DETAILED ACTION
The present office action represents a final action on the merits.
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 .
Priority
This application claims the priority date of foreign application JP2023-115465 of July 13, 2023.
Status of Claims
Claims 1 and 13-14 are amended and claims 1-7 and 9-14 are pending.
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.
Claims 13 and 14 are 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 13 line 15 recites the limitations, “the obtaining.” There is insufficient antecedent basis for this limitation in the claim because claim 13 is an independent claim and the term is not referenced in claim 13. Examiner is interpreting “the obtaining” as “the obtaining unit.” Appropriate correction is requested.
Claim 14 line 16 recites the limitations, “the obtaining.” There is insufficient antecedent basis for this limitation in the claim because claim 14 is an independent claim and the term is not referenced in claim 14. Examiner is interpreting “the obtaining” as “the obtaining unit.” Appropriate correction is requested.
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 1-7 and 9-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-7 and 9-12 are drawn to a software-operated medical system for processing and display of medical information, which is within the four statutory categories (i.e., machine). Claim 13 is drawn to a software-operated control method for processing and display of medical information, which is within the four statutory categories (i.e., process). Claim 14 is drawn to a non-transitory computer-readable storage medium storing thereon a computer program, which is within the four statutory categories (i.e., machine).
Claims 1-7 and 9-12 recite a software-operated medical system for processing and display of medical information comprising:
an electronic medical record terminal,
an image capture apparatus that includes image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating a digital electric lesion image of a lesion area,
at least one memory storing computer instructions, and
at least one processor, that upon execution of the stored computer instructions, operates the medical system to function as:
a specifying unit configured to specify a photographing person of the image capture apparatus based on the photographing person information received from the photographing person via an input unit and a user interface;
an obtaining unit configured to obtain patient information associated with the photographing person information from a patient information table data structure, associating the patient information and the photographing person information and regarding a patient whose medical record information is processed for display on the electronic medical record terminal that is being operated by the photographing person specified by the specifying unit; and
an associating unit configured to automatically associate the digital lesion image obtained by the image capture unit performing image capturing and the patient information obtained by the obtaining unit from a patient information table data structure with each other, wherein,
in a case where it is determined that the obtaining unit fails to obtain the patient information due to a communication failure that happens before the lesion image is captured, the obtaining unit first stores photographing person information specified by the specifying unit, and only after capturing the digital lesion image, the at least one processor reads and processes the stored photographing person information, and only thereafter obtains the patient information based on the read and processed photographing person information using at least said patient information table data structure.
Claim 13 recites a software-operated control method for processing and display of medical information that includes an electronic medical record terminal and an image capture apparatus that includes an image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating a digital electric lesion image of a lesion area, the method comprising:
specifying, a photographing person of the image capture apparatus based on the photographing person information received from the photographing person via an input unit and a user interface;
obtaining, patient information associated with the photographing person information from a patient information table data structure, associating the patient information and the photographing person information and regarding a patient whose medical record information is processed for displaying on the electronic medical record terminal that is being operated by the photographing person specified by the specifying unit; and
automatically associating the digital lesion image obtained by the image capture unit performing image capturing and the patient information obtained by the obtaining unit from a patient information table data structure to each other wherein,
in a case where the obtaining of the patient information fails due to a communication failure that happens before the lesion image is captured, first storing photographing person information specified by the specifying unit, and only after capturing the digital lesion image, reading and processing the stored photographing person information, and only thereafter obtaining the patient information based on the read and processed photographing person information using at least said patient information table data structure.
Claim 14 recites a non-transitory computer-readable storage medium storing thereon a computer program which, when loaded into and executed by a computer processor provided in a medical system that includes an electronic medical record terminal and an image capture apparatus that includes an image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating a digital electric lesion image of a lesion area, causes the computer to perform processes comprising:
specifying a photographing person of the image capture apparatus based on the photographing person information received from the photographing person via an input unit and a user interface;
obtaining patient information associated with the photographing person information from a patient information table data structure associating the patient information and the photographing person information and regarding a patient whose medical record information is processed for displaying on the electronic medical record terminal that is being operated by the photographing person specified by the specifying unit; and
automatically associating the digital lesion image obtained by the image capture unit performing image capturing and the patient information obtained by the obtaining unit from a patient information table data structure, to each other,
wherein, in a case where the obtaining of the patient information fails due to a communication failure that happens before the lesion image is captured, first storing photographing person information specified by the specifying unit, and only after capturing the digital lesion image, reading and processing the stored photographing person information, and only thereafter obtaining the patient information based on the read and processed photographing person information using at least said patient information table data structure.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components (e.g., medical record terminal computer, medical system, etc.). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 2-7 and 9-12 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. These limitations only serve to further limit the abstract idea (or contain the same additional elements found in the independent claim or contain additional elements not found in the independent claims as detailed below), and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 13, and 14.
