DETAILED ACTION
This office action is based on the claim set submitted and filed on 03/06/2025.
Claims 1-21 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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/02/2025, are in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-20 are drawn to a system and Claim 21 is drawn to a method, and of which are within the four statutory categories (i.e., a machine and a process). Claims 1-21 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 generating an imaging study protocol. Collecting patient data and imaging study to generate a protocol are steps that could have been performed by a human performing the steps tailoring a protocol using patient and study data but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Methods of Organizing Human Activity.
Independent Claim 1 and similarly claim 21, recites the steps of:
“one or more processors; non-transitory, computer readable media comprising instructions stored therein, wherein the instructions, when executed by the one or more processors, will cause the system to:
receive, from one or more data sources, information about a subject patient and information about a subject imaging study;
determine, based on the information about the subject patient and the information about the subject imaging study, one or more risk factors particular to the subject patient;
select two or more models, wherein the two or more models comprise at least one model of each of at least two aspects of the subject imaging study; and
apply the two or more models to generate a baseline study protocol for the subject imaging study, wherein the baseline study protocol is based upon at least the information about the subject patient and the one or more risk factors, and wherein the baseline study protocol comprises parameters of the at least two aspects of the subject imaging study”.
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human user/actor interacting with a computing system to apply a study protocol that constitute certain methods of organizing human activity, but for the recitation of generic computer components. The limitations encompass a user the ability to collect patient data, study data, to determine risk factor(s) and select and apply model(s) to generate a study protocol tailored for the patient, which are steps that could be performed by a human actor interacting with other user(s) and/or a machine as such identifying an abstract idea. This abstract idea could have been performed by a human actor but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for configuring and tailoring a study protocol for a patient. If a claim limitation(s), under its broadest reasonable interpretation, covers performance of the limitation(s) by a human actor 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 limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of methods of organizing human activity 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 “processors, non-transitory computer readable medium” that iteratively analyzes said data to determine an output performing generic computer functions for determining a care plan such 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 as a tool to perform an abstract idea, see MPEP 2106.05(f), and mere data gathering and outputting process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). 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 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). 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 2-20 include all of the limitations of claim(s) 1, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2-5, 12-16, and 19-20, 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 a performing the steps by a human actor arranging/organizing patient data, which is a certain methods of organizing human activity, 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 6-11 and 17-18, 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 a performing the steps by a human actor organizing patient data, which is a certain methods of organizing human activity, 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 “processors, user interface/graphical user interface, fluid injector, electronic medical record (EMR), electronic health record (EHR), digital pathology system (DPS). Picture archive and communication system (PACS), radiology analytics system (RAS), database. sensor” 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 of the claim(s), i.e., “display[ing]”, that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, adding insignificant extra-solution activity to the judicial exception, (e.g. “monitoring injections...), to the abstract idea and does not affect the generation of the data object and as such amounts to insignificant extra and post/extra-solution activity, and 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 and outputting process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). 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. 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 8, 12-19 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Thuering et al. (WO 2021/222771 A1- “Thuering”)
Regarding Claim 1 (Original), Thuering teaches a system for generating protocols that can be used for medical imaging studies (Thuering: [00130], comprising:
one or more processors; non-transitory, computer readable media comprising instructions stored therein, wherein the instructions, when executed by the one or more processors, will cause the system to:
receive, from one or more data sources, information about a subject patient and information about a subject imaging study Thuering discloses a management system acquiring patient measurements and information from different sources such as imaging system, patient sensor, user device auxiliary system such as EHS, EMR, PACS, RIS, etc. (Thuering: [00156-00158], [00172-00174], [00195])
determine, based on the information about the subject patient and the information about the subject imaging study, one or more risk factors particular to the subject patient Thuering discloses the management system using the information provided to predict a risk for the patient such adverse event(s) (Thuering: [00180-00182], [00199]
select two or more models, wherein the two or more models comprise at least one model of each of at least two aspects of the subject imaging study; Thuering discloses the management system may select algorithms or aspects such as fluid injection and imaging parameters adapted to a guideline, practice, preference, etc., associated with the patient adverse events in response to the selected algorithm(s) (Thuering: [00182-00183], [00195-00196], [00233])
apply the two or more models to generate a baseline study protocol for the subject imaging study, wherein the baseline study protocol is based upon at least the information about the subject patient and the one or more risk factors, and wherein the baseline study protocol comprises parameters of the at least two aspects of the subject imaging study Thuering disclose the management system may apply the algorithms to determine adjustment to injection and imaging protocol [baseline protocol] based on determined patient risk, for example, adjust parameters such as scan time and tube kVp, etc. (Thuering: [00183], [00199], [00216]
Regarding Claim 2 (Original), Thuering teaches the system according to claim 1, wherein the baseline study protocol comprises a contrast injection protocol comprising at least a total contrast dose and a maximum flow rate, and an image acquisition protocol comprising at least scan parameters, scan duration, a timing parameter for coordination with a contrast injection, and one or more image reconstruction algorithms Thuering discloses protocol includes maximum flow rate, total volume of contrast delivered, scan time, scan duration, tube kVp to allow an adequate image contrast with a reduced total iodine loading (Thuering:[00199]).
