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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 June 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 08 May 2025. As directed by the amendment: Claims 1, 16, and 21-23 have been amended, and claims 8-15, 19, and 25 are cancelled. Claims 1-7, 16-18, 20-24, and 26-32 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are accordingly withdrawn. However, the current claim amendments have resulted in further rejections under 35 U.S.C. 112(b), which are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections of claims 16, 21, and 23 under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any embodiment or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments as to the rejection of claim 26 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends that a person of skill in the art would not be motivated to modify the blades shown in FIGS. 32A-32D of Lavigne (US 10,687,877) to include the staple legs shown in FIGS. 1A-1D of Lavigne, because the blades in FIGS. 32A-32D are specifically designed/shaped for interfacet implantation and the blades in FIGS. 1A-1D would not resist withdrawal from the cartilage surfaces. Examiner respectfully submits that Lavigne contemplates that any of the embodiments has the advantage of being able to be used either as a trans-facet or inter-facet implant (col. 16 / lines 31-34), and therefore the embodiment shown in FIGS. 32A-32D can be used as a trans-facet implant that is inserted through the bones. The modification to have the bone-engaging features with a sharp tip as shown in FIGS. 1A-1D would then be obvious to allow ease of insertion into the bone with reduced tissue damage for such a trans-facet implant. Even if the implant is used for interfacet implantation, the contemplation of Lavigne that any of the embodiments has the advantage of being able to be used either as a trans-facet or inter-facet implant means that the tips of FIGS. 1A-1D could be used for interfacet implantation, for example if the cartilage surfaces are damaged or thin and would not withstand engagement by the notches of FIGS. 32A-32D, and/or if the bone portions are spaced such that they frictionally engage the blades with sufficient force to not require the notches for anti-backout.
Applicant's arguments as to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends that Lavigne (US 10,687,877) discloses a bone screw having windows formed through the shafts, resulting in interrupted/discontinuous shaft. Examiner respectfully submits that, as required by claim 1, an entire length of the fastener shaft can be taken vertically from proximal to distal along the side shown in FIG. 32D, which is continuous or not interrupted because there are no windows along that entire length. The outer surface is interpreted as defined in part by the minor diameter and also includes the helical thread; this outer surface is continuous along the entire length as defined above, at least as much as the instant invention which also comprises a helical thread that interrupts the minor diameter along a particular length of the shaft.
Applicant's arguments as to the rejection of claim 22 under 35 U.S.C. 103 have been fully considered but they are not persuasive, for the same reasons as described above with respect to claim 26, where, as contemplated by Lavigne, any of the embodiments has the advantage of being able to be used either as a trans-facet or inter-facet implant (col. 16 / lines 31-34).
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 1-7 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 1, the limitation “wherein the outer surface of the fastener shaft along an entire length of the fastener shaft is continuous” (lines 10-11) renders the claims indefinite because the scope of the term “continuous” is unclear. If, as previously recited in claim 1, the outer surface is defined by the minor diameter, it is unclear if this minor diameter must extend continuously along an entire length of the fastener shaft, i.e. vertically from proximal to distal along a side of the shaft, and if so, how it is not broken (made uncontinuous) along the length by the helical thread, which comprises a crest that interrupts the minor diameter along the length. For examination purposes, the outer surface will be interpreted as defined in part by the minor diameter and also include the helical thread.
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 1-3, 5, 6, 22, 26, 27, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 10,687,877 to Lavigne et al. (hereinafter, “Lavigne”), in view of U.S. Patent No. US 8,337,205 to Reed.
