DETAILED ACTION
This is the initial Office action for non-provisional application 19/629,600 filed March 26, 2026, which claims priority from non-provisional application 18/459,862 (now US Patent 12, 611,324) filed September 1, 2023, which claims priority from provisional application 63/403,492 filed September 2, 2022. Claims 1-20, as originally filed, 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 . 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5-9, 14, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birnbaum (US 8,142,381).
Regarding claim 1, Birnbaum discloses an orthopedic walker (foot brace device 10) comprising a base (top shoe assembly 20) including a heel region, a midfoot region, and a forefoot region, at least one slot (openings 124, 124’) formed in an anterior periphery of the base (20) and configured to receive a fastening element (strap member 31), and an outsole (sole assembly 60) secured to the base, wherein the at least one slot (124, 124’) extends along a first axis oriented at an oblique angle relative to a vertical axis of the walker (see annotated Fig. 1A below) thereby capable of directing a fastening force along a non-vertical load path that corresponds to a natural loading direction of a lower limb during ambulation (as a foot moves through the positions shown in Figs. 2A-2C, a loading force from a lower limb will be applied to strap member 31 received through openings 124, 124’) (Figs. 1-2C; column 2, lines 36-42 & 53-64).
Although Birnbaum fails to expressly teach that the at least one slot (124, 124’) is molded, this is 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
PNG
media_image1.png
724
580
media_image1.png
Greyscale
Regarding claim 3, Birnbaum discloses that the base (20) includes a second slot (openings 126, 126’) extending along a second axis oriented at a greater angle than the first axis relative to the vertical axis (see annotated Fig. 1A above), wherein the second axis is capable of directing a fastening force toward the forefoot region (Figs. 1-2; column 2, lines 53-64).
Although Birnbaum fails to expressly teach that the second slot (126, 126’) is molded, this is 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 5, Birnbaum discloses that the base (20) includes a transition surface (upper edges 23, 23’) extending between the at least one molded slot (124, 124’) and a toe end of the base (20), wherein the transition surface (23, 23’) defines a reduced-profile region capable of reducing interference during forward rollover (Figs. 2-A).
Regarding claim 6, Birnbaum discloses that the base (20) and the outsole (60) cooperative define a first trajectory along an upper surface of the base (20) and a second trajectory along an interface between the base (20) and the outsole (60), wherein the second trajectory is oriented at a greater angle than the first trajectory thereby capable of increasing flexibility at the forefoot region (see annotated Fig. 2B below).
PNG
media_image2.png
252
524
media_image2.png
Greyscale
Regarding claim 7, Birnbaum discloses that the base (20) and the outsole (60) further define a third trajectory at a distal end of the outsole (60), wherein the third trajectory is generally parallel to the second trajectory thereby capable of promoting smooth toe-off (see annotated Fig. 2B above).
Regarding claims 8 and 9, the first, second, and third trajectories of the walker (10) taught by Birnbaum define a multi-stage rocker profile capable of guiding a load path from a heel strike through toe-off along a non-linear path, wherein the multi-stage rocker profile is capable of reducing resistance to externally rotated foot positions during ambulation (compared to outsoles having linear rollover motion).
Regarding claim 14, Birnbaum discloses that the outsole (60) includes a plurality of attachment posts (lower tubular members 70) extending into corresponding openings (upper tubular guides 90) of the base (20), wherein the attachment posts (70) thereby form a distributed mechanical interlock that is capable of resisting shear forces during ambulation (Fig. 3; column 3, lines 51-53; column 4, lines 4-12).
Regarding claim 20, Birnbaum discloses an orthopedic walker (foot brace device 10) comprising a base (top shoe assembly 20) including a heel region and a forefoot region, and an outsole (sole assembly 60) secured to the base, wherein the base (20) and the outsole (60) cooperatively define a rocker profile including a heel region (rear sole member 66), a midfoot region (middle sole member 67), and a toe region (front sole member 68), wherein the rocker profile includes a first curvature and a second curvature different from the first curvature, and wherein the first curvature and the second curvature are configured to produce a non-linear rollover path that accommodates external rotation of a user’s foot and reduces compensatory gait adjustments (Figs. 1-2C; Abstract; column 2, lines 36-52; column 3, lines 36-50).
