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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 01, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on July 01, 2024 are accepted.
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 1-3 and 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-11 are drawn to a “system” which describes one of the four statutory categories, i.e., a machine.
Claims 12-20 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 and 12 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: generating thermal imaging spatial data and thermal imaging temperature data”, “determine blood pressure data”, “fit data representative of a cardiac characteristic”, and “output an alert indicating a predetermined cardiovascular event”.
In claims 1 and 12, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person receives thermal image signal data and visually examines, i.e., perform an observation, the data, either in a printout or an electronic format, he/she would be able to identify the spatial and temperature information of the data, which is what a thermal image by natural comprises. He/she would further be able to determine a blood pressure data and to fit data representative of a cardiac characteristic mentally. In regard to output an alert, it could also be performed by noting it down on a piece of paper, hence also a mental process. There is nothing recited in the claim to suggest an undue level of complexity in how the thermal imaging spatial data and temperature data is generated, how the blood pressure data is determined, how the data is fit, and how an alert it output. Therefore, a person would be able to perform the identification and selection mentally or with a generic computer.
Prong Two: Claims 1 and 12 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recite additional steps of “visual sensor and thermal camera”, “one or more processor and the non-transitory computer-readable medium”, and “a supervised ML model”.
The visual sensor and the thermal camera present data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The supervised ML model is used to apply the abstract idea (i.e., configured to input data to determine a blood pressure data) without placing any limitation on how the supervised ML model operates. This limitation, together with the processor and the non-transitory computer-readable medium, amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 12 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of “visual sensor and thermal camera”, “one or more processor and the non-transitory computer-readable medium”, and “a supervised ML model”.
The visual sensor and the thermal camera present data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools.
The supervised ML model is used to apply the abstract idea (i.e., configured to input data to determine a blood pressure data) without placing any limitation on how the supervised ML model operates. This limitation, together with the processor and the non-transitory computer-readable medium, amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f).
A thermal camera acquires thermal image data. A supervised ML model implemented by a computer and a processor may be configured to input the thermal image data. This is evidenced by Elzeiny et al., “Machine learning approaches to automatic stress detection: a review”, IEEE conference publication, 2018 IEEE AICCSA. In Elzeiny, it teaches on p.2,Col. Left, II.A. “to determine the stress level of the drive, researchers designed a thermal-imaging based system to track facial area in order to measure the temperature of the driver’s blood”. And on p.1, Col. Right, it further teaches that “the values of the extracted features are used directly as an input to a supervised classifier or cluster analysis…In a supervised learning, the machine develops and trains the predictive model by using labeled data to predict future output by learning from a known set of input and output data”.
Accordingly, these additional steps and tools of thermal cameral and using a supervised ML model for imaging data analysis amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Describe the temperature characteristics of the thermal image signals (claim 11).
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
describing what the thermal camera monitors (claims 2-3 and 13-14);
describing further functions performed by the thermal camera (signal output) (claims 3 and 14);
describing additional element that is a well-known routine and conventional tool (claims 10 and 20 – an uncooled microbolometers: Kitamura et al., US 2023/0023522 A1)
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
It is noted that claims 4-9 and 15-19 are eligible. Specifically, claims 4, 5, 15, 16 recite features that amount to significantly more than the above identified abstract idea. Claims 6-9 and 17-19 recite features that requires tools that are not well known and therefore the respective claims as a whole thus amounts to significantly more than the exception itself.
Claim Rejections - 35 USC § 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli et al., US 2018/0092574 A1, hereinafter Tzvieli, in view of Gizewski et al., US 2008/0161661 A1, hereinafter Gizewski.
Claims 1 and 12. Tzvieli teaches a monitoring system and method (Abstract: systems and methods for detecting a physiological response based on thermal measurements), comprising:
a visual sensor configured to monitor one or more cardiovascular features of a human subject wherein the visual sensor comprises a thermal camera ([0129]: a thermal camera that covers a cheek to capture an ROI located on a cheek with a first set of pixels; and [0286]: the camera is a thermal camera); and
one or more processors communicatively coupled to the visual sensor and a non-transitory computer-readable medium containing instructions (FIG.34a and 34b) that when executed by the one or more processors causes the one or more processors to perform operations comprising:
in response to receiving thermal image signals from the visual sensor, generate thermal imaging spatial data and thermal imaging temperature data,
execute a supervised machine learning model configured to input the thermal imaging spatial data and the thermal imaging temperature data to determine a blood pressure data for the human subject ([0296]: a personalized model is utilized. I involves a training phase and an operation phase….Training the personalized model may be based on known machine learning methods such as neural networks, supervised machine learning…) , wherein
the supervised machine learning model has been trained to fit data representative of a cardiac characteristic ([0296]: the personalized model may decouple commonly coupled ROIs and/or putative physiological responses from the applications, allowing the user to train the system to detect arbitrary personalized thermal and/or FSCC patterns… Training the personalized model may be based on known machine learning methods such as neural networks, supervised machine learning…); and
in an event the blood pressure data for the human subject indicates a predetermined cardiovascular event, output an alert ([0297]: the system may alert when the user is in the desired/undesired state).