As to claim 1, Lavigne discloses a bone disunion fastener, shown in FIGS. 32A-32D, comprising: a fastener shaft (shaft 10 of 1) (col. 8 / lines 52-57) comprising: a proximal end; a distal end; a longitudinal axis; an outer surface defined by a minor diameter of the fastener shaft (the outer surface of the shaft is defined partially by the minor diameter because it includes the surface at the minor diameter); a fastener head (18) disposed at the proximal end of the fastener shaft; and a helical thread (12) disposed about the fastener shaft along the longitudinal axis, FIG. 32D, defining a threaded portion (a portion of the shaft that is threaded, e.g. proximal portion between windows 15) of the fastener shaft, wherein the outer surface of the fastener shaft along an entire length of the fastener shaft is continuous (the outer surface of the fastener shaft along an entire length of the shaft, where the entire length is taken vertically from proximal to distal along the side shown in FIG. 32D, is continuous or not interrupted because there are no windows along that entire length; the outer surface is defined by and includes the minor diameter as well as the thread/crests, i.e. is the entire outer surface of the shaft, which is continuous along the entire length as defined above); and a bone staple (2) comprising: a first end (on the left in FIG. 32A) comprising a first bone-engaging feature (276 on the left) (col. 13 / lines 37-43), FIG. 32A; a second end (on the right in FIG. 32A) comprising a second bone-engaging feature (276 on the right); and a middle portion extending between the first end and the second end, the middle portion comprising an opening configured to receive the fastener shaft therethrough and engage the fastener head disposed at the proximal end of the fastener shaft, FIG. 32C; wherein the first bone-engaging feature, the second bone-engaging feature, and the middle portion of the bone staple are integrally formed with each other as a single piece, FIGS. 32A and 32D; wherein, when the bone disunion fastener is implanted along a disunion between a first bone portion and a second bone portion (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of said intended use; the fastener is fully capable of being implanted along a disunion between first and second bone portions since it is a bone fastener): the first bone-engaging feature is configured to engage the first bone portion to couple the first end of the bone staple to the first bone portion (interpreted as language of intended use; the first feature is fully capable of engaging the first bone portion if the first end of the staple is placed adjacent to the first bone portion); the second bone-engaging feature is configured to engage the second bone portion to couple the second end of the bone staple to the second bone portion (interpreted as language of intended use; the second feature is fully capable of engaging the second bone portion if the second end of the staple is placed adjacent to the second bone portion and since the first and second ends and features are spaced apart); the bone staple, when coupled to the first bone portion and the second bone portion, is configured to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion (interpreted as language of intended use; the staple is fully capable of resisting a force transmitted between the bone portions since its ends are engaged into the bone portions to hold them securely relative to each other, therefore stabilizing the disunion between the bone portions); and the fastener head sits flush within the opening of the bone staple when the bone disunion fastener is implanted along the disunion between the first bone portion and the second bone portion, FIG. 32C.
As to claim 2, Lavigne discloses the bone disunion fastener of claim 1, wherein the fastener shaft is formed as a single piece with the fastener head, FIG. 32C.
As to claim 3, Lavigne discloses the bone disunion fastener of claim 2, wherein, when the bone disunion fastener is implanted along the disunion between the first bone portion and the second bone portion, the fastener head directly engages the middle portion of the bone staple to couple the fastener shaft to the bone staple, FIG. 32A.
As to claim 5, Lavigne discloses the bone disunion fastener of claim 1, wherein at least one of the first bone-engaging feature and the second bone-engaging feature comprises at least one of: one or more roughened surfaces; one or more teeth; one or more blades; one or more ribs; and one or more legs (the bone-engaging features 276 are blades or legs), FIG. 32A.
As to claim 6, Lavigne discloses the bone disunion fastener of claim 5, wherein: the first bone-engaging feature comprises a first leg projecting away from the first end of the bone staple along a first inferior direction; and the second bone-engaging feature comprises a second leg projecting away from the second end of the bone staple along a second inferior direction, wherein the first inferior direction is substantially parallel to the second inferior direction, FIG. 32A.
Lavigne is silent as to a concave undercut surface; the concave undercut surface is oriented towards one of the proximal end and the distal end of the fastener shaft; the concave undercut surface is shaped to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion.
As to claim 1, Reed teaches a bone disunion fastener (20) comprising a fastener shaft (23 and 24) comprising a proximal end; a distal end; and a longitudinal axis, FIG. 2A; a helical thread (24a) disposed about the fastener shaft along the longitudinal axis, the helical thread comprising a concave undercut surface (34, 35) (col. 5 / line 60 – col. 6 / line 2), FIG. 3; and a bone staple (26) comprising a bone-engaging feature (distal end of 26) and an opening configured to receive the fastener shaft therethrough, FIGS. 2A and 6; wherein the concave undercut surface is oriented towards the proximal end of the fastener shaft; the concave undercut surface is shaped to resist at least one force transmitted between the first bone portion and the second bone portion (col. 7 / lines 8-14) (at least a longitudinally separating force is resisted by the longitudinal clamping between the staple and the concave undercut surfaces of the thread).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Lavigne’s helical thread with a concave undercut surface as taught by Reed, oriented towards the proximal end of the fastener shaft so that the staple and the concave undercut surfaces of the thread create a longitudinal clamping force that would resist any longitudinally separating or translating force transmitted between the bone portions, therefore further stabilizing the bone portions into which the staple is engaged and accordingly further stabilizing the disunion. Lavigne’s helical thread would be provided with the surfaces (Reed, 34, 35) that form a proximally oriented concavity. The disunion, into which Lavigne’s fastener is fully capable of being implanted, may be provided with a complementarily shaped female thread (Reed, FIG. 4) that is tapped to receive the fastener with the concave undercut surface (e.g. internal sides of the bone portions that form the disunion are tapped with the female thread), the interaction between the threads providing a centering force that prevents spreading of the bone portions (Reed, col. 6 / lines 45-59); the concave undercut surface is therefore shaped to resist outward radial forces transmitted between the first bone portion and the second bone portion by providing a centering force, therefore stabilizing the disunion, and the bone staple also resists the outward radial forces transmitted between the first bone portion and the second bone portion since each of its ends are inserted into each of the bone portions and the structure of the staple holds them together.
