DETAILED ACTION
Primary Examiner acknowledges Claim 1-27 are pending in this application as originally filed on June 14, 2023.
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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
In particular, the patent documents listed on Page 4, Middle Paragraph, and Last Paragraph and the several NPL documents listed on Page 3, Last Paragraph; Page 4, First Paragraph. Additionally, it is noted the aforementioned NPL documents have not been filed with a legible copy within this instant application, pursuant to 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Appropriate correction is required.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specifically, the abstract is over 150 words in length. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 and 25-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 1, Line 7 recites the limitation “the cooling subsystem”; however, this limitation does not appear to have antecedent basis in the claims. Primary Examiner is unsure how the limitation of “the cooling subsystem” relates to the formerly introduced “heat transfer subsystem” of Claim 1, Line 3. Consequently, Primary Examiner is unsure if the limitation of “the cooling subsystem” is a typographical error and should read “the heat transfer subsystem” or alternatively if Applicant is attempting to introduce the “cooling subsystem” as an additional component. Hence, the breadth and scope of the claimed subject matter is unclear and indefinite. Still further, it should be noted as claims appear to contain variants of “cool or heat” it is unclear how the “cooling system” is able to provide the functionality of “heat”. Dependent claims, Claims 2-16, incorporate the indefinite subject matter from which they depend. Explicitly, it is noted the term “cooling subsystem” is explicitly referenced in Claims 4, 10, and 12. Appropriate correction and clarification is required.
Specifically, Claim 1, Line 14 recites “cooled air or breathable gas”; however, the breadth and scope of this limitation appears to be unclear, when the former recitations appear to emphasis the duality of “cool or heat” and its variants as the functionality of the claimed system. Primary Examiner is unsure if perhaps this is a typographical error and should read “cooled or heated air or breathable gas” or alternatively if Applicant is attempting to narrow the functionality of the temperature sensors to be only concerned with “cooled air or breathable gas” – perhaps as a functionality only provided by the “cooling subsystem” as introduced in Claim 1, Line 7. Dependent claims, Claims 2-16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 4, Line 1 recites the limitation “the cooling subsystem cooling subsystem” which appears to be unclear. Primary Examiner is unsure if the limitation of “the cooling subsystem” is a typographical error and should read “the cooling subsystem”. Consequently, the breadth and scope of the claimed subject matter is unclear and indefinite. Dependent Claim 5 incorporates the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 5, Lines 2 and 3 recites the limitation “cooled or heated air or breathable gas”; however, this recitation appears to be in conflict with the explicit concerns and operations of the “cooling subsystem”. It appears the operation of the “cooling subsystem” should be limited to “cool” and its variants only. Thus, the recitation of “cooled or heated” appears to be indefinite. Appropriate correction and clarification is required.
Specifically, Claim 10, Line 1 recites the limitation “cooled or heated air or breathable gas”; however, this recitation appears to be in conflict with the explicit concerns and operations of the “cooling subsystem”. It appears the operation of the “cooling subsystem” should be limited to “cool” and its variants only. Thus, the recitation of “cooled or heated” appears to be indefinite. Dependent Claim 11 incorporates the indefinite subject matter from which it depends and appears to explicitly recite the indefinite terminology of “cooled or heated”. Appropriate correction and clarification is required.
Specifically, Claim 11, Line 1 recites the limitation “the air block”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure how the term “the air block” relates to the formerly introduced limitation of “a gas block” of Claim 10, Line 1. Does Applicant intent for these terms “gas block” and “air block” to be coextensive or separate and distinct? Regardless, the breadth and scope of the claimed subject matter is unclear and indefinite. Appropriate correction and clarification is required.
Specifically, Claim 12, Lines 1 and 2 recite the limitation “a heat transfer subsystem”; however, the breadth and scope of this limitation is unclear. What is the relationship if any between the formerly recited “heat transfer subsystem” of Claim 1, Line 3? Is the “heat transfer subsystem” of Claim 12 an additional “heat transfer subsystem” or some other feature. Dependent claims, Claims 13-16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 12, Line 2 recites the limitation “the gas block”; yet, this limitation appears to lack antecedent basis in the claims, based on the dependency of Claim 12 to Claim 1. It appears the former introduction of “a gas block” is in Claim 10, Line 1. Consequently, Primary Examiner is unsure if Applicant intends for the parentage of Claim 12 to include Claim 10, or if this is an attempt to introduce the gas block in another claim lineage. Hence, the breadth and scope of the claimed subject matter is unclear and indefinite. Dependent claims, Claims 13-16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 12, Line 2 recites the limitation “the thermal electric cooling (TEC) device”; yet, this limitation appears to lack antecedent basis in the claims. The term “the thermal electric cooling (TEC) device” was not formerly introduced thus the breadth and scope of the claim limitation is unclear. Dependent claims, Claims 13-16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 13, Lines 4 and 6 recites the limitation “cooled or heated air or breathable gas”; however, this recitation appears to be in conflict with the explicit concerns and operations of the “cooling subsystem”. It appears the operation of the “cooling subsystem” should be limited to “cool” and its variants only. Thus, the recitation of “cooled or heated” appears to be indefinite. Appropriate correction and clarification is required.
Specifically, Claim 14 recites “a heat exchange transfer subsystem coupled to the heat transfer subsystem”; however, the breadth and scope of this limitation is unclear. The term” heat transfer subsystem” as initially introduced in Claim 1, Line 3; however, along the parentage of Claim 14, Applicant recites another “heat transfer subsystem” of Claim 12, which appears to be related only to the “cooling subsystem”. Primary Examiner is unclear how many “heat transfer subsystem” are required and further whether the “heat transfer subsystem” of Claim 12 is a misnomer and should be the “heat exchange transfer subsystem”. Dependent claims, Claims 15 and 16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 25, Line 2 recites the limitation “the thermal electric cooling (TEC) device”; yet, this limitation appears to lack antecedent basis in the claims. The term “the thermal electric cooling (TEC) device” was not formerly introduced thus the breadth and scope of the claim limitation is unclear. Dependent claims, Claims 26 and 27, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-14 and 17-27 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by over Geist et al. (2012/0031405) OR, IN THE ALTERNATIVE, under 35 U.S.C. 103 as obvious over Geist et al. (2012/0031405) in view of Fearnot et al. (2013/0000642).
