DETAILED ACTION
This is a Non-Final Rejection for Application 18/889,306 filed September 18, 2024. Priority to Provisional Application 63/583,565 filed September 18, 2023 is acknowledged. Claims 1-24 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/05/25 has been entered.
Election/Restrictions
Claim 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 21, 2025.
Response to Amendment
The examiner acknowledges the amendments to claims 1 and 23. The amendments change the scope of the claims. Therefore, new grounds of rejection are presented below.
The amendment to the specification filed on 05/05/2025 is acknowledged. This amendment overcome the drawing objection, which is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 11/05/2025 have been fully considered but they are not persuasive. Applicant argues that “the cited prior art fails to disclose or suggest that "a first structural band of the one or more structural bands extends in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle," as required by amended Claim 1.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a first structural band in a horseshoe pattern) were not recited in the previously rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The added limitations were not previously presented, therefore new grounds of rejection are provided below.
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.
Claims 23 and 24 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 23 recites the limitation "at least one of the one or more attachment openings" in lines 18-19. There is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome with language such as “at least one attachment opening”.
Claim 24 requires the limitation “the first structural band is oriented along a path of maximum pressure during the patient’s gait” in lines 4-5. It is unclear if this limitation was intended to recite the second structural band instead as the first structural band is a horseshoe pattern about an upper portion of the patient’s ankle, which is not along the path of maximum pressure during the patient’s gait according to Applicant’s specification. Instead, the specification states that “the center gait-oriented structural band 142 can be oriented along a path of maximum pressure during gait that extends from the patient’s Achilles tendon to the center of the midfoot/base of the third metatarsal head, and then curves medially towards the first toe”. This more aligns with the second structural band which is further supported by the drawings. The examiner will interpret the claim as reciting the second structural band being oriented along a path of maximum pressure during the patient’s gait since this is the interpretation most consistent with the specification and drawings.
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 1-15 and 23-24 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).
Claims 1 and 23 recite the limitation “wherein a first structural band of the one or more structural bands extends in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle”. This limitation requires the patient’s ankle to be part of the invention which is excluded from the scope of patentable subject matter under 35 U.S.C. 101. This rejection may be overcome with language such as “wherein a first structural band of the one or more structural bands is configured to extend
Claim 24 recites the limitations “wherein a second structural band of the one or more structural bands is aligned centrally with the patient's Achilles tendon” and “the second structural band at least partially extending from a base of the patient's third metatarsal and towards the patient's first toe”. These limitations require the patient’s Achilles tendon, the patient's third metatarsal, and the patient's first toe to be part of the invention which are excluded from the scope of patentable subject matter under 35 U.S.C. 101. These rejections may be overcome with language such as “wherein a second structural band of the one or more structural bands is configured to be aligned centrally with the patient's Achilles tendon” and “the second structural band configured to be at least partially extending from a base of the patient's third metatarsal and towards the patient's first toe”.
Claims 2-15 are rejected for depending from claim 1 and consequently containing the limitations of claim 1. The 101 rejections of claims 2-15 are overcome by amending claim 1 to overcome the 101 rejection therein.
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.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2001/0027284 (Wellershaus) in view of US 2022/0401245 (Johnson) and US 2019/0240057 (Gunnsteinsson et al.).
