DETAILED ACTION
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2-3, 5-8, 11-13, 15-18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lower et al. (US 5613971).
Regarding claim 2, Lower et al disclose a drill guide assembly (Fig. 1), including: a guide body (12, 14) having a first end and a second end and a slot extending from the first end toward the second end; a curved guide arm 16 including a first arm connected at an angle to a second arm, the first arm terminating in a distal tip 18; wherein the second arm is slidable within the slot of the guide body via cam lock 17 (Figs. 1-3, col. 2, lines 40-67 and col. 3); and a hollow drill guide or cannulated sleeve 22 removably coupled to the guide body wherein the first end wherein the first end has a plurality of teeth or ridges (28, Fig. 1) that extend distally with respect to the longitudinal axis, each of the ridges terminating in a pointed tip which defines the first end of the cannulated sleeve (col. 2, lines 40-67, col. 3 and col. 4, lines 1-4). Lower et al. also disclose a strike plate (defined by knob 26, Fig. 1) positioned at the second end of the drill guide sleeve.
Regarding claim 12, the method of using a drill guide assembly, including the steps of: providing a drill guide assembly, including: a guide body having a first end and a second end; a guide arm slidably coupled to the guide body and having a first portion and a second portion, wherein the first and second portions are connected at an angle to each other, and the first portion terminates in a distal tip; and a drill guide sleeve removably coupled to the guide body, including: a cannulated sleeve having a first end and a second end and extending along a central longitudinal axis, wherein the first end comprises a plurality of ridges that extend distally with respect to the longitudinal axis, each of the ridges terminating in a pointed tip which defines the first end of the cannulated sleeve, and the second end comprises a strike plate; positioning the distal tip in place at a first location; positioning the guide sleeve in place at a second location; and inserting a drill into the guide sleeve to form a tunnel within a bone, are performed when the Lower et al. drill guide is assembled and positioned to establish a location and trajectory for forming a bone tunnel in bone (Summary of Invention).
Regarding claims 3 and 13, the drill guide sleeve is removably coupled to the guide body by a clamp mechanism (spring-loaded pawl 30 that engages the cannulated sleeve) (Fig. 3, col. 2, lines 40-67, col. 3 and col. 4, lines 1-4).
Regarding claims 5 and 15, the guide sleeve is positioned substantially perpendicular to the second portion of the guide arm while in use (Fig. 1, col. 2, lines 40-67, col. 3 and col. 4, lines 1-4).
Regarding claims 6 and 16, the distal tip of the first portion of the guide arm extends substantially perpendicular thereto (Fig. 1, col. 2, lines 40-67, col. 3 and col. 4, lines 1-4).
Regarding claims 7 and 17, the guide body further comprises a slot extending from the first end toward the second end and dimensioned to accept the second portion of the guide arm (Fig. 1, col. 2, lines 40-67, col. 3 and col. 4, lines 1-4).
Regarding claims 8 and 18, the second portion of the guide arm is slidably coupled to the guide body through the slot (Fig. 1, col. 2, lines 40-67, col. 3 and col. 4, lines 1-4).
Regarding claims 11 and 21, the guide arm is curved (Fig. 1, col. 2, lines 40-67, col. 3 and col. 4, lines 1-4).
Claim(s) 2-3, 5-9, 11-13, 15-19 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ardito et al. (US 10045789).
Regarding claims 2 and 12, Ardito et al. disclose a drill guide assembly (110, 210, Figs. 2-3) including: a carriage or guide body (140 or 240, Figs. 2-3) having a first end and a second end and a slot extending from the first end toward the second end; a guide arm slidably coupled to the guide body, the guide arm having a first arm or portion (124, 224, Figs. 2-3) connected at an angle to a second arm or portion (Figs. 2-3), the first portion terminating in a distal tip (126, 226, Figs. 2-3); and a bullet or drill guide sleeve removably coupled to the guide body, the drill guide sleeve including a cannulated sleeve (170, 270, Figs. 2-3), the cannulated sleeve having a first end and a second end and extending along a central longitudinal axis, wherein the first end has a plurality of teeth or ridges 270t (Figs. 12A-12B) that extend distally with respect to the longitudinal axis, each of the ridges terminating in a pointed tip which defines the first end of the cannulated sleeve (col. 16, lines 22-67, cols. 17-18 and col. 19, lines 1-8, see marked up Fig. 3 on the following page). Ardito et al. also disclose a strike plate (defined by proximal end 270p, Figs. 12A-12B) positioned at the second end of the drill guide sleeve.