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (US 2007/0293798).
Hu discloses an orthopedic walker (walker 200) comprising a base (base member 202) including a sidewall (side strut support 238) extending upward from a footbed (resilient layer 206), an outsole (outsole 204) secured to the base (202), and a lattice structure formed in the sidewall (238), the lattice structure including a plurality of ribs defining recesses therebetween, wherein at least one rib extends obliquely relative to a longitudinal rib, wherein the obliquely extending rib is oriented to such that it would be capable of resisting torsional deformation of the sidewall (238) during gait (see annotated Fig. 22 below; ¶ 0077-0079).
PNG
media_image3.png
737
533
media_image3.png
Greyscale
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 2, 4, 10, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Birnbaum as applied to claims 1 and 3 above.
Regarding claims 2 and 4, the fastening force of the first axis applied at the oblique angle by the walker (10) taught by Birnbaum will implicitly include both vertical and anterior components and the second slot (126, 126’) will stabilize the forefoot region independently of the heel region. Although Birnbaum fails to expressly teach that the oblique angle is between 30 degrees and 60 degrees and the second axis is oriented between 60 degrees and 90 degrees relative to the vertical axis, it would have been obvious to one having ordinary skill in the art to construct the walker taught by Birnbaum such that the oblique angle is between 30 degrees and 60 degrees and the second axis is oriented between 60 degrees and 90 degrees relative to the vertical axis 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).
Regarding claims 10 and 11, Birnbaum discloses the invention substantially as claimed, as described above, and although Birnbaum discloses that rear, middle, and front assemblies of the outsole (60) compress independent from each other depending on a user’s gait (Abstract) such that a heel thickness of the outsole (60) will be greater than a toe thickness of the outsole (60) during a heel rise stage of the user’s gait (Fig. 2C) thereby approximating a natural foot rollover geometry. Although Birnbaum fails to expressly teach that a ratio of the heel thickness to the toe thickness is between 1.15 and 1.45 or approximately 1.35, it would have been obvious to one having ordinary skill in the art to construct the walker taught by Birnbaum such that a ratio of the heel thickness to the toe thickness is between 1.15 and 1.45 or approximately 1.35 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).
Claims 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Birnbaum as applied to claim 1 above, in view of Grim et al. (US 2014/0265018).
Regarding claim 12, Birnbaum discloses the invention substantially as claimed, as described above, but fails to teach that the base has a peripheral edge extending beyond the outsole at a posterior portion of the walker, wherein the peripheral edge forms a barrier to rearward separation of the outsole.
Grim discloses an orthopedic walker (orthopedic walking boot 100) comprising a base (base 102/302) and an outsole (outer sole 104) secured to the base (102/302), wherein the base (102/302) forms a peripheral edge (heel bumper 306) that extends past the outsole (104) at a posterior portion of the walker (100) thereby forming a barrier to rearward separation of the outsole (104) (Figs. 1 & 4A; ¶ 0042, 0056, & 0059).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the walker taught by Birnbaum such that the base has a peripheral edge extending beyond the outsole at a posterior portion of the walker thereby forming a barrier to rearward separation of the outsole as taught by Grim for the purpose of securing the outsole to the base using a single shot molding process.
Regarding claims 14 and 15, Birnbaum discloses the invention substantially as claimed, as described above, but fails to teach that the outsole includes a plurality of attachment posts extending into corresponding openings of the base, wherein the attachment posts forming a distributed mechanical interlock that resists shear forces during ambulation, and wherein at least one of the attachment posts extends through a plurality of openings to form a continuous post structure that increases resistance to frontal impact.
