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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 4/25/26 is acknowledged.
Claims 27-34 are canceled.
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.
Claim 40 is 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.
The language: “a first end of the implant” and “a second end of the implant” make the claims indefinite. Even though the rejection is not directed to a lack of antecedent basis, the language used in claim 40 is similar to the language used in claim 39. Claim 40 depends on claim 39. The Examiner suggests to differentiate the “ends” of claim 40. For example, change the ends for “top” and “bottom” or “third end” and “fourth end”. Correction is required.
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 1-7, 9, 10, 12, 13, 17, 18, 20, 22-24, 35, 37, 38, and 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ralph et al US Patent 7,833,253 B2.
Regarding claim 1, Ralph et al discloses an osteotomy gap filling implant (50, see Fig. 5), comprising a plurality of implant segments (52, 53), at least some of the segments comprising a porous body (see col. 6, lines 46-56); and(b) a non-porous flexible spine (49, see col. 10, lines 52-64) extending through the plurality of implant segments (52,53).
Regarding claims 2 and 3, see col. 10, lines 35-38 disclosing the flexibility capability of the implant.
Regarding claim 4, see Fig. 5 disclosing the top plate (53) and the lower body (51).
Regarding claim 5, see Fig. 5 showing the radially nested plates (53).
Regarding claim 6, see Fig. 4C showing the spine (49) extending through the lower bodies.
Regarding claim 7, see below for Examiner’s interpretation of the curved edge and the curved gap.
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Regarding claims 9, 10 and 38, see figure below for the vertical break and the flexural gap.
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Regarding claim 12, see Fig. 5A showing a taper body extending from the first end to the second end of the implant.
Regarding claim 13, see element (49) in Fig. 4B showing a single piece spine.
Regarding claim 17, see Fig. 3 element (32).
Regarding claim 18, the segment is porous.
Regarding claim 20, the insert (32) comprises holes (see Fig. 3).
Regarding claim 22, see Figs. 19-19A disclosing the burr hole cover (191).
Regarding claims 23 and 43-44, a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S.P.Q. 324 (CCPA 1974). Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. In re Klug, 333 F2d 905, 142 U.S.P.Q. 161 (CCPA 1964). In an ex parte case, product-by-process claims are not construed as being limited to the product formed by the specific process recited. In re Hirao et al., 535 F2d 67, 190 U.S.P.Q. 15, see footnote 3 (CCPA 1976). The at least some of the segments are capable of being molded to the spine.
Regarding claim 24, see Fig. 15.
Regarding claim 35, Ralph et al discloses an osteotomy gap filling implant (50) , comprising a plurality of implant segments (52, 53), at least some of the segments comprising a porous body (see col. 6, lines 46-56); and(b) a non-porous flexible spine (49) extending through the plurality of implant segments; (c) wherein at least some of the porous bodies comprise a series of nested top plates (See Fig. 5) rotatable relative to one another (they can rotate because element 51 can bend to any direction) and a lower body (51) descending from each nested top plate;(d) wherein at least some of the implant segments are bendable without buckling about multiple degrees of freedom at bend locations aligned with rotation centers between adjacent nested top plates.
Regarding claim 37, the spine extends through the lower bodies and the bodies are porous.
Regarding claim 42, see Fig. 15 showing a kerf filling implant.
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.
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ralph et al US Patent 7,833,253 B2.
Ralph et al discloses an implant that can be made of metal, plastic or composite materials. However, the spine (49) only discloses that can be made of a strengthening material.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the material of the spine of the Ralph et al reference because Applicant has not disclosed that by having a metal material provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the Ralph et al reference material because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the Ralph et al reference to obtain the invention as specified in claim 21.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 13, 17, 18, 20, and 23-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al US Patent Pub. 2023/0263935A1.
Regarding claims 1 and 35, Lee et al an osteotomy gap filling implant (10), comprising a plurality of implant segments (200), at least some of the segments comprising a porous body (see abstract); and(b) a non-porous flexible spine (100) extending through the plurality of implant segments.
Regarding claims 2, 3, 13, 25 and 26, see Figs. 5a-b disclosing a high flexibility capable of elongating in length by at least 300%.
Regarding claims 17, 18 and 20, see paragraphs 77, 81 having holes (inserts) for receiving screws.
Regarding claim 23, a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S.P.Q. 324 (CCPA 1974). Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. In re Klug, 333 F2d 905, 142 U.S.P.Q. 161 (CCPA 1964). In an ex parte case, product-by-process claims are not construed as being limited to the product formed by the specific process recited. In re Hirao et al., 535 F2d 67, 190 U.S.P.Q. 15, see footnote 3 (CCPA 1976). The at least some of the segments are capable of being molded to the spine.
Regarding claim 24, see Figs. 6a-b disclosing a cranial osteotomy gap filling implant.
Allowable Subject Matter
Claims 8, 11, 14-16, 19, 36, 39, and 41 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.
Claim 40 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 5/1/26
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