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Regarding claim 12, the method of using a drill guide assembly, including the steps of: providing a drill guide assembly, including: a guide body having a first end and a second end; a guide arm slidably coupled to the guide body and having a first portion and a second portion, wherein the first and second portions are connected at an angle to each other, and the first portion terminates in a distal tip; and a drill guide sleeve removably coupled to the guide body, including: a cannulated sleeve having a first end and a second end and extending along a central longitudinal axis, wherein the first end comprises a plurality of ridges that extend distally with respect to the longitudinal axis, each of the ridges terminating in a pointed tip which defines the first end of the cannulated sleeve, and the second end comprises a strike plate; positioning the distal tip in place at a first location; positioning the guide sleeve in place at a second location; and inserting a drill into the guide sleeve to form a tunnel within a bone, are performed when the Ardito et al. drill guide is assembled and positioned to establish a location and trajectory for forming a bone tunnel in bone (Abstract).
Regarding claims 3 and 13, the drill guide sleeve is removably coupled to the guide body by a clamp mechanism (spring-loaded pin 253 that engages the cannulated sleeve) (Figs. 9A-11, col. 30, lines 22-67 and col. 31, lines 1-34).
Regarding claims 5 and 15, the guide sleeve is positioned substantially perpendicular to the second portion of the guide arm while in use (Fig. 1).
Regarding claims 6 and 16, the distal tip (126, 226, Figs. 2-3) of the first portion of the guide arm extends substantially perpendicular thereto (Figs. 2-3).
Regarding claims 7 and 17, the guide body further comprises a slot extending from the first end toward the second end and dimensioned to accept the second portion of the guide arm (marked up Fig. 3 on previous page).
Regarding claims 8 and 18, the second portion of the guide arm is slidably coupled to the guide body through the slot (marked up Fig. 3 on previous page).
Regarding claims 9 and 19, Ardito et al. disclose a locking mechanism 160 attached at the first end of the guide body; and wherein the locking mechanism is engaged with one of the plurality of detents of the second portion of the guide arm in a locked position within the slot of the guide body (Figs. 7 and 8, col. 16, lines 22-67, cols. 17-25).
Regarding claims 11 and 21, the guide arm is curved (see marked up Fig. 3 in this office action).
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.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lower et al. (US 5613971) in view of Randall et al. (US 6514261).
Lower et al. disclose all elements of the claimed invention except for a clamp mechanism including a clamp lever extending from the spring, wherein depressing the lever rotates the clamp (for e.g. a pawl) of the clamp mechanism to a second position.
Randall et al. disclose a sleeve indexing mechanism in which a pinion 48 is rotated by means of a lever handle 50 which includes a drive gear 52 wherein the lever handle is biased by means of a spring 54 to its open position (col. 4, lines 38-67 and col. 5, lines 1-23).
Therefore, it would have been recognized by one of ordinary skill in the art to have substituted a pawl mechanism with a lever as, for example, taught by Randall et al. for the locking mechanism of Lower et al. device wherein so doing would amount to mere substitution of one functionally equivalent locking mechanism for incrementally moving an element with respect to another within the same art and the selection of any of these mechanisms would work equally well in the claimed device.
Response to Arguments
Applicant’s arguments have been carefully considered by the Examiner. The Terminal Disclaimer filed on July 27, 2026 has been approved, thereby overcoming the double-patenting rejections made in the previous office action.
Applicant’s arguments with respect to the rejections under 35 USC 102(a)(1) as being anticipated by Lower et al. are not persuasive because Lower et al. disclose all elements of Applicant’s claimed invention. Element 26 (Fig. 1) is interpreted as a strike plate, i.e. a plate structure that can be struck with a hand or a tool, if required, for positioning the drill guide sleeve.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(2) over Ardito et al. are not persuasive because Ardito et al. disclose all elements of Applicant’s claimed invention. Proximal end 270p is interpreted as a strike plate, i.e. a plate structure that can be struck with a hand or a tool, if required, for positioning the drill guide sleeve.
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 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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September 1, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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