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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 lines 2-3 recite “…wherein the body temperature estimation model includes a blood vessel connecting the eye and a brain…”. The examiner notes that this creates confusion regarding the scope of the claim as multiple interpretations of this element can be reasonably made. The literal interpretation of this element has the model containing a blood vessel of its own. Another interpretation is the body temperature estimation model comprises another model/sub-model of a blood vessel that connects the eye and a brain. For purposes of compact prosecution, the examiner is interpreting the above element as the body temperature estimation model comprises another model/sub-model of a blood vessel that connects the eye and a brain.
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.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
A body temperature estimation device comprising:
a measurement unit that measures a temperature of an eye of an animal; and
a body temperature estimation unit that estimates a core body temperature of the animal by setting the temperature measured by the measurement unit in a body temperature estimation model and simulating heat conduction.
Independent Claim 4 recites:
A body temperature estimation device comprising:
a measurement unit that measures a temperature of an eye of an animal; and
a body temperature estimation unit that estimates a core body temperature of the animal by inputting the temperature measured by the measurement unit in a body temperature estimation equation indicating a relationship between a temperature of an eye of the animal and a core body temperature of the animal.
Independent claim 5 recites:
A body temperature estimation method comprising:
a measurement step of measuring a temperature of an eye of an animal; and
a body temperature estimation step of estimating a core body temperature of the animal by setting the temperature measured in the measurement step in a body temperature estimation model and simulating heat conduction.
Independent claim 6 recites:
A body temperature estimation system comprising:
a temperature measurement device that measures a temperature of an eye of an animal; and
a body temperature estimation device that estimates a core body temperature of the animal by setting the temperature measured by the temperature measurement device in a body temperature estimation model and simulating heat conduction.
Step 1:
The examiner finds claims 1, 4, and 6 drawn to a machine and claim 5 drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of measuring, estimating, and simulating recite a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “measuring” a temperature in independent Claims 1 and 4-6 is a mental process capable of being performed in the human mind. For example, the human mind is capable of determining an abnormally high body temperature by placing their hand on the forehead of a patient and “measuring” the degree of abnormality. The step of “estimating” a core body temperature in independent Claims 1 and 4-6 can be reasonably interpreted as either a mental process or a mathematical concept. As a mental process, the human mind is capable of estimating a temperature a patient by processing stimuli of touch when placing your hand on a patient’s skin. As a mathematical concept, techniques such as rounding and using compatible numbers may be used to simplify calculation and provide an estimated value. The step of “simulating” heat conduction in independent Claims 1 and 4-6 can also be reasonably interpreted as either a mental process or a mathematical concept. As a mental process, the human mind is capable of mentally reconstructing/simulating a scenario (such as mentally creating the scene of a car accident when hearing the details on the evening news).
The claimed steps measuring, estimating, and simulating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 2-3, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 1-6 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for measuring, estimating, and simulating merely invoke a computer as a tool.
• The data-gathering step (measuring) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for measuring, estimating, and simulating.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for measuring, estimating, and simulating. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: a measurement unit and an estimation unit.
The examiner notes that a body temperature estimation device, which comprises the measurement unit and estimation unit, is recited with a high level of generality that the function may be performed by a general computer/computing components. The measurement unit and estimation unit are merely “applying” the functions of measuring and estimating (functions that are well-understood, routine, and conventional to a general computer) within the body temperature measurement device.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tremblay (US 20230043342 A1 using the priority date of provisional application 63/006,063).
Regarding claim 4, Tremblay teaches a body temperature estimation device comprising:
a measurement unit that measures a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation unit that estimates a core body temperature of the animal by inputting the temperature measured by the measurement unit in a body temperature estimation equation indicating a relationship between a temperature of an eye of the animal and a core body temperature of the animal [0067 “…the system is configured to process one or more thermal images and/or other data to determine and/or estimate the person of interest's core temperature”].
Claim Rejections - 35 USC § 102/103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-2 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Tremblay (US 20230043342 A1 using the priority date of provisional application 63/006,063) or, in the alternative, under 35 U.S.C. 103 as obvious over Tremblay in view of Kamiyama (US 7441950 B2).
Regarding claim 1, Tremblay teaches a body temperature estimation device comprising:
a measurement unit that measures a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation unit that estimates a core body temperature of the animal by setting the temperature measured by the measurement unit in a body temperature estimation model [0118 “…the system may model a rate of change in the face temperature as it adjusts to the new environment which may then be used with minimal samples (e.g., only two samples) with some known time between them to estimate the “true” core body temperature or the “true” face temperature”] and simulating heat conduction [simulating heat conduction could be considered inherent as measuring core body temperature is not considered a localized measurement and instead is the measurement of the temperature reflecting the state of a body’s vital organs].
In the alternative, Tremblay teaches a body temperature estimation device comprising:
a measurement unit that measures a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation unit that estimates a core body temperature of the animal by setting the temperature measured by the measurement unit in a body temperature estimation model [0118 “…the system may model a rate of change in the face temperature as it adjusts to the new environment which may then be used with minimal samples (e.g., only two samples) with some known time between them to estimate the “true” core body temperature or the “true” face temperature”].
Tremblay teaches measuring core body temperature, but fails to explicitly teach simulating heat conduction.
