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 1-18, in the reply filed on 22 September 2025, is acknowledged.
Claims 19-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 22 September 2025.
Applicant's election with traverse of Species D and Species H in the reply filed on 22 September 2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious burden to examine all species together. Applicant contends that a thorough search of the subject matter of one species would encompass a search of the subject matter of the other species. This is not found persuasive because a serious examination burden includes factors not limited to searching, including but not limited to non-prior art issues under 35 U.S.C. 101 or 35 U.S.C. 112, first paragraph. Even with regard to searching alone, different species may require a divergent search into different areas for particular features such as flexibility, or pins with or without flutes.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/444,226, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. ‘226 fails to provide adequate support for, at least, a pinning and drilling instrument comprising a pin portion inserted a first distance into bone, and a drill portion inserted a second further distance into the bone to create an implant receiving aperture. Accordingly, the claims are afforded a priority date of 11 August 2023.
Claim Objections
Claims 1-18 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 6: “after the inserting of the pinning”
Claim 2 / line 2: “location by the further inserting of the pinning”
Claim 3 / line 4: “wherein the further inserting of the pinning”
Claim 3 / line 6: “the [[pin]] drill portion”
Claim 4 / line 2: “wherein the inserting of the pin portion”
Claim 4 / line 4: “the one or more bone portions”
Claim 4 / line 5: “wherein the creating of the implant receiving aperture”
Claim 4 / line 8: “one or more bone portions”
Claim 5 / line 2: “wherein the placing of the implant”
Claim 6 / line 9: “when the second cross-sectional area”
Claim 7 / lines 2-4: “after the inserting of the pinning and drilling instrument the first distance into the one or more bone portions and before the creating of the implant receiving aperture at the location by the further inserting of the pinning and drilling instrument”
Claim 7 / line 5: “imaging [[the]] a position”
Claim 8 / line 3: “separated”
Claim 8 / line 4: “wherein the imaging of the position”
Claim 10 / lines 1-5: “wherein the creating of the implant receiving aperture at the location by the further inserting of the pinning and drilling instrument the second further distance into the one or more bone portions is performed when it is determined, from the imaged position of the pin portion, that the pin portion is spaced apart from a joint space adjacent the one or more bone portions
Claim 11 / line 1: “wherein the placing of the implant”
Claim 13 / lines 1-2: “wherein the creating of the implant receiving aperture at the location by the further inserting of the pinning and drilling instrument”
Claim 14 / line 2: “the one or more bone portions”
Claim 14 / line 15: “after the inserting of the second pinning”
Claim 17 / line 4: “wherein the placing of the drill guide”
Claim 18 / lines 2-6: “after the inserting of the first pinning and drilling instrument the first distance into the first bone, after the inserting of the second pinning and drilling instrument the third distance into the second bone, after the placing of the drill guide, and before the creating of the first and second implant receiving apertures, imaging [[the]] a position of the pin portion of the first pinning and drilling instrument within the first bone and imaging [[the]] a position of the pin portion of the second”
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.
Claims 4-6 are rejected under 35 U.S.C. 112(b) 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.
As to claim 4, the limitation “the drill flutes of the drill portion” renders the claims indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the claim will be interpreted as “wherein the creating of the implant receiving aperture at the location [[by]] comprises rotationally driving [[the]] drill flutes of the drill portion into the location at the one or more bone portions to create the implant receiving aperture of a second diameter”.
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.
Claims 1-5 and 11 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,226,756 to Teisen et al. (hereinafter, “Teisen”).
As to claim 1, Teisen discloses a method of placing an implant at one or more bone portions, the method comprising: inserting a pinning and drilling instrument (100a), FIGS. 7-10, a first distance (distance that 176 protrudes out of 152, FIG. 9) into the one or more bone portions at a location at the one or more bone portions such that a pin portion (protruding portion of 176) of the pinning and drilling instrument is inserted into the one or more bone portions at the location (col. 10 / lines 21-51); after inserting the pinning and drilling instrument the first distance into the one or more bone portions, creating an implant receiving aperture at the location by further inserting the pinning and drilling instrument a second further distance (portion of a length of 164) into the one or more bone portions at the location at the one or more bone portions such that a drill portion (164) of the pinning and drilling instrument is inserted into the one or more bone portions to create the implant receiving aperture at the location (col. 10 / lines 51-57); and placing an implant (screw) at the implant receiving aperture (col. 11 / lines 9-11).
