DETAILED ACTION
This Office action is based on the amendments and request for continued examination of application 18/176,966 filed January 20, 2026. Claims 9, 12, and 22-26 have been amended, claims 13 and 27 have been cancelled, and claims 29 and 30 are newly presented; claims 9-12, 14-26, and 28-30 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 20, 2026 has been entered.
Response to Arguments
Applicant’s arguments filed January 20, 2026 have been considered but are moot because they do not apply to the current rejections below.
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 9-12, 19, 20, 22, and 26, are rejected under 35 U.S.C. 103 as being unpatentable over Ibarra et al. (WO 2022/020769), in view of Schwartz (US 2009/0076425), in even further view of Jensen et al. (US 7,666,155) and Chan (US 2009/0306565).
Regarding claim 9, Ibarra discloses an orthosis system (foot suspension system 100/1800) (Figs. 1A-1B, 16, & 18; ¶ 0066) comprising:
at least a cuff (sleeve 130 + halo 1610) configured to secure to a leg (Figs. 1A-1B, 16, & 18; ¶ 0070 & 0148-0150);
one or more struts (vertical bar 120) connected to the at least a cuff (130+1610) (Figs. 1A-1B, 16, & 18; ¶ 0075 & 0148); and
a footplate (boot 110 + inner boot cover 1900) connected, using a coupler system, to the one or more struts (120), wherein the footplate (110+1900) is flexible and flexes at a forefoot (toe area 116) of the footplate (110+1900) relative to a hindfoot (rear area 117) when the orthosis system (100/1800) is employed for ambulation, wherein the coupler system includes a proximal coupler that couples the one or more struts (120) to the at least a cuff (130+1610) and a distal coupler that couples the one or more struts (120) to the footplate (110+1900), the proximal coupler and the distal coupler together defining a load-bearing interface configured to transfer load from the footplate (110+1900) to the at least a cuff (130+1610) through the one or more struts (120) during ambulation (Figs. 1A-1B & 18-19; ¶ 0148-0150 & 0156-0158).
However, Ibarra fails to teach that the footplate is ambidextrous.
Schwartz discloses an orthosis system (podiatric/orthopedic system 100) comprising an ambidextrous footplate (equilateral foot bed 110) (Fig. 1; ¶ 0049-0050 & 0053).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the footplate of the orthosis system taught by Ibarra to be ambidextrous as taught by Schwartz for the purpose of providing lower costing orthosis systems for users.
However, the combination of Ibarra and Schwartz fails to teach that the coupler system is a quick connect coupler system.
Jensen discloses an orthosis system (off-weighting device 100) comprising a cuff (sleeve attachments 114 + sleeve 116), one or more struts (support struts 102 with outer and inner struts 118, 122), and a proximal quick connect coupler (snap slots 1402 + snap hooks 1222) that couples the one or more struts (102) to the cuff (114+116) (Figs. 1, 9B, 12A, & 14B; column 5, lines 59-63; column 6, lines 1-2; column 12, lines 34-40; column 14, lines 118-27).
Chan discloses an orthosis system (rehabilitation walking boot) comprising one or more struts (leg supports 20) and a footplate (foot support 10) connected, using a quick connect coupler system, to the one or more struts (20), wherein the quick connect coupler system comprises a distal quick connect coupler (slots 14 + inserts 21) that couples the one or more struts (120) to the foot plate (10) (Figs. 1-4; ¶ 0029-0030 & 0035).
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 coupler system of the orthosis system taught by the combination of Ibarra and Schwartz such that the proximal coupler is a proximal quick connect coupler as taught by Jensen and the distal coupler is a distal quick connect coupler as taught by Chan such that the coupler system is a quick connect coupler system for the purpose of providing a convenient and efficient coupler system for assembling and dismantling the orthosis system as needed.
Regarding claims 10 and 11, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, and Ibarra further discloses that the at least a cuff (130+1610) comprises a tibial cuff (halo 1610) and an off-loading cuff (sleeve 130) (Figs. 16 & 18; ¶ 0070 & 0148-0150).
Regarding claim 12, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, and Ibarra further discloses that an embodiment of a strut (120) that is telescoping (Figs. 11A-11B; ¶ 0125-0128).
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 orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan such that the one or more struts are telescoping as further taught by Ibarra for the purpose of enabling the orthosis system to be customized for different users depending on leg length.
Further, the quick connect coupling system of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan enables the one or more struts to removably connect to one or more of the at least a cuff and the footplate.
Regarding claim 19, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, and Ibarra further discloses that the one or more struts (120) are extensible (¶ 0077).
