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 .
Status of Claims
Claims 1-21 are pending and examined below
Response to Arguments
The remarks of 03/20/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of amended claim 1, in particular applicant argues the following claim limitations:
“a rigid, monolithic base”
Regarding the first bullet point – Applicant argues that the proposed modification of Lecomte in view of Moser would change the principle of operation of the prior art being modified because the base of Lecomte is flexible while the base of Moser is rigid.
However, this concern is specifically addressed in Lecomte. Column 5, Lines 40-45 of Lecomte “reads the first flexible member 30 can be substantially inelastic, so as to provide a rigid connection”. Lecomte continues to read “other flexible members 40,50, which are described below, can be formed of similar materials and have similar connections to the first flexible member 30”. Therefore, 30 and 40 can be replaced by a rigid, monolithic base, as suggested in Moser, and the principle of action is still based on actuator 80 and the speed of the user.
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, 7-9, 11, 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,980,648 (Lecomte) in view of US 2019/0021882 (Moser)
Regarding claim 1, Lecomte discloses a prosthetic ankle assembly (Fig. 1B) comprising:
a prosthetic adapter (Fig. 1B, 10);
a hydraulic cylinder (Fig. 1B, 80) rotatably attached to the prosthetic adapter to define a first pivot point (Fig. 1, 14), the hydraulic cylinder configured to resist rotation of the ankle assembly (Col. 7, Lines 21-24, wherein “providing a dampening effect” corresponds to configured to resist rotation”); and
a second pivot point (see annotated Fig. 1B below) and a third pivot point (see annotated Fig. 1B below), wherein the first pivot point and the second pivot point define a first pivot distance (see annotated Fig. 1B below), the second pivot point and the third pivot point define a second pivot distance (see annotated Fig. 1B below), and the first pivot point and the third pivot point define a third pivot distance (see annotated Fig. 1B below); and
wherein the first pivot distance is greater than 30 millimeters, the second pivot distance is greater than 30 mm, and the third pivot distance is greater than 30 mm (see Fig. 1B, wherein 52 has the length of a foot – therefore the first, second, and third pivot distance inherently must be greater than 30mm)
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Lecomte discloses a second pivot point and a third pivot point (Fig. 1) but doesn't explicitly teach or disclose a monolithic base
Moser discloses a rigid, monolithic base (Fig. 1, 12a, ¶0034) attached to the prosthetic adapter (Fig. 1, 16) to define a second pivot point (Fig. 1, 24) and attached to the hydraulic cylinder to define a third pivot point (Fig. 1, 30)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic ankle assembly of Lecomte with a rigid, monolithic base, as taught by Moser, in order to transfer proximal forces distally to the prosthetic foot.
Regarding claim 5, Lecomte discloses wherein the hydraulic cylinder (Fig. 1b, 80) is a hydraulic cylinder configured to dampen rotation of the prosthetic ankle assembly (Col. 7, Lines 21-24, “providing a dampening effect”)
Regarding claim 7, Lecomte discloses wherein an axis of rotation is positioned forward of a pyramid connector axis (see annotated Fig. 1B below) and is configured to be in line with a center of mass of a user when the user is in a standing position (see Fig. 1B, wherein the axis of rotation is in line with center of mass of user in a standing position because it is positioned at a point about 1/3 of the foot’s length forward from the back of the heel)
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Regarding claim 8, Lecomte discloses wherein an axis of rotation is positioned forward of a pyramid connector axis (see annotated Fig. 1B below) and is configured to be in line with a center of mass of a user when the user is in a standing position (see Fig. 1B, wherein the axis of rotation is in line with center of mass of user in a standing position because it is positioned at a point about 1/3 of the foot’s length forward from the back of the heel)
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Regarding claim 9, Lecomte discloses a hydraulic cylinder (see rejection of claim 1) configured to dampen rotation of the hydraulic ankle assembly (Col. 7, Lines 21-24, “providing a dampening effect”) but doesn't explicitly teach or disclose a plurality of cavities and channels configured to channel a hydraulic fluid and a plantarflexion lock valve.