As to claim 2, Teisen discloses the method of claim 1, wherein the implant receiving aperture is created at the location by further inserting the pinning and drilling instrument the second further distance into the one or more bone portions while the pin portion of the pinning and drilling instrument is at the location at the one or more bone portions (col. 10 / lines 45-55; 152 and 154 advanced together).
As to claim 3, Teisen discloses the method of claim 2, wherein the drill portion of the pinning and drilling instrument includes drill flutes (168) that begin where the pin portion ends (in the assembled position), FIG. 9, and wherein further inserting the pinning and drilling instrument the second further distance into the one or more bone portions comprises rotationally driving the drill flutes of the pin portion into the location at the one or more bone portions (col. 8 / lines 28-42).
As to claim 4, Teisen discloses the method of claim 1, wherein inserting the pin portion of the pinning and drilling instrument into the one or more bone portions at the location comprises creating a tacking aperture of a first diameter that extends into the one or more bones at the location (col. 10 / lines 48-51), and wherein creating the implant receiving aperture at the location by rotationally driving the drill flutes of the drill portion into the location at the one or more bone portions comprises creating the implant receiving aperture of a second diameter that extends into the one or more bones at the location (col. 10 / lines 51-55), wherein the second diameter of the implant receiving aperture is greater than the first diameter of the tacking aperture (since the diameter of 164 is greater than the diameter of 176), FIG. 9.
As to claim 5, Teisen discloses the method of claim 4, wherein placing the implant at the implant receiving aperture comprises placing a portion of the implant within the implant receiving aperture (col. 11 / lines 9-11), and wherein the portion of the implant is larger than the first diameter of the tacking aperture (since the tacking aperture is formed by 154/176 which fits within bore 159 of 152, which bore 159 also receives a K-wire over which the cannulated implant is inserted, therefore the implant is larger than the K-wire and therefore also larger than 154/176 and its tacking aperture) and smaller than the second diameter of the implant receiving aperture (pedicle screw diameter is about 4 mm, col. 11 / lines 18-19, and the drill portion 164 diameter is about 4.5 mm, col. 8 / lines 53-58, so that the implant/pedicle screw is smaller than the second diameter of the implant receiving aperture formed by the drill portion).
As to claim 11, Teisen discloses the method of claim 1, wherein placing the implant at the implant receiving aperture comprises placing a portion of the implant within the implant receiving aperture, and wherein the portion of the implant that is placed within the implant receiving aperture has an implant portion length that is equal to a length of the drill portion (where the drill portion is interpreted as comprising the portion of 164 that is drilled into the bone to create the implant receiving aperture, and the implant receiving aperture can be of any depth, col. 10 / lines 51-56).
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.
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.
Claims 1, 4, 6-8, 10, and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 11,051,804 to Gaston et al. (hereinafter, “Gaston”), in view of Teisen.
As to claim 1, Gaston discloses a method of placing an implant (6) at one or more bone portions (110, 115), the method comprising: inserting a pinning and drilling instrument (30 and 31) a first distance (distance that 30 is advanced into the bone portion) into the one or more bone portions at a location at the one or more bone portions such that a pin portion (30) of the pinning and drilling instrument is inserted into the one or more bone portions at the location (col. 14 / lines 18-29), FIG. 16; after inserting the pinning and drilling instrument the first distance into the one or more bone portions, creating an implant receiving aperture at the location by inserting the pinning and drilling instrument (at 31) a second distance (distance that 31 is advanced into the bone portion) into the one or more bone portions at the location at the one or more bone portions such that a drill portion (63) of the pinning and drilling instrument, FIG. 10, is inserted into the one or more bone portions to create the implant receiving aperture at the location (col. 17 / line 55 – col. 18 / line 25), FIGS. 17-18; and placing an implant at the implant receiving aperture (col. 19 / lines 20-34), FIGS. 20-21.
As to claim 4, Gaston discloses the method of claim 1, wherein inserting the pin portion of the pinning and drilling instrument into the one or more bone portions at the location comprises creating a tacking aperture of a first diameter that extends into the one or more bones at the location, and wherein creating the implant receiving aperture at the location by rotationally driving the drill flutes of the drill portion into the location at the one or more bone portions comprises creating the implant receiving aperture of a second diameter that extends into the one or more bones at the location, wherein the second diameter of the implant receiving aperture is greater than the first diameter of the tacking aperture, FIGS. 9-10.
