DETAILED ACTION
Claim Objections
Claim 14 is objected to because of the following informalities. In claim 14, “screw-engaging member” should be - - screw-engaging members - - to correct a minor typographical error. Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter “each side including a concave portion.” See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 11, Applicant is mixing features of two separate embodiments (Figs 1A-8) and Figs. 9-17 and seeks to introduce new matter when the angle is greater than 0° because it is only applicable to the embodiment of Figs. 9-17 in which the drill is fixed at a 0° angle with respect to a longitudinal axis of the passage of the drill guide.
In claim 19, the recitation “drill guide comprises a drill insert configured to be received in a drill sleeve” seeks to introduce new matter because it is only applicable to the embodiment of Figs. 9-17 in which the drill is fixed at a 0° angle with respect to a longitudinal axis of the passage of the drill guide.
Regarding claim 20, Applicant is mixing features of two separate embodiments (Figs 1A-8) and Figs. 9-17 and seeks to introduce new matter when the angle is greater than 0° because it is only applicable to the embodiment of Figs. 9-17 in which the drill is fixed at a 0° angle with respect to a longitudinal axis of the passage of the drill guide.
Regarding claim 21, the recitation “…, each side including a concave portion” seeks to introduce new matter because Applicant’s disclosure, as originally filed, does not describe this feature or the criticality thereof. Figs. 5B-6 and 13 appear to show a surface having a compound curvature.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-7 and 9-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 1, 13 and 22, the recitation “a longitudinal axis through the passage of the drill guide” renders the claim vague and indefinite because the longitudinal axis is not defined by the structure of the drill guide. A passage lacks structure. It is suggested that Applicant recite a drill guide body defining a first end and a second end, a passage extending through the drill guide body between the first end and the second end, and a longitudinal axis extending through the first end, the second end and through the passage.
In claim 19, the recitation “…drill insert configured to be received in a drill sleeve” renders the claim vague and indefinite because it is unclear what the relationship of the drill sleeve is with respect to the drill guide. For examination, it is assumed that the drill sleeve is part of the drill guide.
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.
For a zero angle, claim(s) 1-4, 6-7 and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Millela et al. (WO 2015066038 A1).
Regarding claim 1, Millela et al. disclose a drill guide 100 (Fig. 1A) including: a first end 130; a second end 118; and a passage extending from the first end to the second end, wherein the second end 118 has deflectable leaves (i.e. is compressible) and includes anti-rotational features in the form of projections and detents (not threads) for cooperation with structures in a plate hole (Figs. 1A-1B, 3B, paras [0012] and [0013]).
Regarding claims 2 and 3, Millela et al. disclose the second end 118 to have a plurality of cutouts or slits defining deflectable leaves (Figs. 1A-1B, para [0013]).
Regarding claim 4, the cutouts extends at an angle with respect to the distal end because of the taper (Figs. 1A-1B, 3A, 3B, 3D).
Regarding claim 6, the second end 118 compresses when the second
end is partially inserted into a plate hole of a bone plate and expands when the second end is fully inserted into the plate hole (para [0013]).
Regarding claim 7, the anti-rotational features include a plurality
of protrusions (for e.g. detents, projections, para [0013]).
Regarding claim 9, Millela et al. disclose the plurality of protrusions to mate or abut structures in a hole of a bone plate (para [0013]).
Regarding claims 10 and 11, Millela et al. disclose the second end to have a cylindrical portion and a tapered or frustoconical portion (Figs. 1A-1B, 3A-3C).
Regarding claim 12, Millela et al. disclose second end 118 to have deflectable leaves 120, interpreted to mean flexible material capable of compression upon insertion into the plate hole (para [0013]).
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.
For a zero angle, claim(s) 13-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Millela et al. (WO 2015066038 A1) in view of Leither et al. (US 9144443).
Regarding claims 13 and 14, Millela et al. disclose a system for angling a drill including: a bone plating system (Figs. 1 and 8 ) including: a bone plate 300 having a bone-contacting surface and an upper surface; a plate hole through the bone-contacting surface and the upper surface; a plurality of screw-engaging members on an inner surface of the plate hole (paras [0019]-[0020] and [0026]); and a drill guide 200 including a first end, a second end, and a passage extending from the first end to the second end, wherein the second end is compressible and includes anti-rotational features (in the form threads, projections, detents, keys para [0013]) for cooperation with the plurality of the screw-engaging members when the second end is received within the plate hole.
Regarding claim 15, once the anti-rotational features of the drill guide engage the corresponding features of a plate hole the resisting forces are axial forces towards and from a midpoint of the drill guide since the anti-rotational features are distributed symmetrically about a longitudinal axis of the drill guide (Figs. 1A-1B and 3A-3D).
Regarding claim 16, Millela et al. disclose a drill bit of a drill received in the drill guide (para [0022]).
Regarding claim 17, Millela et al. disclose a drill inserted through the passage at an angle ranging from approximately 0° to 15° (including 0°) from an axis perpendicular to a center of the plate hole (Fig. 5C).