Regarding claim 1, Wellershaus discloses a patient-specific ankle-foot orthotic (AFO) (Wellershaus discloses a foot lifter orthesis that is made to fit a wearer and is directed to the ankle and foot of the wearer. See the abstract and Fig. 1.), the AFO comprising:
a body (Leg shell 1 is interpreted as a body. See Fig. 1.) comprising:
an upper support member (The upper portion of leg shell 1 is interpreted as an upper support member. See the annotated Fig. below.) comprising:
a first outer surface and a first inner surface (The upper portion of leg shell 1 shows an outer surface in Fig. 1 and must have an inner surface opposite.),
the first inner surface designed to selectively engage with at least a portion of a patient’s calf (The upper portion of leg shell 1 is designed to engage the calf of the wearer. See [0013].);
a lower support member (The lower portion of leg shell 1 is interpreted as a lower support member. See the annotated Fig. below.) comprising:
a second outer surface and a second inner surface (The lower portion of leg shell 1 shows an outer surface in Fig. 1 and must have an inner surface opposite.),
the second inner surface designed to selectively engage with at least a portion of the patient’s ankle (The lower portion of leg shell 1 is designed to engage the ankle of the wearer. See [0013].);
a footplate (Forefoot shell section 3 is interpreted as a footplate. See Fig. 1.) comprising:
a third outer surface and a third inner surface (The forefoot shell section 3 shows an outer surface and inner surface in Fig. 1.),
the third inner surface designed to selectively engage with at least a portion of the patient’s foot (The forefoot shell section is designed to engage the patient’s foot. See [0014].); and
one or more structural bands disposed on portions of the first outer surface, second outer surface, and third outer surface (Wire inlays 4 are interpreted as structural bands and are disposed on portions of the outer surfaces of the upper and lower portions of the leg shell 1 and the forefoot shell section 3. See the annotated Fig. below.).
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Wellershaus does not disclose wherein a first structural band of the one or more structural bands extends in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle; and the design of the body based on a 3D model of the patient's lower leg, wherein the design of the body is patient-specific and pathology-specific.
However, Gunnsteinsson discloses an orthopedic walker comprising a body 180 as shown in Fig. 10D. The body 180 comprises structural features reinforcing the body in the form of supplementary material sections 181-184. The reinforcement feature 182 corresponds to the malleolus or ankle and is shown in Fig. 10D to have an arching, horseshoe-like shape. See [0164].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a wire inlay of Wellershaus in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle as taught by Gunnsteinsson. A skilled artisan would have been motivated to do so because Gunnsteinsson teaches that the reinforcement feature 182 reinforces the malleolus to provide improved stability and/or immobilization to the user's ankle ([0165]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foot orthotics with reinforcing members.
Additionally, Johnson discloses a knee-ankle-foot orthosis that, according to [0181], is manufactured using a scan of the wearer’s leg and then 3D printing the resulting custom orthotic. [0030] discloses that the scan is a 3D scan that is then fabricated. This makes the design of the knee-ankle-foot orthotic patient-specific and pathology-specific, and based on a 3D model of the patient’s lower leg. The orthotic is pathology-specific because biomechanical deformities are included since the orthotic is based on a scan of the wearer’s leg.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the device of Wellershaus to be 3D printed and based on a scan of the user’s leg as taught by Johnson. A skilled artisan would have been motivated to do so because Johnson teaches that by scanning the wearer’s leg and 3D printing the resulting orthotic, the orthotic is custom designed for the user ([0030]). One of ordinary skill in the art would recognize that custom designed orthotics are more effective in treating deformities and are more comfortable for the intended wearer. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle-foot orthotics.
As a result of the combination, Wellershaus in view of Johnson and Gunnsteinsson discloses wherein a first structural band of the one or more structural bands extends in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle (In view of Gunnsteinsson, a wire inlay of Wellershaus is positioned in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle to provide improved stability and/or immobilization to the user's ankle.); and
the design of the body based on a 3D model of the patient's lower leg, wherein the design of the body is patient-specific and pathology-specific (The design of the device of Wellershaus, which includes its body, is made using a scan of a wearer’s leg and then the device of Wellershaus is 3D printed. The resultant device of Wellershaus is patient-specific and pathology-specific because biomechanical deformities are included since the orthotic is based on a scan of the wearer’s leg).
Regarding claim 11, Wellershaus in view of Johnson, Gunnsteinsson discloses the patient-specific AFO of claim 1, wherein the one or more structural bands are edge structural bands (The wire inlays 4 are interpreted as edge structural bands. Absent a special definition of “edge structural bands” in the specification, the term is given its broadest reasonable interpretation in the art. The examiner is interpreting the term “edge structural bands” to be structural bands positioned near an edge of the device.).
