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 Species A (Fig 3-7c) in the reply filed on 3/23/2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/23/2026.
Drawings
New corrected drawings for Figs 3-10b in compliance with 37 CFR 1.121(d) are required in this application because a) the lines, numbers, figures and letters are not uniform, clean and well defined (of a generally poor quality) (37 CFR 1.84(I)). These figures appear to be photocopies. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiman US 2022/0008212.
Regarding Claim 1, Weiman discloses an expandable coronal implant (#20, Fig 7) comprising:
a top endplate and a bottom endplate configured to engage adjacent vertebrae (see Fig below, Fig 1a-6c);
a dual actuator assembly including a rotatable drive screw actuator having a shaft and a rotatable actuator nut concentric to the drive screw actuator (see Fig below); and a plurality of driving ramps including a front ramp, a mid-ramp, and a rear ramp positioned along the shaft of the drive screw actuator and engaged with the top and bottom endplates (see Fig below) via complementary ramped surfaces (ramped surfaces #128, #130, #132 of the driving ramps engaged with complimentary ramped surfaces #122, #124, #126 paragraph 54),
wherein when inserted in a disc space, the implant has an ipsilateral side (side where the rear ramp is located, see Fig below) and a contralateral side (side where the front ramp is located, see Fig below), and wherein rotation of the drive screw actuator and/or the actuator nut causes movement of one or more of the driving ramps, thereby causing independent expansion in height of the contralateral and/or ipsilateral sides of the implant to correct a coronal deformity (Fig 9c, abstract, paragraph 50-51).
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Regarding Claim 4, Weiman discloses the shaft of the drive screw actuator (Fig 7) includes a first threaded portion (#92), a second threaded portion (#90), a first non-threaded portion (#100) separating the first threaded portion from the second threaded portion (Fig 7), and a second non-threaded portion (#94) toward a distal end of the shaft (Fig 7, paragraph 50).
Regarding Claim 5, Weiman discloses the rear ramp is positioned on the actuator nut (Fig 8c, 9c, paragraph 51), which is positioned on the first threaded portion of the drive screw actuator (paragraph 50, Fig 8c, 9c), the mid-ramp is positioned on the second threaded portion of the drive screw actuator (paragraph 50, Fig 8c, 9c), and the front ramp is positioned on the second non-threaded portion of the drive screw actuator (paragraph 50, Fig 8c, 9c).
Claims 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiman US 2022/0008212.
Regarding Claim 9, Weiman discloses an expandable coronal implant (Fig 7) comprising:
a top endplate and a bottom endplate configured to engage adjacent vertebrae (see Fig below), wherein the top and bottom endplates are angled to provide an initial reverse taper configured to match an angle of a disc space upon insertion (paragraph 51, the driving ramps can be actuated such that there is an initial reverse taper, where the nut and shaft can be rotated simultaneously to slightly increase the height in parallel and then only the nut rotated slightly such that the initial reverse taper has an asymmetric taper such that the contralateral side is greater in height than the ipsilateral side);
a dual actuator assembly including a rotatable drive screw actuator having a shaft and a rotatable actuator nut concentric to the drive screw actuator (see Fig below); and a plurality of driving ramps including a front ramp, a mid-ramp, and a rear ramp positioned along the shaft of the drive screw actuator and engaged with the top and bottom endplates (see Fig below) via complementary ramped surfaces (ramped surfaces #128, #130, #132 of the driving ramps engaged with complimentary ramped surfaces #122, #124, #126 paragraph 54),
wherein after insertion into the disc space, the implant is expanded by rotating the drive screw actuator and/or the actuator nut to cause movement of one or more of the driving ramps, thereby causing the endplates to expand to provide a neutral position or angle opposite to the initial reverse taper to correct a coronal deformity (paragraph 50-51, the nut/screw actuator can move one or more of the ramps to provide a neutral position where the plates are parallel to each other or opposite to the initial reverse taper, Fig 9c).
