DETAILED ACTION
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 .
Response to Amendment
This action is responsive to the amendment filed 10/02/2025. Claim 19 has been canceled, thus claims 1-18 and 20-30 remain pending.
Claim Objections
Claim 13 is objected to because of the following informalities: In claim 13 ln 14 “the outer shell” should read ---an outer shell---. Examiner notes “an outer shell” is introduced in dependent claim 16 as well.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a body engagement element” (claim 11 (twice), ln. 1-2; claim 12, ln. 1; claim 22 (twice), ln. 1-2; claim 23)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure for the “body engaging element” can be found at least in paragraphs [0185] and [0188] of the specification (e.g. a belt or strap).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This claim interpretation supersedes all prior claim interpretations from the Office Actions issued 9/23/2024 and 1/31/2025.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 6,440,159) in view of Pedrow (US 4,928,335) and Goldsmith (US 5,407,421).
Regarding claim 1, Edwards discloses an apparatus (Fig. 1, wrap 10. See annotated Fig. 1 below for convenience), comprising: a treatment delivery component configured to be releasably secured around a treatment portion of a user's body (Fig. 1, body wrap 11A is configured to be releasably secured around a treatment portion of a user’s body. Fig. 6 depicts the wrap around the ankle of the user. Figs. 13-16 depicts the wrap around the upper arm and shoulder area of the user), the treatment delivery component including: an outer shell (Fig. 1, therapy section 12 is part of the outer shell of the device); and a thermal delivery component having a thermal applicator removably disposed proximate to the outer shell (Fig. 1, pocket 14 is a “thermal delivery component” configured to hold a thermal unit 16. Thermal unit 16 is removably disposed proximate to the therapy section 12 portion of the outer shell), the thermal applicator configured to conduct therethrough a liquid from a thermal source and to exchange thermal energy between the treatment portion and the liquid (Col. 4, ln. 62 – col. 5, ln. 20 discloses that the thermal unit 16 may be a small hot water bottle. Therefore, a small hot water bottle would “conduct” water by allowing water to pass into the bottle and exchange thermal energy from the hot water with the treatment portion of the user); the treatment delivery component including a first portion (Fig. 1, short connecting means 26 is considered a “first portion”) and a second portion extending from the first portion (Fig. 1, long connection means 18 is considered a “second portion” that extends from the connecting means 26); the treatment delivery component being reconfigurable between: (a) a first configuration in which the treatment portion is a first treatment portion that includes a lower leg of the user's body, the first portion is configured to be disposed around a calf and shin of the user's body and not extend above a knee of the user's body such that the calf and shin are substantially enclosed by the first portion, and the second portion is configured to be disposed around a foot of the user's body such that the foot is enclosed by the second portion (Fig. 6 depicts this configuration wherein the first portion is disposed on the calf and shin and the second portion is disposed on the foot of the user; see Co. 10, ln. 32-34); and (b) a second configuration in which the treatment portion is a second treatment portion that includes an upper arm and a deltoid of the user's body, edges of the second portion being distal from eachother and edges of the first portion being coupled to eachother such that the first portion defines an enclosed channel through which an arm of the user can be inserted to cause the first portion to be disposed around the upper arm and not extend past a wrist of the user's body, and the second portion is configured to be disposed on a deltoid of the user's body (Figs. 13-16 depict the short connection means 26 (i.e. “first portion”) disposed on the upper arm of the user and the long connection means 18 (i.e. “second portion”) disposed on the deltoid of the user).
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The modified apparatus of Edwards does not explicitly have the thermal applicator being in fluid communication with a thermal conduit that is releasably coupleable to a thermal source (However, it is very likely that the “small hot water bottle” contemplated by Edwards would have some type of inlet that could be considered a “thermal conduit” that is configured to releasably couple to a hot water source like a faucet).
However, Pedrow teaches a therapeutic pillow comprising a fillable bladder 60 for providing temperature therapy (Fig. 8). Pedrow discloses that this fillable bladder map3 have an externally accessible filler cap like that of a hot water bottle (Fig. 7, filler cap 64; see col. 5, ln. 6-14). This filler cap as associated inlet would serve as a “thermal conduit” that releasably couples to a thermal source (i.e. hot or cold water).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thermal unit/hot water bottle of Edwards to have a filler cap an inlet as taught by Pedrow to allow a user to refill the thermal unit with hot or cold water as necessary. This modified device would thus have a “thermal conduit” (i.e. inlet with a fill cap) that would be releasably coupleable to a hot or cold water source.
