DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 23 March 2026 has been entered. Claims 1-10 are currently amended. Claims 11-12 are new. Claims 1-12 are pending in the application. Applicant’s arguments and amendments to the drawings, claims, and specification have overcome the objections and rejections under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 21 October 2025, except for those restated below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “power control unit” in claim 1 and “temperature control unit” in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 6-7 recite a flow rate of 120 L/min, which is not disclosed in the specification (see par. 0031 of the specification, which discloses a flow rate of 120 L/hour). For examination purposes, the claim will be read as reciting a flow rate of 120 L/hour.
New claim 11 recites wherein measuring the indication of heat transferred comprises measuring one or more of a voltage or energy difference between the N-doped portion and the P-doped portion caused by a change in temperature at the location, and this limitation also lacks support in the original disclosure, which does not mention measuring a voltage or energy difference across a thermoelement in order to determine heat transfer.
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 1-12 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.
Although some issues have been resolved with the amendments, the claims continue to be replete with grammatical and idiomatic errors. Further, it is unclear whether some limitations are duplicates of limitations that have already been claimed or are intended to recite further structure. For examination purposes, the claims are read as laid out in the following art rejections under 35 U.S.C. 103, according to the examiner’s best understanding of the structure and distinctive features of each claim.
In multiple claims, it is unclear whether the phrase “treat hypothermia” means to cause hypothermia therapeutically or to treat the symptoms of hypothermia by warming. For examination purposes, the phrase will be read in all instances as to cause hypothermia.
Numerous terms throughout the claims are recited with the term “the” without sufficient antecedent basis for each limitation in the claims. Examiner recommends amending the claims to keep all terminology consistent.
In claim 1, it is unclear whether the thermoelements themselves measure the indication of heat transferred at each respective location. For examination purposes, this limitation will be read as wherein the device is configured to measure a temperature at each respective location of a thermoelement. Dependent claims 2-12 are necessarily rejected as depending upon a rejected base claim.
Also in claim 1, it is unclear in the limitation “a connection to a power control unit (PCU) consisting of four wheels, fixed on the rear panel of the case” if the connection or the power control unit consists of four wheels, and it is further unclear how either element could consist of (rather than comprise) four wheels. For examination purposes, this limitation will be read as a connection to a power control unit.
In claim 2, it is unclear what a diameter of 8 mm would mean in the case wherein the thermoelectric elements are flat parallelepipeds rather than cylindrical, which renders the scope of the claim unclear. For examination purposes, the claim will be read as wherein the thermoelectric elements have a length of at least 5 mm.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “cooling the brain at a controlled rate up to 30 °C”, and the claim also recites “in a range of 28 °C-30 °C” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 contains the trademark/trade name Arduino®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a microprocessor and, accordingly, the identification/description is indefinite.
Claim 5 also recites the limitation “wherein the device is configured to record a fault related to a source status,” which renders the scope of the claim unclear because it is unclear what the terms “fault” or “source status” are intended to mean, and the specification does not appear to define the terms. For examination purposes, the claim will be read without this limitation.
The term “easily” in claim 7 is a relative term which renders the claim indefinite. The term “easily” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed degree of ease in connecting and separating the components of claim 7 is therefore rendered indefinite. Similarly, in claim 4, the limitation “without harming the patient” is indefinite in scope. For examination purposes, this limitation will be read as non-invasively.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Vergara et al. (US PGPub No. 2016/0270952), hereinafter Vergara, in view of Berger et al. (US PGPub No. 2018/0085001), hereinafter Berger, and further in view of Zumbrunnen et al. (US PGPub No. 2017/0209304), hereinafter Zumbrunnen.
