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 .
Prosecution Reopened
In view of the appeal brief filed on July 9th, 2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/08/2026 is being considered by the examiner.
The information disclosure statement filed 08/10/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. There was no copy of the foreign patent document WO 2026/136069. It has been placed in the application file, but the information referred to therein has not been considered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-27, 30, 32, and 35-41 are rejected under 35 U.S.C. 103 as being unpatentable over Youngblood et al. (U.S. PGPub. No. 2018/0000255) herein referred to as “Youngblood” in view of Kaforey et al. (U.S. PGPub. No. 2017/0209305) herein referred to as “Kaforey” further in view of Benyaminpour et al. (US 20170246031 A1) herein referred to as “Benyaminpour”.
Regarding claim 25, Youngblood discloses a pad for targeted temperature management ("TTM"), comprising:
a multilayered pad cover including (mattress pad 11, Paragraph [0078], Figure 1):
a flexible outer layer (the waterproof material is covered on the exterior surfaces with an interlock or knit fabric (i.e., flexible outer layer), Paragraph [0107]);
and an impermeable film between the outer layer and an enclosed space enclosed by the pad cover (the mattress pad includes at least two layers of a waterproof material that are laminated, affixed to each other, adhered to each other etc., wherein the waterproof material is a urethane or a mixture of urethane and ethylene-vinyl acetate (EVA), Paragraph [0106], the first layer of waterproof material is welded to the second layer of waterproof material along a continuous perimeter, creating at least one interior chamber constructed and configured to retain fluid, Paragraph [0106]),
the impermeable film configured to retain a fluid conveyed through the enclosed space (creating at least one interior chamber constructed and configured to retain fluid, Paragraph [0106]);
the pad is configured for placement over a portion of a mattress (mattress pad 11 is configured to be placed over a mattress (i.e., covers a portion of a mattress, the entire mattress), Paragraph [0078], Figure 1),
the pad cover is configured to conform around a limb or body of a patient placed thereon (mattress pad 11 conforms to the body of a patient (i.e., the examiner interprets the use of the phrase “configured to conform around a limb or body of a patient placed thereon” as the mattress pad cover being deformable to conform to the contour or shape of a limb or body of a patient placed on the mattress pad), Figure 1, Paragraph [0078]).
However Youngblood does not explicitly disclose wherein the flexible outer layer is formed of a conformable material having a thermal conductivity that increases in accordance with collapsing cells of the conformable material.
Kaforey discloses wherein the flexible outer layer is formed of a conformable material having a thermal conductivity that increases in accordance with collapsing cells of the conformable material (the warming pad 100 comprises a foam body 150 formed from one or more layers of flexible foam materials, such as polyurethane foam, viscoelastic foam, polyurethane foam material comprises collapsing cells which increases the thermal conductivity of the material, Paragraph [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood to incorporate the teachings of Kaforey by including wherein the flexible outer layer is formed of a conformable material having a thermal conductivity that increases in accordance with collapsing cells of the conformable material. The motivation to do so being to aid in positioning a patient (Kaforey, Paragraph [0047]).
Further, Youngblood does not explicitly disclose a plurality of thermally conductive beads loosely packed in the enclosed space to allow the fluid to flow around the beads and wherein the pad cover and the beads are configured to conform around a limb or body of a patient placed thereon and a flow path of the fluid around the beads is contingent upon a position of the limb or body of the patient on the pad.
Benyaminpour discloses a cooling or heating pad (Abstract) comprising a plurality of thermally conductive beads loosely packed in the enclosed space to allow the fluid to flow around the beads (when the conductive material is powder or beads, it is preferred that the material is contained within a thin bladder forming the pad, the conductive material can be used alone or in combination with a gel (seen as the fluid), Paragraph [0028]),
wherein the pad cover and the bead conform around a limb or body of a patient placed thereon (the cooling or heating pad is flexible or malleable or moldable to conform to the shape of the body area in need of treatment or being treated, Paragraph [0010], Preferably, the porous wall or layer is flexible so that it can conform to the desired shape of the body area when in position for use, Paragraph [0036]),
and a flow path of the fluid around the beads is contingent upon a position of the limb or body of the patient on the pad (Alternatively, the temperature-retentive material can be provided within a thin bladder containing within the bladder a highly temperature-conductive material such as aluminum oxide. Aluminum oxide can be provided as a powder, or as small beads. Other temperature-conductive or temperature-retentive materials, such as a polymeric gel, in the form of beads, or as a fluid, can also be included within the bladder, with or without aluminum oxide, Paragraph [0090], the gel would disperse around the beads based upon the position of the limb or body of the patient on the pad as the cooling or heating pad is flexible or malleable or moldable to conform to the shape of the body area in need of treatment or being treated, Paragraph [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey to incorporate the teachings of Benyaminpour by including wherein a plurality of thermally conductive beads loosely packed in the enclosed space to allow the fluid to flow around the beads and wherein the pad cover and the beads are configured to conform around a limb or body of a patient placed thereon and a flow path of the fluid around the beads is contingent upon a position of the limb or body of the patient on the pad. The motivation to do so being to allow the pad to be flexible or moldable to conform to the shape of the body area in need of treatment or being treated while applying the desired temperature through the temperature conductive material (Benyaminpour, Paragraphs [0010], [0028], [0036], and [0090]).
