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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 February 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 02 February 2026. As directed by the amendment: claims 1, 2, 7, 11, 17, 18, 22, 28, and 29 have been amended, claims 23, 30, and 33-39 are cancelled, and claims 40-46 are newly added. Claims 1-22, 24-29, 31, 32, and 40-46 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the previous claim objections, which are repeated below in relevant part, in addition to further claim objections as necessitated by the claim amendments.
Response to Arguments
Applicant's arguments filed 02 February 2026 with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends that neither Zipnick (US 8,795,367) nor Dollinger (US 8,403,959) disclose rotating the staple in a plane that is non-parallel to a longitudinal axis of the cage. As to Dollinger, Applicant contends that the staple rotates in a plane that is parallel to the longitudinal axis of the cage. Examiner respectfully submits that Zipnick discloses rotating the staple in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in direction D24 in a plane of the staple that is perpendicular to a longitudinal axis of the cage) (col. 76 / lines 61-65), FIGS. 288-291. Examiner respectfully submits that Dollinger also discloses rotating the staple (from the position of FIG. 15 to the position of FIG. 16, about axis 41) in a plane that is non-parallel to a longitudinal axis of the cage, because the staple rotates in a plane of the page in FIG. 15, which is coaxial with a longitudinal axis of the cage running along a length of the cage in the plane of the page, where coaxial is non-parallel because parallel requires non-intersecting. In another interpretation, the staple rotates in at least one plane perpendicular to the page in FIG. 15, because at least portions of the staple, e.g. surrounding the pivot point, are disposed in this perpendicular plane during rotation, where the perpendicular plane is non-parallel to the longitudinal axis of the cage as interpreted above. In yet another interpretation, the cage has various longitudinal axes that can be drawn at an angle to the page, where the staple rotates in a plane of the page which is non-parallel to these longitudinal axes.
Claim Objections
Claims 1-22, 24-29, 31, 32, and 40-46 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 4: “providing [[an]] the implant device”
Claim 5: “The method of claim 1 wherein the rotating of the staple comprises rotating the staple relative to the cage, and wherein the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises:
Claim 6: “The method of claim 1 wherein the rotating of the staple comprises rotating the staple relative to the cage whereby a first portion of the staple extends above a top surface of the cage and a second portion of the staple extends below a bottom surface of the cage, and wherein the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises:
Claim 11 / line 2: “the side wall is on the opposite side”
Claim 17 / lines 1-3: “wherein is an osteotomy space created within the vertebral body”
Claim 18 / line 7: “providing [[an]] the implant device”
Claim 22 / line 5: “adjacent surface”
Claim 28 / line 3: “of [[a]] the spine”
Claim 28 / line 10: “alters [[an]] the alignment of the spine”
Claim 40 / line 2: “providing [[an]] the implant device”
Claim 40 / line 4: “a first side of [[a]] the vertebral body”
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 1-6, 8-16, 18-22, 24-29, 31, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 8,795,367 to Zipnick in view of U.S. Patent No. US 8,403,959 to Dollinger.
As to claim 1, Zipnick discloses a method to secure an implant device to a vertebral body, the method comprising: providing an implant device (D10) comprising a cage (D16) and a staple (D11), FIGS. 288-291; positioning the cage in a space adjacent to a portion of the vertebral body (FIG. 289; the cage is in a space adjacent to the superior or inferior vertebral body; col. 28 / lines 44-48; col. 76 / line 50 – col. 77 / line 10); and positioning the staple to engage a side wall of the vertebral body whereby the staple secures the implant device to the vertebral body, FIG. 290; and the step of positioning the staple to engage the side wall of the vertebral body comprises rotating the staple in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in direction D24 in a plane of the staple that is perpendicular to a longitudinal axis of the cage) (col. 76 / lines 61-65), FIGS. 288-291.
As to claim 5, Zipnick discloses rotating the staple relative to the cage (in direction D24) (col. 76 / lines 61-63), FIGS. 288-290.
As to claim 5, Zipnick discloses rotating the staple relative to the cage.
As to claim 6, Zipnick discloses rotating the staple relative to the cage whereby a first portion of the staple extends above a top surface of the cage and a second portion of the staple extends below a bottom surface of the cage (col. 76 / lines 61-63), FIGS. 288-290.
