DETAILED ACTION
This is the first office action on the merits in this application. The claims of January 31, 2025, are under consideration. Claims 1-20 stand pending.
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 § 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 8 and 17 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. Claims 8 and 17 refer to “an upper surface” and “a lower surface”. Claims 1 and 11, from which claims 8 and 17 depend, also teaches “an upper surface” and “a lower surface”. It is unclear, as claimed, if these are intended to be the same upper and lower surfaces, or different surfaces. Clarification is required.
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.
Claim(s) 1-9, 11, 15-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Padovani et al. (US 2015/0328005 A1).
Regarding claim 1, Padovani teaches an interbody implant 1100 as at figs. 13A-D configured to permit intra-implant movement (e.g. at spring structures 1190) while minimizing movement at a bone-implant interface (as through use of protrusions 1113), comprising:
an implant body 1112 formed to permit a desired range of intra-implant movement between an upper surface thereof 1142 and a lower surface thereof 1144 (movement at the spring structure 1190);
an upper fixation element 1113 adapted to secure an upper portion of the implant body 1100 to a superior bone; and
a lower fixation element 1113 adapted to secure a lower portion of the implant body 1100 to an inferior bone.
Regarding claim 2, the implant body 1112 is formed as a single piece (single piece/unitary [0153]).
Regarding claims 3 and 4, the implant 1100 is formed as a plurality of pieces assembled together (e.g. cage 1112 and fasteners 1130). Alternatively, 1112, itself, can be understood to be various ‘pieces’ assembled together – [0170] describes use of 3D printing methods to build the implant. 3D printing is known as ‘additive manufacturing’ in which various pieces are assembled together into a single structure.
Further regarding claim 4, and regarding claim 5, the manufacturing method being 3D printing or machining is considered a product by process limitation. MPEP 2113. Examiner takes the position that the Padovani structure is substantially identical to the claimed structures, and that manufacturing the structure by either additive or subtractive methods does not change the structures of the device. Applicant now has the burden of demonstrating a non-obvious difference which results from the claimed manufacturing methods.
Examiner rejects claim 5 under both 35 USC 102(a)(1) and 103, as permitted by MPEP 2113. Even if some difference to the structure exists as a result of the manufacturing method, it is old and well known to manufacture devices by subtractive methods. It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Padovani device of subtractive (machining) methods as a matter of being able to form the device in a fast and automated manner in which a computer operated machining system can make the structure faster than a 3D printer.
Regarding claim 6, the upper fixation element 1113 comprises a first bone screw 1130 passing through an upper aperture 1160/1134 of the implant body 1112, and wherein the lower fixation element 1113 comprises a second bone screw 1130 passing through a lower aperture 1160/1134 of the implant body 1112.
Regarding claim 7, each fixation element 1113 comprises a screw. (As noted in rejecting claim 6, 1113 is considered to include a screw 1130).
Regarding claim 8, as best understood, the upper surface 1142 of the implant body 1112 and the lower surface 1144 of the implant body 1112 comprise roughened or porous surfaces [0170] for facilitating bone on-growth or ingrowth.
Regarding claim 9, the upper portion of the implant body 1112 is flexibly affixed to the lower portion of the implant 1100 via a plurality of flexures 1191a/b extending between the upper portion and the lower portion.
Regarding claim 11, Padovani teaches an interbody implant 1100 as at figs. 13A-D configured to permit intra-implant movement (at spring element 1190) while minimizing movement at a bone-implant interface (at the teeth 1113), comprising:
an implant body 1112 comprising a superior portion (up in fig. 13C) connected to an inferior portion (down in fig. 13C) by a plurality of flexures 1191a/b formed to permit a desired range of intra-implant movement between a superior surface 1142 thereof and an inferior surface 1144 thereof;
a superior fixation element 1113 adapted to secure the superior portion of the implant body to a superior bone; and
an inferior fixation element 1113 adapted to secure the inferior portion of the implant body to an inferior bone.
