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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 06/25/2026, the following occurred: Claims 1, 3, 4, 7, 10-12 and 17-20 have been amended. Claims 2, 5, 6, 8, 9 and 13-16 were canceled.
Claims 1, 3, 4, 7, 10-12 and 17-20 are currently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4, 7, 10-12 and 17-20 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, 19 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recites a system, an apparatus and a non-transitory computer readable medium for information acquisition and output on use of a contrast agent, which are within a statutory category.
Step 2A1
Regarding claims 1, 19 and 20, the limitation of (claim 1 being representative) collecting a contrast image, acquire an upper limit of a use amount of the contrast agent available for the subject during the procedure, acquire an estimation result of the contrast image for each contrast imaging condition about the subject; and output information on a use of the contrast agent based on the upper limit of the use amount of the contrast agent and the estimation result, wherein, when at least one of a number of times, a time duration, and an amount with which the contrast agent is to be injected into the subject is acquired, the information on the use of the contrast agent includes information on a change to the contrast imaging condition that enables the acquired at least one of the number of times, the time duration, and the amount to be achieved, wherein the information on the change includes a change in an injection position at which the contrast agent is injected into the subject or a change in a medical device for injecting the contrast agent into the subject and further regarding claim 19- the additional limitation of collect a contrast image of a subject as crafted, is/are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect a contract image, acquire upper limit of a use amount of the contrast agent, acquire an estimation result and output information in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “collect…acquire…acquire… and output information” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., (in claim 1) a medical information processing system, a medical image diagnostic apparatus, an injector, first processing circuitry, a medical information processing apparatus and second processing circuitry, (in claim 19) processing circuitry and an injector and (in claim 20) a non-transitory computer readable medium, a computer and an injector, the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a medical information processing system, a medical image diagnostic apparatus, an injector, first processing circuitry, a medical information processing apparatus and processing circuitry. Claim 19 recites the additional element of processing circuitry and an injector. Claim 20 recites the additional element of a non-transitory computer readable medium, a computer and an injector. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server for enabling access to medical information or generic computer components for performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 19 and 20 further recite the additional element of controlling an operation of the injector to inject a contrast agent into a blood vessel of a subject during a procedure. This additional element is recited at a high level of generality (i.e. a general means to collect collecting a contrast image) and amounts to the mere collection of data, which is a form of extra-solution activity. Applicant disclosure at page 12 states that the injection of the contrast agent may be performed manually by the user. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the medical information processing system, the medical image diagnostic apparatus, the injector, the first processing circuitry, the second processing circuitry, the medical information processing apparatus, the processing circuitry, the non-transitory computer readable medium and the computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of controlling an operation of the injector to inject a contrast agent into a blood vessel of a subject during a procedure was considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. Applicant disclosure at page 12 states that the injection of the contrast agent may be performed manually by the user. The prior art of record indicates that controlling an operation of the injector to inject a contrast agent into a blood vessel of a subject during a procedure, thereby collecting contrast image, is well-understood, routine, conventional activity (see Sasaki at [0108] and [0109] and Chino at [0026] and [0044]). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 1, 3, 4, 7, 10-12 and 17-18 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 as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 3 further merely describe(s) the information on the use of the contrast agent. Claim(s) 4, 7, 10, 11, 12 and 17 further merely describe(s) outputting/displaying information. Claim(s) 18 further merely describe(s) the analysis result. As can be seen, all of dependent claims further define/narrow the abstract idea. Claim(s) 17 also include the additional element of “an X-ray diagnostic apparatus” which is analyzed the same as the medical image diagnostic apparatus above and does not provide practical application or significantly more for the same reasons. Claims 1, 3, 4, 7, 10-12 and 17-18 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1, 19 and 20.
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.
The factual inquiries 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, 4, 7, 10-12 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki (US 2022/0031277), in view of Chino (US 2016/0051200) and in further view of Kalafut (US 2010/0114064).