Claims 2-4, 6, 10, 12-14 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2001/0027284 (Wellershaus) in view of US 2022/0401245 (Johnson) and US 2019/0240057 (Gunnsteinsson et al.), and further in view of US 2022/0313467 (Ducharme).
Regarding claim 2, Wellershaus in view of Johnson and Gunnsteinsson discloses the patient-specific AFO of claim 1.
Wellershaus in view of Johnson and Gunnsteinsson does not disclose a baseline thickness of about 1.5 mm to 5.0 mm.
However, Ducharme discloses an analogous ankle and foot brace comprising a sleeve 23. The sleeve 23 of the brace 10 of Ducharme is preferably from 2 to 10 mm is thickness. See [0075].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the baseline thickness of the device of Wellershaus to be 5 mm as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that a 5 mm baseline thickness allows for a low profile, which means that the brace can be worn under a user’s shoe ([0075]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the baseline thickness to be about 1.5 mm to 5.0 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses a baseline thickness of about 1.5 mm to 5.0 mm (The thickness of the device of Wellershaus can be about 5 mm which is within the claimed range in view of Ducharme.).
Regarding claim 3, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses the patient-specific AFO of claim 2, wherein the one or more structural bands include a width of about 1.0 mm to 10.0 mm (The wire inlays 4 are made of pre-bent spring steel wire with a diameter of 1.5 to 2 mm. See [0010] and [0015]. Therefore, the width of the wire inlays 4 are 1.5 to 2 mm which is within the claimed range.) and
contribute to an added thickness of about 0.5 mm to 5.0 mm to the baseline thickness (The wire inlays 4 are made of pre-bent spring steel wire with a diameter of 1.5 to 2 mm. See [0010] and [0015]. Therefore, the added thickness of the wire inlays 4 are 1.5 to 2 mm which is within the claimed range.).
Regarding claim 4, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses the patient-specific AFO of claim 3, wherein the lower support member comprises one or more struts (The lower portion of leg shell 1 is interpreted as comprising a strut. The term “strut” is being interpreted as its general definition absent a special definition in the specification. A strut is defined as “a rod or bar forming part of a framework and designed to resist compression” according to Google Dictionary.).
Regarding claim 6, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses the patient-specific AFO of claim 3.
Wellershaus in view of Johnson, Gunnsteinsson and Ducharme as applied above does not disclose wherein the upper support member includes one or more ventilation holes.
However, Ducharme further discloses that the material of the analogous brace comprises perforations such as pores or holes to allow evaporation of perspiration. See [0017].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add perforation to the material of Wellershaus as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that the perforations allow for evaporation of perspiration ([0017]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses wherein the upper support member includes one or more ventilation holes (The upper portion of the leg shell 1 includes ventilation holes.).
Regarding claim 10, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses the patient-specific AFO of claim 3, wherein the footplate comprises one or more raised walls (Fig. 1 shows wherein the forefoot shell section 3 comprises raised walls.).
Regarding claim 12, Wellershaus in view of Johnson and Gunnsteinsson discloses the patient-specific AFO of claim 1.
Wellershaus in view of Johnson and Gunnsteinsson does not disclose wherein the one or more structural bands are peripheral structural bands.
However, Ducharme discloses a series of plantar supports 150 as shown in Fig. 3. The two plantar supports 150 that are closer to the peripherals are interpreted as peripheral structural bands.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the plantar supports 150 of Ducharme to the outer surface of the footplate shell section 3 of Wellershaus as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that the plantar support 150 may be used to change the angle of the foot of the wearer ([0062]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses wherein the one or more structural bands are peripheral structural bands (The two plantar supports 150 of Ducharme disposed on the outer surface of the forefoot shell section 3 of Wellershaus that are closer to the peripherals are interpreted as peripheral structural bands. Absent a special definition of “peripheral structural bands” in the specification, the term is given its broadest reasonable interpretation in the art. The examiner is interpreting the term “peripheral structural bands” to be structural bands positioned at a peripheral of the device.).