Regarding claim 20, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, and Ibarra further discloses that the footplate (110+1900) comprises a distal coupler (located proximate rear area 117 for accommodating a first end 122 of vertical bar 120), a heel pad (rear cushion 1970), a heel cup (rear portion 1910 of inner boot cover 1900), and a toe pad (toe cushion 1960) (Figs. 1A-1B, 16, & 18-19; ¶ 0075 & 0158-0161).
Regarding claim 22, Ibarra discloses a kit (foot suspension system 100/1800) (Figs. 1A-1B & 18; ¶ 0066) comprising:
at least a cuff (inner sleeve of sleeve 130) configured to secure to a leg (Figs. 1A-1B; ¶ 0070);
one or more struts (vertical bar 120) connectable, without tools, to the at least a cuff (130) (Figs. 1A-1B; ¶ 0075);
a footplate (boot 110) connected to the one or more struts (120), wherein the footplate (110) is flexible and flexes at a forefoot (toe area 116) of the footplate (110) relative to a hindfoot (rear area 117) when the orthosis system (100/1800) is employed for ambulation (Figs. 1A-1B & 18; ¶ 0156-0158); and
one or more of a splint system and a casting system (rigid outer sleeve of sleeve 130) (¶ 0070 & 0074).
However, Ibarra fails to teach that the footplate is ambidextrous.
Schwartz discloses an orthosis system (podiatric/orthopedic system 100) comprising an ambidextrous footplate (equilateral foot bed 110) (Fig. 1; ¶ 0049-0050 & 0053).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the footplate of the orthosis system taught by Ibarra to be ambidextrous as taught by Schwartz for the purpose of providing lower costing orthosis systems for users.
However, the combination of Ibarra and Schwartz fails to teach that the coupler system is a quick connect coupler system.
Jensen discloses an orthosis system (off-weighting device 100) comprising a cuff (sleeve attachments 114 + sleeve 116), one or more struts (support struts 102 with outer and inner struts 118, 122), and a proximal quick connect coupler (snap slots 1402 + snap hooks 1222) that couples the one or more struts (102) to the cuff (114+116) (Figs. 1, 9B, 12A, & 14B; column 5, lines 59-63; column 6, lines 1-2; column 12, lines 34-40; column 14, lines 118-27).
Chan discloses an orthosis system (rehabilitation walking boot) comprising one or more struts (leg supports 20) and a footplate (foot support 10) connected, using a quick connect coupler system, to the one or more struts (20), wherein the quick connect coupler system comprises a distal quick connect coupler (slots 14 + inserts 21) that couples the one or more struts (120) to the foot plate (10) (Figs. 1-4; ¶ 0029-0030 & 0035).
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 coupler system of the orthosis system taught by the combination of Ibarra and Schwartz such that the proximal coupler is a proximal quick connect coupler as taught by Jensen and the distal coupler is a distal quick connect coupler as taught by Chan such that the coupler system is a quick connect coupler system for the purpose of providing a convenient and efficient coupler system for assembling and dismantling the orthosis system as needed.
Regarding claim 26, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, and Ibarra further discloses that an embodiment of a strut (120) that is telescoping (Figs. 11A-11B; ¶ 0125-0128).
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 orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan such that the one or more struts are telescoping as further taught by Ibarra for the purpose of enabling the orthosis system to be customized for different users depending on leg length.
Further, the quick connect coupling system of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan enables the one or more struts to removably connect to one or more of the at least a cuff and the footplate.
Claims 14-16, 21, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ibarra in view of Schwartz, Jensen, and Chan as applied to claims 9 and 22 above, and in further view of Townsend et al. (US 6,692,454).
Regarding claims 14 and 28, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, but fails to teach that the footplate comprises separated lateral and medial forefoot platforms configured to flex independently of one another.
Townsend discloses a footplate (heel-sole counter 13’) comprising separated lateral and medial forefoot platforms (medial and lateral extensions 52, 53) configured to flex independently of one another (Fig. 25; column 20, lines 11-56).
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 footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan to comprise separated lateral and medial forefoot platforms configured to flex independently of one another as taught by Townsend for the purpose of allowing more unrestricted forefoot motion as a user’s foot recovers.
Regarding claim 15, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, and Ibarra further discloses that the forefoot (116) of the footplate (110) flexes with respect to the hindfoot (117) during a terminal stance phase and then returns to its original configuration as the orthosis system (100) transitions to a swing phase of gait (Fig. 18; ¶ 0156-0157).
However, the combination of Ibarra / Schwartz / Jensen / Chan fails to expressly teach that the footplate provides propulsive energy return.