The dependent claims include additional limitations, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 13, and 14.
The additional elements from claim 1 include:
a software-operated medical system (apply it, MPEP 2106.05(f)).
stores (apply it, MPEP 2106.05(f)).
associating unit (apply it, MPEP 2106.05(f)).
at least one memory storing computer instructions, and
at least one processor, that upon execution of the stored computer instructions, operates the medical system to function as
The additional elements from claims 1, 13, and 14 include:
an electronic medical record terminal (apply it, MPEP 2106.05(f)).
an image capture apparatus (apply it, MPEP 2106.05(f)).
a user interface (apply it, MPEP 2106.05(f)).
image capture unit (apply it, MPEP 2106.05(f)).
a specifying unit configured to (apply it, MPEP 2106.05(f)).
an obtaining unit configured to (apply it, MPEP 2106.05(f)).
The additional elements from claim 14 include:
a non-transitory computer-readable storage medium storing thereon a computer program (apply it, MPEP 2106.05(f)).
a medical system (apply it, MPEP 2106.05(f)).
a computer (apply it, MPEP 2106.05(f)).
The dependent claims include the following additional elements beyond those recited in the independent claims:
a transmitting unit configured (apply it, MPEP 2106.05(f)).
an image management apparatus (apply it, MPEP 2106.05(f)).
a recording unit configured to (apply it, MPEP 2106.05(f)).
a management unit configured to (apply it, MPEP 2106.05(f)).
the obtaining unit stores (apply it, MPEP 2106.05(f)).
a management apparatus (apply it, MPEP 2106.05(f)).
These additional elements, in the independent claims and in the dependent claims are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception – for example, the recitation of “an associating unit”, “a medical system”, “an electronic medical record terminal”, “an image capture apparatus”, “image capture unit”, “a specifying unit”, “an obtaining unit”, “a non-transitory computer-readable storage medium storing thereon a computer program”, “a computer”, “a transmitting unit”, “an image management apparatus”, “a recording unit”, “a management unit”, “a management apparatus”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g., see Specification Paragraphs [0039]-[0040], [0043], [0053]-[0058], and [0271] (See MPEP 2106.05(f)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., the Specification Paragraphs [0039]-[0040], [0043], [0053]-[0058], and [0271] discloses that the additional elements (i.e., a medical system, an electronic medical record terminal, an image capture apparatus, image capture unit, a specifying unit, an obtaining unit, a non-transitory computer-readable storage medium storing thereon a computer program, a computer, a transmitting unit, an image management apparatus, a recording unit, a management unit, the obtaining unit stores, a management apparatus) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., a computer);
Relevant court decisions: The following example of court decision demonstrating well understood, routine and conventional activities, e.g., see MPEP 2106.05(d)(II): See e.g. Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1316, 120 USPQ2d 1527, 1549 (Fed. Cir. 2016), BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed. Cir. 2016). Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking) – similarly, the current invention uses an electronic medical record terminal and display to specify a photographing person and identify a patient.
Dependent claims 2-7 and 9-12 include other limitations, but none of these functions are deemed significantly more than the abstract idea. Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves any other technology, and their collective functions merely provide conventional computer implementation.
The application, is an attempt to organize human activity, using a medical system, a control method thereof, and a non-transitory computer-readable storage medium, which is not patentable. Therefore, whether taken individually or as an ordered combination, claims 1-7 and 9-14 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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.
Claims 1-4 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hirakawa (U.S. Pub. No. 2021/0012870 A1) in view of Takahashi (U.S. Pub. No. 2023/0337893 A1), Vija (U.S. Pub. No. 2022/0346747 A1) and Tsuchino (U.S. Pat. No. 6431440 B1).
