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
In the preliminary amendments filed on 21 March 2024, the following has occurred: claims 1-16 have been amended; claims 17-18 are newly added.
Now claims 1-18 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP23315102.6, filed on 25 April 2023.
Information Disclosure Statement
The Information Disclosure Statement(s) filed on 21 March 2024 and 26 June 2025, have been considered by the Examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a processing unit in claim 1
at least one entity in claims 2-14
The processing unit is being read from paragraph [0079], as a generic off-the-shelf processor (i.e., a CPU) and the entity is being read from paragraphs [0028]-[0030], as a generic off-the-shelf algorithm (i.e., software).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the medical device" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the second entity" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 16 is rejected under 35 U.S.C. 101 because, the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claim 16 recites the limitation “A computer program comprising instructions which, when executed by a computer”, as drafted, is a computer program (i.e., software) that, under its broadest reasonable interpretation, amounts to no more than an arrangement of signals (i.e., data), signal per se. The claim does not recite any structure that have a physical or tangible form to show that the computer program is anything other than a propagation of electrical signals (i.e., a product that does not have a physical or tangible form). As such, claim 16, does not fall within one of the four statutory categories of invention (i.e., a method, a machine, manufacture, or composition of matter). See MPEP 2106.03.
The Examiner suggests changing, “A computer program comprising instructions which, when executed by a computer” to -- A computer program product comprising instructions stored on a non-transitory computer readable medium (CRM) which, when executed by a computer--, the Examiner notes this will overcome the non-statutory rejection as the broadest reasonable interpretation of computer program product would be a system. Further noting this will not raise written description issues.
For Examination purposes claim 16, will be treated as a system for further 101 analyses below.
Claims 1-18 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 and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite system and computer implemented method for determining a dynamic examination process to organize the interaction between various human users and generic computer components. The limitations of:
Claim 1, which is representative of claims 15 and 16
determining a dynamic examination process, comprising […]: determine a dynamic examination process based on a pathology hypothesis using a predefined algorithm, the dynamic examination process being associated with [… collecting …] medical data, wherein the dynamic examination process is adaptable during an execution thereof based on the obtained medical data.
, as drafted, is a system, which under its broadest reasonable interpretation, covers a method of
organizing human activity (i.e., managing personal behavior including following rules or
instructions) via organization of human activity with generic computer components. That is, by human users interacting with a processing unit (claim 1), a computer (claims 15 and 16), the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. For example, by using a processing unit (claim 1), a computer (claims 15 and 16), the claim encompasses collection of data, determination of a hypothesis via organization of the collected data and providing an output to a human user to adjust a human user process. 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 “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the
claim recites the additional elements of a processing unit (claim 1), a computer (claims 15 and 16) which implements the abstract idea. The processing unit (claim 1), a computer (claims 15 and 16) are recited at a high-level of generality (i.e., a general-purpose computers/ computer components implementing generic computer functions; see Applicant’s Specification paragraph [0079]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does 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.
The claim recites the additional elements of “obtaining medical data…”. The “obtaining medical data…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does 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 elements of a processing unit (claim 1), a computer (claims 15 and 16) to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “obtaining medical data…” were considered generally linking the abstract idea to particular technological environment and/or extra-solution activity. The “obtaining medical data…” steps have been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.05(d)(II)(i) “Receiving or transmitting data over a network” is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 2-14 and 16-18 are similarly rejected because either further define 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.
Claims 2-4, 13 are directed toward using an entity (i.e., software), however does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claims 5, 8, 11 and 18 recites the additional element of “at least one medical device comprises an ultrasound system”, however these are recited at a high level of generality (i.e., generic off- the shelf medical devices) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements “at least one medical device comprises an ultrasound system” were considered generally linking the abstract idea to particular technological environment. The “at least one medical device comprises an ultrasound system” has been re- evaluated under the “significantly more” analysis and determined to amount to be well- understood, routine, and conventional elements/functions. As described in Igler (20180089380): paragraph [0029]; Knoplioch (20210005307): paragraph [0048]; Morgas (20200121951): paragraph [0003]; use of a medical device to capture data is well-understood, routine, and conventional elements. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 6-7 and 12 further describe the dynamic adaptation, however does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claims 9-10 and 17 further describe communication of data, however digital communication of data was already considered above and is incorporated herein.
