DETAILED ACTION
This is a Non-Final Rejection for Application 18/189,063 filed March 23, 2023. This application claims the benefit of Provisional Application 63/269,798 filed March 23, 2022. Claims 5-22 are currently pending.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 6, 2026 has been entered.
Response to Amendment
The cancellation of claims 1-4 is acknowledged. The rejections drawn to claims 1-4 are withdrawn as a result of the cancellation.
It is acknowledged that claims 5 and 11-16 have been amended to overcome the prior rejection of record. Therefore, new grounds of rejection are presented below.
New claims 17-22 are acknowledged.
Response to Arguments
Applicant's arguments filed January 6, 2026 have been fully considered but they are not persuasive.
Applicant argues that Buethorn does not teach the reinforced AFO having a stirrup footplate component bonded to a main body and the claimed rectangular configuration.
This argument is not persuasive as these feature were not previously required. New grounds of rejection are presented below that address these features.
Applicant argues that Buethorn does not teach surrounding a user's ankle, and the does not include a foot portion configured to sit below and extend to a front portion of a user's foot.
This argument is moot as the rejection below depends on a different embodiment of Buethorn where these features are disclosed. See the rejection below.
Applicant argues that Buethorn teaches away from the AFO set forth in claims 11 and 13 by specifically avoiding ground interaction during terminal stance.
This argument is moot as the rejection below depends on a different embodiment of Buethorn where these features are disclosed. See the rejection below.
Applicant argues that the devices disclosed in Kimura et al. would not be considered by one skilled in the art when attempting to develop an improved AFO.
This argument is unpersuasive as Kimura is drawn to ankle-joint support and holders which falls in the same classification as Buethorn. Additionally, it has been held that a prior art reference must either be in the field of the inventor's endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Kimura is in the field of endeavor and is reasonably pertinent to the problem of instability in AFOs.
Applicant argues that Oster et al. does not teach a stirrup footplate that is symmetrical along a central axis.
This argument is unpersuasive as Fig. 3 of Oster clearly shows the sole 22 symmetrical about the central reference axis 36 which is further supported by Col. 4, Lns 58-61 calling the sole 22 a mirror image about the axis 36.
Claim Objections
Claim 11 is objected to because of the following informalities: “the first side extensions” in line 16 should not be plural since only one first side extension is claimed. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “wherein main body” in line 1 should recite the continuous main body previously claimed. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 is rejected because it cannot depend from itself and it is unclear which claim claim 21 was intended to depend from. Claim 21 will be interpreted as depending from claim 20 for the purposes of examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 5-22 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 5 recites “an upper section extending upwardly from the heel section and configured to substantially surround the user's heel and extending upward from below the ankle both medially and laterally to a point above an ankle joint of the user”. An ankle joint of the user is positively recited as part of the claimed structure. This rejection may be overcome with language such as “an upper section extending upwardly from the heel section and configured to substantially surround the user's heel and configured to extend
Claim 11 recites “wherein the heel end of the stirrup footplate has a cross-like structure with a central portion of the cross-like structure is configured to be situated below the heel of the user”; “wherein the heel extension is configured to extend~ beyond the user's heel and up a back portion of the AFO”; “the first side extensions is configured to extend from below the heel and up a medial side of the AFO”; and “wherein the heel end, the first side extension and the second side extension of the stirrup footplate providing addition support holding the user's foot in place.” These limitations encompass parts of a human organism. This rejection may be overcome with language such as “wherein the heel end of the stirrup footplate has a cross-like structure with a central portion of the cross-like structure [[is]] configured to be situated below the heel of the user”; “wherein the heel extension is configured to extend is configured to extend from below the heel and up a medial side of the AFO”; and “wherein the heel end, the first side extension and the second side extension of the stirrup footplate are configure to provide additional
Claim 17 recites “wherein the footplate of the AFO main body and the front end portion of the stirrup footplate extend to a position below the user's toes.” This limitation encompasses the user’s toes. This rejection may be overcome with language such as “wherein the footplate of the AFO main body and the front end portion of the stirrup footplate are configured to extend to a position below the user's toes.”
