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 .
Priority
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: Claims 5-6 were not disclosed in the parent application (see 112 rejection below). As such Claims 5-6 have an effective filing date of the filing of the current application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “third and fourth endplates move away from the central axis in a second direction […] the second direction being opposite tot the first direction” in claim 5, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The limitations of Claims 5-6 were not disclosed in the specification, see 112 rejection below.
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 5-6 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.
In Claim 5, it is not clear how “the third and fourth endplates move away from the central axis in a second direction and the third and fourth endplates move away from one another along the longitudinal dimension of the implant, the second direction being opposite to the first direction along the superior-inferior dimension.” Claim 1 defines the first direction as also moving away from the central axis (see claim 1 lines 7-8). As can be seen in Figs 3-4 of the current application, all endplates move away from the central axis X in the superior-inferior direction. Likewise, looking at Fig 2, the only direction opposite to the first direction and away from the central axis would be a lateral direction (perpendicular to axis X and the superior-inferior direction) which was not disclosed in the original specification. As such Claims 5-6 are unclear. Examiner is withholding any additional 112 rejections, including 112(a), until clarification from applicant.
Should applicant remove the language that the second direction is opposite the first direction, then Shoshtaev would read on claims 5-6 as follows:
Regarding Claim 5, Shoshtaev discloses a third endplate and a fourth endplate positioned on an opposite side of the central axis from the first endplate and the second endplate (see Fig below), respectively, the third and fourth endplates being movably connected to the chassis such that, during expansion of the expandable implant, the third and fourth endplates move away from the central axis in a second direction (as seen in Fig 70, 72, expands vertically away from the central axis) and the third and fourth endplates move away from one another along the longitudinal dimension of the implant (as seen in Fig 70, 71, expands horizontally along the longitudinal dimension), t
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Regarding Claim 6, Shoshtaev discloses the chassis (which comprises of #1340 as seen in Fig 73 as well as wedges #1314, #1316 and fastener #1312) includes a first wedge (#1314) and a second wedge (#1316), the first and third endplates movably connected to the first wedge and the second and fourth endplates movably connected to the second wedge such that, during expansion of the expandable implant, the first and third endplates move along respective surfaces of the first wedge and the second and fourth endplates move along respective surfaces of the second wedge (as seen in Figs 70-72).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12, 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12- of U.S. Patent No. 12,491,086 (hereinafter ‘086). Although the claims at issue are not identical, they are not patentably distinct from each other because:
In Claim 12, ‘086 discloses an expandable implant positionable in an intervertebral space defined between two vertebrae on opposing sides of the intervertebral space in a superior-inferior dimension (see claim 12, directed to an intervertebral implant where intervertebral implants are for placement in the disc space), the expandable implant comprising:
a chassis including a first wedge and a second wedge (claim 12, col 10 lines 41-42) spaced apart from one another at fixed locations along a central axis of the expandable implant (claim 12, col 10 lines 57-60);
a first endplate (one of the “pair of first endplates” claim 12, col 10 line 44) and a second endplate (one of the “pair of second endplates” claim 12, col 10 line 44) coupled to the first wedge and the second wedge (claim 12, col 10 lines 45-50), respectively, such that, during expansion of the expandable implant, the first endplate moves away from the second endplate along a first surface of the first wedge and the second endplate moves away from the first endplate along a first surface of the second wedge (claim 12, col 10 lines 45-56), the first and second endplates each having a respective abutment surface (claim 12, col 10 lines 44-56, each plate has an abutment surface that is opposite the surface that engages the respective wedge) facing away from the respective first and second wedge, each abutment surface configured to abut a first one of the two vertebrae (claim 12, col 10 lines 44-56, as the endplates move along the wedge, they move away from the central axis and as such moves closer to abutting a surface of respective vertebra).