As to Claim 1, Geist discloses a system for regulating the temperature of the brain (“brain cooling system” Abstract) of a human subject, the system comprising: a heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming – “Brain cooling system 10 includes a gas delivery system 20 and a cooling apparatus 40.” Para 0017, wherein 40 – “The cooling apparatus 40, or the location at which the cooling apparatus 40 cools the respiratory gas to be inhaled by a subject, may even be located just upstream (e.g., within about 18 inches, within about 12 inches, etc.) from the interface element 30, or from a location at which respiratory gas enters the nasal cavity of the subject.” Para 0026, also see: “In some embodiments, the cooling apparatus 40 may utilize known convective heat transfer methods. As an example, the cooling apparatus 40 may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment. In some embodiments, the cooling apparatus 40 may employ a coolant (e.g., FREON, etc.). In other embodiments, the cooling apparatus 40 may use one or more thermoelectric Peltier effect devices, such as those manufactured by Tellurex Corporation of Traverse City, Mich., to draw heat directly from a radiator/heat sink.” Para 0027; and wherein 57 - “A rewarming element 57 may enable use of brain cooling system 10 to facilitate a post-cooling increasing the temperature of a subject's brain, or "rewarming." In some embodiments, the rewarming element 57 may comprise an element configured to heat respiratory gas. Such a rewarming element 57 may communicate with the gas delivery system 20, which may introduce heated respiratory gas (relative to the temperature of the previously delivered cool respiratory gas and, in some embodiments, gradually increasing over time) into the subject's nasal cavity. In some embodiments, the cooling apparatus 40 may also serve as a rewarming element 57. By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows. Although the rewarming element 57 is depicted in FIG. 1 as comprising at least a part of the same element as the cooling apparatus 40, the cooling apparatus 40 and the rewarming element 57 may comprise separate elements.” Para 0044) configured to input a flow of air or breathable gas (22 via 20, “The pressurization apparatus 25 of a gas delivery system 20 of a brain cooling system 10 of the present invention may receive air, oxygen, or an oxygen-rich mixture of gases from a source 22. The source 22 may comprise a source of substantially pure oxygen (e.g., a gas tank, etc., containing the oxygen), the atmosphere, or a combination of the source of oxygen and the atmosphere. ”Para 0018), cool (via 40) or heat (via 57) the air or breathable gas (22 via 20), and output cooled (via 40) or heated (via 57) air or breathable gas to a line (29, “The pressurization apparatus 25 compresses the respiratory gas so that it may be delivered, under positive pressure, to an outlet 26 of the pressurization apparatus, and through an inspiratory breathing conduit 29 that communicates with the interface element 30. In some embodiments, the inspiratory breathing conduit 29 may be coupled directly to the outlet 26 of the pressurization apparatus 25.” Para 0019) to a device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024) adapted to deliver the cooled (via 40) or heated (via 57) air or breathable gas to a human subject; a flow control device (25, Para 0019-0022) coupled to the cooling subsystem (40, “The cooling apparatus 40, or the location at which the cooling apparatus 40 cools the respiratory gas to be inhaled by a subject, may even be located just upstream (e.g., within about 18 inches, within about 12 inches, etc.) from the interface element 30, or from a location at which respiratory gas enters the nasal cavity of the subject.” Para 0026, also see: “In some embodiments, the cooling apparatus 40 may utilize known convective heat transfer methods. As an example, the cooling apparatus 40 may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment. In some embodiments, the cooling apparatus 40 may employ a coolant (e.g., FREON, etc.). In other embodiments, the cooling apparatus 40 may use one or more thermoelectric Peltier effect devices, such as those manufactured by Tellurex Corporation of Traverse City, Mich., to draw heat directly from a radiator/heat sink.” Para 0027) configured to control a flow rate (“Moreover, the respiratory gas may be delivered by the pressurization apparatus 25 at a substantially constant rate of flow. "Substantially constant," when used in reference to "rate of flow" or "flow rate," includes, but is not limited to, flow rates that vary by no more than about 10% from a predetermined flow rate.” Para 0023) of the flow of the air or breathable gas input (29 as connected to 40, as shown in Figure 1 proximate to the air/gas source 22) to the heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming) and a flow rate of the cooled (via 40) or heated (via 57) air or breathable gas output to the line (29 as connected to 30, as shown in Figure 1 proximate to the patient interface device 30); one or more flow rate sensor (50/52, “Signals from one or more other sensors of the brain cooling system (e.g., temperature sensor 52, etc.) may be transmitted to and/or received by a processing element 62' associated with the pressurization apparatus 25…[to] automatically control operation of the pressurization apparatus 25 (e.g., increase or decrease the rate at which respiratory gases flow, etc.)” Para 0050; also see: “one or more sensors” associated with other components of the cooling subsystem may be utilized to provide a signal of “desired parameters (e.g., gas mix, pressure, flow rate, etc.)” Para 0049) coupled to the line (29) configured to measure at least a flow rate of flow of the cooled (via 40) or heated (via 57) air or breathable gas; one or more temperature sensor (50/52, “a temperature sensor 52 may be configured for use in directly monitoring the subject's temperature (e.g., a so-called "physiologic tunnel," such as a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes), which provides a direct measure of brain temperature; eardrum, or tympanic membrane temperature; temperature within the nasal cavity, etc.).)” Para 0034) configured to measure at least a temperature of the brain or brain correlative site of the human subject (via 52) and the temperature of the flow of cooled (via 40) or heated (via 57) air or breathable gas; and a controller (62, “Some embodiments of a brain cooling system 10 may also include a control system 60, which may comprise a processing element 62, such as a computer processor and associated memory, a microcontroller, or the like. The processing element 62 may be programmed to control operation of at least one of the pressurization apparatus 25, the cooling apparatus 40, any humidification component 55, any rewarming element 57, any body warming element 59, and one or more other elements of the brain cooling system 10.” Para 0046) coupled to the heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming), the flow control device (25), the one or more flow rate sensor (50/52, Paras 0049 and 0050), the one or more temperature sensor (50/52, Paras 0034 and 0050), the controller (62) configured to adjust at least one of: a cooling (via 40) or heating (via 57) rate (“configured to cool the respiratory gas to a desired, or predetermined, temperature (e.g., about 1.degree. C., up to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.) or to a temperature within a desired range of temperatures.” Para 0027), the temperature (“When a user enters such a selection (e.g., a target temperature, etc.) into the input/output element 64, the input/output element 64 generates and transmits signals to the processing element 62, which then correspondingly increases or decreases a temperature of the cooling apparatus 40, causing the cooling apparatus 40 to operate in the manner desired by the user.” Para 0048), and the flow rate (“Moreover, the respiratory gas may be delivered by the pressurization apparatus 25 at a substantially constant rate of flow. "Substantially constant," when used in reference to "rate of flow" or "flow rate," includes, but is not limited to, flow rates that vary by no more than about 10% from a predetermined flow rate.” Para 0023) of the flow cooled (via 40) or heated (via 57) air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site (via 52) and the measured flow rate (via 50/52, Paras 0049 and 0050) to regulate the temperature of the brain of the human subject.
Regarding the term “flow rate sensor”, although Geist does not expressly disclose the explicit use of a “flow rate sensor”, Geist discloses the functionality by which “one or more other sensors of the brain cooling system (e.g., temperature sensor 52, etc.) may be transmitted to and/or received by a processing element 62' associated with the pressurization apparatus 25…[to] automatically control operation of the pressurization apparatus 25 (e.g., increase or decrease the rate at which respiratory gases flow, etc.)” Para 0050. Additionally, as seen in Paragraph 0049, Geist discloses “one or more sensors” associated with other components of the cooling subsystem may be utilized to provide a signal of “desired parameters (e.g., gas mix, pressure, flow rate, etc.)”. Consequently, although the explicit structure utilized may not be a specific “flow rate sensor” the effective result of Geist is a calculative value representative of flow rate.
Nevertheless, should Applicant respectfully disagree that the functionality by which “flow rate” can be determined is not the same as the claimed “ one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas”, and that Geist does not expressly disclose the claimed “ one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas”.
Primary Examiner presents Fearnot et al. (2013/0000642) which explicitly discloses the use of “ one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas”.
Fearnot teaches an additional system (Figure 1) suitable for imparting regulation of temperature of the brain of a human subject (“The present disclosure provides, among other things, a system for providing therapeutic cooling or hypothermia to localized areas of the body such as the brain.” Abstract) including a heat transfer subsystem (“A cooling system for applying localized hypothermic treatment may include a heat-transfer medium consisting essentially of a breathable gas, with the gas supplied in at least one canister at a pressure greater than atmospheric pressure.” Para 0016) suitable for imparting breathable gas (via 20, “In the illustrated embodiment, system 20 includes a source of compressed gas, such as a canister 22, a delivery tube 24 connected to canister 22, and a pair of insertion tubes 26, 28 connected to delivery tube 24.” Para 0032) to be output along a line (24, “a delivery tube 24” Para 0032) to a device (26/28, “a pair of insertion tubes 26, 28 connected to delivery tube 24.” Para 0032) to deliver breathable gas to a human subject; a flow control device (32, “Accordingly, canister 22 has a valve or regulator 32 and an opening 34 for allowing gas to be released from canister 22 at one or more flow rates or pressure levels.” Para 0033) configured to control the flow rate of the breathable gas to the line (24); one or more flow rate sensors (70, “For monitoring the patient, system 20 may include one or more monitors or sensors 70. In the illustrated embodiment, sensor 70 is connected to the end of one of insertion tubes 26, 28, and in other embodiments it will be understood that sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask. … For example, sensor 70 may be a flow rate monitor or sensor in the flow of gas in tube 26 and/or 28. ” Para 0060, and “For example, if sensor 70 is a flow rate sensor, it will give the user notification of decreasing flow indicative of a low gas supply in canister 22 or other flow-inhibiting or -reducing problem.” Para 0061) coupled to the line (24, “sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask” Para 0060); one or more temperature sensor (70, “For monitoring the patient, system 20 may include one or more monitors or sensors 70. In the illustrated embodiment, sensor 70 is connected to the end of one of insertion tubes 26, 28, and in other embodiments it will be understood that sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask. … As another example, sensor 70 may be a temperature sensor (such as an infrared sensor) along the outside of tube 26 and/or 28 and positioned against or within a mask, tissue or cavities (e.g. a sinus) to monitor temperature of the gas or tissues (e.g. those next to the brain or the brain cavity). Such a temperature sensor is along the outside of tube 26 and/or 28 (or through a second lumen if tube 26 and/or 28 is a dual-lumen tube), or within the space between a mask and the patient's face to obtain readings representative of gas or tissue temperature and to keep the temperature sensor out of gas flow if desired.” Para 0060, and “If sensor 70 is a tissue-temperature sensor, it will give the user notification of temperature decreases or increases, and the user can adjust flow to maintain a desired cooled temperature or to change the temperature to a desired level. Based on flow and gas temperature, a target amount or duration of gas flow can be calculated so that at least an approximate period of use of system 20 to achieve a desired cooling effect is derived.” Para 0061) to measure at least a temperature of a brain or a brain correlative site (“tissue-temperature sensor” Para 0061), and a controller (defined by the feedback response of the observer/user to the changes noticed in the readouts 72, “One or more such readouts 72 may be provided to the user on a monitor screen, a hand-held screen, or other types of read-out display. A particular example is a display (e.g. screen, LCD, etc.) mounted on or fixed to mask 40'. Such a display is fixed to a side surface or top surface of mask 40' in a location and position that does not impair the observation of the patient's eyes. That is, when the observer or user is focused on the patient's face, both the patient's eyes and readout(s) 72 are within the field of vision of the observer. Such placement is advantageous at least because it permits easy observation of both the patient's eyes and the display at the same time.” Para 0062) coupled to the system (Figure 1) to adjust the operational parameters of the system (Figure 1).
