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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 7-12 & 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et al. (US PG Pub No. 2016/0310295).
Regarding Claim 7, Reed et al. discloses an interbody spacer (300, Figs. 8A-8B, Paragraphs [0062-0068]) comprising: a cage (312, Fig. 8A, Paragraph [0062]) defining an interior (316, Fig. 8A) and a rear opening (upper and lower openings defined through rear endwall for 352 & 352, Fig. 8A); and an anchor assembly (See examiner annotated Fig. 8A below) sized and configured for insertion into the rear opening and into the interior (via 318 & 318, Fig. 8B, Paragraphs [0062, 0064]); wherein the anchor assembly includes at least two non-screw bone anchors (upper blade 352 & lower blade 352, Figs. 8A-8B, Paragraphs [0062, 0065-0067]) rotatably attached (via hinge 358, Paragraph [0066]) to an endplate (350, Fig. 8A) (Paragraphs [0066-0068]).
PNG
media_image1.png
559
450
media_image1.png
Greyscale
Regarding Claim 8, Reed et al. discloses wherein the endplate is sized and configured to cover the rear opening (from the proximal direction when 350 is attached to 312 as seen in Fig. 8B).
Regarding Claim 9, Reed et al. discloses wherein the bone anchors are irremovably attached to the endplate prior to insertion into the cage (“In some embodiments, the body portion 312 is configured to be inserted into a disc space prior to inserting and attaching the end member 350. After clearing a disc space and performing a total or partial discectomy, the body portion 312 can be inserted first into a desirable location. Afterwards, the end member 350 with the one or more blades 352 connected thereto can be attached to the body portion 312.”, Paragraphs [0068, 0065]).
Regarding Claim 10, Reed et al. discloses wherein insertion of the anchor assembly into the cage rotates the bone anchors into a deployed configuration (“As the spacer body 312 is attached or affixed to the end member 350, the one or more hinged blades 352 engage the ramped surfaces 318 of the spacer 312, thereby causing the blades 352 to spread apart and expand outwardly.”; Paragraph [0067]; “During engagement between the body portion 312 and the end member 350, the blades 352 extend outwardly and into adjacent bone members.”, Paragraphs [0065-0068]).
Regarding Claim 11, Reed et al. discloses wherein the anchor assembly includes a low-profile undeployed configuration in which the bone anchors are oriented for insertion into the cage (Fig. 8A) and a high-profile deployed configuration in which the anchor assembly is inside the cage and the bone anchors extend out of the cage (Fig. 8B)(“The blades 352 may have a first, collapsed orientation where the angle between the blades 352 is small and a second, expanded orientation where the angle between the blades 352 is increased to be larger than in the collapsed orientation.” Paragraph [0067]).
Regarding Claim 12, Reed et al. discloses wherein insertion of the anchor assembly into the cage locks the endplate to the cage (“The spacer body 312 can be removably coupled, attached, or affixed to the end member 350. The spacer body 312 can be attached to the end member 350 by a coupling mechanism, friction fit, interference fit, or any other connection means. For example, the spacer body 312 and the end member 350 may be assembled together using, alone or in combination, a dovetail assembly, dowel pins, hooks, staples, screws, adhesives, and the like, or any suitable fasteners known in the art.”, Paragraphs [0064, 0067]).
Regarding Claim 15, Reed et al. discloses wherein each bone anchor includes a first flat surface (planar upper surface of upper 352 and planar lower surface of lower 352, Fig. 8A, Paragraph [0065]) configured to abut an inner surface of the endplate (inner surface adjacent 358/358 within 350 for housing/engaging the upper and lower 352 & 352, Figs. 8A-B) and a second flat surface (proximal most end surfaces at hinge 358 of each upper and lower 352 which engages the inner surface, Paragraph [0066]) configured to abut the inner surface of the endplate to define two limits of rotation for each anchor (“The one or more blades 352 may be attached together via a hinge 358. For example, the hinge 358 may be in the form of a cantilevered v-spring with a cross-sectional configuration in the form of a V connecting two blades 352. The hinge 358 may include a living hinge, barrel hinge, piano hinge, ball and socket type hinge, spring, or other suitable hinge known in the art. In one embodiment, the hinge 358 may include a living hinge connecting the blades 352. Living hinges may include one-piece flexing devices or functional hinges having a flexing zone between the blades 352. The living hinge may be constructed of pliant and/or flexible materials having properties which tolerate the repeated tension and compression of the opposing surfaces (i.e., the blades 352)”, Paragraphs [0066-0067]).