REGARDING CLAIM 19
Sasaki discloses a medical image diagnostic apparatus comprising an injector and processing circuitry configured to collect a contrast image of a subject ([0060] teaches acquires the X-ray images acquired by the X-ray diagnostic apparatus (interpreted by Examiner as the medical image diagnostic apparatus), [0111] teaches acquire the blood vessel images from the X-ray diagnostic apparatus and at [0109] teaches acquiring plurality of contrast images (interpreted by Examiner as the a contrast image of a subject)), wherein the processing circuitry is configured to control an operation of the injector to inject the contrast agent into a blood vessel of the subject during the procedure, thereby collecting the contrast image ([0108] teaches a contrast medium is injected into his/her blood vessel by the X-ray diagnostic apparatus. The contrast medium may be manually injected by the user such as a doctor, or may be automatically injected by an injector disposed on the X-ray diagnostic apparatus. [0109] teaches the acquisition function acquires a plurality of contrast images by repeatedly emitting X-rays after the contrast medium is injected into the blood vessel of the subject (interpreted by examiner as wherein the processing circuitry is configured to control an operation of the injector to inject the contrast agent into a blood vessel of the subject during the procedure, thereby collecting the contrast image)), when at least one of a number of times, a time duration, and an amount with which the contrast agent is to be injected into the subject is acquired, the information on the use of the contrast agent includes information on a change to the contrast imaging condition that enables the acquired at least one of the number of times, the time duration, and the amount to be achieved, wherein the information on the change includes a change in a medical device for injecting the contrast agent into the subject (Sasaki at [0041] teaches the filter in the X-ray diaphragm changes radiation quality of the X-rays to be transmitted due to a material or a thickness thereof for the purpose of reducing an exposure dose for the subject P1 and improving image quality of the X-ray image, and reduces a soft ray component that is easily absorbed by the subject P1, or reduces a high energy component that causes deterioration in contrast of the X-ray image. The filter changes the dose and the irradiation range of the X-rays due to a material, a thickness, a position, and the like thereof, and attenuates the X-rays so that the X-rays emitted from the X-ray tube to the subject P1 are distributed in a predetermined manner (interpreted by Examiner as information on a change to the contrast imaging condition that enables the acquired at least one of the number of times, the time duration, and the amount to be achieved) Sasaki at [0064] teaches movement of device and moving forward and backward (interpreted by Examiner as a change in a medical device for injecting the contrast agent into the subject)).
Sasaki does not explicitly disclose, however Chino discloses:
acquire an estimation result of the contrast image for each contrast imaging condition about the subject (Chino at [0044] teaches acquires contrast agent injection information such as the injection amount of the contrast agent, [0063] teaches estimating the position of the blood vessel of the subject at which the contrast agent has arrived, [0064] teaches estimating the arrival position of the contrast agent based on the position, the injection time included in the contrast agent injection information, and the imaging time of the slice image included in the image management information corresponding to the slice image. Then, the output unit can display the injection position of the contrast agent and the arrival position of the contrast agent, which is estimated by the information acquisition unit, and [0089] teaches the estimation of the accuracy of the contrast of the subject and the like (all interpreted by Examiner as the estimation result of the contrast image for each contrast imaging condition about the subject)); and output information on use of the contrast agent based on the upper limit of the use amount of the contrast agent and the estimation result (Chino at [0007] teaches an output unit that outputs the contrast agent injection information associated with the slice image and [0028] teaches providing the user with useful information for the diagnosis of a patient (interpreted by Examiner as the output information on use of the contrast agent based on the upper limit of the use amount of the contrast agent, of Kalafut below, and the estimation result)), wherein the information on the change includes a change in an injection position at which the contrast agent is injected into the subject (Chino at [0064] teaches outputting the position calculated by the information acquisition unit so as to be superimposed on the slice image. [0072] teaches the system can provide the user with information that is helpful in understanding the status of the contrast that changes with a specific position (interpreted by examiner as wherein the information on the change includes a change in an injection position))
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki to incorporate the medical imaging system and contrast agent as taught by Chino, with the motivation of providing a medical imaging program system capable of easily checking the imaging timing of an image and the injection timing of a contrast agent. (Chino at [0006]).
