DETAILED ACTION
This action is in response to the amendment filed 8/25/2025. Currently, claims 18, 19, 24-30, 33 and 35-38 are pending in the application. Claims 1-17, 20-23, 31, 32, 34 and 39 are cancelled 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant’s amendment to claim 18 is sufficient to overcome the previous objection to claim 18.
Applicant's arguments filed 8/25/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a relatively large distance between the forefoot anchor and the heel bone, in use; the forefoot anchor is spaced far from the heel bone such that the at least one working strap spans the distance to provide full support for the at least one foot arch; the at least one working strap spans the relatively large distance between the heel bone and at least one head of the metatarsal bones while crossing under the sole of the foot; a relatively large span for the tensioned working strap) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s argument that Arensdorf et al. does not teach a structure positioned around the foot at distal ends of the metatarsal bones, the examiner respectfully disagrees. It is clear from at least Figure 3 of Arensdorf et al. that the athletic sock 24 is positioned around the foot at distal ends of the metatarsal bones.
Claim Objections
Claim 18 is objected to because of the following informalities: claim 18 recites “the forefoot anchor having an open front end, an open rear end, and a longitudinal length extending from the distal part of the metatarsal bones rearward toward a medial part of the metatarsal bones,” which is a claim limitation 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 18, 19, 24-30, 33 and 35-38 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 18 recites “the at least one working strap, when attached to the forefoot anchor, extending between the heel bone of the foot at least one head of the metatarsal bones and crossing under the sole of the foot.” The meaning of this claim limitation is unclear. For purposes of examination, the examiner will interpret this claim limitation to mean --- the at least one working strap, when attached to the forefoot anchor, extending between the heel bone of the foot and one head of the metatarsal bones and crossing under the sole of the foot---. Claims 19, 24-30, 33 and 35-38 depend on claim 18 and therefore, include the same error.
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 18, 19, 24-30, 33 and 35-38 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.
Claim 18 is 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 18 recites “the forefoot anchor having an open front end, an open rear end, and a longitudinal length extending from the distal part of the metatarsal bones rearward toward a medial part of the metatarsal bones,” which is a claim limitation indicating that Applicant is attempting to claim the metatarsal bones (which are non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 19, 24-30, 33 and 35-38 depend on claim 18 and therefore, include the same error.
Claims 18, 19, 24-30, 33 and 35-38 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.
Claim 18 is 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 18 recites “the at least one working strap, when attached to the forefoot anchor, extending between the heel bone of the foot at least one head of the metatarsal bones and crossing under the sole of the foot,” which is a claim limitation indicating that Applicant is attempting to claim the foot (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 19, 24-30, 33 and 35-38 depend on claim 18 and therefore, include the same error.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 18, 19, 24, 25, 33 and 35-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arensdorf et al. (US 5,676,641).
In regards to claim 18, Arensdorf et al. teaches in Figures 1-11
a forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) configured to be anchored around a foot (foot 22) at a location of a distal part of the metatarsal bones (ossis metatarsi I-V) (as shown in Figure 3, the athletic sock 24 is anchored around the foot 22 at a location of a distal part of the metatarsal bones (ossis metatarsi I-V); column 3, lines 25-29 teach “the sheath 20 being slipped over the foot 22 which preferably has an athletic sock 24 thereon” and “the sheath 20 has a front opening 26 from which the toes of the foot 22 extend”), the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) having an open front end (front opening 26), an open rear end (heel opening 28), and a longitudinal length extending from the distal part of the metatarsal bones rearward toward a medial part of the metatarsal bones (as shown in Figure 3, the athletic sock 24 has a longitudinal length extending from the distal part of the metatarsal bones rearward toward a medial part of the metatarsal bones); and
at least one working strap (strap members 32, 34) configured to be anchored around the heel (as shown in Figures 3, 10 and 11; column 4, lines 27-29 teaches “the strap members 32 and 34 are of identical construction and have central stirrup portions 70 and 72;” column 5, lines 3-4 teaches “stirrup 72 crossing the heel 30”) and having ends (ends 40, 42, 48, 50) attached to (as shown in Figure 3) or attachable to (column 3, lines 45-54 teaches “the opposed ends 40 and 42 of strap member 32 are provided with corresponding fasteners 44 and 46 which are adapted to mate with the material comprising strap member 32, fasteners 44 and 46 being preferably composed of VELCRO® hook material” and “likewise, opposed ends 48 and 50 of strap member 34 are provided with respective VELCRO® fasteners 52 and 54 which are adapted to mate with the material of member 34 upon pressure contact therewith”) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28), the at least one working strap (strap members 32, 34), when attached to (as shown in Figure 3) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28), extending between the heel bone (heel 30) of the foot (foot 22) and one head of the metatarsal bones and crossing under the sole of the foot (as shown in at least Figure 3);
