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 Arguments
Applicant's arguments filed 23 March 2026 have been fully considered but they are not persuasive.
Applicant argues that even if “a number of thermoelectric devices” is generously interpreted as being a single thermoelectric device despite “thermoelectric devices” being plural, and even if the single thermoelectric device is generously interpreted as an array despite not being “a series of persons or things: an assemblage, an arrangement,” a single thermoelectric device cannot constitute more than one array of the “layered arrays” and therefore Sweeny fails to disclose the claimed layered arrays of thermoelectric device. However, this is not found to be persuasive. Sweeney states that in Fig. 4 mattress 26 that underlies an infant is compartmentalized into mattress segments 42 so that individual mattress segments can affect differing temperatures to the infant. Each mattress segment 42 is in heat conducting relationship with a separate thermoelectric device 28 so that each mattress segment 42 can be set to a different temperature from the other mattress segments 42. Therefore, Sweeney teaches both a plurality of thermoelectric devices each of which are arranged in layered arrays of one.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered newly added claim 41 been renumbered 44.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21, 22, 24 and 32-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 0 862 901 A1 to Sweeney et al. (Sweeney) in view of US 2020/0214471 A1 to Paperno (Paperno) and 10,376,412 B2 to Brienza et al. (Brienza).
Regarding claims 21, Sweeney teaches a system (incubator 10), comprising a neonatal bed (bed support tray 24) configured for receiving a neonatal patient (Fig. 1), the neonatal bed comprising a deformable pad (gel mattress 26 as deformability of the mattress 26 is inherent in the material selected by Sweeney of a silicon or polyurethane gel) having a filling material (silicon or polyurethane gel as taught by Sweeney) therein, and a thermal exchange mechanism including a plurality of thermoelectric devices (thermoelectric devices 28, Fig. 4; Fig. 4 shows that each segment includes one thermoelectric device of the thermoelectric devices 28) arranged in layered arrays (if only one then it is arranged in a layered array of one and each segment includes a layered array of one thermoelectric device 28) coupled with the deformable pad (Fig. 4), wherein the thermal energy exchange mechanism is configured to extract thermal energy from the neonatal patient to cool the neonatal patient via thermal conduction through the filling material of the deformable pad (Col. 3, lines 54-57 which state in part “the mattress 26 contains a heat conductive material that readily conducts heat to and from the infant 18” and Col. 4, lines 1-11 which state in part “A thermoelectric device 28 is located in heat conductive relationship with the mattress 26, and as shown, the thermoelectric device 28 is positioned beneath the mattress 26 with respect to the infant 18 so that the thermoelectric device 28 can readily provide heat to or remove heat from the mattress directly. The thermoelectric device 28 could be placed in other positions…”). However, Sweeney is silent with respect to the plurality of thermoelectric devices being embedded in the filling material and the filling material including embedded microparticles having a thermal conductivity greater than 10 Watt/meter-oC to enhance a thermal conductivity of the filling material.
Paperno teaches an analogous device (title “Support Assembly for Infant”) to that of Sweeney including a heating or cooling assembly (300) having one or more heating or cooling elements (310) including thermoelectric device ([0033] which states in part “one or more heating or cooling elements 310 (e.g., resistive heating elements, thermoelectric elements such as Peltier elements micro chips, phase change material)”) that can be incorporated into the support pad (100) to heat or cool a surface of the pad by embedding the devices in the support pad, providing the devices on an outer surface of the support pad, or providing the devices in a separate component that can be removably coupled to the support pad ([0033]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney with the embedded configuration of Paperno as an obvious matter of engineering design choice given the interchangeability of these device configurations as taught by Paperno and the teaching of Sweeney that the devices could be located in other positions.
Brienza teaches an actively and selectively cooled cushioning surface (title) where the preferred heat exchange materials for the gel pads (23) including a polyurethane gel (23B) modified with ceramic microspheres and a polyurethane gel (23C) with resin microspheres. Each of these materials are designed to maximize thermal conductivity while still providing adequate cushion support (Col. 9, lines 10-17). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney to include the polyurethane gel modified with ceramic or resin microspheres of Brienza to maximize thermal conductivity as taught by Brienza. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney to include the polyurethane gel modified with ceramic or resin microspheres of Brienza to maximize thermal conductivity as taught by Brienza.
While Brienza is silent with respect to a thermal conductivity greater than 10 Watt/meter-oC, it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the claimed thermal conductivity since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. This is true as Brienza teaches that each of the materials are designed to maximize thermal conductivity while still providing adequate cushioning support (Col. 9, lines 10-17).
Regarding claim 22, the combination teaches the system of claim 21, as well as Sweeney teaches wherein the thermal energy exchange mechanism is configured to deliver thermal energy to the neonatal patient to warm the neonatal patient (Col. 3, lines 54-57 which state in part “the mattress 26 contains a heat conductive material that readily conducts heat to and from the infant 18” and Col. 4, lines 1-11 which state in part “A thermoelectric device 28 is located in heat conductive relationship with the mattress 26, and as shown, the thermoelectric device 28 is positioned beneath the mattress 26 with respect to the infant 18 so that the thermoelectric device 28 can readily provide heat to or remove heat from the mattress directly.”).
