DETAILED ACTION
This office action is based on the claim set submitted and filed on 04/02/2026.
Claims 1, 13, and 15 have been amended.
Claims 1-17 are currently pending and have been examined.
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 .
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.
Claim 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-12 are drawn to a method, Claims 13-14 are drawn to a system, and Claims 15-17 is drawn to an art of manufacturer, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 1-17 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for determining and managing contrast media/substance levels for medical procedures. This abstract idea could have been performed by a human actor to implement the abstract idea for steps citing a process directed to collecting a patient data to determine substance quantity to plan a medical procedure and adjusting the procedure parameters, which both the instant claims and the abstract idea are defined as Certain Methods of Organizing Human Activity (managing personal behavior and following rules or instructions).
Independent Claim 1 recites the steps of:
“a) receiving anamnesis data of an examination object, the anamnesis data received from a memory, a processor, or a user input device,
b) determining a maximum value of a substance quantity based on the anamnesis data, the maximum value determined by a look-up table in the memory or a function performed by the processor
c) receiving planning information that has information with regard to a planned sequence of a procedure, wherein the procedure comprises an administration of substance, the planning information received from the memory, the processor, or the user input device
d) acquiring, from a substance injector or from the user input device, an instantaneous value of the substance quantity,
e) determining a required value of the substance quantity for the planned procedure based on the instantaneous value and the planning information, the required value comprising a remaining part of the substance quantity to be used for a remainder of the sequence of the procedure, and
f) providing the procedure parameter based on the required value and maximum value of the substance quantity, wherein the procedure parameter has information with regard to a deviation or conformity between the required value and the maximum value of the substance quantity, the procedure parameter stored in the memory, displayed on a display, or transmitted to the processor; and
g) adapting (1) the administration of the substance as a control, instruction, and/or workflow indication, and/or adapting (2) medical imaging by a medical imaging device, the adapting occurring during the performance of the procedure based on the procedure parameter; and
h) administering, by the substance injector, the substance and/or generating, by the medical imaging device, medical imaging data based on the adapting.”
Independent Claim 13 recite similar steps as in Claim 1 to include:
a substance injector configured to inject a substance into an examination object during a procedure,
a medical imaging device configured to image the substance in the examination object during the procedure,
a memory configured to store a computer program, and
a processor configured, by the computer program,
Independent Claim 15 recites similar steps as in Claim 1 to include:
A non-transitory computer readable storage medium having a computer program that, when executed by a computer, cause administration of a substance to a patient, the computer program including acts for
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper, reciting an abstract idea for Certain Methods of Organizing Human Activity along with Mental Process, but for the recitation of generic computer components. For example, the limitations encompass a user to follow steps to determine appropriate contrast medica parameters for a patient procedure by collecting the patient pre-procedure test values such as kidney function parameters to determine maximum contrast agent to be used for the patient for planning a medical procedure, monitoring the contrast media usage and adjust parameters. These limitations encompass activity of a single person or multiple people and a computer, following rules or instructions to perform the steps of the claimed invention, e.g., determining medical procedure contrast media, while following instruction(s), which constitutes Certain Methods of Organizing Human Activity. Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, memory, non-transitory readable medium, substance injector, medical imaging device, user device” that iteratively takes input data performing known functions for determining and applying or adjusting parameters for a procedure, i.e., “adapting (1) the administration of the substance as a control, instruction, and/or workflow indication ... and/or adapting (2) medical imaging by a medical imaging device”, that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer/device as a tool to perform an abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and mere data gathering process that does not add a meaningful limitation to the above abstract idea and adding insignificant extra-solution activity to the judicial exception, (i.e. “administering, by the substance injector, the substance and/or generating, by the medical imaging device, medical imaging data based on the adapting”), see MPEP 2106.05(d)-(g). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] 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, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea, i.e., collection of data performed by a user input and providing an instruction for administration of substance by an apparatus, such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and mere data gathering process that does not add a meaningful limitation to the above abstract idea and adding insignificant extra-solution activity to the judicial exception, see MPEP 2106.05(d)-(g), and Mayo Collaborative Servs. v. Prometheus Labs. Inc. 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 mere instructions to apply an exception using a generic computer component cannot provide an 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."). The claims are not patent eligible.