The modified apparatus of Edwards does not have a pressure delivery component including a pressure applicator having a plurality of pressure elements, each pressure element being in fluid communication with a respective fluid passage in a pressure conduit releasably coupleable to a source of pressurized fluid and changeable, in response to receiving the pressurized fluid, from a collapsed configuration to an expanded configuration having a greater volume than the collapsed configuration.
However, Goldsmith teaches a compressive wrap comprising an outer shell (Figs. 1 and 4, flexible outer sheet), a pressure delivery component comprising a plurality of pressure elements (Fig. 4 depicts an air bladder 30. Col. 3, ln. 66 – col. 4, ln. 2, discloses there can be multiple pressure elements), and a removable thermal element (Fig. 4, thermal bladder 70). The pressure elements additionally are connected to a fluid passage in a pressure conduit (Fig. 4, inlet valve 40 allows gas to be admitted into the bladder 30). This allows the bladder 30 to collapse and expand via inflation and deflation. Goldsmith further teaches that inclusion of the pressure bladder provides uniform pressure on the user’s skin which in turn applies uniform heating or cooling (Col. 3, ln. 44-51).
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Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the treatment delivery component of the modified device of Edwards to additionally have a plurality of pressure bladders as taught by Goldsmith. Inclusion of pressure bladders provides uniform pressure on the user’s skin, which in turn applies uniform heating or cooling.
Regarding claim 2, the modified apparatus of Edwards has the first portion forming a first tubular segment (Edwards, Fig. 1, short connecting means 26 is considered a “first portion” that forms a first tubular segment when wrapped around a body part) and the second portion forming a second tubular segment extending at a non-zero angle from the first tubular segment (Edwards, Fig. 1, long connection means 18 is considered a “second portion” that forms a second tubular segment when wrapped around a body part. See annotated Fig. 1 above for the “non-zero angle” between the two segments), the first tubular segment is configured to be closed edge to edge in the first configuration around the calf and shin of the user's body (Edwards, Fig. 6 depicts the first tubular section around the calf and shin of the user) and is configured to be closed edge to edge in the second configuration around the upper arm of the user's body (Edwards, Fig. 16, depicts the first tubular section around the upper arm of the user), and the second tubular segment is configured to be closed edge to edge in the first configuration around the foot of the user's body (Edwards, Fig. 6 depicts the second tubular section around the foot of the user), and is configured to be open on at least one edge in the second configuration to be disposed on at least the deltoid of the user's body (Edwards, Fig. 16, depicts the second tubular section as open such that it is disposed on the deltoid of the user).
Regarding claim 3, the modified apparatus of Edwards has the second portion configured to be disposed on at least a portion of a pectoral muscle and a trapezius muscle of the user's body (Edwards, Fig. 16, depicts the upper right ear 22 on the pectoral muscle and the opposing ear located on the trapezius muscle of the user).
Regarding claim 4, the modified apparatus of Edwards has the treatment delivery component further including the outer shell (Edwards, Fig. 1, the entire body of the device serves as the “shell”), the first portion including a first portion of the outer shell and the second portion including a second portion of the outer shell:
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Regarding claim 5, the modified apparatus of Edwards has the pressure applicator coupled to the outer shell (Goldsmith, Fig. 4, bladder 30 would be coupled to the shell of the device of Edwards), and the thermal applicator releasably coupleable to one or more of the outer shell and the pressure applicator (Edwards, Fig. 1, thermal unit 16 is removably coupled to the entire device, whereby thermal unit 16 would be removable coupled to both the shell and the pressure applicator in the modified device).
Regarding claim 6, the modified apparatus of Edwards has the outer shell including a first fastener portion disposed on a first side of the first portion (Edwards, Fig. 1, first attaching element 120 is a “first fastener portion” coupled to a first side of short connection means 26), and a second fastener portion disposed on a side of the second portion (Edwards, Fig. 1, first attaching element 64 is a “second fastener portion” coupled to a first side of long connecting means 18), in the first configuration, each of the first fastener portion and the second fastener portion are engaged (Edwards, Fig. 6, depicts, each of the attaching elements 64 and 120 engaged such that the device is wrapped around both the shin/calf and the foot of the user) and in the second configuration, the first fastener portion is engaged and the second fastener portion is disengaged (Edwards, Fig. 16, depicts only one of the fasteners engaged such that the open end of the device sits on the deltoid of the user while the opposite end of the device is wrapped around the user’s upper arm).
