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
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 5/13/26 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/13/26.
Claim Rejections - 35 USC § 112
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.
Claim 3 is 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.
Claim 3 is rejected as indefinite for the recitation of “etches at equal intervals configured to align with the monoaxial locking drill guide” in lines 2-3. As shown in Fig. 34a-34b and recited in Para. [0143], the monoaxial locking drill guide 530 is not described or shown to have marking that line up with the etches in the drill guide.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1- 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Synthes (Synthes. (2009, January). 2.4 mm variable angle lcp two-column Volar distal radius plate ... yumpu.com. https://www.yumpu.com/en/document/read/45617639/24-mm-variable-angle-lcp-two-column-volar-distal-radius-plate-/1, Last accessed on May 26, 2026) in view of Sixto, Jr et al (US Patent Pub. 20090118770A1) and Arthrex (Arthrex. (2023, September). 2.4mm Sterile Distal Radius Plate Implant Kit: Surgical Technique Guide, https://www.arthrex.com/resources/LT1-000270-en-US/24-mm-distal-radius-plate-sterile-implant-kit?objectID=human.resource.en.a476bb06-72cb-40df-9f7e-ea28eb01c7c2.1&queryID=ac9429c3fba836dd1d635244b28fbb79, last accessed on May 26, 2026).
Synthes recites an instrument set. Specifically in regards to claim 1, Synthes recites a drill bit (1.8mm drill bit, Pg. 17) including a shaft with cutting flutes, the shaft having a series of markings (As shown in the top figures. on Pg. 17 and 22 the drill bit has markings that can be aligned with the depth gauge and fixed angle drill guide shown in the bottom Fig. on Pg. 21.) (Pg. 17 and 21-22); a calibrated measuring block (Top Fig. Pg. 22) configured to provide a calibrated measurement when drilling holes through a monoaxial volar targeting guide, the calibrated measuring block having a cannulated body with a cylindrical distal tip (Pg. 22); and a calibrated polyaxial drill guide (duel ended guide Pg. 3) configured to measure drilled depths for monaxial and polyaxial trajectories in plate holes, wherein the guide has a monoaxial measuring block (Pg. 21 under heading 4b) on one end of a handle (Pg. 3 and 20-21); and wherein the series of markings on the drill bit (Pg. 17 and 21-22) align with the calibrated measuring block, and the monoaxial measuring block on the calibrated polyaxial drill guide to determine a screw size for a given drilled hole (Pg. 16-17 and 21-22). However, the reference is silent as to a monoaxial locking drill guide, and the calibrated polyaxial drill guide having a polyaxial measuring block.
Sixto recites an instrument set. Specifically in regards to claim 1, Sixto recites a fracture plate (600) having an instrument set with a monoaxial locking drill guide (1400) configured to lock into monoaxial holes in the plate (600), the monoaxial locking drill guide (1400) includes a cylindrical body with a central cannulation (1412) (Fig. 24 and 41-42; and Para. [0184]-[0185]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the instrument set of Synthes by adding a locking monoaxial drill guide as taught in Sixto in order to allow for the driving of a conventional drill, and pre-installed on the plate so the surgeon may quickly drill several bone holes, such that the axis of each hole is in perfect alignment with the hole thread axis (Para. [0185]). However, the references are silent as to the calibrated polyaxial drill guide having a polyaxial measuring block.
Arthrex recites an instrument set. Specifically in regards to claim 1, Arthrex recites a fracture plate (see Pg. 3), and a calibrated polyaxial drill guide (variable-angle locking drill guide Pg. 3) configured to measure drilled depths for monaxial and polyaxial trajectories in plate holes, the calibrated polyaxial drill guide having a polyaxial measuring block (block shown in bottom of Pg. 3 ranging from 8-24) and a monoaxial measuring block (block shown in bottom of Pg. 3 ranging from 10-26) on opposite ends of a handle (Pg. 3 and 5-6); wherein the series of markings on the drill bit (bit shown on Pg. 4) align with the polyaxial and monoaxial measuring blocks on the calibrated polyaxial drill guide to determine a screw size for a given drilled hole (Arthrex recites the arrow on either side of the guide denotes which laser marking side should be used to find the correct length screw. The arrow should be pointing down toward the bone to read the correct length.) (Pg. 4 and images of Steps 3-4 on Pg. 5-6). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the calibrated drill guide of Synthes by having monoaxial and polyaxial measuring blocks as taught in Arthrex in order to allow for a single guide to drill an opening for a screw and measure the length of the needed screw of both variable angle and fixed angle screws (Pg. 3).
