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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The domestic benefit data in the Application Data Sheet lists an unrelated application to another inventive entity: 17/864,755. If Applicant desired to claim the benefit of a prior-filed application, a corrected Application Data Sheet must be filed showing the appropriate priority document.
Acknowledgment is made of applicant's claim for foreign priority based on European applications filed on 16 July 2021. It is noted, however, that applicant has not filed a certified copy of these application as required by 37 CFR 1.55.
Accordingly, the effective filing date accorded to this application is the actual filing date of 29 May 2025.
To claim the benefit of either any prior-filed domestic application or of any foreign applications, appropriate correction is required.
Specification
The abstract of the disclosure is objected to because it contains language that can be implied: “The present disclosure provides.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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.
Claims 7, 8, 10, 16, 17 and 19 are 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.
Claims 7 and 16 both appear to be missing language for remaining limitations, as well as a period at the end of each claim, making the intent of the claims unclear. As best understood and for purposes of examination, the claims will be considered at reciting the included language and concluding with proximal movement of the translation member moves a distal portion of the fusion device.
In addition, claim 8, line 3, after “endplate” (second instance), includes an underline under a comma, indicating a claim amendment; however, no amended status identified is present.
Claim 10, “the first and second endplates” lacks consistent antecedent basis.
Claim 17 includes an underline under the period at the end of the sentence indicating an amendment; however, no amended status identifier is present.
Claim 19, “the first and second endplates” lacks consistent antecedent basis.
Dependent claims are also rejected because they depend from and include the limitations of their respective parent claim(s).
Appropriate correction is required.
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.
Claims 1, 7-12 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gleason (2021/0030561; cited by Applicant).
Regarding claim 1, Gleason discloses an adjustable spinal fusion device (annotated Fig. 7, below), comprising:
an upper endplate 104 having proximal and distal ends, and an outer surface for placement against a first vertebral body;
a lower endplate 102 having proximal and distal ends, and an outer surface for placement against a second vertebral body; and
a translation member 106, 110 configured to move proximally at portion 106 thereof in discrete increments (e.g., as by a user determining to rotate by a discrete predetermined amount) relative to the upper and lower endplates to adjust an angle (Fig. 7) between the upper and lower endplates by moving the distal end of the upper endplate away from the distal end of the lower endplate (Fig. 7) and maintaining a fixed distance between the proximal end of the upper endplate and the proximal end of the lower endplate (id.).
Regarding claim 7, the translation member 106, 110 comprises an angled surface extending downward from the upper endplate 104 towards the lower endplate 102 in the proximal direction, the device further comprising a ramp for cooperating with the angled surface of the translation member such that proximal movement of the translation member moves the distal ends of the endplates apart (annotated Fig. 7, supra).
Regarding claim 8, proximal movement of the translation member 106, 110 causes the angled surface to engage the ramp and move the distal end of the upper endplate away from the distal end of the lower endplate, and wherein the proximal ends of the endplates remain substantially fixed relative to each other as the distal ends are moved apart (annotated Fig. 7, supra).
Regarding claim 9, the translation member 106, 110 comprises a bore with a hexagonal mating feature for receiving a surgical instrument to effect movement in the longitudinal direction (id.).
Regarding claim 10, the proximal ends of the upper and lower endplates 104, 102 are pivotally coupled to each other (Figs. 5 and 6).
Regarding claim 11, the lower endplate 102 comprises one or more projections (screws) extending laterally therefrom (from threaded aperture 119; Figs. 5 and 6), and wherein the upper endplate 104 comprises one or more openings (Fig. 6), wherein the projections (screws) extend through the openings (Fig. 6) to couple the upper endplate 104 to the lower endplate 102 (id.).
