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 .
Response to Amendment
The Amendment filed April 2nd, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed December 2nd, 2025.
Response to Arguments
Applicant’s arguments, see pgs. 11, 13-14, and 16-17, filed 04/02/2026, with respect to the rejection of claim 20 under 35 U.S.C. 102 (a)(1) and rejections of claims 1 and 19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found prior art reference, Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728). The newly found prior art reference also discloses treatment of the subtalar joint and teaches that at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray, that a fibular osteotomy includes at least one incision that extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray, and making at least one incision adjacent the subtalar joint, wherein the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray, as recited in amended claims 1, 19, and 20 respectively.
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.
Claim(s) 1-2, 4, 8, 11-13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 20140128985 A1), herein after referred to as Sanders, in view of Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728), herein after referred to as Mulligan, in further view of Goldberg et al. (US 10117749 B2), herein after referred to as Goldberg, and in further view of Rydell et al. (US 20070027547 A1), herein after referred to as Rydell.
Regarding claim 1, Sanders discloses a method for performing an arthroplasty (paragraph 0001) of a subtalar joint (16), the method comprising: making at least one incision (fig. 47, 1502) adjacent the subtalar joint (16, paragraph 0208); accessing at least a portion of the subtalar joint (16, paragraph 0208), wherein the subtalar joint (16) comprises a joint space (fig. 3 illustrates a joint space between the talus 12 and calcaneal 14 bones wherein an implant system 100 is disposed) defined superiorly by a first articular surface (12) and inferiorly by a second articular surface (14); preparing at least one of the first articular surface (12) and the second articular surface (14) to form a first interfacing surface and a second interfacing surface (paragraph 0199 discloses preparing the surface of a talus 12 and a calcaneal 14 bones to receive an implant component). Sanders further discloses, securing an implant (paragraph 0200) such that the implant (100) is positioned substantially inferior relative to the first interfacing surface (fig. 3 illustrates a subtalar implant inferior to the bottom surface of talus 12) and substantially superior relative to the second interfacing surface (fig. 3 illustrates a subtalar implant superior to the top surface of the calcaneus 14) and closing the at least one incision (fig. 47, 1518). Sanders discloses making an incision, but fails to disclose that the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray.
Mulligan also discloses a method for performing a procedure of a subtalar joint (pg. 1344 col. 1). Mulligan teaches that the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray (pg. 1346 col. 1 discloses accessing a subtalar joint using a lateral transfibular approach comprising an incision, straight or curvilinear, that extends and is adjacent to the distal end/tip of a fibula towards a cuboid i.e. the cuboid of fourth and fifth metatarsals/rays as seen in fig. 5 annotated below).
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The claimed invention of the present application falls within a similar or same field of endeavor as the invention disclosed in Mulligan such as arthrodesis procedures. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sanders to include making at least one incision adjacent the subtalar joint, wherein the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray as taught by Mulligan as the modification merely involves a combination of known methods of making incisions for access to a subtalar joint that achieves predictable results of treating a subtalar joint.
Sanders as modified by Mulligan does not disclose identifying at least one landmark on at least one of the first interfacing surface and the second interfacing surface; determining at least one significant point on at least one of the first interfacing surface and the second interfacing surface relative to the at least one landmark; placing at least one trial implant at least partially within the joint space; and stabilizing the subtalar joint.