Regarding Claim 16, Reed et al. discloses wherein the bone include a first bone anchor (upper 352) configured to deploy through a top of the cage (via upper 318 & 318 through upper opening formed through 342) and a second bone anchor (lower 352) configured to deploy through a bottom of the cage (via lower 318 & 318 through lower opening formed through 344)(Paragraphs [0063, 0065-0066]).
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.
Claim(s) 1 & 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (US PG Pub No. 2016/0310295) in view of Rhoda (US PG Pub No. 2012/0283838) and Mozeleski et al. (US PG Pub No. 2016/0151171).
Regarding Claims 1, 3 & 5-6, Reed et al. discloses an interbody spacer (300, Figs. 8A-8B, Paragraphs [0062-0068]) comprising: a cage (312, Fig. 8A, Paragraph [0062]) including: a top surface (342, Fig. 8A) and a bottom surface (344, Fig. 8A) interconnected by a left sidewall (left side wall when viewing Fig. 8A), a right sidewall (right side wall when viewing Fig. 8A) and an endwall (rear endwall which abuts plate 350 when viewing Fig. 8A) defining an interior (316, Fig. 8A) having a rear opening (upper and lower openings defined through rear endwall for 352 & 352, Fig. 8A); at least one top ramped surface (each upper ramped surface 318 & 318, Fig. 8A, Paragraphs [0063, 0067]) in the interior interconnected with a corresponding top exit opening in the top surface (central aperture defined through bone-contacting top surface 342 , Figs. 8A-8B); at least one bottom ramped surface (each lower ramped surface 318 & 318, Fig. 8A, Paragraphs [0063, 0067]) in the interior interconnected with a corresponding bottom exit opening in the bottom surface (central aperture defined through bone-contacting bottom surface 344, Figs. 8A-8B); and an anchor assembly (See examiner annotated Fig. 8A below) including: a plate (350, Fig. 8A) configured for insertion into the rear opening and into the interior (Fig. 8B, Paragraphs [0062, 0064]); the plate including an instrument opening (windows in 350, Figs. 8A-8B); and at least two non-screw bone anchors (upper blade 352 & lower blade 352, Figs. 8A-8B, Paragraphs [0062, 0065-0067]) rotatably connected to the plate (via hinge 358, Paragraph [0066]); wherein the cage and anchor assembly are configured such that insertion of the anchor assembly into the cage causes the bone anchors to rotate out of the top and bottom exit openings (Paragraphs [0067-0068]).
PNG
media_image1.png
559
450
media_image1.png
Greyscale
Reed et al. does not disclose a threaded bore in the interior facing the rear opening configured for threaded engagement with an insertion instrument, wherein the plate’s instrument opening is aligned with the threaded bore, and wherein an alignment slot is formed across the threaded bore for alignment with an insertion instrument.
Rhoda discloses various embodiments of an interbody spacer (10, Figs. 1-4A) comprising a top surface (15, Fig. 4) and a bottom surface (30, Fig. 4) interconnected by a left sidewall (18, Fig. 1), a right sidewall (16, Fig. 1), a proximal/rear endwall (14, Fig. 1) and a distal/front endwall (12, Fig. 1), wherein the proximal and distal endwalls and the left and right sidewalls may each comprise an aperture formed therethrough (32, 32, 38, 38, Figs. 2-4, Paragraphs [0088, 0092-0093]) configured to be engaged by an instrument inserter such that an instrument can engage the spacer at any of the four endwalls/sidewalls, wherein each of the apertures are in alignment with and face another of the apertures which it opposes (Figs. 1-4). Rhoda further discloses in Paragraph [0011] that “In another embodiment, instead of instrument receiving channels, the implant may have a threaded hole on the anterior, anterio-lateral, or lateral side of the implant for receiving a threaded arm of an insertion tool’, wherein a distal endwall threaded hole (22 in 12, Figs. 1-2) is depicted in Fig. 2 and is shown to further include an alignment slot formed thereacross such that the threaded hole is recessed slightly within the distal endwall (Figs. 2 & 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cage of Reed et al. to add an alignment slot centered along and formed slightly recessed in the front/distal endwall and a threaded aperture extending centrally through the front/distal endwall as taught by Rhoda in order to provide the implant with a means for connecting to a threaded insertion instrument at the front/distal/anterior end of the implant so that the cage can be introduced, removed, or repositioned as necessary during a procedure.
