DETAILED ACTION
This action is responsive to the RCE filed 12/23/25.
Claims 1-9, 12-13, 15-16, 19-23, 27 and 29-33 are rejected.
Claim 14 is objected to for being dependent of a rejected base claim.
Claim 28 is allowed.
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.
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 .
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 29 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.
Regarding claim 29, it is not clear what is meant by the limitation ‘two or more overlapping chambers’.
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.
Claim(s) 1-2, 4, 6-7, 9, 16, 19-21, 27 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt (US 20140046410) in view of Stefanile et al. (US 6312453, “Stefanile”) and Akira (JP H08131473).
Regarding claim 1, Wyatt teaches a cooling cap assembly (Abstract, “A system and method for scalp cooling to avoid hair loss in patients undergoing chemotherapy with a cooling bonnet”) comprising: a heat exchanger configured to be placed around a head of a patient, wherein the heat exchanger (Fig. 1, cooling bonnet 3) comprises a base portion (Fig. 1, the base portion can be considered the portion of the cooling bonnet 3 which connects directly with circulation hose bundle 10), a central top lobe extending from the base portion (Fig. 1, middle flap 8), and first and second side arms extending from the base portion (Fig. 1, right flap 6 and left flap 7), and wherein, in the overlapping configuration, the first and second side arms wrap around sides of the head of the patient from the back of the head to the front of the head, and overlap at the front of the head (Fig. 6, showing right and left flaps 6/7 wrapping around the head from the back of the head to the front of the head and overlapping at the front of the head).
Wyatt fails to teach at least one of the first or second side arms having a fastener at a distal end thereof configured to hold the first and second side arms of the heat exchanger in an overlapping configuration; and a compression assembly configured to be placed around the head separately from the heat exchanger, wherein the compression assembly comprises an enclosure and an inflatable member coupled to an internal surface of the enclosure, wherein when placed around the head, the inflatable member is positioned between the enclosure and the heat exchanger, and wherein the heat exchanger is separate from and moveable relative to the inflatable member.
Regarding the fastener aspect, Stefanile teaches an analogous cooling cap assembly (Abstract, “The device fits closely over the infant's skull and is cooled by a recirculating cooling fluid passing through a serpentine conduit.”): a heat exchanger configured to be placed around a head of a patient (Fig. 1, cooling liner 20 and col. 4, lines 18-34, ‘the device includes cooling liner 20 shaped to fit closely over the infant's skull and receive and distribute a cooling fluid around those portions of the skull that contain the portions of the brain that are to be cooled.’), wherein the heat exchanger comprises a base portion first and second side arms extending from the base portion (Figs. 1 and 6, overlapping flap 40 and tabs 42 can be considered ‘first and second side arms’ which extend from a base portion), at least one of the first and second arms having a fastener at a distal end thereof configured to hold the first and second side arms of the heat exchanger in an overlapping configuration (Figs. 1 and 6 and col. 5, lines 21-29, ‘ Overlapping flap 40 and tab 42 may carry some type of fastener, such as a hook and loop fastener or snaps. Circular tabs 44 may also be provided with fasteners. In order to shape cooling liner 20 to the skull of an infant, circular tabs 44 are caused to be superimposed on each other and tab 42 is overlaid by closure flap 40.’), wherein, in the overlapping configuration, the first and second side arms wrap around sides of the head of the patient from the back of the head to the front of the head, and overlap at the front of the head (Fig. 1, showing cooling liner 20 wrapping around the head from the back of the head to the front of the head, with flap 40 and tab 42 overlapping at the front of the head).
Therefore, in view of Stefanile it would have been obvious to POSITA at the time that the invention as filed to modify Wyatt by providing the first and second side arms of Wyatt with fasteners in order to facilitate the maintenance of the wrap around the head of the user, as taught by Stefanile.