As to claim 8, Zipnick discloses the method of claim 1 wherein the implant device further comprises an anchor frame (D12).
As to claim 9, Zipnick discloses the method of claim 1 wherein: the implant device further comprises an anchor frame (D12); and the anchor frame is configured to receive one or more screws (through D26 and D27) (col. 77 / lines 1-10), FIG. 291.
As to claim 10, Zipnick discloses the method of claim 1 wherein: the implant device further comprises an anchor frame (D12); and the anchor frame is configured to pivot about a pivot axis (about longitudinal axis of the cage, in direction D25), FIG. 288.
As to claim 11, Zipnick discloses the method of claim 1 wherein: the implant device further comprises an anchor frame (D12); and the method further comprises: positioning the anchor frame on a first side of the vertebral body; and securing the anchor frame to the first side wall of the vertebral body whereby the anchor frame further secures the implant device to the vertebral body, FIG. 290.
As to claim 12, Zipnick discloses the method of claim 1 wherein: the implant device further comprises an anchor frame (D12); and the anchor frame and the staple are configured to apply opposing forces to the vertebral body (when secured to opposing sides of the vertebral body).
As to claim 13, Zipnick discloses the method of claim 1 wherein: the vertebral body being one of a plurality of vertebral bodies of a spine having an alignment; and the cage having a dimension configured to alter the alignment of the spine (col. 20 / lines 4-27; at least alters the longitudinal alignment of the different vertebral bodies).
As to claim 14, Zipnick discloses the method of claim 1 wherein: the vertebral body being one of a plurality of vertebral bodies of a spine having an alignment; and the cage having a dimension configured to correct a deformity in the alignment of the spine (col. 40 / line 44 – col. 41 / line 13).
As to claim 15, Zipnick discloses the method of claim 1 wherein: the vertebral body being one of a plurality of vertebral bodies of a spine having an alignment; and the cage having a dimension configured to alter the alignment of the spine in at least one of a coronal plane, a sagittal plane, and an axial plane when the implant device is secured to the vertebral body (since the presence of the cage at least alters the longitudinal alignment of the different vertebral bodies, which is in part in a coronal plane).
As to claim 46, Zipnick discloses the method of claim 1 wherein the space adjacent to the portion of the vertebral body comprises a space between the portion of the vertebral body and a portion of an adjacent vertebral body, FIG. 289.
Zipnick is silent as to positioning, from a first side of the vertebral body, the cage in the space adjacent to the portion of the vertebral body.
Zipnick contemplates that the staple (D11) and anchor frame (D12) are at opposite ends of a cage that is inserted such that the staple is adjacent a target tissue site and the anchor frame is adjacent a surgical opening through which the cage is inserted (col. 76 / line 50 – col. 77 / line 10), indicating that the cage is inserted in a direction along its length with the stowed staple at the leading end, where the leading end also includes a tapered nose that can facilitate leading of the implant device, FIG. 288-290. Zipnick also contemplates that an implant device can be inserted in a direction normal to its width, i.e. in a direction along its length (col. 86 / line 64 – col. 87 / line 3), FIG. 310.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to insert Zipnick’s implant device in a direction along its length, so that the tapered nose can facilitate leading of the implant device into the space adjacent to the portion of the vertebral body. The cage would be positioned from a first side of the vertebral body and moved in the direction along its length to enter the space. The staple (D11), which is adjacent to the tapered nose, would be advanced through the space until it passes through the space to the opposite side of the vertebral body where it can be rotated to engage a side wall on the opposite side of the vertebral body, as required by Zipnick (col. 76 / line 50 – col. 77 / line 10).
Zipnick is silent as to positioning, from the first side of the vertebral body, the staple to engage a side wall on an opposite side of the vertebral body (claim 1); the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises extending the staple longitudinally relative to an adjacent surface of the cage (claim 2); the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises constraining a rotational position of the staple relative to the cage with a key and a stop (claim 3); wherein the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises retracting the staple (claim 4); wherein the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises: rotating the staple relative to the cage; and retracting the staple relative to the cage (claim 5); wherein the step of positioning, from the first side of the vertebral body, the staple to engage the side wall on the opposite side of the vertebral body further comprises: rotating the staple relative to the cage; and retracting the staple relative to the cage (claim 6); wherein the anchor frame is configured to pivot about a pivot axis that is non-parallel with a rotation axis of the staple (claim 10); wherein: the side wall is the opposite side of the vertebral body from a first side wall on the first side of the vertebral body (claim 11).