Regarding claim 8, the modified apparatus of Edwards has in the first configuration, the first fastener portion configured to close edges of the first side of the first portion to cause the first portion to be wrapped around the calf and shin of the user's body (Edwards, Fig. 6 depicts the first fastener closed such that the device is wrapped around the calf and shin of the user), and the second fastener portion closes edges of the first side of the second portion to facilitate wrapping of the second portion around the foot of the user's body (Edwards, Fig. 6 depicts the second fastener closed such that the device is wrapped around the foot of the user), and in the second configuration, the first fastener portion is configured to close edges of the first side of the first portion to wrap the first portion around the upper arm of the user's body (Edwards, Fig. 16, depicts the first fastener closed such that the device is wrapped around the upper arm of the user).
Regarding claim 9, the modified apparatus of Edwards has the outer shell further including a third fastener portion disposed on a second side of the second portion opposite the first side, the third fastener portion is engaged in a first configuration to be able to at least partially close edges of the second side of the second portion to facilitate wrapping of the second portion around the foot of the user’s body (Edwards, Col. 8, ln. 9-26, discloses that the first attaching element 64 attaches the left section 18A to the right section 18B, whereby the second side of the second portion opposite the first side must also have a “third fastener portion” (e.g. the hook-and-loop mate to first attaching element 64. Fig. 6 depicts the configuration wherein the device is wrapped around the foot of the user), and is engaged in the second configuration to be able to at least partially close edges of the second side of the second portion to facilitate wrapping of the first portion around the upper arm of the user’s body (Edwards, Fig. 16, depicts the configuration wherein the device is wrapped around the upper arm of the user).
Regarding claim 10, the modified apparatus of Edwards has a fourth fastener portion disposed on the second side of the second portion, the fourth fastener portion is engaged in the first configuration to be able to at least partially close corresponding edges of the second side of the second portion to facilitate wrapping of the second portion around the foot of the user's body (Edwards, Fig. 6, depicts the device as wrapped around the foot of the user, whereby a fourth fastener portion must exist to mate with the second fastener portion), and in the second configuration, the fourth fastener portion is either disengaged or engaged such that corresponding edges of second side of the second portion are open to enable the second portion to be disposed on the deltoid of the user's body (Edwards, Fig. 16, depicts the fourth fastener portion as disengaged to allow the second portion to be disposed on the deltoid of the user).
Regarding claim 11, the modified apparatus of Edwards has a body engagement element, the body engagement element configured to be disposed around at least a portion of a torso of the user to secure the second portion to the deltoid of the user's body (Edwards, Figs. 13-16, strap 56 wraps around a portion of the user’s torso to secure the second portion of the wrap to the deltoid of the user).
Regarding claim 12, the modified apparatus of Edwards has the body engagement element coupled to the fourth fastener portion in the second configuration (Edwards, Figs. 13 and 16, strap 56 attaches to the outside of the wrap where the fourth fastener (i.e. corresponding connection structure that mates with the attaching element 134 of the strap 56) would be located).
Claims 13-30 are rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry (US 2013/0030331 A1) in view of Edwards (US 6,440,159) and KR2004 (KR-200428134-Y1).
