DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to the amendment filed on 04/30/2026. Claims 1-24 and 26-54 are as previously presented. Claim 25 is amended. As such, claims 1-54 are pending in the instant application.
All claim objections and rejections pursuant of 35 U.S.C. 112(b) are withdrawn in light of the amendment.
Claim Objections
Claims 6, 11, 25, 30, and 48 are objected to because of the following informalities:
Claim 6 (line 1) and Claim 25 (lines 1-2): “the cushioning polymer” should read “the viscoelastomeric and cohesive cushioning polymer” for consistency and clarity.
Claim 11 (line 2), claim 30 (line 2), and claim 48 (line 2): “about 5 w% catalyst” should read “about 5 wt% catalyst”.
Appropriate correction is required.
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)(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 1-5, 14-24, 33-42, and 49-54 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by DeFranks & Kirtikar (US 20190174930 A1; hereinafter “DeFranks”).
Regarding claim 1, DeFranks discloses a decubitus prevention device (100; Figs. 6-7; [0001]) comprising a massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) and a thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14), each comprising a top side and a bottom side (see a top side and a bottom side for each of 128 and 114 with air bladders 130 in Annotated Fig. 6 below);
wherein the massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) comprises a housing component (side rail assembly 122 and breathable material base layer 120; Fig. 6; [0052], lines 1-3) and at least one manipulation element (at least one air bladder 130; Fig. 6), wherein the at least one manipulation element (at least one air bladder 130; Fig. 6) is disposed within the housing component (side rail assembly 122 and breathable material base layer 120 create well or cavity 124 which provides space for innercore unit 112 to be inserted into, where the innercore unit 112 includes air bladders 130; Fig. 6; [0052], lines 3-5);
wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) comprises a polymeric member (upper cradle foam layer 128, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070], lines 1-6) and at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14), wherein the at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14) is at least partially disposed within the polymeric member (openings 170 are disposed within the upper cradle foam layer 128; Figs. 6 & 10); and
wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) is disposed upon the top side of the massage member such that the bottom side of the thermal support member is in contact with the at least one manipulation element (Figs. 6-7, where the bottom side of upper cradle foam layer 128 is in contact with the top side of air bladders 130).
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Annotated Fig. 6
Regarding claim 2, DeFranks discloses the invention as set forth in claim 1, wherein the housing component (side rail assembly 122 and breathable material base layer 120; Fig. 6; [0052], lines 1-3) comprises a frame element (side rail assembly 122; Fig. 6) and at least one cross member element (breathable material base layer 120; Fig. 6).
Regarding claim 3, DeFranks discloses the invention as set forth in claim 1, wherein the massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) further comprises at least one elevation element (see Annotated Fig. 6 below) disposed upon the bottom side thereof.
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Annotated Fig. 6
Regarding claim 4, DeFranks discloses the invention as set forth in claim 1, wherein the at least one manipulation element (at least one air bladder 130; Fig. 6) comprises a first type of massage member (air bladder 130 in a first location; Fig. 6; ; [0053], lines 13-17, where air bladders 130 can be located with respect to a head, foot, torso, and/or upper leg of a user; [0054], lines 1-6, where the air bladders 130 can be selectively controlled and inflated to provide a desired massage function for a specific location on a user’s body) and a second type of massage member (air bladder 130 in a second location; Fig. 6; [0053], lines 13-17, where air bladders 130 can be located with respect to a head, foot, torso, and/or upper leg of a user; [0054], lines 1-6, where the air bladders 130 can be selectively controlled and inflated to provide a desired massage function for a specific location on a user’s body).
Regarding claim 5, DeFranks discloses the invention as set forth in claim 1, wherein the polymeric member (upper cradle foam layer 128, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070], lines 1-6) comprises a viscoelastomeric and cohesive cushioning polymer ([0070], lines 1-7, where it is inherent viscoelastic materials, including viscoelastic foams, return to their original innate form after being strained and all polymers listed in paragraph 0070 are viscoelastic, hence all of the polymers listed in paragraph 0070 are viscoelastomeric and cohesive cushioning polymers).
Regarding claim 14, DeFranks discloses the invention as set forth in claim 1, wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) further comprises a bottom side barrier layer disposed upon the bottom side thereof (a bottom-most layer of upper cradle foam layer 128 to provide a bottom side barrier between an upper portion of the upper cradle foam layer 128 and the air bladders 130; Fig. 6).
Regarding claim 15, DeFranks discloses the invention as set forth in claim 1, wherein the thermal support member 9upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) further comprises a top side barrier layer disposed upon the top side thereof (a top-most layer of upper cradle foam layer 128 to provide a top side barrier between a bottom portion of the upper cradle foam layer 128 and comfort layer 116; Fig. 6).
Regarding claim 16, DeFranks discloses the invention as set forth in claim 1, further comprising a thermal device component (air blower assembly 202; Fig. 6; [0056], lines 1-5) connected to the at least one thermal element (air blower assembly 202 provides air flow to air flow permeable strips 208, where air flow permeable strips 208 are in fluid communication with openings 170; [0055], lines 10-23; [0062], lines 6-8).
Regarding claim 17, DeFranks discloses the invention as set forth in claim 16, wherein the thermal device component (air blower assembly 202; Fig. 6; [0056], lines 1-5) comprises a wireless user interface ([0078], where the air blower assembly 202 controls the pressure of the air bladders 130 and regulates fluid flow as desired).
Regarding claim 18, DeFranks discloses the invention as set forth in claim 1, wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) is at least partially encased in a sheath member (cover 118 at least partially encases upper cradle foam layer 128; [0074]).
Regarding claim 19, DeFranks discloses the invention as set forth in claim 1, wherein the massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) and the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) are collectively at least partially encased in a single sheath member (cover 118 at least partially encases foam assembly 114 with air bladders 130 and upper cradle foam layer 128; [0074]).
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Regarding claim 20, DeFranks discloses a decubitus prevention device (100; Figs. 6-7; [0001]) comprising a massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6), a thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) and a therapeutic member (comfort layer 116; Fig. 6), each comprising a top side and a bottom side (see a top side and a bottom side for each of 128 and 114 with air bladders 130 in Annotated Fig. 6 above);
wherein the massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) comprises a housing component (side rail assembly 122 and breathable material base layer 120; Fig. 6; [0052], lines 1-3) and at least one manipulation element (at least one air bladder 130; Fig. 6), wherein the at least one manipulation element (at least one air bladder 130; Fig. 6) is disposed within the housing component (side rail assembly 122 and breathable material base layer 120 create well or cavity 124 which provides space for innercore unit 112 to be inserted into, where the innercore unit 112 includes air bladders 130; Fig. 6; [0052], lines 3-5); and
wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) comprises a polymeric member (upper cradle foam layer 128, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070], lines 1-6) and at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14), wherein the at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14) is at least partially disposed within the polymeric member (openings 170 are disposed within the upper cradle foam layer 128; Figs. 6 & 10);
wherein the therapeutic member (comfort layer 116; Fig. 6) comprises a mitigation member having a top side and a bottom side (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) and a thermal-conductive polymer ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer);
wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) is disposed upon the top side of the massage member such that the bottom side of the thermal support member is in contact with the at least one manipulation element (Figs. 6-7, where the bottom side of upper cradle foam layer 128 is in contact with the top side of air bladders 130); and
wherein the therapeutic member (comfort layer 116; Fig. 6) is disposed upon the top side of the thermal support member (comfort layer 116 is disposed on a top side of the upper cradle foam layer 128, see Annotated Fig. 6 above).
Regarding claim 21, DeFranks discloses the invention as set forth in claim 20, wherein the housing component (side rail assembly 122 and breathable material base layer 120; Fig. 6; [0052], lines 1-3) comprises a frame element (side rail assembly 122; Fig. 6) and at least one cross member element (breathable material base layer 120; Fig. 6).
Regarding claim 22, DeFranks discloses the invention as set forth in claim 20, wherein the massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) further comprises at least one elevation element disposed upon the bottom side thereof (see Annotated Fig. 6 below).
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Annotated Fig. 6
Regarding claim 23, DeFranks discloses the invention as set forth in claim 20, wherein the at least one manipulation element (at least one air bladder 130; Fig. 6) comprises a first type of massage member (air bladder 130 in a first location; Fig. 6; ; [0053], lines 13-17, where air bladders 130 can be located with respect to a head, foot, torso, and/or upper leg of a user; [0054], lines 1-6, where the air bladders 130 can be selectively controlled and inflated to provide a desired massage function for a specific location on a user’s body) and a second type of massage member (air bladder 130 in a second location; Fig. 6; [0053], lines 13-17, where air bladders 130 can be located with respect to a head, foot, torso, and/or upper leg of a user; [0054], lines 1-6, where the air bladders 130 can be selectively controlled and inflated to provide a desired massage function for a specific location on a user’s body).
Regarding claim 24, DeFranks discloses the invention as set forth in claim 20, wherein the polymeric member (upper cradle foam layer 128, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070], lines 1-6) comprises a viscoelastomeric and cohesive cushioning polymer ([0070], lines 1-7, where it is inherent viscoelastic materials, including viscoelastic foams, return to their original innate form after being strained and all polymers listed in paragraph 0070 are viscoelastic, hence all of the polymers listed in paragraph 0070 are viscoelastomeric and cohesive cushioning polymers).
