DETAILED ACTION
This Office action is based on the amendment filed April 19, 2026 for application 18/903,726. Claims 1, 3, 5, 7, 12, and 13 have been amended and claim 8 has been cancelled; claims 1-7 and 9-14 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant’s arguments filed April 19, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Bruce discloses straps which extend upwardly and are secured around the ankle or lower leg region rather than wrapping around the foot to retain a sole portion against the sole of the foot, the examiner disagrees. As shown in Figs. 10-11 of Bruce, the ankle support (30) is configured to be wrapped around a user’s foot such that the sole portion (base portion 14) is held against the sole of the user’s foot (¶ 0040). Further, the sheet of material (15) from which the ankle support (30) is formed includes an outer surface that is complementary to fastening material carried by the fasteners (13) (¶ 0046) such that the exact placement of the straps (11, 12) and securement to the sheet of material (15) will depend on the intended use based on the user. A recitation of the intended use of the claimed invention (i.e., the opposed sole side portions are configured to be secured together over an upper portion of the foot to wrap around and retain the sole portion against the sole of the foot of the user) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to Applicant’s argument that Bruce only discloses a single fastener (13) at the end of strap (12), wherein the strap (12) wraps around the ankle of lower leg region and does not engage the sole portion of the device, the examiner disagrees. Claim 1 does not recite the type of attachment feature at the second opposed free end of each second bandage portion member. Therefore, fastener (13) is one attachment feature at the end of one of the second bandage portion members (12) of the ankle support (30) taught by Bruce and the outer surface of sheet of material (15) is another attachment feature at the end of the other second bandage portion member (17) since it allows for attachment with fasteners (13) (¶ 0046-0048).
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 1-7 and 9-14 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 recite the limitations “such that the opposed sole side portions are secured together over an upper portion of the foot to wrap around and retain the sole portion against the sole of the foot of the user” in lines 14-17; however, this limitation appears to be directed to a process of using the foot compression garment. While Applicant may use functional language to define the invention by what it does or how it is used rather than what it is, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). MPEP 2173.05(p). For examination purposes, the above limitation of claim 1 has been interpreted as “such that the opposed sole side portions are configured to be secured together over an upper portion of the foot to wrap around and retain the sole portion against the sole of the foot of the user” in order to clearly describe the structure and functional abilities of the claimed foot compression garment rather the method of actually using the foot compression garment.
Claims 2-7, 9-12, and 14 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 1.
Claim 13 recite the limitations “such that the opposed sole side portions are secured together over an upper portion of the foot to wrap around and retain the sole portion against the sole of the foot of the user” in lines 15-18; however, this limitation appears to be directed to a process of using the foot compression garment rather than the method for producing the foot compression garment. While Applicant may use functional language to define an invention by what it does or how it is used, claim 13 appears to recite limitations directed to a process of making the foot compression garment and a process of using the foot compression garment. Since the preamble clearly states that claim 13 is “A method for producing a single piece foot compression garment”, the above limitation of claim 1 has been interpreted as “such that the opposed sole side portions are configured to be secured together over an upper portion of the foot to wrap around and retain the sole portion against the sole of the foot of the user” in order to clearly maintain the recited limitation as being only directed to the method for producing rather than a method of using the foot compression garment.
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.
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 1-7 and 9-14 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).
Claims 1 and 13 each recite the limitation “the heel portion extending upward from the sole portion along a posterior aspect of the foot and toward an ankle region of the user” in lines 20-21 of claim 1 and in lines 20-22; however, this limitation positively recites “a posterior aspect of the foot” of the user to define the structure of the foot compression garment as well as the method for producing the foot compression garment. By defining the heel portion as extending along a posterior aspect of the user’s foot, the posterior aspect of the user’s foot is required for the heel portion to extend along rather than the heel portion being configured to extend along a posterior aspect of the user’s foot. For examination purposes, the above limitation of claims 1 and 13 has been interpreted as “the heel portion extending upward from the sole portion and configured to extend along a posterior aspect of the foot and toward an ankle region of the user” such that “a posterior aspect of the foot” of the user.
