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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 26 April 2023 and 06 December 2023 have been received and considered by the Examiner.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted:
Group I, Claims 1-15, drawn to: A temperature-management device, a wearable sleeve, a heater assembly, a foot heating pad, a popliteal fossa heating pad, and a physical connector.
Group II, Claims 16-20, drawn to: A temperature-management device, a first and second pad, electrical wiring, a pouch, and a connector portion.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a heater assembly, comprising a first and second heating pad, with a connector between said pads, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Santa Maria et al. (US 20180271696 A1, hereinafter “Santa Maria”).
Santa Maria discloses: a heater assembly (Paragraph 0040, The following disclosure describes various embodiments of a method, device and system for regulating body temperature of a mammal. The various embodiments generally combine delivery of heat with delivery of blood flow regulation therapy to increase and/or maintain body temperature) including: a first and second heating pad (Figures 3A-3B, Paragraph 0046, Thermal energy member 103 includes two heat delivery devices (each labeled 103), which are attached to interface member 101 so as to be located at the popliteal fossa (posterior portion of the knee) and on a portion of the sole of the foot), and a connector between said pads (Paragraph 0054, In FIG. 3B, three connectors 104 are shown—two connectors 104a for delivering thermal energy to thermal energy transfer members 103, and one connector 104b for delivering compression force to blood flow regulation member 102)
During a telephone conversation with Alan Hale on 17 November 2025, a provisional election was made without traverse to prosecute the invention of Group I, Claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santa Maria (US 20180271696 A1)
Regarding Claim 1, Santa Maria discloses: A temperature-management device (Paragraph 0040, The following disclosure describes various embodiments of a method, device and system for regulating body temperature of a mammal. The various embodiments generally combine delivery of heat with delivery of blood flow regulation therapy to increase and/or maintain body temperature) comprising:
a wearable sleeve (Paragraph 0042, Body interface member 101 is configured to attach to a patient and to contain or otherwise attach to blood flow regulation member 102 and thermal energy transfer member 103. All of these features will be described in further detail below. In general, in some embodiments, body interface member 101 may include one or more sleeves that fit over at least a portion of a lower limb (or upper limb in alternative embodiments) including:
a foot portion configured to cover at least a portion of a sole of a foot of a patient (See Annotated Figure 3B), (Paragraph 0042, In one embodiment, for example, body interface member 101 may fit over a portion of the lower limb, including at least part of the popliteal fossa, at least part of the sole of the foot, and an area between the two);
a calf portion configured to cover at least a portion of a calf of the patient (See Annotated Figure 3B), (Paragraph 0042, In one embodiment, for example, body interface member 101 may fit over a portion of the lower limb, including at least part of the popliteal fossa, at least part of the sole of the foot, and an area between the two),
the calf portion having one or more compression bladders associated therewith (Paragraph 042, Blood flow regulation member 102 may include one intermittent compression member attached to body interface member 101 in a location between the two heat delivery members of thermal energy transfer member 103. This is only one example, however, and many alternatives are possible);
and a popliteal fossa portion configured to cover at least a portion of a popliteal fossa of the patient (See Annotated Figure 3B), (Paragraph 0042, In one embodiment, for example, body interface member 101 may fit over a portion of the lower limb, including at least part of the popliteal fossa, at least part of the sole of the foot, and an area between the two);
and a heater assembly (Figure 1, thermal energy transfer 103, connection 104), configured to be secured to the wearable sleeve (Paragraph 0042, Body interface member 101 is configured to attach to a patient and to contain or otherwise attach to blood flow regulation member 102 and thermal energy transfer member 103), the heater assembly including:
a foot heating pad (Paragraph 0046, Thermal energy member 103 includes two heat delivery devices (each labeled 103), which are attached to interface member 101 so as to be located at the popliteal fossa (posterior portion of the knee) and on a portion of the sole of the foot);
a popliteal fossa heating pad (Paragraph 0042, Thermal energy transfer member 103 may include one or more heat delivery members for delivering heat to one or more areas of the limb. In one embodiment, for example, body interface member 101 may fit over a portion of the lower limb, including at least part of the popliteal fossa, at least part of the sole of the foot, and an area between the two. Thermal energy transfer member 103 may include a heat delivery member at the popliteal fossa and another heat delivery member at the sole of the foot);
and a physical connector (Paragraph 0043, Connector 104 may include any suitable connector or combination of connectors for transferring any combination of thermal energy, electrical power, a fluid, data and/or the like between body interface member 101 and central unit 107) coupling the foot heating pad and the popliteal fossa heating pad (Paragraph 0054, In FIG. 3B, three connectors 104 are shown—two connectors 104a for delivering thermal energy to thermal energy transfer members 103, and one connector 104b for delivering compression force to blood flow regulation member 102)
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Santa Maria, Annotated Figure 3B
Regarding Claim 2, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: wherein the foot portion includes an inflatable heel pad configured to be fluidly coupled to at least one of the one or more compression bladders (Figure 4A, Paragraph 0060, In these embodiments, blood flow regulation member 112 may be one intermittent compression delivery member, configured for positioning on the patient's lower limb between the two thermal energy transmission members 113 on the foot and the popliteal fossa. For example, blood flow regulation member 112 may be positioned on the calf).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Hawkins (EP 0303029 A1).
