DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-4, 6, 7, 9, and 10, as filed 12/04/2025, are currently pending and have been considered below.
Foreign priority is generally acknowledged to JAPAN 2023-170721 which was filed 09/29/2023.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
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, 6, 7, 9, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
1. A medical image capturing apparatus with examination support comprising:
one or more processors; and
one or more memories that store a program including one or more commands executed by the one or more processors,
wherein the one or more processors execute the program stored in the one or more memories to: (insignificant extra-solution activity; applying the abstract idea with a generic computer)
acquire an examination order for a subject of a medical image diagnostic examination (insignificant extra-solution activity; mere data-gathering);
acquire subject information regarding the subject (insignificant extra-solution activity; mere data-gathering);
acquire examination information regarding the medical image diagnostic examination performed on the subject (insignificant extra-solution activity; mere data-gathering); and
automatically create a first examination protocol applied to the medical image diagnostic examination performed based on the examination order, based on the subject information and the examination, and an analysis result of past examination information regarding a past medical image diagnostic examination performed in past on the subject, wherein the first examination protocol comprises a first imaging protocol and a first processing sequence (abstract idea – mental process; a clinician or imaging tech could practicably review the patient’s information and create an exam protocol)
set the first examination protocol onto the medical image capturing apparatus such that the medical image capturing apparatus captures a medical image of the subject according to the first imaging protocol and processes the medical image according to the first processing sequence (additional element – insignificant extra-solution activity, namely, storing data in memory); and
in response to the first examination protocol being modified, store a modification history of the first examination protocol, wherein the modification history is at least one of an operator who has approved or disapproved the first examination protocol, a modification portion of the captured medical image, a comment made during a modification, and a number of times of modifications (additional element – insignificant extra-solution activity, namely, storing data in memory).
2. The examination support device according to claim 1, wherein the one or more processors
acquire a second examination protocol associated with the examination order (insignificant extra-solution activity; mere data-gathering), and
create the first examination protocol by modifying the second examination protocol based on the examination information and the subject information (abstract idea – mental process).
3. The examination support device according to claim 2,
wherein the one or more processors display, on a display device, a comparison result obtained by comparing the first examination protocol with the second examination protocol (insignificant extra-solution activity; applying the abstract idea with a generic computer; general data output).
4. The examination support device according to claim 2,
wherein the one or more processors perform at least any one of substitution of a sequence, order change of a sequence, addition of a sequence, or deletion of a sequence in the second examination protocol in a case of creating the first examination protocol (abstract idea – mental process).
6. The examination support device according to claim 1,
wherein the one or more processors display, on a display device, an authentication screen for an operator to input whether or not to approve the first examination protocol (insignificant extra-solution activity; applying the abstract idea with a generic computer).
7. The examination support device according to claim 1,
wherein the one or more processors receive modification of the created first examination protocol (insignificant extra-solution activity; mere data-gathering).
Claim 1 is presented as an exemplary independent claim but the same analysis applies to the other claims 9-10.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because, other than reciting generic computer terms like processors and memories, nothing in the claims precludes the italicized portions such as the creation of a first examination protocol from practically being performed in the mind of a clinician.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims and set forth in the analysis above.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, executing the program with a processor amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification as published [0062], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, acquiring an examination order, subject information, and examination information amount to mere data gathering and selecting a particular data source or type of data to be manipulated and setting data in memory amounts to data outputting, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claims 3 and 6 recite display elements which amount to invoking computers as a tool to perform the abstract idea. Claims 2 and 5 recite additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. For example, acquiring information and setting information in memory amount to receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 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, 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Aizawa (JP2020187542A) in view of Gopal (US20070049815A1).
