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 Species F in the reply filed on 23 June 2026 is acknowledged.
Claims 17, 24, 26, 48, 55 and 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 June 2026.
Claim Objections
Claims 20, 38 and 51 are objected to because of the following informalities:
Claim 20, line 1: --the-- should be added between “wherein” and “plurality”.
Claim 38, line 4: --the-- should be added before “normal”.
Claim 38, line 7: --the-- should be added before “normal”.
Claim 51, line 1: --the-- should be added between “wherein” and “plurality”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 63 is rejected under 35 U.S.C. 101 because the claim is not a proper process claim. See MPEP 2106.03. The definition of a process claim is a follows: A process defines “actions,” i.e., an invention that is claimed as an act or step, or a series of acts or steps. As explained by the Supreme Court, a “process” is “a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.” Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972). See MPEP 2106.03 and 2106.07(a).
Claim 63 is not a proper process claim since it fails to provide a series of acts and steps to be performed upon the subject-matter to be transformed and reduced to a different state or thing. Claim 63 discloses a method of “providing” components of a spinal implant assembly for a kit without providing any actual steps. The claim does not add anything significantly more to the assembly, other than the assembly being available for use. See MPEP 2106.05.
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.
Claim 63 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 63 attempts to claim a process without setting forth any steps involved in the process. It has been held that a claim which recites only an apparatus and does not provide any active, positive steps delimiting how this apparatus is actually practiced is indefinite. See 101 rejection above and MPEP 2173.05(q), wherein claim 63 only claims “providing” components of a spinal implant assembly for a kit ready for use.
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(s) 1-4, 32-35, 63, 65, 67, 68, 76, 78 and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul et al., U.S. PG-Pub 2002/0062153 in view of Evans, U.S. PG-Pub 2011/0118852.
Regarding claims 1 and 32, Paul et al. discloses a spinal implant assembly/kit for a spinal implant assembly comprising: a first endplate (82) having a first non-planar inner surface (surface facing 84); a second endplate (86) having a second non-planar inner surface (surface facing 84) facing toward the first non-planar inner surface; at least one fastener (one or more pins) attaching the first endplate and the second endplate to one another; and a layer (84) between the first non-planar inner surface and the second non-planar inner surface and having a non-planar upper surface (surface facing 82) facing toward the first non-planar inner surface and a non-planar lower surface (surface facing 86) facing toward the second non-planar inner surface, wherein, at a front region of the spinal implant assembly, the first non-planar inner surface and the second non-planar inner surface define a vertically biased interface (examiner annotated Fig. 11 below and paragraph [0039]).
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Paul et al. does not disclose the layer being a piezoelectric layer comprising a piezoelectric material.
Evans discloses a spinal implant assembly having a piezoelectric material (106) between first and second members (108) (Fig. 1D), the piezoelectric material generating or emitting a signal in the form of an electromagnetic field into surrounding bone, tissues, and/or bodily fluids to promote and/or enhance osteoblastic activity in the surrounding bone, tissues, and/or bodily fluids, thereby enhancing bone remodeling and/or fusion (abstract and paragraph [0019]).
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 layer of Paul et al. to be piezoelectric material in view of Evans to permit generating or emitting a signal in the form of an electromagnetic field into surrounding bone, tissues, and/or bodily fluids to promote and/or enhance osteoblastic activity in the surrounding bone, tissues, and/or bodily fluids, thereby enhancing bone remodeling and/or fusion.
Regarding claims 2-4 and 33-35, Paul et al. discloses wherein the first endplate (82) has an outer surface (30) defining, at a front region thereof, a first nose surface, the first nose surface comprising a first downwardly sloped and horizontally extending surface; and the second endplate (86) has an outer surface (also 30) defining, at a front region thereof, a second nose surface, the second nose surface comprising a second downwardly sloped and horizontally extending surface, wherein the spinal implant assembly has a downwardly extending nose surface at a front region (26) thereof corresponding to a combination of the first nose surface and the second nose surface; wherein the first non-planar inner surface (surface of 82 facing 84) has first undulations (ridges and grooves) and the second non-planar inner surface (surface of 86 facing 84) has second undulations (ridges and grooves), the first undulations and the second undulations defined in a longitudinal direction (direction of 26 towards 28) of the spinal implant assembly and conforming to one another; and wherein the non-planar upper surface (surface of 84 facing 82) of the layer (84) conforms to and is adjacent to the first non-planar inner surface, and the non-planar lower surface (surface of 84 facing 86) of the layer conforms to and is adjacent to the second non-planar inner surface (Fig. 11D and paragraph [0039]).