Goldberg also teaches a method for performing an arthroplasty (col.4 lines 26-30) of a subtalar joint (col.4 lines 28-29). Goldberg also teaches preparing (col. 11 lines 58-62 disclose preparing a space between the talus 102 and calcaneum 104) at least one of the first articular surface (102) and the second articular surface (104) to form a first interfacing surface (col. 10 lines 5-7 an implant component 22 to be rigidly attached to the talus) and a second interfacing surface (col. 10 lines 27-29 disclose an implant component 24 to be rigidly attached to the calcaneum). Goldberg also teaches securing an implant (20, col. 12 lines 45-48 disclose a fixation hole to allow insertion of fixing members such as a screw, bolt, or pin) such that the implant (20) is positioned substantially inferior relative to the first interfacing surface (fig. 8 illustrates a anatomical bottom view of the talus where the implant is positioned inferior to the talus’ bottom surface) and substantially superior relative to the second interfacing surface (fig. 5 illustrates a anatomical top view of the calcaneum wherein the implant is positioned superior to the calcaneum’s top surface). Goldberg further teaches identifying at least one landmark (col. 12 lines 6-7 discloses a method of identifying at least one landmark or middle facets 2 and 6) on at least one of the first interfacing surface (fig. 4 illustrates middle facet 6 on the talus) and the second interfacing surface (fig. 1 illustrates middle facet 2 on the calcaneum); determining at least one significant point (col. 12 lines 6-9) on at least one of the first interfacing surface (102) and the second interfacing surface (104) relative to the at least one landmark (col. 12 lines 6-9 disclose identifying a central point on at least one landmark to use as a reference for making bony cuts); placing at least one trial implant at least partially within the joint space (col. 12 lines 9-12 disclose a trial implant placed in situ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sanders in view of Mulligan to include the use of identifying landmarks and determining significant points as taught by Goldberg in order to aid in the implantation of a subtalar joint that provides a realistic emulation of the functions of a healthy natural subtalar joint (Goldberg col. 1 lines 7-10). Sanders as modified by Mulligan and Goldberg fails to disclose or suggest stabilizing the subtalar joint.
Rydell also teaches a method for performing an arthroplasty (paragraph 0004) of a subtalar joint (114), the method comprising: making at least one incision adjacent the subtalar joint (paragraph 0034 discloses a lateral incision on the side of the foot). Rydell also teaches wherein the subtalar joint (114) comprises a joint space (0034 discloses a space between talus and calcaneal bones) defined superiorly by a first articular surface (fig. 1 illustrates a talus 108 or first articular surface of the subtalar joint 114) and inferiorly by a second articular surface (fig. 1 illustrates a calcaneus 110 or second articular surface of the subtalar joint 114); preparing at least one of the first articular surface (108) and the second articular surface (110) to form a first interfacing surface and a second interfacing surface (paragraph 0028 discloses preparing at least one of the articulating surfaces to receive an implant 116). Rydell also teaches securing an implant (116) such that the implant (116) is positioned substantially inferior relative to the first interfacing surface (108) and substantially superior relative to the second interfacing surface (110, fig. 1 illustrates a subtalar implant 116 disposed inferior to the talus and superior to the calcaneal bone). Rydell further teaches stabilizing the subtalar joint (114, paragraph 0033 discloses restraining an implant 116 with adjacent soft tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sanders in view of Mulligan and Goldberg to include the step of stabilizing the subtalar joint as taught by Rydell in order to reduce bone on bone impingement and increase the articulation of the joint (Rydell 0006).
Regarding claim 2, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Goldberg further teaches positioning the trial implant such that at least a portion of the trial implant contacts the first (102) and second interfacing surfaces (104, col. 12 lines 9-12 disclose a trial implant placed in situ).
Regarding claim 4, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Mulligan further teaches performing a fibular osteotomy to access at least a portion of the at least one of the subtalar joint and the joint space (see pg. 1346 col. for fibular osteotomy and fig. 1 for exposure of subtalar joint).
Regarding claim 8, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Rydell further teaches stabilizing the subtalar joint (114) comprises manipulating one or more soft tissue structures adjacent the subtalar implant (116) after the implant has been placed and fixated at least partially within the joint space (paragraph 0034 discloses manipulating adjacent soft tissue to restrain the implant 116 after inserting the subtalar implant into the space between the talus 108 and calcaneus 110) to reach a first stability (paragraph 0034 discloses restraining an implant with adjacent soft tissue to reduce anterior and posterior movement during articulation).