Claim 18 recites “wherein the front end portion of the stirrup footplate extends to a position beyond the user's toes.” This limitation encompasses the user’s toes. This rejection may be overcome with language such as “wherein the front end portion of the stirrup footplate is configured to extend
Claim 20 recites “wherein the footplate of the AFO main body and the front end portion of the stirrup footplate extend to a position below the user's toes.” This limitation encompasses the user’s toes. This rejection may be overcome with language such as “wherein the footplate of the AFO main body and the front end portion of the stirrup footplate are configured to extend to a position below the user's toes.”
Claim 21 recites “wherein the front end portion of the stirrup footplate extends to a position beyond the user's toes.” This limitation encompasses the user’s toes. This rejection may be overcome with language such as “wherein the front end portion of the stirrup footplate is configured to extend
Claims 6-10, 12-16, 19 and 22 are rejected for depending from and not curing the deficiencies of a rejected claim.
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(s) 5-6, 8, 10 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0238928 (Buethorn) in view of US 2014/0213953 (Heyd et al.), US 2012/0304491 (Kimura et al.) and US 2020/0383423 (Lee).
Regarding claim 5, Buethorn discloses a reinforced ankle foot orthosis (AFO) (Abstract – “A corrective device to be worn on a human foot having a misalignment and positioned inside of footwear.”), comprising:
an AFO main body formed of a first material ([0108] – “A medium height orthotic support device implementation 340 is shown in FIGS. 24-29 as having an inner shell 342 and an outer shell 344.” The inner shell 342 is interpreted as an AFO main body. [0108] – “the inner shell 342 and the outer shell 344 can be made from substantially the same material, similar material or even different material”.), comprising:
a heel section configured to surround a user's heel (posterior wall portion 352),
a footplate extending forwardly from a bottom portion of the heel section in a manner to support a forefoot of a user (base portion 306; Figs. 27 and 28.);
an upper section extending upwardly from the heel section and configured to substantially surround the user's heel and extending upward from below the ankle both medially and laterally to a point above an ankle joint of the user (posterior medial wall portion 348; posterior lateral wall portion 350; [0109] – “The inner shell 342 further includes an anterior medial wall portion 344, an anterior lateral wall portion 346, a posterior medial wall portion 348, a posterior lateral wall portion 350, and a posterior wall portion 352, which are shaped and extended farther than corresponding regions of the inner shell 302 of the short height orthotic device 300 to provide orthotic support and/or manipulation to a human foot and additional regions and can include those regions mentioned above for the short height orthotic device and also can include but not be limited to such regions as malleolus regions and talocrural regions.” Fig. 27.); and
wherein the material forming the main body has a predetermined level of flexibility ([0108] – “the inner shell 342 and the outer shell 344 […] may have varying rigidity and flexibility characteristics to accomplish an overall targeted balance of a desired degree of orthotic support and/or manipulation and an acceptable user comfort level.”); and
a stirrup footplate coupled to a bottom side of the AFO main body to provide reinforcement (outer shell 344), the stirrup footplate having a generally plate-like elongated configuration which extends along a main axis ([0110] – “The outer shell 344 includes the base portion 320 with the anterior portion 322 and the heel portion 323.” Figs. 24-28.), the stirrup footplate further having a front end portion coupled to and positioned below substantially an entire length of the footplate of the AFO (anterior portion 322; Figs. 24, 27 and 28; [0110] – “In other implementations the anterior portion 308 can be adjusted to extend either more or less forward than depicted in FIG. 24”.), wherein a forefoot structure formed by the coupled stirrup footplate and the footplate of the AFO is configured to create a ground reaction force that encourages knee extension, propulsion at push-off and contralateral increase step length (anterior portion 308; [0108] – “the inner shell 342 and the outer shell 344 […] may have varying rigidity and flexibility characteristics to accomplish an overall targeted balance of a desired degree of orthotic support and/or manipulation and an acceptable user comfort level.” A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114(II). In the instant case, the anterior portion 308 is capable of creating a ground reaction force that encourages knee extension, propulsion at push-off and contralateral increase step length due to its rigidity/flexibility.) and having a heel end (heel portion 323);
wherein the stirrup footplate is formed from a second material having a predetermined stiffness which is stiffer than the first material of the AFO, wherein the stirrup footplate will provide a support profile that provides a combined level of support to the user's heel and footplate when the AFO is worn by a user ([0108] – “the inner shell 342 and the outer shell 344 can be made from substantially the same material, similar material or even different material […] and may have varying rigidity and flexibility characteristics to accomplish an overall targeted balance of a desired degree of orthotic support and/or manipulation and an acceptable user comfort level.”).
