DETAILED ACTION
This action is responsive to the RCE filed 9/5/25.
Claims 27-57 are rejected.
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 27-29, 41, 43, 55 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fronda et al. (US 20140236271, “Fronda”).
Regarding claim 27, Fronda teaches a method of cooling a scalp of a head of a patient (Par. 1, ‘This invention relates to headwear for removing heat from a person's scalp in order to prevent hair loss.’) to reduce hair loss resultant from chemotherapy (Par. 45, ‘The headwear 2 is able to prevent or reduce hair loss during chemotherapy, and thereby to provide an important psychological boost to the person 70 at a time when they need it and are being treated by the chemotherapy for cancer.’), the method comprising: placing a heat exchanger around a portion of the scalp of a patient (Fig. 2 and Abstract, ‘Headwear (2) for removing heat from a person's scalp in order to prevent hair loss, comprising a body portion (4) for fitting over the scalp […]’), the heat exchanger coupled to a cooling unit comprising a compressor (Fig. 4 and par. 48, ‘In contrast, in the apparatus 76, the cold fluid is cooled using a refrigeration unit such as the illustrated heat/cooler unit 90. The refrigeration unit may be a Peltier cooler which operates using a Peltier effect. Alternatively, the refrigeration unit may be a compressor such for example as a compressor used for a refrigeration unit in a refrigerator.’); administering a cooling treatment using the heat exchanger and the cooling unit in conjunction with a chemotherapy treatment at a first location in an infusion center (Abstract, ‘Headwear (2) for removing heat from a person's scalp in order to prevent hair loss […]’; par. 45, ‘The headwear 2 is able to prevent or reduce hair loss during chemotherapy, and thereby to provide an important psychological boost to the person 70 at a time when they need it and are being treated by the chemotherapy for cancer.’); and continuing the cooling treatment using the heat exchanger and the cooling unit while the patient, with the cooling unit, is moving independently to a second location in the infusion center different from the first location (Par. 44, ‘Thus the person 70 is able to move the entire apparatus 20 from one position to another, for example if the person 70 should wish to obtain a beverage or something else during a treatment session. Because the apparatus is battery powered, the apparatus 40 is not limited to movement which is the length of an electrical lead plugged into a socket which would be required if the apparatus were mains powered.’).
Regarding claim 43, Fronda teaches a method of cooling a scalp of a head of a patient (Par. 1, ‘This invention relates to headwear for removing heat from a person's scalp in order to prevent hair loss.’) diagnosed with cancer to reduce hair loss resultant from chemotherapy (Par. 45, ‘The headwear 2 is able to prevent or reduce hair loss during chemotherapy, and thereby to provide an important psychological boost to the person 70 at a time when they need it and are being treated by the chemotherapy for cancer.’), the method comprising: placing a heat exchanger (Abstract, ‘Headwear (2) for removing heat from a person's scalp in order to prevent hair loss, comprising a body portion (4) for fitting over the scalp […]’) and compression assembly (Par. 6, ‘The headwear is able to be used with a pressure which causes the body portion to be pressed into good contact with the person's scalp’) around a portion of the scalp of the patient diagnosed with cancer (Fig. 2), the heat exchanger coupled to a cooling unit (Fig. 4, headwear 2 coupled to apparatus 76 which comprises a heat pump unit 88); cooling a fluid (Par. 48, ‘In contrast, in the apparatus 76, the cold fluid is cooled using a refrigeration unit such as the illustrated heat/cooler unit 90.’) and circulating the fluid through the heat exchanger using the cooling unit at a first location (Fig. 4, showing the cooling fluid circulating through headwear 2 and heater/cooler 90); and moving, by the patient independently, the cooling unit from the first location to a second location while circulating the fluid through the heat exchanger using the cooling unit (Par. 44, ‘Thus the person 70 is able to move the entire apparatus 20 from one position to another, for example if the person 70 should wish to obtain a beverage or something else during a treatment session. Because the apparatus is battery powered, the apparatus 40 is not limited to movement which is the length of an electrical lead plugged into a socket which would be required if the apparatus were mains powered.’), wherein circulating the fluid removes heat from the scalp to reduce hair loss resultant from chemotherapy (Par. 45, ‘The headwear 2 is able to prevent or reduce hair loss during chemotherapy […]’).
Regarding claim 28, Fronda further teaches wherein the cooling treatment comprises continuously circulating a fluid through the heat exchanger (Fig. 4 and Abstract, ‘[…] the body portion (4) comprises a plurality of internal walls (14) which define a passageway (18) through the body portion (4) from the inlet (6) to the outlet (8) whereby the cold fluid is able to circulate through the body portion (4)’).