Regarding claim 11, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Sanders further teaches, securing the implant (100, paragraph 0200) comprises placing at least a first implant component (102) adjacent the first interfacing surface (12) and placing a second implant component (104) adjacent the second interfacing surface (14, fig. 3 illustrates and paragraph 0072 discloses a first and second implant components adapted to be attached to the talus 12 and calcaneus 14).
Regarding claim 12, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 11. Sanders further teaches, placing a third implant component at least partially within the joint space (fig. 3 illustrates a third implant component 106 placed within the joint space between the talus 12 and calcaneus 14) such that the third implant component (fig. 3, 106) is positioned substantially inferior relative to the first implant component (fig.3, 102) and substantially superior relative to the second implant component (fig. 3, 104).
Regarding claim 13, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 11. Goldberg further teaches at least one significant point (36) is at least one center of rotation (36) disposed on the second interfacing surface (fig. 16 illustrates a calcaneal portion with a pivot point 36 about which pivoting of the talar portion can occur).
Regarding claim 16, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Goldberg further teaches, the at least one landmark comprises one or more facets (fig.1 and fig.4 illustrate facets 1-6) substantially disposed on a superior surface of the calcaneum (fig. 1 illustrates facets disposed on the superior surface of the calcaneum).
Regarding claim 17, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Sanders further teaches, the first interfacing surface is an inferior surface (20) of the talus (12), and the second interfacing surface is a superior surface (22) of the calcaneum (14, fig. 3 illustrates an implant 100 that interfaces the talus 12 and calcaneus 14).
Regarding claim 18, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Rydell further teaches, the step of stabilizing the subtalar joint (114) comprises manipulating one or more soft tissue structures (paragraph 0034 discloses manipulating adjacent soft tissue to restrain an implant).
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 20140128985 A1), herein after referred to as Sanders, in view of Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728), herein after referred to as Mulligan, in further view of Goldberg et al (US 10117749 B2), herein after referred to as Goldberg, in further view of Rydell et al. (US 20070027547 A1), herein after referred to as Rydell, as applied to claim 1 above, and in further view of Dacosta et al. (US 20170360577 A1).
Regarding claim 3, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 2. Dacosta also discloses a method comprising: making at least one incision adjacent the subtalar joint (500, paragraph 0046 discloses making an incision from a lateral position down to the subtalar joint); accessing at least a portion of the subtalar joint (paragraph 0046 discloses exposing a joint), wherein the subtalar joint (500) comprises a joint space (506) defined superiorly by a first articular surface (502) and inferiorly by a second articular surface (504). Dacosta also teaches placing at least one trial implant (100) at least partially within the joint space (fig. 24 implant trial 100 disposed in the joint space 506); securing an implant such that the implant (100) is positioned substantially inferior relative to the first interfacing surface (502) and substantially superior relative to the second interfacing surface (504, 424 fig. 22 and fig. 24 implant trial 100 disposed in the joint space 506); and closing the at least one incision (fig. 22 - 424). Dacosta further teaches placing a first implant trial (100) at least partially within the joint space (fig. 24 implant trial 100 disposed in the joint space 506); and placing a second implant trial (130) at least partially within the joint space (fig. 6 illustrates implant trials of different sizes that may be disposed in the joint space 506); wherein the implant trial (100) comprises a first size and the second implant trial (130) comprises a second size, wherein the second size is different from the first size (fig. 6 illustrates trial implants of different sizes).
The claimed invention of the present application falls within the same field of endeavor as the invention disclosed in Dacosta, orthopedic implants, device, systems, and methods for implanting, which includes an analogous device and method for subtalar joint implantation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the subtalar implant of Sanders in view of Mulligan, Goldberg, and Rydell to include implant trials wherein the first implant trial comprises a first size and the second implant trial comprises a size different from the first size, and perform the steps of placing the first implant trial at least partially within the joint space and placing the second implant trial at least partially within the joint space, as taught by Dacosta in order to allow for the desired correction and restoration of function (Dacosta paragraph 0002).
