DETAILED ACTION
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 .
Acknowledgements
This communication is in response to Applicant’s Remarks filed 3/16/2026.
Claims 1, 10, 14 are amended.
Claims 5, 6, 16, 20, 22 are cancelled.
Claims 1-4, 7-15, 17-19, 21, 23 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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.
Claims 1-4, 7-15, 17-19, 21, 23 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, 10, 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites method and device for providing a medical recommendation. The limitations of (Claim 1 being representative of) receiving a data record of a patient; automatically determining one or more observables based on the data record, wherein the one or more observables describe a clinical condition of the patient; […];receiving, via the user interface, user input including at least one of a confirmation or a rejection of the one or more observables or an evaluation related to the one or more observablesas drafted is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. That is, other that reciting (claim 1, 14) a computer or (claim 14) a memory and processor to execute instructions, the claimed invention amounts to managing personal behavior or interaction between people (i.e., a person following a series of rules or steps). For example, but for the various general-purpose computer elements, the claims encompass a person using collected patient data to analyze patient data and then provide a recommendation for diagnosing or treating the patient based on user information in the manner described in the identified abstract idea, supra. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.4(a)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of (Claim 1, 10, 14) a computer having an interface and units or (Claim 14) memory and at least one processor. These additional elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., a generic general-purpose computer or components thereof, see, e.g., Para. [0021, 0091, 0096]) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of controlling, with a processor of a computer system, the imaging modality to acquire an image. The controlling of the imaging modality does not appear to have any functional relationship to the claimed invention. There is no indication that the imaging modality is operating in a manner different than it would normally operate, meaning the “controlling” is akin to “apply it” therefore the additional element amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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 also recites the additional element of an interface. The interface merely generally links the abstract idea to a particular technological environment or field of use. Generally linking an abstract idea to a particular technological environment or field of use is insufficient to provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
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 element of using a general-purpose computer (or components thereof) to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
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 element of controlling, with a processor of a computer system, the imaging modality to acquire an image amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, alternately and as discussed above with respect to integration of the abstract idea into a practical application, the additional element of an interface was considered to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claim is not patent eligible.
Dependent claims
Claims 2-4, 7-9, 11-13, 15, 17-19, 21, 23 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim 2 does no more than merely describe applying a general algorithm to the data. Claim 3, 18 merely describes determining observables from the data. Claim 4, 15, 19 merely describes the providing the action recommendation. Claim 7 merely describes identifying a reference to compare patients to. Claim 8 merely describes the particulars of identifying reference patients. Claim 9 merely describes applying a decision tree. Claim 12, 13 merely describes using generic computer components. Claim 21 merely describes transmitting a protocol. Claim 23 merely describes the user input.
Claim 11, 17 describes the additional element of an action recommendation device and a medical examination or treatment device. These additional elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., a generic general-purpose computer or components thereof, see, e.g., Para. [0021, 0091, 0096]) such that it amounts no more than application of the abstract idea (apply it”). MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. Claim 11, merely describes the examination and treatment system. Claim 17 merely describes providing the action recommendation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 7, 10, 12-15, 17, 19, 21, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20150331995) further in view of Olszewski (US 20120209093) further in view of Perrey (US 20200113542) in view of Gualtieri (US 20210335481) in view of Carlsen (US 20100183206)
CLAIM 1, 10, 14
Zhao teaches A computer-implemented method for providing a patient-specific medical action recommendation, the computer-implemented method comprising (Zhao para 180 describes the invention as a system and method and para 28 describes the invention as analyzing data and providing a recommended next step/treatment. para 180 describes the invention as a system and method implemented by hardware, circuitry, software. See also 179.))
receiving a data record of a patient; (Zhao Para. 25 teaches receiving data record of a patient)
automatically determining one or more observables based on the data record, wherein the one or more observables describe a clinical condition of the patient; (Zhao Para. 32 teaches self-learning and communicating wherein the system communicates with data sources to retrieve medical data and integrate data objects with each other based on metadata. One example of medical data is a “medical condition.”)