Tzvieli does not teach that (1) one or more cardiovascular features are monitored, (2) generate thermal imaging spatial data and thermal imaging temperature data and (3) determine a blood pressure data for the human subject.
However, in an analogous thermal camera monitoring system field of endeavor, Gizewski teaches
(1) one or more cardiovascular features are monitored ([0055]: the data preparation may include…categorizing the data by physiological characteristics such as heart rate, respiratory rate, blood type, blood pressure, blood chemistry composition),
(2) generate thermal imaging spatial data and thermal imaging temperature data ([0037]: a IR imager may be used to capture the sized digital radiometric images of the body[‘s surface area…this permits the detection of…discrete temperature variation and other abnormalities that display unique temperature variations; and [0041]: both visual images and the thermos graphic data may be captured along with location identification data) and
(3) determine a blood pressure data for the human subject ([0055]: the data preparation may include…categorizing the data by physiological characteristics such as heart rate, respiratory rate, blood type, blood pressure, blood chemistry composition).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Tzvieli employ such features of (1) one or more cardiovascular features are monitored, (2) generate thermal imaging spatial data and thermal imaging temperature data and (3) determine a blood pressure data for the human subject as taught in Gizewski for the advantage of “providing a comprehensive and automated system for establishing a diagnosis, prescribing a treatment and monitoring a condition’s progression and the effectiveness of the treatment”, as suggested in Gizewski, [0008].
Claims 2 and 13. Tzvieli further teaches that
the cardiovascular features include one or more of a carotid artery in a neck, a carotid artery in a temple, an artery in an arm, and an artery in a hand ([0098]: the physiological response may be a physiological signal of the user. In one example, the physiological response is a heart rate of the user, and in this example, ROI is on the skin above at least one of the superficial temporal artery and the frontal superficial temporal artery).
Claims 3 and 14. Gizewski further teaches that
the thermal image signals output by the thermal camera represent the one or more cardiovascular features ([0055]: the data preparation may include…categorizing the data by physiological characteristics such as heart rate, respiratory rate, blood type, blood pressure, blood chemistry composition).
Claim 11. Gizewski further teaches that
the thermal image signals represent temperature characteristics including one or more of measurements of relative temperatures, maximum temperature, temperature gradient, body temperature, and core temperature (Claim 8: high-definition infrared (IR) imagery for detecting, locating and capturing body temperature).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tzvieli et al., US 2018/0092574 A1, hereinafter Tzvieli, in view of Gizewski et al., US 2008/0161661 A1, hereinafter Gizewski, further in view of Kitamura et al., US 2023/0023522 A1, hereinafter Kitamura.
Claims 10 and 20. Tzvieli and Gizewski teaches all the limitations of claims 1 and 12.
Neither of them teaches that the thermal camera comprises an uncooled microbolometer array.
However, in an analogous thermal camera configuration field of endeavor, Kitamura teaches that
the thermal camera comprises an uncooled microbolometer array ([0073]: the thermal camera receives, at an infrared ray detection element including an uncooled microbolometer focal plane array).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Tzvieli and Gizewski combined employ such a feature of comprising an uncooled microbolometer array as taught in Kitamura for the advantage of a conventional option of thermal imaging detector that does not require a cryogenic cooling system.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 and 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 12,023,135. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications disclose substantially identical subject matter with the instant claims being simply broader than the patent claims. Both the instant application and the ‘135 patent disclose a monitoring system and method that determines blood pressure data for a human subject.
Claim 1 of the ‘135 patent reads on claims 1-5 and 11 of the instant application.
Claim 16 of the ‘135 patent reads on claims 12-16 of the instant application.
Examiner’s Notes
Claims 4-9 and 15-19 are patent eligible and they are not rejected under prior arts.
Claims 6-10 and 17-20 are not rejected on the ground of nonstatutory double patenting.
Claims 6-9 and 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798