As to claim 1, Dollinger teaches providing an implant device, FIGS. 15-17, comprising a cage (10) and a staple (24); positioning, from a first side, the cage; positioning, from the first side, the staple to engage a side wall on an opposite side; and the step of positioning, from the first side, the staple to engage the side wall on the opposite side, comprises rotating the staple (from the position of FIG. 15 to the position of FIG. 16, about axis 41) in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in a plane of the page in FIG. 15, which is coaxial with a longitudinal axis of the cage running along a length of the cage in the plane of the page, where coaxial is non-parallel because parallel requires non-intersecting; in another interpretation, the staple rotates in at least one plane perpendicular to the page in FIG. 15, because at least portions of the staple, e.g. surrounding the pivot point, are disposed in this perpendicular plane during rotation, where the perpendicular plane is non-parallel to the longitudinal axis of the cage as interpreted above; in another interpretation, the cage has various longitudinal axes that can be drawn at an angle to the page, where the staple rotates in a plane of the page which is non-parallel to these longitudinal axes).
As to claim 2, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises extending the staple longitudinally relative to an adjacent surface of the cage (col. 5 / line 48 – col. 6 / line 5), FIG. 15.
As to claim 3, Dollinger teaches the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises constraining a rotational position of the staple relative to the cage with a key (rounded hinge portions) and a stop (distal end of cage, which constrains a rotational position of the staple relative to the cage when the staple abuts the stop and is resisted from rotating back into the position of FIG. 15).
As to claim 4, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises retracting the staple (into the position in FIG. 16).
As to claim 5, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises: rotating the staple relative to the cage (from the position of FIG. 15 to the position of FIG. 16, about axis 41); and retracting the staple relative to the cage (into the position in FIG. 16).
As to claim 6, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises: rotating the staple relative to the cage (from the position of FIG. 15 to the position of FIG. 16, about axis 41) whereby a first portion of the staple extends above a top surface of the cage and a second portion of the staple extends below a bottom surface of the cage; and retracting the staple relative to the cage (into the position in FIG. 16).
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 implant device of Zipnick to comprise a push/pull element 40 as taught in Dollinger that passes through the cage and is attached to the staple on its distal end to allow for manipulation and deployment of the staple at the far distal end of the cage and on the opposite side of the vertebral body by a practitioner at the proximal first side of the vertebral body, thus improving the minimal invasiveness of the procedure as a tool need not be applied to both ends of the space to separately deploy the staple. The staple would be modified in view of Dollinger so that it is deployed in a retracted position, and then the step of positioning the staple to engage the side wall on the opposite side of the vertebral body would comprise extending the staple longitudinally relative to an adjacent surface of the cage so that the ends of the staple can spring out of the cage, rotating the staple relative to the cage in a plane that is non-parallel to a longitudinal axis of the cage (interpretations above) by virtue of the ends of the staple springing out so that a first portion of the staple extends above the cage and a second portion extends below the cage so that the first and second portions can engage superior and inferior portions of the vertebral side wall, and retracting the staple relative to the cage for final stabilization. Zipnick requires rotating the staple but does not specifically recite how to rotate the staple positioned at the opposite side of the vertebral body; providing a push/pull element and staple structure as taught by Dollinger would allow performance of the extension, rotation, and retraction of the staple, all performed from a distance by manipulation of a proximal end of the push/pull element. Then, it would have been obvious to position and manipulate the staple from the first side of the vertebral body from which the cage is positioned to enter the space, since the practitioner would have access to this first side since it is the side where the surgical opening is made. The staple is on the far side wall on the opposite side of the vertebral body, but because it is attached to the push/pull element, it can be manipulated into positions by the push/pull element from the first side of the vertebral body. The anchor frame would remain as disclosed in Zipnick, with the push/pull element in Dollinger passing through the anchor frame. Since the anchor frame is on the first side of the vertebral body, it is more easily accessed by the practitioner and can be pivoted through the access port. As required by Zipnick, the anchor frame pivots about a pivot axis (Zipnick, pivot axis is a longitudinal axis of the cage to achieve rotation in direction D25) into a deployed position to engage the first side wall on the first side of the vertebral body. Thus, the anchor frame pivots about a pivot axis that is non-parallel with the rotation axis of the staple (as modified in view of Dollinger, the rotation axis 41 of the staple is perpendicular to the pivot axis of the anchor frame disclosed in Zipnick).