Regarding claim 13, Wellershaus in view of Johnson and Gunnsteinsson discloses the patient-specific AFO of claim 1.
Wellershaus in view of Johnson and Gunnsteinsson does not disclose wherein the one or more structural bands are crossing structural bands.
However, Ducharme discloses two anterior struts 140 that form a gusset and another two anterior struts 152 opposite the struts 140. These struts 140, 152 cross beneath the device and are interpreted as crossing structural bands. See Figs. 3 and 4.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the struts of Ducharme to the outer surface of the forefoot shell portion 3 of Wellershaus as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that the struts anchor the base of the device and allow for the device to better fit various foot shapes ([0056] and [0057]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses wherein the one or more structural bands are crossing structural bands (The struts 140, 152 of Ducharme added to the outer surface of the forefoot shell portion 3 of Wellershaus are interpreted as crossing structural bands. Absent a special definition of “crossing structural bands” in the specification, the term is given its broadest reasonable interpretation in the art. The examiner is interpreting the term “crossing structural bands” to be structural bands that cross a centerline of the device.).
Regarding claim 14, Wellershaus in view of Johnson and Gunnsteinsson discloses the patient-specific AFO of claim 1.
Wellershaus in view of Johnson and Gunnsteinsson does not disclose wherein the one or more structural bands are gait-oriented structural bands.
However, Ducharme discloses a series of plantar supports 150 as shown in Fig. 3. The plantar supports 150 are interpreted as gait oriented structural bands.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the plantar supports 150 of Ducharme to the outer surface of the footplate shell section 3 of Wellershaus as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that the plantar support 150 may be used to change the angle of the foot of the wearer ([0062]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses wherein the one or more structural bands are gait-oriented structural bands (The plantar supports 150 of Ducharme disposed on the outer surface of the forefoot shell section 3 of Wellershaus are interpreted as gait-oriented structural bands. Absent a special definition of “gait-oriented structural bands” in the specification, the term is given its broadest reasonable interpretation in the art. The examiner is interpreting the term “gait-oriented structural bands” to be structural bands aligned with the direction of a user’s gait.).
Regarding claim 24, Wellershaus in view of Johnson and Gunnsteinsson discloses the patient-specific AFO of claim 1.
Wellershaus in view of Johnson and Gunnsteinsson does not disclose wherein a second structural band of the one or more structural bands is aligned centrally with the patient's Achilles tendon, the second structural band at least partially extending from a base of the patient's third metatarsal and towards the patient's first toe such that the second structural band is oriented along a path of maximum pressure during the patient's gait.
However, Ducharme discloses an ankle brace with a series of plantar supports 150 as shown in Fig. 3. The plantar supports are aligned centrally on the bottom of the foot plate of the brace and extend the entire length of the brace.
While Ducharme is not so specific as to disclose that the plantar supports are aligned centrally with the Achilles tendon and extending from a base of the patient's third metatarsal and towards the patient's first toe, it would have been an obvious matter of design choice to centrally align the plantar supports and for the plantar supports to extend from a base of the patient's third metatarsal and towards the patient's first toe, since such a modification would have involved a mere rearrangement of parts. The court has held that the particular placement of a component is an obvious matter of design choice absent criticality of the placement. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a plantar support of Ducharme to the foot sole region of Wellershaus aligned centrally with the patient's Achilles tendon and partially extending from a base of the patient's third metatarsal and towards the patient's first toe as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that the plantar supports connect the heel to the distal part of the brace ([0062]), which leads to the foot sole region being reinforced. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle orthotics with reinforcing members.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses wherein a second structural band of the one or more structural bands is aligned centrally with the patient's Achilles tendon, the second structural band at least partially extending from a base of the patient's third metatarsal and towards the patient's first toe such that the second structural band is oriented along a path of maximum pressure during the patient's gait (In view of Ducharme, the brace of Wellershaus comprises a plantar support, which is interpreted as a second structural band, that is aligned centrally with the patient's Achilles tendon and at least partially extends from a base of the patient's third metatarsal and towards the patient's first toe such that the second structural band is oriented along a path of maximum pressure during the patient's gait.).
