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 12/11/2025 has been received and made of record. Claims 17-33 are currently pending, of which claims 17-28 and 31-33 are being examined.
Response to Arguments
It is noted that applicant does not provide arguments in the response filed 12/11/2025.
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive. Applicant argues with respect to continuity that that parent support is present and refers to Figures 9-10 and 30. However, there are no Figures 9-10 and 30 in the parent application. It appears applicant is pointing to the current drawings. The parent application only has 4 Figures, which do not support the claimed subject matter as previously set forth. Therefore, the arguments are not persuasive.
Applicant’s arguments with respect to Lavery as a primary reference have been considered but are moot because the new ground of rejection does not rely on the reference applied in the prior rejection of record for any matter specifically challenged in the argument. Lavery, Slautterback, Bledsoe and Walborn are still applicable as teaching references as set forth below.
In response to applicant's argument that Powell is for a night restraint and not an insole integrated forefoot wedge inside an ambulatory boot, 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. Furthermore, Powell does disclose a forefoot wedge (100) as set forth below. Applicant’s arguments are therefore not persuasive.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/154,102, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application does not provide support for the claims 17-28 and 31-33 reciting an insole having an angular incline from a ball of the foot region to a distal toe region at an angle between 18 and 30 degrees.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-28 and 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 recites in lines 24-27 “wherein a forefoot portion of the insole includes an integral wedge that defines a fixed angular incline from a ball of foot region to a distal toe region, the incline being between 18° and 300, the incline being established by the insole geometry independent of any rocker angle of the protective foot covering”. Applicant’s original specification however, discloses that the insole may be raised or inclined by insertion of rigid/semi-rigid inserts (230, 232; Figures 15 and 30; [0076]). These inserts however are separate inserts that can be inserted and not “an integral wedge” that defines a “fixed angle”. For purposes of examination, it is being interpreted that the wedge can be a separate element and is not required to be integrally formed with the insole. Furthermore, applicant’s original specification does not provide support for the include being established by the insole geometry independent of an rocker angle of the protective foot covering. As discussed, the wedge or insert is a separate element and thus the angle is not established solely by the geometry of the sole. Furthermore, applicant’s specification does not disclose a foot covering having a rocker angle, so it is not disclosed that the insole geometry is independent of any rocker angle. The insole is resting and supported by the foot covering though, and would therefore be somewhat dependent on the geometry of the foot covering.
Claim 21 has been amended to recite the insole includes “a viscoelastic polyurethane foam top layer laminated to a stiffer support layer”. While PORON is known to be a polyurethane foam, it is not inherently a viscoelastic polyurethane foam top layer laminated to a stiffer support layer. The only disclosure of polyurethane in applicant’s specification is a “rigid thermoplastic polyurethane (TPU) shell with soft ethylene-vinyl acetate (EVA) liners may be used” in paragraph [0066], but that is not adequate support or disclosure for the newly added claim limitation of “a viscoelastic polyurethane foam top layer laminated to a stiffer support layer”.
Claim 24 recites “the insole comprises a compressible resilient top portion and a rigid lower portion, the rigid lower portion forming the integral forefoot wedge of 18-30 degrees”. Applicant’s specification discloses “Insole 200 may have an insole top layer 224 and an insole bottom layer 224.Top layer 224 may be a gel or foam to provide comfort to a user, while the bottom layer 224 may provide support and rigidity to provide the desired toe inclination and be formed of a rigid plastic or composite and the like.” [0074]. There is not support for the lower rigid portion forming the integral forefoot wedge of 18-30 degrees since there is no wedge shown in the embodiment of Figure 10.
Claim 31 has been amended to recite “the ankle foot brace comprises a rigid thermoplastic polyurethane (TPU) shell and soft ethylene vinyl acetate (EVA) liners at a cuff region and along an insole facing surface”. The specification discloses these materials in paragraph [0066] but does not specify they are at a cuff region and along an insole facing surface.
Claim 32 recites “under typical donning tension” and “relative to unweighted, unfastened state”. The original specification does not specify that the reduction by 25% is “under typical donning tension” “relative to an unweighted, unfastened state”. It just discloses that it is configured to be resilient and deformable to reduce the distance between the distal ends of the winds by up to 25%.
The remaining claims are rejected due to their dependency.
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.
Claims 17-28 and 31-33 are 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 17 recites “an ankle foot brace
Claim 17 recites in lines 24-27 “the incline being between 18° and 300, the incline being established by the insole geometry independent of any rocker angle of the protective foot covering”. This limitation is unclear since the foot covering has not been positively recited (see above). Furthermore, it is not clear if a rocker angle is required. In applicant’s disclosure, the insole is resting and supported by the foot covering though, and would therefore be somewhat dependent on the geometry of the foot covering. Thus, it is unclear to what extent this recitation limits the claim.