Sasaki and Chino does not explicitly disclose, however Kalafut discloses:
acquire, for a contrast agent used for collection of the contrast image, an upper limit of the use amount of the contrast agent available for the subject during a procedure (Kalafut at [0102] teaches taking measures to reduce the amount of contrast agent used during the imaging procedure and [0072] teaches patient past history of contrast usage and considers height, weight, body surface area (BSA), creatinine level, body mass index (BMI) etc. [0076] teaches for example, if contrast dose and history exceeds some set amount, the contrast delivery system may provide the operator with an alert or automatically adjust the contrast injection parameters such as total contrast dose or dilution (interpreted by examiner as acquire, for a contrast agent used for collection of the contrast image, an upper limit of the use amount of the contrast agent available for the subject during a procedure));
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki and the medical imaging system and contrast agent of Chino to incorporate the upper limit of the use amount of the contrast agent available for the subject during a procedure as taught by Kalafut, with the motivation of reducing the potential risk of Contrast induced nephropathy (CIN). (Kalafut at [0076]).
REGARDING CLAIMS 1 and 20
Claims 1 and 20 are analogous to Claim 19 thus Claims 1 and 20 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 19.
REGARDING CLAIM 3
Sasaki, Chino and Kalafut disclose the limitation of claim 1.
Sasaki and Kalafut do not explicitly disclose wherein the information on use of the contrast agent includes a use plan of the contrast agent based on at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject, however Chino further discloses:
The medical information processing system according to claim 1, wherein the information on use of the contrast agent includes a use plan of the contrast agent based on at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject (Chino at [0044] teaches the contrast agent injection unit injects a contrast agent into the subject. When injecting a contrast agent into the subject, the contrast agent injection unit acquires contrast agent injection information (interpreted by Examiner as the use plan of the contrast agent). The contrast agent injection information is information indicating the injection time of the contrast agent, the injection duration of the contrast agent, the injection pressure of the contrast agent, the injection rate of the contrast agent, the injection amount of the contrast agent, the amount of iodine, and/or the type of the contrast agent (interpreted by Examiner as based on at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject). The contrast agent injection unit supplies the contrast agent injection information to the injection information acquisition unit).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki and the use of contrast agent available for the subject during a procedure of Kalafut to incorporate the information on use of the contrast agent includes a use plan of the contrast agent based on at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject as taught by Chino, with the motivation of providing a medical imaging program system capable of easily checking the imaging timing of an image and the injection timing of a contrast agent. (Chino at [0006]).
REGARDING CLAIM 4
Sasaki, Chino and Kalafut disclose the limitation of claim 1.
Sasaki and Kalafut do not explicitly disclose wherein the second processing circuitry outputs at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject together with at least one of an injection position at which the contrast agent is injected into the subject, a cumulative amount of the contrast agent used for the subject during the procedure, and the total amount, however Chino further discloses:
The medical information processing system according to claim 1, wherein the second processing circuitry outputs at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject together with at least one of an injection position at which the contrast agent is injected into the subject, a cumulative amount of the contrast agent used for the subject during the procedure, and the total amount (Chino at [0064] teaches the output unit can display the injection position of the contrast agent (interpreted by Examiner as wherein the processing circuitry outputs an injection position at which the contrast agent is injected into the subject) Moreover, [0075] teaches displaying the amount of contrast agent at the imaging time of the image).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki and the use of contrast agent available for the subject during a procedure of Kalafut to incorporate outputting at least one of the number of times, the time during which, and the amount with which the contrast agent is able to be injected into the subject together with at least one of an injection position at which the contrast agent is injected into the subject, a cumulative amount of the contrast agent used for the subject during the procedure, and the total amount as taught by Chino, with the motivation of providing a medical imaging program system capable of easily checking the imaging timing of an image and the injection timing of a contrast agent. (Chino at [0006]).
REGARDING CLAIM 7
Sasaki, Chino and Kalafut disclose the limitation of claims 1 and 5.