Regarding claims 65 and 76, Paul et al. discloses wherein the first endplate (82) comprises a first lumen; the second endplate (86) comprises a second lumen; the layer (84) comprises a third lumen; and the first lumen, the second lumen, and the third lumen are in registration with reach other (representative illustration shown by 66 in Fig. 7, Fig. 11 and paragraph [0039]).
Regarding claims 67, 68, 78 and 79, the embodiment of Fig. 11 of Paul et al. discloses the invention essentially as claimed except for wherein the first endplate comprises a first grooved recess; the second endplate comprises a second grooved recess; and the first grooved recess and the second grooved recess are in registration with each other to form a grooved recess configured to receive a portion of a spinal implant inserter; and wherein a back region of the second endplate comprises a threaded hole configured to receive a threaded portion of a spinal implant inserter.
Another embodiment of Paul et al., Figs. 2-3, discloses grooved recesses (20) and a threaded hole (24) sized to receive a surgical instrument such as an inserter for implantation (paragraph [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 embodiment of Fig. 11 of Paul et al. such that the first endplate comprises a first grooved recess; the second endplate comprises a second grooved recess; and the first grooved recess and the second grooved recess are in registration with each other to form a grooved recess configured to receive a portion of a spinal implant inserter; and wherein a back region of the second endplate comprises a threaded hole configured to receive a threaded portion of a spinal implant inserter in view of the embodiment of Figs. 2-3 of Paul et al. to permit receiving a surgical instrument such as an inserter to aid a surgeon in placing the implant within a disc space of a patient.
Regarding claim 63, Paul et al. discloses a method to make a kit for a spinal implant assembly, the method comprising: providing a first endplate (82) having a first non-planar inner surface (surface facing 84); providing a second endplate (86) having a second non-planar inner surface (surface facing 84); providing at least one fastener (one or more pins) attaching the first endplate and the second endplate to one another; and providing a layer (84) between the first non-planar inner surface and the second non-planar inner surface and having a non-planar upper surface (surface facing 82) facing toward the first non-planar inner surface and a non-planar lower surface (surface facing 86) facing toward the second non-planar inner surface, wherein, at a front region of the spinal implant assembly, the first non-planar inner surface and the second non-planar inner surface define a vertically biased interface (examiner annotated Fig. 11 above and paragraph [0039]).
Paul et al. does not disclose the layer being a piezoelectric layer comprising a piezoelectric material.
Evans discloses a spinal implant assembly having a piezoelectric material (106) between first and second members (108) (Fig. 1D), the piezoelectric material generating or emitting a signal in the form of an electromagnetic field into surrounding bone, tissues, and/or bodily fluids to promote and/or enhance osteoblastic activity in the surrounding bone, tissues, and/or bodily fluids, thereby enhancing bone remodeling and/or fusion (abstract and paragraph [0019]).
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 layer of Paul et al. to be piezoelectric material in view of Evans to permit generating or emitting a signal in the form of an electromagnetic field into surrounding bone, tissues, and/or bodily fluids to promote and/or enhance osteoblastic activity in the surrounding bone, tissues, and/or bodily fluids, thereby enhancing bone remodeling and/or fusion.
Claim(s) 64, 66 and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul et al., U.S. PG-Pub 2002/0062153 in view of Evans, U.S. PG-Pub 2011/0118852 as applied above, and further in view of Cain et al., U.S. PG-Pub 2021/0085480.
Regarding claim 64, Paul et al. in view of Evans discloses the method essentially as claimed except for wherein at least one or providing the first endplate, providing the second endplate, and providing the at least one fastener comprising using three-dimensional (3D) printing.
Cain et al. discloses a spinal implant formed by three-dimensional (3D) printing which is suitable additive manufacturing technique known in the art (paragraphs [0009] and [0036]).
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 method of Paul et al. such that providing the first endplate, providing the second endplate, and providing the at least one fastener comprising using three-dimensional (3D) printing further in view of Cain et al. as such is a suitable additive manufacturing technique for spinal implants that is well-known in the art.
Regarding claims 66 and 77, Pual et al. in view of Evans disclose the invention essentially as claimed except for wherein the first endplate comprises lattices in a side surface of the first endplate; and the second endplate comprises lattices in a side surface of the second endplate.
Cain et al. discloses a spinal implant having lattices (166) in side surfaces (112, 114) (Figs. 1 and 7 and paragraph [0132]) which is advantageous as such permits the implant to mimic the structure of cancellous bone (paragraph [0038]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a side surface of the first and second endplates of Paul et al. to have lattices further in view of Cain et al. to permit the implant to mimic the structure of cancellous bone for tissue ingrowth/fusion within a disc space of a patient.
Allowable Subject Matter
Claims 5-7, 15-16, 18-23, 25, 36-38, 46-47, 49-54, 56, 69-75 and 80-86 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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