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 .
This communication is in response to the amendment received on 08/25/2025. Claims 1-4 and 7 remain pending in this application.
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 1 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.
In particular, claim 1 has bee amended to recite “specify the fastener as a cause of the decrease in the rest level by analyzing image data obtained by photographing the patient, identifying the fastener in the image data, and correlating a timing of attachment of the identified fastener with a timing of the decrease in the rest level”, and the current specification recites “…a photographed image of the face of a patient and an analysis result of an expression based on the photographed image. Examples of the training data used for training of such a machine learning model include the value of the rest level decided by a doctor or staff. A machine learning model trained to output a determination result regarding a level of discomfort of the patient using the rest level may be used, in addition to the value of the rest level…” in [0036], and “With the determination function 545, the processing circuitry 54 acquires a photographed image from the photographing apparatus 70, specifies a fastener 60 attached to the patient using the photographed image, and determines a cause of the change in the rest level based on a result of calculation of the rest level and a result of the specification of the fastener 60. For the specification of the fastener 60, a known image analysis technique, for example, can be used. With the determination function 545, the processing circuitry 54 specifies a timing when each of the fasteners 60 was attached to the patient using the specification result of the fastener 60, and determines, if the rest level changes at a timing when one of the fasteners 60 was attached, that the fastener 60 is the cause of the change in the rest level, and notifies the operator of a determination result.” In [0064], and “…The processing circuitry 54 acquires photographed images obtained in the past few seconds from a point in time when the rest level has decreased below the threshold value A, based on the rest level becoming smaller than the threshold value at time T3. The processing circuitry 54 applies a known image analysis technique to the acquired photographed images, and extracts fasteners 60 included in the photographed images. Thereafter, the extracted fasteners 60 are compared with the shape data, etc. of the fasteners 60 registered in advance to specify the types of the extracted fasteners 60, and the timings when the fasteners 60 were attached is specified. If, for example, a fastener 60 not included in the previous photographed image appears in the subsequent photographed image, the processing circuitry 54 determines that the fastener 60 was attached at that timing…” in [0069].
The current specification describes that the processing circuitry determines whether the fastener was attached or not based on the photographs using “a known image analysis”. It’s unclear how the processing circuitry determines the change in the rest level for the patient. It’s unclear which image analysis being used by the current system and how the system determines “cause of the decrease in the rest level” using the photographs of the patient.
Claims 2-4 inherit the deficiencies of claim 1 through dependency and are therefore also rejected.
Claim 7 recites “an output apparatus according to claim 1”, therefore, claim 7 is rejected for the same reason given for claim 1.
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 1-4 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-4 and 7 are drawn to an apparatus (a system), which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Claim 1 has been amended to recite:
“acquire identification information for identifying a state of a patient fastened to a radiotherapy apparatus with a fastener, the identification information including at least one of a vital sign, an oxygen saturation (Sp02), a beta wave observation result, an expression, or a complexion;
calculate a rest level of the patient based on the identification information, the rest level being calculated by at least one of:
combining a measurement value of a parameter contained in the identification information, a degree of change in the measurement value over time, and an evaluation value obtained by converting an analysis result into a numerical value; and
inputting the identification information into a trained machine learning model comprising a multilayer neural network configured to output the rest level;
determine that the rest level has decreased below a predetermined threshold value representing a level of discomfort greater than a reference normal state in which the fastener is not attached;
in response to determining that the rest level has decreased below the predetermined threshold value, output a warning comprising at least one of: an audio warning sound, a spoken warning message, a visual warning message displayed on a display, or graphical alteration of the rest level display; and
specify the fastener as a cause of the decrease in the rest level by analyzing image data obtained by photographing the patient, identifying the fastener in the image data, and correlating a timing of attachment of the identified fastener with a timing of the decrease in the rest level”
The limitations of “acquire identification information for identifying a state of a patient fastened to a radiotherapy apparatus with a fastener,..”, “determine that the rest level has decreased below a predetermined threshold value representing a level of discomfort greater than a reference normal state in which the fastener is not attached”and “specify the fastener as a cause of the decrease in the rest level by analyzing image data obtained by photographing the patient, identifying the fastener in the image data, and correlating a timing of attachment of the identified fastener with a timing of the decrease in the rest level” corresponds to “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processing circuitry device does not take the claim out of the methods of organizing human interactions grouping.
The limitations of calculate a rest level of the patient based on the identification information, the rest level being calculated by at least one of: (i) combining a measurement value of a parameter contained in the identification information, a degree of change in the measurement value over time, and an evaluation value obtained by converting an analysis result into a numerical value; and {ii) inputting the identification information into a trained machine learning model comprising a multilayer neural network configured to output the rest level;” correspond to performing mathematical calculations, therefore the limitation falls within the “mathematical concept” grouping of abstract ideas.
Dependent claim 3 also correspond to certain method of organizing human activities, as claim 3 recites “acquire, as a reference value, a rest level in a normal state in which the fastener is not attached, and calculate an amount of change in the rest level relative to the reference value”. This limitation also corresponds to a method of managing interactions between people, such as user following rules and instructions.
Claim 7 recites a radiotherapy apparatus comprising the output apparatus of claim 1, and therefore is rejected for the same reasons given for claim 1 above.