As to claim 6, Gaston discloses the method of claim 4, wherein the pin portion of the pinning and drilling instrument comprises a first cross-sectional area of the pinning and drilling instrument, wherein the drill portion of the pinning and drilling instrument comprises a second cross-sectional area of the pinning and drilling instrument, wherein the second cross-sectional area is greater than the first cross-sectional area, FIGS. 9-10.
As to claim 7, Gaston discloses the method of claim 1, further comprising: after inserting the pinning and drilling instrument the first distance into the one or more bone portions and before creating the implant receiving aperture at the location by inserting the pinning and drilling instrument the second distance into the one or more bone portions, imaging the position of the pin portion within the one or more bone portions at the location (col. 14 / lines 45-51; because the anatomical position is achieved by the pin portions being implanted, fluoroscopy of the anatomical position would include imaging of the pin portion and its position).
As to claim 8, Gaston discloses the method of claim 7, wherein the one or more bone portions comprise a first bone and a second bone separate by a joint space, FIG. 15. and wherein imaging the position of the pin portion comprises imaging the position of the pin portion within one of the first bone and the second bone and relative to the joint space (since imaging the position of the pin portion would be relative to the bone and the adjacent joint space).
As to claim 12, Gaston discloses the method of claim 1, further comprising: placing a drill guide (27) at the one or more bone portions (col. 13 / line 57 – col. 14 / line 17), FIG. 15, wherein the pinning and drilling instrument is inserted at the drill guide and into the one or more bone portions at the location so as to provisionally fixate the drill guide at the one or more bone portions using the pinning and drilling instrument, FIGS. 16-18.
As to claim 13, Gaston discloses the method of claim 12, wherein creating the implant receiving aperture at the location by inserting the pinning and drilling instrument the second distance into the one or more bone portions at the location comprises inserting the pinning and drilling instrument through the drill guide so that the drill portion is extended out from the drill guide (col. 11 / line 61 – col. 12 / line 6, col. 17 / line 55 – col. 18 / line 25), FIGS. 17-18.
As to claim 14, Gaston discloses the method of claim 1, wherein the one or more bones comprises a first bone and a second bone (110, 115), wherein the implant (6) is a staple that comprises a first leg (14), a second leg (15), and a bridge (11) that bridges between the first leg and the second leg (col. 7 / line 64 – col. 8 / line 15), FIGS. 1-2, wherein the implant receiving aperture is a first implant receiving aperture, wherein the location is a first location at the first bone, wherein the pinning and drilling instrument is a first pinning and drilling instrument inserted into the first bone the first distance and inserted into the first bone the second distance to create the first implant receiving aperture at the first bone, and further comprising: inserting a second pinning and drilling instrument (other 30 and 31) a third distance (distance that the other 30 is advanced into the respective bone portion) into the second bone at a second location at the second bone such that a pin portion (30) of the second pinning and drilling instrument is inserted into the second bone at the second location (col. 14 / lines 18-29), FIG. 16; after inserting the second pinning and drilling instrument the third distance into the second bone, creating a second implant receiving aperture at the second location by inserting the second pinning and drilling instrument (at 31) a fourth distance (distance that 31 is advanced into the respective bone portion) into the second bone at the second location such that a drill portion (63) of the second pinning and drilling instrument is inserted into the second bone to create the second implant receiving aperture at the second location (col. 17 / line 55 – col. 18 / line 25), FIGS. 17-18; and placing the first leg of the staple at the first implant receiving aperture and the second leg of the staple at the second implant receiving aperture (col. 19 / lines 28-34).
As to claim 15, Gaston discloses the method of claim 14, wherein the first distance corresponds to a length of the first leg of the staple, and wherein the third distance corresponds to a length of the second leg of the staple (col. 19 / lines 15-19; the first and second distances correspond to a length of the first leg and the third and fourth distances correspond to a length of the second leg).
As to claim 16, Gaston discloses the method of claim 14, further comprising: placing a drill guide (27) at the first bone and the second bone (col. 13 / line 57 – col. 14 / line 17), FIG. 15, wherein the first pinning and drilling instrument is inserted at the drill guide and into the first bone and the second pinning and drilling instrument is inserted at the drill guide and into the second bone so as to provisionally fixate the drill guide at the first and second bones, FIGS. 16-18.
As to claim 17, Gaston discloses the method of claim 16, wherein the drill guide comprises a trialing member (bridge of body 43) that simulates at least one dimension (length of the staple bridge 11) of the staple, FIG. 15, and wherein placing the drill guide at the first bone and the second bone comprises placing the trialing member at the first bone (adjacent and overlying), at the second bone (adjacent and overlying), and across a joint space separating the first bone and the second bone, FIG. 15.