Regarding Claim 14, ‘086 discloses a third endplate and a fourth endplate positioned on an opposite side of the central axis from the first endplate and the second endplate (see claim 12 where four endplates are claimed, the first and third endplates making up the “pair of first endplates” and the second and fourth endplates making up the “pair of second endplates”), respectively, the third and fourth endplates being coupled to the respective first and second wedges such that, during expansion of the expandable implant, the third endplate moves away from the fourth endplate along a second surface of the first wedge and the fourth endplate moves away from the third endplate along a second surface of the second wedge, the second surfaces of the first and second wedges being on an opposite side of the central axis from the first surfaces of the respective first and second wedges (see claim 12, col 10 lines 43-56), wherein the third and fourth endplates each have a respective abutment surface facing away from the respective first and second wedge, each abutment surface of the third and fourth endplates configured to abut a second one of the two vertebrae (claim 12, col 10 lines 44-56, as the endplates move along the wedge, they move away from the central axis and as such moves closer to abutting a surface of respective vertebra).
Regarding Claim 15, ‘086 discloses a first collar and a second collar connected to the first endplate and the second endplate (see claim 13), respectively, the first and second collars being translatable away from one another along the central axis to drive movement of the respective first and second endplates during expansion of the expandable implant (see claim 13).
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.
Claims 1-3, 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shoshtaev US 2019/0269521.
Regarding Claim 1, Shoshtaev discloses an expandable implant (Fig 70-75) positionable in an intervertebral space defined between two vertebrae on opposing sides of the intervertebral space in a superior-inferior dimension (paragraph 3), the expandable implant comprising:
a chassis (Fig 73) extending along a central axis (see Fig below) parallel to a longitudinal dimension of the expandable implant (see Fig below where #1342 or #1344 defines a longitudinal dimension for the implant);
a first endplate and a second endplate (see Fig below) each movably connected to the chassis (as seen in Fig 70-72) such that, during expansion of the expandable implant, the first and second endplates move away from the central axis in a first direction along the superior-inferior dimension (as seen in Fig 70, 72, expands vertically) and the first and second endplates move away from one another along the longitudinal dimension of the implant (as seen in figs 70-71, expands horizontally along the longitudinal dimension), the first and second endplates each having a respective abutment surface facing away from the chassis (see Fig below), each abutment surface configured to abut a first one of the two vertebrae (see Fig below).
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Regarding Claim 2, Shoshtaev discloses the first and second endplates are each movably connected to the chassis such that, during expansion of the expandable implant, each of the first and second endplates moves away from the central axis along a dimension orthogonal (vertical dimension, Fig 70, 72) to a plane (Fig 70, 72, horizontal plane defined by each abutment surface) defined by the respective abutment surface (as seen in Fig 70, 72, the endplates moves vertically away from the central axis) .
Regarding Claim 3, Shoshtaev discloses the chassis (which comprises of #1340 as seen in Fig 73 as well as wedges #1314, #1316 and fastener #1312) includes a first wedge (#1314) and a second wedge (#1316), the first endplate movably connected to the first wedge and the second endplate movably connected to the second wedge such that, during expansion of the expandable implant, the first endplate moves along a surface of the first wedge and the second endplate moves along a surface of the second wedge (as seen in Figs 70-72).
Regarding Claim 10, Shoshtaev discloses the abutment surfaces of the first and second endplates each have inward ends facing one another along the longitudinal dimension and outward ends facing away from one another along the longitudinal dimension (see Fig below, the inward surface of the second endplate not readily seen in Fig 71 but would have an inward end facing the inward end of the first endplate),
wherein each of the abutment surfaces of the first and second endplates also have first and second lateral edges on opposite sides of the abutment surfaces (see Fig below) along a lateral dimension (as indicated by the double arrowed dash line below) extending orthogonally to both the longitudinal dimension and the superior-inferior dimension (see Fig below), wherein an abutment footprint of the expandable implant is defined by an area bounded by the outward ends and the first and second lateral edges of the first and second endplates (see Fig below), and wherein the expandable implant is configured such that the abutment footprint increases during expansion of the expandable implant (as seen in Fig 70-72).
Regarding Claim 11, Shoshtaev discloses the expandable implant is configured such that, during expansion of the expandable implant, the abutment footprint increases in length along the longitudinal dimension while the abutment footprint maintains its width along the lateral dimension (see Fig above in claim 10 and see Fig 70-72, the lateral dimension or width of the implant does not change).
