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 .
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 13 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 13 recites the limitation "each curvilinear end" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is additionally unclear how the invention described in claim 11 includes the rod body having the claimed groove. As best understood, claim 11 describes the embodiment of Figure 21 while claim 13 includes a feature of a separate embodiment depicted in Figure 22. Examiner has withdrawn this claim from examination.
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, 8-12, 14, 18-20 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 2, Gradl discloses the implant device of claim 1, wherein the rod body includes a head portion (4’) connected to a separate shaft portion (4’’).
Regarding claim 3, Gradl discloses the implant device of claim 2, wherein the head portion is joined to the shaft portion with a pin (15) extending through the head portion and the shaft portion.
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).
Regarding claim 11, 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 surface), 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’), the rod body includes a shaft portion (at 4’, FIG. 1), a separate first head portion (7), and a separate second head portion (7’) (the head portions are separate from one another), the first end and the second end are rotatably disposed in the corresponding first and second sockets (FIGS. 3-4).
Regarding claim 12, Gradl discloses the implant device of claim 11, wherein the first or second head portion is joined to the shaft portion with a pin (15) extending through the head portion and the shaft portion.
Regarding claim 14, Gradl discloses the implant device of claim 11, further comprising a retaining structure, wherein the retaining structure comprises a spike (9) protruding from the first or second endplate.
Regarding claim 18, Gradl discloses the implant device of claim 11, 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 19, Gradl discloses the implant device of claim 11, wherein the first end and the second end are semi spherical in shape (FIG. 1).
Regarding claim 20, Gradl discloses the implant device of claim 11, 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 and 15 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 claims 5 and 15, Gradl discloses the implant device of claims 4 and 14, 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 and 16 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 claims 6 and 16, Gradl discloses the implant device of claims 1 and 11, 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 and 17 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 claims 7 and 17, Gradl discloses the implant device of claims 1 and 11, 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
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