DETAILED ACTION
This is a Final Rejection for Application 18/943,530 filed November 11, 2024. The present application is a continuation of U.S. Serial No. 15/350,656, filed November 14, 2016, which claims priority to U.S. Provisional Application No. 62/255,023, filed November 13, 2015. Claims 1-5, 18-25 and 27 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 .
Election/Restrictions
Claims 1-5, 18-25 and 27 remain drawn to invention I, which was elected without traverse in the reply filed on February 24, 2026.
Response to Amendment
The amended claims filed July 23, 2026 are acknowledged.
The claim objections indicated in the Office action filed April 23, 2026 are overcome by amendment and are hereby withdrawn.
The 35 USC § 112(b) claim rejection indicated in the Office action filed April 23, 2026 is overcome by amendment and is hereby withdrawn.
The scope of independent claim 1 has been amended, therefore new grounds of rejection are presented below.
Response to Arguments
Applicant's arguments filed July 23, 2026 have been fully considered but they are not persuasive.
Applicant argues that the combination of Phillips in view of Patchel does not teach the limitations of amended claim 1.
Applicant’s argument attacks Patchel’s spring 218 as creating the opposite of a free floating assembly however, the combination proposed in response to claim 26 in the Office action filed April 23, 2026 does not rely on Patchel’s spring 218 to teach the claimed limitation. The combination proposed in response to claim 26 in the previous Office action is to modify the carriage 36 of Phillips to include a slot and to modify the forefoot securement assembly 20 of Phillips to include a fastener. The slot and fastener are taught by Patchel in the form of slot 212 and fasteners 214. These features teach the claimed limitation without the spring 218 of Patchel, therefore the argument is unpersuasive.
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) 1-5, 18-25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0209163 (Phillips) in view of US 5,358,469 (Patchel et al.).
Regarding claim 1, Phillips discloses an ankle stretch orthosis (Abstract – “An ankle foot orthosis includes a leg member, a foot member, and a drive member.” See [0037] and Figs. 1-7.) comprising
a foot assembly having a ball support assembly adjustably mounted on a foot plate (Fig. 6 is an exploded view of the foot member of the ankle foot orthosis. Foot member 12 is interpreted as a foot assembly; forefoot securement assembly 20 is interpreted as a ball support assembly; and rigid base 22 is interpreted as a foot plate.),
the foot assembly comprising an adjustment mechanism configured for selectively adjusting a position of the ball support assembly relative to the foot plate to align the ball support assembly with a ball portion of a foot that is one of supinated and pronated ([0034] – “The forefoot plate 32 may be slidably adjusted, such as by loosening the set screw 3[9] and sliding the forefoot plate on the base 22”. Set screw 39 is interpreted as an adjustment mechanism and the set screw 39 is configured to allow for adjustment of the forefoot plate 32, which is a component of the forefoot securement assembly 20, to align the forefoot plate 32 with a ball portion of a foot that is one of supinated and pronated.).
Phillips does not disclose wherein the adjustment mechanism is configured to permit the ball support assembly to float freely during use of the orthosis to automatically adjust its position for pronation or supination of the foot.
However, Patchel discloses “a dynamic ankle splint incorporating a correction cradle. The correction cradle applies a torsional force to the foot, thus permitting correction of inversion and eversion of the foot in conjunction with correction of dorsiflexion and plantar flexion.” (abstract) See Figs. 14 and 15. The ankle splint comprises a cradle 194 which supports a foot carriage 196. The cradle 194 is analogous to the carriage 36 of Phillips and the carriage 196 is analogous to the forefoot securement assembly 20 of Phillips. The cradle 194 includes a slot 212 that fasteners 214 are coupled to facilitate sliding of the carriage 196 along slot 212 (Col. 10, Lns. 14-34). Therefore, Patchel discloses wherein the adjustment mechanism is configured to permit the ball support assembly to float freely during use of the orthosis to automatically adjust its position for pronation or supination of the foot (The fasteners 214 are configured to permit the carriage 196 to float freely during use of the orthosis to automatically adjust its position for pronation or supination of the foot since the fastener 214 is loosely connected to the cradle 194.).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a slot and fasteners to the carriage 36 and forefoot securement assembly 20 of Phillips, respectively as taught by Patchel. A skilled artisan would have been motivated to do so because Patchel teaches that the slot 212 and fastener 214 permits correction of inversion and eversion of the foot (Col. 11, Lns. 15-23). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn ankle orthotics.
Regarding claim 2, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, further comprising a cuff configured to receive the foot therein so that a longitudinal axis of the foot is generally parallel with a longitudinal axis of the foot plate ([0018] – “Referring to FIGS. 1-4 and 6, the foot member 12 includes a heel securement assembly 18”. The heel securement assembly 18 is interpreted as a cuff and is configured to receive the foot therein so that a longitudinal axis of the foot is generally parallel with a longitudinal axis of the rigid base 22.),
the adjustment mechanism being configured for selectively adjusting the position of the ball support assembly along a lateral axis transverse to the longitudinal axis of the foot plate (In view of Patchel, the fastener and slot are configured to adjust a position of the carriage 36 along a lateral axis transverse to the longitudinal axis of the device; Col. 10, Lns. 14-34.).
