DETAILED ACTION
This action is in response to the amendment filed 6/17/2026. Currently, claims 8-15, 17-19 and 22-30 are pending in the application. Claims 1-7, 16, 20 and 21 are cancelled by Applicant. New claims 28-30 are added by Applicant.
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 .
Response to Arguments
Applicant’s amendment to claim 19 is not sufficient to overcome the previous objection to claim 19. Claim 19, therefore, remains objected to as detailed below.
Applicant’s arguments with respect to the previous rejections of claims 8-27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been fully considered and are persuasive. The rejections of claims 8-27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been withdrawn.
As admitted by Applicant in the filed Remarks, Applicant failed to amend claim 8 to overcome the previous Double Patenting rejection of claim 8. The Double Patenting rejection of claim 8, is therefore, maintained as detailed below.
Applicant's remaining arguments filed 6/17/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the Birmingham and Dittmer et al. references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Birmingham to also include a lower fastening system comprising at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe; and wherein the at least one connecting strap is a synthetic strap as taught by Dittmer et al. because this element is known to provide an additional mechanism to hold the brace more “firmly in place,” as Dittmer et al. teaches in column 3, lines 37-41.
In response to applicant's argument that Birmingham and Dittmer et al. are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Birmingham and Dittmer et al. are in the field of the inventor’s endeavor (ankle orthoses).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Objections
Claim 8 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the lateral sidewall of said heel enclosure" in lines 16-17 of the claim should be amended to recite ---the lateral sidewall---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), "the medial sidewall of said heel enclosure" in lines 18-19 of the claim should be amended to recite ---the medial sidewall---. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a wearer” in line 4 of the claim should be amended to recite ---the wearer---. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the brace” in line 1 of the claim should be amended to recite ---the external ankle brace---. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the brace” in line 1 of the claim should be amended to recite ---the external ankle brace---. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: in order to correct a typographical/grammatical error, “the sidewalls are contoured to the donned by the wear when the wearer is wearing” should be amended to recite ---the sidewalls are contoured to be donned by the wearer when the wearer is wearing---. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the sidewalls” in lines 1-2 of the claim should be amended to recite ---the medial and lateral sidewalls---. Appropriate correction is required.
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.
Claim 28 is 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. Claim 28 recites “the external gauntlet ankle / foot orthosis at least one of limits or prevents ankle inversion, eversion, dorsiflection and/or plantar flexion.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s disclosure does not teach that the present invention functions to limit or prevent dorsiflection and/or plantar flexion as claimed. To the contrary, Applicant’s original disclosure explicitly teach that “the external ankle brace permits dorsiflexion and plantar flexion” (see [0037] of the publication of the present application).
Claim 29 is 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. Claim 29 recites “the external brace is configured so that, when donned by the wearer, a first sub-portion and a second sub-portion respectively of the medial and lateral sidewalls partially wrap over a top of the wearer's foot.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original specification does not teach each of the medial and lateral sidewalls having a portion that partially wraps over a top of the wearer’s foot. Nor is this feature shown in Applicant’s figures.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 28 recites the limitation "the external gauntlet ankle / foot orthosis" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,957,611. Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding claim 8, all of the limitations therein are substantially recited and anticipated by claim 1 of US ‘611.
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.
Claim(s) 8-15, 17, 19, 22-26, 28 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birmingham (US 6,299,587) in view of Dittmer et al. (US 6,669,659).