As to claim 22, Lavigne discloses a bone disunion fastener, shown in FIGS. 32A-32D, comprising: a fastener shaft (shaft 10 of 1) (col. 8 / lines 52-57) comprising: a proximal end; a distal end; and a longitudinal axis; a helical thread (12) disposed about the fastener shaft along the longitudinal axis, FIG. 32D; and a bone staple (2) comprising: a first end (on the left in FIG. 32A) comprising a first bone-engaging feature (276 on the left) (col. 13 / lines 37-43), FIG. 32A, projecting inferiorly away from the first end of the bone staple toward the distal end of the fastener shaft, wherein the first bone-engaging feature comprises: a first inwardly-facing surface; and a first outwardly-facing surface; a second end (on the right in FIG. 32A) comprising a second bone-engaging feature (276 on the right) projecting inferiorly away from the second end of the bone staple toward the distal end of the fastener shaft; and a middle portion extending between the first end and the second end, the middle portion comprising an opening configured to receive the fastener shaft therethrough, FIG. 32C, wherein the first bone-engaging feature, the second bone-engaging feature, and the middle portion of the bone staple are monolithically formed as a single piece, FIGS. 32A and 32D; wherein, when the bone disunion fastener is implanted along a disunion between a first bone portion and a second bone portion (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of said intended use; the fastener is fully capable of being implanted along a disunion between first and second bone portions since it is a bone fastener): the first bone-engaging feature comprises a first distal tip configured to penetrate into the first bone portion to couple the first end of the bone staple to the first bone portion (interpreted as language of intended use; the first feature is fully capable of penetrating into the first bone portion if the first end of the staple is placed adjacent to the first bone portion); the second bone-engaging feature comprises a second distal tip configured to penetrate into the second bone portion to couple the second end of the bone staple to the second bone portion (interpreted as language of intended use; the second feature is fully capable of penetrating into the second bone portion if the second end of the staple is placed adjacent to the second bone portion and since the first and second ends and features are spaced apart); and the bone staple, when coupled to the first bone portion and the second bone portion, is configured to resist the at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion (interpreted as language of intended use; the staple is fully capable of resisting a force transmitted between the bone portions since its ends are engaged into the bone portions to hold them securely relative to each other, therefore stabilizing the disunion between the bone portions).
As to claim 31, Lavigne discloses the bone disunion fastener of claim 22, wherein, when the bone disunion fastener is implanted along the disunion between the first bone portion and the second bone portion, a fastener head (18) disposed at the proximal end of the fastener shaft directly engages the middle portion of the bone staple to couple the fastener shaft to the bone staple, FIG. 32A.
Lavigne is silent as to wherein the first outwardly-facing surface extends further toward the distal end of the fastener shaft than the first inwardly-facing surface; the bone-engaging features comprise sharpened distal tips.
