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 § 102
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 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, 5-11, and 13-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Willis et al. (US 10182923 B2) (hereon referred to as Willis).
Regarding claim 1, Willis teaches an interbody implant (10) for fusion of a superior vertebra and an inferior vertebra of a patient (see Col. 2, ll. 62-67 and Col. 3, ll. 1-15), the interbody implant (10) comprising:
a body (10) with a solid, unitary structure (see Col. 3, ll. 46-67), the body defining:
a superior side (12) shaped to abut an inferior end plate of the superior vertebra, the superior side defining a first aperture (18);
an inferior side (14) shaped to abut a superior end plate of the inferior vertebra, the inferior side defining a second aperture (18);
a leading end (20);
a trailing end (22);
a first lateral side (26);
a second lateral side (28); and
a bone growth cavity (inner sides of apertures 18, see 19) extending between the first aperture (18) and the second aperture (19); and
one or more porous layers (34) that are secured to the superior side (12), the inferior side (14), the first lateral side (26), and the second lateral side (28, see labelled diagram of Fig. 2B below) by a homogenous interface between the body and the one or more porous layers (see Col. 3, ll. 46-67) wherein the homogenous interface comprises a melted portion of at least one of the body and one of the one or more porous layers (see Col. 3, ll. 46-67, noting that the device may be made via 3-D printing, hence creating a melted portion of the porous layer).
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Regarding claim 5, Willis teaches the interbody implant of claim 1, wherein the one or more porous layers comprises a single porous layer that extends across the inferior side, the first lateral side, the superior side, and the second lateral side (see Fig. 2B).
Regarding claim 6, Willis teaches the interbody implant of claim 1, wherein the one or more porous layers terminate short of the leading end (see Fig. 2B).
Regarding claim 7, Willis teaches the interbody implant of claim 6, wherein the leading end (20) comprises a solid bumper (30) positioned to protect the one or more porous layers from abrasion against bone during insertion of the interbody implant between the superior vertebra and the inferior vertebra (see Col. 3, ll. 28-45).
Regarding claim 8, Willis teaches the interbody implant of claim 7, wherein the leading end (20) comprises an exterior surface (see Fig. 2B) that is flush with adjoining exterior surfaces of the one or more porous layers (see Col. 4, ll. 27-52).
Regarding claim 9, Willis teaches the interbody implant of claim 1, wherein at least one of the one or more porous layers comprises a generally uniform thickness (see Col. 3, ll. 46-67).
Regarding claim 10, Willis teaches the interbody implant of claim 1, wherein at least one of the one or more porous layers comprises a variable thickness (see Col. 4, ll. 27-52).
Regarding claim 11, Willis teaches the interbody implant of claim 10, wherein at least one of the one or more porous layers comprises: a flat interior surface (18) facing and secured to the superior side (12), the inferior side (14), the first lateral side (26), or the second lateral side (28); and a convex exterior surface (see labelled diagram of Fig. 2B below).
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Regarding claim 13, Willis teaches the interbody implant of claim 1, wherein: the body comprises a solid structure on the trailing end (see Fig. 2B), the solid structure defining a non-porous interface that facilitates attachment of the interbody implant to an implant inserter (see Col. 3, ll. 28-45); and the one or more porous layers extend to cover lateral aspects of the trailing end (see Fig. 2B).
Regarding claim 14, Willis teaches the interbody implant of claim 1, wherein the one or more porous layers are further secured to inwardly-facing surface of the bone growth cavity (see Col. 3, ll. 16-27).
Regarding claim 15, Willis teaches the interbody implant of claim 1, wherein the superior side comprises a boss extending through the one or more porous layers (see labelled diagram of Fig. 2B below).
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Regarding claim 16, Willis teaches the interbody implant of claim 1, further comprising a nano-thick coating of osteogenic material that covers the body and/or the one or more porous layers (note that polymer is considered an osteogenic material. Because the entire implant may be made of polymer, including the top nano-thick layer thereof, this limitation is met, see Col. 2, ll. 62-67 and Col. 3, ll. 1-15).
