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 Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive. Regarding the rejection of claims 1, 2, and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Early, applicant argues an objective of Early’s is to provide an ankle fusion nail system without violating surrounding joints while the invention requires the intramedullary nail passes through/violates the middle facet of the subtalar joint. The examiner disagrees that “without violating surrounding joints” means without passing through joints. Early prefers the intramedullary nail be located only within the talus and tibia in the same manner as the invention, such that the nail does not fuse the whole hindfoot (Early par.5). The nail of Early is implanted in the same location as the nail of the instant application as shown in figs. 2 and 3 of Early. The examiner interprets the phrase “without violating surrounding joints” to mean without fusing surrounding joints such that they no longer function in their normal manner.
Applicant argues Early explicitly teaches placing a nail in front of the subtalar joint in order to avoid violating that joint and such a nail is not inserted through the calcaneus. Applicant argues claim 1 recites placing a nail into the talus and the tibia through the calcaneus and such a placement violates the subtalar joint. This is not persuasive because Early par.45 discloses “Referring again to FIGS. 2 and 3, a drill guide (not shown) is used to align the tibia 44 and talus bone 48 so that the tibial cavity 66 is located intramedullary within tibia 44 and in front of the subtalar joint 52 as illustrated. Once the tibial cavity 66 is created from the bottom of the foot 40 in front of the subtalar joint 52 and into the center of the leg bone, tibia, 44, the talar cavity 68 is created as best seen in FIG. 3”. This paragraph makes it clear that the cavity is created from the bottom of the foot and into the tibial intramedullary canal. How could the cavity be created from the bottom of the foot without passing through the calcaneus? There is no path from the bottom of the foot into the intramedullary canal of the tibia and the talus that could avoid the calcaneus as shown in the annotated figs. 2 and 3 below. The examiner acknowledges that Early states “in front of the subtalar joint” but takes this to mean either above/past the subtalar joint such that the nail is only located in the tibia and talus as shown in figs. 2 and 3 since par.45 says the tibial cavity 66 is located within the tibia 44 and in front of the subtalar joint 52 as illustrated”. This means Early considers “in front of the subtalar joint” to be illustrated and the figures show the cavity above the subtalar joint. The cavity is clearly not positioned anteriorly beyond the calcaneus. Alternatively, “in front of the subtalar joint” could mean in the front of the subtalar joint since the cavity and nail are clearly located above an anterior portion of the calcaneus. Based on the method described in par.45 of Early wherein the cavity is formed from the bottom of the foot, and the figures which show the nail in the same location as the instant application which is inserted through the calcaneus, the examiner maintains that Early anticipates claim 1.
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Regarding the rejection of claim 20 under 35 U.S.C. 103 as being unpatentable over Early in view of Pochatko, applicant argues any combination of Pochatko with Early is contraindicated because Early discloses introduction of the nail in front of the subtalar joint and Pochatko’s purpose is immobilization of the ankle and subtalar joints while Early’s objective is to not violate surrounding joints. This is not persuasive because as discussed above, Early discloses creating the cavity for the nail “from the bottom of the foot” which requires the nail to pass through the calcaneus. Early says “in front of the subtalar joint” but it is not clear what “in front of” means. In front of could mean proximal of the calcaneus, as in the drill extends beyond/proximal of the subtalar joint into the talus and tibia, or could mean a front/anterior portion of the subtalar joint. It is clear, however, from figs. 2 and 3 of Early and the surgical approach “through the bottom of the foot” described by Early that the nail must pass through the calcaneus when inserted “from the bottom of the foot” in order to be positioned within the intramedullary canal of the tibia. Regarding Pochatko, while Pochatko discloses fusing the ankle and subtalar joint, this feature was not relied upon in the rejection. Pochatko was applied to teach a specific location when performing a fusion procedure through the bottom of the foot which is the same as the approach used by Early. Therefore, the combination of Pochatko and Early is not contraindicated.