In another embodiment, shown in FIG. 21B, Lavigne teaches a bone staple (2) comprising a first bone-engaging feature (20 on the left) projecting inferiorly away from the first end of the bone staple toward the distal end of the fastener shaft (col. 24 / lines 19-26), wherein the first bone-engaging feature comprises: a first inwardly-facing surface (surface facing other 20), FIG. 21A; and a first outwardly-facing surface, wherein the first outwardly-facing surface extends further toward the distal end of the fastener shaft than the first inwardly-facing surface (due to chamfer 218 that cuts away a distal portion of the inwardly-facing surface), FIG. 21A; a second bone-engaging feature (20 on the right); the bone-engaging features comprising sharpened distal tips due to the chamfer creating a relatively sharpened cutting tip due to the taper to a point.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the tips of the bone-engaging features in Lavigne’s embodiment shown in FIGS. 32A-32D with a chamfer, so that the first outwardly-facing surface extends further toward the distal end of the fastener shaft than the first inwardly-facing surface, as taught by Lavigne FIG. 21B, to allow ease of insertion into the bone with reduced tissue damage. As contemplated by Lavigne, any of the embodiments has the advantage of being able to be used either as a trans-facet or inter-facet implant (col. 16 / lines 31-34), and therefore the embodiment shown in FIGS. 32A-32D can be used as a trans-facet implant that is inserted through the bones. The modification to have a chamfer creating a sharpened distal tip would then be obvious to allow ease of insertion into the bone with reduced tissue damage for such a trans-facet implant.
Lavigne is silent as to a concave undercut surface; the concave undercut surface is oriented towards one of the proximal end and the distal end of the fastener shaft; the concave undercut surface is shaped to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion.
Reed teaches a bone disunion fastener (20) comprising a fastener shaft (23 and 24) comprising a proximal end; a distal end; and a longitudinal axis, FIG. 2A; a helical thread (24a) disposed about the fastener shaft along the longitudinal axis, the helical thread comprising a concave undercut surface (34, 35) (col. 5 / line 60 – col. 6 / line 2), FIG. 3; and a bone staple (26) comprising a bone-engaging feature (distal end of 26) and an opening configured to receive the fastener shaft therethrough, FIGs. 2A and 6; wherein the concave undercut surface is oriented towards the proximal end of the fastener shaft; the concave undercut surface is shaped to resist at least one force transmitted between the first bone portion and the second bone portion (col. 7 / lines 8-14) (at least a longitudinally separating force is resisted by the longitudinal clamping between the staple and the concave undercut surfaces of the thread).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Lavigne’s helical thread with a concave undercut surface as taught by Reed, oriented towards the proximal end of the fastener shaft so that the staple and the concave undercut surfaces of the thread create a longitudinal clamping force that would resist any longitudinally separating or translating force transmitted between the bone portions, therefore further stabilizing the bone portions into which the staple is engaged and accordingly further stabilizing the disunion. Lavigne’s helical thread would be provided with the surfaces (Reed, 34, 35) that form a proximally oriented concavity. The disunion, into which Lavigne’s fastener is fully capable of being implanted, may be provided with a complementarily shaped female thread (Reed, FIG. 4) that is tapped to receive the fastener with the concave undercut surface (e.g. internal sides of the bone portions that form the disunion are tapped with the female thread), the interaction between the threads providing a centering force that prevents spreading of the bone portions (Reed, col. 6 / lines 45-59); the concave undercut surface is therefore shaped to resist outward radial forces transmitted between the first bone portion and the second bone portion by providing a centering force, therefore stabilizing the disunion, and the bone staple also resists the outward radial forces transmitted between the first bone portion and the second bone portion since each of its ends are inserted into each of the bone portions and the structure of the staple holds them together.
As to claim 26, Lavigne discloses a bone disunion fastener, shown in FIGS. 32A-32D, comprising: a fastener shaft (shaft 10 of 1) (col. 8 / lines 52-57) comprising: a proximal end; a distal end; and a longitudinal axis; a helical thread (12) disposed about the fastener shaft along the longitudinal axis, FIG. 32D; and a bone staple (2) comprising: a first end (on the left in FIG. 32A) comprising a first bone-engaging feature (276 on the left) projecting inferiorly away from the first end of the bone staple toward the distal end of the fastener shaft (col. 13 / lines 37-43), FIG. 32A, wherein the first bone-engaging feature comprises: a first longitudinal axis; and a first outer surface (surface facing outward away from the other 276) extending alongside the first longitudinal axis; a second end (on the right in FIG. 32A) comprising a second bone-engaging feature (276 on the right) projecting inferiorly away from the second end of the bone staple toward the distal end of the fastener shaft, wherein the second bone-engaging feature comprises: a second longitudinal axis; and a second outer surface extending alongside the second longitudinal axis; and a middle portion extending between the first end and the second end, the middle portion comprising an opening configured to receive the fastener shaft therethrough, FIG. 32C; wherein, when the bone disunion fastener is implanted along a disunion between a first bone portion and a second bone portion (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of said intended use; the fastener is fully capable of being implanted along a disunion between first and second bone portions since it is a bone fastener): the first bone-engaging feature is configured to penetrate into the first bone portion to couple the first end of the bone staple to the first bone portion (interpreted as language of intended use; the first feature is fully capable of penetrating into the first bone portion if the first end of the staple is placed adjacent to the first bone portion); the second bone-engaging feature is configured to penetrate into the second bone portion to couple the second end of the bone staple to the second bone portion (interpreted as language of intended use; the second feature is fully capable of engaging the second bone portion if the second end of the staple is placed adjacent to the second bone portion and since the first and second ends and features are spaced apart); and the bone staple, when coupled to the first bone portion and the second bone portion, is configured to resist the at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion (interpreted as language of intended use; the staple is fully capable of resisting a force transmitted between the bone portions since its ends are engaged into the bone portions to hold them securely relative to each other, therefore stabilizing the disunion between the bone portions).