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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.
Claims 1, 3-4, 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee US 2013/0245767 in view of Kirwan US 2010/0185289.
Regarding Claim 1, Lee discloses an expandable implant (Fig 7) positionable in an intervertebral space defined between two vertebrae on opposing sides of the intervertebral space in a superior-inferior dimension (abstract), the expandable implant comprising:
a chassis extending along a central axis parallel to a longitudinal dimension of the expandable implant (see Fig below);
a first fastener and a second fastener each movably connected to the chassis such that, during expansion of the expandable implant, the first and second fasteners move away from the central axis in a first direction along the superior-inferior dimension (Fig 7, paragraph 73-74, the collars #210a-b translate in order to move the terminal ends of the fasteners in the superior-inferior direction) and the first and second fasteners move away from one another along the longitudinal dimension of the implant (Fig 7, paragraph 73-74, they move away from each other), the first and second fasteners each having a respective abutment surface facing away from the chassis (surface that faces away from the chassis, see below), each abutment surface configured to abut a first one of the two vertebrae (see Fig below, paragraph 73-74).
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Regarding Claim 3, Lee discloses the chassis includes a first wedge and a second wedge (not easily seen in Fig 7 but the chassis define internal first and second wedges with ramped surfaces that guide the movement of fasteners #120 out of the chassis, an example can be seen in Fig 1b below), the first fastener movably connected to the first wedge and the second fastener movably connected to the second wedge such that (see Fig below, Fig 7, paragraph 73-74), during expansion of the expandable implant, the first fastener moves along a surface of the first wedge and the second fastener moves along a surface of the second wedge (see Fig below, Fig 7, paragraph 73-74).
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Regarding Claim 4, Lee discloses n the chassis is configured such that, during expansion of the expandable implant, the first and second wedges are positioned at fixed locations relative to one another (Fig 7, paragraph 73-74, where the wedges do not move during expansion).
Regarding Claim 7, Lee discloses a first collar (#210a) and a second collar (#210b) connected to the first fastener and the second fastener (Fig 7), respectively, the first and second collars being translatable away from one another along the central axis to drive movement of the respective first and second fasteners during expansion of the expandable implant (paragraph 73-74).
Regarding Claim 8, Lee discloses a threaded shaft (#206, Fig 7) extending along the central axis and in threaded engagement with the first and second collars (paragraph 73) such that, during expansion of the expandable implant, rotation of the threaded shaft about the central axis induces simultaneous translation of the first and second collars away from one another along the central axis (Fig 7, paragraph 73-74).
Regarding Claim 9, Lee discloses the first and second collars are connected to the first and second fasteners so as to permit the first and second fasteners to translate relative to the respective first and second collars along the superior-inferior dimension (Fig 7, paragraph 73-74, the collars translate in order to move the terminal ends of the fasteners in the superior-inferior direction), and wherein the first and second collars are connected to the first and second fasteners so as to restrict the first and second fasteners from translating relative to the respective first and second collars in an axial dimension along the central axis (see rejection above for claim 3 and Fig 7 where the collars restrict movement along the threaded shaft #7 and between the first and second wedges).
Lee discloses the claimed invention as discussed above but does not disclose the first and second fasteners are in the form of endplates.
Kirwan discloses a similar implant (Fig 18) with a chassis (#52) and fasteners (#84) that engage ramp surfaces (#102) of an internal wedge (Fig 24), where the fasteners can come in a variety of different configurations (Fig 18, 30, 33, paragraph 68), one configuration is that the fasteners are in the form of endplates (#80, Fig 33), each endplate has abutment surface (outer surface of the endplate that is opposite the internal surface that engages the ramp surfaces of the wedge, Fig 33) that engages a respective vertebra (Fig 33, paragraph 65, 77), where this provides a known shape for the fasteners to contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra (paragraph 65, 77).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the fasteners of Lee to be in the form of endplates in view of Kirwan above because these provide a known alternative shape for fasteners that contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra.
Claims 1, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee US 2013/0245767 in view of Kirwan US 2010/0185289.