Regarding claim 33, DeFranks discloses the invention as set forth in claim 20, wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) further comprises a bottom side barrier layer disposed upon the bottom side thereof (a bottom-most layer of upper cradle foam layer 128 to provide a bottom side barrier between an upper portion of the upper cradle foam layer 128 and the air bladders 130; Fig. 6).
Regarding claim 34, DeFranks discloses the invention as set forth in claim 20, wherein the thermal support member 9upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) further comprises a top side barrier layer disposed upon the top side thereof (a top-most layer of upper cradle foam layer 128 to provide a top side barrier between a bottom portion of the upper cradle foam layer 128 and comfort layer 116; Fig. 6).
Regarding claim 35, DeFranks discloses the invention as set forth in claim 20, further comprising a thermal device component (air blower assembly 202; Fig. 6; [0056], lines 1-5) connected to the at least one thermal element (air blower assembly 202 provides air flow to air flow permeable strips 208, where air flow permeable strips 208 are in fluid communication with openings 170; [0055], lines 10-23; [0062], lines 6-8).
Regarding claim 36, DeFranks discloses the invention as set forth in claim 35, wherein the thermal device component (air blower assembly 202; Fig. 6; [0056], lines 1-5) comprises a wireless user interface ([0078], where the air blower assembly 202 controls the pressure of the air bladders 130 and regulates fluid flow as desired).
Regarding claim 37, DeFranks discloses the invention as set forth in claim 20, wherein the mitigation member comprises at least one aperture (at least one perforation 166 provided on comfort layer 116; Fig. 11).
Regarding claim 38, DeFranks discloses the invention as set forth in claim 37, wherein the at least one aperture (at least one perforation 116; Fig. 11) is disposed upon the top side of the mitigation member (at least one perforation 166 provided on top side of comfort layer 116; Fig. 11) and extends at least partially through the mitigation member to form at least one channel (at least one perforation 166 extends through comfort layer 116 to form at least one air flow channel, where comfort layer 116 provides mitigation, see claim 20 above; Fig. 11; [0069], lines 1-9).
Regarding claim 39, DeFranks discloses the invention as set forth in claim 38. DeFranks further discloses the therapeutic member (comfort layer 116; Fig. 6) comprises the mitigation member (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) having a top side and a bottom side (see claim 20 above) and the thermal-conductive polymer ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer), where the mitigation member (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) comprises the at least one aperture (see claim 37 above), where the at least one aperture forms the at least one channel at a top side of the mitigation member and at least partially within the mitigation member (see claim 38 above). Hence, the at least one channel (at least one perforation 166 extends through comfort layer 116 to form at least one air flow channel, where comfort layer 116 provides mitigation, see claim 20 above; Fig. 11; [0069], lines 1-9) comprises the thermal-conductive polymer at least partially disposed therein ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer).
Regarding claim 40, DeFranks as modified teaches the invention as set forth in claim 20. DeFranks further discloses the therapeutic member (comfort layer 116; Fig. 6) comprises the mitigation member (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) having a top side and a bottom side (see claim 20 above) and the thermal-conductive polymer ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer). Additionally, DeFranks discloses the therapeutic member can be defined by multiple layers, wherein the layers of the therapeutic member can have different properties and dimensions ([0069], last sentence of paragraph). Hence, the therapeutic member (comfort layer 116; Fig. 6) comprises the thermal-conductive polymer disposed upon at least the top side of the mitigation member ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer).
Regarding claim 41, DeFranks as modified teaches the invention as set forth in claim 40, wherein the therapeutic member (comfort layer 116; Fig. 6) further comprises the thermal-conductive polymer disposed at least partially through the mitigation member ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer) for at least the same reasoning as claim 40 above.
Regarding claim 42, DeFranks discloses the invention as set forth in claim 41. DeFranks further discloses the therapeutic member can be defined by multiple layers, wherein the layers of the therapeutic member can have different properties and dimensions ([0069], last sentence of paragraph). Additionally, DeFranks discloses the therapeutic member (comfort layer 116; Fig. 6) comprises the mitigation member (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) having a top side and a bottom side (see claim 20 above) and the thermal-conductive polymer ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer). Hence, the therapeutic member (comfort layer 116; Fig. 6) further comprises a layer of the thermal-conductive polymer disposed upon the top side of the mitigation member ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer; [0069], last sentence of paragraph).
Regarding claim 49, DeFranks as modified teaches the invention as set forth in claim 20, wherein the therapeutic member (comfort layer 116; Fig. 6) further comprises a barrier layer disposed upon the bottom side thereof (a bottom-most layer of comfort layer 116 on the bottom side of comfort layer 116 provides a barrier between an upper portion of comfort layer 116 and upper cradle foam layer 128; Figs. 6 and 11).
Regarding claim 50, DeFranks as modified teaches the invention as set forth in claim 20, wherein the therapeutic member (comfort layer 116; Fig. 6) further comprises a comfort layer disposed upon the top side thereof (comfort layer 116 can be defined by multiple layers with different properties and dimensions, hence comfort layer 116 may include a top-most comfort layer on the top side of comfort layer 116; Figs. 6 and 11; [0069], last sentence of paragraph).
Regarding claim 51, DeFranks as modified teaches the invention as set forth in claim 20, wherein at least one of the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) and the therapeutic member (comfort layer 116; Fig. 6) is at least partially encased in a sheath member (cover 118 at least partially encases upper cradle foam layer 128 and comfort layer 116; Figs. 6-7; [0074]).
Regarding claim 52, DeFranks as modified teaches the invention as set forth in claim 20, wherein the massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6), the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) and the therapeutic member (comfort layer 116; Fig. 6) are collectively at least partially encased in a single sheath member (cover 118 at least partially encases upper cradle foam layer 128 and comfort layer 116; Figs. 6-7; [0074]).
Regarding claim 53, DeFranks discloses a method of preparing a decubitus prevention device ([0001]; [0042], lines 1-4; [0047]) comprising:
providing a massage member (foam encased bucket assembly 114 with air bladders 130 inside for massage; Figs. 6-7; [0054], lines 3-6) having a top side and a bottom side (see Annotated Fig. 6 below) comprising a housing component (side rail assembly 122 and breathable material base layer 120; Fig. 6; [0052], lines 1-3) and at least one manipulation element, wherein the at least one manipulation element (at least one air bladder 130; Fig. 6) is disposed within the housing component (side rail assembly 122 and breathable material base layer 120 create well or cavity 124 which provides space for innercore unit 112 to be inserted into, where the innercore unit 112 includes air bladders 130; Fig. 6; [0052], lines 3-5);
providing a thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) having a top side and a bottom side (see Annotated Fig. 6 below) comprising a polymeric member (upper cradle foam layer 128, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070], lines 1-6) and at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14), wherein the at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14) is at least partially disposed within the polymeric member (openings 170 are disposed within the upper cradle foam layer 128; Figs. 6 & 10); and
disposing the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) upon the top side of the massage member such that the bottom side of the thermal support member is at least in partial contact with the at least one manipulation element (Figs. 6-7, where the bottom side of upper cradle foam layer 128 is in contact with the top side of air bladders 130) to form the decubitus prevention device (Figs. 6-7; [0047]).
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Regarding claim 54, DeFranks discloses the invention as set forth in claim 53, further comprising:
d. providing a therapeutic member (comfort layer 116; Fig. 6) having a top side and a bottom side (see Annotated Fig. 6 below) comprising a mitigation member (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) and a thermal-conductive polymer ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer), wherein DeFranks further discloses the therapeutic member (comfort layer 116; Fig. 6) comprises the mitigation member (comfort layer 116 overlays upper cradle foam layer 128 and provides mitigation; Figs. 6-7; [0069], lines 1-3) having a top side and a bottom side (see claim 20 above) and the thermal-conductive polymer ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer), wherein DeFranks additionally discloses the therapeutic member can be defined by multiple layers, wherein the layers of the therapeutic member can have different properties and dimensions ([0069], last sentence of paragraph), hence, the therapeutic member (comfort layer 116; Fig. 6) the thermal-conductive polymer is at least partially disposed within the mitigation member ([0040], lines 9-11, where comfort layer 116 is the uppermost comfort layer, and comfort layer 116 includes a polymeric foam, hence comfort layer 116 comprises a thermal-conductive polymer); and
e. disposing the therapeutic member (comfort layer 116; Fig. 6) upon the top side of the thermal support member (comfort layer 116 is disposed on a top side of the upper cradle foam layer 128, see Annotated Fig. 6 below).
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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.
Claims 12 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over DeFranks (US 20190174930 A1).
Regarding claim 12, DeFranks discloses the invention as set forth in claim 1, but does not explicitly disclose wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) has a 00 Shore Hardness of about 0 to about 30.