In regards to claims 8 and 24, Birmingham teaches in Figures 1 and 2 (note: Figure 2 is taught in column 3, lines 7-9 to be the ankle-foot orthosis system 10 of Figure 1 but with an alternative embodiment of the post member 12a, 12b)
a heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) having a rear portion (arched portion of U-shaped member 28 positioned rearward of attachment post 40 and second post member 46) and a forward portion (horizontal portions of U-shaped member 28 positioned forward of attachment post 40 and second post member 46, first attachment post 40, second post member 46), wherein
said rear portion (arched portion of U-shaped member 28 positioned rearward of attachment post 40 and second post member 46) is for receiving a heel portion of a shoe (as shown in Figure 1),
the external ankle brace (ankle-foot orthosis system 10) is configured to restrict movement of an ankle (inasmuch no mechanism to permit inversion or eversion of the ankle is taught) in a first direction (inversion-eversion) and permit movement of the ankle (via pivotal connection, taught in columns 3-4, lines 60-1) in a second direction (dorsiflexion-plantarflexion) normal to (dorsiflexion-plantarflexion movement occurs in a plane that is perpendicular to the plane of inversion-eversion) the first direction (inversion-eversion), wherein said external ankle brace (ankle-foot orthosis system 10) is configured to be disposed on an exterior of (as shown in Figure 1) the shoe (shoe 30) and the shoe (shoe 30) having (as taught in column 3, lines 54-57) the heel portion (heel 38), a sole (sole sidewall 32), a toe (front portion 36), a top (upper portion of shoe 30), and oppositely disposed sides (left and right sides of shoe 30),
said forward portion (horizontal portions of U-shaped member 28 positioned forward of attachment post 40 and second post member 46, first attachment post 40, second post member 46) includes a medial sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) and a lateral sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) for collectively surrounding (as shown in Figure 2) the oppositely disposed sides (medial and lateral sides) of the shoe (shoe 30), the medial (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) and lateral (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) sidewalls being cantilevered (as shown in Figure 2) from the rear portion (arched portion of U-shaped member 28 positioned rearward of attachment post 40 and second post member 46) of the heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46), the medial (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) and lateral (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) sidewalls each being configured to extend from (as shown in Figure 1) the heel portion (heel 38) of the shoe (shoe 30) in a longitudinal direction beyond a talus of a wearer’s foot and toward the wearer’s toe (as shown in Figure 1), each of the medial (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) and lateral (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) sidewalls being at least partially located adjacent (near) to (as shown in Figure 1) an instep area of a corresponding medial or lateral side of the shoe (shoe 30), and
the external ankle brace (ankle-foot orthosis system 10) further comprises:
a lateral upright extension (lateral post 12a or 12b) selectively (via pivotal connection, taught in columns 3-4, lines 60-1) perpendicular to (as shown in Figure 2) at least the lateral sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) of said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) and pivotally attached (via pivotal connection, taught in columns 3-4, lines 60-1) to said lateral sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10);
a medial upright extension (medial post 12a or 12b) selectively (via pivotal connection, taught in columns 3-4, lines 60-1) perpendicular to (as shown in Figure 2) at least the medial sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) of said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) and pivotally attached (via pivotal connection, taught in columns 3-4, lines 60-1) to said medial sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10).
Birmingham does not teach a lower fastening system comprising at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe; and wherein the at least one connecting strap is a synthetic strap.
However, Dittmer et al. teaches in Figures 1 and 4 and column 3, lines 37-41 an analogous device that includes a lower fastening system (lowermost strap 60) comprising at least one connecting strap (lowermost strap 60) for connecting (column 3, lines 37-41 teaches “Velcro strap 60 wraps around opposing segments of assemblies 12 and 14 and the leg of the person to hold the splint firmly in place”) said lateral sidewall (lateral segment 12f or 14f) to said medial sidewall (medial segment 12f or 14f) underneath the sole of the shoe (as shown in Figure 1, the lowermost strap 60 extends underneath the sole of the shoe); and wherein the at least one connecting strap (lowermost strap 60) is a synthetic strap (column 3, line 39 teaches “Velcro strap 60;” Velcro® is a synthetic material).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Birmingham to also include a lower fastening system comprising at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe; and wherein the at least one connecting strap is a synthetic strap as taught by Dittmer et al. because this element is known to provide an additional mechanism to hold the brace more “firmly in place,” as Dittmer et al. teaches in column 3, lines 37-41.
In regards to claim 9, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figure 2 and columns 3-4, lines 60-1 a lateral ankle joint (formed by pivotal connection taught in columns 3-4, lines 60-1) that pivotally connects (as taught in columns 3-4, lines 60-1) said lateral upright extension (lateral post 12a or 12b) to said lateral sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) and allows said lateral upright extension (lateral post 12a or 12b) to move in the second direction (dorsiflexion-plantarflexion) relative to said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46).
In regards to claim 10, Birmingham and Dittmer et al. teach the apparatus of claims 8 and 9. Birmingham teaches in Figure 2 that said lateral ankle joint (formed by pivotal connection taught in columns 3-4, lines 60-1) in combination with said lateral upright extension (lateral post 12a or 12b) and said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) is configured to prevent movement of the ankle in (inasmuch the pivotal connection, attachment device 26, U-shaped member 28, first attachment post 40, second post member 46 and lateral post 12a or 12b form a physical support that inhibits inversion or eversion of the ankle) the first direction (inversion-eversion).
In regards to claim 11, Birmingham and Dittmer et al. teach the apparatus of claims 8 and 9. Birmingham teaches in Figure 2 and columns 3-4, lines 60-1 a medial ankle joint (formed by pivotal connection taught in columns 3-4, lines 60-1) that pivotally connects (as taught in columns 3-4, lines 60-1) said medial upright extension (medial post 12a or 12b) to said medial sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) and allows said medial upright extension (medial post 12a or 12b) to move in the second direction (dorsiflexion-plantarflexion) relative to said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46).