Regarding claim 7, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Dacosta also discloses a method comprising: making at least one incision adjacent the subtalar joint (500, paragraph 0046 discloses making an incision from a lateral position down to the subtalar joint); accessing at least a portion of the subtalar joint (paragraph 0046 discloses exposing the joint), wherein the subtalar joint (500) comprises a joint space (506) defined superiorly by a first articular surface (502) and inferiorly by a second articular surface (504). Dacosta teaches temporarily fixing (paragraph 0047 discloses fixing a talus or calcaneum using a retractor 510 and k-wires 520/522) at least one of a calcaneum (502) and a talus (504) before preparing at least one of the first articular surface (502) and the second articular surface (504, 0047 discloses performing cartilage resections after the joint distraction and paragraph 0048 discloses flattening, drilling, or scraping the surfaces of the bones).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sanders in view of Mulligan, Goldberg, and Rydell to include temporarily fixing at least one of a calcaneum and a talus before preparing at least one of the first articular surface and the second articular surface, as taught by Dacosta in order to allow for the desired correction and restoration of function (Dacosta paragraph 0002).
Claims 5-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 20140128985 A1), herein after referred to as Sanders, in view of Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728), herein after referred to as Mulligan, in further view of Goldberg et al. (US 10117749 B2), herein after referred to as Goldberg, in further view of Rydell et al. (US 20070027547 A1), herein after referred to as Rydell, as applied to claim 1 above, and in further view of Werber et al. (US 20170189197 A1), herein after referred to as Werber.
Regarding claim 5, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Werber discloses accessing at least a portion of the subtalar joint (fig. 6, 602 illustrates and paragraph 0052 discloses accessing a portion of the subtalar joint), wherein the subtalar joint comprises a joint space (fig. 5 discloses a subtalar joint space 114) defined superiorly by a first articular surface (106) and inferiorly by a second articular surface (108). Werber also teaches placing at least one trial implant at least partially within the joint space (fig.7b illustrates and paragraph 0060 discloses placing a trial implant within the joint space), stabilizing the subtalar joint (paragraph 0039 discloses stabilizing the subtalar joint), and closing the at least one incision (paragraph 0052 discloses closing an access). Werber further teaches, analyzing a first position and a first function (paragraph 0052 discloses evaluating an initial position and range of motion) of the implant (104) after the implant has been placed within at least a portion of the joint space (fig. 6, 624).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sanders in view of Mulligan, Goldberg, and Rydell to include the step of analyzing a first position and a first function of the implant after the implant had been placed within at least a portion of the joint space as taught by Werber, in order to overcome reduced natural and expected motion in the subtalar joint and subjecting patients to additional surgical procedures, pain, and discomfort (Weber paragraphs 0012-0013).
Regarding claim 6, Sanders in view of Mulligan, in further view of Goldberg, in further view of Rydell, and in further view of Werber disclose the invention as claimed as discussed above with respect to claim 5. Werber further teaches adjusting the implant (104) within at least a portion of the joint space (fig.7b illustrates and paragraph 0060 discloses placing an implant within the joint space) such that the implant comprises a second position and a second function (paragraph 0052 discloses adjusting and repositioning the implant and re-evaluating the range of motion), wherein the second position and function are different (paragraph 0052 discloses repositioning an implant to allow for a normal range of motion) than the first position and function (paragraph 0052 discloses initially positioning an implant and the implant having an abnormal range of motion).
Regarding claim 9, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 8. Werber discloses accessing at least a portion of the subtalar joint (fig. 6, 602 illustrates and paragraph 0052 discloses accessing a portion of the subtalar joint), wherein the subtalar joint comprises a joint space (fig. 5 discloses a subtalar joint space 114) defined superiorly by a first articular surface (106) and inferiorly by a second articular surface (108). Werber teaches confirming stability of the subtalar joint (114; paragraph 0052 discloses evaluating the foots range of motion after stabilizing the alignment between the talus 106 and calcaneus 108 with a subtalar implant 104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sanders in view of Mulligan, Goldberg, and Rydell to include the step of confirming the stability of the subtalar joint, in order to correct the alignment between a person’s talus and calcaneus and reduce the tendency for abnormal motion (Werber paragraph 0038).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 20140128985 A1), herein after referred to as Sanders, in view of Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728), herein after referred to as Mulligan, in further view of Goldberg et al (US 10117749 B2), herein after referred to as Goldberg, in further view of Rydell et al. (US 20070027547 A1), herein after referred to as Rydell, as applied to claim 1 above, and in further view of Wahl et al. (US 11033305 B2), herein after referred to as Wahl.