Claims 18-28 and 31-33 recite the limitation "The ankle foot orthotic" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested this be “The ankle foot orthotic assembly” to properly refer to the preamble in claim 1.
Claim 24 recites “the insole comprises a compressible resilient top portion and a rigid lower portion, the rigid lower portion forming the integral forefoot wedge of 18-30 degrees”. Applicant’s specification discloses “Insole 200 may have an insole top layer 224 and an insole bottom layer 224.Top layer 224 may be a gel or foam to provide comfort to a user, while the bottom layer 224 may provide support and rigidity to provide the desired toe inclination and be formed of a rigid plastic or composite and the like.” [0074]. The wedge as discussed with respect to claim 17 is a separate element. Therefore, it is unclear if the wedge is required to be more rigid or if the rigid portion is part of the insole.
Claim 32 recites “under typical donning tension”. It is unclear what would be considered “typical donning” versus untypical donning. Furthermore, such limitations are not present in the original specification and thus do not give any light into what would be considered typical.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17, 19, 22, 26-28, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Powell et al (US 5,887,591) in view of Lavery et al (US 6,485,447 B1).
Regarding claims 17 and 28, Powell discloses an ankle foot orthotic assembly (Figures 1-2), comprising: an ankle foot brace (10) capable of being inserted into an interior cavity of a protective foot covering (intended use), the ankle foot brace having a rear heel portion, an internal foot side portion, an external foot side portion and a bottom portion (Figure 1-2), a removable insole (300) received on the bottom portion within the brace (Figures 1-2; Col. 5, lines 20-35), the bottom portion inwardly extending along a perimeter of the rear heel portion, the internal foot side portion, and the external foot side portion, the removable insole having a bottom surface positioned adjacent a top surface of the inwardly extending bottom portion (Figures 1-2; Col. 5, lines 20-35) and a plurality of releasable straps (80) coupled to the brace and arranged to secure the insole and a user's ankle and foot inside a cavity formed by the rear heel portion, the internal foot side portion, the external foot side portion, and the bottom portion (Figures 1-2) wherein a forefoot portion of the insole includes an integral wedge (100) that defines a fixed angular incline from a ball of foot region to a distal toe region, the incline being between 18° and 30°, the incline being established by the insole geometry independent of any rocker angle of the protective foot covering (See Figures 1-2; Col. 4, lines 39-47; Col. 5, lines 56-65).
Powell discloses a removable insole (padding 300) and appears to show it angled (see unlabeled portion of 300 between toes and wedge) but does not explicitly disclose wherein the insole is configured with an angular incline from a ball of the foot regain to distal toe region at an angle of between 18 and 30 degrees. Lavery teaches a foot support device having a removable insole (12) having a bottom surface configured to be inserted adjacent to a top portion of the inwardly extending bottom portion (Figure 1; Col. 3, lines 60-67) , and wherein the insole (12) is configured with an angular incline from a ball of the foot region to distal toe region at an angle of between 18 and 30 degrees (Lavery discloses the surface is adjusted at hinged portion to provide various rocker angles including 20 degrees, Col. 3, lines 50-67; furthermore, the claim requires the insole be “configured” with an incline and thus a flexible pad or cushion is capable of having the angle between 18-30 degrees). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Powell having the insole taught by Lavery for providing cushioning between the user’s foot and the inclined wedge.
Regarding claim 19, Powell further discloses wherein each of the releasable straps is releasable by one of a hook and loop fastener and a buckle (90, Figures 1-2; Col. 3, line 65 to Col. 4 line 4).
Regarding claim 22, Powell and Lavery teach that as applied above. Lavery further teaches wherein the releasable straps are threaded though openings in the ankle foot brace at predetermined positions (32; see openings in Figure 1). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Powell having the straps through openings as taught by Lavery to prevent the straps from slipping while allowing them to be removed for washing.
Regarding claim 26, Powell discloses an ankle portion of the ankle foot brace and a foot portion of the ankle foot brace are integrally formed (Figure 1).
Regarding claim 27, Powell and Lavery teach that as applied above. Lavery discloses the surface to provide various rocker angles including 20 degrees and thus would be capable of adjusting to 21 degrees, Col. 3, lines 50-67. Furthermore, dependent on the place from which being measured it would be 21 degrees).
