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 .
Status of the Application
Claims 1-20 have been examined in this application. This communication is the first action on merits. The Information Disclosure Statement (IDS) filed on 05/29/2024 has been acknowledged by the Office.
Claim Objections
Claim(s) 1, 3, 4, 5, 6, 10, 11, 12, 15, 17, 19, and 20 are objected to because of the following informalities:
Regarding claim 1, 3-6, 9-12, 15, 17, 19 and 20, the following element(s) are recited: ‘the body’ and/or ‘the enclosure’, yet the claim(s) as noted above, do not include proper secondary antecedent basis. Specifically, in primary form the following is stated ‘a viscoelastic body’ AND ‘an inflatable enclosure’. Therefore, the Examiner suggests that all claims include secondary antecedent basis of the following: “the viscoelastic body” AND “the inflatable enclosure”
Regarding claim 15, the following element is recited: ‘the first strip’, yet the claim does not include proper secondary antecedent basis. Specifically, in primary form the following is stated ‘a first longitudinal strip’. Therefore, the Examiner suggests that all claims include secondary antecedent basis of the following: “a/the first longitudinal strip”
Regarding claim 20, the following element is recited: ‘the support device’ AND ‘the second surface’, yet the claim does not include proper secondary antecedent basis. Specifically, in primary form the following is stated ‘a patient support device’ and ‘a substantially flat surface’. Therefore, the Examiner suggests that all claims include secondary antecedent basis of the following: ‘a/the patient support device’ AND ‘a/the substantially flat surface’
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.
Claim(s) 5, 7-9, 12, and 16 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.
The term “a length sufficient to extend” in claim 5 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure does not set forth a standard, criteria, or reference point that would allow one of ordinary skill in the art to ascertain the scope of the term with reasonable certainty. In the absence of guidance, “a length sufficient to extend” is left to a subjective determination by one of ordinary skill in the art, and is deemed indefinite.
The term “about 0.2 to about 2.5” and “between about -5°C and about 5°C” in claim 7 is a relative term which renders the claim indefinite. There is a lack of clarity as to the scope and metes and bounds of the claim. Particularly because it is unclear what the scale a person of ordinary skill in the art would attribute to ‘about’ and particularly alongside a range. It’s unclear if ‘about’ should include values greater/less than 0.2 and 2.5 | AND | greater/less than -5°C and 5°C, as applicant does not establish a scale for what the measure of ‘about’ should incorporate and such scale is left up to a broad and open-ended interpretation. For the purposes of examination, the limitations are construed as “ 0.2 to 2.5” and “between -5°C and 5°C”
The term “about 2 pcf to about 8 pcf (about 35 kilograms per cubic meter to about 128 kilograms per cubic meter)” in claim 8 is a relative term which renders the claim indefinite. There is a lack of clarity as to the scope and metes and bounds of the claim. Particularly because it is unclear what the scale a person of ordinary skill in the art would attribute to ‘about’ and particularly alongside a range. It’s unclear if ‘about’ should include values greater/less than 2pcf and 8pcf, as applicant does not establish a scale for what the measure of ‘about’ should incorporate and such scale is left up to a broad and open-ended interpretation. For the purposes of examination, the limitations are construed as “ 2 pcf to 8 pcf ( 35 kilograms per cubic meter to 128 kilograms per cubic meter)”.
Claim 8 recites the limitation "(about 35 kilograms per cubic meter to about 128 kilograms per cubic meter)". There is insufficient antecedent basis for this limitation in the claim. Parenthetical language in a claim is generally treated as non-limiting unless the context clearly indicates otherwise. As stated in Claim 8, it does not specify whether the parenthetical language is intended to define a required density range or whether it is merely supplemental / exemplary. As a result, the claim fails to provide clear language as to whether this numerical range forms a positive limitation in which the Examiner must rely for purposes of examination.
The term “different types of viscoelastic foam” in claim 9 is a relative term which renders the claim indefinite. The term “types” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim does not define what constitutes a “type” of viscoelastic foam (i.e. differences in composition, formulation, mechanical properties, or any other distinguishing characteristic). The disclosure likewise does not provide an objective standard or criteria for determining when two foams constitute “different types.” Thus, the determination of what qualifies as a “type” is left to subjective interpretation, and one of ordinary skill in the art would not be reasonably apprised of the scope of the limitation. As such, the term fails to set forth clear metes and bounds of the claimed invention and renders the claim indefinite.
