DETAILED ACTION
This is the initial Office action for application 18/903,726 filed October 1, 2024, which claims foreign priority from GB2315082.4 filed October 2, 2023. Claims 1-14, as originally filed, 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.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) and receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 5 and 12 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 5 recites that “the heel portion comprises … opposed side portions” in lines 2-3; however, claim 1 previously recites the limitation “the heel portion comprises a pair of spaced apart side portions” in line 24 such that is unclear whether or not these are the same “side portions” of the heel portion. Further, claim 5 recites the limitation “the side portions” in lines 4-5. Although that limitation of claim 5 continues to recites “and the upper and lower end of the heel portion” in line 5, because claim 1 previously recites various side portions including “a pair of side portions” in line 6 and “a pair of spaced apart side portions” in line 24 and claim 5 also recites “opposed side portions” in line 3, it’s unclear which side portions are being referred to in lines 4-5 of claim 5. Clarification is requested.
Claim 12 recites the limitation “(e.g. VelcroTM)”; however, the phrase “e.g.” (for example) renders the claim indefinite because it is unclear whether the limitation following the phrase (VelcroTM) are part of the claimed invention. See MPEP 2173.05(d). Further, 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. For examination purposes, claim 12 has been interpreted to not include the limitation “(e.g. VelcroTM)”.
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, 8, 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 side portions (distal straps 11) comprising a first side portion and a second side portion, each 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 side portion (11) comprises at least one first attachment feature (fasteners 13) configured in use to releasably engage the second side portion (11) (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) extending from and permanently attached to the sole portion (14) and located between the pair of opposed side portions (11), in which the heel portion (34/36) is configured in use to be positioned adjacent a heel of the foot of the user (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, and a second opposed free end, in which the second opposed free end of at least one second bandage portion member (12) comprises a second attachment feature (fastener 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);
in which the heel portion (34/36) comprises a pair of spaced apart side portions with a central portion extending therebetween, and in in which the second bandage members (12, 17) are permanently attached at or adjacent the corresponding side portions of the heel portion (34/36) and extending laterally therefrom such that the 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).
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 the heel portion (34/36) comprises a lower end permanently attached to the sole portion (14), an opposed upper end, and opposed side portions extending therebetween, in which the central portion is located between the side portions and the upper and lower end of the heel portion (34/36), and in which 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 8, Bruce discloses that the second bandage portion (12+17) is attached to the heel portion (34/36) of the first bandage portion (11+14+34/36) by stitching (stitch lines 40) or mechanical bonding (Fig. 7; ¶ 0049).
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 side portions (distal straps 11) comprising a first side portion and a second side portion, each side portion (11) comprising a first end and a second opposed end, in which the second opposed end of the first side portion (11) comprises at least one first attachment feature (fasteners 13) (Fig. 7; ¶ 0040);
attaching the first end of each of the first and second side portions (11) to a corresponding side portion of the sole portion (14) such that the first and second side portions (11) extend laterally therefrom such that the at least one first attachment feature (13) is configured in use to releasably engage the second side portion (Figs. 5, 7, & 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) attached to and extending from the sole portion (14) and located between the pair of opposed side portions (11), in which the heel portion (34/36) is configured in use to be positioned adjacent a heel of the foot of the user (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) 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); 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) 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 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.
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
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 10/30/2025