Regarding claim 3, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the adjustment mechanism is configured to selectively permit movement of the ball support assembly relative of the foot plate when the foot is secured to the orthosis ([0034] – “The forefoot plate 32 may be slidably adjusted, such as by loosening the set screw 3[9] and sliding the forefoot plate on the base 22”.).
Regarding claim 4, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, further comprising a lower leg assembly, the foot assembly being selectively rotatable relative to the lower leg assembly ([0027] – “Referring now to FIGS. 1-4 and 6, the illustrated foot member 12 includes a strut, generally indicated at 74, that is hingedly secured to the bracket 64, more specifically the lateral portion of the bracket, to allow for pivotal movement between the leg member 14 and the foot member 12 about a pivot axis PA1 (FIGS. 3 and 4).” Leg member 14 is interpreted as a lower leg assembly.).
Regarding claim 5, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the ball support assembly comprises a ball support plate having an elongate slot and a ball support mount, the adjustment mechanism comprising a fastener extending through the slot and selectively securing the ball support plate to the ball support mount. (Carriage 36 is interpreted as a ball support plate and forefoot plate 32 is interpreted as a ball support mount. In view of Patchel, carriage 36 has an elongate slot and forefoot plate 32. The fastener in view of Patchel extends through the slot and selectively secures the forefoot plate 32 to the carriage 36.).
Regarding claim 18, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the foot assembly further comprises a heel support mounted on the foot plate, the adjustment mechanism being configured to selectively adjust the position of the ball support assembly relative to the heel support ([0018] – “Referring to FIGS. 1-4 and 6, the foot member 12 includes a heel securement assembly 18”. The heel securement assembly 18 is interpreted as a heel support and set screw 39 is configured to allow for adjustment of the forefoot plate 32 relative to the heel securement assembly 18.).
Regarding claim 19, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the adjustment mechanism comprises an axial adjustment mechanism configured for selectively adjusting the position of the ball support assembly along a longitudinal axis of the foot plate ([0034] – “The forefoot plate 32 may be slidably adjusted, such as by loosening the set screw 3[9] and sliding the forefoot plate on the base 22”.).
Regarding claim 20, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the foot plate defines an axially extending track, and wherein the ball support assembly is slidably mounted on the track ([0020] – “The carriage 36 includes pins 37 that slidably retain the carriage on a flange or rail 38 of the base 22.” Rail 38 is interpreted as an axially extending track that the forefoot securement assembly 20 is slidably mounted on.).
Regarding claim 21, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 20, wherein the adjustment mechanism comprises a thumb screw configured to be loosened to permit the ball support assembly to slide axially along the track and tightened to secure the ball support assembly to the track (Set screw 39; See [0020] and [0034].).
Regarding claim 22, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the ball support assembly comprises a ball support plate and a ball support pad attached to the ball support plate ([0020] – “The forefoot plate 32 includes a pad 35, which has a generally planar support surface on which the forefoot of the wearer rests.” Forefoot plate 32 is interpreted as a ball support plate and pad 35 is interpreted as a ball support pad.).
Regarding claim 23, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the ball support assembly is selectively movable in medial and lateral directions relative to the foot plate (The forefoot plate 32 is selectively movable in medial and lateral directions relative to the rigid base 22 via the slot and fasteners in view of Patchel.).
Regarding claim 24, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the adjustment mechanism comprises a pronation/supination adjustment mechanism configured to adjust the position of the ball support assembly to accommodate a foot that is one of pronated and supinated (The fasteners and slot in view of Patchel are interpreted as a pronation/supination adjustment mechanism as the fastener and slot allow pronation and supination of the foot.).
Regarding claim 25, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, wherein the ball support assembly comprises a ball support plate defining an arcuate elongate slot, the adjustment mechanism comprising at least one fastener extending through the arcuate elongate slot (In view of Patchel, carriage 36 has an elongate slot and the fastener in view of Patchel extends through the slot and selectively secures the forefoot plate 32 to the carriage 36.).
Regarding claim 27, Phillips in view of Patchel discloses an ankle stretch orthosis as set forth in claim 1, further comprising a plurality of hook and loop fasteners configured to secure a ball portion of the foot against the ball support assembly (Strap 34 and strap 26 are configured to secure a ball portion of the foot against the forefoot securement assembly 20. [0019] – “The first strap component 26a includes fastening components, such as hook and loop components, so that the strap 26 is adjustable and may be tightened over the wearer's foot F.” [0021] – “The strap 34 includes a releasable fastening component, such as hook and look components, to adjustably tighten the strap and releasably fasten the forefoot of the wearer to the plate 32.”).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Rachael Bredefeld can be reached at (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH R. BROWN/Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
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