Regarding claim 13, Quisenberry discloses an apparatus, comprising: a treatment delivery component (#1000 fig 10-11) configured to be releasably secured around a treatment portion of a user's body (par 0032 "the therapy cuff 104 is wrapped around a circumference of the bodily appendage 211 such as, for example, an ankle, a foot, an arm, or a leg of a patient."), the treatment delivery component including: a first portion (see Quisenberry annotated fig 11 below) forming a first tubular segment (see fig 10, and par 0032 disclosing “wrapped around”); and a second portion (see Quisenberry annotated fig 11 below) forming a second tubular segment extending at a non-zero angle from the first tubular segment (see fig 10, and par 0032 disclosing “wrapped around”);a pressure delivery component (#1002 fig 10, par 0052) coupled to the outer shell, the pressure delivery component including a pressure applicator having a plurality of pressure elements (#1002(1)-1002(4) fig 10), each pressure element being in fluidic communication with a respective fluid passage in a pressure conduit (#1004 fig 10, par 0052) releasably coupleable to a source of pressurized fluid (par 0052 “compression fluid source”, see fig 10 showing a plug type device for connection to fluid source thus disclosing releasably coupled) and changeable, in response to receiving the pressurized fluid, from a collapsed configuration to an expanded configuration having a greater volume than the collapsed configuration (par 0008 discloses inflating the compression bladders for application of pressure thus disclosing expanded/inflated and collapsed/deflated configurations); and a thermal delivery component (#1102 fig 11, par 0053) having a thermal applicator disposed proximate to the pressure applicator (see for example fig 2C showing thermal applicator 252 internal to pressure applicator 262 with 257 being the treatment portion), the thermal applicator being in fluidic communication with a thermal conduit (#1104, 1105 fig 11, par 0053) releasably coupleable to a thermal source and configured to conduct therethrough a liquid from the thermal source and to exchange thermal energy between the treatment portion and the liquid (par 0053 “thermal fluid reservoir”, see fig 10 showing a plug type device for connection to source thus disclosing releasably coupled), the thermal applicator including a central portion (see Quisenberry annotated fig 11 below) having a first width (see Quisenberry annotated fig 11 below), and a first side portion (see Quisenberry annotated fig 11 below) and a second side portion (see Quisenberry annotated fig 11 below) that, together with the central portion, have a second width (see Quisenberry annotated fig 11 below) greater than the first width, and the treatment delivery component being reconfigurable between: (a) a first configuration in which the treatment portion is a first treatment portion that includes a lower leg of the user's body (par 0032 disclosing wrapping around an ankle, foot or leg); and (b) a second configuration in which the treatment portion is a second treatment portion that includes an upper arm (par 0032 disclosing wrapping around an arm), wherein the pressure applicator is configured to apply pressure to the thermal applicator to enhance apposition of the central portion of the thermal applicator to at least part of the treatment portion in either of the first configuration or the second configuration (fig 2c showing compression/pressure applicators 262 being external to the thermal applicator 252 such that when 262 expands it enhance apposition of 252 on the treatment portion 257).
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Quisenberry annotated fig 11
Quisenberry does not expressly disclose a first fastener portion being coupled to a first side of the first portion and configured to close the first side of the first portion edge to edge and the second portion including a second fastener portion disposed on a first side of the second portion and configured to couple the first side of the second tubular segment edge to edge, and a third fastener portion disposed on a second side of the second portion opposite the first side of the second portion, the third fastener portion configured to at least partially close the second side of the second portion edge to edge and is further silent to the treatment delivery component being can be set in: (a) a first configuration in which the treatment portion is a first treatment portion that includes a lower leg of the user's body, the first portion is configured to be disposed around a calf and shin of the user's body and not extend above a knee of the user's body, and the second portion is configured to be disposed on a foot of the user's body; and (b) a second configuration in which the treatment portion is a second treatment portion that includes an upper arm and deltoid of the user's body, the first portion is configured to be disposed on the upper arm and not extend past a wrist of the user's body, and the second portion is configured to be disposed on a the deltoid of the user's body. Quisenberry is further silent to the thermal applicator being removably disposed proximate to the pressure applicator.
