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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 - 19 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 8, 10 – 14 and 16 - 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Overes et al. (US 2010/0152856 A1) in view of Yen (US 2016/0270928 A1).
Regarding claim 1, Overes discloses a prosthetic spinal implant (Abstract), comprising:
a first endplate component (Fig. 2, ref. 3, and Fig. 6A, ref. 610) and a second endplate component (Fig. 2, ref. 5 and Fig. 6A, ref. 612) operably connected to form an articulating joint (Figs, 2. 6A), wherein the first endplate component and the second endplate component each comprise an inner surface with an interlocking component (each endplate has an inner interlocking component, Fig. 2, refs. 10, 10’ and Fig. 6, refs. 614, 615), and an exterior surface adapted to engage with bone (the top or outer axial surfaces are considered the exterior surface, such as shown in Fig. 6, ref. 611, 612)
but is silent regarding a flexible core between the first endplate component and the second endplate component, wherein the flexible core fills around the interlocking component of the first endplate component and the interlocking component of the second endplate component.
Yen teaches a spinal spacer having a first and second endplate (Fig. 4A, refs. 100, 200) and a flexible core between them (ref. 900, Fig. 4A), wherein the flexible core fills the space about inner components of the endplates (Fig. 4A, paragraph [0022]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Overes to include the flexible core between the endplates, as taught by Yen, for the purpose of creating a solid and flexible spacer to maintain its deformability and the ability to bounce back and to reduce risk to the implant (paragraph [0034]).
Regarding claim 2, Overes in view of Yen discloses the prosthetic spinal implant of claim 1, wherein the flexible core is configured to limit movement of the first endplate components and relative to the second endplate component (Yen, paragraph [0034] discloses that the flexible core material is configured in such a way that after some movement of the endplates, they “bounce back”, thus limiting movement).
Regarding claim 3, Overes in view of Yen discloses the prosthetic spinal implant of claim 1, wherein the inner surface of the first endplate component and the inner surface of the second endplate component each comprise one or more porous sections configured to receive a portion of the flexible core to bond the first and second endplate components to one another (Fig. 6B of Overes best shows one or more porous sections in the forms of windows or openings to receive the flexible material as taught by Yen).
Regarding claim 4, Overes in view of Yen discloses the prosthetic spinal implant of claim 1, wherein the interlocking component is a u-shaped component forming an arch over the inner surface (Overes, Figs. 1b shows opposing u-shaped components, refs. 10, 10’, 20a, 20b, 25, 30, 30b forming arches).
Regarding claim 5, Overes in view of Yen discloses the prosthetic spinal implant of claim 4, wherein the u-shaped component comprises a bridge portion and two base portions, and the base portions are greater in width than the bridge portion (see remarked Fig. 1B below).
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Regarding claim 6, Overes in view of Yen discloses the prosthetic spinal implant of claim 4, wherein the u-shaped component comprises a pair of base portions each of which taper towards a bridge portion of the u-shaped component (see remarked Fig. 1B above).
Regarding claim 7, Overes in view of Yen discloses the prosthetic spinal implant of claim 1, wherein the interlocking component of the first endplate component and the interlocking component of the second endplate component interlock to prevent over-rotation of the first endplate component and the second endplate component (Overes, as shown in Figs.1B – 6D, the interlocking form prevents over-rotation in specific directions).
Regarding claim 8, Overes discloses a prosthetic spinal implant, comprising:
a first endplate component (Fig. 6A, ref. 610) and a second endplate component (ref. 612) each comprising an exterior surface adapted to engage with bone (paragraph [0044], the superior and inferior surfaces), an inner surface formed with one or more cavities, and one or more internal reservoirs, wherein each of the one or more internal reservoirs extends from at least one of the one or more cavities (see remarked Fig. 6A below which shows cavities carved out from exterior surfaces and lead into internal reservoirs or open spaces within the implant); and
but does not disclose a flexible core bonding the first endplate component to the second endplate component, wherein a portion of the flexible core fills the one or more internal reservoirs of the first endplate component and the one or more internal reservoirs of the second endplate component.
Yen teaches a spinal spacer having a first and second endplate (Fig. 4A, refs. 100, 200) and a flexible core between them (ref. 900, Fig. 4A), wherein the flexible core fills resevoirs within the inner components of the endplates (Fig. 4A, paragraph [0022]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Overes to include the flexible core between the endplates, as taught by Yen, for the purpose of creating a solid and flexible spacer to maintain its deformability and the ability to bounce back and to reduce risk to the implant (paragraph [0034]).
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Regarding claim 10, Overes in view of Yen discloses the prosthetic spinal implant of claim 8, wherein the one or more internal reservoirs includes a first reservoir and a second reservoir (any of the internal open spaces/reservoirs may be a first and second reservoir).
