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 .
Terminal Disclaimer
The terminal disclaimer filed on 7/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 12,491,016 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 13-15, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich (U.S. Patent 5,059,193, hereinafter “Kuslich”) and in view of Brenzel et al. (U.S. Pub. No. 2009/0182336 A1, hereinafter “Brenzel”).
Kuslich discloses, regarding claim 13, a spinal implant (10, see Fig. 2) comprising a proximal end (see annotated Fig. 3 below) comprising a sliding unit (18), a distal end (14), a body (12) comprising a plurality of struts (26), wherein each strut of the plurality of struts extends from the sliding unit at the proximal end and the distal end of the spinal implant (see Fig. 1), and a rod (16) extending through the sliding unit at the proximal end to the distal end of the spinal implant (see Figs. 1-3), and wherein the spinal implant is configured to transition from a first state (see Fig. 3) comprising a first height (see annotated Fig. 3 below), a first width (see annotated Fig. 3 below), and a first length (see annotated Fig. 3 below), to a second state (see Fig. 1) comprising a second height (see annotated Fig. 2 below), a second width (see annotated Fig. 2B below), and a second length (see annotated Fig. 2 below).
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Regarding claim 14, further comprising a flexible membrane (200) in contact with the plurality of struts (see Figs. 19-20, see lines 10-17 of column 9 “the implant is identical to that shown in FIG. 1”).
Regarding claim 15, wherein the flexible membrane comprises a continuous flexible material that partially covers the body of the spinal implant on an interior or exterior of the plurality of struts (see Figs. 19-20).
Regarding claim 18, wherein the spinal implant is configured to transition from the first state to the second state upon application of mechanical force to the proximal end of the spinal implant that moves the proximal end of the spinal implant toward the distal end of spinal implant (see Fig. 2, see lines 6-36 of column 8).
Regarding claim 19, wherein the spinal implant is shaped as a sphere (see Fig. 1, note spherical in second state), ovoid, dimpled ovoid, or cylinder (see Fig. 3, note cylindrical in first state) in the first state and/or the second state (see Figs. 1 and 3).
Kuslich fails to explicitly disclose, regarding claim 13, wherein the spinal implant is configured to reversibly transition from the first state to the second state.
Brenzel discloses an expandable implant for fracture repair (see Fig. 1), with a rod (124) that transitions from a first state to a second expanded state by ratcheting engagement with sliding unit (108, see Fig. 1, see para. [0230]), wherein the ratcheting engagement during the transition can be one-way or reversible (see para. [0276]) in order to enable tension to be maintained (see para. [0274]) while also enabling the expandable implant to be re-collapsed if adjustment is needed (see para. [0276]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal implant in Kuslich to include a reversible ratchet engagement between the rod and the sliding unit in view of Brenzel in order to enable tension to be maintained while also enabling the expandable implant to be re-collapsed if adjustment is needed.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich in view of Brenzel, as applied to claim 13 above.
Kuslich in view of Brenzel discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 20, wherein the spinal implant in the first state has: (i) a length of from about 1 cm to about 10 cm; (ii) a width of from about 0.5 cm to about 5 cm; and (iii) a height of from about 0.2 cm to about 1 cm; and wherein the spinal implant in the second state has: (iv) a length of from about 0.5 cm to about 5 cm; (v) a width of from about 1 cm to about 10 cm; and (vi) a height of from about 0.3 cm to about 5 cm.
One having ordinary skill in the art at the time the invention was made would recognize that having a smaller footprint during the first state would enable less tissue trauma, while having a larger footprint during the second state would enable more expansion of the vertebral space. Thus, the size of the implant during the first and second states are result effective variables. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant in the first state has: (i) a length of from about 1 cm to about 10 cm; (ii) a width of from about 0.5 cm to about 5 cm; and (iii) a height of from about 0.2 cm to about 1 cm; and wherein the spinal implant in the second state has: (iv) a length of from about 0.5 cm to about 5 cm; (v) a width of from about 1 cm to about 10 cm; and (vi) a height of from about 0.3 cm to about 5 cm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 1-7, 9, 12, 21-22, 25, 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich (U.S. Patent 5,059,193, hereinafter “Kuslich”) in view of Brenzel et al. (U.S. Pub. No. 2009/0182336 A1, hereinafter “Brenzel”) in view of Olmos et al. (U.S. Pub. No. 2008/0140207 A1, hereinafter “Olmos”) and in view of Warfield (U.S. Pub. No. 2004/0244179 A1, hereinafter “Warfield”).