Claim 14 recites the additional element of “an artificial intelligence (AI) model”, however these are recited at a high level of generality (i.e., generic off- the shelf models) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements “an artificial intelligence (AI) model” were considered generally linking the abstract idea to particular technological environment. The “an artificial intelligence (AI) model” has been re- evaluated under the “significantly more” analysis and determined to amount to be well- understood, routine, and conventional elements/functions. As described in Arroyo Camejo (20220068472): paragraph [0107]; Knoplioch (20210005307): paragraph [0026]; Morgas (20200121951): paragraph [0097]; use of an AI model is well-understood, routine, and conventional elements. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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) 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Pub. No. 2022/0068472 (hereafter “Arroyo Camejo”; already of record in the IDS).
Regarding (Currently Amended) claim 1, Arroyo Camejo teaches a system for determining a dynamic examination process (Arroyo Camejo: paragraphs [0014]-[0018], “systems, devices, and methods to facilitate an improvement in controlling magnetic resonance imaging systems… Automation of protocol adjustments during the scan workflow… Smart, live adaptations of the preconfigured scan program (i.e., adaptations of scan parameters, addition or removal of scan protocols to the scan workflow) considering the individual patient characteristics”), comprising
a processing unit (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0085], “units or modules of the system or the control device mentioned above can be completely or partially realized as software modules running on a processor of a system or a control device”) configured to:
determine a dynamic examination process based on a pathology hypothesis using a predefined algorithm (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0012], “selection of the appropriate scan program based on patient indication or/and suspected pathologies”, paragraphs [0069]-[0072], “Based on these results, patient-specific adaptions of the scan workflow may be generated by the scan workflow guidance system with preconfigured scan protocols and scan programs. This means, that protocols of the scan workflow yet not applied to the MRI system are adapted based on the results”, paragraph [0123], “an image analysis module (especially each comprised of, e.g., one or a combination of several deep convolutional neural nets or machine learning based pattern detection algorithms) able to detect one or a specific combination of relevant features from the input MR image”, paragraphs [0215]-[0219], “image analysis modules 28 are special finding detectors F, that find patient-specific circumstances that require a scan workflow adaptation… different classes of, e.g., radiological findings, pathologies”. Also see, paragraphs [0005], [0090], [0107, [0125]-[0129]),
the dynamic examination process being associated with obtaining medical data (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0002], “Magnetic resonance imaging is one of the most powerful, diagnostic tools available. It allows for imaging of biological structures and tissues in a non-invasive fashion”, paragraph [0059], “At examination time, the automated or user-induced selection of a preconfigured scan program (or a number of scan protocols) based on, e.g., the patient's scan indication, the scanner performing a number of scan steps (at least one) generating a number of images or physiological data. These scans are performed according to said selection of the initial protocols of the scan program”),
wherein the dynamic examination process is adaptable during an execution thereof based on the obtained medical data (Arroyo Camejo: paragraphs [0014]-[0018], “Automation of protocol adjustments during the scan workflow… Smart, live adaptations of the preconfigured scan program (i.e., adaptations of scan parameters, addition or removal of scan protocols to the scan workflow) considering the individual patient characteristics”, paragraph [0082], “use a preconfigured scan protocol and/or scan program with the capability to perform patient specific adaptions, wherein the scan protocols and/or scan programs, which are selected by a master user, are getting adapted based on acquired data, e.g. image data, and/or (master) user selected presetting”).
Regarding (Currently amended) claim 2, Arroyo Camejo teaches the limitations of claim 1, and further teaches wherein the dynamic examination process defines at least one entity configured to one of execute and control a task (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0107], “A smart module typically comprises a scan protocol and additional components, preferably an auto planner and/or an automatic quality assessment module… performed with the help of intelligent algorithms (e.g., machine learning, deep-learning or classical, rule-based algorithms)”, paragraph [0123], “an image analysis module (especially each comprised of, e.g., one or a combination of several deep convolutional neural nets or machine learning based pattern detection algorithms) able to detect one or a specific combination of relevant features from the input MR image”, paragraph [0207], “In a smart module S toolbox T a user or the scan workflow guidance system 22 may find already configured models”).
Regarding (Currently amended) claim 3, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein the at least one entity is adaptable during execution of the dynamic examination process based on the obtained medical data (Arroyo Camejo: paragraph [0018], “Smart, live adaptations of the preconfigured scan program (i.e., adaptations of scan parameters, addition or removal of scan protocols to the scan workflow) considering the individual patient characteristics”, paragraph [0025], “patient specific adaptions (i.e. to suggest or execute patient specific adaptions), preferably wherein the scan protocols and/or scan programs, which are selected by a user, are getting adapted based on image data and/or user selected presetting”, paragraph [0072], “that protocols of the scan workflow yet not applied to the MRI system are adapted based on the results”, paragraph [0085], “applications already installed on an existing system can be updated”, paragraph [0089], “Based on the findings, the scan workflow may be adapted and/or extended by the scan workflow guidance system. This way, the workflow that initially starts in a standardized way ultimately becomes disease as well as patient specific”, paragraph [0109], “a scan program with a set of smart modules”).