Regarding claim 14, Sanders in view of Mulligan, in further view of Goldberg, and in further view of Rydell disclose the invention as claimed as discussed above with respect to claim 1. Wahl discloses a subtalar joint (18) comprising a joint space defined superiorly by a first articular surface (14) and inferiorly by a second articular surface (16); preparing at least one of the first articular surface (14) and the second articular surface (16) to form a first interfacing surface and a second interfacing surface (col. 14, lines 1-5 disclose preparing the surface of the calcaneus for the implantation of the subtalar plate implant 512). Wahl also teaches securing an implant (col. 5, lines 45-49) such that the implant is positioned substantially inferior relative to the first interfacing surface and substantially superior relative to the second interfacing surface (fig. 1a). Wahl further teaches aligning one or more components of the subtalar joint (col. 4 lines 57-59 discloses implanting a subtalar plate implant to properly align the talus and calcaneus).
The claimed invention of the present application falls within a similar or same field of endeavor as the invention disclosed in Wahl, artificial joint prosthesis, which includes an analogous device and/or method for subtalar joint implantation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the subtalar implantation method of Sanders in view of Mulligan, Goldberg, and Rydell to include the step of aligning one or more components of the subtalar joint as taught by Wahl in order to provide stable correction of the subtalar joint and proper alignment of the talus and calcaneus, while preserving joint motion (Wahl Col. 4 lines 56-60) and suit the comfort of the patient (Wahl Col. 5 lines 8-9).
Regarding claim 15, Sanders in view of Mulligan, in further view of Goldberg, in further view of Rydell and in further view of Wahl disclose the invention as claimed as discussed above with respect to claim 14. Wahl further teaches, aligning the subtalar joint (18) comprises manipulating at least one of a talus and a calcaneum (16) such that at least a head of the talus (14) is disposed substantially superior relative to at least a portion of the calcaneum (col. 4 lines 58-59 disclose and fig. 1b illustrates an implant disposed in the subtalar joint which aligns the talus and calcaneus such that the talus head is superiorly aligned to a portion of the calcaneus).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (US 10117749 B2), herein after referred to as Goldberg, in further view of Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728), herein after referred to as Mulligan.
Regarding claim 19, Goldberg discloses a method for performing arthroplasty (col. 4 lines 26-56) of a subtalar joint (figs. 1-4). Goldberg also discloses identifying at least one landmark (col. 12 lines 6-7 discloses a method of identifying at least one landmark) on at least one of an inferior surface (fig. 1 illustrates an anatomical top view of middle facet 2 disposed on the calcaneum or inferior interfacing surface of the subtalar joint); and a superior surface (fig. 4 illustrates an anatomical bottom view of middle facet 6 disposed on the talus or superior interfacing surface of the subtalar joint); determining at least one center of rotation (col. 12 lines 6-9) disposed on at least one of the inferior and superior surfaces (fig. 16 illustrates a pivot point 36 disposed on the inferior surface or calcaneum); placing at least one trial implant adjacent the inferior and superior surfaces (col. 12 lines 9-12 disclose a trial implant placed in situ); and securing an implant such that the implant is positioned substantially between the inferior (fig. 5 illustrates a top anatomical view of the calcaneum or inferior surface with an implant component 24) and superior surfaces (fig. 8 illustrates a bottom anatomical view of a talus or superior surface with an implant component 22). Goldberg fails to disclose performing a fibular osteotomy to access at least a portion of the subtalar joint, including at least one incision that extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray.