As to claim 27, Lavigne discloses the bone disunion fastener of claim 26, wherein, when the bone disunion fastener is implanted along the disunion between the first bone portion and the second bone portion, a fastener head disposed at the proximal end of the fastener shaft directly engages the middle portion of the bone staple to couple the fastener shaft to the bone staple, FIG. 32A.
Lavigne is silent as to a concave undercut surface; the concave undercut surface is oriented towards one of the proximal end and the distal end of the fastener shaft; the concave undercut surface is shaped to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion.
As to claim 26, Reed teaches a bone disunion fastener (20) comprising a fastener shaft (23 and 24) comprising a proximal end; a distal end; and a longitudinal axis, FIG. 2A; a helical thread (24a) disposed about the fastener shaft along the longitudinal axis, the helical thread comprising a concave undercut surface (34, 35) (col. 5 / line 60 – col. 6 / line 2), FIG. 3; and a bone staple (26) comprising a bone-engaging feature (distal end of 26) and an opening configured to receive the fastener shaft therethrough, FIGs. 2A and 6; wherein the concave undercut surface is oriented towards the proximal end of the fastener shaft; the concave undercut surface is shaped to resist at least one force transmitted between the first bone portion and the second bone portion (col. 7 / lines 8-14) (at least a longitudinally separating force is resisted by the longitudinal clamping between the staple and the concave undercut surfaces of the thread).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Lavigne’s helical thread with a concave undercut surface as taught by Reed, oriented towards the proximal end of the fastener shaft so that the staple and the concave undercut surfaces of the thread create a longitudinal clamping force that would resist any longitudinally separating or translating force transmitted between the bone portions, therefore further stabilizing the bone portions into which the staple is engaged and accordingly further stabilizing the disunion. Lavigne’s helical thread would be provided with the surfaces (Reed, 34, 35) that form a proximally oriented concavity. The disunion, into which Lavigne’s fastener is fully capable of being implanted, may be provided with a complementarily shaped female thread (Reed, FIG. 4) that is tapped to receive the fastener with the concave undercut surface (e.g. internal sides of the bone portions that form the disunion are tapped with the female thread), the interaction between the threads providing a centering force that prevents spreading of the bone portions (Reed, col. 6 / lines 45-59); the concave undercut surface is therefore shaped to resist outward radial forces transmitted between the first bone portion and the second bone portion by providing a centering force, therefore stabilizing the disunion, and the bone staple also resists the outward radial forces transmitted between the first bone portion and the second bone portion since each of its ends are inserted into each of the bone portions and the structure of the staple holds them together.
Lavigne is silent as to wherein no portion of the first outer surface comprises protrusions or indentations that protrude away from or toward the first longitudinal axis; wherein no portion of the second outer surface comprises protrusions or indentations that protrude away from or toward the second longitudinal axis.
In another embodiment, shown in FIGS. 1A-1D, Lavigne teaches a bone staple (2) comprising bone-engaging features comprising an outer surface, wherein no portion of the outer surface comprises protrusions or indentations that protrude away from or toward the longitudinal axis of the bone-engaging feature.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lavigne’s staple from the embodiment of FIGS. 32A-32D to have bone-engaging features of the shape shown in Lavigne’s FIGS. 1A-1D, since the bone-engaging features have a sharp tip for facilitating bone anchoring and since the simple substitution of one known element for another to obtain predictable results (bone anchoring) is within the ordinary skill in the art. Since the outer surface of each bone-engaging feature is smoothly cylindrical, no portion of the outer surface comprises protrusions or indentations that protrude away from or toward the respective longitudinal axis. As contemplated by Lavigne, any of the embodiments has the advantage of being able to be used either as a trans-facet or inter-facet implant (col. 16 / lines 31-34), and therefore the embodiment shown in FIGS. 32A-32D can be used as a trans-facet implant that is inserted through the bones. The modification to have the bone-engaging features with a sharp tip would then be obvious to allow ease of insertion into the bone with reduced tissue damage for such a trans-facet implant.
