DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 September 2025 has been entered.
Response to Amendment
As directed by the amendment filed 15 September 2025: claim 28 has been amended, claims 1 and 16-22 stand withdrawn, and claims 4-6, 9, 10, 15, 23-27, 32, 34, and 35 are cancelled. Claims 1-3, 7, 8, 11-14, 16-22, 28-31, 33, and 36-38 currently stand pending in the application.
Response to Arguments
Applicant's arguments filed 15 September 2025, as to the drawing objections, have been fully considered but they are not persuasive. Applicant contends that FIGS. 12-13 depict how conjoint rotation and longitudinal movement are possible in the instant invention, due to gapping between the distal end of the main body and the proximal surface of the distal retention plate, and between the proximal end of the main body and the distal surface of the proximal retention plate. Examiner respectfully submits that the “gaps” pointed to by Applicant in the annotated drawing (see Arguments, page 13) are filled by spacers 60, and therefore any gaps or spaces between the retention plates and the respective ends of the main body do not allow for longitudinal movement of the distal retention plate relative to the main body since the spacers fill the gaps or spaces therefore establishing a set relative longitudinal location of the plates and main body. The drawing objection does not contend that rotation of said proximal retention plate effecting conjoint rotation of said distal retention plate is not shown, but rather that in the embodiment where conjoint rotation is disclosed (FIGS. 12-13), the distal retention plate being longitudinally movable relative to the distal end surface of the main body is not shown in the drawings, for the reasons as described above.
Applicant's arguments filed 15 September 2025, as to the rejections under pre-AIA 35 U.S.C. 103(a), have been fully considered but they are not persuasive. Applicant contends that Phan ‘127 (US 2010/0318127) discloses a device comprising a second proximal wing 30 movably mounted intermediate the length of the rod 61 (i.e. between the first distal end and the second proximal end of the rod) (see Arguments, pages 18-20), and therefore Phan ‘127 does not teach a structure in which a second wing is mounted to the proximal end of the rod. Rather, Applicant contends that fastener 62 is mounted to the end of the rod 61 so that fastener 62 is always disposed on Phan ‘127’s rod proximal to where the rod extends through Phan ‘127’s second wing 30. Examiner respectfully submits that the proximal end of the rod as claimed can be interpreted to mean a proximal end portion of the rod, e.g. the proximal end of the rod could comprise the proximal half of the rod (or any proximal portion) that is more proximal than the distal half of the rod and therefore comprises the rod’s proximal end (or half). In other words, the term “proximal end” does not require only a proximal-most end face of the rod, but could include any proximal portion of the rod up to and including such a proximal-most end face. The rod has a distal end and a proximal end; this could be interpreted, in the above example, to mean that the rod has a distal half and a proximal half. Therefore, even if the fastener 62 in Phan ‘127 is more proximal to the second wing/proximal plate, they both are on the proximal end of the rod, in both FIGS. 6 and 8.
Applicant further contends that the Phan ‘127 second wing is not “fixed” to the Phan ‘127 rod 61, as is now required by amended claim 28, because the second wing must be movable relative to the rod. Examiner respectfully submits that the term “fixed” is commonly understood to mean securely placed or fastened. The second wing in Phan ‘127 is fixed to the rod because it is securely placed thereon or fastened thereto. Phan ‘127 discloses that the wings 30 are rotated relative to the body 20, and this rotation may be caused by the surgeon manipulating the rod 61 and applying the rotational force (par. [0052]). This indicates that the rod is fixed to the wings with sufficient force such that manipulation of the rod can apply a rotational force to the wings, i.e. the rod and wings move together. Even if this were not the case, the second wing/proximal plate is fixed to the rod at least because of fastener 62 and body 20 which prevent the second wing/proximal plate from disengaging or threading off of either end of the rod, so that the second wing/proximal plate is fixed to the rod because it is securely placed thereon. The claims will also be interpreted in this way, where the term “fixed” is interpreted to mean securely placed or fastened, since any narrower interpretation, e.g. that the plates are immovable or welded to the central rod, would comprise new matter. Examiner notes that the specification recites that the plates are “mounted” to the rod, so the term “fixed” in the claims is interpreted in light of the specification to be a synonym for mounted.
