DETAILED ACTION
In Applicant’s Response filed 8/21/25, Applicant has amended claims 1, 3, 17, 21 and 22; and added new claim 23. Currently, claims 1-23 are pending (claims 12-16 were previously withdrawn).
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/21/25 was filed after the mailing date of the Non-Final Rejection on 5/21/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-11 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schenkl (US 4702255) in view of Chatzistergos et al (WO 2018/115874) and further in view of Burns (US 2790254).
With respect to claim 1, Schenkl discloses an orthotic device for a patient’s foot (abstract lines 1-2), the orthotic device comprising:
a shell (shell 13) configured to structurally support the patient’s foot (col 4 line 67 – col 5 line 3), the shell having a variable thickness along a dimension of the shell (the arch 17 is thicker than other regions of the shell 13 thus providing variable thickness along the length dimension of the shell 13; see col 6 lines 1-2, 5-7 and 17; fig 2-6; see also claim 6);
the shell having variable thickness along a length of the shell (the arch 17 is thicker than other regions of the shell 13 thus providing variable thickness along the length dimension of the shell 13; see col 6 lines 1-2, 5-7 and 17; fig 2-6; see also claim 6) and sides configured for extending upwards alongside the foot of the patient (as shown in fig 6, at least part of the shell 13 includes sides that extend upwards alongside the foot of the patient), the shell including a distal lateral contour that is configured to match a distal lateral contour of the foot of the patient and a distal medial contour that is configured to match a distal medial contour of the foot of the patient (col 5 lines 8-25; col 6 lines 1-8 and 17-21; see figs 2-6; see also, specifically, col 6 lines 32-36 disclosing that the orthotic can be custom fit to the foot by machining);
wherein the shell (13) is configured to undergo flexion throughout the shell (col 6 lines 19-21);
wherein the variable thickness of the shell targets areas of increased stress (col 5 lines 8-25).
Schenkl does not, however, disclose that the shell is formed by a plurality of layers integrally formed with each other.
Chatzistergos, however, teaches an orthotic device for a foot (support structure suitable for cushioning footbeds such as in insoles in footwear – abstract) manufactured by an additive manufacturing process (pg 6 line 22) to comprise a shell that includes a plurality of layers integrally formed with each other (pg 19 line 5; the structure is 3D printed using fused deposition modeling – pg 18 lines 26). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the shell of the orthotic of Schenkl having a plurality of layers integrally formed with each other, as taught by Chatzistergos, in order to customize the orthotic for a given user and/or purpose (Chatzistergos abstract).
Schenkl in view of Chatzistergos does not, however, explicitly disclose that the variable thickness of the shell is based at least on distributing stress throughout the shell.
Burns, however, teaches a foot pad which is configured to provide a desirable distribution of weight with respect to the foot structure to take the weight off the arch and to distribute more of the weight onto the outside marginal area of the foot between the heel and the ball of the foot with as much weight as possible removed from the heel and ball of the foot (col 1 lines 43-50). Specifically, Burns teaches that a cushion 32 and elevations 14 and 26 are preferably made of a thickness determined by the individual user's foot in order to secure the best weight distribution wherein the elevations 14 and 26 and cushion 32 are made as thick as possible since the thicker these three elements are made, the more weight is carried on elevations 14 and 26 (col 5 lines 34-50). Thus, the foot pad in Burns has a variable thickness based on distributing stress throughout the foot pad. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided the variable thickness in the shell of the orthotic device of Schenkl in view of Chatzistergos based at least on distributing stress throughout the shell, as taught by Burns, in order to provide a desirable distribution of weight with respect to the foot structure so that the circulation of blood in the foot is free and normal, the muscles of the foot function and develop in the proper manner, and there is no undue pressure upon the joints. (Burns col 1 lines 24-40).
With respect to claim 2, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the orthotic device is a shoe insert configured to be worn on the patient’s foot (abstract lines 9-11).
With respect to claim 3, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the shell (13) includes a base wall (upstanding wall portion at heel flange 18 as shown in fig 2), a first sidewall and a second sidewall opposite the first sidewall (the oppositely disposed upstanding wall portions shown in fig 2 that are configured to be positioned along the medial and lateral portions of the foot during use) to completely contain a heel of the patient’s foot (col 4 line 65 – col 5 line 3).
With respect to claim 4, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the shell (13) is configured to provide medial support for the patient’s foot (as shown in fig 6, at least part of the shell 13 includes areas of increased thickness on the medial side to thereby provide medial support to the foot).
