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 Amendment
The amendment filed 01/07/2026 has been entered. Claims 1-2, 5, 8-13, 16-22, 25-26 & 32 remain pending in the application. Claim 33 has been entered. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed 11/05/2025.
Response to Arguments
Applicant's arguments with respect to claims 1-2, 5, 8-13, 16-22, 25-26 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. The previous rejection relied on Christensen in view of Abreu. The new rejection relies on Christensen in view of Goor. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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 1-2, 5, 8-9, 12, 25 & 32 is rejected under 35 U.S.C 103 as being unpatentable over Christensen et al. (US 20090177184) herein referred to as Christensen, in view of Goor (US 6319205) herein referred to as Goor.
Regarding Claim 1, Christensen discloses a therapeutic cooling system configured to cool a body portion (Figure 8), the cooling system comprising: a conformal for covering said body portion configured to extract heat energy from said body portion (Figure 8, 800), wherein said conformal covering is configured to cool one or more fingers or toes (Figure 7; Paragraph [0130]; wherein device 700 is configured to cool a hand or a foot therefore cools the fingers and toes); a sensor device within said conformal covering for sensing a parameter of said body portion (Figure 7, 760), wherein the parameter is at least one selected from the group consisting of: temperature proximate to said body portion, a body metabolism condition of said body portion, and a presence of a therapeutic drug in said body portion (Paragraph [0131]; wherein sensor 761 senses the temperature of the fluid of the conformal covering therefore is seen as proximate to the body portion); an actuator configured for changing an amount of heat energy extracted from said body portion (Paragraph [0133]; wherein controller acts as an actuator by changing the temperature of the device therefore allowing for an adjustment of the amount of heat energy being extracted as well as an actuator can be used); a control unit configured for regulating said actuator responsive to control input from said sensor device (Figure 8, 864). However, Christensen does not explicitly a plurality of individual digit sleeves, each digit sleeve configured to fit over a single finger or toe and to extract heat from said single finger or toe, wherein said individual digit sleeves are structurally separate from each other and are not connected to a palm covering or a sole covering.
Goor discloses therapeutic thermal system (Figure 8) a plurality of individual digit sleeves (Figure 8, 91 & 92), each digit sleeve configured to fit over a single finger or toe and to extract heat from said single finger or toe (Figure 8, 91 & 92; Column 4, lines 58-59; wherein Vasodilation brings warm blood to the skin to increase heat radiation to the environment which is extracting heat;), wherein said individual digit sleeves are structurally separate from each other and are not connected to a palm covering or a sole covering (Figure 8, 91 & 92). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as taught by Christensen to allow for heat extraction from each single finger structurally separated as disclosed by Goor. The motivation being other sites may be used but the finger allows for an advantage due to its easy access (Goor, Column 8, lines 65-67).
Regarding claim 2, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1 wherein said sensor device measures temperature proximate to said body portion (Christensen, Paragraph [0131]; wherein sensor 761 senses the temperature of the fluid of the conformal covering therefore is seen as proximate to the body portion)
Regarding claim 5, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1 wherein said control unit is further configured to adjust an amount of heat extracted from said body portion based on said presence of a therapeutic drug in said body portion, based on manual input, or based on an amount of hair between a skin surface and said conformal covering (Christensen, Paragraph [0132]; The controller is configured to receive inputs from a user and appropriately control the components in accordance with the various inputs and software instructions retained in the controller's memory therefore would be able to adjust an amount of heat being extracted from the body portion by adjusting the temperature which is also discussed in Paragraphs [0145]-[0146])
Regarding claim 8, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1 wherein said control unit is further configured to adjust an amount of heat extracted from said body portion to maintain a safe temperature of said body portion (Christensen, Paragraph [0132]; The controller is configured to receive inputs from a user and appropriately control the components in accordance with the various inputs and software instructions retained in the controller's memory therefore would be able to adjust an amount of heat being extracted from the body portion by adjusting the temperature which is also discussed in Paragraphs [0145]-[0146]; Paragraph [0103]; wherein temperature is monitored to not go pass a safe level).
Regarding claim 9, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1 further comprising a safety device configured to adjust cooling of said body portion in order to maintain a safe temperature of said body portion (Christensen, Paragraph [0103]; wherein a thermocouple monitors the temperature as well works with a thermo switch to shut off the power if cooling passes a safe level).
Regarding claim 12, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1 wherein said conformal covering is further configured to apply compression to said body portion (Christensen, Paragraph [0133]; wherein compression pressurized force is provided to the pressurized volume of the conformal covering).