Edwards teaches an apparatus (Fig. 1, apparatus 10. See annotated Fig. 1 below for convenience), comprising: a treatment delivery component configured to be releasably secured around a treatment portion of a user's body (Fig. 1, body wrap 11A is configured to be releasably secured around a treatment portion of a user’s body. Fig. 6 depicts the wrap around the ankle of the user. Figs. 13-16 depicts the wrap around the upper arm and shoulder area of the user), the treatment delivery component including: a first portion forming a first tubular segment (Fig. 1, short connecting means 26 is considered a “first portion” that forms a first tubular segment when wrapped around a body part), a first fastener portion being coupled to a first side of the first portion and configured to close the first side of the first portion edge to edge (Fig. 1, first attaching element 120 is a “first fastener portion” coupled to a first side of short connection means 26. First attaching element 120 is configured to close the first side by mating with the opposite side of the short connection means 26 to form the “first tubular segment.” See Col. 9, ln. 14-30); and a second portion forming a second tubular segment extending at a non-zero angle from the first tubular segment (Fig. 1, long connection means 18 is considered a “second portion” that forms a second tubular segment when wrapped around a body part. See annotated Fig. 1 below for the “non-zero angle” between the two segments), the second portion including a second fastener portion disposed on a first side of the second portion and configured to couple the first side of the second tubular segment edge to edge (Fig. 1, first attaching element 64 is a “second fastener portion” coupled to a first side of long connecting means 18. First attaching element 64 is configured to couple the first side of the second tubular segment by mating with the opposite side of the long connection means 18 to form the “second tubular segment.” See Col. 8, ln. 9-26), and a third fastener portion disposed on a second side of the second portion opposite the first side of the second portion, the third fastener portion configured to at least partially close the second side of the second portion edge to edge (Col. 8, ln. 9-26, discloses that the first attaching element 64 attaches the left section 18A to the right section 18B, whereby the second side of the second portion opposite the first side must also have a “third fastener portion” (e.g. the hook-and-loop mate to first attaching element 64). When these two fastener portions are connected, the first and second sides of the second portion are closed “edge to edge”); and the treatment delivery component being reconfigurable between: (a) a first configuration in which the treatment portion is a first treatment portion that includes a lower leg of the user's body, the first portion is configured to be disposed on a calf and shin of the user's body and not extend above a knee of the user's body, and the second portion is configured to be disposed on a foot of the user's body (Fig. 6 depicts this configuration wherein the first portion is disposed on the calf and shin and the second portion is disposed on the foot of the user; see Co. 10, ln. 32-34); and (b) a second configuration in which the treatment portion is a second treatment portion that includes an upper arm and deltoid of the user's body, the first portion is configured to be disposed on an upper arm and not extend past a wrist of the user's body, and the second portion is configured to be disposed on a deltoid of the user's body (Figs. 13-16 depict the short connection means 26 (i.e. “first portion”) disposed on the upper arm of the user and the long connection means 18 (i.e. “second portion”) disposed on the deltoid of the user). Edwards further discloses the treatment delivery component including a thermal applicator removably disposed proximate to the pressure applicator (Fig. 1, pocket 14 is a “thermal delivery component” configured to hold a thermal unit 16. Thermal unit 16 is removably disposed proximate to the therapy section 12 portion of the outer shell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize fasteners for the first and second portions such that the treatment delivery components is reconfigurable between first and second configurations as doing so allows for the apparatus to be used for both the user’s leg/foot and the users shoulder/arm, thus increasing the treatment areas the device can be used for. It would have further been obvious to ensure the thermal applicators of Quisenberry are removably disposed proximate to the pressure applicator as taught by Edwards as doing so allows for the thermal applicator to be removed so that the treatment device may be used to provide just pressure without thermal effect and decreasing un-necessary bulk in these instances.
Modified Quisenberry remains silent to the thermal applicator/pressure applicator being configured such that in response to the treatment portion having a circumference or lateral extent less than the second width of the thermal applicator, opposing segments of the first and second side portions of the thermal applicator contact each other and do not contact the treatment portion so as to be wasted.
KR2004 teaches a treatment delivery component (#100 fig 3) with a first fastener (#80 fig 3, pg 3 “The coupling means 80 can be formed by a zipper”) such that in response to the treatment portion having a circumference or lateral extent less than the width of the treatment component, opposing segments of the first and second side portions of the treatment component contact each other and do not contact the treatment portion so as to be wasted (see KR2004 annotated fig 3 below showing the zipper causing edge to edge connection such that excess width of the component curves outward to face each other and not contact the treatment portion).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a zipper(s) as taught by KR2004 as a further fastener on modified Quisenberry, as doing so enables an additional configuration that prevents overlap of the thermal applicators on the skin thus preventing localized areas of extreme thermal application therefore preventing heat or cold burns. A zipper(s) provides the predictable result of attaching ends of the treatment delivery component, can resist high levels of tension, and can be used in conjunction with other fastening means.
Examiner notes: Although KR2004 does not expressly disclose in the specification the claimed “wasted” configuration, it is seen that utilizing this structure results in the “wasted” configuration.