Regarding Claim 5 (Original), Thuering teaches the system according to claim 4, wherein the system is configured to allow a user to accept or change the sequence based on the user's knowledge or preference Thuering discloses protocol algorithms adjustment is presented to the user via the user interface for approval by the user (Thuering: [00177], [00183]).
Regarding Claim 8 (Original), Thuering teaches the system according to claim 1, further comprising a user interface, wherein expected parameters of the baseline study protocol are displayed for user confirmation or further adjustment discloses protocol algorithms adjustment is presented to the user via the user interface for approval by the user (Thuering: [00177], [00183]).
Regarding Claim 12 (Original), Thuering teaches the system according to claim 1, wherein at least one of the two or more models relates to at least one of a fluid injection aspect of the subject imaging study and an image creation aspect of the subject imaging study discloses algorithms to determine the injection protocol and/or the imaging protocol (Thuering: [00199], [00218]).
Regarding Claim 13 (Original), Thuering teaches the system according to claim 12, wherein at least two of the two or more models relate to at least one of the fluid injection aspect of the subject imaging study and the image creation aspect of the subject imaging study Thuering discloses the management system may plurality of algorithms or aspects such as fluid injection and imaging study aspect (Thuering: [00182-00183], [00195-00196], [00233]).
Regarding Claim 14 (Original), Thuering teaches the system according to claim 13, wherein a first of the two or more models relates to the fluid injection aspect of the subject imaging study and a second of the two or more models relates to the image creation aspect of the subject imaging study Thuering discloses the management system may plurality of algorithms or aspects such as fluid injection and imaging study aspect (Thuering: [00182-00183], [00195-00196], [00233]).
Regarding Claim 15 (Original), Thuering teaches the system according to claim 1, wherein the parameters include at least one of the following: total contrast volume, maximum flow rate, contrast delivery rate, average flow rate, contrast temperature, contrast viscosity, contrast concentration, IV access location, region of scan, potential applied to X-ray tube, maximum current applied to X-ray tube, scan speed, scan duration, radiation dose, signal / noise ratio, contrast / noise ratio, or spatial / resolution ratio Thuering discloses protocol includes maximum flow rate, total volume of contrast delivered, scan time, scan duration, tube kVp to allow an adequate image contrast with a reduced total iodine loading (Thuering:[00199]).
Regarding Claim 16 (Original), Thuering teaches the system according to claim 1, wherein the information about the subject patient comprises at least one of height, weight, body mass index, cardiac output, gender, age, ethnicity, thoracic width, thoracic circumference, medications taken, underlying medical conditions, physical ability, vital signs, pregnant / expecting to become pregnant, genetic predisposition of the subject patient, allergies, results of previous imaging exams for the subject patient, and known radiation sensitivity of the subject patient (Thuering: [0013], [0068], [00173]).
Regarding Claim 17 (Original), Thuering teaches the system according to claim 1, wherein the one or more data sources comprise at least one of an electronic medical record (EMR) system comprising an electronic medical record of the patient, an electronic health record (EHR) system, a patient procedure tracking system, a radiology analytics system (RAS), a digital pathology system (DPS), a picture archive and communication system (PACS), a hospital data system, a hospital purchase order system comprising an order for a study to be performed for the subject patient, a database comprising previous scan results for the patient, a database comprising previous scan results for one or more other patients, or a government guidelines database of acceptable radiation dose and contrast dose levels (Thuering: [00158]).
Regarding Claim 18 (Original), Thuering teaches the system according to claim 1, wherein the information about the subject imaging study comprises information about a fluid injector associated with the subject imaging study wherein the information about the fluid injector includes information from a test injection or patency check using saline, information about capabilities and tolerances of the fluid injector, and/or presence of external sensors for monitoring injections performed by the fluid injector Thuering discloses fluid injector system to test injection and sensor data during the test injection, flow and pressure using saline test injection and patient experiences an extravasation in response to a fluid injection and sensor located proximate to the injection site to monitor injection (Thuering: [00129], [00213], [00227]).
Regarding Claim 19 (Original), Thuering teaches the system according to claim 1, wherein the one or more risk factors are related to at least one of contrast dose, radiation dose, risk of extravasation, patient discomfort, risk of anaphylactic shock, and image quality (Thuering: [00181], [00205-00206]).
Regarding Claim 21 (Original), Thuering teaches a method for generating protocols that can be used for medical imaging studies, comprising:
The claim recites substantially similar limitations to claim 1, as such, are rejected for similar reasons as given above.
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Thuering et al. (WO 2021/222771 A1- “Thuering”) in view of Seah et al. (US 2025/0069240 A1– “Seah”)
Regarding Claim 3 (Original), Thuering teaches the system according to claim 1, wherein the two or more models comprise a plurality of models of one aspect of the imaging procedure, wherein the two or more models are configured to operate in parallel to transform a same or similar inputs Thuering discloses algorithms of one aspect of the imaging procedure, however does not expressly discloses the models or algorithms operate in parallel to transform same inputs.