Buethorn does not disclose wherein the AFO is unitary; a closure mechanism coupled to the heel section to provide closure of the AFO around the user's ankle; wherein the stirrup footplate is bonded to a bottom side of the AFO main body; the heel end with a cross-like shape bonded to and positioned below the heel section of the AFO, wherein the cross-like configuration has a pair of lateral extensions extending substantially perpendicularly from the main axis and sized so that an end portion of each lateral extension will extend up a side of the heel portion, the cross-like configuration further having a heel extension at the heel end extending along the main axis, the heel extension extending at least partially up a rear portion of the heel section of the AFO; and wherein the bonding of the stirrup footplate to the main body forms the unitary reinforced AFO.
However, Heyd teaches an analogous AFO with an inner and outer shell and a closure mechanism (Fig 1, closure mechanism 52).
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 system of Buethorn with a closure mechanism as taught by Heyd et al in order to better engage the user (Heyd et al [0030]).
Buethorn in view of Heyd is silent on wherein the AFO is unitary; wherein the stirrup footplate is bonded to a bottom side of the AFO main body; the heel end with a cross-like shape bonded to and positioned below the heel section of the AFO, wherein the cross-like configuration has a pair of lateral extensions extending substantially perpendicularly from the main axis and sized so that an end portion of each lateral extension will extend up a side of the heel portion, the cross-like configuration further having a heel extension at the heel end extending along the main axis, the heel extension extending at least partially up a rear portion of the heel section of the AFO; and wherein the bonding of the stirrup footplate to the main body forms the unitary reinforced AFO.
However, Kimura teaches an analogous foot orthosis that is combined with a larger foot support (in this case a shoe) having a heel end with a cross-like shape configured to be positioned below the heel section of the heel section of the AFO (Fig 25-26, body 1, heel end 23, cross with extensions 3), wherein the cross-like configuration has a pair of lateral extensions extending substantially perpendicularly from the main axis and sized so that an end portion of each lateral extension will extend up a side of the heel portion (Fig 26, lateral extensions 3 and 3’; [0071], body is a thermoplastic so it is formable), the cross-like configuration further having a heel extension at the heel end extending along the main axis (Fig 25-26, body 1, heel end 23).
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 shape of the heel and ankle portion of Buethorn in view of Heyd to have a cross configuration as taught by Kimura in order to allow for better modification to the user (Kimura et al [0076]).
Buethorn in view of Heyd and Kimura is silent on wherein the AFO is unitary; wherein the stirrup footplate is bonded to a bottom side of the AFO main body; and wherein the bonding of the stirrup footplate to the main body forms the unitary reinforced AFO.
However, Lee teaches an analogous foot plate bonded to a main body in the form of an outsole 24 attached to a lower surface of a midsole 22 by adhesive bonding. See [0016] and Fig. 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 outer shell to be adhesively bonded to the inner shell of Buethorn in view of Heyd and Kimura as taught by Lee so that the shells retain their positions relative to one another to prevent slipping and to absorb and disperse shocks applied to the foot during walking and running (Lee [0016]). By bonding the outer shell and inner shell of Buethorn, the AFO is unitary.
