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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 August 2026 has been entered.
Response to Arguments
Applicant's arguments filed 24 August 2026 have been fully considered but they are not persuasive.
Applicant argues that nothing in Roslonski actually discloses the release of the compressed gas preventing backpressure from building up in the conduit and limiting the injection of additional compressed gas coolant or allowing a substantially continuous flow of compressed gas coolant. This is not found to be persuasive. A fair reading of Roslonski discloses that the pressure within the compress is maintained at a substantially constant level by valve 6, for a particular flow rate of the refrigerant, the rate of volitization and expansion and consequently the temperature of the refrigerant bandage will also remain substantially constant (Col. 5, lines 46-58). The pressure and temperature applied to the area to be treated can thus be accurately controlled by the appropriate selection of valve 6 and regulation valve 4 (Col. 5, lines 57-59). This makes clear that there is a continuous flow of compressed gas in Roslonski to ensure accurate pressure (i.e. preventing backpressure from building up beyond the acceptable level) and accurate temperature within the bandage. If there is no continuous flow then there is no ensuring of accurate pressure and temperature within the bandage.
Applicant argues that Roslonski and Hadtke are related to treating sprains, strains and bruises not heat related illnesses. This is not found to be persuasive as prolonged exposure to high heat causes muscle pain and cramps and therefore muscle pain and cramps are a heat related illness.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 8, 11-13, 15-18, 37 and 49-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,449,379 to Hadtke (Hadtke) in view of US 3,871,381 to Roslonski (Roslonski)
Regarding claim 1, Hadtke teaches a wearable cooling apparatus (title “Apparatus for Applying Desired Temperature and Pressure to an Injured Area”) comprising a flexible insulating pad (spacer layer 34) having an open-sided channel (channel 30) formed in a surface thereof (spaces between integrally formed projections 35 which may extend from one or both sides of the layer 34), a thermally conductive membrane (bottom layer 36) secured to the surface of the pad (Fig. 3), wherein the membrane covers an open end of the open-sided channel to form a conduit (Fig. 3) through which gas can flow and walls of the conduit are provided by a surface of the open-sided channel formed in the pad and a surface of the membrane covering the open end of the open-sided channel (Fig. 3), an inlet valve (implicit on can 20) in fluid communication with a first end of the conduit( Col. 3, lines 33-68, Figs. 2, 3, 4A-4C) and configured to be connected to a cannister of compressed gas coolant (aerosol can 20) such that the cannister can inject the compressed gas coolant through the inlet valve into the conduit and flow through the conduit (Fig. 2), an outlet valve (outlet valve 18) in fluid communication with a second end of the conduit (Fig. 3) and configured to release the compressed gas coolant from the conduit (abstract which states “a relief valve is coupled to the inflation chamber so that the pressure within the inflation chamber is maintained at a predetermined pressure.”), and that by varying the flow rate and the length of the tortuous path, various combinations of surface temperatures and pressures may be applied to the injured area (Col. 5, lines 7-15).
However, Hadtke does not teach wherein the release of the compressed gas coolant prevents backpressure from building up in the conduit and limiting the injection of additional compressed gas coolant and thereby allows a substantially continuous flow of the compressed gas coolant through the conduit which provides continued cooling necessary to treat heat related illness.
Roslonski teaches an analogous device (title “Cold Compress Device”) to that of Hadtke as well as an inlet valve (valve 4) that controls the rate of flow of refrigerant from tank (2) into sleeve (1) and a pressure relief valve (6) connected to the wall of sleeve (1) and communicating between the interior of the sleeve and an ambient atmosphere. Roslonski teaches that by controlling the rate of flow of the refrigerant from the tank (2) to the sleeve (1), inlet valve (4) controls the temperature of the refrigerant within the compress and that since pressure of the refrigerant within the sleeve is maintained at a substantially constant level by valve (6), for a particular flow rate of refrigerant, the rate of volitization and expansion and consequently the temperature of the refrigerant within the bandage also will remain substantially constant (Col. 5, lines 30-56). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hadtke with the valve configuration of Roslonski to allow for a substantially constant temperature within the device.
Regarding claim 4, the combination teaches the apparatus of claim 1 as well as Hadtke teaching wherein a sheet (40) covers the open side of the open-sided recess and is secured between the membrane and the pad.
Regarding claim 8, the combination teaches the apparatus of claim 1 as well as Hadtke teaching wherein the membrane comprises a material which enhances thermal conduction (Col. 3, lines 60-62).
Regarding claim 11, the combination teaches the apparatus of claim 1 as well as Hadtke teaching the apparatus further comprising a canister (20) of compressed gas in fluid communication with the inlet valve and configured to inject compressed gas into the conduit via the inlet valve (Col. 3, lines 46-50).
