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.
Claims 25-27, 34-35, and 39-43 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.
Claims 25, 34, and 43 all recite the limitation "the body" in lines 2, 2, and 1, respectively. This recitation is unclear, as it is not clear which body applicant is referring to. For examination purposes, the office will interpret each of these recitations to read “the body of the instrument”.
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 20 and 43-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hollis et al. (US 20220409248 A1) (hereon referred to as Hollis).
Regarding claim 20 (first interpretation), Hollis teaches a method comprising:
cutting a metatarsal bone (2) of a foot into a first metatarsal portion (2a) and a second metatarsal (2b) portion (see Para. [0078]);
inserting a stem portion (102) of an intramedullary implant (100) releasably connected to a body of an instrument (240) into a medullary canal (380) of the first metatarsal portion (2a) and positioning a plate portion (120) of the intramedullary implant (100) overlying the second metatarsal portion (2b);
inserting a pin (162) into the second metatarsal portion (2b);
using a bone positioning device (200) operatively connected to the body of the instrument to engage the pin (162) inserted into the second metatarsal portion (2b) and apply a force to the pin (162) to move the second metatarsal portion (2b) in at least a frontal plane (see Para. [0079]); and
inserting a fixation member (104) through a fixation aperture (130) extending through the plate portion (120) of the intramedullary implant (100) and into the second metatarsal portion (2b) to fixate a moved position of the second metatarsal portion relative to the first metatarsal portion (see Para. [0084]).
Regarding claim 44, Hollis teaches the method of claim 20, wherein: inserting the stem portion (102) of the intramedullary implant (100) into the medullary canal (380) of the first metatarsal portion (2a) comprises moving the body of the instrument (240) to insert the stem portion (102) of the intramedullary implant (100) into the medullary canal (380) of the first metatarsal portion (2a) and positioning the fixation aperture (130) extending through the plate portion (120) of the intramedullary implant (100) overlying the second metatarsal portion (2b; see Para. [0080]).
Regarding claim 45, Hollis teaches the method of claim 44 wherein inserting the stem portion (102) of the intramedullary implant (100) into the medullary canal (380) of the first metatarsal portion (2a) comprises inserting the stem portion (102) of the intramedullary implant (100) at an angle relative to a shaft of the first metatarsal portion (2a; see Para. [0084]) and further comprising pushing the plate portion (120) of the intramedullary implant (100) against a medial surface of the second metatarsal portion (see Para. [0071]) to
(i) move the second metatarsal portion (2b) laterally relative to the first metatarsal portion (see Para. [0082]) and
(ii) reduce the angle of the stem portion (120) of the intramedullary implant (100) relative to the shaft of the first metatarsal portion (2a; see Para. [0084]).
Regarding claim 46, Hollis teaches the method of claim 20, wherein inserting the fixation member (104) through the fixation aperture (130) extending through the plate portion (120) of the intramedullary implant (100) and into the second metatarsal portion (2b) comprises inserting at least two fixation members (404a, 404b) through at least two fixation apertures (430a, 430b) extending through the plate portion (120) of the intramedullary implant (100) and into the second metatarsal portion (2b; see Para. [0112], noting embodiments may be combined).
Regarding claim 47, Hollis teaches the method of claim 20, wherein inserting the fixation member (104) through the fixation aperture (130) extending through the plate portion (120) of the intramedullary implant (100) comprises guiding the fixation member (104) through a screw insertion aperture (246) of the instrument (240) co-axially aligned with the fixation aperture (130) extending through the plate portion of the intramedullary implant (see Para. [0080]).
Regarding claim 48, Hollis teaches the method of claim 20, further comprising inserting a fixation member (404b) through a fixation aperture (430b) extending through the stem portion (424) of the intramedullary implant (100) and into the first metatarsal portion (2a; see Para. [0093], noting that the second fixation aperture may be formed on stem portion 424, and Para. [0112], noting embodiments may be combined).