wherein the device is configured to be adjusted from (column 4-5, lines 61-35 detail the method of adjusting the device from the fitting position to the working position by wrapping the device; also shown in Figures 5-9) a fitting position (shown in Figures 1, 4 and 5), in which the at least one working strap (strap members 32, 34) is not tensioned in order to place the device on the foot of the user, to a working position (shown in Figures 3, 10 and 11), in which the at least one working strap (strap members 32, 34) is tensioned between (as shown in Figures 3, 10 and 11, the strap members 32, 34 are tension along a length that extends between the heel 30 and the distal end of the athletic sock 24) the heel (heel 30) of the foot (foot 22) and (portion(s) of) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) such that at least part of the at least one working strap (strap members 32, 34) when tensioned (column 3, lines 39-46 teaches “two elongated elastic strap members 32 and 34 are crossed under the bottom portion 36 of the sheath 20 and anchored at the intersection thereof by stitching the members to a seam 38 at the bottom of the sheath 20” and “the strap members 32 and 34 are longitudinally stretchable and are placed in tension as they are drawn into their respective operative positions illustrated by the sequence depicted in FIGS. 6-9”) is positioned under the sole of the foot (foot 22) to support the at least one foot arch of the user (as shown in Figure 4, strap members 32, 34 cross under the foot arch of the user; thus, when tensioned, strap members 32, 34 exert a tension force against the user’s foot arch and thus, provide a supporting force thereto).
In regards to claim 19, Arensdorf et al. teaches the apparatus of claim 18. Arensdorf et al. teaches in Figures 3, 10 and 11 that the at least one working strap (strap members 32, 34) comprises a first working strap section (central stirrup portion 70) which, when in the working position (shown in Figures 3, 10 and 11), extends between (as shown in Figures 3, 10 and 11) (portion(s) of) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) proximal to (at a location proximal to) the head of metatarsal bone I (caput ossis metatarsi I) and a heel bone and at least one second working strap section (central stirrup portion 72) which, when in the working position (shown in Figures 3, 10 and 11), extends between (as shown in Figures 3, 10 and 11) (portion(s) of) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) proximal to (at a location proximal to) the head of metatarsal bone V (caput ossis metatarsi V) and the heel bone.
In regards to claim 24, Arensdorf et al. teaches the apparatus of claim 18. Arensdorf et al. teaches in column 3, lines 31-37 and column 4, lines 28-29 and 46-48 that a force required to elastically deform the at least one working strap (strap members 32, 34) is greater than a force required to elastically deform the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) (column 4, lines 28-29 teaches “the strap members 32 and 34 are of identical construction and have central stirrup portions 70 and 72, respectively;” column 4, lines 46-48 teaches “the stirrup portions 70 and 72 are made from an elastic material having a relatively low stretch factor, preferably approximately 30 percent;” column 3, lines 31-37 teaches “the sheath 20 is made from an elastic fabric such as SPANDEX®” and “the preferred material has four-way stretchability, meaning that it has resilience in directions up and down the leg as well circumferentially”).
In regards to claim 25, Arensdorf et al. teaches the apparatus of claim 18. Arensdorf et al. teaches in the Figures 1, 4 and 5, the abstract, column 1, lines 12-17 and column 3, lines 45-54 that the device is implemented as a brace (column 1, lines 12-17 that the device is “a support which presents structure for insuring a desired lift to the ankle as well as rigidity to the medial and lateral sides of the ankle by providing a combination of medial and lateral braces”) configured to be fitted over the foot (the abstract teaches that in use “the sheath is positioned on the foot of the wearer”), and wherein, when in the fitting position (shown in Figures 1, 4 and 5), ends (ends 40, 42, 48, 50) of the at least one working strap (strap members 32, 34) are disconnected from (as shown in Figures 4 and 5) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) and are releasably attachable to (as shown in Figure 3; indirectly via VELCRO® attachment of ends 40, 42, 48, 50 to respective strap members 32, 34; column 3, lines 45-54 teaches “the opposed ends 40 and 42 of strap member 32 are provided with corresponding fasteners 44 and 46 which are adapted to mate with the material comprising strap member 32, fasteners 44 and 46 being preferably composed of VELCRO® hook material” and “likewise, opposed ends 48 and 50 of strap member 34 are provided with respective VELCRO® fasteners 52 and 54 which are adapted to mate with the material of member 34 upon pressure contact therewith;” VELCRO® is a releasable fastening mechanism) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28).
