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 of Invention III (claims 19-20) in the reply filed on January 14, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The Examiner notes that claims 1-18 have been cancelled and new claims 21-31 depend from claim 19. Therefore, claims 19-31 have been examined.
Claim Objections
Claim 19 is objected to because of the following informalities: the word “and” between “surfaces,” and “posterior” (line 3) should be deleted. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: the comma and a space between “strut” and “from” (line 3) should be deleted. 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 19-31 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. Claim 19 recites the limitation "the tray" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Claims 20-31 depend from claim 19 and are therefore also rejected. The Examiner notes that claims 21, 22, 27, and 28 also recite “the tray.” For examination purposes, the Examiner is interpreting claim 19 as including a tray.
Claim 22 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 22 recites the limitation "the…implant inserter assembly" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting “the…implant inserter assembly” as “the…implant inserter.”
Claims 27 and 28 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. Claim 27 recites the limitation "the…implant inserter assembly" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 28 depends from claim 27 and is therefore also rejected. For examination purposes, the Examiner is interpreting “the…implant inserter assembly” as “the…implant inserter.”
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.
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.
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 19-24 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Bal et al. (US 2015/0305881 A1) in view of Lynn et al. (US 2016/0030188 A1), Kleiner et al. (US 10,245,159 B1), and Greenhalgh et al. (US 2016/0296344 A1).
Claim 19. Bal discloses a system for spinal surgery, comprising:
an interbody implant (cage 1), including a body having top and bottom surfaces (surfaces with upper and lower teeth 1.4), opposite side surfaces (surfaces having cut 1.3 as shown in Fig. 2), and posterior and anterior surfaces (surface adjacent expansion end 2.1 and surface with instrument hollow 1.5), and a central strut (expansion end 2.1) from the anterior surface in the direction of the posterior surface,
the posterior surface including a posterior opening (hole 1.6) accounting for at least 30% of the posterior surface (see Fig. 2, which shows that hole 1.6 extends along at least 30% of the length of the posterior surface), and the side surfaces each including a side opening (cut 1.3) accounting for at least 50% of each of the side surfaces (see Figs. 1 and 2, which show that cut 1.3 extends along at least 50% of the length of each side surface),
wherein the posterior opening allows for bone graft to flow into the interbody implant, and the side openings allow for the bone graft to flow out of the interbody implant and into a patient's surrounding disc space (see paras. 0072-0073);
an implant inserter (instrument 3) releasably connected to the interbody implant and including an inserter tube (fixator 3.3.2), the implant inserter having uniform internal areas for transmission of bone graft therethrough, and through the posterior opening of the interbody implant (Figs. 1-5).
Claim 23. Bal discloses a release tube (fixator 3.3.1) and a tube (adapter 3.2), wherein the inserter tube is received in the release tube and the tube is received in the inserter tube (Figs. 1-5).
Claim 29. Bal discloses a release tube (fixator 3.3.1) connected to the inserter tube (Figs. 1-5).
Bal fails to disclose that the system is a kit (claim 19), a graft funnel configured to removably engage a proximal end of the implant inserter (claim 19), a graft plunger configured to be inserted through the graft funnel so as to advance bone graft through the implant inserter, and moving bone graft through the interbody implant and into the disc space (claim 19), wherein the interbody implant is attached to the implant inserter and disposed in the tray (claim 19), an instrument selected from a group consisting of a slap hammer, an inserter slap hammer adaptor, a side grip remover/repositioner instrument, a hooked remover/repositioner instrument and a threaded remover/repositioner instrument (claim 20), wherein the graft funnel and graft plunger are disposed in the tray (claim 21), wherein the interbody implant, implant inserter assembly, graft funnel and graft plunger have predetermined positions in the tray (claim 22), wherein the tube is a cannula (claim 23), and an impactor receivable in the inserter tube to transmit an impact force directly to the interbody implant (claim 24).
Lynn teaches that a kit for spinal surgery comprises an interbody implant and a variety of instruments (see para. 0031). Lynn also teaches that the instruments include: an implant inserter including an inserter tube (outer member 310) and a tube (rod 340) in the form of a cannula (see para. 0147) to provide means to deliver bone graft to the interbody implant (see para. 0147); and a slap hammer/impactor (slap hammer 380) to provide means for aiding insertion of the interbody implant and implant inserter (see para. 0130) (Figs. 11-12B).
Kleiner teaches a graft funnel (funnel 30) configured to removably engage a proximal end of an implant inserter (tube 2) and a graft plunger (plunger 12) configured to be inserted through the graft funnel so as to advance bone graft through the implant inserter, and moving bone graft through the interbody implant and into the disc space, to provide for controlled insertion of bone graft (see col. 25, l. 63 through col. 26, l. 4) (Figs. 7A-7E).
Greenhalgh teaches that various components of a kit are provided in a tray (see Fig. 13 and para. 0123), wherein the tray is configured such that the components have predetermined positions in the tray (see Fig. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the interbody implant and the instruments as a kit (claim 19) disposed in predetermined positions in a tray (claims 19, 21, and 22), as suggested by Lynn and Greenhalgh, in order to provide the surgeon with all components needed for the surgical procedure organized and ready for use. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit to include a graft funnel and a graft plunger (claim 19), as suggested by Kleiner, to provide for controlled insertion of bone graft. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit such that the tube is a cannula (claim 23), as suggested by Lynn, to provide means to deliver bone graft to the interbody implant. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit to include a slap hammer/impactor (claims 20 and 24), as suggested by Lynn, to provide means for aiding insertion of the interbody implant and implant inserter.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Bal et al. (US 2015/0305881 A1) in view of Lynn et al. (US 2016/0030188 A1), Kleiner et al. (US 10,245,159 B1), and Greenhalgh et al. (US 2016/0296344 A1) as applied to claim 19 above, and further in view of Barrett et al. (US 2012/0065734 A1).
Bal, Lynn, Kleiner, and Greenhalgh fail to teach a cover plate configured to removably engage the posterior opening of the interbody implant (claim 25).
Barrett teaches a cover plate (element 110) configured to removably engage a posterior opening (one of openings receiving screws 60 as shown in Fig. 5C) of an interbody implant (spacer 5 and plate 10) to provide a smooth surface that reduces the risk of injury to tissue (see para. 0032) (Figs. 5A-5D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit such that it includes a cover plate (claim 25), as suggested by Barrett, to provide a smooth surface that reduces the risk of injury to tissue.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bal et al. (US 2015/0305881 A1) in view of Lynn et al. (US 2016/0030188 A1), Kleiner et al. (US 10,245,159 B1), and Greenhalgh et al. (US 2016/0296344 A1) as applied to claim 29 above, and further in view of Grimberg et al. (US 2016/0106551 A1).
Bal, Lynn, Kleiner, and Greenhalgh fail to teach disassembly pliers having tips and a compressible handle (claim 30), wherein the disassembly pliers release the interbody implant from the inserter tube (claim 31).
Grimberg teaches disassembly pliers (pliers 270) having tips (attached to tube 2) and a compressible handle (see Fig. 68A), wherein the disassembly pliers release an interbody implant (cage 60) from an inserter tube (installer 250) (see para. 0321) (Figs. 68A-B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit such that it includes disassembly pliers (claims 30 and 31), as suggested by Grimberg, to simplify removal of the implant inserter from the interbody implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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