Claims 2-7, 9-12, and 14 are included in the rejection under 35 U.S.C. 101 and section 33(a) of the America Invents Act based on their dependence from rejected claim 1.
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.
Claims 1-6, 9, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruce et al. (US 2007/0197944).
Regarding claim 1, Bruce discloses a single piece foot compression garment (ankle support 30, the various elements of support 30 are rigidly secured together as a single unit) capable of treating lymphedema in a foot of a user (Figs. 7-11; ¶ 0048), the single piece foot compression garment (30) comprising:
a first bandage portion (distal straps 11 + base portion 14 + spacer material 34) composed of elastic material (Fig. 7; ¶ 0018, 0040, & 0048-0050), in which the first bandage portion (11+14+34/36) comprises:
a sole portion (base portion 14 including portions of material encircling heel opening 36) configured in use to be positioned adjacent a sole of a foot of a user (Fig. 7; ¶ 0040);
a pair of opposed sole side portions (distal straps 11) comprising a first sole side portion and a second sole side portion, each sole side portion (11) comprising a first end permanently attached to the sole portion (14) and extending laterally therefrom, and a second opposed free end, and in which the second opposed free end of the first sole side portion (11) comprises at least one first attachment feature (fasteners 13) capable in use to releasably engage the second sole side portion (11) such that the opposed sole side portions (11) are capable of being secured together over an upper portion of the foot to wrap around and retain the sole portion (14) against the sole of the foot of the user when in use (Figs. 5, 7, & 11; ¶ 0040); and
a heel portion (spacer material 34/36, shown as 34 in drawings but referred to as 36 within the specification) comprising a lower end adjacent the sole portion (14) (adjacent heel opening 36) and an opposed upper end, the heel portion (34/36) extending upward from the sole portion (14) and configured to extend along a posterior aspect of the foot and toward an ankle region of the user when in use (Figs. 7-8 & 11; ¶ 0049-0050); and
a second bandage portion (proximal strap 12 + tab 17) composed of elastic material, in which the second bandage portion comprises a pair of opposed second bandage portion members (proximal strap 12, tab 17), each second bandage portion member (12, 17) having a first end permanently attached to the heel portion by stitching (lateral stitch lines 40) or mechanical bonding, and a second opposed free end, in which the second opposed free end of each second bandage portion member (12, 17) comprises a second attachment feature (fastener 13 on proximal strap 12, outer surface of sheet of material 15 on tab 17 which allows attachment of fasteners 13) capable in use for releasable engagement to a corresponding sole side portion (11) of the first bandage portion (11+14+34/36), and in which the second bandage portion members (12, 17) are capable in use to extend across the dorsum and anterior ankle of the foot of the user while leaving a posterior ankle region free from coverage (Figs. 7 & 11; ¶ 0040-0041, 0044, & 0046-0048);
in which the heel portion (34/36) comprises a pair of spaced apart heel side portions (portions adjacent stitch lines 40) with a central portion extending therebetween, and in in which the second bandage members (12, 17) are permanently attached at or adjacent the corresponding heel side portions and extending laterally therefrom such that the central portion of the heel portion (34/36) may be free from contact or overlap with the second bandage portion members (12, 17) (Figs. 7-8 & 11; ¶ 0049).
Regarding claim 2, Bruce discloses that the central portion of the heel portion (34/36) is a single layer of material (¶ 0049-0050).
Regarding claim 3, Bruce discloses that the second bandage portion (12+17) is configured in use to extend across and apply compressive forces to a dorsum and anterior ankle of the foot of the user (the outer layer of support 30 is engageable by fasteners 13 such that the exact placement of and tension provided by proximal strap 12 will be determined by the user) (Figs. 5 & 10; ¶ 0041 & 0047-0048).
Regarding claim 4, Bruce discloses that the second bandage portion (12+17) is configured in use to not extend across or apply compressive forces to the posterior ankle of the foot of the user (Fig. 11; ¶ 0049-0050).