Moser discloses wherein the hydraulic cylinder comprises a plurality of cavities (Fig. 1, 26A + 26B, ¶0037) and channels (¶0037, “bypass passages”) configured to channel a hydraulic fluid (¶0039, “hydraulic fluid”) and a plantarflexion lock valve (Fig. 1, 32) positioned within at least one of the cavities (Fig. 2, wherein 32 is positioned within a cavity) and the channels (Fig. 1, 34); and wherein the plantarflexion lock valve allows hydraulic fluid to circulate until the prosthetic ankle assembly reaches a maximum dorsiflexion position and locks at the maximum dorsiflexion position (¶0039, wherein “dorsiflexion limit” corresponds to maximum dorsiflexion position”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte with a plurality of cavities, a plurality of channels, and a plantarflexion lock valve, as taught by Moser, in order to set adjustable limits for both plantarflexion and dorsiflexion for increased patient safety.
Regarding claim 11, Lecomte discloses a prosthetic ankle assembly (Fig. 1A) comprising:
a rigid, monolithic base (Fig. 1A, 30, see also Col. 5, Lines 40-42, wherein 30 forms a rigid connection) attached to at least one composite foot spring (Fig. 1, wherein 30 is attached to 50, see also Col. 5, Lines 36-40 for carbon and glass fiber composite material), the rigid base defining a foot pivot axis (Fig. 1, wherein 16 corresponds to the foot pivot axis),
a prosthetic adapter (Fig. 1B, 10) rotatably attached to the rigid base (Fig. 1, wherein 10 is rotatably attached to 30 at 16), the prosthetic adapter comprising a prosthetic pyramid (Fig. 1B, 12) with a pyramid axis (see annotated Fig. 1B below); the foot pivot axis positioned forward of the pyramid connector axis (see annotated Fig. 1B below, wherein the foot pivot axis is positioned forward of the pyramid connector axis)
a hydraulic cylinder (Fig. 1B, 80) defining a hydraulic cylinder axis between rotatable connection points (see annotated Fig. 1B below) and attached to the prosthetic adapter (Fig. 1B, wherein 80 is connected to 10 at 14);
wherein a moment arm distance between the hydraulic cylinder axis and the foot pivot axis is greater than 25 millimeters (see Fig. 1A, wherein 52 has the length of a foot, therefore the moment arm distance is inherently greater than 25mm)
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Lecomte doesn't explicitly teach or disclose a rigid monolithic base that is rotatably connected to the prosthetic adapter and the hydraulic cylinder.
Moser discloses a rigid monolithic base (Fig. 1, 12A) attached to at least one composite foot spring (Fig. 1, wherein 12B and 12C form a composite foot spring), the rigid base defining a foot pivot axis (Fig. 1, wherein 24 corresponds to the foot pivot axis)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic foot assembly of Lecomte with a rigid monolithic base, as taught by Moser, in order to in order to transfer proximal forces distally to the prosthetic foot.
Regarding claim 17, Lecomte discloses a prosthetic ankle assembly comprising:
a hydraulic cylinder (Fig. 1, 80) rotatably attached to the metal base and configured to control rotation of the prosthetic ankle assembly (Col. 7, Lines 21-24, wherein “providing a dampening effect” corresponds to configured to control rotation”); and
a prosthetic adapter (Fig. 1B, 10) rotatably attached to the metal base and the hydraulic cylinder (Fig. 1B, wherien 10 and 80 are rotatably attached at 14) and configured to be attached to a prosthetic worn by a user (Col. 4, Lines 61-63, wherien 10 is to another prosthetic device), the prosthetic adapter comprising a pyramid connector (Fig. 1b, 12) that defines a pyramid connector axis,
Lecomte doesn't explicitly teach or disclose a rigid, monolithic base configured to be attached to a foot spring assembly and attached to both a hydraulic cylinder and a prosthetic adapter or a force triangle that defines an axis of rotation forward of the pyramid connector axis.
