment 348 substantially conforms to the contour of the ring 290 of the C1 vertebra 292 [0031], Montello is silent to the size and shape of the first attachment being a reverse of a 3D representation of an actual size and shape of the first vertebra.
Sperling discloses designing and fabricating customized bone plates in the analogous art of patient-specific orthopedic devices. Sperling discloses that the bone-contacting surface of the plate is custom made by mirroring the bone surface in a 3D representation and custom manufacturing the plate to exactly fit the contour of the bone [0116] so that the plates are anatomically correct and appropriately sized for the patient [0162]. Sperling discloses that using plates which are not anatomically correct can result in impingement on soft tissues and patient discomfort [0009]. Sperling discloses that the methodology described is applicable to other bones including vertebral bodies [0078, 0162].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the vertebra attachment portions of Montello with a method such as 3D printing from a digital 3D representation of the bone as taught by Sperling in order to create custom bone contacting surfaces which perfectly fit the size and shape of the patient’s bones in order to ensure soft tissue is not impinged and ensure best fit with the patient.
Regarding Claim 2, Montello discloses the first attachment (348) comprises a C1 attachment [0131], wherein the second attachment (352+354) comprises a C2 attachment [0132], wherein the first vertebra comprises a C1 vertebra, and wherein the second vertebra comprises a C2 vertebra (Fig. 33B, [00131-0132]).
Regarding Claim 3, Montello in view of Sperling discloses the device as described above. Montello discloses the stabilizing bridge (32v) further comprises C1 instrumentation holes (350) fully capable of guiding an instrumentation drill into the C1 vertebra (holes 350 in first attachment 348 are fully capable of guiding a bone drill, reamer or other tool through into the C1 vertebra because they are positioned over the C1 vertebra). Sperling further discloses that screw holes on the plates are premeditated based on bone thickness [0026, Sperling]. It would have been obvious to one having ordinary skill in the art to select parameters of the holes to align with where desired bone thickness is as taught by Sperling in order to avoid areas with undesirable bone thickness for a fastener.
Regarding Claim 6, Montello in view of Sperling discloses the device as described above. As modified by Sperling, the C1 attachment size and shape are a reverse of a 3D representation of an actual size and shape of a posterior arch of the C1 vertebra.
Regarding Claim 7, Montello in view of Sperling discloses the device as described above. Montello discloses the implant further comprising a plurality of C1 fixing holes (350) fully capable of guiding respective fixating microscrews (34) into the posterior arch of the C1 vertebra (Fig. 33B, [0131]). Sperling further discloses that screw holes on the plates are premeditated based on bone thickness [0026, Sperling]. It would have been obvious to one having ordinary skill in the art to select parameters of the screw holes to align with where desired bone thickness is as taught by Sperling in order to avoid areas with undesirable bone thickness for a fastener.
Regarding Claim 8, the plurality of C1 fixing holes (350) configured to guide respective fixating microscrews (34) into the posterior arch at different angles relative to each other (different trajectories of holes and screw head orientations shown in Fig. 33A-B, Montello).
Regarding Claim 9, Montello in view of Sperling discloses the device as described above. As modified by Sperling to make the bone plate customized to the patient as described in the modification above, the C2 attachment (352+354) comprises a C2 attachment size and shape that are a reverse of a 3D representation of an actual size and shape of the C2 vertebra.
Regarding Claim 10, as modified by Sperling, the C2 attachment size and shape are a reverse of an actual size and shape of a 3D representation of a spinous process of the C2 vertebra (engaging portions 352 and 354 form the notch 356 which is the reverse (indentation surrounding the contour of) the spinous process as shown in Fig. 33B, Montello).
Regarding Claim 11,Montello discloses the implant further comprising a plurality of C2 fixing holes (358) are fully capable of guiding respective fixating microscrews (34) into the spinous process of the C2 vertebra (Fig. 33B) [0132]. Sperling further discloses that screw holes on the plates are premeditated based on bone thickness [0026, Sperling]. It would have been obvious to one having ordinary skill in the art to select parameters of the screw holes to align with where desired bone thickness is as taught by Sperling in order to avoid areas with undesirable bone thickness for a fastener.
Regarding Claim 12, the plurality of C2 fixing holes (358) are fully capable of guiding respective fixating microscrews (34) into the spinous process at different angles relative to each other (different trajectories of holes and screw head orientations shown in Fig. 33A-B, Montello).
Regarding Claim 13, the C1 attachment (348) forms a crossbar and wherein the C2 attachment (352+354) extends transverse to the C1 attachment (348) (Fig. 33A, Montello).
Regarding Claim 14, the C1 attachment (348) is configured to be secured to a posterior arch of the C1 vertebra [0131, Montello].
Regarding Claim 15, the C2 attachment (352+354) comprises two prongs (352 and 354) extending transverse to the C1 attachment (348) and separated from each other by a gap (356) (Fig. 33A, Montello).
Regarding Claim 16, the two prongs (352 and 354) are configured to receive a spinous process of the C2 vertebra (320) therebetween (Fig. 33B, Montello).
Regarding Claim 18, the stabilizing bridge (32v) comprises a plastic material (“polymers such as PEEK, reinforced plastics”, [0137, Montello]).
Regarding Claim 52, Montello discloses the stabilizing bridge further comprising a plurality of C2 instrumentation holes (358) are fully capable of guiding an instrumentation drill into the spinous process of the C2 vertebra (where the screws are in Fig. 33B) [0132]. Sperling further discloses that screw holes on the plates are premeditated based on bone thickness [0026, Sperling]. It would have been obvious to one having ordinary skill in the art to select parameters of the holes to align with where desired bone thickness is as taught by Sperling in order to avoid areas with undesirable bone thickness for a fastener.
Response to Arguments
Applicant's arguments filed 09/05/2025 with respect to Neo et al. (US Publication No. 2018/0161075 A1) have been fully considered but they are not persuasive. Applicant argues that Neo does not teach the first attachment comprises a size and shape that are a reverse of a 3D representation of an actual size and shape of a first vertebra. This is not persuasive because the portion over the first vertebra is molded over the first vertebra, it takes on the exact shape of the first vertebra and therefore has identical structural features to a 3D representation of an actual size and shape of the first vertebra. Applicant argues that Neo would not work for the C1-C2 level, however the examiner disagrees. Not only is the particular C1-C2 level not a requirement of the independent claim 1, with regards to the rejection of claim 2, Neo specifically discloses that the bridges disclosed can be used “at any level of the spine” in [0062].
Applicant’s arguments with respect to claim(s) 1-16, 18 as rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montello et al. (US Publication No. 2015/0012039 A1) have been considered but are moot because the new ground of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. see Form PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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