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 § 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) 1-7, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Pub. No. 2017/0224505 A1, hereinafter “Butler”) in view of Seifert (U.S. Pub. No. 2019/0328540 A1, hereinafter “Seifert”) and in view of Kang et al. (U.S. Pub. No. 2021/0259855 A1, hereinafter “Kang”).
Butler discloses, regarding claim 1, an implant (260, see Figs. 39-46), comprising: an upper support (268) comprising, the upper support comprising a first end (see annotated Fig. 40 below), a second end opposite the first end (see annotated Fig. 40 below), a first side extending between the first end and the second end (see annotated Fig. 40 below), and a second side opposite the first side and extending between the first end and the second end (see annotated Fig. 40 below); a lower support (270) coupled to the upper support (see Figs. 39-46); a rear portion (264) comprising a first side portion (see annotated Fig. 40 below), a second side portion opposite the first side portion (see annotated Fig. 40 below), a rear nose extending between the first side portion and the second side portion (see annotated Fig. 43 below), and a hole (see annotated Fig. 40), the rear nose configured to engage with the upper support and the lower support (see annotated Fig. 43 below); and a control member (266) configured to control relative movement between the upper support and the lower support (see paras. [0060]-[0061]).
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Regarding claim 2, wherein manipulation of the control member causes a front portion (262) to move towards the rear portion and causes the upper support to move away from the lower support (see Fig. 43), wherein the front portion comprises a first wedge surface configured to engage the first end of the upper support and the rear portion (see annotated Fig. 43) comprises a second wedge surface configured to engage the first end of the upper support (see annotated Fig. 43 above).
Butler discloses, regarding claim 15, an implant (260, see Figs. 39-46), comprising: a first support (268); a second support (270); a rear portion (264) comprising a first side portion (see annotated Fig. 40 above), a second side portion opposite the first side portion (see annotated Fig. 40 above), a rear nose extending between the first side portion and the second side portion (see annotated Fig. 43 above), a first groove proximate to the first side portion (see annotated Fig. 40 above), a second groove proximate to the second side portion (see annotated Fig. 40 above), wherein the first groove is configured to engage the first support and the second groove is configured to engage the second support (see Figs. 43-44); and a control member (266) configured to control relative movement between the first support and the second support (see paras. [0060]-[0061]).
Regarding claim 16, wherein a front portion (262) engages the first support at a first end of the first support (see Fig. 43) and the rear portion (264) engages the first support at a second end of the first support opposite the first end (see Fig. 43).
Regarding claim 17, wherein the first support comprises a side projection configured to be received in a side slot of the second support such that during expansion of the implant sidewalls of the side projection remain proximate corresponding sidewalls of the side slot (see annotated Fig. 42 below).
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Regarding claim 19, wherein manipulation of the control member causes a front portion (262) to move towards the rear portion (264) and causes the first support to move away from the second support (see Fig. 43).
Regarding claim 20, wherein the control member comprises a head (280) and a shaft (284), and wherein the head of the control member comprises a tool port (286) in communication with an opening (288) on a side of the shaft to enable delivery of material to an interior of the implant via the tool port (see Fig. 40, see para. [0061]).
Butler fails to disclose, regarding claim 1, wherein the upper support includes an upper plate configured to receive a first anchoring member, wherein the lower support includes a lower plate configured to receive a second anchoring member; and wherein the rear portion includes a hole extends from the first side portion to the second side portion; regarding claim 3, wherein the upper support and the lower support are identical; regarding claim 4, further comprising a plurality of anchoring members, including the first anchoring member and the second anchoring member; regarding claim 5, wherein the implant has a longitudinal axis; and the upper plate is configured to receive an anchoring member such that a center-line trajectory of the anchoring member and the longitudinal axis of the implant form a plate angle greater than 0 degrees; regarding claim 6, wherein the upper plate is further configured to receive a first retention member, and wherein the lower plate is further configured to receive a second retention member; wherein the first retention member and the second retention member each comprises a flat portion and a rounded shoulder portion; and wherein the rounded shoulder portion of the first retention member is configured to engage a head of the first anchoring member; regarding claim 7, wherein the lower support is coupled to the upper support in a non-hinged fashion; regarding claim 15, further comprising a first bone screw; a second bone screw; an upper plate configured to receive the first bone screw, the upper plate configured to receive the first bone screw such that a first center-line trajectory of the first bone screw is angled towards a first lateral side; a lower plate configured to receive the second bone screw such that a second center-line trajectory of the second bone screw is angled towards the first lateral side; and wherein the rear portion includes a hole extends from the first side portion to the second side portion; regarding claim 18, wherein the first support receives the first bone screw at a position offset to the first side and the second support receives the second bone screw at a position offset to the second side.