Sasaki further discloses:
The medical information processing system according to claim 5, wherein the second processing circuitry displays, as the information on change, an injection position before change and at least one injection position after change on a contrast image in which a blood vessel of the subject is contrasted and further displays an amount of the contrast agent to be reduced by changing the injection position in association with the at least one injection position after change (Sasaki at [0108] teaches previously acquiring the blood vessel image acquired from the subject P1. By way of example, the blood vessel image can be acquired by imaging the subject P1 in a state in which a contrast medium is injected into his/her blood vessel by the X-ray diagnostic apparatus. [0041] teaches the filter in the X-ray diaphragm changes radiation quality of the X-rays to be transmitted due to a material or a thickness thereof for the purpose of reducing an exposure dose for the subject P1 and improving image quality of the X-ray image, and reduces a soft ray component that is easily absorbed by the subject P1, or reduces a high energy component that causes deterioration in contrast of the X-ray image. [0042] teaches adjusting a position of the filter to control dose distribution of the X-rays emitted to the subject P1 and [0114] teaches improving accuracy in synthesis of the X-ray image I13t and the blood vessel image I14t by also applying the rotation/translation matrix W to the blood vessel image I14t to change the position and orientation thereof similarly to the X-ray image I13t (interpreted by Examiner as displays, as the information on change, an injection position before change and at least one injection position after change on a contrast image in which a blood vessel of the subject is contrasted and further displays an amount of the contrast agent to be reduced by changing the injection position in association with the at least one injection position after change)).
REGARDING CLAIM 10
Sasaki, Chino and Kalafut disclose the limitation of claims 1 and 5.
Sasaki and Kalafut do not explicitly disclose wherein the processing circuitry outputs the information on change together with an amount of the contrast agent to be reduced by changing the contrast imaging condition, however Chino further discloses:
The medical information processing system according to claim 5, wherein the second processing circuitry outputs the information on change together with an amount of the contrast agent to be reduced by changing the contrast imaging condition (Chino at [0048] teaches a graph showing change in the injection amount of the contrast agent and [0061]teaches outputting image captured and outputting contrast agent injection information (interpreted by Examiner as means to output the information on change together with an amount of the contrast agent to be reduced by changing the contrast imaging condition)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki and the use of contrast agent available for the subject during a procedure of Kalafut to incorporate outputting the information on change together with an amount of the contrast agent to be reduced by changing the contrast imaging condition as taught by Chino, with the motivation of providing a medical imaging program system capable of easily checking the imaging timing of an image and the injection timing of a contrast agent. (Chino at [0006]).
REGARDING CLAIM 11
Sasaki, Chino and Kalafut disclose the limitation of claims 1 and 5.
Sasaki further discloses:
The medical information processing system according to claim 5, wherein the second processing circuitry outputs the information on change together with information corresponding to each contrast imaging condition before and after change, the information being at least either at least one of a number of times, a time during which, and an amount with which the contrast agent is able to be injected into the subject or an injection position at which the contrast agent is injected into the subject (Sasaki at [0108] teaches previously acquiring the blood vessel image acquired from the subject P1. By way of example, the blood vessel image can be acquired by imaging the subject P1 in a state in which a contrast medium is injected into his/her blood vessel by the X-ray diagnostic apparatus. [0041] teaches the filter in the X-ray diaphragm changes radiation quality of the X-rays to be transmitted due to a material or a thickness thereof for the purpose of reducing an exposure dose for the subject P1 and improving image quality of the X-ray image, and reduces a soft ray component that is easily absorbed by the subject P1, or reduces a high energy component that causes deterioration in contrast of the X-ray image. [0042] teaches adjusting a position of the filter to control dose distribution of the X-rays emitted to the subject P1 and [0114] teaches improving accuracy in synthesis of the X-ray image I13t and the blood vessel image I14t by also applying the rotation/translation matrix W to the blood vessel image I14t to change the position and orientation thereof similarly to the X-ray image I13t (interpreted by Examiner as displays, as the information on change, an injection position before change and at least one injection position after change on a contrast image in which a blood vessel of the subject is contrasted and further displays an amount of the contrast agent to be reduced by changing the injection position in association with the at least one injection position after change)).
REGARDING CLAIM 12
Sasaki, Chino and Kalafut disclose the limitation of claims 1 and 5.
Sasaki and Kalafut do not explicitly disclose wherein the processing circuitry outputs the information on change together with at least either a cumulative amount of the contrast agent used for the subject during the procedure or the total amount, however Chino further discloses:
The medical information processing system according to claim 5, wherein the second processing circuitry outputs the information on change together with at least either a cumulative amount of the contrast agent used for the subject during the procedure or the total amount (Chino at [0007] teaches an output unit that outputs the contrast agent injection information associated with the slice image and [0028] teaches providing the user with useful information for the diagnosis of a patient (interpreted by Examiner as means to output the information on change together with at least either a cumulative amount of the contrast agent used for the subject during the procedure or the total amount)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki and the use of contrast agent available for the subject during a procedure of Kalafut to incorporate outputting the information on change together with at least either a cumulative amount of the contrast agent used for the subject during the procedure or the total amount as taught by Chino, with the motivation of providing a medical imaging program system capable of easily checking the imaging timing of an image and the injection timing of a contrast agent. (Chino at [0006]).
