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 1-5 and 7-22 are pending and examined below
Response to Arguments
The remarks of 10/21/2025 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 claims 1 and 20, in particular the following claim language:
“a base body having a forefoot body with a front sole region and a mounting body configured to receive an adapter that allows the prosthetic foot to be attached to a user's body, the mounting body being flexibly and integrally connected to the forefoot body”
This argument is moot in light of the new 103 rejection below.
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) 1-4, 7-9, 11, 13, 14, 17, 19, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US by US 6,596,029 (Gramnas) in view of 2004/0068326 (‘326) in view of US 2004/0068328 (‘328)
Regarding claim 1, Gramnas discloses a prosthetic foot (Fig. 1) comprising:
a base body (Fig. 2, 9) having a forefoot body (Fig. 2, 1) with a front sole region (See annotated Fig. 2) and a mounting body (see annotated Fig. 2 provided above) configured to receive an adapter (see annotated Fig. 2 provided above) that allows the prosthetic foot to be attached to a user’s body (see annotated Fig. 2, wherein adapter is well known in the art to attach to a user’s body);
a heel body (Fig. 2, 2) having a rear sole region (heel plate 11, figure 1); and
a slot (Col. 2, Lines 37-39, wherein “recesses corresponds to a slot”) configured to receive and retain at least one spring element (Col. 2, Lines 35-40, wherein “inserted in recesses” corresponds to receive and retain), the spring element configured to be pushed or inserted into the slot (Col 2, Lines 39-42, wherein easily removed or inserted” corresponds to configured to be pushed or inserted into the slot), wherein the heel body (Fig. 2, 2) is connected to the base body (Fig. 2, 3) only through the spring element (See Fig. 2, wherein 2 is connected to 9 through 3), and wherein, in a disposed state, the spring element engages in the base body and the heel body such that the heel body is spring mounted relative to the base body (See Figs. 3 and 4, wherein 2 is mounted relative to 9 by a resilient rubber element 12 – which corresponds to spring loaded).
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Gramnas discloses a mounting body (Fig. 2, 5) but doesn’t explicitly teach or disclose that the mounting body is flexibly connected to the forefoot body and configured so that the forefoot body is capable of moving relative to the adapter to absorb and release forces exerted on the prosthetic foot.
‘326 discloses a prosthetic foot (Fig. 2, 110) comprising a mounting body (Fig. 2, 60) flexibly connected to the forefoot body (Fig. 2, wherein 60 is flexibly connected to 34) and configured so that the forefoot body is capable of moving relative to the adapter to absorb and release forces exerted on the prosthetic foot (¶0023, wherein “store and return energy during use” corresponds to absorb and release forces exerted on the prosthetic foot)
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 mounting body of Gramnas to be flexibly connected to the forefoot body, as taught by ‘326, in order to store and return energy during use, contributes to extra spring or cushion of the foot, and improve vertical shock resistance (‘326, ¶0023)
Gramnas discloses a mounting body and a forefoot body (see annotated Fig. 2 above) but doesn't explicitly teach or disclose the mounting body being flexibly and integrally connected to the forefoot body. ‘326 doesn't explicitly teach or disclose the mounting body being flexibly and integrally connected to the forefoot body.
‘328 discloses a prosthetic foot (Fig. 4) wherein the mounting body (Fig. 1a, wherein 14 has an attachment section 322 – corresponding to a mounting body) is flexibly (¶0035, wherein “store and return energy” corresponds to flexibly connected) and integrally connected the forefoot body (Fig. 4, wherein 322 is integrally connected to forefoot 314)
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 mounting body and forefoot body of Gramnas in view of ‘326 to be integrally connected, as taught by ‘, in order to store and return energy during use, contribute to extra spring or cushion of the foot, and improve vertical shock resistance (¶0035)
Regarding claim 2. Gramnas discloses the spring element (8) is secured centrally to the base body (3) using one of an adhesive connection, a screw connection, a latching connection, or a press fit connection (“The fit between the rods and the recesses is such that the rods…. can easily be removed from or inserted in these”, Col. 2, Lines 39-42).
Regarding claim 3, Gramnas discloses wherein the spring element (8) is mounted such that a front region of the base body or a rear region of the heel body can be movable in a longitudinal direction along a longitudinal axis of the spring element relative to the position on the spring element secured to the base body (“There are also further advantages, than the above mentioned, with mounting the rods freely in recesses in the front and rear foot portions. By this design, it is easy to adjust the length f the foot prosthesis to the needs of the prosthesis wearer by choosing rods of suitable length or by cutting existing rods before they are inserted in its mountings”)
Regarding claim 4, Gramnas discloses wherein the front sole region is located on an underside of the forefoot body (see annotated Fig. 2 below, wherein front sole region is on the underside of 1) and the adapter is disposed on an upper surface of the mounting body parallel to an adapter plane.