As to Applicant’s argument that it is possible that the wings 30 of Phan ‘127 could be maintained in position by the hand of a surgeon, or by the surrounding anatomy during use, Examiner respectfully submits that even if these situations were to occur, they would also result in the wings being fixed to the rod. The claims do not require the fixation to be independent of any external factors, and even if they did, the term “fixed” is interpreted as above to mean securely placed or fastened, which is disclosed by Phan ‘127 as discussed above. Any frictional resistance between the wings/plates and the rod, to perform the action disclosed by Phan ‘127 where the manipulation of the rod applies a rotational force to the wings, would not preclude the wings being able to move toward each other along the rod. The frictional resistance would simply be overcome by a sufficient force to allow the wings to move relative to the rod when desired. As a visualizing example, a nut can be threaded partially onto a screw and the screw can be held by one end without the nut falling right off, due to the relative frictional resistance between the screw and the nut. Then, the nut can be further threaded onto the screw by overcoming the resistance to allow relative movement of the nut.
As to Phan ‘277 (US 2010/0312277), the plates in Phan ‘127 are fixedly mounted to the rod as described above and to allow for the disclosure in Phan ‘127 that the manipulation of the rod applies a rotational force to the wings. The wings and rod are fixedly connected enough so that movement of one causes movement of the other(s).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, rotation of said proximal retention plate effecting conjoint rotation of said distal retention plate, in the same embodiment as the proximal surface of the distal retention plate being longitudinally movable relative to the distal end surface of the main body (claim 28), must be shown or the feature(s) canceled from the claim(s). The embodiment of FIGS. 12-13 is described in the specification as having such features, but the drawings depict the rod 55 as an apparently monolithic structure, and it is not clear from the features shown in the drawings how the rod is connected securely enough to the plates so that rotation of the proximal plate effects conjoint rotation of the distal plate, while also allowing the distal plate to move longitudinally relative to the main body. If the distal plate moves longitudinally away from the main body (claims 37-38) and thus from the vertebral bodies, then, if the proximal and distal plates were fixed to the central rod (to enable conjoint rotation), then the proximal plate would be pulled into the vertebral bodies when the distal plate moves away from them, which would not allow the proximal plate to be rotated. It is also not clear from the drawings how the spacers 60 shown in FIG. 13 allow for movement of the plates relative to the main body. Explanation is necessary, but new drawings and/or amendments to the specification would likely comprise new matter.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 8, 11, 12, 14, 28-31, 33, 37, and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. US 2012/0004729 to Zipnick in view of U.S. Patent Application Publication No. US 2010/0318127 to Phan et al. (hereinafter, “Phan ‘127”) and U.S. Patent Application Publication No. US 2010/0312277 to Phan et al. (hereinafter, “Phan ‘277”).
As to claim 28, Zipnick discloses a method for preventing movement of a first vertebral body relative to a second vertebral body of a spinal joint, shown for example in FIGS. 289-291, said method comprising: providing a spinal fusion implant (D10) (par. [0724]-[0725]), FIG. 288, comprising: a main body (D16) having a distal end surface (distal end surface of D10 adjacent D11), a proximal end surface (end surface of D10 adjacent D12), a superior surface (top of implant) extending between the distal end surface and the proximal end surface, and an inferior surface (bottom of implant) extending between the distal end surface and the proximal end surface; a distal retention plate (D11) disposed at, and rotatably movable (D24) relative to, the distal end surface of the main body (par. [0725]), FIG. 288, the distal retention plate having (i) a first, non-rotated position, FIG. 289, in which the distal retention plate is co-planar with the superior surface of the main body and the inferior surface of the main body (where the superior surface and the inferior surface each extend across the entire respective top and bottom of the main body such that they include the angled portion that is co-planar with the plate), and (ii) a second, rotated position, FIG. 290, in which the distal retention plate is not co-planar with the superior surface of the main body and the inferior surface of the main body, wherein the distal retention plate comprises a distal surface and a proximal surface; a proximal retention plate (D12) rotatably movable (D25) relative to the proximal end surface of the main body (par. [0725]), FIG. 288; while said distal retention plate is disposed in said first, non-rotated position, inserting said main body into the spinal joint between the first vertebral body and the second vertebral body of the spinal joint (par. [0725]) such that said superior surface of said main body engages the first vertebral body and said inferior surface of said main body engages the second vertebral body (at least part of the superior surface engages the first vertebral body and at least part of the inferior surface engages the second vertebral body), FIG. 289; rotating said distal retention plate from said first, non-rotated position to said second, rotated position, such that a first portion (one end) of said distal retention plate extends superior to said main body and engages the first vertebral body, FIG. 290, and a second portion (other end) of said distal retention plate extends inferior to said main body and engages the second vertebral body, whereby to inhibit retraction of said main body and hold said spinal fusion implant, the first vertebral body and the second vertebral body in a stable relationship relative to one another.