Regarding the rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Early in view of Janna, applicant argues any combination of Janna with Early is contraindicated because the nail of Janna is pinned to the calcaneus and violates the subtalar joint while Early’s objective is to avoid violation of the subtalar joint. This is not persuasive because Janna was applied to teach a guidewire for placing an intramedullary nail which is commonplace in orthopedic surgery. As discussed above, Early discloses drilling into the bottom of the foot to the intramedullary canal of the tibia which requires passing through the calcaneus and talus, therefore it is proper to look to Janna for using a guidewire that passes through the bottom of the foot.
Regarding claim 6, applicant argues that applicant fails to note where any of the cited references teach advancing through the sustentaculum tali. The rejection of claim 6 points to the rejection of claim 4 which explains that Pochatko teaches the optimal insertion site for an intramedullary nail for fusing an ankle joint is at the junction of the sustentaculum tali and the calcaneal body (Pochatko pg.545, col.2, par.2).
Regarding claim 7, applicant argues the primary reference to Early does not teach inserting the nail through the calcaneus. As discussed above, Early discloses going through the bottom of the foot into the intramedullary canal of the tibia which requires passage through the calcaneus and talus. The nail of Early is free and clear of the calcaneus in its implanted position.
Regarding claims 23 and 24, applicant argues they fail to see wherein the cited references show the limitations, but the rejections refer to the rejections of claims 4 and 6 which explain that Pochatko teaches the limitations.
Arguments regarding the rejection of claims 9, 10, and 26 under 35 U.S.C. 103 as being unpatentable over Early, Janna, Pochatko, and Richter, and the rejection of claims 11-13 under 35 U.S.C. 103 as being unpatentable over Early, Janna, Pochatko, Richter, and Duggal have been addressed above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 was amended to require that the intramedullary nail goes through a calcaneus, therefore claim 14, which depends from claim 1 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Early et al. US 2014/0114313 (hereafter referred to as Early).
Regarding claim 1, Early discloses a method for fusing a tibiotalar joint of a patient with an intramedullary device while leaving an adjacent subtalar joint intact (figs. 2 and 3; par.45 discloses fusion of the ankle only away from the subtalar joint 52), comprising placing an intramedullary nail 10 into a talus 48 and a tibia 44 through a calcaneus (see annotated figs. 2-3 above; par.45 discloses “from the bottom of the foot 40” which means the nail must pass through the calcaneus in order to be received within the intramedullary canal of the tibia and the talus) without violating a posterior facet of the adjacent subtalar joint of the patient (figs. 2 and 3 show the nail anterior of the posterior facet of the subtalar joint) and fixing the intramedullary nail to the talus and the tibia (figs. 2 and 3 shows screws fixing the nail to the talus and tibia).
Regarding claim 2, see par.44 for compression of the tibiotalar joint.
Regarding claim 14, see par.45 for the nail being inserted from the bottom of the foot therefore the nail necessarily passes through the calcaneus into the talus and the tibia.
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Early in view of Pochatko et al, Anatomic Structures at Risk: Combined Subtalar and Ankle Arthrodesis with a Retrograde Intramedullary Rod, Foot & Ankle International, 1995;16(9):542-547. doi:10.1177/107110079501600905 (hereafter referred to as Pochatko). Early discloses a method for fusing a tibiotalar joint of a patient with an intramedullary device while leaving adjacent subtalar joint intact (figs. 2 and 3; par.45 discloses fusion of the ankle only away from the subtalar joint 52), comprising inserting an intramedullary nail 10 through a calcaneus, into a talus and a tibia of a patient (figs. 2 and 3; par.45 discloses the nail being inserted from the bottom of the foot therefore the nail necessarily passes through the calcaneus into the talus and the tibia) without violating a posterior facet of an adjacent talocalcaneal joint (fig.2), and fixing the intramedullary nail to the talus and the tibia with the intramedullary nail free and clear of the calcaneus (figs. 2 and 3 shows screws fixing the nail to the talus and tibia, and the nail located proximal of the calcaneus). Early discloses the invention substantially as claimed but does not specifically disclose that the nail is inserted just medial to a main body of the calcaneus at a planar aspect of a sustentaculum tali.