Regarding the remaining limitations, Fearnot is explicitly concerned with at least one of the sensors (70) to be the claimed “one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas”. Explicitly, Fearnot states “For monitoring the patient, system 20 may include one or more monitors or sensors 70. In the illustrated embodiment, sensor 70 is connected to the end of one of insertion tubes 26, 28, and in other embodiments it will be understood that sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask. … For example, sensor 70 may be a flow rate monitor or sensor in the flow of gas in tube 26 and/or 28. ” (Para 0060), and “For example, if sensor 70 is a flow rate sensor, it will give the user notification of decreasing flow indicative of a low gas supply in canister 22 or other flow-inhibiting or -reducing problem.” (Para 0061). The resultant effect of utilizing at least one of the sensors of Fearnot to be the claimed “flow rate” sensor is the ability to “give the user notification of decreasing flow indicative of a low gas supply in canister 22 or other flow-inhibiting or -reducing problem.” (Para 0061), whereby the decreased flow indication would effectuate the ability of the system to perform the desired functionality of “regulating the temperature of the brain of a human subject”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the system of Geist to explicitly include the functionality of “one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas” as taught by Fearnot to notify and effectively warn the user of undesirable conditions which would effectuate the ability of the system to perform the desired functionality of “regulating the temperature of the brain of a human subject”.
As to Claim 17, Geist discloses a method for cooling the brain (“brain cooling system” Abstract) of a human subject, the method comprising: receiving a flow of the air or breathable gas (22 via 20, “The pressurization apparatus 25 of a gas delivery system 20 of a brain cooling system 10 of the present invention may receive air, oxygen, or an oxygen-rich mixture of gases from a source 22. The source 22 may comprise a source of substantially pure oxygen (e.g., a gas tank, etc., containing the oxygen), the atmosphere, or a combination of the source of oxygen and the atmosphere. ”Para 0018); cooling (via 40, “The cooling apparatus 40, or the location at which the cooling apparatus 40 cools the respiratory gas to be inhaled by a subject, may even be located just upstream (e.g., within about 18 inches, within about 12 inches, etc.) from the interface element 30, or from a location at which respiratory gas enters the nasal cavity of the subject.” Para 0026, also see: “In some embodiments, the cooling apparatus 40 may utilize known convective heat transfer methods. As an example, the cooling apparatus 40 may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment. In some embodiments, the cooling apparatus 40 may employ a coolant (e.g., FREON, etc.). In other embodiments, the cooling apparatus 40 may use one or more thermoelectric Peltier effect devices, such as those manufactured by Tellurex Corporation of Traverse City, Mich., to draw heat directly from a radiator/heat sink.” Para 0027) or heating (via 57, “A rewarming element 57 may enable use of brain cooling system 10 to facilitate a post-cooling increasing the temperature of a subject's brain, or "rewarming." In some embodiments, the rewarming element 57 may comprise an element configured to heat respiratory gas. Such a rewarming element 57 may communicate with the gas delivery system 20, which may introduce heated respiratory gas (relative to the temperature of the previously delivered cool respiratory gas and, in some embodiments, gradually increasing over time) into the subject's nasal cavity. In some embodiments, the cooling apparatus 40 may also serve as a rewarming element 57. By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows. Although the rewarming element 57 is depicted in FIG. 1 as comprising at least a part of the same element as the cooling apparatus 40, the cooling apparatus 40 and the rewarming element 57 may comprise separate elements.” Para 0044) the flow of the air or breathable gas; outputting a flow of cooled (via 40) or heated (via 57) air or breathable gas to a line (29, “The pressurization apparatus 25 compresses the respiratory gas so that it may be delivered, under positive pressure, to an outlet 26 of the pressurization apparatus, and through an inspiratory breathing conduit 29 that communicates with the interface element 30. In some embodiments, the inspiratory breathing conduit 29 may be coupled directly to the outlet 26 of the pressurization apparatus 25.” Para 0019) coupled to a device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024) adapted to deliver the cooled (via 40) or heated (via 57) air or breathable gas to a human subject; controlling (via 62, “Some embodiments of a brain cooling system 10 may also include a control system 60, which may comprise a processing element 62, such as a computer processor and associated memory, a microcontroller, or the like. The processing element 62 may be programmed to control operation of at least one of the pressurization apparatus 25, the cooling apparatus 40, any humidification component 55, any rewarming element 57, any body warming element 59, and one or more other elements of the brain cooling system 10.” Para 0046) a flow rate (25, Para 0019-0022; more explicitly: “Moreover, the respiratory gas may be delivered by the pressurization apparatus 25 at a substantially constant rate of flow. "Substantially constant," when used in reference to "rate of flow" or "flow rate," includes, but is not limited to, flow rates that vary by no more than about 10% from a predetermined flow rate.” Para 0023) of the flow of air or breathable gas and a flow rate of the cooled (via 40) or heated (via 57) air or breathable gas to the line (29); measuring at least a flow rate of the cooled (via 40) or heated (via 57) air or breathable gas (50/52, “Signals from one or more other sensors of the brain cooling system (e.g., temperature sensor 52, etc.) may be transmitted to and/or received by a processing element 62' associated with the pressurization apparatus 25…[to] automatically control operation of the pressurization apparatus 25 (e.g., increase or decrease the rate at which respiratory gases flow, etc.)” Para 0050; also see: “one or more sensors” associated with other components of the cooling subsystem may be utilized to provide a signal of “desired parameters (e.g., gas mix, pressure, flow rate, etc.)” Para 0049); measuring at least a temperature of a brain or brain correlative site of the human subject and a temperature of the flow of the cooled (via 40) or heated (via 57) air or breathable gas (50/52, “a temperature sensor 52 may be configured for use in directly monitoring the subject's temperature (e.g., a so-called "physiologic tunnel," such as a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes), which provides a direct measure of brain temperature; eardrum, or tympanic membrane temperature; temperature within the nasal cavity, etc.).)” Para 0034); and adjusting a cooling (via 40) or heating (via 57) rate (“configured to cool the respiratory gas to a desired, or predetermined, temperature (e.g., about 1.degree. C., up to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.) or to a temperature within a desired range of temperatures.” Para 0027), the temperature (“When a user enters such a selection (e.g., a target temperature, etc.) into the input/output element 64, the input/output element 64 generates and transmits signals to the processing element 62, which then correspondingly increases or decreases a temperature of the cooling apparatus 40, causing the cooling apparatus 40 to operate in the manner desired by the user.” Para 0048), and the flow rate (“Moreover, the respiratory gas may be delivered by the pressurization apparatus 25 at a substantially constant rate of flow. "Substantially constant," when used in reference to "rate of flow" or "flow rate," includes, but is not limited to, flow rates that vary by no more than about 10% from a predetermined flow rate.” Para 0023) of the flow cooled (via 40) or heated (via 57) air or breathable gas delivered to the human subject
Regarding the term “flow rate sensor”, although Geist does not expressly disclose the explicit use of a “flow rate sensor”, Geist discloses the functionality by which “one or more other sensors of the brain cooling system (e.g., temperature sensor 52, etc.) may be transmitted to and/or received by a processing element 62' associated with the pressurization apparatus 25…[to] automatically control operation of the pressurization apparatus 25 (e.g., increase or decrease the rate at which respiratory gases flow, etc.)” Para 0050. Additionally, as seen in Paragraph 0049, Geist discloses “one or more sensors” associated with other components of the cooling subsystem may be utilized to provide a signal of “desired parameters (e.g., gas mix, pressure, flow rate, etc.)”. Consequently, although the explicit structure utilized may not be a specific “flow rate sensor” the effective result of Geist is a calculative value representative of flow rate.