Claim(s) 10-11 are also rejected under 35 U.S.C 112(b) or 35 U.S.C 112 (pre-AIA ), second paragraph, as being dependent upon a rejected base claim (claim 9).
The term “from about 0.5 inch to 3.0 inches or, preferably about 1.5 inches thick.” in claim 12 is a relative term which renders the claim indefinite. There is a lack of clarity as to the scope and metes and bounds of the claim. Particularly because it is unclear what the scale a person of ordinary skill in the art would attribute to ‘about’ and particularly alongside a range. It’s unclear if ‘about’ should include values greater/less than 0.5 inch and 3.0 inches | AND | greater/less than 1.5 inches, as applicant does not establish a scale for what the measure of ‘about’ should incorporate and such scale is left up to a broad and open-ended interpretation. For the purposes of examination, the limitations are construed as “from 0.5 inch to 3.0 inches or, preferably 1.5 inches thick.”
The term “about 0.25 inch to about 1.0 inch thick.” in claim 16 is a relative term which renders the claim indefinite. There is a lack of clarity as to the scope and metes and bounds of the claim. Particularly because it is unclear what the scale a person of ordinary skill in the art would attribute to ‘about’ and particularly alongside a range. It’s unclear if ‘about’ should include values greater/less than 0.25 and 1.0 inch, as applicant does not establish a scale for what the measure of ‘about’ should incorporate and such scale is left up to a broad and open-ended interpretation. For the purposes of examination, the limitations are construed as “ 0.25 inch to 1.0 inch thick.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5, 8, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kea et al., hereinafter 'Kea' (US 20180353360 A1) in view of Daly (WO 2010106103 A1).
In regards to Claim 1, Kea teaches: A patient support device (10 - Fig. 3) for positioning a patient (66 - Fig. 3) on an operating table (12 - Fig. 1, Para 0033: "The support surface 12 may be provided by a bed, gurney, stretcher, cot, operating table, or other support structure 14 for medical and/or patient care use, e.g., for supporting a person in a supine or other position.") during a surgical procedure (Para 0003) and for lateral patient transfer (Fig. 15, Para 0068), the patient support device comprising: a [[viscoelastic]] foam body (18 - Fig. 2, Para 0033) comprising a substantially flat first surface (shown in Fig. 2 to be of a flat surface) configured to be in contact with the patient (Para 0036: "The high-friction pad 18 is placed on top of the inflatable device 16 to provide a resting surface for a patient."), an opposing substantially flat second surface (62- Fig. 2), and a peripheral edge extending therebetween (34/36/38 - Fig. 19); an inflatable enclosure (40 - Fig. 19) connected to the second surface of the body that defines an inflatable cavity (84 - Fig. 19) configured to receive a pressurized gas (Para 0037: "The inflatable device 16 generally includes an inflatable body 40 that defines the internal cavity configured to be inflated with air or another gaseous substance", further noting Fig. 23 and Para 0073), wherein the enclosure comprises a plurality of perforations (90 - Fig. 5) extending through a portion of the enclosure (Para 0053-0054) positioned to allow the pressurized gas to pass from the cavity through the plurality of perforations toward the operating table (Para 0050-0051, specifically Para 0050: "Referring to FIGS. 5 and 6, the inflatable device 16 includes a plurality of passages 90 in the bottom sheet 62 that permit air to pass from the cavity to the exterior of the inflatable device 16. The passages 90 extend from the cavity through the bottom sheet 62 to the exterior of the inflatable device 16. Air passing through the passages 90 is forced between the bottom surface 30 of the inflatable device 16 and the surface upon which the inflatable device 16 sits (e.g., the support surface 12), reducing friction between the bottom surface 30 and the support surface 12. This permits easier movement of the inflatable device 16 when a patient 66 is positioned on the inflatable device 16, as described in greater detail elsewhere herein. {……..} The diameter of the passages impacts, at least partly, the effectiveness of the inflatable device 16 for maneuvering a patient. For example, if the passages 90 are too small, they may not allow enough air to pass through and will not be effective in decreasing the friction between the bottom surface 30 and the surface upon which it sits. On the other hand, if the passages are too large, too much air will pass through and the inflatable device 16 will partially or wholly deflate, also minimizing the effectiveness of the inflatable device 16."); [[and at least one lower pad comprising viscoelastic foam connected to the inflatable enclosure, the at least one lower pad comprising an outwardly facing surface configured to contact the operating table for holding the patient support device in place against the operating table.]]
