Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/16/2026 has been entered.
DETAILED ACTION
Notices to Applicant
This communication is a non-final rejection. Claims 1-4, 6, 7, 9, 10, and 12, as filed 06/16/2026, 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 § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. Claim 12 is separately rejected because it requires capturing “another medical image…according to a modified first imaging protocol” which presupposes a capture under the unmodified protocol followed by a further capture after modification. The disclosed procedure modifies the protocol at the protocol-creation stage and only then sets it as the examination protocol. Only then does the modality perform the examination. The Examiner is unable to locate support for a capture, modify, re-capture sequence.
Applicant is encouraged to cite to support in the specification for these features if it exists.
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, 10, and 12 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)
control 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);
determine whether to modify the first examination protocol according to whether a current imaging condition of the first imaging protocol satisfies a predetermined imaging condition; and (abstract idea – mental process; a clinician or imaging tech could practicably make this determination)
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 medical image capturing apparatus 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 medical image capturing apparatus 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 medical image capturing apparatus 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 medical image capturing apparatus 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 medical image capturing apparatus 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.
12. (New) The medical image capturing apparatus according to claim 1, wherein the one or more processors further control the medical image capturing apparatus to capture another medical image of the subject according to a modified first imaging protocol included in the modified first examination protocol and to process the another medical image according to a modified first processing sequence included in the modified first examination protocol. (insignificant extra-solution activity; generally linking the exception to the medical imaging field; the claim merely recites the result with no mechanism to capture or process the image, and the apparatus performs its ordinary imaging function under whatever protocol it is sent).
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 1-3, 6, 7, 9, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gotman (US20070109294A1) in view of Jattke (US20170261569A1) and Takada (US20060242095A1).
Regarding claim 1, Gotman 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 (Abstract) to:
--acquire an examination order for a subject of a medical image diagnostic examination (“The operator types the patient data, e.g. name, weight, requesting physician, requested procedure, etc., into data entry fields 122,” [0038]; FIG. 4; “protocols are further mapped to a requesting physician 108 and a requested procedure 110,” [0036]);
--acquire subject information regarding the subject ([0038]; “menu of available protocols in accordance with entered patient size, patient age, radiologist identification, radiologist preferences, and the nature and region of patient to be scanned, and generating an operator interactive display of the limited number of protocols,” claim 23);
--acquire examination information regarding the medical image diagnostic examination performed on the subject (“determines the nature and region of the scan to be performed, the physician and physician's preferences and scans, and other such information,” [0038]; “the patient doze might be optimized depending on where the radiation is coming from, e.g. from the side or other direction, according to the size of the patient, the region of the scan, clinical study, e.g. trauma, required image quality, etc.,” [0042]);
--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 (“a parameters optimization means 150 automatically optimizes various scan parameters such as the kV and mA for the protocol selected by the protocol selection means 120, saving the operator the time to make these selections depending on clinical study,” [0042]), and
--an analysis result of past examination information regarding a past medical image diagnostic examination performed in past on the subject (“The pre-fetch means 152 retrieves previous scans, which have been stored from previous exams from the same or different modality, into the workstation on which the physician examines the current scans of the patient,” [0043]; “if there are earlier related scans, e.g., whether the current examination is one of a series of follow-up examinations, and determines the parameters and protocols used in the previous scans. The previously used parameters and protocols are offered to the operator to be used in conjunction with the protocol selection and parameter optimizing steps,” [0044]; “searching the hospital archive database to determine if a current examination is a follow-up examination, determining parameters and scan protocols used in prior scans, and setting the scanner to conduct the follow-up examination using the same parameters and scan protocols,” claim 23),
--wherein the first examination protocol comprises a first imaging protocol and a first processing sequence (“A post-processing means 136 searches the post-processing memory or database 134 for the post-processing package that matches type of scan and other parameters entered by the operator into the data entry fields 122,” [0040]; FIG. 3; “the user sets up the MPR as a standard post-processing for all spine exams, Cardiac Review package as a standard post-processing for all cardiac exams,” [0039]);
--control the medical image capturing apparatus to capture a medical image of the subject according to the first imaging protocol (“The scanner home page 60 includes icons 62 and buttons 64 which are used to interactively control the scanner 24,” [0033]; “a mobile protocol means for remotely specifying and loading examination protocols into the hospital database, wherein the interface means automatically uploads the examination protocols into the scanner,” claim 18;) and
--to process the medical image according to the first processing sequence (“The post-processing package is started automatically to generate post-processed images and film as the data is acquired; e.g., the cardiac study is displayed in Cardiac Review package automatically, every spine examination is displayed automatically in real-time MPR, the Dental application is launched automatically for a dental examination, etc,” [0040]).