In regards to claim 33, Arensdorf et al. teaches the apparatus of claim 18. Arensdorf et al. teaches in column 3, lines 45-54 and Figures 3, 10 and 11 wherein, when in the working position (shown in Figures 3, 10 and 11), tension in the least one working strap (strap members 32, 34) is adjustable (column 3, lines 45-54 teaches “the opposed ends 40 and 42 of strap member 32 are provided with corresponding fasteners 44 and 46 which are adapted to mate with the material comprising strap member 32, fasteners 44 and 46 being preferably composed of VELCRO® hook material” and “likewise, opposed ends 48 and 50 of strap member 34 are provided with respective VELCRO® fasteners 52 and 54 which are adapted to mate with the material of member 34 upon pressure contact therewith;” VELCRO® is an adjustable fastening mechanism).
In regards to claim 35, Arensdorf et al. teaches the apparatus of claims 18 and 19. Arensdorf et al. teaches in Figures 3, 4, 10 and 11 that the first working strap section (central stirrup portion 70) and the at least one second working strap section (central stirrup portion 72), when in the working position (shown in Figures 3, 10 and 11), cross under (as shown in Figure 4) the sole of the foot (foot 22).
In regards to claim 36, Arensdorf et al. teaches the apparatus of claims 18 and 19. Arensdorf et al. teaches in Figures 3, 10 and 11 that, when in the working position (shown in Figures 3, 10 and 11), the first working strap section (central stirrup portion 70) forms a medial loop (Figure 11 teaches the central stirrup portion 70 being looped around a medial side of the foot 22) and/or the at least one second working strap section (central stirrup portion 72) forms a lateral loop (Figure 10 teaches the central stirrup portion 72 being looped around a lateral side of the foot 22).
In regards to claim 37, Arensdorf et al. teaches the apparatus of claims 18, 19 and 36. Arensdorf et al. teaches in Figures 10 and 11 that at least one of the first working strap section (central stirrup portion 70) and the at least one second working strap section (central stirrup portion 72) are anchorable around the heel (heel 30) of the foot (foot 22) by the respective medial or lateral loop (Figure 10 teaches the central stirrup portion 72 being looped around a lateral side of the foot 22 such that the central stirrup portion 72 is wrapped around the lateral side of the heel 30; Figure 11 teaches the central stirrup portion 70 being looped around a medial side of the foot 22 such that the central stirrup portion 70 is wrapped around a medial side of the heel 30).
In regards to claim 38, Arensdorf et al. teaches the apparatus of claims 18, 19 and 36. Arensdorf et al. teaches Figures 3, 10 and 11 that in the medial loop (Figure 11 teaches the central stirrup portion 70 being looped around a medial side of the foot 22) and/or the lateral loop (Figure 10 teaches the central stirrup portion 72 being looped around a lateral side of the foot 22), when in the working position (shown in Figures 3, 10 and 11), comprises a first loop section configured to follow the foot outline and a second loop section configured to extend under the foot arch, between a medial side of the foot arch and a lateral side of the foot arch (Figures 3 and 11 teach the central stirrup portion 70 having a second loop section extending under the foot arch, which is looped around a medial side of the foot 22, with a first loop section of central stirrup portion 70 being contoured to the medial side of the foot 22; Figures 3 and 10 teach the central stirrup portion 72 having a second loop section extending under the foot ach, which is looped around a lateral side of the foot 22, with a first loop section of the central stirrup portion 72 being contoured to the lateral side of the foot 22; the second loop section is capable of being positioned to extend under the boot arch and between a medial side of the foot arch and a lateral side of the user, depending on the size of the foot of the user, and the placement of the second loop section therearound).
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) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arensdorf et al. (US 5,676,641) in view of Gaylord (US 2019/0015234).
In regards to claim 26, Arensdorf et al. teaches the apparatus of claims 18 and 25. Arensdorf et al. teaches in Figures 3, 10 and 11 that the brace (column 1, lines 12-17 that the device is “a support which presents structure for insuring a desired lift to the ankle as well as rigidity to the medial and lateral sides of the ankle by providing a combination of medial and lateral braces”) comprises textile connecting parts (central stirrup portion 70/inelastic spacer 78 and central stirrup portion 72/inelastic spacer 88) configured to extend between (extend between portions of, as shown in Figures 3, 10 and 11) the forefoot anchor (tubular, sock-like elastic sheath 20, front opening 26, athletic sock 24, heel opening 28) and the heel (heel 30) of the foot (foot 22) to cover at least a portion of the instep of the foot (foot 22) and/or the sole of the foot (foot 22) (as shown in Figures 3, 10 and 11).
