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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 5, 2026 has been entered.
Response to Arguments
Applicant's arguments filed April 16, 2026 have been fully considered but they are not persuasive.
As discussed in the advisory action mailed April 23, 2026 and reiterated herein, Applicant argues that the claim amendments distinguish the claims from the rejection of record. Examiner does not agree. In particular, Applicant argues that the applied prior art fails to teach the newly recited claim limitations of "the extent and shape of the articulating surface is customized for the patient and prepared to have a low surface roughness to provide smooth interaction with and support for the sesamoid bones, and wherein the extent and shape of the articulating surface is partly determined by simulating healthy sesamoid gliding path using 3D imaging data of the patient's joint."
As described in the final office action, mailed December 9, 2025, "the extent and shape of the articulating surface to provide free, non-interfered interaction with and support for the sesamoid bones" is based on at least paragraphs [0035],[0045], [0051] and [0058] of primary prior art reference to Montross U.S. publication no. 20210059829 A1. Moreover, as applied in the final office action, secondary reference to Bake et al. U.S. publication no. 2019/0328548 A1 ("Bake") teaches "articular surface [as applied to articular surface of Montross] is to 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 that in applying the teachings of Bake to the invention of Montross the articular surface which supports the sesamoid bones should be formed in a customized manner based on 3D imaging data to simulate the natural cartilage of the patient's bone in order to provide a low surface roughness for smooth interaction with said sesamoid bones substantially as claimed.
Moreover, the newly recited claim limitation “the extent and shape of the articulating surface is partly determined by simulating the healthy sesamoid gliding path using 3D imaging data of the patient’s joint” is a product-by-process type claim limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. It appears that the extent and shape of the articulating surface of the device derived from Montross in view of Bake, namely customization by the imaging and design process disclosed by Bake would result in the same articular surface substantially as claimed. Indeed, once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show an unobvious difference. MPEP 2113(II). Nonetheless, even if Applicant did show a structural difference between articular surfaces derived from the imaging and design of Montross in view of Bake, 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, even if a structural difference could be shown between the articular surface derived from the teachings of Montross in view of Bake, as compared with the claimed invention, such distinguishing features are known at least by the prior art to Otto.
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, 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 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.), wherein the bone contacting surface [including ‘anchoring base portion’ of 200 or ‘anchoring wings of the base portion’ of 600] comprises structures designed to attach to corresponding structures of the implant receiving surface (e.g., figures 3A-H and 6A-E, etc.); and a contour curvature of an articulating surface (220, seq.) of the metatarsal implant (200, seq.) 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 (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. Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show an unobvious difference. MPEP 2113(II).
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.
Moreover, Montross further teaches forming an extent and shape of the articulating surface to provide free, non-interfered interaction with and support for the sesamoid bones (see at least paragraphs [0035],[0045], [0051] and [0058]). However, Montross is silent regarding said extent and shape is “customized” for the patient and prepared to have a low surface roughness to provide smooth interaction with the supported sesamoid bones. Regardless, 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 that in applying the teachings of Bake to the invention of Montross the articular surface which supports the sesamoid bones of Montross should be formed in a customized manner based on 3D imaging data to simulate the natural cartilage of the patient's bone and should be provided with an articular surface that has a low surface roughness for smooth interaction with said sesamoid bones because polished surfaces are known to be ideal for reducing damage to the patient when an implant is provided that articulates against a patient’s tissue and/or bone with predictable results and a reasonable expectation of success.
Moreover, the newly recited claim limitation “the extent and shape of the articulating surface is partly determined by simulating the healthy sesamoid gliding path using 3D imaging data of the patient’s joint” is a product-by-process type claim limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. It appears that the extent and shape of the articulating surface of the device derived from Montross in view of Bake, namely customization by the imaging and design process disclosed by Bake would result in the same articular surface substantially as claimed. Indeed, once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show an unobvious difference. MPEP 2113(II). Nonetheless, even if Applicant could show a structural difference between articular surfaces derived from the imaging and design of Montross in view of Bake, 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, even if a structural difference could be shown between the articular surface derived from the teachings of Montross in view of Bake, as compared with the claimed invention, such distinguishing features are known at least by the prior art to 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 Steines et al. U.S. publication no. 20130211531 A1 (“Steines”) or Montross in view of Bake in view of Otto et al. U.S. publication no. 2010/0076563 A1 (“Otto”) and further in view of Steines.
Regarding claim 3, Montross in view of Bake or Montross in view of Bake in view of Otto, as applied above, teaches the invention substantially as claimed
Montross in view of Bake or 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 or 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
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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