Regarding claim 6, Buethorn in view of Heyd, Kimura and Lee discloses the ankle foot orthosis (AFO) of claim 5 wherein the stirrup footplate has a predetermined thickness in a range of 1/16 inch to 1/4 inch (Buethorn claim 5; 0.0625 inches is 1/16 inch.).
Regarding claim 8, Buethorn in view of Heyd, Kimura and Lee discloses the ankle foot orthosis of claim 5 wherein the pair of lateral extensions includes an outside extension and an inside extension, and wherein the outside extension is configured to extend upwardly to a location below a user's fibula making up the lateral malleolus and tibia making up the medial malleolus (posterior medial wall portion 348; posterior lateral wall portion 350; [0109] – “The inner shell 342 further includes an anterior medial wall portion 344, an anterior lateral wall portion 346, a posterior medial wall portion 348, a posterior lateral wall portion 350, and a posterior wall portion 352, which are shaped and extended farther than corresponding regions of the inner shell 302 of the short height orthotic device 300 to provide orthotic support and/or manipulation to a human foot and additional regions and can include those regions mentioned above for the short height orthotic device and also can include but not be limited to such regions as malleolus regions and talocrural regions.” Fig. 27.).
Regarding claim 10, Buethorn in view of Heyd, Kimura and Lee discloses the ankle foot orthosis of claim 5 wherein the AFO main body is sized to fit within a shoe of the user (Buethorn Fig. 29).
Regarding claim 17, Buethorn in view of Heyd, Kimura and Lee discloses the AFO of claim 5 wherein the footplate of the AFO main body extend to a position below the user's toes (anterior portion 308; Figs. 24, 27 and 28; [0110] – “In other implementations the anterior portion 308 can be adjusted to extend either more or less forward than depicted in FIG. 24”.).
Buethorn in view of Heyd, Kimura and Lee, as applied above, does not disclose the front end portion of the stirrup footplate extend to a position below the user's toes.
However, Buethorn discloses another embodiment that is a short height orthotic support device implementation 300 where [0107] – “the anterior portion 322 can be adjusted to extend either further or less forward than depicted in FIG. 22 according to the degree of extension of the anterior portion 308 of the inner shell 302.”
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 length of the anterior portion 322 of the outer shell 344 of Buethorn in view of Heyd, Kimura and Lee as taught by Buethorn to adjust the flexibility and support of the outer shell (Buethorn [0107]).
Regarding claim 18, Buethorn in view of Heyd, Kimura and Lee discloses the AFO of claim 17 wherein the front end portion of the stirrup footplate extends to a position beyond the user's toes (As a result of the modification in response to claim 17, the anterior portion 322 extends to a position beyond the user’s toes as the anterior portion 308 does as well and the length of the anterior portion 322 is modified to extend the same length. Fig. 28.).
Regarding claim 19, Buethorn in view of Heyd, Kimura and Lee discloses the AFO of claim 5 wherein bonding of the stirrup footplate to the footplate of the AFO main body is achieved by thermal bonding, mechanical bonding or adhesive bonding (As a result of the modification in response to claim 5, the outer shell and inner shell are bonded by adhesive bonding as taught by Lee.).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0238928 (Buethorn) in view of US 2014/0213953 (Heyd et al.), US 2012/0304491 (Kimura et al.) and US 2020/0383423 (Lee), and further in view of WO 2019/076647 (Best).
Regarding claim 7, Buethorn in view of Heyd, Kimura and Lee discloses the ankle foot orthosis (AFO) of claim 6.
Buethorn in view of Heyd, Kimura and Lee is silent on wherein the stirrup footplate is formed of polypropylene and carbon infused polycarbonate.