Kuslich discloses, regarding claim 1, a device (see Fig. 2) comprising a spinal implant (10), wherein the device comprises: (a) the spinal implant (10), wherein the spinal implant comprises a proximal end (see annotated Fig. 3 below) comprising a sliding unit (18), a distal end (14), a body (12) comprising a plurality of struts (26), wherein each strut of the plurality of struts extends from the sliding unit at the proximal end to the distal end (see Fig. 1), and a rod (16) extending through the sliding unit at the proximal end of the spinal implant (see Fig. 3), and wherein the spinal implant is configured to transition from a first state (see Fig. 3) comprising a first height (see annotated Fig. 3 below), a first width (see annotated Fig. 3 below), and a first length (see annotated Fig. 3 below), to a second state (see Fig. 1) comprising a second height (see annotated Fig. 2 below), a second width (see annotated Fig. 2B below), and a second length (see annotated Fig. 2 below); (b) a shaft (118) comprising a proximal end (see annotated Fig. 2 below), a distal end (120) wherein the distal end of the shaft is coupled to the proximal end of the spinal implant (see lines 14-20 of column 8, note coupled via ratchet); (c) an actuator (122) at the proximal end of the shaft, wherein the actuator is operatively coupled to the spinal implant via the shaft (see Fig. 2), wherein the actuator is configured to transition the spinal implant from the first state to the second state upon activation (see lines 6-36 of column 8) by transmitting mechanical force to the sliding unit (18) at the proximal end of the spinal implant (see Figs. 2 and 2A-B), thereby moving the sliding unit along the rod toward the distal end of the spinal implant (see Figs. 2 and 2A-B).
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Regarding claim 4, wherein the rod is centrally located in the spinal implant (see Fig. 1).
Regarding claim 5, wherein the actuator is configured to transition the spinal implant from the first state to the second state by transmitting mechanical force to the proximal end of the spinal implant to move the proximal end of the implant toward the distal end of spinal implant (see Fig. 2, see lines 6-36 of column 8).
Regarding claim 6, wherein the device further comprises a handle (119), wherein the proximal end of the shaft is in contact with the handle (see Fig. 2) and, optionally, wherein the actuator is located on the handle (see Fig. 2).
Regarding claim 7, wherein the plurality of struts: (i) form a plurality of lattice cells, wherein the plurality of lattice cells have a polygonal, square, rectangular, triangular, diamond, circular, elliptical, oval, oblong, lens, asteroid, deltoid, slit, or amorphous shape; or (ii) converge at both the proximal end and the distal end of the spinal implant (see Fig. 3, note that struts 26 converge at ends past slots 24) and are spaced apart therebetween, and wherein each of the plurality of struts has one or more curves (see Fig. 1, note spaced apart via slots 24).
Regarding claim 9, wherein the spinal implant is shaped as a sphere (see Fig. 1, note spherical in second state), ovoid, dimpled ovoid, or cylinder (see Fig. 3, note cylindrical in first state) in the first state and/or the second state (see Figs. 1 and 3).
Kuslich discloses, regarding claim 21, a method of altering a relative angle between vertebrae in a spine of a subject (see lines 20-36 of column 8 “outer surfaces of the implant 10 abut against the opposing surfaces of the vertebrae 100,110. Continued expansion of the implant 10 causes the vertebra 100, 110 to stretch apart slightly” e.g. restoring height to the degenerated disc would alter the relative angle between the vertebrae) comprising: (a) inserting the spinal implant of claim 1 into the spine of the subject (see Fig. 2A); (b) transitioning the spinal implant from the first state to the second state by activating actuator (see Figs. 2 and 2B), thereby altering the relative angle between at least two of the vertebrae of the spine (see lines 20-36 of column 8 “outer surfaces of the implant 10 abut against the opposing surfaces of the vertebrae 100,110. Continued expansion of the implant 10 causes the vertebra 100, 110 to stretch apart slightly” e.g. restoring height to the degenerated disc would alter the relative angle between the vertebrae); and (c) detaching the shaft of the device from the spinal implant (see lines38-40 of column 8).
Regarding claim 22, wherein activating the actuator in step (b) increases the height of the spinal implant (see Fig. 2).
Regarding claim 25, wherein, prior to step (a), the method further comprises creating an intervertebral space within the spine of the subject (see lines 49-52 of column 6 “bore 114”).
Kuslich discloses, regarding claim 30, a kit (see Fig. 2) comprising: (i) the device of claim 1 (10, see Fig. 1); and, optionally, one or more of the following: (ii) a handle (119, see Fig. 2), wherein the actuator and the display are located on the handle; (iii) a release mechanism attached to the handle; and (iv) a coaxial bone access system.