Regarding claim 14, Modified Quisenberry discloses the first portion is configured to be closed edge to edge in the first configuration around the calf and shin of the user's body by engaging the first fastener portion (Edwards: Fig. 6 depicts the first portion of the wrap closed edge to edge around the lower leg 152 of the user, KR2004 further discloses an additional edge to edge configuration), and closed edge to edge in the second configuration around the upper arm of the user's body by engaging the first fastener portion (Edwards: Fig. 16 depicts the first portion closed around the upper arm of the user), and the second portion is configured to be closed edge to edge in the first configuration around the foot of the user's body by engaging each of the second and third fastener portions (Edwards: Fig. 6 depicts the second portion of the wrap closed edge to edge around the foot 154 of the user), and is open on at least one edge in the second configuration to be disposed on at least the deltoid of the user's body by disengaging at least the second fastener portion (Edwards: Fig. 16 depicts the second portion of the wrap as open around the shoulder 230 of the user).
Regarding claim 15, Modified Quisenberry discloses the second portion is configured to be disposed on at least a portion of a pectoral muscle and a trapezius muscle of the user's body (Edwards: Fig. 16 depicts the upper right ear 22 on the pectoral muscle and the opposing ear located on the trapezius muscle of the user).
Regarding claim 16, Modified Quisenberry discloses the treatment delivery component further includes: outer shell, at least one of the pressure delivery component or the thermal delivery component disposed on the outer shell (Quisenberry fig 2C depicting an enclosure structure/shell around pressure applicator 262).
Regarding claim 17, modified Quisenberry discloses the first portion including a first portion of the outer shell and the second portion including a second portion of the outer shell (see fig 10-11 showing the same structure being used on the first and second portions).
Regarding claim 18, modified Quisenberry discloses the pressure applicator coupled to the outer shell, and the thermal applicator releasably coupleable to one or more of the outer shell and the pressure applicator (see fig 2C showing pressure on outer shell and thermal on pressure applicator).
Regarding claim 20, modified Quisenberry discloses each of the first fastener portion and the second fastener portion include a zipper (as taught by KR2004), the first fastener portion configured to be disposed in front of the shin of the user in the first configuration (see Edwards fig 6 showing fastening at shin) and between the upper arm and torso of the user in the second configuration (see Edwards fig 13-16 showing fastening between arm and torso), and the second fastener portion configured to be disposed in front of a sole of the foot of the user in the first configuration (see Edwards fig 6).
Regarding claim 21, Edwards discloses a fourth fastener portion disposed on the second side of the second portion, the fourth fastener portion is engaged in the first configuration to be able to at least partially close corresponding edges of the second side of the second portion to facilitate wrapping of the second portion around the foot of the user's body (Fig. 6 depicts the device as wrapped around the foot of the user, whereby a fourth fastener portion must exist to mate with the second fastener portion), and in the second configuration, the fourth fastener portion is either disengaged or engaged such that corresponding edges of second side of the second portion are open to enable the second portion to be disposed on the deltoid of the user's body (Fig. 16 depicts the fourth fastener portion as disengaged to allow the second portion to be disposed on the deltoid of the user).
Regarding claim 22, Edwards discloses a body engagement element, the body engagement element configured to be disposed around at least a portion of a torso of a user to secure the second portion to the deltoid of the user's body (Figs. 13-16, strap 56 wraps around a portion of the user’s torso to secure the second portion of the wrap to the deltoid of the user).
Regarding claim 23, Edwards discloses the body engagement element is coupled to the fourth fastener portion in the second configuration (Figs. 13 and 16, strap 56 attaches to the outside of the wrap where the fourth fastener (i.e. corresponding connection structure that mates with the attaching element 134 of the strap 56) would be located).