Gaston is silent as to creating an implant receiving aperture at the location by further inserting the pinning and drilling instrument a second further distance (claim 1); further comprising: temporarily terminating insertion of the pin portion of the pinning and drilling instrument the first distance into the one or more bone portions at the location when the second-cross-sectional area contacts the one or more bone portions at the location (claim 6); further comprising: after inserting the first pinning and drilling instrument the first distance into the first bone, after inserting the second pinning and drilling instrument the third distance into the second bone, after placing the drill guide, and before creating the first and second implant receiving apertures, imaging the position of the pin portion of the first pinning and drilling instrument within the first bone and imaging the position of the pin portion of the second pinning and drilling instrument within the second bone (claim 18).
As to claim 1, Teisen teaches a method of placing an implant at one or more bone portions, the method comprising: inserting a pinning and drilling instrument (100), FIGS. 1-3, a first distance (length of 108, FIG. 3) into the one or more bone portions at a location at the one or more bone portions such that a pin portion (108) of the pinning and drilling instrument is inserted into the one or more bone portions at the location (col. 7 / lines 24-29); after inserting the pinning and drilling instrument the first distance into the one or more bone portions, creating an implant receiving aperture at the location by further inserting the pinning and drilling instrument a second further distance (portion of a length of 106) into the one or more bone portions at the location at the one or more bone portions such that a drill portion (portion of 106 including 112) of the pinning and drilling instrument is inserted into the one or more bone portions to create the implant receiving aperture at the location (col. 7 / lines 41-49).
As to claim 4, Teisen teaches the method of claim 1, wherein inserting the pin portion of the pinning and drilling instrument into the one or more bone portions at the location comprises creating a tacking aperture of a first diameter that extends into the one or more bones at the location, and wherein creating the implant receiving aperture at the location by rotationally driving the drill flutes of the drill portion into the location at the one or more bone portions comprises creating the implant receiving aperture of a second diameter that extends into the one or more bones at the location, wherein the second diameter of the implant receiving aperture is greater than the first diameter of the tacking aperture (since the diameter of the drill portion is greater than the diameter of the pin portion), FIG. 3.
As to claim 6, Teisen teaches the method of claim 4, wherein the pin portion of the pinning and drilling instrument comprises a first cross-sectional area of the pinning and drilling instrument, wherein the drill portion of the pinning and drilling instrument comprises a second cross-sectional area of the pinning and drilling instrument, wherein the second cross-sectional area is greater than the first cross-sectional area, FIG. 3, and further comprising: temporarily terminating insertion of the pin portion of the pinning and drilling instrument the first distance into the one or more bone portions at the location when the second-cross-sectional area contacts the one or more bone portions at the location (col. 7 / lines 29-43; temporarily terminating insertion to perform imaging).
As to claim 7, Teisen teaches the method of claim 1, further comprising: after inserting the pinning and drilling instrument the first distance into the one or more bone portions and before creating the implant receiving aperture at the location by further inserting the pinning and drilling instrument the second further distance into the one or more bone portions, imaging the position of the pin portion within the one or more bone portions at the location (col. 7 / lines 29-45).
As to claim 8, Teisen teaches the method of claim 7, wherein imaging the position of the pin portion comprises imaging the position of the pin portion within the bone.
As to claim 12, Teisen teaches the method of claim 1, further comprising: placing a drill guide (104) at the one or more bone portions, wherein the pinning and drilling instrument is inserted at the drill guide and into the one or more bone portions at the location so as to provisionally fixate the drill guide at the one or more bone portions using the pinning and drilling instrument, FIGS. 1-3.