Regarding (Currently amended) claim 4, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein the task and/or the entity is associated with at least one of: biomarkers, computational tools, analyzing and/or processing components, measurement tasks, and/or measurement values, acquisition modes, probe types, machine parameters, scan parameters, acquisition process for obtaining medical data, processing tools, reporting tools, and selecting medical data (Arroyo Camejo: paragraphs [0002]-[0004], “diagnostic tools… different scanner types”, paragraph [0042], “protocols could be a T2 FLAIR axial measurement and a DWI axial measurement with a suitable parameter set”, paragraph [0048], “clinical indication(s) for the MRI exam, suspected findings or pathologies to be fed into the scan-user-interface automatically”, paragraphs [0083]-[0085], “controlling components of a magnetic resonance imaging system, e.g., a sequence control unit for measurement sequence control, a memory, a radio-frequency transmission device that generates, amplifies, and transmits RF pulses, a gradient system interface, a radio-frequency reception device to acquire magnetic resonance signals, and/or a reconstruction unit to reconstruct magnetic resonance image data”, paragraph [0107], “The expression “Smart” refers to their property containing analytical tools from a “Smart Component Toolbox””, paragraph [0135]-[0137], “task to curate the set of scan workflow adaptation”, paragraph [0141], “an analysis tool providing insights into protocol usage”, paragraphs [0169]-[0172], “switched into different operating modes… measurement sequence control”).
Regarding (Currently amended) claim 5, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein the dynamic examination process defines at least one predefined acquisition mode of the medical device, the acquisition mode being associated with a group of entities (Arroyo Camejo: paragraph [0025], “a scan workflow guidance system which is configured to use a preconfigured scan protocol and/or scan program by patient specific adaptions (i.e. to suggest or execute patient specific adaptions), preferably wherein the scan protocols and/or scan programs, which are selected by a user, are getting adapted based on image data and/or user selected presetting”, paragraph [0037], “an MRI system”, paragraph [0042], “The protocols of the initial scan steps may follow a preset standard or be configurable (within certain boundaries) by the MR scanner user. E.g., for a standard neurological MRI examination, the initial scan protocols could be”, paragraph [0107], “A smart module typically comprises a scan protocol and additional components, preferably an auto planner and/or an automatic quality assessment module… performed with the help of intelligent algorithms (e.g., machine learning, deep-learning or classical, rule-based algorithms)”. Also see, paragraphs [0123], [0207]).
Regarding (Currently amended) claim 6, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein adapting the dynamic examination process comprises at least one of: based on the medical data obtained by a first entity re-executing the first entity or first group of entities using at least one adapted machine parameter, and based on the medical data obtained by the first entity or first group of entities one of selecting and adapting a second entity or a second group of entities (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0020], “recommending protocol adaptations and the addition/removal of scan steps to the MR user as required… executing those scan workflow adaptations autonomously”, paragraph [0025], “execute patient specific adaptions), preferably wherein the scan protocols and/or scan programs, which are selected by a user, are getting adapted based on image data and/or user selected presetting”, paragraphs [0067]-[0068], “performing a number of n≥10 scans according to the adapted scan workflow… depending on the initially selected scan program and effective scan workflow adaptations, additional variants of steps 3)-6) could be executed by the scanner”, paragraph [0072], “protocols of the scan workflow yet not applied to the MRI system are adapted based on the results. Alternatively or additionally, new predefined protocols could be automatically fetched from the database of the protocol management system and added to the scan workflow”, paragraph [0077], “the workflow describes the order of protocols (e.g., first T1, then T2, then DWI), while the scan queue also stores the necessary protocol parameters for each specific protocol, so that the scanner can execute it as soon as it hits this step”, paragraph [0095], “imaging parameters of the sequence are adapted”, paragraph [0151], “the decisions for modification can happen after each protocol, so there are not only two parts, but in principle there could be 1 to m-parts of the scan queue”. The Examiner notes a parameter can be adapted and the workflow continue to be executed as well as new entities could be selected and adapted into the workflow, which teaches what is required of the claim under the broadest reasonable interpretation).