Regarding claim 29, Fronda further teaches wherein the cooling treatment removes heat from the scalp to reduce hair loss resultant from chemotherapy (Par. 45, ‘The headwear 2 is able to prevent or reduce hair loss during chemotherapy […]’).
Regarding claims 41 and 55, Fronda further teaches wherein the cooling unit comprises an internal power source (Par. 27, ‘Advantageously, the apparatus is battery powered.’).
Regarding claim 57, Fronda further teaches wherein the heat exchanger comprises a temperature sensor (Fig. 4 and par. 46, ‘The apparatus 76 comprises an upstream temperature sensor 78, a downstream temperature sensor 80’) and administering the cooling treatment is based on a temperature measured by the temperature sensor (Par. 46, ‘In operation, the feed pump 84 and the drain pump 96 are speed controlled by a microprocessor (not shown) which uses information from the temperature sensors 78, 80 and the pressure sensor 82.’).
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) 42, 44, 46, 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fronda.
Regarding claims 42 and 56, Fronda, as modified, fails to teach wherein the cooling treatment circulates fluid through the heat exchanger at a temperature of from about -10° C to about 5° C.
The examiner maintains, however, that it would have been obvious to POSITA at the time the invention was filed to optimize the temperature of the fluid circulating through the heat exchanger 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 44, Fronda further teaches actuating a fluid pump to increase a pressure applied by the compression assembly to the head via the heat exchanger (Par. 22, ‘The apparatus of the invention may operate such that pressure in the headwear is maintained by a pump which pumps cold fluid, for example water, to the headwear faster than it can flow through the flow restrictor.’).
Fronda, as modified, fails to explicitly teach that the pump is actuated by the patient.
The examiner, maintains, that it would have been obvious to POSITA to make the compression pump actuatable by the patient, since Fronda is explicitly intended to be portable (Par. 50). Therefore, it follows that POSITA would find it obvious to configure the device to be actuatable by the patient in order to allow the device to be operated in a location absent a doctor or clinician.
Regarding claim 46, Fronda, as modified, fails to teach wherein each of placing the heat exchanger, placing the compression assembly, and actuating the fluid pump is performed without the assistance of a medical professional.
The examiner, maintains, however, that it would have been obvious to POSITA to make the heat-exchange element and compression assembly operatable by a patient without assistance, since Fronda is explicitly disclosed to be portable (Par. 50). Therefore, it follows that POSITA would find it obvious to configure the device to be usable by a patient without the assistance in order to allow the device to be operated in a location absent a doctor or clinician.
Claim(s) 30-32, 34, 45 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fronda in view of in view of Akira (JP H08131473).
Regarding claims 30 and 45, Fronda while teaching a compression assembly, fails to teach placing the compression assembly on the head of the patient after placing the heat exchanger.
Akira teaches a method of cooling a scalp of a head of a patient (Par. 1, ‘The present invention relates to a head cooling device, More specifically, it relates to a device for cooling the head by supplying a cooling medium to the vicinity of the surface of the head.’), the method comprising: placing a heat exchanger around a portion of the scalp 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.’), the heat exchanger coupled to a cooling unit comprising a compressor (Pg. 4, par. 3, ‘compressor-type cooler’); and placing a compression assembly on the head of the patient after placing the heat exchanger (fig. 3, pressing body 3 placed over heat exchange section 4).
Therefore, since both Fronda and Akira teach different means for applying compression in order to facilitate contact between a heat exchanger and the scalp of a patient, it would have been obvious to POSITA at the time that the invention was filed to substitute one known compression means for the other in order to achieve the predictable result of a means for applying compression in order to facilitate contact between a heat exchanger and the scalp of a patient. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 31, Fronda, as modified, further teaches actuating a fluid pump to increase a pressure applied by the compression assembly to the head via the heat exchanger (Fronda has previously been modified in view of Akira to comprise the compression assembly of Akira; see Akira, pg. 4, par. 6, ‘the pressurizing unit 8 supplies pressurized air to the air bag 3a to inflate the air bag 3a, As shown by B in FIG. 6, the heat exchange section 4 can be pressed against the head and the neck (seethe lowermost solid line in FIG. 6) with an appropriate pressure.’).
Fronda, as modified, fails to explicitly teach that the pump is actuated by the patient.