Regarding claim 24, the modified apparatus of Quisenberry (as modified in the rejection of claim 13 above) is also a method comprising: configuring a treatment delivery component (Q: #1000 fig 10-11) for delivery of a first pressure treatment modality by a pressure delivery component having a pressure applicator (Q: par 0052) and a first thermal treatment modality by a thermal delivery component having a thermal applicator (Q: par 0053) to a first treatment portion of a user's body that includes a lower leg below a knee of the user's body (Edwards, Fig. 6, depicts treating the ankle area of the user), the treatment delivery component including an outer shell coupled to the pressure applicator (The main body of Edwards is considered “an outer shell”); disposing the treatment delivery component in operative relationship with the first treatment portion with the thermal applicator adjacent to a surface of the first treatment portion (Edwards, Fig. 6, depicts the user wearing the device on an ankle, Q: fig 2C showing thermal applicator 252 against treatment portion 257); coupling the treatment delivery component to a control unit, the control unit having a pressure source and a thermal source, the coupling including coupling to the pressure source a pressure conduit coupled to the pressure applicator and coupling to the thermal source a thermal conduit coupled to the thermal applicator (Q: par 0052-0053); delivering the first pressure treatment modality to the first treatment portion by the pressure delivery component (Edwards, Fig. 6, a user wearing the device would experience pressure delivery); delivering the first thermal treatment modality to the first treatment portion by the thermal delivery component (Edwards, Fig. 6, a user wearing the device would experience thermal therapy); removing the treatment delivery component from the first treatment portion (Edwards, Figs. 13-16, depict the user wearing the device in another manner, which would require the removal of the treatment delivery component from the leg of the user); configuring the treatment delivery component for delivery of a second pressure treatment modality by the pressure delivery component and a second thermal treatment modality by the thermal delivery component to a second treatment portion of the user's body that includes an upper arm above a wrist and deltoid of the user's body (Edwards, Fig. 16 depicts the second modality on the upper arm and shoulder of the user), the configuring including releasably coupling the thermal applicator to one or more of the outer shell and the pressure applicator (Edwards, Fig. 1, thermal unit 16 is removable); disposing the treatment delivery component in operative relationship with the second treatment portion with the thermal applicator adjacent to a surface of the second treatment portion (Edwards, Fig. 16); coupling the treatment delivery component to the control unit (Q: abstract disclosing a control unit); delivering the second pressure treatment modality to the second treatment portion by the pressure delivery component (Edwards, Fig. 16, a user wearing the device would experience pressure delivery in this second modality); delivering the second thermal treatment modality to the second treatment portion by the thermal delivery component (Edwards, Fig. 16, a user wearing the device would experience thermal therapy in this second modality); and removing the treatment delivery component from the second treatment portion (Edwards, Fig. 16, at some point the user would remove the device once therapy is complete), wherein the pressure applicator applies pressure to the thermal applicator to enhance apposition of the central portion of the thermal applicator to at least part of at least one of the first or second treatment portions of the user's body while delivering at least one of the first or second thermal treatment modalities such that in response to the treatment portion having a circumference or lateral extent less than the second width of the thermal applicator, opposing segments of the first and second side portions of the thermal applicator contact each other and do not contact the treatment portion so as to be wasted (Q and KR2004 disclosing the claimed circumference less than second width configurations in claim 13 above).
Regarding claim 25, the modified Quisenberry has configuring the treatment delivery component for delivery of the desired pressure treatment modality and the desired thermal treatment modality via the first treatment portion or the second treatment portion including releasably coupling the thermal applicator to one or more of the outer shell and the pressure applicator (Edwards, Fig. 1, thermal unit 16 is removable).
Regarding claim 26, the modified of Quisenberry has the treatment delivery component including a first portion and a second portion extending at a non-zero angle from the first portion (See Quisenberry fig 10), configuring the treatment delivery component for delivery of the first pressure treatment modality to the first treatment portion includes disposing the first portion on a calf and shin of the user's body, and disposing the second portion on a foot of the user's body (Edwards, Fig. 6), and configuring the treatment delivery component for delivery of the second pressure treatment modality to the second treatment portion includes disposing the first portion on the upper arm of the user's body, and disposing the second portion on the deltoid of the user's body (Edwards, Fig. 16).
Regarding claim 27, the modified of Quisenberry has the treatment delivery component including: a first portion forming a first tubular segment (Edwards, Fig. 1, short connecting means 26 is considered a “first portion” that forms a first tubular segment when wrapped around a body part), and the second portion forming a second tubular segment extending at a non-zero angle from the first tubular segment (Edwards, Fig. 1, long connection means 18 is considered a “second portion” that forms a second tubular segment when wrapped around a body part. See annotated Fig. 1 above for the “non-zero angle” between the two segments), configuring the treatment delivery component for delivery of the first pressure treatment modality to the first treatment portion includes closing the first tubular segment edge to edge around the calf and shin of the user's body and closing the second tubular segment edge to edge around the foot of the user's body (Edwards, Fig. 6), and configuring the treatment delivery component for delivery of the second pressure treatment modality to the second treatment portion includes closing the first tubular segment edge to edge around the upper arm of the user's body, and the second tubular segment is configured to be open on at least one edge to be disposed on at least the deltoid of the user's body (Edwards, Fig. 16).