With respect to claim 5, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the shell (13) is configured to provide lateral support for the patient’s foot (as shown in fig 6, at least part of the shell 13 includes areas of increased thickness on the lateral side to thereby provide lateral support to the foot).
With respect to claim 6, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the shell (13) is configured to undergo deformation without sustaining structural damage (the shell 13 is constructed having high fracture resistance providing flex in different areas while being substantially less breakable than prior art devices – see col 5 lines 57-61, col 6 lines 19-21 and 28-31).
With respect to claim 7, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that a thickness of the shell at a first longitudinal position of the shell is different than a thickness of the shell at a second longitudinal position of the shell (the arch 17 is thicker than other regions of the shell 13 thus providing variable thickness along the length dimension of the shell 13; see col 6 lines 1-2, 5-7 and 17; fig 2-6 illustrate increased thickness in center of the device at the arch region (fig 4) as compared to thinner regions at the center in the heel region (fig 6) thus illustrating differences in thickness at the two longitudinal positions; see also claim 6).
With respect to claim 8, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the variable thickness is configured to accommodate for differences in an anatomical structure of the patient’s foot (col 5 lines 8-25; col 6 lines 1-8 and 17-21).
With respect to claim 9, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the orthotic device is configured for use with a patient having valgus of the patient’s foot (the bottom surface of shell 13 is formed having specific predetermined angles and thicknesses required to alter the function of the foot to correct the foot problem of a user and the finished orthotic can be custom fit to a wearer’s foot – thus the device is interpreted as being capable of being configured for use for valgus of the foot when customized for a patient having this issue; see col 5 lines 8-15 and col 6 lines 32-33) the shell configured to provide gradual offset to an anatomy of the patient’s foot (see figs 2-6).
With respect to claim 10, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that the orthotic device is configured for use with a patient having varus of the patient’s foot (the bottom surface of shell 13 is formed having specific predetermined angles and thicknesses required to alter the function of the foot to correct the foot problem of a user such as, i.e. excessive pronation – col 5 lines 8-15; correction of pronation and treatment of varus of the foot are interpreted as being equivalent since both involve correction of a foot that is turned inwards) the shell configured to provide gradual offset to an anatomy of the patient’s foot (see fig 2-6).
With respect to claim 11, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Schenkl also discloses that a geometric shape and the variable thickness of the shell are configured to account for unique anatomical structure of the patient’s foot to relieve stress along edges, sides, and a bottom of the patient’s foot (col 5 lines 8-25; col 6 lines 1-8 and 17-21; see figs 2-6).
With respect to claims 17-18, Schenkl discloses an orthotic device for a patient’s foot (abstract lines 1-2), the orthotic device comprising:
a shell (shell 13) configured to structurally support the patient’s foot (col 4 line 67 – col 5 line 3), the shell having a variable thickness along a dimension of the shell (the arch 17 is thicker than other regions of the shell 13 thus providing variable thickness along the length dimension of the shell 13; see col 6 lines 1-2, 5-7 and 17; fig 2-6; see also claim 6);
the shell having variable thickness along a length of the shell (the arch 17 is thicker than other regions of the shell 13 thus providing variable thickness along the length dimension of the shell 13; see col 6 lines 1-2, 5-7 and 17; fig 2-6; see also claim 6) and sides configured for extending upwards alongside the foot of the patient (as shown in fig 6, at least part of the shell 13 includes sides that extend upwards alongside the foot of the patient), the shell including a distal lateral contour that is configured to match a distal lateral contour of the foot of the patient and a distal medial contour that is configured to match a distal medial contour of the foot of the patient (col 5 lines 8-25; col 6 lines 1-8 and 17-21; see figs 2-6; see also, specifically, col 6 lines 32-36 disclosing that the orthotic can be custom fit to the foot by machining);
wherein the shell (13) is configured to undergo flexion throughout the shell (col 6 lines 19-21);
wherein the variable thickness of the shell targets areas of increased stress (col 5 lines 8-25).
Schenkl does not, however, explicitly disclose that the device is “manufactured using additive manufacturing” or disclose that the shell comprises a plurality of layers integrally formed with each other.
Chatzistergos, however, teaches an orthotic device for a foot (support structure suitable for cushioning footbeds such as in insoles in footwear – abstract) manufactured by an additive manufacturing process (pg 6 line 22) to comprise a shell that includes a plurality of layers integrally formed with each other (pg 19 line 5; the structure is 3D printed using fused deposition modeling – pg 18 lines 26). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the shell of the orthotic of Schenkl having a plurality of layers integrally formed with each other, as taught by Chatzistergos, in order to customize the orthotic for a given user and/or purpose (Chatzistergos abstract).
