DETAILED ACTION
Applicant’s response, filed 28 Nov. 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Any reference to the previous Office action refers to the Office action mailed 27 May 2025. Furthermore, references to Applicant’s specification refer to the published version of the specification.
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 .
Status of Claims
Claims 1-16, 27-28, and 30 are cancelled.
Claim 31 is newly added.
Claims 17-26, 29, and 31 are pending.
Claims 17-26, 29, and 31 are rejected.
Claim 20 is objected to.
Priority
Applicant’s claim for the benefit of a prior-filed application, PCT/EP2020/066150 filed 10 June 2020, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant's claim for foreign priority based on an application, EP19180212.3 filed 14 June 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Accordingly, the effective filing date of the claimed invention is 14 June 2019.
Drawings
The objection to the drawings received 24 Nov. 2021 in the previous Office action has been withdrawn in view of replacement drawings received 28 Nov. 2025.
The drawings received 28 Nov. 2025 are accepted.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites “The method of claim 20,, wherein…”, which is a grammatical error and one of the commas after “20” should be removed.
Appropriate correction is required.
Claim Interpretation
Claim 29 recites “…wherein the processor is adapted for: calculating…; obtaining…”. Applicant’s specification at para. [0046] discloses a processor can be adapted for calculating (e.g. configured to calculate), be adapted for obtaining (e.g. configured to obtain). Therefore, the term adapted for will be interpreted to mean the processor is programmed to perform the recited functions.
Claim 22 recites “…at least one value representative of temperature of surroundings of the body…for use in calculations of radiative heat transport”. The italicized portion is interpreted to recite an intended use of the value representative of temperature of surroundings, but the temperature is not required to be used to calculate radiative heat transport within the metes and bounds of the claim.
Claim 24 recites “…wherein calculating any of the values…takes a surface area into account, said surface area being obtained or calculated from the at least one property of the body received as input”. The limitation regarding how the surface was obtained or calculated is interpreted to define the process in which the surface area was previously calculated, but the claim does not require an active step of calculating the surface area within the metes and bounds of the claims. See MPEP 2113 I. regarding product by process limitations.
Claim Interpretation-35 USC § 112(f)
This interpretation is previously recited:
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 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.
The claim limitations interpreted under 35 U.S.C. 112(f) are as follows:
“controllable heating and/or cooling means for bringing a core body temperature of said animal or human body to a predetermined target temperature” in claim 29.
Applicant’s specification at para. [0064]-[0065] discloses the heating and/or cooling means can include an enclosure, such as a cabinet, for containing the body with a medium to transfer heat or cooling, a heated and/or cooled shelf, an extracorporeal blood circulation device. Applicant’s specification at para. [0152]-[0154] further discloses such heating or cooling elements can include a fan for blowing heated or cooled air, ohmic heater elements, and/or peltier elements. Therefore, the limitation will be interpreted as such, including equivalents thereof.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 16, 27-28, and 30 under 35 U.S.C. 112(b) in the previous Office action has been withdrawn in view of the cancellation of these claims received 28 Nov. 2025.
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.
Claims 17-26, 29, and 31 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Any newly recited portion is necessitated by claim amendment.
Claim 29, and claims dependent therefrom, recite “A hyperthermia treatment system, comprising a device…, a controllable environment comprising controllable heating and/or cooling means…, wherein said device is adapted for receiving sensor data from said plurality of temperature sensors, taking said sensor data into account…, and controlling heating and/or cooling…”. Claim 29 later recites the device includes and input device in addition to a processor adapted for performing the calculating, obtaining, and calculating steps. The use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). In the instant case, it is not clear if the wherein clause relating to “said device is adapted for…”, is generally reciting how the device is intended to be operated and the device is only required to be capable of performing the recited features, if claim 29 intends for some part of the device (e.g. the processor or input), to be adapted to perform the recited functions, or if the limitation intends to require the device have additional structure (e.g. other than the input or processor) that is adapted for performing the step. Therefore it is unclear if a device capable of performing the receiving, taking, and controlling limitations reads on the claim (e.g. the device is in communication with the heating and/or cooling means), or if the claim requires the processor, input, or some other component of the device to be configured to perform the recited functions. In the interest of compact prosecution, claim 29 will be interpreted to mean the processor is further adapted for the receiving, taking, and controlling the heating and/or cooling means, in light of Applicant’s remarks filed 28 Nov. 2025 at pg. 8, para. 5-6. It is suggested Applicant amend the claims to clearly reflect the processor is adapted to perform the recited functions, consistent with Applicant’s remarks.
Dependent claims 17-26 are indefinite for recitation of “The method of claim 29…”. There is insufficient antecedent basis for a method of claim 29, because claim 29 recites “A hyperthermia treatment system”, but not a method. For purpose of examination, the claims will be interpreted to mean “The system of claim 29…”.
Dependent claim 19 is indefinite for recitation of “The method of claim 29, further comprising receiving…sensor data…”. This limitation has been interpreted to mean “The system of claim 29, further comprising receiving…”, as noted above. Given claim 29 recites a system, it is unclear if the additional step of “…receiving…sensor data” is intending to recite an additional method step, or if claim 19 intends to further limit some programming or part of the system or device to be configured to receive sensor data. If Applicant intends for the receiving to be an additional method step, then the claims are further indefinite for reciting both an apparatus and method steps of using the apparatus in a single claim. See MPEP 2173.05(p). If Applicant intends for claim 19 to limit some programming or part of the system, as presently claimed it is not clear what part or component of the system is intended to be adapted to receive the information. However, given claim 29 already recites “said device is adapted for receiving sensor data from said plurality of temperature sensors, taking said sensor data into account for calculating said temperatures…said processor is adapted for…calculating said temperatures in the body by numerically solving said bioheat model by taking…said sensor data…into account”, claim 19 is interpreted as not further limiting the system of claim 29.
Claim 23 is indefinite for recitation of “The method of claim 29, further comprising: calculating…, and/or calculating…, and/or calculating…, and/or calculating…”. The limitation is indefinite for the same reasons discussed above regarding claim 19 regarding whether the claim is intending to recite an additional method step, or intends to further limit some programming or part of the system or device to be configured to perform the calculating. For purpose of examination, claim 23 is interpreted to mean the processor is further adapted for performing the calculating.
Claim 26 is indefinite for recitation of “The method of claim 29, A method comprising:…providing the at least one property of the body as input into a computer-implemented method in accordance with claim 16….”. First, given the claim recites both “The method of claim 29” and then “A method comprising”, it is unclear if claim 26 is intended to be a dependent claim of the system of claim 29, or if this is intended to be an independent method claim. Furthermore, given claim 16 is cancelled, the metes and bounds of “a computer-implemented method in accordance with claim 16” are not clear. It appears “A method comprising” was intended to be removed, and therefore claim 26 will be interpreted to mean “The system of claim 29, comprising..”. However, for the reasons discussed above for claims 19 and 23, this raises further issues regarding whether claim is intending to recite an additional method step, or intends to further limit some programming or part of the system or device to be configured to perform the measuring, providing, and performing. Clarification is requested.
Dependent claim 31 is indefinite for recitation of “…for each interior compartment that is an organ/remainder compartment”. Claim 29, from which claim 31 depends, recites “…wherein each of the anatomical segments comprise a plurality of compartments comprising at least one interior compartment representative of a core and/or bone part…wherein the at least one interior compartment of the at least one trunk segment comprises a plurality of organ compartments”. However, claim 29 does not refer to any interior compartments that are remainder compartments. As a result, it is unclear if the recited equation for the interior compartments are intended to be for only the interior compartments that are organ compartments, or if a “remainder” compartment is intended to refer to an interior compartment representative of core and/or bone. Clarification is requested via claim amendment. For purpose of examination, “each interior compartment that is an organ/remainder compartment” is interpreted to refer to each interior compartment that is an organ compartment”. It is noted that claim 25 does require at least one interior compartment of the trunk segment also comprises a remainder compartment.
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Claim 31 is indefinite for recitation of:
The equation uses an ellipsis “…” between Qcond(i,j) and Qmet(i,j), and it is unclear what calculations are encompassed by “…”. As a result, the metes and bounds of what equations for thermal resistance between the blood compartment and a node (i,j) that are encompassed by the claim are not clear. Clarification is requested.
Claim 31 is indefinite for recitation of “Qcond, E, I” in the equation for the exterior component. The metes and bounds of the equation are not clear because this term is not defined by the claims.
Claim 31 is indefinite for recitation of “Qcond(i,j) is the heat flow by conduction to the next node”. There is insufficient antecedent basis for “the next node” because claim 31 does not previously recite a next node. And while claim 31 does recite “a node (i,j), it is unclear which node would be considered “the next node”, given the claim does not recite multiple nodes let alone a sequence of nodes. Given the claim does not define j, it is also unclear if the next node would refer to node (i+1, j), node (i, j + 1), or even node (i+1, j+1). As a result it is unclear what heat flow is being referenced. For purpose of examination, claim 31 is interpreted to mean “Qcond(i,j) is a heat flow by conduction to a next node”.
Claim 31 is indefinite for recitation of “the metabolic heat generated in the node (i,j)”, “the density of node (i,j), “the volume of node (i,j)”, “the blood perfusion rate of node (i,j)”. There is insufficient antecedent basis for each of these characteristics or quantities of the node (i,j) because the claims previously do not recite any metabolic heat, density, volume, or blood perfusion rate of a node (i,j). Furthermore, claim 31 does not serve define what a node (i,j) is, such that it would be clear the node (i,j) inherently possesses the recited characteristics. For purpose of examination, the limitations will be interpreted to mean “a metabolic heat generated in the node (i,j)”, “a density of node (i,j), “a volume of node (i,j)”, “a blood perfusion rate of node (i,j)”.
Response to Arguments
Applicant's arguments filed 28 Nov. 2025 regarding 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
Applicant remarks that claim 29 is amended to recite the processor, rather than the device, is adapted to perform the receiving, taking, and controlling limitations, and thus the rejection should be withdrawn (Applicant’s remarks at pg. 8, para. 5-6).
This argument is not persuasive because claim 29 does not recite the processor as being adapted to perform these functions. Instead, claim 29 still recites “…wherein said device is adapted for receiving…, taking…, and controlling…”. It is suggested that Applicant move this wherein clause to the end of claim 29 and recite “…wherein the processor is further adapted for receiving…, taking…, and controlling…”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This rejection is newly recited and necessitated by claim amendment.
Dependent claim 19 recites “The method of claim 29, further comprising receiving, as input, sensor data from one or more temperature sensors on or in the body, and taking sensor data into account when numerically solving said bioheat model”. Claim 29, from which claim 19, depends, already recites “a plurality of temperature sensors for measuring temperatures on or in the body…said device is adapted for receiving sensor data from said plurality of temperature sensors, taking said sensor data into account for calculating said temperatures…said processor is adapted for…calculating said temperatures in the body by numerically solving said bioheat model by taking…said sensor data…into account”. Therefore, claim 29 already requires the limitations of claim 19, and claim 19 fails to further limit the subject matter of claim 29.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
The rejection of claims 16, 27-28, and 30 under 35 U.S.C. 101 in the previous Office action has been withdrawn in view of the cancellation of these claims received 28 Nov. 2025.
The rejection of claims 17-26, 29, and 31 under 35 U.S.C. 101 in the previous Office action has been withdrawn in view of claim amendments received 28 Nov. 2025. The claims integrate the recited judicial exception of calculating temperatures in the body into a practical application of controlling a heating and/or cooling means to bring the core body temperature of the animal or human to a predetermined target temperature in response to the calculated temperatures. Applicant’s arguments regarding 35 U.S.C. 101 at pg. 9, para. 6 to pg. 10, para. 2, relating the instant claims to those in Diehr which integrate the judicial exception into the practical application of operating a rubber-mold press are persuasive. Here, the instant claims control a cooling and/or heating means to maintain a target body temperature of an animal or human in response to the calculated temperatures (i.e. cooling the body if the calculated temperatures exceed the target or heating the body if the calculated temperatures are below the target). It is noted that this statement is based on the claim interpretation set forth above under 35 U.S.C. 112(b) for claim 29.
Claim Rejections - 35 USC § 103
The rejection of claims 16, 27-28, and 30 under 35 U.S.C. 103 in the previous Office action has been withdrawn in view of the cancellation of these claims received 28 Nov. 2025.
The previous rejections of claims 17-26 under 35 U.S.C. 103 in the previous Office action have been withdrawn in view claim amendments received 28 Nov. 2025. However a new grounds of rejection is set forth below in view of the claim amendments.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-19, 21-26, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Xiang (2008) in view of Ferreira (2009), Reifman (2017), and Vaity (2015). Any newly recited portion is necessitated by claim amendment.
Cited references:
Xiang et al., Comprehensive evaluation on the heating capacities of four typical whole body hyperthermia strategies via compartmental model, 2009, International Journal of Heat and Mass Transfer, 51, pg. 5486-5496; cited in IDS filed 24 Nov. 2021 (previously cited);
Ferreira et al., A transient three-dimensional heat transfer model of the human body, 2009, International Communications in Heat and Mass Transfer, 36, pg. 718-724 (Previously cited);
Reifman, US 2019/0192009 A1, effectively filed 18 Aug. 2017 (previously cited); and
Vaity et al., Cooling techniques for targeted temperature management post-cardiac arrest, 2015, Critical Care, 19:103, pg. 2-6 (previously cited).
Regarding independent claim 29, Xiang discloses a method for modeling temperature in a human body (Abstract), which comprises the following steps.
Xiang discloses receiving properties of a body, including volumes of muscle, fat, and skin in the body (Table 1). While Xiang does not explicitly disclose the property was obtained by measurements of the body, the process in which the at least one property was previously obtained is a product by process limitation that is not required within the metes and bounds of the claim. See MPEP 2213 I. Because the volumes of muscle, fat, and skin are properties of the body, they are the same product as the at least one property of the claim, even if determined by another method.
Xiang discloses determining a thermal conduction between tissue layers (i.e. at least one body-specific parameter) based on the properties of the body (e.g. the volumes), wherein the thermal conduction is a parameter of a compartment model of heat transfer in a person (i.e. a bioheat model) (Figure 3, e.g. Qcond; pg. 5488, col. 2, para. 1 to pg. 5490, col. 1, para. 3 to col. 2, para. 1, e.g. heat conductance between tissue layers).
Xiang discloses obtaining a heat loss through convection from the patent’s skin to the air, including the temperature of the air in addition to a radiant heat exchange based on the surrounding temperature (i.e. at least one environment-specific parameter that is indicative of at least one thermal property of the environment and/or a property of thermal exchange between the body and environment) (pg. 5490, col. 2, para. 2-3). Xiang further discloses the surrounding temperature can be from a controllable environment (Fig. 9; pg. 5493, col. 2, para. 2, e.g. different methods of hyperthermia therapy; FIG. 7, e.g. 100 W heat vs 200 W heat input).
Xiang discloses calculating temperatures over time in the body by solving the compartment model (Figure 6-8, e.g. temperature of tissues over time; pg. 5491, col. 2, para. 2 to pg. 5492, col. 2, para. 1, e.g. 49 energy balance equations are solved to determine temperature), wherein solving the model takes into account the heat conduction between tissue types (i.e. the body-specific parameter) and the heat exchange between the person and the environment (i.e. the environment-specific parameter) (Figure 3; Figure 4).
Xiang discloses the compartment model (i.e. the bioheat model) comprises 49 energy balance equations (pg. 5491, col. 2, para. 2), wherein the equations are representative of an equivalent thermal circuit (Fig. 2; Fig. 4) for modeling heat between tissue types within the body (Fig. 3) and between the body and environment (pg. 5490, col. 2, para. 2, e.g. section 2.5).
Xiang further discloses the thermal circuit comprises a blood compartment and a plurality of anatomical segments, including compartments for a leg (i.e. a lower extremity segment), an arm segment (i.e. an upper extremity segment), abdomen and thorax segments (i.e. at least a trunk segment), and a head segment (Fig. 2, e.g. blood compartment, and compartments for leg, foot, hand, arm, head, neck, thorax, etc.).
Xiang discloses each anatomical segment comprises a plurality of interior compartments including core, muscle, fat, and skin (Table 1; Figure 3; pg. 5487, col. 2, para. 1; Fig. 11).
Xiang further discloses an environment for controlling the temperature of a person (Fig. 1, e.g. see heat exchanger, pump and pipe; pg. 5487, col. 1, para. 3 to col. 2, para. 1).
Regarding independent claims 29, and dependent claim 25-26, Xiang does not disclose the following:
First, regarding claim 29, Xiang does not explicitly disclose a device or computer-readable medium for performing the predicting, including an input for receiving the at least one property of the body and a processor. However, Xiang does disclose the simulations are performed with Matlab software (pg. 5491, col. 2, para. 2), which would require a suitable computer with an input, processor, and computer readable medium for running the software. Furthermore, the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. See MPEP 2144.04 III.
Further regarding claims 25 and 29, while Xiang discloses the abdomen compartment and thorax compartment each comprise a core compartment representing major internal organs in the compartment (i.e. a plurality of organ compartments representative of at least two internal organs) (pg. 5487, col. 2, para. 1, e.g. basal blood flow rate for major organs collected for compartment model; Fig. 2), Xiang does not disclose at least one interior compartment (e.g. the core) of the trunk segment specifically includes a plurality of organ compartments of at least two internal organs that are connected in parallel in the equivalent thermal circuit, as recited in claim 29. Xiang further does not disclose the trunk segment also comprises a remainder compartment representative of the interior part of the trunk segment connected in parallel with the organ compartments, as recited in claim 25.
However, Ferreira discloses a heat transfer model of the human body, which similarly includes various compartments (i.e. anatomical segments) of the body, including a head, neck, trunk, abdomen, etc. (Abstract; Fig. 3, e.g. trunk section; Fig. 5, e.g. see different body compartments; pg. 723, col. 2, para. 4)), and models the tissues of skin, fat, muscle, bone, brain, viscera, lung, and heart (pg. 718, col. 2, para. 2; Table 2, e.g. tissue model parameters; Fig. 5, e.g. tissue compartments). Ferreria discloses the trunk compartment (i.e. trunk segment) includes tissue for skin, fat, and muscle (Fig. 3, e.g. see 3 outer rings), in addition to compartments for both the lung and heart tissue (i.e. at least two internal organs) and viscera (i.e. remainder) (Fig. 3; pg. 718, col. 2, para. 3). Ferreria further discloses the heart, lung, and viscera tissue are connected in parallel (FIG. 5, e.g. blood flows separately through each tissue of the trunk segment from arterial to venous reservoir; pg. 721, col. 1, para. 2 to col. 2, para. 1). Ferreira further discloses the lung, heart, and viscera were considered because the lungs blood flow is approximately equal to the cardiac output, the heart has a high metabolic heat generation, and the viscera also has high metabolic heat generation and blood flow (pg. 718, col. 2, para. 3).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Xiang to have included a plurality of organ compartments and a remainer compartment connected in parallel in the interior compartment of the trunk segment, as shown by Ferreira above. One of ordinary skill in the art would have been motivated to combine the methods of Xiang and Ferreria in order to account for tissues with high blood flow and high metabolic heat generation in the model, as shown by Ferreria (pg. 718, col. 2, para. 3), thus providing better temperature predictions. This modification would have had a reasonable expectation of success given both Xiang and Ferreria model heat transfer in a human body divided into anatomical segments representing different tissue compartments, and thus the specific organ tissues of Ferreira are applicable to the model of Xiang.
Further regarding claims 26 and 29, Xiang in view of Ferreira do not disclose a plurality of temperature sensors for measuring temperatures on or in the body, wherein the device is adapted for receiving sensor data from the plurality of temperature sensors, and calculating the temperatures in the body by taking into account the sensor data while numerically solving the model. Xiang in view of Ferreira do not disclose measuring at least one property of a human or animal body, providing the property as an input into the model, and performing model.
However, Reifman discloses a method and system for real-time estimating of human core body temperature using non-invasive measurements (Abstract), which comprises a plurality of sensors for receiving physiological data, including skin temperature and heart rate data (e.g. a property of a body) ([0003]; [0023]) and a processor that receives the measured physiological data ([0037]; FIG. 6). Reifman further discloses the physiological data is used in a model to generate an estimated body core temperature, and modifies parameters of the model ([0003]; [0022]; Fig. 4), which demonstrates the prediction of core temperature takes into account the sensor data (e.g. skin temperature). Reifman further discloses the method and system allows for real-time estimation of human core body temperature ([0002]), and automatically accounts for individual-specific variations in thermoregulatory responses due to acclimation and reactions to exogenous factors ([0022]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the method of Xiang in view of Ferreira to have used a plurality of temperature sensors to have measured skin temperature and heart rate data of the body, received the sensor data from the sensors, and used the sensor and property data in calculating the body temperatures as shown by Reifman, discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Xiang in view of Ferreira with Reifman in order to optimize parameters of the model and account for individual variations in heat acclimation, thus improving temperature predictions, and to allow for real-time estimation of body temperature as shown by Reifman ([0002]-[0003]; [0022]). This modification would have had a reasonable expectation of success given Xiang does disclose using skin temperature data from the literature to validate the model and compare predicted temperatures to known literature values (pg. 5492, col. 2, para. 1; Fig. 5), such that the method of using actual measured skin temperatures to optimize the model of Reifman is applicable to Xiang.
Last regarding claim 29, Xiang in view of Ferreira and Riefman do not disclose the processor is adapted to control the heating and/or cooling means in response to the calculated temperatures in the body.
However, Vaity discloses cooling techniques for targeted temperature management (Abstract; ; pg. 1, col. 1, para. 1), and discloses conventional cooling methods including surface cooling systems (pg. 3, col. 1, para. 1), and intravascular cooling systems available on the market, which can be controlled to cool or warm the body through cool or warm saline and have computerized temperature control with auto-feedback mechanisms (pg. 3, col. 2, para. 1-4). Vaity further discloses an advantage to surface cooling systems is most have computerized auto-feedback mechanisms that allows user to set target temperatures and the system modifies the water temperature using feedback from the patient’s skin and core temperature sensors, allowing for rapid initiation of treatment (pg. 3, col. 1, para. 2).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Xiang in view of Ferreira and Riefman to have used the calculated temperatures to control the heating and/or cooling surface to achieve a target temperature in a subject, as shown by Vaity above. One of ordinary skill in the art would have been motivated combine the methods of Xiang in view of Ferreira and Riefman with Vaity to have allowed for rapid initiation of treatment, as shown by Vaity (pg. 3, col. 1, para. 2). This modification would have had a reasonable expectation of success given Xiang discloses a feedback loop (Fig. 4) with predicting body temperature during hyperthermia treatment, such that the surface system of Vaity is applicable to the calculated temperatures of Xiang.
Therefore, the invention is prima facie obvious.
Regarding the dependent claims:
Regarding claim 17, Xiang further discloses obtaining a plurality of temperature measurements, including a neutral ambient air temperature (pg. 5491, col. 2, para. 2) and during a whole body hyperthermia session representing different temperatures (Fig. 6-8, e.g. different W energy, or heat, inputs for hyperthermia session), wherein the local temperature is input into the model (Fig. 4).
Regarding claim 18, Xiang further discloses adjusting the heat being applied to the subject (i.e. the environmental parameter) to compare different whole body hyperthermia methods in determining the most efficient method to elevate a patient’s body temperature (i.e. optimize a temperature toward a target temperature) (FIG. 9; pg. 5493, col. 2, para. 2 to pg. 5494, col. 2, para. 3).
Regarding claim 19, claim 19 fails to further limit the subject matter of claim 29 as discussed above, and therefore is rejected for the same reasons as claim 29.
Regarding claim 21, Xiang discloses determining the body-specific property comprises determining a thermal conduction between tissue layers (i.e. compartments of the model) based on the properties of the body (e.g. the volumes) (Figure 3, e.g. Qcond; pg. 5488, col. 2, para. 1 to pg. 5490, col. 1, para. 3 to col. 2, para. 1, e.g. heat conductance between tissue layers).
Regarding claim 22¸ Xiang further discloses determining a convection parameter, hair and temperature of an air to which the body is exposed, in addition to a value representative of temperature of surroundings of the body in the environments (pg. 5490, col. 2, para. 2 section 2.5, e.g. heat loss through convention as function of air temperature). Xiang further discloses determining amounts of heat input to the subject from a controllable environment (FIG. 6-9; pg. 5493, col. 2, para. 2 through pg. 5494 regarding comparison of heating strategies).
Regarding claim 23¸ Xiang further discloses calculating a rate of convection between the patient’s body’s surface (i.e. the skin, or exterior compartment) and the environment using the convection parameter, hair (pg. 5490, col. 2, para. 2, e.g. QConv). Xiang also determines a rate of conductive heat exchange for the skin based on the surrounding temperature (pg. 5490, col. 2, para. 3, e.g. Qradi).
Regarding claim 24, Xiang further discloses the calculations of the rate of convention and rate of heat exchange each take into account the area of body surface, A (pg. 5490, col. 2, para. 2-3).
Regarding claim 31, Xiang discloses the plurality of equations representing the anatomical segments with index i at equations (1)-(10) (pg. 5488, col. 1, para. 1 to pg. 4890, col. 2, para. 3), comprising the following:
Xiang discloses the equation for the blood compartment at eqn. (5) (pg. 5490, col. 1, para. 1, eqn (5)). Xiang discloses a term p(i,j)*V(i,j)w(I,j)+pb*cb(T(i,j) – Tb) called Qblood (see eqn (5) and also eqn (9)) that is equal to the thermal resistance term Rb(Ti,j – Tb) in the claims, as evidenced by Applicant’s own specification at para. [0074]. Xiang additionally includes a Qres term in the equation for the blood compartment, but notes that this term applies only to the thorax core (pg. 5490, col. 1, para. 1); the equation of (5) is equal to the equation of the claims without this Qres term, and thus a blood compartment other than for the thorax core in Xiang discloses the equation for the blood compartment in the claims.
Xiang discloses the equation for each intermediate compartment of muscle and fat (pg. 4890, col. 2, para. 1-2, eqn(2)-(3)). Again, it is noted that Qblood in the equation is equal to the term Rb(Ti,j – Tb) in the claims.
Xiang discloses the equation for the skin (i.e. exterior compartment) (pg. 5490, col. 1, para. 1, eqn. 4). The term Qevap in eqn. 4 of Xiang is considered to read on Qocnd,E,I in the claim, and as discussed above, Qblood is equal to the term Rb(Ti,j – Tb) in the claim.
Xiang discloses the equation for each core compartment (i.e. interior compartment) (pg. 4890, col. 2, para. 2, eqn (1)). Again, it is noted that Qblood in the equation is equal to the term Rb(Ti,j – Tb) in the claims. In addition, the claim include a phrase “…”, which is not clear, but is interpreted to mean the equation can include additional terms, such as Qresp in eqn (1) of Xiang.
Xiang discloses the definitions of the terms (pg. 5487, Nomenclature box; pg. 5490, col. 1, para. 1 to col. 2, para. 5; Table 2).
Xiang discloses the at least one environmental-specific parameter includes a convection parameter, hair and temperature of an air to which the body is exposed, in addition to a value representative of temperature of surroundings of the body in the environments (pg. 5490, col. 2, para. 2 section 2.5, e.g. heat loss through convention as function of air temperature).
Therefore, the invention is prima facie obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Ferreira, Reifman, and Vaity as applied to claim 29 above, and further in view of Grady (2016).
Cited reference: Grady et al. US 2016/0287338 A1 (previously recited)
Regarding claim 20¸ Xiang in view of Ferreira, Reifman, and Vaity disclose the system of claim 29, as applied above. Further regarding claim 20, Xiang further discloses the at least one trunk segment includes both a thorax and abdomen compartment, each which include a core compartment representing internal organs (Fig. 2; pg. 5487, col. 2, para. 1). Xiang in view of Ferreira make obvious a thoracic compartment comprising a plurality of internal organs (e.g. heart and lung) connected in parallel, as applied to claim 29 above.
Further regarding claim 20¸ Xiang in view of Ferreira do not disclose the plurality of organ compartments are interior compartments of the abdomen segment.
However, Grady discloses a method for providing personalized estimates of bioheat transfer (Abstract), and discloses receiving a patient-specific model of a patient’s anatomy (Abstract), including a heat-transfer model of the whole body including multiple organs ([00037]; [0062]; [0071]). Grady discloses modeling bioheat in an individual’s entire body and in isolated organs ([0004]; [0022]), including deep organs known to source heat, such as the liver ([0038]), and additionally the kidney (e.g. organs of the abdomen) ([0037]; [0066]; [0071], e.g. whole body including multiple organs). Grady discloses estimating heat content in the target tissues using the model ([0067]), and further discloses the model can be extracted from a medical imaging scan ([0037] and heat transfer properties can be acquired from imaging sources ([0043]; [0062]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Xiang in view of Ferreira, as applied to claim 16 above, to have included organ compartments for the liver and kidney in the bioheat model, as shown by Grady, discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Xiang in view of Ferreira with Grady, in order to account for deep organs known to source heat and be able to estimate heat content in particular organs, as shown by Grady ([0038]; [0066]-[0067]). This modification would have had a reasonable expectation of success given each of Xiang and Ferreira disclose a whole body model with compartments having interior compartments for different tissue types, such that the additional tissue types of Grady would be applicable to the models of Xiang and Ferreira, and furthermore, given Grady explains the model can be extracted from a medical imaging scan ([0037] and heat transfer properties can be acquired from imaging sources ([0043]; [0062]).
Therefore, the invention is prima facie obvious.
Response to Arguments
Applicant's arguments filed 28 Nov. 2025 regarding 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant remarks that Xiang, Ferriera, Vaity, and Reifman fail to disclose or suggest the technical problem addressed by the present invention of controlling a target temperature in a human or animal body when said body is in a controllable environment, and that in Xiang, no differentiation is made for variables such as the temperature in a layer of a segment, and thus each of the segment layers only receives a single set of physical properties, and thus the method of Xiang cannot take into account differences between organs in a layer in order to accurately model individual organs and adjust target temperature accordingly (Applicant’s remarks at pg. 11, para. 3 to pg. 12, para. 2). Applicant then discusses examples regarding the liver having a high metabolic rate, and thus Xiang can result in local overheating because Xiang does not appreciate the need for differentiating between internal organs in the same segment layer or compartment (Applicant’s remarks at pg. 12, para. 3 to pg. 13, para. 2).
This argument is not persuasive. First, the argument is not commensurate with the scope of claim 29. Claim 29 recites “calculating said temperatures in the body”, but does not require the calculated temperatures are for particular organs/tissues, layers, segments, or compartments. Instead, the claims encompass calculating at least two temperatures (e.g. a skin and core temperature) using a bioheat model, and then controlling the heating and/or cooling means based on these calculated temperatures.
Furthermore, regarding the modeling of specific organs, Xiang is not relied upon for this limitation, and instead, Ferreira incorporates modeling additional tissues representing organs
Applicant remarks that Ferreira does not disclose the use of a bioheat model that takes into account at least one body-specific parameter, sensor data, and environment-specific parameters, and furthermore, that the characterization of Fig. 3 of Ferriera as suggesting the claimed “plurality of organ compartments representative of at least two internal organs connected in parallel” is inaccurate because the three sections of Fig. 3 are not organ compartments, but each contain a variety of different tissues belonging to both organs and other tissues present in the trunk (Applicant’s remarks at pg. 13, para. 3-4).
This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ferreira is not relied upon to disclose the use of a bioheat model that takes into account at least one body-specific parameter, sensor data, and environment-specific parameters.
Furthermore, claim 29 also recites that each anatomical segment comprises multiple compartments, such as an interior compartment, and an interior compartment contains at least two organ compartments. Therefore, like in Ferreira, each anatomical segment contains a variety of tissues.
Furthermore, it is not persuasive that that the different layers of the sections of the anatomical segments (e.g. neck, trunk, arms, etc.) are not compartments as alleged by Applicant.
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Applicant’s own specification at para. [0010] discusses Xiang, and states “The four concentric layers of these cylinders…act as compartments of the model, which have variables and properties associated therewith”. Fig. 2 of Xiang demonstrating the different compartment layers is provided below for convenience. Applicant’s specification at para. [0072] refers to “a ‘compartment’, which models a specific part of the body’s anatomy”.
The various “sections” of Xiang demonstrating different concentric layers of tissue (e.g. bone, skin, fat, muscle) are referred to as compartments in Applicant’s own specification, and fall within the explanation of a compartment provided by Applicant’s specification at [0072], given each tissue “models a specific part of the body’s anatomy”. Applicant also does not appear to contest that Xiang does disclose the muscle, fat, skin, and core compartments of claim 29.
For comparison, the various tissue layers of Ferreira depicted in Fig. 3, as well as a representation of the system model in Fig. 5 are provided below:
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Ferreira includes concentric layers that include specific organs (Fig. 3 on left), instead of relying on a simple “core” compartment as in Xiang (see FIG. 2 of Xiang above), and also depicts a tissue as it’s own compartment receiving blood flow from the arterial reservoir (see Fig. 5 on the right). It is not persuasive, nor consistent with Applicant’s specification considering the concentric layers of Xiang compartments, but not the concentric layers of Ferreira. Furthermore, given the layers in Ferreira do model a specific organ (e.g. lung, heat, etc.) (also see Table 2 defining specific tissue parameters), these are considered “compartments” in light of Applicant’s explanation of a compartment. Ferreira also models each tissue compartment as receiving blood from the arterial reserve and back into the venous reserve, demonstrating the parallel connectivity (i.e. blood does not flow in series from one tissue/organ to another).
Applicant remarks that Reifman does not disclose the claimed compartmentalization and control of a target body temperature, while Vaity does not disclose the specific body temperature modeling and calculations, and therefore, the proposed combination of Xiang, Ferreira, Reifman, and Vaity would not have been obvious or resulted in the claimed invention (Applicant’s remarks at pg. 13, para. 5 to pg. 14, para. 2).
This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Reifman is not utilized to disclose the claimed compartmentalization and control of a temperature, and instead is used to disclose the use of sensor data in a model for predicting temperature. Similarly, Vaity is relied upon to disclose controlling the temperature of a body to achieve a target temperature, and not the temperature modeling and calculations.
Conclusion
No claims are allowed.
Claims 17-26, 29, and 31 are patent eligible for the reasons set forth above.
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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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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