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
Claims 4, 7-8, 10, and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/29/2025.
Applicant’s election without traverse of thread species 7 (Figs. 8A-8C) and tip species A (Figs. 1D-1F) in the reply filed on 09/29/2025 is acknowledged.
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.
Claims 1-3, 5, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKenna et al. (US 20130204160 A1) (hereon referred to as McKenna).
Regarding claim 1, McKenna teaches a surgical device (see Fig. 1A) comprising:
an inner stylet component (200) comprising a first handle (202) and an elongated rod (204) having a proximal end (210) attached to a bottom surface of the first handle (202) and a distal end (206) comprising a needle tip (212);
an outer stylet component (100) comprising a second handle (102) and an elongated cannula (104) having a proximal end (106) attached to a bottom surface of the second handle (102) and a distal open end (110) comprising cutting elements (117) formed on an outer surface (see Para. [0030]);
wherein the elongated rod (204) of the inner stylet (200) component is sized to removably fit and slide within (see Para. [0031]) the elongated cannula (104) of the outer stylet component (100);
wherein the first handle (202) is configured to sit onto and interlock with the second handle (102);
wherein the elongated rod (204) is sized so that the needle tip (212) protrudes through the distal open end (110) of the elongated cannula (104), when the first (202) and second (102) handles are interlocked (see Para. [0033]); and
wherein rotating the interlocked first and second handles moves forward the elongated cannula and the needle tip (see Para. [0033]) and cuts a profile in an insertion site with the cutting elements of the outer cannula and generates an opening in the insertion site with the needle tip (see Paras. [0048-0049]).
Regarding claim 2, McKenna teaches the device of claim 1, wherein the needle tip (212) comprises a trocar needle tip (see Para. [0032]).
Regarding claim 3, McKenna teaches the device of claim 2, wherein the trocar needle tip (212) comprises a three-sided cutting conical form (see Para. [0032]).
Regarding claim 5, McKenna teaches the device of claim 1, wherein the cutting elements (117) of the elongated cannula (104) are configured to cut radially and/or straight into the insertion site (note that this is a functional recitation, satisfied by the devices ability to be placed straight into bone, see Para. [0030]).
Regarding claim 11, McKenna teaches the device of claim 1, wherein the distal open end (110) of the elongated cannula (104) further comprises one or more fenestrations (112) configured to be used for delivering of graft material into the insertion site (see Para. [0028]).
Regarding claim 12, McKenna teaches the device of claim 1, wherein the inner stylet component (200) and the outer stylet component (100) comprises stainless steel (see Paras. [0025 and 0031]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elias et al. (US 3850158 A) (hereon referred to as Elias).
Regarding claim 1, Elias teaches a surgical device (see Fig. 1) comprising:
an inner stylet component (14) comprising a first handle (13) and an elongated rod (see Fig. 4) having a proximal end (19) attached to a bottom surface of the first handle (see Col. 2, ll. 39-63) and a distal end (23) comprising a needle tip (31);
an outer stylet component (18) comprising a second handle (17) and an elongated cannula (22) having a proximal end (24) attached to a bottom surface of the second handle (17) and a distal open end (see Fig. 3) comprising cutting elements (25) formed on an outer surface (see Fig. 3);
wherein the elongated rod (see Fig. 4) of the inner stylet (14) component is sized to removably fit and slide within (see Col. 2, ll. 39-63) the elongated cannula (22) of the outer stylet component (18);
wherein the first handle (13) is configured to sit onto and interlock with the second handle (17);
wherein the elongated rod (see Fig. 4) is sized so that the needle tip (31) protrudes through the distal open end (see Fig. 3) of the elongated cannula (22), when the first (13) and second (17) handles are interlocked (see Fig. 1); and
wherein rotating the interlocked first and second handles moves forward the elongated cannula and the needle tip (see Col. 4, ll. 1-36) and cuts a profile in an insertion site with the cutting elements of the outer cannula and generates an opening in the insertion site with the needle tip (see Col. 4, ll. 1-36).
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.
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.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Elias (US 3850158 A) in view of Gray et al. (US 20190223917 A1) (hereon referred to as Gray).
Elias teaches a surgical device as outlined in the rejection of claim 1 above, however fails to teach the cutting elements of the elongated cannula comprising quad-lead cutting threads and dual-lead cutting threads (claim 6), wherein the cutting elements of the elongated cannula comprise a quad-lead helix cutting thread that has four sharp cutting edges (claim 9).
Gray teaches a bone anchor comprising a threaded shaft (10) which consists of quad lead threads (62) and dual lead threads (60), wherein the threads are cutting edges (see Para. [0013]), and whereon the quad lead thread is a helical cutting thread (see Para. [0013] and Fig. 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the threads of Elias to be quad-lead and dual-lead cutting threads (claim 6), or wherein the threads comprise a quad-lead helix cutting thread that has four sharp cutting edges (claim 9), as this would prevent unwanted movement of sliding of the screw (see Para. [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773