As to claim 16, Zipnick/Dollinger disclose the vertebral body having a superior endplate having a superior endplate surface plane and an inferior endplate having an inferior endplate surface plane; the cage having an upper surface defining an upper surface plane and a lower surface defining a lower surface plane; but are silent as to the upper surface plane and the lower surface plane of the cage being offset by an offset dimension; and the offset dimension is configured to alter an angle between the superior endplate surface plane and the inferior endplate surface plane of the vertebral body when the implant device is secured to the vertebral body.
In another embodiment, Zipnick teaches that the cage can have an offset dimension configured to alter an angle between the superior endplate surface plane and the inferior endplate surface plane of the vertebral body when the implant device is secured to the vertebral body (col. 93 / lines 54-58).
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 implant device of Zipnick’s embodiment shown in FIGS. 288-291 to have an offset dimension between its upper and lower surface planes, to alter an angle between the superior endplate surface plane and the inferior endplate surface plane of the vertebral body when the implant device is secured to the vertebral body, to treat a deformity in the alignment of the spine.
As to claim 18, Zipnick discloses a method to secure an implant device to a first vertebral body and a second vertebral body, the method comprising: identifying a first vertebral body of a first vertebra and a second vertebral body of a second vertebra (D14 and D15, FIG. 290, identified at least visually), identifying a space (intervertebral space, identified at least visually) between a first bone portion (endplate) of the first vertebral body and a second bone portion (endplate) of the second vertebral body; providing an implant device (D10) comprising a cage (D16) and a staple (D11), FIGS. 288-291; positioning the cage in the space (FIG. 289; col. 28 / lines 44-48; col. 76 / line 50 – col. 77 / line 10); and positioning the staple to engage a side wall on an opposite side of the first bone portion and a side wall on an opposite side of the second bone portion whereby the staple secures the implant device to the first vertebral body and the second vertebral body; and the step of positioning the staple to engage the side wall on the opposite side of the first bone portion and the side wall on the opposite side of the second bone portion comprises rotating the staple in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in direction D24 in a plane of the staple that is perpendicular to a longitudinal axis of the cage) (col. 76 / lines 61-65), FIGS. 288-291.
As to claim 19, Zipnick discloses the method of claim 18 wherein the first bone portion is an endplate of the first vertebral body and the second bone portion is an endplate of the second vertebral body (col. 28 / lines 44-48).
As to claim 20, Zipnick discloses the method of claim 18 wherein the space between the first bone portion and the second bone portion is anterior to a spinal canal in the first vertebral body and the second vertebral body (since it is in the disc space), FIG. 45.
As to claim 24, Zipnick discloses the method of claim 18 wherein: the implant device further comprises an anchor frame (D12); and the method further comprises: positioning the anchor frame on a side wall of the first bone portion and a side wall of the second bone portion, FIG. 290; and securing the anchor frame to the side wall of the first bone portion and the side wall of the second bone portion whereby the anchor frame further secures the implant device to the first vertebral body and the second vertebral body, FIG. 290.
As to claim 25, Zipnick discloses the method of claim 18 wherein: the first vertebral body and the second vertebral body being two of a plurality of vertebral bodies of a spine having an alignment; and the cage having a dimension configured to alter the alignment of the spine when the implant device is secured to the first vertebral body and the second vertebral body (col. 20 / lines 4-27; at least alters the longitudinal alignment of the different vertebral bodies).
As to claim 26, Zipnick discloses the method of claim 18 wherein: the first vertebral body and the second vertebral body being two of a plurality of vertebral bodies of a spine having an alignment; and the cage having a dimension configured to alter the alignment of the spine in at least one of a coronal plane, a sagittal plane, and an axial plane when the implant device is secured to the first vertebral body and the second vertebral body (since the presence of the cage at least alters the longitudinal alignment of the different vertebral bodies, which is in part in a coronal plane).
