DETAILED ACTION
This action is in response to Applicant’s amendment filed on January 29, 2026.
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
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, 7-10, 16-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark (U.S. Patent No. 4801263).
Clark discloses a bone graft delivery system kit comprising: a handle (32); a first elongate tube (44) having a first length (Figure 4) configured to be coupled to the handle; a second elongate tube (56) having a second length (Figure 6) configured to be coupled to the handle; and one or more plungers (10, 14 66) configured to be removably received in the handle and one or both of the first elongate tube and the second elongate tube (Column 4, lines 62-67 and Column 5, Lines 1-30).
Regarding claim 6, the distal end of each of the one first elongate tube and the second elongate tube comprises a first engagement feature configured to engage a second engagement feature positioned at a proximal end of an implant. The shape of the distal end itself can be considered the engagement feature. The implant only being functionally claimed is not required in the claim.
Regarding claim 7, the handle (32) comprises an opening (30) configured receive the bone graft material.
Regarding claim 8, the handle (32) further comprising an actuation mechanism (18) configured to be actuated to move one of the one or more plungers within one or both of the first elongate tube and the second elongate tube.
Regarding claim 9, the actuation mechanism can be considered a trigger since depressing it triggers bone substitute material to be extruded.
Regarding claim 10, the kit further comprising a bone graft loading (68) configured to coupled to one or both of the first elongate tube and the second elongate tube. It is considered that element 68 is capable of performing the claimed function.
Regarding claim 16, each of the first elongate tube and the second elongate tube is sufficiently rigid to maintain a permanent shape during positioning of the first elongate tube or the second elongate tube within the body of the patient (Figure 4, 6).
Regarding claim 17, the kit further comprises at least one applicator (20) configured to coupled to one or both of the first elongate tube and the second elongate tube.
Regarding claim 18, the at least one applicator comprising a curve proximate a distal end of the at least one applicator. The applicator being cylindrical, has a curve in the claimed location.
Regarding claim 20, each of the first elongate tube and the second elongate tube is coupled to a distal end cap (40) and a proximal end cap (46).
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) 3, 15, is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark (U.S. Patent No. 4801263) in view of McGill et al. (U.S. Patent No. 8038682).
Clark discloses the claimed invention except for each of the first elongate tube and second elongate tube comprises one or more markers configured to indicate a position of the first elongate tube or the second elongate tube within a body of a patient with the use of a radiopaque marker. McGill teaches a device for delivering material into a vertebra having a tube (102) with radiopaque markers to monitor a position of the cannula using a fluoroscope (Column 7, Lines 24-29). It would have been obvious to one skilled in the art to construct the device with one or more markers and in particular radiopaque markers in view of McGill et al. to monitor a position of the device under fluoroscopy.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark (U.S. Patent No. 4801263).
Regarding claim 11-14, Clark discloses the claimed invention and including the one or both of the tubes preloaded with material (Column 4, lines 62-67 and Column 5, Lines 1-30). Clark fails to disclose the type of material loaded in the elongate tube. It would have been obvious to one having ordinary skill to use the claimed materials of claims 11-14, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Allowable Subject Matter
Claims 2, 4-5, 19 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose the particulars of the one or more tips and the details applicator.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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