Regarding the compression assembly aspect, Akira teaches a cooling cap assembly (Fig. 3) comprising: a heat exchanger configured to be placed around a head of a patient (Fig. 3, heat exchange section 4; and par. 7, ‘According to another aspect of the present invention, there is provided a head cooling device having an outer shell surrounding a head and a neck and a cooling / heating medium flow path in contact with the head and the neck.’); and a compression assembly (Fig. 3, pressing body 3) configured to be placed around the head separately from to the heat exchanger (Pg. 3, par. 6, ‘Further, the heat exchange section 4 is not fixed to the pressing body 3, but is removably accommodated inside the pressing body 3.’; therefore, the pressing body 3 is capable of being placed around the head separately from the heat exchanger), wherein the compression assembly comprises an enclosure (Fig. 3, outer case 1) and an inflatable member (Fig. 3, air bags 3a), coupled to an internal surface of the enclosure (Fig. 3, pressing body 3 coupled to the internal surface of outer case 1), wherein when placed around the head, the inflatable member is positioned between the enclosure and the heat exchanger (Fig. 3, pressing body 3 positioned between outer case 1 and heat exchange section 4), and wherein the heat exchanger is separate from and moveable relative to the inflatable member (Pg. 3, par. 6, ‘Further, the heat exchange section 4 is not fixed to the pressing body 3, but is removably accommodated inside the pressing body 3.’).
Therefore, in view of Akira, it would have been obvious to POSITA at the time that the invention was filed to further modify Wyatt by providing a compression assembly, in the manner described by Akira, in order to facilitate heat transfer with the scalp of the user by improving contact between the heat exchanger and the scalp of the user, as taught by Akira.
Regarding claim 27, Wyatt, as modified, teaches a cooling cap assembly (Abstract, “A system and method for scalp cooling to avoid hair loss in patients undergoing chemotherapy with a cooling bonnet”) comprising: a heat exchanger configured to be placed on a head of a patient (Fig. 1, cooling bonnet 3), wherein the heat exchanger comprises a base portion (Fig. 1, the base portion can be considered the portion of the cooling bonnet 3 which connects directly with circulation hose bundle 10), a central top lobe extending from the base portion (Fig. 1, middle flap 8), and first and second side arms extending from the base portion (Fig. 1, right flap 6 and left flap 7), at least one of the first or second side arms having a fastener at a distal end thereof configured to hold the first and second side arms of the heat exchanger in an overlapping configuration (Wyatt has previously been modified in view of Stefanile to comprise fasteners; see Stefanile, figs. 1 and 6 and col. 5, lines 21-29, ‘ Overlapping flap 40 and tab 42 may carry some type of fastener, such as a hook and loop fastener or snaps. Circular tabs 44 may also be provided with fasteners. In order to shape cooling liner 20 to the skull of an infant, circular tabs 44 are caused to be superimposed on each other and tab 42 is overlaid by closure flap 40.’), wherein, in the overlapping configuration, the first and second side arms wrap around sides of the head of the patient from the back of the head to the front of the head, and overlap at the front of the head (Fig. 6, showing right and left flaps 6/7 wrapping around the head from the back of the head to the front of the head and overlapping at the front of the head); and a compression assembly (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, fig. 3) configured to be placed around the head separately from to the heat exchanger (See Akira, pg. 3, par. 6, ‘Further, the heat exchange section 4 is not fixed to the pressing body 3, but is removably accommodated inside the pressing body 3.’), wherein the compression assembly comprises an enclosure (See Akira, fig. 3, outer case 1) and an inflatable member (See Akira, fig. 3, air bags 3a) coupled to an internal surface of the enclosure (See Akira, fig. 3, pressing body 3 coupled to the internal surface of outer case 1), wherein the inflatable member comprises a top inflatable portion (See Akira, Figs. 7-8, airbag 3a located on a top portion of the pressing body 3), a first inflatable side portion (See Akira, figs. 7-8, airbag 3a located on a first side portion of the pressing body 3), and a second inflatable side portion (See Akira, figs. 7-8, airbag 3a located on a second side portion of the pressing body 3), wherein each portion comprises a chamber (See Akira, fig. 7, each airbag 3a can be considered a chamber), wherein when placed around the head, the inflatable member is positioned between the enclosure and the heat exchanger (See Akira, fig. 3, pressing body 3 positioned between outer case 1 and heat exchange section 4), and wherein the heat exchanger is separate from and moveable relative to the inflatable member (See Akira, pg. 3, par. 6, ‘Further, the heat exchange section 4 is not fixed to the pressing body 3, but is removably accommodated inside the pressing body 3.’).