Schenkl in view of Chatzistergos does not, however, explicitly disclose that the variable thickness of the shell is based at least on distributing stress throughout the shell.
Burns, however, teaches a foot pad which is configured to provide a desirable distribution of weight with respect to the foot structure to take the weight off the arch and to distribute more of the weight onto the outside marginal area of the foot between the heel and the ball of the foot with as much weight as possible removed from the heel and ball of the foot (col 1 lines 43-50). Specifically, Burns teaches that a cushion 32 and elevations 14 and 26 are preferably made of a thickness determined by the individual user's foot in order to secure the best weight distribution wherein the elevations 14 and 26 and cushion 32 are made as thick as possible since the thicker these three elements are made, the more weight is carried on elevations 14 and 26 (col 5 lines 34-50). Thus, the foot pad in Burns has a variable thickness based on distributing stress throughout the foot pad. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided the variable thickness in the shell of the orthotic device of Schenkl in view of Chatzistergos based at least on distributing stress throughout the shell, as taught by Burns, in order to provide a desirable distribution of weight with respect to the foot structure so that the circulation of blood in the foot is free and normal, the muscles of the foot function and develop in the proper manner, and there is no undue pressure upon the joints. (Burns col 1 lines 24-40).
With respect to claim 19, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 17) and Schenkl also discloses that the orthotic device is configured for use with a patient having valgus of the patient’s foot (the bottom surface of shell 13 is formed having specific predetermined angles and thicknesses required to alter the function of the foot to correct the foot problem of a user and the finished orthotic can be custom fit to a wearer’s foot – thus the device is interpreted as being capable of being configured for use for valgus of the foot when customized for a patient having this issue; see col 5 lines 8-15 and col 6 lines 32-33) the shell configured to provide gradual offset to an anatomy of the patient’s foot (see figs 2-6).
With respect to claim 20, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 17) and Schenkl also discloses that the orthotic device is configured for use with a patient having varus of the patient’s foot (the bottom surface of shell 13 is formed having specific predetermined angles and thicknesses required to alter the function of the foot to correct the foot problem of a user such as, i.e. excessive pronation – col 5 lines 8-15; correction of pronation and treatment of varus of the foot are interpreted as being equivalent since both involve correction of a foot that is turned inwards) the shell configured to provide gradual offset to an anatomy of the patient’s foot (see fig 2-6).
With respect to claim 21, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Chatzistergos teaches that a thinner portion of the shell is formed by fewer layers than a thicker portion of the shell (Chatzistergos teaches use of fused deposition modeling which involves building the structure layer by layer – melted material is deposited, one layer at a time, until the desired height is reached – thus, thinner portions inherently will be formed by fewer layers of material than thicker portions using this additive manufacturing process). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the shell of the orthotic of Schenkl in view of Chatzistergos and further in view of Burns so that a thinner portion of the shell comprises fewer layers than a thicker portion of the shell, which inherently will occur when using fused deposition modeling processes as taught by Chatzistergos, in order to customize the orthotic for a given user and/or purpose (Chatzistergos abstract).
With respect to claim 22, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Chatzistergos teaches that at least a minimum thickness throughout the shell is formed by the plurality of layers (the structure includes at least a single layer of material which is interpreted as providing a minimum thickness of the shell). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the shell of the orthotic of Schenkl in view of Chatzistergos and further in view of Burns so that the plurality of layers define at least a minimum thickness throughout the shell as taught by Chatzistergos in order to provide at least a minimal level of cushioning for the user’s foot.
With respect to claim 23, Schenkl in view of Chatzistergos and further in view of Burns discloses the orthotic device substantially as claimed (see rejection of claim 1) and Chatzistergos further teaches that the orthotic device is manufactured by an additive manufacturing process (pg 6 line 22). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the shell of the orthotic of Schenkl in view of Chatzistergos and further in view of Burns using additive manufacturing, as taught by Chatzistergos, in order to customize the orthotic for a given user and/or purpose (Chatzistergos abstract).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 8/21/25 have been fully considered as follows:
Regarding the objections to the drawings, Applicant’s amendments to the claims have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 101, Applicant’s amendments have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 9-16 have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Citation of Pertinent Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Charlesworth et al (US 2017/0318900) teaches a method of making a foot orthotic using additive manufacturing (para [0009]) with the benefit of thereby providing the ability to create orthotics having complex shapes and/or patterns (para [0102]).
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786