displaying the one or more observables via a user interface; (Zhao Para. 0026 describes displaying the observable "chest pain". See also FIG. 8A element 802 which shows a table showing observables which are images, symptoms, wall thickness measurements and more)
receiving, via the user interface, user input including at least one of a confirmation or a rejection of the one or more observables or an evaluation related to the one or more observables (Zhao Para 27 describes certain data may be manipulated by a user and make any corrections such as moving the outline of the stenosis on an image)
providing an action recommendation regarding further steps for at least one of diagnosing or treating the patient based on the user input, the action recommendation […] (Zhao Para 28 describes the system can analyze the data and provide intelligence, diagnosis, and recommend next steps. Zhao para 27 teaches the user input can be used to manipulate the data record and the action recommendation is based on the data record therefore the action recommendation is based on the user input. Zhao para 27-29 teaches an recommended action)
applying a designated data analysis algorithm to a designated data element from the data record […] (Zhao Para 53 teaches a model (data analysis algorithm) is applied to a user with medical data (data element) in order to determine additional medical data that the user is likely to be interested in (action recommendation). Zhao Para 53 also teaches multiple models and one model is selected for a particular user. Zhao Para 54 teaches the models are trained and adjusted to create updated model for future use. Zhao Para 44 teaches a user database/patient database (data record) storing medical data.)
and the designated data element is selected from the data record; and (Zhao para 28 teaches analysis on combined data including medical history. para 50 teaches selecting an image for analysis. )
wherein an imaging protocol for examining the patient using the imaging modality is determined based on the user input […] (Zhao, Para 122 teaches the user can select parameters for processing a specific image selected by the user. See also para 125 where image operations are based on user input.)
Zhao does not explicitly teach
the action recommendation including a recommendation for further examination of the patient via an imaging modality using an imaging modality and […]
controlling, with a processor of a computer system, the imaging modality to acquire a medical image of the patient based on an imaging protocol for examining the patient, the imaging protocol being determined based on the user input.
Olszewski does teach
the action recommendation including a recommendation for further examination of the patient via an imaging modality using an imaging modality; and (Olszewski, Para 49 teaches recommending a further imaging using an imaging modality)
controlling, with a processor of a computer system, the imaging modality to acquire a medical image of the patient based on an imaging protocol for examining the patient, the imaging protocol being determined based on the user input. (Olszewski para 47-40 teach using user input to determine an imaging modality and imaging protocol. Para 55 teaches after determining the imaging modality and determining the imaging protocol then a signal is provided to the imaging system and is used to scan the patient.)
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the action recommendation as taught by Zhao with a further examination using the imaging modality and controlling of the imaging modality to acquire the image based on an imaging protocol determined based on user input as taught by Olszewski because it would be beneficial for patients to have further examination if they need it in order to supplement findings (see Olszewski at Para 50)
Zhao in view of Olszewski does not teach the imaging protocol being determined based on the user input
Perrey in view of Olszewski does not teach the imaging protocol being determined based on the user input (Perrey para 45 teaches user inputs including a desired scan protocol )
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the imaging protocol as taught by Zhao in view of Olszewski with imaging protocol being determined based on the user input as taught by Perrey because it would be beneficial for have more accuracy of a medical diagnosis of the resulting images (see Perrey para 11)
Zhao in view of Olszewski in view of Perrey does not teach a recommendation for applying a designated data analysis algorithm to a designated data element from the data record, […] the designated data analysis algorithm is selected from a plurality of available data analysis algorithms,
Gualtieri does teach a recommendation for applying a designated data analysis algorithm to a designated data element from the data record, […] the designated data analysis algorithm is selected from a plurality of available data analysis algorithms, (Gualtieri para 26 teaches recommending algorithms from a set of algorithms)
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the algorithm as taught by Zhao in view of Olszewski with the recommending an algorithm from a plurality of available algorithms as taught by Gualtieri. It would be beneficial to recommend an algorithm based on the structure as taught by Gualtieri para 4.
Zhao in view of Olszewski in view of Perrey in view of Gualtieri does not teach adjust the action recommendation to update the imaging protocol to include at least one of […] or updated image acquisition parameters during an imaging procedure performed by the imaging modality.,
Carlsen does teach adjust the action recommendation to update the imaging protocol to include at least one of […] or updated image acquisition parameters during an imaging procedure performed by the imaging modality. (Carlsen para 16 teaches adjusting the acquisition protocol during dynamic medical image acquisition. Para 29 teaches An acquisition protocol may be a set of parameters, apparatus settings and operation instructions used in performing a dynamic imaging sequence. 59 teaches table speed, gating and triggering levels. 67 teaches amount of contrast agent used. 68 teaches timing of the start of scanning sequence, e.g. the delay after injection of contrast agent or synchronization with patient motion. Examiner interprets additional limitation as optional due to claim language “or”)
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the image acquisition as taught by Zhao in view of Olszewski in view of Perrey in view of Gualtieri with the adjust the action recommendation to update the imaging protocol to include updated image acquisition parameters during an imaging procedure as taught by Carlsen because it would be beneficial to improve accuracy as taught by Carlsen para 4.