Arensdorf et al. does not teach that a force required to elastically deform the forefoot anchor is greater than a force required to elastically deform the textile connecting parts.
However, Gaylord teaches in Figures 1 and 6, [0034] and [0055] an analogous device wherein a force required to elastically deform the forefoot anchor (ankle support sleeve 20) is greater than a force required to elastically deform ([0055] teaches “the ankle support sleeve 20 is substantially inelastic;” [0034] teaches “at least a portion of the tibial-tendon support strap 13 may be elastic;” thus, the force required to elastically deform the inelastic ankle support sleeve 20 is greater than the force required to elastically deform the elastic tibial-tendon support strap 13) the textile connecting parts (tibial-tendon support strap 13).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the brace of Arensdorf et al. such that a force required to elastically deform the forefoot anchor is greater than a force required to elastically deform the textile connecting parts as taught by Gaylord because this element is known to enable the forefoot anchor to provide stabilization and enable the textile connecting parts to “maintain tension,” as Gaylord teaches in [0034] and [0055].
In regards to claim 27, Arensdorf et al. and Gaylord teach the apparatus of claims 18, 25 and 26. Arensdorf et al. teaches in Figure 4 and column 4, lines 35-48 that each of the textile connecting parts (central stirrup portion 70/inelastic spacer 78 and central stirrup portion 72/inelastic spacer 88) comprise a first section (central stirrup portions 70, 72) and a second section (inelastic spacers 78, 88), wherein a force required to elastically deform the second section (inelastic spacers 78, 88) is greater than a force required to elastically deform (column 4, lines 35-48 teaches inelastic spacers 78, 88 being inelastic and that “the stirrup portions 70 and 72 are made from an elastic material;” thus, it would require greater force to elastically deform the inelastic spacers 78, 88 than to elastically deform the elastic central stirrup portions 70, 72) the first section (central stirrup portions 70, 72).
In regards to claim 28, Arensdorf et al. and Gaylord teach the apparatus of claims 18 and 25-27. Arensdorf et al. teaches in Figure 4 that the second section (inelastic spacers 78, 88) comprises at least one of a tactile marker (inasmuch as the position of the inelastic spacers 78, 88 is capable of being felt and noted by the user) and a visual marker (inasmuch as the position of the inelastic spacers 78, 88 is capable of being visually observed and noted by the user) configured to mark (indicate) a predetermined configuration (inasmuch as achievement of the configuration is predetermined by/during design of the device) of the at least one working strap (strap members 32, 34).
Claim(s) 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arensdorf et al. (US 5,676,641) in view of Collier et al. (US 2016/0030222).
In regards to claim 29, Arensdorf et al. teaches the apparatus of claims 18 and 25. Arensdorf et al. does not teach that foot-contacting parts of the brace comprise anti-slip material.
However, Collier et al. teaches in Figure 15B, [0036] and claim 5 an analogous device wherein foot-contacting parts of the brace (inner surface of the leading loop 4) comprise anti-slip material (inner surface gripping material 10; [0036] teaches “to keep the device from slipping when worn, an inner surface gripping material 08 and 10, such as silicone, can be disposed on the leg cuff 03 and leading loop 04, respectively, to create friction;” claim 5 teaches “an anti-slip material disposed on an inner surface of the leading loop”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify foot-contacting parts of the brace of Arensdorf et al. to comprise anti-slip material as taught by Collier et al. because this element is known “to keep the device from slipping when worn,” as Collier et al. teaches in [0036].
In regards to claim 30, Arensdorf et al. and Collier et al. teach the apparatus of claims 18, 25 and 29. Arensdorf et al. does not teach that the anti-slip material is positioned on an inner part of the forefoot anchor.
However, Collier et al. teaches in Figures 1 and 15B, [0036] and claim 5 an analogous device wherein the anti-slip material (inner surface gripping material 10) is positioned on (as shown in Figure 15B; [0036] teaches “to keep the device from slipping when worn, an inner surface gripping material 08 and 10, such as silicone, can be disposed on the leg cuff 03 and leading loop 04, respectively, to create friction;” claim 5 teaches “an anti-slip material disposed on an inner surface of the leading loop”) an inner part (inner surface of the leading loop 4) of the forefoot anchor (leading loop 4; Figure 1 teaches the leading loop 4 being positioned on the user’s forefoot 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 anti-slip material of Arensdorf et al. as modified by Collier et al. to be positioned on an inner part of the forefoot anchor as taught by Collier et al. because this element is known “to keep the device from slipping when worn,” as Collier et al. teaches in [0036].
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael 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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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 1/13/2025