DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4-6, it is unclear if the screw plate retainer of claim 1 is the same or different from the blocking assembly of claims 4 and 5. For the purpose of examination, it is assumed they are the same.
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.
Claims 1, 3-6, 9, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0067071 (Weiman) in view of U.S. Patent No. 6,454,807 (Jackson) and U.S. Patent Application Publication No. 2014/0228957 (Niemiec).
Regarding claims 1 and 9, Weiman discloses a method for spinal fusion treatment using a variable lordotic interbody spacer (see Abstract and Figs. 74-82B) in a disc space, the method comprising: providing a variable lordotic interbody spacer (10) including: a superior endplate (16); an inferior endplate (14); a face plate (300) having an actuation channel (366); the face plate coupled to the superior end plate and the inferior endplate (see Fig. 77); an actuation frame (18) positioned between the superior endplate and the inferior endplate; and an actuation screw (200) configured to be received in the actuation channel (see paragraph [0182]), and inserting the variable lordotic interbody spacer in the disc space (see paragraph [0177]); and rotating the actuation screw to move the actuation frame between the superior endplate and the inferior endplate to adjust the position of the endplates (see paragraph [0194], e.g.), and wherein the actuation screw is configured to be retained in the face plate by a screw plate retainer (450) (see paragraph [0183]).
Weiman fails to disclose each endplate arm coupled to the rear surface of the face plate via a hinge opposite from the base (claim 9) such that an actuation screw adjusts an angle between the superior and inferior endplates (claim 1), wherein the superior endplate and the inferior endplate pivot about a pivot axis, and wherein the pivot axis is posterior to the face plate (claim 1). However, Jackson discloses a spinal implant (1) including superior and inferior endplates (10/11), arms (21) of the endplates coupled to a rear surface (42) of a face plate (12) via a hinge (50/51) opposite from bases (20) of the endplates such that an actuation screw (13) adjusts an angle between the superior and inferior endplates (see col. 6, lines 12-37). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the endplates of Weiman to be hingedly connected to the face plate as suggested by Jackson in order to facilitate providing an optimal angle between adjacent vertebrae between which the apparatus is implanted (see Jackson, col. 6, lines 22-37).
Regarding claims 1 and 4-6, Weiman fails to suggest wherein the actuation screw is configured to be retained in the face plate by a screw plate retainer fastener to a front surface of the face plate (claim 1); wherein the variable lordotic interbody spacer includes at least one blocking assembly formed on a front surface of the face plate, each blocking assembly comprising a blocking screw and a blocking screw channel, wherein the blocking assembly allows for threaded insertion of the blocking screw into the corresponding blocking screw channel (claim 4); wherein one blocking assembly is located adjacent to the head of the actuation screw, wherein, when tightened, the blocking screw of the one blocking assembly prevents the operation of the actuation screw (claim 5); and wherein the variable lordotic interbody spacer includes at least one bone screw channel formed through the face plate between the front and rear surfaces, wherein one blocking assembly is located adjacent to a corresponding bone screw channel, and wherein, when tightened, the blocking screw of the one blocking assembly retains a bone screw in the corresponding bone screw channel. However, Niemiec discloses an intervertebral implant that comprises a blocking assembly (696/694) formed on and fastened to a front surface of a face plate (672), the blocking assembly comprising a blocking screw (694) and a blocking screw channel (696), wherein the blocking assembly allows for threaded insertion of the blocking screw into the corresponding blocking screw channel, wherein one blocking assembly is located adjacent to a head of an actuation screw (700), wherein, when tightened, the blocking screw of the one blocking assembly prevents the operation of the actuation screw such that the blocking screw acts as a screw plate retainer configured to retain the actuator screw in the face plate (see paragraph [0120]), and further comprising at least one bone screw channel (for receiving screw 690) formed through the face plate between the front and rear surfaces, wherein one blocking assembly is located adjacent to a corresponding bone screw channel, and wherein, when tightened, the blocking screw of the one blocking assembly retains a bone screw in the corresponding bone screw channel (see paragraph [0120]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Weiman to include the blocking assembly and bone screw configuration suggested by Niemiec in order to facilitate secure positioning and fixation of the implant in a desired, implanted position (see paragraph [0120]).
Regarding claim 3, Weiman, as modified by Jackson in claim 1 above, suggests wherein, when rotated, the actuation screw moves the actuation frame toward the face plate to adjust the angle formed between the superior and inferior endplates (see paragraphs [0119] and [0194], e.g.).
Further regarding claim 9, Weiman discloses wherein the rear surface of the face plate includes a protrusion (see rear of 300 including channel 366) having the actuation channel passing through and guiding the body of the actuation screw, wherein the protrusion is further coupled to the hinge (suggested by Jackson as noted above regarding claims 1 and 9).
Regarding claim 12, Weiman discloses wherein each of the superior endplate and the inferior endplate have a recess (310/39 ramped portions) to receive a knob (412) formed on the actuation frame.
Regarding claim 13, Weiman discloses wherein an area inside the superior endplate, the inferior endplate, and the actuation frame form graft window regions (44a/44b), the graft window regions allowing for insertion of graft material within the variable lordotic interbody spacer.
Claims 2 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable Weiman in view of Jackson and Niemiec, and further in view of U.S. Patent Application Publication No. 2007/0270965 (Ferguson).
Regarding claim 2, Weiman discloses the actuation frame having first and second frame arms (outer arms of frame 18), but fails to disclose wherein stabilizer channels are formed in the face plate and each stabilizer channel is configured to receive a frame arm of the actuation frame. However, Ferguson discloses an intervertebral device including a face plate (32) and frame (26), wherein the frame and face plate together include at least two stabilizer channels (72/76) and arms (30) are configured to be received in corresponding stabilizer channels. It would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to modify the face plate and frame of Weiman to include corresponding stabilizer channels for receiving frame arms of the actuation frame as suggested by Ferguson in order to more securely connect the frame and face plate together. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have face plate have the stabilizer channel and the frame have the arms since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
Regarding claim 14, Weiman discloses a method of implanting a standalone variable lordotic interbody spacer between two adjacent vertebrae (see Abstract and Figs. 74-82B), the method comprising: providing the standalone variable lordotic interbody spacer (10) including: a face plate (300) having an actuation channel (366) formed through a portion of the face plate; a superior endplate (16) coupled to the face (see Fig. 77); an inferior endplate (14) coupled to the face plate (see Fig. 77); an actuation frame (18) positioned between the superior endplate and the inferior endplate, the actuation frame having an arm (one of outer arms of frame 18); and an actuation screw (200) configured to be received in the actuation channel (see paragraph [0182]), wherein the actuation screw is further configured to move the actuation frame between the superior endplate and the inferior endplate to adjust the position of the endplates (see paragraph [0194], e.g.); inserting the variable lordotic interbody spacer in the disc space (see paragraph [0177]); and rotating the actuation screw to move the actuation frame between the superior endplate and the inferior endplate to adjust the position of the endplates (see paragraph [0194], e.g.).
Weiman fails to disclose a stabilizer channel formed through a portion of the face plate, the stabilizer channel having a plus-shaped recess, and the actuation frame arm configured to be received in the plus-shaped recess. However, Ferguson discloses an intervertebral device including a face plate (32) and frame (26), wherein the frame and face plate together include at least one plus-shaped stabilizer channel recess (76) and a corresponding arm (30) configured to be received in the plus-shaped recess. It would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to modify the face plate and frame arms of Weiman to include at least one corresponding plus-shaped stabilizer channel and corresponding arm as suggested by Ferguson in order to more securely connect the frame and face plate together. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have face plate have the stabilizer channel and the frame have the arms since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
Weiman fails to disclose the actuation screw adjusting an angle between the superior and inferior endplates, wherein the superior endplate and the inferior endplate pivot about a pivot axis, and wherein the pivot axis is posterior to the face plate. However, Jackson discloses a spinal implant (1) including superior and inferior endplates (10/11), arms (21) of the endplates coupled to a rear surface (42) of a face plate (12) via a hinge (50/51) opposite from bases (20) of the endplates such that an actuation screw (13) adjusts an angle between the superior and inferior endplates (see col. 6, lines 12-37). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the endplates of Weiman to be hingedly connected to the face plate as suggested by Jackson in order to facilitate providing an optimal angle between adjacent vertebrae between which the apparatus is implanted (see Jackson, col. 6, lines 22-37).
Weiman fails to suggest wherein the actuation screw is configured to be retained in the face plate by a screw plate retainer fastener to a front surface of the face plate (claim 1). However, Niemiec discloses an intervertebral implant that comprises a screw plate retainer (696/694) fastened to a front surface of a face plate (672), the retainer configured to retain an actuator screw (700) in the face plate (see paragraph [0120]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Weiman to include the screw plate retainer suggested by Niemiec in order to facilitate secure positioning of the implant in a desired position (see paragraph [0120]).
Regarding claim 15, Weiman discloses wherein the actuation frame includes actuation ramp pins (460a/b/c/d) in the form of discrete vertical protrusions on top and bottom surfaces of the actuation frame.
Regarding claim 16, Weiman discloses wherein the actuation ramp pins extend perpendicular from the first and second frame arms (see Figs. 74-82B).
Regarding claim 17, Weiman discloses wherein, when in the expanded position, a gap is formed between superior endplate and inferior endplate (see Fig. 77, e.g.).
Regarding claim 18, Weiman, as modified by Jackson in claim 14 above, suggests wherein, when rotated, the actuation screw moves the actuation frame toward the face plate to adjust the angle formed between the superior and inferior endplates (see paragraphs [0119] and [0194], e.g.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Weiman in view of Jackson and Niemiec, and further in view of U.S. Patent Application Publication No. 2010/0185289 (Kirwan).
Regarding claim 7, Weiman discloses wherein each of the superior endplate and the inferior endplate has first and second endplate arms coupled by an endplate base (see Figs. 74-82B; outer arms of each plate coupled to an end 39), but fails to disclose each of the superior endplate and the inferior endplate further includes a center housing formed between and in parallel with each corresponding endplate arm and coupled at one end to the corresponding endplate base, the superior endplate and the inferior endplate center housings forming a receptacle channel in between, wherein the receptacle of the actuation frame is guided by the receptacle channel when the actuation frame moves with respect to the face plate. However, Kirwan discloses an intervertebral implant wherein each of a superior endplate and an inferior endplate (top and bottom surfaces of implant 50) further includes a center housing (67) formed between and in parallel with corresponding endplate arms and coupled at one end to the corresponding endplate base, the superior endplate and the inferior endplate center housings forming a receptacle channel (95) in between, wherein the receptacle of an actuation frame (58) is guided by the receptacle channel when the actuation frame moves with respect to the apparatus. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the endplates of Weiman include a central housing as suggested by Kirwan in order to add additional structural support to the apparatus.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Weiman in view of Jackson and Niemiec, and further in view of U.S. Patent Application Publication No. 2007/0282441 (Stream).
Regarding claim 8, Weiman fails to suggest wherein the variable lordotic interbody spacer includes at least one tool keying recess and at least one tapped recess formed on the front surface of the face plate, wherein the at least one tool keying recess and the at least one tapped recess are formed so as to lock the apparatus to a corresponding tool. However, Stream discloses an intervertebral implant that comprises at least one tool keying recess (102) and at least one tapped recess (112) formed on the front surface of a face of the implant, wherein the at least one tool keying recess and the at least one tapped recess are formed so as to lock the apparatus to a corresponding tool (see paragraph [0120]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the face plate apparatus of Weiman to include the recesses suggested by Stream in order to allow the apparatus to be inserted into a desired location via a securely-gripping insertion tool.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable Weiman in view of Jackson and Niemiec, and further in view of U.S. Patent Application Publication No. 2016/0166396 (McClintock).
Regarding claim 10, Jackson suggests wherein the hinge comprises tabs (32) located on an end of each endplate arm coupled to the rear surface of the face plate, but fails to disclose the coupling being via pins, wherein the tabs are fastened via the pins to the rear surface of the facet plate at a corresponding pin recess. However, McClintock discloses a spinal implant (100) including superior and inferior endplates (110/130), wherein arms of the endplates are coupled to a rear surface of a face plate (152) via a hinge (151/153), wherein the hinge comprises tabs (120/140) located on an end of each endplate arm coupled to the rear surface of the face plate via pins (151/153), wherein the tabs are fastened, via the pins, to the rear surface of the facet plate at corresponding pin recesses (169). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the hinge to utilize pins to fasten the tabs to the rear surface of the face plate in order to more securely fasten the endplate arms to the face plate.
Regarding claim 11, Jackson suggests wherein the rear surface of the face plate is formed with a tapered wall (tapering defining grooves 50/51) to provide clearance for the hinge.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
Applicant argues on page 7 of the Remarks that Weiman and Jackson fails to disclose the actuation screw configured to be retained in the face plate by a screw plate retainer fastened to a front surface of the face plate, and that the remaining reference fail to teach such a feature. The examiner disagrees. As noted above regarding the rejections of claims 1 and 14, the Niemiec reference does teach an intervertebral implant that comprises a screw plate retainer (696/694) fastened to a front surface of a face plate (672), the retainer configured to retain an actuator screw (700) in the face plate (see paragraph [0120]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Weiman to include the screw plate retainer suggested by Niemiec in order to facilitate secure positioning of the implant in a desired position (see paragraph [0120]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773