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Regarding Claim 10, Weiman discloses the implant has an ipsilateral side (back side adjacent to the rear ramp, Fig 8c) and a contralateral side in the disc space (front side adjacent the front ramp, Fig 8c), and the initial reverse taper has an asymmetric taper such that the contralateral side is greater in height than the ipsilateral side (paragraph 51 where the nut and shaft can be rotated simultaneously to slightly increase the height in parallel and then only the nut rotated slightly such that the initial reverse taper has an asymmetric taper such that the contralateral side is greater in height than the ipsilateral side ).
Regarding Claim 11, Weiman discloses the implant is expandable to tilt the top and bottom endplates to the angle opposite to the initial reverse taper such that the ipsilateral side is greater in height than the contralateral side to correct the coronal deformity (paragraph 51, see Fig 9c).
Regarding Claim 12, Weiman discloses the implant is expandable such that the top and bottom endplates are parallel to one another in the neutral position (paragraph 51 “results in parallel expansion”).
Claims 1, 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan US 2022/0117754.
Regarding Claim 1, Sullivan discloses an expandable coronal implant (Fig 6) comprising:
a top endplate and a bottom endplate configured to engage adjacent vertebrae (see Fig below);
a dual actuator assembly including a rotatable drive screw actuator having a shaft and a rotatable actuator nut concentric to the drive screw actuator (see Fig below); and
a plurality of driving ramps including a front ramp, a mid-ramp, and a rear ramp positioned along the shaft of the drive screw actuator and engaged with the top and bottom endplates (see Fig below) via complementary ramped surfaces (ramped surfaces #94, #96, #98 of the driving ramps engaged with complimentary ramped surfaces #80, #90, #92 paragraph 93),
wherein when inserted in a disc space, the implant has an ipsilateral side (side where the rear ramp is located, see Fig below) and a contralateral side (side where the front ramp is located, see Fig below), and wherein rotation of the drive screw actuator and/or the actuator nut causes movement of one or more of the driving ramps, thereby causing independent expansion in height of the contralateral and/or ipsilateral sides of the implant to correct a coronal deformity (Fig 5b, 5e, paragraph 87-88, 90).
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Regarding Claim 3, Sullivan discloses the rear ramp defines female ramped grooves (#98) forming a male triangular area with a vertex pointing toward the front of the implant (see Fig below), the mid-ramp defines female ramped grooves (#96) forming a male triangular area with a vertex pointing toward the rear of the implant (see Fig below), and the front ramp defines female ramped grooves (#94) forming a male triangular area with a vertex pointing toward the front of the implant (see Fig below).
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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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sullivan US 2022/0117754 in view of Weiman US 2017/0100257 (‘257).
Sullivan discloses the claimed invention as discussed above where the ramps have respective through bores (#63, #61, #59, Fig 7f) to receive the shaft of the drive screw actuator (Figs 6-7) but does not disclose the dual actuator assembly is laterally offset relative to a central longitudinal axis of the implant, and the front ramp, mid-ramp, and rear ramp define through bores along the offset axis to receive the shaft of the drive screw actuator.
Weiman ‘257 discloses an expandable implant (Fig 74) comprising top and bottom plates (#14, #16), ramps (#366, #412), an actuator assembly comprising a drive screw actuator with a shaft (#200), the actuator assembly is laterally offset relative to a central longitudinal axis of the implant (see Fig below as well as Fig 75a-75b), and ramps define through bores (#300, #418) along the offset axis to receive the shaft of the drive screw actuator (see Fig below, Fig 74) such that at least the rear driving ramp (#306) can include a graft delivery hole (#512) which allow graft material to be inserted into the implant (paragraph 182).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Sullivan such that the dual actuator assembly is laterally offset relative to a central longitudinal axis of the implant, and the front ramp, mid-ramp, and rear ramp define through bores along the offset axis to receive the shaft of the drive screw actuator in view of Weiman ‘257 above so as to accommodate a graft delivery hole in at least the rear driving ramp so that graft material is able to be inserted into the implant.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Weiman US 2022/0008212 in view of Sullivan US 2022/0117754.