Regarding claim 1, Vergara teaches a smart thermoelectric brain hypothermia device (Fig. 1: portable thermoelectric cooling device 10), comprising:
a flexible helmet (Fig. 1: helmet 12);
a flexible bottom plate made of an antibacterial, insulating material (par. 0049: “The bottom copper foil was covered with a thin layer […] of soft heat conductive elastomer such as SE4445 CV Gel (Dow Corning) or SSP-1850C (Specialty Silicone Products Inc.®);” examiner notes that the disclosed silicone gels are non-porous and thus antibacterial to some degree, as broadly as claimed);
a plurality of flexible thermoelements located in a plurality of slots of the bottom plate (Figs. 7A-7C: flexible heat exchanger modules 110; par. 0041: “The layers generally comprise an elastomeric bottom layer 112 preferably comprising a soft heat conductive elastomer which interfaces skin of the patient with a conductive foil layer 114 (e.g., copper foil). A TEC device layer 116 is seen with one TEC 117b seen in the cross-section of FIG. 7C”)
and during operation configured to: apply cooling or heating at each respective location (par. 0026: “Cooling and heating is preferably performed on the helmet and collar using a plurality of thermoelectric cooling devices (TECs) 22”);
wherein the device is configured to measure an indication of heat transferred at each respective location by the thermoelement during operation (Fig. 1: temperature sensors 28; par. 0027: “these temperature sensors can be positioned in alignment with each TEC to sense the temperature of the patient skin at that location”),
a plurality of water collectors to provide fluid circulation through copper pipes of the flexible thermoelements (Figs. 1-2: tubing 26; par. 0026: “the extracted heat being collected by a thermally conductive collector 24 (e.g., copper structure) connected through fluid channels (e.g., tubing) 26 to the fluid circulator and heat exchanger 20”);
a plurality of flexible hoses providing hydraulic connection between thermoelements (Fig. 1: hoses connecting water circulator 20 to helmet 12 and copper tubing 24 at each thermoelectric cooler 22);
a plurality of electrical wires that allow the flexible thermoelements to be electrically connected to each other (Figs. 7A-7C and par. 0041: “Electrical connection pairs 132a, 132b, 132c and 132d, are seen in the figures for connecting each of the four TECs”);
a top sheet made of a flexible soft, insulating, antibacterial material (par. 0042: “A flexible upper layer 124 provides strength, preferably comprising a reinforced elastomer, such as nylon-polydimethylsiloxane (PDMS) or other reinforced silicon sheet”);
a flexible filler between the flexible thermoelements and between the bottom sheet and the top sheet (par. 0049: “The bottom (cold) sides of the TECs were bonded (glued) directly onto another copper foil which was separated from the upper foil (bottom of the water chamber) by the body of the TEC and filled with heat insulation material such as neoprene, styrofoam, or insulating foam (not shown in the drawings of FIG. 7A through FIG. 7C)”);
a metal connector fixed on the flexible helmet and electrical connection cables for connection to a power control unit (Figs. 1, 5: power supply connected to helmet via electrical connection cables, power supply 18);
a closed water pump to remove the heat released from the heated surface of the flexible thermoelements, and a radiator and fan circulation system (par. 0032: “a water circulator (pump) and heat exchanger (e.g., external to helmet and collar) utilized for cooling a computer CPU can be utilized (e.g., Colace EX2-755). In using a simple heat exchanger of this type, the coolant is brought back to approximately room temperature and cycled back through to the passageways adjacent the TECs. The TEC helmet and collar are coupled to the heat exchanger, such as using flexible plastic tubing. Thus, when cooling a patient, each TEC unit cools its interior side toward the conductive inner layer adjacent the scalp/skin of the patient. The waste heat on the opposite side of each TEC is coupled into the cooling fluid and carried (i.e., pumped) to an external heat exchanger which extracts the heat and returns the coolant to absorb additional heat”);
a DC switched-mode power supply (Fig. 1: power supply 18; par. 0026: “power supply 18 is configured for making the device portable, as it is preferably compatible with AC/DC power available in ambulances”);
a memory and a processor (Fig. 1 and par. 0030: “the electronic control module (ECM) 16 may alternatively incorporate at least one computer 42, such as comprising a central processing unit (CPU) 44 and memory 46”),
a touch control panel and power button (Fig. 4 and par. 0034: “A user interface 60 is coupled to the processor for controlling all desired aspects of operation and displaying information about the patient and system operation. In at least one embodiment, this user interface comprises a touch-based interface, such as a thin-film-transistor liquid crystal display TFT-LCD”).
Vergara does not explicitly teach wherein the metal connector is made as a hemisphere. However, it would have been an obvious matter of design choice to make the metal connector of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Vergara does not explicitly teach an LED indicator but does teach visual alarms (par. 0034: “an alarm interface 58 which provides visual and auditory alarms”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select an LED indicator as a visual alarm, since one of ordinary skill in the art would have been choosing from a finite number of identified, predictable mechanisms for visual alarms, with a reasonable expectation of success.