Kea does not explicitly teach: viscoelastic [[foam body]], and at least one lower pad comprising viscoelastic foam connected to the inflatable enclosure, the at least one lower pad comprising an outwardly facing surface configured to contact the operating table for holding the patient support device in place against the operating table.
Daly teaches: viscoelastic [[foam body]] ("The first core element can have a viscoelastic temperature sensitive polyurethane foam material. It will be appreciated that this provides good comfort and pressure reduction as well as heat sensitive conformity to the user to provide good pressure relief. The viscoelastic foam can have a density in a range of 40 kg/m.sup.3 and 60 kg/m.sup.3, and can have a hardness in a range between 60 and 110 Newtons at substantially 23°C."), and at least one lower pad comprising viscoelastic foam connected to the inflatable enclosure ("the second core element can have an open-cell, high resilience polyurethane foam material, which provides good support and durability."), the at least one lower pad comprising an outwardly facing surface configured to contact the operating table for holding the patient support device in place against the operating table ("the second core element can have an open-cell, high resilience polyurethane foam material, which provides good support and durability.").
Kea and Daly are considered analogous art because both references relate to patient support devices incorporating cushioning foam and inflatable structures for patient positioning and transfer. 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 the patient support device of Kea to incorporate the viscoelastic foam features taught by Daly, with a reasonable expectation of success, in order to enhance users: pressure relief, comfort, and stability during patient positioning and transfer. Such that viscoelastic foam properties are well known features created for such improvements.
In regards to Claim 2, Kea in view of Daly teaches: The patient support device of claim 1, wherein Kea further teaches, wherein the pressurized gas passing through the plurality of perforations reduces friction between the patient support device and a surface of the operating table (Para 0050-0051, specifically Para 0050: "Referring to FIGS. 5 and 6, the inflatable device 16 includes a plurality of passages 90 in the bottom sheet 62 that permit air to pass from the cavity to the exterior of the inflatable device 16. The passages 90 extend from the cavity through the bottom sheet 62 to the exterior of the inflatable device 16. Air passing through the passages 90 is forced between the bottom surface 30 of the inflatable device 16 and the surface upon which the inflatable device 16 sits (e.g., the support surface 12), reducing friction between the bottom surface 30 and the support surface 12. This permits easier movement of the inflatable device 16 when a patient 66 is positioned on the inflatable device 16, as described in greater detail elsewhere herein. {……..}The diameter of the passages impacts, at least partly, the effectiveness of the inflatable device 16 for maneuvering a patient. For example, if the passages 90 are too small, they may not allow enough air to pass through and will not be effective in decreasing the friction between the bottom surface 30 and the surface upon which it sits. On the other hand, if the passages are too large, too much air will pass through and the inflatable device 16 will partially or wholly deflate, also minimizing the effectiveness of the inflatable device 16."), thereby allowing the patient support device to slide more easily over the surface of the operating table than when the pressurized gas is not provided to the inflatable cavity (Para 0050: "Air passing through the passages 90 is forced between the bottom surface 30 of the inflatable device 16 and the surface upon which the inflatable device 16 sits (e.g., the support surface 12), reducing friction between the bottom surface 30 and the support surface 12. This permits easier movement of the inflatable device 16 when a patient 66 is positioned on the inflatable device 16, as described in greater detail elsewhere herein.").
In regards to Claim 3, Kea in view of Daly teaches: The patient support device of claim 1, Kea further teaches, further comprising at least one strap (52 - Fig. 7), but Kea does not explicitly teach, for carrying the patient support device connected to the body and/or enclosure of the patient support device.
Daly further teaches: for carrying the patient support device connected to the body and/or enclosure of the patient support device ("For example, the handling means can be attached to the base portion of the envelope such that at least two handles at each side of the cushion are provided. It will be appreciated that this allows lifting of the cushion with or without a user placed on the cushion.").
Kea and Daly are considered analogous art because both references address medical support cushions and patient transfer systems equipped with handling or manipulation features. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the strap system of Kea to incorporate the carrying-handle concepts taught by Daly, with a reasonable expectation of success, in order to facilitate lifting, transport, and maneuvering of the patient support device by caregivers.