Dependent Claims 2-12, 14, and 16-17 include all of the limitations of claim(s) 1, 13, and 15, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 3-9 and 16-17, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human interaction with a device following instruction that falls under “Certain Methods of Organizing Human Activity”, along with “Mental Process”, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 2, 10-11, and 14, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human interaction with a device following instruction that falls under “Certain Methods of Organizing Human Activity”, along with “Mental Process”, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “processor, contrast agent, apparatus, machine learning, medical imaging device, substance injector” that implement the identified abstract idea. These hardware components are recited at a high level of generality (i.e., general purpose computers/components implementing generic computer functions; applicant's specification makes no mention of any specific hardware) to perform the steps, e.g., “administration of the substance...” that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, 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. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sawada et al. (US 2025/0022572 A1- “Sawada”) in view of Eusemann et al. (US 2012/0236995 A1 “Eusemann”)
Regarding Claim 1 (Currently Amended), Sawada teaches a method for providing a procedure parameter, the method comprising:
a) receiving anamnesis data of an examination object, the anamnesis data received from a memory, a processor, or a user input device, Sawada discloses collecting data of a patient that includes patient information (e.g., age, gender, etc.), medical history (e.g., past treatment contrast information), disease history, lab results, renal condition, received from a control unit and database (Sawada: [Fig. 1], [0042], [0050], [0060])
b) determining a maximum value of a substance quantity based on the anamnesis data, the maximum value determined by a look-up table in the memory or a function performed by the processor Sawada discloses a contrast agent amount model is a trained model trained using multiple sets of training data recorded in association with patient information, renal condition, dynamic information, etc. for calculating the acceptable amount of contrast agent where the patient information acquired and the surgical procedure acquired are feed to a plan model to acquire a treatment plan ID based on guideline defined by a medical society and the control unit searches for the treatment plan DB using the treatment plan ID as a key to extract a record and outputs the information regarding the treatment plan and appropriate range (Sawada: [Fig. 14], [0057-0058], [0061], [0085], [0118-0122])
c) receiving planning information that has information with regard to a planned sequence of a procedure, wherein the procedure comprises an administration of substance, Sawada discloses a preoperative use amount [planning information] and five stages of administering a contrast during a patient procedure (e.g., an intravascular treatment) over the time line of the procedure comprising different time points (Sawada: [Fig. 12, 14, 15 A-B], [0067], [0072], [0088], [0115-0116], [0122])
d) acquiring, from a substance injector or from the user device, an instantaneous value of the substance quantity, Sawada discloses acquiring intraoperative values and display the relationship between the intraoperative acceptable amount of the contrast agent and the amount of the contrast agent already administered at different stages and different time points of the procedure (Sawada: [Fig. 4, 5], [0072-0074], [0089], [0123])
e) determining a required value of the substance quantity for the planned procedure based on the instantaneous value and the planning information, the required value comprising a remaining part of the substance quantity to be used for a remainder of the sequence of the procedure, Sawada discloses a control unit acquiring a treatment plan and output information regarding the plan, acquires amount of already administered agent to the patient, and acquires the treatment progress status in real-time and the information are used by the contrast agent amount model to acquire an intraoperative acceptable amount and the control unit keeps updating the information where doctor(s) may determines an acceptable amount of the contrast agent for each patient by comparing intraoperative acceptable amount to the preoperative acceptable amount during patient procedure and determining a change in value based on the output information and the amount of already administered agent to the patient and the selected treatment plan limits, and may reduce amount of contrast agent where the contrast dosage is adjusted to not exceed the standard amount of contrast agent [determining a required value of the substance] (Sawada: [Fig. 4, 5, 15A-B], [0032], [0067-0068], [0078], [0089-0090], [0122-0124], [0129-0130]), and