Nevertheless, should Applicant respectfully disagree that the functionality by which “flow rate” can be determined is not the same as the claimed “measuring at least the flow rate of the flow of the cooled or heated air or breathable gas” , and that Geist does not expressly disclose the claimed “measuring at least the flow rate of the flow of the cooled or heated air or breathable gas”.
Primary Examiner presents Fearnot et al. (2013/0000642) which explicitly discloses the use of “measuring at least the flow rate of the flow of the cooled or heated air or breathable gas”.
Fearnot teaches an additional system (Figure 1) suitable for imparting regulation of temperature of the brain of a human subject (“The present disclosure provides, among other things, a system for providing therapeutic cooling or hypothermia to localized areas of the body such as the brain.” Abstract) including a heat transfer subsystem (“A cooling system for applying localized hypothermic treatment may include a heat-transfer medium consisting essentially of a breathable gas, with the gas supplied in at least one canister at a pressure greater than atmospheric pressure.” Para 0016) suitable for imparting breathable gas (via 20, “In the illustrated embodiment, system 20 includes a source of compressed gas, such as a canister 22, a delivery tube 24 connected to canister 22, and a pair of insertion tubes 26, 28 connected to delivery tube 24.” Para 0032) to be output along a line (24, “a delivery tube 24” Para 0032) to a device (26/28, “a pair of insertion tubes 26, 28 connected to delivery tube 24.” Para 0032) to deliver breathable gas to a human subject; a flow control device (32, “Accordingly, canister 22 has a valve or regulator 32 and an opening 34 for allowing gas to be released from canister 22 at one or more flow rates or pressure levels.” Para 0033) configured to control the flow rate of the breathable gas to the line (24); one or more flow rate sensors (70, “For monitoring the patient, system 20 may include one or more monitors or sensors 70. In the illustrated embodiment, sensor 70 is connected to the end of one of insertion tubes 26, 28, and in other embodiments it will be understood that sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask. … For example, sensor 70 may be a flow rate monitor or sensor in the flow of gas in tube 26 and/or 28. ” Para 0060, and “For example, if sensor 70 is a flow rate sensor, it will give the user notification of decreasing flow indicative of a low gas supply in canister 22 or other flow-inhibiting or -reducing problem.” Para 0061) coupled to the line (24, “sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask” Para 0060); one or more temperature sensor (70, “For monitoring the patient, system 20 may include one or more monitors or sensors 70. In the illustrated embodiment, sensor 70 is connected to the end of one of insertion tubes 26, 28, and in other embodiments it will be understood that sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask. … As another example, sensor 70 may be a temperature sensor (such as an infrared sensor) along the outside of tube 26 and/or 28 and positioned against or within a mask, tissue or cavities (e.g. a sinus) to monitor temperature of the gas or tissues (e.g. those next to the brain or the brain cavity). Such a temperature sensor is along the outside of tube 26 and/or 28 (or through a second lumen if tube 26 and/or 28 is a dual-lumen tube), or within the space between a mask and the patient's face to obtain readings representative of gas or tissue temperature and to keep the temperature sensor out of gas flow if desired.” Para 0060, and “If sensor 70 is a tissue-temperature sensor, it will give the user notification of temperature decreases or increases, and the user can adjust flow to maintain a desired cooled temperature or to change the temperature to a desired level. Based on flow and gas temperature, a target amount or duration of gas flow can be calculated so that at least an approximate period of use of system 20 to achieve a desired cooling effect is derived.” Para 0061) to measure at least a temperature of a brain or a brain correlative site (“tissue-temperature sensor” Para 0061), and a controller (defined by the feedback response of the observer/user to the changes noticed in the readouts 72, “One or more such readouts 72 may be provided to the user on a monitor screen, a hand-held screen, or other types of read-out display. A particular example is a display (e.g. screen, LCD, etc.) mounted on or fixed to mask 40'. Such a display is fixed to a side surface or top surface of mask 40' in a location and position that does not impair the observation of the patient's eyes. That is, when the observer or user is focused on the patient's face, both the patient's eyes and readout(s) 72 are within the field of vision of the observer. Such placement is advantageous at least because it permits easy observation of both the patient's eyes and the display at the same time.” Para 0062) coupled to the system (Figure 1) to adjust the operational parameters of the system (Figure 1).
Regarding the remaining limitations, Fearnot is explicitly concerned with at least one of the sensors (70) to be the claimed “measuring at least the flow rate of the flow of the cooled or heated air or breathable gas”. Explicitly, Fearnot states “For monitoring the patient, system 20 may include one or more monitors or sensors 70. In the illustrated embodiment, sensor 70 is connected to the end of one of insertion tubes 26, 28, and in other embodiments it will be understood that sensor 70 may be placed in other appropriate locations, e.g. on or in tube 24 or a mask. … For example, sensor 70 may be a flow rate monitor or sensor in the flow of gas in tube 26 and/or 28. ” (Para 0060), and “For example, if sensor 70 is a flow rate sensor, it will give the user notification of decreasing flow indicative of a low gas supply in canister 22 or other flow-inhibiting or -reducing problem.” (Para 0061). The resultant effect of utilizing at least one of the sensors of Fearnot to be the claimed “flow rate” sensor is the ability to “give the user notification of decreasing flow indicative of a low gas supply in canister 22 or other flow-inhibiting or -reducing problem.” (Para 0061), whereby the decreased flow indication would effectuate the ability of the system to perform the desired functionality of “regulating the temperature of the brain of a human subject”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the method of Geist to explicitly include the functionality of “measuring at least the flow rate of the flow of the cooled or heated air or breathable gas” as taught by Fearnot to notify and effectively warn the user of undesirable conditions which would effectuate the ability of the system to perform the desired functionality of “regulating the temperature of the brain of a human subject”.
As to Claims 2 and 18, Geist discloses the controller (62) is configured to adjusts the temperature and flow rate of the flow of cooled (via 40) or heated (via 57) air or breathable gas to provide therapeutic hypothermic (TH) and/or targeted temperature management (TTM) to normothermic levels (“methods for returning the temperature of a subject's brain to a state of normal thermia (e.g., normal body temperature)” Para 0005, which includes methodologies of cooling and/or rewarming).
As to Claims 3 and 19, Geist discloses the controller (62) is configured to control the flow control device (25) to provide a flow rate of the cooled (via 40) or heated (via 57) air or breathable gas at a flow rate in the range of 0 to 50 LPM. Explicitly, Geist discloses “configured to deliver the respiratory gas at a flow rate of at least about 25 liters per minute (e.g., 30 liters per minute, 50 liters per minute…).” (Para 0021) which meet the limitations of the claims.
As to Claims 4 and 20, Geist discloses the cooling subsystem (40) is configured to input the air or breathable gas (via 20) having a temperature in the range of about -10 to about 10 degrees C. Explicitly, Geist discloses “configured to cool the respiratory gas to a desired, or predetermined, temperature (e.g., about 1.degree. C., up to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.) or to a temperature within a desired range of temperatures.” (Para 0027). As the disclosure of “about 1.degree. C., … about 10.degree. C.” is within the claimed range of about -10 to about 10 degrees C, Geist meets the limitation of the claims.
As to Claims 5 and 21, Geist discloses the controller (62) is configured to control the cooling subsystem (40) to cool (via 40) the air or breathable gas and provide the flow of the cooled (via 40) air or breathable gas delivered to the human subject having a temperature in the range of about -14 to about 7 degrees C. Explicitly, Geist discloses “configured to cool the respiratory gas to a desired, or predetermined, temperature (e.g., about 1.degree. C., up to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.) or to a temperature within a desired range of temperatures.” (Para 0027). As the disclosure of “about 1.degree. C.” is within the claimed range of -14 to 7 degrees C, Geist meets the limitation of the claims.