Regarding claim 25, Christensen discloses a therapeutic cooling system configured to cool a body portion (Figure 8), the cooling system comprising: a conformal covering for covering said body portion configured to extract heat energy from said body portion (Figure 8, 800), wherein said conformal covering is configured to cool one or more fingers (Figure 7; Paragraph [0130]; wherein device 700 is configured to cool a hand or a foot); a cooling device (Figure 7, 720A & 720B); a sensor device within said conformal covering for sensing a parameter of said body portion (Figure 7, 760), wherein the parameter is at least one selected from the group consisting of: temperature proximate to said body portion, a body metabolism condition of said body portion, and a presence of a therapeutic drug in said body portion (Paragraph [0131]; wherein sensor 761 senses the temperature of the fluid of the conformal covering therefore is seen as proximate to the body portion); an actuator configured for changing an amount of heat energy extracted from said body portion (Paragraph [0133]; wherein controller acts as an actuator by changing the temperature of the device therefore allowing for an adjustment of the amount of heat energy being extracted as well as an actuator can be used); a control unit configured for regulating said actuator responsive to control input from said sensor device (Figure 8, 864). However, Christensen does not explicitly disclose a plurality of individual digit sleeves, each digit sleeve configured to fit over a single finger or toe and to extract heat from said single finger or toe, wherein said individual digit sleeves are structurally separate from each other and are not connected to a palm covering or a sole covering.
Goor discloses therapeutic thermal system (Figure 8) a plurality of individual digit sleeves (Figure 8, 91 & 92), each digit sleeve configured to fit over a single finger or toe and to extract heat from said single finger or toe (Figure 8, 91 & 92; Column 4, lines 58-59; wherein Vasodilation brings warm blood to the skin to increase heat radiation to the environment which is extracting heat;), wherein said individual digit sleeves are structurally separate from each other and are not connected to a palm covering or a sole covering (Figure 8, 91 & 92). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as taught by Christensen to allow for heat extraction from each single finger structurally separated as disclosed by Goor. The motivation being other sites may be used but the finger allows for an advantage due to its easy access (Goor, Column 8, lines 65-67).
Regarding claim 32, Christensen in view of Goor discloses the therapeutic cooling system of Claim 25 wherein said cooling device is a part of said conformal covering (Christensen, Figure 7, 720A &720B)
Claims 10, 13 & 33 are rejected under 35 U.S.C 103 as being unpatentable over Christensen and Goor in view of Paxman et al. (US 20130138185) herein referred to as Paxman.
Regarding claim 10, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1. However, Christensen in view of Goor does not explicitly disclose wherein said actuator, said control unit and a source of cooling are secured to a patient to enable said patient to walk during treatment.
Paxman discloses a therapeutic thermal management system configured to cool a first
body portion (Figure 1) wherein said actuator, said control unit and a source of cooling are secured to a patient to enable said patient to walk during treatment (Figure 1; wherein actuator and control unit are on wheels allowing for patient to be able to move with the source of cooling 210 on). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Christensen and Goor to be portable as taught by Paxman. The motivation being to be able to move the unit easily (Paxman, Paragraph [0168])
Regarding claim 13, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1. However, Christensen in view of Goor does not explicitly disclose a second conformal covering for covering a second body portion configured to extract heat energy from said a second body portion, wherein said second conformal covering is configured to operate independently of said first conformal covering.
Paxman discloses a therapeutic thermal management system (Figure 4) wherein a second conformal covering for covering a second body portion configured to extract heat energy from said a second body portion (Figure 210a & 210), wherein said second conformal covering is configured to operate independently of said first conformal covering (Figure 4; wherein fluid from the 210a is transferred through 220a tubing and the connector 230 to 220 tubing to the second body portion and if the temperature of the second body portion is lower than the liquid, heat energy is applied). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Christensen and Goor to be portable as taught by Paxman. The motivation being to supply heat extraction to two different locations (Paxman, Abstract)
Regarding claim 33, Christensen in view of Goor discloses the therapeutic cooling system of Claim 1 wherein: said one or more parameters comprises a temperature of at least one of the one or more body portions (Christensen, Paragraph [0061]; wherein temperature of the patient is monitored); said therapeutic cooling system is configured to be secured to a patient and to allow said patient to be ambulatory (Goor, Column 19 lines, 11-14; wherein device can be used during exercise stress test therefore is seen as secure and allowing for patient to be ambulatory); and said conformal covering is further configured to apply compression to said one or more fingers or toes (Goor, abstract; wherein the finger sleeve applies pressure through a pressure cuff therefore is applying compression to the fingers). However, Christensen in view of Goor does not explicitly disclose said control unit is configured to control said actuator in response to detection of a presence of a therapeutic drug in said body portion.