f) providing the procedure parameter based on the required value and maximum value of the substance quantity, wherein the procedure parameter has information with regard to a deviation or conformity between the required value and the maximum value of the substance quantity, the procedure parameter stored in the memory, displayed on a display, or transmitted to the processor Sawada discloses based on comparing intraoperative acceptable amount [maximum require value] to the preoperative acceptable amount of the selected treatment plan, the doctor may reduce amount of contrast agent used [procedure parameter] based on standard amount of contrast agent (Sawada: [Fig. 1, 4, 5, 13, 15A-B], [0080], [0090-0091], [0124], [0129-0130], [0133]),
g) adapting (1) the administration of the substance as a control, instruction, and/or workflow indication, and/or adapting (2) medical imaging by a medical imaging device, the adapting occurring during the performance of the procedure based on the procedure parameter.” Sawada discloses control unit may receive modification of the treatment plan and modifies the contrast agent administration plan on the basis of the modified treatment plan altering and controlling the treatment workflow where the control unit provide control signal to the contrast agent administration pump connected to and control an imaging device on the basis of the intraoperative acceptable amount and the administered amount of the contrast agent to reduce or increase the amount of the contrast agent to be administered on imaging procedure (Sawada: [0035], [0039-0040], [0089], [0098-0100], [0133], [claim 3, 5]),
h) administering, by the substance injector, the substance and/or generating, by the medical imaging device, medical imaging data based on the adapting Sawada discloses the contrast agent to be administered corresponding to the agent administration modified plan (Sawada: [0133]).
Sawada discloses using patient information, procedure ID and other information to search a database for treatment plan suitable for the patient that includes contrast amount information appropriate for the patient based on provided information. However, Sawada does not expressly disclose a “look-up” table.
Eusemann discloses storing a look-up table with information associating patient information of substance combinations and maximum contrast characteristics (Eusemann: [Fig. 3-4], [0013-0015]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Sawada determining contrast agent appropriate range from the database using procedure ID and incorporate a look-up table for the contrast agent, as taught by Eusemann which help in automatically identifying contrast agent parameters and X-ray tube voltage for use in imaging (Eusemann: [0013]).
Regarding Claim 2 (Previously Presented), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the substance comprises a contrast agent, and wherein the procedure comprises the medical imaging having the administration of the contrast agent (Sawada: [Fig. 1], [0039]).
Regarding Claim 3 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the procedure parameter comprises an adaptation parameter for the adaptation of the administration of substance, wherein the administration of the substance adapts based on the adaptation parameter in such a manner that the maximum value of the substance quantity is complied with Sawada discloses calculating acceptable amount of contrast media using dynamic information parameters as such based on comparing the contrast agent already administered against the intraoperative acceptable amount, the value can be adjusted (Sawada: [0058], [0061]).
Regarding Claim 4 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the determination of the required value of the substance quantity comprises an extrapolation of the instantaneous value of the substance quantity based on the planning information Sawada discloses calculating the acceptable amount by subtracting the amount of contrast already administered from the intraoperative amount for correcting the preoperative value and also determine safety value setting (Sawada: [Fig. 3, 10, 15A-B], [0056], [0092-0095]).
Regarding Claim 5 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the planned sequence of the procedure comprises multiple procedure steps, wherein the planning information has at least one planning value of the substance quantity in the procedure steps, which procedure steps comprise the administration of the substance, and wherein the determination of the required value of the substance quantity is based on the at least one planning value of the substance quantity Sawada discloses different treatment plans where each plan comprises procedure steps and which steps indicates an administration of contrast agent and value of the contrast agent amount (Sawada: [Fig. 12, 14, 15A-B], [0067-0069], [0115-0116]).