Kamiyama teaches simulating heat conduction [col. 2 lns. 34-48].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Tremblay and incorporate the teachings of Kamiyama to include simulating heat conduction. Doing so configures the system to model how heat moves within a patient, allowing for an accurate prediction of internal temperatures as well as the ability to personalize a model to a patient.
Regarding claim 2, Tremblay and Kamiyama teach the body temperature estimation device according to claim 1, wherein the measurement unit measures a temperature of a lacrimal caruncle portion of the eye of the animal [Tremblay 0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”, the examiner is interpreting Tremblay’s disclosure of a “corner of the eye” as the lacrimal caruncle].
Regarding claim 5, Tremblay teaches a body temperature estimation method comprising:
a measurement step of measuring a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation step of estimating a core body temperature of the animal by setting the temperature measured in the measurement step in a body temperature estimation model [0118 “…the system may model a rate of change in the face temperature as it adjusts to the new environment which may then be used with minimal samples (e.g., only two samples) with some known time between them to estimate the “true” core body temperature or the “true” face temperature”] and simulating heat conduction [simulating heat conduction could be considered inherent as measuring core body temperature is not considered a localized measurement and instead is the measurement of the temperature reflecting the state of a body’s vital organs].
In the alternative, Tremblay teaches a body temperature estimation method comprising:
a measurement step of measuring a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation step of estimating a core body temperature of the animal by setting the temperature measured in the measurement step in a body temperature estimation model [0118 “…the system may model a rate of change in the face temperature as it adjusts to the new environment which may then be used with minimal samples (e.g., only two samples) with some known time between them to estimate the “true” core body temperature or the “true” face temperature”].
Tremblay teaches measuring core body temperature, but fails to explicitly teach simulating heat conduction.
Kamiyama teaches simulating heat conduction [col. 2 lns. 34-48].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Tremblay and incorporate the teachings of Kamiyama to include simulating heat conduction. Doing so configures the system to model how heat moves within a patient, allowing for an accurate prediction of internal temperatures as well as the ability to personalize a model to a patient.
Regarding claim 6, Tremblay teaches a body temperature estimation system comprising:
a temperature measurement device that measures a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation device that estimates a core body temperature of the animal by setting the temperature measured by the temperature measurement device in a body temperature estimation model [0118 “…the system may model a rate of change in the face temperature as it adjusts to the new environment which may then be used with minimal samples (e.g., only two samples) with some known time between them to estimate the “true” core body temperature or the “true” face temperature”] and simulating heat conduction [simulating heat conduction could be considered inherent as measuring core body temperature is not considered a localized measurement and instead is the measurement of the temperature reflecting the state of a body’s vital organs].
In the alternative, Tremblay teaches a body temperature estimation system comprising:
a temperature measurement device that measures a temperature of an eye of an animal [0036 “…obtain a temperature measurement on the person's forehead, corner of their eye, or other desired location”]; and
a body temperature estimation device that estimates a core body temperature of the animal by setting the temperature measured by the temperature measurement device in a body temperature estimation model [0118 “…the system may model a rate of change in the face temperature as it adjusts to the new environment which may then be used with minimal samples (e.g., only two samples) with some known time between them to estimate the “true” core body temperature or the “true” face temperature”].
Tremblay teaches measuring core body temperature, but fails to explicitly teach simulating heat conduction.
Kamiyama teaches simulating heat conduction [col. 2 lns. 34-48].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Tremblay and incorporate the teachings of Kamiyama to include simulating heat conduction. Doing so configures the system to model how heat moves within a patient, allowing for an accurate prediction of internal temperatures as well as the ability to personalize a model to a patient.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tremblay and Kamiyama as applied to claim 1 above, and further in view of Abreu (US 20090105605 A1).
Regarding claim 3, Tremblay and Kamiyama teach the body temperature estimation device according to claim 1, wherein the body temperature estimation device includes a body temperature estimation model [Tremblay 0118], and
wherein the body temperature estimation unit simulates heat transport [Kamiyama col. 2 lns. 34-48], but fails to teach the body temperature estimation model includes a blood vessel connecting the eye and a brain and an organ covering the blood vessel, and the body temperature estimation unit simulation includes blood passing through the blood vessel.
As best understood, Abreu teaches body temperature estimation including a blood vessel connecting the eye and a brain and an organ covering the blood vessel and blood passing through the blood vessel [0447 “The preferred path for achieving thermal equilibrium with brain tissue temperature is through the central venous system which exits the brain and enters the orbit as the superior ophthalmic vein. The arterial blood is 0.2 to 0.3 degrees Celsius lower when compared to the central venous blood, and said arterial blood is not the actual equivalent of the brain temperature. Thus although arterial blood may be of interest in certain occasions, the venous system is the preferred carrier of thermal energy for measurement of brain temperature”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Tremblay and Kamiyama and incorporate the teachings of Abreu to include the body temperature estimation model includes a blood vessel connecting the eye and a brain and an organ covering the blood vessel, and the body temperature estimation unit simulation includes blood passing through the blood vessel. Doing so model and estimation unit to model how heat moves within a patient at a particular region of interest (i.e., the eye), allowing for an accurate prediction of internal temperatures as well as the ability to personalize a model to a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/ Examiner, Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791