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
As noted in the interview summary mailed 11/24/2025, the office has agreed to rejoin Species Groups IV-X. In keeping with this agreement, applicant’s election without traverse of Claim Group II and Species Groups IV-X in the reply filed on 11/24/2025 is acknowledged.
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 31 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.
Claim 31 recites the limitation "the intramedullary implant insertion and bone positioning instrument" in line 1. There is insufficient antecedent basis for this limitation in the claim. No intramedullary implant insertion and bone positioning instrument is introduced prior to this recitation in claim 31 or claim 21, upon which claim 31 depends. For examination purposes, the claim will be interpreted to read, “further comprising a intramedullary implant insertion and bone positioning instrument which”.
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 21-34 and 38-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bregman et al. (US 20220354513 A1) (hereon referred to as Bregman).
Regarding claim 21, Bregman teaches a method comprising:
cutting a metatarsal bone of a foot into a first metatarsal portion (22c) and a second metatarsal portion (22a; see Para. [0031]);
inserting a stem portion (54) of an intramedullary implant (52) into the first metatarsal portion and positioning a fixation aperture (62) extending through a plate portion of the intramedullary implant overlying the second metatarsal portion (see Paras. [0033-0044]);
using a bone positioning device (consisting of 100 and 71) releasably connected to the intramedullary implant (52) to move the second metatarsal portion (22a) relative to the first metatarsal portion (22c) in at least one plane (see Para. [0039]); and
inserting a fixation member (76) through the fixation aperture (62) extending through the plate portion of the intramedullary implant (52) and into the second metatarsal portion (22a) to fixate a moved position of the second metatarsal portion (22a) relative to the first metatarsal portion (22c; see Para. [0100]).
Regarding claim 22, Bregman teaches the method of claim 21, wherein:
the bone positioning device (100) comprises an intramedullary implant insertion and bone positioning instrument (64);
inserting the stem portion (54) of an intramedullary implant (52) into the first metatarsal portion (22c) comprises, with the intramedullary implant (52) releasably connected to the intramedullary implant insertion and bone positioning instrument (64), moving the intramedullary implant insertion and bone positioning instrument (64) to insert the stem portion (54) of the intramedullary implant (42) into the first metatarsal portion (see Para. [0090]); and
positioning the fixation aperture (62) of the intramedullary implant (52) overlying the second metatarsal portion (22a) comprises, with the intramedullary implant (52) releasably connected to the intramedullary implant insertion and bone positioning instrument (64), moving the intramedullary implant insertion and bone positioning instrument (64) to position the fixation aperture of the intramedullary implant (52) overlying the second metatarsal portion (see Para. [0090]).
Regarding claim 23, Bregman teaches the method of claim 22, wherein:
moving the intramedullary implant insertion and bone positioning instrument (64) to insert the stem portion (54) of the intramedullary implant (52) into the first metatarsal portion (22c) comprises inserting the stem portion (54) of the intramedullary implant (52) at an angle relative to a shaft of the first metatarsal portion (see Para. [0102] and Fig. 10B); and
moving the intramedullary implant insertion and bone positioning instrument (64) to position the fixation aperture (62) of the intramedullary implant overlying the second metatarsal portion (22a) comprises pushing the plate portion of the intramedullary implant (52)_ against a medial surface of the second metatarsal portion (see Para. [0089]) to
(i) move the second metatarsal portion laterally relative to the first metatarsal portion (see Para. [0089]) and
(ii) reduce the angle of the stem portion of the intramedullary implant relative to the shaft of the first metatarsal portion (see Para. [0102]).
Regarding claim 24, Bregman teaches the method of claim 21, wherein using the bone positioning device (100) releasably connected to the intramedullary implant (52) to move the first metatarsal portion relative to the second metatarsal portion in at least one plane comprises applying a force between a contact surface of the bone positioning device and a bone portion underlying the contact surface (see Para. [0089]).
Regarding claim 25, Bregman teaches the method of claim 24, wherein the bone portion underlying the contact surface is the first metatarsal portion (see Para. [0089]).
Regarding claim 26, Bregman teaches the method of claim 21, wherein using the bone positioning device (100) releasably connected to the intramedullary implant (52) to move the first metatarsal portion relative to the second metatarsal portion in at least one plane comprises applying a force to move the second metatarsal portion in a transverse plane for treating a bunion deformity (see Para. [0089] and Fig. 10A).
Regarding claim 27, Bregman teaches the method of claim 21, wherein using the bone positioning device (100) releasably connected to the intramedullary implant (52) to move the first metatarsal portion relative to the second metatarsal portion in at least one plane comprises applying a force in a direction generally perpendicular to a length of the intramedullary implant (shown in Figs. 9-10B).
Regarding claim 28, Bregman teaches the method of claim 21, wherein using the bone positioning device (100) to move the second metatarsal portion relative to the first metatarsal portion in at least one plane comprises shifting the second metatarsal portion laterally in a transverse plane (shown in Figs. 9-10B) and rotating the second metatarsal portion in a frontal plane (see Para. [0094]).