Claims 5, 7-9, 15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2001/0027284 (Wellershaus) in view of US 2022/0401245 (Johnson), US 2019/0240057 (Gunnsteinsson et al.) and US 2022/0313467 (Ducharme), and further in view of US 2014/0371648 (DeHeer).
Regarding claim 5, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses the patient-specific AFO of claim 4.
Wellershaus in view of Johnson, Gunnsteinsson and Ducharme does not disclose wherein each of the one or more struts is angled by about 10.0 degrees to 40.0 degrees from vertical.
However, DeHeer discloses an analogous ankle and foot brace comprising an elongated rod 44, which is interpreted as a strut. The elongated rod 44 may have an angle of 10 degrees from vertical. See [0020].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to angle the forefoot shell section 3 and the rest of the leg shell 1 of Wellershaus to be 10 degrees less than 90 as taught be DeHeer. A skilled artisan would have been motivated to do so because DeHeer teaches that the angle places the wearer’s foot in dorsiflexion to treat equinus ([0020] and the abstract). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses wherein each of the one or more struts is angled by about 10.0 degrees to 40.0 degrees from vertical (The lower portion of the leg shell 1 of Wellershaus is angled 10.0 degrees from vertical.).
Regarding claim 7, Wellershaus in view of Johnson, Gunnsteinsson and Ducharme discloses the patient-specific AFO of claim 3.
Wellershaus in view of Johnson, Gunnsteinsson and Ducharme does not disclose wherein the upper support member includes at least one attachment opening.
However, DeHeer discloses an analogous ankle and foot brace comprising side slots 62, which are interpreted as attachment openings. See [0043] and Fig. 4.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the side slots 62 of DeHeer to the upper portion of the leg shell 1 of Wellershaus as taught by DeHeer. A skilled artisan would have been motivated to do so because DeHeer teaches that the side slots 62 allows for straps to fix the device to a wearer ([0041]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses wherein the upper support member includes at least one attachment opening (The upper portion of the leg shell 1 of Wellershaus comprises the side slots 62 of DeHeer.).
Regarding claim 8, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses the patient-specific AFO of claim 7.
Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer as applied above does not disclose an anterior plate, the anterior plate comprising a fourth outer surface having at least one attachment slot and a fourth inner surface, the fourth inner surface designed to selectively engage with an anterior portion of the patient’s lower leg.
However, DeHeer further discloses padding 80 which is interpreted as an anterior plate. See [0042] and Fig. 4.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the padding 80 of DeHeer to the device of Wellershaus as taught by DeHeer. A skilled artisan would have been motivated to do so because DeHeer teaches that the padding increases the comfort of the user ([0054]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses an anterior plate (The device of Wellershaus comprises the padding 80 of DeHeer.),
the anterior plate comprising a fourth outer surface having at least one attachment slot (The padding 80 of DeHeer comprises an outer surface and an attachment slot as is shown in Fig. 4.) and
a fourth inner surface (The padding 80 of DeHeer must comprise an inner surface opposite the outer surface. See Fig. 4.),
the fourth inner surface designed to selectively engage with an anterior portion of the patient’s lower leg (The padding 80 of DeHeer is designed to engage the anterior of a patient’s lower leg. See Fig. 4 and [0042].).
Regarding claim 9, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses the patient-specific AFO of claim 8, further comprising at least one attachment member designed to selectively engage with the at least one attachment opening and the at least one attachment slot (Wellershaus discloses a strap 2 that is designed to engage with the attachment opening on the padding 80 of DeHeer and the slot 62 of DeHeer positioned on the upper portion of the leg shell 1 of Wellershaus.).
Regarding claim 15, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses the patient-specific AFO of claim 8, wherein the body and the anterior plate are additively manufactured (The leg shell 1 of Wellershaus and the padding 80 of DeHeer are both manufactured and meet the prior claim limitations. The leg shell 1 of Wellershaus is 3D printed in view of the modification in claim 1 from the teachings of Johnson and the process which the padding 80 of DeHeer is disclosed broadly as plastic molding ([0037] of DeHeer).).