However, DeFranks does disclose the foam layers can have a desired hardness ([0072], lines 1-2, where the viscoelastic foam layers have a density of 1.5 pounds per cubic foot to 6 pounds per cubic foot and an indention load deflection (ILD) off 7 to 16 poundsxforce ([0072], lines 14-18; [0073], lines 1-43), where the upper cradle foam layer 128 is a foam layer.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to discover the optimal workable ranges of 00 shore hardness of the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) since the general conditions of the claimed method are disclosed in the prior art (See MPEP § 2144.05.II.A) and there are a finite number of identified, predictable solutions to determine a 00 shore hardness of a foam material when provided a desired indention load deflection range and density range.
Regarding claim 31, DeFranks as modified teaches the invention as set forth in claim 20, but does not explicitly disclose wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) has a 00 Shore Hardness of about 0 to about 30.
However, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to discover the optimal workable ranges of 00 shore hardness of the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) such that the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) has a 00 Shore Hardness of about 0 to about 30 for at least the reasoning provided above (see claim 12 above).
Claims 6-8, 10-11, 25-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over DeFranks (US 20190174930 A1) as applied to claims 5 and 24 above, and further in view of Kriesel & Goodenough (US 20040134669 A1; hereinafter “Kriesel”).
Regarding claim 6, DeFranks discloses the invention as set forth in claim 5, but fails to explicitly disclose wherein the cushioning polymer is formed from a reaction media ([0071], lines 1-7) comprising:
a. about 3 wt% to about 20 wt% isocyanate prepolymer or silicone prepolymer;
b. about 20 wt% to about 40 wt% polyols; and
c. about 40 wt% to about 80 wt% epoxidized triglyceride plasticizer.
However, Kriesel teaches an energy absorbing compound that is a polymeric compound (Abstract) made up of:
a. about 5 wt% to about 20 wt% prepolymer including isocyanate ([0011], lines 6-7; [0012], lines 7-8);
b. about 20 wt% to about 40 wt% thermoplastic polymer ([0012], lines 6-7), where the thermoplastic polymer includes polydienes such as polybutadiene, where polybutadiene is a low molecular weight hydroxyl terminated polybutadiene ([0023], lines 1-4); and
c. about 50 wt% to about 70 wt% epoxidized vegetable oil ([0010], lines 5-6; [0018], lines 5-9), where the epoxidized vegetable oil is obtained by the epoxidation of triglycerides ([0017], lines 8-11).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify DeFranks with Kriesel such that wherein the cushioning polymer ([0070], lines 1-7, where it is inherent viscoelastic materials, including viscoelastic foams, return to their original innate form after being strained and all polymers listed in paragraph 0070 are viscoelastic, hence all of the polymers listed in paragraph 0070 are viscoelastomeric and cohesive cushioning polymers) is formed from a reaction media ([0071], lines 1-7) comprising:
a. about 3 wt% to about 20 wt% isocyanate prepolymer (Kriesel: ([0011], lines 6-7; [0012], lines 7-8, where a range of about 5 wt% to about 20 wt% satisfies the disclosed range of about 3 wt% to about 20 wt%);
b. about 20 wt% to about 40 wt% polyols (Kriesel: [0012], lines 6-7; [0023], lines 1-4); and
c. about 40 wt% to about 80 wt% epoxidized triglyceride plasticizer (Kriesel: [0010], lines 5-6; [0018], lines 5-9; [0017], lines 8-11, where a range of about 50 wt% to about 70 wt% satisfies the disclosed range of about 40 wt% to about 80 wt%) to provide the decubitus prevention device foam layers with resilient and elastic characteristic to provide proper support of a user’s body and increase comfort during use of the device while minimizing the structural damage of the foam layers over time (Kriesel: [0009], lines 6-11; [0016]).
Regarding claim 7, DeFranks as modified discloses the invention as set forth in claim 6, but fails to explicitly teach wherein the polyols comprise hydroxyl terminated polyols (Kriesel: [0023], lines 1-4).
Regarding claim 8, DeFranks as modified discloses the invention as set forth in claim 6, wherein the polyols comprise a polybutadiene polyol (Kriesel: [0023], lines 1-4).
Regarding claim 10, DeFranks as modified discloses the invention as set forth in claim 6, wherein the epoxidized triglyceride plasticizer is an epoxidized soybean oil plasticizer (Kriesel: [0010], lines 5-6; [0018], lines 5-9; [0017], lines 8-1; see claim 6 above).
Regarding claim 11, DeFranks as modified discloses the invention as set forth in claim 6, wherein the reaction media ([0071], lines 1-7) further comprises a catalyst ([0071], lines 3-5), but fails to explicitly teach the reaction media ([0071], lines 1-7) further comprises about 0.001 wt% to about 5 wt% catalyst.
However, Kriesel teaches an energy absorbing compound that is a polymeric compound (Abstract), where 0.001% to 5% of the weight of the energy absorbing compound is a catalyst ([0028], lines 1-3).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify DeFranks with Kriesel such that the reaction media ([0071], lines 1-7) further comprises about 0.001 wt% to about 5 wt% catalyst (Kriesel: [0028], lines 1-3) to aid in the formation of the reaction media (Kriesel: [0015], lines 6-7).
Regarding claim 25, DeFranks as modified teaches the invention as set forth in claim 20, disclose wherein the cushioning polymer is formed from a reaction media ([0071], lines 1-7) comprising:
a. about 3 wt% to about 20 wt% isocyanate prepolymer or silicone prepolymer;
b. about 20 wt% to about 40 wt% polyols; and
c. about 40 wt% to about 80 wt% epoxidized triglyceride plasticizer.
However, Kriesel teaches an energy absorbing compound that is a polymeric compound (Abstract) made up of:
a. about 5 wt% to about 20 wt% prepolymer including isocyanate ([0011], lines 6-7; [0012], lines 7-8);
b. about 20 wt% to about 40 wt% thermoplastic polymer ([0012], lines 6-7), where the thermoplastic polymer includes polydienes such as polybutadiene, where polybutadiene is a low molecular weight hydroxyl terminated polybutadiene ([0023], lines 1-4); and
c. about 50 wt% to about 70 wt% epoxidized vegetable oil ([0010], lines 5-6; [0018], lines 5-9), where the epoxidized vegetable oil is obtained by the epoxidation of triglycerides ([0017], lines 8-11).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify DeFranks with Kriesel such that wherein the cushioning polymer ([0070], lines 1-7, where it is inherent viscoelastic materials, including viscoelastic foams, return to their original innate form after being strained and all polymers listed in paragraph 0070 are viscoelastic, hence all of the polymers listed in paragraph 0070 are viscoelastomeric and cohesive cushioning polymers) is formed from a reaction media ([0071], lines 1-7) comprising:
a. about 3 wt% to about 20 wt% isocyanate prepolymer (Kriesel: ([0011], lines 6-7; [0012], lines 7-8, where a range of about 5 wt% to about 20 wt% satisfies the disclosed range of about 3 wt% to about 20 wt%);
b. about 20 wt% to about 40 wt% polyols (Kriesel: [0012], lines 6-7; [0023], lines 1-4); and
c. about 40 wt% to about 80 wt% epoxidized triglyceride plasticizer (Kriesel: [0010], lines 5-6; [0018], lines 5-9; [0017], lines 8-11, where a range of about 50 wt% to about 70 wt% satisfies the disclosed range of about 40 wt% to about 80 wt%) to provide the decubitus prevention device foam layers with resilient and elastic characteristic to provide proper support of a user’s body and increase comfort during use of the device while minimizing the structural damage of the foam layers over time (Kriesel: [0009], lines 6-11; [0016]).
Regarding claim 26, DeFranks as modified teaches the invention as set forth in claim 25, wherein the polyols comprise hydroxyl terminated polyols (Kriesel: [0023], lines 1-4).
Regarding claim 27, DeFranks as modified teaches the invention as set forth in claim 25, wherein the polyols comprise a polybutadiene polyol (Kriesel: [0023], lines 1-4).
Regarding claim 29, DeFranks as modified teaches the invention as set forth in claim 25, wherein the epoxidized triglyceride plasticizer is an epoxidized soybean oil plasticizer (Kriesel: [0010], lines 5-6; [0018], lines 5-9; [0017], lines 8-1; see claim 25 above).
Regarding claim 30, DeFranks as modified teaches the invention as set forth in claim 25, wherein the reaction media ([0071], lines 1-7) further comprises a catalyst ([0071], lines 3-5), but fails to explicitly teach the reaction media ([0071], lines 1-7) further comprises about 0.001 wt% to about 5 wt% catalyst.
However, Kriesel teaches an energy absorbing compound that is a polymeric compound (Abstract), where 0.001% to 5% of the weight of the energy absorbing compound is a catalyst ([0028], lines 1-3).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify DeFranks with Kriesel such that the reaction media ([0071], lines 1-7) further comprises about 0.001 wt% to about 5 wt% catalyst (Kriesel: [0028], lines 1-3) to aid in the formation of the reaction media (Kriesel: [0015], lines 6-7).
Claims 9 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over DeFranks (US 20190174930 A1) in view of Kriesel (US 20040134669 A1) as applied to claims 8 and 27 above, and further in view of Kriesel (US 20190002623 A1; hereinafter “Kriesel ‘623”).