Regarding claim 26, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 25.
Youngblood further discloses wherein the pad comprises one or more inlets configured for charging the enclosed space with the fluid (fluid is delivered to the at least one interior chamber via a fluid supply line 16 that enters the continuous perimeter via an opening sized to sealingly receive the fluid supply line 16, Paragraph [0106], Figure 1).
Regarding claim 27, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 26.
Youngblood further discloses wherein the pad comprises one or more outlets configured for discharging the fluid from the conduit layer (fluid is removed from the at least one interior chamber via a fluid return line 17 that exits the continuous perimeter via an opening sized to sealingly receive the fluid return line 17, Paragraph [0106], Figure 1).
Regarding claim 30, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 25.
Youngblood further discloses wherein the outer layer is a thin layer of breathable fabric (the waterproof material is covered on the exterior surfaces with an interlock or knit fabric, Paragraph [0107], Paragraph [0130]).
Regarding claim 32, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 31.
Youngblood discloses wherein the outer layer includes a thin layer of breathable fabric over the conformable material (the waterproof material is covered on the exterior surfaces with an interlock or knit fabric, Paragraph [0107], Paragraph [0130]).
Regarding claim 35, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 25
However Youngblood in view of Kaforey does not explicitly disclose wherein the flow path of the fluid through the pad continuously adapts as the patient moves on the pad.
Benyaminpour further discloses wherein the flow path of the fluid through the pad continuously adapts as the patient moves on the pad (Flexibility of materials forming the outer housing can also facilitate contouring of the cooling pad device to a particular shape of a body area. In other words, the outer housing can be rigid and molded to a particular shape, or can be semi-rigid to flexible to be conformed to shape of the area of the body where therapy is needed, Paragraph [0034], Alternatively, the temperature-retentive material can be provided within a thin bladder containing within the bladder a highly temperature-conductive material such as aluminum oxide. Aluminum oxide can be provided as a powder, or as small beads. Other temperature-conductive or temperature-retentive materials, such as a polymeric gel, in the form of beads, or as a fluid, can also be included within the bladder, with or without aluminum oxide, Paragraph [0090], the gel would disperse around the beads based upon the position of the limb or body of the patient on the pad as the cooling or heating pad is flexible or malleable or moldable to conform to the shape of the body area in need of treatment or being treated, Paragraph [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey and Benyaminpour to incorporate the teachings of Benyaminpour by including wherein the flow path of the fluid through the pad continuously adapts as the patient moves on the pad. The motivation to do so being to conform the pad to the shape of the area of the body where therapy is needed (Benyaminpour, Paragraphs [0090] and [0010]).
Regarding claim 36, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 25.
Youngblood further discloses wherein the pad is configured for inducing therapeutic hypothermia with chilled fluid as the fluid (the predefined programs 740 are general sleep settings for various conditions or body types, in one embodiment a weight loss predefined program sets a surface temperature at a very cold setting to increase a metabolic response, temperature settings are automatically adjusted to be as cold as tolerable by the user, Paragraphs [0165], [0166], (seen as configured to be able to induce hypothermia as the fluid can be chilled), wherein thermoelectric cooling modules 33A-33D to cool the fluid inside the reservoir 22 to a selected (set) temperature, Paragraph [0081], [0084], [0094], [0101]).