Regarding claim 32, Powell discloses wherein the ankle foot brace includes medial and lateral wind portion (wide edges of 20) and wherein under typical donning tension, the distance between distal ends of the wing portions is reduced by up to 25% relative to an unweighted, unfastened state (the restraint 10 is made of plastic material such a polypropylene (Col. 5, lines 50-55) which is disclosed by applicant as being a suitable material in [0072] and thus would be capable of deforming).
Claims 18, 20, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Powell et al (US 5,887,591) in view of Lavery et al (US 6,485,447 B1) in view of Slautterback et al (US 7,182,743 B2).
Regarding claim 18, Powell and Lavery disclose that as applied above but does not disclose wherein the protective foot covering is a boot having an integral fastenable flap to allow, when opened, insertion of the ankle foot brace and to hold the ankle foot brace in place when closed and retained on the user's foot and lower leg. Slautterback teaches an orthopedic night splint having an ankle foot brace (10) having an insole (16) and configured to be inserted into a protective foot covering (18), wherein the protective foot covering is a boot (18) having an integral fastenable flap (34) to allow, when opened, insertion of the ankle foot brace and to hold the ankle foot brace in place when closed and retained on the user's foot and lower leg (Figures 1 and 3). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the ankle brace of Powell and Lavery having the protective foot covering of Slautterback for providing a cushioning barrier and slipper-like feel when worn at night (Abstract, Slautterback).
Regarding claim 20, Powell and Lavery discloses that as applied above. Slautterback further teaches wherein the fastenable flap is one of a hook and loop fastener (40, 42; Col. 5, lines 10-15).
Regarding claim 24, Slautterback further teaches wherein decorative laces are applied to a tongue portion of the boot (Col. 5, lines 20-30).[AltContent: rect]
Regarding claim 25, Slautterback further teaches wherein the fastenable flap is configured to be positionable in an open position thereby exposing an interior of the boot to enhance user entry (Figure 3; Col. 5, lines 20-30).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Powell et al (US 5,887,591) in view of Lavery et al (US 6,485,447 B1) in view of Hanft (US 2023/0134968 A1).
Regarding claim 21, Powell discloses that as applied above wherein the insole (300) is a foam layer laminated to a stiffer support layer (15; Col. 5, lines 21-40) but does not disclose a viscoelastic polyurethane foam. Hanft teaches a foot protective device wherein an insole comprises a polyurethane PORON material ([0024], [0096]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Powell and Lavery wherein the foam is polyurethane PORON as taught by Hanft for providing high impact absorbing compression properties.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Powell et al (US 5,887,591) in view of Lavery et al (US 6,485,447 B1) in view of Bledsoe et al (US 2009/0043234 A1).
Regarding claim 23, Powell and Lavery discloses that as applied above. Powell further discloses a rigid lower portion forming the forefoot wedge of 18-30 degrees (Col. 4, lines 39-50). Powell does not disclose wherein the insole is comprised of a compressible resilient top portion. Bledsoe teaches a similar walking boot wherein an insole is comprised of a compressible resilient top portion and a rigid lower portion for accommodating varying shapes of the foot ([0070]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Powell and Lavery wherein the insole is comprised of a compressible resilient top portion and a rigid lower portion as taught by Bledsoe for accommodating varying shapes of the foot.
Claims 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Powell et al (US 5,887,591) in view of Lavery et al (US 6,485,447 B1) in view of Walborn et al (US 2015/0164179).
Regarding claim 31, Powell and Lavery discloses that as applied above. Powell discloses a rigid plastic polypropelene (Col. 5, lines 50-55) and softer foam liner (300, Col. 5, lines 36-40) but does not disclose wherein the ankle foot brace is composed of a rigid TPU shell with soft EVA liners. Walborn teaches an orthopedic device wherein the ankle foot brace is composed of a rigid TPU shell with soft EVA liners ([0036]-[0037]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Powell and Lavery made of TPU and EVA as taught by Walborn for user comfort while providing durability. Furthermore, it has been held that the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art. In re Leshin, 227 F.2d 197,125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide the device of Lavery made of TPU and EVA or any other suitable material that would provide comfort and stability to the user.
Regarding claim 33, Powell and Lavery discloses that as applied above but does not disclose wherein the ankle foot brace and insole are in mirror image pairs configured for a user's left and right ankle and foot. Walborn teaches wherein the ankle foot brace and insole are in mirror image pairs configured for a user's left and right ankle and foot (Figure 4; [0033]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Powell and Lavery wherein the ankle foot brace and insole are in mirror image pairs as taught by Walborn so that they can be used on a user's left and right ankle and foot.
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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/KARI K RODRIQUEZ/ Primary Patent Examiner, Art Unit 3786