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 Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, “at locking tab” should be “a locking tab”.
Appropriate correction is required.
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 3 and 12 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.
Regarding claim 3, the claim fails to recite from which claim it depends. For the purpose of examination, it is assumed claim 3 depends from claim 1.
Regarding claim 12, it is unclear if the claim requires the body and locking tab to each be integrally formed, or if the claim requires the body and the locking tab to be connected to each other via an integral formation. For the purpose of examination, the latter interpretation is assumed.
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 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.
Claims 1, 3, 8, and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Application Publication No. 2006/0195100 (Kirschman).
Regarding claim 1, Kirschman discloses an interbody spacer for spinal fusion surgery (see Abstract), the interbody spacer comprising: a body (24) configured for insertion within an interbody space between two adjacent vertebrae (see paragraph [0068]), the body including material (42) defining at least one fastener-receiving opening (44) defining a length for receiving a fastener for securing the body to at least one of the adjacent vertebrae (see paragraph [0071] and Figs. 21-23); and a locking tab (62/62a) including a first arm (62) extending along the length of the at least one fastener-receiving opening (see Figs. 21-23), wherein the first arm has a base directly attached to the material defining the at least one fastener-receiving opening and a free end free from attachment to the material defining the at least one fastener-receiving opening (see marked-up Fig. 14 below), and a second arm (62a) extending transversely from the free end of the first arm and into the at least one fastener-receiving opening (see Figs. 21-23 and paragraph [0078]), wherein the second arm is configured to be engaged by the fastener (46) as the fastener is inserted longitudinally into the at least one fastener-receiving opening (see Figs. 21-23 and paragraph [0078]), wherein the first arm is resiliently deflectable when the fastener engages the second arm as the fastener is inserted longitudinally into the at least one fastener-receiving opening to enable the second arm to be moved away from the at least one fastener-receiving opening (see Figs. 21-23 and paragraph [0078]; resiliently deflectable in direction of double arrow C), thereby enabling the fastener to enter the fastener-receiving opening (see Figs. 21-23 and paragraph [0078]).
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As noted above, Kirschman appears to disclose the second arm (62a) extending transversely from the free end of the first arm (62) and into the at least one fastener-receiving opening (see Figs. 21-23 and paragraph [0078]). Alternatively, if the claim language is understood to require the second arm to extend transversely from an extreme distal end of the first arm, it would be obvious as a matter of design choice to have the second arm extend transversely from an extreme distal end of the first arm (62) and into the at least one fastener-receiving opening as such a modification would still allow the detent mechanism to operative as intended without changing the principle of operation of the detent locking mechanism or rendering the detent locking mechanism unsatisfactory for its intended purpose.
Regarding claim 3, Kirschman discloses wherein the first arm is configured to rebound back into the fastener-receiving opening after the fastener clears the second arm to block the fastener from being withdrawn from the at least one fastener-receiving opening (see Figs. 21-23 and paragraph [0078]).
Regarding claim 8, Kirschman discloses wherein the body (24) includes first and second opposite side walls (32a/42a/48 on one side; 32b/42b/50 on the other side), and front (42) and rear (32) walls extending between and interconnecting the first and second side walls (see Figs. 3, 6, 8-11), interior surfaces of the front and rear walls and interior surfaces of the first and second side walls defining an interior cavity (34) in the body, the at least one fastener-receiving opening being formed in the front wall (apertures 44 are formed in front wall 42, see Fig. 11, e.g.).
Regarding claim 9, Kirschman discloses wherein the at least one fastener-receiving opening comprises first and second fastener-receiving openings formed in the front wall (two apertures 44 are formed in front wall 42, see Fig. 11 and paragraph [0071], e.g.).
Claim 10 is rejected under 35 U.S.C. 103 as obvious over Kirschman in view of U.S. Patent Application Publication No. 2014/0094856 (Sinha).
Regarding claim 10, Kirschman is silent regarding wherein the fastener-receiving opening defines a notch for receiving a rib on the fastener for preventing the fastener from rotating relative to the spacer. However, Sinha discloses a system including a fastener (10) and implant (12), the implant defining a fastener-receiving opening (12a) that defines a notch (36) for receiving a rib (projection of outer sidewall surface 20b of head 20 of fastener 10, see paragraph [0040]) on the fastener for preventing the fastener from rotating relative to the implant (see paragraphs [0040] and [0061]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the fastener-receiving opening and fastener of Kirschman to include a notch and rib, respectively, as suggested by Sinha in order to facilitate locking of the fastener relative to the spacer by preventing rotation of the fastener relative to the spacer (see Sinha, paragraphs [0040] and [0061]).
Claim 11-13 are rejected under 35 U.S.C. 103 as obvious over Kirschman in view of U.S. Patent Application Publication No. 2005/0177237 (Shappley).
Regarding claims 11-13, Kirschman discloses the interbody spacer set forth in claim 1 (see analysis of claim 1 above) and discloses wherein the body and the locking tab are integrally formed with a gap between the body and part of the locking tab to permit the locking tab to move relative to the body (see paragraphs [0062] and [0078] and Figs. 21-23), but is silent regarding a method of making the interbody spacer set forth in claim 1 comprising 3D printing the interbody spacer (claim 11); wherein 3D printing the interbody spacer comprises printing a gap between the body and the locking tab to permit the locking tab to move relative to the body, unmelted powder stock material being disposed in the gap between the body and locking tab (claim 13). However, Shappley discloses a method of making interbody spinal implants that comprises 3D printing the implants (see paragraphs [0014], [0139]); wherein 3D printing an implant comprises printing a gap via unmelted powder stock material being disposed in the gap (see paragraphs [0151] and [0152]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to 3D print the interbody spacer of Kirschman as suggested by Shappley in order to easily enable the control of the three dimensional shape of a fabricated material and provide the ability to precisely determine local geometric features and composition of a manufactured piece, to an extent that is not possible with most other manufacturing methods (see Shappley, paragraph [0014] and [0139]). Further, it would be obvious to use unmelted powder stock to form a gap between the body and locking tab, as Kirschman suggests providing a gap between to permit the locking tab to move relative to the body (see Kirschman, paragraph [0078]), and Shappley suggests unmelted stock powder can form an empty, unbound space in a 3D printed implant (see paragraphs [0151] and [0152]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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