In regards to Claim 5, Kea in view of Daly teaches: The patient support device of claim 1, Kea further teaches, wherein the body has a length sufficient to extend from at least thighs of the patient to at least shoulders (18 as shown in Fig. 3 extends from at least the top of the thighs to the head of the user - therefore at least the shoulders) of the patient to support a torso of the patient placed on the body (Fig. 3 shows a torso of the patient being placed on the body 18).
In regards to Claim 8, Kea in view of Daly teaches: The patient support device of claim 1, Daly teaches, wherein the viscoelastic foam has a density of about 2 pcf to about 8 pcf (about 35 kilograms per cubic meter to about 128 kilograms per cubic meter) {Noting the prior art of Daly states: "The foam material can have a density in a range between 30 kg per cubic metre (kg/m.sup.3) to 50 kg/m.sup.3, and the hardness can be in a range between 80 Newtons and 175 Newtons.", thus it is within the range stated of about 35 kg/m3 and about 128kg/m3}.
Kea and Daly are considered analogous art because both references disclose support cushions including foam structures with specific density characteristics for medical patient positioning applications. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the foam density parameters of Kea using the viscoelastic foam density ranges taught by Daly, with a reasonable expectation of success, in order to provide known beneficial foam properties such as conformability, durability, and appropriate load distribution, noting that Daly’s density range falls within the claimed density range.
In regards to Claim 12, Kea in view of Daly teaches (as best understood by the 112(b) indicated above): The patient support device of claim 1, Daly further teaches, wherein the body comprises an elongated pad having a length that is greater than its width, and wherein the body is from about 0.5 inch to 3.0 inches or, preferably about 1.5 inches thick ("the polyurethane foam material has a thickness which is in a range of 3 cm to 15 cm, for example in a range of 4 cm to 10 cm, especially 5 cm to 8 cm. Preferably, the thickness is determined in a decompressed state of the resilient core or the cushion.", noting that the length shown is much greater than the described width shown in Fig. 3/6).
Kea and Daly are considered analogous art because both are directed to elongated cushion assemblies for supporting a patient on a medical support surface. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the body geometry and thickness of Kea’s foam component using the elongated pad and thickness teachings of Daly, with a reasonable expectation of success, in order to achieve improved structural support, appropriate cushioning thickness, and ergonomic patient alignment consistent with medical support surface design.
In regards to Claim 13, Kea in view of Daly teaches: The patient support device of claim 1, Kea further teaches, wherein the inflatable enclosure comprises a first sheet (60 - Fig. 2) connected to the second surface of the body and a second sheet connected to the first sheet defining the inflatable cavity (62 - Fig. 2), and wherein the plurality of perforations extend through the second sheet (Para 0050-0053, specifically Para 0050: "Referring to FIGS. 5 and 6, the inflatable device 16 includes a plurality of passages 90 in the bottom sheet 62 that permit air to pass from the cavity to the exterior of the inflatable device 16. The passages 90 extend from the cavity through the bottom sheet 62 to the exterior of the inflatable device 16. Air passing through the passages 90 is forced between the bottom surface 30 of the inflatable device 16 and the surface upon which the inflatable device 16 sits (e.g., the support surface 12), reducing friction between the bottom surface 30 and the support surface 12. This permits easier movement of the inflatable device 16 when a patient 66 is positioned on the inflatable device 16, as described in greater detail elsewhere herein.).
In regards to Claim 14, Kea in view of Daly teaches: The patient support device of claim 13, Kea further teaches, wherein the first sheet and/or the second sheet comprise a synthetic polymer comprising nylon, polyethylene, or polypropylene (Para 0038: "As an example, the top and/or bottom sheets 60, 62 may be formed of a material that is liquid repellant and/or impermeable and may have little to no air permeability, while being permeable to moisture vapor, such as polyester and/or nylon (polyamide). Some materials may further include an additive, such as coatings, laminates, and the like. For example, a coated nylon taffeta material is one example of a material which can provide these properties, and further, the coating on such a material may have a higher coefficient of friction than the sheet material itself, creating a configuration with a high-friction material (the coating) on one surface and a low-friction material (the sheet material with or without an additive) on the opposite side, as described in greater detail elsewhere herein. The additives to the material may provide one or more of the following: decreasing the static potential (as described below), increasing the coefficient of friction of the top sheet, and decreasing the coefficient of the bottom sheet.").
