DETAILED ACTION
In Applicant’s Response filed 4/1/26, Applicant has amended claims 1 and 3; and added new claims 8-11. Currently, claims 1-11 are 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/10/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 10-11 are objected to because of the following informalities: in claim 10 line 1: “The external ankle brace” should be “The footwear” (since claim 10 depends from claim 9 which is directed to “footwear”); in claim 11 line 6: “the wearers foot” should be “the foot of the wearer”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 8 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 8 contains the trademark/trade name Velcro. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a hook and loop fastening system and, accordingly, the identification/description is indefinite.
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.
Claims 1-5, 7 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11413180 (hereinafter the ‘180 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the present application and claim 1 of the ‘180 patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘180 Patent is in effect a “species” of the broader, “generic” invention recited in claim 1 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 1 of the present application is anticipated by claim 1 of the ‘180 patent and, therefore, is not patentably distinct from claim 1 of the ‘180 patent.
All of the limitations of claims 2-5 and 7 can be found in claims 2-6 of the ‘180 Patent. All the limitations of claim 9 can be found in claim 17 if the ‘180 patent.
Claims 6, 8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,413,180 B2 in view of Birmingham (US 6299587 B1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious in view of the ‘180 patent and the Birmingham reference to one having ordinary skill in the art at the time of the invention.
With respect to claim 6, all the limitations of the external ankle brace of claim 6 of the present application are disclosed in claim 1 of the ‘180 patent except that there is no disclosure of the heel enclosure further including oppositely disposed upper and lower ends, where said medial ankle joint is positioned closer to said upper end than the position of said lateral ankle joint.
Birmingham, however, teaches an external ankle brace (ankle-foot orthosis system 10 in figures 1-4) comprising a heel enclosure (28, 40, 46 28; Figure 2) which further includes oppositely disposed upper and lower ends (see Annotated Figure 2), where said medial ankle joint (22b-52) is positioned closer to said upper end than the position of said lateral ankle joint (22a-24) (see Annotated Figure 2, when assembled the medial ankle joint 22b-52 is closer to the upper end than it is to the position of the lateral ankle joint 22a-24).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of claim 1 of the ‘180 patent so that the heel enclosure further includes oppositely disposed upper and lower ends, where said medial ankle joint is positioned closer to said upper end than the position of said lateral ankle joint, like in Birmingham, since such a modification would have merely require repositioning of the medial ankle joint and/or lateral ankle joint and rearranging parts of an invention involves only routine skill in the art.
With respect to claim 8, all the limitations of the external ankle brace of claim 8 of the present application are disclosed in claim 1 of the ‘180 patent except that there is no disclosure of the at least one connecting strap of the upper fastening system being a Velcro connecting strap.
Birmingham, however, teaches an external ankle brace (ankle-foot orthosis system 10 in figures 1-4) for restricting movement of an ankle in a first direction (device contains no rotatable sections for moving the foot side to side; see structure in Figure 2) and permitting movement of the ankle in a second direction (plantar and dorsiflexion, pivot connections 22a and 22b allow movement in those directions of the foot seen in Figure 1), wherein said external ankle brace is disposed on the exterior of a shoe (See Figure 1) and the shoe having a heel portion, a sole, and oppositely disposed sides (See Figures 1 and 3, where an entire standard shoe that includes these customary features is shown being worn in conjunction with the ankle brace 10), comprising: an upper fastening system (See Figure 1, 90 and 92) comprising at least one connecting strap (90; fig 1) for removably connecting (Col. 4 lines 42-51, 90 is a selectively detachable strap) said lateral sidewall to said medial sidewall across the top of the shoe (Col. 4 lines 42-51, attached between 40 and 46, see Annotated Figure 2 where 40 and 46 are part of the sidewalls; fig 1 shows connection across the top of the shoe), wherein the strap 90 is preferably a hook and loop attachment strap (e.g. Velcro) (col 4 lines 49-50).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of claim 1 of the ‘180 patent so that the at least one connecting strap of the upper fastening system is a Velcro connecting strap, as taught by Birmingham, in order to permit selective detachment of the strap for easier application and/or removal of the brace from a patient’s body.
With respect to claim 11, all the limitations of the external ankle brace of claim 11 of the present application are disclosed in claim 1 of the ‘180 patent except that there is no disclosure of the external ankle brace being configured so that respective portions of the medial and lateral sidewalls extend in a manner that a foot of a wearer, when the external ankle brace is worn by the wearer, is located directly between the medial and lateral sidewalls and the medial and lateral sidewalls extend from the heel portion of the shoe in the longitudinal direction towards a toe of the wearers foot with the foot directly located in between ends of the sidewalls.
