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 .
Response to Amendment
The amendment filed 12/3/2025 has been received and made of record. As requested, claims 1-10, 12-17, and 19-20 are currently pending and are being examined.
Response to Arguments
Applicant’s amendment has overcome the previous 112(b) rejections, which have therefore been withdrawn.
Applicant's arguments filed 12/3/2025 with respect to the rejection under 35 U.S.C. 102 have been fully considered and are moot in light of the amendment. In response to the applicant’s arguments regarding the newly added claim limitation and the previously made rejection, attention is directed to the new the prior art of record Levitt (US 3,219,032) as applied to the claims in the rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 has been amended to be dependent on claim 18, which is cancelled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Brass (US 2014/0350447) in view of Levitt (US 3,219,032).
Regarding claim 1, Brass discloses a foot orthosis (1) for correcting foot malpositions (Abstract), comprising a toe segment (toe pouch 4 including annular brace 6 and splint leg 10) configured to be fastened to a toe (Figure 1; [0023], [0025], [0027]) and a ball segment (11) configured to be arranged in the region of a metatarsophalangeal joint (Figures 1-2) each of which are pivotably connected relative to one another by means of a joint unit (13; [0027]), wherein in a fastened state in which the foot orthosis is fastened to the foot, the foot orthosis is configured to exert a first corrective force (F1) on the toe via the toe segment and to exert a second corrective force (F2) on the metatarsophalangeal joint via the ball segment in the opposite direction to the first corrective force (Figure 1; [0027]), wherein the joint unit is configured such that the toe segment and the ball segment are pivotable relative to each other about a pivot axis (12) which is substantially parallel to a flexion-extension joint axis of the metatarsophalangeal joint (Figure 1-2; [0027]), wherein the toe segment comprises a toe support section (6, 10), which in the fastened state, lies against a lateral side of the toe (Figures 1-2; [0025], [0027]) and forms a bracket (10) and a toe base section (6) connected with the bracket which, in the fastened state, at least partially engages around the toe (Figures 1-2) and wherein the toe support section is configured to receive and transmit tensile forces ([0025], [0029]), compressive forces along its longitudinal axis and transverse forces transverse to its extension axis (splint 10 and brace 6 transmit force F1 which is in the transverse direction and capable of transmitting compressive forces, Figures 1-2; [0025], [0027]). Brass does not disclose the toe base section is integrally formed with the bracket. Levitt teaches a similar splint having a toe segment that forms a bracket (front part of 5) and a toe base (9) that is integrally formed with the bracket (Figures 2-3). Brass teaches having the toe base (9) being integral to bracket (5) as an alternative to providing them as separate parts (18, 22; Figure 7-9) and teaches that providing the toe base and bracket as integral piece allows the device to be quickly and easily attached or removed with no special skill or adjustment of buckles, laces, fasteners, or the like (Col. 3, lines 16-25; Col. 4, lines 13-16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the toe base section integrally formed with the bracket as taught by Levitt to allow the device to be quickly and easily attached or removed with no special skill or adjustment of buckles, laces, fasteners, or the like. Furthermore, it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 2, Bass discloses the foot orthosis is configured such that, in the fastened state, the toe segment extends in sections along a lower side or along an upper side of the toe (Figures 1-2).
Regarding claim 3, Bass discloses wherein in the fastened state, the toe segment is configured to transmit at least one of a shearing for or a bending force or both between the joint unit and the toe to be treated in direction of the first corrective force in order to generate the first corrective force ([0027], [0037]).
Regarding claim 4, Bass discloses wherein the first corrective force is provided in the form of a clamping force or bending force induced by elastic deformation of the toe segment ([0011], [0034]).
Regarding claim 5, Bass discloses the device capable of use such that wherein in the fastened state, the toe segment is arranged in a clamping position in which the toe segment is elastically deflected in a direction opposite to the first corrective force relative to a rest position of the toe segment in which the toe segment is arranged in a decoupled state of the foot orthosis being decoupled from the foot ([0011], [0034]).
Regarding claim 6, Bass discloses wherein the foot orthosis being configured such that, in the fastened state of the foot orthosis, a sideways protruding section of a metatarsophalangeal ball is received in a recess or through hole of the ball segment ([0032]; Figure 4).
Regarding claim 7, Bass discloses wherein the second corrective force is provided in the form of a clamping force induced by an elastic deformation of the ball segment ([0011], [0034]).