As to claim 8, Zipnick discloses the method according to claim 28, wherein said main body is solid (because it is constructed of a solid material such as a metal, ¶586).
As to claim 11, Zipnick discloses the method according to claim 28, wherein said main body comprises at least one opening (D18) formed therein configured to permit bone in-growth (par. [0724]), FIG. 288.
As to claim 12, Zipnick discloses the method according to claim 11, wherein said at least one opening extends completely through said main body from said superior surface of said main body to said inferior surface of said main body, shown in FIG. 288.
As to claim 14, Zipnick discloses the method according to claim 28, wherein at least one of said superior surface of said main body and said inferior surface of said main body comprises at least one protrusion (walls separated and created by grooves D17) configured to inhibit retraction of said main body when said main body is positioned between the first vertebral body and the second vertebral body.
As to claim 29, Zipnick discloses the method according to claim 28, wherein the spinal fusion implant further comprises a longitudinally-extending bore (D18) formed in said main body (the bore has a dimension that extends longitudinally, and also includes bores through the walls of the main body, shown in Fig. 288), said longitudinally-extending bore being disposed in substantial coincidence with a longitudinal axis of symmetry of said main body, shown in FIG. 288.
As to claim 33, Zipnick discloses the method according to claim 28 wherein at least a portion of said proximal retention plate (D12) extends beyond said superior surface and said inferior surface of said main body (at least in the second, rotated position), shown in FIG. 288.
Although Zipnick discloses a distal retention plate and a proximal retention plate that are both rotated ninety degrees into a second rotated deployed position after insertion between the two vertebral bodies (par. [0725]), Zipnick is silent as to the mechanism that rotates the plates. Zipnick discloses the claimed invention except for wherein the proximal surface of the distal retention plate is longitudinally movable relative to the distal end surface of the main body; a central rod having a distal end and a proximal end, wherein said distal retention plate is fixed to said distal end of said central rod, wherein said proximal retention plate is fixed to said proximal end of said central rod (claim 28); wherein the central rod is disposed in said longitudinally-extending bore (claim 30); wherein said distal end of said central rod protrudes from said distal end of said main body and said proximal end of said central rod protrudes from said proximal end of said main body (claim 31); further comprising longitudinally moving the distal retention plate relative to the distal end surface of the main body (claim 37); wherein longitudinally moving the distal retention plate comprises moving the distal retention plate between a position in which the distal retention plate contacts the distal end surface of the main body and a position in which the distal retention plate is spaced from the distal end surface of the main body (claim 38).
As to claim 28, Phan ‘127 teaches a spinal implant, in the same field of endeavor, comprising a main body (20) and distal and proximal plates (30s) (¶48), shown in FIGS. 6-9, wherein the distal and proximal plates have a first, non-rotated position, shown in FIG. 8, during insertion between the bones (¶51), and are rotated into a second, rotated and deployed position, shown in FIG. 6, after insertion to engage the bones; a central rod (61) (¶50), wherein said distal plate is fixed (commonly understood to mean securely placed or fastened; the plates are fixed to the central rod because manipulation of the rod applies a rotational force to the plates, par. [0052], so that the plates and rod are securely fastened together) to a distal end of said central rod, wherein said proximal plate is fixed (commonly understood to mean securely placed or fastened; the plates are fixed to the central rod because manipulation of the rod applies a rotational force to the plates, par. [0052], so that the plates and rod are securely fastened together) to a proximal end of said central rod, FIG. 6.
As to claim 30, Phan ‘127 teaches wherein the central rod is disposed in a longitudinally-extending bore of the main body.
As to claim 31, Phan ‘127 teaches wherein said distal end of said central rod protrudes from said distal end of said main body and said proximal end of said central rod protrudes from said proximal end of said main body (in order for the rod ends to be received in the respective distal or proximal plate).
As to claim 37, Phan ‘127 teaches longitudinally moving the distal retention plate relative to the distal end surface of the main body (in order to allow the teeth 33 to move out from the aperture 52, FIG. 7, and then to rotate into the second rotated and deployed position without scraping the teeth against the main body).