As to claim 27, Zipnick discloses the method of claim 18 wherein the step of positioning the cage in the space from a first side of the first bone portion and the second bone portion comprises positioning the cage in the space from one of a lateral approach (col. 94 / lines 44-45), FIGS. 6, 45, and 290, an oblique approach or an anterior approach relative to the first vertebral body and the second vertebral body.
Zipnick is silent as to positioning the cage in the space from a first side of the first bone portion and a first side of the second bone portion.
Zipnick contemplates that the staple (D11) and anchor frame (D12) are at opposite ends of a cage that is inserted such that the staple is adjacent a target tissue site and the anchor frame is adjacent a surgical opening through which the cage is inserted (col. 76 / line 50 – col. 77 / line 10), indicating that the cage is inserted in a direction along its length with the stowed staple at the leading end, where the leading end also includes a tapered nose that can facilitate leading of the implant device, FIG. 288-290. Zipnick also contemplates that an implant device can be inserted in a direction normal to its width, i.e. in a direction along its length (col. 86 / line 64 – col. 87 / line 3), FIG. 310.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to insert Zipnick’s implant device in a direction along its length, so that the tapered nose can facilitate leading of the implant device into the space. The cage would be positioned from a first side of the first bone portion and a first side of the second bone portion and moved in the direction along its length to enter the space. The staple (D11), which is adjacent to the tapered nose, would be advanced through the space until it passes through the space to the opposite side of the bone portions where it can be rotated to engage side walls on the opposite side, as required by Zipnick (col. 76 / line 50 – col. 77 / line 10). The anchor frame at the trailing end would be secured to the side wall on the first sides of the bone portions.
Zipnick is silent as to positioning, from the first side of the first bone portion and the first side of the second bone portion, the staple to engage a side wall on an opposite side of the first bone portion and a side wall on an opposite side of the second bone portion (claim 18); wherein the step of positioning, from the first side of the first bone portion and the first side of the second bone portion, the staple to engage the side wall on the opposite side of the first bone portion and the side wall on the opposite side of the second bone portion further comprises retracting the staple relative to the cage (claim 21); wherein the step of positioning, from the first side of the first bone portion and the first side of the second bone portion, the staple to engage the side wall on the opposite side of the first bone portion and the side wall on the opposite side of the second bone portion further comprises extending the staple longitudinally relative to an adjacent surface of the cage; and retracting the staple relative to the cage (claim 22).
As to claim 18, Dollinger teaches providing an implant device, FIGS. 15-17, comprising a cage (10) and a staple (24); positioning, from a first side, the cage; positioning, from the first side, the staple to engage a side wall on an opposite side; and the step of positioning, from the first side, the staple to engage the side wall on the opposite side, comprises rotating the staple (from the position of FIG. 15 to the position of FIG. 16, about axis 41) in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in a plane of the page in FIG. 15, which is coaxial with a longitudinal axis of the cage running along a length of the cage in the plane of the page, where coaxial is non-parallel because parallel requires non-intersecting; in another interpretation, the staple rotates in at least one plane perpendicular to the page in FIG. 15, because at least portions of the staple, e.g. surrounding the pivot point, are disposed in this perpendicular plane during rotation, where the perpendicular plane is non-parallel to the longitudinal axis of the cage as interpreted above; in another interpretation, the cage has various longitudinal axes that can be drawn at an angle to the page, where the staple rotates in a plane of the page which is non-parallel to these longitudinal axes).
As to claim 21, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises retracting the staple relative to the cage (into the position in FIG. 16).
As to claim 22, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises extending the staple longitudinally relative to an adjacent surface of the cage (col. 5 / line 48 – col. 6 / line 5), FIG. 15; and retracting the staple relative to the cage (into the position in FIG. 16).