In regards to claim 12, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figure 1 that the shoe (shoe 30) is an athletic shoe (Figure 1 teaches shoe 30 being a sneaker, which is an athletic shoe).
In regards to claim 13, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figure 2 an upright fastening system (calf band 18a) comprising one connecting strap (calf band 18a), the one connecting strap (calf band 18a) being the only connecting strap of (as shown in Figure 2) the upright fastening system (calf band 18a), the one connecting strap (calf band 18a) for connecting (as shown in Figure 2) said lateral upright extension (lateral post 12a or 12b) to said medial upright extension (medial post 12a or 12b) above the ankle (as shown in Figure 2, the calf band 18a connects posts 12a and 12b at a position that would be located above the wearer’s ankle in use).
Birmingham does not teach the one connecting strap for removably connecting said lateral upright extension to said medial upright extension above the ankle.
However, Dittmer et al. teaches in Figure 1 and column 3, lines 38-41 an analogous device with the one connecting strap (uppermost strap 60) for removably connecting (column 3, lines 37-41 teaches “Velcro strap 60 wraps around opposing segments of assemblies 12 and 14 and the leg of the person to hold the splint firmly in place;” Velcro® is a removable fastening mechanism) said lateral upright extension (lateral segments 12a-12e or 14a-14e) to said medial upright extension (medial segments 12a-12e or 14a-14e) above the ankle (as shown in Figure 1, the uppermost strap 60 connects segments 12a-12e and 14a-14e at a position that would be located above the wearer’s ankle in use).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the one connecting strap of Birmingham as modified by Dittmer et al. to provide the one connecting strap for removably connecting said lateral upright extension to said medial upright extension above the ankle as taught by Dittmer et al. because this element is known to enable the upright fastening system to more firmly and adjustably “hold the splint firmly in place,” as Dittmer et al. teaches in column 3, lines 37-41.
In regards to claim 14, Birmingham and Dittmer et al. teach the apparatus of claims 8, 9 and 11. Birmingham teaches in Figure 2 that the external ankle brace (ankle-foot orthosis system 10) prevents inversion and eversion (inasmuch no mechanism to permit inversion or eversion of the ankle is taught; further, the pivotal connections, attachment device 26, U-shaped member 28, first attachment post 40, second post member 46, post 12a and post 12b form physical supports that inhibit inversion or eversion of the ankle), the movement of the ankle in the first direction (inversion-eversion) being inversion.
In regards to claim 15, Birmingham and Dittmer et al. teach the apparatus of claims 8, 9 and 11. Birmingham teaches in Figure 2 and columns 3-4, lines 60-1 that the external ankle brace (ankle-foot orthosis system 10) permits dorsiflexion and plantar flexion (via pivotal connection, taught in columns 3-4, lines 60-1), the movement of the ankle in the second direction (dorsiflexion-plantarflexion) being dorsiflexion.
In regards to claim 17, Birmingham and Dittmer et al. teach the apparatus of claims 8, 9 and 11. Birmingham teaches in Figure 2 and 3-4, lines 60-1 that said medial ankle joint (formed by pivotal connection taught in columns 3-4, lines 60-1) in combination with said medial upright extension (medial post 12a or 12b) and said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) is configured to prevent movement in (inasmuch the pivotal connections, attachment device 26, U-shaped member 28, first attachment post 40, second post member 46, post 12a and post 12b form physical supports that inhibit inversion or eversion of the ankle) the first direction (inversion-eversion).
In regards to claim 19, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figure 2 an upright fastening system (calf band 18a) comprising at least one connecting strap (calf band 18a) for connecting (as shown in Figure 2) said lateral upright extension (lateral post 12a or 12b) to said medial upright extension (medial post 12a or 12b) above the ankle (as shown in Figure 2, the calf band 18a connects posts 12a and 12b at a position that would be located above the wearer’s ankle in use).
Birmingham does not teach the upright fastening system comprising at least one connecting strap for removably connecting said lateral upright extension to said medial upright extension above the ankle, the at least one connecting strap of the upright fastening system extending in front of the shin of a wearer of the shoe when worn by the wearer.