Reed et al. further fails to disclose a left locking slot formed in the left sidewall and a right locking slot formed in the right sidewall; the plate including a left locking tab configured to flex with respect to the plate and enter into locking engagement with the left locking slot; the plate including a right locking tab configured to flex with respect to the plate and enter into locking engagement with the right locking slot; wherein the cage and anchor assembly are configured such that insertion of the anchor assembly into the cause causes the left and right locking tabs to lock into the left and right locking slots; and wherein the plate includes a left hook extending outwardly from the left locking tab configured to snap into locking engagement with the left locking slot and a right hook extending outwardly from the right locking tab configured to snap into locking engagement with the right locking slot. Reed et al. does disclose in Paragraph [0064] that “[0064] The spacer body 312 can be removably coupled, attached, or affixed to the end member 350. The spacer body 312 can be attached to the end member 350 by a coupling mechanism, friction fit, interference fit, or any other connection means. For example, the spacer body 312 and the end member 350 may be assembled together using, alone or in combination, a dovetail assembly, dowel pins, hooks, staples, screws, adhesives, and the like, or any suitable fasteners known in the art.”
Mozeleski et al. discloses an interbody spacer (100, Figs. 1-13) comprising a cage (200, Figs. 2 & 4) comprising a top surface (202, Fig. 2), a bottom surface (204, Paragraph [0060]), a proximal/rear end wall (206, Fig. 4), an interior opening (210), and opposing left and right sidewalls (left 207 & right 207, Fig. 4, Paragraph [0062]), and a plate (300, Fig. 1, 3, & 5) configured to be removably connected to the proximal/rear end wall of the cage (Paragraphs [0066-0067]), wherein each of the opposing left and right sidewalls of the cage comprise a locking slot formed in an outer surface thereof (left and right cage coupling portions 220 & 222 which include slots, Figs. 2 & 4, 6A-6B, Paragraph [0062, 0071]), and wherein the plate comprises a left locking tab (left clasp 320, Figs. 3, 5 & 6B) with a left hook at the distal end thereof (left protrusion 326, Fig. 5, Paragraph [0071]) extending from a left side of the distal/front face of the plate (308, Fig. 5), and a right locking tab (right clasp 322, Figs. 3, 5 & 6B) with a right hook at the distal end thereof (right protrusion 326, Fig. 5, Paragraph [0071]), wherein the left and right tabs are configured to flex with respect to the plate so that the hooks thereof snap into locking engagement with the left and right locking slots, respectively (“ In some embodiments, the clasp 322 can be configured to deflect during the coupling process and to return toward the undeflected position when locking into position in the channel 222. In some embodiments, the intervertebral cage 200 can include a chamfer 224 configured to deflect the clasp 322 outwards during the coupling process.”, Paragraphs [0071-0072]), in order to couple the plate to the cage (Paragraph [0072]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coupling arrangement between the cage and the plate of the spacer of Reed et al. to add left and right locking tabs with hooks to the distal/rear face of the plate and add corresponding left and right slots to the left and right sidewalls of the cage as taught by Mozeleski et al. in order to provide the spacer with a connection means for the two components which allows a user to quick connect and releasably but securably assemble the plate on the cage during use.
Regarding Claim 4, the combination of Reed et al., Rhoda, and Mozeleski et al. discloses the claimed invention as stated above in Claim 1, except wherein the plate includes a left plate aperture and a right plate aperture sized and configured to receive posts of an insertion instrument. It appears from Figs. 8A-8B that the plate (350) comprises left and right circular apertures therein (not labeled, Fig. 8A) but the specification does not describe them. Fig. 5 depicts a related embodiment of spacer (10) comprising a cage (12) and a plate (50) removably coupled to the cage (Paragraph [0045]), wherein the plate comprises a left aperture and a right aperture formed through the proximal/rear face thereof which are each capable of receiving posts of an insertion instrument.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide the proximal/rear face of the plate of the combination with a left and a right aperture as taught by Reed et al. so that the plate can be more easily grasped by an insertion tool during use.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (US PG Pub No. 2016/0310295) in view of Mozeleski et al. (US PG Pub No. 2016/0151171).