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 implant device of Zipnick to comprise a push/pull element 40 as taught in Dollinger that passes through the cage and is attached to the staple on its distal end to allow for manipulation and deployment of the staple at the far distal end of the cage and on the opposite side of the bone portions by a practitioner at the proximal first side of the bone portions, thus improving the minimal invasiveness of the procedure as a tool need not be applied to both ends of the space to separately deploy the staple. The staple would be modified in view of Dollinger so that it is deployed in a retracted position, and then the step of positioning the staple to engage the side wall on the opposite sides of the bone portions would comprise extending the staple longitudinally relative to an adjacent surface of the cage so that the ends of the staple can spring out of the cage, rotating the staple relative to the cage in a plane that is non-parallel to a longitudinal axis of the cage (interpretations above) by virtue of the ends of the staple springing out so that a first portion of the staple extends above the cage and a second portion extends below the cage so that the first and second portions can engage superior and inferior portions of the bone portion side walls, and retracting the staple relative to the cage for final stabilization. Zipnick requires rotating the staple but does not specifically recite how to rotate the staple positioned at the opposite side of the bone portions; providing a push/pull element and staple structure as taught by Dollinger would allow performance of the extension, rotation, and retraction of the staple, all performed from a distance by manipulation of a proximal end of the push/pull element. Then, it would have been obvious to position and manipulate the staple from the first sides of the bone portions from which the cage is positioned to enter the space, since the practitioner would have access to these first sides since they are the sides where the surgical opening is made. The staple is on the far side walls on the opposite sides of the bone portions, but because it is attached to the push/pull element, it can be manipulated into positions by the push/pull element from the first sides of the bone portions. The anchor frame would remain as disclosed in Zipnick, with the push/pull element in Dollinger passing through the anchor frame. Since the anchor frame is on the first sides of the bone portions, it is more easily accessed by the practitioner and can be pivoted through the access port. As required by Zipnick, the anchor frame pivots about a pivot axis (Zipnick, pivot axis is a longitudinal axis of the cage to achieve rotation in direction D25) into a deployed position to engage the first side wall on the first sides of the bone portions.
As to claim 28, Zipnick discloses a method for performing surgery to correct an alignment of a spine, the method comprising: creating at least one access opening to one or more vertebral body of a spine of a patient (col. 33 / lines 6-10; col. 44 / lines 32-38; col. 75 / lines 35-38), FIG. 45; providing an implant device (D10) comprising a cage (D16) and a staple (D11), FIGS. 288-291; positioning, through the at least one access opening, the cage in contact with the one or more vertebral body (FIG. 289; col. 28 / lines 44-48; col. 76 / line 50 – col. 77 / line 10); and positioning the staple to engage a side wall of the one or more vertebral body whereby the staple secures the implant device to the one or more vertebral body and a dimension of the cage alters an alignment of the spine (col. 20 / lines 4-27; at least alters the longitudinal alignment of the different vertebral bodies); and the step of positioning the staple to engage the side wall of the vertebral body comprises rotating the staple in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in direction D24 in a plane of the staple that is perpendicular to a longitudinal axis of the cage) (col. 76 / lines 61-65), FIGS. 288-291.
As to claim 31, Zipnick discloses the method of claim 28 wherein the step of positioning the cage in contact with the one or more vertebral body comprises positioning the cage between a first endplate of a first vertebral body and a second endplate of a second vertebral body of the one or more vertebral body (col. 28 / lines 44-48).
Zipnick is silent as to positioning, from a first side of the one or more vertebral body, the cage in contact with the one or more vertebral body.
Zipnick contemplates that the staple (D11) and anchor frame (D12) are at opposite ends of a cage that is inserted such that the staple is adjacent a target tissue site and the anchor frame is adjacent a surgical opening through which the cage is inserted (col. 76 / line 50 – col. 77 / line 10), indicating that the cage is inserted in a direction along its length with the stowed staple at the leading end, where the leading end also includes a tapered nose that can facilitate leading of the implant device, FIG. 288-290. Zipnick also contemplates that an implant device can be inserted in a direction normal to its width, i.e. in a direction along its length (col. 86 / line 64 – col. 87 / line 3), FIG. 310.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to insert Zipnick’s implant device in a direction along its length, so that the tapered nose can facilitate leading of the implant device into the space. The cage would be positioned from a first side of the one or more vertebral body and moved in the direction along its length into contact with the one or more vertebral body and between endplates of adjacent vertebral bodies. The staple (D11), which is adjacent to the tapered nose, would be advanced through the space until it passes through the space to the opposite side of the one or more vertebral body where it can be rotated to engage side walls on the opposite side of the one or more vertebral body, as required by Zipnick (col. 76 / line 50 – col. 77 / line 10; col. 93 / lines 13-17). The anchor frame at the trailing end would be secured to the side wall on the first side of the one or more vertebral body.