Regarding claim 2, Wyatt, as modified, further teaches wherein the inflatable member comprises a deflated configuration and an inflated configuration, and wherein transitioning the inflatable member from the deflated to the inflated configuration increases a pressure applied to the head of the patient (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, Abstract, ‘[…] a pressing body which is mounted on the inside surface of the outside shells and expands to press the heat exchange part to the head and the neck when pressure fluid is supplied thereto’).
Regarding claim 4, Wyatt, as modified, further teaches wherein the enclosure is configured to generate a counter pressure when the inflatable member is in the inflated configuration (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, Abstract, ‘[…] the pressing body 3 which is mounted on the inside surface of the outside shells 1, 2 and expands to press the heat exchange part 4 to the head and the neck when the pressure fluid is supplied thereto.’).
Regarding claim 6, Wyatt, as modified, further teaches wherein the inflatable member comprises a top inflatable portion (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, Figs. 7-8, airbag 3a located on a top portion of the pressing body 3), a first inflatable side portion (See Akira, figs. 7-8, airbag 3a located on a first side portion of the pressing body 3), and a second inflatable side portion (See Akira, figs. 7-8, airbag 3a located on a second side portion of the pressing body 3), wherein each portion comprises a chamber (See Akira, Fig. 7, each airbag 3a can be considered a chamber).
Regarding claim 7, Wyatt, as modified, further teaches wherein a length of the first inflatable side portion and a length of the second inflatable side portion are each more than a length of the top inflatable portion (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, fig. 7, showing that the side portion of the pressing body 3 is longer than the top portion of pressing body 3).
Regarding claim 9, Akira, as modified, further teaches wherein the inflatable member comprises a fluid barrier (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, fig. 6, the side-walls of each airbag 3a can be considered a fluid barrier).
Regarding claim 16, Wyatt, as modified, further teaches wherein each of the base portion, the central top lobe, and the first and second side arms of the heat exchanger comprises at least a portion of a fluid channel (Fig. 1, circulation channel 9 extends through the base portion, the right flap 6, the middle flap 8 and the left flap 7 of cooling bonnet 3).
Regarding claim 19, Wyatt, as modified, teaches wherein the heat exchanger comprises one or more fluid channels (Fig. 1, circulation channel 9), but fails to teach that each channel comprises a cross-sectional area of from about 9 mm2 to about 100 mm2.
The examiner notes, however, that the cooling power of a heat-transfer device is a result-effective variable, since it affects the degree of cooling applied to the user. Further, the cooling power of a fluid heat-transfer device is related to the flow-rate of the heat transfer device which is related to the cross-sectional area of the flow channels. Further, since the cross-sectional area of the flow channels affects a result effective variable (the degree of cooling applied to the user), it is also a result effective variable. Therefore, POSITA would have found it obvious to further modify Wyatt, as modified, by optimizing the cross-sectional area of the fluid flow channels to within the claimed range, 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. In re Aller, 105 USPQ 233.
Regarding claim 20, Wyatt, as modified, fails to teach a liner configured to be disposed between the heat exchanger and a scalp of the patient; and a fastener releasably coupled to the compression assembly and the patient.