Regarding Claim 13, Reed et al. discloses the claimed invention as stated above in Claim 7, except wherein the cage includes deflectable locking tabs sized and configured for locking engagement with the endplate. Reed et al. does disclose in Paragraph [0064] that “[0064] The spacer body 312 can be removably coupled, attached, or affixed to the end member 350. The spacer body 312 can be attached to the end member 350 by a coupling mechanism, friction fit, interference fit, or any other connection means. For example, the spacer body 312 and the end member 350 may be assembled together using, alone or in combination, a dovetail assembly, dowel pins, hooks, staples, screws, adhesives, and the like, or any suitable fasteners known in the art.”
Mozeleski et al. discloses an interbody spacer (100, Figs. 1-13) comprising a cage (200, Figs. 2 & 4) comprising a top surface (202, Fig. 2), a bottom surface (204, Paragraph [0060]), a proximal/rear end wall (206, Fig. 4), an interior opening (210), and opposing left and right sidewalls (left 207 & right 207, Fig. 4, Paragraph [0062]), and a plate (300, Fig. 1, 3, & 5) configured to be removably connected to the proximal/rear end wall of the cage (Paragraphs [0066-0067]), wherein each of the opposing left and right sidewalls of the cage comprise a locking slot formed in an outer surface thereof (left and right cage coupling portions 220 & 222 which include slots, Figs. 2 & 4, 6A-6B, Paragraph [0062, 0071]), and wherein the plate comprises a left locking tab (left clasp 320, Figs. 3, 5 & 6B) with a left hook at the distal end thereof (left protrusion 326, Fig. 5, Paragraph [0071]) extending from a left side of the distal/front face of the plate (308, Fig. 5), and a right locking tab (right clasp 322, Figs. 3, 5 & 6B) with a right hook at the distal end thereof (right protrusion 326, Fig. 5, Paragraph [0071]), wherein the left and right tabs are configured to flex with respect to the plate so that the hooks thereof snap into locking engagement with the left and right locking slots, respectively (“ In some embodiments, the clasp 322 can be configured to deflect during the coupling process and to return toward the undeflected position when locking into position in the channel 222. In some embodiments, the intervertebral cage 200 can include a chamfer 224 configured to deflect the clasp 322 outwards during the coupling process.”, Paragraphs [0071-0072]), in order to couple the plate to the cage (Paragraph [0072]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coupling arrangement between the cage and the endplate of the spacer of Reed et al. to include left and right locking tabs with hooks configured for locking engagement with corresponding left and right slots as taught by Mozeleski et al., wherein the left and right locking tabs/hooks extend from left and right sidewalls of the cage and the left and right locking slots are on left and right sides of the front/distal face of the endplate, in order to provide the spacer with a connection means for the two components which allows a user to quick connect and releasably but securably assemble the plate on the cage during use, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claim 14, Reed et al. discloses the claimed invention as stated above in Claim 7, except wherein the endplate includes deflectable locking tabs sized and configured for locking engagement with the cage. Reed et al. does disclose in Paragraph [0064] that “[0064] The spacer body 312 can be removably coupled, attached, or affixed to the end member 350. The spacer body 312 can be attached to the end member 350 by a coupling mechanism, friction fit, interference fit, or any other connection means. For example, the spacer body 312 and the end member 350 may be assembled together using, alone or in combination, a dovetail assembly, dowel pins, hooks, staples, screws, adhesives, and the like, or any suitable fasteners known in the art.”