However, Dittmer et al. teaches in Figure 1 and column 3, lines 38-41 an analogous device with an upright fastening system (middle strap 60) comprising at least one connecting strap (middle strap 60) for removably connecting (column 3, lines 37-41 teaches “Velcro strap 60 wraps around opposing segments of assemblies 12 and 14 and the leg of the person to hold the splint firmly in place;” Velcro® is a removable fastening mechanism) said lateral upright extension (lateral segments 12a-12e or 14a-14e) to said medial upright extension (medial segments 12a-12e or 14a-14e) above the ankle (as shown in Figure 1, the middle strap 60 connects segments 12a-12e and 14a-14e at a position that would be located above the wearer’s ankle in use), the at least one connecting strap (middle strap 60) of the upright fastening system (middle strap 60) extending in front of the shin of a wearer of the shoe when worn by the wearer (as shown in Figure 1).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the upright fastening system of Birmingham as modified by Dittmer et al. to provide the upright fastening system comprising at least one connecting strap for removably connecting said lateral upright extension to said medial upright extension above the ankle, the at least one connecting strap of the upright fastening system extending in front of the shin of a wearer of the shoe when worn by the wearer as taught by Dittmer et al. because this element is known to enable the upright fastening system to more firmly and adjustably “hold the splint firmly in place,” as Dittmer et al. teaches in column 3, lines 37-41.
In regards to claim 22, Birmingham and Dittmer et al. teach the apparatus of claims 8, 9 and 11. Birmingham teaches in Figure 2 that said lateral ankle joint (formed by pivotal connection taught in columns 3-4, lines 60-1) in combination with said lateral upright extension (lateral post 12a or 12b) and said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) and said medial ankle joint (formed by pivotal connection taught in columns 3-4, lines 60-1) in combination with said medial upright extension (medial post 12a or 12b) and said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) are configured to prevent movement in (inasmuch the pivotal connections, attachment device 26, U-shaped member 28, first attachment post 40, second post member 46, post 12a and post 12b form physical supports that inhibit inversion or eversion of the ankle) the first direction (inversion-eversion).
In regards to claim 23, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figures 1 and 2 and column 4, lines 43-45 an upper fastening system (strap 90) comprising at least one connecting strap (strap 90) for (indirectly) connecting (via attachment between attachment posts 40, 46, as taught in column 4, lines 43-44) said lateral sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) to said medial sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) only across the top of (as shown in Figure 1) the shoe (shoe 30), wherein the at least one connecting strap (strap 90) of the upper fastening system (strap 90) is for removably (column 4, lines 43-45 teaches “selectively detachable strap 90”) connecting (indirectly, via attachment between attachment posts 40, 46, as taught in column 4, lines 43-44) the lateral sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the lateral side of ankle-foot orthosis system 10) to the medial sidewall (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) across the top of (as shown in Figure 1) the shoe (shoe 30).
In regards to claim 25, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham does not teach an upright fastening system comprising two separate connecting straps for removably connecting said lateral upright extension to said medial upright extension above the ankle.
However, Dittmer et al. teaches in Figure 1 an analogous device with an upright fastening system (uppermost strap 60 and middle strap 60) comprising two separate connecting straps (uppermost strap 60 and middle strap 60) for removably connecting (column 3, lines 37-41 teaches “Velcro strap 60 wraps around opposing segments of assemblies 12 and 14 and the leg of the person to hold the splint firmly in place;” Velcro® is a removable fastening mechanism) said lateral upright extension (lateral segments 12a-12e or 14a-14e) to said medial upright extension (medial segments 12a-12e or 14a-14e) above the ankle (as shown in Figure 1, uppermost strap 60 and middle strap 60 connect to assemblies 12 and 14 at locations positioned above the user’s ankle).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Birmingham as modified by Dittmer et al. to include an upright fastening system comprising two separate connecting straps for removably connecting said lateral upright extension to said medial upright extension above the ankle as taught by Dittmer et al. because this element is known to enable the upright fastening system to more securely and adjustably “hold the splint firmly in place,” as Dittmer et al. teaches in column 3, lines 37-41.
In regards to claim 26, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham and Dittmer et al. do not teach that the at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe comprises two connecting straps for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe comprises two connecting straps for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that providing two of the at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe taught by Birmingham as modified by Dittmer et al. would provide an additional mechanism to hold the brace more firmly in place.
In regards to claim 28, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figure 2 that the external gauntlet ankle / foot orthosis (ankle-foot orthosis system 10) at least one of limits or prevents ankle inversion, eversion (inasmuch as attachment upper post member 12, pivot connection members 22a, 22b, pivot connection member 24, post member 40, second post member 46 and pivotal connection member 52 are shown in Figure 2 to provide structural elements positioned on the medial and lateral sides of the user’s ankle in use, such that ankle inversion and eversion is limited and prevented by the presence of these structures), dorsiflection and/or plantar flexion.