Regarding the liner aspect, Stefanile teaches an analogous cooling cap assembly (Abstract) which comprises a heat exchanger (Fig. 1, cooling liner 20), and a liner configured to be disposed between the heat exchanger and a scalp of the patient (Fig. 1, inner liner 24). Stefanile further teaches that the inner liner is useful for transporting moisture that may form on the scalp due to condensation or perspiration (Col. 3, lines 58-64).
Therefore, in view of Stefanile, it would have been obvious to POSITA at the time that the invention was filed to further modify Wyatt, as modified, by including an inner liner, in order to facilitate the wicking of moisture away from the scalp, as taught by Stefanile.
Regarding the fastener aspect, Stefanile further teaches an outer cap (Fig. 1, outer cap 22) which can comprise a chin strap of adjustable length in order to facilitate retainment of the outer cap to the head of the user (Col. 8 lines 36-38, ‘Additional means can be provided to retain outer cap 22 on the infant's head, such as a chin strap of adjustable length.’)
Therefore, in view of Stefanile, it would have been obvious to POSITA at the time that the invention was filed to further modify Wyatt, as modified, by providing a chin strap attached to the enclosure (outer case 1) in order to facilitate retention of the device to the head of the user, as taught by Stefanile.
Regarding claim 21, Wyatt, as modified, teaches a cooling unit (Fig. 1, ice water recirculation system 2); comprising a fluid connector releasably coupled to the heat exchanger (Fig. 1, hose bundle 10 connecting ice reservoir 14 with cooling bonnet 3); a reservoir (Fig. 1, ice reservoir 14); and a pump (Par. 17, “ice reservoir 14 containing a circulating pump […]”), but fails to teach compressor.
Akira, however, teaches an analogous cooling unit (Fig. 16) comprising: a fluid connector releasably coupled to the heat exchanger (Fig. 3, cooling/heating medium coupler 4c), a compressor (Pg. 4, par. 3, ‘compressor-type cooler’), a reservoir (Fig. 16, cooling/heating medium tank 17), and a pump (Fig. 17, cooling/heating medium circulating pump 18).
Therefore, since both Wyatt and Akira teaches different cooling-unit types for cooling a fluid circulating through a scalp heat-exchanger, it would have been obvious to POSITA at the time that the invention was filed to substitute a compressor-type cooler, as taught by Akira, for the ice reservoir type cooler, as taught by Wyatt, in order to arrive at the predictable result of a cooling-unit type for cooling a fluid circulating through a scalp heat-exchanger. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claims 30-31, Wyatt, as modified, further teaches wherein the fastener is on a scalp facing surface of the distal end of the at least one of the first or second side arms portions (Wyatt has previously been modified in view of Stefanile to comprise such fasteners; see Stefanile, fig. 1, flap 40 attaches to tab 42 along a scalp facing surface of flap 40 and col. 5, lines 21-29, ‘Overlapping flap 40 and tab 42 may carry some type of fastener, such as a hook and loop fastener or snaps. Circular tabs 44 may also be provided with fasteners. In order to shape cooling liner 20 to the skull of an infant, circular tabs 44 are caused to be superimposed on each other and tab 42 is overlaid by closure flap 40.’).
Regarding claim 32, Wyatt, as modified, further teaches wherein, in a flattened configuration, the central top lobe of the heat exchanger extends beyond the first and second side arms of the heat exchanger, as measured along a longitudinal axis of the heat exchanger defined by the base portion and the central top lobe (Figs. 1 and 4, showing middle flap 8 extending beyond side flaps 6/7 along a longitudinal axis while in a flattened configuration).
Regarding claim 33, Wyatt, as modified, further teaches wherein the base portion is disposed at the back of the head (Fig. 3, showing the base portion at the back of the head), the central top portion is disposed at the top ridge or forefront of the head (Fig. 6, showing middle flap 8 disposed at the top ridge or forefront of the head), and the first and second side arms are disposed at the left and right hemispheres of the head of the head (Fig. 6, showing left flap 7 disposed at the left hemisphere of the head and right flap 6 disposed at the right hemisphere of the head.).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt in view of Stefanile and Akira, as applied to claims 1-2, 4, 6-7, 9, 16, 19-21, 27 and 30-33, above, and further in view of Vergara et al. (US 20190262169, “Vergara”).