Best teaches an analogous foot orthotic plastic that is formed of polypropylene and carbon infused polycarbonate (pg. 2, lns. 10-20; pg. 2, ln. 25-pg. 3 ln. 10, mixture of polypropylene and polycarbonate, both infused with carbon via the wood).
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 material Buethorn in view of Heyd, Kimura and Lee to be the mixture as taught by Best in order to create a stable but light weight system (Best pg. 2, lns. 10-20).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0238928 (Buethorn) in view of US 2014/0213953 (Heyd et al.), US 2012/0304491 (Kimura et al.) and US 2020/0383423 (Lee), and further in view of US 5,425,701 (Oster et al.).
Regarding claim 9, Buethorn in view of Heyd, Kimura and Lee discloses the ankle foot orthosis of claim 8.
Buethorn in view of Heyd, Kimura and Lee is silent on wherein the stirrup footplate is symmetric relative to the main axis and each of the lateral extensions are of the same length.
Oster teaches an analogous foot support system with a t-shape having a stirrup footplate continuous main body that is symmetrical along the main axis (col. 4, lns. 60-65, sole 22 is mirrored)
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 stirrup shaping of Buethorn in view of Heyd, Kimura and Lee to be symmetrical as taught by Oster in order to allow for use with either foot (Oster col. 4, lns. 55-60).
Claim(s) 11, 13 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0238928 (Buethorn) in view of US 2012/0304491 (Kimura et al.), US 2020/0383423 (Lee) and US 5,762,622 (Lamont).
Regarding claim 11, Buethorn discloses an ankle foot orthosis (AFO) (Abstract – “A corrective device to be worn on a human foot having a misalignment and positioned inside of footwear.”) comprising:
a main boot portion configured to surround a user's ankle ([0108] – “A medium height orthotic support device implementation 340 is shown in FIGS. 24-29 as having an inner shell 342 and an outer shell 344.” The inner shell 342 is interpreted as an AFO main boot portion. Posterior medial wall portion 348; posterior lateral wall portion 350; [0109] – “The inner shell 342 further includes an anterior medial wall portion 344, an anterior lateral wall portion 346, a posterior medial wall portion 348, a posterior lateral wall portion 350, and a posterior wall portion 352, which are shaped and extended farther than corresponding regions of the inner shell 302 of the short height orthotic device 300 to provide orthotic support and/or manipulation to a human foot and additional regions and can include those regions mentioned above for the short height orthotic device and also can include but not be limited to such regions as malleolus regions and talocrural regions.” Fig. 27.);
a foot portion configured to sit below and extend to a front end of a user's foot (base portion 306; Figs. 27 and 28.); and
a stirrup footplate having a continuous main body which is coupled to the foot portion (outer shell 344), the stirrup footplate having a front end portion and a heel end portion (anterior portion 322; heel portion 323), wherein the front end portion is situated below the foot portion and extending to a location proximate a front end of the foot portion thereby providing additional support for the front of the user's foot (anterior portion 322; Figs. 24, 27 and 28; [0110] – “In other implementations the anterior portion 308 can be adjusted to extend either more or less forward than depicted in FIG. 24”.), providing support for a user's sagittal plane deficits when used, and creating a ground reaction force that encourages knee extension, propulsion at push-off and contralateral increase step length ( [0108] – “the inner shell 342 and the outer shell 344 […] may have varying rigidity and flexibility characteristics to accomplish an overall targeted balance of a desired degree of orthotic support and/or manipulation and an acceptable user comfort level.” A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114(II). In the instant case, the AFO is capable of providing support for a user's sagittal plane deficits when used, and creating a ground reaction force that encourages knee extension, propulsion at push-off and contralateral increase step length due to its rigidity/flexibility.).