Regarding claim 9, DeFranks as modified discloses the invention as set forth in claim 8, but fails to explicitly teach wherein the polyols further comprise a polyether diol.
However, Kriesel ‘623 teaches thermosetting reaction media with plasticizers, where the plasticizers include epoxidized vegetable oil; cross-linking polyols to straight chain producing polyether diols; and isocyanate prepolymer ([0055], lines 2-11).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify DeFranks with Kriesel ‘623 such that the polyols (Kriesel: [0012], lines 6-7; [0023], lines 1-4) further comprise a polyether diol (Kriesel ‘623: [0055], lines 8-9) to achieve a desired viscoelastomeric and cohesive cushioning polymer (Kriesel ‘623: [0056], lines 9-15).
Regarding claim 28, DeFranks as modified teaches the invention as set forth in claim 25, the polyols (Kriesel: [0012], lines 6-7; [0023], lines 1-4) further comprise a polyether diol (Kriesel ‘623: [0055], lines 8-9).
Claims 43 and 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over DeFranks (US 20190174930 A1) as applied to claim 20 above, and further in view of Kriesel (US 20040134669 A1) and Kriesel ‘623 (US 20190002623 A1).
Regarding claim 43, DeFranks discloses the invention as set forth in claim 20, but fails to disclose wherein the thermal-conductive polymer is formed from a reaction media ([0071], lines 1-7) comprising:
a. about 2 wt% to about 20 wt% prepolymer; and
b. about 40 wt% to about 80 wt% epoxidized triglyceride plasticizer.
However, Kriesel teaches an energy absorbing compound that is a polymeric compound (Abstract) made up of:
a. about 5 wt% to about 20 wt% prepolymer including isocyanate ([0011], lines 6-7; [0012], lines 7-8);
b. about 20 wt% to about 40 wt% thermoplastic polymer ([0012], lines 6-7), where the thermoplastic polymer includes polydienes such as polybutadiene, where polybutadiene is a low molecular weight hydroxyl terminated polybutadiene ([0023], lines 1-4); and
c. about 50 wt% to about 70 wt% epoxidized vegetable oil ([0010], lines 5-6; [0018], lines 5-9), where the epoxidized vegetable oil is obtained by the epoxidation of triglycerides ([0017], lines 8-11).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify DeFranks with Kriesel such that the thermal-conductive polymer is formed from a reaction media ([0071], lines 1-7) comprising:
a. about 2 wt% to about 20 wt% prepolymer (Kriesel: [0011], lines 6-7; [0012], lines 7-8, where a range of about 3 wt%); and
b. about 40 wt% to about 80 wt% epoxidized triglyceride plasticizer (Kriesel: [0010], lines 5-6; [0018], lines 5-9; [0017], lines 8-11, where a range of about 50 wt% to about 70 wt% satisfies the disclosed range of about 40 wt% to about 80 wt%) to provide the decubitus prevention device foam layers with resilient and elastic characteristic to provide proper support of a user’s body and increase comfort during use of the device while minimizing the structural damage of the foam layers over time (Kriesel: [0009], lines 6-11; [0016]).
DeFranks, as modified by Kriesel above, fails to explicitly teach wherein the thermal-conductive polymer is formed from a reaction media further comprising:
a. about 1 wt% to about 65 wt% straight chain polyols;
b. about 3 wt% to about 50 wt% crosslinking polyols; and
c. 0 wt% to about 40 wt% viscosity reducing plasticizer.
However, Kriesel ‘623 teaches a reaction media including about 35 wt% to about 55 wt% polyols, where said polyols include straight chain linking diols, such as polyether diols ([0053], lines 7-8), and cross-linking triols, such as polyether triols ([0056], last sentence of paragraph; claim 1, lines 2-9). Additionally, Kriesel ‘623 teaches epoxidized triglycerides can be substituted or replaced with ester plasticizers ([0053], lines 35-37), where ester plasticizers reduce viscosity ([0053], lines 40-43; [0068], lines 28-30). Hence, if the reaction media disclosed in claim 43 includes epoxidized triglyceride plasticizer, there will be no ester plasticizer in the reaction media.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the reaction media of DeFranks with the composition of the reaction media taught by Kriesel ‘623 such that the thermal-conductive polymer (thermal-conductive polymer of comfort layer 116; [0040], lines 9-11) is formed from a reaction media further comprising:
a. about 1 wt% to about 65 wt% straight chain polyols (Kriesel ‘623: claim 1, lines 2-9, where a range of about 35 wt% to about 55 wt% falls with the disclosed range of about 1 wt% to about 65 wt%);
b. about 3 wt% to about 50 wt% crosslinking polyols (Kriesel ‘623: claim 1, lines 2-9); and
c. 0 wt% to about 40 wt% viscosity reducing plasticizer (Kriesel ‘623: [0053], lines 35-37, where the reaction media contains epoxidized triglyceride plasticizer, see above, hence the reaction media contains 0 wt% ester plasticizer, where ester plasticizer is a viscosity reducing plasticizer, see [0053], lines 40-43; [0068], lines 28-30) to achieve a highly effective stable, cohesive, and thermal-conductive polymer (Kriesel ‘623: [0052], lines 4-7).
Regarding claim 45, DeFranks as modified teaches the invention as set forth in claim 43, wherein the straight chain polyols (Kriesel ‘623: claim 1, lines 2-9) comprise polyether diols (Kriesel ‘623: ([0053], lines 7-8) and the crosslinking polyols (Kriesel ‘623: claim 1, lines 2-9) comprise polyether triols ([0056], last sentence of paragraph).
Regarding claim 46, DeFranks as modified teaches the invention as set forth in claim 43, wherein the epoxidized triglyceride plasticizer comprises epoxidized soybean oil plasticizer (Kriesel: [0010], lines 5-6; [0018], lines 5-9; [0017], lines 8-1).
Regarding claim 47, DeFranks as modified teaches the invention as set forth in claim 43, but fails to teach wherein the viscosity reducing plasticizer comprises ester plasticizer (Kriesel ‘623: [0053], lines 35-37; [0053], lines 40-43; [0068], lines 28-30).
Regarding claim 48, DeFranks as modified teaches the invention as set forth in claim 43, wherein the reaction media further comprises about 0.001 wt% to about 5 wt% catalyst (Kriesel: [0028], lines 1-3).
Claims 13 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over DeFranks (US 20190174930 A1) as applied to claims 1 and 20 above, and further in view of Copetti & Lepore (WO 2019223896 A1; hereinafter “Copetti”).
Regarding claim 13, DeFranks discloses the invention as set forth in claim 1, but fails to wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6; [0062], lines 1-2 & lines 6-8, where the air flow path provided by the opening 170 aligned with air flow permeable strips 208 for active controlled temperature settings in the head, neck, lumbar, and/or leg regions, see [0055], lines 16-21 and [0079], lines 6-14) further comprises a thermal element support component disposed at least partially within the polymeric member such that the thermal element support component is in contact with the at least one thermal element (openings 170 to provide an airflow path for cooling air flow; Fig. 10; [0062], lines 1-2 & lines 6-8; [0055], lines 16-21; [0079], lines 6-14).
However, Copetti teaches a decubitus prevention device (1; Fig. 2) as a mattress (2; Fig. 2; Pg. 8, lines 24-25) including at least one thermal support member with a support material (support material 44; Fig. 3; Pg. 9, lines 1-2) with at least one thermal element at least partially disposed within the material (tubular passages 9 for flow are disposed within support material 44; Fig. 3; Pg. 9, lines 2-5, where the flow is used for heating and/or cooling purposes, Pg. 14, lines 6-16) wherein the thermal support member further includes a thermal element support component disposed at least partially within the support material (supporting channels in support material 44; Fig. 3) such that the thermal element support component is in contact with the at least one thermal element (tubes 9 are in contact and securely positioned in supporting channels of support material 44; Fig. 3) such that the thermal support member comprises tubes supported in supportive channels.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the thermal support member of DeFranks (upper cradle foam layer 128 with openings 170 for cooling air flow; Fig. 6) with the structure of the thermal support member of Copetti (see above) such that wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow including support material 44 of Copetti) further comprises a thermal element support component (Copetti: supporting channels in support material 44 and upper cradle foam layer 128; Fig. 3) disposed at least partially within the polymeric member (supporting channels of Copetti in support material 44 of Copetti and upper cradle foam layer 128) such that the thermal element support component (Copetti: supporting channels in support material 44 and upper cradle foam layer 128; Fig. 3) is in contact with the at least one thermal element (upper cradle foam layer 128 is in contact with openings 170, see claim 1 above, hence supporting channels of Copetti are also in contact with openings 170) to better provide adjustable heated and/or cooled air flow to the user (Copetti: Pg. 10, lines 15-25; Pg. 14, lines 6-16).
