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 § 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.
Claim 31 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyler et al. (4,735,208).
Wyler et al. disclose a flexible plunger 10 (Figs. 1-3) capable of use in a bone fusion system, the flexible plunger comprising:
a handle (i.e., a portion capable of being grasped) 32;
a first straight flexible rod (i.e., a wire, which can be characterized as a fine flexible rod) 18;
a second straight flexible rod (id.) 18; and
a sleeve 34, 20, 38 integrally coupled with the handle 32, wherein a portion of the first straight flexible rod 18 and a portion of the second straight flexible rod 18 that extend out from the sleeve away from the handle have different lengths (Figs. 1 and 2) such that a distal tip of the first straight flexible rod is offset from a distal tip of the second straight flexible rod when both are fully extended away from the sleeve (id.). It is noted that the preamble states an intended use for which the device of Wyler et al. is capable. For example, the device of Wyler et al. is capable of being plunged (i.e., pushed or inserted) into tissue involved in a bone fusion procedure, if desired, to deliver electrical stimulation.
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 1, 12 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich et al. (2002/0010472; previously cited by Examiner) in view of McLean (2017/0325969; cited by Applicant).
Regarding claim 1, Kuslich et al. disclose a bone fusion system (Figs. 5-7 and paras. 0003, 0004 and 0006) for inserting material into a bone fusion device in a desired location, the system comprising:
a bone fusion body (e.g., an expandable fabric bag that contains the bone replacement material that causes stabilization through bony fusion; id.); and
a delivery apparatus (Fig. 5) comprising a delivery member 40 having an elongated hollow shaft (para. 0032) that leads to an exit aperture 30, the exit aperture formed by an L-shaped cutout of a tip of the elongated hollow shaft (Fig. 6).
Thus, Kuslich et al. disclose the claimed invention except the docking rod.
McLean discloses also discloses a graft delivery apparatus including a delivery member (i.e., cannula) (para. 0004) and teaches configuring the delivery member with structure 24 to accept a docking rod 22 (i.e., guide pin) (Fig. 2; paras. 0004 and 0014) to guide the delivery member along the docking rod to a desired orientation relative to a bone fusion body (i.e., an implant; id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the delivery member 40 of Kuslich et al. with structure to accept include a docking rod, in view of McLean, to guide the delivery member 40 along the docking rod to a desired orientation relative to the bone fusion body.
Regarding claim 12, Kuslich et al. disclose a method of operation of a bone fusion system (Figs. 5-7 and paras. 0003, 0004 and 0006), the method comprising:
providing a bone fusion body (e.g., an expandable fabric bag that contains the bone replacement material that causes stabilization through bony fusion; id.); and
a delivery member 40 having an elongated hollow shaft (para. 0032) that leads to an exit aperture 30, and further wherein the exit aperture is formed by an L-shaped cutout of a tip of the elongated hollow shaft (Fig. 6).
Thus, Kuslich et al. disclose the claimed method except for detachably coupling the delivery member 40 to a docking rod.
McLean discloses also discloses a graft delivery method (para. 0004) and teaches detachably coupling a delivery member (i.e., cannula; id.) to a docking rod 22 to guide the delivery member along the docking rod to a desired orientation relative to a bone fusion body (i.e., an implant; id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the method of Kuslich et al. with a step of detachably coupling the delivery member 40 to a docking rod, in view of McLean, to guide the delivery member 40 along the docking rod to a desired orientation relative to the bone fusion body.
Regarding claim 24, Kuslich et al. disclose a delivery apparatus for use in a bone fusion system (Figs. 5-7 and paras. 0003, 0004 and 0006), the delivery apparatus comprising:
an elongated hollow shaft 40 having an entrance aperture through which graft material is delivered (para. 0032), an exit aperture 30, and wherein the exit aperture 30 is formed by an L-shaped cutout of a tip of the elongated hollow shaft 40 (Fig. 6).
Kuslich et al. do not disclose the elongated hollow shaft having one or more coupling hoops extending from an outer surface of the elongated hollow shaft 40 between the exit aperture and the entrance aperture, and a funneling chamber coupled to the entrance aperture of the elongated hollow shaft 40.
McLean also discloses a delivery apparatus for use in a bone fusion system (Figs. 1, 2 and para. 0004) and teach that an elongated hollow shaft 12 can be configured with a coupling hoop 24 extending from outer surface of the elongated hollow shaft 12 between an exit aperture and an entrance aperture to accept a guide pin 22, and with a funneling chamber 18 integrally coupled to the entrance aperture of the elongated hollow shaft 12. This configuration allows the elongated hollow shaft to accept a guide pin to guide the elongated hollow shaft along the guide pin to a desired orientation relative to a bone fusion body (i.e., an implant; para. 0004). The funneling chamber 18 facilitates the introduction of bone graft material (para. 0010). Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the elongated hollow shaft 40 of Kuslich et al. to include a coupling hoop extending from an outer surface of the elongated hollow shaft 40 between the exit aperture and the entrance aperture, the coupling hoop accepting a guide pin, and a funneling chamber coupled to the entrance aperture of the elongated hollow shaft 40, in view of McLean, to allow the elongated hollow shaft 40 to accept an included guide pin to guide the elongated hollow shaft along the guide pin to a desired orientation relative to the bone fusion body, and to facilitate the introduction of bone graft material.
Regarding claim 25, the apparatus of the combination includes a docking rod 22 (i.e., the guide pin) that detachably couples with the elongated hollow shaft 40 by sliding through the coupling hoop 24.
Regarding claim 26, a first side of the L- shaped cutout (Kuslich et al.; Fig. 6) is substantially parallel with a central axis of the elongated hollow shaft 40 (id.).
Regarding claim 27, McLean further teaches that the docking rod 22 detachably couples with a handle 34 (i.e., a portion that facilitates holding) (Fig. 2) by sliding into a handle channel 34a of the handle such that the docking rod 22 is concurrently positioned through the coupling hoop 24 and the handle channel 34a. This configuration facilitates guiding the elongated hollow shaft along the docking rod to a desired orientation relative to the bone fusion body.
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the device of the combination so that the docking rod 22 detachably couples with a handle by sliding into a handle channel of the handle such that the docking rod is concurrently positioned through a coupling hoop and a handle channel, in view of McLean, to facilitate guiding the elongated hollow shaft along the docking rod to a desired orientation relative to the bone fusion body.
Allowable Subject Matter
Claim 33 is allowed.
Claims 2-5, 7-11, 13-16 and 18-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
Claim 33 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations recited in independent claim 33. In particular, none of the cited references teach or suggest detachably coupling a delivery member to a bone fusion body, and sliding the first and second straight flexible rods into any elongated hollow shaft of a delivery member, wherein an elongated hollow shaft that leads to an exit aperture is positioned adjacent to a bone fusion body, as required by claim 33.
Response to Arguments
Applicant’s arguments, see Remarks filed 16 December 2025, with respect to the rejection of claims 1, 12 and 24-27 under 35 U.S.C. 103 over Kleiner et al. (2013/0345710) in view of McLean (2017/0325969) have been fully considered and are persuasive for the reasons set forth therein with regard to Kleiner et al. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been found, as set forth above. It is noted that McLean was not relied upon in the prior Office action for the L-shaped cutout of a tip of the elongated hollow shaft, and remains applicable. It is further noted that the indicated allowability of claim 31 is withdrawn because new grounds of rejection have been found, as set forth above.
The present Office action is accordingly non-final.
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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773