Gotman does not expressly disclose but Jattke teaches: determine whether to modify the first examination protocol according to whether a current imaging condition of the first imaging protocol satisfies a predetermined imaging condition (“The evaluation unit checks the scan protocol with respect the permissible SAR. If this check reveals that the permissible SAR is not adhered to, the scan protocol is modified,” [0006]; “at least one preference parameter stored in the protocol to be used directly as the basis of a solution strategy to prevent the SAR being exceeded,” [0022]; “a repetition time, a flip angle, and a slice number,” [0044]; “the permissible SAR may be stored in a database to which the evaluation unit 33 has access,” [0040]).
A POSITA before the effective filing date would have been motivated to expand Gotman’s protocol production system to include the checks and modifications of Jattke because this would streamline the imaging process by avoiding manual interventions and thereby save time (“able swiftly to proceed…In addition, apart from the time saved, the operator does not have to cope with any technical restrictions of the magnetic resonance device,” Jattke [0010]). The Examiner further notes that Gotman already optimizes the protocol’s acquisition parameters automatically and hands the protocol off to the scanner. Adding a check of those parameters against a stored limit before the scan runs is the application of a known technique to a system that is ready to receive it. This would yield the predictable result of a protocol that runs within its limits and reduces the chances of dangerous scans being performed.
Gotman does not expressly disclose but Takada 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, a modification portion of the captured medical image, a comment made during a modification, and a number of times of modifications (“the altering reason of the parameters can be received from an input device (not shown) by the protocol parameter alteration history record part 14 and can be included in the protocol alteration history data,” [0057]; “has a function for detecting the altered parameters of the protocol by reading the protocol after the update stored in the protocol data storage unit 4 and the original protocol before the update temporarily-stored in the protocol parameter storing part 15 and comparing both the protocols, and a function for generating protocol alteration history data on the basis of the detecting result,” [0055]).
A POSITA before the effective filing date would have been motivated to expand Gotman and Jattke’s protocol production and modification system to include the record of modification history as taught by Takada because this would improve traceability of the modifications and solve the problem of: “when another operator inadvertently alters the parameter without involvement of the original operator, the original operator does not have means for knowing the alteration of the parameter.” Takada [0008]. The Examiner further notes that Takada’s recordkeeping does not disturb the protocol determination and modification of Gotman and Jattke, and thus the results of the combination would have been predictable and result in an auditable record of protocol changes.
Regarding claim 2, Gotman further discloses:
--acquire a second examination protocol associated with the examination order (“With reference to FIG. 3, a protocol optimization means 70 optimizes selecting a correct exam protocol from a plurality of protocols stored in a protocols memory 72 at the hospital database 18,” [0034]; “The protocols are further mapped to a requesting physician 108 and a requested procedure 110,” [0036]), and
--create the first examination protocol by modifying the second examination protocol based on the examination information and the subject information (“a parameters optimization means 150 automatically optimizes various scan parameters such as the kV and mA for the protocol selected by the protocol selection means 120, saving the operator the time to make these selections depending on clinical study… according to the size of the patient, the region of the scan, clinical study, e.g. trauma, required image quality, etc” [0042]).