Regarding claim 32, DeFranks as modified teaches the invention as set forth in claim 20, wherein the thermal support member (upper cradle foam layer 128 with openings 170 for cooling air flow including support material 44 of Copetti) further comprises a thermal element support component (Copetti: supporting channels in support material 44 and upper cradle foam layer 128; Fig. 3) disposed at least partially within the polymeric member (supporting channels of Copetti in support material 44 of Copetti and upper cradle foam layer 128) such that the thermal element support component (Copetti: supporting channels in support material 44 and upper cradle foam layer 128; Fig. 3) is in contact with the at least one thermal element (upper cradle foam layer 128 is in contact with openings 170, see claim 20 above, hence supporting channels of Copetti are also in contact with openings 170).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over DeFranks (US 20190174930 A1) in view of Kriesel (US 20040134669 A1) in view of Kriesel ‘623 (US 20190002623 A1) as applied to claim 43 above, and further in view of Volker et al. (DE 10108038 C1; hereinafter “Volker”).
Regarding claim 44, DeFranks as modified teaches the invention as set forth in claim 43, wherein the prepolymer is isocyanate prepolymer (Kriesel: ([0011], lines 6-7; [0012], lines 7-8), but fails to teach the prepolymer is selected from a group consisting of isocyanate prepolymer and silicone prepolymer.
However, Volker teaches a mixture to make foam, wherein the mixture includes a prepolymer, where the prepolymer can be an isocyanate prepolymer ([0006], lines 1-2, see provided translation) or a silicone prepolymer ([0012], lines 2-6, see provided translation).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify DeFranks with Volker such that the prepolymer (see claim 43 above) is selected from a group consisting of isocyanate prepolymer (Kriesel: ([0011], lines 6-7; [0012], lines 7-8) and silicone prepolymer (Volker: [0012], lines 2-6, see provided translation) as both silicone prepolymers and isocyanate prepolymers are commonly used components in a reaction media to make foam (Volker: [0012], lines 5-6; [0006], lines 3-5).
Response to Arguments
Applicant's arguments filed on 04/30/2026 have been fully considered but they are not persuasive.
35 U.S.C. 102(a)(2) Rejections
With regard to claim 1, Applicant argues a person of ordinary skill in the art would discern the purpose of DeFranks "active comfort controlled bedding system 100" is to merely enhance sleep comfort of a particular user based on a myriad of factors (pg. 13-14 of Remarks filed on 04/30/2026). As such, DeFranks fails to disclose or suggest the active comfort controlled bedding system 100 can prevent or eliminate decubitus ulcers or provide relief to burn victims, patients with a fever, and the like. While DeFranks does disclose an "active comfort controlled bedding system" ([0001]), the system includes variable firmness control, where the variable firmness can be in the form of a repeating pattern such as to provide a massaging action and/or therapeutic benefit or the like, and variable climate control ([0001]). DeFranks further discloses a need for a bedding system/mattress that changes with a user as the requirements of each consumer can change significantly over the course of a mattress's lifespan as a consumer's weight, activity level, health, and preferred sleeping position change ([0002]); hence, the active comfort controlled bedding system disclosed by DeFranks is capable of providing climate controls and massage functions, or other therapeutic functions, to a user in poor health (e.g., bedridden due to illness, have a fever, have severe burns, etc.) ([0001]-[0002]). Additionally, DeFranks states body temperature is a critical factor of restful sleep as the body prefers a certain temperature range in order to achieve and maintain deep uninterrupted sleep ([0005]); hence, the system disclosed by DeFranks could improve comfort for those with severe burns and/or a fever. Additionally, Applicant’s claimed invention and DeFranks system are both classified under A61G7/057 and A61H2205/081; hence, DeFranks is an analogous to the claimed invention.
On page 14, Applicant states a person of ordinary skill in the art would recognize, in light of Applicant’s specification, that Applicant discloses polymeric member 130 is formed from cushioning polymer 132; however, DeFranks discloses DeFranks discloses an "upper cradle foam layer 129, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams" ([0070], lines 1-6). As such, DeFranks fails to disclose a thermal support member comprising a polymeric member, as recited in claim 1. Applicant provides the definitions of “polymer” and “foam” from Merriam Webster dictionary to further support the distinction between a polymer and a foam. While DeFranks discloses an upper cradle foam layer, it would be well understood by one of ordinary skill in the art that the upper cradle foam layer is specifically a polymeric foam (see [0070], lines 1-6). Hence, the upper cradle polymeric foam layer disclosed by DeFranks can be interpreted as a polymeric member of DeFranks system.
On pages 15-16, Applicant argues one of ordinary skill in the art would recognize the at least one thermal element, as recited in claim 1, is a material object, in light of Applicant’s specification; therefore, DeFranks fails to disclose or teach the thermal element of claim 1, and further fails to disclose or teach at least one thermal element is at least partially disposed within the polymeric member. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the at least one thermal element being a material object) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, Applicant’s specification recites “the at least one thermal element is at least partially disposed within the polymeric member” (pg. 4), “the thermal device component [is] connected to the at least one thermal element” (pg. 5), “the thickness of the polymeric member 130 will be sufficient to at least substantially encase the thermal element 140” (pg. 20), “[t]he purpose of the thermal element 140 is to provide a heating and/or cooling effect to the user. In some preferred embodiments, the thermal element 140 can have both heating and cooling capabilities” (pg. 25), and “the thermal element 140 will typically have a substantially hollow structure (e.g., tubing, piping, HVAC ducting, etc.)” (pg. 25). As such, the specification does not explicitly disclose the at least one thermal element as a material object, and one of ordinary skill in the art may recognize and interpret the at least one thermal element to be an opening at least partially within the polymeric member with the purpose of providing a heating or cooling function, in light of Applicant’s specification. Additionally, the openings disclosed by DeFranks are at least partially disposed within the upper cradle foam layer, which is a polymeric foam layer; therefore, DeFranks does disclose the at least one thermal element is at least partially disposed within the polymeric member.
On page 15, Applicant further argues DeFranks fails to disclose or suggest a “cooling” air flow, but instead specifically discloses and teaches the air flow is at ambient temperature. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a cooling air flow/temperature) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, DeFranks discloses a climate control function ([0001]) with associated methods of adjusting temperature within the system ([0006]), where the blower (202) includes a thermoelectric device, a convective heater, a heat pump, a dehumidifier and/or any other type of conditioning device ([0056]). DeFranks further discloses "one or more settings of the control system may include a desired climate setting corresponding to areas of the bedding system configured for air flow" and that the system provides temperature feedback to adjust the climate settings to maintain a comfortable climate and surface temperature for the user ([0079]-[0080]). Hence, it would be well-understood by one of ordinary skill in the art that the system disclosed by DeFranks is capable of delivering a “cooling” air flow.
In regard to claim 2, Applicant states the purpose of the cross member element according to Applicant’s specification (pg. 16 of Remarks), and argues a person of ordinary skill in the art would not recognize the breathable material base layer (120), disclose by DeFranks, to reasonably provide enhanced structural stability to the frame housing, nor the housing component (pg. 17 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the purpose of the cross member element is to provide enhance structural stability to the frame element, and thus the housing component) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 3, Applicant states the elevation elements 166 are disposed on the bottom side of the massage member 150 such that they can assist with setting the device at a particular height that can be static or adjustable (e.g., rails, extensions, pegs, blocks, wheels, rollers, etc.); therefore, DeFranks breathable material layer 120 is not equivalent to Applicant’s elevation element 166 (pgs. 17-18 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the elevation elements assisting with setting the device at a static or adjustable height) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 4, Applicant argues DeFranks only discloses one type of manipulation element, namely an air bladder (pgs. 19-20 of Remarks). While DeFranks does mainly disclose massage members configured as air bladders, DeFranks further disclose multiple air bags positioned and oriented in various locations within the system, such that an individually controlled massage function can be provided to each of the head, foot, torso, and/or upper leg of a user ([0053]-[0054]). Therefore, DeFranks discloses at least four types of manipulation elements, specifically airbladder, as DeFranks discloses a head massage air bladder, a foot massage air bladder, a torso massage air bladder, and an upper leg massage air bladder.
In regard to claim 5, Applicant defines “viscoelastomeric” as “a substance (such as a polymer) having viscous and elastic properties and which exhibits viscous flow elastic properties (as opposed to densifying compressive elastic properties, such as with foam or rubber) to return to its original innate form upon subjection and subsequent removal of a stretching or compressive force”, as recited on pg. 16 of Applicant’s specification, and argues DeFranks fails to disclose or teach a viscoelastomeric and cohesive cushioning polymer according to the provided definition (pgs. 20-21 of Remarks). Applicant’s definition of "viscoelastomeric" (pg. 16 of Applicant’s specification) further states the terms "viscoelastomeric" and "viscoelastic" can be used interchangeably. It is well-known to one of ordinary skill in the art that the suitable polymeric foams listed for the upper cradle foam layer 128 (polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070]) are viscoelastic materials. As such, DeFranks does disclose a viscoelastomeric and cohesive cushioning polymer (upper cradle foam layer 128).
In regard to claims 14-15, Applicant argues DeFranks does not disclose or teach forming a laminated-type structure, and does not disclose or teach a bottom side barrier layer or a top side barrier layer capable of preventing potential leakage of plasticizer (pgs. 21-24 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., forming a laminated-type structure, preventing potential leakage of plasticizer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regard to claim 16, Applicant argues the air blower disclosed by DeFranks fails to provide heated and/or cooled air, but instead provides ambient temperature air (pgs. 24-25 of Remarks). However, the system disclosed by DeFranks has a climate control function ([0001]) with associated methods of adjusting temperature within the system ([0006]). Furthermore, the blower (202) disclosed by DeFranks includes a thermoelectric device, a convective heater, a heat pump, a dehumidifier and/or any other type of conditioning device ([0056]). Hence, the blower disclosed by DeFranks would be capable of providing heated/cooled air.