Regarding claim 5, Bruce discloses that each second bandage portion member (12, 17) is attached to the heel portion (34/36) from at or adjacent the upper end to at or adjacent the lower end of the heel portion (34/36) (Fig. 7; ¶ 0049-0050).
Regarding claim 6, Bruce discloses that a distance between the first end of a first second bandage portion member (12) and the first end of a second second bandage portion member (17) is at least 2.0 cm (the width of the heel portion 34/36 between the bandage portions members 12, 17 is about 1 to 3 inches which is equal to 2.54 to 7.62 cm) (¶ 0050).
Regarding claim 9, Bruce discloses that the first bandage portion (11+14+34/36) and/or the second bandage portion (12+17) is composed of a textile fabric (0013 & 0044).
Regarding claim 12, Bruce discloses that at least one of the first attachment feature (13) and/or the second attachment feature (13) comprises hook and eye fasteners (¶ 0046).
Regarding claim 13, Bruce discloses a method for producing a single piece foot compression garment (ankle support 30, the various elements of support 30 are rigidly secured together as a single unit) (Figs. 7-11; ¶ 0048), comprising:
forming a first bandage portion (distal straps 11 + base portion 14 + spacer material 34) composed of elastic material (Fig. 7; ¶ 0018, 0040, & 0048-0050), comprising:
obtaining a sole portion (base portion 14 including portions of material encircling heel opening 36) configured in use to be positioned adjacent a sole of a foot of a user (Fig. 7; ¶ 0040);
obtaining a pair of opposed sole side portions (distal straps 11) comprising a first sole side portion and a second sole side portion, each side portion (11) comprising a first end and a second opposed end, in which the second opposed end of the first sole side portion (11) comprises at least one first attachment feature (fasteners 13) capable in use to releasably engage the second sole side portion (11) such that the opposed sole side portions (11) are capable of being secured together over an upper portion of the foot to wrap around and retain the sole portion (14) against the sole of the foot of the user when in use (Fig. 7; ¶ 0040);
attaching the first end of each of the first and second sole side portions (11) to a corresponding sole side portion such that the first and second sole side portions (11) extend laterally therefrom such that the at least one first attachment feature (13) is capable in use to releasably engage the second sole side portion such that the opposed sole side portion (11) are capable of being secured together over an upper portion of the foot to wrap around and retain the sole portion (14) against the sole of the foot of the user (Figs. 5, 7, & 10-11; ¶ 0040 & 0045); and
obtaining a heel portion (spacer material 34/36, shown as 34 in drawings but referred to as 36 within the specification) comprising a lower end adjacent the sole portion (14) and an opposed upper end, the heel portion (34/36) extending upward from the sole portion (14) along a posterior aspect of the foot and toward an ankle region of the user when in use (Figs. 7-8 & 11; ¶ 0049-0050); and
forming a second bandage portion (proximal strap 12 + tab 17) composed of elastic material (Fig. 7; ¶ 0018 & 0040-0041), comprising:
obtaining a pair of opposed second bandage portion members (proximal strap 12, tab 17), each second bandage portion member (12, 17) having a first end and a second opposed end comprising an attachment feature (fastener 13, outer surface of sheet of material 15 which allows attachment of fasteners 13) configured in use for releasable engagement to a corresponding side portion (11) of the first bandage portion (11+14+34/36) (Fig. 7; ¶ 0040-0041, 0044, & 0046-0048); and
permanently attaching the first end of each second bandage portion member (12, 17) at or adjacent to a corresponding side portion of the heel portion (34/36) of the first bandage portion (11+14+34/36) by stitching (lateral stitch lines 40) or mechanical bonding such that a central portion of the heel portion (34/36) is free from contact or overlap with the second bandage portion members (12, 17) (Figs. 7-8 & 11; ¶ 0049).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bruce as applied to claim 1 above, in view of Schettler (US 2017/0239098).
Bruce discloses the invention substantially as claimed, as described above, but fails to teach that an elongation of the central portion of the heel portion is at least 110% of an unstretched length of the central portion of the heel portion, wherein the textile fabric comprises 87% polyamide and 13% elastane based on a weight of the textile fabric.
