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 .
According to the Amendment filed on 12/2/25, Claims 13, 24 are amended, and claims 27-28 are added.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new matter issue is “the first guide feature is positioned to guide a first cutter to cut a metatarsus of the metatarsocuneiform joint, to remove part of the metatarsus; ……. wherein the joint alignment feature is disposed between the first guide feature and an entirety of the at least one indexing feature”
wherein is different than what the drawings and the specifications are teaching (see modified fig. 21 of the present application below)
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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) 13, 15-17, 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawrence et al. (US 20110178524) in view of Sanford (US 20020198530 A1).
Lawrence discloses an osteotomy guide fig. 3a comprising: a guide body defining a joint alignment slot 250 that facilitates alignment of the osteotomy guide with the metatarsocuneiform joint via insertion of an element 28, fig. 2c into the metatarsocuneiform joint, and a first guide slot 30b, fig. 1a spaced apart from the joint alignment slot 250 and parallel to the joint alignment slot fig. 3a such that, with the osteotomy guide positioned to align the joint alignment slot with the metatarsocuneiform joint, the first guide slot 30b is capable to guide a first cutter to cut a metatarsus of the metatarsocuneiform joint, to remove part of the metatarsus, wherein the osteotomy guide is configured to be fixed to at least one of the metatarsus and the cuneiform with one or more fixation elements 24, fig. 1a, further comprising a second guide slot 30a that is capable to guide a second cutter to cut a cuneiform of the metatarsocuneiform joint to remove part of the cuneiform when the osteotomy guide is positioned to align the joint alignment slot with the metatarsocuneiform joint, further comprising a one-piece guide body fig. 1a, 2 that defines the first and second guide slots and the joint alignment slot, further comprising at least one first bone fixation hole 362, fig. 3b that is positioned to be aligned with the metatarsus when the joint alignment feature is aligned with the metatarsocuneiform joint, further comprising at least one second bone fixation hole fig. 3d that is positioned to be aligned with the cuneiform when the joint alignment feature is aligned with the metatarsocuneiform joint, further comprising at least one indexing feature (see modified fig. 1b below) sized and shaped to abut a diaphysis of the metatarsus when the joint alignment feature slot is aligned with the metatarsocuneiform joint fig. 1b, wherein the at least one indexing feature comprises a first surface (see modified fig. 1b below) positioned to abut the diaphysis, and a second surface (see modified fig. 1b below) oriented nonparallel to the first surface and positioned to abut the diaphysis simultaneously with the first surface, wherein the first and second surfaces are planar surfaces fig. 1b.
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Lawrence fails to teach a feeler gauge sized to be inserted into the joint alignment slot, such that the feeler gauge is configured to align the joint alignment slot with the metatarsocuneiform joint.
Sanford teaches aperture 120, fig. 21 (joint alignment slot as claimed) is shaped complementary to the stem 112 of spacer 110, figs. 20-21 (feeler gauge as claimed) so that the stem 112 is slidably received in the aperture 120 but is prevented from rotating relative thereto (para. 26) such that the spacer 110 is configured to align the joint alignment slot 120 with the joint fig. 21.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the guiding system of Lawrence with a feeler gauge sized to be inserted into the joint alignment slot in view of Sanford in order to facilitating aligning the guide body with respect to the joint.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawrence in view of Sanford and further in view of Graham (US 20120095465).
Lawrence in view of Sanford fail to teach a guide body comprising an outward flare positioned to accommodate a medial protuberance of the cuneiform when the osteotomy guide is fixed to a medial side of at least one of the metatarsus and the cuneiform.
Graham teaches a guide body fig. 4 comprising an outward flare (the side of the guide body where hole 170 is located in fig. 4) where positioned to accommodate a medial protuberance of the cuneiform fig. 2 when the osteotomy guide is fixed to a medial side of at least one of the metatarsus and the cuneiform fig. 2.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the guide body of Lawrence in view of Sanford with an outward flare further in view of Graham for effectively accommodating the width of the cuneiform during fixation of the guide body on bones.
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claim(s) under Lawrence have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sanford.
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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775