In regards to Claim 15, Kea in view of Daly teaches: The patient support device of claim 1, Kea further teaches, wherein the plurality of perforations are provided as a first longitudinal strip (see annotated Fig. 5.1 from Kea), a second longitudinal strip separate from the first strip that (see annotated Fig. 5.1 from Kea) passes along a central longitudinal axis of the enclosure (see annotated Fig. 5.1 from Kea), and a third longitudinal strip that is separate from the first strip and the second strip (see annotated Fig. 5.1 from Kea).
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Annotated Fig. 5.1 from Kea
In regards to Claim 16, Kea in view of Daly teaches (as best understood by the 112(b) indicated above): The patient support device of claim 1, Daly further teaches, wherein the at least one lower pad is about 0.25 inch to about 1.0 inch thick ("the polyurethane foam material has a thickness which is in a range of 3 cm to 15 cm, for example in a range of 4 cm to 10 cm, especially 5 cm to 8 cm. Preferably, the thickness is determined in a decompressed state of the resilient core or the cushion.", noting that 3cm is 1.181 inches therefore about 1.0 inch thick).
Kea and Daly are considered analogous art because each describes layered foam pad components used in support devices for patient handling and stabilization. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the lower pad thickness of Kea using the foam thickness ranges taught by Daly, with a reasonable expectation of success, in order to provide a stable contact layer optimized for support-surface friction interaction and load transfer, noting Daly’s values encompass the claimed range.
In regards to Claim 17, Kea in view of Daly teaches: The patient support device of claim 1, Kea teaches, wherein the [[at least one lower pad]] is thinner than the body (Para 0061: "The high-friction pad 18 has a thickness of approximately 0.5 inch+/−0.125 inch, and in some embodiments is as thick as 1.0 inch or as thin as 0.125 inch.").
Kea does not explicitly teach: at least one lower pad
Daly teaches: at least one lower pad ("an average cell size of the foam material is substantially 1 mm or higher, particularly the average cell size is in a range of 1 mm to 3 mm.", noting that the quoted mm height is thinner than the quoted body height).
Kea and Daly are considered analogous art because both disclose foam layers of varying thicknesses for patient-support cushioning systems. Therefore, it would have been obvious to a person of ordinary skill to modify Kea’s high-friction pad thickness using Daly’s teachings on foam pad structures, with a reasonable expectation of success, in order to ensure that the lower pad is thinner than the primary body to optimize stability, reduce bulk, and improve contact with the operating table.
In regards to Claim 18, Kea in view of Daly teaches: The patient support device of claim 1, Kea further teaches, wherein the surgical procedure is a procedure performed with the patient in a Trendelenburg or reverse Trendelenburg position (Para 0002: "The present invention generally relates to an apparatus, system, and method for supporting a patient for a medical procedure, and in particular for supporting a patient when positioned in a non-parallel or tilted position, such as in the Trendelenburg position.").
In regards to Claim 19, Kea in view of Daly teaches: A patient system for patient support and lateral transport, comprising: the patient support device of claim 1, Kea further teaches, further comprising an inlet tube in fluid communication with the cavity of the enclosure (140 - Fig. 19, Para 0073); and a blower connected to the inlet tube for providing the pressurized gas to the inflatable cavity of the enclosure through the inlet tube (144 - Fig. 23, Para 0071-0073).