Moser discloses a rigid, monolithic base (Fig. 1, 12a) a base configured to be attached to a foot spring assembly (Fig. 1, wherein 12a is attached to foot spring 12b) and attached to both a hydraulic cylinder (Fig. 1, cylinder 26) and a prosthetic adapter (Fig. 1, 16); and wherein the rigid, monolithic base, the hydraulic cylinder, and the prosthetic adapter define a force triangle that defines an axis of rotation of the prosthetic ankle assembly (see annotated Fig. 1 below), and wherein the axis of rotation is positioned forward of the pyramid connector axis (see annotated Fig. 1 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the foot spring assembly, hydraulic cylinder and prosthetic adapter of Lecomte to be attached to a rigid, monolithic base as taught by Moser, in order to transfer proximal forces distally to the prosthetic
foot.
Regarding claim 18, Lecomte discloses wherein an axis of rotation is positioned forward of a pyramid connector axis (see annotated Fig. 1B below) and is configured to be in line with a center of mass of a user when the user is in a standing position (see Fig. 1B, wherein the axis of rotation is in line with center of mass of user in a standing position because it is positioned at a point about 1/3 of the foot’s length forward from the back of the heel)
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Regarding claim 19, Lecomte disclose wherein a moment arm distance between the hydraulic cylinder and a foot pivot axis is greater than 25 mm (see Fig. 1A, wherein 52 has the length of a foot therefore the moment arm distance is inherently greater than 25mm)
Regarding claim 20, Lecomte further discloses the hydraulic cylinder is configured to dampen rotation of the prosthetic ankle assembly (Col. 7, Lines 21-24, “providing a dampening effect”)
Regarding claim 21, Lecomte discloses a hydraulic cylinder (see rejection of claim 17) configured to dampen rotation of a prosthetic ankle assembly (Col. 7, Lines 21-24, “providing a dampening effect”) but doesn't explicitly teach or disclose a plurality of cavities and channels configured to channel a hydraulic fluid and a plantarflexion lock valve.
Moser discloses wherein the hydraulic cylinder comprises a plurality of cavities (Fig. 1, 26A + 26B, ¶0037) and channels (¶0037, “bypass passages”) configured to channel a hydraulic fluid (¶0039, “hydraulic fluid”) and a plantarflexion lock valve (Fig. 1, 32) positioned within at least one of the cavities (Fig. 2, wherein 32 is positioned within a cavity) and the channels (Fig. 1, 34); and wherein the plantarflexion lock valve allows hydraulic fluid to circulate until the hydraulic ankle assembly reaches a maximum dorsiflexion position and locks at the maximum dorsiflexion position (¶0039, wherein “dorsiflexion limit” corresponds to maximum dorsiflexion position”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte with a plurality of cavities, a plurality of channels, and a plantarflexion lock valve, as taught by Moser, in order to set adjustable limits for both plantarflexion and dorsiflexion for increased patient safety.
Claim(s) 2-4, 6, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,980,648 (Lecomte) in view of 20190021882 (Moser), as applied to claims above and further in view of non-patent literature titled “Unity for Pro-Flex: Instructions for Use” (Pro-Flex)
Regarding claim 2, Lecomte discloses a second pivot distance (see rejection of claim 1 above) but doesn't explicitly teach or disclose wherein the second pivot distance is about 30 mm to about 35 mm. Moser doesn't explicitly teach or disclose wherein the second pivot distance is about 30 mm to about 35 mm
Proflex discloses a prosthetic ankle assembly (Fig. 3 below) wherein the second pivot distance is about 30mm to about 35mm (see annotated Fig. 3 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the second pivot distance of Lecomte in view of Moser to be about 30mm to about 35mm, as taught by Proflex, in order to in order to ensure biomimetic rollover while maintaining the robust design of the foot.