Seifert discloses an implant (600, see Fig. 12A) comprising an upper support (602) and lower support (604), wherein the upper support comprises an upper plate (648) configured to receive (via bore 650) a first anchoring member (651, see Fig. 12A, see para. [0127]); wherein the lower support comprises a lower plate (660) configured to receive (via bore 662) a second anchoring member (663); wherein the implant has a longitudinal axis (658, see Fig. 12C); and the upper plate is configured to receive an anchoring member (651) such that a center-line trajectory (652) of the anchoring member and the longitudinal axis of the implant form a plate angle greater than 0 degrees (see annotated Fig. 12C below); wherein the upper plate is further configured to receive a first retention member (656), and wherein the lower plate is further configured to receive a second retention member (666); wherein the first retention member and the second retention member each comprises a flat portion (see annotated Fig. 12A below) and a rounded shoulder portion (see annotated Fig. 12A below); and wherein the rounded shoulder portion of the first retention member is configured to engage a head of the first anchoring member (see para. [0144]); wherein the lower support is coupled to the upper support in a non-hinged fashion (see Fig. 12B, see para. [0118] “unitary”); wherein the upper plate configured to receive the first bone screw (651) such that a first center-line trajectory (652) of the first bone screw is angled towards a first lateral side (see Figs. 12C-D); wherein the lower plate configured to receive the second bone screw (663) such that a second center-line trajectory (652) of the second bone screw is angled towards the first lateral side (see Figs. 12C-D); wherein the first support receives the first bone screw at a position offset to the first side and the second support receives the second bone screw at a position offset to the second side (see annotated Fig. 12D below); wherein the upper support and the lower support are identical (see Fig. 12A, see also para. [00129] “all of the same features” and “may be symmetrical with respect to each other”); and further comprising a first bone screw / anchoring member (651) and a second bone screw / anchoring member (663) in order to provide a vertical extension from the upper and lower plates that is configured to receive bone screws to attach the implant to the vertebral body (see para. [0018]).
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Kang discloses an implant (100, see Fig. 3) with an upper support (102), lower support (120), rear portion (170), front portion (140), and control member (180); wherein the rear portion has a hole extending from the first side to the second side portion (176) in order to receive pins (192 and 194) to prevent removal of the control member from the rear portion (see para. [0081]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the upper and lower supports in Butler to include upper and lower plates, first and second bone screws / anchoring members, and retention members in view of Seifert in order to provide a vertical extension from the upper and lower plates that is configured to receive bone screws to attach the implant to the vertebral body. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the rear portion in Butler to include a hole extending from the first side to the second side portion in view of Kang in order to prevent removal of the control member from the rear portion.
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Pub. No. 2017/0224505 A1, hereinafter “Butler”) in view of Seifert (U.S. Pub. No. 2019/0328540 A1, hereinafter “Seifert”).