As to claim 38, Phan ‘127 teaches wherein longitudinally moving the distal retention plate comprises moving the distal retention plate between a position in which the distal retention plate contacts the distal end surface of the main body, FIG. 8, and a position in which the distal retention plate is spaced from the distal end surface of the main body (in order to move the teeth out from the aperture 52).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to include in Zipnick a central rod as taught by Phan ‘127, to connect the distal and proximal plates to each other so that the proximal and distal plates can be rotated simultaneously from the first, non-rotated position to the second, rotated and deployed position to inhibit retraction of the main body and hold the implant and vertebral bodies in a stable relationship, using only one incision and only access from the proximal end and without having to separately manipulate the distal plate, which reduces the invasiveness of the procedure and speeds up healing time. Zipnick requires such rotation of a distally located plate that is only accessible from the proximal end of the body, and modification in view of Phan ‘127 to include a central rod connecting the plates would make that conjoint rotation possible. As applied to Zipnick, the central rod would extend through the longitudinally-extending bore formed in the main body, as well as through the proximal and distal walls of the main body where the central rod then is fixed to the plates. Since Zipnick’s distal and proximal plates are fixed at and rotate about their centers (see Zipnick FIG. 288) which are in substantial coincidence with a longitudinal axis of symmetry of the main body, the bore and the central rod disposed through the bore would also extend along this longitudinal axis in order to engage and rotate the plates about this axis. The distal retention plate would be fixed to or securely placed on or fastened to a distal end of the central rod and the proximal retention plate would be fixed to or securely placed on or fastened to a proximal end of the central rod; as taught by Phan ‘127, the ends of the central rod would protrude from the respective ends of the main body in Zipnick in order for the rod ends to be received in the respective distal or proximal plate. As required by Zipnick, the proximal and distal plates rotate about their centers so that in the second, rotated position, the first portion of the distal plate that engages the first vertebral body and the second portion of the distal plate that engages the second vertebral body would be of substantially equal length to substantially equally engage and maintain the first and second vertebral bodies in a stable relationship relative to one another and the implant.
Further, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide the distal retention plate of Zipnick with teeth as taught by Phan ‘127, on each free end of Zipnick’s plate (on either side of the rotational center), to bite into the bones for more secure fixation in the rotated position. It also would have been obvious in view of Phan ‘127 to correspondingly provide apertures in the main body of Zipnick to receive the teeth when the plate is in the first, non-rotated position, so that the plate can have its low invasive first non-rotated position, and then to longitudinally move the plate away from the main body when it is to be rotated into the second, rotated and deployed position so that the teeth can move out from the aperture in the main body without scraping the teeth against the main body or against the bone while the plate is being rotated. Then the plate can be longitudinally moved back toward the body to engage the teeth into the bone when the plate is in the deployed rotational position.
Zipnick discloses the claimed invention except for wherein rotation of said proximal retention plate effects conjoint rotation of said distal retention plate; using said proximal retention plate to rotate said distal retention plate from said first, non-rotated position to said second, rotated position (claim 28).
As to claim 28, Phan ‘277 teaches a spinal implant, in the same field of endeavor, comprising a main body (43) and distal and proximal plates (41 and 47) (¶25), shown in FIGS. 7-11, wherein the distal and proximal plates have a first, non-rotated position, shown in FIG. 8, during insertion between the bones (¶29), and are rotated into a second, rotated and deployed position, shown in FIG. 9, after insertion to engage the bones; a central rod (48) (¶27), wherein said distal plate is fixed to a distal end of said central rod, wherein said proximal plate is fixed to a proximal end of said central rod (since the plates and rod rotate together and thus are securely fastened together), FIG. 7, and further wherein rotation of said proximal plate effects conjoint rotation of said distal plate (¶38); using said proximal plate to rotate said distal plate from said first, non-rotated position to said second, rotated position.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to use rotation of the proximal plate to effect conjoint rotation of the distal plate as taught by Phan ‘277, so that both plates can be simultaneously rotated from the first, non-rotated position to the second, rotated and deployed position to inhibit retraction of the main body and hold the implant and vertebral bodies in a stable relationship, using only one incision and only access from the proximal end and without having to separately manipulate the distal plate, which reduces the invasiveness of the procedure and speeds up healing time. Manipulating the proximal plate provides greater area for gripping. The threaded interaction as taught by Phan ‘127 would still allow for rotation of the proximal plate to rotate the central rod and the distal plate as long as there is some frictional resistance between the proximal plate and the central rod, as there must be since as shown in Phan ‘127 the plates are able to hold a rotated position without falling back down due to gravity. Since Phan ‘127 teaches manipulating the central rod to rotate the plates, there is frictional resistance between them, and thus the proximal plate could also be used to rotate the rod (and thus the distal plate).