Regarding claim 12, Gleason discloses an adjustable spinal fusion device (annotated Fig. 7), comprising:
an upper endplate 104 having proximal and distal ends, and an outer surface for placement against a first vertebral body;
a lower endplate 102 having proximal and distal ends, and an outer surface for placement against a second vertebral body;
a translation member 106, 110 configured to move longitudinally in a first direction relative to the upper and lower endplates to adjust an angle between the upper and lower endplates by moving the distal end of the upper endplate away from the distal end of the lower endplate and maintaining a fixed distance between the proximal end of the upper endplate and the proximal end of the lower endplate (annotated Fig. 7); and
a mechanism, e.g., threads of the screw 110, for inhibiting movement of the translation member 106, 110 in a second direction opposite of the first direction.
Regarding claim 16, the translation member 106, 110 comprises an angled surface extending downward from the upper endplate 104 towards the lower endplate 102 in the proximal direction, the device further comprising a ramp for cooperating with the angled surface of the translation member such that proximal movement of the translation member moves the distal ends of the endplates apart (annotated Fig. 7, supra).
Regarding claim 17, proximal movement of the translation member 106, 110 causes the angled surface to engage the ramp and move the distal end of the upper endplate away from the distal end of the lower endplate, and wherein the proximal ends of the endplates remain substantially fixed relative to each other as the distal ends are moved apart (annotated Fig. 7, supra).
Regarding claim 18, the translation member 106, 110 comprises a bore with a hexagonal mating feature for receiving a surgical instrument to effect movement in the longitudinal direction (id.).
Regarding claim 19, the proximal ends of the upper and lower endplates 104, 102 are pivotally coupled to each other (Figs. 5 and 6).
Regarding claim 20, the lower endplate 102 comprises one or more projections (screws) extending laterally therefrom (from threaded aperture 119; Figs. 5 and 6), and wherein the upper endplate 104 comprises one or more openings (Fig. 6), wherein the projections (screws) extend through the openings (Fig. 6) to couple the upper endplate 104 to the lower endplate 102 (id.).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-6 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gleason (2021/0030561; cited by Applicant) in view of Suddaby (2004/0044411).
Regarding claim 2, Gleason discloses the claimed invention except for, wherein the translation member 106, 110 comprises a plurality of teeth and one of the upper or lower endplates 104, 102 comprises a plurality of projections that cooperate with the teeth, wherein the projections move relative to the teeth as the translation member is moved proximally.
Suddaby teaches an adjustable implant (Fig. 1) comprising teeth 28, 30 (i.e., teeth and “projections”) on mutually engaging surfaces of the implant to permit expansion, prevent unintended collapse, and provide useful tactile or audible feedback to the surgeon (para. 0021).
Regarding claim 2, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide desired surfaces of Gleason, including on the surface of the translation member portion 106 that mutually engages the ramps of the upper endplate 104 (annotated Fig. 7, supra), with cooperating teeth (i.e., teeth and projections) in view of Suddaby, to facilitate expansion, prevent unintended collapse, and provide useful tactile or audible feedback to the surgeon.
Regarding claim 3, the teeth of the fusion device of the combination form spaces therebetween and the projections (the cooperating teeth) are configured to move from a first space between a first tooth and a second tooth and a second space between the second tooth and a third tooth, wherein the first and second spaces are the discrete increments (Suddaby, Fig. 1).
Regarding claim 4, the teeth of the fusion device of the combination (supra) inhibit distal movement of the translation member 106, 110 (supra).
Regarding claim 5, projections (cooperating teeth) are disposed on the upper endplate 104 of the combination (supra).
Regarding claim 6, the teeth are also disposed on the lower endplate if desired (supra).
Regarding claim 13, the combination comprises a plurality of teeth and a plurality of projections that cooperate with the teeth, wherein the projections move relative to the teeth as the translation member 106, 110 is moved longitudinally (supra).
Regarding claim 14, the teeth of the fusion device of the combination form spaces therebetween and the projections (the cooperating teeth) are configured to move from a first space between a first tooth and a second tooth and a second space between the second tooth and a third tooth, wherein the first and second spaces are the discrete increments (Suddaby, Fig. 1).
Regarding claim 15, the teeth of the fusion device of the combination (supra) inhibit distal movement of the translation member 106, 110 (supra).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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