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Regarding claim 7, Gramnas discloses a front sole region that has a convex shape (see annotated Figure 1 provided below) but does not explicitly teach or discloses at least 40% of the contact surface. ‘326 discloses a front sole region with a convex shape (Fig. 2, wherein 34 has a convex shape) but doesn't explicitly teach or disclose that is has a convex shape over 40% of a contact surface of the front sole region.
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However, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gramnas in view of ‘326 to have a convex shape over at least 40% of a contact surface of the front sole region since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. See MPEP 2144.05. In the instant case, modifying Gramnas in view of ‘326 so that at least 40% of the front sole has a convex shape will not affect the foots ability to allow the user to safely and efficiently ambulate using a prosthesis. Further, applicant places no criticality on the range claimed, indicating simply that “the front sole region can have a convex shape at least in sections, preferably over at least 50% or 30% of the contact surface. The contact surface can be defined such that it is the surface that comes into contact with the ground during anormal walking or running movement on a level surface”.
Regarding claim 8, Gramnas discloses wherein: the base body (3) comprises a stop element (9, figure 2) which extends downward a longitudinal axis of the spring element, and which rests on the spring element (see figure 2). Gramnas does not explicitly disclose an angle of 30 to 60 degrees. ‘326 doesn't explicitly teach or disclose a stop element which extends downward at an angle of 30 to 60 degrees.
However, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stop element of Gramnas in view of ‘326 to extend downward at an angle of 30 to 60 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. See MPEP 2144.05. In the instant case, modifying Gramnas so that at the stop element extends downward at an angle of 30 to 60 degrees will not affect the foots ability to allow the user to safely and efficiently ambulate using a prosthesis. Further, applicant places no criticality on the range claimed, indicating simply that “In one embodiment, a longitudinal axis of the stop element is inclined approx. 30° relative to an adapter plane.
Regarding claim 9, Gramnas discloses wherein: the spring element (8), in the disposed state, is disposed in a plane that is substantially parallel to the adapter plane (see annotated figure 2 below), or is disposed in a plane that rises toward a front of the prosthetic foot.
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Regarding claim 11, The claimed phrase “wherein the prosthetic foot is produced in an additive process” is being treated as a product by process limitation; that is, that the prosthetic foot is produced in an additive process. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Regarding claim 13, Gramnas discloses wherein: the spring element comprises fiber-reinforced plastic (“The rods can for example be manufactured of carbon/graphite fibres or glass fibres held together with thermosetting resin or thermoplastic resin”, Col. 3, Lines 66-67).
Regarding claim 14, Gramnas wherein the spring element (8) comprises GFRP or CFRP (“The rods can for example be manufactured of carbon/graphite fibres or glass fibres held together with thermosetting resin or thermoplastic resin”, Col. 3, Lines 66-67).
Regarding claim 17, Gramnas discloses wherein the adapter plane is defined by mounting points on the upper surface of the mounting body (6) that are configured to mount the adapter (5) (see annotated figure 2 below).