Regarding claim 1, Hirakawa discloses a software-operated medical system for processing and display of medical information comprising (Paragraphs [0034]-[0035] discuss a medical department workstation to observe an image by executing a software program for each processing.):
an electronic medical record terminal,
at least one memory storing computer instructions, and
at least one processor, that upon execution of the stored computer instructions, operates the medical system to function as (Paragraphs [0019] and [0031]-[0035] discuss a memory that stores instructions for a computer to execute, and a processor that is configured to execute stored instructions, in which the processor receives the observation information on the subject and medical information system that includes a medical department workstation that is a computer used by a diagnostician to create an electronic medical record and includes various apparatus including an apparatus that generates a medical image by imaging the diagnosis target part of the examinee, storage of a medical image acquired by imaging, interpretation of a medical image by a radiologist, and creation of an interpretation report.):
a specifying unit configured to specify a photographing person of the image capture apparatus based on the photographing person information received from the photographing person via an input unit (Paragraphs [0006], [0020], [0040], [0058]-[0059], and FIG. 3 discuss a display unit and the reception unit receives observation information on a subject and an operator such as a diagnostician and a radiologist creates an interpretation of the image in a medical document; an image ID for identifying a medical image to be interpreted, a radiologist ID for identifying an image diagnostician who performed the interpretation, a lesion name, position information of a lesion, and findings, is recorded.);
an obtaining unit configured to obtain patient information associated with the photographing person information from a patient information table data structure, associating the patient information and the photographing person information and regarding a patient whose medical record information is processed for display on the electronic medical record terminal that is being operated by the photographing person specified by the specifying unit (Paragraphs [0004], [0040], [0059] and FIG. 3 discuss analysis result generated by analysis processing is stored in a database so as to be associated with examination information, such as a patient name, gender, age, and a modality that has acquired the medical image, and provided for diagnosis and an interpretation report is registered in which information, such as an image ID for identifying a medical image to be interpreted, a radiologist ID for identifying an image diagnostician who performed the interpretation, a lesion name, position information of a lesion, and findings, is recorded and the reception unit receives observation information on a subject, for example, in a case where cancer is found as a result of the interpretation of the medical images displayed by the operator, the operator inputs the characters “the patient had cancer.” from the input unit.); and
an associating unit configured to automatically associate the digital lesion image obtained by the image capture unit performing image capturing and the patient information obtained by the obtaining unit from a patient information table data structure with each other, wherein (Paragraphs [0033], [0035], [0037], [0053], and FIG. 3 discuss an apparatus that generates a medical image showing a diagnosis target part by imaging the diagnosis target part of the examinee and the image data is registered in the image database and includes an image ID, imaging method, a patient identification for identifying an examinee, an examination ID for identifying an examination, patient information, imaging information, etc.; the computer used by a diagnostician for each processing, such as the creation of a medical record of patient (electronic medical record), sending a request to view an image to the image server, display of an image received from the image server, automatic detection or highlighting of a lesion-like portion in an image, sending a request to view an interpretation report to the interpretation report server, and display of an interpretation report received from the interpretation report server, is performed.),
in a case where it is determined that the obtaining unit, the obtaining unit stores photographing person information specified by the specifying unit, after capturing the digital lesion image, the at least one processor reads the stored photographing person information, and only thereafter obtains the patient information based on the read and processed photographing person information using at least said patient information table data structure (Paragraphs [0004], [0019]-[0020], [0031], [0033]-[0035], [0037], and FIGS. 3, 6 discuss the medical information system for performing imaging of an examination target part of an examinee, storage of a medical image, interpretation by a radiologist and creation of an interpretation report, and viewing of an interpretation report using an interpretation terminal apparatus that displays patient information (the name, age, and gender of patient, an examination part (imaging part), imaging information (an imaging protocol, an imaging sequence, an imaging method, imaging conditions), the interpretation medical department workstation includes the medical document display control apparatus used by a diagnostician to observe the details of an image associated with a patient, the processor receives the observation information on the subject, acquires the relation information on the analysis result obtained by immediately analyzing the received observation information and the relation information derived from the observation information input by the operator can be displayed on the display unit in real time as the information currently desired by the operator.).
Hirakawa does not explicitly disclose:
an image capture apparatus that includes image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating a digital electric lesion image of a lesion area,
a user interface;
in a case where the obtaining unit fails to obtain the patient information due to a communication failure before the lesion image is captured, the obtaining unit stores photographing person information specified by the specifying unit, after capturing the lesion image, reads the stored photographing person information, and then obtains the patient information based on the photographing person information read.
Takahashi teaches:
an image capture apparatus that includes image capture unit performing image capturing by reading an optical image, and generating
a user interface (Paragraphs [0067]-[0068] include an input/output interface.)
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, an image capture apparatus that includes image capture unit performing image capturing by reading an optical image, and generating Takahashi, in order to confirm and grasp what time the lesion detected by the detection processing is captured during the examination. (Takahashi Paragraph [0004]).
Vija teaches:
reads an optical image using a solid-state image sensor (Paragraphs [0043]-[0044] discuss solid-state detectors and capturing images and reading the image.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, reads an optical image using a solid-state image sensor, as taught by Vija, in order to prevent an error in quantitative functional imaging. (Vija Paragraph [0003]).