CLAIM 2
Zhao teaches wherein the automatically determining one or more observables comprises: applying a state analysis algorithm to the data record, the state analysis algorithm configured to extract observables from data records. [Zhao Para 32 describes the ECCD engine which determines types of medical data, i.e., observables to extract. The ECCD engine is capable of se-learning based on rules or models based on prior interactions or behaviors of a user or users (interpreted as a state analysis algorithm which is undefined) ]
CLAIM 4, 19
Zhao teaches wherein the providing an action recommendation comprises: determining at least one tentative diagnosis based on the user input; and determining the action recommendation based on the at least one tentative diagnosis. [Zhao Para 27 teaches medical data manipulated by user input. Zhao Par 28 teaches determining a diagnosis based on that data and determining a recommended treatment.]
CLAIM 7
Zhao teaches further comprising: identifying one or more reference patients, from a plurality of comparison patients, based on the data record; extracting comparison information from patient data associated with the one or more reference patients; and determining the action recommendation additionally based on the comparison information. [Zhao Para 82 teaches comparing data to other patients in the patient database and then determining the best treatment from that comparison]
CLAIM 12
Zhao teaches A non-transitory computer program product including a computer program loadable into a memory of a computer of a clinical examination and treatment system,
the computer program having program sections that, when executed by the computer, cause the clinical examination and treatment system to perform the computer-implemented method of claim 1. [Zhao Para 179 teaches code stored and executed on non-transitory computer-readable storage media]
CLAIM 13
Zhao teaches A non-transitory computer-readable medium storing program sections that are executable by a computer to cause the computer to perform the computer- implemented method of claim 1. [Zhao Para 179 teaches code stored and executed on non-transitory computer-readable storage media]
CLIAM 15, 17
Zhao teaches wherein the providing provides the action recommendation based on the user input and the data record. [Zhao Para 28 describes a system analyzing patient data records and Zhao Para 26 teaches certain data may be manipulated by a user to make any corrections. The system uses this data and providing a recommended next step/treatment.]
CLAIM 21
Zhao teaches claim 1 [See claim 1 rejection above]
Zhao does not teach transmitting the imaging protocol to a medical modality.
Olszewski does teach transmitting the imaging protocol to the medical modality. (Olszewski para 47-40 teach using user input to determine an imaging modality and imaging protocol. Para 55 teaches after determining the imaging modality and determining the imaging protocol then a signal (i.e., imaging protocol) is provided to the imaging system and is used to scan the patient according to the imaging protocol.)
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the action recommendation as taught by Zhao with transmitting the imaging protocol to the imaging modality as taught by Olszewski because it would be beneficial for patients to have further specific imaging examination in order to supplement findings (see Olszewski at Para 50)
CLAIM 23
Zhao teaches wherein the user input includes an adjustment to the one or more observables. (Zhao Para 27 describes certain data may be manipulated by a user and make any corrections such as moving the outline of the stenosis on an image)
Claims 3, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20150331995) further in view of Olszewski (US 20120209093) further in view of Perrey (US 20200113542) in view of Gualtieri (US 20210335481) in view of Carlsen (US 20100183206) in view of Smith (US 20050214731)
CLAIM 3, 18
Zhao in view of Olszewski in view Perrey teaches The computer-implemented method of claim 1, [Zhao, Para 28 describes analyzing data and providing a recommended next step/treatment]
wherein the automatically determining one or more observables comprises: [Zhao, Para. 32 teaches self-learning and communicating wherein the system communicates with data sources to retrieve medical data and integrate data objects with each other based on metadata. One example of medical data is a “medical condition.”]
selecting the one or more observables from a database, wherein the database includes a plurality of observables, [Zhao, Para 49 teaches that obtaining medical data or records (plurality of observables) from a database.]
a plurality of conditions [Zhao, Para. 69 teaches the system determines a probability of a medical condition by using information such as medical images and medical history (observables). Examiner interprets the plurality of conditions to be in a database in order for a computer-implemented system to determine any of the plurality of conditions.]