The recitation “additively manufactured” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I). Therefore, despite the different processes used in Wellershaus, Johnson and DeHeer from the present invention, the claimed invention is obvious from and unpatentable over the proposed combination of Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer.
Regarding claim 23, Wellershaus discloses a patient-specific ankle-foot orthotic (AFO), the AFO (Wellershaus discloses a foot lifter orthesis that made to fit a wearer and is directed to the ankle and foot of the wearer. See the abstract and Fig. 1.) comprising:
an additively manufactured body (Leg shell 1 is interpreted as a body. See Fig. 1. The leg shell 1 of Wellershaus is injection molded ([0010] of Wellershaus).) comprising:
an upper support member (The upper portion of leg shell 1 is interpreted as an upper support member. See the annotated Fig. below.) comprising:
a first outer surface and a first inner surface (The upper portion of leg shell 1 shows an outer surface in Fig. 1 and must have an inner surface opposite.),
the first inner surface designed to selectively engage with a portion of a patient’s calf (The upper portion of leg shell 1 is designed to engage the calf of the wearer. See [0013].);
a lower support member (The lower portion of leg shell 1 is interpreted as a lower support member. See the annotated Fig. below.) comprising:
a second outer surface and a second inner surface (The lower portion of leg shell 1 shows an outer surface in Fig. 1 and must have an inner surface opposite.),
the second inner surface designed to selectively engage with a portion of the patient’s ankle (The lower portion of leg shell 1 is designed to engage the ankle of the wearer. See [0013].);
a footplate (Forefoot shell section 3 is interpreted as a footplate. See Fig. 1.) comprising:
a third outer surface and a third inner surface (The forefoot shell section 3 shows an outer surface and inner surface in Fig. 1.),
the third inner surface designed to selectively engage with a portion of the patient’s foot (The forefoot shell section is designed to engage the patient’s foot. See [0014].);
one or more structural bands disposed on portions of the first outer surface, second outer surface, and third outer surface (Wire inlays 4 are interpreted as structural bands and are disposed on portions of the outer surfaces of the upper and lower portions of the leg shell 1 and the forefoot shell section 3. See the annotated Fig. below.); and
wherein the one or more structural bands include a width of about 1.0 mm to 10.0 mm (The wire inlays 4 are made of pre-bent spring steel wire with a diameter of 1.5 to 2 mm. See [0010] and [0015]. Therefore, the width of the wire inlays 4 are 1.5 to 2 mm which is within the claimed range.) and
contribute to an added thickness of about 0.5 mm to 5.0 mm to the baseline thickness (The wire inlays 4 are made of pre-bent spring steel wire with a diameter of 1.5 to 2 mm. See [0010] and [0015]. Therefore, the added thickness of the wire inlays 4 are 1.5 to 2 mm which is within the claimed range.).
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The recitation “additively manufactured” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I). Therefore, despite the different process used in Wellershaus from the present invention, the claimed invention is obvious from and unpatentable over Wellershaus.
Wellershaus does not disclose the design of the body based on a 3D model of the patient's lower leg, wherein the design of the body is patient-specific and pathology-specific, an anterior plate comprising: a fourth outer surface having at least one attachment slots and a fourth inner surface, the fourth inner surface designed to selectively engage with an anterior portion of the patient’s lower leg; at least one attachment member designed to selectively engage with at least one of the one or more attachment openings and the at least one attachment slots to secure the AFO to the patient’s lower leg; and a baseline thickness of about 1.5 mm to 5.0 mm , and wherein a first structural band of the one or more structural bands extends in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle.