In regards to claim 2, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Synthes recites include a primary proximal laser etch configured to align with one measuring block (Pg. 22). However, it is silent as to the etches matching the calibrated guide. Arthrex further recites wherein the series of marking on the drill bit (Arthrex recites that the bit can have more than one laser etch, Note on Pg. 3) match the polyaxial and monoaxial measuring blocks on the calibrated polyaxial drill guide (Pg. 3). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the calibrated drill guide of Synthes by having monoaxial and polyaxial measuring blocks as taught in Arthrex in order to allow for a single guide to drill an opening for a screw and measure the length of the needed screw of both variable angle and fixed angle screws (Pg. 3).
In regards to claim 3, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Synthes recites include a primary proximal laser etch configured to align with one measuring block and drill guides (Pg. 22). However, it is silent as to the etches matching the monoaxial drill guide. Sixto recites wherein the series of marking on the drill bit include distal secondary laser etches at equal intervals configured to align with the monoaxial locking drill guide (If Synthes were to be modified to include a monoaxial locking guide any measurement markings thereon would match the drill bit in a similar fashion as taught in Pg. 16-17 and 21-22 if Synthes.). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the instrument set of Synthes by adding a locking monoaxial drill guide as taught in Sixto in order to allow for the driving of a conventional drill, and pre-installed on the plate so the surgeon may quickly drill several bone holes, such that the axis of each hole is in perfect alignment with the hole thread axis (Para. [0185]).
In regards to claim 4, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Sixto further recites wherein the monoaxial locking drill guide (1400) defines a counterbore, a threaded recess, a drive recess, and a drill cannulation (1412) along a central tool axis (Fig. 41-42). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the instrument set of Synthes by adding a locking monoaxial drill guide as taught in Sixto in order to allow for the driving of a conventional drill, and pre-installed on the plate so the surgeon may quickly drill several bone holes, such that the axis of each hole is in perfect alignment with the hole thread axis (Para. [0185]).
In regards to claim 5, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. However, the references are silent as to a wire sleeve. Sixto further recites a K-wire sleeve (1700) with a threaded distal end, wherein the counterbore and the threaded recess in a top of the monoaxial locking drill guide (1400) facilitates a connection with the threaded K-wire sleeve (Fig. 52-54; and Para. [0198]-[0201]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the instrument set of Synthes by adding a k-wire sleeve as taught in Sixto in order to allow for the drill guide to adapt to allow the passage of a wire (Para. [0199]).
In regards to claim 6, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Synthes recites wherein the calibrated measuring block (Pg. 22) has a rectangular block face with an enlarged grip (Pg. 22 and bottom of Pg. 32).
In regards to claim 7, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Synthes recites wherein the calibrated measuring block (Pg. 22) has a viewing window with calibrated etches surrounding the window, and when the drill bit is positioned through the calibrated measuring block, one of the markings on the drill bit align with the calibrated etches to indicate the screw size for the given drilled hole (Pg. 22).
In regards to claim 8, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Arthrex further recites wherein the polyaxial measuring block has a polyaxial tip that provide 20 degrees of polyaxial positioning in the plate holes (The polyaxial tip recites a tip that allows for a 20º cone of variability for each screw option.) (Pg. 3 under Variable-Angle Locking Drill Guide Use). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the calibrated drill guide of Synthes by having monoaxial and polyaxial measuring blocks as taught in Arthrex in order to allow for a single guide to drill an opening for a screw and measure the length of the needed screw of both variable angle and fixed angle screws (Pg. 3).
In regards to claim 9, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Synthes further recites wherein the monoaxial measuring block (Pg. 21 under 4b) has a nominal angle tip that provides a zero degree nominal trajectory in the plate holes (Pg. 21).
In regards to claim 10, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Arthrex further recites wherein the polyaxial and monoaxial measuring blocks (Pg. 3) include a viewing window with calibrated etches surrounding the window, and when the drill bit is positioned through the calibrated measuring block, one of the markings on the drill bit align with the calibrated etches to indicate the screw size for the given drilled hole (Arthrex recites the arrow on either side of the guide denotes which laser marking side should be used to find the correct length screw. The arrow should be pointing down toward the bone to read the correct length.) (Pg. 4 and images of Steps 3-4 on Pg. 5-6). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the calibrated drill guide of Synthes by having monoaxial and polyaxial measuring blocks as taught in Arthrex in order to allow for a single guide to drill an opening for a screw and measure the length of the needed screw of both variable angle and fixed angle screws (Pg. 3).
In regards to claim 11, Synthes in view of Sixto and Arthrex recite an instrument set as recited above. Synthes further recites monoaxial and polyaxial volar targeting guides configured to attach to respective plates to drill pilot holes at appropriate trajectories for each plate hole (Pg. 22 and 33).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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