Regarding claim 1, Aizawa discloses: A medical image capturing apparatus with examination support comprising: one or more processors; and one or more memories that store a program including one or more commands executed by the one or more processors, wherein the one or more processors execute the program stored in the one or more memories (“HIS1 is a computer system that provides business support in hospitals. Specifically, HIS1 has various subsystems such as an electronic medical record system and an ordering system. HIS1 (subsystem) is a processor such as a CPU (Central Processing Unit), a memory such as a ROM (Read Only Memory) or a RAM (Random Access Memory), a display, a server device having an input interface and a communication interface, a client terminal, or the like. Including computer,” page 2; “Modality 5 performs imaging (imaging) according to imaging conditions (imaging protocol) determined based on inspection instructions and the like. Examples of the modality 5 include an X-ray computed tomography apparatus, an X-ray diagnostic apparatus, a magnetic resonance imaging apparatus, an ultrasonic diagnostic apparatus, a nuclear medicine diagnostic apparatus, and the like,” page 2) to:
--acquire an examination order for a subject of a medical image diagnostic examination (“The information acquisition function 151 acquires patient information and an examination order from HIS1 via the communication interface 11…The examination order includes, for example, a patient ID, an examination ID, a type of modality 5, an imaging site, an imaging method, an imaging direction, the presence or absence of a contrast medium, a assumed disease name, and the like” page 3);
--acquire subject information regarding the subject (“The information acquisition function 151 acquires patient information and an examination order from HIS1 via the communication interface 11…The basic patient information includes, for example, patient ID, patient name (name), age (date of birth), gender, height, weight, blood type, and the like” page 3);
--acquire examination information regarding the medical image diagnostic examination performed on the subject (“the information acquisition function 151 acquires an inspection instruction created according to an inspection order,” page 3); and
--automatically create a first examination protocol applied to the medical image diagnostic examination performed based on the examination order, based on the subject information, the examination information, (“The determination function 153 determines the imaging protocol applied to the modality 5 based on the patient information, the examination order, and the examination instruction acquired by the information collecting function 111,” page 4), and an analysis result of past examination information regarding a past medical image diagnostic examination performed in past on the subject (“Information about the requesting doctor (doctor display area R3), sent comment (sent comment display area R5), each comment about sent (each comment display areaR6), information about examination (examination list display area R7), and comment about each examination. (Inspection list comment display area R8) may be supplied from HIS1 together with the inspection order, or may be supplied from a RIS terminal or the like,” page 3; the “trained model” in the claims on page 1 is an analysis result based on past information; “A determination unit that compares the imaging protocol of the modality determined by the determination unit with the imaging protocol actually used in the modality, and determines whether or not both imaging protocols match,” page 1),
--wherein the first examination protocol comprises a first imaging protocol and a first processing sequence (“Modality 5 performs imaging (imaging) according to imaging conditions (imaging protocol) determined based on inspection instructions and the like. Examples of the modality 5 include an X-ray computed tomography apparatus, an X-ray diagnostic apparatus, a magnetic resonance imaging apparatus, an ultrasonic diagnostic apparatus, a nuclear medicine diagnostic apparatus, and the like.
Modality 5 is operated by, for example, an operator such as a doctor or a radiological technologist. The medical image (image data) generated by the imaging in the modality 5 is transmitted to the PACS 7…incidental information includes, for example, information such as patient ID, an examination ID, and an imaging condition (imaging protocol) in [DICOM] format,” page 2; DICOM encompasses both acquisition parameters (imaging protocol) and post-processing instructions);
--set the first examination protocol onto the medical image capturing apparatus such that the medical image capturing apparatus captures a medical image of the subject according to the first imaging protocol and processes the medical image according to the first processing sequence (“An output unit that outputs the shooting protocol determined by the determination unit to the modality, and an output unit,” page 1; “Modality 5 performs imaging (imaging) according to imaging conditions (imaging protocol) determined based on inspection instructions and the like,” page 2; “Returning to FIG. 2, the transmission function 154 transmits (outputs) the imaging protocol determined by the determination function 153 to the modality 5 that performs imaging,” page 5. Thus, the determination function 153 creates the protocol, the transmission function 154 outputs it to modality 5, and modality 5 performs imaging according to the protocol. The protocol encompasses both acquisition and processing parameters (i.e., DICOM data).).
Aizawa discloses that a protocol can be modified because it detects whether the “actually used” protocol has discrepancies compared to the (base) protocol. Aizawa does not expressly disclose, but Gopal teaches: in response to the first examination protocol being modified, store a modification history of the first examination protocol, wherein the modification history is at least one of an operator who has approved or disapproved the first examination protocol (radiologist ID [0030]), a modification portion of the captured medical image (“The radiologist may approve a release of the patient 152, request additional scans, request repetition of selected scans, or request more information such as patient's files or an exterior image of the patient, which is particularly advantageous in the trauma cases,” [0031]), a comment made during a modification (recording notes during an examination in [0025]), and a number of times of modifications.
One of ordinary skill in the art would be have been motivated before the effective filing date to expand the automated protocol generation of Aizawa to include Gopal’s operator identification and comment recording because this would improve quality control and regulatory compliance by tracking who authorized a change and why (see Gopal [0012]).
Additionally, it can be seen that each element is taught by either Aizawa or Gopal. The operator tracking of Gopal does not affect the normal functioning of the elements of the claim which are taught by Aizawa. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Gopal with the teachings of Aizawa since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable, namely, an auditable record ensuring that protocol modifications are properly authorized and documented.