Regarding claim 12, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the compressed gas is carbon dioxide (Col. 5, lines 15-18).
Regarding claim 13, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the canister is lightweight and portable (Col. 3, lines 46-50).
Regarding claim 15, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the temperature of the gas injected into the conduit is controlled via the flow rate of the gas from the canister (Col. 5, lines 12-15).
Regarding claim 16, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the gas cannister does not require electric power to release compressed gas (Col. 3, lines 46-50).
Regarding claim 17, the combination teaches the apparatus of claim 1, but not wherein the open-sided recess is U-shaped in cross section. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hadtke to have a cross-section of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Regarding claim 18, the combination teaches the apparatus of claim 1, but not specifically wherein the open-sided recess is molded into the surface of the pad or the membrane. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of the product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the product was made by a different process. Here the claimed product is the same as the product of Hadtke and therefore the claim is unpatentable.
Regarding claim 37, the combination teaches the apparatus of claim 1, as well as Hadtke teaching wherein the inlet valve is a 2-way splitter valve (Col. 4, line 56-Col. 5, line 6).
Regarding claim 49, Hadtke teaches a portable apparatus (title “Apparatus of Applying Desired Temperature and Pressure to an Injured Area”) to treat heat related illnesses of an individual by wrapping the apparatus around a torso of the individual and activating the apparatus (Col. 4, lines 19-35 which states in part “Likewise, for a large wrap, for example, for treating the upper or lower back, a full leg or a full arm, a third pattern, added around the central tool, is installed to seal the outer pathway. Thus a pathway including 56, 58 and 60 is created. In this way, one tool with independently mounted sealing patterns may be employed to produce a variety of wraps which may be used to treat many areas of the body.”), the apparatus comprising a flexible insulating pad (spacer layer 34), wherein the pad includes a channel (channel 30) formed in a first surface thereof (spaces between integrally formed projections 35 which may extend from one or both sides of layer 34), wherein the channel wraps around the pad (see Figs. 5-8), includes minimal acute turns (Figs. 5-8), has a first side that is open along the first surface of the pad (Fig. 3), and includes sides having a smooth surface (Fig. 3), a thermally conductive membrane (bottom layer 36) secured to the first surface of the pad (Fig. 3), wherein the membrane covers the first side of the channel so as to form a conduit (Fig. 3) wrapping around the pad (Figs. 3 and 5-8), an inlet valve (implicit on can 20) in fluid communication with a first end of the conduit to receive a compressed gas coolant (Fig. 2), an outlet valve (outlet valve 18) in fluid communication with a second end of the conduit (Figs. 2 and 3) to release a gas coolant (abstract which states “a relief valve is coupled to the inflation chamber so that the pressure within the inflation chamber is maintained at a predetermined pressure.”), and a canister (aerosol can 20) of the compressed gas coolant in fluid communication with the inlet valve and configured to inject the compressed gas coolant into the inlet valve, wherein when initiated, the compressed gas coolant is injected into the inlet valve from the cannister (Col. 5, lines 22-27 which state “As is known in the art, any of these compressed gases may be provided in a small canister equipped with a valve sized to accommodate the flexible tube 22. Thus, the apparatus according to the present invention is fully portable and may be applied immediately at the site of the injury.”), when the compressed gas coolant exits the cannister and enters the conduit via the inlet valve it expands and the expansion thereof provides cooling (inherent in the use of compressed gasses to provide cooling), coolant gas flows through the conduit and provides cooling to the torso of the individual the apparatus is wrapped around (Col. 4, lines 19-42) and the gas coolant is released from the exit valve after it traverses the conduit and arrives at the exit value (Fig. 2)
However, Hadtke does not teach the release of the gas coolant prevent back pressure from limiting the ability of additional compressed gas coolant to be received at the inlet and provides a substantially continuous flow of the gas coolant through the conduit or the substantially continuous flow of the gas coolant through the conduit provides cooling necessary for treating heat related illnesses of the individual.
Roslonski teaches an analogous device (title “Cold Compress Device”) to that of Hadtke as well as an inlet valve (valve 4) that controls the rate of flow of refrigerant from tank (2) into sleeve (1) and a pressure relief valve (6) connected to the wall of sleeve (1) and communicating between the interior of the sleeve and an ambient atmosphere. Roslonski teaches that by controlling the rate of flow of the refrigerant from the tank (2) to the sleeve (1), inlet valve (4) controls the temperature of the refrigerant within the compress and that since pressure of the refrigerant within the sleeve is maintained at a substantially constant level by valve (6), for a particular flow rate of refrigerant, the rate of volitization and expansion and consequently the temperature of the refrigerant within the bandage also will remain substantially constant (Col. 5, lines 30-56). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hadtke with the valve configuration of Roslonski to allow for a substantially constant temperature within the device.
