DETAILED ACTION
This action is in response to the Response filed 7/16/2026. Currently, claims 1-23 are pending in the 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 .
Election/Restrictions
Applicant's election with traverse of Invention I and Species I (corresponding to claims 1-5) in the reply filed on 7/16/2026 is acknowledged. The traversal is on the ground(s) that the election/restriction is the result of an examiner refusing to examine more than one independent claim. This is not found persuasive for the reason(s) detailed in the Requirement for Election/Restriction mailed 2/9/2026. Applicant also argues that there is no explanation or evaluation as to why the identified species present mutual exclusivity. In response, the examiner notes that the Requirement for Election/Restriction mailed 2/9/2026 explicitly states: “The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. For instance, Species I includes sub-portions and Species II includes uprights extensions. In addition, these species are not obvious variants of each other based on the current record.”
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/16/2026.
Claim 5 depends on withdrawn claim 23 and therefore, is also withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract exceeds the permitted length of 150 words. Currently, the abstract is 155 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 is not structured as a single sentence, as required. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the orthosis” in line 4 of the clam should be amended to recite ---the external gauntlet ankle / foot orthosis---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to correct a typographical error, “wherein: Wherein” in line 14 of the claim should be amended to recite ---wherein:---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: claim 1 recites “a first structural section including sub-portions,” “a second structural section including sub-portions” and “a connector sub-portion,” which are claim limitations lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: claim 1 recites “first structural extension” and “second structural extension,” which are claim limitations lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: claim 2 recites “first structural extension” and “second structural extension,” which are claim limitations lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. 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.
Claims 1-4 are 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 1 recites “the sub-portions” in line 13 of the claim. It is unclear if these recited “sub-portions” are intended to correspond to the sub-portions of the first structural section or the sub-portions of the second structural section that are previously recited in the claim. Claims 2-4 depend on claim 1 and therefore, include the same error.
Claims 1-4 are 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 1 recites the limitation "the apparatus of claim 2" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 depend on claim 1 and therefore, include the same error.
Claims 1-4 are 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 1 recites the limitation "the first structural extension" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 depend on claim 1 and therefore, include the same error.
Claims 1-4 are 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 1 recites the limitation "the second structural extension" in lines 14-15 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 depend on claim 1 and therefore, include the same error.
Claims 1-4 are 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 1 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 hook-and-loop fastener material and, accordingly, the identification/description is indefinite. Claims 2-4 depend on claim 1 and therefore, include the same error.
Claim 2 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 2 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 hook-and-loop fastener material and, accordingly, the identification/description is indefinite.
Claim 2 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 2 recites the limitation "the first structural extension" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 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 2 recites the limitation "the second structural extension" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 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 3 recites “the sub-portions” in line 2 of the claim. It is unclear if these recited “sub-portions” are intended to correspond to the sub-portions of the first structural section or the sub-portions of the second structural section that are previously recited in claim 1 (upon which claim 3 depends).
Claim 4 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 4 recites the limitation "the first ankle joint" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-4 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “a first structural section including sub-portions respectively coinciding with an outer portion of a foot and ankle and an inner portion of the foot and ankle,” which is a claim limitation indicating that Applicant is attempting to claim a foot and ankle (which are non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 2-4 depend on claim 1 and therefore, include the same error.
Claims 1-4 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-4 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “a second structural section including sub-portions respectively coinciding with an outer portion of a lower leg and an inner portion of a lower leg,” which is a claim limitation indicating that Applicant is attempting to claim a lower leg (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 2-4 depend on claim 1 and therefore, include the same error.
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) 1, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (US 2005/0274046 A1) in view of Crispin (US 4,771,768 A).
Regarding claim 1, Schwartz teaches in [0016], [0019-0020] and Figures 1 and 2
an external gauntlet ankle / foot orthosis (fracture walker 10) configured for application over a shoe ([0020] teaches “liner 18 is form fitted about the lower extremity 78;” a user is capable of positioning a foot wearing a shoe within line 18) configured to provide ankle and foot stability at least one of prophylactically or following trauma (the structure of the fracture walker 10 provides a physical barrier to stabilize the ankle and foot therein), wherein the orthosis (fracture walker 10) includes:
a first structural section (foot platform 12) including ([0016] teaches “foot platform 12 includes a base 26 with a rear lip 28 around the back of a foot and frame members 30 extending therefrom around the medial and lateral sides of a foot”) sub-portions (medial and lateral frame members 30) respectively coinciding with an outer portion of a foot and ankle and an inner portion of the foot and ankle ([0016] teaches “frame members 30 extending therefrom around the medial and lateral sides of a foot”); and
a second structural section (leg assembly 16) including ([0016] teaches “leg assembly 16 includes uprights 38”) sub-portions (uprights 38) respectively coinciding with an outer portion of a lower leg and an inner portion of a lower leg (as shown in Figure 2), wherein
the second structural section (leg assembly 16) is attached to the first structural section (foot platform 12) via (as shown in Figure 1; [0019] teaches “hinge assemblies 14 attach uprights 38 and frame members 30 via hinge attachment apertures 40 and hinge attachment locations 34”) a plurality of ankle joints (hinge assemblies 14), and
the sub-portions (medial and lateral frame members 30) of the first structural section (foot platform 12) are connected by (as shown in Figure 1; [0019] teaches “each strap attachment aperture 32 has a chafe 72 attached thereto” and “straps 20b are threaded through chafes 72”) a connector sub-portion (proximal strap 20b and corresponding chafe 72), the connector sub-portion (proximal strap 20b and corresponding chafe 72) having (as shown in Figure 1) a height that extends upward at least to a height of respective forward-most portions of the sub-portions (medial and lateral frame members 30).
