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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 13 April 2026. As directed by the amendment: claims 1-8, 10, 11, 13, 14, 17, and 18 have been amended, claims 19-26 are canceled, and claims 27-30 are newly added. Claims 1-18 and 27-30 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous claim objections, which are correspondingly withdrawn. Further claim objections as necessitated by the claim amendments are presented below.
The amendments to the claims are not sufficient to overcome the previous rejections under 35 U.S.C. 112(b), which are repeated below.
Response to Arguments
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any embodiment of the references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1-18 and 27-30 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: “a drill portion”
Claim 1 / line 12: “the drill portion”
Claim 1 / line 14: “placing [[an]] the implant”
Claim 30 / line 4: “the drill portion”
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.
Claim 27 is rejected under 35 U.S.C. 112(a) 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.
As to claim 27, the limitation “wherein the distance is within a range from 12 mm to 16 mm” is not supported by the specification as originally filed. The specification recites that the distance, which is the pin portion length, is selected from the group consisting of 12 mm, 13 mm, and 16 mm (par. [0018]). The entire range of lengths from 12 mm to 16 mm, e.g. every length between and including 12 mm and 16 mm, is not disclosed.
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 “driving [[the]] drill flutes of the drill portion”.
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 1-5, 11, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over 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, FIG. 4, a first distance (distance that 108 protrudes from 106, FIG. 4; 108 is shown labelled in 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 in FIG. 4, shown labelled in FIG. 3) of the pinning and drilling instrument is inserted into the one or more bone portions at the location (col. 7 / lines 24-29), the pin portion (108) projecting from a drilling portion (106) of the instrument a distance (length of 108, FIG. 4); after the inserting of 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 the drill portion (106) of the pinning and drilling instrument is inserted into the one or more bone portions while the pin portion remains projecting from the drilling portion the distance (since the pin portion and the drill portion are monolithic, col. 6 / lines 56-58) to create the implant receiving aperture at the location (col. 7 / lines 42-45).
As to claim 2, Teisen discloses the method of claim 1, wherein the implant receiving aperture is created at the location by the 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 (since the pin portion and the drill portion are monolithic, col. 6 / lines 56-58).
As to claim 3, Teisen discloses the method of claim 2, wherein the drill portion of the pinning and drilling instrument includes drill flutes (120) that begin where the pin portion ends (col. 6 / lines 46-51), FIG. 4, and wherein the 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 drill portion into the location at the one or more bone portions (since the flutes are helical flutes and act like a drill bit).
As to claim 4, Teisen discloses the method of claim 1, wherein the inserting of 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 (diameter of 108) that extends into the one or more bone portions at the location (col. 5 / line 65 – col. 6 / line 9), and wherein the creating of the implant receiving aperture at the location comprises rotationally driving the drill flutes of the drill portion into the location at the one or more bone portions (since the flutes are helical flutes and act like a drill bit, col. 6 / lines 46-51) to create the implant receiving aperture of a second diameter (diameter of 106) that extends into the one or more bone portions at the location (col. 5 / line 65 – col. 6 / line 9, col. 7 / lines 15-51), wherein the second diameter of the implant receiving aperture is greater than the first diameter of the tacking aperture (since the diameter of 106 is greater than the diameter of 108), FIG. 4.
Teisen does not explicitly recite, in this embodiment, placing an implant at the implant receiving aperture (claim 1); wherein the placing of 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 is larger than the first diameter of the tacking aperture and smaller than the second diameter of the implant receiving aperture (claim 5); and wherein the placing of 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 (claim 11). Teisen does recite that Jamshidi needles are used to prepare the bone to place screws (col. 3 / lines 16-36); the cannula (104) is used to place/guide the pinning and drilling instrument and an implant (col. 7 / lines 7-14); and a screw implant is placed at an implant receiving aperture created by a pinning and drilling instrument in another embodiment (col. 11 / lines 9-11). Teisen teaches, in the other embodiment, wherein the placing of 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 implant is received in the implant receiving aperture which is larger than the tacking aperture) and smaller than the second diameter of the implant receiving aperture (since the implant receiving aperture receives the implant and thus has a larger diameter than the implant so the implant can fit inside it) (claim 5); and wherein the placing of 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 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 11).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Teisen’s method, placing an implant at the implant receiving aperture, since in other embodiments Teisen discloses that the implant receiving aperture created by a pinning and drilling instrument is used to prepare a bone for insertion of an implant such as a screw. Since the instrument is used to break the cortex of the bone, there is less possibility of damaging the implant/screw during its insertion. The implant/screw would then accomplish any intended surgical outcome such as fusion. As taught by Teisen in the other embodiment, the placing of the implant at the implant receiving aperture comprises placing a portion of the implant within the implant receiving aperture. The portion of the implant would be larger than the first diameter of the tacking aperture (since the implant is received in the implant receiving aperture which is larger than the tacking aperture) and smaller than the second diameter of the implant receiving aperture (since the implant receiving aperture receives the implant and thus has a larger diameter than the implant so the implant can fit inside it). 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, since the drill portion creates the implant receiving aperture into which the portion of the implant is placed, and the drill portion can be interpreted as the portion of the length of 106 that is drilled into the bone to create the implant receiving aperture that is of the length to receive the portion of the implant.