a plurality of rules, each of the plurality of rules associating a probability of occurrence of at least one condition with a presence or absence of an observable. [Zhao, Para 28 teaches an ECCD that analyzes medical data to provide a diagnosis. The analysis is based on a set of rules. Para 98 teaches an embodiment of the ECCD system determines the likelihood (probability) of an abnormal medical condition. Further, Para 98 teaches the probability is determined by certain medical data (observable) exceeding or dropping below a threshold (presence or absence)]
Zhao in view of Olszewski in view of Perry in view of Gualtieri does not explicitly teach each of the plurality of conditions describing one or more feature patterns of data records of patients, and being associated with one or more of the plurality of observables, and
Smith does teach each of the plurality of conditions describing one or more feature patterns of data records of patients, and being associated with one or more of the plurality of observables, and
[Smith, Para 57 teaches a database consisting of symptoms (observables) or fact patterns (feature patterns) relating to relating conditions]
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the database of conditions as taught by Zhao in view of Olszewski in view of Perry in view of Gualtieri with each condition describing a feature pattern and being associated one or more observables as taught by Smith because it would be beneficial to have a clear framework for analyzing the complexity of interrelationships between various diseases and their indicators in order to improve diagnosis, manage disease and prescribe treatments (see Smith at Para 0008).
Claims 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20150331995) further in view of Olszewski (US 20120209093) further in view of Perrey (US 20200113542) in view of Gualtieri (US 20210335481) in view of Carlsen (US 20100183206) in view of Casey (US 20210210189)
CLAIM 8
Zhao in view of Olszewski in view Perrey teaches The computer-implemented method of claim 7, further comprising: [Zhao, Para 28 describes a system analyzing data and providing a recommended next step/treatment]
Zhao in view of Olszewski in view of Perry in view of Gualtieri may not explicitly teach wherein the one or more reference patients are additionally identified based on the user input.
However, Casey does teach wherein the one or more reference patients are additionally identified based on the user input. [Casey, Para 31 teaches reference patients are selected based on user input form a clinician, surgeon physician or healthcare provider. Additionally, adjusting weights of similarity or outcome parameters can be selected by healthcare providers which would identify reference patients]
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the selecting reference patients as taught by Zhao in view of Olszewski in view of Perry in view of Gualtieri with the selecting reference patients based on user input as taught by Casey. It would be beneficial for reference patients to be selected based on user input because it takes advantage of the expertise of medical professionals and would lead to more accurate modeling because the training data is improved, which by definition helps supervised learning (see Casey at Para 36, 38)
CLAIM 9
Zhao in view of Olszewski in view of Perry in view of Gualtieri teaches The computer-implemented method of claim 1, [Zhao, Para 28 describes analyzing data and providing a recommended next step/treatment]
wherein the providing an action recommendation comprises: [Zhao, Para 28 describes a system analyzing data and providing a recommended next step/treatment]
Zhao in view of Olszewski in view of Perry in view of Gualtieri does not explicitly teach:
selecting a designated decision tree, from a plurality of decision trees, based on at least one of the user input, the one or more observables or the data record of the patient,
wherein each of the plurality of decision trees has a plurality of different paths and each of the plurality of different paths provides at least one discrete step for at least one of diagnosis or treatment of the patient;
determining a path within the designated decision tree based on at least one of the user input, the one or more observables or the data record of the patient; and
providing the action recommendation based on the path within the designated decision tree.
Casey does teach:
selecting a designated decision tree, from a plurality of decision trees, based on at least one of the user input, the one or more observables or the data record of the patient, wherein each of the plurality of decision trees has a plurality of different paths and each of the plurality of different paths provides at least one discrete step for at least one of diagnosis or treatment of the patient; . [Casey, Para 36 teaches decision trees may be one of the AI techniques in treatment planning. Decision trees by definition have plurality of paths with discrete steps wherein a path is determined based on the input data and a final result is achieved at the leaf node. Para 37 teaches the result is a treatment plan.]
determining a path within the designated decision tree based on at least one of the user input, the one or more observables or the data record of the patient; and providing the action recommendation based on the path within the designated decision tree. [Decision trees paths by definition are determined based on the input data in order to land at a final result at a leaf node. Para 33 describes the input data as data including patient parameters and a data record of the patient (observables). Para 37 describes the leaf node as a treatment plan (action recommendation)]
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the providing an action recommendation as taught by Zhao in view of Olszewski in view of Perry in view of Gualtieri with the decision trees as taught by Casey. It would be beneficial to use decision trees to generate action recommendations because it is a supervised machine learning technique that can draw upon large datasets to generate and optimize patient-specific treatments to achieve favorable treatment outcomes (See Casey at Para. 3).