Regarding claim 3, Wyatt, as modified, teaches a pressurizing unit coupled to the inflatable member (Wyatt has previously been modified in view of Akira to comprise a compressions assembly; see Akira, fig. 3, pressurizing unit 8), but fails to teach that the pressurizing unit comprises a fluid pump.
Vergara teaches an analogous cooling cap assembly (Par. 265 and fig. 68c, HEM helmet 330) comprising: a heat exchanger configured to be wrapped around a head of a patient (Par. 265 and fig. 68c, TEC arrays 116); and a compression assembly (Fig. 5, air bladder 176; par. 309, ‘In another embodiment, the HEM and/or soft good, as the case may be, comprises and air bladder. Generally, an air bladder is contained within the soft good, separated from the mechanical subassemblies by a layer of fabric material (See, FIG. 5).’) releasably coupled to the heat exchanger (Par. 284 states that the HEM is removable from the soft good 192 which contains air bladder 176 as a separate component, see fig. 5), wherein the compression assembly comprises an enclosure (Fig. 5, pocket within soft good 192 containing air bladder 176) and an inflatable member coupled to an internal surface of the enclosure (Fig. 5, air bladder 176 within a pocket of soft good 192), wherein when coupled, the inflatable member is positioned between the enclosure and the heat exchanger (Fig. 5, air bladder 176 is positioned between an outer surface of soft good 192 and the HEM module containing TEC elements 180), and wherein the heat exchanger is separate from and moveable relative to the inflatable member (Par. 284 states that the HEM is removable from the soft good 192 which contains air bladder 176 as a separate component, see fig. 5); and a fluid pump coupled to the inflatable member (Par. 138, ‘In one embodiment, two wires are used to provide power (12V and ground) to an air pressure pump included in the distal connector (HEM side) of the umbilical 102, and designed to pressurize and deflate the air bladder 176 by the user with pushbutton switches built-in the connector case.’).
Therefore, since both Wyatt, as modified, and Vergara teach different pressurizing units for supplying pressurized fluid to a compression assembly, it would have been obvious to POSITA at the time that the invention was filed to substitute one known pressurizing unit, for other, in order to arrive at the predictable result of a pressurizing unit for supplying a pressurized fluid to a compression assembly. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 5, Wyatt, as modified, fails to teach wherein the compression assembly is configured to generate from about 0.5 Ib/in2 to about 5 lb/in2 of compression to the head when the inflatable member is in the inflated configuration.
Vergara, however, further teaches generating a compressive force of 2 psi which is within the claim range (Par. 311, ‘In yet another preferred embodiment, the HEM device shall contain an air bladder capable of generating compression up to 2 psi.’), and further teaches that the compressive force enhances user comfort and improves thermal contact between the heat transfer element and user (Par. 138)
Therefore, in view of Vergara, it would have been obvious to POSITA to further modify Wyatt, as modified, by configuring the compression assembly to supply a compressive for of 2 psi, as taught by Vergara, in order to enhance comfort and improve thermal contact between the heat transfer element and the user.
Claim(s) 8 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt in view of Stefanile and Akira, as applied to claims 1-2, 4, 6-7, 9, 16, 19-21, 27 and 30-33, above, and further in view of Quinsberry (US 20180055721).
Regarding claim 8, Wyatt, as modified, fails to teach wherein side inflatable portions of the inflatable member are configured to adjustably overlap so as to surround at least a portion of the head.