Regarding claim 37, Youngblood discloses a pad for targeted temperature management ("TTM"), comprising:
a multilayered pad cover (mattress pad 11, Paragraph [0078], Figure 1) including:
a flexible outer layer of a breathable fabric over a conformable material (the waterproof material is covered on the exterior surfaces with an interlock or knit fabric (i.e., flexible outer layer), Paragraph [0107]),
wherein the outer layer is configured to press against skin of a limb of a patient placed on the pad (mattress pad 11 conforms to the body of a patient (i.e., the examiner interprets the use of the phrase “configured to conform around a limb or body of a patient placed thereon” as the mattress pad cover being deformable to conform to the contour or shape of a limb or body of a patient placed on the mattress pad), Figure 1, Paragraph [0078]);
and an impermeable film between the outer layer and an enclosed space enclosed by the pad cover (the mattress pad includes at least two layers of a waterproof material that are laminated, affixed to each other, adhered to each other etc., wherein the waterproof material is a urethane or a mixture of urethane and ethylene-vinyl acetate (EVA), Paragraph [0106], the first layer of waterproof material is welded to the second layer of waterproof material along a continuous perimeter, creating at least one interior chamber constructed and configured to retain fluid, Paragraph [0106]),
wherein the impermeable film is configured to retain a fluid conveyed through the enclosed space (creating at least one interior chamber constructed and configured to retain fluid, Paragraph [0106]),
one or more inlets configured for charging the encloses space with the fluid (fluid is delivered to the at least one interior chamber via a fluid supply line 16 that enters the continuous perimeter via an opening sized to sealingly receive the fluid supply line 16, Paragraph [0106], Figure 1);
and one or more outlets configured for discharging the fluid from the enclosed space (fluid is removed from the at least one interior chamber via a fluid return line 17 that exits the continuous perimeter via an opening sized to sealingly receive the fluid return line 17, Paragraph [0106], Figure 1),
wherein the pad is configured for placement over a portion of a mattress (mattress pad 11 is configured to be placed over a mattress (i.e., covers a portion of a mattress, the entire mattress), Paragraph [0078], Figure 1).
However Youngblood does not explicitly disclose wherein the flexible outer layer is formed of a conformable material having a thermal conductivity that increases in accordance with collapsing cells of the conformable material.
Kaforey discloses wherein the flexible outer layer is formed of a conformable material having a thermal conductivity that increases in accordance with collapsing cells of the conformable material (the warming pad 100 comprises a foam body 150 formed from one or more layers of flexible foam materials, such as polyurethane foam, viscoelastic foam, polyurethane foam material comprises collapsing cells which increases the thermal conductivity of the material, Paragraph [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood to incorporate the teachings of Kaforey by including wherein the flexible outer layer is formed of a conformable material having a thermal conductivity that increases in accordance with collapsing cells of the conformable material. The motivation to do so being to aid in positioning a patient (Kaforey, Paragraph [0047]).
Further, Youngblood does not explicitly disclose wherein the pad comprises a plurality of thermally conductive beads loosely packed in the enclosed space to allow the fluid to flow around the beads, wherein the pad cover and the beads are configured to conform around the limb or body of the patient placed thereon, and a flow path of the fluid around the beads is contingent upon and continuously adaptable to a position of the limb or body of the patient on the pad as the patient moves on the pad.
Benyaminpour discloses a cooling or heating pad (Abstract) comprising a plurality of thermally conductive beads loosely packed in the enclosed space to allow the fluid to flow around the beads (when the conductive material is powder or beads, it is preferred that the material is contained within a thin bladder forming the pad, the conductive material can be used alone or in combination with a gel (seen as the fluid), Paragraph [0028]),
wherein the pad cover and the bead conform around a limb or body of a patient placed thereon (the cooling or heating pad is flexible or malleable or moldable to conform to the shape of the body area in need of treatment or being treated, Paragraph [0010], Preferably, the porous wall or layer is flexible so that it can conform to the desired shape of the body area when in position for use, Paragraph [0036]),
and a flow path of the fluid around the beads is contingent upon a position of the limb or body of the patient on the pad (Alternatively, the temperature-retentive material can be provided within a thin bladder containing within the bladder a highly temperature-conductive material such as aluminum oxide. Aluminum oxide can be provided as a powder, or as small beads. Other temperature-conductive or temperature-retentive materials, such as a polymeric gel, in the form of beads, or as a fluid, can also be included within the bladder, with or without aluminum oxide, Paragraph [0090], the gel would disperse around the beads based upon the position of the limb or body of the patient on the pad as the cooling or heating pad is flexible or malleable or moldable to conform to the shape of the body area in need of treatment or being treated, Paragraph [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey to incorporate the teachings of Benyaminpour by including wherein a plurality of thermally conductive beads loosely packed in the enclosed space to allow the fluid to flow around the beads and wherein the pad cover and the beads are configured to conform around a limb or body of a patient placed thereon and a flow path of the fluid around the beads is contingent upon a position of the limb or body of the patient on the pad. The motivation to do so being to allow the pad to be flexible or moldable to conform to the shape of the body area in need of treatment or being treated while applying the desired temperature through the temperature conductive material (Benyaminpour, Paragraphs [0010], [0028], [0036], and [0090]).
Regarding claim 38, Youngblood in view of Kaforey and Benyaminpour discloses the pad of claim 25.
However Youngblood does not explicitly disclose wherein collapsing of the collapsing cells expels air from the cells thereby increasing the thermal conductivity of the conformable material.
