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 Objections
Claims 14, 15, 16 and 17 are objected to because of the following informalities:
Claim 14, line 4: “the” (between “from” and “side”) should be changed to --a--.
Claim 15, line 3: “the” (between “from” and “end”) should be changed to --an--.
Claim 15, line 8: “an” (between “toward” and “end”) should be changed to --the--.
Claim 16, line 3: “the” (between “from” and “end”) should be changed to --an--.
Claim 16, line 8: “an” (between “toward” and “end”) should be changed to --the--.
Claim 17, line 2: “the” (between “limit” and “drilling”) should be removed.
Appropriate correction is required.
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, 2, 4, 5, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim, WO 2021/020656 (as evidenced by English language equivalent U.S. PG-Pub 2023/0301696).
Regarding claim 1, Kim discloses an implant drill, comprising: a drill body; and a reverse flute (115) formed in a form of a groove on an outer circumference of the drill body so that cut bone chips are collected as the drill body rotates, and having a rotational direction and reverse directionality of the drill body so that the collected bone chips are pushed toward an end portion entering an inside of a drilling hole of the drill body by a rotation of the drill body (Fig. 4 and paragraph [0064] of U.S. PG-Pub 2023/0301696).
Regarding claims 2, 4 and 5, Kim discloses wherein the reverse flute (115) is formed as a spiral shape; wherein a plurality of reverse flutes are arranged radially along a circumferential direction of the drill body when viewed in a plan view of the drill body; and wherein the reverse flute is formed to have a round transverse cross-section (Figs. 4 and 5).
Regarding claims 13 and 14, Kim discloses wherein the drill body includes a threaded cutting edge (via threading 111) formed on an outer circumference thereof; and wherein the threaded cutting edge includes a steep surface facing the end portion of the drill body and a gentle surface facing an opposite side of the end portion of the drill body, and wherein the threaded cutting edge has a spiral direction opposite to a rotational direction of the drill body when viewed from the side surface of the drill body (examiner annotated Fig. 4 below).
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Claim Rejections - 35 USC § 103 112
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim, WO 2021/020656 in view of Kim, U.S. PG-Pub 2009/0136898.
Regarding claim 3, Kim (WO 2021/020656) discloses the invention essentially as claimed except for wherein the reverse flute is formed straight.
Kim (U.S. PG-Pub 2009/0136898) discloses an implant drill having straight flutes (42) formed on an outer circumference of a drill body (Figs. 2a-2b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reverse flute of Kim (WO 2021/020656) to be formed straight in view of Kim (U.S. PG-Pub 2009/0136898) as such is a well-known, art-recognized equivalent for collecting and directing bone chips when drilling.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim, WO 2021/020656 in view of Ellis, U.S. PG-Pub 2005/0203526.
Regarding claim 6, Kim discloses the invention essentially as claimed except for wherein the reverse flute is formed to have a triangular or square transverse cross-section.
Ellis discloses a drill with flutes that are formed to have a round transverse cross-section (disclosed as arcuate) but may be triangular (discloses V-shaped which just as much “triangular” as applicant’s fig. 9) and or square in cross-section, each providing a passageway for the release of debris cut by the drill bit as it is inserted through a substrate that is typically bone (paragraph [0072]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reverse flute of Kim to be formed to have a triangular or square transverse cross-section in view of Ellis to permit a functionally equivalent means for providing a passageway for the release of debris cut by the drill as it is inserted through bone.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim, WO 2021/020656 in view of Leblanc et al., U.S. PG-Pub 2018/0281085.
Regarding claim 7, Kim discloses the invention essentially as claimed except for wherein the reverse flute is formed to increase in depth toward the end portion of the drill body.
Leblanc et al. discloses a drill having a drill body with flutes (5) that can increase in depth toward an end portion (3) of the drill body (Fig. 2 and paragraph [0039]) as such contributes to having a lot of space available for removing bone chips, thus limiting friction, and, as a consequence, the risk of screw effect is diminished and thermal effect during drilling is reduced (paragraph [0036]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reverse flute of Kim to be formed to increase in depth toward the end portion of the drill body in view of Leblanc et al. to permit having more space available for removing bone chips, thus limiting friction to diminish screw effect and reduce thermal effect during drilling.
Claim(s) 8-12, 15, 16 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim, WO 2021/020656 (as evidenced by English language equivalent U.S. PG-Pub 2023/0301696) in view of Okazaki, JP 2003-245283 (as evidenced by the attached WIPO English machine translation).