Mozeleski et al. discloses an interbody spacer (100, Figs. 1-13) comprising a cage (200, Figs. 2 & 4) comprising a top surface (202, Fig. 2), a bottom surface (204, Paragraph [0060]), a proximal/rear end wall (206, Fig. 4), an interior opening (210), and opposing left and right sidewalls (left 207 & right 207, Fig. 4, Paragraph [0062]), and a plate (300, Fig. 1, 3, & 5) configured to be removably connected to the proximal/rear end wall of the cage (Paragraphs [0066-0067]), wherein each of the opposing left and right sidewalls of the cage comprise a locking slot formed in an outer surface thereof (left and right cage coupling portions 220 & 222 which include slots, Figs. 2 & 4, 6A-6B, Paragraph [0062, 0071]), and wherein the plate comprises a left locking tab (left clasp 320, Figs. 3, 5 & 6B) with a left hook at the distal end thereof (left protrusion 326, Fig. 5, Paragraph [0071]) extending from a left side of the distal/front face of the plate (308, Fig. 5), and a right locking tab (right clasp 322, Figs. 3, 5 & 6B) with a right hook at the distal end thereof (right protrusion 326, Fig. 5, Paragraph [0071]), wherein the left and right tabs are configured to flex with respect to the plate so that the hooks thereof snap into locking engagement with the left and right locking slots, respectively (“ In some embodiments, the clasp 322 can be configured to deflect during the coupling process and to return toward the undeflected position when locking into position in the channel 222. In some embodiments, the intervertebral cage 200 can include a chamfer 224 configured to deflect the clasp 322 outwards during the coupling process.”, Paragraphs [0071-0072]), in order to couple the plate to the cage (Paragraph [0072]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coupling arrangement between the cage and the endplate of the spacer of Reed et al. to add left and right locking tabs with hooks to the distal/rear face of the endplate and add corresponding left and right slots to the left and right sidewalls of the cage as taught by Mozeleski et al. in order to provide the spacer with a connection means for the two components which allows a user to quick connect and releasably but securably assemble the plate on the cage during use.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (US PG Pub No. 2016/0310295) in view of Kaufmann et al. (US PG Pub No. 2017/0340453).
Regarding Claim 17, Reed et al. discloses the claimed invention as stated above in claim 7, and further discloses wherein one of the bone anchors is configured to deploy through a top of the cage (upper 352 extends along upper 318 & 318 and through upper opening formed through 342) and one of the bone anchors is configured to deploy through a bottom of the cage (lower 352 extends along lower 318 & 318 and through lower opening formed through 344)(Paragraphs [0063, 0065-0066]). Reed et al. does not disclose wherein the at least two non-screw bone anchors includes four non-screw bone anchors including two bone anchors configured to deploy through the top of the cage and two bone anchors configured to deploy through the bottom of the cage.
Kaufmann et al. discloses various embodiments (Figs. 1-30) of interbody spacers (100, 200, 300), each comprising a cage (110, 210, 310) and an anchor assembly (111/112; 211/212; 311/312; 411/412’ 411’/412’; 507; 611/612), wherein one particular embodiment depicted in Fig. 26 comprises a cage having an interior with a set of upper curved channels formed therein (401 & 401’) and a set of lower curved channels formed therein (402 & 402’), the upper and lower curved channels configured to slidably accept a set of two upper non-screw bone anchors (411 & 411’) and a set of two lower non-screw bone anchors (412 & 412’) (Paragraph [0049]) which are pivotally coupled via resilient hinge member (407) such that the anchors are coupled to each other in a pivotal manner and pivot about 405, (Paragraph [0049]). Another related embodiment depicted in Fig. 26 comprises a cage having an interior with a set of upper ramped channels formed therein and a set of lower ramped channels formed therein, the upper and lower ramped channels configured to slidably accept a set of two upper non-screw bone anchors and a set of two lower non-screw bone anchors (Paragraph [0050]) which are pivotally coupled via resilient hinge member (507), and Paragraph [0050] states that “While many of the anchors shown thus far resemble nails and may have cross-sections that are generally cylindrical other embodiments may have more flattened anchors and the like. For example, FIG. 26 shows two flattened anchors that deploy simultaneously. In this embodiment the anchors are pivotally coupled to one another via resilient member 507 but they need not be in order to still simultaneously deploy. FIG. 26 shows two flattened channels configured to receive the flattened anchors. Anchors may have multiple tines (not shown) that share a common base and the like.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bone anchors of the spacer of Reed et al. such that the upper bone anchor is defined by two tines sharing a base and the lower bone anchor is defined by two tines sharing a base so that the spacer has four distinct non-screw bone anchors as taught by Kaufmann et al. as an alternate and functionally equivalent anchor arrangement for engaging adjacent vertebrae during a spinal procedure.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zappacosta et al. (US PG Pub No. 2019/0192310) in view of Bergey (US PG Pub No. 2014/0180417).