Regarding claim 50, Hadtke teaches a method of treating an individual experiencing heat related illnesses in a timely manner (see for example the abstract), the method compressing obtaining a portable heat related illnesses treatment apparatus (title “Apparatus for Applying a Desired Temperature and Pressure to an Injured Area”), wherein the apparatus comprising a flexible insulating pad (spacer layer 34), wherein the pad includes a channel (channel 30) formed in a first surface thereof (spaces between integrally formed projections 35 which may extend from one or both sides of layer 34), wherein the channel wraps around the pad (see Figs. 5-8), includes minimal acute turns (Figs. 5-8), has a first side that is open along the first surface of the pad (Fig. 3), and includes sides having a smooth surface (Fig. 3), a thermally conductive membrane (bottom layer 36) secured to the first surface of the pad (Fig. 3), wherein the membrane covers the first side of the channel so as to form a conduit (Fig. 3) wrapping around the pad (Figs. 3 and 5-8), an inlet valve (implicit on can 20) in fluid communication with a first end of the conduit to receive a compressed gas coolant (Fig. 2), an outlet valve (outlet valve 18) in fluid communication with a second end of the conduit (Figs. 2 and 3) to release a gas coolant (abstract which states “a relief valve is coupled to the inflation chamber so that the pressure within the inflation chamber is maintained at a predetermined pressure.”), obtaining a cannister of compressed gas (aerosol can 20), wrapping the apparatus around a torso of the individual (Col. 4, lines 19-35 which states in part “Likewise, for a large wrap, for example, for treating the upper or lower back, a full leg or a full arm, a third pattern, added around the central tool, is installed to seal the outer pathway. Thus a pathway including 56, 58 and 60 is created. In this way, one tool with independently mounted sealing patterns may be employed to produce a variety of wraps which may be used to treat many areas of the body.”), connecting the cannister to the inlet valve (Col. 5, lines 22-24 which states “ As is known in the art, any of these compressed gases may be provided in a small canister equipped with a valve sized to accommodate the flexible tube 22.”), and activating the cannister so as to inject the compressed gas coolant into the inlet valve (see for example Col. 5, lines 7-21), wherein when the compressed gas coolant exits the cannister and enters the conduit via the inlet valve it expands and the expansion thereof provides cooling (inherent in the use of compressed gasses to provide cooling), coolant gas flows through the conduit and provides cooling to the torso of the individual the apparatus is wrapped around (Col. 4, lines 19-42) and the gas coolant is released from the exit valve after it traverses the conduit and arrives at the exit value (Fig. 2)
However, Hadtke does not teach the release of the gas coolant prevent back pressure from limiting the ability of additional compressed gas coolant to be received at the inlet and provides a substantially continuous flow of the gas coolant through the conduit or the substantially continuous flow of the gas coolant through the conduit provides cooling necessary for treating heat related illnesses of the individual.
Roslonski teaches an analogous device (title “Cold Compress Device”) to that of Hadtke as well as an inlet valve (valve 4) that controls the rate of flow of refrigerant from tank (2) into sleeve (1) and a pressure relief valve (6) connected to the wall of sleeve (1) and communicating between the interior of the sleeve and an ambient atmosphere. Roslonski teaches that by controlling the rate of flow of the refrigerant from the tank (2) to the sleeve (1), inlet valve (4) controls the temperature of the refrigerant within the compress and that since pressure of the refrigerant within the sleeve is maintained at a substantially constant level by valve (6), for a particular flow rate of refrigerant, the rate of volitization and expansion and consequently the temperature of the refrigerant within the bandage also will remain substantially constant (Col. 5, lines 30-56). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hadtke with the valve configuration of Roslonski to allow for a substantially constant temperature within the device.
Regarding claim 51, the combination teaches the method of claim 50, as well as wherein the wrapping the apparatus around a torso of the individual includes wrapping the apparatus so that the thermally conductive membrane is in contact with the torso of the individual (Col. 4, lines 19-35 which states in part “Likewise, for a large wrap, for example, for treating the upper or lower back, a full leg or a full arm, a third pattern, added around the central tool, is installed to seal the outer pathway. Thus a pathway including 56, 58 and 60 is created. In this way, one tool with independently mounted sealing patterns may be employed to produce a variety of wraps which may be used to treat many areas of the body.”).
Claim(s) 48, 27 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 2017/0246031 A1 to Benyaminpour et al. (Benyaminpour) and US 2018/0055142 A1 to Yu et al. (Yu).
Regarding claims 48 and 27 Hadtke in view of Roslonski teaches the apparatus of claim 1, but not the pad comprising a flexible self-skinning foam that is self-skinning polyurethane.