Regarding claim 11, Overes in view of Yen discloses the prosthetic spinal implant of claim 10, wherein the one or more cavities include a first set of cavities aligned with the first reservoir and second set of cavities aligned with the second reservoir (one of the sides of the implant may contain the first set of cavities which extend inwardly to the open spaces/reservoirs and a second side of the implant may contain the second set of cavities).
Regarding claim 12, Overes in view of Yen discloses the prosthetic spinal implant of claim 11, wherein the first reservoir and the first set of cavities are formed in a first lateral side of each of the first endplate component and the second endplate component and the second endplate component and the second reservoir and the second set of cavities are form in a second lateral side of each of the first endplate component and the second endplate component (see remarked Fig. 6A above which shows a symmetric implant having cavities on both lateral sides that lead into reservoirs).
Regarding claim 13, Overes in view of Yen discloses the prosthetic spinal implant of claim 8, wherein the first endplate component and the second endplate component each comprise a u-shaped component that interlock to form an articulating joint (see remarked Fig. 6A below).
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Regarding claim 14, Overes discloses a prosthetic spinal implant (Abstract), comprising:
a first endplate component and a second endplate component operably connected to form an articulating joint (see remarked Fig. 6A below), wherein the first endplate component and the second endplate component each comprise,
an exterior surface adapted to engage with bone (top and bottom surfaces respectfully),
an inner surface formed with,
a first set of cavities at a first lateral side of the endplate component, a second set of cavities at a second lateral side of the endplate component (see remarked Fig. 6A below), and
a u-shaped interlock component extending from the inner surface (refs. 615, 614 form u-shaped structures configured to interlock to form the joint);
a first reservoir formed in the first lateral side of the endplate component, wherein the first reservoir extends from at least one cavity of the first set of cavities (the reservoirs are taken to be the internal spaces between the interlocking components that extend from the side cavities);
a second reservoir formed in the second lateral side of the endplate component, wherein the second reservoir extends from at least one cavity of the second set of cavities (the implant is shown to be symmetric, therefore the second lateral side hid from view in Fig. 6A will have a second set of cavities and reservoirs);
but is silent regarding a flexible core between the first endplate component and the second endplate component, wherein a portion of the flexible core fills the first reservoir and the second reservoir of both the first endplate component and the second endplate component and the flexible core surrounds the u-shaped interlock component of the first endplate component and the second endplate.
Yen teaches a spinal spacer having a first and second endplate (Fig. 4A, refs. 100, 200) and a flexible core between them (ref. 900, Fig. 4A), wherein the flexible core fills reservoirs within the inner components of the endplates (Fig. 4A, paragraph [0022]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Overes to include the flexible core between the endplates, as taught by Yen, for the purpose of creating a solid and flexible spacer to maintain its deformability and the ability to bounce back and to reduce risk to the implant (paragraph [0034]).
Regarding claim 16, Overes in view of Yen discloses the prosthetic spinal implant of claim 14, wherein the flexible core supports bonding of the first endplate component and the second endplate component (Yen teaches a flexible core formed from silicone which can hold parts together while allowing a limiting about of movement, this is considered to be a bond).
Regarding claim 17, Overes in view of Yen discloses the prosthetic spinal implant of claim 14, wherein the u-shaped interlock component is positioned between the first set of cavities and the second set of cavities (the inner part of the U-shaped component is between the two exterior lateral surfaces which define the cavities, thus being between them).
Regarding claim 18, Overes in view of Yen discloses the prosthetic spinal implant of claim 14, wherein the u-shaped interlock component of the first endplate component is perpendicular to the u-shaped interlock component of the second endplate component when the first endplate component is connected to the second endplate component to form the articulation joint (Fig. 6A shows components 615 and 614’ to be perpendicular).
Regarding claim 19, Overes in view of Yen discloses the prosthetic spinal implant of claim 14, wherein the flexible core is a single piece component (Yen, Fig. 4A shows the flexible core as an elastic polymeric biomaterial, such as silicone, which form a solid piece filling the space or negative space of the implant).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Overes et al. (US 2010/0152856 A1) in view of Yen (US 2016/0270928 A1) and in view of Duarte et al. (US 2017/0312089 A1).
Regarding claim 15, Overes in view of Yen discloses the prosthetic spinal implant of claim 14, except wherein the exterior surface of the first endplate component and the second endplate component comprises an osteoconductive material.
Duarte teaches an analogous spinal implant (Abstract) comprising an exterior surface having an osteoconductive material (paragraph [0007]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Overes in view of Yen such that the exterior side of the base comprises an osteoconductive material, as taught by Duarte, for the purpose of stimulation of new bone growth (Duarte, paragraph [0007]).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists the prior art used in the current rejection and not already of record.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/TESSA M MATTHEWS/Examiner, Art Unit 3773