Regarding Claim 1, Lee discloses an expandable implant (Fig 7) positionable in an intervertebral space defined between two vertebrae on opposing sides of the intervertebral space in a superior-inferior dimension (abstract), the expandable implant comprising:
a chassis extending along a central axis parallel to a longitudinal dimension of the expandable implant (see Fig below);
a first fastener and a second fastener each movably connected to the chassis such that, during expansion of the expandable implant, the first and second fasteners move away from the central axis in a first direction along the superior-inferior dimension (Fig 7, paragraph 73-74, the collars #210a-b translate in order to move the terminal ends of the fasteners in the superior-inferior direction) and the first and second fasteners move away from one another along the longitudinal dimension of the implant (Fig 7, paragraph 73-74, they move away from each other), the first and second fasteners each having a respective abutment surface facing away from the chassis (surface that faces away from the chassis, see below), each abutment surface configured to abut a first one of the two vertebrae (see Fig below, paragraph 73-74).
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Lee discloses the claimed invention as discussed above but does not disclose the first and second fasteners are in the form of endplates.
Kirwan discloses a similar implant (Fig 18) with a chassis (#52) and fasteners (#84) that engage ramp surfaces (#102) of an internal wedge (Fig 24), where the fasteners can come in a variety of different configurations (Fig 18, 30, 33, paragraph 68), one configuration is that the fasteners are in the form of endplates (#80, Fig 30 in the form of a thin curved plate), each endplate has abutment surface (outer surface of the endplate that is opposite the internal surface that engages the ramp surfaces of the wedge, Fig 30) that engages a respective vertebra (Fig 30, paragraph 65, 78), where this provides a known shape for the fasteners to contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra and provide resistance to withdrawal of the endplate from the vertebra (paragraph 65, 78).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the fasteners of Lee to be in the form of endplates in view of Kirwan above because these provide a known alternative shape for fasteners that contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra and provide resistance to withdrawal of the endplate from the vertebra.
Regarding Claim 10, Lee as modified discloses wherein the abutment surfaces of the first and second endplates each have inward ends facing one another along the longitudinal dimension and outward ends facing away from one another along the longitudinal dimension (see Fig below, as discussed above, the fasteners are replaced with curved plates #80 in view of Kirwan above, where with the modification, the endplates would still have inward ends and outward ends),
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wherein each of the abutment surfaces of the first and second endplates also have first and second lateral edges on opposite sides of the abutment surfaces (see Fig below) along a lateral dimension (along direction “z” below) extending orthogonally to both the axial dimension (along direction “x”) and the superior-inferior (along direction “y”) dimension (see Fig below where with the modification in view of Kirwan, the abutment surfaces have lateral edges extending along a lateral dimension),
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wherein an abutment footprint of the expandable implant is defined by an area bounded by the outward ends and the first and second lateral edges of the first and second endplates, and wherein the expandable implant is configured such that the abutment footprint increases during expansion of the expandable implant (Fig 7 in Lee when the endplates expand and extend outward from the chassis, the footprint increases).
Claims 12-17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee US 2013/0245767 in view of Kirwan US 2010/0185289.
Regarding Claim 12, Lee discloses an expandable implant (Fig 7) positionable in an intervertebral space defined between two vertebrae on opposing sides of the intervertebral space in a superior-inferior dimension (abstract), the expandable implant comprising:
a chassis (see Fig below) including a first wedge and a second wedge spaced (not easily seen in Fig 7 but the chassis define internal first and second wedges with ramped surfaces that guide the movement of fasteners #120 out of the chassis, an example can be seen in Fig 1b below) apart from one another at fixed locations along a central axis (see Fig below, axis extending along shaft #202) of the expandable implant (see Fig below);
a first fastener and a second fastener coupled to the first wedge and the second wedge (see Fig below and as discussed in the paragraph above), respectively, such that, during expansion of the expandable implant, the first fastener moves away from the second fastener along a first surface of the first wedge and the second fastener moves away from the first fastener along a first surface of the second wedge (Fig 7, paragraph 74), the first and second fasteners each having a respective abutment surface facing away from the respective first and second wedge (see Fig below, surface that is opposite the surface that engages the respective wedge), each abutment surface configured to abut a first one of the two vertebrae (see Fig below, paragraph 73-74).