Regarding claim 6, Aizawa does not expressly disclose but Gopal teaches: wherein the one or more processors display, on a display device, an authentication screen for an operator to input whether or not to approve the first examination protocol (“accept” button 80 [0024]; radiologist ID matching in [0030]).
The motivation to combine is the same as in claim 1.
Claims 9 and 10 are substantially similar to claim 1 and are rejected with the same reasoning.
Claims 2-4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Aizawa (JP2020187542A) in view of Gopal (US20070049815A1) and Kaufholz (US20180356482A1).
Regarding claim 2, Aizawa and Gopal do not expressly disclose but Kaufholz teaches: wherein the one or more processors
--acquire a second examination protocol associated with the examination order (“extract from the selected examination protocol that represents the examination information, the required actions and feedback the need to take these required actions to the user,” [0014]), and
--create the first examination protocol by modifying the second examination protocol based on the examination information and the subject information (“adapt the selected examination protocol to run safely, or select a protocol that involves suppression of metal artefacts, such as a SEMAC or MAVRIC technique,” [0014]; “The analysis unit may also autonomously select the proper imaging sequence and inform the user over the user [interface of the amended MR examination] protocol,” [0015]).
One of ordinary skill in the art would have been motivated to expand Aizawa and Gopal’s imaging support device that automatically determines an imaging protocol to include Kaufholz’s analysis and amendment of the selected examination protocol because this would make the imaging workflow more tailored to the patient at hand and thus more efficient (see Kaufholz [0016]).
Regarding claim 3, Aizawa does not expressly disclose but Kaufholz teaches: wherein the one or more processors display, on a display device, a comparison result obtained by comparing the first examination protocol with the second examination protocol (“In the event the selected examination protocol is not fit to be applied, then the analysis module may issue a warning to the user interface,” [0014]; “The analysis module may be configured to derive this proper sequential order form the examination protocol and feedback that order to the user over the user interface,” [0019]; feedback in [0020]).
The motivation to combine is the same as in claim 2.
Regarding claim 4, Aizawa does not expressly disclose but Kaufholz teaches: wherein the one or more processors perform at least any one of substitution of a sequence, order change of a sequence, addition of a sequence, or deletion of a sequence in the second examination protocol in a case of creating the first examination protocol (“For example, the information on the patient may concern the presence of (metallic) implants, which could prompt the requirement to adapt the selected examination protocol to run safely, or select a protocol that involves suppression of metal artefacts, such as a SEMAC or MAVRIC technique,” [0014]).
The motivation to combine is the same as in claim 2.
Regarding claim 7, Aizawa discloses: wherein the one or more processors receive modification of the created first examination protocol (“As described above, in the present embodiment, the imaging protocol of modality 5 determined by the determination function 153 is compared with the imaging protocol actually used in the modality 5, and whether or not both imaging protocols match is determined,” page 7).
Response to arguments
Applicant's arguments filed 12/04/2025 have been fully considered and are discussed below.
Regarding the subject matter ineligibility rejections, Applicant argues that the claimed invention is not directed to an abstract idea in Step 2A Prong One because they now include hardware-level image acquisition and processing functions. Remarks page 9. The Examiner disagrees because limiting the claim to a particular technological environment, i.e., a medical image capturing apparatus, does not preclude the invention from reciting and being directed to an abstract idea. The mental process is still part of claim 1; other limitations include additional elements that are analyzed separately above. Further, MPEP 2106.04(d) states that “[g]enerally linking the use of a judicial exception to a particular technological environment or field of use” does not integrate the judicial exception into a practical application (Step 2A Prong Two: No). The hardware is recited at a very high level and has no structure beyond a generical computer.
Applicant argues that the claimed invention integrates any abstract idea into a practical application by improving technology (Step 2A Prong Two). Remarks page 9. The asserted technological problems, requiring an operator to “manually confirm and recreate the protocol, resulting in significant workload and reduced consistency,” id., is not a technical problem as set forth in MPEP 2106.04(d)(1). This section requires that the additional elements reflect an improvement to technology or a technical field, not merely that the abstract idea’s result is useful to users. Here, the imaging modality captures and processes images in a manner that uses only generic computer functions. No improvements to the software or hardware are recited. “Consistent imaging behavior” and “reduced operator burden” are benefits of the abstract idea itself, not improvements to imaging technology.
The eligibility rejections are maintained.
Regarding the prior art rejections, applicant’s arguments are moot in view of the new grounds of rejection including Gopal.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office Action (See MPEP 706.07(a)). Accordingly, 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 extension fee 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 JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624