Claims 4, 28, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Lavigne in view of Reed (hereinafter, “Lavigne/Reed”), as applied to claims 1-3, 5, 6, 22, 26, 27, and 31 above, and further in view of U.S. Patent No. US 8,940,029 to Leung et al. (hereinafter, “Leung”).
As to claims 4, 28, and 32, Lavigne/Reed are silent as to wherein: the fastener head comprises a first locking feature; and the middle portion comprises a second locking feature configured to engage the first locking feature and lock the fastener head to the bone staple.
Leung teaches a polyaxial fastener (14) comprising a fastener head (24) comprising a first locking feature (thread 36) (col. 5 / lines 47-53), FIG. 1; and a middle portion comprising an opening (54) comprising a second locking feature (thread 70) configured to engage the first locking feature and lock the fastener head to the middle portion (col. 6 / lines 28-61), FIGS. 2-4, to allow locking and therefore stabilization of a polyaxial fastener.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fastener head in Lavigne/Reed to have a first locking feature by at least partially externally threading the head, as taught by Leung, and to modify the opening in the middle portion of the bone staple to have a second locking feature comprising an internal thread configured to engage the first locking feature, so that when the fastener head is fully seated within the opening, the complementary threads engage each other to lock the fastener head to the bone staple, to lock and stabilize the fastener in a given position relative to the staple and to stabilize the assembly.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lavigne in view of Reed (hereinafter, “Lavigne/Reed”), as applied to claims 1-3, 5, 6, 22, 26, 27, and 31 above, and further in view of U.S. Patent Application Publication No. US 2010/0094358 to Moore et al. (hereinafter, “Moore”).
As to claim 7, Lavigne/Reed are silent as to wherein: the first bone-engaging feature comprises a first plurality of legs projecting away from the first end of the bone staple inferiorly; and the second bone-engaging feature comprises a second plurality of legs projecting away from the second end of the bone staple inferiorly.
As to claim 5, Moore discloses the bone disunion fastener of claim 1, wherein at least one of the first bone-engaging feature and the second bone-engaging feature comprises at least one of: one or more roughened surfaces; one or more teeth; one or more blades; one or more ribs; and one or more legs (each of the first and second bone-engaging features comprises legs 13).
As to claim 7, Moore discloses the bone disunion fastener of claim 5, wherein the first bone-engaging feature comprises a first plurality of legs (pair of legs 13 on the left side or end) projecting away from the first end of the bone staple inferiorly; and the second bone-engaging feature comprises a second plurality of legs (pair of legs 13 on the right side or end) projecting away from the second end of the bone staple inferiorly.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the staple in Lavigne/Reed such that each of the first and second bone-engaging features comprises a plurality of legs, since the mere duplication of the essential working parts of a device involves only routine skill in the art, and providing more legs would provide greater fixation strength or allow fixation of more bone portions. The first plurality of legs would comprise a pair of legs projecting away from the first end of the bone staple inferiorly, and spaced around one side of the fastener head; and the second plurality of legs would comprise a pair of legs projecting away from the second end of the bone staple inferiorly, and spaced around the other side of the fastener head. Lavigne contemplates the use of pluralities of legs, shown for example in FIGS. 29A, 30A, and 31C, for greater fixation strength.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lavigne in view of Reed and U.S. Patent Application Publication No. US 2019/0105131 to Barton et al. (hereinafter, “Barton”).