Regarding Claim 6 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 5, wherein the procedure parameter moreover comprises information with regard to a deviation or conformity between the required value and the at least one planning value of the substance quantity Sawada discloses calculating an error or variation between preoperative plan use amount of contrast agent and intraoperative use amount and confirm the amount of the contrast agent value for use and display the contrast agent administrated together with the actual value to confirm that the contrast agent is administered according to the treatment plan (Sawada: [Fig. 6 A-B, 15A-B], [0071-0073], [0090-0091], [0111], [0124], [0127-0132]).
Regarding Claim 7 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 5, wherein the extrapolation of the instantaneous value of the substance quantity is based in addition on a deviation between the instantaneous value and the at least one planning value of the substance quantity (Sawada: Fig. 3, 6 A-B, 10, 11, 15A-B], [0080], [0090-0094], [0111], [0124]).
Regarding Claim 8 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the procedure parameter has a residual value of the substance quantity, which residual value is determined by a comparison of the maximum value and the instantaneous value of the substance quantity Sawada discloses a dosage gauge indicating the remaining of contrast agent at the end of each stage recognizing how much amount in the intraoperative acceptable amount has already been administered by the dosage gauge where the intraoperative acceptable amount is the maximum amount of the contrast agent that can be administered in a state in which the risk of developing the contrast induced-nephropathy is suppressed to an appropriate range (Sawada: [Fig. 4], [0067-0068]).
Regarding Claim 9 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the anamnesis data comprises laboratory values, pre- procedural examination information, and/or information from further procedures with regard to the examination object (Sawada: [0042])
Regarding Claim 10 (Previously Presented), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the instantaneous value of the substance quantity is acquired with the aid of a user input on the user input device and/or is provided by the substance injector for the administration of the substance Sawada receiving an input via input unit and calculate the administered amount acquired from a contrast agent administration pump acquiring contrast agent already administered value at differ time intervals or points (Sawada: [0060], [0069], [0101], [0123], [0141]).
Regarding Claim 11 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the determination of the maximum value of the substance quantity and/or the determination of the required value of the substance quantity is based on machine learning Sawada discloses contrast agent amount model is a machine learning model trained using multiple sets based on patient information renal condition (Sawada: [0057]).
Regarding Claim 12 (Original), the combination of Sawada and Eusemann teaches the method as claimed in claim 1, wherein the acts d) to f) are repeatedly performed until the occurrence of a termination condition (Sawada: [Fig. 3, 14], [0063], [0125]).
Regarding Claim 13 (Currently Amended), Sawada teaches a system comprising: a substance injector configured to inject a substance into an examination object during a procedure, (Sawada: [Fig. 1], [0037], [0040])
a medical imaging device configured to image the substance in the examination object during the procedure (Sawada: [Fig. 1], [0037], [0039])
a memory configured to store a computer program, a processor configured, by the computer program, to:
the claim recites substantially similar limitations to claim 1, as such, are rejected for similar reasons as given above.
Regarding Claim 14 (Previously Presented), the combination of Sawada and Eusemann teaches the system as claimed in claim 13, wherein the processor is configured so as to provide the procedure parameter to the substance injector and/or the medical imaging device, Sawada discloses medical imaging device(s) and a contrast agent administration pump (Sawada: [0098])
wherein the substance injector is configured so as to adapt an administration of the substance in dependence upon the procedure parameter, wherein the medical imaging device is configured to adapt a recording of medical imaging data of the examination object in dependence upon the procedure parameter Sawada discloses the contrast agent administration pump receives a signal from a processor/control unit for administration of contrast agent based on calculated amount of the intraoperative and the already administered contrast to the patient in addition the medical imaging device(s) is acquiring images in real-time as such altering the treatment that is subjected to contrast imaging Sawada discloses control unit may receive modification of the treatment plan and modifies the contrast agent administration plan on the basis of the modified treatment plan where the control unit provide control signal to the contrast agent administration pump on the basis of the intraoperative acceptable amount and the administered amount of the contrast agent to reduce or increase the amount of the contrast agent to be administered on imaging procedure (Sawada: [Fig. 12], [0035], [0060], [0098-0099], [0123], [0133], [0146]).
