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 .
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.
Election/Restrictions
The preamble of new claims 23-26 is “a metatarsal implant for use in a surgical kit,” while the body of the claim recites specific features included in the metatarsal kit, including a metatarsal guide tool and metatarsal saw guide. Thus, the claim is indefinite because it is unclear if the claim is intended to be directed to the scope of just the metatarsal implant for use in a surgical kit or includes further requirement of features of the metatarsal surgical kit. For purposes of examination, it is assumed Applicant is seeking coverage for the surgical kit (i.e., requires amended preamble for clarity) because independent claim 23 does not include any limitations with respect to the metatarsal implant, itself, beyond what is already recited and being examined with respect to independent clam 1. The difference between independent claims 1 and 23 is recitations with respect to the surgical kit.
Restriction requirement mailed June 20, 2025 restricted at least, but not exclusively, between the elected metatarsal implant of Group I and a surgical kit including the metatarsal implant, namely Group II. For at least the reasons discussed above, new claims 23-26 appear to be drawn to and for purposes of examination are considered to be drawn to non-elected Group II. Thus, claims 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 18, 2025. The restriction requirement was made final in the non-final rejection mailed September 8, 2025, as acknowledged by Applicant.
Response to Arguments
Applicant’s arguments, see amendment and remarks, filed November 21, 2025, with respect to rejection of claims 1-3 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 1-3 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed November 21, 2025 have been fully considered, but they are not persuasive. Applicant argues that Montross et al. U.S. publication no. 2021/0059829 A1 (“Montross”) in view of Bake et al. U.S. publication no. 2019/0328548 A1 (“Bake”) fails to teach or suggest the newly amended claim limitation “the contour curvature of the articulating surface of the metatarsal implant corresponds to the curvature of the simulated healthy articulating surface of the metatarsal head and extends to interact with sesamoid bones in the metatarsophalangeal joint.” In particular, Applicant identifies one sentence in paragraph [0032] of Montross and, by misconstruing the sentence, alleges that Montross teaches against the newly recited claim limitation. In particular, Applicant misconstrues Montross’ recitation that the implant does “not interfere” with the sesamoid apparatus to necessarily mean that Montross “avoids interaction with sesamoid bones” and further alleges that Montross would have to be “modified” to meet the limitations contained within the amended claims.
However, contrary to Applicant’s remarks, paragraph [0032] of Montross and all other teachings found within Montross fail to support any argument that the invention of Montross “avoids interaction with sesamoid bones” and/or that Montross would have to be “modified” in any way to meet the limitations contained within the amended claims. While paragraph [0032] of Montross is directed to an object of the invention including an implant that does not undesirably “interfere with the sesamoid apparatus,” other paragraphs of Montross (e.g., including at least paragraphs [0045], [0051] and [0058]) show that the invention of Montross avoids undesired “interference” between the implant and sesamoid bones by “freeing up the sesamoids” (as described in at least paragraph [0045]) and/or by configuring and implanting the implant in such a way that the metatarsal bone is not undesirably shortened during the surgical procedure (e.g., see at least paragraph [0058]). Not only does Applicant’s remarks misconstrue the Montross disclosure, but also the misconstrued interpretation goes against express teaching of Montross, namely that it is desirable to configure the implant and use it in such a way that the implant is to “allow the sesamoids to glide onto the implant, thereby desirably not being “jammed” by the implant” (e.g., see at least paragraph [0051]). Thus, by reading paragraph [0032] within the context of reference (including paragraphs [0045], [0051] and [0058] thereof), it is clear that the implant of Montross does “not interfere” with the sesamoid apparatus, but rather “allows the sesamoids to glide onto the implant” or has an extension of the articulating surface that “interacts with the sesamoid bones” substantially as claimed. Finally, it is noted that the features of an extending portion of the articular surface that interact with the sesamoid bone in the metatarsophalangeal joint, as found in the specification, upon which Applicant’s amendment relies are not recited in the rejected claim(s) with the same scope as described in Applicant’s specification. For example, the claim broadly requires a portion of an articular surface to “interact with sesamoid bones,” while Applicant’s filed specification specifies features that “…also extends far enough to always interact with the sesamoid bones, even when the toe is
straight. In this way, full account is taken of the sesamoid bones, which move around the metatarsal head as the toe is bent…” (filed specification page 11). Thus, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, Applicant’s arguments are not persuasive, and the rejection is maintained.
Applicant fails to particularly point out any supposed errors with respect to the non-statutory double patenting rejection. The non-statutory double patenting rejection is maintained.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Montross et al. U.S. publication no. 2021/0059829 A1 (“Montross”) in view of Bake et al. U.S. publication no. 2019/0328548 A1 (“Bake”).