As to claim 27, Teisen is silent as to the distance is within a range from 12 mm to 16 mm. Teisen contemplates that the distance (the length of 108) is in a range of about 10-30 mm (col. 6 / lines 10-13).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the distance within a range from 12 mm to 16 mm, which is part of the range of the length of 108 disclosed by Teisen, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Teisen teaches that the range of 10-30 mm reflects typical anatomical lengths of a pedicle cortical bone, so providing the distance within a range from 12 mm to 16 mm would accommodate a particular pedicle cortical bone with a corresponding anatomical length, for example of a younger patient, so that the pin portion can penetrate through the cortical bone.
Claims 1, 4, 6-8, 10, 12-18, 28, and 29 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 the inserting of 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 the inserting of 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 bone portions at the location, and wherein the creating of the implant receiving aperture at the location 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 that extends into the one or more bone portions 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 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 inserting of the pinning and drilling instrument the second distance into the one or more bone portions, imaging a 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 separated by a joint space, FIG. 15, and wherein the imaging of 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 the creating of the implant receiving aperture at the location by the 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 bone portions 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 the inserting of 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 the placing of 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.
As to claim 29, Gaston discloses the method of claim 28, wherein the implant comprises a staple (col. 7 / line 64 – col. 8 / line 15), FIGS. 1-2.
Gaston is silent as to the pin portion projecting from a drilling portion of the instrument a distance; creating an implant receiving aperture at the location by further inserting the pinning and drilling instrument a second further distance such that the drill portion is inserted into the one or more bone portions while the pin portion remains projecting from the drilling portion the 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 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 a position of the pin portion of the first pinning and drilling instrument within the first bone and imaging a position of the pin portion of the second pinning and drilling instrument within the second bone (claim 18); wherein the distance is equal to a length of an implant portion of the implant (claim 28); the implant portion is a leg of the staple (claim 29).
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, FIG. 4, a first distance (distance that 108 protrudes from 106, FIG. 4; 108 is shown labelled in 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 in FIG. 4, shown labelled in FIG. 3) of the pinning and drilling instrument is inserted into the one or more bone portions at the location (col. 7 / lines 24-29), the pin portion (108) projecting from a drilling portion (106) of the instrument a distance (length of 108, FIG. 4); after the inserting of 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 the drill portion (106) of the pinning and drilling instrument is inserted into the one or more bone portions while the pin portion remains projecting from the drilling portion the distance (since the pin portion and the drill portion are monolithic, col. 6 / lines 56-58) to create the implant receiving aperture at the location (col. 7 / lines 42-45).
As to claim 4, Teisen discloses the method of claim 1, wherein the inserting of 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 (diameter of 108) that extends into the one or more bone portions at the location (col. 5 / line 65 – col. 6 / line 9), and wherein the creating of the implant receiving aperture at the location comprises rotationally driving the drill flutes of the drill portion into the location at the one or more bone portions (since the flutes are helical flutes and act like a drill bit, col. 6 / lines 46-51) to create the implant receiving aperture of a second diameter (diameter of 106) that extends into the one or more bone portions at the location (col. 5 / line 65 – col. 6 / line 9, col. 7 / lines 15-51), wherein the second diameter of the implant receiving aperture is greater than the first diameter of the tacking aperture (since the diameter of 106 is greater than the diameter of 108), FIG. 4.
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. 4, 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 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 the second further distance into the one or more bone portions, imaging a 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 the imaging of 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 the inserting of the first pinning and drilling instrument the first distance into the first bone, after the placing of the drill guide, and before the creating of the first implant receiving aperture, imaging a 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 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.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the distance equal to a length of an implant portion of the implant, where the implant portion is a leg of the staple, since the distance is the length of the pin portion and the pin portion provides a guide tacking aperture, i.e. a guide pin/guiding hole, for subsequent formation of the implant receiving aperture by the larger diameter drill portion, and the implant receiving aperture has a length equal to a length of the staple leg in order to receive the staple leg. Therefore, to provide a guide pin/guiding hole for the drill portion to create the implant receiving aperture of the same length as the staple leg, the guide pin/guiding hole would also be the same length. This would reduce stress and strain on the drill portion as it is creating the implant receiving aperture and reduce stress and strain on the bone, reducing the chance of damage or cracking.
As to claim 10, Gaston is silent as to 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.
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 bone portions, 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, 12-18, 28, and 29 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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Teisen in view of U.S. Patent Application Publication No. US 2021/0346072 to Lee et al. (hereinafter, “Lee”).
As to claim 30, Teisen discloses a powered driver (140; manually powered) that is engaged, via shaft 102, to both the pin portion and the drilling portion of the pinning and drilling instrument (since the pin portion and the drill portion are monolithic, col. 6 / lines 56-58).
Teisen is silent as to wherein the pinning and drilling instrument comprises a driver engagement portion, and further comprising inserting the driver engagement portion of the pinning and drilling instrument into the powered driver.
Lee teaches an instrument comprising a driver engagement portion (proximal end of shaft 14), FIGS. 3-5, and further comprising inserting the driver engagement portion of the instrument into a powered driver (18; manually powered) (par. [0039]-[0041]), FIG. 5.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the shaft (Teisen, 102) of the pinning and drilling instrument in Teisen to the powered driver (Teisen, manually powered handle 140) by inserting a proximal end of the shaft, called a driver engagement portion, into the powered driver, as taught by Lee, since constructing a formerly integral structure in various elements involves only routine skill in the art. Providing the shaft and the powered driver as separate parts that are connected to each other would simplify manufacturing. Inserting the driver engagement portion into the powered driver would engage both the pin portion and the drilling portion of the pinning and drilling instrument to the powered driver since the pin portion and the drill portion on the end of the shaft are monolithic (col. 6 / lines 56-58).
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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