Regarding Claim 3, Santa Maria discloses all of the limitations of Claim 2. Santa Maria does not explicitly disclose the inflatable heel pad further incorporating a one-way valve.
However, Hawkins does disclose: wherein the inflatable heel pad is fluidly coupled to a channel having a one-way valve associated therewith (Columns 2-3, lines 44-3, Figure 1 shows an inflatable bifurcate bladder 10 for use in a pair of anti-g trousers. The limbs 11 and 12 of the bladder each extend inside one leg of the trousers (not shown). The bladder 10 is provided with an internal bifurcate inflation tube 20. The limbs 21 and 22 of the tube each terminate at a position corresponding to the calf portion of the trousers. Pressurising fluid is admitted to tube 20 through valve 30 (see Figure 2) and a hose/connector assembly shown schematically at 31. The positive pressure of the fluid urges valve diaphragm 32 against exhaust ports 33 and 34 so that the fluid is deflected through inlet bypass ports 35 and 36 and into tube 20 to inflate bladder 10)
Both Santa Maria and Hawkins disclose a wearable assembly configured for a user’s lower body, applying compressive force though pressurized and inflatable bladder arrangements. It would have been obvious to one skilled in the art before the effective filing date to incorporate the art-recognized valve elements disclosed by Hawkins with the overall device disclosed by Santa Maria, so as to provide an effective means of controlling and regulating fluid pressure in the system.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Avitable et al. (US 20120065664 A1, hereinafter “Avitable”).
Regarding Claim 4, Santa Maria discloses all of the limitations of Claim 1. Santa Maria discloses various arrangements in which different areas of a user’s body remain covered or uncovered, but does not explicitly disclose a knee cut-out.
Avitable does disclose: wherein the popliteal fossa portion of the wearable sleeve has a knee cut-out, such that the wearable sleeve is open around a knee of the patient (Paragraph 0021, A knee opening 19 is formed through the sleeve 10 that is generally aligned with the back of the knee when the sleeve is applied to the leg. The layers have the same geometric shape and are superposed on each other so that edges of the layers generally coincide)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the knee cut-out taught by Avitable to allow for more mobility and flexibility for a wearer of the sleeve assembly disclosed by Santa Maria. (See also, Tobler et al. US 5626556 A)
Regarding Claim 6, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: wherein the calf portion of the wearable sleeve is detachable from one or more of the foot portion or the popliteal fossa portion (Paragraph 0033, the thigh section 11a is removable from the remainder of the sleeve 10 to convert the sleeve from thigh length to knee length. In particular, the proximal portion of the sleeve 10 that includes the proximal bladder 24a and the bridge members 84 are removable from the remainder of the sleeve. Tear lines comprising perforation lines 93 in the intermediate layers 14, 16, extend transversely across the intermediate layers adjacent to where the bridge members 84 join thigh section 11a to the calf and ankle sections 11b, 11 c).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Avitable’s perforated tear lines to allow for ease in removal of different sections of the leg sleeve in accordance with the needs of a user (Paragraph 0037, It is understood that the tear lines may be in other locations other than illustrated for removing the thigh section 11a from the remainder of the sleeve 10. As illustrated, the calf and ankle sections 11b, 11c do not have tear lines between them. It is also understood that the sleeve 10 may be configured to have other removable portions in addition to or instead of the thigh section 11a within the scope of the present invention)
Claims 7, 9, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Liang et al. (US 20200246180 A1, hereinafter “Liang”).
