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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 17, 2026 has been entered.
In the submission, Applicant has been amended claim 19 and cancelled claim 24. Claims 19, 21-23 and 25-27 are pending in the instant application.
Response to Arguments
Applicant’s argues the Office Action applies and inappropriate standard for meeting the written description requirement and that claims 19, 21-23 and 25-27 satisfies the written description requirement (see pages 5-6 of the remarks filed April 17, 2026). The Office disagrees.
Applicant’s disclosure including the claims and drawings as originally filed does not provide support for “wherein the orthotic foot support is configured to: distribute at least a portion of forces placed on the user’s foot to the user’s dorsum or talar area”. The specification in para. [0016] recites “forces placed on the foot F during walking, standing or other activity are distributed throughout the internal device 12, while the wound W is exposed to little or no forces.” Further, the specification in para. [0017] recites “[f]orces on the walking boot are distributed about the assembly 10 and away from the wound W.” Therefore persons of ordinary skill in the art would recognize that the written description provides for forces to be distributed throughout the internal device (12), not the dorsum or talar area of the foot.
Applicant’s arguments, see page 7 of the of the remarks, filed April 17, 2026, with respect to the 102 (a)(1) rejection of claims 19 and 25 as being anticipated by Bledsoe and the 102(a)(1) rejection of claims 19, 21, 22 and 25-27 as being anticipated by Romo et al. as evidenced by Grim et al. have been fully considered and are persuasive. The 102(a)(1) rejection of claims 19, 21, 22 and 25-27 has been withdrawn.
Applicant's arguments filed April 17, 2026 with respect to the 103 rejection of claims 19 and equally claim 23 and 24 (now cancelled) as being obvious over Romo et al. in view of Grim, have been fully considered but they are not persuasive.
Applicant asserts that the M.P.E.P. § 716.01(a) states that Examiners must consider evidence of unexpected results, long-felt but unmet need, and skepticism of experts when timely presented by declaration or affidavit. Applicant submits herewith the Declaration of Normal S. Turner, M.D. and the Declaration of M. Mark Melin, M.D. Together, these declarations establish objective evidence of the nonobviousness of the orthotic foot support recited in claim 19. The Office disagrees.
The submitted the declarations are insufficient because: 1). The showing is not commensurate in scope with the claims since a nexus between the objective evidence of nonobviousness and the claimed invention has not been established by declarants. 2). The declaration indicates FootPakTM satisfies a long-felt need that was unmet by PegAssistTM with conventional walking boots or inflatable air cast. However, there is no showing that others of ordinary skill in the art were working on the problem and if so, for how long. In addition, there is no evidence that if persons skilled in the art who were presumably working on the problem knew of the teachings of the above cited references, they would still be unable to solve the problem. See MPEP § 716.04. And, declarants do not indicate what feature(s) of the claim met a long-felt need. 3.) Declarant Melin alludes to unexpected results by stating “[e]arly data have demonstrated excellent outcomes managing foot ulcerations” and tomography data demonstrate that FootPakTM redistributes forces across more surfaces area of the foot that PegAssistTM can, providing more substantial relief of hot spots than is possible combining PegAssistTM with standard walking boot or air cast device”; however, no such data or evidence of expected results has been provided.
Therefore, the Office concludes that claims 19, 21-23 and 25-27 are unpatentable over Romo et al. in view of Grim et al. Note the amended rejections below.
37 CFR 1.1312 Declaration
The declarations of M. Mark Melin, M.D. and Norman S. Turner, M.D. under 37 CFR 1.132 filed April 17, 2026 are insufficient to overcome the rejection of claims 19, 21-23 and 25-27 based upon the combination of Romo et al. and Grim et al. applied under 35 U.S.C. 103 as set forth in the last Office action because: 1). The showing is not commensurate in scope with the claims since a nexus between the objective evidence of nonobviousness and the claimed invention has not been established by declarants. 2). The declaration indicates FootPakTM satisfies a long-felt need that was unmet by PegAssistTM with conventional walking boots or inflatable air cast. However, there is no showing that others of ordinary skill in the art were working on the problem and if so, for how long. In addition, there is no evidence that if persons skilled in the art who were presumably working on the problem knew of the teachings of the above cited references, they would still be unable to solve the problem. See MPEP § 716.04. 3.) Declarant Melin alludes to unexpected results by stating “[e]arly data have demonstrated excellent outcomes managing foot ulcerations” and tomography data demonstrate that FootPakTM redistributes forces across more surfaces area of the foot that PegAssistTM can, providing more substantial relief of hot spots than is possible combining PegAssistTM with standard walking boot or air cast device”; however, no such data has been presented.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim Objections
Claim 23 is objected to because of the following informalities: claim 23, line 1, “if formed” should read --is formed--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 19 and 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. More specifically, applicant’s claim 19 which introduces the recitation of “wherein the orthotic foot support is configured to: distribute at least a portion of forces placed on the user’s foot to the user’s dorsum or talar area” invokes new matter. The specification in para. [0016] recites “forces placed on the foot F during walking, standing or other activity are distributed throughout the internal device 12, while the wound W is exposed to little or no forces.” Further, the specification in para. [0017] recites “[f]orces on the walking boot are distributed about the assembly 10 and away from the wound W.” Therefore persons of ordinary skill in the art person would recognize that the written description provides for forces to be distributed throughout the internal device (12), not the dorsum or talar area of the foot.