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Regarding Claim 14, Lee discloses a third fastener and a fourth fastener positioned on an opposite side of the central axis from the first fastener and the second fastener (see Fig below), respectively, the third and fourth fasteners being coupled to the respective first and second wedges such that, during expansion of the expandable implant, the third fastener moves away from the fourth fastener along a second surface of the first wedge and the fourth fastener moves away from the third fastener along a second surface of the second wedge, the second surfaces of the first and second wedges being on an opposite side of the central axis from the first surfaces of the respective first and second wedges (Fig 7, paragraph 74 and as discussed above where the third and fourth fasteners move in similar fashion to the first and second fasteners but move in opposite directions and engage an opposite surface of their respective wedge), wherein the third and fourth fasteners each have a respective abutment surface facing away from the respective first and second wedge (see Fig below, surface that is opposite the surface that engages the respective wedge), each abutment surface of the third and fourth fasteners configured to abut a second one of the two vertebrae (see Fig below).
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Regarding Claim 15, Lee discloses a first collar (#210a) and a second collar (#210b) connected to the first fastener and the second fastener (see Fig 7), respectively, the first and second collars being translatable away from one another along the central axis to drive movement of the respective first and second fasteners during expansion of the expandable implant (paragraph 73-74).
Regarding Claim 16, Lee discloses a threaded shaft (#206, Fig 7) extending along the central axis and in threaded engagement with the first and second collars (paragraph 73) such that, during expansion of the expandable implant, rotation of the threaded shaft about the central axis induces simultaneous translation of the first and second collars away from one another along the central axis (Fig 7, paragraph 73-74).
Regarding Claim 17, Lee discloses the first and second collars are connected to the first and second fasteners so as to permit the first and second fasteners to translate relative to the respective first and second collars along the superior-inferior dimension (Fig 7, paragraph 73-74, the collars translate in order to move the terminal ends of the fasteners in the superior-inferior direction), and wherein the first and second collars are connected to the first and second fasteners so as to restrict the first and second fasteners from translating relative to the respective first and second collars in an axial dimension along the central axis (Fig 7 where the collars restrict movement along the threaded shaft #7 and between the first and second wedges).
Regarding Claim 20, Lee discloses the expandable implant is elongated along the central axis (as seen in Fig 7) such that a longitudinal dimension of the expandable implant extends along the central axis (Fig 7).
Lee discloses the claimed invention as discussed above but does not disclose the first and second fasteners are in the form of endplates.
Kirwan discloses a similar implant (Fig 18) with a chassis (#52) and fasteners (#84) that engage ramp surfaces (#102) of an internal wedge (Fig 24), where the fasteners can come in a variety of different configurations (Fig 18, 30, 33, paragraph 68), one configuration is that the fasteners are in the form of endplates (#80, Fig 33), each endplate has abutment surface (outer surface of the endplate that is opposite the internal surface that engages the ramp surfaces of the wedge, Fig 33) that engages a respective vertebra (Fig 33, paragraph 65, 77), where this provides a known shape for the fasteners to contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra (paragraph 65, 77).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the fasteners of Lee to be in the form of endplates in view of Kirwan above because these provide a known alternative shape for fasteners that contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra.
Regarding Claim 13, Lee as modified discloses the first and second endplates are movably connected to the respective first and second wedges such that (Fig 7 of Lee, paragraph 74), during expansion of the expandable implant, each of the first and second endplates moves away from the central axis along the superior-inferior dimension (paragraph 74, Fig 7 of Lee where the terminal ends of the endplates, as modified by Kirwan, move away from the central axis and out the chassis along a superior-inferior dimension during expansion), the superior-inferior dimension being orthogonal to a plane defined by each abutment surface of the first and second endplates (see Fig 7, 28, 33 in Kirwan where when located inside the chassis and prior to expanding, the abutment surface defines a plane parallel to the central axis, where the superior-inferior dimension is orthogonal to the plane and central axis).