Tsuchino teaches:
in a case where the obtaining unit fails to obtain the patient information due to a communication failure before the lesion image is captured, the obtaining unit stores photographing person information specified by the specifying unit, after capturing the lesion image, reads the stored photographing person information, and then obtains the patient information based on the photographing person information read (Column 1 lines 32-37 and Column 3 lines 19-24 discuss in a hospital, patients from a plurality of diagnosis & treatment departments are radiographed in a radiographic inspection room to obtain radiation images and correlation between a patient and a radiographed image (or between a patient and a radiation image conversion panel) is sometimes difficult and by using this patient identification information, patient information can be correlated with a radiation image accurately, and thereby, the radiation image can accurately be correlated with a patient which is an object.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, in a case where the obtaining unit fails to obtain the patient information due to a communication failure before the lesion image is captured, the obtaining unit stores photographing person information specified by the specifying unit, after capturing the lesion image, reads the stored photographing person information, and then obtains the patient information based on the photographing person information read, as taught by Tsuchino, in order to ensure that the diagnosis is made using the correct radiation image information and proper medical treatment is given to the patient. (Tsuchino Column 1 lines 40-44).
Regarding claim 2, Hirakawa discloses further comprising an image transmitting unit configured to transmit the lesion image obtained by the image capture unit performing image capturing and the patient information obtained from the patient information table by the obtaining unit in association with each other, to an image management apparatus (Paragraphs [0004]-[0005], [0033], [0035], [0037]-[0038], [0042] discuss an apparatus that generates a medical image of an examinee transmits the medical image to the image server and where a viewing request from the interpretation WS is received through the network, the image server searches for a medical image registered in the image database and transmits the searched medical image to the interpretation WS that is a request source, the image data includes accessory information, for example image ID, patient ID, etc., the image associated with patient name, gender and age.).
Regarding claim 3, Hirakawa discloses further comprising a patient information transmitting unit configured to transmit the patient information obtained from the patient information table by the obtaining unit, to the image capture apparatus (Paragraphs [0004]-[0005] and [0037] discusses image data of the medical images acquired by the modality including a plurality of medical images and accessory information are registered in the image database, the accessory information includes, for example, an image ID for identifying each medical image, a patient identification (ID) for identifying an examinee, an examination ID for identifying an examination, a unique ID (UID: unique identification) allocated for each medical image, patient information, patient name, gender, and age, an examination part (imaging part), imaging information, etc. and where a viewing request is received the image server searches for a medical image registered and transmits it.).
Regarding claim 4, Hirakawa discloses wherein the image capture apparatus includes a patient information recording unit configured to record the transmitted patient information obtained by transmitting the photographing person information and the lesion image obtained by the image capture unit performing image capturing, in association with each other (Paragraphs [0004]-[0005], [0031], [0033], and [0037] discuss medical information system for performing imaging of an examination target part of an examinee, storage of a medical image acquired by imaging and image data, radiologist and diagnostician information, and accessory information including, for example, an image ID for identifying each medical image, a patient identification (ID) for identifying an examinee, an examination ID for identifying an examination, a unique ID (UID: unique identification) allocated for each medical image, examination date and examination time at which the medical image is generated, the type of a modality used in an examination for acquiring a medical image, patient information such as the name, age, and gender of patient, an examination part, imaging information (an imaging protocol, sequence, method, conditions, the use of a contrast medium, and the like) are registered in the image database and the medical image generated by the modality (an apparatus that generates a medical image) is transmitted to the image server and stored therein.).
Regarding claim 9, Hirakawa discloses wherein the image capture apparatus causes the image capture unit to capture an image of a lesion and generate a lesion image in accordance with an instruction to capture an image of a lesion, and associates the patient information with the lesion image based on the photographing person information (Paragraphs [0008], [0031], [0037], [0040], and FIGS. 1-3 discuss a medical information system for performing imaging of an examination target part of an examinee, storage of a medical images acquired by imaging, interpretation of a medical image by a radiologist and creation of an interpretation report, and viewing of an interpretation report by a diagnostician in a medical department of a request source and detailed observation of a medical image to be interpreted, on the basis of an examination order from a diagnostician (doctor) in a medical department using a known ordering system and a medical document display control apparatus according to the embodiment of the present invention includes a reception unit that receives observation information on a subject, an acquisition unit that acquires relation information on an analysis result obtained by immediately analyzing the observation information received by the reception unit, the database information includes a radiologist ID for identifying an image diagnostician who performed, the interpretation.)
Regarding claim 10, Hirakawa discloses further comprising:
a management apparatus that manages medical record information of patients and information regarding medical workers, and an image management apparatus that manages lesion images of patients in association with the patient information (Paragraphs [0031] and [0037] discuss medical information system for performing imaging of an examination target part of an examinee, storage of a medical image acquired by imaging and image data, radiologist and diagnostician information, and accessory information including, for example, an image ID for identifying each medical image, a patient identification (ID) for identifying an examinee, an examination ID for identifying an examination, a unique ID (UID: unique identification) allocated for each medical image, examination date and examination time at which the medical image is generated, the type of a modality used in an examination for acquiring a medical image, patient information such as the name, age, and gender of patient, an examination part, imaging information (an imaging protocol, sequence, method, conditions, the use of a contrast medium, and the like) are registered in the image database.).