In regards to Claim 20, Kea teaches: A patient support device (10 - Fig. 3) for positioning a patient (66 - Fig. 3) on an operating table (12 - Fig. 1, Para 0033: "The support surface 12 may be provided by a bed, gurney, stretcher, cot, operating table, or other support structure 14 for medical and/or patient care use, e.g., for supporting a person in a supine or other position.") during a surgical procedure (Para 0003) and for lateral patient transfer (Fig. 15, Para 0068), the support device comprising: a [[viscoelastic]] foam body (18 - Fig. 2, Para 0033) comprising a substantially flat first surface (shown in Fig. 2 to be of a flat surface) configured to be in contact with the patient (Para 0036: "The high-friction pad 18 is placed on top of the inflatable device 16 to provide a resting surface for a patient."), an opposing substantially flat second surface (62- Fig. 2), and a peripheral edge extending therebetween (34/36/38 - Fig. 19); and an inflatable enclosure (40 - Fig. 19) connected to the second surface of the body that defines an inflatable cavity (84 - Fig. 19) configured to receive a pressurized gas (Para 0037: "The inflatable device 16 generally includes an inflatable body 40 that defines the internal cavity configured to be inflated with air or another gaseous substance", further noting Fig. 23 and Para 0073), wherein the enclosure comprises a plurality of perforations (90 - Fig. 5) extending through a portion of the enclosure (Para 0053-0054) positioned to allow the pressurized gas to pass from the cavity through the plurality of perforations toward the operating table (Para 0050-0051, specifically Para 0050: "Referring to FIGS. 5 and 6, the inflatable device 16 includes a plurality of passages 90 in the bottom sheet 62 that permit air to pass from the cavity to the exterior of the inflatable device 16. The passages 90 extend from the cavity through the bottom sheet 62 to the exterior of the inflatable device 16. Air passing through the passages 90 is forced between the bottom surface 30 of the inflatable device 16 and the surface upon which the inflatable device 16 sits (e.g., the support surface 12), reducing friction between the bottom surface 30 and the support surface 12. This permits easier movement of the inflatable device 16 when a patient 66 is positioned on the inflatable device 16, as described in greater detail elsewhere herein. {……..}The diameter of the passages impacts, at least partly, the effectiveness of the inflatable device 16 for maneuvering a patient. For example, if the passages 90 are too small, they may not allow enough air to pass through and will not be effective in decreasing the friction between the bottom surface 30 and the surface upon which it sits. On the other hand, if the passages are too large, too much air will pass through and the inflatable device 16 will partially or wholly deflate, also minimizing the effectiveness of the inflatable device 16.").
Kea does not explicitly teach: viscoelastic [[foam body]]
Daly teaches: viscoelastic ("The first core element can have a viscoelastic temperature sensitive polyurethane foam material. It will be appreciated that this provides good comfort and pressure reduction as well as heat sensitive conformity to the user to provide good pressure relief. The viscoelastic foam can have a density in a range of 40 kg/m.sup.3 and 60 kg/m.sup.3, and can have a hardness in a range between 60 and 110 Newtons at substantially 23°C."), and at least one lower pad comprising viscoelastic foam connected to the inflatable enclosure ("the second core element can have an open-cell, high resilience polyurethane foam material, which provides good support and durability."), the at least one lower pad comprising an outwardly facing surface configured to contact the operating table for holding the patient support device in place against the operating table ("the second core element can have an open-cell, high resilience polyurethane foam material, which provides good support and durability.").
Kea and Daly are considered analogous art because both references relate to patient support devices incorporating foam layers and inflatable enclosures for surgical positioning and patient transfer. 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 the patient support device of Kea to incorporate the viscoelastic foam body and at least one lower pad comprising viscoelastic foam as taught by Daly, with a reasonable expectation of success, in order to improve patient comfort, pressure relief, and stability of the support device against the operating table, as viscoelastic foam properties and lower pad positioning are well known to provide such functional benefits in support systems.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over 'Kea' (US 20180353360 A1) in view of Daly (WO 2010106103 A1) and further in view of Rigoni et al., hereinafter 'Rigoni' (US 20170216117 A1).
In regards to Claim 4, Kea in view of Daly teaches: The patient support device of claim 1, Kea further teaches, further comprising: a plurality of loop straps (52 - Fig. 7), each loop strap having opposing ends connected to the body (56 having a clip and buckle on either side, and looped and connected to the body) [[and/or enclosure to form loops for carrying the patient support device]]; and at least one extended strap (51 - Fig. 11) comprising a first end portion (51 A - Fig. 11), a second end portion (51B - Fig. 11), and an intermediate portion therebetween (49 - Fig. 12), wherein the intermediate portion of the at least one extended strap is attached to the enclosure while the end portions of the at least one extended strap are not connected to the enclosure (Para 0066: "In some embodiments, the pieces of the arm wraps 49 may then be sewn or otherwise attached to both the high-friction pad 18 and the counterpart connection strips 112. In still other embodiments, the arm wraps 49 may be sewn or otherwise attached directly to the bottom surface 79 of the high-friction pad 18, such that they are in contact with the inflatable device 16.", noting that the other sections of 51A and 51B are not connected or fastened to the enclosure, shown in Fig. 11).