Townsend discloses a footplate (heel-sole counter 13/26/13’) having a forefoot (extension 27) that flexes with respect to a hindfoot during a terminal stance phase and then returns to its original configuration, thereby providing propulsive energy return, as the footplate (13/26/13’) transitions to a swing phase of gait (column 17, lines 57-63; column 18, lines 7-26; column 20, lines 11-32).
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 footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan such that the footplate provides propulsive energy return as taught by Townsend for the purpose of providing assistance during the stance phase heel off portion of gait.
Regarding claim 16, the combination of Ibarra / Schwartz / Jensen / Chan / Townsend discloses the invention substantially as claimed, as described above, and Schwartz further discloses that the orthosis system is configured to fit both a left leg and a right leg (¶ 0050 & 0053).
Therefore, the ambidextrous footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan / Townsend would be configured to fit both a left leg and a right leg as further taught by Schwartz.
Regarding claim 21, the combination of Ibarra / Schwartz / Jensen / Chan / Townsend discloses the invention substantially as claimed, as described above, and Ibarra further discloses that the orthosis system (100) is configured to enable immobilization of a foot with the footplate (110) (¶ 0067).
Regarding claims 29 and 30, the combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, but fails to teach that the ambidextrous footplate comprises a spring plate.
Townsend discloses a footplate (heel-sole counter 26 with foot plate extension 27) comprises a spring plate (Fig. 15A; column 18, lines 7-25).
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 footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan to comprise separated lateral and medial forefoot platforms configured to flex independently of one another as taught by Townsend for the purpose of providing assistance during the stance phase heel-off portion of gait.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ibarra in view of Schwartz, Jensen, and Chan as applied to claim 9 above, in further view of Townsend as applied to claim 15 above, and in even further view of Franke et al. (US 2013/0267878).
The combination of Ibarra / Schwartz / Jensen / Chan / Townsend discloses the invention substantially as claimed, as described above, and Ibarra further discloses that the footplate (110+1900) comprises a cushioned heel region (rear cushion 1970) capable of providing energy dissipation during a heel strike (Fig. 19; ¶ 0161).
However, the combination of Ibarra / Schwartz / Jensen / Chan / Townsend fails to teach that the footplate comprises a combat boot tread.
Franke discloses an orthosis system (load redistribution system 101/702) comprising a footplate (outsole 104/704) comprising a boot tread (Figs. 1A & 7A; ¶ 0064 & 0095).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date, to modify the footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan / Townsend to have a boot tread as taught by Franke for the purpose of aiding in ambulation.
Although the combination of Ibarra / Schwartz / Jensen / Chan / Townsend / Franke fails to expressly teach that the boot tread is a combat boot tread, it would have been an obvious matter of design choice to construct the boot tread of the footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan / Townsend / Franke to be a combat boot tread since it has been held that the configuration of a claimed device (e.g., boot treads on an orthosis system) was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed device was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ibarra in view of Schwartz, Jensen, and Chan as applied to claim 9 above, and in further view of Franke et al. (US 2013/0267878).
The combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, but fails to teach that the footplate is sized and configured for use with footwear.
Franke discloses an orthosis system (load redistribution system) comprising a footplate (outsole) sized and configured for use with footwear (¶ 0007).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date, to modify the footplate of the orthosis system taught by the combination of Ibarra / Schwartz / Jensen / Chan to be sized and configured for use with footwear as taught by Franke for the purpose of enabling a user to wear their shoes as desired.
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ibarra in view of Schwartz, Jensen, and Chan as applied to claim 22 above, and in further view of Root et al. (US 2022/0387658).
The combination of Ibarra / Schwartz / Jensen / Chan discloses the invention substantially as claimed, as described above, but fails to teach that the one or more of a splint system and casting system is the splint system, wherein the splint system is a garment-based splint system or a foam-based splint system, or the one or more of a splint system and casting system is the casting system.
Root discloses a splint or casting system (orthopedic limb stabilization device 1500) comprising a garment (sleeve 1501) filled with foam (foam 1505) such that the splint or casting system (1500) is a garment- and foam-based splint system (Figs. 15A-15C; ¶ 0135 & 0170).
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 splint or casting system of the kit taught by the combination of Ibarra / Schwartz / Jensen / Chan to be a garment- and foam-based splint system as taught by Root for the purpose of providing a splint system that forms a precise fitting rigid structure in minutes.
Further, since Applicant has not provided any structural distinction between a “splint system” and a “casting system” and the system (1500) taught by Root is configured to stabilize a limb such that it can be considered a splint or casting system, the structure of the prior art meets the claimed limitations.
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.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 6/12/2026
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