Regarding claim 11, Hirakawa discloses wherein the specifying unit specifies a photographing person based on the information regarding medical workers managed by the management apparatus (Paragraphs [0031] FIGS. 1-2 discuss the medical information system for storage of a medical image acquired by imaging, interpretation of a medical image by a radiologist and creation of an interpretation report and viewing by a diagnostician in a medical department of a request source and detailed observation of a medical image to be interpreted, on the basis of an examination order from a diagnostician in a medical department using a known ordering system.).
Claim 5-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hirakawa in view of Takahashi, Vija and Tsuchino and in further view of Ban (U.S. Pub. No. 2014/0368545 A1).
Regarding claim 5, Hirakawa discloses wherein the specifying unit specifies a photographing person based on information input to the image capture apparatus by the photographing person (Paragraphs [0006], [0020], [0040], [0058]-[0059], and FIG. 3 discuss a display unit and the reception unit receives observation information on a subject and an operator such as a diagnostician and a radiologist creates an interpretation of the image in a medical document; an image ID for identifying a medical image to be interpreted, a radiologist ID for identifying an image diagnostician who performed the interpretation, a lesion name, position information of a lesion, and findings, is recorded.), and
the obtaining unit specifies a patient whose medical record information is to be displayed on the electronic medical record terminal that is being operated by the photographing person specified by the specifying unit, based on information regarding the photographing person specified by the specifying unit and information of the electronic medical record terminal, and obtains patient information of the specified patient (Paragraphs [0031], [0037], and FIG. 3 discuss medical information system for performing imaging of an examination target part of an examinee, storage of a medical image acquired by imaging and image data, radiologist and diagnostician information, and accessory information including, for example, an image ID for identifying each medical image, a patient identification (ID) for identifying an examinee, an examination ID for identifying an examination, a unique ID (UID: unique identification) allocated for each medical image, examination date and examination time at which the medical image is generated, the type of a modality used in an examination for acquiring a medical image, patient information such as the name, age, and gender of patient, an examination part, imaging information (an imaging protocol, sequence, method, conditions, the use of a contrast medium, and the like) are registered in the image database and include a display of patient information and interpretation report of radiologist.).
Hirakawa does not explicitly disclose:
login information of the electronic medical record terminal.
Ban teaches:
login information of the electronic medical record terminal (Paragraphs [0017] and [0193]-[0194] discuss an operation of selecting the partial region based on the at least one ID device of the operator that logs into a medical diagnostic system for diagnosing the object.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, login information of the electronic medical record terminal, as taught by Ban, in order to efficiently provide medical information by efficiently disposing a plurality of display devices. (Ban Paragraph [0011]).
Regarding claim 6, Hirakawa discloses further comprising a management unit configured to manage a user in the electronic medical record terminal and a patient whose medical record information is to be displayed on the electronic medical record terminal, in association with each other, wherein (Paragraphs [0004], [0031], and FIG. 3 discuss the medical information system and the interpretation report screen of a radiologist using an interpretation terminal apparatus that displays patient information.),
the user management unit manages the user by using a medical worker information table including the photographing person information (Paragraphs [0006], [0020], [0040], [0058]-[0059], and FIG. 3 discuss a display unit and the reception unit receives observation information on a subject and an operator such as a diagnostician and a radiologist creates an interpretation of the image in a medical document; an image ID for identifying a medical image to be interpreted, a radiologist ID for identifying an image diagnostician who performed the interpretation.).
Hirakawa does not explicitly disclose:
manage a user for which login authentication was successfully performed,
the user management unit manage the user by using a medical worker information table including the photographing person information and a password corresponding to the photographing person information.
Ban teaches:
manage a user for which login authentication was successfully performed (Paragraphs [0017] and [0193]-[0194] discuss when an operator of the medical information providing apparatus logs into the medical diagnostic system to image an object, an ID device of the operator may include log-in information related to the medical diagnostic system, and the medical information providing apparatus may detect the operator by detecting the ID device that is logged into the medical diagnostic system.).
the user management unit manage the user by using a medical worker information table including the photographing person information and a password corresponding to the photographing person information (Paragraphs [0194] discuss detect specific operator who logs in the medical diagnostic system to image the object.)
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, manage a user for which login authentication was successfully performed, as taught by Ban, in order to efficiently provide medical information by efficiently disposing a plurality of display devices. (Ban Paragraph [0011]).