Kea nor Daly do not explicitly teach: and/or enclosure to form loops for carrying the patient support device
Rigoni teaches: and/or enclosure to form loops for carrying the patient support device (29B - Fig. 5, Para 0109)
Kea, Daly, and Rigoni are considered analogous art because all references relate to patient support devices including foam bodies and strap configurations for positioning and carrying a patient during surgical procedures. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the loop and extended strap system of Kea to incorporate the “and/or enclosure to form loops for carrying the patient support device” teachings of Rigoni, with a reasonable expectation of success, in order to provide improved handling and transport of the patient support device by caregivers.
Claim(s) 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over 'Kea' (US 20180353360 A1) in view of Daly (WO 2010106103 A1) and further in view of Pigazzi et al., hereinafter 'Pigazzi' (US 10912699 B2).
In regards to Claim 6, Kea in view of Daly teaches: The patient support device of claim 1, Daly further teaches, wherein the body and the at least one lower pad comprise the viscoelastic foam comprising at least one of a polyurethane foam ("Particularly, the second core element can have an open-cell, high resilience polyurethane foam material, which provides good support and durability. The foam material can have a density in a range between 30 kg per cubic metre (kg/m.sup.3) to 50 kg/m.sup.3, and the hardness can be in a range between 80 Newtons and 175 Newtons. The first core element can have a viscoelastic temperature sensitive polyurethane foam material. It will be appreciated that this provides good comfort and pressure reduction as well as heat sensitive conformity to the user to provide good pressure relief. The viscoelastic foam can have a density in a range of 40 kg/m.sup.3 and 60 kg/m.sup.3, and can have a hardness in a range between 60 and 110 Newtons at substantially 23°C.")
Kea and Daly are considered analogous art because both references relate to patient support devices incorporating viscoelastic foam for cushioning and support. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the foam components of Kea to incorporate the viscoelastic foam teachings of Daly, with a reasonable expectation of success, in order to provide improved patient comfort, pressure relief, and mechanical support through the known viscoelastic foam properties.
Kea nor Daly explicitly teach: formed from a polyhydroxy polyol mixed with toluene di-isocyanate, polyester polyols, and/or polyether.
Pigazzi teaches: formed from a polyhydroxy polyol mixed with toluene di-isocyanate, polyester polyols, and/or polyether ("The viscoelastic foam of the present application may be a polyurethane foam made by mixing polyhydroxy polyol with toluene di-isocyanate or other and different methods as are known in the art. For example, Toluene di-isocyanate may be used in combination with polyester polyols and polyether to make viscoelastic foam.").
Kea, Daly, and Pigazzi are considered analogous art because all references relate to patient support devices incorporating viscoelastic foam for cushioning, with known chemical formulations. Therefore, it would have been obvious to a person of ordinary skill in the art to further modify the foam of Kea and Daly to include the polyhydroxy polyol mixed with toluene di-isocyanate, polyester polyols, and/or polyether composition taught by Pigazzi, with a reasonable expectation of success, in order to achieve known material advantages such as improved foam resilience, durability, and pressure-conforming properties.
In regards to Claim 9, Kea in view of Daly teaches: The patient support device of claim 1, neither Kea nor Daly explicitly teach, wherein the body and the at least one lower pad comprise different types of viscoelastic foam materials.
Pigazzi teaches: wherein the body and the at least one lower pad comprise different types of viscoelastic foam materials (Col 2 Lines 24-46).
Kea, Daly, and Pigazzi are considered analogous art because all references relate to patient support devices incorporating viscoelastic foam components. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the foam components of Kea and Daly to include different types of viscoelastic foam materials as taught by Pigazzi, with a reasonable expectation of success, in order to achieve improved pressure distribution, support characteristics, and patient comfort.
Claim(s) 7, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over 'Kea' (US 20180353360 A1) in view of Daly (WO 2010106103 A1) in view of Pigazzi et al. (US 10912699 B2) and further in view of Gomez (WO 2021087155 A2).
In regards to Claim 7, Kea in view of Daly teaches: The patient support device of claim 1, neither Kea nor Daly explicitly teach, wherein the viscoelastic foam has a coefficient of friction of from about 0.2 to about 2.5 and a glass transition temperature of between about -5°C and about 5°C.
Pigazzi teaches: wherein the viscoelastic foam has a coefficient of friction of from about 0.2 to about 2.5 ("The coefficient of static friction between the viscoelastic foam and the surface of a support table is greater than 0.2, or is in the range of approximately 0.2 or 0.5 to approximately 0.7 or 1.0.").