Pochatko teaches a method related to fusion of a tibiotalar joint, in the same field of endeavor, wherein it was determined that the optimal insertion site for an intramedullary nail for fusing an ankle joint is at the junction of the sustentaculum tali and the calcaneal body (pg.545, col.2, par.2) for the purpose of centering the intramedullary nail in the talus and tibia (pg.544, col.1, par.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an insertion site just medial to a main body of the calcaneus at the sustentaculum tali as taught by Pochatko for the method of Early in order to ensure that the nail is optimally placed in the center of the talus and tibia.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Early as applied to claim 2 above, and further in view of Janna et al. US 2006/0200141 (hereafter referred to as Janna). Early discloses the method of claim 2 as discussed above but Early does not disclose using a guidewire for placing of the intramedullary nail.
Janna teaches a method of fusing a tibiotalar joint, in the same field of endeavor, wherein the method includes using a guidewire for placing an intramedullary nail 112 for the purpose of assisting with the placement of the nail (par.57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Early to include using a guidewire for placing the intramedullary nail as taught by Janna in order to optimize placement of the nail in the tibia and talus. It is customary in the art of prosthetics to use guidewires for guiding drilling/reaming and placing implants.
Claims 4-8, 20, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Early in view of Janna as applied to claim 3 above, and further in view of Pochatko.
Regarding claim 4, Early in view of Janna discloses the method of claim 3, but Early in view of Janna does not disclose starting the guidewire just medial to a main body of a calcaneus at a planar aspect of a sustentaculum tali.
Pochatko teaches a method related to fusion of a tibiotalar joint, in the same field of endeavor, wherein it was determined that the optimal insertion site for an intramedullary nail for fusing an ankle joint is at the junction of the sustentaculum tali and the calcaneal body (pg. 545, col.2, par.2) for the purpose of centering the intramedullary nail in the talus and tibia (pg. 544, col.1, par.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a guidewire insertion site just medial to a main body of the calcaneus at the sustentaculum tali as taught by Pochatko for the method of Early in view of Janna in order to ensure that the nail is optimally placed in the center of the talus and tibia.
Regarding claim 5, Early discloses the nail is inserted from the bottom of the foot (par.45) therefore the nail necessarily passes through the calcaneus into the talus and the tibia. Janna also teaches a retrograde approach (par.57) therefore it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to insert the guidewire through the calcaneus into the talus and tibia in the same manner that the nail is inserted in order to guide correct placement of the nail.
Regarding claim 6, Janna teaches using a guidewire to guide a reamer (par.57) as is custom in the art. Pochatko teaches the optimal insertion site as discussed above with respect to claim 4. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to insert the guidewire such that the reamer is advanced through the sustentaculum tali and into an inferior aspect of the talus without violating the posterior facet of the subtalar joint in order to form a channel in the correct position for the nail.
Regarding claim 7, see figs. 2 and 3 of Early which show the intramedullary nail inserted from the bottom of the foot (through the calcaneus) so that the intramedullary nail is free and clear of the calcaneus. No part of the nail is located in the calcaneus in figs. 2 and 3 of Early.
Regarding claim 8, Early in view of Janna in view of Pochatko discloses the method of claim 7 as discussed above, but Early in view of Janna does not disclose the step of making a plantar incision over the guidewire and placing a retractor medial to a sustentaculum to protect a flexor hallucis longus tendon and an adjacent neurovascular bundle prior to the reaming.
