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 Invention II (claims 14-29) in the reply filed on December 31, 2025 is acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 31, 2025.
Applicant’s election without traverse of Implant Species B (Figs. 13D-G) in the reply filed on December 31, 2025 is acknowledged.
Applicant's election with traverse of Instrument Species F (Figs. 34A-C) in the reply filed on December 31, 2025 is acknowledged. The traversal is on the ground(s) that Species G through Species N should be grouped with Species F because of the relationship between Figs. 34A-C and the aforementioned non-elected species as stated in the specification (see pgs. 4-6 of Applicant’s Remarks). This is not found persuasive because the aforementioned non-elected species are different configurations of the instrument as a whole, wherein the different configurations are achieved by adding and/or removing parts of the instrument.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (such as, for example, Species K), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 31, 2025.
Claim 25 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (such as, for example, Species H), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 31, 2025.
Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (such as, for example, Species I), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 31, 2025.
Claims 14-19, 24, and 27-29 have been examined.
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 14-17, 19, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maestro et al. (US 2022/0296285 A1).
Claim 14. Maestro discloses a method comprising:
cutting a metatarsal bone (metatarsal M) of a foot into a first metatarsal portion (diaphysis 1) and a second metatarsal portion (head 2) (see para. 0174, which states that rectilinear cut D is made in metatarsal M) (see Fig. 1a);
inserting a stem portion (keel 4 and intermediate portion 6) of an intramedullary implant (implant 3) releasably connected to a body (frame 101 and body 102, which includes the portion of tool 10 extending parallel to implant 3 and also the portion of tool 10 extending perpendicular to implant 3 and in contact with plate 5) of an instrument (tool 10) and an intramedullary insertion body (wire B’) connected to the body of the instrument into a medullary canal of the first metatarsal portion (see Fig. 21);
positioning a plate portion (plate 5) of the intramedullary implant overlying the second metatarsal portion (see Fig. 21);
moving the intramedullary insertion body relative to the intramedullary implant to apply a force to the first metatarsal portion (see Figs. 21-22, which show movement of distal end 1015 relative to the remainder of tool 10 such that wire B’ moves relative to implant 3); and
inserting a fixation member (screw 9) through a fixation aperture (hole 52) 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 (see Figs. 21-22).
Claim 15. Maestro discloses wherein moving the intramedullary insertion body relative to the intramedullary implant to apply the force comprises pulling the first metatarsal portion toward the body of the instrument (diaphysis 1 is pulled toward the portion of tool 10 extending perpendicular to implant 3 and in contact with plate 5) while the plate portion of the intramedullary implant pushes against the second metatarsal portion (plate 5 pushes against head 2 due to the presence of screws 9) (see Fig. 22).
Claim 16. Maestro discloses wherein moving the intramedullary insertion body relative to the intramedullary implant to apply the force to the first metatarsal portion comprises pushing the plate portion of the intramedullary implant against the second metatarsal portion to move the second metatarsal portion laterally in a transverse plane (plate 5 pushes against head 2 due to the presence of screws 9) (see Fig. 22).
Claim 17. Maestro discloses wherein the intramedullary implant is releasably connected to the body at a fixed position relative to the body (see Fig. 21, which shows that wire B’ corresponds in size to orifice 1014 in frame 101, and thus wire B’ is in fixed position relative to frame 101), the intramedullary insertion body is movable relative to the intramedullary implant connected at the fixed position (see Figs. 21-22), and moving the intramedullary insertion body relative to the intramedullary implant to apply the force comprises moving the intramedullary insertion body relative to the intramedullary implant connected at the fixed position (see Figs. 21-22).
Claim 19. Maestro discloses wherein the intramedullary implant is releasably connected to the body of the instrument (via securing rod 1022 as stated in para. 0251) with a longitudinal axis (longitudinal axis 41) of the intramedullary implant positioned parallel to the intramedullary insertion body (see Fig. 21, which shows that longitudinal axis 41 extends through wire B’; note that the claim does not require that the longitudinal axis of the intramedullary implant be positioned parallel to the longitudinal axis of the intramedullary insertion body).