Claims 2 and 4 are ultimately dependent from claim 1 and include all the limitations of claim 1. Therefore, claims 2 and 4 recite the same abstract idea. Claims 2 and 4 describe a further limitation regarding the basis for calculating a rest level of the patient. These are all just further describing the abstract idea recited in claim 1, without adding significantly more.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “an output apparatus comprising processing circuitry configured to: acquire identification information…, calculate a rest level of the patient…, determine that the rest level has decreased…, in response to determining that the rest level has decreased below the predetermined threshold value, output a warning comprising at least one of: an audio warning sound, a spoken warning message, a visual warning message displayed on a display, or graphical alteration of the rest level display, and specify the fastener as a cause of the decrease in the rest level by analyzing image data obtained by photographing the patient…”-claim 1, “the display is configured to display the change in the rest level over time in the rest level display section comprising a graph in which a horizontal axis represents time and a vertical axis represents a rest level”-claim 2, “the processing circuitry is further configured to: acquire…a rest level in a normal state…, and calculate an amount of change in the rest level… and output the calculated amount of change in the rest level”-claim 3 and “A radiotherapy apparatus, comprising: the output apparatus according to claim 1; a bed on which the patient is placed; an irradiator unit configured to emit radiation; a gantry configured to support the irradiator; and a measurement device configured to measure the identification information of the patient”-claim 7, which are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Additionally, the function of “in response to determining that the rest level has decreased below the predetermined threshold value, output a warning comprising at least one of: an audio warning sound, a spoken warning message, a visual warning message displayed on a display, or graphical alteration of the rest level display” correspond to insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processing circuitry to perform the acquiring, calculating, determining and specifying steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Argument 1: Applicant argues that claim 1 has been amended and is directed to a specific improvement in the functioning of a radiotherapy apparatus, claim 1 recites the acquisition of physiological and image-based patient data from sensors, the processing of that multimodal data to compute a quantified rest level using defined algorithms or a specific machine learning architecture, and a real-time generation of tangible sensory outputs that alert the operator and identify a physical cause of discomfort. Applicant argues that these operations are rooted in the technical field of radiotherapy patient management and address a specific technological problem, namely, detecting and responding to patient discomfort during immobilization using a technical solution.
In response, Examiner submits that the functions of “acquire identification information for identifying a state of a patient fastened to a radiotherapy apparatus with a fastener,..”, “determine that the rest level has decreased below a predetermined threshold value representing a level of discomfort greater than a reference normal state in which the fastener is not attached” and “specify the fastener as a cause of the decrease in the rest level by analyzing image data obtained by photographing the patient, identifying the fastener in the image data, and correlating a timing of attachment of the identified fastener with a timing of the decrease in the rest level” corresponds to “certain methods of organizing human activity” with a recitation of generic computing component (the processing circuitry). The current specification describes both the processing circuitry and the sensors as generic computing components. Such as, the current specification recites “The processing circuitry 54 is a processor that executes programs stored in the storage circuitry 58, etc., and controls the components in accordance with the programs, thereby executing radiotherapy” in [0032] and “The measurement device 40 for measuring the vital signs is realized by, for example, general equipment such as respiratory waveform measurement equipment, blood pressure measurement equipment, electrocardiographic wave measurement equipment, and the like. Also, the measurement device 40 is realized by a device such as an electroencephalograph for observing beta waves or an optical camera for generating an image for determining the patient’s expression and/or complexion. The identification information measured by the measurement device 40 is transmitted to the console 50. Also, a wearable terminal including a sensor to be attached to an arm or a forehead may be used. In this case, the effect on the patient caused by the measurement of the identification information can be suppressed to be low.” in [0021].
Examiner submits that using a processing circuitry to perform both the acquiring, determining calculating and specifying steps (detecting and responding to patient discomfort during immobilization) amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, the function of “in response to determining that the rest level has decreased below the predetermined threshold value, output a warning comprising at least one of: an audio warning sound, a spoken warning message, a visual warning message displayed on a display, or graphical alteration of the rest level display” correspond to insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Argument 2: Applicant argues that the claimed subject matter is integrated into a practical application, since the outputs generated by the processing circuitry are not abstract.
Examiner submits that the function of “in response to determining that the rest level has decreased below the predetermined threshold value, output a warning comprising at least one of: an audio warning sound, a spoken warning message, a visual warning message displayed on a display, or graphical alteration of the rest level display” correspond to insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Argument 3: Applicant argues that claims recite additional features amount to significantly more, the specific combination of multimodal biometric inputs defined computational methods for calculating a rest level (including machine learning using a multilayer neural network), threshold-based triggering, and image-based fastener cause determination is neither conventional nor routine in the field of radiotherapy.
In response, Examiner submits that MPEP recites “mere instructions to implement an abstract idea on a computer” does not qualify as “significantly more” when recited in a claim with a judicial exception (see MPEP § 2106.05 A. The current claims recite the additional element of using a processing circuitry to perform the acquiring, calculating, determining and specifying steps, which amounts to no more than mere instructions to apply the exception using a generic computer component.
Therefore, the arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Obeid Mamon can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687