Regarding claim 1, under a first interpretation Montross discloses a metatarsal implant (200- figures 3A-3H; 600-figures 6A-6E; seq. or the like) for repairing damage in a metatarsophalangeal joint of a patient (figures 3A-3H and 6A-6E), the metatarsal implant (200, 600, seq.) being adapted to be attached to an implant receiving surface which has been created on a metatarsal head of the patient by sawing of sections of the metatarsal head (figures 3, 4, 6, 11, and 17, etc.; and paragraphs [0038], [0050]-[0051], etc.), wherein a bone contacting surface (as shown as bone contacting surfaces including ‘anchoring wings of the base portion’ of 200- in figures 3A-3H and/or bone contacting surfaces including ‘anchoring wings of the base portion’ of 600 in figures 6A-6E; seq. or the like for corresponding implant compared to trial) of the metatarsal implant (200, 600, seq. or the like) is designed to correspond to the implant receiving surface (figure 3 and 6), and a contour of an articulating surface (220, seq.) of the metatarsal implant (200, seq.) is designed to correspond to curvature of a simulated healthy articulating surface of the metatarsal head prior to damage at a site of diseased cartilage and/or bone (e.g., see at least paragraph [0035]), where the contour curvature (i.e., curvature of surface 220 that “mimics the natural anatomy of the joint”- see paragraph [0035]) of the articulation surface (220, seq.) is generated based on a determined surface curvature of the cartilage and/or bone in a predetermined area at the site of diseased cartilage and/or bone, to mimic an original undamaged articulating surface of the metatarsal head (e.g., see at least paragraph [0035]), wherein the contour curvature of the articulating surface of the metatarsal implant corresponds to the curvature of the simulated healthy articulating surface of the metatarsal head (i.e., “mimics the natural anatomy of the joint” – see at least paragraph [0035]) and extends to interact with sesamoid bones in the metatarsophalangeal joint (i.e., “In some embodiments, the plantar cortex is quite useful and unique and will allow the sesamoids to glide onto the implant, thereby desirably not being “jammed” by the implant.”- paragraph [0051]). Under the first interpretation the claim language “the contour curvature of the articulation surface is generated based on a determined surface curvature of the cartilage and/or bone in a predetermined area at the site of diseased cartilage and/or bone, to mimic the original undamaged articulation surface of the metatarsal head” is interpreted as a product by process type claim language. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. MPEP 2113. Under the first interpretation, the invention of Montross described as “mimicking the natural anatomy of the joint” paragraph [0035] anticipates the structure implied by the generating step recited by claim 1; thus, anticipating the claim.
Under a second interpretation, the structure implied by the claim language “the contour curvature of the articulation surface is generated based on a determined surface curvature of the cartilage and/or bone in a predetermined area at the site of diseased cartilage and/or bone, to mimic the original undamaged articulation surface of the metatarsal head” of claim 1 extends beyond the structure disclosed by Montross.
Regardless, in the same field of endeavor, namely metatarsal implants, Bake teaches a contour curvature of an articulation surface of a metatarsal implant is generated based on a determined surface curvature of cartilage and/or bone in a predetermined area at a site of diseased cartilage and/or bone, to mimic original undamaged articulation surface of the metatarsal head (e.g., see at least paragraphs [0146], [0313], [0342]-[0344], etc.,).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to form the contour of curvature that mimics the natural anatomy of the joint in the invention of Montross by the method of generating the contour curvature as taught and/or suggested by Bake in order to ensure that the contour curvature is optimized for a particular patient and surgical procedure with predictable results and a reasonable expectation of success.
Regarding claim 2, Montross discloses the implant (200, 600, seq.) further comprising an implant peg (320, seq.) extending from the bone contacting surface of the metatarsal implant (200, 600, seq.) (e.g., see at least figure 3 and 6).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Montross et al. U.S. publication no. 2021/0059829 A1 (“Montross”) in view of Steines et al. U.S. publication no. 20130211531 A1 (“Steines”) or Montross in view of Bake et al. U.S. publication no. 2019/0328548 A1 (“Bake”) and further in view of Steines.
Regarding claim 3, Montross or Montross in view of Bake, as applied above, teaches the invention substantially as claimed
Montross or Montross in view of Bake, as applied above, is silent regarding the articulating surface of the metatarsal implant comprising a positioning mark substantially as claimed.
In the same field of endeavor, namely bone implants, steins teaches an articulating surface of an implant comprising a positioning mark (e.g., see at least paragraph [0786]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to include a positioning mark on the articulating surface of the metatarsal implant of Montross or Montross in view of Bake, as taught and/or suggested by Steines, in order to aid in the implant positioning during and/or after surgery, especially when a polymeric material is selected for the articular surface, with predictable results and a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/617,609 (reference application). See especially claims 1 and 7 of the copending application. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims are narrower than the present application claims in some respects and broader in others. With regard to those limitations making the copending application narrower than the present application (e.g., with regard to osseointegration features), species anticipates genus. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). With regard to the claim limitation regarding the implant receiving surfaces matching the bone contacting surfaces found in the present application claim, but not present in the copending application claims, such features are taught by Montross for at least the reasons discussed hereinabove. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to include the matching implant receiving and bone contacting surfaces of Montross in the invention of the copending application claims in order to aid in rotational stability of the implant base with predictable results and a reasonable expectation of success. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774