Regarding claim 15, the superior fixation element 1113 comprises a first bone screw 1130 passing through a superior aperture 1160/1134 of the implant body 1112, and wherein the inferior fixation element 1113 comprises a second bone screw 1130 passing through an inferior aperture 1160/1134 of the implant body 1112.
Regarding claim 16, each fixation element 1113 comprises a screw. (As noted in rejecting claim 15, 1113 is considered to include a screw 1130).
Regarding claim 17, as best understood, the superior surface 1142 of the implant body 1112 and the inferior surface 1144 of the implant body 1112 comprise roughened or porous surfaces [0170] for facilitating bone on-growth or ingrowth.
Regarding claim 18, the superior portion of the implant body 1112 is flexibly affixed to the inferior portion of the implant 1100 via a plurality of flexures 1191a/b extending between the upper portion and the lower portion.
Regarding claim 20, the plurality of flexures 1191a/b are modifiable to modify a stiffness of the implant body via modifications of the flexures comprising a modification selected from the group consisting of a width of the flexure, a height of the flexure, a curvature of the flexure, a thickness of the flexure, and a length of the flexure:
Examiner takes the position that this claim is essentially non-limiting. Examiner can think of essentially no design of a flexure which is not capable of being modified in any of the claimed ways – during design phase of the implant body; production phase (3D printing); or even by the surgeon during a surgical procedure (as by use of a special tool to e.g. cut a portion of one of the flexures). Examiner considers essentially any modification made to these flexures to inherently affect a stiffness of the body.
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.
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Padovani in view of Melkent (US 2008/0161919 A1).
Regarding claims 10 and 19, Padovani teaches the limitations of claims 1 and 11,as above; and further teaches the implant body 1112 comprises:
the upper portion of the implant body 1112 (the portion which includes 1113 and 1142);
the lower portion of the implant body 1112 (the portion which includes 1113 and 1144);
a plurality of flexures 1191a/b extending between the upper portion of the implant body and the lower portion of the implant body, wherein the upper portion, the lower portion, and the plurality of flexures are formed as a unitary construct as seen at fig. 13C;
an upper and lower porous insert 1150 formed to promote bone on-growth or ingrowth affixed to the upper portion ([0166] teaches the spacer 1150 can be configured for on-growth; an upper portion and a lower portion of 1150 read on the claim); and
Examiner takes the position that the various claimed inserts are given essentially no structure, and there is no reason that differently constructed structures cannot all be called “inserts”.
Padovani fails to teach an insert inserted between the upper portion of the implant body and the lower portion of the implant body to modify a kinematic profile between the upper portion of the implant body and the lower portion of the implant body imparted by the plurality of flexures in the absence of the insert.
Melkent teaches an implant 10 with a body 20 for receiving an insert 40 between an upper portion (up in fig. 1) and a lower portion (down in fig. 1) of the implant body 20 to modify a kinematic profile between the upper and and lower portions. Presence of relief cuts 30 which provide flexibility within 20 are noted [0020]. Insertion of inserts 40 into relief cuts 30 is taught to adjust stiffness (a kinematic profile) of 20. [0021]
Melkent’s relief cuts 30 are considered essentially analogous to the open region of spring structure 1190 of Padovani. It would have been obvious to one with ordinary skill in the art at the time of the invention to include an insert into the region 1190 of Padovani in view of the Melkent teaching. One would have done so by providing Padovani with a structure which correlates to some or all of the opening 1190 to be inserted therein. Such a structure would have affected rigidity of the device (Melkent [0021]).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Padovani.
Regarding claims 12-14, the limitations of claim 11 were taught by Padovani, but Padovani fails to teach the implant being formed of a plurality of pieces assembled together; or the particular claimed assembly methods. Padovani teaches forming the device by 3D printing. [0170]
Padovani discloses the claimed invention except for the multi-piece construction.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Padovani device of multiple pieces since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Examiner takes the position that claiming the manufacturing methods is claiming a product by process limitation. MPEP 2113. Examiner takes the position that the Padovani structure renders obvious the instant claims, and that manufacturing the structure by either additive or subtractive methods does not change the structures of the device. Applicant now has the burden of demonstrating a non-obvious difference which results from the claimed manufacturing methods.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799