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’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/402,891, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-21 (all pending claims) are directed to the embodiment of figs. 17A-17E which is not disclosed in provisional application 63,402/891. Accordingly, claims 1-21 have an effective filing date of 2/8/2023 which is the filing date of provisional application 63/483,949.
Drawings
The drawings were received on 3/5/2024. These drawings are acceptable and have been entered.
Claim Objections
Claims 4, 12-16, and 18 are objected to because of the following informalities:
Claim 4, lines 1-2 recite “further each further comprise” which appears to be in error for --each further comprise--.
Claims 12-15 each refer to “the plurality of shims” which appears to be in error for --the plurality of shim inserts--.
Claim 16, line 1 recites “comprising wedge implant sleeve” which appears to be in error for --comprising a wedge implant sleeve--.
Claim 18, lines 1-2 recite “further each further comprise” which appears to be in error for --each further comprise--.
Appropriate correction is required.
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 1-21 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.
Regarding claim 1, it is unclear if the system requires “at least one” or “a plurality” of shim inserts. Lines 1-2 recite “at least one of a plurality of shim inserts” which appears to require at a minimum, just one shim insert since the claim recites “a wedge implant sleeve and at least one” shim insert, but it is unclear if the system requires a plurality of shim inserts. For examination, the claim is interpreted as only positively reciting the at least one shim insert. If applicant intended to positively recite a plurality of shim inserts the claim could be amended to clarify that the system comprises a wedge implant sleeve and a plurality of shim inserts, wherein at least one of the plurality of shim inserts is configured to be placed within the wedge implant sleeve.
Regarding claims 4-6, it is unclear what is considered “at least one recess” (claim 4) and what is considered “openings passing therethrough” (claims 5-6). The specification refers to 159 as “a mating recess 159 in the sleeve 152 to secure the shim 154 within the sleeve 152” (par.107), and does not discuss “openings passing therethrough”. Based on figs. 17A and 17B, the recess 159 appears to extend through the lateral wall of the wedge implant sleeve. Are the “openings passing therethrough” of claims 5 and 6 the same as the at least one recess of claim 4? Are the “openings passing therethrough” the same as the recess 159 in figs. 17A, 17B, and 17E? Since applicant refers to the through hole 159 as a recess, the examiner interprets the term recess to also include a through hole. Please clarify what the difference is between the at least one recess and the openings passing therethrough, and please explain how they each relate to the description of figs. 17A-17E.
Claim 8 recites the limitation "the osseo-integration material" in line 1. There is insufficient antecedent basis for this limitation in the claim. (Claim 8 depends from claim 6 which doesn’t not recite an osseo-integration material.)
Claim 14, lines 1-2 recite “wherein the plurality of shims are angular tapers”. It is unclear what this means. How are the shims “angular tapers”?
Claim 15 recites the limitation "the angular taper of the respective shim" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, as discussed above with respect to claim 1, it is unclear if the claim requires at least one shim insert or a plurality of shim inserts. For examination, the claim is interpreted as only positively reciting the at least one shim insert since the claim recites “comprising a wedge implant sleeve…and at least one…shim insert”. If applicant intended to positively recite a plurality of shim inserts the claim could be amended to clarify that the system comprises a wedge implant sleeve and a plurality of shim inserts, wherein at least one of the plurality of shim inserts is configured to be placed within the central cavity of the wedge implant sleeve.
Regarding claims 18-20, as discussed above with respect to claims 4-6, it is unclear what is considered “at least one recess” (claim 18) and what is considered “openings passing therethrough” (claims 19-20). The specification refers to 159 as “a mating recess 159 in the sleeve 152 to secure the shim 154 within the sleeve 152” (par.107), and does not discuss “openings passing therethrough”. Based on figs. 17A and 17B, the recess 159 appears to extend through the lateral wall of the wedge implant sleeve. Are the “openings passing therethrough” of claims 19 and 20 the same as the at least one recess of claim 18? Are the “openings passing therethrough” the same as the recess 159 in figs. 17A, 17B, and 17E? Since applicant refers to the through hole 159 as a recess, the examiner interprets the term recess to also include a through hole. Please clarify what the difference is between the at least one recess and the openings passing therethrough, and please explain how they each relate to the description of figs. 17A-17E. Claim 20 is especially confusing because it depends from claim 18 and as such requires both “at least one recess configured to engage with the at least one interface member” (claim 18) and “openings passing therethrough…configured to engage with the at least one interface member” (claim 20). How can there be both recesses and openings that engage with the at least one interface member? For examination, the examiner interprets the recesses and openings to be the same since the specification only mentions recess 159 for securing the shim within the sleeve.
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 1-6, 9-11, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaccaro US 6,102,950 (hereafter referred to as Vaccaro).
Regarding claim 1, Vaccaro discloses an implant system capable of being used in a wedge osteotomy (fig.1), comprising a wedge implant sleeve 20 and at least one 40 of a plurality of shim inserts (while only one shim insert appears to be positively claimed, Vaccaro further discloses providing a plurality of sizes and angles of inserts in col.6, lines 7-9) configured to be placed within the wedge implant sleeve (figs. 1, 2, and 7).