Regarding claim 8, Bass discloses a metatarsal segment (5) configured to be fastened to the metatarsus of the foot to be treated and, in the fastened state, to exert a holding force on the metatarsus (F3, Figure 1; [0027]).
Regarding claim 9, Bass discloses wherein at least one of the two segment, ball segment, the metatarsal segment, or any combination thereof comprises a base section (10) and a support section (6) introducing corrective or holding forces into the foot, wherein as compared to the base section (10), the support section (6) has a lower stiffness against shear forces, bending forces, or both shear forces and bending forces in the direction of the first or second corrective force (section 6 being made of pliant, bendable material such as fabric or tape has a lower stiffness than splint leg 10 which is of a metal or plastic having spring stiffness [0034]).
Regarding claim 10, Bass discloses wherein the toe support section (6) is made of a material having a lower modulus of elasticity or a lower strength or a lower hardness than the base section (10; section 6 being made of pliant, bendable material such as fabric or tape has a lower stiffness than splint leg 10 which is of a metal or plastic having spring stiffness [0034]).
Regarding claim 12, Bass discloses wherein in the fastened state, the joint unit (13) is arranged laterally at the foot or extends along the dorsum of the foot or along the sole of the foot, and wherein the joint unit is provided in the form of a swivel joint or a bending joint (Figures 1-2; [0027]).
Regarding claim 13, Bass discloses wherein the joint unit is provided in the form of a hubless swivel joint which is provided with a through hole (hole through which tubular rivet 14a extends to connect hinge legs 10,11; [0031]; Figures 3-4) along its pivot axis.
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brass (US 2014/0350447) in view of Levitt (US 3,219,032) in view of Harada (US 2011/0088145).
Regarding claims 14 and 19, Brass discloses that as applied above wherein a recess or hole is sized for accommodating hallux-valgus malposition, ball shaped swelling of the foot in the big toe region ([0032]) but does not disclose it has a diameter of 2 cm or 2.5 cm. Harada teaches a support for foot deformations of the hallux valgus and swellings wherein a hole (10) has a diameter of at least 2 or 2.5 cm ([0088]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the recess/hole of Brass in view of Levitt having a diameter of at least 2 or 2.5 cm as taught by Harada as being a suitable size for reducing friction against deformations of the hallux valgus and swellings in the big toe ([0088] of Harada). Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Brass (US 2014/0350447) in view of Levitt (US 3,219,032) in view of Schenk (US 2,013,068).
Regarding claims 16 and 17, Brass in view of Levitt discloses that as applied above but does not disclose a heel segment configured to be fastened to the heel of the foot to be treated and, in the fastened state, to exert a holding force on a rear part of the foot. Schenk teaches a bunion brace having a heel segment (22) configured to be fastened to the heel of the foot to be treated and, in the fastened state, to exert a holding force on a rear part of the foot (insofar as it is engaging and holding the device on the foot, Figure 1; page 1 Col. 2, lines 41-55). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Brass and Levitt having the heel segment as taught by Schenk to aid in keeping the device properly positioned on the user.
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brass (US 2014/0350447) in view of Levitt (US 3,219,032) in view of Wood (US 1,1240,286).
Regarding claims 15 and 20, Brass in view of Levitt discloses that as applied above but does not disclose wherein the ball segment and the metatarsal segment are coupled to each other such that each are translatory displaceable relative to each other, each are fixable in a desired position relative to each other in a force-fitting manner or a form-fitting manner or both, and are translatory displaceable relative to each other along a longitudinal axis of the foot orthosis, or along a transverse axis of the foot orthosis, or both. Wood teaches an orthopedic appliance for foot treatment wherein a ball segment (15, 12) and a metatarsal segment (21, 22) are coupled to each other such that each are translatory displaceable relative to each other (via hook 31 and notches 32), each are fixable in a desired position relative to each other in a force-fitting manner or a form-fitting manner or both (via engaging the hook 31 with one of the notches, Fig. 1), and are translatory displaceable relative to each other along a longitudinal axis of the foot orthosis, or along a transverse axis of the foot orthosis, or both (Figure 1; page 1 lines 98-107). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Brass and Levitt wherein ball segment and the metatarsal segment are translatory displaceable along a longitudinal axis of the foot orthosis so as to adjust the position across the foot (page 1 lines 98-107 of Wood).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786