Butler discloses, regarding claim 8, an implant (260, see Figs. 39-46) comprising: an upper support (268) configured to engage the first portion of bone, the upper support comprising a first rail (see annotated Fig. 40 above), and a side projection (see annotated Fig. 42 above), a lower support (270) coupled to the upper support (see Fig. 39), the lower support being configured to engage the second portion of bone (see Fig. 43, note ridges on top and bottom surfaces), a second rail (see annotated Fig. 40 above), and a side slot (see annotated Fig. 42 above) configured to receive the side projection of the upper support (see annotated Fig. 42 above), a rear portion (264) comprising a first side portion (see annotated 40 above), a second side portion opposite the first side portion (see annotated Fig. 40 above), a first groove proximate to the first side portion (see annotated Fig. 40 above), and a second groove proximate to the second side portion (see annotated Fig. 40 above), wherein the first groove is configured to receive the first rail of the upper support and the second groove is configured to receive the second rail of the lower support (see Figs. 43-44); and a control assembly (266) configured to control relative movement between the upper support and the lower support (see paras. [0060]-[0061]).
Regarding claim 9, wherein manipulation of the control assembly causes a front portion (262) to move towards the rear portion (264) and causes the upper support to move away from the lower support (see Fig. 43).
Regarding claim 12, wherein: the control assembly further comprises a front portion (262) configured to engage the upper support at the first end of the upper support (see Fig. 43); and the rear portion (264) is further configured to engage the upper support at a second end of the upper support, the second end being opposite the first end (see Fig. 43).
Regarding claim 13, wherein the control assembly further comprises a control member (266) adjustably engaging the front portion and the rear portion (see Fig. 44).
Regarding claim 14, wherein during expansion of the implant a sidewall of the side projection remains proximate a sidewall of the side slot (see Figs. 42-43).
Butler fails to explicitly disclose, regarding claim 8, a first anchoring member; a second anchoring member; an upper plate at a first end of the upper support, the upper plate configured to receive the first anchoring member such that a first center line trajectory of the first anchoring member is angled towards a first side of the implant to secure the upper support to the first portion of bone; the lower support comprising a lower plate at a first end of the lower support, the lower plate configured to receive the second anchoring member such that a second center line trajectory of the second anchoring member is angled towards the first side; regarding claim 10, wherein the first anchoring member and the second anchoring member are bone screws; regarding claim 11, wherein the upper plate is further configured to receive a first retention member, and wherein the lower plate is further configured to receive a second retention member; wherein each of the first retention member and the second retention member comprises a flat portion and a rounded shoulder portion; and wherein the rounded shoulder portion of the first retention member is configured to engage a head of the first anchoring member.
Seifert discloses an implant (600, see Fig. 12A) comprising an upper support (602) and lower support (604), wherein the upper support comprises an upper plate (648) configured to receive (via bore 650) a first anchoring member (651, see Fig. 12A, see para. [0127]); wherein the lower support comprises a lower plate (660) configured to receive (via bore 662) a second anchoring member (663); wherein the implant has a longitudinal axis (658, see Fig. 12C); and the upper plate is configured to receive an anchoring member (651) such that a center-line trajectory (652) of the anchoring member and the longitudinal axis of the implant toward the first side (see annotated Fig. 12C above); wherein the upper plate is further configured to receive a first retention member (656), and wherein the lower plate is further configured to receive a second retention member (666); wherein the first retention member and the second retention member each comprises a flat portion (see annotated Fig. 12A above) and a rounded shoulder portion (see annotated Fig. 12A above); and wherein the rounded shoulder portion of the first retention member is configured to engage a head of the first anchoring member (see para. [0144]); wherein the upper plate configured to receive the first bone screw (651) such that a first center-line trajectory (652) of the first bone screw is angled towards a first lateral side (see Figs. 12C-D); wherein the lower plate configured to receive the second bone screw (663) such that a second center-line trajectory (652) of the second bone screw is angled towards the first lateral side (see Figs. 12C-D); and further comprising a first bone screw / anchoring member (651) and a second bone screw / anchoring member (663) in order to provide a vertical extension from the upper and lower plates that is configured to receive bone screws to attach the implant to the vertebral body (see para. [0018]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the upper and lower supports in Butler to include upper and lower plates, first and second bone screws / anchoring members, and retention members in view of Seifert in order to provide a vertical extension from the upper and lower plates that is configured to receive bone screws to attach the implant to the vertebral body.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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