Kaforey discloses wherein collapsing of the collapsing cells expels air from the cells thereby increasing the thermal conductivity of the conformable material (the warming pad 100 comprises a foam body 150 formed from one or more layers of flexible foam materials, such as polyurethane foam, viscoelastic foam, polyurethane foam material comprises collapsing cells that expel air which increases the thermal conductivity of the material, Paragraph [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey and Benyaminpour to incorporate the teachings of Kaforey by including wherein collapsing of the collapsing cells expels air from the cells thereby increasing the thermal conductivity of the conformable material. The motivation to do so being to aid in positioning a patient (Kaforey, Paragraph [0047]).
.
Regarding claim 39, Youngblood in view of Kaforey and Benyaminpour discloses pad of claim 25.
However Youngblood does not explicitly disclose wherein the conformable material includes a viscoelastic or low-resilience polyurethane foam.
Kaforey discloses wherein the conformable material includes a viscoelastic or low-resilience polyurethane foam (the warming pad 100 comprises a foam body 150 formed from one or more layers of flexible foam materials, such as polyurethane foam, viscoelastic foam, in some examples a viscoelastic pad formed from viscoelastic polyurethane will have one or more of the following mechanical properties: a ball rebound in the range of approximately 0.1 percent to approximately 1.9 percent; a compression set (22 hrs@ 70° C.), for a 25 percent compression, of less than 0.5 percent (ASTM D-3574); an air flow in the range of 0.3 to 1.0 cubic foot per minute (ASTM D-3574); an indentation force deflection in the range of approximately 10 to approximately 15 pounds, and preferably about 11 pounds (ASTM D-3574); a tensile strength in the range of approximately 8 pounds per square inch to approximately 12 pounds per square inch; a coefficient of static friction in the range of 0.2 to 1.0; and a density in the range of approximately 83 kilograms per cubic meter to approximately 103 kilograms per cubic meter, and preferably about 93 kilograms per cubic meter (ASTM D-3574), Paragraph [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey and Benyaminpour to incorporate the teachings of Kaforey by including wherein the conformable material includes a viscoelastic or low-resilience polyurethane foam. The motivation to do so being to aid in positioning a patient (Kaforey, Paragraph [0047]).
Regarding claim 40, Youngblood in view of Kaforey and Benyaminpour discloses pad of claim 37.
However Youngblood does not explicitly disclose wherein collapsing of the collapsing cells expels air from the cells thereby increasing the thermal conductivity of the conformable material.
Kaforey discloses wherein collapsing of the collapsing cells expels air from the cells thereby increasing the thermal conductivity of the conformable material (the warming pad 100 comprises a foam body 150 formed from one or more layers of flexible foam materials, such as polyurethane foam, viscoelastic foam, polyurethane foam material comprises collapsing cells that expel air which increases the thermal conductivity of the material, Paragraph [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey and Benyaminpour to incorporate the teachings of Kaforey by including wherein collapsing of the collapsing cells expels air from the cells thereby increasing the thermal conductivity of the conformable material. The motivation to do so being to aid in positioning a patient (Kaforey, Paragraph [0047]).
Regarding claim 41, Youngblood in view of Kaforey and Benyaminpour discloses pad of claim 37.
However Youngblood does not explicitly disclose wherein the conformable material includes a viscoelastic or low-resilience polyurethane foam.
Kaforey discloses wherein the conformable material includes a viscoelastic or low-resilience polyurethane foam (the warming pad 100 comprises a foam body 150 formed from one or more layers of flexible foam materials, such as polyurethane foam, viscoelastic foam, in some examples a viscoelastic pad formed from viscoelastic polyurethane will have one or more of the following mechanical properties: a ball rebound in the range of approximately 0.1 percent to approximately 1.9 percent; a compression set (22 hrs@ 70° C.), for a 25 percent compression, of less than 0.5 percent (ASTM D-3574); an air flow in the range of 0.3 to 1.0 cubic foot per minute (ASTM D-3574); an indentation force deflection in the range of approximately 10 to approximately 15 pounds, and preferably about 11 pounds (ASTM D-3574); a tensile strength in the range of approximately 8 pounds per square inch to approximately 12 pounds per square inch; a coefficient of static friction in the range of 0.2 to 1.0; and a density in the range of approximately 83 kilograms per cubic meter to approximately 103 kilograms per cubic meter, and preferably about 93 kilograms per cubic meter (ASTM D-3574), Paragraph [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Youngblood in view of Kaforey and Benyaminpour to incorporate the teachings of Kaforey by including wherein the conformable material includes a viscoelastic or low-resilience polyurethane foam. The motivation to do so being to aid in positioning a patient (Kaforey, Paragraph [0047]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jackson et al. (US 20190358440 A1) discloses a thermal treatment assembly including the use of thermal beads.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794