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 Preliminary Amendment
This office action is in response to the preliminary amendment filed on 05/03/2024. Per the amendment claim 53 is as currently amended, and claims 1-52 & 54 are as previously presented. As such, claims 1-54 are pending in the instant application. The amendments made to the specification and drawings have been considered and entered in the instant application. The Examiner acknowledges the Electronic Filing Certificate 37 CFR 1.8 and Replacement Drawings submitted with the preliminary amendment filed on 05/03/2024, and both are entered in the instant application.
Claim Objections
Claims 25 and 44 are objected to because of the following informalities:
Claim 25, line 1: “the cushioning polymer” should read “a cushioning polymer” to establish antecedent basis.
Claim 44, line 2: “from the group” should read “from a group” to establish antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the cushioning polymer". There is insufficient antecedent basis for this limitation in the claim. Due to claim 6’s dependency on claim 5, it is unclear if “the cushioning polymer” recited in claim 6 is a recitation of the viscoelastomeric and cohesive cushioning polymer disclosed in claim 5, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the limitation of “the cushioning polymer” recited in claims 6 will be interpreted as – the viscoelastomeric and cohesive cushioning polymer.
Claims 7-11 are rejected due to dependency on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 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 as modified teaches 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 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) further comprises at least one elevation element disposed upon the bottom side thereof (see Annotated Fig. 6 below).
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Regarding claim 23, DeFranks as modified teaches 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 as modified teaches 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 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; 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 as modified teaches 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 as modified teaches 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 as modified teaches 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 as modified teaches 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 as modified teaches 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 & Kirtikar (US 20190174930 A1), hereinafter DeFranks.
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 as applied to claims 1, 5, and 20 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, 28, and 43, 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over DeFranks in view of Kriesel as applied to claims 6-8 and 25-30 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).
Regarding claim 43, DeFranks as modified teaches the invention as set forth in claim 20, 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 (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 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