Claim 27. Maestro discloses inserting a fixation member (screw 8) through a fixation aperture (hole 43 in keel 4) extending through the stem portion of the intramedullary implant and into the first metatarsal portion (see Fig. 24).
Claim 28. Maestro discloses wherein the fixation aperture extending through the stem portion comprises a fixation aperture located in a proximal-most half of the stem portion (see Fig. 21; note that the claim does not define proximal or distal with respect to any components of the instrument or implant, with respect to any anatomical structures of the patient, or with respect to the surgeon, and thus keel 4 can be considered to be the proximal-most half of the stem portion).
Claim 29. Maestro discloses wherein the first metatarsal portion is a proximal metatarsal portion and the second metatarsal portion is a distal metatarsal portion (see Fig. 21; note that the claim does not define proximal or distal with respect to any components of the instrument or implant, with respect to any anatomical structures of the patient, or with respect to the surgeon, and thus diaphysis 1 can be considered to be a proximal metatarsal portion and head 2 can be considered to be a distal metatarsal portion).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Maestro et al. (US 2022/0296285 A1) in view of Pech et al. (US 2009/0036931 A1).
Claim 24. Maestro discloses wherein the body comprises an intramedullary implant receiving surface (surface of body 102 in contact with plate 5 as shown in Fig. 21) against which the intramedullary implant is configured to positioned (see Fig. 21) and releasably connected (via securing rod 1022 as stated in para. 0251)
Maestro fails to disclose wherein the intramedullary implant receiving surface comprises a hook wrapping at least partially about a thickness of the plate portion of the intramedullary implant (claim 24).
Pech teaches an instrument (insertion aid 18 as shown in Figs. 4-5) having a body, wherein the body comprises an intramedullary implant receiving surface (bottom face 19 and recess 20) against which an intramedullary implant (bone plate 1 as shown in Figs. 1a and 4) is configured to be positioned (see para. 0056, which states that recess 20 receives bearing portion 20) and releasably connected (via fixing screw 30 as shown in Figs. 7a-7c), wherein the intramedullary implant receiving surface comprises a hook (defined by the shape of recess 20 and bottom face 19 as shown in Fig. 5) wrapping at least partially about a thickness of a plate portion (bearing portion 2) of the intramedullary implant (see para. 0056, which states that the shape of recess 20 is congruent to bearing portion 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Maestro such that the intramedullary implant receiving surface is configured similar to that of Pech, wherein the intramedullary implant receiving surface includes a recess having a shape congruent to the shape of the plate portion of the intramedullary implant such that the intramedullary implant receiving surface comprises a hook wrapping at least partially about a thickness of the plate portion of the intramedullary implant (claim 24), as such a complementary shape between the intramedullary receiving surface and the plate portion would allow for a more secure fit between the instrument and the intramedullary implant.
Allowable Subject Matter
Claim 18 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.
The following is a statement of reasons for the indication of allowable subject matter: Maestro fails to disclose inserting the stem portion (keel 4 and intermediate portion 6) and the intramedullary insertion body (wire B’) into the medullary canal with the intramedullary insertion body positioned adjacent to the intramedullary implant (implant 3) and moving the intramedullary insertion body and the intramedullary implant away from each other. Instead, Maestro teaches that the intramedullary insertion body and the intramedullary implant are moved toward each other (see Figs. 22-23). Korman (US 2022/0401139 A1) teaches inserting an intramedullary insertion body (IM hook 113) connected to an instrument (system 100) into a medullary canal of a first metatarsal portion (proximal fragment 710) (Figs. 10-19), wherein the intramedullary insertion body is configured similar to Applicant’s intramedullary insertion body (intramedullary insertion body 306 – see Figs. 34A-C), but fails to teach the use of the intramedullary insertion body in conjunction with an intramedullary implant and therefore fails to teach moving the intramedullary insertion body and the intramedullary implant away from each other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Prosecution Insights