Seah discloses deep learning applying imaging models in parallel (Seah: [0043], [0048]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Thuering incorporate a parallel processing of models for protocols, as taught by Seah which help improve the reliability of predictions models (Seah: [0017]).
Regarding Claim 4 (Original), Thuering teaches the system according to claim 1, wherein the two or more models are applied in a sequence, wherein the sequence is determined based upon at least one or more patient characteristics and a desired optimization of the one or more risk factors Thuering discloses applying algorithms using patient attributes and risk factors (: [00183], [00186-00189]). However, Thuering does not expressly discloses a sequence processing of models.
Seah discloses deep learning applying imaging models in sequence (Seah: [0043], [0048]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Thuering incorporate a sequence processing of models for protocols, as taught by Seah which help improve the reliability of predictions models (Seah: [0017]).
Claims 6-7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thuering et al. (WO 2021/222771 A1- “Thuering”) in view of Kalafut et al. (US 2015/0141813 A1– “Kalafut”)
Regarding Claim 6 (Original), Thuering teaches the system according to claim 1, wherein the instructions, when executed by the one or more processors, will additionally cause the system to: perform one or more iteration cycles through at least one of the two or more models to optimize one or more of the parameters of the baseline study protocol
Thuering discloses in response to determine adverse event through the selected algorithm(s), the system my recommend to adjust the injection and imaging protocol that may be interpreted as performing an optimization of the parameters of the study protocol (Thuering: [00199]). However, Thuering does not expressly discloses performing an iteration or repeated cycle.
Kalafut discloses modifying imaging protocol settings to optimize the parameters of the baseline protocol via performing a number of scanning at of different settings [iteration or repeated cycle] to determine best-fit parameter (Kalafut: [0122-0123], [0126]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Thuering incorporate repeating the scanning at different settings to determine optimal setting, as taught by Kalafut which help determine more optimum injection parameters for the imaging setting of interest (Kalafut: [0123]).
Regarding Claim 7 (Original), the combination of Thuering and Kalafut teaches the system according to claim 6, wherein the instructions, when executed by the one or more processors, will additionally cause the system to: present to a user in a selectable format an outcome of one or more of the iteration cycles if none of the iteration cycles provides an optimized outcome Kalafut discloses providing outcomes of the different setting at different scanning presented to the user providing among the outcomes setting that does not provide optimal outcome (Kalafut: [Table 10], [0123], [0133]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 6, and incorporated herein.
Regarding Claim 20 (Original), Thuering teaches the system according to claim 6, wherein the one or more iteration cycles optimize one or more parameters of the baseline study protocol by applying an algorithm that minimizes or maximizes selected parameter values, an algorithm for ensuring that certain parameters are within a target or threshold range, or a weighted function to parameter values of the baseline study protocol Thuering discloses the system my recommend to adjust the injection and imaging protocol adjust a maximum flow rate, adjust a maximum pressure, adjust parameter(s) that meets the threshold level of the patient wellbeing (Thuering: [00192-00193], [00199], [00244], [00249], [00260]). Kalafut discloses modifying imaging protocol settings to optimize the parameters of the baseline protocol via performing a number of scanning at of different settings [iteration or repeated cycle] to determine best-fit parameter (Kalafut: [0122-0123], [0126]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 6, and incorporated herein.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Thuering et al. (WO 2021/222771 A1- “Thuering”) in view of Bravomalo et al. (US 2012/0108914 A1– “Bravomalo”)
Regarding Claim 9 (Original), Thuering teaches the system of claim 8, wherein the user interface provides one or more selectable user interface elements which allows an operator to adjust the one or more risk factors particular to the subject patient Thuering discloses adjustment or limits are presented to a user via application on the user interface (Thuering: [00130]). However, Thuering does not expressly discloses adjusting risk factors.
Bravomalo discloses a user interface allowing adjusting risk one or more factor(s) (Bravomalo: [Fig. 20-22], [0092], [0102]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have Thuering incorporate adjusting risk factors setting on a user interface, as taught by Bravomalo which help producing a desired results and achieve target goals (Bravomalo: [0064]).
Regarding Claim 10 (Original), the combination of Thuering and Bravomalo teaches the system of claim 9, wherein at least one of the one or more selectable user interface elements is in the form of a slider bar that is adjustable by a user Bravomalo discloses that risk factor(s) may be adjusted independently by sliding the adjustment slider bars (Bravomalo: [0106]).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 9, and incorporated herein.
Regarding Claim 11 (Original), the combination of Thuering and Bravomalo teaches the system of claim 10, wherein the user interface is a graphical user interface display screen, and the one or more user interface elements can be adjusted by a touch of the user on the graphical user interface display screen (Thuering: [00125], [00165]).
Prior Art Cited but not Applied
The following document(s) were found relevant to the disclosure but not applied:
US 2023/0360777 “Scherrer” discloses input examination data sets to create model of imaging protocols.
US 2018/0239876 “Zanca” discloses providing a patient-specific contrast injection protocol.
The references are relevant since it discloses controlling contrast medica injection during patient procedure based on collected patient information.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687