Regarding claim 17, Willis teaches an interbody implant (10) for fusion of a superior vertebra and an inferior vertebra of a patient (see Col. 2, ll. 62-67 and Col. 3, ll. 1-15), the interbody implant (10) comprising:
a body (10) with a solid, unitary structure (see 21), the body defining:
a superior side (12) shaped to abut an inferior end plate of the superior vertebra, the superior side defining a first aperture (18);
an inferior side (14) shaped to abut a superior end plate of the inferior vertebra, the inferior side defining a second aperture (18);
a leading end (20);
a trailing end (22);
a first lateral side (26);
a second lateral side (28); and
a bone growth cavity (inner sides of apertures 18, see 19) extending between the first aperture (18) and the second aperture (19); and
one or more porous layers (34) that are secured to the superior side (12), the inferior side (14),
wherein at least one of the one or more porous layers (34) comprises a smooth surface with a variable thickness on at least one of the superior side and the inferior side (see Col. 3, ll. 46-67).
Regarding claim 18, Willis teaches the interbody implant of claim 17, wherein at least one of the one or more porous layers (34) comprises:a flat interior surface (18) facing and secured to the superior side (12) or the inferior side (14); and a convex exterior surface (see labelled diagram of Fig. 2B above).
Regarding claim 19, Willis teaches the interbody implant of claim 18, wherein at least one of the one or more porous layers comprises a leading edge at which the variable thickness approaches zero (see labelled diagram of Fig. 2B below, noting that by way of the porous surface transition to a non-porous surface, a thickness of zero of the porous surface is achieved).
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Regarding claim 20, Willis teaches the interbody implant of claim 17, wherein each of the one or more porous layers is formed of a substantially uniform mixture of osteogenic material (note that polymer is considered an osteogenic material, see Col. 2, ll. 62-67 and Col. 3, ll. 1-15) and thermoplastic polymer (see Col. 2, ll. 64-67, Col. 3, ll. 1-15 and Col. 3, ll. 46-67, noting the device may be 3D printed, therefore requiring PLA, PVC, or another thermoplastic material to be used).
Regarding claim 21, Willis teaches an interbody implant (10) for fusion of a superior vertebra and an inferior vertebra of a patient (see Col. 2, ll. 62-67 and Col. 3, ll. 1-15), the interbody implant (10) comprising:
a body (10) with a solid, unitary structure (see Col. 3, ll. 46-67), the body defining:
a superior side (12) shaped to abut an inferior end plate of the superior vertebra, the superior side defining a first aperture (18);
an inferior side (14) shaped to abut a superior end plate of the inferior vertebra, the inferior side defining a second aperture (18);
a leading end (20);
a trailing end (22);
a first lateral side (26);
a second lateral side (28); and
a bone growth cavity (inner sides of apertures 18, see Col. 3, ll. 16-27) extending between the first aperture (18) and the second aperture (19); and
one or more porous layers (34) that are secured to the superior side (12) and the inferior side (14);
wherein: the leading end (20) comprises a solid bumper (30) positioned to protect the one or more porous (34) layers from abrasion against bone during insertion of the interbody implant (10) between the superior vertebra and the inferior vertebra (see Col. 4, ll. 3-26);
the body (10) comprises a solid structure (24) on the trailing end (22), the solid structure (24) defining a non-porous interface that facilitates attachment of the interbody implant to an implant inserter (see Col. 3, ll. 28-45);
the one or more porous layers (34) extend from the solid bumper (30) to cover lateral aspects of the trailing end (see Fig. 2B and Col. 3, ll. 46-67); and
the one or more porous layers (34) extend uninterrupted along the superior side, the first lateral side, the inferior side, the second lateral side, and the bone growth cavity (see Fig. 2B and Col. 3, ll. 46-67).
Regarding claim 22, Willis teaches the interbody implant of claim 21, wherein at least one of the one or more porous layers (34) comprises a variable thickness (see Col. 3, ll. 46-67).
Regarding claim 23, Willis teaches the interbody implant of claim 17, wherein each of the one or more porous layers (34) is formed of a substantially uniform mixture of bone growth material (see Col. 1, ll. 31-40) and thermoplastic polymer (see Col. 2, ll. 64-67, Col. 3, ll. 1-15 and Col. 3, ll. 46-67, noting the device may be 3D printed, therefore requiring PLA, PVC, or another thermoplastic material to be used).
Allowable Subject Matter
Claims 2-4 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.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claim 2. In particular, none of the cited references teach or suggest wherein each of the one or more porous layers comprises a web-like scaffold having curved surfaces that define substantially spherical voids, the substantially spherical voids being interconnected at tangent points as required by claim 2.
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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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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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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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