Regarding claim 3, Lecomte discloses a first pivot distance (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the first pivot distance is about 50 mm to about 60 mm. Moser doesn't explicitly teach or disclose wherein the first pivot distance is about 50 mm to about 60 mm
Proflex discloses wherein the first pivot distance is about 50mm to about 60mm (see annotated Fig. 3 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first pivot distance of Lecomte in view of Moser to be about 50mm to about 60mm, as taught by Proflex, in order to in order to ensure biomimetic rollover while maintaining the robust design of the foot.
Regarding claim 4, Lecomte discloses a third pivot distance (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the third pivot distance is about 50mm to about 60mm. Moser doesn't explicitly teach or disclose wherein the third pivot distance is about 50mm to about 60mm
Proflex discloses wherein the first pivot distance is about 50mm to about 60mm (see annotated Fig. 3 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the third pivot distance of Lecomte in view of Moser to be about 50mm to about 60mm, as taught by Proflex, in order to in order to ensure biomimetic rollover while maintaining the robust design of the foot.
Regarding claim 6, Lecomte further discloses wherein the hydraulic cylinder (Fig. 1, 80) is a hydraulic cylinder configured to dampen rotation of the prosthetic ankle assembly (Col. 7, Lines 21-24, “providing a dampening effect”)
Regarding claim 12, Lecomte discloses a prosthetic ankle assembly with a moment arm distance (see rejection of claim 11) but doesn't explicitly teach or disclose wherein the moment arm distance is about 25 mm to about 40 mm. Moser doesn't explicitly teach or disclose wherein the moment arm distance is about 25 mm to about 40 mm.
Proflex discloses a moment arm distance of about 25mm to 40mm (see annotated Fig. 3 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the moment arm distance of Lecomte in view of Moser to be about 25mm to about 40mm, as taught by Proflex, in order to ensure both biomimetic rollover while maintaining the robust design of the foot.
Regarding claim 13, Lecomte discloses a prosthetic ankle assembly with a moment arm distance (see rejection of claim 11) but doesn't explicitly teach or disclose wherein the moment arm distance is about 31.7mm. Moser doesn't explicitly teach or disclose wherein the moment arm distance is about 31.7mm.
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Proflex discloses a moment arm distance of about 31.7mm (see annotated Fig. 3 below)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the moment arm distance of Lecomte in view of Moser to be about 25mm to about 40mm, as taught by Proflex, in order to ensure both biomimetic rollover while maintaining the robust design of the foot.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,980,648 (Lecomte) in view of 2019/0021882 (Moser), as applied to claims above, and further in view of US 2019/0269529 (Arabian)
Regarding claim 10, Lecomte discloses a hydraulic cylinder (see rejection of claim 1) configured to dampen rotation of the prosthetic ankle assembly (Col. 7, Lines 21-24, wherein “providing a dampening effect” corresponds to configured to resist rotation”) but doesn't explicitly teach or disclose a plurality of cavities and channels configured to channel a hydraulic fluid
Moser discloses wherein the hydraulic cylinder comprises a plurality of cavities (Fig. 1, 26A + 26B, ¶0037) and channels (¶0037, “bypass passages”) configured to channel a hydraulic fluid (¶0039, “hydraulic fluid”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte with a plurality of cavities and channels, as taught by Moser, in order to set adjustable limits for both plantarflexion and dorsiflexion for increased patient safety.
Lecomte doesn't explicitly teach or disclose an accumulator and an orifice; and wherien the orifice is comprised of a leak path through mating threads. Moser doesn't explicitly teach or disclose an accumulator and an orifice; and wherein the orifice is comprised of a leak path through mating threads.