As to claim 23, Lavigne discloses a bone disunion fastener, shown in FIGS. 32A-32D, comprising: a fastener shaft (shaft 10 of 1) (col. 8 / lines 52-57) comprising: a proximal end; a distal end; a longitudinal axis; a fastener head (18) disposed at the proximal end of the fastener shaft; and a first helical thread (12) disposed about the fastener shaft along the longitudinal axis, FIG. 32D; and a bone staple (2) comprising: a first end (on the left in FIG. 32A) comprising a first staple leg (276 on the left) projecting inferiorly away from the first end of the bone staple (col. 13 / lines 37-43), FIG. 32A; a second end (on the right in FIG. 32A) comprising a second staple leg (276 on the right) projecting inferiorly away from the second end of the bone staple; and a middle portion extending between the first end and the second end, the middle portion comprising an opening configured to receive the fastener shaft therethrough and engage the fastener head, FIG. 32C, wherein no portion of the first staple leg and the second staple leg projects superiorly above the middle portion of the bone staple, FIG. 32A; wherein, when the bone disunion fastener is implanted along a disunion between a first bone portion and a second bone portion (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of said intended use; the fastener is fully capable of being implanted along a disunion between first and second bone portions since it is a bone fastener): the first staple leg is configured to engage the first bone portion to couple the first end of the bone staple to the first bone portion (interpreted as language of intended use; the first leg is fully capable of engaging the first bone portion if the first end of the staple is placed adjacent to the first bone portion); the second staple leg is configured to engage the second bone portion to couple the second end of the bone staple to the second bone portion (interpreted as language of intended use; the second leg is fully capable of engaging the second bone portion if the second end of the staple is placed adjacent to the second bone portion and since the first and second ends and features are spaced apart); the bone staple, when coupled to the first bone portion and the second bone portion, is configured to resist the at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion (interpreted as language of intended use; the staple is fully capable of resisting a force transmitted between the bone portions since its ends are engaged into the bone portions to hold them securely relative to each other, therefore stabilizing the disunion between the bone portions); and the fastener head sits flush within the opening of the bone staple when the bone disunion fastener is implanted along the disunion between the first bone portion and the second bone portion, FIG. 32C.
As to claim 24, Lavigne discloses the bone disunion fastener of claim 23, wherein, when the bone disunion fastener is implanted along the disunion between the first bone portion and the second bone portion, the fastener head directly engages the middle portion of the bone staple to couple the fastener shaft to the bone staple, FIG. 32A.
Lavigne is silent as to a first concave undercut surface; and a second helical thread disposed about the fastener shaft along the longitudinal axis adjacent the first helical thread, the second helical thread comprising a second concave undercut surface; the first concave undercut surface is oriented towards one of the proximal end and the distal end of the fastener shaft; the second concave undercut surface is oriented towards the other one of the proximal end and the distal end of the fastener shaft; the first concave undercut surface and the second concave undercut surface are shaped to resist at least one force transmitted between the first bone portion and the second bone portion to stabilize the disunion.
As to claim 23, Barton teaches a bone fastener (10), FIGS. 2-3, comprising a fastener shaft comprising a proximal end; a distal end; and a longitudinal axis; a first helical thread (31) disposed about the fastener shaft along the longitudinal axis, the first helical thread comprising a first concave undercut surface (43) (par. [0051]), FIG. 3; and a second helical thread disposed about the fastener shaft along the longitudinal axis adjacent the first helical thread (par. [0003]); the first concave undercut surface is oriented towards the distal end of the fastener shaft; the first concave undercut surface is shaped to resist at least one force (par. [0048]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Lavigne’s helical thread with upper and lower concave undercut surfaces as taught by Barton, to resist lateral forces transmitted between the bone portions and to act as a mechanical retention or friction retention feature to three-dimensionally stabilize the fastener shaft within the bone and therefore to stabilize the disunion. Lavigne’s helical thread would be provided with the upper and lower concave undercut surfaces taught by Barton that form a distally oriented concavity. Lavigne’s fastener is fully capable of being implanted into the disunion, where the concavities in the thread would mechanically retain the implant in the bone, therefore resisting at least lateral forces transmitted between the bone portions.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Lavigne’s fastener shaft with a second helical thread of the same type as the first helical thread taught by Barton and adjacent to it, since Barton contemplates the provision of multi-lead multiple thread forms of any combination of the disclosed threads (par. [0003]), and since the mere duplication of the essential working parts of a device involves only routine skill in the art. Providing two helical threads with the upper and lower concave undercut surfaces as taught by Barton would provide greater mechanical retention of the fastener in the bone. The second helical thread would comprise upper and lower concave undercut surfaces as taught by Barton, including a second concave undercut surface (41) oriented towards the proximal end. The first concave undercut surface of the first helical thread and the second concave undercut surface of the second helical thread are shaped to resist the lateral forces as taught by Barton to stabilize the fastener shaft within the bone and therefore to stabilize the disunion.
Claims 16-18, 20, 21, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2020/0100820 to Hollis et al. (hereinafter, “Hollis”), in view of U.S. Patent Application Publication No. US 2006/0204930 to Sul.