Paxman discloses a therapeutic thermal management system (Figure 4) said control unit
is configured to control said actuator in response to detection of a presence of a therapeutic drug in said body portion (Paxman, Paragraph [0028]; wherein patients undergoing different drug treatments are able to have a preprogrammed control module that allows for the desired heat transfer characteristics to be actuated); Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Christensen and Goor to be controlled based on presence of a therapeutic drug as taught by Paxman. The motivation being allows for the desired heat transfer characteristics based on different drug treatments (Paxman, Paragraph [0028])
Claims 11 & 26 are rejected under 35 U.S.C 103 as being unpatentable over Christensen and Goor in view of Swyer et al. (US 2014034777) herein referred to as Swyer.
Regarding claim 11, Christensen in view of Goor discloses the therapeutic cooling system of claim 1 wherein the said body portion is a hand (Paragraph [0130]; wherein device 700 is configured to cool a hand or a foot). However, Christensen in view of Goor does not explicitly disclose wherein said conformal covering is configured to allow use of said hand.
Swyer discloses a therapeutic cooling system (Figure 1) wherein said body portion includes a hand (Figure 1, 102), and said conformal covering is configured to allow use of said hand (Figure 2, patch; wherein the patch only overs a portion of the palm therefore the fingers are still able to be used). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the conformal covering taught by Christensen and Goor to allow use of a hand as taught by Swyer. The motivation being it would be obvious to try different conformal covering designs for the purpose of allowing hand use (MPEP § 2143 (E)).
Regarding claim 26, Christensen in view of Goor discloses the therapeutic cooling system of claim 25. However, Christensen in view of Goor does not explicitly disclose wherein said cooling device comprises a vortex tube, a closed loop heat pump, a remote radiator, a pre-cooled gas, a thermoelectric cooler, or a source of gas at ambient temperature and cooling is affected by expansion of said gas.
Swyer discloses a therapeutic cooling system (Figure 1) wherein the cooling system comprises an expansion chamber wherein the air is cooled (Figure 3, Paragraph [0084]; wherein heat transfer of air by conducting it into an expansion chamber of a refrigeration cycle 140, wherein the air is to be cooled). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the cooling system taught by Christensen and Goor to include the teachings of Swyer’s cooling system. The motivation being applying a known technique, cooling air is by expansion of said air to a known device, a cooling system such as Christensen’ s to yield predictable results such as cooled air for treatment (MPEP § 2143 (D)).
Claims 16-17, 19 & 21-22 are rejected under 35 U.S.C 103 as being unpatentable over Paxman and Christensen in further view of Goor.
Regarding claim 16, Paxman discloses a therapeutic thermal management system configured to cool a first body portion and warm a second body portion (Figure 4), the system comprising: a first conformal covering for covering said first body portion (Figure 4, 210a), configured to extract heat energy from said first body portion (Paragraph [0213]; wherein if the temperature of the coolant from the heat exchanger is than the temperature of the user of 210a scalp then heat is transferred from the scalp of the user to the coolant); a second conformal covering for covering said second body portion (Figure 4, 210), configured to apply heat energy from said second body portion (Figure 4; wherein fluid from the 210a is transferred through 220a tubing and the connector 230 to 220 tubing to the second body portion and if the temperature of the second body portion is lower than the liquid, heat energy is applied); an actuator configured for changing an amount of heat energy extracted from said first body portion and applied to said second body portion (Figure 4, 110; Paragraph [0213]; wherein heat exchanger 110 can change the temperature of the fluid within the system which allows for the changing of heat energy extraction and delivery); a control unit configured for regulating said actuator (Figure 4, 130). However, Paxman does not explicitly disclose wherein said first conformal covering comprises a plurality of individual digit sleeves, each digit sleeve configured to fit over a single finger or toe and to extract heat from said single finger or toe, wherein said individual digit sleeves are structurally separate from each other and are not connected to a palm covering or a sole covering; wherein first and second sensor devices within said first and said second conformal coverings for sensing a parameter of said first and second body portions.