Regarding claim 18, Millela et al. disclose a drill that is inserted through the passage along an axis perpendicular to a center of the plate hole (the approach angle of the drill is selected based on the angle of screw placement in the plate hole (Fig. 4 shows holes that have central axes intersecting a longitudinal axis of the plate in a perpendicular direction and some holes with central axes inclined relative to a longitudinal axis of the plate).
Regarding claim 19, drill guide 200 includes a drill insert 204 received in a drill sleeve 202 (Fig. 3A and para [0016]).
Millela et al. disclose all elements of the claimed invention except for plate holes with scalloped regions or keyways and wherein the distal or second end of the drill guide has
Leither et al. disclose scalloped regions or keyways in threaded plate holes (Figs. 12 and 13) wherein the keyways mate with corresponding keys (mating portion) of a drill guide (col. 8, lines 60-67 and col. 9, lines 1-15).
It would have been obvious to one of ordinary skill in the art to have substituted threads with keys and keyways (disclosed by Millela et al., para [0013]) by providing corresponding keyways or scalloped regions in plate holes (as taught by Leither et al.) wherein so doing would amount to simple substitution of one type of anti-rotation feature for another to provide secure engagement of the drill guide with the plate hole in which it is placed.
Regarding claim 21, the combination of Millela et al. and Leither et al. disclose keyways in the form of scalloped regions in a plate hole and keys with corresponding convex and concave portions engaging the keyways.
For a zero angle, claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Millela et al. (WO 2015066038 A1) and Leither et al. (US 9144443), as applied to claim 13, further in view of Frick (US 7824063).
Millela et al. disclose knurling on a proximal end (for e.g. 124) of the drill guide for ease of gripping and manipulation (para [0013]). The combination of Millela et al. and Leither et al. discloses all elements of the claimed invention (see previous discussion for claim 13) except for the knurl pattern to have a groove width ranging from approximately 0.9 mm to 1.5 mm.
It is well known to provide a knurled pattern on a handgrip wherein pattern can be diamond-shaped (criss-cross) pattern or a pattern of ridges with a height and spacing wherein the spacing between the ridges is not critical but is typically about 5 mm, as evidenced by Frick (col. 8, lines 22-51).
It would have been obvious to one of ordinary skill in the art to have provided a knurl pattern on the proximal end of the drill guide with spacing that is suitable for gripping, as taught by Frick, wherein the spacing is a matter of design based on manufacturing and cost constraints.
For a zero and non-zero angle (approximately from 0° to 15°), claim(s) 1-3, 6-7, 13-14, 15-18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ralph et al. (US 20030083667) in view of Aebi et al. (US 11464526).
Regarding claims 1, 13 and 22, Ralph et al. disclose a drill guide 100 including: a first end; a second end; and a passage extending from the first end to the second end, wherein the second end cooperates with a plate hole, wherein the second end is non-threaded, and wherein the drill guide is configured to receive a drill at an angle ranging from approximately 0° to 15° from a longitudinal axis through the passage of the drill guide (Fig. 3a-3c, and 4a and paras [0062]-[0067]).
Regarding claim 10, Ralph et al. disclose the second end to be frustoconical (Fig. 3a).
Regarding claim 19, Ralph et al. the drill guide 100 to include a collet or drill insert configured to be received in a drill sleeve or body of the drill guide.
Regarding claims 16-18, Ralph et al. disclose a drill bit or drill through the drill guide (paras [0042], [0052] and [0066]).
Ralph et al. disclose all elements of the claimed invention except for: (1) the second end to include at least one cutout or a plurality of cutouts (claims 2 and 3); (2) the second end compresses when the second end is partially inserted into a plate hole of a bone plate and expands when the second end is fully inserted into the plate hole (claim 6); (3) the second end includes anti-rotational features including a plurality of protrusions (claims 6-7 and 14); (4) the plurality of protrusions abut structures in a hole of a bone plate.
Aebi et al. disclose: (1) providing slots 216 on a distal end of a drill guide or sleeve to make the distal end flexible or compressible by forming blades such that the blades engage the hole of bone plate; and (2) anti-rotational features in the form of locking rides 222 that engage scalloped regions in an inner surface of the plate hole to lock and orient the drill guide in the screw hole.
It would have been obvious to one of ordinary skill in the art to have substituted the locking mechanism of Ralph et al. (116a and 116b in para [0057]) with the mechanism as taught by Aebi et al. for the predictable result of locking the drill guide with respect to the bone plate.
Regarding claims 22, the drill guide of the combination of Ralph et al. and Aebi et al. has slots or cutouts that extend transverse to the longitudinal axis (interpreted to mean have a width transverse to the longitudinal axis).
Response to Arguments
Applicant's arguments have been fully considered by the Examiner and are not persuasive with respect to the rejections of claims 1-4, 6-7 and 9-12 under 35 U.S.C. 102(a)(1) over Millela et al. (WO 2015066038 A1) because the range approximately 0° to 15° from a longitudinal axis defined by the passage through the drill guide body includes 0°.
New grounds of rejection have been made in this office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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July 21, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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