Vergara does not explicitly teach wherein the memory comprises non-transitory computer readable instructions configured to cause the processor to perform determining, based on the measured indications of heat transfer at the locations corresponding to the plurality of slots, a three-dimensional heat map. However, in an analogous art, Berger teaches determining brain temperatures at a plurality of locations to form a 3D heat map during therapeutic hypothermia (Fig. 6 and par. 0073: “real time patient temperature information in the form of a patient scalp isotherm map 131 and/or a patient 3D temperature estimation mapping 132 for display on a human head image on a display device during the induced systemic hypothermia”), which makes it possible for a clinician to monitor cooling or warming progress more effectively (par. 0055: “A clinical practitioner can use the benchmark scalp isotherm map collection 114 during induced either systemic or local brain hypothermia to assist him to decide whether the patient's brain is being cooled according to a predetermined clinical protocol. Similarly, a clinical practitioner can use the benchmark scalp isotherm map collection 114 during restoration of a patient's brain from an induced hypothermic state to a normal core body temperature to assist him to decide whether the patient's brain is being warmed according to a predetermined clinical protocol to avoid too rapid warming which can inadvertently lead to neurodamage”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Vergara by providing the capability to determine a 3D heat map, as taught by Berger, in order to assist clinicians in monitoring cooling or warming progress more effectively, as taught by Berger.
Vergara further does not explicitly teach a flexible combined hose consisting of water pipes and a plurality of electrical wires, wherein the helmet, flexible combined hose, and power control unit are connectable to and separable from one another. However, in an analogous art, Zumbrunnen a portable hypothermia system with parts that can be connected and separated from one another (Fig. 1: cap system 102 connectable to and separable from cooler system 101 via conduits 107; par. 0030: “electrical and plumbing conduits 107 linking the cooler system with the said cap system”) in order to increase ease of use (par. 0033: “Contributing to the ease-of-use and self-managed objects of this invention are the preferred use of gender specific plumbing connectors for direction of fluid flow and a standard everyday and familiar phone jack connector for the sensor wire connections. Said connectors 115 have their mating fluid and sensor connectors located on cooler system 101. The user cannot connect either type together incorrectly”), as well as encapsulating connection cables in a combined hose to eliminate condensation and minimize heat gain (Fig. 1: electrical and plumbing conduits 107 and sensor connector 116 encapsulated by combined hose 109; par. 0030: “The plumbing conduits 107 are encapsulated by a vapor barrier and thermal insulation 109 (shown partially) to eliminate condensation and minimize heat gain respectively”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by encapsulating the fluid, electrical, and signal connections in a combined vapor barrier and thermal insulation, as taught by Zumbrunnen, in order to eliminate condensation and minimize heat gain, as taught by Zumbrunnen. It would further have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Vergara in light of Zumbrunnen by making the parts of the device connectable to and separable from one another, in order to increase ease of use, as taught by Zumbrunnen.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Vergara further teaches wherein the flexible helmet is made of a single piece hemisphere that can take the shape of a human skull (Figs. 8A-8B);
wherein the device is capable of drawing at least 480 W of DC power (par. 0046: “A 600 watt 12V DC power supply was utilized”),
and wherein the device has a cooling capacity of at least 240 W (par. 0046: “A commercially available combination water circulator and heat exchanger was utilized (e.g., Koolance® EX2-755; heat exchange power 500-600 watts)”),
and wherein the flexible thermoelectric elements comprise individual parallelepiped thermoelectric modules with a length of at least 5 mm (Fig. 7B and par. 0046: “The helmet utilized 50 TECs (e.g., Custom Thermoelectric® 01711-5L31-06CF) having a size of approximately 15 mm×15 mm each”),
wherein each flexible thermoelectric element comprises a copper pipe sealed to a silicone hose without hydraulically leaking (par. 0026: “a thermally conductive collector 24 (e.g., copper structure) connected through fluid channels (e.g., tubing) 26”)
and copper wires on two sides (Fig. 7B: electrical connection pairs 132).
Vergara does not explicitly teach wherein the flexible thermoelectric elements comprise 120 individual thermoelectric modules. However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of the combined reference with 120 individual thermoelectric modules, since applicant has not disclosed that the specific number of thermoelectric modules solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any number of thermoelectric modules.
Regarding claim 5, the combination teaches the device of claim 1 as described previously. Vergara further teaches wherein the device is configured to draw at least 480 W of DC power (par. 0046: “A 600 watt 12V DC power supply was utilized”),
which is taken from a vehicle battery or an electrical network (par. 0061: “a DC source, such as an automotive battery”),
and wherein the device further comprises a programmable microprocessor (Fig. 4: processor circuit 56; par. 0033: “a processor circuit 56 having an analog-to-digital (AD) converter and a microcontroller”),
wherein the microprocessor is configured to perform PID control (Fig. 4: PID control circuit 62; par. 0035: “Processor circuit 56 also controls the amount of cooling or heating provided by the TECs in the helmet or collar devices. In FIG. 4 a proportional-integral-derivative (PID) circuit 62 is seen coupled to a pulse width modulating (PWM) controller 64, which outputs a PWM signal to a power switching circuit 66”);
wherein the device is capable of switching from a cooling mode to a heating mode using a switching element comprising one or more of a transistor, thyristor, triac, or H-bridge (par. 0035: “an H-bridge circuit allows outputting a desired positive or negative voltage/current, whereby the TECs can be operated to provide cooling, or alternatively heating, to the cranial and neck regions of the patient”);
and wherein the device is configured to control the thermoelectric elements based on at least one temperature sensor (par. 0028: “device programming is configured to drive the TEC units based on a difference in temperature between temperature measured by the temperature sensors and a temperature set point, and to execute desired (programmed) patterns of cooling and heating cycles”).
Regarding claim 8, the combination teaches the device of claim 1 as described previously. Vergara further teaches wherein the device is configured to perform PID control (see rejection for claim 5), wherein the helmet comprises 120 flexible thermoelectric modules (see rejection for claim 2), configured to provide cooling or heating at different points (see rejection for claim 1), and to monitor temperature while performing thermal treatment (par. 0029: “Temperature control is performed through a controller 36, such as a proportional-integral-derivative (PID), connected to one or more thermoelectric cooler (TEC) drivers 38;” par. 0068: “the method of using sophisticated feedback circuitry to fix (or clamp) the patient scalp temperature to values as low as 5° C. (to avoid frostbite), while assuring that the hot side of the TECs are close to ambient temperatures (at about 20° C. to 25° C.), has been shown to be feasible with current technology. The inventive apparatus also permits warm to cold and vice versa transitions in a fast and safe manner, such as following programmed patterns. An important safeguard of the electronic control unit that automatically regulates the temperature of the cooling units, such as the helmet and collar, is that it allows flexible and accurate control of cooling and re-warming of the patients' brain by medical personnel”);
and Berger further teaches wherein the device includes computer-specific software written configured to determine heat and temperature mapping of the brain using 3D brain heat mapping techniques (par. 0062: “The neuroprotection processor 102B runs a 3D thermal model of an upper generally hemispherical section of a human head including its brain, cranium and scalp, for determining the patient 3D temperature estimation mapping 123. A suitable 3D thermal model can be based on a mathematical model”).
Regarding the limitation of wherein the device is configured to perform diagnostic thermography and hypothermic treatment simultaneously, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this instance, since the device of the combined reference is capable of monitoring brain temperature while performing thermal therapy, this limitation is considered to be met by the prior art.
Regarding claims 4 and 9-10, the combination teaches the devices of claims 1 and 5 as described previously. The combination further teaches wherein the device is configured to cool or heat by changing a direction of a current applied to the flexible thermoelectric helmet (see rejection of claim 5) and to measure temperature in at least 120 different points in the brain and to convert the data into a 3D image (see Berger at Figs. 9-10: temperature sensors 163; par. 0077: “the scalp temperature measurement acquisition device 101C includes about 25×8=200 sensors 163”), comprises 120 thermoelectric modules (see rejection of claim 2) to provide cooling or heating at different points (see rejection of claim 1), and is configured to monitor temperature in a 3D heat map to perform non-invasive diagnostic thermography while performing thermal treatment (see rejection of claim 8). Berger further teaches wherein the device is configured to measure, record, and display the temperatures and heat amounts in the brain at different depths (Figs. 5A-FD: temperature estimation mapping 123 at various transverse cross sections 127-129), and Vergara further teaches wherein the device is configured to treat the patient by applying local hypothermia by directly contacting the skull without using any intermediates (Fig. 1 and par. 0042: “increase the flexibility, stretchability, and bendability of the active heat-transfer devices to assure that they closely follow the contours of the head (helmet) and neck (collar) and fit tightly against the scalp”), and wherein the device is portable (Fig. 1 and par. 0026: “an example embodiment 10 of the inventive portable thermoelectric cooling device”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Vergara in view of Berger and Zumbrunnen and further in view of Leckrone (WO 0205736 A2).
Vergara in view of Berger and Zumbrunnen teaches the device of claim 1 as described previously. Vergara further teaches wherein the device has a cooling capacity of at least 125 W (par. 0052: “An overall heat pumping power of approximately 125 watts for the 25 TECs”) without exposing a patient to a radiation field (the device does not use radiation) and is configured to cool in a controlled manner with a predefined speed (par. 0011: “The portable thermoelectric cooling device for therapeutic craniocervical hypothermia described in this disclosure is particularly well-suited as an emergency response tool to rapidly attain (i.e., in less than 15 minutes) local brain hypothermia on individuals”) to treat patients by cooling the brain in brain diseases, anesthesia, cardiology, or COVID-19 (par. 0007: “While [general] hypothermia may be beneficial when several organs are affected in cases of multi-system failure, it may be unnecessary and even deleterious in diseases of the brain proper like stroke and status epilepticus. In contrast, locally-delivered hypothermia is generally regarded as a safe intervention, not causing significant reductions in the body core temperature”),
and wherein the device is configured to heat the brain to a normal temperature at a controlled rate after hypothermia (par. 0068: “The inventive apparatus also permits warm to cold and vice versa transitions in a fast and safe manner, such as following programmed patterns”).
The combination does not explicitly teach wherein the device is configured to maintain a patient’s brain temperature at 28 °C – 30 °C or wherein the device is capable of cooling or heating at a rate of 0.5 °C/min. However, in an analogous art, Leckrone teaches 30 °C as an acceptable lower limit for brain temperature during therapeutic hypothermia (page 3, lines 30-31: “to rapidly reduce brain core temperature down to no lower than about 30.0° Celsius”) and that providing hypothermia as quickly as possible after the onset of an ischemic or anoxic condition can significantly reduce further injury (page 1, lines 21-27: “Under ischemic or anoxic conditions, reversible brain damage can start as early as four minutes after the condition has begun and irreversible brain damage can start as early as six minutes after the condition has begun. Lowering brain temperature, hypothermia, slows brain metabolic activity to slow or reduce brain injury. Early hypothermia of the brain in the initial critical minutes after injury can significantly reduce further injury compared with hypothermia of the brain performed once the patient reaches a facility such as a hospital”).
In light of Leckrone’s teaching, one of ordinary skill in the art would have considered the cooling rate of a therapeutic hypothermia device to be a result-effective variable, in that a more rapid cooling rate may provide better protection from anoxic or ischemic brain injury. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the device of the combined reference to maintain a core brain temperature of 30 °C, as taught by Leckrone, and to have a cooling rate of 0.5 °C/min, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Vergara in view of Berger, Zumbrunnen, and Leckrone, and further in view of Kreck (WO 2012012740).
Vergara in view of Berger and Zumbrunnen teaches the device of claim 1 as described previously. The combination further teaches wherein the device is configured to diagnose at least one disease at the same time it cools the patient’s brain, as laid out previously in the rejection of claim 8.
The combination in view of Leckrone further teaches wherein the device has a cooling capacity of at least 125 W and is configured to maintain a patient’s brain temperature at 28 °C – 30 °C or with a cooling rate of 0.5 °C/min (which would inherently reach a target temperature of 30 °C within 5 minutes), as laid out previously in the rejection of claim 3.