Regarding claim 7, Hirakawa discloses wherein the obtaining unit specifies the patient associated with the same user as the photographing person specified by the specifying unit, based on information managed by the user management unit, and obtains patient information corresponding to the patient (Paragraphs [0020], [0031], [0037], and FIG. 3 discuss receiving observation information on the subject and the relation information derived from the observation information input by the diagnostician and radiologist is displayed in real time and the medical information system for performing imaging of an examination target part of an examinee, radiologist and diagnostician information, and accessory information including, for example, an image ID for identifying each medical image, a patient identification (ID) for identifying an examinee, an examination ID for identifying an examination, a unique ID (UID: unique identification) allocated for each medical image, examination date and examination time at which the medical image is generated, the type of a modality used in an examination for acquiring a medical image, patient information such as the name, age, and gender of patient, an examination part, imaging information (an imaging protocol, sequence, method, conditions, the use of a contrast medium, and the like) are registered in the image database.).
Regarding claim 12, Hirakawa discloses wherein the electronic medical record terminal performs based on the information regarding medical workers that is managed by the management apparatus, and performs control to display the medical record information managed by the management apparatus (Paragraphs [0004], [0031], [0034]-[0035], and FIG. 3 discuss the medical information system and the interpretation report screen of a radiologist using an interpretation terminal apparatus that displays patient information, the interpretation medical department workstation includes the medical document display control apparatus used by a diagnostician to observe the details of an image associated with a patient.).
Hirakawa does not explicitly disclose:
performs login authentication based on the information regarding medical workers and performs control to display the medical record information in accordance with login authentication having been successfully performed.
Ban teaches:
performs login authentication based on the information regarding medical workers and performs control to display the medical record information in accordance with login authentication having been successfully performed (Paragraphs [0017] and [0193]-[0194] discuss when an operator of the medical information providing apparatus logs into the medical diagnostic system to image an object, an ID device of the operator may include log-in information related to the medical diagnostic system, and the medical information providing apparatus may detect the operator by detecting the ID device that is logged into the medical diagnostic system.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, performs login authentication based on the information regarding medical workers and performs control to display the medical record information in accordance with login authentication having been successfully performed, as taught by Ban, in order to efficiently provide medical information by efficiently disposing a plurality of display devices. (Ban Paragraph [0011]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hirakawa in view of Takahashi and Tsuchino.
Regarding claim 13, Hirakawa discloses a software-operated control method for processing and display of medical information that includes an electronic medical record terminal and the method comprising (Paragraphs [0017] and [0031]-[0035] discuss a medical department workstation to observe an image by executing a software program for each processing and medical document display control method and a medical department workstation is a computer used by a diagnostician to create an electronic medical record and includes various apparatus including an apparatus that generates a medical image by imaging the diagnosis target part of the examinee.):
specifying a photographing person of the image capture apparatus based on the photographing person information received from the photographing person via an input unit (Paragraphs [0006], [0020], [0040], [0058]-[0059], and FIG. 3 discuss a display unit and the reception unit receives observation information on a subject and an operator such as a diagnostician and a radiologist creates an interpretation of the image in a medical document; an image ID for identifying a medical image to be interpreted, a radiologist ID for identifying an image diagnostician who performed the interpretation, a lesion name, position information of a lesion, and findings, is recorded.);
obtaining patient information associated with the photographing person information from a patient information table data structure, associating the patient information and the photographing person information and regarding a patient whose medical record information is processed for displaying on the electronic medical record terminal that is being operated by the photographing person specified by the specifying unit (Paragraphs [0004], [0040], [0059] and FIG. 3 discuss analysis result generated by analysis processing is stored in a database so as to be associated with examination information, such as a patient name, gender, age, and a modality that has acquired the medical image, and provided for diagnosis and an interpretation report is registered in which information, such as an image ID for identifying a medical image to be interpreted, a radiologist ID for identifying an image diagnostician who performed the interpretation, a lesion name, position information of a lesion, and findings, is recorded and the reception unit receives observation information on a subject, for example, in a case where cancer is found as a result of the interpretation of the medical images displayed by the operator, the operator inputs the characters “the patient had cancer.” from the input unit.); and
automatically associating the digital lesion image obtained by the image capture unit performing image capturing and the patient information obtained by the obtaining unit from a patient information table data structure to each other, wherein (Paragraphs [0033], [0035], [0037], [0053], and FIG. 3 discuss an apparatus that generates a medical image showing a diagnosis target part by imaging the diagnosis target part of the examinee and the image data is registered in the image database and includes an image ID, imaging method, a patient identification for identifying an examinee, an examination ID for identifying an examination, patient information, imaging information, etc.; the computer used by a diagnostician for each processing, such as the creation of a medical record of patient (electronic medical record), sending a request to view an image to the image server, display of an image received from the image server, automatic detection or highlighting of a lesion-like portion in an image, sending a request to view an interpretation report to the interpretation report server, and display of an interpretation report received from the interpretation report server, is performed.),
in a case, first storing photographing person information specified by the specifying unit, and only after capturing the digital lesion image, reading and processing the stored photographing person information, and only thereafter obtaining the patient information based on the read and processed photographing person information using at least said patient information table data structure (Paragraphs [0004], [0019]-[0020], [0031], [0033]-[0035], [0037], and FIGS. 3, 6 discuss the medical information system for performing imaging of an examination target part of an examinee, storage of a medical image, interpretation by a radiologist and creation of an interpretation report, and viewing of an interpretation report using an interpretation terminal apparatus that displays patient information (the name, age, and gender of patient, an examination part (imaging part), imaging information (an imaging protocol, an imaging sequence, an imaging method, imaging conditions), the interpretation medical department workstation includes the medical document display control apparatus used by a diagnostician to observe the details of an image associated with a patient, the processor receives the observation information on the subject, acquires the relation information on the analysis result obtained by immediately analyzing the received observation information and the relation information derived from the observation information input by the operator can be displayed on the display unit in real time as the information currently desired by the operator.).