Regarding claim 24, the combination teaches the system of claim 21 as well as Sweeney teaching wherein the filling material is moldable gel (as deformability of the mattress 26 is inherent in the material selected by Sweeney of a silicon or polyurethane gel it is inherently moldable via its deformation), but not a viscosity of between 10,000 centipoise and 1,000,000 centipoise. It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the material to have a viscosity as claimed, since it has been held where the general conditions of a claim are disclosed in the prior art (here a deformable gel pad), discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 32, the combination teaches the system of claim 21, but not wherein the microparticles are stainless steel or aluminum. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected stainless steel or aluminum as the material for the microparticles, since it has been held to be within the general skill of a worker int eh art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 33, the combination teaches the system of claim 1 as well as Sweeney teaching wherein the deformable pad is divided into temperature zones (compartmentalized mattress segments 42) for warming or cooling portions of the neonatal patient differently (Col. 5, lines 39-56).
Regarding claim 34, the combination teaches the system of claim 33 as well as Sweeney further teaching wherein each of the temperature zones includes a number thermoelectric devices arranged in the layered arrays as a subset of the plurality of thermoelectric devices (Fig. 4).
Regarding claim 35, the combination teaches the system of claim 34 as well as wherein each of the temperature zones includes one or more temperature sensors (34, Fig. 4) to measure temperature for regulating the temperature (Col. 5, lines 53-56).
Regarding claim 36, the combination teaches the system of claim 21 as well as wherein the deformable pad includes one or more monitoring temperature sensors (34) for keeping the neonatal patient safe from extreme temperatures.
Regarding claim 37, the combination teaches the system of claim 21 as well as Sweeney teaching an electric base (controller 30) to distribute power to the plurality of devices.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney and Paperno as applied to claim 21 above, and further in view of US 5,566,413 to Webb et al. (Webb).
Regarding claim 23, Sweeney in view of Paperno teaches the system of claim 21, but not wherein the deformable pad is continuously deformable between a flat top surface and a contoured top surface, the contoured top surface including a formed depression configured to receive the neonatal patient thereon. Webb teaches an infant restraint (10) including a pad (12) that is a block of an appropriate material such as a polyurethane foam and includes a concave depression (28) incorporated in the top (23). The concave depression is sculpted so as to produce an uneven texture or topography which increases the surface area of the material actually in contact with the infant and thereby assists in frictional prevention of movement of the infant relative to the pad (Col. 2, lines 48-61). Therefore, it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the pad of Sweeney to include the concave depression of Webb to position the infant and assist in frictional prevention of movement as taught by Webb.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney and Paperno as applied to claim 37 above, and further in view of US 6,589,270 B2 to Augustine (Augustine).
Regarding claim 38, Sweeney in view of Paperno teaches the system of claim 37, as well as Sweeney teaching wherein the electrical base (30) is a conventional controller that can sense the temperature and, depending on a desired set point, can send a signal to control the thermoelectric device (28) to attain and maintain that desired temperature (Col. 4, lines 41-53). However, Sweeney is silent regarding a processor and a power converter. Augustine teaches an analogous device to that of Sweeney including a heater (902), a controller (910) that may comprise a programmable general purpose processor, a programmable special purpose processor, a specially-designed electronic circuit, or an application specific integrated circuit (ASIC), or any equivalent, and a power supply (908). The controller (910) and the power supply (908) may be integrated mechanically into a single unit and the power supply may comprise a battery, battery pack, an AC/DC converter, or any other equivalent device that may be switched on and off to the heater (902). It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney to include the processor and power converter of Augustine to allow for control of the thermal element as taught by Augustine (Col. 12, lines 31-51). This is especially true as Sweeney generally teaches the use of a conventional controller and logic to attain and maintain s desired temperature.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Paperno.
Regarding claim 40, Sweeney teaches a system (incubator 10), comprising a neonatal bed (bed support tray 24) configured for receiving a neonatal patient (Fig. 1), the neonatal bed comprising a deformable pad (gel mattress 26 as deformability of the mattress 26 is inherent in the material selected by Sweeney of a silicon or polyurethane gel) having a filling material (silicon or polyurethane gel as taught by Sweeney) therein, the filling material being a semi-solid material (Sweeny teaches a silicon or polyurethane gel which is a semi-solid) and a thermal exchange mechanism coupled with the deformable pad (Fig. 1), the thermal exchange mechanism including a plurality of thermoelectric devices (thermoelectric devices 28, Fig. 4) coupled with the deformable pad (Fig. 4), the deformable pad being divided into temperature zones for warming or cooling portions of the neonatal patient differently (Col. 5, lines 39-56 which states in part “each mattress segment is in heat conducting relationship with a separate thermoelectric device 28 so that each mattress segment 42 can be set to a different temperature from the other mattress segments 42.”), and each of the temperature zones including a number of thermoelectric devices (Fig. 4 which shows that each zone includes one thermoelectric device which is a number of thermoelectric devices) arranged in layered arrays (if only one then it is arranged in a layered array of one) as a subset of the plurality of thermoelectric devices, wherein the thermal energy exchange mechanism is configured to extract thermal energy from the neonatal patient to cool the neonatal patient via thermal conduction through the filling material of the deformable pad (Col. 3, lines 54-57 which state in part “the mattress 26 contains a heat conductive material that readily conducts heat to and from the infant 18” and Col. 4, lines 1-11 which state in part “A thermoelectric device 28 is located in heat conductive relationship with the mattress 26, and as shown, the thermoelectric device 28 is positioned beneath the mattress 26 with respect to the infant 18 so that the thermoelectric device 28 can readily provide heat to or remove heat from the mattress directly. The thermoelectric device 28 could be placed in other positions…”). However, Sweeney is silent with respect to the plurality of thermoelectric devices being embedded in the filling material or the filling material having a viscosity between above 10,000 centipoise and 1,000,000 centipoise.