As to claim 18, Teisen teaches the method of claim 17, further comprising: after inserting the first pinning and drilling instrument the first distance into the first bone, after placing the drill guide, and before creating the first and second implant receiving apertures, imaging the position of the pin portion of the first pinning and drilling instrument within the first bone (col. 7 / lines 29-45).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a pinning and drilling instrument as taught by Teisen in Gaston’s method, to create both the tacking aperture and the implant receiving aperture using one combined tool, since forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, and providing both apertures using one tool that is advanced a first distance and a second further distance sequentially would reduce the number of required steps and shorten the surgical time and cost. The pinning and drilling instrument would be inserted through Gaston’s drill guide to form the tacking aperture and the implant receiving aperture in appropriate location on the bone. Then, as taught by Teisen, after inserting the pinning and drilling instrument the first distance into the first bone, after placing Gaston’s drill guide, and before creating the implant receiving aperture, the method would include temporarily terminating insertion of the pin portion of the pinning and drilling instrument the first distance into the one or more bone portions at the location when the second-cross-sectional area contacts the one or more bone portions at the location in order to image the position of the pin portion of the pinning and drilling instrument within the first bone in order to determine the placement and orientation of the pin portion to ensure that this positioning is accurate before further drilling into the bone with the larger diameter drill portion, while allowing repositioning of the pin portion and the pinning and drilling instrument if so deemed necessary before further damaging the bone with the drill portion. The imaging of the pin portion would comprise imaging the position of the pin portion within one of the first bone and the second bone and relative to the joint space since the position of the pin portion must be a certain distance from the joint space in order to accommodate a staple with a certain length bridge.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a second pinning and drilling instrument of the same form as the first pinning and drilling instrument taught by Teisen, since the mere duplication of the essential working parts of a device involves only routine skill in the art, and providing duplicate pinning and drilling instruments would allow the pinning and drilling instruments to fixate the drill guide at the first and second bones simultaneously (as contemplated by Gaston, FIG. 17), maintaining the bones in the desired relative position to each other and to the drill guide. Then, as applied to Gaston, the first pinning and drilling instrument is inserted through a respective hole in the drill guide and into the first bone the first distance and further inserted into the first bone the second further distance to create the first implant receiving aperture at the first bone, a second pinning and drilling instrument is inserted through a respective hole in the drill guide and a third distance into the second bone at a second location at the second bone such that a pin portion of the second pinning and drilling instrument is inserted into the second bone at the second location, and a second implant receiving aperture is created at the second location by further inserting the second pinning and drilling instrument a fourth further distance into the second bone at the second location, and the legs of the staple are placed at the respective implant receiving apertures. Then, the imaging as taught by Teisen would include imaging the position of the pin portion of the first pinning and drilling instrument within the first bone and imaging the position of the pin portion of the second pinning and drilling instrument within the second bone, after inserting the first pinning and drilling instrument the first distance into the first bone, after inserting the second pinning and drilling instrument the third distance into the second bone, after placing the drill guide, and before creating the first and second implant receiving apertures.
As to claim 10, Gaston is silent as to wherein when it is determined, from the imaged position of the pin portion, that the pin portion is spaced apart from a joint space adjacent the one or more bones, creating the implant receiving aperture at the location by further inserting the pinning and drilling instrument the second further distance into the one or more bone portions.
As taught by Teisen above, the method includes imaging the position of the pin portion within the first bone in order to determine the placement and orientation of the pin portion to ensure that this positioning is accurate before further drilling into the bone with the larger diameter drill portion to create the implant receiving aperture. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to determine from the imaged position of the pin portion, that the pin portion is spaced apart from a joint space adjacent the one or more bones, since the pin portion creates a tacking aperture that indicates the position of the implant receiving aperture for one of the staple legs, and the pin portion being spaced apart from a joint space a certain distance would indicate the required staple bridge length. Once this is determined, and if the required staple bridge length is compatible with the intended staple for implantation, then the method can proceed to creating the implant receiving aperture at the location by further inserting the pinning and drilling instrument the second further distance into the one or more bone portions. Gaston contemplates that the implant receiving apertures are positioned at a desired location and spacing across the joint space for insertion of the staple legs into the respective bones (col. 14 / lines 7-15), and imaging as taught by Teisen would be used to confirm this positioning.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gaston in view of Teisen (hereinafter, “Gaston/Teisen”), as applied to claims 1, 4, 6-8, 10, and 12-18 above, and further in view of U.S. Patent Application Publication No. US 2022/0370211 to Campbell et al. (hereinafter, “Campbell”).
Gaston/Teisen are silent as to wherein the first bone is a metatarsal, the second bone is a cuneiform, and the joint space is the tarsometatarsal joint space.
Campbell teaches that a staple can be used to fixate a tarsometatarsal joint by extending a first staple leg into a metatarsal, a second staple leg into a cuneiform, with the staple bridge extending across the tarsometatarsal joint space (par. [0262]), FIG. 65.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of Gaston/Teisen to a tarsometatarsal joint wherein the first bone is a metatarsal, the second bone is a cuneiform, and the joint space is the tarsometatarsal joint space, by creating the first and second implant receiving apertures in the metatarsal and the cuneiform for receiving the staple legs, since Campbell teaches that a staple is an appropriate fixation means for this joint, and the method of Gaston/Teisen would ensure appropriate location of the staple across the joint.
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775