Regarding Claim 18, Zappacosta et al. discloses an interbody spacer system (Figs. 136-140C, Paragraphs [0093-0095, 0247-0265]) comprising: an interbody spacer (spacer and plate assembly 2000, Figs. 131-135) including a cage (spacer 2002, Figs. 131-133) and an anchor assembly (plate 2004, Figs. 131-135, and bone screws/fasteners, not shown, Paragraph [0264]); the anchor assembly including at least two bone anchors (three bone screws/fasteners inserted through the three through-holes 2064, 2066, 2068 in plate 2004, not shown in Figs. 131-135, Paragraphs [0252, 0256, 0264]) rotatably connected (via the three through-holes 2064, 2066, 2068 which are unthreaded and thus allow each screw/fastener to rotate about its longitudinal axis within the respective hole prior to being locked into plate with the respective locking screw 2070, 2072, 2074, Fig. 131, Paragraph [0256]) to a plate (plate 2004, Figs. 131-135); the plate having an instrument opening (2046, Figs. 131, 134, Paragraph [0249]) having a cross-sectional shape (square or square with rounded edges, Fig. 134, Paragraph [0252]); the cage including a threaded bore (2026, Figs. 131 & 135, Paragraph [0249]) in an interior of the cage (2027, Fig. 131) aligned with the instrument opening (Fig. 134, 136-140C, Paragraph [0259]); and an insertion instrument (insertion tool 2006, Figs. 136-140C, Paragraph [0247]) including a main body (2070, Figs. 136, 137, 139, 140A-140C) having a cross-sectional shape (both the cross-section taken through the length of 2070 along the longitudinal axis thereof, and the vertical cross-section taken perpendiculary to the longitudinal axis through the outer periphery of 2070, See examiner annotated Fig. 140A below) corresponding to the shape of the instrument opening (“The coupling shaft 2070 is configured to extend through the non-threaded bore 2046 in the plate 2004 (shown in FIG. 131) before extending through the threaded bore 2026 of the spacer 2002 (also shown in FIG. 131).”, Figs. 136, 137, 139, 140A-C) and sized and configured for insertion into the instrument opening and into threaded engagement with the threaded bore (Paragraph [0259]).
PNG
media_image2.png
451
335
media_image2.png
Greyscale
Zappacosta et al. does not disclose that the bone anchors are non-screw bone anchors.
Bergey discloses an interbody spacer system (Figs. 1-2, Paragraphs [0026-0042]) comprising an interbody spacer comprising a cage (implant 100) and an anchor assembly (plate 130 and anchors 150, 150’, 150”), the anchor assembly comprising a plate (plate 130) configured to be attached to the cage (Figs. 1-2, Paragraph [0032]) and three non-screw fasteners (150, 150’, 150”, Paragraph [0036]) each configured to be inserted through a respective one of three non-threaded fastener holes (142, 144, 146) formed through the plate, wherein each non-screw fastener is a spiral curved blade fastener (Paragraphs [0036-0039]) which comprises a head portion (152, Paragraph [0036]) and a shank portion (154, Paragraph [0036]) with flattened free end/tip (158), linear or helical splines (160) therealong, and a curved angulation such that the shank curves in a direction away from the outermost surfaces of the cage once inserted therein (Figs. 1-2, Paragraph [0039]). Bergey teaches that the curved angulation of the spiral curved blade fastener optimizes the compressive subsidence of the respective vertebral segments into which they are inserted for fixation (Paragraphs [0011, 0039]), “overcomes the problems encountered with the current art requiring screws to be inserted at trajectories that are difficult to achieve given common human anatomical structures and would not require insertion with screw drivers or hinged screw drivers.” (Paragraph [0018]), and “Furthermore, because the spiral blades are angled relative to the intervertebral plane, there is no difficult trajectory needed to place the screws as with previous devices. As opposed to devices employing blades without plate fixation, the embodiments of the invention employ spiral blades affixed to a rigid plate, which provide better fixation, stabilization, and the ability to remove this device without destruction of the vertebral anatomy if required.” (Paragraph [0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the fasteners used in the system of Zappacosta et al. to comprise non-threaded spiral curved blade shanks as taught by Bergey in order to provide the system with alternate and functionally equivalent fasteners which are easier to remove from the patient without causing destruction of the vertebral anatomy if required.