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Regarding claim 19, The claimed phrase “the additive process is a 3D printing process” is being treated as a product by process limitation; that is, that the prosthetic foot is produced in 3D printing process. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Regarding claim 20, Gramnas discloses a prosthetic foot (Fig. 1) comprising:
a base body (Fig. 2, 9) having a forefoot body (Fig. 2, 1) with a front sole region (See annotated Fig. 2 below) and a mounting body (see annotated Fig. 2) configured to receive an adapter (see annotated Fig. 2) that allows the prosthetic foot to be attached to a user’s body (see annotated Fig. 2, wherein adapter is well known in the art to attach to a user’s body);
a heel body (Fig. 2, 2) having a rear sole region (Fig. 1, 11); and
a slot (Col. 2, Lines 37-39, wherein “recesses corresponds to a slot”) configured to receive at least one spring element (Col. 2, Lines 35-40, wherein “inserted in recesses” corresponds to receive spring element 8) having a longitudinal axis (Fig. 2, wherein 8 has a longitudinal axis), the spring element configured to be pushed or inserted into the slot to engage with (Col. 2, Lines 35-40, wherein “inserted in recesses” corresponds to configured to be inserted) and extend from the heel body to the base body (Fig. 2, wherein 8 extends from heel body 2 to base body 9) proximate the front sole region (Fig. 2, wherein 8 is engaged with front sole region 1 corresponding to proximate), engaging with the front sole region (see Fig. 2, wherein 8 engages with 1), the spring element secured at a position on the spring element to at least the base body (Fig. 2, wherein 8 is secured to 9 at its posterior end),
wherein, in a disposed state, the spring element (Fig. 2, 8) engages in the base body (Fig. 2, 9) and the heel body (Fig. 2, 2) such that the heel body is spring mounted relative to the base body (See Figs. 3 and 4, wherein 2 is mounted relative to 9 by a resilient rubber element 12 – which corresponds to spring loaded), such that a portion of the spring element engaging with the heel body rotates about the longitudinal axis of the spring element (see Figs. 3 and 4, wherein 2 is free to rotate about longitudinal axis) and a portion of the spring element engaging with the front sole region rotates about the longitudinal axis of the spring element (Fig. 2, wherein spring 8 can flex to rotate 1 about longitudinal axis) and wherein the heel body is connected to the base body only through the spring element (See Fig. 2, wherein 2 is connected to 9 only through 8)
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Gramnas discloses a mounting body (Fig. 2, 5) but doesn’t explicitly teach or disclose that the mounting body is flexibly connected to the forefoot body and configured so that the forefoot body is capable of moving relative to the adapter to absorb and release forces exerted on the prosthetic foot.
‘326 discloses a prosthetic foot (Fig. 2, 110) comprising a mounting body (Fig. 2, 60) flexibly connected to the forefoot body (Fig. 2, wherein 60 is flexibly connected to 34) and configured so that the forefoot body is capable of moving relative to the adapter to absorb and release forces exerted on the prosthetic foot (¶0023, wherein “store and return energy during use” corresponds to absorb and release forces exerted on the prosthetic foot)
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 mounting body of Gramnas to be flexibly connected to the forefoot body, as taught by ‘326, in order to store and return energy during use, contributes to extra spring or cushion of the foot, and improve vertical shock resistance (‘326, ¶0023)
Gramnas discloses a mounting body and a forefoot body (see annotated Fig. 2 above) but doesn't explicitly teach or disclose the mounting body being flexibly and integrally connected to the forefoot body. ‘326 doesn't explicitly teach or disclose the mounting body being flexibly and integrally connected to the forefoot body.
‘328 discloses a prosthetic foot (Fig. 4) wherein the mounting body (Fig. 1a, wherein 14 has an attachment section 322 – corresponding to a mounting body) is flexibly (¶0035, wherein “store and return energy” corresponds to flexibly connected) and integrally connected the forefoot body (Fig. 4, wherein 322 is integrally connected to forefoot 314)
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 mounting body and forefoot body of Gramnas in view of ‘326 to be integrally connected, as taught by ‘328, in order to store and return energy during use, contribute to extra spring or cushion of the foot, and improve vertical shock resistance (¶0035)
Regarding claim 21, Gramnas discloses wherein ends of the spring element project loosely into openings in the base body (3) and heel body (2) such that the spring element is not fixed at the ends to the prosthetic foot (“The fit between the rods and the recesses is such that the rods are rotatable in the recesses and can easily be removed from or inserted in these”, Col. 2, Lines 39-42”)
Regarding claim 22, Gramnas discloses wherein the spring element (8, Fig. 2) is configured to bend at heel body strike (See Col. 2, Lines 35-38, wherein rods 8 are made of a flexible glass fibre and therefore are configured to bend under the forces of heel body strike).
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US by US 6,596,029 (Gramnas) in view of US 2004/0068326 (‘326) in view of US 2004/0068328 (‘328), as applied to claims above, and further in view of US 2009/0265019 (‘019)
Regarding claim 5, Gramnas discloses a mounting body (6) and a forefoot body (1) but doesn’t explicitly teach or disclose a web connection between the two. ‘326 doesn’t explicitly teach or disclose a web connection. ‘328 doesn't explicitly teach or disclose a web connection.