Regarding Claim 7, Santa Maria discloses all of the limitations of Claim 1. Santa Maria does not explicitly disclose the foot heating pad further including a visual indicator.
Liang does disclose: wherein the foot heating pad has a visual indicator that corresponds with a corresponding indicator associated with the foot portion of the wearable sleeve (Paragraph 0082, The sleeve 900 may comprise one or more features configured to enable easier application of the sleeve 900 to patients. For example, the sleeve 900 may comprise a heel locator 914 configured to be positioned at/over the patient's heel. The heel locator 914 may comprise an opening/cavity and/or visual marker in the sleeve 900).
Liang and Santa Maria disclose similar wearable temperature management devices, directed primarily to a user’s lower body. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Liang’s visual markers to allow for more user-friendly and accurate operation of the overall device disclosed by Santa Maria (Paragraph 0083, Such devices may include various features (e.g., visual and/or physical indicators) for helping users avoid mistakes in application)
Regarding Claim 9, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: further comprising an extension component configured to connect to the calf portion over a shin of the patient (Paragraph 0058, Referring now to FIGS. 4A and 4B, in an alternative embodiment, a body temperature regulation system 110 may include all the same components as described in relation to the previous embodiment, except that a body interface member 111 may be one, continuous sleeve, rather than multiple sleeves. Such a sleeve/interface member 111 may be pulled on over the foot and up onto the leg L, like a long sock)
If the Applicant is not convinced, Liang more explicitly discloses the above limitation as follows: (Paragraph 0069, FIG. 8 provides another diagram illustrating heating and compression areas that may be associated with any of the embodiments of sleeves described herein. As shown in FIG. 8, in some embodiments, sleeves may deliver heat or compression to different areas of the patient's body), (Paragraph 0080, the sleeve 900 may comprise one or more straps 910 configured to be wrapped at least partially around a knee and/or other portion of a patient's limb. The arms 910 may be adjustable to allow for wrapping around patients of different sizes. For example, the straps 910 may include Velcro or other types of fastening features for fastening the straps 910 to one another around the patient's limb. Moreover, the length of the sleeve 900 may be adjusted (e.g., at a neck portion 912 between the second portion 903 and the third portion 905) by extending and/or tightening portions of the sleeve 900 and/or by folding and/or securing portions of the sleeve 900 onto and/or to other portions of the sleeve 900).
Liang and Santa Maria disclose similar wearable temperature management devices, directed primarily to a user’s lower body. It would have been obvious to one skilled in the art before the effective filing date to incorporate the modified sleeve arrangements taught by both Liang and Santa Maria in their various embodiments, so as to provide a user with a variety of arrangements that could be customized based on comfort and need.
Regarding Claim 11, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: the heater assembly includes one or more color-coded indicators indicating a size of the heater assembly (Paragraph 0122, the sleeve may be configured to be adjustable to varying sizes to accommodate varying sizes of patients' limbs. However, a single size may be manufactured with features enabling the placement of the sleeve 1800 across a wide range of anatomical sizes); and the wearable sleeve includes one or more corresponding color-coded indicators on indicating a size of the wearable sleeve relative to the heater assembly (Paragraph 0107, In some embodiments, the heel locator 1714 may comprise a hole, slit, or similar opening in the sleeve that is designed to be placed specifically around the heel. The heel locator 1714 may additionally or alternatively be marked by one or more visual indicators (e.g., text and/or graphics) that may be sufficiently distinguishable by the human eye. Such visual indicators may be included independently of, or in conjunction with, the described anatomical hole, slit, or similar opening. In some embodiments, placement features may be adapted to any of the knee, elbow, wrist, shoulder, and/or other key anatomical landmarks/features. In some embodiments, the sleeve 1700 may comprise differing materials, textures, and/or colors distinguishing between an inner surface 1713 (e.g., a skin-contacting surface) and an outer surface 1715 (e.g., an environment-facing surface)).