As to Claim 6, Geist discloses the one or more temperature sensor (50/52, “a temperature sensor 52 may be configured for use in directly monitoring the subject's temperature (e.g., a so-called "physiologic tunnel," such as a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes), which provides a direct measure of brain temperature; eardrum, or tympanic membrane temperature; temperature within the nasal cavity, etc.).)” Para 0034) includes a tympanic sensor (“or tympanic membrane temperature” Para 0034) or temporal artery sensor (“a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes” Para 0034).
As to Claims 7 and 22, Geist discloses the device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024) adapted to deliver the cooled (via 40) or heated (via 57) air or breathable gas to a human subject includes a nasal cannula (“nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024).
As to Claim 8, Geist discloses one or more temperature sensors (50/52) are adapted to be placed on an end of the nasal cannula. Explicitly, Geist discloses the orientation of temperature sensor (50) located in proximity to the device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024), whereby the device can be a nasal cannula.
As to Claims 9 and 23, Geist discloses the controller (62) is configured to control the flow control device (25) to adjust the pressure of the flow of the cooled (via 40) or heated (via 57) air or breathable gas. Explicitly, Geist discloses “Alternatively, or in addition, the pressurization apparatus 25 may include or have associated therewith a control system 60'. In some embodiments, the control system 60' associated with the pressurization apparatus 25 may include a processing element 62' and an input/output element 64'. The input/output element 64' may enable a user to select one or more of a desired gas mixture (e.g., a particular amount of oxygen), a desired pressure, and a desired flow rate of the respiratory gas to be delivered by the pressurization apparatus 25. … A processing element 62' that receives such signals may be programmed to automatically operate one or more features of the pressurization apparatus 25 in such a way that one or more desired parameters (e.g., gas mix, pressure, flow rate, etc.) are substantially constantly maintained by the pressurization apparatus 25.” (Para 0049).
As to Claims 10 and 24, Geist discloses the cooling subsystem (40) includes a gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) comprised of thermally conductive material, the gas block (“a radiator, heat sink-type configuration”) including an inlet (via 29 proximate to 20, as shown in Figure 1) configured to input the flow of air or breathable gas (via 20) and an outlet (via 29 proximate 50, as shown in Figure 1) configured to output the flow of cooled (via 40) air or breathable gas.
As to Claim 11, Geist discloses the gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) includes a plurality of flow channels (defined by the circuitous structure of a radiator - “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. Cool and warm fluid transport conduits 46' and 47' enable circulation of a heat transfer fluid 48' between the cooling element 42' and the fluid refrigeration apparatus 49'." Para 0028) comprised of thermally conductive material configured to cool (via 40) the flow of air or breathable gas and direct the flow of cooled (via 40) air or breathable gas to the outlet (via 29 proximate 50, as shown in Figure 1).
As to Claims 12 and 25, Geist discloses the cooling subsystem (40) includes a gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) that includes a heat transfer subsystem (defined by the flow of “a coolant (e.g., FREON, etc.).” Para 0027, and “ In addition to the conduit and the cooling element, a cooling apparatus of the present invention may include a fluid refrigeration apparatus for cooling the heat transfer fluid, as well as a cool fluid transfer conduit for providing cooled heat transfer fluid from the outlet of the refrigeration apparatus to the inlet end of the channel of the cooling element and a warm fluid transfer conduit for transporting warmer heat transfer fluid from the outlet end of the channel of the cooling element to the inlet of the refrigeration apparatus.” Para 0010; also see: “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033) coupled to the gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) and configured as the thermal electric cooling (TEC) device (defined as the combination of 40 and 49, wherein 40 – “The cooling apparatus 40, or the location at which the cooling apparatus 40 cools the respiratory gas to be inhaled by a subject, may even be located just upstream (e.g., within about 18 inches, within about 12 inches, etc.) from the interface element 30, or from a location at which respiratory gas enters the nasal cavity of the subject.” Para 0026, also see: “In some embodiments, the cooling apparatus 40 may utilize known convective heat transfer methods. As an example, the cooling apparatus 40 may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment. In some embodiments, the cooling apparatus 40 may employ a coolant (e.g., FREON, etc.). In other embodiments, the cooling apparatus 40 may use one or more thermoelectric Peltier effect devices, such as those manufactured by Tellurex Corporation of Traverse City, Mich., to draw heat directly from a radiator/heat sink.” Para 0027; and wherein 49 – “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033).
As to Claims 13 and 26, Geist discloses the controller (62) is configured to control a current or voltage (“By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows.” Para 0044) applied to the TEC (defined as the combination of 40 and 49) to provide cooling (via 40) temperature on a side of the TEC (defined as the combination of 40 and 49) in contact with the gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) to cool (via 40) the source of the flow of air or breathable gas (via 20) and provide the flow of the cooled (via 40) air or breathable gas or to provide a heating (via 57) temperature on a side of the TEC (defined as the combination of 40 and 49) in contact with the gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) to heat (via 57) the source of the flow of air or breathable gas (via 20) to increase the temperature of the flow of the heated (via 57) air or breathable gas.
As to Claim 14 and 27, Geist discloses a heat exchange transfer subsystem (49, “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033) coupled to the a heat transfer subsystem (defined by the flow of “a coolant (e.g., FREON, etc.).” Para 0027, and “ In addition to the conduit and the cooling element, a cooling apparatus of the present invention may include a fluid refrigeration apparatus for cooling the heat transfer fluid, as well as a cool fluid transfer conduit for providing cooled heat transfer fluid from the outlet of the refrigeration apparatus to the inlet end of the channel of the cooling element and a warm fluid transfer conduit for transporting warmer heat transfer fluid from the outlet end of the channel of the cooling element to the inlet of the refrigeration apparatus.” Para 0010; also see: “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033) configured to remove heat from the heat transfer subsystem (10).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Geist et al. (2012/0031405) in view of Fearnot et al. (2013/0000642), as applied to Claim 14, and further in view of Fletcher et al. (2005/0065581).
As to Claims 15 and 16, the modified Geist, specifically Geist discloses a gas block (“may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) which provides convective heat transfer methods utilizing “one or more thermoelectric Peltier effect devices…to draw heat directly from a radiator/heat sink” (Para 0027), the use of “coolant” (Para 0027) to facilitate heat transfer, and “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. Cool and warm fluid transport conduits 46' and 47' enable circulation of a heat transfer fluid 48' between the cooling element 42' and the fluid refrigeration apparatus 49'." (Para 0028). Further, Geist discloses the construction of the heat exchange transfer system to include a series of tubes (45, 46, 47, best seen Figures 2 and 4) to effect the thermal conductivity and heat transfer of the subsystems. Finally, Geist discloses a heat exchange transfer subsystem (49, “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033) includes a conductor block (defined by the circuitous structure of a chiller - “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. Cool and warm fluid transport conduits 46' and 47' enable circulation of a heat transfer fluid 48' between the cooling element 42' and the fluid refrigeration apparatus 49'." Para 0028) coupled to a side of the TEC (defined as the combination of 40 and 49) and conductive pipes (defined by the lines via 45/46/47 of coolant within the chiller).
Yet, the modified Geist does not expressly disclose the construction of the heat exchange transfer subsystem to include the use of “conductive fins” coupled to the conductive pipes (Claim 15), nor the use of “a fan coupled to the conductive fins” (Claim 16).
Fletcher teaches a flexible heat exchanger (Title), wherein the heat exchanger is constructed of various shapes (“a plurality of the thermally conductive members have thermally conductive pins, fins, bars or the like that project into the volume of a heat exchanger to form an efficient heat exchange interface with heat exchange fluid in the volume.” Para 0033) to provide efficient heat exchange utilizing a fan in the form of feed pumps (70/72 – “A first feed pump 70 upstream from heat exchanger 10 delivers fluid 65 from reservoir 62 to heat exchanger 10. A second feed pump 72 is located downstream from heat exchanger 10. Second feed pump 72 draws fluid 65 from heat exchanger 10 and returns the fluid to reservoir 62. First and second feed pumps 70 and 72 are balanced so that within volume 20 of heat exchanger 10 the pressure of fluid 65 is substantially equal to the ambient air pressure.” Para 0059) to deliver/draw the fluid (best seen Figures 6-8 and Paras 0059-0064, 0068, and 0069).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heat exchange transfer subsystem to include the use of thermally conductive fins, and further the use of the thermally conductive fins in combination with a fan, as taught by Fletcher for the purpose of providing efficient heat exchange.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,406,022.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claims 1 and 17 are merely broader than patent claims 1 and 17. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims: 18/334,728
Differences Underlined
Patent Claims: 10,406,022
Differences Underlined
1.A system for regulating the temperature of the brain of a human subject, the system comprising:
a heat transfer subsystem configured to input a flow of air or breathable gas, cool or heat the air or breathable gas, and output cooled or heated air or breathable gas to a line coupled to a device adapted to deliver the cooled or heated air or breathable gas to a human subject;
a flow control device coupled to the cooling subsystem configured to control a flow rate of the flow of the air or breathable gas input to the heat transfer subsystem and a flow rate of the cooled or heated air or breathable gas output to the line;
one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas;
one or more temperature sensors configured to measure at least a temperature of a brain or a brain correlative site of the human subject and the temperature of the flow of cooled air or breathable gas; and
a controller coupled to the heat transfer subsystem, the flow control device, the one or more flow rate sensors, and the one or more temperature sensors, the controller configured to adjust at least one of: a cooling or heating rate, the temperature, and the flow rate of flow of cooled or heated air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site to regulate the temperature of the brain of the human subject.