REGARDING CLAIM 18
Sasaki, Chino and Kalafut disclose the limitation of claim 1.
Sasaki and Kalafut do not explicitly disclose wherein the processing circuitry acquires the analysis result based on luminal structure information of a blood vessel of the subject, a position of a region of interest, and an injection position at which the contrast agent is injected into the subject, however Chino further discloses:
The medical information processing system according to claim 1, wherein the second processing circuitry acquires the analysis result based on luminal structure information of a blood vessel of the subject, a position of a region of interest, and an injection position at which the contrast agent is injected into the subject (Chino at [0064] teaches the information acquisition unit segments the blood vessels, and acquires information indicating the position of the subject, at which the contrast agent has been injected, based on the image management information and the contrast agent injection information. Then, the information acquisition unit estimates the arrival position of the contrast agent based on the position, the injection time included in the contrast agent injection information, and the imaging time of the slice image included in the image management information corresponding to the slice image. Then, the output unit can display the injection position of the contrast agent and the arrival position of the contrast agent (interpreted by Examiner as acquires the analysis result based on luminal structure information of a blood vessel of the subject, a position of a region of interest, and an injection position at which the contrast agent is injected into the subject)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical image processing apparatus of Sasaki and the use of contrast agent available for the subject during a procedure of Kalafut to incorporate acquiring the analysis result based on luminal structure information of a blood vessel of the subject, a position of a region of interest, and an injection position at which the contrast agent is injected into the subject as taught by Chino, with the motivation of providing a medical imaging program system capable of easily checking the imaging timing of an image and the injection timing of a contrast agent. (Chino at [0006]).
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1, 3, 4, 7, 10-12 and 17-20, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
The pending claims are not directed to a certain method of organizing human activity. Rather, the claims are directed to a specific technological implementation for improving contrast-enhanced medical imaging procedures… The amended claims therefore specifically define a data conversion process that generates the information on the use of the contrast agent from particular types of medical imaging data. Further, the information on the use of the contrast agent is specifically defined… Thus, the claimed data conversion process is not a generic information processing operation, but instead is a specifically described technological implementation that generates information for modifying physical parameters of a contrast-enhanced imaging procedure. The data used in the claimed conversion process is also specifically defined… As described in the Specification, the processing circuitry estimates a contrast image for each contrast imaging condition and determines whether a contrast imaging condition is appropriate based on the estimated contrast image. For example, when the contrast of an estimated contrast image is insufficient, the corresponding contrast imaging condition is inappropriate. The processing circuitry can therefore output information on the use of the contrast agent while confirming that the contrast imaging conditions are appropriate. A user may then adjust the injection position or the medical device to achieve a desired value, such as a desired number of times, time duration, or amount with which the contrast agent is injected into the subject, while maintaining appropriate contrast imaging conditions.
Regarding 1, The Examiner respectfully disagrees. The claims recite an abstract idea as they encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect a contract image, acquire upper limit of a use amount of the contrast agent, acquire an estimation result and output information in the manner described in the identified abstract idea, supra. Specifically defining data is of no significance when it comes to removing idea from being abstract. The claims merely output data on the use of the contrast agent, and that is an abstract idea. The claims do not provide a technical improvement as generating information for modifying physical parameters of a contrast-enhanced imaging procedure is an abstract idea and does not improve upon the functioning of a computer nor provide improvements in a technical field. The user uses the information that is being outputted to manually adjust the injection position or the medical device, and that aids a user in conducting a procedure. Moreover, the Specification provides support for improvements to the image quality, improvements to the contrast in the contrast image and improvements in prognosis, none of which are technical improvements.