Though Santa Maria in view of Liang does not explicitly disclose color-coded indicators, it would be obvious to one of ordinary skill in the art before the effective filing date to incorporate the variety of disclosed visual indicators and the varying sizes of the wearable sleeve taught by Liang to provide a clear differentiating element for the sizes of the sleeve and heater assembly. It is known in the art to adjust materials, textures, and/or colors to allow for a user to easily distinguish between different features and elements in an assembly (See also, McEwen US 20010041910 A1).
Regarding Claim 14, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: wherein the wearable sleeve and the heater assembly are configured such that, when the heater assembly is secured to the wearable sleeve: at least a portion of the physical connector is disposed on an outside of the wearable sleeve (Paragraph 0054, In FIG. 3B, three connectors 104 are shown—two connectors 104a for delivering thermal energy to thermal energy transfer members 103, and one connector 104b for delivering compression force to blood flow regulation member 102);
Santa Maria does not explicitly disclose the arrangement of the heat pads being on an inside of the wearable sleeve, however, it would have been an obvious modification to place the heater assembly closer to a user’s skin and contained within the wearable sleeve.
Liang does explicitly disclose: wherein the wearable sleeve and the heater assembly are configured such that, when the heater assembly is secured to the wearable sleeve:
the foot heating pad and the popliteal fossa heating pad are disposed on an inside of the wearable sleeve (Paragraph 0063, FIG. 6A illustrates an inner surface of at least a portion of a sleeve 600 in accordance with some embodiments of the present disclosure. The inner surface may comprise a warming portion 602 and/or a non-warming portion 604 (e.g., a compression portion). The warming portion 602 and/or non-warming portion 604 may be configured to contact and/or otherwise interface with a patient's skin), (Paragraph 0089, FIG. 11 provides a side view of a sleeve 1100 configured to provide heating and compression to a limb of a patient. The sleeve 1100 comprises warming portions 1102 configured to deliver heated gas/fluid 1107 to target areas (e.g., the popliteal fossa 1120 and/or the sole of the foot 1122) of the patient's limb 1101);
and at least a portion of the physical connector is disposed on an outside of the wearable sleeve (Paragraph 0082, the sleeve 900 may comprise an inlet and/or outlet port 916 configured to receive fluid, gas, and/or electricity from an external source (e.g., a controller) and/or have fluid drawn therefrom. As shown, the port 916 may be accessible outside of the sleeve to allow for engagement therewith using a corresponding connector associated with a fluid and/or electrical supply device).
Liang and Santa Maria disclose similar wearable temperature management devices, directed primarily to a user’s lower body. It would have been obvious to one skilled in the art before the effective filing date to incorporate the modified sleeve arrangements taught by both Liang and Santa Maria in their various embodiments, so as to provide a user with a variety of arrangements that could be customized based on comfort and need. Placing the heater assembly within the wearable sleeve provides an additional degree of security and more direct thermotherapy treatment to a user.
Regarding Claim 15, Santa Maria in view of Liang discloses all of the limitations of Claim 14. Liang further discloses: wherein the at least a portion of the physical connector is configured to run outside of the calf portion of the wearable sleeve (Figure 9, Paragraph 0023, FIG. 9 provides a view of a sleeve configured to provide heating and/or compression via a first portion configured to contact a calf of a patient and a second portion configured to contact a sole of a foot of the patient in accordance) when the heater assembly is secured to the wearable sleeve (Paragraph 0082, the sleeve 900 may comprise an inlet and/or outlet port 916 configured to receive fluid, gas, and/or electricity from an external source (e.g., a controller) and/or have fluid drawn therefrom. As shown, the port 916 may be accessible outside of the sleeve to allow for engagement therewith using a corresponding connector associated with a fluid and/or electrical supply device).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Schirrmacher (US 20050256556 A1)
Regarding Claim 8, Santa Maria discloses all of the limitations of Claim 1. Santa Maria does not explicitly disclose a closable cover for the heater assembly.
