DETAILED ACTION
This Office Action is in response to the amendment filed August 30, 2025. The specification and claims 19 and 25 have been amended and claim 20 has been cancelled. Claims 19 and 20-27 are pending in the instant application.
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 filed August 30, 2025 has been received and made of record. Note the acknowledged PTO-1449 enclosed herewith.
Response to Arguments
Applicant's arguments filed August 30, 2025 have been fully considered but they are not persuasive. In regards to Bledsoe with respect to the 102(a)(1) rejection of claim 19, Applicant argues “ Bledsoe fails to set forth an orthotic foot support that, in relevant part, is configured to distribute force applied to the user’s foot to the dorsum or talar area of the user’s foot, Bledsoe fails to set forth all of the features recited in claim 19 as amended herein, the examiner disagrees.
Bledsoe discloses “[w]eight applied to the foot is transferred to the walking shell by contact between the sides of the foot, arch, and heel and the arch, heel and sides of the foot-shaped cavity as well as the bottom of the cavity thereby decreasing the peak or maximum unit pressure on the plantar surface of the foot”. Thus, depending in which type of shell bootie (14) and midsole (28) are positioned will determine the distribution of the forces on the shell. If bootie (14) and midsole (28) are positioned in a shell that covers the dorsum and talar, the weight applied to the foot will also be distributed to the areas of the dorsum and talar area of the foot. Therefore, the orthotic foot support of Bledsoe is configured to distribute force applied to the user’s foot to the dorsum or talar area of the user’s foot in that it is capable of performing such a function.
In regards to Romo et al. with respect to the 102(a)(1) rejection of claim 19, Applicant argues the following:
“[c]laim 19 is amended to include subject matter previously recited in claim 20. Previous claim 20 was not subject to rejection as being anticipated by Romo. Applicant therefore submits that claims 19 and 21-27 are novel under 35 U.S.C. § 102(a)(1) over Romo for at least all of the reasons that previous claim 20 was deemed novel over Romo.”
Applicant must note that claim 20 was not deemed novel over Romo et al. Claim 20 was rejected as being anticipated by Bledsoe et al., and in order to avoid duplicate rejections, claim 20 was not rejected by Romo et al.
Applicant’s arguments with respect to claims 21-27 are predicated upon the assumption that claim 19 is novel, however the Office has not deemed claim 19 as such, therefore these arguments are moot.
Specification
The objection to the specification provided in the previous Office Action has been withdrawn in light of the amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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, nowhere in the disclosure, including the claims as originally filed, are the words dorsum or talar presented.
Claim Rejections - 35 USC § 102
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 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.
Regarding claim 19, Bledsoe et al. discloses a medical boot for diabetic and other patients that anticipate Applicant’s presently claimed invention. More specifically, Bledsoe et al. discloses an orthotic foot support (bootie 14 and midsole 28; Figs. 1 and 16a) comprising: a lower portion (toe box 48, tongue 50 and inner sole 60; col. 8, lines 53-56) comprising a pliable material (constructed from spongy foam material; col. 8, lines 50-51) and conformed to at least a portion of a user's forefoot and at least a portion of the user's midfoot (the toe box and tongue are capable of conforming to a portion of the user’s forefoot and midfoot when a foot is placed in the bootie since it is constructed of soft spongy foam); and an upper portion (first back portion 54 and second back portion 58, see col. 8, lines 54-55) comprising a pliable material (constructed from spongy foam material; col. 8, lines 50-51) and conformed to at least a portion of the user's hindfoot and at least a portion of the user's ankle (capable of conforming to a portion of the user’s hind foot, e.g., heel and ankle when a foot is placed in the bootie since it is constructed of soft spongy foam); 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 (1. depending in which type of shell bootie 14 and midsole 28 are positioned will determine the distribution of the forces on the shell; thus, if bootie 14 and midsole 28 are positioned in a shell that covers the dorsum and talar, the weight applied to the foot will also be distributed to the areas of the dorsum and talar area of the foot, therefore, the orthotic foot support of Bledsoe is configured to distribute force applied to the user’s foot to the dorsum or talar area of the user’s foot in that it is capable of performing such a function; 2 the spongy foam of bootie 14 is capable receiving force from walking and standing, and then distributing the forces to throughout the bootie and to portions of the foot on which it is applied); and remove excess tolerance between the user's foot and an inner surface of an external device in multiple dimensions (the bootie is configured to remove excess tolerance between the user's foot and an inner surface of an external device, constituted by walking shell 12, specifically when positioned within the walker shell and secured therein by hook and loop material straps 44, see Figs. 2, 17 and 18 and col. 8, lines 35-49).
Regarding claim 25, Bledsoe et al. discloses an orthotic foot assembly (constituted by walking boot 10, see Fig. 1, col. 7, lines 56-58) comprising: the orthotic foot support (bootie 14) of claim 19; and an external device (walking shell 12, see col. 8, lines 1).
Claim(s) 19, 21, 22 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.”) as evidenced by 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 liner, 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.
Regarding claim 21, 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 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 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 25, 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, 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, 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).
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) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romo et al., as evidenced by Grim et al.) in view of U.S. Patent No. 5,329,705 (“Grim et al.”).
Regarding claim 23, Romo et al. discloses the orthotic foot support of claim 19, further comprising a supplemental layer (constituted by insole 114). Romo et al. fails to explicitly disclose the insole is a cushioning layer.
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), for the purpose of providing relief to an ulcerated or injured portions of the foot (col. 4, lines 30-33).
In view of Grim et al., it would have been obvious to one having ordinary skill in the art to have constructed the insole of Romo et al. from cushioning material in order to provide relief to and ulcerated or injured portions of the user’s foot.
Regarding claim 24, Romo et al. discloses the orthotic foot support of claim 19, except that the support further comprises 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), have individuals removable sections (68), which create an opening in the insole when removed for the purpose of providing relief to an ulcerated or injured portions 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 to have constructed the support of Romo et al. with an opening in order to provide relief to and ulcerated or injured portions of the user’s foot.
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 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