Quinsberry teaches an analogous cooling cap assembly (Abstract, ‘the disclosure relates to a head wrap ’) comprising: a heat exchanger configured to be wrapped around a head of a patient (Par. 7, ‘ A heat-transfer fluid is circulated through a fluid bladder via a first fluid port and a second fluid port.’; fig. 1D, fluid bladder 150); and a compression assembly coupled to the heat exchanger (Par. 7, ‘A compressed gas is applied to a compression bladder via a compression port. ’), wherein the compression assembly comprises an inflatable member (Fig. 1D, compression bladder 151), and wherein side inflatable portions of the inflatable member are configured to adjustably overlap so as to surround at least a portion of the head (Figs. 1a and 3, respectively showing the compression assembly in an unfolded configuration and a folded configuration in which the side inflatable portions overlap to surround the head).
Therefore, since both Wyatt, as modified, and Quinsberry teach different configurations for compression bladders used in cooling cap assemblies, it would have been obvious to POSITA at the time that the invention was filed to substitute one known compression bladder configuration for the other in order to achieve the predictable result of a compression bladder for use in a cooling cap assembly. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 29, Wyatt, as modified, further teaches wherein the inflatable member comprises two or more overlapping chambers (Wyatt has previously been modified in view of Quinsberry to comprise an overlapping inflatable member; see Quinsberry, figs. 1a-d, 3, showing a compression bladder 151 having multiple air chambers and with overlapping flap portions).
Claim(s) 12-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt in view of Akira and Stefanile, as applied to claims 1-2, 4, 6-7, 9, 16, 19-21, 27 and 30-33, above, and further in view of Lowe et al. (US 20140142473, “Lowe”).
Regarding claim 12, Wyatt, as modified, teaches wherein the heat exchanger comprises a set of fluid barriers (Fig. 1, showing a set of fluid barriers guiding the flow of fluid within the cooling bonnet 3), but fails to teach wherein each fluid barrier of the set of fluid barriers is about 5 mm to about 15 mm from an adjacent fluid barrier in the set of fluid barriers.
Lowe teaches an analogous cooling assembly (Abstract) which comprises a fluid heat exchanger configured to be wrapped around a patient (Fig. 1, therapy wrap 30; par. 118, ‘ The wrap includes a pair of layers 33, 35 defining a flexible fluid bladder 37 through which a heated or cooled liquid is circulated’), and a compression assembly (Fig. 3, gas pressure bladder 38), wherein the compression assembly comprises an inflatable member (Par. 142, ‘Gas pressure bladder 38 is adapted to receive a gas (e.g. air), which can be regulated to provide the desired amount of inflation of the bladder or pressure therein.’), wherein the fluid heat exchanger comprises a set of fluid barriers (Figs. 1-2 and par. 146, ‘Exemplary wrap 30 includes a plurality of fences 62 and dot connections 65. ’), and wherein each fluid barrier of the set of fluid barriers is about 5 mm to about 15mm from an adjacent fluid barrier in the set of fluid barriers (Par. 21, ‘The attachment points may have an average center-to-center spacing between adjacent attachment points between about 0.35 inch and about 0.5 inch. ’; for instance .35 inches is equivalent to 8.89 mm which is within the claimed range).
Lowe further teaches that the set of fluid barriers minimize or eliminate undesirable ballooning of the bladder when the fluid and gas bladders are pressurized (Par. 146).
Therefore, in view of Lowe, it would have been obvious to POSITA at the time that the invention was filed to further modify Akira, as modified, by providing the dot connections spaced within the claimed range, in order to prevent undesirable ballooning of the fluid bladders, as taught by Lowe.
Regarding claim 13, Wyatt, as modified, further teaches wherein each fluid barrier in the set of fluid barriers comprises a diameter of from about 5 mm to about 10 mm (Wyatt has previously been modified in view of Lowe to include dot connection points; see Lowe, par. 21, ‘The attachment points may a diameter being between about 0.15 inch and about 0.35 inch.’ For instance, .35 inches is equivalent to 8.89 mm which is within the claimed range).
Regarding claim 15, Akira, as modified, teaches that the fluid barrier can take on many different shapes (Akira has previously been modified by Lowe to include dot connection; see Lowe, par. 133), but fails to teach wherein at least one fluid barrier of the set of fluid barriers comprises a torus shape.