In regard to claims 17-19, Applicant argues the claims ultimately depend from claim 1, and thus incorporate the limitations of claim 1, and therefore, are patentable over DeFranks (pgs. 26-29 of Remarks). However, claim 1 is not patentable over DeFranks (see response to claim 1 arguments above), and do not overcome their respective rejections under 35 U.S.C. 102(a)(2) rejections.
In regard to claim 20, Applicant argues a person of ordinary skill in the art would discern the purpose of DeFranks "active comfort controlled bedding system 100" is to merely enhance sleep comfort of a particular user based on a myriad of factors (pgs. 29-31 of Remarks). As such, DeFranks fails to disclose or suggest the active comfort controlled bedding system 100 can prevent or eliminate decubitus ulcers or provide relief to burn victims, patients with a fever, and the like. While DeFranks does disclose an "active comfort controlled bedding system" ([0001]), the system includes variable firmness control, where the variable firmness can be in the form of a repeating pattern such as to provide a massaging action and/or therapeutic benefit or the like, and variable climate control ([0001]). DeFranks further discloses a need for a bedding system/mattress that changes with a user as the requirements of each consumer can change significantly over the course of a mattress's lifespan as a consumer's weight, activity level, health, and preferred sleeping position change ([0002]); hence, the active comfort controlled bedding system disclosed by DeFranks is capable of providing climate controls and massage functions, or other therapeutic functions, to a user in poor health (e.g., bedridden due to illness, have a fever, have severe burns, etc.) ([0001]-[0002]). Additionally, DeFranks states body temperature is a critical factor of restful sleep as the body prefers a certain temperature range in order to achieve and maintain deep uninterrupted sleep ([0005]); hence, the system disclosed by DeFranks could improve comfort for those with severe burns and/or a fever. Additionally, Applicant’s claimed invention and DeFranks system are both classified under A61G7/057 and A61H2205/081; hence, DeFranks is an analogous to the claimed invention.
On pages 31-32, Applicant states a person of ordinary skill in the art would recognize, in light of Applicant’s specification, that Applicant discloses polymeric member 130 is formed from cushioning polymer 132; however, DeFranks discloses DeFranks discloses an "upper cradle foam layer 129, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams" ([0070], lines 1-6). As such, DeFranks fails to disclose a thermal support member comprising a polymeric member, as recited in claim 20. Applicant provides the definitions of “polymer” and “foam” from Merriam Webster dictionary to further support the distinction between a polymer and a foam. While DeFranks discloses an upper cradle foam layer, it would be well understood by one of ordinary skill in the art that the upper cradle foam layer is specifically a polymeric foam (see [0070], lines 1-6). Hence, the upper cradle polymeric foam layer disclosed by DeFranks can be interpreted as a polymeric member of DeFranks system.
On pages 32-33, Applicant argues one of ordinary skill in the art would recognize the at least one thermal element, as recited in claim 20, is a material object, in light of Applicant’s specification; therefore, DeFranks fails to disclose or teach the thermal element of claim 20, and further fails to disclose or teach at least one thermal element is at least partially disposed within the polymeric member. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the at least one thermal element being a material object) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, Applicant’s specification recites “the at least one thermal element is at least partially disposed within the polymeric member” (pg. 4), “the thermal device component [is] connected to the at least one thermal element” (pg. 5), “the thickness of the polymeric member 130 will be sufficient to at least substantially encase the thermal element 140” (pg. 20), “[t]he purpose of the thermal element 140 is to provide a heating and/or cooling effect to the user. In some preferred embodiments, the thermal element 140 can have both heating and cooling capabilities” (pg. 25), and “the thermal element 140 will typically have a substantially hollow structure (e.g., tubing, piping, HVAC ducting, etc.)” (pg. 25). As such, the specification does not explicitly disclose the at least one thermal element as a material object, and one of ordinary skill in the art may recognize and interpret the at least one thermal element to be an opening at least partially within the polymeric member with the purpose of providing a heating or cooling function, in light of Applicant’s specification. Additionally, the openings disclosed by DeFranks are at least partially disposed within the upper cradle foam layer, which is a polymeric foam layer; therefore, DeFranks does disclose the at least one thermal element is at least partially disposed within the polymeric member.
In regard to claim 21, Applicant argues a person of ordinary skill in the art would not recognize the breathable material base layer (120), disclose by DeFranks, to reasonably provide enhanced structural stability to the frame housing, nor the housing component (pgs. 33-34 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the purpose of the cross member element is to provide enhance structural stability to the frame element, and thus the housing component) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 22, Applicant argues DeFranks breathable material layer 120 is not equivalent to Applicant’s elevation element 166, as DeFranks breathable material layer 120 cannot assist with setting the device at a particular height that can be static or adjustable, as Applicant’s elevation elements 166 can (pgs. 34-36). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the elevation elements assisting with setting the device at a static or adjustable height) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 23, Applicant argues DeFranks only discloses one type of manipulation element, namely an air bladder (pgs. 36-37 of Remarks). While DeFranks does mainly disclose massage members configured as air bladders, DeFranks further disclose multiple air bags positioned and oriented in various locations within the system, such that an individually controlled massage function can be provided to each of the head, foot, torso, and/or upper leg of a user ([0053]-[0054]). Therefore, DeFranks discloses at least four types of manipulation elements, specifically airbladder, as DeFranks discloses a head massage air bladder, a foot massage air bladder, a torso massage air bladder, and an upper leg massage air bladder.
In regard to claim 24, Applicant defines “viscoelastomeric” as “a substance (such as a polymer) having viscous and elastic properties and which exhibits viscous flow elastic properties (as opposed to densifying compressive elastic properties, such as with foam or rubber) to return to its original innate form upon subjection and subsequent removal of a stretching or compressive force”, as recited on pg. 16 of Applicant’s specification, and argues DeFranks fails to disclose or teach a viscoelastomeric and cohesive cushioning polymer according to the provided definition (pgs. 37-38 of Remarks). Applicant’s definition of "viscoelastomeric" (pg. 16 of Applicant’s specification) further states the terms "viscoelastomeric" and "viscoelastic" can be used interchangeably. It is well-known to one of ordinary skill in the art that the suitable polymeric foams listed for the upper cradle foam layer 128 (polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams; [0070]) are viscoelastic materials. As such, DeFranks does disclose a viscoelastomeric and cohesive cushioning polymer (upper cradle foam layer 128).
With regard to claims 33-34, Applicant argues DeFranks does not disclose or teach forming a laminated-type structure, and does not disclose or teach a bottom side barrier layer or a top side barrier layer capable of preventing potential leakage of plasticizer (pgs. 39-42 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., forming a laminated-type structure, preventing potential leakage of plasticizer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regard to claim 35, Applicant argues the air blower disclosed by DeFranks fails to provide heated and/or cooled air, but instead provides ambient temperature air (pgs. 42-43 of Remarks). However, the system disclosed by DeFranks has a climate control function ([0001]) with associated methods of adjusting temperature within the system ([0006]). Furthermore, the blower (202) disclosed by DeFranks includes a thermoelectric device, a convective heater, a heat pump, a dehumidifier and/or any other type of conditioning device ([0056]). Hence, the blower disclosed by DeFranks would be capable of providing heated/cooled air.
With regard to claims 36-38, Applicant argues the claims ultimately depend from claim 20, and thus incorporate the limitations of claim 20, and therefore, are patentable over DeFranks (pgs. 43-46 of Remarks). However, claim 20 is not patentable over DeFranks (see response to claim 20 arguments above), and do not overcome their respective rejections under 35 U.S.C. 102(a)(2) rejections.
With regard to claims 39-42, Applicant argues DeFranks discloses gel is infused into the foam, but fails to show any residing gel in the openings. As such, a person of ordinary skill in the art could only conclude DeFranks fails to disclose or teach a mitigation member comprising at least one channel having a thermal-conductive polymer at least partially disposed therein (pgs. 46-52 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., gel residing in, or being infused in, the foam) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regard to claim 49, Applicant states the purpose of the barrier layer 340 includes, halting the migration of liquid reaction media during production, preventing direct contract between the thermal-conductive polymer 330 and top side 121 of the thermal support member 120, and preventing any potential leakage of plasticizer which may occur from migrating into the thermal support member 120, according to Applicant’s specification (pg. 53 of Applicant’s specification). As such, Applicant argues DeFranks fails to disclose or teach a barrier layer as defined by Applicant’s specification (pg. 53 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., purpose of barrier layer is halting the migration of liquid reaction media during production, preventing direct contract between the thermal-conductive polymer and top side of the thermal support member, and preventing any potential leakage of plasticizer which may occur from migrating into the thermal support member) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 50, Applicant argues DeFranks fails to disclose or teach any comfort layer as defined by Applicant’s specification (see pgs. 54-55 of Remarks). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., comfort layer adds additional layer of comfort, provides an aesthetically pleasing visual attribute, provides an aesthetically pleasing feeling, buffers the user from “feeling” the presence of optional channels, reduces or eliminates pressure points, prevents direct contact between the thermal-conductive polymer and a bedding sheet or an optional sheath member, retards potential leakage of plasticizer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, the optional comfort layer disclosed by DeFranks (116) does provide a comfort layer to add additionally of comfort (last sentence of [0069]).
