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 the election/restriction in the reply filed on November 10, 2025 is acknowledged.
Applicant has elected Group I: Claims 1-24, drawn to a method of performing a minimally invasive metatarsal correction procedure.
Claims 25-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 10, 2025.
Claims 1-31 are presently pending in this application.
Examiner’s Note
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.
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, 3, 8, 9, 11, 12, and 22-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bays et al. (US 2017/0079669), herein referred to as Bays.
Regarding claim 1, Bays discloses a method of performing a minimally invasive metatarsal correction procedure (¶4), the method comprising positioning at least one guide surface (18, 20) of a bone preparation guide (12) over a metatarsal (50) and/or a cuneiform (52) of a patient to be prepared (figure 3A), wherein the at least one guide surface (18, 20) has a length extending from a first end (figure 1) to a second end (figure 1), and the length of the at least one guide surface (18, 20) is less than a diameter of the metatarsal (50) and/or the cuneiform (52) to be prepared (figure 3A), guiding a bone preparation instrument (e.g. saw, ¶31) along the at least one guide surface (18, 20) to prepare an end of the metatarsal (50) and/or an end of the cuneiform (52) (¶31), wherein guiding the bone preparation instrument (e.g. saw, ¶31) along the at least one guide surface (18, 20) comprises translating the bone preparing instrument (e.g. saw, ¶31, ¶57) along the length of the at least one guide surface (18, 20) and angling the bone preparation instrument (e.g. saw, ¶31, ¶57) beyond one or both of the first end and the second end of the at least one guide surface (18, 20) to prepare the end of the metatarsal (50) and/or the end of the cuneiform (52) beyond one or both of the first end and the second end of the at least one guide surface (18, 20), moving the metatarsal (50) relative to the cuneiform (52) (¶102), and fixating a moved position of the metatarsal (50) (figure 3A).
Regarding claim 3, Bays discloses wherein the bone preparation guide (12) has a first sidewall (figure 1) defining the first end of the at least one guide surface (18, 20) and a second sidewall (figure 1) defining the second end of the at least one guide surface (18, 20).
Regarding claim 8, Bays discloses wherein the bone preparation guide (12) comprise a body (figure 1) defining the at least one guide surface (18, 20), a first arm (42) extending outwardly from the body (figure 1), and a second arm (40) extending outwardly from the body (figure 1), the first arm (42) defining a first fixation hole (considered wherein element 48 is situated in) (figure 1) and the second arm (40) defining a second fixation hole (considered wherein element 46 is situated in) (figure 1), and further comprising positioning the first fixation hole (considered wherein element 48 is situated in) over the metatarsal (50) (figure 3A) and inserting a first fixation pin (48) through the first fixation hole (figures 1 and 3A) and percutaneously into the metatarsal (50) (figure 3A), and positioning the second fixation hole (considered wherein element 46 is situated in) (figure 1) over the cuneiform (52) and inserting a second fixation pin (46) through the second fixation hole (figures 1 and 3A) and percutaneously into the cuneiform (52) (figure 3A).
Regarding claim 9, Bays discloses wherein positioning the first fixation hole (considered wherein element 48 is situated in) (figure 1) over the metatarsal (50) (figure 3A) and positioning the second fixation hole (considered wherein element 46 is situated in) (figure 1) over the cuneiform (52) comprises positioning the first fixation hole (considered wherein element 48 is situated in) and the second fixation hole (considered wherein element 46 is situated in) offset from a skin of the patient (figure 3A).
Regarding claim 11, Bays discloses further comprising making an incision through a skin of the patient (¶5, ¶6) and inserting the body of the bone preparation guide (12) into the incision (figure 3A), wherein the body defines a third fixation hole (44) (figure 1), and further comprising inserting a third fixation pin (¶34) through the third fixation hole (44) of the body inserted into the incision (¶34 and figure 3A) and into an underlying bone (¶34 and figure 3A).
Regarding claim 12, Bays discloses wherein the at least one guide surface (18, 20) comprise a first guide surface (20) and a second guide surface (18) separated from the first guide surface (20) (figure 1), positioning at least one guide surface of the bone preparation guide (12) over the metatarsal (50) and/or the cuneiform (52) of the patient (figure 3A) to be prepared comprises positioning the first guide surface (20) over the metatarsal (50) and positioning the second guide surface (18) over the cuneiform (52) (figure 3A), and guiding the bone preparation instrument (e.g. saw, ¶31, ¶57) along the at least one guide surface (18, 20) comprises guiding the translating the bone preparing instrument (e.g. saw, ¶31, ¶57) along the length of the first guide surface (20) and angling the bone preparation instrument (e.g. saw, ¶31, ¶57) beyond one or both of the first end and the second end of the first guide surface (20) to prepare the end of the metatarsal (50) and translating the bone preparing instrument (e.g. saw, ¶31, ¶57) along the length of the second guide surface (18) and angling the bone preparation instrument (e.g. saw, ¶31, ¶57) beyond one or both of the first end and the second end of the second guide surface to prepare the end of the cuneiform (52) (figure 3A).