wherein: Wherein the first structural extension (foot platform 12) and the second structural extension (leg assembly 16) is secured by (as shown in Figure 1; [0016] teaches “straps 20 include straps 20a that are used to tighten leg assembly 16 and straps 20b that are used to tighten base 26”) two straps (two straps 20a and two straps 20b, as shown in Figure 1).
Schwartz does not teach that the straps are structured as removable Velcro straps and D rings.
However, Crispin teaches in column 7, lines 4-17 and Figure 1 an analogous device wherein the straps (flexible straps 96 and 98) are structured as removable Velcro straps and D rings (as taught in column 1, lines 4-17).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the straps of Schwartz to be structured as removable Velcro straps and D rings as taught by Crispin because this element is known to be an alternative strapping configuration that enables the straps to be conveniently and easily tensioned and fictionally attached to hold the set amount of tension, as Crispin teaches in column 7, lines 4-17.
Regarding claim 3, Schwartz and Crispin teach the apparatus of claim 1. Schwartz teaches in Figure 1 a bottom strapping system (two straps 20b and corresponding chafes 72; [0019] teaches “each strap attachment aperture 32 has a chafe 72 attached thereto” and “straps 20b are threaded through chafes 72;” can be considered a “bottom” strapping system inasmuch as straps 20b are shown in Figure 1 to be positioned near the bottom of fracture walker 10) connecting (as shown in Figure 1) the sub-portions (medial and lateral frame members 30).
Regarding claim 4, Schwartz and Crispin teach the apparatus of claim 1. Schwartz teaches in Figure 1 and [0016] that the first ankle joint (first hinge assembly 14; [0016] teaches “a pair of hinge assemblies 14”) and a second ankle joint (second hinge assembly 14; [0016] teaches “a pair of hinge assemblies 14”) of the plurality of ankle joints (hinge assemblies 14) include (inasmuch as they are structured as) respective hinge components (hinge assemblies 14).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (US 2005/0274046 A1), in view of Crispin (US 4,771,768 A) and further in view of Hu et al. (US 2009/0287127 A1).
Regarding claim 2, Schwartz and Crispin teach the apparatus of claim 1. Schwartz teaches in Figure 1 and [0016] that the first structural extension (foot platform 12) and the second structural extension (leg assembly 16) is secured by (as shown in Figure 1; [0016] teaches “straps 20 include straps 20a that are used to tighten leg assembly 16 and straps 20b that are used to tighten base 26”) two straps (two straps 20a and two straps 20b, as shown in Figure 1).
Schwartz does not teach that the straps are structured as removable Velcro straps and D rings.
However, Crispin teaches in column 7, lines 4-17 and Figure 1 an analogous device wherein the straps (flexible straps 96 and 98) are structured as removable Velcro straps and D rings (as taught in column 1, lines 4-17).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the straps of Schwartz to be structured as removable Velcro straps and D rings as taught by Crispin because this element is known to be an alternative strapping configuration that enables the straps to be conveniently and easily tensioned and fictionally attached to hold the set amount of tension, as Crispin teaches in column 7, lines 4-17.
Schwartz and Crispin do not teach that the first structural section and the second structural section are made of thermoplastic.
However, Hu et al. teaches in [0094-0095] an analogous device wherein the first structural section (side shell portions 310) and the second structural section (unitary dorsal shell 302, posterior shell 304) are made of thermoplastic ([0094] teaches “exemplary suitable materials for forming the shells can include metals, such as aluminum, carbon, composite materials, such as carbon fiber/epoxy composites, glass fiber/epoxy composites, or suitable plastic materials, such as thermoplastic or thermosetting polymers, fiber reinforced plastic, molded chopped fibers, or any other suitable material”; [0095] teaches “the shell configuration includes a unitary dorsal shell 302, a posterior shell 304, and side shell portions 310 extending along the lateral and medial sides of an outsole 312”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the first structural section and the second structural section of Schwartz as modified by Crispin to be made of thermoplastic as taught by Hu et al. because this element is known to be an “exemplary suitable” material from which the first structural section and the second structural section can be formed, as Hu et al. teaches in [0094].
Conclusion
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 9/17/2026