Regarding claim 28, the modified Quisenberry has configuring the treatment delivery component for delivery of the second pressure treatment modality to the second treatment portion including disposing the second tubular segment on a portion of a pectoral muscle and a trapezius muscle of the user's body (Edwards, Fig. 16).
Regarding claim 29, the modified of Quisenberry has the outer shell forming a first portion and the second portion extending at a non-zero angle from the first portion (Edwards See annotated Fig. 1 in the rejection of claim 4), a first fastener portion disposed on a first side of the first portion (Edwards, Fig. 1, first attaching element 120 is a “first fastener portion” coupled to a first side of short connection means 26), and a second fastener portion disposed on a side of the second portion (Edwards, Fig. 1, first attaching element 64 is a “second fastener portion” coupled to a first side of long connecting means 18); configuring the treatment delivery component for delivery of the first pressure treatment modality to the first treatment portion includes engaging each of the first portion and the second portion (Edwards, Fig. 6), and configuring the treatment delivery component for delivery of the second pressure treatment modality to the second treatment portion includes engaging the first fastener portion and disengaging the second fastener portion (Edwards, Fig. 16).
Regarding claim 30, modified Quisenberry has the outer shell further including a third fastener portion disposed on a second side of the second portion opposite the first side (Edwards, Col. 8, ln. 9-26, discloses that the first attaching element 64 attaches the left section 18A to the right section 18B, whereby the second side of the second portion opposite the first side must also have a “third fastener portion” (e.g. the hook-and-loop mate to first attaching element 64)), configuring the treatment delivery component for delivery of the first pressure treatment modality to the first treatment portion further includes engaging the third fastener portion to at least partially close corresponding edges of the second side of the second portion to facilitate wrapping of the second portion around the foot of the user's body (Edwards, Fig. 6), and configuring the treatment delivery component for delivery of the second pressure treatment modality to the second treatment portion further includes engaging the third fastener to at least partially close edges of the second side of the second portion to facilitate wrapping of the first portion around the upper arm of the user's body (Edwards, Fig. 16).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Pedrow and Goldsmith, as applied to claims 1, and further in view of Falconio-West (9,642,559).
Regarding claim 7, the modified apparatus of Edwards does not have each of the first fastener portion and the second fastener portion include a zipper, the first fastener portion configured to be disposed in front of the shin of the user in the first configuration and between the upper arm and torso of the user in the second configuration, and the second fastener portion configured to be disposed in front of a sole of the foot of the user in the first configuration.
However, Falconio-West teaches a compression sleeve that uses hook-and-loop fasteners to wrap the sleeve around a body part of the user (Col. 5, ln. 2-4). Additionally, Falconio-West teaches that these hook-and-loop attachment mechanisms could be replaced with zippers (Col. 5, ln. 10-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the hook-and-loop fasteners of the modified apparatus of Edwards for zippers as taught by Falconio-West. Such a modification is the simple substitution for one known fastener type (i.e. zippers) for another known fastener type (i.e. hook-and-loop) within a pressure application device with the predictable result of allowing a user to releasable couple the apparatus to a body part. Furthermore, use of zippers would provide extra security of the device compared to hook-and-loop, thereby reducing the chances of accidentally removing the device during use. The resultant device would naturally place the zippers at the shin and top of the foot of the user, as this is where the hook-and-loop fasteners of Edwards would already be located when worn by the user.
Response to Arguments
In response to applicant’s remarks that the amendments of the independent claims overcome the previous rejections, new grounds of rejection has been provided for claims 13-30. However, the same grounds of rejection is being relied upon for amended claim 1 and dependents. During the interview conducted on September 23, 2025, the examiner generally agreed that the prior art relied upon does not disclose the foot being entirely enclosed, such that the toes are also covered for example. However, the claim language calls to “the foot is enclosed by the second portion.” It is seen that the broadest reasonable interpretation of this claim language includes the embodiment of Edwards wherein the second portion wraps around the foot to enclose it without enclosing the entirety of the foot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lowe et al (2013/0012847) discloses an adjustable therapy device configured to change sizes for different target body parts.
Schirrmacher et al (7,896,910) and Wright (5,074,285) disclose therapy wraps that apply both thermal and pressure therapy.
Mason (5,417,720) and Molloy (5,086,771) discloses therapy devices configured to be placed on both the leg and should areas of the user.
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 KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
