DETAILED ACTION
Response to Amendment
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, 5, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weksel et al. (US 2018/0264201; hereafter Weksel).
In regard to claim 1, Weksel discloses a tubular needle (20) comprising: a housing (24) defined by a housing proximal end and a housing distal end (see Fig. 3), wherein the housing proximal end includes a connector (see par. [0029]); a straight section (straight portion of 22 extending from 24 to 20c) comprising a proximal end and a distal end (see Fig. 3), the proximal end operably connected to the housing distal end (see Fig. 3); a curved section (20c) comprising a proximal end and a distal end, wherein the proximal end is operably connected to the distal end of the straight section (see Fig. 3), and wherein the distal end of the curved section comprises a sharpened tip (30). Please see other figures for relevant embodiments as well.
In regard to claim 5, Weksel discloses wherein the curved section is configured in a segment of a circle, a segment of an ellipse, or a segment of a parabola (see shapes in Figs 3-5).
In regard to claim 8, Weksel discloses wherein the straight section, curved section, or both are constructed from stainless steel, nitinol, tantalum, cobalt, chrome, titanium, nickel, and/or combinations or alloys thereof (see par. [0011]).
Claim(s) 1, 3, 5, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koch (US 5,284,476).
In regard to claim 1, Koch discloses a tubular needle (10) comprising: a housing (12) defined by a housing proximal end and a housing distal end (see Fig. 1), wherein the housing proximal end includes a connector (14; see col. 4, lines 7-9); a straight section (20) comprising a proximal end and a distal end (see col. 4, lines 16-25), the proximal end operably connected to the housing distal end (see Figs. 1-4); a curved section (22 including 23) comprising a proximal end and a distal end (see Figs. 1-4), wherein the proximal end is operably connected to the distal end of the straight section (see any of the figures discussed above), and wherein the distal end of the curved section comprises a sharpened tip (23 including 31; see col. 4, line 25- col. 5, line 18).
In regard to claim 3, Koch discloses wherein the straight section has a length of about 0.1-1 inches (see col. 4, lines 23-25; 8 mm is within the recited range) and the curved section has a length of about 0.1-5 inches (see col. 4, lines 32-37; total length is 20 mm with the straight section being 8 mm, the curved section is 12 mm; 12 mm is with the recited range).
In regard to claim 5, Koch discloses wherein the curved section is configured in a segment of a circle, a segment of an ellipse, or a segment of a parabola (see col. 4, lines 50-64).
In regard to claim 8, Koch discloses wherein the straight section, curved section, or both are constructed from stainless steel (see col. 4, lines 18-19), nitinol, tantalum, cobalt, chrome, titanium, nickel, and/or combinations or alloys thereof.
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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Weksel or Koch in view of Dickinson (US 2,211,537).
In regard to claim 2, Weksel and Koch are silent as to wherein the connector comprises a series of screw threads.
In a similar art, Dickinson discloses a needle hub with a tapered cavity (C) adapted to fit upon a corresponding tapered nozzle of a syringe (see col. 2, lines 6-9) but Dickinson further teaches that an equivalent embodiment is a screw-threaded configuration (see col. 2, line 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify either Weksel or Koch with the screw-threads of Dickinson because substituting equivalents to achieve a predictable result in considered well-within the skill of the ordinary artisan.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Weksel in view of Koch.
In regard to claim 3, Weksel fails wherein the straight section has a length of about 0.1-1 inches and the curved section has a length of about 0.1-5 inches.
In a similar art, Koch discloses the length of the curved section is 12 mm and the length of the straight section is 8 mm.
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 device of Weksel with the dimensions of Koch if the procedure being performed dictated the need for the recited dimensions.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Weksel or Koch in view of Dishler (US 6,135,984).
In regard to claim 4, Weksel and Koch both appear to show wherein the curved section comprises a central angle of about 150-270 degrees (the angles appear to match the recited angles). If the applicant disagrees, in a similar art, Dishler explicitly shows multiple curved needles with central angles of between about 150-270 degrees (see Figs. 9-11). Dishler shows that such angles are known in the art and could be utilized by the ordinary skilled artisan to access the body in a particular way that is advantaged by the disclosed central angle.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Koch in view of Kurose (US 5,222,502).
In regard to claim 6, Koch discloses the length of the curved section is 12 mm and the length of the straight section is 8 mm but Koch is silent as to the length of the hub (12).
In a similar art, Kurose discloses a similar hub (10), wherein the hub is 10 to 30 mm in length (see col. 4, lines 22-24). Kurose shows that such dimensions are known sizes for hubs. A possible size for the hub of Koch is 10 mm, with the curved section being 12 mm and the straight section being 8 mm with the total length being 30 mm.
In this embodiment of Koch, the curved section comprises about 40-90 percent of a total length of the tubular needle (12 mm is 40% of 30), the straight section comprises as about 5-50 percent of the total length of the tubular needle (8 mm is 27% of 30), and the housing comprises about 5-50 percent of the total length of the tubular needle (10 mm is 33% of 30).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Weksel in view of Koch and further in view of Kurose.
In regard to claim 6, Weksel is silent as to specific lengths.
In a similar art, Koch discloses the length of the curved section is 12 mm and the length of the straight section is 8 mm and Kurose discloses a similar hub (10), wherein the hub is 10 to 30 mm in length (see col. 4, lines 22-24). Koch and Kurose show that such dimensions are known sizes for needles. A possible size for the hub of Weksel is 10 mm as modified by Kurose, with the curved section being 12 mm and the straight section being 8 mm (as modified by Koch) with the total length being 30 mm.
In this embodiment of Weksel, the curved section comprises about 40-90 percent of a total length of the tubular needle (12 mm is 40% of 30), the straight section comprises as about 5-50 percent of the total length of the tubular needle (8 mm is 27% of 30), and the housing comprises about 5-50 percent of the total length of the tubular needle (10 mm is 33% of 30).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Weksel or Koch in view of Fischer (US 5,289,919).
In regard to claim 7, Weksel and Koch are both silent as to the needle configured within a kit comprising a plurality of tubular needles of various sizes and shapes.
In a similar art, Fischer discloses a kit for assembling a variety of dental devices using a plurality of delivery tips that differ from one another as to either size or type. The kit also includes a plurality of differently sized syringes each being releasably attachable to any one of the plurality of delivery tips. An organizer displays the syringes and delivery tips in such way that the size and type of syringe and delivery tip desired is easily identifiable. The kit may include adapters which connect any of the plurality of delivery tips to either a vacuum source or to an air bulb. The delivery tips may be color coded such that the size and type of delivery tip is indicated by the color code of the delivery tip. Fischer discloses (see col. 3, lines 48-59) a kit 10 may also comprise a plurality of delivery tips 20a-20f of different sizes and/or types. Each delivery tip 20 comprises a hub means for providing releasable attachment to the connector 14 of any syringe 12a-12b. In the presently preferred embodiment, the hub means comprises a luer lock male connector 18 which is insertable into the luer lock female connector 14 for a secure fit. Any of the different sizes and/or types of delivery tips 20a-20f are releasably connectable to any of the different sizes and types of syringes 12a-12b. The hub 18 of the delivery tips 20a-20f are preferably comprised of a medical grade plastic material.
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 device of Weksel or Koch with the kit configuration of Fischer in order to provide a convenient kit with multiple needles of different sizes and shapes that could be used in a surgical procedure.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/1/2025, with respect to the Kurth rejection have been fully considered and are persuasive. The Kurth rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783