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 .
DETAILED ACTION
1. This office action is in response to the after final amendment and arguments filed 4/25/2025. As directed by the amendment, claim 8 has been amended and no claims have been added or canceled. Thus, claims 1-30 are pending in the application.
Response to Amendment
2. Applicant's request filed 4/25/25 for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn. Applicant’s arguments regarding Wyatt et al (2015/0065930) not disclosing the treatment delivery component as “reconfigurable between a first configuration and a second configuration” (See Page 13 of response) is persuasive.
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
3. 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.
4. 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 § 102
5. 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 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.
6. 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.
7. Claims 13-15 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards et al (6,440,159).
Regarding claim 13, Edwards discloses 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).
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Regarding claim 14, Edwards 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 (Fig. 6 depicts the first portion of the wrap closed edge to edge around the lower leg 152 of the user), and closed edge to edge in the second configuration around the upper arm of the user's body by engaging the first fastener portion (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 (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 (Fig. 16 depicts the second portion of the wrap as open around the shoulder 230 of the user).
Regarding claim 15, Edwards 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 (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 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).
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claims 1-6, 8-12, 16-19, and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Pedrow (4,928,335) and Goldsmith (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 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).
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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 map 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).
Regarding claim 16, Edwards discloses an outer shell (Fig. 1, the entire body of the device serves as the “shell”); 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 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 map 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).
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).
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 17, the modified apparatus of Edwards 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 18, 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 19, the modified apparatus of Edwards has the thermal applicator having a central portion having a first width and a first side portion and a second side portion that, together with the central portion, have a second width (Edwards, Figs. 1-2, thermal unit 16 has two separate dimensions considered two different “widths”), the thermal applicator being releasably couplable to the outer shell near opposed edges by the first side portion and the second side portion (Edwards, Fig. 1, thermal unit 16 is removably attached to the main shell of the device. The thermal unit 16 attaches to the device via pocket 14, which is located near the first and second side portions), the pressure applicator operable to apply pressure to the thermal applicator to enhance apposition of the central portion of the thermal applicator to the first or second treatment portions and, the first or second treatment portions configured to have a circumference or lateral extent less than the second width of the thermal applicator, to urge at least a portion of inner surfaces of each of the first side portion and the second side portion towards and into contact with each other (Goldsmith, Col. 3, ln. 44-51, discloses that inclusion of the pressure bladder provides uniform pressure on the user’s skin. In the modified device, this would result in the pressure applicator enhancing apposition of the central portion of the thermal applicator to the first and second treatment portions).
Regarding claim 24, the modified apparatus of Edwards (as modified in the rejection of claim 1 above) is also a method comprising: configuring a treatment delivery component (Edwards, body wrap 11A) for delivery of a first pressure treatment modality by a pressure delivery component having a pressure applicator (Goldsmith, Fig. 4 air bladder 30) and a first thermal treatment modality by a thermal delivery component having a thermal applicator (Edwards, Fig. 1, thermal unit 16) 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);
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 (Edwards, the user of the device is considered a type of “control unit.” This person would couple the thermal source of Edwards to the required thermal liquid (e.g. hot water) and would couple the air bladder of Goldsmith to an air source to inflate the air bladder);
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 (Edwards, the user of the device is considered a type of “control unit.” This person would couple the thermal source of Edwards to the required thermal liquid (e.g. hot water) and would couple the air bladder of Goldsmith to an air source to inflate the air bladder. This procedure would need to be done each time the device is worn);
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).
Regarding claim 25, the modified of Edwards 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 Edwards has the treatment delivery component including a first portion and a second portion extending at a non-zero angle from the first portion (See annotated Fig. 1 in the rejection of claims 4 and 17), 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 Edwards 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 of Edwards 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 Edwards has the outer shell forming a first portion and the second portion extending at a non-zero angle from the first portion (See annotated Fig. 1 in the rejection of claims 4 and 17), 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, the modified 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 (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).
11. Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Pedrow and Goldsmith, as applied to claims 1 and 13 above, and further in view of Falconio-West (9,642,559).
Regarding claims 7 and 20, 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 compare to hook-and-loop, thereby reducing the chances of accidentally removing the device during use. The resultant device would naturally place the sippers at the shing and sold of the foot of the user, as this we where the hook-and-loop fasteners of Edwards would already be located when worn by the user.
Conclusion
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY A STANIS whose telephone number is (571)272-5139. The examiner can normally be reached on Mon - Fri 8:30-5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY A STANIS/Primary Examiner, Art Unit 3785
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