Regarding claim 2, see Vaccaro figs.1, 2, and 7 for the wedge implant sleeve 20 having a substantially U-shape having lateral walls 22, 24 joined by a hinge region 60, and a central cavity 70 between the lateral walls configured to receive at least one of the plurality of shim inserts therein.
Regarding claim 3, see fig.3 for the shim inserts comprising a tapered member having an angular taper along a longitudinal length thereof and interface members 46 on the side walls of the tapered member.
Regarding claims 4-6, see figs.2 and 4 for lateral walls 22, 24 each further comprising recesses/openings 26 passing therethrough. At least fig.7 shows the recesses/openings 26 are capable of engaging with the interface members 46 since fig.7 shows the interface member 46 abutting the recess/openings 26.
Regarding claim 9, see col.5, lines 48-53 for titanium.
Regarding claim 10, see col.5, lines 48-53 for “resilience” and “spring hinging” which means the material is a shape memory material. Springs have shape memory.
Regarding claim 11, see figs. 5 and 6 for the hinge region being thinner than the walls.
Regarding claim 16, Vaccaro discloses an implant system capable of being used in a wedge osteotomy (fig.1), comprising wedge implant sleeve 20 having a substantially U-shape having lateral walls 22, 24 joined by a hinge region 60, and a central cavity 70 between the lateral walls and at least one 40 of a plurality of shim inserts (while only one shim insert appears to be positively claimed, Vaccaro further discloses providing a plurality of sizes and angles of inserts in col.6, lines 7-9) configured to be placed within the central cavity of the wedge implant sleeve (figs. 1, 2, and 7).
Regarding claim 17, see fig.3 for the shim inserts comprising a tapered member having an angular taper along a longitudinal length thereof and interface members 46 on the side walls of the tapered member.
Regarding claims 18-20, see figs.2 and 4 for lateral walls 22, 24 each further comprising recesses/openings 26 passing therethrough. At least fig.7 shows the recesses/openings 26 are capable of engaging with the interface members 46 since fig.7 shows the interface member 46 abutting the recess/openings 26.
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.
Claims 7, 8, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Vaccaro as applied to claims 2, 6, and 16 above, and further in view of To et al. US 2020/0229939 (hereafter referred to as To).
Regarding claims 7, 8, and 21, Vaccaro discloses the wedge osteotomy implant system of claims 2, 6, and 16 as discussed above, but Vaccaro does not disclose that each of the lateral walls of the wedge implant sleeve further comprise an osseo-integration material, wherein the osseo-integration material comprises a least one of porous titanium, porous titanium alloy, porous tantalum, and porous tantalum alloy.
To teaches a wedge implant system, in the same field of endeavor wherein outer walls of the implant comprise porous titanium (par.29) for the purpose of providing a desired characteristic including osteogenesis, osteoinduction, osteointegration, and an increase in implant surface area which can be used to facilitate the same (par.41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the porous titanium surface layer as taught by To to the lateral walls of the wedge implant sleeve of Vaccaro in order to improve osteogenesis, osteoinduction, and osteointegration of the implant.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Vaccaro as applied to claim 2 above, and further in view of Gray US 2008/0294260 (hereafter referred to as Gray).
Regarding claims 12-15, Vaccaro discloses the wedge osteotomy implant system of claim 2 as discussed above, but Vaccaro does not disclose that each of the plurality of shims has an angular taper between about 2 degrees and 20 degrees, or between about 6 degrees and 14 degrees, or that the plurality of shim inserts are provided in 1 degree to 5 degree angular taper increments, or that each of the plurality of shim inserts have indicia markings corresponding to the angular taper of the respective shim insert.
Gray teaches a wedge implant, in the same field of endeavor, wherein a surgical kit can be provided with various slopes of implants in three degree increments to achieve a desired angle of about 0 to 18 degrees for the purpose of achieving a desired angular adjustment (par.42). Gray further teaches the implant can comprise color coding or indicia for the purpose of indicating size, slope, and other parameters (par.42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the plurality of shim inserts disclosed by Vaccaro in different sizes including angular tapers of between 6 and 14 degrees since Gray teaches providing angles of 0-18 degrees for optimizing the implant for a particular patient and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A). It would also have been obvious to provide the differently sloped shim inserts of Vaccaro in angular increments of 3 degrees as taught by Gray in order to tailor the implant to a particular patient. Finally, it would have been obvious to provide each of the plurality of shim inserts of Vaccaro with indicia markings corresponding to an angular taper as taught by Gray in order to inform the practitioner of what slope they are selecting. Providing implants in a range of sizes/angles, in increments, and with indicia are all conventional features of implant kits well-known in the art of prosthetics for allowing the surgeon to select a desired configuration of implant for a particular patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McCormack et al. US 11,065,039 discloses a wedge implant sleeve with a hinge region and a tapered shim insert, wherein an interface member on the shim insert is received within openings in the wedge implant sleeve (figs.90-92). McCormack et al. US 2010/0069912 discloses a wedge implant sleeve with a hinge region and a shim insert (figs.16A-16D). Thalgott et al. US 2008/0281425 discloses a wedge implant sleeve with a hinge region and a shim insert, wherein the sleeve comprises blind recesses that engage with interface members of the shim insert (figs. 6a-6d).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774