Even assuming, arguendo, that the claims recite an abstract idea, the claims integrate any such alleged abstract idea into a practical application. Specifically, the claims recite controlling operation of an injector to inject a contrast agent into a blood vessel of a subject during a procedure and outputting information specifying changes to physical contrast imaging conditions, including changes in an injection position and/or changes in a medical device used to inject the contrast agent. As described in the Specification, changing the injection position and/or the medical device enables clinically useful contrast images to be obtained while reducing contrast agent consumption and avoiding excessive administration of the contrast agent. Accordingly, the claims improve the operation of contrast-enhanced medical imaging procedures and impose meaningful limits on any alleged abstract idea. For at least these reasons, Applicant respectfully submits that the pending claims integrate any alleged abstract idea into a practical application and are patent eligible under Step 2A. Further, for at least the same reasons, the ordered combination of the claimed elements amounts to significantly more than any alleged abstract idea.
Regarding 2, The Examiner respectfully disagrees. The claims do not integrate the abstract idea into a practical application, nor do the claims control the medical device/an injector to inject a contrast agent into a blood vessel. The claims merely output data on the use of the contrast agent. Applicants disclosure at page 12 states that the injection of the contrast agent may be performed manually by the user and as applicant mentions above “A user may then adjust the injection position or the medical device to achieve a desired value, such as a desired number of times, time duration, or amount with which the contrast agent is injected into the subject”, and this cannot provide a practical application, as this is done manually by following instructions. Moreover, reducing contrast agent consumption and avoiding excessive administration of the contrast agent may improve the operation of contrast-enhanced medical imaging procedures, but this is not a technical improvement and cannot integrate the abstract idea into a practical application.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1, 3, 4, 7, 10-12 and 17-20, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
… Sasaki does not disclose or suggest outputting information on a change to a contrast imaging condition under which a desired value can be achieved, as recited… Moreover, Sasaki does not disclose or suggest information on a change including a change in an injection position at which the contrast agent is injected into the subject or a change in a medical device for injecting the contrast agent into the subject. Accordingly, Applicant respectfully submits that Sasaki fails to disclose or suggest at least the aforementioned features recited in amended independent claims 1, 19 and 20… Chino, however, likewise fails to disclose or suggest outputting information on a change to a contrast imaging condition under which a desired value can be achieved… Nor does Kalafut disclose outputting information on a change to a contrast imaging condition under which a desired value of at least one of a number of times, a time during which, and an amount with which the contrast agent is injected into the subject can be achieved. Accordingly, Applicant respectfully submits that Kalafut fails to disclose or suggest at least the aforementioned features recited in amended independent claims 1, 19 and 20.
Regarding 1, The Examiner respectfully submits that Sasaki teaches the information on the use of the contrast agent includes information on a change to the contrast imaging condition that enables the acquired at least one of the number of times, the time duration, and the amount to be achieved, see Sasaki at [0041] that teaches the filter in the X-ray diaphragm changes radiation quality of the X-rays to be transmitted due to a material or a thickness thereof for the purpose of reducing an exposure dose for the subject P1 and improving image quality of the X-ray image, and reduces a soft ray component that is easily absorbed by the subject P1, or reduces a high energy component that causes deterioration in contrast of the X-ray image. The filter changes the dose and the irradiation range of the X-rays due to a material, a thickness, a position, and the like thereof, and attenuates the X-rays so that the X-rays emitted from the X-ray tube to the subject P1 are distributed in a predetermined manner, which is interpreted by Examiner as information on a change to the contrast imaging condition that enables the acquired at least one of the number of times, the time duration, and the amount to be achieved. Moreover, Chino teaches outputting information on use of the contrast agent, see Chino at [0007] that teaches an output unit that outputs the contrast agent injection information associated with the slice image and [0028] teaches providing the user with useful information for the diagnosis of a patient. Chino also teaches wherein the information on the change includes a change in an injection position at which the contrast agent is injected into the subject, see Chino at [0064] that teaches outputting the position calculated by the information acquisition unit so as to be superimposed on the slice image, [0072] that teaches the system can provide the user with information that is helpful in understanding the status of the contrast that changes with a specific position, which Examiner interprets as wherein the information on the change includes a change in an injection position.
Given the broadest reasonable interpretation, the cited references in combination teach the claimed feature.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Given the broadest reasonable interpretation, the cited references teach the argued feature(s)
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Nachaliel (US 2007/0258896) discloses contrast agent in medical imaging.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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