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.
Response to Arguments
Applicant's arguments filed July 10, 2026 with respect to the rejection of claims under 35 U.S.C. 103 as being unpatentable 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”) in view of Otto et al. U.S. publication no. 2010/0076563 A1 (“Otto”) have been fully considered, but they are not persuasive.
Applicant argues that the applied prior art fails to disclose the claim scope of the newly amended claims.
In particular, the claims have been amended to require, “the articulating surface of the metatarsal implant is shaped to reproduce a contour curvature that corresponds to an original, undamaged articulating surface of the metatarsal head” and “the extent and shape of the articulating surface are configured such that, in use, a gliding motion of the sesamoid bones along a healthy gliding path relative to the metatarsal head is maintained.”
The plain meaning of the claim terms and metes and bounds of the claim derived from the claimed structural configuration is taught by the applied prior art of Montross in view of Bake and further in view of Otto. In particular, Montross may inherently teach the articulating surface of the metatarsal implant is shaped to reproduce a contour curvature that corresponds to an original, undamaged articulating surface of the metatarsal head by teaching that the articular surface should “mimic” the natural surface. However, even if not anticipated by Montross, these limitations are clearly obvious over a combination of Montross in view of Bake in view of Otto, wherein Bake express teaches using a low friction patient customized articular surface and Otto teaches generating a patient specific articular surface by simulating motion under 3D imaging. Moreover, Montross teaches “the extent and shape of the articulating surface are configured such that, in use, a gliding motion of the sesamoid bones along a healthy gliding path relative to the metatarsal head is maintained” because Montross teaches the articular surface extends to interact -to at least some degree- 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]). Moreover, Montross discloses the extent and shape of the articulating surface (220) are configured such that, in use, a gliding motion of the sesamoid bones along a healthy gliding path (i.e., gliding path formed by combination of plantar cortex and edge of implant head- see paragraph [0051]) relative to the metatarsal head [i.e., bone upon which implant is implanted] is maintained (i.e., gliding of the sesamoid bones onto the implant in healthy gliding path as disclosed in paragraph [0051] anticipates the scope of the claimed invention) so as to teach the invention in accordance with the broad claim scope.
Moreover, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., “the articulating surface extends far enough to always interact with the sesamoid bones, even when the toe is straight” -publication of Applicant’s filed specification at paragraphs [0021], [0067] and [0093]-) along with all of the other limitations contained within the claims, while not expressly taught by Montross in view of Bake in view of Otto, are not recited in accordance with this narrowed scope in the rejected claim(s). 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). Also see Early U.S. publication no. 2014/0316530 A1 cited in the conclusion of this office action.
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.
Claims 1, 2 and 27 are 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 Bake et al. U.S. publication no. 2019/0328548 A1 (“Bake”) or in the alternative Montross in view of Bake and further in view of Otto et al. U.S. publication no. 2010/0076563 A1 (“Otto”).
Regarding claims 1 and 27, 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 drilling, milling and/or 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), such that the bone contacting surface [including ‘anchoring base portion’ of 200 or ‘anchoring wings of the base portion’ of 600] of the metatarsal implant (200- figures 3A-3H; 600-figures 6A-6E; seq. or the like) is configured to match and attach to the implant receiving surface (e.g., figures 3A-H and 6A-E, etc.); and a contour curvature (figure 3C, etc.) of an articulating surface (220) of the metatarsal implant (200) is designed to correspond to a curvature of a simulated healthy articulating surface of the metatarsal head prior to damage at a site of diseased cartilage and/or bone, wherein the articulating surface (220) is shaped to reproduce a contour curvature that corresponds to an original, undamaged articulating surface of the metatarsal head (e.g., see at least paragraph [0035]- i.e., curvature of surface 220 that “mimics the natural anatomy of the joint”-), wherein the contour curvature of the articulating surface of the metatarsal implant inherently corresponds to the curvature of the simulated healthy articulating surface of the metatarsal head because it is design and configured to mimic the articular surface onto which it is implanted (e.g., see at least paragraph [0035]) and the articular surface extends to interact -to at least some degree- 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]), wherein the extent and shape of the articulating surface (220) are configured such that, in use, a gliding motion of the sesamoid bones along a healthy gliding path (i.e., gliding path formed by combination of plantar cortex and edge of implant head- see paragraph [0051]) relative to the metatarsal head [i.e., bone upon which implant is implanted] is maintained (i.e., gliding of the sesamoid bones onto the implant in healthy gliding path as disclosed in paragraph [0051] anticipates the scope of the claimed invention).