Regarding claims 8-12, Kim discloses the invention essentially as claimed except for further comprising a vertical cutting edge protruding from the end portion of the drill body; wherein the vertical cutting edge is formed in a shape of a “1” having a left side surface and a right side surface when viewed in plan view; wherein the end portion of the drill body form which the vertical cutting edge begins to protrude is formed in a flat shape; wherein a space portion in which bone chips are collected is formed between the left side of the vertical cutting edge and the end portion of the drill body and between the right side surface of the vertical cutting edge and the end portion of the drill body, respectively; and wherein the vertical cutting edge has a triangular profile that is sharp toward an end when viewed from the left side surface or the right side surface.
Okazaki discloses a drill having a drill body (1) with a vertical cutting edge (3) protruding from an end portion of the drill body, wherein the vertical cutting edge is formed in a shape of a “1” having a left side surface and a right side surface when viewed in plan view; wherein the edge portion of the drill body from which the vertical cutting edge beings to protrude is formed in a flat shape; wherein a space portion is formed between the left side of the vertical cutting edge and the end portion of the drill body, and between the right side surface of the vertical cutting edge and the end portion of the drill body, respectively; and wherein the vertical cutting edge has a triangular profile that is sharp toward an end (2) when viewed from the left side surface or the right side surface as such vertical cutting edge allows for easier positioning and improved punching efficiency of the drill and allows for fine correction work and prevention of unnecessary damage to bone (examiner annotated Figs. 2-3 below and paragraphs [0012] and [0014] of the attached WIPO English machine translation).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drill of Kim to include a vertical cutting edge protruding from the end portion of the drill body; wherein the vertical cutting edge is formed in a shape of a “1” having a left side surface and a right side surface when viewed in plan view; wherein the end portion of the drill body form which the vertical cutting edge begins to protrude is formed in a flat shape; wherein a space portion in which bone chips are collected is formed between the left side of the vertical cutting edge and the end portion of the drill body and between the right side surface of the vertical cutting edge and the end portion of the drill body, respectively; and wherein the vertical cutting edge has a triangular profile that is sharp toward an end when viewed from the left side surface or the right side surface in view of Okazaki to permit easier positioning and improved punching efficiency of the drill and allowing for fine correction work and prevention of unnecessary damage to bone.
Regarding claims 15 and 16, Kim discloses an implant drill, comprising: a drill body having a shank (120) to be coupled to a handpiece and a cutting edge (via 111) formed on an outer circumference thereof; and a reverse flute (115) formed in a form of a groove on an outer circumference of the drill body so that cut bone chips are collected as the drill body rotates, and having a rotational direction and reverse directionality of the drill body so that the collected bone chips are pushed toward an end portion entering an inside of a drilling hole of the drill body by a rotation of the drill body (Figs. 3-4 and paragraph [0064] of U.S. PG-Pub 2023/0301696).
Kim does not disclose a vertical cutting edge formed to protrude from the end portion of the drill body.
Okazaki discloses a drill having a drill body (1) with a vertical cutting edge (3) protruding from an end portion of the drill body (examiner annotated Figs. 2-3 above) as such vertical cutting edge allows for easier positioning and improved punching efficiency of the drill and allows for fine correction work and prevention of unnecessary damage to bone (paragraphs [0012] and [0014] of the attached WIPO English machine translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drill of Kim to include a vertical cutting edge formed to protrude from the end portion of the drill body in view of Okazaki to permit easier positioning and improved punching efficiency of the drill and allowing for fine correction work and prevention of unnecessary damage to bone.
Regarding claims 18-21, Kim discloses wherein the reverse flute (115) is formed in a spiral shape (Fig. 4); wherein a plurality of reverse flutes (115) has six reverse flutes which are arranged radially along a circumferential direction of the drill body when viewed in a plan view of the drill body (paragraph [0067] of English language equivalent U.S. PG-Pub 2023/0301696); wherein the reverse flute is formed to have a round transverse cross-section (Fig. 5); and wherein the drill body includes a plurality of cutting edges at an end portion of the drill body (via 111) (Fig. 4).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim, WO 2021/020656 in view of Okazaki, JP 2003-245283 as applied above, and further in view of Kim, U.S. PG-Pub 2023/0404705.
Regarding claim 17, Kim (WO 2021/020656) in view of Okazaki discloses the invention essentially as claimed except for wherein the implant drill has a stopper between the drill body and the shank to limit drilling depth.
Kim (U.S. PG-Pub 2023/0404705) discloses an implant drill having a drill body (168) having a shank (102) and a stopper (120) between the drill body and the shank (Fig. 1) to minimize tissue damage and provide improved visibility to the surgeon (paragraph [0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drill of Kim (WO 2021/020656) to include a stopper between the drill body and the shank to limit drilling depth further in view of Kim (U.S. PG-Pub 2023/0404705) to permit minimizing tissue damage and providing improved visibility to a surgeon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775