Schirrmacher, however, does disclose: wherein the wearable sleeve (Paragraph 0050, Modular heat transfer therapy apparatus 100 generally comprises first modular member 102 and second modular member 104, which forms a cover for the first modular member and in FIG. 1 is shown in the form of a sleeve. In other words, apparatus 100 is adapted to be wrapped around at least a portion of a patient's body and form a sleeve around that portion) includes a closable cover (Paragraph 0059, Outer back side portion 114 of second modular member has an opening 124 formed therein for receiving first modular member 102 as shown in FIG. 4. A portion of back side 114, such as portion 126, can be pulled back (FIG. 2) to facilitate positioning the remaining portion of first modular member 102 into the pouch. Numeral 114a indicates the inner surface of back side portion 114 and is shown in the inner surface portion 126. Any suitable fastening means can be used to close opening 124. For example, zipper 127 can be provided along the sides of the opening) configured to be covered over one or more portions of the heater assembly (Paragraph 0052, the fluid supplied to inner bladder 108 can have a temperature higher than ambient so as to heat the animate body part) when the heater assembly is secured to the wearable sleeve. (Paragraph 0015, a method of assembling heat transfer apparatus for an animate body comprises providing a plurality of same sized bladders adapted for carrying heat transfer medium; providing a plurality of differently sized covers each with a pouch, wherein the pouches are of the same size and are adapted to receive a respective one of the bladders; selecting a cover; and inserting one of the bladders in the pouch of the selected cover).
Both Schirrmacher and Santa Maria disclose wearable apparatuses for temperature-based therapy. It would have been obvious to one skilled in the art before the effective filing date to incorporate the Schirrmacher’s modular arrangement to allow for a greater degree of customization based on the particular needs of a user. Furthermore, the modular arrangement also allows for addressing concerns regarding sanitation and replaceability of an component (Paragraph 0007, the therapy component is typically in direct contact with the skin, but RF welded soft heat exchangers cannot be machine washed making it more difficult to provide sanitary treatment in clinical settings or in rental situations. Finally, hook and loop fasteners have a limited lifetime and when they wear out, the entire therapy component must be scrapped)
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) view of Tobler et al. (US 5626556 A, hereinafter “Tobler”).
Regarding Claim 10, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: further comprising a fluid interface attached to the wearable sleeve and includes three fluidly-isolated conduits (Paragraph 0043, Connector 104 may include any suitable connector or combination of connectors for transferring any combination of thermal energy, electrical power, a fluid, data and/or the like between body interface member 101 and central unit 107), (Paragraph 0056, In FIG. 3, connector 104 is illustrated for simplicity as one connector 104. However, in embodiments like the one shown, where there are three separate body interface members 101 and thus three separate components to provide thermal energy and compression, three connectors 104 would actually be connected to central unit 107 to provide thermal energy and compression to the three separate components. in fluid communication with three compression bladders of the one or more compression bladders, respectively (Paragraph 0051, In various alternative embodiments, blood flow regulation member(s) 102 may include sequential compression devices, mechanical squeezing or force application through tightening of a sleeve around the extremity, mechanical alteration or stretching of skin, delivery of one or more pharmacological agents, or a combination thereof. Any of these embodiments may include one or multiple chambers filled with a fluid, such as air, water, or a high specific heat gas or liquid)
However, Santa Maria does not disclose a fluid interface that is heat-sealed to the wearable sleeve. Tobler does disclose: a fluid interface that is heat-sealed to the wearable sleeve (Column 4, lines 54-61, The sealing lines, which may, for example, be provided by heat-sealing, adhesive, radio frequency ("R.F.") welding, etc., define a plurality of longitudinally disposed chambers 38a, 38b, 38c, 38d, 38e and 38f which in per se known manner are capable of retaining pressurized air in order to exert compressive pressure to the leg during successive pressure-applying cycles) and includes three fluidly-isolated conduits (Figure 1, Column 5, lines 14-17, In known manner, the sleeve is provided with a set of conduits 46a, 46b, 46c and 46d having a connector 48 for connecting the conduits to a controller (not shown) having a source of pressurized air) in fluid communication with three compression bladders (Column 5, lines 22-24, As shown, conduit 46a leads into the ankle chambers, conduit 46c into the calf chambers, and conduit 46d into the thigh chambers) of the one or more compression bladders, respectively (Column 5, lines 1-6, When positioned around the leg, chambers 38a and b will apply compressive pressure to the ankle region; chambers 31c and d to the calf region; as heretofore noted openings 16, 22a and 22b will be in the knee region to enhance flexibility; and chambers 38e and f will apply compressive pressure to the thigh region).