Regarding Claim 6, Weiman discloses the actuator nut includes a cylindrical body (as seen in fig 7) having an enlarged head (#110) defining an instrument recess (paragraph 51 where the head includes a recess in the form of at least one slot for engagement with an instrument) and a neck (where #54 is pointing to in Fig 7) with a reduced diameter (Fig 7, then neck has a smaller diameter than the head). It is also noted that the nut (#54) is placed over the first threaded portion (#92 as seen in Fig 7, 8c, 9), and where the nut is rotated to expand the implant (paragraph 51), where nuts are by definition internally threaded but Weiman does not explicitly disclose the neck defining an internal threaded portion, which engages with the first threaded portion of the shaft of the drive screw actuator.
Sullivan discloses a similar device (see rejection for claim 1 above in view of Sullivan) where the nut has an enlarged head (#78, Fig 6) and a neck (where #54 is pointing to in Fig 6) the neck defining an internal threaded portion (as seen in Fig 7f, paragraph 89), which engages with a first threaded portion (#74) of the shaft of the drive screw actuator (#52) such that the nut is rotated/threaded along the first threaded portion to expand the implant (paragraph 87, 89).
As such it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the nut of Weiman to be internally threaded such that the neck is also internally threaded in view of Sullivan above so that when rotated, the nut is rotated/threaded along the first threaded portion to expand the implant.
Claim 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Weiman US 2022/0008212 in view of Faulhaber US 2017/0266016.
Weiman discloses the claimed invention as discussed above where the actuator nut is secured to the rear ramp (paragraph 51) but does not disclose the actuator nut is secured to the rear ramp with a first retaining clip fit into an annular groove along an outside of the actuator nut and a corresponding interior annular groove along an interior of the rear ramp, the actuator nut is secured to the rear ramp with a second retaining clip fit beneath the first retaining clip around the head of the actuator nut and resting in the interior annual groove along the interior of the rear ramp.
Faulhaber discloses an implant (Fig 24) with an actuator nut (#114, Fig 24) having a head (where #114 is pointing to in Fig 24), the actuator nut is secured to a housing (#218) with a first retaining clip fit (see Fig below, paragraph 53, can be in the form of a c-ring) into an annular groove (#184) along an outside of the actuator nut and a corresponding interior annular groove along an interior of the housing (see Fig below, paragraph 61), the actuator nut is secured to the rear ramp with a second retaining clip (see Fig below, paragraph 61 where it can be in the form of a c-ring) fit beneath the first retaining clip around the head of the actuator nut and resting in the interior the rear ramp (see Fig below, paragraph 61) to retain the nut to the housing (paragraph 61).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the implant of Weiman to include the first and second retaining clips retained on corresponding grooves on actuator nut and in the rear ramp in view of Faulhaber above because this provides a known alternate configuration to retain the nut in the rear ramp. [Examiner notes that threads #108 in Weiman are optional, see paragraph 51 “may include an outer threaded portion 108…”].
Weiman as modified by Faulhaber disclose that the first and second clips are in respective grooves in the rear ramp (paragraph 61 in Faulhaber) and does not disclose the second clip also resting in the interior annual groove along the interior of the rear ramp.
However, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the interior of the rear ramp only include one interior annual groove to house the first and second clips because this allows for ease of manufacturing where only one groove is carved out. Furthermore, this would be an obvious design choice with only two finite solutions for housing first and second clips (where each clips has a groove or both clips share the same groove) and applicant has not disclosed that this configuration solves any stated problem or is for any particular purpose other than for the purpose of housing the clips.
Conclusion
See PTO-892 for art of cited interest, in particular other expandable implants.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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