Pochatko teaches a method related to fusion of a tibiotalar joint, in the same field of endeavor, wherein Pochatko teaches a larger incision on the plantar aspect of the foot and using retractors could possibly reduce the risk of injury to subcalcaneal structures (pg.544, col.2, par.1). Pochatko teaches flexor hallucis longus as well as nerves are structures at risk of injury in the procedure (pg.543 Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Early in view of Janna to include the step of making a plantar incision over the guidewire and placing a retractor medial to a sustentaculum to protect a flexor hallucis longus tendon and an adjacent neurovascular bundle prior to the reaming since Pochatko teaches using an incision and retractors in order to protect structures, including flexor hallucis longus tendon and adjacent nerves, at risk during the procedure.
Regarding claim 20, see the rejection of claim 4 above. It would have been further obvious to insert the intramedullary nail along the guidewire and along the same path taught by Pochatko in order to ensure that the nail is optimally placed in the center of the talus and tibia.
Regarding claim 22, see the rejection of claim 3 above.
Regarding claim 23, see the rejection of claim 4 above.
Regarding claim 24, see the rejection of claim 6 above.
Regarding claim 25, see the rejection of claim 8 above.
Claims 9, 10, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Early in view of Janna in view of Pochatko as applied to claim 8 above, and further in view of Richter et al. US 2011/0282397 (hereafter referred to as Richter).
Regarding claims 9 and 26, Early in view of Janna in view of Pochatko discloses the method of claims 8 and 25 as discussed above, but Early in view of Janna in view of Pochatko does not disclose placing a drill sleeve over the guidewire prior to reaming in order to protect soft tissue.
Richter teaches a method for fusing a tibiotalar joint, in the same field of endeavor, wherein a drill sleeve 1458 is placed over a guidewire 1262 prior to reaming for the purpose of protecting a drill (par.98; fig.14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Early in view of Janna in view of Pochatko to include the step of placing a drill sleeve over a guidewire prior to reaming in order to protect the drill as taught by Richter, which also protects the surrounding soft tissue.
Regarding claim 10, Early in view of Janna in view of Pochatko in view of Richter discloses the method of claim 9 as discussed above. Early further discloses placing a plurality of screws 56 for fixing the intramedullary nail to the talus and tibia (Early figs. 2 and 3), but Early in view of Janna in view of Pochatko does not disclose using an outrigger to place the plurality of screws.
Richter teaches a method for fusing a tibiotalar joint, in the same field of endeavor, wherein an outrigger 1870 is used to insert a plurality of fasteners 22 for the purpose of aiming the fasteners relative to the position of the nail 18 (par.101; fig.19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Early in view of Janna in view of Pochatko to include the step of using an outrigger to place the plurality of screws as taught by Richter in order to align the screws relative to the nail as is customary in the art.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Early in view of Janna in view of Pochatko in view of Richter as applied to claim 10 above, and further in view of Duggal et al. US 2011/0166609 (hereafter referred to as Duggal).
Regarding claim 11, Early in view of Janna in view of Pochatko in view of Richter discloses the method of claim 10 as discussed above, however, Early in view of Janna in view of Pochatko in view of Richter does not disclose placing a compression screw in the tibia and talus with the outrigger outside of the intramedullary nail.
Duggal teaches a method for fusing a tibiotalar joint, in the same field of endeavor, wherein a supplemental compression screw 340 is placed in the tibia 2 and talus 6 with an outrigger 300 outside of an intramedullary nail 100 for the purpose of supplementing the nail for greater compression of the joint (par.130; fig. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Early in view of Janna in view of Pochatko in view of Richter to include the step of placing a compression screw in the tibia and talus with the outrigger outside of the intramedullary nail as taught by Duggal in order to improve the compression and fusing of the tibiotalar joint.
Regarding claim 12, Early shows multiple interlocking screws 56 placed proximally in the nail and the tibia in fig. 3.
Regarding claim 13, Early shows screw 56 through the nail 10 into the talus in a trans malleolar fashion in fig.3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Manderson US 2005/0107791 discloses a method of fusing just a tibiotalar joint (pars. 1, 13, and 39 disclose options of fusing tibiotalar or tibotalocalcaneal joints), the method comprising inserting an intramedullary nail into a talus and a tibia through a calcaneus (fig.1).
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774