Buethorn does not disclose wherein the AFO is a unitary single piece; wherein the continuous main body is bonded to the foot portion; wherein the front end portion is substantially rectangular; and wherein the heel end of the stirrup footplate has a cross-like structure with a central portion of the cross-like structure is situated below the heel of the user, the cross-like structure further having a heel extension, a first side extension and a second side extension, wherein the heel extension extends beyond the user's heel and up a back portion of the AFO, the first side extensions extend from below the heel and up a medial side of the AFO and the second side extension is configured to extend from below the heel and up a lateral side of the AFO, wherein the heel end, the first side extension and the second side extension of the stirrup footplate providing addition support holding the user's foot in place.
However, Kimura teaches an analogous foot orthosis that is combined with a larger foot support (in this case a shoe) having a heel end with a cross-like shape configured to be positioned below the heel section of the heel section of the AFO (Fig 25-26, body 1, heel end 23, cross with extensions 3), wherein the cross-like configuration has a pair of lateral extensions extending substantially perpendicularly from the main axis and sized so that an end portion of each lateral extension will extend up a side of the heel portion (Fig 26, lateral extensions 3 and 3’; [0071], body is a thermoplastic so it is formable), the cross-like configuration further having a heel extension at the heel end extending along the main axis (Fig 25-26, body 1, heel end 23).
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 shape of the heel and ankle portion of Buethorn in view of Heyd to have a cross configuration as taught by Kimura in order to allow for better modification to the user (Kimura et al [0076]).
Buethorn in view of Kimura does not disclose wherein the AFO is a unitary single piece; wherein the continuous main body is bonded to the foot portion; wherein the front end portion is substantially rectangular.
However, Lee teaches an analogous foot plate bonded to a main body in the form of an outsole 24 attached to a lower surface of a midsole 22 by adhesive bonding. See [0016] and Fig. 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 outer shell to be adhesively bonded to the inner shell of Buethorn in view of Heyd and Kimura as taught by Lee so that the shells retain their positions relative to one another to prevent slipping and to absorb and disperse shocks applied to the foot during walking and running (Lee [0016]). By bonding the outer shell and inner shell of Buethorn, the AFO is unitary.
Buethorn in view of Kimura and Lee does not disclose wherein the front end portion is substantially rectangular.
However, Lamont discloses an analogous ankle foot orthosis with a cushion 14 analogous to the shells of Buethorn in view of Kimura and Lee. Lamont teaches that the cushion 14 has a central portion 48 and a pair of side panels or wings 50 and 52 and that the central portion 48 of the cushion has a somewhat rectangular configuration. Col. 3, Lns. 54-64 and Figs. 1 and 2.
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 front end portion of the anterior portion 322 of Buethorn in view of Kimura and Lee to be substantially rectangular as taught by Lamont such that the cushion is shaped to accommodate the user’s foot within a boot (Lamont Col. 4, Lns. 3-10).
Regarding claim 13, Buethorn in view of Kimura, Lee and Lamont discloses the AFO of claim 11 wherein the continuous main body is generally elongated extending along a main axis (outer shell 344 extends along a main axis. Fig. 24.).
Regarding claim 20, Buethorn in view of Kimura, Lee and Lamont discloses the AFO of claim 13 wherein the main body foot portion extend to a location below the user's toes (anterior portion 308; Figs. 24, 27 and 28; [0110] – “In other implementations the anterior portion 308 can be adjusted to extend either more or less forward than depicted in FIG. 24”.).
Buethorn in view of Kimura, Lee and Lamont, as applied above, does not disclose the front end portion of the stirrup footplate extend to a position below the user's toes.
However, Buethorn discloses another embodiment that is a short height orthotic support device implementation 300 where [0107] – “the anterior portion 322 can be adjusted to extend either further or less forward than depicted in FIG. 22 according to the degree of extension of the anterior portion 308 of the inner shell 302.”
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 length of the anterior portion 322 of the outer shell 344 of Buethorn in view of Heyd, Kimura and Lee as taught by Buethorn to adjust the flexibility and support of the outer shell (Buethorn [0107]).