However, Johnson discloses a knee-ankle-foot orthosis that, according to [0181], is manufactured using a scan of the wearer’s leg and then 3D printing the resulting custom orthotic. [0030] discloses that the scan is a 3D scan that is then fabricated. This makes the design of the knee-ankle-foot orthotic patient-specific and pathology-specific, and based on a 3D model of the patient’s lower leg. The orthotic is pathology-specific because biomechanical deformities are included since the orthotic is based on a scan of the wearer’s leg.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the device of Wellershaus to be 3D printed and based on a scan of the user’s leg as taught by Johnson. A skilled artisan would have been motivated to do so because Johnson teaches that by scanning the wearer’s leg and 3D printing the resulting orthotic, the orthotic is custom designed for the user ([0030]). One of ordinary skill in the art would recognize that custom designed orthotic are more effective in treating deformities and are more comfortable for the intended wearer. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle-foot orthotics.
DeHeer discloses padding 80 which is interpreted as an anterior plate. See [0042] and Fig. 4.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the padding 80 of DeHeer to the device of Wellershaus as taught by DeHeer. A skilled artisan would have been motivated to do so because DeHeer teaches that the padding increases the comfort of the user ([0054]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
Ducharme discloses an analogous ankle and foot brace comprising a sleeve 23. The sleeve 23 of the brace 10 of Ducharme is preferably from 2 to 10 mm is thickness. See [0075].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the baseline thickness of the device of Wellershaus to be 5 mm as taught by Ducharme. A skilled artisan would have been motivated to do so because Ducharme teaches that a 5 mm baseline thickness allows for a low profile, which means that the brace can be worn under a user’s shoe ([0075]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to ankle and foot support braces.
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the baseline thickness to be about 1.5 mm to 5.0 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Finally, Gunnsteinsson discloses an orthopedic walker comprising a body 180 as shown in Fig. 10D. The body 180 comprises structural features reinforcing the body in the form of supplementary material sections 181-184. The reinforcement feature 182 corresponds to the malleolus or ankle and is shown in Fig. 10D to have an arching, horseshoe-like shape. See [0164].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add a wire inlay of Wellershaus in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle as taught by Gunnsteinsson. A skilled artisan would have been motivated to do so because Gunnsteinsson teaches that the reinforcement feature 182 reinforces the malleolus to provide improved stability and/or immobilization to the user's ankle ([0165]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foot orthotics with reinforcing members.
As a result of the combination, Wellershaus in view of Johnson, Gunnsteinsson, Ducharme and DeHeer discloses the design of the body based on a 3D model of the patient's lower leg, wherein the design of the body is patient-specific and pathology-specific (The design of the device of Wellershaus, which includes its body, is made using a scan of a wearer’s leg and then the device of Wellershaus is 3D printed. The resultant device of Wellershaus is patient-specific and pathology-specific because biomechanical deformities are included since the orthotic is based on a scan of the wearer’s leg),
an anterior plate (The device of Wellershaus comprises the padding 80 of DeHeer.) comprising:
a fourth outer surface having at least one attachment slots (The padding 80 of DeHeer comprises an outer surface and an attachment slot as is shown in Fig. 4.) and
a fourth inner surface (The padding 80 of DeHeer must comprise an inner surface opposite the outer surface. See Fig. 4.),
the fourth inner surface designed to selectively engage with an anterior portion of the patient’s lower leg (The padding 80 of DeHeer is designed to engage the anterior of a patient’s lower leg. See Fig. 4 and [0042].);
at least one attachment member designed to selectively engage with at least one of the one or more attachment openings and the at least one attachment slots to secure the AFO to the patient’s lower leg (Wellershaus discloses a strap 2 that is designed to engage with the attachment opening on the padding 80 of DeHeer and the slot 62 of DeHeer positioned on the upper portion of the leg shell 1 of Wellershaus.); and
a baseline thickness of about 1.5 mm to 5.0 mm (The thickness of the device of Wellershaus can be about 5 mm which is within the claimed range in view of Ducharme.), and
wherein a first structural band of the one or more structural bands extends in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle (In view of Gunnsteinsson, a wire inlay of Wellershaus is positioned in a horseshoe pattern about an upper portion of the patient's ankle between a medial side of the patient's ankle and a lateral side of the patient's ankle to provide improved stability and/or immobilization to the user's ankle.).
Conclusion
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786