Grim discloses an orthopedic walker (orthopedic walking boot 100) comprising a base (base 102/502) and an outsole (outer sole 104) secured to the base (102/502), wherein the outsole (104) includes a plurality of attachment posts (interlocks 120) extending into corresponding openings (through holes 118, 504) of the base (102/502), wherein the attachment posts (120) forming a distributed mechanical interlock that resists shear forces during ambulation, and wherein at least one of the attachment posts extends through a plurality of openings (504) to form a continuous post structure (toe bumper 510) thereby increasing resistance to frontal impact (Figs. 1, 3, & 7A-7B; ¶ 0042, 0051-0052, & 0063-0064).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the walker taught by Birnbaum such that that the outsole includes a plurality of attachment posts extending into corresponding openings of the base, wherein the attachment posts forming a distributed mechanical interlock that resists shear forces during ambulation, and wherein at least one of the attachment posts extends through a plurality of openings to form a continuous post structure that increases resistance to frontal impact as taught by Grim for the purpose of providing a toe protecting section.
Claims 13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Birnbaum as applied to claim 1 above, in view of Hu et al. (US 2007/0293798), as evidenced by Mauldin et al. (US 4,572,169) and Fout et al. (US 2010/0100020) with respect to claims 16-18.
Regarding claim 13, Birnbaum discloses the invention substantially as claimed, as described above, but fails to teach that the base includes a groove extending along a peripheral edge and receiving a portion of the outsole, wherein the groove constrains lateral displacement of the outsole relative to the base.
Hu discloses an orthopedic walker (walker 32) comprising a base (base 34) and an outsole (outsole 38), wherein the base (34) includes a groove (peripheral recess 74) extending along a peripheral edge and receiving a portion of the outsole (38), and wherein the groove (74) and an interlocking ridge (ridge 72) may be reversed such that the groove (74) would thereby be capable of constraining lateral displacement of the outsole (38) relative to the base (Figs. 8-9; ¶ 0055 & 0062).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the orthopedic walker taught by Birnbaum such that the base is provided with a groove at a distal end of the base to interface with and secure the outsole within a peripheral edge of the base and an internal peripheral edge of the base sits flush against an inside surface of the outsole as taught by Hu for the purpose of increasing traction and resisting delamination of the outsole from the base.
Regarding claims 16-18, Birnbaum discloses the invention substantially as claimed, as described above, and further discloses that the base (20) includes a sidewall (lateral portions 21, 21’). However, Birnbaum fails to teach that the sidewall has a lattice structure defined by intersecting ribs forming a plurality of recesses thereby reducing weight while maintaining structural rigidity, wherein at least one rib extends at an oblique angle or orientation relative to a longitudinal rib thereby increasing resistance to bending loads applied during ambulation, and wherein the oblique angle corresponds to an orientation of an upper peripheral edge of the base such that load transfer through the sidewall is aligned with a direction of force application from a user’s lower limb.
Hu discloses an orthopedic walker (walker 200) comprising a base (base member 202) including a sidewall (side strut supports 238) having a lattice structure defined by intersecting ribs forming a plurality of recesses thereby capable of reducing weight while maintaining structural rigidity, wherein at least one rib extends at an oblique angle or orientation relative to a longitudinal rib thereby capable of increasing resistance to bending loads applied during ambulation, and wherein the oblique angle corresponds to an orientation of an upper peripheral edge of the base (202) such that load transfer through the sidewall (238) is aligned with a direction of force application from a user’s lower limb (see annotated Fig. 21 below; ¶ 0077-0079).
PNG
media_image4.png
766
648
media_image4.png
Greyscale
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the walker taught by Birnbaum such that the sidewall has a lattice structure defined by intersecting ribs forming a plurality of recesses, wherein at least one rib extends at an oblique angle or orientation relative to a longitudinal rib, and wherein the oblique angle corresponds to an orientation of an upper peripheral edge of the base as taught by Hu for the purpose of reinforcing and enhancing the structural rigidity of the sidewall as evidenced by Mauldin (Fig. 4; column 3, lines 45-55) and Fout (Fig. 4; ¶ 0045).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KERI J NELSON/Primary Examiner, Art Unit 3786 7/24/2026
Prosecution Insights