In regards to claim 30, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham teaches in Figure 1 that the sidewalls (horizontal portion of U-shaped member 28 positioned forward of attachment post 40 or second post member 46 and positioned on the medial side of ankle-foot orthosis system 10) are contoured to the donned by the wear when the wearer is wearing the shoe (shoe 30) and the brace (ankle-foot orthosis system 10) is worn over the shoe (as shown in Figure 1).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birmingham (US 6,299,587), in view of Dittmer et al. (US 6,669,659) and further in view of Peters (US 5,676,642).
In regards to claim 18, Birmingham and Dittmer et al. teach the apparatus of claims 8, 9 and 11. Birmingham teaches in Figure 2 that said heel enclosure (attachment device 26, U-shaped member 28, first attachment post 40, second post member 46) further includes oppositely disposed upper (topmost edges of first attachment post 40 and second post member 46) and lower ends (bottommost edges of U-shaped member 28).
Birmingham and Dittmer et al. do not teach where said medial ankle joint is positioned closer to said upper end than the position of said lateral ankle joint.
However, Peters teaches in Figures 1 and 4, column 5, lines 17-28 and column 6, lines 32-36 an analogous device where said medial ankle joint (inner rivet 12; column 6, lines 32-36 teaches that the inner rivet 12 defines a pivot point) is positioned closer to said upper end than the position of (Figure 4, column 5, lines 17-28 and column 6, lines 32-36 teach that the inner rivet 12 is positioned closer to the topmost edges of uprights 36, 38 than the outer rivet 14) said lateral ankle joint (outer rivet 14; column 6, lines 32-36 teaches that the outer rivet 14 defines a pivot point).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the medial and lateral ankle joints of Birmingham as modified by Dittmer et al. such that said medial ankle joint is positioned closer to said upper end than the position of said lateral ankle joint as taught by Peters because this element is known to enable the external ankle brace to pivot “along the same axis as the foot, providing maximum comfort and maximum flexing of the ankle forward and backward (plantarflexion and dorsiflexion),” as Peters teaches in column 5, lines 17-28.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birmingham (US 6,299,587), in view of Dittmer et al. (US 6,669,659) and further in view of Drillio (US 2014/0066829).
In regards to claim 27, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham and Dittmer do not teach that the heel enclosure is a rigid heel enclosure.
However, Drillio teaches in the abstract and [0025] an analogous device with the heel enclosure (“cup for receiving the heel,” taught in the abstract) being rigid (the abstract teaches “a rigid, unitary cup for receiving the heel”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the heel enclosure of Birmingham as modified by Dittmer et al. to be rigid as taught by Drillio because this element is known to enable the heel enclosure to provide support and stability.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birmingham (US 6,299,587), in view of Dittmer et al. (US 6,669,659) and further in view of Fuller, II et al. (US 5,496,263 A).
In regards to claim 29, Birmingham and Dittmer et al. teach the apparatus of claim 8. Birmingham and Dittmer et al. do not teach that the external brace is configured so that, when donned by the wearer, a first sub-portion and a second sub-portion respectively of the medial and lateral sidewalls partially wrap over a top of the wearer's foot leaving a gap.
However, Fuller, II et al. teaches in Figures 1 and 2, column 7, lines 34-44 and column 9, lines 54-58 an analogous device wherein the external brace (ankle brace 20) is configured so that (as shown in Figures 1 and 2), when donned by the wearer (as shown in Figures 1 and 2) a first sub-portion (first and second portions of the respective first and second upwardly extending sides 34 that are “drawn together” in use, as taught in column 7, lines 34-44) and a second sub-portion (second upwardly extending side 34) respectively of the medial and lateral sidewalls (two upwardly extending sides 34) partially wrap over a top of the wearer's foot (column 7, lines 34-44 teaches “the sides 34 are drawn together in order to conform to the configuration of the user's foot;” column 9, lines 54-58 teaches “since the anterior 36 and posterior 38 support straps are located relatively high on the ankle module 24, the natural flexibility of the material from which the sides 34 of the module is constructed allows them to bend and flex as they are drawn by the straps 36, 38”) leaving a gap (as shown in Figures 1 and 2).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the external brace of Birmingham as modified by Dittmer et al. to be configured so that, when donned by the wearer, a first sub-portion and a second sub-portion respectively of the medial and lateral sidewalls partially wrap over a top of the wearer's foot leaving a gap as taught by Fuller, II et al. because this “this configuration provides a wide degree of adjustability while at the same time providing excellent support for a tarsal joint 54 (FIG. 2a),” as Fuller, II et al. teaches in column 7, lines 34-44.
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 VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 7/6/2026
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