Regarding claim 29, Bregman teaches the method of claim 21, wherein:
the bone positioning device (100) comprises a body (110) extending from a first end (120) to a second end (130), a contact surface (124) positioned extending beyond an end of the intramedullary implant (see Fig. 12A), and a shaft (36) operatively connected to the contact surface (see Fig. 12A); and
using a bone positioning device (100) releasably connected to the intramedullary implant (52) to move the second metatarsal portion (22b) relative to the first metatarsal portion (22a) in at least one plane comprises moving the shaft (36) relative to the body (110) to move the contact surface (124) against an underlying bone portion (see Para. [0078]).
Regarding claim 30, Bregman teaches the method of claim 21, wherein the first metatarsal portion (22a) is a proximal metatarsal portion and the second metatarsal portion (22b) is a distal metatarsal portion (see Para. [0072]).
Regarding claim 31, Bregman teaches the method of claim 21, further comprising a intramedullary implant insertion and bone positioning instrument (64) which comprises a body that releasably connects (via 58) to the intramedullary implant (52) with a longitudinal axis of the stem portion (54) of the intramedullary implant (52) positioned generally parallel to and offset from a longitudinal axis of the body (see labelled diagram of Fig. 11C below).
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Regarding claim 32, Bregman teaches the method of claim 26, wherein the force is laterally directed (see Para. [0089]).
Regarding claim 33, Bregman teaches the method of claim 21, wherein cutting the metatarsal bone of the foot into the first metatarsal portion and the second metatarsal portion (see Para. [0089]) comprises:
attaching a cut guide (38) proximal of a target cut location on the metatarsal bone and distal of the target cut location (see Para. [0081]); and
guiding a cutting instrument (50) with the cut guide (38) to cut the metatarsal bone at the target cut location (see Para. [0087]).
Regarding claim 34, Bregman teaches the method of claim 33, wherein attaching the cut guide (38) proximal of the target cut location on the metatarsal bone and distal of the target cut location comprises inserting a proximal fixation pin (48) through a proximal pin receiving aperture (46) of the cut guide (38) and inserting a distal fixation pin (48) through a distal pin receiving aperture (46) of the cut guide, and further comprising, after cutting the metatarsal bone of the foot into the first metatarsal portion and the second metatarsal portion, removing the cut guide from the first metatarsal portion and the second metatarsal portion while leaving at least the distal fixation pin inserted into the second metatarsal portion (see Para. [0087]).
Regarding claim 38, Bregman teaches the method of claim 21, wherein inserting the fixation member (76) through the fixation aperture (62) extending through the plate portion of the intramedullary implant (52) and into the second metatarsal portion (22a) comprises inserting at least two fixation members (70, 76) through at least two fixation apertures (60, 62) extending through the plate portion of the intramedullary implant (52) and into the second metatarsal portion (22a).
Regarding claim 39, Bregman teaches the method claim 21, wherein inserting the fixation member (76) through the fixation aperture (62) extending through the plate portion of the intramedullary implant (52) comprises guiding the fixation member (76) through a screw insertion aperture (71) of the bone positioning device (100 and 71) co-axially aligned with the fixation aperture (62) extending through the plate portion of the intramedullary implant (see Para. [0100]).
Regarding claim 40, Bregman teaches the method of claim 39, wherein:
the bone positioning device (consisting of 100 and 71) comprises a body (72) connected to a shaft (75) configured to control positioning of a contact surface relative to the body (see Para. [0100]), and a detachable guide body (71) couplable to the body (72); and
the detachable guide body (72) defines the screw insertion aperture of the bone positioning device (100 and 71) co-axially aligned with the fixation aperture (62) extending through the plate portion of the intramedullary implant (52).
Regarding claim 41, Bregman teaches the method of claim 21, further comprising inserting a fixation member (70) through a fixation aperture (60) extending through the stem portion (54) of the intramedullary implant (52) and into the first metatarsal portion (see Para. [0091]).
Regarding claim 42, Bregman teaches the method of claim 41, wherein:
the bone positioning device (consisting of 100 and 71) comprises a body (71) connected to a shaft (72) configured to control positioning of a contact surface relative to the body (see Para. [0100]);
the body comprises a screw insertion aperture (inside 71) positioned co-axially aligned with the fixation aperture extending through the stem portion of the intramedullary implant (see Fig. 13A); and
inserting the fixation member (70) through the fixation aperture (60) extending through the stem portion (54) of the intramedullary implant (52) and into the first metatarsal portion (22c) comprises guiding the fixation member co-axially through the screw insertion aperture of the body (see Para. [0100-0101]).
Regarding claim 43, Bregman teaches the method of claim 21, wherein:
the stem portion (54) of the intramedullary implant (52) comprises a screw aperture (60);
the bone positioning device (consisting of 100 and 71) comprises a body (71) connected to a shaft (72) configured to control positioning of a contact surface relative to the body (see Para. [0100]); and
the body (71) is releasably connected to the intramedullary implant (52) with an attachment rod (70) inserted through a screw insertion aperture of the body (see Fig. 13A) and the attachment rod (70) being threadingly engaged with the screw aperture (60) of the intramedullary implant (see Para. [0092]).
Allowable Subject Matter
Claim 35 is 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773