Kuslich fails to disclose, regarding claim 1, (a) wherein the spinal implant is configured to reversibly transition from the first state to the second state, (c) wherein the actuator is configured to reversibly transition (d) an indicator for identifying a property of the spinal implant in the second state, wherein the indicator is present on the actuator; and wherein the distal end of the shaft is reversibly coupled to the proximal end of the spinal implant; regarding claim 2, wherein the property is a height or a volume; and regarding claim 3, wherein the indicator comprises a display; regarding claim 12, wherein the device further comprises: (i) a loop, a fastener, a hook, a screw connection, or a magnet that attaches the shaft to the spinal implant; and/or (ii) a release mechanism operatively coupled to the shaft, whereby operation of the release mechanism is configured to detach the shaft from the spinal implant, optionally wherein the release mechanism is configured as a lever, a rotating disk, a push-button, a screw connection, or a slide block; and regarding claim 29, wherein the handle further comprises a release mechanism configured to detach the shaft from the spinal implant, wherein step (c) further comprises activating the release mechanism, thereby detaching the shaft from the spinal implant.
Brenzel discloses an expandable implant for fracture repair (see Fig. 1), with a rod (124) that transitions from a first state to a second expanded state by ratcheting engagement with sliding unit (108, see Fig. 1, see para. [0230]), wherein the ratcheting engagement during the transition can be one-way or reversible (see para. [0276]) in order to enable tension to be maintained (see para. [0274]) while also enabling the expandable implant to be re-collapsed if adjustment is needed (see para. [0276]).
Olmos discloses an expandable vertebral device (see Figs. 25-26), wherein the device includes (d) an indicator (440) for identifying a property of the implant in the second state on an actuator (402, see para. [0185]); wherein the property is a height (see para. [0185]); wherein the indicator comprises a display (440, see Fig. 25, see para. [0185]) in order to illustrate to the surgeon the exact height of the implant as it is expanded (see para. [0185]).
Warfield discloses a ratcheting gun and expansion bolt (see Figs. 5-6), which is being considered analogous art since the reference is reasonably pertinent to the particular problem with which the inventor was involved, the ratcheting gun is used to expand a bolt from a first configuration to a second configuration, with a shaft (55, see Figs. 5-6) that is reversibly coupled to the proximal end of an expandable device (15, see para. [0040], coupling reversed by 25), with a handle (44), an actuator (23) configured to expand the device (see Figs. 5-6), and wherein the handle further comprises a release mechanism (25) operatively coupled to the shaft / configured to detach the shaft from the spinal implant (see para. [0040]), wherein step (c) further comprises activating the release mechanism, thereby detaching the shaft from the spinal implant (see para. [0040]) in order to enable release of the device from the expandable device (see para. [0040]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal implant in Kuslich to include a reversible ratchet engagement between the rod and the sliding unit in view of Brenzel in order to enable tension to be maintained while also enabling the expandable implant to be re-collapsed if adjustment is needed. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device in Kuslich to include an indicator for identifying a height in view of Olmos in order to illustrate to the surgeon the exact height of the implant as it is expanded. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal end of the shaft in Kuslich to be reversibly coupled to the proximal end of implant via a release mechanism and activating the release mechanism, thereby detaching the shaft from the spinal implant in view of Warfield in order to enable release of the device from the expandable device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich in view of Benzel in view of Olmos and in view of Warfield, as applied to claim 1 above, and in further view of Pisharodi (U.S. Patent 5,390,683, hereinafter “Pisharodi”).
Kuslich in view of Benzel in view of Olmos and in view of Warfield discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 8, wherein the plurality of struts are deformable and comprise nitinol, stainless steel, or platinum.
Pisharodi discloses a spinal implant (see Fig. 5) with a plurality of struts (77), wherein the plurality of struts are deformable and comprise stainless steel (see lines 34-43 of column 3) in order to make the implant out of a strong, thin, and non-porous material that enables radially outward expansion (see lines 35-49 of column 3).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant in Kuslich in view of Benzel in view of Olmos and in view of Warfield to comprise stainless steel in order to make the implant out of a strong, thin, and non-porous material that enables radially outward expansion.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich in view of Benzel in view of Olmos and in view of Warfield, as applied to claim 1 above.
Kuslich in view of Benzel in view of Olmos and in view of Warfield discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 10, wherein the spinal implant in the first state has: (i) a length of from about 1 cm to about 10 cm; (ii) a width of from about 0.5 cm to about 5 cm; and (iii) a height of from about 0.2 cm to about 1 cm; and wherein the spinal implant in the second state has: (iv) a length of from about 0.5 cm to about 5 cm; (v) a width of from about 1 cm to about 10 cm; and (vi) a height of from about 0.3 cm to about 5 cm.
