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 .
Response to Amendment
This office action is in response to the amendment filed May 20, 2026. As directed by the amendment, claims 1, 11, 13 have been amended and claims 2-3, 12 have been cancelled. As such, claims 1, 4-11, 13-20 remain under consideration in the instant application.
Election/Restrictions
Newly amended claim 1 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 1 describes the embodiment of Figure 5a, wherein the rod comprises apertures and a passageway to connect them, whereas original claims 1-3 described the embodiment of Figure 21, wherein the head is connected to the shaft via pin. The two embodiments are mutually exclusive.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, the newly added limitations are withdrawn from consideration as being directed to a non-elected invention and the claims are being considered without them. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11, 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Newly amended claim 11 recites a shaft portion with separate head portions (belonging to Figure 21) and also apertures and passageways in the rod (belonging to Figure 5a). The two are mutually exclusive and therefore the inclusion of both limitations is new matter.
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.
Claim(s) 1, 4, 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gradl et al. (US 2008/0015704), hereinafter “Gradl”.
Regarding claim 1, Gradl discloses an implant device (1) for grafting together adjacent bony structures of a body comprising: a first endplate (5’) having a first outer surface (upper), and a first inner disc portion having a first integrally formed socket (6’); a second endplate (5’’) having a second outer surface (lower surface), and a second inner disc portion having a second integrally formed socket (6’’); and a rod (4’ with 4’’) having a longitudinally extending rod body and a first end (7) and a second end (7’), wherein the first end is rotatably disposed in the first socket and the second end is rotatably disposed in the second socket (FIGS. 3-4).
Regarding claim 4, Gradl discloses the implant device of claim 1, further comprising a retaining structure, wherein the retaining structure comprises a spike (9) protruding from the first or second endplate.
Regarding claim 8, Gradl discloses the implant device of claim 1, further comprising a fastener (12) adapted to extend through an aperture (11) in the first or second endplate into the bony structure for securing the first or second endplate to the bony structure.
Regarding claim 9, Gradl discloses the implant device of claim 1, wherein the first end and the second end are semi spherical in shape (FIG. 1).
Regarding claim 10, Gradl discloses the implant device of claim 1, wherein the first end and the second end are spherical in shape (FIG. 1).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gradl in view of McLaughlin et al. (US 2011/0251691), hereinafter “McLaughlin”.
Regarding claim 5, Gradl discloses the implant device of claim 4, except wherein the first or second endplate further comprises a cleat shorter than the spike extending from endplate. McLaughlin teaches an implant device (10) for grafting together adjacent bony structures of a body comprising: a first endplate (20) and a second endplate (40), and further comprising a retaining structure including a spike (94) protruding from the first or second endplate, wherein the first or second endplate further comprises a cleat (106) shorter than the spike extending from endplate. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to combine a cleat with the spiked endplate of Gradl, for the purpose of adding texture and grip to the endplate when in contact with the vertebrae. In this case, one would add short cleats to the outer surfaces of the endplates of Gradl.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gradl in view of Kim et al. (US 2007/0168033), hereinafter “Kim”.
Regarding claim 6, Gradl discloses the implant device of claim 1, except further comprising a fusion shaft member disposed on the rod body, wherein the fusion shaft member includes a body having a ring shape. Kim teaches an implant device (100, FIGS. 12-15) for grafting together adjacent bony structures of a body comprising: a first endplate (110), a second endplate (120), a rod body (130), and further comprising a fusion shaft member (150) disposed on the rod body, wherein the fusion shaft member includes a body having a ring shape (FIG. 15). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to combine a fusion shaft member with the device of Gradl, in order to enclose the rod body such that surrounding tissue does not interfere with the function of the device. In this case, one would form a fusion member surrounding the rod body of Gradl.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gradl in view of Lindner et al. (US 2006/0293755), hereinafter “Lindner”.
Regarding claim 7, Gradl discloses the implant device of claim 1, except wherein the first and second endplates include a passageway for transporting bone material therethrough. Lindner teaches an implant device (1) for grafting together adjacent bony structures of a body comprising: a first endplate (upper 4) and a second endplate (lower 4), wherein the first and second endplates include a passageway (43) for transporting bone material therethrough. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to combine a passageway in the endplates of the device of Gradl, in order to allow bone material through. In this case, one would form apertures such as those of Lindner in the endplates of Gradl.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
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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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775
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