Birmingham, however, teaches an external ankle brace (ankle-foot orthosis system 10 in figures 1-4) for restricting movement of an ankle in a first direction (device contains no rotatable sections for moving the foot side to side; see structure in Figure 2) and permitting movement of the ankle in a second direction (plantar and dorsiflexion, pivot connections 22a and 22b allow movement in those directions of the foot seen in Figure 1), wherein said external ankle brace is disposed on the exterior of a shoe (See Figure 1) and the shoe having a heel portion, a sole, and oppositely disposed sides (See Figures 1 and 3, where an entire standard shoe that includes these customary features is shown being worn in conjunction with the ankle brace 10), comprising: a rigid heel enclosure (26, 40, 46) having a rear portion (Figure 2, U-bend 28) and a forward portion (See Annotated Figure 2, where the forward portion is the part of element 26 identified as being the medial and lateral side walls), said rear portion (Figure 2, U-bend 28) for receiving the heel of the shoe (See Figure 1), said forward portion having a medial sidewall and a lateral sidewall (See Annotated Figure 2) for surrounding the sides of the shoe (See Figures 1 and 3 in view of Annotated Figure 2), wherein the external ankle brace is configured so that respective portions of the medial and lateral sidewalls extend in a manner that a foot of a wearer, when the external ankle brace is worn by the wearer (as shown in figs 1 and 3), is located directly between the medial and lateral sidewalls (as shown in fig 3, the shoe is located directly between the sidewalls and, therefore, the foot inside the shoe is also at this position) and the medial and lateral sidewalls extend from the heel portion of the shoe in the longitudinal direction towards a toe of the wearers foot (as shown in fig 1 in view of the annotated fig 2) with the foot directly located in between ends of the sidewalls (as shown in fig 3).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of claim 1 of the ‘180 patent so that the external ankle brace is configured so that respective portions of the medial and lateral sidewalls extend in a manner that a foot of a wearer, when the external ankle brace is worn by the wearer, is located directly between the medial and lateral sidewalls and the medial and lateral sidewalls extend from the heel portion of the shoe in the longitudinal direction towards a toe of the wearers foot with the foot directly located in between ends of the sidewalls, as taught by Birmingham, in order to restrict movement of the ankle to thereby control alignment and motion of the ankle when using the brace.
ANNOTATED FIG 2 of Birmingham:
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Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,413,180 B2 in view of Birmingham (US 6299587 B1).
With respect to claim 10, all the limitations of the external ankle brace of claim 10 of the present application are disclosed in claim 17 of the ‘180 patent except that there is no disclosure of the shoe being a laced shoe located in the brace and located directly between the medial sidewall and the lateral sidewall. Birmingham, however, teaches an external ankle brace (ankle-foot orthosis system 10 in figures 1-4) for restricting movement of an ankle in a first direction (device contains no rotatable sections for moving the foot side to side; see structure in Figure 2) and permitting movement of the ankle in a second direction (plantar and dorsiflexion, pivot connections 22a and 22b allow movement in those directions of the foot seen in Figure 1), wherein said external ankle brace is disposed on the exterior of a shoe (See Figure 1) wherein the shoe is a laced shoe (as shown in fig 1) and is located in the brace and located directly between the medial sidewall and the lateral sidewall (as shown in fig 3). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of claim 1 of the ‘180 patent so that the shoe is a laced shoe located in the brace and located directly between the medial sidewall and the lateral sidewall, as taught by Birmingham, in order to permit a user to easily apply and/or remove the shoe via the laces and, furthermore, to restrict movement of the ankle to thereby control alignment and motion of the ankle when using the brace.
Allowable Subject Matter
Claims 1-11 are free of art but are still subject to the objections and rejections provided above. Additionally, any changes or amendments to the claims may result in new rejections being made in future Actions.
The following is a statement of reasons for the indication of allowable subject matter:
Applicant's arguments, see Applicant's Response filed 4/1/26, with respect to the claim rejections under 35 USC 103 have been fully considered and are persuasive. Applicant argued that the prior art of record fails to disclose at least one connecting strap for connecting said lateral sidewall to said medial sidewall underneath the sole of the shoe, as recited in independent claim 1.
The closest prior art of record teaching such structure is Dittmer (US 6669659 B2) which teaches an ankle brace (See Figure 1) usable with a shoe comprised of an analogous lateral sidewall 12 and a medial side wall 14 and a strap 60 (See Figure 1) that wraps around the opposing segments 12 and 14 (Col. 3 lines 37-50), where the strap 60 has a buckle 62 and a Velcro surface (See Figure 6, and Col. 3 lines 50-57) making the strap 60 a removable strap; this allows the strap to accommodate a body part of any size (Col. 3 lines 50-57) as well as not damage the shoe the brace is being used with; also this would more securely hold the medial and lateral sidewalls of the splint together on the shoe and more firmly in place (Col. 4 lines 2 -6) (Col. 3 lines 37-41); also see Figure 1 where the strap 60 goes underneath the sole of the shoe. As argued by Applicant, however, adding the strap 60 from Dittmer to the Birmingham device would at least partly destroy the function of the Birmingham device because it already includes a strap 90 which functions to urge u-shaped member 28 against the sole of the shoe and does not appear to be deficient in any way or need to be supplemented to more firmly hold the u-shaped member in place (Applicant’s arguments, pages 8-9 of the Response). Applicant further argued that one having ordinary skill in the art would have had “no reason to look to another reference for a secure attachment scheme and…add a strap” to the device of Birmingham because Birmingham discloses use of a fastener in the embodiment of figures 5-7 which serves this purpose by more securely holding the u-shaped member 28 to the sole of the shoe (Applicant’s arguments pages 8-9 of the Response).
The Office is persuaded by these arguments and therefore agrees with Applicant that the prior art of record fails to disclose the subject matter outlined above.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 4/1/26 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments to claim 1 have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn. New objections have been given, however, as necessitated by Applicant’s amendments to the claims.
Regarding the claim rejections under 35 USC 101, Applicant’s amendments to claim 3 have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments have been fully considered and are persuasive as discussed in the “Allowable Subject Matter” section of this Action. Therefore, the claim rejections have been withdrawn.
Regarding the Double Patenting rejections, in the absence of any arguments in response to these rejections or filing of a terminal disclaimer, the rejections have been maintained. Additionally, rejections of new claims 8-11 have been added.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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