Paperno teaches an analogous device (title “Support Assembly for Infant”) to that of Sweeney including a heating or cooling assembly (300) having one or more heating or cooling elements (310) including thermoelectric device ([0033] which states in part “one or more heating or cooling elements 310 (e.g., resistive heating elements, thermoelectric elements such as Peltier elements micro chips, phase change material)”) that can be incorporated into the support pad (100) to heat or cool a surface of the pad by embedding the devices in the support pad, providing the devices on an outer surface of the support pad, or providing the devices in a separate component that can be removably coupled to the support pad ([0033]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney with the embedded configuration of Paperno as an obvious matter of engineering design choice given the interchangeability of these device configurations as taught by Paperno and the teaching of Sweeney that the devices could be located in other positions.
Regarding a viscosity of the semi-solid filling material being between 10,000 centipoise and 1,000,000 centipoise. As Sweeny teaches a semi-solid material, it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the material to have a viscosity as claimed, since it has been held where the general conditions of a claim are disclosed in the prior art (here a deformable gel pad), discovering the optimum or workable ranges involves only routine skill in the art.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney and Paperno, and further in view of US 2018/0295980 A1 to Boersma et al. (Boersma).
Regarding claim 41, Sweeney in view of Paperno teaches the system of claim 40, but not wherein each of the temperature zones includes at least a top array of thermoelectric devices and a bottom array of thermoelectric devices positioned vertically in relation to each other for enhancing an efficiency of thermal energy transfer through the deformable pad. Boersma which is considered to be reasonably pertinent to the problem being solved (efficient thermal transfer) teaches that stacking thermoelectric elements provides larger temperature differences. Therefore, it would have been obvious to modify Sweeny to provide a stacked thermoelectric device configuration to allow for larger temperature differences as taught by Boersma ([0037]).
Claim(s) 42 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney and Paperno, and further in view of Brienza.
Regarding claim 42, Sweeney in view of Paperno teaches the system of claim 40, but not wherein the filling material includes embedded microparticles having a thermal conductivity greater than 10 Watt/meter-oC to enhance a thermal conductivity of the filling material. Brienza teaches an actively and selectively cooled cushioning surface (title) where the preferred heat exchange materials for the gel pads (23) including a polyurethane gel (23B) modified with ceramic microspheres and a polyurethane gel (23C) with resin microspheres. Each of these materials are designed to maximize thermal conductivity while still providing adequate cushion support (Col. 9, lines 10-17). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney to include the polyurethane gel modified with ceramic or resin microspheres of Brienza to maximize thermal conductivity as taught by Brienza. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sweeney to include the polyurethane gel modified with ceramic or resin microspheres of Brienza to maximize thermal conductivity as taught by Brienza.
While Brienza is silent with respect to a thermal conductivity greater than 10 Watt/meter-oC, it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the claimed thermal conductivity since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. This is true as Brienza teaches that each of the materials are designed to maximize thermal conductivity while still providing adequate cushioning support (Col. 9, lines 10-17).
Regarding claim 43, the combination teaches the system of claim 42, but not wherein the microparticles are stainless steel or aluminum. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected stainless steel or aluminum as the material for the microparticles, since it has been held to be within the general skill of a worker int eh art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney and Paperno as applied to claim 33 above, and further in view of US 2015/0209174 A1 to Abreu (Abreu).
Regarding claim 44, Sweeney in view of Paperno teaches the system of claim 33, but not wherein each of the temperature zones includes at least a top array of thermoelectric devices and a bottom array of thermoelectric devices positioned vertically in relation to each other for enhancing an efficiency of thermal energy transfer through the deformable pad. Abreu teaches an active thermal transfer device (422) including a multi-layer Peltier stack (426), which enables a higher temperature differential than a single Peltier junction ([0315]). Therefore, it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermoelectric devices of Sweeney to include a multi-layer Peltier stack to enable a high temperature differential as taught by Sweeney thus increasing efficacy of the system. While the references are silent with respect to the top and bottom array of each temperature zone having thermoelectric devices, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized multiple thermoelectric devices within each temperature zone, since it has been held that mere duplication of the essential working parts of a device involves only routine sill in the art.
Conclusion
Applicant's amendment necessitated any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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