Benyaminpour teaches an analogous device (title “Portable Therapeutic System Using Hot or Cold Temperature”) to that of Hadtke as well as teaching the inclusion of an outer layer which is positioned away from the skin surface when in use whose material is an insulating material which can prevent, reduce or retard loss of heat or cold from the pad and that one preferred material is a polymeric foam material ([0108]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a polymeric foam material for the outer covering of the pad to prevent, reduce or retard loss of heat or cold from the pad as taught by Benyaminpour.
However, Benyaminpour does not teach that the foam is a flexible self-skinning polyurethane foam.
Yu teaches foams, foamable compositions and methods of making integral skin foams (title) and that integral skin foams are well-known foams, typically polyurethane and/or polyisocyanurate foams which has a specialized structure comprising a relatively low density, cellular portion (sometimes referred to as the “cushion portion”) integrally connoted to a relatively high density, typically microcellular portions located at a surface of the foam (sometimes referred to as the “skin portion”). These foams are used in large part because the skin provides a cosmetically acceptable appearance while also providing enhanced resistance to abrasion and cracking ([0003]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an integral skin foam to allow for enhanced resistance to abrasion and cracking during use as taught by Yu.
Regarding claim 42, Hadtke in view of Roslonski teaches the apparatus of claim 1, but not the pad comprising a self-skinning foam.
Benyaminpour teaches an analogous device (title “Portable Therapeutic System Using Hot or Cold Temperature”) to that of Hadtke as well as teaching the inclusion of an outer layer which is positioned away from the skin surface when in use whose material is an insulating material which can prevent, reduce or retard loss of heat or cold from the pad and that one preferred material is a polymeric foam material ([0108]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a polymeric foam material for the outer covering of the pad to prevent, reduce or retard loss of heat or cold from the pad as taught by Benyaminpour.
However, Benyaminpour does not teach that the foam is a flexible self-skinning polyurethane foam.
Yu teaches foams, foamable compositions and methods of making integral skin foams (title) and that integral skin foams are well-known foams, typically polyurethane and/or polyisocyanurate foams which has a specialized structure comprising a relatively low density, cellular portion (sometimes referred to as the “cushion portion”) integrally connoted to a relatively high density, typically microcellular portions located at a surface of the foam (sometimes referred to as the “skin portion”). These foams are used in large part because the skin provides a cosmetically acceptable appearance while also providing enhanced resistance to abrasion and cracking ([0003]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an integral skin foam to allow for enhanced resistance to abrasion and cracking during use as taught by Yu.
Yu, additional teaches a method of manufacturing including forming the pad via a mold ([0004]), the pad comprising a flexible self-skinning foam ([0004, 0473]), and applying a back pressure to the mold to enable the surface of the pad to increase in density ([0475]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the pad as taught by Yu to allow a cosmetically acceptable appearance while also providing enhanced resistance to abrasion.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 6,113,626 to Clifton et al. (Clifton).
Regarding claim 1, Hadtke in view Roslonski teaches the apparatus of claim 1, but not wherein a plurality of pads are connected such that the pads articulate with respect to each other. Clifton teaches an analogous device (title “Heat Transfer Blanket for Controlling Patient’s Temperature”) which includes multiple pads (111, 141, 171) that articulate with respect to each other (Fig. 4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hadtke to include multiple articulatable pads to allow for more coverage as taught by Clifton (Figs. 3 and 4).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 8,113,910 B2 Fortner (Fortner).
Regarding claim 28, Hadtke in view Roslonski teaches the apparatus of claim 1, but not specifically wherein the pad is bonded to the membrane via a high strength flexible urethane adhesive. Fortner teaches bonding fabric using an adhesive, especially a urethane adhesive is applied to the pad to adhere the pad to a garment. A urethane adhesive in liquid form is applied to the garment pad and then the garment pad is pressed onto the garment. Once the urethane adhesive cures, the garment pad is thereby permanently adhered to the garment (Col. 6, lines 22-34). It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized urethane adhesive, since it has been held to be within the general skill of a worker int eh art to select a known material on the basis of tis suitability for the intended use as a matter of obvious design choice.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 2017/0189225 A1 to Voorhees et al. (Voorhees).
Regarding claim 32, Hadtke in view of Roslonski teaches the apparatus of claim 1, but not wherein the membrane is a cured sheet of hydrogel. Voorhees teaches an analogous device (title “Medical Pad and System for Thermotherapy”) including a hydrogel layer interconnected to an extending across one side of the fluid circulation layer to define an adhesive surface for adherence to a patient’s skin (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the hydrogel layer as taught by Voorhees to allow for better thermal conductivity.
Conclusion
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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