As to claim 16, Hollis discloses a bone disunion fastener comprising: a first shaft (106) comprising: a proximal end; a distal end; and a longitudinal axis, FIG. 1A-1F; a first helical thread disposed about the first shaft along the longitudinal axis; and a bone plate (102 and 104) (par. [0042]) comprising: a bone-facing side, FIG. 1F; a superior side opposite the bone-facing side, FIG. 1E; and a rim connecting the bone-facing side and the superior side, the rim defining: a first end (see annotated figure below) consisting essentially of a single first opening (116) configured to receive the first shaft therethrough and into a first bone portion (interpreted as language of intended use); a second end (see annotated figure below) consisting essentially of a single second opening (diagonally opposite 116) configured to receive a second shaft (108) therethrough and into a second bone portion (interpreted as language of intended use); a middle portion (remainder of the plate excluding the circled portions in the annotated figure below) that connects the first end to the second end; a first void; and a second void (see annotated figure below); wherein: the middle portion extends between the first end and the second end of the bone plate, wherein the middle portion is narrowest in width at a location midway between the first end and the second end, FIGS. 1E-1F, and wherein the single first opening and the single second opening of the bone plate are laterally offset from each other at each end of the middle portion, such that: a longitudinal midline of the bone plate, parallel to the middle portion, longitudinally bisects the bone plate into a first longitudinal portion and a second longitudinal portion opposite the first longitudinal portion, such that the first and second longitudinal portions are substantially equal in size to each other; the first end is positioned on an opposite side of the longitudinal midline from the first void; the second end is positioned on an opposite side of the longitudinal midline from the second void; the rim is asymmetrical across the longitudinal midline; and when the first shaft is implanted across a disunion between the first bone portion and the second bone portion, the first shaft is configured to penetrate through the single first opening of the bone plate, through the first bone portion, and into the second bone portion to stabilize the disunion between the first bone portion and the second bone portion (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of said intended use; the first shaft, after insertion through the first opening of the bone plate, is fully capable of penetrating through the first bone portion underlying the first end of the bone plate and into the second bone portion to stabilize the disunion by connecting the bone portions, based on the shape of the bone portions and the shape of the disunion where the bone portions abut each other; for example, a first bone portion that is surrounded by a second bone portion with complementary V-shapes would allow the first shaft to penetrate through the first bone portion and into part of the second bone portion).
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Hollis, partial FIG. 1E, annotated
As to claim 17, Hollis discloses the bone disunion fastener of claim 16, wherein the bone plate comprises a bone-engaging feature (104) comprising at least one of: one or more roughened surfaces; one or more teeth; one or more blades; one or more ribs; and one or more legs (142, 144) (par. [0046]), FIG. 1E.
As to claim 18, Hollis discloses the bone disunion fastener of claim 16, wherein: the second shaft comprises: a proximal end; a distal end; and a longitudinal axis; and a second helical thread disposed about the second shaft along the longitudinal axis of the second shaft.
As to claim 20, Hollis discloses the bone disunion fastener of claim 18, wherein, when the second shaft is implanted across the disunion between the first bone portion and the second bone portion, the second shaft is configured to penetrate through the single second opening of the bone plate, through the second bone portion, and into the first bone portion to stabilize the disunion between the first bone portion and the second bone portion (interpreted as language of intended use, as above; the second shaft, after insertion through the second opening of the bone plate, is fully capable of penetrating through the second bone portion underlying the second end of the bone plate and into the first bone portion to stabilize the disunion by connecting the bone portions, based on the shape of the bone portions and the shape of the disunion where the bone portions abut each other; for example, a first bone portion that is surrounded by a second bone portion with complementary V-shapes would allow the second shaft to penetrate through the second bone portion and into part of the first bone portion).
Hollis is silent as to the first helical thread comprising a first concave undercut surface; and the second helical thread comprising a second concave undercut surface.
As to claim 16, Sul teaches a fastener, in the same field of endeavor of bone fasteners, comprising a shaft comprising a first helical thread disposed about the first shaft along the longitudinal axis, the first helical thread comprising a first concave undercut surface (100c), FIG. 3, to increase a contact area and an engaging force between the fastener and the bone into which the fastener is engaged, so that stress concentration can be restricted, thereby dispersing a physiological load (par. [0013]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Hollis’ first helical thread with a first concave undercut surface and the second helical thread with a second concave undercut surface as a micro-pattern on the respective thread inclines as taught by Sul, to increase a contact area and an engaging force betwee