Hirakawa does not explicitly disclose:
an image capture apparatus that includes an image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating a digital electric lesion image of a lesion area;
a user interface;
in a case where the obtaining of the patient information fails due to a communication failure that happens before the lesion image is captured, storing photographing person information specified by the specifying unit, after capturing the lesion image, reading the stored photographing person information, and then obtaining the patient information based on the photographing person information read.
Takahashi teaches:
an image capture apparatus that includes an image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating an electric lesion image (Paragraphs [0029]-[0030] discuss the image acquisition unit sequentially acquires current images of a lesion captured by the endoscope.),
a user interface (Paragraphs [0067]-[0068] include an input/output interface.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, an image capture apparatus that includes an image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating an electric lesion image and a user interface, as taught by Takahashi, in order to confirm and grasp what time the lesion detected by the detection processing is captured during the examination. (Takahashi Paragraph [0004]).
Tsuchino teaches:
in a case where the obtaining of the patient information fails due to a communication failure that happens before the lesion image is captured, first storing photographing person information specified by the specifying, and only after capturing the lesion image, reading and processing the stored photographing person information, and then obtaining the patient information based on the read and processed photographing person information (Column 1 lines 32-37 and Column 3 lines 19-24 discuss in a hospital, patients from a plurality of diagnosis & treatment departments are radiographed in a radiographic inspection room to obtain radiation images and correlation between a patient and a radiographed image (or between a patient and a radiation image conversion panel) is sometimes difficult and by using this patient identification information, patient information can be correlated with a radiation image accurately, and thereby, the radiation image can accurately be correlated with a patient which is an object.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Hirakawa to include, in a case where the obtaining of the patient information fails due to a communication failure that happens before the lesion image is captured, first storing photographing person information specified by the specifying, and only after capturing the lesion image, reading and processing the stored photographing person information, and then obtaining the patient information based on the read and processed photographing person information, as taught by Tsuchino, in order to ensure that the diagnosis is made using the correct radiation image information and proper medical treatment is given to the patient. (Tsuchino Column 1 lines 40-44).
Claim 14, recites essentially the same limitations as claim 13 with the exception of a control method of a medical system that includes an electronic medical record terminal and an image capture apparatus that includes an image capture unit, the method comprising and with the additional limitations whereby Hirakawa discloses a non-transitory computer-readable storage medium storing thereon a computer program which, when loaded into and executed by a computer processor provided in a medical system that includes an electronic medical record terminal and an image capture apparatus that includes an image capture unit performing image capturing by reading an optical image using a solid-state image sensor, and generating a digital electric lesion image of a lesion area, causes the computer to perform processes comprising (Paragraphs [0017], [0031]-[0035], and Claim 11 discuss non-transitory computer-readable storage medium storing therein a medical document display control program for causing a computer to execute and medical document display control method and a medical department workstation is a computer used by a diagnostician to create an electronic medical record and includes various apparatus including an apparatus that generates a medical image by imaging the diagnosis target part of the examinee.).