With regard to claims 51-52, Applicant argues the claims ultimately depend from claim 20, and thus incorporate the limitations of claim 20, and therefore, are patentable over DeFranks. However, claim 20 is not patentable over DeFranks (see response to claim 20 arguments above), and do not overcome their respective rejections under 35 U.S.C. 102(a)(2) rejections.
In regard to claim 53, Applicant argues a person of ordinary skill in the art would discern the purpose of DeFranks "active comfort controlled bedding system 100" is to merely enhance sleep comfort of a particular user based on a myriad of factors (pgs. 59-60 of Remarks). As such, DeFranks fails to disclose or suggest the active comfort controlled bedding system 100 can prevent or eliminate decubitus ulcers or provide relief to burn victims, patients with a fever, and the like. While DeFranks does disclose an "active comfort controlled bedding system" ([0001]), the system includes variable firmness control, where the variable firmness can be in the form of a repeating pattern such as to provide a massaging action and/or therapeutic benefit or the like, and variable climate control ([0001]). DeFranks further discloses a need for a bedding system/mattress that changes with a user as the requirements of each consumer can change significantly over the course of a mattress's lifespan as a consumer's weight, activity level, health, and preferred sleeping position change ([0002]); hence, the active comfort controlled bedding system disclosed by DeFranks is capable of providing climate controls and massage functions, or other therapeutic functions, to a user in poor health (e.g., bedridden due to illness, have a fever, have severe burns, etc.) ([0001]-[0002]). Additionally, DeFranks states body temperature is a critical factor of restful sleep as the body prefers a certain temperature range in order to achieve and maintain deep uninterrupted sleep ([0005]); hence, the system disclosed by DeFranks could improve comfort for those with severe burns and/or a fever. Additionally, Applicant’s claimed invention and DeFranks system are both classified under A61G7/057 and A61H2205/081; hence, DeFranks is an analogous to the claimed invention.
On pages 60-61, Applicant states a person of ordinary skill in the art would recognize, in light of Applicant’s specification, that Applicant discloses polymeric member 130 is formed from cushioning polymer 132; however, DeFranks discloses DeFranks discloses an "upper cradle foam layer 129, where suitable foams include polyurethane foams, polystyrene foams, polyethylene foams, polypropylene foams, and/or polyether-polyurethane foams" ([0070], lines 1-6). As such, DeFranks fails to disclose a thermal support member comprising a polymeric member. Applicant provides the definitions of “polymer” and “foam” from Merriam Webster dictionary to further support the distinction between a polymer and a foam. While DeFranks discloses an upper cradle foam layer, it would be well understood by one of ordinary skill in the art that the upper cradle foam layer is specifically a polymeric foam (see [0070], lines 1-6). Hence, the upper cradle polymeric foam layer disclosed by DeFranks can be interpreted as a polymeric member of DeFranks system.
On pages 61-62, Applicant argues one of ordinary skill in the art would recognize the at least one thermal element is a material object, in light of Applicant’s specification; therefore, DeFranks fails to disclose or teach the thermal element, and further fails to disclose or teach at least one thermal element is at least partially disposed within the polymeric member. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the at least one thermal element being a material object) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, Applicant’s specification recites “the at least one thermal element is at least partially disposed within the polymeric member” (pg. 4), “the thermal device component [is] connected to the at least one thermal element” (pg. 5), “the thickness of the polymeric member 130 will be sufficient to at least substantially encase the thermal element 140” (pg. 20), “[t]he purpose of the thermal element 140 is to provide a heating and/or cooling effect to the user. In some preferred embodiments, the thermal element 140 can have both heating and cooling capabilities” (pg. 25), and “the thermal element 140 will typically have a substantially hollow structure (e.g., tubing, piping, HVAC ducting, etc.)” (pg. 25). As such, the specification does not explicitly disclose the at least one thermal element as a material object, and one of ordinary skill in the art may recognize and interpret the at least one thermal element to be an opening at least partially within the polymeric member with the purpose of providing a heating or cooling function, in light of Applicant’s specification. Additionally, the openings disclosed by DeFranks are at least partially disposed within the upper cradle foam layer, which is a polymeric foam layer; therefore, DeFranks does disclose the at least one thermal element is at least partially disposed within the polymeric member.
On pages 61-62, Applicant further argues DeFranks fails to disclose or suggest a “cooling” air flow, but instead specifically discloses and teaches the air flow is at ambient temperature. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a cooling air flow/temperature) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, DeFranks discloses a climate control function ([0001]) with associated methods of adjusting temperature within the system ([0006]), where the blower (202) includes a thermoelectric device, a convective heater, a heat pump, a dehumidifier and/or any other type of conditioning device ([0056]). DeFranks further discloses "one or more settings of the control system may include a desired climate setting corresponding to areas of the bedding system configured for air flow" and that the system provides temperature feedback to adjust the climate settings to maintain a comfortable climate and surface temperature for the user ([0079]-[0080]). Hence, it would be well-understood by one of ordinary skill in the art that the system disclosed by DeFranks is capable of delivering a “cooling” air flow.
In regard to claim 54, Applicant argues the claims ultimately depend from claim 53, and thus incorporate the limitations of claim 53, and therefore, are patentable over DeFranks (pgs. 62-63 of Remarks). However, claim 53 is not patentable over DeFranks (see response to claim 53 arguments above), and do not overcome their respective rejections under 35 U.S.C. 102(a)(2) rejections.
35 U.S.C. 103 Rejections
In regard to claims 12 and 31, Applicant argues a person of ordinary skill would discern that since the thermal support member comprises a polymer, whereas the upper cradle foam layer 128 is a foam; therefore, DeFranks provides no guidance as to how to determine an optimal workable range of 00 shore hardness, or what an optimal workable rang of 00 shore hardness would be, for the thermal support member (pgs. 68 and 72-73 of Remarks). While DeFranks upper cradle foam layer 128 is made of foam, the layer is made specifically of a polymeric foam ([0070]); therefore, DeFranks does provide guidance as to how to determine an optimal workable range of 00 shore hardness, or what an optimal workable rang of 00 shore hardness would be, for DeFranks upper cradle foam layer 128.
On pages 73-74, Applicant argues Kriesel (US 2004/0134669 A1) is commonly owned by Matthew W. Kriesel and, as such, is not available as prior art. While Kriesel does commonly own US PGPub 2004/0134669 A1, US PGPub 2004/0134669 A1 was published on July 15, 2004, which is more than one year prior to the effective filing date of the instant application (i.e., February 2, 2022). Hence US PGPub 2004/0134669 A1 qualifies as prior art under 102(a)(1).
In regard to claim 6, Applicant argues the gel of DeFranks is required to be “thermally conductive”, and DeFranks, nor Kriesel, teach that its energy absorbing compound is thermally conductive (pg. 73 of Remarks). However, the gel taught by DeFranks is not required, but is optional (see [0070]). Further the Office Action (mailed 10/31/2026) does not rely on the gel disclosed by DeFranks for any thermally conductive properties or functions.
With regard to claim 7, Applicant argues DeFranks in view of Kriesel fails to teach all limitations of claims 1 and 6 (pgs. 80-82). However, DeFranks teaches all limitation of claim 1 (see explanation for claim 1 above), and DeFranks in view of Kriesel teaches all limitations of claim 6 (see explanation for claim 6 above). Applicant further argues the addition of Kriesel would render the invention of DeFranks unsuitable for its intended purpose (pg. 81 of Remarks), but fails to provide any evidence or support for said statement. Hence, Applicant’s argument is not persuasive.
With regard to claims 8 and 10-11, Applicant argues DeFranks in view of Kriesel fails to teach all limitations of claims 1 and 6 (pgs. 82-87). However, DeFranks teaches all limitation of claim 1 (see explanation for claim 1 above), and DeFranks in view of Kriesel teaches all limitations of claims 6 (see explanation for claim 6 above). Applicant further argues the addition of Kriesel would render the invention of DeFranks unsuitable for its intended purpose (pgs. 82-87 of Remarks), but fails to provide any evidence or support for said statement. Hence, Applicant’s argument is not persuasive.
In regard to claim 25, Applicant argues DeFranks in view of Kriesel fails to teach all limitations of claims 20 and 24 (pgs. 87-93 of Remarks). However, DeFranks teaches all limitation of claims 20 and 24 (see explanation for claims 20 and 24 above). Applicant further argues the gel of DeFranks is required to be “thermally conductive”, and DeFranks, nor Kriesel, teach that its energy absorbing compound is thermally conductive (pg. 93 of Remarks). However, the gel taught by DeFranks is not required, but is optional (see [0070]). Further the Office Action (mailed 10/31/2026) does not rely on the gel disclosed by DeFranks for any thermally conductive properties or functions.