Regarding (Currently amended) claim 7, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein adapting the second entity comprises at least one of: removing the second entity from the dynamic examination process, adding the second entity to the dynamic examination process, and adapting at least one parameter of the second entity (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0020], “recommending protocol adaptations and the addition/removal of scan steps to the MR user as required… executing those scan workflow adaptations autonomously”, paragraph [0072], “protocols of the scan workflow yet not applied to the MRI system are adapted based on the results. Alternatively or additionally, new predefined protocols could be automatically fetched from the database of the protocol management system and added to the scan workflow”, paragraph [0095], “imaging parameters of the sequence are adapted”, claim 8, “adding a set of finding detectors after the n-th initial scan protocol has finished, the finding detectors designed to check the acquired image for the appearance of specific features and adding, replacing, or removing preconfigured scan steps to/in/from a scan queue based on the type of identified findings”).
Regarding (Currently amended) claim 8, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein the at least one entity is executable using a medical device (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0001], “a system and a method for standardized MRI examinations with patient-centric scan workflow adaptations, especially for controlling a magnetic resonance imaging (“MRI”) system”, paragraph [0037], “an MRI system”, paragraph [0107], “smart modules can be preconfigured scan protocols, automated planning and quality assurance steps”, claim 12. “A magnetic imaging system comprising a system for standardized MRI examinations with patient-centric scan workflow adaptations, to perform a method according to claim 7”).
Regarding (Currently amended) claim 9, Arroyo Camejo teaches the limitations of claim 2, and further teaches wherein the dynamic examination process defines a group of interconnected entities wherein at least two entities of the group of interconnected entities depend on each other (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0024], “the workflow steps comprising a number of protocols”, paragraphs [0105]-[0107], “a toolbox of fundamental building blocks (e.g., sequences, reconstructions, and appropriate parameter sets). The healthcare provider may use the scan protocol & program editor to preconfigure their own standardized smart modules comprised of preconfigured scan protocols, automated planning, and quality assurance steps… A smart module typically comprises a scan protocol and additional components, preferably an auto planner and/or an automatic quality assessment module… performed with the help of intelligent algorithms (e.g., machine learning, deep-learning or classical, rule-based algorithms)”, paragraph [0123], “an image analysis module (especially each comprised of, e.g., one or a combination of several deep convolutional neural nets or machine learning based pattern detection algorithms) able to detect one or a specific combination of relevant features from the input MR image”, paragraphs [0207]-[0210], “In a smart module S toolbox T a user or the scan workflow guidance system 22 may find already configured models… a set of finding detectors F can be added after the n-th initial scan protocol P has finished. The finding detectors F will check the acquired image for the appearance of specific features (i.e., findings) and add, replace or remove preconfigured scan steps to/in/from the scan queue 23 based on the type of identified findings”. Also see, paragraph [0077]).
Regarding (Currently amended) claim 10, Arroyo Camejo teaches the limitations of claim 9, and further teaches wherein at least two entities of the group of interconnected entities are configured to communicate with each other through a digital communication channel (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0152], “components of the system are part of a data-network, wherein preferably the data-network and a medical imaging system (i.e., the magnetic resonance imaging system which provides image data) are in data-communication with each other, wherein the data-network preferably comprises parts of the internet and/or a cloud-based computing system, wherein preferably the system according to the disclosure or a number of components of this system is realized in this cloud-based computing system”).
Regarding (Currently amended) claim 11, Arroyo Camejo teaches the limitations of claim 1, and further teaches wherein the obtained medical data comprise at least one of: data acquired from the subject in real-time, medical examination data, and data acquired by at least one medical device (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0001], “a system and a method for standardized MRI examinations with patient-centric scan workflow adaptations, especially for controlling a magnetic resonance imaging (“MRI”) system”, paragraph [0018], “Smart, live adaptations”. paragraph [0037], “an MRI system”, paragraph [0107], “smart modules can be preconfigured scan protocols, automated planning and quality assurance steps”, paragraph [0077], “all past and planned scan steps. While past scan steps remain in the queue as historical record”, claim 12. “A magnetic imaging system comprising a system for standardized MRI examinations with patient-centric scan workflow adaptations, to perform a method according to claim 7”).
Regarding (Currently amended) claim 12, Arroyo Camejo teaches the limitations of claim 1, and further teaches wherein the dynamic examination process is adaptable in real-time (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0018], “Smart, live adaptations of the preconfigured scan program (i.e., adaptations of scan parameters, addition or removal of scan protocols to the scan workflow) considering the individual patient characteristics (e.g., scan indication, health record, behavior during scan, findings in the initial MR images)”, paragraph [0031], “live guidance through the scan workflow guidance system”).