1. A system for cooling the brain of a human subject, the system comprising:
a cooling subsystem configured to input a flow of air or breathable gas, cool the air or breathable gas, and output cooled air or breathable gas to a line coupled to a device adapted to deliver the cooled air or breathable gas to a human subject, the cooling subsystem including a flat gas block comprised of a thermally conductive material and a flat thermal electric cooling (TEC) device coupled between the flat gas block and a flat conductor block;
a flow control device coupled to the cooling subsystem configured to control a flow rate of the flow of the air or breathable gas input to the cooling subsystem and a flow rate of the cooled air or breathable gas output to the line;
one or more flow rate sensors coupled to the cooling subsystem configured to measure at least a flow rate of flow of cooled air or breathable gas;
one or more temperature sensors configured to measure at least a temperature of a brain or a brain correlative site of the human subject and the temperature of the flow of cooled air or breathable gas; and
a controller coupled to the cooling subsystem, the flow control device, the one or more flow rate sensors, and the one or more temperature sensors, the controller configured to adjust a cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas to cool the brain of the human subject.
2. The system of claim 1 in which the controller is configured to adjust the temperature and the flow rate of the flow of cooled or heated air or breathable gas to provide therapeutic hypothermic (TH) and/or target temperature management (TTM) to normothermic levels.
2. The system of claim 1 in which the controller is configured to adjust the temperature and the flow rate of the flow of cooled air or breathable gas to provide therapeutic hypothermic (TH) and/or target temperature management (TTM) to normothermic levels.
3. The system of claim 1 in which the controller is configured to control the flow control device to provide a flow rate of the cooled or heated air or breathable gas at flow rate in the range of about 0 L/min to about 50 L/min.
3. The system of claim 1 in which the controller is configured to control the flow control device to provide a flow rate of the cooled air or breathable gas at flow rate in the range of about 0 L/min to about 50 L/min.
4. The system of claim 1 in which the cooling subsystem cooling subsystem is configured to input the air or breathable gas having a temperature in the range of about -10 ºC to about 10 ºC.
4. The system of claim 1 in which the cooling subsystem cooling subsystem is configured to input the air or breathable gas having a temperature in the range of about −10° C. to about 10° C.
5. The system of claim 4 in which the controller is configured to control the cooling subsystem to cool the air or breathable gas and provide the flow of cooled or heated air or breathable gas delivered to the human subject having a temperature in the range of about -14 ºC to about 7 ºC.
5. The system of claim 4 in which the controller is configured to control the cooling subsystem to cool the air or breathable gas and provide the flow of cooled air or breathable gas delivered to the human subject having a temperature in the range of about −14° C. to about 7° C.
6. The system of claim 1 in which the one or more temperature sensors includes a tympanic sensor or temporal artery sensor.
6. The system of claim 1 in which the one or more temperature sensors includes a tympanic sensor or temporal artery sensor.
7. The system of claim 1 in which the device adapted to deliver the cooled or heated air or breathable gas to a human subject includes a nasal cannula.
7. The system of claim 1 in which the device adapted to deliver the cooled air or breathable gas to a human subject includes a nasal cannula.
8. The system of claim 7 in which the one or more temperature sensors are adapted to be placed on an end of the nasal cannula.
8. The system of claim 7 in which the one or more temperature sensors are adapted to be placed on an end of the nasal cannula.
9. The system of claim 1 in which the controller is configured to control the flow control device to adjust a pressure of the flow of cooled or heated air or breathable gas.
9. The system of claim 1 in which the controller is configured to control the flow control device to adjust a pressure of the flow of cooled air or breathable gas.
10. The system of claim 1 in which the cooling subsystem includes a gas block comprised of a thermally conductive material, the gas block including an inlet configured to input the flow of air or breathable gas and an outlet configured to output the flow of cooled or heated air or breathable gas.
10. The system of claim 1 in which the cooling subsystem includes a gas block comprised of a thermally conductive material, the gas block including an inlet configured to input the flow of air or breathable gas and an outlet configured to output the flow of cooled air or breathable gas.
11. The system of claim 10 in which the air block includes a plurality of flow channels comprised of the thermally conductive material configured to cool the flow of air or breathable gas and provide and direct the flow of cooled or heated air or breathable gas to the outlet.
11. The system of claim 10 in which the air block includes a plurality of flow channels comprised of the thermally conductive material configured to cool the flow of air or breathable gas and provide and direct the flow of cooled air or breathable gas to the outlet.
12. The system of claim 1 in which the cooling subsystem includes a heat transfer subsystem coupled to the gas block and configured as the thermal electric cooling (TEC) device.
12. The system of claim 1 in which the cooling subsystem includes a heat transfer subsystem coupled to the gas block and configured as a thermal electric cooling (TEC) device.
13. The system of claim 12 in which the controller is configured to control a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of the flow of air or breathable gas and provide the flow of cooled or heated air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of the flow of air or breathable gas to increase the temperature of the flow of cooled or heated air or breathable gas.
13. The system of claim 12 in which the controller is configured to control a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of the flow of air or breathable gas and provide the flow of cooled air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of the flow of air or breathable gas to increase the temperature of the flow of cooled air or breathable gas.
14. The system of claim 13 further including a heat exchange transfer subsystem coupled to the heat transfer subsystem configured to remove heat from the heat transfer subsystem.
14. The system of claim 13 further including a heat exchange transfer subsystem coupled to the heat transfer subsystem configured to remove heat from the heat transfer subsystem.
15. The system of claim 14 in which heat exchange transfer subsystem includes a conductor block coupled to a side of the TEC and conductive pipes coupled to conductive fins.
15. The system of claim 14 in which heat exchange transfer subsystem includes a conductor block coupled to a side of the TEC and conductive pipes coupled to conductive fins.
16. The system of claim 15 further including a fan coupled to the conductive fins.
16. The system of claim 15 further including a fan coupled to the conductive fins.
17. A method for cooling the brain of a human subject, the method comprising: receiving a flow of the air or breathable gas; cooling or heating the flow of the air or breathable gas;
outputting a flow of cooled or heated air or breathable gas to a line coupled to a device adapted to deliver the cooled or heated air or breathable gas to a human subject;
controlling a flow rate of the flow of the air or breathable gas and a flow rate of the cooled or heated air or breathable gas output to the line;
measuring at least a flow rate of flow of cooled or heated air or breathable gas; measuring at least a temperature of a brain or brain correlative site of the human subject and a temperature of the flow of cooled or heated air or breathable gas; and
adjusting a cooling rate, the temperature, and the flow rate of flow of cooled or heated air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled or heated air or breathable gas to cool the brain of the human subject.
17. A method for cooling the brain of a human subject, the method comprising: receiving a flow of the air or breathable gas; cooling the air or breathable gas;
outputting a flow of cooled air or breathable gas to a line coupled to a device adapted to deliver the cooled air or breathable gas to a human subject, the device including a flat gas block comprised of a thermally conductive material and a flat thermal electric cooling (TEC) device coupled between the flat gas block and a flat conductor block
controlling a flow rate of the flow of the air or breathable gas and a flow rate of the cooled air or breathable gas output to the line;
measuring at least a flow rate of flow of cooled air or breathable gas;
measuring at least a temperature of a brain or brain correlative site of the human subject and a temperature of the flow of cooled air or breathable gas; and
adjusting a cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas to cool the brain of the human subject.