Both Tobler and Santa Maria disclose wearable interfaces that utilize compressive elements to provide therapeutic treatment for a user. It would have been obvious to one skilled in the art before the effective filing date to incorporate the art-recognized attachment means of heat-sealing, as disclosed by Tobler, to ensure the fluid-interface would be properly secured to the sleeve, reducing the likelihood of fluid leaks that would affect the pressure distribution of the bladders.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Tobler, further in view of Wyatt et al. (WO 2018013188 A1, hereinafter “Wyatt”).
Regarding Claim 5, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: wherein the physical connector of the heater assembly includes electrical wiring (Paragraph 0043, Connector 104 may include any suitable connector or combination of connectors for transferring any combination of thermal energy, electrical power, a fluid, data and/or the like between body interface member 101 and central unit 107), but does not explicitly disclose the connector contained within a connector portion of a fluid-tight pouch
Matthew does disclose a compression device (Page 30, lines 10-21, The compression device 750 shown in FIGS. 36-37 is configured to be wearable on a user's leg outside existing clothing. In this embodiment, individual segments 752, 753 are wrapped around the thigh and calf, respectively, and are connected by a segment 751) comprised of electrical wiring (Page 8, lines 13-15, FIG. 52 is a depiction of a compression engine according to a further aspect of the present disclosure including a pre-tensioning element connected to an SMA wire and electrical wires according to one embodiment of the compression device disclosed herein) within a connector portion of a pouch (Page 26, lines 3-6, In an additional feature, the compression device 600 may be provided with a removable pouch 640 shown in FIG. 30. The pouch 640 may be removably mounted to the base panel 602, such as at a location 605. The pouch 640 may be configured to receive a cooling or heating element 642 as desired by the user),
Matthew teaches a variety of embodiments and arrangements of the compression device. It would have been obvious to one skilled in the art before the effective filing date to modify the heating element taught by Santa Maria to further include a removable pouch as taught by Matthew to safely encase the electronic elements in such a way that it does not cause discomfort to a user (The pouch may be configured to insulate the user from any heat build-up that might occur when the battery is powering the device 10).
Though Santa Maria in view of Matthew does not explicitly disclose a fluid-tight pouch, it is known in the art of compression devices to incorporate fluid-tight elements. For example, Tobler discloses a plurality of fluid-tight pouches (Column 4, lines 54-61, The sealing lines, which may, for example, be provided by heat-sealing, adhesive, radio frequency ("R.F.") welding, etc., define a plurality of longitudinally disposed chambers 38a, 38b, 38c, 38d, 38e and 38f which in per se known manner are capable of retaining pressurized air in order to exert compressive pressure to the leg during successive pressure-applying cycles)
Both Tobler and Santa Maria disclose wearable interfaces that utilize compressive elements to provide therapeutic treatment for a user. It would have been obvious to one skilled in the art before the effective filing date to incorporate the art-recognized attachment means of heat-sealing, as disclosed by Tobler, to ensure the fluid-interface would be properly secured, and reducing the likelihood of fluid leaks that would affect the pressure distribution of the bladders and the transfer for fluid from any of the connecting conduit elements.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Pickett et al. (US 20060004245 A1, hereinafter “Pickett”).