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.
Claim(s) 19, 21-23 and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 9,668,907 (“Romo et al.”) in view of U.S. Patent No. 5,329,705 (“Grim et al.”).
Regarding claim 19, Romo et al. discloses an orthopedic device that anticipates Applicant’s presently claimed invention. More specifically, Romo et al. discloses an orthotic foot support (constituted by soft good liner 112, see Fig. 1, col. 7, lines 29-30) comprising: a lower portion (the portion covering the user’s foot; note the disclosure that an insole may be placed on a proximal portion of the liner, col. 7, lines 30-31) comprising a pliable material (the liner is disclosed as a soft good liner, the liner is necessarily foldable over the user’s leg and foot and therefore pliable, see Fig. 1) and conformed to at least a portion of a user's forefoot and at least a portion of the user's midfoot (as can be seen from Fig. 1, the liner is foldable over the user’s leg and foot and is therefore capable of conforming to both forefoot and midfoot of a user); and an upper portion (the portion of the liner covering the back portion of the foot and lower leg) comprising a pliable material (liner 112 is as soft good liner and is necessarily pliable since it is foldable around a leg, see Fig. 1) and conformed to at least a portion of the user's hindfoot and at least a portion of the user's ankle (the liner is capable of being folded around a portion of the user’s hindfoot and ankle, see Fig. 1 and col. 7, lines 29-31); wherein the orthotic foot support is configured to: distribute at least a portion of forces placed on the user's foot to the user's dorsum or talar area (the forces placed on the user’s foot are capable of being distributed to the shell and soft goods liner, both of which overlay the dorsum and talar area of the user’s foot; and remove excess tolerance between the user's foot and an inner surface of an external device in multiple dimensions (while external device, walker 100, immobilizes the foot, see col. 2, lines 13-17 and col. 6, lines 24-35, the liner which covers the foot in multiple dimensions is capable of removing excess tolerance between the user's foot and an inner surface of the walker).
It must be noted that soft good liners, which line walkers and covers the lower leg, ankle and foot, is evidenced by Grim et al., see soft goods support (20), col. 4, line 5 and Fig. 2.
Romo et al. fails to disclose an opening configured to accommodate a wound on the user's foot or ankle. However, Grim et al. in the disclosure of an analogous orthotic device teaches it is known to provide a proximal end of a liner (soft goods support member 20) with a supplemental cushioning layer (inner sole assembly 52, which includes an air blader and a resilient layer, col. 4, lines 9-27; thus a cushioning layer), having individual removable sections (68), which create an opening in the insole when the individual sections are removed for the purpose of providing relief to an ulcerated or injured portion of the foot (col. 4, lines 22-33).
In view of Grim et al., it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have constructed the support of Romo et al. with a supplement cushioning layer having an opening in order to provide relief to an ulcerated or injured portion of the user’s foot.
Regarding claim 21, modified Romo et al. discloses the orthotic foot support of claim 19, wherein the external device comprises a device that immobilizes the user's foot while allowing the user to walk, stand, or engage in other activity (walker 100, which is semi-rigid or substantially rigid, immobilizes the user’s foot, see Fig. 1, col. 2, lines 13-17 and col. 6, lines 24-35; the device is used for walking).
Regarding claim 22, Romo et al. discloses the orthotic foot support of claim 21, wherein the external device comprises a walking boot, shoe cast, or foot brace (see the see the walking boot, constituted by walker 100, in Fig. 1).
Regarding claim 23, modified Romo et al. discloses the orthotic foot support of claim 19, wherein the opening is formed within a supplemental cushioning layer (note the rejection of claim 19 above).
Regarding claim 25, modified Romo et al. discloses an orthotic foot assembly (walker 100, see Fig. 1) comprising: the orthotic foot support (liner 112) of claim 1; and an external device (base shell 102, dorsal shell 104 and outsole 116).
Regarding claim 26, modified Romo et al. discloses the orthotic foot assembly of claim 25, wherein the external device comprises a device that immobilizes the user's foot while allowing the user to walk, stand, or engage in other activity (walker 100, which a semi-rigid or substantially rigid, immobilizes the user’s foot, see Fig. 1, col. 2, lines 13-17 and col. 6, lines 24-35; the device is used for walking).
Regarding claim 27, modified Romo et al. discloses the orthotic foot assembly of claim 26, wherein the external device comprises a walking boot, shoe cast, or foot brace (as can be seen from Fig. 1, the external device (100) is a walking boot).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786
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