The examiner maintains, however, that it would have been obvious to POSITA at the time that the invention was filed to further modify Wyatt, as modified, to construct the fluid barriers in a torus shape rather than a circular shape, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt in view of Stefanile, Akira and Vergara, as applied to claims 3 and 5, above, and further in view of Hopper et al. (US 20140343639, “Hopper”).
Regarding claim 22, Wyatt, as modified, further teaches wherein the cooling unit comprises a fluid reservoir (Fig. 1, reservoir 14) and a housing (Fig. 1, showing the cooling unit housing), but fails to teach that the cooling unit comprises a battery and that the fluid reservoir is releasably coupled to the housing.
Regarding the battery aspect, Vergara teaches a cooling unit which comprises a housing (Fig. 1, housing of control unit 100), a battery (Pars. 100-101, ‘The control unit 100 can be designed so that its functionality is sustained for long periods (more than 45 minutes) when operating on battery power alone if and when it is disconnected from the mains AC power 106. This is made possible by the inclusion of a set of internal batteries 108.’), and a fluid reservoir (Fig. 2, fluid reservoir 146).
Therefore, in view of Vergara, it would have been obvious to POSITA at the time that the invention was filed to further modify Wyatt, as modified, by providing the cooling unit with batteries in order to allow the system to operate when disconnected from an AC power source.
Regarding the releasable reservoir aspect, Hopper teaches an analogous thermal control system for circulating a thermal fluid through various thermal pads (Abstract) wherein a reservoir comprises a removable reservoir to facilitate filling of the reservoir (Par. 4 and fig. 3).
Therefore, in view of Hopper, it would have been obvious to POSITA at the time that the invention was filed to further modify Wyatt, as modified, by configuring the reservoir to be removable, in order to facilitate refilling of the reservoir, as taught by Hopper.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt in view of Akira, Stefanile, Vergara and Hopper, as applied to claim 22, above, and further in view of Elkins (US 20020138033).
Regarding claim 23, Wyatt, as modified, teaches wherein the cooling unit is configured to circulate a fluid through the heat exchanger (Abstract, “A system and method for scalp cooling to avoid hair loss in patients undergoing chemotherapy with a cooling bonnet, a recirculating ice-water system with ice water circulation hoses, a reservoir, a circulating pump and a power supply”), but fails to teach wherein the fluid comprises one or more of water and salt, water and glycol, and water and alcohol.
Elkins teaches an analogous cooling cap assembly (Abstract), comprising a heat exchanger configured to be wrapped around a head of a patient (Fig. 2, heat exchange bladder 30; par. 22, ‘The purpose of the animate body heat exchanger of the preferred embodiment is to cool the head ’), wherein the cooling unit is configured to circulate a fluid through the heat exchanger (Par. 22, ‘Thus, the control unit includes a mechanism for cooling and circulating a liquid coolant. ’), wherein the fluid comprises one or more of water and salt, water and glycol, and water and alcohol (Par. 22, ‘In a practical realization of this preferred embodiment, the liquid was a 20 percent propylene glycol solution in distilled water’).
Therefore, since both Wyatt, as modified, and Elkins teach different heat exchange fluids for circulating through a cooling cap assembly, it would have been obvious to POSITA at the time that the invention was filed to substitute one known heat exchange fluid for the other in order to achieve the predictable result of a heat exchange fluid for circulating through a cooling cap assembly. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-9, 12-13, 15-16, 19-23, 27 and 29-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,141,309 (‘309) in view of Stefanile and Wyatt. Although the claims at issue are not identical, they are not patentably distinct from each as illustrated by the comparison below.