Response to Arguments
Applicant’s arguments filed 5/26/26 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the Prong 1 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 1 as amended recites an abstract idea, a method of organizing human activity. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant states, “claim 1, amended herein, recites at least nine different hardware and specific software and data organizational structural components. If fact, almost all nine recited claim elements are either hardware or software and data organizational structural components. Moreover, the recited elements are not some generic hardware or software components because they implement the specific operational logic (by executing improved specific software), to achieve very specific functionality of the system, beyond the generic function.” (Remarks, pages 10-11). Examiner respectfully disagrees. The application is not an improvement to the functioning of the hardware and specific software and data organizational structural components, but is an improvement to the abstract idea and does not result in significantly more than the abstract idea. The Application does not contain any benefits improving functionality of the computer. Applicant states, the court “in McRo ruled that an indication that a claim is directed to an improvement in computer- related technology may include "a particular solution to a problem or a particular way to achieve a desired outcome defined by the claimed invention, as opposed to merely claiming the idea of a solution or outcome." The applicant reiterates that the system is able to process and display lesion images of a patient (i.e., the medical examination data) in a situation when there is a communication failure during the process of obtaining patient's other information (i.e., personal or some prior information), without losing time for re-processing the patient's information before displaying medical lesion images and performing medical examination and diagnostics…the invention is directed to a technical improvement of a complex image processing system with multiple hardware components (as described above) by improving efficiency and timing of the automated diagnostic process, particularly when the system is utilized in live or real-time environment. It specifically addresses and solves the problem of wasting time or re- running process steps when there is a communication failure during input and processing of the patient's personal information.” (Remarks, pages 11-12). Obtaining patient data and associating it with the photographing person information, is not a technical problem rooted in the technology. The claims as written fail to result in a technical improvement. The improvement is to the abstract idea, a photographing person associating the image of the lesion with patient information, such as a patient name and gender written in electronic medical records.
The components are well understood and routine. Applicant states, “ the aforementioned "additional" elements of the amended claims 1, 13, and 14, whether considered individually or in an ordered combination, are not routine, conventional or well-known. Accordingly, it is submitted that unless the Examiner can prove otherwise by providing one or more of the factors under the Berkheimer guideline, Applicant's pending claims pass the step 2B of the Supreme Court's Alice two-step test.” (Remarks, page 13). Examiner respectfully disagrees. Here, the invention is performed by generic computing components. All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. For the reasons stated above, claim similarly fails to overcome the 35 U.S.C. 101 rejection.
While practical application is a way to overcome the Prong 2 35 U.S.C. 101 rejection, claim 1 as written fails to result in a practical application. Applicant states, “Given the significant number of different ways to display and associate medical images of a patient, patient's information and photographing person information, the software-driven automated solution of the present invention provides a more precise and structured solution for processing and collecting medical images of a patient during a time-sensitive period of medical examination than other known methods and systems. Thus, the present invention offers an improvement to a computerized system used for medical imagining, as recited in amended claims 1, 13, and 14, and discussed herein.” (Remarks, page 13). Examiner respectfully disagrees. The Application does not contain any benefits improving computer functionality or any other additional element. Here, the application is organizing human activity, directed to the abstract idea of a photographing person associating the image of the lesion with patient information such as a patient name and gender written in electronic medical records - a photographing person logs into an electronic medical record terminal, displays medical record information of a patient whose image is to be captured, performs identity confirmation, and then captures an image of a lesion and the photographing person then performs an operation of associating patient information displayed on the electronic medical record terminal with the image of the lesion. Software storing patient information upon the occurrence of a communication failure is not a practical application. Further, improving efficiency and timing of the automated diagnostic process and obtaining patient information through stored data structures is not a technical improvement. There is no improvement to the functioning of the computerized system, the improvement is to the abstract idea. The additional elements in claim 1 include a medical record terminal, image capture unit, memory, processor, etc., however, they do not result in a practical application as they are recited at an apply it level, as stated above.
Rejections under 35 U.S.C. 103:
Applicant argues the amendments overcome the previous rejection. Examiner concedes that the amendments overcome the prior rejection. Applicant states, “Hirakawa, Takahashi, Vija and Tsuchino, either alone or in combination, do not describe or suggest that (1) "in a case where it is determined that the obtaining unit fails to obtain the patient information due to a communication failure that happens before the lesion image is captured" (2) "the obtaining unit first stores photographing person information specified by the specifying unit," and (3) "only after capturing the lesion image, it reads and processes the stored photographing person information", and (4) "only thereafter obtains the patient information based on the read and processed photographing person information using at least said patient information table data structure", as recited in amended claim 1 (and similar claim limitations in claims 13 and 14).” (Remarks, page 20). Examiner respectfully disagrees and notes that the broadest reasonable interpretation of the prior art discussed in the cited prior art includes a radiologist ID attributable to a specific radiologist that is responsible for photographing a lesion whether the patient data is obtained prior to or after the lesion is captured. Further, Applicant’s arguments with respect to amended claim 1 have been considered and the Examiner’s rejection has been amended to address Applicant’s claim 1 amendments.
Applicant’s arguments with respect to claims 1, 13, and 14 have been considered and overcome the previous rejection. Examiner’s rejection has been amended to address Applicant’s claim 1, 13, and 14 amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
Prosecution Insights