Under a first interpretation, disclosure of Montross that the articulating surface “mimics the natural anatomy of the joint” – paragraph [0035]- inherently covers the claim scope of the contour curvature being “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, wherein the articulating surface of the metatarsal implant is shaped to reproduce a contour curvature that corresponds to an original, undamaged articulating surface of the metatarsal head, 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” substantially as claimed.
Under a second interpretation, the structure implied by the claim language “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, wherein the articulating surface of the metatarsal implant is shaped to reproduce a contour curvature that corresponds to an original, undamaged articulating surface of the metatarsal head, 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” of claim 1 extends beyond the articular surface mimicking structure disclosed by Montross. Additionally, Montross is silent regarding the articulating surface is customized for a patient and prepared to have a low surface roughness where it interacts and supports the sesamoid bones.
Regardless, in the same field of endeavor, namely metatarsal implants, Bake teaches a contour curvature of an articulation surface of a metatarsal implant is custom designed for a specific patient (e.g., paragraphs [0054], [0229], [0258], etc.) such that it 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, wherein the articulating surface of the metatarsal implant is shaped to reproduce a contour curvature that corresponds to an original, undamaged articulating surface of the metatarsal head, 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 (e.g., also see at least paragraphs [0146], [0313], [0342]-[0344], etc.,). Moreover, Bake further teaches articular surfaces of a joint implant should be customized for the patient and prepared to have a low surface roughness to provide smooth interaction with the body portion in which it articulates against and supports (e.g., see at least paragraph [0206]), and wherein the extent and shape of the [customized] articulating surface is partly determined by simulating the articular path using 3D imaging data of the patient's joint (see at least paragraphs [0146], [0206], [0309], [0313], [0342]-[0344], etc.).
Thus, 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 and provides smooth interaction with the tissue into which it is implanted with predictable results and a reasonable expectation of success.
Montross in view of Bake is silent regarding the extent and shape of the contour curvature of the articulating surface is configured to match a contour of a 3D image of a “simulated healthy articulating surface” of the undamaged first metatarsal head in a predetermined area at a site of diseased cartilage and/or bone; and wherein the shape and dimensions of the metatarsal implant are configured to correspond to a 3D image of a simulated healthy undamaged first metatarsal head in a predetermined area at a site of the diseased cartilage and/or bone substantially as claimed.
Otto teaches forming articular surfaces (for any type of joint – see at least paragraph [0050]), wherein the articular surface is formed at least partly by determining the desired surface structure based on simulating the healthy gliding path using 3D imaging data of the patient’s joint (e.g., see at least paragraphs [0050]-[0054], [0075], etc.). Therefore, 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 articulating surface with a design that corresponds to simulated healthy articulation, as taught and/or suggested by Otto in order to optimize the kinematics and surgical outcome of a joint implant 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 Bake et al. U.S. publication no. 2019/0328548 A1 (“Bake”) in view of Otto et al. U.S. publication no. 2010/0076563 A1 (“Otto”), as applied above, and further in view of Steines.
Regarding claim 3, Montross in view of Bake in view of Otto, as applied above, teaches the invention substantially as claimed
Montross in view of Bake in view of Otto, 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 in view of Bake in view of Otto, 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 and 27 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
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. Early U.S. publication no. 2014/0316530 A1 teaches an articulating surface of a metatarsal implant configured to mimic the natural surface of a metatarsal implant and including an articulating surface 66 “extending far enough to always interact with the sesamoid bones, even when the toe is straight” (e.g., see at least figures 2 and 3 and paragraph [0048], etc.).
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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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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