Application claim 1
Claim 1 of ‘309
1. A cooling cap assembly comprising:
a heat exchanger configured to be placed around a head of a patient,
wherein the heat exchanger comprises a base, a central top lobe extending from the base portion, and first and second side arms extending from the base portion; and
at least one of the first or second side arms having a fastener at a distal end thereof configured to hold the first and second side arms of the heat exchanger in an overlapping configuration, wherein, in the overlapping configuration, the first and second side arms wrap around sides of the head of the patient from the back of the head to the front of the head, and overlap at the front of the head;
a compression assembly configured to be placed around the head separately from to the heat exchanger,
wherein the compression assembly comprises an enclosure and an inflatable member coupled to an internal surface of the enclosure, wherein when placed around the head, the inflatable member is positioned between the enclosure and the heat exchanger, and
wherein the heat exchanger is separate from and moveable relative to the inflatable member.
1. A cooling cap assembly comprising:
a heat exchanger configured to be wrapped to fit around a head of a patient; and
a compression assembly releasably coupled to the heat exchanger,
wherein the compression assembly comprises an enclosure and an inflatable member coupled to an internal surface of the enclosure, wherein the inflatable member comprises at least three chambers and when coupled, the inflatable member is positioned between the enclosure and the heat exchanger,
wherein the heat exchanger is adjustable independent of the compression assembly and the heat exchanger is separate from and moveable relative to the inflatable member, and
wherein the inflatable member comprises a top portion defining a longitudinal axis, a first side portion, a second side portion, and a base portion, and
wherein the first and second side portions extend from the base portion at an acute angle with respect to the longitudinal axis.
As can be seen from the comparison above, claim 15 of ‘309 fails to recite aspects of the heat exchanger including the side arms and top the lobe extending from the base portion; and at least one of the first and second side arms comprising a fastener. However, these aspects are seen to be obvious over Wyatt and Stefanile, as discussed with respect to rejection of claim 1, above.
Allowable Subject Matter
Claims 28 is allowed.
Claim 14 is objected to for being dependent on rejected base claims.
The following is an examiner’s statement of reasons for allowance:
The examiner could find neither reason nor motivation within the prior art of record that would have led POSITA to further modify Akira, as modified, in order to position a temperature sensor within an opening of at least one of the claimed fluid barriers, as disclosed with reference to the embodiment of fig. 11b and par. 77 in applicant’s disclosure.
Therefore, claim 28 is allowed. Further, claim 14 would be allowable if rewritten to include all the limitations of the intervening claims from which it depends.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's preemptive arguments filed 12/3/35 related to Wyatt have been fully considered but they are not persuasive.
Applicant argues that Wyatt cannot be used to teach first and second side arms that warp around sides of the head ‘from the back of the head to the front of the head’. The examiner disagrees with applicant’s narrow interpretation of the claim language and maintains that POSITA would regard the wrapping configuration shown in fig. 3 of Wyatt to satisfy the broadest reasonable interpretation of the claim language.
Regarding applicant’s argument that modifying Wyatt to would render the device in-operable in vehicle mode, the examiner disagrees and maintains that applicant has not provided any specific arguments explaining why modifying Wyatt to comprise a compression system would render it incompatible with a 12-volt vehicle battery. The examiner notes that vehicle batteries are often used to power air-compressors in order to pressurize tires. Therefore, the examiner disagrees that vehicle batteries are fundamentally incompatible with air-compression systems, such as the one disclosed by Akira.
Finally, with respect to applicant’s assertion that modifying Wyatt to comprise a compression assembly would render the device unsafe, the examiner disagrees. Compression is widely used in the prior-art; therefore, the examiner maintains that POSITA would understand how to apply compression in safe-manner without endangering the patient. Further the examiner rejects the premise that the combination would necessitate a bodily incorporation of the exact pressing body disclosed by Akira into Wyatt. For instance, POSITA would understand that compression would only be necessary in places which are actively cooled and would know how to modify the design of Akira to fit the use case of Wyatt. Therefore, the examiner disagrees that the combination would inherently compress the carotid arteries of the user since these areas are not natively cooled by Wyatt. Further, it is well-established that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights