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 .
Status of Claims
Claims 1-15 are cancelled.
Claims 16-30 are pending.
Claims 16-30 are rejected.
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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 24 Nov. 2021, 28 Jan. 2022, and 21 Jan. 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner.
Drawings
The drawings received 24 Nov. 2021 are objected to for the following reasons:
FIG. 1-5 fail to comply with 37 CFR. 1.84(u)(1), which states View numbers must be preceded by the abbreviation "FIG." (i.e. with a period after FIG).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claim 27 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, claim 28 is a work station that only comprises the device of claim 27, and thus is a substantial duplicate of claim 27.
Claim Interpretation
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)
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.
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 claims 16, 27, and 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 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 16-30 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.
Claims 16 and 27, and claims dependent therefrom, are indefinite for recitation of “…said body-specific parameters” and “said environment-specific parameters” in the calculating step. There is insufficient antecedent basis for multiple body-specific and environment-specific parameters in the claim because claim 16 only previously recites “at least one body-specific parameter” and “at least one environment-specific parameter”. Thus it is unclear if only one body and environment parameter is required or if the claim requires multiple body parameters and multiple environment parameters. For purpose of examination the claim will be interpreted to mean “said at least one body-specific parameter” and “said at least one environment-specific parameter”.
Independent claims 26, and 28-30 are rejected for the same reasons discussed above for claims 16 and 27 because they include the same language as claims 16 and 27 by reference.
Claim 29 recites “A hyperthermia treatment system, comprising a device in accordance with claim 27…, 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…”. "[A]pparatus 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) (emphasis in original). See MPEP 2114. It is not clear if the wherein clause relating to “said device is adapted for…”, is reciting an intended use of the device, or if claim 29 intends for the some part of the device of claim 27 to be further adapted to perform the recited functions, such as the processor of claim 27. Therefore it is unclear if a device capable of performing the receiving, taking, and controlling limitations reads on the claim, or if the claim requires the processor of the device is adapted (i.e. programmed to) perform the recited functions. For purpose of examination, claim 29 will be interpreted to mean the processor is further adapted for the receiving, taking, and controlling the heating and/or cooling means.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 30 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because: the subject matter of claim 30 is a computer program on computer readable media. A review of the specification does not show a definition of computer readable media that excludes an embodiment that is information in a signal. As such, an embodiment of the claims read on non-statutory subject matter (In re Nuijten 84 USPQ2d 1495 (2007)). The applicants may overcome the rejection by 1) amendment of the claims to be limited to physical forms of computer readable storage media described in the specification or 2) by amending the claimed subject matter to be limited to “non-transitory computer readable medium”, see the notice regarding Computer Readable Media (1351 OG 212 (23 February 2010)).
Claims 16-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claims 16 and 26-29 being representative) is directed to a method and device for predicting temperatures. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES] While claim 30 does not fall into a statutory category, in the interest of compact prosecution, claim 30 is analyzed with respect to Step 2A and Step 2B below.
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claims 16 and 27 recite the following steps which fall under the mathematical concepts and/or mental processes groupings of abstract ideas:
calculating at least one body-specific parameter of a bioheat model based on the at least one property of the body,
obtaining at least one environment-specific parameter that is indicative of at least one thermal property of said controllable environment and/or of at least one property of a thermal exchange between said body and said controllable environment, and
calculating said temperatures in the body by numerically solving said bioheat model taking said body-specific parameters and said environment-specific parameters into account,
wherein said bioheat model comprises a plurality of equations representative of an equivalent thermal circuit for modeling heat flows in the body and between the body and the controllable environment, said equivalent thermal circuit comprising a blood compartment and a plurality of anatomical segments, the plurality of anatomical segments comprising at least a lower extremity segment, an upper extremity segment, a trunk segment and a head segment, wherein each of the anatomical segments comprises a plurality of compartments, the plurality of compartments comprising at least one interior compartment representative of a core and/or bone part of the anatomical segment, at least one intermediate compartment representative of a muscle and/or fat part of the anatomical segment and an exterior compartment representative of a skin part of the anatomical segment, wherein the at least one interior compartment of the at least one trunk segment comprises a plurality of organ compartments representative of respectively at least two internal organs, wherein said at least two organ compartments are connected in parallel in said equivalent thermal circuit.
Independent claims 26 and 28-30 recite the same abstract ideas discussed above for claims 16 and 27. Claim 29 further recites the mental process and mathematical concept of calculating temperatures by taking sensor data into account.
The identified claim limitations falls into one of the groups of abstract ideas of mathematical concepts and/or mental processes for the following reasons. In this case the steps of calculating at least one body-specific parameter of a bioheat model based on a property of the body and calculating temperatures in the body by numerically solving said bioheat model taking parameters into account recite the mathematical concept of a mathematical calculation. See MPEP 2106.04(a)(2) I. Furthermore, the step of obtaining an environment-specific parameter indicative of a thermal property of a controllable environment recites a mental process because it encompasses simply reading a temperature value of the controllable environment. Last, the bioheat model comprising a plurality of equations in the form of a circuit modeling heat flows and comprising a plurality of compartments further represents a mathematical relationship. Overall, the bioheat model represents an organization of mathematical relationships of heat exchange between different bodily compartments and thus is similar to the mathematical concept of organizing information and manipulating information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014).
Dependent claims 17-25 further recite an abstract idea and/or are part of the abstract idea identified above. Dependent claim 17 further recites the mental process of obtaining a plurality of values of each environment-specific parameter and the mathematical concept of calculating temperatures for each of the different values. Dependent claim 18 further recites the mental process of adjusting a previous value of the different values to determine a next value for which temperatures are calculated. Dependent claim 19 further limits the mathematical concept of solving the bioheat model to take into account sensor data. Dependent claim 20 further limits the mathematical relationship of the bioheat model. Dependent claim 21 further limits the mathematical concept of calculating a body-specific parameters to determine values representing thermal conduction. Dependent claim 22 further limits the mental process of obtaining an environment-specific parameter to be one of the recited values. Dependent claim 23 further recites a mathematical concept and mental process of calculating a value representative of a rate of convention and/or rate of radiative heat exchange. Dependent claim 24 further limits the mathematical calculation of calculating the values of the rate of convective and/or radiative heat exchange. Dependent claim 25 further limits the mathematical relationship of the compartments of the bioheat mode. Therefore, claims 26-30 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
Dependent claims 17-18 and 20-25 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements of claims 16, 19, and 26-30 include:
a computer (claim 16);
an input for receiving at least one property of said body obtained by measurements of the body (claims 27 and 28-29);
a processor (claims 27 and 28-29);
a computer program product (e.g. memory) (claim 30);
receiving as input at least one property of said body obtained by measurements of the body (claims 16 and 26-30);
receiving, as input, sensor data from one or more temperature sensors on or in the body (i.e. receiving data) (claim 19);
providing the at least one property of the body as input to a computer-implemented method in accordance with claim 16 (claim 26); and
receiving sensor data from said plurality of temperature sensors (claim 29)
The additional elements of claims 26 and 29 further include:
measuring at least one property of a human or animal body (claim 26);
a plurality of temperature sensors for measuring temperatures on or in the body (claim 29).
Last, the additional elements of claim 29 further include:
a controllable environment comprising controllable heating and/or cooling means for bringing a core body temperature of said animal or human body to a predetermined target temperature; and
controlling said controllable heating and/or cooling means in response to said calculated temperatures in the body.
First, the additional elements of a processor, computer program product, receiving data, and data input are generic computer components and/or processes. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Furthermore, the additional elements of measuring a property of a human or animal body and temperature sensors only serves to collect data for use by the abstract idea, which amount to insignificant extra-solution activity and do not integrate the recited judicial exception into a practical application. See MPEP 2106.05(g).
Last, the additional element of a controllable environment comprising controllable heating and/or cooling means for bringing a core body temperature of said animal or human body to a predetermined target temperature and controlling the heating and/or cooling means in response to calculated body temperatures do not integrate the recited judicial exception into a practical application because the limitation amounts to mere instructions to apply the exception in a generic way. MPEP 2106.05(f) states the recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it". In the instant case, the claim generically applies the judicial exception of calculating temperatures to control the heating and/or cooling means in any way. However, the claim does not provide details regarding how the heating and/or cooling is controlled depending on the calculated temperatures. However, it is noted that if claim 29 was amended to require controlling the heating and/or cooling means to bring the core body temperature of said animal or human body to a predetermined target temperature in response to said calculated temperatures in the body, claim 29 would integrate the recited judicial exception into a practical application.
Therefore, the additionally recited elements amount to insignificant extra-solution activity and/or amount to mere instructions to apply the exception, and as such, the claims as a whole do no integrate the abstract idea into practical application. Thus, claims 16-30 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception. Dependent claims 17-18 and 20-25 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements of claims 16, 19, and 26-30 include:
a computer (claim 16);
an input for receiving at least one property of said body obtained by measurements of the body (claims 27 and 28-29);
a processor (claims 27 and 28-29);
a computer program product (e.g. memory) (claim 30);
receiving as input at least one property of said body obtained by measurements of the body (claims 16 and 26-30);
receiving, as input, sensor data from one or more temperature sensors on or in the body (i.e. receiving data) (claim 19);
providing the at least one property of the body as input to a computer-implemented method in accordance with claim 16 (claim 26); and
receiving sensor data from said plurality of temperature sensors (claim 29)
First, the additional elements of a processor, computer program product, receiving data, and data input are conventional computer components and/or processes. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
The additional elements of claims 26 and 29 further include:
measuring at least one property of a human or animal body (claim 26);
a plurality of temperature sensors for measuring temperatures on or in the body (claim 29).
The additional element of measuring a property of a human or animal body and a plurality of temperature sensors for measuring temperatures are well-understood, routine, and conventional. This position is supported by Applicant’s own specification and Li et al. (Review of Flexible Temperature Sensing Networks for Wearable Physiological Monitoring, 2017, Adv. Helathcare Mater., 6(1601371), pg. 1-23).
Applicant’s specification at pg. 18, lines 3-24, which discloses measuring at least one property can be estimated by tape measurements, bioelectrical impedence measurements, hydrodensitometry, medical imaging, or any other method known in the art for determining a fat component of the body, and that bone and muscle components can be measured using any suitable techniques known in the art such as medical imaging. Furthermore, Li reviews temperature sensing networks (Abstract), and discloses temperature is one of the basic physiological parameters in detecting human activities, and numerous sensor devices have been realized to detect temperature through physical changes, including resistive temperature detectors, thermally sensitive resistors, mercury thermometers, infrared sensors, etc. (pg. 2, col. 1, para. 2). Li further discloses wearable applications demand multiple temperature sensors that are attached on moving objects, citing multiple studies (pg. 8, col. 2, para. 2 to pg. 9, col. 1, para. 1; pg. 11, col. 2, para. 2; Figure 8)
Last, the additional elements of claim 29 further include:
a controllable environment comprising controllable heating and/or cooling means for bringing a core body temperature of said animal or human body to a predetermined target temperature; and
controlling said controllable heating and/or cooling means in response to said calculated temperatures in the body.
Controlling environments with a controllable heating and or cooling means and controlling the heating and/or cooling means are well-understood, routine, and conventional. This position is supported by Vaity et al. (Cooling techniques for targeted temperature management post-cardiac arrest, 2015, Critical Care, 19:103, pg. 2-6). Vaity reviews cooling techniques for targeted temperature management (Abstract; ; pg. 1, col. 1, para. 1), and discloses conventional cooling methods including cold saline, crushed ice, or ice bags, surface cooling systems, including a plurality of commercially available products readily available (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 most surface systems 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 (pg. 3, col. 1, para. 2), further demonstrating the combination of a computer, temperature sensors, and a controlling environment for heating and/or cooling are conventional.
Therefore, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
Claim Rejections - 35 USC § 103
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 16-18, 21-25, 27-28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Xiang (2008) in view of Ferreira (2009).
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; and
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.
Regarding independent claims 16, 27-28, and 30, 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 let (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).
Regarding independent claims 16, 27-28 and 30, and dependent claim 25, Xiang does not disclose the following:
Regarding claims 16, 25, 27-28, and 30¸ Xiang does not disclose at least one interior compartment of the trunk segment 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 claims 16-17. Xiang further does not disclose the trunk segment comprises the at least two organ compartments, or that 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, 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, e.g. core would include major organs).
Furthermore, Ferreira discloses a heat transfer model of the human body, which similarly includes various compartments 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 considers the tissues of skin, fat, muscle, bone, brain, viscera, lung, and heart (pg. 718, col. 2, para. 2). 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; 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.
Further regarding claims 27-28 and 30, 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.
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 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).
Therefore, the invention is prima facie obvious.
Claims 19 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Ferreira as applied to claims 16 above, and further in view of Reifman (2017).
Cited reference: Reifman, US 2019/0192009 A1, effectively filed 18 Aug. 2017.
Regarding claims 19 and 26, Xiang in view of Ferreira make obvious the method and device of claims 16 and 27 as applied above.
Regarding claim 19, Xiang in view of Ferreira do not disclose receiving, as input, sensor data from one or more temperature sensors on or in the body, and taking said sensor data into account when numerically solving said bioheat model.
Regarding claim 26, Xiang in view of Ferreira do not disclose measuring at least one property of a human or animal body and providing the at least one property of the body as input. Instead, Xiang discloses receiving a property of a body as applied to claim 16 above.
However, Reifman discloses a method and system for real-time estimating of human core body tempereature using non-invasive measurements (Abstract), which comprises a plurality of sensors for receiving physiological data, including skin temperature ([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 temperature, and modifies parameters of the model ([0003]; [0022]; Fig. 4). Reifman further discloses the method and system allows for real-time estimation of human core body temperature ([0002]).
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 measure temperature in the body, receiving the sensor data from the sensors, and use the sensor data in calculating the 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, thus improving temperature predictions, and to allow for real-time estimation of body temperature as shown by Reifman ([0002]-[0003]; [0022]).
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 as applied to claims 16 above, and further in view of Grady (2016).
Cited reference: Grady et al. US 2016/0287338 A1.
Regarding claim 20¸ Xiang in view of Ferreira disclose the method of claim 16, 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 16 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 ([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.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Ferreira as applied to claims 27 above, and further in view of Reifman (2017) and Vaity (2015).
Cited references:
Reifman, US 2019/0192009 A1, effectively filed 18 Aug. 2017; and
Vaity et al., Cooling techniques for targeted temperature management post-cardiac arrest, 2015, Critical Care, 19:103, pg. 2-6.
Regarding claim 29, Xiang in view of Ferreira make obvious the method and device of claims 27 as applied above.
Further regarding claim 29, 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).
Xiang in view of Ferreira, as applied to claim 27 above, do not disclose the following:
Regarding claim 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 taking the sensor data into account for calculating the temperatures.
However, Reifman discloses a method and system for real-time estimating of human core body tempereature using non-invasive measurements (Abstract), which comprises a plurality of sensors for receiving physiological data, including skin temperature ([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 temperature, and modifies parameters of the model ([0003]; [0022]; Fig. 4). Reifman further discloses the method and system allows for real-time estimation of human core body temperature ([0002]).
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 measure temperature in the body, receiving the sensor data from the sensors, and use the sensor data in calculating the 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, thus improving temperature predictions, and to allow for real-time estimation of body temperature as shown by Reifman ([0002]-[0003]; [0022]).
Further 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-feedba