18. The method of claim 17 further including adjusting the temperature and the flow rate of the flow of cooled or heated air or breathable gas to provide therapeutic hypothermic (TH) and target temperature management (TTM) to normothermic levels.
18. The method of claim 17 further including adjusting the temperature and the flow rate of the flow of cooled air or breathable gas to provide therapeutic hypothermic (TH) and target temperature management (TTM) to normothermic levels.
19. The method of claim 17 further including providing a flow rate of cooled or heated air or breathable gas at a flow rate in the range of about 0 to about 50 L/m.
19. The method of claim 17 further including providing a flow rate of cooled air or breathable gas at a flow rate in the range of about 0 to about 50 L/m.
20. The method of claim 17 further including receiving the flow of the air or breathable gas having a temperature in the range of about -10 ºC to about 10 ºC.
20. The method of claim 17 further including receiving the flow of the air or breathable gas having a temperature in the range of about −10° C. to about 10° C.
21. The method of claim 20 further including cooling the flow of the air or breathable gas to a temperature in the range of about -14 ºC to about 7 ºC.
21. The method of claim 20 further including cooling the flow of the air or breathable gas to a temperature in the range of about −14° C. to about 7° C.
22. The method of claim 17 in which the device adapted to deliver the flow of the air or breathable gas to the human subject includes a nasal cannula.
22. The method of claim 17 in which the device adapted to deliver the flow of the air or breathable gas to the human subject includes a nasal cannula.
23. The method of claim 17 further including adjusting a pressure of the flow of cooled or heated air or breathable gas.
23. The method of claim 17 further including adjusting a pressure of the flow of cooled air or breathable gas.
24. The method of claim 17 further including providing a gas block comprised of a thermally conductive material, the gas block including an inlet to receive the flow of air or breathable gas and an outlet configured to output the flow of cooled or heated air or breathable gas.
24. The method of claim 17 further including providing a gas block comprised of a thermally conductive material, the gas block including an inlet to receive the flow of air or breathable gas and an outlet configured to output the flow of cooled air or breathable gas.
25. The method of claim 24 further including providing a heat transfer subsystem coupled to the gas block configured as the thermal electric cooling (TEC) device.
25. The method of claim 24 further including providing a heat transfer subsystem coupled to the gas block configured as a thermal electric cooling (TEC) device.
26. The method of claim 25 further including controlling a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of flow of air or breathable gas and provide a flow of cooled or heated air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of flow of air or breathable gas to increase the temperature of the flow of cooled or heated air or breathable gas.
26. The method of claim 25 further including controlling a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of flow of air or breathable gas and provide a flow of cooled air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of flow of air or breathable gas to increase the temperature of the flow of cooled air or breathable gas.
27. The method of claim 26 further including providing a heat exchange transfer subsystem coupled to the heat transfer system configured to remove heat from the heat transfer subsystem
27. The method of claim 26 further including providing a heat exchange transfer subsystem coupled to the heat transfer system configured to remove heat from the heat transfer subsystem.
It should be noted despite the several instances of “or heat” and its variants, the generic concept of “regulating the temperature” includes the directionality of “cooling” which reduces the temperature and “heating” which increases the temperature. Thus, the patent claims are a “species” of the “generic” invention as the patent claims are only concerned with the “cooling” action of “regulating the temperature”.
Further, it should be noted that in a system/method operating for the features of “cooling” action the ability to modify the system/method to operate in the alternative imparting “heating” features is simply a reversal of the electrical current – as stated by Geist et al. (2012/0031405) – “By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows.” (Para 0044).
Thus, Claims 1-27 are deemed rejected on the grounds of nonstatutory double patenting.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,737,912. Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claims 1 and 17 are merely broader than patent claims 1 and 17. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims: 18/334,728
Differences Underlined
Patent Claims: 11,737,912
Differences Underlined
1.A system for regulating the temperature of the brain of a human subject, the system comprising:
a heat transfer subsystem configured to input a flow of air or breathable gas, cool or heat the air or breathable gas,
and output cooled or heated air or breathable gas to a line coupled to a device adapted to deliver the cooled or heated air or breathable gas to a human subject;
a flow control device coupled to the cooling subsystem configured to control a flow rate of the flow of the air or breathable gas input to the heat transfer subsystem and a flow rate of the cooled or heated air or breathable gas output to the line;
one or more flow rate sensors coupled to the line configured to measure at least a flow rate of flow of the cooled or heated air or breathable gas;
one or more temperature sensors configured to measure at least a temperature of a brain or a brain correlative site of the human subject and the temperature of the flow of cooled air or breathable gas; and
a controller coupled to the heat transfer subsystem, the flow control device, the one or more flow rate sensors, and the one or more temperature sensors, the controller configured to adjust at least one of: a cooling or heating rate, the temperature, and the flow rate of flow of cooled or heated air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site to regulate the temperature of the brain of the human subject.
1. A system for cooling the brain of a human subject, the system comprising:
a cooling subsystem configured to input a flow of air or breathable gas, the cooling subsystem comprising a gas block including a surface in thermal communication with a thermal electric cooling (TEC) device and configured such that the flow of air or breathable gas contacts the gas block at a location in thermal communication with TEC to cool the air or breathable gas
and output cooled air or breathable gas to a line coupled to a device adapted to deliver the cooled air or breathable gas to a human subject;
a flow control device coupled to the cooling subsystem configured to control a flow rate of the flow of the air or breathable gas input to the cooling subsystem and a flow rate of the cooled air or breathable gas output to the line;
one or more flow rate sensors coupled to the cooling subsystem configured to measure at least a flow rate of flow of cooled air or breathable gas;
one or more temperature sensors configured to measure at least a temperature of a brain or a brain correlative site of the human subject and the temperature of the flow of cooled air or breathable gas; and
a controller coupled to the cooling subsystem, the flow control device, the one or more flow rate sensors, and the one or more temperature sensors, the controller configured to adjust a cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas to cool the brain of the human subject.
2. The system of claim 1 in which the controller is configured to adjust the temperature and the flow rate of the flow of cooled or heated air or breathable gas to provide therapeutic hypothermic (TH) and/or target temperature management (TTM) to normothermic levels.
2. The system of claim 1 in which the controller is configured to adjust the temperature and the flow rate of the flow of cooled air or breathable gas to provide therapeutic hypothermic (TH) and/or target temperature management (TTM) to normothermic levels.
3. The system of claim 1 in which the controller is configured to control the flow control device to provide a flow rate of the cooled or heated air or breathable gas at flow rate in the range of about 0 L/min to about 50 L/min.
3. The system of claim 1 in which the controller is configured to control the flow control device to provide a flow rate of the cooled air or breathable gas at flow rate in the range of about 0 L/min to about 50 L/min.
4. The system of claim 1 in which the cooling subsystem cooling subsystem is configured to input the air or breathable gas having a temperature in the range of about -10 ºC to about 10 ºC.
4. The system of claim 1 in which the cooling subsystem cooling subsystem is configured to input the air or breathable gas having a temperature in the range of about −10° C. to about 10° C.
5. The system of claim 4 in which the controller is configured to control the cooling subsystem to cool the air or breathable gas and provide the flow of cooled or heated air or breathable gas delivered to the human subject having a temperature in the range of about -14 ºC to about 7 ºC.
5. The system of claim 4 in which the controller is configured to control the cooling subsystem to cool the air or breathable gas and provide the flow of cooled air or breathable gas delivered to the human subject having a temperature in the range of about −14° C. to about 7° C.
6. The system of claim 1 in which the one or more temperature sensors includes a tympanic sensor or temporal artery sensor.
6. The system of claim 1 in which the one or more temperature sensors includes a tympanic sensor or temporal artery sensor.
7. The system of claim 1 in which the device adapted to deliver the cooled or heated air or breathable gas to a human subject includes a nasal cannula.
7. The system of claim 1 in which the device adapted to deliver the cooled air or breathable gas to a human subject includes a nasal cannula.
8. The system of claim 7 in which the one or more temperature sensors are adapted to be placed on an end of the nasal cannula.
8. The system of claim 7 in which the one or more temperature sensors are adapted to be placed on an end of the nasal cannula.
9. The system of claim 1 in which the controller is configured to control the flow control device to adjust a pressure of the flow of cooled or heated air or breathable gas.
9. The system of claim 1 in which the controller is configured to control the flow control device to adjust a pressure of the flow of cooled air or breathable gas.