The combination does not explicitly teach wherein the device has a flow rate of at least 120 L/hour. However, in an analogous art, Kreck teaches 120 L/hour as a known flow rate for cooling fluid during therapeutic hypothermia (page 45, line 29: “the flow per catheter can be about 2 L/min;” examiner notes that 2 L/min corresponds to 120 L/hour). In light of Kreck’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose a flow rate of 120 L/hour for the device of the combined reference, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Vergara in view of Berger and Zumbrunnen and further in view of Smith (US PGPub No. 2020/0352777), hereinafter Smith.
Vergara in view of Berger and Zumbrunnen teaches the device of claim 1 as described previously. The combination is silent with respect to the details of the thermoelectric coolers and does not explicitly teach wherein the plurality of flexible thermoelements comprise semiconductor elements, each having an N-doped portion and a P-doped portion. However, the examiner takes official notice it is old and notoriously well known, and is capable of instant and unquestionable demonstration as being well known, to construct the thermoelectric coolers of Vergara using N-doped and P-doped semiconductors.
The combination further does not explicitly teach wherein measuring the indication of heat transferred comprises measuring one or more of a voltage or energy difference between the N-doped portion and the P-doped portion caused by a change in temperature at the location. However, in a related thermoelectric cooling/heating art, Smith teaches measuring heat transferred at a particular location by measuring one or more of a voltage or energy difference between the N-doped portion and the P-doped portion caused by a change in temperature at the location, which is taught as an explicit alternative to direct measurement with a heat flux sensor (Fig. 9A: heat transfer thermal load QLoad; par. 0102: “the thermal load applied to a heatsink QLoad may be equal to the power provided to the thermoelectric module PTEM and the heat transfer across the thermoelectric model from the skin of a user to the heatsink QCool. Each of these three terms can be either directly measured by the system or indirectly approximated based on other system information. For example, in one embodiment, a heat flux sensor may be integrated at the interface between the thermoelectric and the heatsink to provide direct measurement of QLoad. In another embodiment, the power electronics of a system may be designed to allow for direct measurement of the power being provided to the thermoelectric PTEM through some combination of the voltage across the thermoelectric module (VTEM), the current provided to the thermoelectric module (ITEM), and the resistance of the thermoelectric module (RTEM)”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the device of the combined reference to include measuring voltage across a thermoelement in the measurement of heat transfer at the thermoelement, as taught by Smith, because one of ordinary skill in the art would have recognized that applying the known technique taught by Smith to the device of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system capable of determining heat transfer without including a separate heat flux sensor.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Vergara in view of Berger and Zumbrunnen and further in view of Rashkovska et al. (WO 2014180941), hereinafter Rashkovska.
Vergara in view of Berger and Zumbrunnen teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the non-transitory computer readable instructions are further configured to cause the processor to determine the three-dimensional heat map based on using, for a plurality of different depths at different locations, at least one corresponding correlation formula between surface temperature and body temperature at a depth to derive an estimated body temperature at a corresponding depth. However, in an analogous art, Rashkovska teaches a system for determining body temperature at different depths that uses at least one corresponding correlation formula between surface temperature and body temperature at a depth to derive an estimated body temperature at a corresponding depth in order to use more feasible, non-invasive temperature measurement methods (Figs. 2-3 and page 7, lines 14-16, “a predictive model D that captures the correlation between the inner variables that cannot be measured and the outer variables that can be measured with sensors;” page 8, lines 4-12: “If the controlled output variable cannot be measured, for example, the temperature inside a knee, the solution that is the subject of the invention is to add a predictive model D to the feedback control loop to obtain estimation of the inner knee temperature 9 instead of the actual inner knee temperature that cannot be measured non-invasively. The predicted inner knee temperature 9 is estimated based on the measured values 6 of other outer system/process variables whose measurement is more feasible. Sensors C1 are added for non-invasive measurement of the outer variables 6 (for example, temperature on the body surface)”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the processor of the combined reference to use at least one correlation formula between surface temperature and body temperature at a depth, as taught by Rashkovska, in order to use more feasible, non-invasive temperature measurement methods, as taught by Rashkovska.
Response to Arguments
Applicant’s arguments, filed 23 March 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vergara and Berger. As described previously, Vergara teaches measuring temperature at each location of a thermoelement, and Berger teaches determining a three-dimensional heat map.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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