Regarding Claim 12, Santa Maria discloses all of the limitations of Claim 1. Santa Maria further discloses: wherein the wearable sleeve includes an adhesive strip configured to secure the heater assembly to the wearable sleeve (Paragraph 0054, multiple straps 105 are used as a means to ensure system 101 is easy to apply, remains in place during the working life, and is easy to remove when necessary. System 100 may include straps or other attachment means that use Velcro, magnets, string, ties, clips, elastic bands and/or the like. System 100 also includes one or more connectors 104, to transfer any combination of thermal energy, electrical power, a fluid, and/or data between body interface member 101 and central unit 107), (Paragraph 0053, Body interface member 101 may include a sleeve, blanket, wrap, patch and/or the like. Proper fit and function may be ensured through the use of adhesives or stickers)
If the Applicant is not convinced, Pickett more explicitly discloses: wherein the wearable sleeve includes an adhesive strip (Paragraph 0069, A self-adhesive hook 145 and loop fastener 146 is attached to cuff material 144 near bladder wall 142. In one embodiment, only one side of self adhesive hook and loop fastener 146 is attached to bladder wall 142. The topside of self-adhesive hook and loop fastener 146 is self-adhesive and covered with a wax paper-type protector. This allows the operator to remove the protector and adhere the end of left leg cuff 150 to the self-adhesive when securing the cuff to the patient) configured to secure the heater assembly (Paragraph 0079, In some embodiments of the invention, a temperature-controlled ECP system is provided […] In a further embodiment of the invention, a reversible heat pump is attached to a set of temperature coils in the cuffs so that cooling or heating may be performed with the same set of coils. In another embodiment, the gas or liquid inflating the bladders may be cooled or heated to provide temperature control. Any of a variety of temperature control systems, as is known in the art, may be used to provide a temperature-controlled ECP system) to the wearable sleeve (Paragraph 0075, FIGS. 16A and 16B illustrate another embodiment of the invention comprising left leg cuff 150 with a leg bladder pocket 162 for holding and reversibly attaching bladder 64. Right leg cuff 156 is identical or similar to left leg cuff 150. Leg bladder pocket 164 comprises a flexible material attached to cuff material 144. In one embodiment, pocket 164 comprises the same material as cuff material 144. Cutouts 131 are optionally provided in cuff material 144 for vascular access or any other procedure requiring access to body areas covered by cuff material 144).
It would have been obvious to one skilled in the art before the effective filing date to modify the attachment means and heater assembly disclosed by Santa Maria to further incorporate selectively attachable heating elements, as taught by Pickett. This would allow for further user-enabled adjustments to the device to better suit their particular heating/compression-related treatment needs.
Claim 13 rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (US 20180271696 A1) in view of Stanfield et al. (US 20160317383 A1, hereinafter “Stanfield”).
Regarding Claim 13, Santa Maria discloses all of the limitations of Claim 1. Santa Maria does not explicitly disclose a delineation pad.
However, Stanfield does disclose: wherein the wearable sleeve includes a heater assembly delineation pad (Paragraph 0127, In some embodiments, the positions of the electrodes 10 are user adjustable and the wearable material 14 can optionally have indicators detailing the position of electrode 10 to allow an individual to accurately repeat the placement) on which the heater assembly is configured to be secured (Paragraph 0031, embodiments described herein may provide interoperable wearable devices which can be used between fields and disciplines, such as electrical stimulation, audio, force feedback, haptic feedback, constriction/compression, temperature, air flow, physiological data acquisition, and so on), (Paragraph 0179, They may be attached or fastened to the garment 14 via using an adhesive technology. Adhesive technology consists of any technology that allows for the removal of electrodes 10, other actuators or other components for maintenance. It may be one or more of; VELCRO®, hook and loops or clasps or pouches. However, the list is just exemplary and should in no way be interpreted as limiting).
Both Stanfield and Santa Maria disclose wearable interfaces for applying sensory stimulation to a user’s body. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Stanfield’s arrangement indicators with the assembly disclosed by Santa Maria, in order to provide a clearer and more user-friendly guide regarding the proper operation of the temperature management device (See also, Drey et al. US 20190231633 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
McEwen (US 20010041910 A1) discloses a tourniquet cuff system for applying pressure to user’s limbs
Drey et al. (US 20190231633 A1) discloses a rehabilitation device that provides compression to a user’s lower leg
Avitable et al. (US 20130324895 A1) discloses a method of constructing a compressive sleeve with a plurality of bladder layers
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/MISHAL ZAHRA HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785