DETAILED ACTION
This is a Non-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 and 18-27 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
Applicant’s election without traverse of invention I in the reply filed on February 24, 2026 is acknowledged. Claims drawn to invention II have been cancelled by Applicant and new claims 18-27 have been added. New claims 18-27 are drawn to the same invention as invention I and will be examined with claims 1-5.
Claim Objections
Claim 1 is objected to because of the following informalities: “a position of ball support assembly” in line 3 is improper grammar and should be “a position of the ball support assembly”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “a position of the ball support assembly” in line 4 is already recited in claim 1 and should be “[[a]] the position of the ball support assembly”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: “a position of the ball support assembly” in line 3 is already recited in claim 1 and should be “[[a]] the position of the ball support assembly”. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: “a ball portion of the foot” in line 2 is already recited in claim 1 and should be “[[a]] the ball portion of the foot”. 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 depends from claim 8 however, claim 8 is cancelled so the dependency of claim 21 is unclear. For the purposes of examination, claim 21 will be interpreted as depending from claim 20 as claim 21 recites “the track” and claim 20 recites “an axially extending track”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 18-22, 24 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0209163 (Phillips).
The examiner notes that the Phillips is one of the inventors of the present application however, US 2012/0209163 was published Aug. 16, 2012 which qualifies it as prior art since the effective filing date of the present application is November 13, 2015.
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 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.).
Regarding claim 3, Phillips 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 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 PA.sub.1 (FIGS. 3 and 4).” Leg member 14 is interpreted as a lower leg assembly.).
Regarding claim 18, Phillips 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 discloses an ankle stretch orthosis as set forth in claim 1, wherein the adjustment mechanism comprises an axial adjustment mechanism configured for selectively adjusting a 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 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 discloses an ankle stretch orthosis as set forth in claim [[8]] 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 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 24, Phillips 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 ([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 a pronation/supination adjustment mechanism since it is capable of adjusting the position of the forefoot securement assembly 20 to accommodate a foot that is one of pronated and supinated.).
Regarding claim 27, Phillips 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.”).
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) 2, 5, 23 and 25-26 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 2, Phillips 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.).
Phillips does not disclose the adjustment mechanism being configured for selectively adjusting a position of the ball support assembly along a lateral axis transverse to the longitudinal axis of the foot plate.
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 the adjustment mechanism being configured for selectively adjusting a position of the ball support assembly along a lateral axis transverse to the longitudinal axis of the foot plate (Fastener 214 and slot 212 are configured to adjust a position of the carriage 36 along a lateral axis transverse to the longitudinal axis of the device.).
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 5, Phillips 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 mount (Carriage 36 is interpreted as a ball support plate and forefoot plate 32 is interpreted as a ball support mount.).
Phillips does not disclose an elongate slot and the adjustment mechanism comprising a fastener extending through the slot and selectively securing the ball support plate to the ball support mount.
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 an elongate slot and the adjustment mechanism comprising a fastener extending through the slot and selectively securing the ball support plate to the ball support mount (Fastener 214 extends through slot 212 and selectively secures the cradle 194 to the carriage 196.).
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 23, Phillips discloses an ankle stretch orthosis as set forth in claim 1.
Phillips does not disclose wherein the ball support assembly is selectively movable in medial and lateral directions relative to the foot plate.
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 ball support assembly is selectively movable in medial and lateral directions relative to the foot plate (Carriage 196 is selectively movable in medial and lateral directions relative 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 25, Phillips discloses an ankle stretch orthosis as set forth in claim 1, wherein the ball support assembly comprises a ball support plate (Carriage 36 is interpreted as a ball support plate.).
Phillips does not disclose an arcuate elongate slot and the adjustment mechanism comprising at least one fastener extending through the arcuate elongate slot.
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 an arcuate elongate slot and the adjustment mechanism comprising at least one fastener extending through the arcuate elongate slot (Slot 212 is an arcuate elongate slot and fasteners 214 extend through the slot.).
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 26, Phillips discloses an ankle stretch orthosis as set forth in claim 1.
Phillips does not disclose wherein the adjustment mechanism is configured to permit the ball support assembly to float 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 during use of the orthosis to automatically adjust its position for pronation or supination of the foot (The fastener 214 are configured to allow the carriage 196 to float 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.
Conclusion
The following prior art made of record and not relied upon are considered pertinent to
applicant's disclosure.
US 5,697,893 (Rhenter)
US 7,112,181 (DeToro et al.)
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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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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