10. The system of claim 1 in which the cooling subsystem includes a gas block comprised of a thermally conductive material, the gas block including an inlet configured to input the flow of air or breathable gas and an outlet configured to output the flow of cooled or heated air or breathable gas.
10. The system of claim 1 in which the cooling subsystem includes a gas block comprised of a thermally conductive material, the gas block including an inlet configured to input the flow of air or breathable gas and an outlet configured to output the flow of cooled air or breathable gas.
11. The system of claim 10 in which the air block includes a plurality of flow channels comprised of the thermally conductive material configured to cool the flow of air or breathable gas and provide and direct the flow of cooled or heated air or breathable gas to the outlet.
11. The system of claim 10 in which the air block includes a plurality of flow channels comprised of the thermally conductive material configured to cool the flow of air or breathable gas and provide and direct the flow of cooled air or breathable gas to the outlet.
12. The system of claim 1 in which the cooling subsystem includes a heat transfer subsystem coupled to the gas block and configured as the thermal electric cooling (TEC) device.
12. The system of claim 1 in which the cooling subsystem includes a heat transfer subsystem coupled to the gas block and configured as the thermal electric cooling (TEC) device.
13. The system of claim 12 in which the controller is configured to control a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of the flow of air or breathable gas and provide the flow of cooled or heated air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of the flow of air or breathable gas to increase the temperature of the flow of cooled or heated air or breathable gas
13. The system of claim 12 in which the controller is configured to control a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of the flow of air or breathable gas and provide the flow of cooled air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of the flow of air or breathable gas to increase the temperature of the flow of cooled air or breathable gas.
14. The system of claim 13 further including a heat exchange transfer subsystem coupled to the heat transfer subsystem configured to remove heat from the heat transfer subsystem.
14. The system of claim 13 further including a heat exchange transfer subsystem coupled to the heat transfer subsystem configured to remove heat from the heat transfer subsystem.
15. The system of claim 14 in which heat exchange transfer subsystem includes a conductor block coupled to a side of the TEC and conductive pipes coupled to conductive fins.
15. The system of claim 14 in which heat exchange transfer subsystem includes a conductor block coupled to a side of the TEC and conductive pipes coupled to conductive fins.
16. The system of claim 15 further including a fan coupled to the conductive fins.
16. The system of claim 15 further including a fan coupled to the conductive fins.
17. A method for cooling the brain of a human subject, the method comprising: receiving a flow of the air or breathable gas; cooling or heating the flow of the air or breathable gas;
outputting a flow of cooled or heated air or breathable gas to a line coupled to a device adapted to deliver the cooled or heated air or breathable gas to a human subject;
controlling a flow rate of the flow of the air or breathable gas and a flow rate of the cooled or heated air or breathable gas output to the line;
measuring at least a flow rate of flow of cooled or heated air or breathable gas; measuring at least a temperature of a brain or brain correlative site of the human subject and a temperature of the flow of cooled or heated air or breathable gas; and
adjusting a cooling rate, the temperature, and the flow rate of flow of cooled or heated air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled or heated air or breathable gas to cool the brain of the human subject.
17. A method for cooling the brain of a human subject, the method comprising: receiving a flow of the air or breathable gas;
providing a cooling subsystem comprising a gas block including a surface in thermal communication with a thermal electric cooling (TEC) device and configured such that the flow of air or breathable gas contacts the gas block at a location in thermal communication with TEC to cool the air or breathable gas;
outputting a flow of cooled air or breathable gas to a line coupled to a device adapted to deliver the cooled air or breathable gas to a human subject;
controlling a flow rate of the flow of the air or breathable gas and a flow rate of the cooled air or breathable gas output to the line;
measuring at least a flow rate of flow of cooled air or breathable gas; measuring at least a temperature of a brain or brain correlative site of the human subject and a temperature of the flow of cooled air or breathable gas; and
adjusting a cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas delivered to the human subject based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas to cool the brain of the human subject.
18. The method of claim 17 further including adjusting the temperature and the flow rate of the flow of cooled or heated air or breathable gas to provide therapeutic hypothermic (TH) and target temperature management (TTM) to normothermic levels.
18. The method of claim 17 further including adjusting the temperature and the flow rate of the flow of cooled air or breathable gas to provide therapeutic hypothermic (TH) and target temperature management (TTM) to normothermic levels.
19. The method of claim 17 further including providing a flow rate of cooled or heated air or breathable gas at a flow rate in the range of about 0 to about 50 L/m.
19. The method of claim 17 further including providing a flow rate of cooled air or breathable gas at a flow rate in the range of about 0 to about 50 L/m.
20. The method of claim 17 further including receiving the flow of the air or breathable gas having a temperature in the range of about -10 ºC to about 10 ºC.
20. The method of claim 17 further including receiving the flow of the air or breathable gas having a temperature in the range of about −10° C. to about 10° C.
21. The method of claim 20 further including cooling the flow of the air or breathable gas to a temperature in the range of about -14 ºC to about 7 ºC.
21. The method of claim 20 further including cooling the flow of the air or breathable gas to a temperature in the range of about −14° C. to about 7° C.
22. The method of claim 17 in which the device adapted to deliver the flow of the air or breathable gas to the human subject includes a nasal cannula.
22. The method of claim 17 in which the device adapted to deliver the flow of the air or breathable gas to the human subject includes a nasal cannula.
23. The method of claim 17 further including adjusting a pressure of the flow of cooled or heated air or breathable gas.
23. The method of claim 17 further including adjusting a pressure of the flow of cooled air or breathable gas.
24. The method of claim 17 further including providing a gas block comprised of a thermally conductive material, the gas block including an inlet to receive the flow of air or breathable gas and an outlet configured to output the flow of cooled or heated air or breathable gas.
24. The method of claim 17 further including providing a gas block comprised of a thermally conductive material, the gas block including an inlet to receive the flow of air or breathable gas and an outlet configured to output the flow of cooled air or breathable gas.
25. The method of claim 24 further including providing a heat transfer subsystem coupled to the gas block configured as the thermal electric cooling (TEC) device.
25. The method of claim 24 further including providing a heat transfer subsystem coupled to the gas block configured as the thermal electric cooling (TEC) device.
26. The method of claim 25 further including controlling a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of flow of air or breathable gas and provide a flow of cooled or heated air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of flow of air or breathable gas to increase the temperature of the flow of cooled or heated air or breathable gas.
26. The method of claim 25 further including controlling a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of flow of air or breathable gas and provide a flow of cooled air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of flow of air or breathable gas to increase the temperature of the flow of cooled air or breathable gas.
27. The method of claim 26 further including providing a heat exchange transfer subsystem coupled to the heat transfer system configured to remove heat from the heat transfer subsystem
27. The method of claim 26 further including providing a heat exchange transfer subsystem coupled to the heat transfer system configured to remove heat from the heat transfer subsystem.
It should be noted despite the several instances of “or heat” and its variants, the generic concept of “regulating the temperature” includes the directionality of “cooling” which reduces the temperature and “heating” which increases the temperature. Thus, the patent claims are a “species” of the “generic” invention as the patent claims are only concerned with the “cooling” action of “regulating the temperature”.
Further, it should be noted that in a system/method operating for the features of “cooling” action the ability to modify the system/method to operate in the alternative imparting “heating” features is simply a reversal of the electrical current – as stated by Geist et al. (2012/0031405) – “By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows.” (Para 0044).
Thus, Claims 1-27 are deemed rejected on the grounds of nonstatutory double patenting.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nakamatsu (4,987,896) and Naaman (5,353,605) each disclose a system for cooling the brain of a patient.
Kumar et al. (2003/0131844) discloses a system for inducing hypothermia via administration of gas – perfluorocarbon mist - to the respiratory pathway of the patient.
Magilton et al. (3,776,241 and 3,897,790); Jiang et al. (2003/0136402); Takeda et al. (8,522,786) and Belson (2015/0068525; 2009/0107491; and 2012/0167878) each disclose the delivery of gas – water vapor / mist / coolant fluid – to the respiratory pathway of the patient for imparting cooling in the brain of the patient.
Kreck et al. (9,320,644) and Harikrishna et al. (2014/0053834) each disclose the delivery of gas to the respiratory pathway of the patient for imparting cooling in the brain of the patient with an external heat exchanger remote from the patient interface.
Klatz (5,752,929) discloses a system for brain resuscitation and organ preservation through application of cooling systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785