Regarding Claim 15 (Currently Amended), Sawada teaches a non-transitory computer readable storage medium having a computer program that, when executed by a computer, cause administration of a substance to a patient (Sawada: [0140-0144]), the computer program including acts for:
the claim recites substantially similar limitations to claim 1, as such, are rejected for similar reasons as given above.
Regarding Claims 16-17 (Original), the claims recite substantially similar limitations to claims 4-5, as such, are rejected for similar reasons as given above.
Response to Amendment
Applicant's arguments filed 04/02/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 8-10.
On page 8 of the remarks, the Applicant argues “the present claims do not fall into one of the three groupings of subject matter...”, Examiner respectfully disagree. The claims, given their broadest reasonable interpretation, recite an abstract idea which have been analyzed under Step 2A, Prong One reciting a process for obtaining/collecting patient and contrast substance data, determining a required substance quantity to change or adapt the substance quantity parameters during a procedure according to output which are steps can be performed by a user interacting with a device(s) following a process/instructions for performing the abstract idea which are concepts that falls within the Certain Methods of Organizing Human Activity grouping and sub grouping sub-grouping "managing personal behavior or interactions between people".
On page 8 of the remarks, the Applicant argues “Further, even if Applicants' claims are found to fall within one of these three groupings, Applicants' claims clearly integrate the alleged judicial exception into a practical application of that exception as the claims apply, rely on, or use the judicial exception...”, Examiner respectfully disagree. The claimed invention is directed to determining a procedure parameter(s) based on the patient and contrast media information which describe steps that have been identified as an abstract idea. While the step of adapting/changing the procedure parameter such as the adjusting of administration of contrast or adjusting parameters of medical imaging device during performance of a procedure are steps identified under the judicial exception that may performed by a user interaction, see (Applicant [075], [086]), as such fall under Methods of Organizing Human Activity. Even if the adjusting of administration of contrast by an apparatus or adjusting parameters of medical imaging device during performance of a procedure, it is performed based on instructions by a processor which may be analyzed under Steps 2A P2 as a mere instruction to apply the abstract idea and mere data gathering process that does not add a meaningful limitation to the identified abstract idea, see MPEP 2106.04(d).
Applicant argued on page 8-9 or the remarks that “the claims are intimately tied to injection of a substance into an object and operation of a medical imaging device or substance injector in a new way that provides benefit to a patient... Claim 1 is directed to a practical application, as further evidenced by the various links to the hardware it takes to make the benefit happen”, Examiner respectfully disagree. The claims, under BRI, are directed to determining a contrast media/agent value required for procedure and adapt/adjust the administration of the contrast agent or device parameters. As mentioned above, the steps are citing a judicial exception while the adapting step has been analyzed under Step 2AP2 as a mere instruction to apply the abstract idea that amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and mere data gathering process that does not add a meaningful limitation to the above abstract idea and adding insignificant extra-solution activity to the judicial exception, (i.e. “administering, by the substance injector, the substance and/or generating, by the medical imaging device, medical imaging data based on the adapting”), see MPEP 2106.05(d)-(g). For example, the claim(s) and specification describe the collection of the data while the administration of substance and adjustment is realized based on a user input to be performed by an apparatus (injector), see (Applicant PGPub [0015], [0027-0029], [0050]), described at a high level of generality and as a generic computing component and as a tool for administrating substance linking the use of the judicial exception to a particular technological environment or field of use. Nowhere in the claims or specification describes the administration and adjustment of contrast, and similarly the adjustment of imaging parameters, as being controlled by the apparatus describing technical implementation such as injection speed, time between injections, etc., but using the apparatus as tool to perform the function linking the use of the judicial exception to a particular technological environment or field of use.