Regarding (Currently amended) claim 13, Arroyo Camejo teaches the limitations of claim 1, and further teaches wherein at least one of: the pathology hypothesis comprises a hypothesis of a pathology family, and the dynamic examination process defines at least one entity configured to: assess the pathology hypothesis or a particular member of a pathology family as a function of the obtained medical data (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0012], “selection of the appropriate scan program based on patient indication or/and suspected pathologies”, paragraphs [0069]-[0072], “Based on these results, patient-specific adaptions of the scan workflow may be generated by the scan workflow guidance system with preconfigured scan protocols and scan programs. This means, that protocols of the scan workflow yet not applied to the MRI system are adapted based on the results”, paragraphs [0123]-[0125]], “an image analysis module (especially each comprised of, e.g., one or a combination of several deep convolutional neural nets or machine learning based pattern detection algorithms) able to detect one or a specific combination of relevant features from the input MR image… the scan workflow guidance system comprises a set of relevant feature detectors associated with the set of image analysis modules that is especially suitably defined as a set of different detectors for different classes of radiological findings, pathologies, image artifacts, or diseases. The set of relevant feature detectors (associated with the set of image analysis modules) may be suitably defined as a set of different detectors for different classes of, e.g. radiological findings, pathologies, image artifacts, or diseases”, paragraphs [0215]-[0219], “image analysis modules 28 are special finding detectors F, that find patient-specific circumstances that require a scan workflow adaptation… different classes of, e.g., radiological findings, pathologies”. Also see, paragraphs [0005], [0090], [0107], [0126]-[0129]).
Regarding (Currently amended) claim 14, Arroyo Camejo teaches the limitations of claim 1, and further teaches wherein at least one of: the predefined algorithm comprises an artificial intelligence (AI) model, and at least one entity comprises an artificial intelligence (AI) model (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0107], “performed with the help of intelligent algorithms (e.g., machine learning, deep-learning or classical, rule-based algorithms). Thus, smart modules can be preconfigured scan protocols, automated planning and quality assurance steps. The expression “Smart” refers to their property containing analytical tools from a “Smart Component Toolbox”. These may be powered by, e.g., rule-based algorithms, machine learning or deep learning algorithms, generally perceived as smart or intelligent”, paragraph [0123], “an image analysis module (especially each comprised of, e.g., one or a combination of several deep convolutional neural nets or machine learning based pattern detection algorithms)”).
REGARDING CLAIM(S) 15
Claim(s) 15 is/are analogous to Claim(s) 1, thus Claim(s) 15 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
Regarding (Currently Amended) claim 16, Arroyo Camejo teaches the limitations of claim 1, and further teaches a computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method according to claim 1 (Arroyo Camejo: paragraphs [0085]-[0086], “a computer program product with a computer program that is directly loadable into the memory of a device of a system or a control device of a magnetic resonance imaging system, and which comprises program units to perform the steps of the inventive method when the program is executed by the control device or the system.”; Also see claim 1, incorporated herein).
Regarding (New) claim 17, Arroyo Camejo teaches the limitations of claim 10, and further teaches wherein the digital communication channel is established according to the dynamic examination process (Arroyo Camejo: Figures 1-2, 4-5, paragraph [0033], “establish and maintain an operation-wide scan program standard for each scan indication.”, paragraph [0152], “components of the system are part of a data-network, wherein preferably the data-network and a medical imaging system (i.e., the magnetic resonance imaging system which provides image data) are in data-communication with each other, wherein the data-network preferably comprises parts of the internet and/or a cloud-based computing system, wherein preferably the system according to the disclosure or a number of components of this system is realized in this cloud-based computing system”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
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.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2022/0068472 (hereafter “Arroyo Camejo”; already of record in the IDS) in view of U.S. Patent Pub. No. 2018/0089380 (hereafter “Igler”).
Regarding (New) claim 18, Arroyo Camejo teaches the limitations of claim 11, and further teaches wherein the at least one medical device comprises an ultrasound system.
Igler teaches wherein the at least one medical device comprises an ultrasound system (Igler: paragraph [0028], “wherein the at least one medical device comprises an ultrasound system image data in the case of a CT system or ultrasound data in the case of an ultrasound device”, claim 3, “operating said medical system to perform said procedure respectively on multiple patients; and dependent on said cause of said deviation, controlling said medical system from said computer to change a sequence in which the procedure is respectively performed on a patient”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using an ultrasound device within the dynamic examination process as taught by Arroyo Camejo with the motivation of “improve corresponding substeps of said systems” (Igler: paragraph [0080]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Pub. No. 20200121951 (hereafter “Morgas”) teaches an adaptive therapy workflow for a particular patient.
U.S. Patent Pub. No. 20210005307 (hereafter “Knoplioch”) teaches a predictive workflow for dynamic AI adjustments.
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/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684