Regarding claim 3, Gotman does not expressly disclose but Takada further 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 (“the alteration information display part 24 displays the protocol alteration information including the altering date-and-time of the parameter, the sequence name, the parameter name, the data value after/before the alteration, and the identification information (e.g., user name) of the user who alters the parameter, based on the protocol alteration history data extracted by the protocol alteration information detecting part 23,” [0110]; FIG. 7; [0087]).
The motivation to combine is the same as in claim 1.
Regarding claim 6, Gotman does not expressly disclose but Takada further 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 (“The user ID input part 5 receives inputs of a user ID and a password and sends the inputted user ID and password to the user ID recognizing part 6,” [0046]; “The protocol parameter alteration information input part 10 receives an input of altering information of the parameters of the protocol displayed on the protocol parameter display part 9 and sends the inputted altering information of the parameters of the protocol to the protocol parameter record part 11,” [0052]).
The motivation to combine is the same as in claim 1.
Regarding claim 7, Gotman does not expressly disclose but Takada further teaches: wherein the one or more processors receive modification of the created first examination protocol (“The protocol parameter alteration information input part 10 receives an input of altering information of the parameters of the protocol displayed on the protocol parameter display part 9 and sends the inputted altering information of the parameters of the protocol to the protocol parameter record part 11,” [0052]).
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.
Regarding claim 12, Gotman does not expressly disclose but Jattke teaches wherein the one or more processors further control the medical image capturing apparatus to capture another medical image of the subject according to a modified first imaging protocol included in the modified first examination protocol and to process the another medical image according to a modified first processing sequence included in the modified first examination protocol (“If this check 130 reveals that the permissible SAR is not adhered to, the scan protocol is modified in act 140, e.g., at least one scan parameter of the scan protocol is amended,” [0042]; modification “may not necessarily stop scanning data being recorded,” [0052]; acquisition proceeds under the amended protocol with iterated checks in [0048]). These teachings of Jattke are viewed particularly in light of Gotman [0040].
The motivation to combine is the same as in claim 1.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gotman (US20070109294A1) in view of Jattke (US20170261569A1), Takada (US20060242095A1), and Kaufholz (US20180356482A1).
Regarding claim 4, Gotman does not expressly disclose 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 (“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 via the user interface the user may be instructed to select a proper imaging s[e]quence, e..g such as SEMAC or MAVRIC. The analysis unit may also autonomously select the proper imaging sequence and inform the user over the user in[t]erface of [the] amended MR exm[i]nation protocol,” [0015]; [0014]).
One of ordinary skill in the art would have been motivated to expand the imaging support device of Gotman, Jattke, and Takada 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]).
Response to arguments
Applicant's arguments filed 06/16/2026 have been fully considered and are discussed below.
Regarding the subject matter ineligibility rejections, Applicant argues that the claimed invention is not directed to a mental process (Step 2A Prong One). Remarks page 9. The Examiner disagrees. Creating a protocol and determining whether to modify it are steps that a technician could perform mentally. The capture and processing limitations are additional elements analyzed in Prong Two. Generally linking to a technical field like medical imaging does not integrate the abstract idea into a practical application. MPEP 2106.04(d).
Applicant argues that the claimed invention integrates any abstract idea into a practical application (Step 2A Prong Two) because automatically creating the protocol and using it to control the imaging apparatus provides a concrete technical improvement in device functioning, namely, ensuring consistent imaging behavior and reducing operator burden. Remarks pages 9-10. This is not persuasive. The improvement must by to technology rather than to the abstract idea or from using computers as tools to perform the abstract idea. In this case, the claims use generic computers with their typical functions to implement data processing that is otherwise abstract. Benefits such as improved consistency and throughput and reduced need for manual steps flow from automating mental processes, and are not technical improvements. The specification’s own stated object is the reduction of the operator’s workload in creating, changing, and performing protocols (spec [0170]-[0177]). Neither the specification nor the claims describes a mechanism by which image capture and processing or image operation is made better along the lines of MPEP 2106.04(d)(1).
Regarding the prior art rejections, Applicant’s arguments, i.e., with respect to Gopal, are moot in light of the new grounds of rejection above.
Conclusion
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.
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, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624
Prosecution Insights