Regarding Claim 19, the combination of Zappacosta et al. and Bergey discloses the claimed invention as stated above in claim 18, and Zappacosta et al. further discloses wherein the cross-sectional shape is non-circular (See examiner annotation Fig. 140A above, the cross-section taken through the length of 2070 along the longitudinal axis thereof is non-circular. It is not clear what the vertical cross-sectional shape taken perpendiculary to the longitudinal axis through the outer periphery of 2070 is, although it is inserted through bore 2046 as stated Paragraph [0252], Fig. 140A-C).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zappacosta et al. (US PG Pub No. 2019/0192310) in view of Bergey (US PG Pub No. 2014/0180417) as applied to Claim 18 above and further in view of Prado et al. (WIPO Pub No. 2015/081142).
Regarding Claim 20, the combination of Zappacosta et al. and Bergey discloses the claimed invention as stated above in claim 18, except wherein the insertion instrument further includes a lock to fix a distance between the cage and anchor assembly for insertion of the spacer. Zappacosta et al. does disclose that a proximal most end of the insertion instrument comprises a knob (enlarged end portion, not labeled, Fig. 140A).
Prado et al. discloses a spinal interbody system (Fig. 1a) comprising various embodiments of an interbody spacer (10, Figs. 1a, 3, 6) and an insertion tool (implant insertion device, Figs. 1a, 1b, 14-16, Paragraphs [036, 037, 042-043, 162]), wherein the insertion tool comprises an outer shaft (20) and an inner shaft (30) with a knob (36) at a proximal most end thereof (Paragraphs [043, 0159]), wherein a tip of the inner shaft (31, Fig. 1b) is configured to connect to an implant body (Paragraph [043]) and wherein the tip (31, Fig. 1b) is not enclosed in the outer shaft when it is fully inserted therewithin (Fig. 1b, Paragraph [043]), and wherein the knob of the inner shaft comprises a hump (37, Fig. 15) for interacting with a complementary window on the outer shaft so as to lock or unlock the inner shaft to the outer shaft (Paragraph [0159]), and “Optionally, the knob comprises a hump 38 for providing tactile feedback in the locking or unlocking of the inner shaft to the outer shaft. The hump 38 interacts with a groove on the inner surface of the outer shaft so as to provide slight resistance and a snap tactile feel to the user during locking or unlocking of the inner shaft to the outer shaft. In some cases, the hump 37 supported by a spring force so that it can be pushed in to unlock from the window on an outer shaft. In some cases, the hump 37 is a flexible element so that it deforms to lock or unlock to the outer shaft.” (Fig. 15)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the insertion instrument of Zappacosta et al. to add a first hump and a second flexible hump on the proximal knob of the inner shaft/main body and a corresponding first window and groove within the proximal opening through the enlarged proximal portion of the insertion tool, respectively, as taught by Prado et al. in order to provide the insertion instrument with a locking means for securing the inner shaft/main body to the rest of the insertion instrument which provides a slight resistance and tactile feedback to a user to indicate that the inner shaft/main body is locked or unlocked from the rest of the insertion instrument, thus allowing the distance between the cage and the plate of the anchor assembly to be fixed once the inner shaft/main body has been fully inserted into the rest of the insertion instrument and engaged with the cage.
Allowable Subject Matter
Claim 2 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.
Response to Arguments
Applicant’s amendments, filed 03/05/26, have overcome the objections to claims 1, 17 & 20.
In regards to Applicant’s arguments, filed 03/05/26, with respect to the Reed et al. in view of Rhoda and Mozeleski rejection of claim 1 and Argument “(1) Instrument opening”: The Applicant contends that Reed’s discloses visualization windows in 350 are not an instrument opening and characterizing them as so reads functionality into Reed that is not present. In response to the applicant's argument, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The windows in 350, Figs. 8A-8B, are fully and structurally capable of being manually grasped by an insertion tool or forceps during a procedure to reposition or remove the implant as needed. Thus, the combination discloses the claimed invention as stated above and the argument has been fully considered but is not persuasive.