Claims 12, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee US 2013/0245767 in view of Kirwan US 2010/0185289.
Regarding Claim 12, Lee discloses an expandable implant (Fig 7) positionable in an intervertebral space defined between two vertebrae on opposing sides of the intervertebral space in a superior-inferior dimension (abstract), the expandable implant comprising:
a chassis (see Fig below) including a first wedge and a second wedge spaced (not easily seen in Fig 7 but the chassis define internal first and second wedges with ramped surfaces that guide the movement of fasteners #120 out of the chassis, an example can be seen in Fig 1b below) apart from one another at fixed locations along a central axis (see Fig below, axis extending along shaft #202) of the expandable implant (see Fig below);
a first fastener and a second fastener coupled to the first wedge and the second wedge (see Fig below and as discussed in the paragraph above), respectively, such that, during expansion of the expandable implant, the first fastener moves away from the second fastener along a first surface of the first wedge and the second fastener moves away from the first fastener along a first surface of the second wedge (Fig 7, paragraph 74), the first and second fasteners each having a respective abutment surface facing away from the respective first and second wedge (see Fig below, surface that is opposite the surface that engages the respective wedge), each abutment surface configured to abut a first one of the two vertebrae (see Fig below).
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Lee discloses the claimed invention as discussed above but does not disclose the first and second fasteners are in the form of endplates.
Kirwan discloses a similar implant (Fig 18) with a chassis (#52) and fasteners (#84) that engage ramp surfaces (#102) of an internal wedge (Fig 24), where the fasteners can come in a variety of different configurations (Fig 18, 30, 33, paragraph 68), one configuration is that the fasteners are in the form of endplates (#80, Fig 30 in the form of a thin curved plate), each endplate has abutment surface (outer surface of the endplate that is opposite the internal surface that engages the ramp surfaces of the wedge, Fig 30) that engages a respective vertebra (Fig 30, paragraph 65, 78), where this provides a known shape for the fasteners to contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra and provide resistance to withdrawal of the endplate from the vertebra (paragraph 65, 78).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the fasteners of Lee to be in the form of endplates in view of Kirwan above because these provide a known alternative shape for fasteners that contact ramp surfaces of the wedge to extend out the chassis and engage respective vertebra and provide resistance to withdrawal of the endplate from the vertebra.
Regarding Claim 18, Lee as modified discloses the abutment surfaces of the first and second endplates each have inward ends facing one another along an axial dimension and outward ends facing away from one another along the axial dimension, the axial dimension extending along the central axis (see Fig below, as discussed above, the fasteners are replaced with curved plates #80 in view of Kirwan above, where with the modification, the endplates would still have inward ends and outward ends).
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wherein each of the abutment surfaces of the first and second fasteners also have first and second lateral edges on opposite sides of the abutment surfaces (see Fig below) along a lateral dimension (along direction “z” below) extending orthogonally to both the axial dimension (along direction “x”) and the superior-inferior (along direction “y”) dimension (see Fig below where with the modification in view of Kirwan, the abutment surfaces have lateral edges extending along a lateral dimension),
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wherein an abutment footprint of the expandable implant is defined by an area bounded by the outward ends and the first and second lateral edges of the first and second endplates (Fig 7 in Lee and with the modification in view of Kirwan, Fig 30, the area bounded by the outward ends and the first and second lateral edges of the first and second endplates define an abutment footprint) , and wherein the expandable implant is configured such that the abutment footprint increases during expansion of the expandable implant (Fig 7 in Lee when the endplates expand and extend outward from the chassis, the footprint increases).
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Regarding Claim 19, Lee as modified discloses the expandable implant is configured such that, during expansion of the expandable implant, the abutment footprint increases in length along the axial dimension while the abutment footprint maintains its width along the lateral dimension (Fig 7 in Lee where during expansion, the endplates move along the central axis and extend outward from the chassis, thus increasing the footprint in length along the axial dimension and the widths of the endplates do not change).
Conclusion
See PTO-892 for art of cited interest, in particular other expandable implants.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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