Schettler discloses a foot compression garment comprising a textile fabric comprised of 87% polyamide and 13% elastane (spandex) based on a weight of the textile fabric, wherein the maximum elongate of the textile fabric is at least 110% of an unstretched length of the fabric (¶ 0020). Although Schettler discloses that the range of elongation is between 15 and 50% of the unstretched length, the elongation of an elastic material is implicitly in addition to the length of the unstretched length as it must be stretched longer than unstretched length during elongation such that the 15 to 50% of elongation is implicitly at least 110% of the unstretched length when the initial unstretched length is included. Further, the material made of 87% polyamide and 13% elastane (spandex) is the same material as disclosed by Applicant and therefore would implicitly have the same properties of elongation as the material disclosed by Application.
Therefore, for examination purposes, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the single piece foot compression garment taught by Bruce such that an elongation of the central portion of the heel member is at least 110% of an unstretched length of the central portion of the heel member, wherein the textile fabric comprises 87% polyamide and 13% elastane based on a weight of the textile fabric as substantially taught by Schettler since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bruce as applied to claim 1 above, in view of Barlow et al. (US 4,597,395).
Bruce discloses a method comprising:
providing the single piece foot compression garment (30) as claimed in claim 1 (see above);
positioning the first bandage portion (11+14+34/36) such that the sole portion (14) is positioned adjacent the sole of the foot of the user and the heel portion (34/36) is positioned adjacent the heel of the foot of the user (Figs. 5-6 & 11; ¶ 0040 & 0050);
extending the pair of opposed side portion (11) across an upper portion of the foot of the user to provide a predetermined compressive force to an underlying region of the foot and engaging the at least one first attachment feature (13) of the second end of the first side portion (11) to the second side portion (11) (Figs. 5 & 10; ¶ 0040 & 0047); and
extending each of the second bandage portions members (12, 17) across an anterior ankle of the foot of the user to provide a predetermined compressive force to the underlying region of the foot and securing the second attachment feature (13) of the at least one second bandage portion member (12) to a side of the single piece foot compression garment (30) (Figs. 5 & 10; ¶ 0041 & 0047).
Although Bruce discloses that the outer layer of the single piece foot compression garment (30) is engageable by the second attachment feature (13) such that the exact placement of the at least one second bandage portion member (12) will be determined by the user (¶ 0040-0041 & 0046-0048), Bruce fails to expressly teach that the second bandage portion members extend across a dorsum of the user’s foot and the second attachment feature is secured to a corresponding side portion of the first bandage portion.
Barlow discloses a method comprising providing a foot compression garment (support 27) having a first bandage portion (heel lock 29) and a second bandage portion (crossover strap 46), wherein the first bandage portion incudes a sole portion (plantar strap 31), a pair of opposed side portions (lateral and medial strap ends 33, 34), and a heel portion (heel strap 36) and the second bandage portion (46) includes a pair of opposed second bandage portion members (medial and lateral strap sections 48, 52) each having an attachment feature (fastener members 49, 53), positioning the first bandage portion (29) such that the sole portion (31) is positioned adjacent a sole of a foot of a user and the heel portion (36) is positioned adjacent a heel of the foot of the user, and extending each of the second bandage portion members (48, 52) across a dorsum and anterior ankle of the foot of the user to provide a predetermined compressive force to an underlying region of the foot and securing the second attachment feature (49, 53) of at least one second bandage portion member (48, 52) to a corresponding side portion (33, 34) of the first bandage portion (29) (Figs. 1-3, 6, & 9; column 4, lines 12-28 & 36; column 5, lines 16-21 & 51-58; column 6, lines 1-4 & 60-63).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by the Bruce such that the second bandage portion members extend across a dorsum of the user’s foot and the second attachment feature is secured to a corresponding side portion of the first bandage portion as taught by Barlow for the purpose of limiting inversion and eversion motions of the ankle and strengthening the foot against potential sprain.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure: Lee et al. (US 2023/0225893), Chiang (US 2009/0198165), Gaylord (US 2008/0208094), and Shaw (US 5,897,518).
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 Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 6/17/2026
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