In regards to Applicant’s arguments, filed 03/05/26, with respect to the Reed et al. in view of Rhoda and Mozeleski rejection of claim 1 and Argument “(2) Threaded bore alignment with the instrument opening”: Firstly, the Applicant contends that Rhoda “does not disclose, teach or suggest alignment between a channel in the cage and a channel in the plate because Rhonda fails to disclose any plate covering an end of the cage. A person of ordinary skill would likewise not find such a teaching in Reed, because Reed destroys the alignment of Rhonda relies by teaching a structure that makes such alignment impossible.” It is noted that the office action does not use Rhoda to teach anything regarding the plate, or modify Rhoda with Reed and thus the argument is moot. Secondly, the Applicant contends that Reed teaches away from a bore aligned with an instrument opening in a plate since any channel of Rhoda would be blocked from aligning with the instrument openings in 350 since Reed’s windows are offset and not aligned with a central axis and thus the combination is inoperable for its intended purpose: As seen in the office action above, Rhoda discloses various embodiments of an interbody spacer (10, Figs. 1-4A) comprising a top surface (15, Fig. 4) and a bottom surface (30, Fig. 4) interconnected by a left sidewall (18, Fig. 1), a right sidewall (16, Fig. 1), a proximal/rear endwall (14, Fig. 1) and a distal/front endwall (12, Fig. 1), wherein the proximal and distal endwalls and the left and right sidewalls may each comprise an aperture formed therethrough (32, 32, 38, 38, Figs. 2-4, Paragraphs [0088, 0092-0093]) configured to be engaged by an instrument inserter such that an instrument can engage the spacer at any of the four endwalls/sidewalls, wherein each of the apertures are in alignment with and face another of the apertures which it opposes (Figs. 1-4). Rhoda further discloses in Paragraph [0011] that “In another embodiment, instead of instrument receiving channels, the implant may have a threaded hole on the anterior, anterio-lateral, or lateral side of the implant for receiving a threaded arm of an insertion tool’, wherein a distal endwall threaded hole (22 in 12, Figs. 1-2) is depicted in Fig. 2 and is shown to further include an alignment slot formed thereacross such that the threaded hole is recessed slightly within the distal endwall (Figs. 2 & 4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cage of Reed et al. to add an alignment slot centered along and formed slightly recessed in the front/distal endwall and a threaded aperture extending centrally through the front/distal endwall as taught by Rhoda in order to provide the implant with a means for connecting to a threaded insertion instrument at the front/distal/anterior end of the implant so that the cage can be introduced, removed, or repositioned as necessary during a procedure. Upon modifying Reed with Rhoda in this manner, a portion of the instrument openings in 350 of Reed would be aligned with the threaded bore in 316 as taught by Rhoda along a horizontal plane which extends through both the threaded bore and the instrument openings, and not along the same alignment axes that the Applicant has annotated in the arguments. It is suggested that if a particular alignment arrangement is desired that the claim be amended to clarify. Thus, the argument has been fully considered but is not persuasive.
In regards to Applicant’s arguments, filed 03/05/26, with respect to the Reed et al. in view of Rhoda and Mozeleski rejection of dependent claim 3: The Applicant contends that Rhoda does not teach or suggest inserting an instrument across the interior to engage an interior bore and Rhoda further teaches away from doing so by disclosing blockages such as elements 511 inside the interior of the cage that would make such an engagement impossible and Rhoda’s channel need not continue to extend through the wall on the opposite tall where the bore would be allegedly located: As stated above, Rhoda discloses in Paragraph [0011] that “In another embodiment, instead of instrument receiving channels, the implant may have a threaded hole on the anterior, anterio-lateral, or lateral side of the implant for receiving a threaded arm of an insertion tool’. Upon modifying Reed with Rhoda as stated in the office action above, a threaded bore would extend centrally through 316. The office action does not use Rhoda to teach any channel opposite the threaded bore in 316. The claims state “a threaded bore in the interior facing the rear opening”, “wherein the threaded bore is configured for threaded engagement with an insertion instrument” and does not state that the threaded bore must be accessed from a particular direction. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “inserting an instrument across the interior to engage the interior bore”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the argument has been fully considered but is not persuasive.
In regards to Applicant’s arguments, filed 03/05/26, with respect to the Reed in view of Rhoda and Mozeleski rejection of dependent claim 6: The Applicant contends that “slot 431 extends across the bore, providing a structural feature not identified by the Office in Fig 2, and not disclosed, taught, or suggested in Rhoda… for at least these reasons, claim 6 is in condition for allowance: Firstly, it is not clear what the Applicant is intending to argue regarding claim 6 as it appears features of the Applicant’s invention are being described. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Thus, the argument has been fully considered but is moot.
In regards to Applicant’s arguments, filed 03/05/26, with respect to the 102(a)(1) Reed et al. rejection of Claims 18-19 and the 103 Reed et al. in view of Michelson rejection of Claim 20: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
Prosecution Insights