‘019 discloses a prosthetic foot, comprising a web connection (“In addition, the proximal and distal ends can be coupled together with hinged connections 68 and 70 or movable or pivotal joint, such as a piano type hinge with a pivot, a living hinge with a flexible web, or the like. The hinged connections maintain the coupled or fixed relationship between the proximal and distal ends of the forefoot leaf springs so that they move together, but allowing the ends to pivot with respect to one another”, ¶0030)
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 mounting body and forefoot body of Gramnas in view of ‘326 in view of ‘328 with a web connection, as taught by ‘326, to maintain the coupled relationship while allows the two sections to pivot with respect to one another (¶0030)
Regarding claim 12, Gramnas discloses at least two of the base body, the heel body (2, figure 2), the forefoot body, the mounting body, the web that flexibly connects the forefoot body to the mounting body, or a stop element (9) that rests on the spring element (8) comprise an integral structure (“The rear foot portions 2 comprises an element 9, which protrudes forward and extends above the rods 8. The bottom surface of this element is curved and extends above the rods at a distance which in the unloaded position of the foot prosthesis successively increases in the direction of the front foot portion 1. The element 9 delimits the upward bending of the rear foot portion 2 relative the front foot portion 1 and secures that the rods 8 are not bended so much that they can break”, Col. 3, Lines 37-44)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US by US 6,596,029 (Gramnas) in view of US 2004/0068326 (‘326) in view of US 2004/0068328 (‘328), as applied to claims above, and further in view of US 2015/0282953 (Smith)
Regarding claim 10, Gramnas does not explicitly teach or disclose a rear stop. ‘326 doesn't explicitly teach or disclose a rear stop. ‘328 doesn't explicitly teach or disclose a rear stop
Smith discloses a rear stop (140, figure 1B) which is space apart from the heel body (110, figure 1b) by a gap (“For example, a gap of about 1/10 inch may be present between the bumper member 140 and the bottom member 110”, ¶0021)
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 Gramnas in view of ‘326 in view of ‘328 with a rear step as taught by Smith, to a dampen vibration and sound generated during heel strike or release (¶0022)
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US by US 6,596,029 (Gramnas) in view of US 2004/0068326 (‘326) in view of US 2004/0068328 (‘328), as applied to claims above, and further in view of US 2016/0175118 A1 (Kania)
Regarding claim 15, Gramnas discloses rods (8) with a circular cross-section but it does not explicitly teach or disclose a leafspring. ‘326 doesn’t explicitly teach or disclose a leaf spring. ‘328 doesn't explicitly teach or disclose a leafspring.
Kania discloses wherein the spring element is a leaf spring (leafspring 12b, figure 2).
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 Gramnas in view of ‘326 in view of ‘328 with a leafspring, as taught by Kania, to provide sufficient strength and flexibility (Kania, ¶0030)
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US by US 6,596,029 (Gramnas) in view of US 2004/0068326 (‘326) in view of US 2004/0068328 (‘328), as applied to claims above, and further in view of US 2005/0033451 (Aigner)
Regarding claim 16, Gramnas discloses a spring element (8) secured to a base body (3) but does not explicitly teach or disclose that it is secured at a position within 10% of the spring’s total length from the center of the spring. ‘326 doesn't explicitly teach or disclose a spring element secured at a position within 10% of the spring’s total length from the center of the spring. ‘328 doesn't explicitly teach or disclose a spring element secured at a position within 10% of the spring’s total length from the center of the spring,
Aigner, a prosthetic foot, discloses a spring element (42, figure 2b) which is secured centrally the position at which the spring element (8) is secured is centrally disposed to the base body (14, figure 4A) at a point within a region of the spring element that comprises 10% of a total length from a center of the spring element (see figure 2B, mounting holes in center of spring 42).
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 spring element of Gramnas in view of ‘326 to be secured to the base body in the center of the spring, as taught by Aigner, for controlled energy storage and return during both plantarflexion and dorsiflexion (¶0037-0038)
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US by US 6,596,029 (Gramnas) in view of US 2004/0068326 (‘326) in view of US 2004/0068328 (‘328) in view of US 2015/0282953 (Smith), as applied to claims above, and further in view of US 2016/0175118 A1 (Kania)
Regarding claim 18, Gramnas doesn’t explicitly teach or disclose a gap of at least 1 cm. ‘326 doesn't explicitly teach or disclose a gap of at least 1 cm. ‘328 doesn't explicitly teach or disclose a gap of at least 1 cm. Smith doesn’t explicitly teach or disclose a gap of at least 1 cm. ‘
Kania discloses wherein the gap is at least 1 cm (…a space 28 between the shank unit 18d, 118d, 218d and the heel unit 18c, 118c, 218c of between about 0.3 inches and 0.7 inches”, ¶0038)
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 Gramnas in view of ‘326 in view of ‘328 in view of Smith with a gap of at least 1cm, as taught by Kania, to prevent components from touching each other at the maximum deflection of the leaf springs (¶0038)
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 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
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774