The examiner, maintains, that it would have been obvious to POSITA to make the compression pump actuatable by the patient, since Fronda is explicitly disclosed to be portable (Par. 50). Therefore, it follows that POSITA would find it obvious to configure the device to be actuated by the patient in order to allow the device to be operated in a location absent a doctor or clinician.
Regarding claim 32, Fronda, as modified, fails to teach wherein each of placing the heat exchanger, placing the compression assembly, and actuating the fluid pump is performed without the assistance of a medical professional.
The examiner, maintains, however, that it would have been obvious to POSITA to make the heat-exchange element and compression assembly placeable on the scalp by a patient without assistance, since Fronda is explicitly disclosed to be portable (Par. 50). Therefore, it follows that POSITA would find it obvious to configure the device to be usable by a patient without the assistance in order to allow the device to be operated in a location absent a doctor or clinician.
Regarding claims 34 and 48, Fronda, as modified, further teaches wherein the compression assembly comprises an inflatable member (Fronda has previously been modified in view of Akira to comprise the compression assembly of Akira; see Akira, Fig. 3, pressing body 3), and actuating the fluid pump increases a pressure inside the inflatable member (See Akira, pg. 3, par. 6, ‘And a pressurizing unit 8 that supplies a pressure fluid (for example, air) to the pressing body 3 with a pressurizing command as an input.’).
Claim(s) 33 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fronda in view of Akira, as applied to claims 30-32, 34, 45 and 48 above, and further in view of Goldsmith (US 5407421).
Regarding claims 33 and 47, Fronda, as modified, teaches a compression assembly (Fronda has previously been modified in view of Akira to comprise the compression assembly of Akira; see Akira, Fig. 3, pressing body 3) inflatable by a fluid pump (See Akira, pg. 3, par. 6, ‘And a pressurizing unit 8 that supplies a pressure fluid (for example, air) to the pressing body 3 with a pressurizing command as an input.’), but fails to teach wherein the fluid pump is a hand pump.
Goldsmith teaches a similar thermotherapeutic device (Col. 3, lines 52-54, ‘Another object is to provide a removable thermal bladder that can be heated or cooled and reattached to the brace.’) which comprises a inflatable member (Abstract, ‘The brace includes one or more air inflatable bladders […]’) for supplying compression (Abstract, ‘ Air is then introduced into the air bladder via an air inlet valve, forming a compressive force on the body part in contact.’) which is inflated using a hand pump (Fig. 1 and col. 6, lines 44-45, ‘Bladder 30 is filled with air such as by using hand bulb 44 (FIG. 1)’).
Therefore, in view of Goldsmith it would have been obvious to POSITA at the time that the invention was filed to further modify Fronda, as modified, by utilizing a hand-pump in place of an electrical pump in order to reduce the bulkiness of the device and increase its portability.
Claim(s) 35-37 and 49-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fronda in view of Zumbrunnen et al. (US 20170209304, “Zumbrunnen”).
Regarding claims 35 and 49, Fronda, as modified, fails to teach wherein continuing the cooling treatment while the patient is moving independently with the cooling unit comprises applying, by the patient, a force to a handle of the cooling unit to move the cooling unit.
Zumbrunnen teaches a method of cooling a scalp of a head of a patient to reduce hair loss resultant from chemotherapy (Abstract, “A non-user assisted, portable, entirely self-managed capable hypothermia device to eliminate hair loss caused by the side effects of certain chemotherapy”), the method comprising: placing a heat exchanger around a portion of the scalp of a patient (Fig. 1 and par. 30, ‘a flexible and conformal cap system 102 that is worn by a user’), the heat exchanger coupled to a cooling unit (Fig. 1, cooler system 101); administering a cooling treatment using the heat exchanger (Par. 64 describes the cooling treatment regimen) and the cooling unit in conjunction with a chemotherapy treatment at a first location in an infusion center (Par. 3, ‘Therapeutic hypothermic treatments can reduce the distressing side effect of alopecia caused by chemotherapy treatment by cooling the scalp to below 19° C. during the chemotherapy session and for a brief time before and after the session.’); and continuing the cooling treatment using the heat exchanger and the cooling unit while the patient, with the cooling unit, is moving independently to a second location in the infusion center different from the first location (Par. 22, ‘Yet another object of the present invention is for the device to be fully functional while in transit or away from the treatment center. This could be for example restroom visits, other appointments, walking to/from one's car, traveling in a car, or simply finishing the cooling phase at home.’); and wherein continuing the cooling treatment while the patient is moving independently with the cooling unit comprises applying, by the patient (claim 1, ‘can be transported by a single person, requires no assistance to a user before, during, or after usage’), a force to a handle of the cooling unit to move the cooling unit (Fig. 1 and par. 32, ‘The purpose of the casters and telescoping handle is to aid in the mobility object of the invention.’).