One having ordinary skill in the art at the time the invention was made would recognize that having a smaller footprint during the first state would enable less tissue trauma, while having a larger footprint during the second state would enable more expansion of the vertebral space. Thus, the size of the implant during the first and second states are result effective variables. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant in Kuslich in view of Olmos and in view of Warfield in the first state has: (i) a length of from about 1 cm to about 10 cm; (ii) a width of from about 0.5 cm to about 5 cm; and (iii) a height of from about 0.2 cm to about 1 cm; and wherein the spinal implant in the second state has: (iv) a length of from about 0.5 cm to about 5 cm; (v) a width of from about 1 cm to about 10 cm; and (vi) a height of from about 0.3 cm to about 5 cm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 11 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich in view of Benzel in view of Olmos and in view of Warfield, as applied to claim 1 above, and in further view of Auyoung et al. (U.S. Pub. No. 2011/0106007 A1, hereinafter “Auyoung”).
Kuslich in view of Benzel in view of Olmos and in view of Warfield disclose all of the features of the claimed invention, as previously set forth above, except regarding claim 11, wherein the spinal implant further comprises a radiopaque marker; regarding claim 27, wherein the spinal implant comprises a radiopaque marker, and repositioning the spinal implant further comprises using an imaging technique to visualize the position of the spinal implant by detecting the radiopaque marker; and regarding claim 28, wherein the imaging technique is x-ray based imaging.
Auyoung discloses a spinal device (230, see Fig. 3B), wherein the expandable portion of the device (240) includes a radiopaque marker (232 M, see Fig. 3B) in order to assist in visualization of device during the procedure using a imaging technique that is x-ray based imaging (see para. [0047]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant in Kuslich in view of Benzel in view of Olmos and in view of Warfield to include a radiopaque marker in further view of Auyong in order to assist in visualization of the spinal implant during the procedure.
Claim(s) 23-24, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuslich in view of Benzel in view of Olmos and in view of Warfield, as applied to claim 1 above, and in further view Chirico et al. (U.S. Pub. No. 2008/0281364 A1, hereinafter “Chirico”).
Kuslich in view of Benzel in view of Olmos and in view of Warfield discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 23, wherein at least one of the vertebrae of the spine is damaged, compromised, or collapsed; and claim 24, wherein the at least one vertebrae that is damaged has a reduced height relative to an undamaged vertebra; regarding claim 26, wherein the method further comprises, before step (c), reattaching the shaft to the spinal implant and repositioning the spinal implant.
Chirico discloses a device (600, see Figs. 6A-6B) with a shaft (621), an actuator (623) configured to transition the implant from the first state to the second state upon activation (see paras. [0087]-[0088]); wherein the device is used to repair compression fractures in spinal bone (see para. [0106]), wherein at least one of the vertebrae of the spine is damaged, compromised, or collapsed (see Fig. 1E); and wherein the at least one vertebrae that is damaged has a reduced height relative to an undamaged vertebra (see Fig. 1E); and wherein once the device has been positioned and is expanded the method further comprises reattaching the shaft to the device and repositioning the device (see para. [0111]) in order to restore the fracture vertebra to its uninjured position by expanding the device (see para. [0107]) and to move the device to a more desired location (see para. [0111]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Kuslich in view of Benzel in view of Olmos and in view of Warfield to include reattaching the shaft to the device and repositioning the device in further view of Chirico and to modify the device in Kuslich in view of Benzel in view of Olmos and in view of Warfiled to be used in at least one of the vertebrae of the spine is damaged, compromised, or collapsed that is damaged has a reduced height relative to an undamaged vertebra in further view of Chirico in order to restore the fracture vertebra to its uninjured position by expanding the device and in order to move the device to a more desired location.
Allowable Subject Matter
Claim(s) 16-17 is/are 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 arguments filed 7/16/2026 have been fully considered but they are not persuasive.
The Applicant asserts that Kuslich fails to teach a reversible transition, since a ratchet gun is used to draw on a tie rod, that when fully expanded the surgeon removes the ratchet gun and severs the barbed end of the tie rod. The Applicant further asserts that the end caps in Kuslich are designed not to separate and prevent the device from reverting back to a nonexpanded state. And the Applicant asserts that the excess tie rod being severed after deployment would preclude any reversal of the change in shape of Kuslich spinal implant.
The Office respectfully disagrees. While Kuslich teaches a ratcheting mechanism and teaches severing the excess tie rod after the implant has been fully expanded and is ready to be left in place; Benzel is now being relied upon to teach the benefits of being able to selectively reverse a ratcheting mechanism before the excess tie rod is severed to be left in place e.g. in order to enable tension to be maintained (see para. [0274]) while also enabling the expandable implant to be re-collapsed if adjustment is needed (see para. [0276]).
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 Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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