Regarding claim 20 (second interpretation), Hollis teaches a method comprising:
cutting a metatarsal bone (2) of a foot into a first metatarsal portion (2a) and a second metatarsal (2b) portion (see Para. [0078]);
inserting a stem portion (102) of an intramedullary implant (100) releasably connected to a body of an instrument (320) into a medullary canal (380) of the first metatarsal portion (2a) and positioning a plate portion (120) of the intramedullary implant (100) overlying the second metatarsal portion (2b);
inserting a pin (162) into the second metatarsal portion (2b);
using a bone positioning device (200) operatively connected to the body of the instrument to engage the pin (162) inserted into the second metatarsal portion (2b) and apply a force to the pin (162) to move the second metatarsal portion (2b) in at least a frontal plane (see Para. [0079]); and
inserting a fixation member (104) through a fixation aperture (130) extending through the plate portion (120) of the intramedullary implant (100) and into the second metatarsal portion (2b) to fixate a moved position of the second metatarsal portion relative to the first metatarsal portion (see Para. [0084]).
Regarding claim 43, Hollis teaches the method of claim 20, wherein the body of the instrument (320) is releasably connected to the intramedullary implant (100) with a longitudinal axis of the intramedullary implant positioned generally parallel to and offset from a longitudinal axis of the body (see Fig. 18 and Para. [0085]).
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.
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.
Claims 20-22, 25-28, 30-35, and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Woodard et al. (US 20200060690 A1) (hereon referred to as Woodard) in view of Hollis et al. (US 20220409248 A1) (hereon referred to as Hollis).
Woodard teaches a method comprising: cutting a metatarsal bone (60) of a foot into a first metatarsal portion (60p) and a second metatarsal (60d) portion (see Para. [0038]);
a body of an instrument (100) for placing into a medullary canal (formed by 550) of the first metatarsal portion (60p);
inserting a pin (440) into the second metatarsal portion (60d);
using a bone positioning device (400) operatively connected to the body of the instrument to engage the pin (440) inserted into the second metatarsal portion (60d) and apply a force to the pin (440) to move the second metatarsal portion (60d) in at least a frontal plane (see Paras. [0046-0047]) (claim 20),
wherein the body of the instrument (100) is positioned on a medial side of the first metatarsal portion and on the medial side of the second metatarsal portion (see Para. [0039]); and
using the bone positioning device (400) to apply the force to the pin (440) to move the second metatarsal portion (60d) in at least the frontal plane comprises applying a laterally-directed force to the pin to move the second metatarsal portion in at least the frontal plane (see Paras. [0046-0047]) (claim 21), wherein the bone positioning device (400) comprises a pin receiving body (415) operatively connected to the body of the instrument (500), and further comprising engaging the pin with the pin receiving body (see Paras. [0048-0049]) (claim 22),
wherein the bone positioning device (400) comprises an arm (300) connected to the body of the instrument (100), a shaft (420) operably connected to the arm (300), and the pin receiving body (415) operatively connected to the shaft (420, see Para. [0040]) (claim 25),
wherein using the bone positioning device (400) to apply the force to the pin (440) to move the second metatarsal portion (60d) in at least a frontal plane comprises moving the shaft (20) relative to the arm and thereby moving the pin receiving body (see Paras. [0046-0047]) (claim 26),
wherein the arm (300) is detachably connected to the body of the instrument (100), and the arm extends in a dorsal direction from the body (see Fig. 5B) and the shaft (420) extends in a lateral direction from the arm (see Para. [0039]) (claim 27),
wherein the first metatarsal portion (60p) is a proximal metatarsal portion and the second metatarsal portion (60d) is a distal metatarsal portion (see Para. [0027]) (claim 28),
wherein inserting the pin (440) into the second metatarsal portion (60d) comprises inserting the pin (440) extending generally perpendicularly relative to a longitudinal axis of the second metatarsal portion (see Fig. 3A) (claim 30),
wherein inserting the pin (440) into the second metatarsal portion (60d) comprises inserting the pin (440) extending dorsally from the second metatarsal portion (see Fig. 3A) (claim 31),
wherein cutting the bone of the foot into the first metatarsal portion (60p) and the second metatarsal portion (60d) comprises:
attaching a cut guide (200) proximal of a target cut location (210) on the metatarsal bone (60) and distal of the target cut location (see Para. [0037]); and
guiding a cutting instrument with the cut guide (200) to cut the metatarsal bone (60) at the target cut location (210; see Para. [0038]) (claim 32),
wherein attaching the cut guide (200) proximal of the target cut location (210) on the metatarsal bone (60) and distal of the target cut location (210) comprises inserting a proximal fixation pin (130) through a proximal pin receiving aperture of the cut guide and inserting that pin that is a distal fixation pin (130) through a distal pin receiving aperture of the cut guide (see Para. [0037], describing the use and configuration of pins), and further comprising, after cutting the metatarsal bone (60) of the foot into the first metatarsal portion (60p) and the second metatarsal portion (60d), removing the cut guide (200) from the first metatarsal portion (60p) and the second metatarsal portion (60d) while leaving the pin inserted into the second metatarsal portion (see Para. [0038] and Fig. 2B) (claim 33),
wherein the bone positioning device (400) comprises an actuator (420) operable to move the pin receiving body (415) relative to the body of the instrument (100), wherein using the bone positioning device (400) to apply the force to the pin to move the second metatarsal portion (60d) in at least the frontal plane comprises actuating the actuator (see Para. [0047]) (claim 34),
wherein the actuator (420) comprises a rotatable knob and/or screw drive (see Para. [0040]) (claim 35),
wherein the arm (300) is positioned at an end of the shaft (420, see Fig. 4A) (claim 39),
wherein the arm (300) defines an arcuate shape (see arcuate shape shown in Fig. 3C) and the shaft is configured to move along an arc defined by the arcuate shape (see Para. [0051]) (claim 40),
wherein the pin receiving body (415) is hingedly connected to the arm (300; note that a hinge is a pin with multiple plate connectors surrounding it, which is satisfied by the shaft 420 connecting arm 300 with body 415) (claim 41),
wherein the shaft (420) comprises a threaded shaft (see Para. [0040]) (claim 42),
However fails to teach inserting a stem portion of an intramedullary implant into the medullary canal of the first metatarsal portion and positioning a plate portion of the intramedullary implant overlying the second metatarsal portion; and inserting a fixation member through a fixation aperture extending through the plate portion of the intramedullary implant and into the second metatarsal portion to fixate a moved position of the second metatarsal portion relative to the first metatarsal portion.
Hollis teaches a method comprising:
cutting a metatarsal bone (2) of a foot into a first metatarsal portion (2a) and a second metatarsal (2b) portion (see Para. [0078]);
inserting a stem portion (102) of an intramedullary implant in the first metatarsal portion (2a) and positioning a plate portion (120) of the intramedullary implant (100) overlying the second metatarsal portion (2b); and
inserting a fixation member (104) through a fixation aperture (130) extending through the plate portion (120) of the intramedullary implant (100) and into the second metatarsal portion (2b) to fixate a moved position of the second metatarsal portion relative to the first metatarsal portion (see Para. [0084]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Woodard to include the implant and step of implanting the same as taught by Hollis, as this is required by Woodard’s method, although a variation of implant configurations is envisioned (see Para. [0027]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Woodard in view of Hollis.
Woodard teaches the method as outlined in the rejection of claim 20 above, and Hollis teaches the intramedullary implant as outlined in the rejection of claim 20 above, however the combination of the two fails to teach wherein the pin has a diameter of at least 2.0 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a pin diameter of at least 2.0 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Allowable Subject Matter
Claims 23, 24, and 36-38 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.
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claim 23. In particular, none of the cited references teach or suggest wherein the pin receiving body comprises a plurality of teeth arrayed in a row defining a plurality of grooves between adjacent pairs of teeth, and engaging the pin with the pin receiving body comprises positioning the pin in one of the plurality of grooves as required by claim 23.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773