In regard to claims 26-27 and 29-30, Applicant argues DeFranks in view of Kriesel fails to teach all limitations of claims 20 and 24-25 (pgs. 93-100). However, DeFranks teaches all limitation of claims 20 and 24 (see explanation for claims 20 and 24 above). Additionally, DeFranks in view of Kriesel teaches all limitations of claim 25 (see 103 rejection of claim 25 above). Applicant further argues the addition of Kriesel would render the invention of DeFranks unsuitable for its intended purpose (pg. 93-100 of Remarks), but fails to provide any evidence or support for said statement. Hence, Applicant’s argument is not persuasive.
On pages 100-101 of the Remarks, Applicant argues Kriesel ‘623 (US 20190002623) is commonly owned, and therefore, is not available as prior art. However, Kriesel ‘623 was published on January 3, 2019, which is more than 1 year before the effective filing date of the instant application (i.e., February 2, 2022). Therefore, PGPub US 2019/0002623 qualifies as prior art under 102(a)(1).
With regard to claims 9 and 28, Applicant argues the addition of Kriesel ‘623 would render the invention of DeFranks unsuitable for its intended purpose as Kriesel '623 is directed to a container comprising a polymer that is adhesive, to stow an item placed within in a fixed stowable and stabilized emplacement position, and a person of ordinary skill in the art would recognize if the adhesive polymer was infused into the foam of DeFranks, the system of DeFranks would become sticky/tacky and render the bed unsuitable for its intended purpose (pgs. 102 and 107 of Remarks). However, the adhesive property disclosed in Kriesel '623 is not explicitly cause by the polyether diol alone, but the increased proportionate amount of polyether diol to polyether triols in combination with the plasticizer (third to last sentence of Kriesel '623 [0052]). Furthermore, it is this combination with an increased polyether straight chain linkage that provides the unexpected adhesive function (Kriesel '623 [0044], lines 12-16; [0052], lines 24-29; second to last line of Kriesel '623 [0052]). This specific combination disclosed by Kriesel '623 is not being taught in combination with DeFranks and Kriesel. Instead, Kriesel '623 is relied upon to teach a polyol that is polyether diol, that is being used in a reaction media with epoxidized vegetable oil and isocyanate prepolymer. Therefore, it's obvious that a polyol, such as polyether diol, to be utilized in a reaction media with epoxidized vegetable oil and isocyanate prepolymer, which when cured, has a viscoelastomeric reaction product (Kriesel '623 [0055], lines 2-17).
In regard to claim 43, Applicant argues the Office utilized impermissible hindsight in an attempt to pick and choose chemical constituents from Kriesel ‘623 while utilizing claim 43 as a template, as one of ordinary skill in the art would have recognized the addition of Kriesel ‘623 would render the invention of DeFranks unsuitable for its intended purpose as Kriesel ‘623 is directed to a container comprising a polymer that is adhesive (pg. 114 of Remarks). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, the adhesive property disclosed in Kriesel '623 is not explicitly cause by the polyether diol alone, but the increased proportionate amount of polyether diol to polyether triols in combination with the plasticizer (third to last sentence of Kriesel '623 [0052]). It is this combination with an increased polyether straight chain linkage that provides the unexpected adhesive function (Kriesel '623 [0044], lines 12-16; [0052], lines 24-29; second to last line of Kriesel '623 [0052]). This specific combination disclosed by Kriesel '623 is not being taught in combination with DeFranks and Kriesel. Instead, Kriesel '623 is relied upon to teach straight chain polyols, crosslinking polyols, and a viscosity reducing plasticizer that is being used in a reaction media with epoxidized vegetable oil and isocyanate prepolymer, which when cured, has a viscoelastomeric reaction product (Kriesel '623 [0055], lines 2-17).
In regard to claim 45, Applicant argues the Office utilized impermissible hindsight in an attempt to pick and choose diols and triols from Kriesel ‘623 while utilizing claim 45 as a template as one of ordinary skill in the art would have recognized the addition of Kriesel ‘623 would render the invention of DeFranks unsuitable for its intended purpose as Kriesel ‘623 is directed to a container comprising a polymer that is adhesive (pg. 119 of Remarks). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, the adhesive property disclosed in Kriesel '623 is not explicitly cause by the polyether diol alone, but the increased proportionate amount of polyether diol to polyether triols in combination with the plasticizer (third to last sentence of Kriesel '623 [0052]). It is this combination with an increased polyether straight chain linkage that provides the unexpected adhesive function (Kriesel '623 [0044], lines 12-16; [0052], lines 24-29; second to last line of Kriesel '623 [0052]). This specific combination disclosed by Kriesel '623 is not being taught in combination with DeFranks and Kriesel. Instead, Kriesel '623 is relied upon to teach straight chain polyols, crosslinking polyols, and a viscosity reducing plasticizer that is being used in a reaction media with epoxidized vegetable oil and isocyanate prepolymer, which when cured, has a viscoelastomeric reaction product (Kriesel '623 [0055], lines 2-17).
In regard to claims 46-48, Applicant argues the Office utilized impermissible hindsight in an attempt to pick and choose the plasticizer constituents from Kriesel ‘623 while utilizing claim 46 as a template as one of ordinary skill in the art would have recognized the addition of Kriesel ‘623 would render the invention of DeFranks unsuitable for its intended purpose as Kriesel ‘623 is directed to a container comprising a polymer that is adhesive (pgs. 121-122, 124-125, and 127 of Remarks). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, the adhesive property disclosed in Kriesel '623 is not explicitly cause by the polyether diol alone, but the increased proportionate amount of polyether diol to polyether triols in combination with the plasticizer (third to last sentence of Kriesel '623 [0052]). It is this combination with an increased polyether straight chain linkage that provides the unexpected adhesive function (Kriesel '623 [0044], lines 12-16; [0052], lines 24-29; second to last line of Kriesel '623 [0052]). This specific combination disclosed by Kriesel '623 is not being taught in combination with DeFranks and Kriesel. Instead, Kriesel '623 is relied upon to teach straight chain polyols, crosslinking polyols, and a viscosity reducing plasticizer that is being used in a reaction media with epoxidized vegetable oil and isocyanate prepolymer, which when cured, has a viscoelastomeric reaction product (Kriesel '623 [0055], lines 2-17).
With regard to claim 13, Applicant argues DeFranks in view of Copetti fails to teach all limitations of claim 1 (pgs. 129-134). However, DeFranks teaches all limitation of claim 1 (see explanation for claim 1 above). Applicant further argues the Office is utilizing impermissible hindsight to pick and choose a thermal element support component using claim 13 as a template (pg. 130 of Remarks). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In regard to claim 32, Applicant argues DeFranks in view of Copetti fails to teach all limitations of claim 20 (pgs. 134-138). However, DeFranks teaches all limitation of claim 20 (see explanation for claim 20 above). Applicant further argues the Office is utilizing impermissible hindsight to pick and choose a thermal element support component using claim 20 as a template (pg. 135 of Remarks). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
With regard to claim 44, Applicant argues the Office is utilizing impermissible hindsight in an attempt to pick and choose the various polymeric constituents of claim 44, while utilizing claim 44 as a template, as a person of ordinary skill in the art would recognize if the adhesive polymer was infused into the foam of DeFranks, the system of DeFranks would become sticky/tacky and render the bed unsuitable for its intended purpose (pgs. 139-140 of Remarks). However, the adhesive property disclosed in Kriesel '623 is not explicitly cause by the polyether diol alone, but the increased proportionate amount of polyether diol to polyether triols in combination with the plasticizer (third to last sentence of Kriesel '623 [0052]). Furthermore, it is this combination with an increased polyether straight chain linkage that provides the unexpected adhesive function (Kriesel '623 [0044], lines 12-16; [0052], lines 24-29; second to last line of Kriesel '623 [0052]). This specific combination disclosed by Kriesel '623 is not being taught in combination with DeFranks and Kriesel. Instead, Kriesel '623 is relied upon to teach a polyol that is polyether diol, that is being used in a reaction media with epoxidized vegetable oil and isocyanate prepolymer. Therefore, it's obvious that a polyol, such as polyether diol, to be utilized in a reaction media with epoxidized vegetable oil and isocyanate prepolymer, which when cured, has a viscoelastomeric reaction product (Kriesel '623 [0055], lines 2-17). Applicant further argues Volker is utilized for teaching a mixture to make foam, whereas Kriesel ‘623 is directed to an adhesive polymer (pg. 140 of Remarks). Volker teaches the use of polymers, such as isocyanate prepolymer and silicon prepolymer, in polymeric foams, specifically polyurethane foam (Volker [0011], lines 3-5; Volker [0012]; Volker [0006]); hence, the addition of Volker does not teach away from the claimed invention, nor does it teach away from the disclosures and teachings of DeFranks, Kriesel, and Kriesel ‘623.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yakam et al. (US 20110302720 A1): Regarding a patient support system designed to prevent pressure sores.
Turo et al. (US 20110239370 A1): Regarding a system to relieve pressure sores on patients.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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