Moreover, while the performing is of “administering” as claimed relays upon the procedure parameter and input provided is being analyzed which are a known procedures for injection and modality adjustment and as such has been analyzed as an insignificant extra-solution activity to the judicial exception, and as a nominal or tangential addition to the abstract idea and does not affect the generation of the data object (procedure parameter).
On page 9 of the remarks, the Applicant argues “Additionally, for step 2B of the Alice/Mayo two-part test, assuming, arguendo, that the claim is directed to an abstract idea, significantly more is recited. The claim as a whole provides a specific improvement over prior methods, resulting in improved therapy planning... Claim 1as a whole integrates the alleged judicial exception into a practical application, adapting substance administration to avoid exceeding a maximum... The adaptation is performed in a way that provides a benefit to the patient by reducing risk of harm, integrating the alleged judicial exception into a practical application...”, Examiner respectfully disagree. As mentioned above, the steps recited in independent claims, when viewed as a whole, recite a judicial exception. As mentioned above, the claims under BRI recites an abstract idea for procedure parameter while citing addition element described at high level and as tool(s) to perform the abstract idea as such the thrust of Applicant's invention is to improve the abstract idea for determine contrast media parameters in an imaging procedure through leveraging computing technology, e.g., processor, imaging device, substance injector, in an understood manner. The features listed in the claims, are not considered an improvement to another technology, or technical field, or an improvement to the functioning of the computer itself rather describes an improvement to analyzing and imaging procedure contrast parameters which is solving a health facility administrative and clinical issue, e.g., “adapting substance administration to avoid exceeding a maximum that provides a benefit to the patient by reducing risk of harm”. The fact that the judicial exception, identified in the rejection above, relies upon collecting user data, analyzing the data for parameters, does not impart an improvement to any existing computer, or any other technology or technical field. At best, this gathering of data to be used by substance injector device may improve the abstract idea of improving managing substance injection. However, improving upon an abstract idea does not make the abstract idea any less abstract.
Therefore, the Applicant argument(s) is/are not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Applicant's arguments with respect to the 35 U.S.C. § 103 rejection on page 10-12.
On page 10 of the remarks, Applicant argues that “determining a required value of the substance quantity for the planned procedure based on the instantaneous value and the planning information, the required value including a remaining part of the substance quantity to be used for a remainder of the sequence of the procedure. Sawada et al. and Eusemann et al., either alone or in combination, do not teach or disclose this limitation... Assuming, arguendo, this is true, Sawada et al. disclose comparing an intraoperative acceptable amount to a preoperative acceptable amount during a patient procedure, not comparing an instantaneous amount to the planning information...”, Examiner respectfully disagree. As described in the above rejection and the response in the Non-Final OA mailed 01/02/2026, Sawada [0122-0123], [0129-0130] describes a control unit acquiring a treatment plan and output information regarding the plan, acquires amount of already administered agent to the patient, and acquires the treatment progress status to acquire an intraoperative acceptable amount in real-time and based on the output information for the amount of already administered agent to the patient and the selected treatment plan limits, the contrast dosage is adjusted to not exceed the standard amount of contrast agent as such determine an updated required value of the substance for the planned procedure.
On page 11 of the remarks, Applicant argues that “Assuming, arguendo, this is true, Sawada et al. disclose comparing an intraoperative acceptable amount to a preoperative acceptable amount during a patient procedure, not comparing an instantaneous amount to the planning information. Accordingly, Sawada et al. do not teach or disclose determining a required value of the substance quantity for the planned procedure based on the instantaneous value...”, Examiner respectfully disagree. As described above and in the above rejection, Sawada discloses a process of acquiring a treatment plan and select the treatment plan values/parameters and acquiring the intraoperative amount based on the already administered substance where the intraoperative amount is compared to the selected plan values to determine the intraoperative amount is acceptable and if the procedure is not at appropriate level of contrast adjust the amount to determine the required value(s) that align with the standard amount of contrast agent.
Therefore, Examiner find the Applicant argument is unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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