Christensen discloses a therapeutic cooling system (Figure 7) wherein a sensor device is
within a conformal covering for sensing a parameter of a body portion (Figure 7, 760; Paragraph [0131]; wherein sensor 761 senses the temperature of the fluid of the conformal covering therefore is seen as proximate to the body portion). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second conformal covering taught by Paxman to include the sensor taught by Christensen. The motivation being to sense the temperature of the fluid flowing through the body and the fluid supply line (Christensen, Paragraph [0131])
Goor discloses therapeutic thermal system (Figure 8) a plurality of individual digit sleeves (Figure 8, 91 & 92), each digit sleeve configured to fit over a single finger or toe and to extract heat from said single finger or toe (Figure 8, 91 & 92; Column 4, lines 58-59; wherein Vasodilation brings warm blood to the skin to increase heat radiation to the environment which is extracting heat;), wherein said individual digit sleeves are structurally separate from each other and are not connected to a palm covering or a sole covering (Figure 8, 91 & 92). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as taught by Christensen to allow for heat extraction from each single finger structurally separated as disclosed by Goor. The motivation being other sites may be used but the finger allows for an advantage due to its easy access (Goor, Column 8, lines 65-67).
Regarding claim 17, Paxman and Christensen in further view of Goor discloses the therapeutic thermal management system of claim 16. Paxman also discloses wherein heat extracted from said first body portion is applied to said second body portion (Figure 4; wherein fluid from the 210a is transferred through 220a tubing and the connector 230 to 220 tubing to the second body portion and if the temperature of the second body portion is lower than the liquid, heat energy is applied).
Regarding claim 19, Paxman and Christensen in further view of Goor discloses the therapeutic thermal management system of claim 16. Christensen also discloses a replaceable liner (Paragraph [0161]; wherein disposable liners or inserts may be used). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Paxman and Christensen in further view of Goor to include the disposable liner as taught by Christensen. The motivation being to meet health and safety requirements (Christensen, Paragraph [0161]).
Regarding claim 21, Paxman and Christensen in further view of Goor discloses the therapeutic thermal management system of claim 16. Paxman also discloses wherein said a control unit is further configured to control at least one of said first and second conformal coverings from zero pressure to a therapeutic pressure to prevent shock to a patient's skin (Figure 4; Paragraph [0114]; wherein control unit controls a pump that is used to create a therapeutic pressure within the conformal coverings, when the pump is not on it would be at zero pressure and then turned on to increase to a therapeutic pressure).
Regarding claim 22, Paxman and Christensen in further view of Goor discloses the therapeutic thermal management system of claim 16. Paxman also discloses wherein said a control unit is further configured to accept manual control inputs from a portable computer device to control a desired temperature of said first conformal covering (Figure 4, 139; Paragraph [0189]; wherein the user interface 139 can be used to manually control the amount of heat being transferrable), wherein optionally said portable computer device is further configured to accept input of a specific drug therapy and responsive to said input automatically initiate an appropriate cooling protocol for said specific drug therapy (Paragraph [0028]; wherein patients undergoing different drug treatments are able to have a preprogrammed module that allows for the desired heat transfer characteristics).
Claims 18 & 20 are rejected under 35 U.S.C 103 as being unpatentable over Paxman, Christensen and Goor in view of Swyer.
Regarding claim 18, Paxman and Christensen in further view of Goor discloses the therapeutic thermal management system of claim 16. However, Paxman and Christensen in further view of Goor does not explicitly disclose wherein at least one of said first and second sensor devices is configured to measure cellular metabolism.
Swyer discloses a therapeutic thermal system (Figure 1) wherein a sensor device is configured to measure cellular metabolism (Figure 150, 3; Paragraph [0009]; wherein sensor can be used to measure metabolic rate by measuring oxygen consumption). Therefore, it would be obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to substitute the sensor taught by Paxman and Christensen in further view of Goor to be the sensor taught by Swyer. The motivation being to monitor the metabolism in a user since heat is being removed from the body therefore increasing the metabolic rate (Swyer, Paragraph [0009])
Regarding claim 20, Paxman, Christensen and Goor in further view of Swyer disclose the therapeutic thermal management system of claim 18. Paxman also discloses wherein said a control unit is further configured to ramp at least one of said first and second conformal coverings from ambient temperature to a therapeutic temperature to prevent shock to a patient's skin (Paragraph [0213]; wherein control unit is used to adjust the temperature of the actuator therefore could adjust it from ambient temperature to a therapeutic temperature)
Conclusion
THIS ACTION IS MADE FINAL. 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 ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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