Mulligan also discloses a method for performing a procedure of a subtalar joint. Mulligan teaches performing a fibular osteotomy to access at least a portion of the subtalar joint (see pg. 1346 col. for fibular osteotomy and fig. 1 for exposure of subtalar joint). Mulligan teaches that the fibular osteotomy includes at least one incision that extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray (pg. 1346 col. 1 discloses accessing a subtalar joint using a lateral transfibular approach comprising an incision, straight or curvilinear, that extends and is adjacent to the distal end/tip of a fibula towards a cuboid i.e. the cuboid of fourth and fifth metatarsals/rays as seen in fig. 5 annotated above).
The claimed invention of the present application falls within a similar or same field of endeavor as the invention disclosed in Mulligan such as arthrodesis procedures. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Goldberg to include performing a fibular osteotomy to access at least a portion of the subtalar joint, including at least one incision that extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray as taught by Mulligan as the modification merely involves a combination of known methods of making incisions for access to a subtalar joint that achieves predictable results of treating a subtalar joint.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (US 10117749 B2), in view of Mulligan et al. (Mulligan RP, Adams SB, Easley ME, DeOrio JK, Nunley JA. Comparison of Posterior Approach With Intramedullary Nailing Versus Lateral Transfibular Approach With Fixed-Angle Plating for Tibiotalocalcaneal Arthrodesis. Foot & Ankle International. 2017;38(12):1343-1351. doi:10.1177/1071100717731728).
Goldberg discloses a method for performing an arthroplasty of a subtalar joint (col. 4 lines 26-30), the subtalar joint (col. 4 lines 28-29) comprising a first surface (fig. 4, 102) and a second surface (fig. 1, 104), the method comprising: identifying at least one landmark (col. 12 lines 6-7 discloses a method of identifying at least one landmark or middle facets 2 and 6) on at least one of the first surface (102, fig. 4 illustrates the talus with a middle facet 6 landmark) and the second articular surface (104, fig. 1 illustrates the calcaneum with a middle facet 2 landmark); determining at least one significant point (col. 12 lines 6-9) in relation to the at least one landmark (col. 12 lines 6-9 disclose identifying a central point on a landmark to use as a reference) and securing an implant between the first (fig. 8 illustrates a talar portion of a subtalar implant secured to the talus 102) and second surfaces (fig.5 illustrates a calcaneal portion of a subtalar implant secured to the calcaneus 104) in a first position (fig. 8 illustrates the talar portion positioned over the middle facet 6 using the identified central point 36 in fig. 17 and fig. 5 also illustrates the calcaneal portion positioned over the middle facet 2 using the identified central point 36 in fig. 16), wherein the first position is based on a position of the at least one significant point (col. 4, lines 1-6 discloses an implant positioned where when viewed from above different regions overlap, preferably where a central point of a landmark was identified). Goldberg fails to disclose making at least one incision adjacent the subtalar joint, wherein the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray.
Mulligan also discloses a method for performing a procedure of a subtalar joint (pg. 1344 col. 1). Mulligan teaches making at least one incision adjacent the subtalar joint, wherein the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray (pg. 1346 col. 1 discloses accessing a subtalar joint using a lateral transfibular approach comprising an incision, straight or curvilinear, that extends and is adjacent to the distal end/tip of a fibula towards a cuboid i.e. the cuboid of fourth and fifth metatarsals/rays as seen in fig. 5 annotated above).
The claimed invention of the present application falls within a similar or same field of endeavor as the invention disclosed in Mulligan such as arthrodesis procedures. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Goldberg to include making at least one incision adjacent the subtalar joint, wherein the at least one incision extends from and is adjacent a distal tip of a fibula extending along a trajectory toward a middle of a cuboid of a fourth ray as taught by Mulligan as the modification merely involves a combination of known methods of making incisions for access to a subtalar joint that achieves predictable results of treating a subtalar joint.
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.
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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