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 1-3, 6-8, 11-12 and 17) in the reply filed on 5/14/2026 is acknowledged.
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.
Claims 1-2, 6, 11-12, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190069910 Powell et al. (hereinafter Powell).
Regarding claim 1, Powell discloses a drill guide (10, Fig. 1, paragraph 18) for facilitating placement of a surgical staple into pre-drilled holes formed in a patient (paragraph 9, an alignment pin is placed into the drilled hole to allow the surgeon to find the location of the hole during surgery), the drill guide comprising:
a support structure (horizontal bar that connects the alignment tubes 14 in Fig. 1); and
a plurality of guide members (14, Fig. 1) coupled to the support structure (as seen in Fig. 1, paragraph 18), each of the guide members having a proximal end (first end region 20, Fig. 1, paragraph 18) and a distal end (second end region 22, Fig. 1, paragraph 18) disposed opposite one another along a longitudinal axis of the guide member (see first and second end regions in Fig. 1; paragraph 18), and each of the guide members comprising:
a tubular portion (16, Fig. 1) extending from the proximal end toward the distal end of the guide member (Fig. 1, paragraph 18), the tubular portion defining a through passage extending along the longitudinal axis of the guide member (opening 26 and drill passage 18, Fig. 1, paragraph 18); and
a track portion extending from the tubular portion toward the distal end of the guide member (bottom half of the tubular portion 14 that defines window 30, Fig. 1, paragraph 18), the track portion defining an open channel in communication with the through passage and extending along the longitudinal axis of the guide member (alignment tube includes window 30 that allows access to the drill passage 18 of the alignment tube 14, Fig. 1, paragraph 20);
wherein the through passage and the open channel are configured for allowing a drill bit to pass therethrough from the proximal end to the distal end of the guide member to form one of the pre-drilled holes (a drill bit 36 of drill 38 is positioned in the aligned opening 26 of drill passage 18, and the drill bit 36 forms a first hole 40 in the bone 24, Fig. 2, paragraph 21); and
wherein the open channel is configured for receiving at least a portion of an arm of the surgical staple therein and guiding the arm of the surgical staple to the distal end of the guide member and into one of the pre-drilled holes (the securing member 44 (which is a staple), is inserted through the windows 30 of the alignment tubes 14 and into the drilled holes 40 to secure the implant 46 to the bone, Fig. 3, paragraph 22).
Regarding claim 2, Powell discloses the limitations of claim 1, and further discloses wherein the guide members are fixedly coupled to the support structure (alignment tubes are attached to the horizontal bar of the support structure, Fig. 1).
Regarding claim 6, Powell discloses the limitations of claim 1, and further discloses wherein the guide members are spaced apart from one another by a fixed distance (as seen in Fig. 1).
Regarding claim 11, Powell discloses the limitations of claim 1, and further discloses wherein the tubular portion comprises an inner surface defining the through passage (as seen in Fig. 1-3, opening 26 has an inner surface), and wherein the inner surface of the tubular portion has a circular cross-sectional shape taken perpendicular to the longitudinal axis of the guide member (paragraph 4, 19, 25, 27, 29, the alignments tubes 14 are substantially cylindrical in shape, therefore it is inferred that the openings 26 also have a circular cross-sectional shape).
Regarding claim 12, Powell teaches the limitations of claim 11, and further discloses wherein the track portion comprises an inner surface at least partially defining the open channel (as seen in Fig. 1-3, the open channel of the track portion has an inner surface), and wherein the inner surface of the track portion has a partial circular cross-sectional shape taken perpendicular to the longitudinal axis of the guide member (paragraph 4, 19, 25, 27, 29, the alignments tubes 14 are substantially cylindrical in shape, therefore it is inferred that inner surface of the track portion also has a partial circular cross-sectional shape).
Regarding claim 17, Powell discloses the limitations of claim 1, and further discloses wherein each of the guide members further comprises a plurality of teeth (29, Fig. 1) disposed at the distal end of the guide member, wherein each of the teeth comprises a sharpened tip (paragraph 14-15, 17, 19-21, 27, 29, Fig. 1-3).
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 3, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Powell in view of US 20040204710 Patel et al. (hereinafter Patel).
Regarding claim 3, Powell discloses the limitations of claim 1.
Powell is silent on wherein the guide members are removably coupled to the support structure.
However, Patel teaches a drill guide (10, Fig. 1, abstract, paragraph 6) that comprises guide members (21, 23, Fig. 1-4) that is removably coupled to a support structure (combined structure of 12, 14, 16, Fig. 1-2, 4) (paragraph 10, 29, as seen in Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Powell with the teachings of the Patel in order to have modular components that provide easier sterilizability for the drill guide components.
Regarding claim 7, Powell discloses the limitations of claim 1.
Powell is silent on wherein the support structure comprises an adjustment mechanism configured for adjusting a spacing between the guide members.
However, Patel teaches a drill guide (10, Fig. 1, abstract, paragraph 6) that comprises guide members (21, 23, Fig. 1-4), a support structure (combined structure of 12, 14, 16, Fig. 1-2, 4) and wherein the support structure comprises an adjustment mechanism (18, Fig. 1-2, 4) configured for adjusting a spacing between the guide members (paragraph 25-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Powell with the teachings of Patel in order to provide customizable adjustability to conform to different patient anatomical structures.
Regarding claim 8, the combination of Powell and Patel teaches the limitations of claim 7, and Patel teaches wherein the support structure comprises a locking mechanism (spring-lock mechanism, paragraph 8, 12, 26) configured for maintaining a spacing between the guide members at a plurality of distances (paragraph 8, 12, 26).
Conclusion
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/KHOA TAN LE/ Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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