Zipnick is silent as to positioning, from the first side of the one or more vertebral body, the staple to engage a side wall on an opposite side of the one or more vertebral body (claim 28); wherein the step of positioning, from the first side of the one or more vertebral body, the staple to engage the side wall on the opposite side of the one or more vertebral body further comprises: extending the staple longitudinally relative to an adjacent surface of the cage; and retracting the staple relative to the cage to engage the side wall on the opposite side of the one or more vertebral body (claim 29).
As to claim 28, Dollinger teaches providing an implant device, FIGS. 15-17, comprising a cage (10) and a staple (24); positioning, from a first side, the cage; positioning, from the first side, the staple to engage a side wall on an opposite side; and the step of positioning, from the first side, the staple to engage the side wall on the opposite side, comprises rotating the staple (from the position of FIG. 15 to the position of FIG. 16, about axis 41) in a plane that is non-parallel to a longitudinal axis of the cage (the staple rotates in a plane of the page in FIG. 15, which is coaxial with a longitudinal axis of the cage running along a length of the cage in the plane of the page, where coaxial is non-parallel because parallel requires non-intersecting; in another interpretation, the staple rotates in at least one plane perpendicular to the page in FIG. 15, because at least portions of the staple, e.g. surrounding the pivot point, are disposed in this perpendicular plane during rotation, where the perpendicular plane is non-parallel to the longitudinal axis of the cage as interpreted above; in another interpretation, the cage has various longitudinal axes that can be drawn at an angle to the page, where the staple rotates in a plane of the page which is non-parallel to these longitudinal axes).
As to claim 29, Dollinger teaches wherein the step of positioning, from the first side, the staple to engage the side wall on the opposite side further comprises extending the staple longitudinally relative to an adjacent surface of the cage (col. 5 / line 48 – col. 6 / line 5), FIG. 15; and retracting the staple relative to the cage (into the position in FIG. 16).
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 implant device of Zipnick to comprise a push/pull element 40 as taught in Dollinger that passes through the cage and is attached to the staple on its distal end to allow for manipulation and deployment of the staple at the far distal end of the cage and on the opposite side of the vertebral body or bodies by a practitioner at the proximal first side of the vertebral body or bodies, thus improving the minimal invasiveness of the procedure as a tool need not be applied to both ends of the space to separately deploy the staple. The staple would be modified in view of Dollinger so that it is deployed in a retracted position, and then the step of positioning the staple to engage the side wall on the opposite sides of the vertebral body or bodies would comprise extending the staple longitudinally relative to an adjacent surface of the cage so that the ends of the staple can spring out of the cage, rotating the staple relative to the cage in a plane that is non-parallel to a longitudinal axis of the cage (interpretations above) by virtue of the ends of the staple springing out so that a first portion of the staple extends above the cage and a second portion extends below the cage so that the first and second portions can engage superior and inferior portions of the vertebral side walls, and retracting the staple relative to the cage for final stabilization. Zipnick requires rotating the staple but does not specifically recite how to rotate the staple positioned at the opposite side of the vertebral body or bodies; providing a push/pull element and staple structure as taught by Dollinger would allow performance of the extension, rotation, and retraction of the staple, all performed from a distance by manipulation of a proximal end of the push/pull element. Then, it would have been obvious to position and manipulate the staple from the first side of the vertebral body or bodies from which the cage is positioned to enter the space, since the practitioner would have access to this first side since it is the side where the surgical opening is made. The staple is on the far side walls on the opposite sides of the vertebral body or bodies, but because it is attached to the push/pull element, it can be manipulated into positions by the push/pull element from the first side of the vertebral body or bodies. The anchor frame would remain as disclosed in Zipnick, with the push/pull element in Dollinger passing through the anchor frame. Since the anchor frame is on the first side of the vertebral body or bodies, it is more easily accessed by the practitioner and can be pivoted through the access port. As required by Zipnick, the anchor frame pivots about a pivot axis (Zipnick, pivot axis is a longitudinal axis of the cage to achieve rotation in direction D25) into a deployed position to engage the first side wall on the first side of the vertebral body or bodies.