Arabian discloses a prosthetic foot assembly (Fig. 1) including and accumulator (Fig. 6, ¶0085, “accumulator”) and an orifice (¶0085, “orifice”); and wherein the orifice is comprised of a leak path through mating threads (¶0080, wherein “leaks of hydraulic fluid” corresponds to a leak path through mating threads)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte in view of Moser with an accumulator and an orifice, as taught by Arabian, in order to offset thermal expansion of the hydraulic fluid (¶0080)
Claim(s) 14-16, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,980,648 (Lecomte) in view of 20190021882 (Moser) in view of non-patent literature titled “Unity for Pro-Flex: Instructions for Use” (Pro-Flex), as applied above, and further in view of US 2019/0269529 (Arabian)
Regarding claim 14, Lecomte discloses a hydraulic cylinder (see rejection of claim 1) configured to dampen rotation of the prosthetic ankle assembly (Col. 7, Lines 21-24, wherein “providing a dampening effect” corresponds to configured to resist rotation”) but doesn't explicitly teach or disclose a plurality of cavities and channels configured to channel a hydraulic fluid
Moser discloses wherein the hydraulic cylinder comprises a plurality of cavities (Fig. 1, 26A + 26B, ¶0037) and channels (¶0037, “bypass passages”) configured to channel a hydraulic fluid (¶0039, “hydraulic fluid”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte with a plurality of cavities and channels, as taught by Moser, in order to set adjustable limits for both plantarflexion and dorsiflexion for increased patient safety.
Lecomte doesn't explicitly teach or disclose an accumulator and an orifice; and wherien the orifice is comprised of a leak path through mating threads. Moser doesn't explicitly teach or disclose an accumulator and an orifice; and wherein the orifice is comprised of a leak path through mating threads. Proflex doesn't explicitly teach or disclose an accumulator and an orifice; and wherein the orifice is comprised of a leak path through mating threads.
Arabian discloses a prosthetic foot assembly (Fig. 1) including and accumulator (Fig. 6, ¶0085, “accumulator”) and an orifice (¶0085, “orifice”); and wherein the orifice is comprised of a leak path through mating threads (¶0080, wherein “leaks of hydraulic fluid” corresponds to a leak path through mating threads)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte in view of Moser in view of Proflex with an accumulator and an orifice, as taught by Arabian, in order to offset thermal expansion of the hydraulic fluid (¶0080).
Regarding claim 15, Lecomte discloses a hydraulic cylinder (see rejection of claim 11) but doesn't explicitly teach or disclose a plantarflexion lock valve.
Moser discloses a plantarflexion lock valve (Fig. 1, 32) positioned within at least one cavity of the plurality of cavities (Fig. 2, wherein 32 is positioned within a cavity) and the channels (Fig. 1, 34); and wherein the plantarflexion lock valve allows hydraulic fluid to circulate until the hydraulic ankle assembly reaches a maximum dorsiflexion position and locks at the maximum dorsiflexion position (¶0039, wherein “dorsiflexion limit” corresponds to maximum dorsiflexion position”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte with a plurality of cavities and channels, and a plantarflexion lock valve, as taught by Moser, in order to set adjustable limits for both plantarflexion and dorsiflexion for increased patient safety.
Regarding claim 16, Lecomte discloses a hydraulic cylinder (see rejection of claim 1) but doesn't explicitly teach or disclose an accumulator and an orifice. Moser doesn't explicitly teach or disclose an accumulator and an orifice. Proflex doesn't explicitly teach or disclose an accumulator and an orifice.
Arabian discloses a prosthetic foot assembly (Fig. 1) including and accumulator (Fig. 6, ¶0085, “accumulator”) and an orifice (¶0085, “orifice”); and wherein the orifice is comprised of a leak path through mating threads (¶0080, wherein “leaks of hydraulic fluid” corresponds to a leak path through mating threads)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the hydraulic cylinder of Lecomte in view of Moser in view of Proflex with an accumulator and an orifice, as taught by Arabian, in order to offset thermal expansion of the hydraulic fluid (¶0080)
Conclusion
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774