Therefore, in view of Zumbrunnen, it would have been obvious to POSITA at the time that the invention was filed to provide an adjustable handle to the portable cooling unit, in order to aid in mobility of the device, as taught by Zumbrunnen.
Regarding claims 36 and 50, Fronda, as modified, further teaches transitioning the handle between a first configuration and a second configuration (Fronda has previously been modified in view of Zumbrunnen to comprise a telescoping handle; see Zumbrunnen, fig. 1 and par. 32, ‘The purpose of the casters and telescoping handle is to aid in the mobility object of the invention.’).
Regarding claims 37 and 51, Fronda, as modified, further teaches wherein continuing the cooling treatment/moving the cooling unit comprises rolling the cooling unit using the handle in the second configuration (Fronda has previously been modified in view of Zumbrunnen to comprise a telescoping handle; see Zumbrunnen, fig. 1 and par. 32, ‘The purpose of the casters and telescoping handle is to aid in the mobility object of the invention.’).
Claim(s) 38 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fronda in view of Hopper et al. (US 20140343639, “Hopper”).
Regarding claims 38 and 52, Fronda teaches wherein the cooling unit comprises a housing coupled to a fluid reservoir (Fig. 4, housing of main tank 94), but fails to teach wherein the method further comprises separating the fluid reservoir from the housing.
Hopper teaches an analogous thermal control system for circulating a thermal fluid through various thermal pads (Abstract) which comprises a housing coupled to a fluid reservoir (Fig. 3, removable reservoir 38 coupled to thermal control unit 22), and wherein the method further comprises separating the fluid reservoir from the housing (Fig. 3 and par. 4, ‘a thermal control unit is provided with a removable reservoir that improves the convenience of using the unit’).
Therefore, in view of Hopper, it would have been obvious to POSITA at the time that the invention was filed to modify Fronda by configuring the reservoir to be removable from the device, in order to facilitate refilling of the reservoir, as taught by Hopper.
Claim(s) 39-40 and 53-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fronda in view of Dabrowiak et al. (US 20200330263).
Regarding claims 39 and 53, Fronda, as modified, teaches wherein when the patient is in the first location, the power source is wall power (Par. 50, ‘With a refrigeration unit, the refrigeration unit would usually be mains operated but with the facility of battery operation to enable a person to move to a new destination and plug back into the mains.’), and when the patient is moving independently to the second location, the power source is a battery (Par. 50, ‘With a refrigeration unit, the refrigeration unit would usually be mains operated but with the facility of battery operation to enable a person to move to a new destination and plug back into the mains.’), but fails to teach the method steps of: determining a power source of the cooling unit; and selecting an active operation state of the cooling unit based on the determined power source.
Dabrowiak teaches an analogous thermotherapeutic device (Abstract), which is configured to operate either from an internal battery power source or an AC power source (Par. 10, ‘a processor connected to various circuits for monitoring the charge status of each of the one or more batteries configured to power the heat exchange system, and for automatically switching from alternating current to battery-supplied direct current if the alternating current supply is interrupted. ’); wherein its method of operation comprises the method steps of determining a power source of the cooling unit, and selecting an active operation state of the cooling unit based on the determined power source (Par. 15, ‘wherein the processor responsive to the interruption of a connection with the alternating current source, controls the compressor to a low speed and to monitors a current draw by the system’).
In view of Dabrowiak, it would have been obvious to POSITA at the time that the invention was filed to configure the device to select an operation mode of the cooling unit based on an identified power source, in order to operate the device at a lower power mode when limited battery power is available, as taught by Dabrowiak.
Regarding claims 40 and 54, Fronda, as modified, further teaches wherein a fluid flow rate of the cooling treatment is based on the determined power source (Fronda has previously been modified in view of Dabrowiak to change the mode of operation based on the identified power source; see Dabrowiak, par. 180, ‘In one embodiment, a look-up table accessible by the processor may contain data indicative of what operating modes can be used depending on duration of transport and/or battery capacity or charge level […] Alternatively, the processor may automatically alter some other operating parameter, such as, for example, pump speed or fluid flow to ensure that the desired operating mode can be maintained for the expected duration of the transport.’).
Response to Arguments
Applicant’s arguments with respect to claim(s) 27 and 43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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
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