Claims 17, 32, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Zipnick in view of Dollinger (hereinafter, “Zipnick/Dollinger”), as applied to claims 1-6, 8-16, 18-22, 24-29, 31, and 46 above, and further in view of U.S. Patent No. US 6,287,308 to Betz et al. (hereinafter, “Betz”).
As to claim 17, Zipnick/Dollinger disclose the method of claim 1 wherein the step of positioning the cage in the space adjacent to a portion of the vertebral body comprises positioning the cage in the space from one of a lateral approach (col. 94 / lines 44-45), FIGS. 6, 45, and 290, an oblique approach or an anterior approach relative to the vertebral body.
Zipnick/Dollinger are silent as to the space is an osteotomy space created within the vertebral body (claim 17); positioning the cage between a first portion of one of the one or more vertebral body and a second portion of the one of the one or more vertebral body (claim 32); wherein the space adjacent to the portion of the vertebral body comprises an osteotomy space created by performing an osteotomy through the vertebral body (claim 45).
Betz teaches that an implant device (40) comprising a cage (43) and a staple (41), FIG. 2, corrects an alignment of the spine by being implanted intravertebrally (col. 7 / lines 1-4), FIG. 7A. Betz teaches performing an osteotomy through a vertebral body to create an osteotomy space within the vertebral body and positioning the cage in the osteotomy space created within the vertebral body (col. 13 / lines 8-19), FIGS. 14B-14C.
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 Zipnick/Dollinger’s implant device in an intravertebral method, since Betz teaches that an implant device can be used to correct an alignment of the spine by being implanted intravertebrally, and combining prior art elements according to known methods to yield predictable results (spinal alignment) is within the ordinary skill in the art. As applied to Zipnick/Dollinger, the method would include performing an osteotomy through a vertebral body to create an osteotomy space within the vertebral body and positioning the cage in the osteotomy space created within the vertebral body, as taught by Betz, and positioning the cage from a first side of the vertebral body as required by Zipnick. The function of the staple in Zipnick/Dollinger would remain unchanged, and would rotate to engage the side wall of the vertebral body to which it is adjacent once it is inserted all the way through the vertebral body. As to claim 32, the method would include positioning the cage between a first portion of one of the one or more vertebral body and a second portion of the one of the one or more vertebral body, after forming an osteotomy between the first and second portions, to alter an angle between the portions to correct the spinal alignment.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 40-44 are allowed.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance: None of the searched, pertinent prior art clearly shows by itself, or in combination with each other, a method as recited in claim 7 or claim 40, comprising providing a staple drive handle assembly having a first drive rod and a second drive rod; positioning a staple to engage an opposite side of the vertebral body by extending the staple longitudinally relative to an adjacent surface of the cage with the first drive rod, rotating the staple relative to the cage with the second drive rod, and retracting the staple relative to the adjacent surface of the cage with the first drive rod.
The closest prior art to Zipnick and Dollinger disclose the steps of providing the implant device comprising a cage and a staple; positioning, from a first side of the vertebral body, the staple to engage a side wall on the opposite side of the vertebral body; and rotating the staple, but are silent as to providing a staple drive handle assembly having a first drive rod and a second drive rod; positioning a staple to engage an opposite side of the vertebral body by extending the staple longitudinally relative to an adjacent surface of the cage with the first drive rod, rotating the staple relative to the cage with the second drive rod, and retracting the staple relative to the adjacent surface of the cage with the first drive rod.
U.S. Patent No. US 9,283,091 to Melkent et al. discloses a staple drive handle assembly having a first drive rod (98) and a second drive rod (I), FIGS. 7-9 and 14-17; where the first drive rod moves a staple (60) longitudinally (staple draws toward cage, col. 12 / lines 12-13) and the second drive rod rotates the staple (col. 10 / line 65 – col. 11 / line 2), but the staple in Melkent does not engage a side wall on an opposite side of the vertebral body from a first side from which a cage (12) is positioned and from which the staple is positioned. It would not have been obvious to utilize Melkent’s assembly to extend, retract, and rotate the staple in Zipnick/Dollinger (or any distally located staple) because the drive rods would not pass through the cage and vertebral space without damaging the device and/or bone.
It would not have been obvious in view of the cited art to make modifications to resolve the above deficiencies and arrive at the claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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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