Kea, Daly, and Pigazzi are considered analogous art because all references relate to patient support devices incorporating viscoelastic foam for cushioning and support. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the viscoelastic foam of Kea and Daly to include the coefficient of friction from about 0.2 to about 2.5 as taught by Pigazzi, with a reasonable expectation of success, in order to improve stability of the support device on the operating table during patient positioning and transfer.
Kea, Daly, nor Pigazzi does not explicitly teach: and a glass transition temperature of between about -5°C and about 5°C
Gomez teaches: and a glass transition temperature of between about -5°C and about 5°C ("The foam is not affected to temperature via the “glass transition” typical of memory foams. It does not require the patient’s warmth or direct contact to provide pressure support or relief, especially in colder operating room environments. Pneumatic foam does not change viscosity based on temperatures in ranges from 0 degrees Fahrenheit to 100 degrees Fahrenheit.").
Kea, Daly, Pigazzi, and Gomez are considered analogous art because all references relate to viscoelastic foam materials in patient support devices with defined mechanical and thermal properties. Therefore, it would have been obvious to a person of ordinary skill in the art to further modify the foam of Kea, Daly, and Pigazzi to include the glass transition temperature of between about -5°C and about 5°C as taught by Gomez, with a reasonable expectation of success, in order to ensure consistent foam performance across operating room temperatures, in combination with the previously taught coefficient of friction from Pigazzi to maintain stability.
In regards to Claim 10, Kea in view of Daly in view of Pigazzi teaches and further in view of Gomez: The patient support device of claim 9, Pigazzi further teaches, wherein the viscoelastic foam material of the body is more absorbent than the viscoelastic foam material of the at least one lower pad (Col 2 Line 47-Col 3 Line 54, noting the discussion of variable rate of recovery resulting in more and less absorbent foams).
Kea, Daly, Pigazzi, and Gomez are considered analogous art because all references relate to patient support devices having viscoelastic foams with variable absorbency and recovery characteristics. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the viscoelastic foam of the body and lower pad in Kea, Daly, and Pigazzi to provide the foam material of the body as more absorbent than the lower pad as taught by Pigazzi, with a reasonable expectation of success, in order to enhance fluid management, pressure distribution, and patient comfort.
In regards to Claim 11, Kea in view of Daly in view of Pigazzi teaches and further in view of Gomez: The patient support device of claim 10, Pigazzi further teaches, wherein the viscoelastic foam material of the body is less dense than is a material of the at least one lower pad (Col 2 Line 47-Col 3 Line 54, noting the discussion of variable rate of recovery resulting in more and less absorbent foams).
Kea, Daly, Pigazzi, and Gomez are considered analogous art because all references relate to patient support devices having layered viscoelastic foams of varying densities. Therefore, it would have been obvious to a person of ordinary skill in the art to modify the viscoelastic foam of the body and lower pad in Kea, Daly, and Pigazzi to have the body foam less dense than the lower pad foam as taught by Pigazzi, with a reasonable expectation of success, in order to improve patient comfort and optimize load distribution across the support surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Davis (US 20210186780 A1) teaches: A transfer mattress includes a top panel, a bottom panel, an outer stringer and an inner stringer. The top panel has a perimeter including a proximal edge and a distal edge, wherein a central longitudinal axis extends from the proximal edge to the distal edge. The bottom panel has a plurality of perforations and a perimeter including a proximal edge and a distal edge coupled to the perimeter of the top panel. The outer stringer and inner stringer each have a superior edge coupled to the top panel and an inferior edge coupled to the bottom panel and a longitudinal portion that is substantially parallel to the central longitudinal axis. The inner stringer is positioned between the central longitudinal axis and the outer stringer.
Liu (US 20180200130 A1) teaches: An inflatable stretcher includes an upper and a lower cover member connected along their outer peripheral edges to define an internal air space. The lower cover member has a plurality of perforations forming an overall pattern contoured to the shape of a human body. First and second partitioning member are disposed in the air space and connected to the upper and lower cover members to divide the air space into a plurality of widthwise-extended air release passages and two lengthwise-extended air flow passages located at two lateral sides of the air release passages. A flow opening is formed between each second partitioning member and each corresponding first partitioning member. The flow openings respectively have a cross-sectional area smaller than that of each air release passage, enabling air supplied from an inflation device into the air space to produce an increased air lifting force at positions corresponding to a patient's hips.
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/MADISON EMANSKI/Primary Examiner, Art Unit 3673