Claims 2 and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zipnick in view of Phan ‘127 and Phan ‘277 (hereinafter, “Zipnick/Phan ‘127/Phan ‘277”), as applied to claims 8, 11, 12, 14, 28-31, 33, 37, and 38 above, and further in view of U.S. Patent No. US 7,172,627 to Fiere et al. (hereinafter, “Fiere”).
Zipnick/Phan ‘127/Phan ‘277 disclose the claimed invention except for wherein said spinal fusion implant further comprises a spacer disposed between said distal end of said main body and said distal retention plate (claim 2); and wherein said spinal fusion implant further comprises a spacer disposed between said proximal end of said main body and said proximal retention plate (claim 36).
Fiere teaches a spinal fusion implant, in the same field of endeavor of spinal implants, comprising a main body (4) having an end (6, adjacent 17) (col. 2 / ll. 50-67), and a retention plate (17) disposed adjacent to the end of the main body (col. 3 / ll. 23-29), shown in FIGs. 1-2; wherein said spinal fusion implant further comprises a spacer (30) disposed between said end of said main body and said retention plate (col. 3 / ll. 66 – col. 4 / ll. 8), to enable the plate to be positioned at a specific distance relative to the main body, taking into account the shape of the edges B of the cortical faces of the vertebral bodies so that the implant substantially fills the disc space for fusion but does not unnecessarily overhang which could cause damage to nerves or tissues.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to include in Zipnick/Phan ‘127/Phan ‘277’s implant a spacer disposed between the distal end of the main body and the distal retention plate, and a spacer disposed between the proximal end of the main body and the proximal retention plate, to enable the respective plates to be positioned at a specific distance relative to the main body to take into account the shape of the edges of the cortical faces of the vertebral bodies so that the implant substantially fills the disc space for fusion but does not unnecessarily overhang which could cause damage to nerves or tissues, as taught by Fiere. A spacer adjacent the distal plate would be between the distal plate and the distal end of the main body.
Claims 3 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zipnick/Phan ‘127/Phan ‘277, as applied to claims 8, 11, 12, 14, 28-31, 33, 37, and 38 above, and further in view of U.S. Patent No. US 7,662,186 to Bagga et al. (hereinafter, “Bagga”).
Zipnick/Phan ‘127/Phan ‘277 disclose the claimed invention except for wherein said distal and proximal retention plates comprise a roughened inboard surface.
Bagga teaches a spinal implant, in the same field of endeavor, comprises a roughened surface formed on each face that contacts bone for gripping adjacent bone and inhibiting migration of the implant (col. 4 / ll. 61-67).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide a roughened inboard surface formed on each of said distal and proximal retention plates of Zipnick/Phan ‘127/Phan ‘277’s device, since the inboard surfaces of the plates are bone contacting, and roughening these surfaces would allow for gripping adjacent bone and inhibiting migration of the implant, as taught by Bagga. This could be in addition to teeth for added security across the entire bone-contacting surface.
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zipnick/Phan ‘127/Phan ‘277, as applied to claims 8, 11, 12, 14, 28-31, 33, 37, and 38 above, and further in view of U.S. Patent Application Publication No. US 2009/0187247 to Metcalf, JR. et al. (hereinafter, “Metcalf”).
Zipnick/Phan ‘127/Phan ‘277 disclose the claimed invention except for wherein a bone growth promoter is disposed in said at least one opening.
Metcalf teaches a spinal fusion implant, in the same field of endeavor, comprising a main body (12) comprising at least one opening (20) formed through the body from a superior to an inferior surface of the body to permit bone in-growth (¶21); wherein a bone growth promoter is disposed in said at least one opening (¶23) to promote bone growth from the upper and lower vertebrae and into the opening.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide a bone growth promoter in the at least one opening in Zipnick’s main body to promote bone growth from the upper and lower vertebrae and into the opening.
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775