Regarding claim 21, Buethorn in view of Kimura, Lee and Lamont discloses the AFO of claim 21 wherein the front end portion of the stirrup footplate extends to a position beyond the user's toes (As a result of the modification in response to claim 20, the anterior portion 322 extends to a position beyond the user’s toes as the anterior portion 308 does as well and the length of the anterior portion 322 is modified to extend the same length. Fig. 28.).
Regarding claim 22, Buethorn in view of Kimura, Lee and Lamont discloses the AFO of claim 13 wherein bonding of the stirrup footplate to the footplate of the AFO main body is achieved by thermal bonding, mechanical bonding or adhesive bonding (As a result of the modification in response to claim 11, the outer shell and inner shell are bonded by adhesive bonding as taught by Lee.).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0238928 (Buethorn) in view of US 2012/0304491 (Kimura et al.), US 2020/0383423 (Lee) and US 5,762,622 (Lamont), and further in view of WO 2019/076647 (Best).
Regarding claim 12, Buethorn in view of Kimura, Lee and Lamont discloses the AFO of claim 11.
Buethorn in view of Kimura, Lee and Lamont does not disclose wherein the continuous main body is formed of polypropylene and carbon infused polycarbonate.
Best teaches an analogous foot orthotic plastic that is formed of polypropylene and carbon infused polycarbonate (pg. 2, lns. 10-20; pg. 2, ln. 25-pg. 3 ln. 10, mixture of polypropylene and polycarbonate, both infused with carbon via the wood).
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 material Buethorn in view of Kimura, Lee and Lamont to be the mixture as taught by Best in order to create a stable but light weight system (Best pg. 2, lns. 10-20).
Claims 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0238928 (Buethorn) in view of US 2012/0304491 (Kimura et al.), US 2020/0383423 (Lee) and US 5,762,622 (Lamont), and further in view of US 5,425,701 (Oster et al.).
Regarding claim 14, Buethorn in view of Kimura, Lee and Lamont discloses the AFO of claim 13.
Buethorn in view of Kimura, Lee and Lamont does not disclose wherein the continuous main body is symmetrical along the main axis.
Oster teaches an analogous foot support system with a t-shape having a stirrup footplate continuous main body that is symmetrical along the main axis (col. 4, lns. 60-65, sole 22 is mirrored)
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 stirrup shaping of Buethorn in view of Heyd, Kimura and Lee to be symmetrical as taught by Oster in order to allow for use with either foot (Oster col. 4, lns. 55-60).
Regarding claim 15, Buethorn in view of Kimura, Lee, Lamont and Oster discloses the AFO of claim 14.
Buethorn in view of Kimura, Lee, Lamont and Oster, as applied above, does not disclose wherein the continuous main body further includes a transition area between the front end portion and the heel end, and wherein a width of the transition area in a direction perpendicular to the main axis is narrower than a width at any portion of the continuous main body.
Oster further disclose regions shown with a difference in width. The insert 30 of Oster is analogous to the outer shell of Buethorn in view of Kimura, Lee, Lamont and Oster, as applied above, and includes a transition area (notches 40) between the front end portion and the heel end, and wherein a width of the transition area in a direction perpendicular to the main axis is narrower than a width at any portion of the continuous main body (Oster Fig 3).
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 stirrup shaping of Buethorn in view of Kimura, Lee, Lamont and Oster, as applied above, to include a narrow transition area as taught by Oster in order to allow for the proper alignment of the insert with the sole (Oster Col. 7, Lns. 21-29).
Regarding claim 16, Buethorn in view of Kimura, Lee, Lamont and Oster discloses the AFO of claim 14 wherein main body has a predetermined thickness which is in a range of 1/16 inch to 1/4 inch (Buethorn claim 5; 0.0625 inches is 1/16 inch.).
Conclusion
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786