Regarding claim 22, Bays discloses wherein positioning the at least one guide surface (18, 20) of the bone preparation guide (12) over the metatarsal (50) and/or the cuneiform (52) further comprises inserting a spacer (14) into a tarsometatarsal joint (“TMT”) between the metatarsal (50) and cuneiform (52) (figure 2B), the spacer (14) extends from a proximal end (figure 2A) to a distal end (figure 2A) and includes an outwardly extending protrusion (62) on a proximal portion of the spacer (14) that defines a tissue retraction space (figure 2A), and inserting the spacer (14) into the tarsometatarsal joint (“TMT”) between the metatarsal (50) and cuneiform (52) comprises positioning tissue of the patient in the tissue retraction space (figure 2B).
Regarding claim 23, Bays discloses wherein the bone preparation guide (12) comprise a body (figure 1) defining the at least one guide surface (18, 20), the body (figure 1) defines a bottom surface (figure 1), a sidewall (figure 1), and an angled surface (figure 1) connecting the bottom surface (figure 1) to the sidewall (figure 1), the angled surface (figure 1) deflecting tissue of the patient (figure 3A).
Regarding claim 24, Bays discloses wherein moving the metatarsal (50) relative to the cuneiform (52) comprises moving the metatarsal (50) after preparing one or both of the end of the metatarsal (50) and the end of the cuneiform (52), and further comprising, after moving the metatarsal (50) relative to the cuneiform (52), compressing (¶106) a prepared end of the metatarsal (50) and a prepared end of the cuneiform (52) together.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bays (US 2017/0079669).
Regarding claim 2, Bay’s method discloses all the features/elements as claimed but lacks a detailed description on wherein the length of the at least one guide surface is within a range from 10 cm to 20 cm.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bay’s method with wherein the length of the at least one guide surface is within a range from 10 cm to 20 cm, since such a modification such a modification is considered optimization of the size of the prior art.
Claim(s) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bays (US 2017/0079669) in view of May et al. (US 2021/0038212), herein referred to as May.
Regarding claim 18, Bay’s method discloses all the features/elements as claimed but lacks further comprising, prior to positioning the at least one guide surface of the bone preparation guide over the metatarsal and/or the cuneiform, inserting a biplanar tissue release instrument at a proximal-lateral comer of the metatarsal to release soft tissue at the proximal-lateral comer of the metatarsal.
However, May teaches prior to positioning the at least one guide surface of a bone preparation guide (¶43) over a metatarsal (¶43) and/or a cuneiform, inserting a biplanar tissue release instrument (10) (figure 5A) at a proximal-lateral comer (¶40) of the metatarsal to release soft tissue (¶43) at the proximal-lateral comer of the metatarsal (¶43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bay’s method with prior to positioning the at least one guide surface of the bone preparation guide over the metatarsal and/or the cuneiform, inserting a biplanar tissue release instrument at a proximal-lateral comer of the metatarsal to release soft tissue at the proximal-lateral comer of the metatarsal as taught by May, since such an instrument can be used as part of a bone positioning technique to correct an anatomical misalignment of a bone or bones (¶30).
Regarding claim 19, the modified Bay’s method has wherein the bi-planar tissue release instrument (10 of May) comprises a first cutting body (12 of May) joined to a second cutting body (14 of May) at an angle (figure 5A of May), and inserting the bi-planar tissue release instrument (10 of May) at the proximal-lateral comer (¶40 of May) of the metatarsal (¶43 of May) comprises inserting the first cutting body (12 of May) in a tarsometatarsal joint (“TMT”, ¶93 of May) between the metatarsal (¶93 of May) and cuneiform (¶93 of May) and inserting the second cutting body (14 of May) between the metatarsal (¶93 of May) and an adjacent metatarsal (¶93 of May).
Regarding claim 20, the modified Bay’s method has wherein the first cutting body (12 of May) has a length (figure 5A of May) extending from a proximal end (figure 5A of May) to a distal end (figure 5A of May), the second cutting body (14 of May) has a length (figure 5A of May) extending from a proximal end (figure 5A of May) to a distal end (figure 5A of May), and the distal end of the first cutting body (12 of May) and the distal end of the second cutting body (14 of May) are each angled inwardly to define a groove (figure 5A of May) therebetween.
Regarding claim 21, the modified Bay’s method has wherein the first cutting body (12 of May) has a length (figure 5A of May) extending from a proximal end (figure 5A of May) to a distal end (figure 5A of May), the second cutting body (14 of May) has a length (figure 5A of May) extending from a proximal end (figure 5A of May) to a distal end (figure 5A of May), the bi-planar tissue release instrument (10 of May) further comprises a handle (44 of May) connected to the proximal end of the first cutting body (12 of May) and to the proximal end of the second cutting body (14 of May), and the bi-planar tissue release instrument (10 of May) defines an opening (figure 5A of May) at the proximal end of the first cutting body (12 of May) and the proximal end of the second cutting body (14 of May) where the first cutting body (12 of May) is joined to the second cutting body (14 of May) to define the angle (figure 5A of May).
Allowable Subject Matter
Claims 4-7, 10, and 13-17 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.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775