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20150331995) further in view of Olszewski (US 20120209093) further in view of Perrey (US 20200113542) in view of Gualtieri (US 20210335481) in view of Carlsen (US 20100183206) in view of Gross (US 20200286608)
CLAIM 11
Zhao in view of Olszewski in view of Perry in view of Gualtieri teaches A clinical examination and treatment system, an action recommendation device of claim 10; [Zhao Para 28 describes a system analyzing data and providing a recommended next step/treatment]
Zhao in view of Olszewski does not explicitly teach and at least one of a medical examination or treatment device configured to be controlled based on the action recommendation provided by the action recommendation device.
Gross does teach and at least one of a medical examination or treatment device configured to be controlled based on the action recommendation provided by the action recommendation device. [Para 6 teaches controlling a treatment device based on a therapy recommendation]
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to modify the providing an action recommendation as taught by Zhao in view of Olszewski in view of Perry in view of Gualtieri with the controlling a treatment device as taught by Casey. It would be beneficial to control a treatment device because it would allow implementing a treatment to be real-time which would be better for the patient (See Gross at Para. 6).
Prior Art Made of Record and Not Relied Upon
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20070222442 Aldefeld
Teaches manipulate image contrast or to update scanning parameters during table motion.
US 20190269384 Lundberg
The processor may ask the operator to check the settings on the ultrasound imaging system and may suggest that the operator change the settings to those that are optimal for the type of tissue identified by the neural network. […] The processor is therefore programmed to prompt the operator to change the imaging parameters (or have the imaging system select the imaging parameters) to better suit the type of tissue detected or in some embodiments to confirm that the operator wants to continue with the imaging parameters they have set
US 20180173852 Lou
The Intelligent Medical Imaging Scanner 105 can then integrate all information to monitor the status of the patients during the scan and adjusts parameters accordingly.
US 20120271840 VOSNIAK
[0026] In an exemplary embodiment, a scan of the object, for example a patient, is performed using a protocol selected by the user or modified by the user. For example, the scan may be performed based on the current scan protocol 114, the stored scan protocol 118, the recommended scan protocol 119, or a modification of at least one of the current scan protocol 114, the stored scan protocol 118, or the recommended scan protocol 119. During the scan, the rules engine 112 may provide notifications to the operator if the scan varies from the selected scan protocol, for example, the recommended scan protocol 119. The operator may then restart the scan and/or adjust the scan on the fly.
Response to Arguments Regarding U.S.C. 101 Rejection
Applicant argues pg. 10-11:
" With respect to certain methods of organizing human activity, the MPEP specifies that "this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances." MPEP 2106.04(a)(2)(11). The pending claims do not recite fundamental economic principles or practices, commercial or legal interactions, or personal behavior or interactions between people. Thus, the pending claims are not directed to a method of organizing human activity. The Office Action alleges that certain methods of organizing human activity "includes a person's interaction with a computer." Office Action, page 3. However, the pending claims recite steps that are carried out by a computer system to improve organization of examination and treatment processes of a patient. See Specification, paragraph [0006]. The claims are not directed to a person's interaction with a computer as alleged."
Examiner responds:
The Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow for providing a medical recommendation. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to providing a recommendation, the claimed invention is directed to an abstract idea. Examiner notes the “controlling an imaging modality” is akin to “apply it” therefore the additional element amounts no more than mere instructions to apply the exception using a generic computer component.
Applicant argues pg. 11:
" Further, even assuming, arguendo, that the pending claims were directed to an abstract idea, claim 1 recites additional elements that integrate the alleged abstract idea into a practical application of the alleged abstract idea. The Office Action identifies the step of element of "controlling, with a processor of a computer system, the imaging modality to acquire a medical image of the patient based on the imaging protocol for examining the patient" as an additional element. However, the Office Action alleges that this step "amounts to no more than mere instructions to apply the exception using a generic computer component." Office Action, page 4. Applicants respectfully disagree.
The automatic control of the imaging modality reduces "the workload of medical staff and eliminate[s] or reduce[s] errors in the preparation of the examination process using technical systems." Specification, paragraph [0005]. In the least, the additional element of controlling the imaging modality improves the technical field of medical imaging and provides a practical application of any alleged abstract idea within the pending claims."
Examiner responds:
The Examiner respectfully disagrees. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claimed invention recites the additional element(s) of controlling, with a processor of a computer system, the imaging modality to acquire an image. While these additional elements implement the results of the abstract idea, there is no indication that these additional elements operate in a manner different than they normally operate. Operating another device in the manner it normally operates is insufficient to improve that other technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present.
Further, "the workload of medical staff and eliminate[s] or reduce[s] errors in the preparation of the examination process using technical systems." Here, the Applicant’s argued problem is not a technological problem caused by the computer to which the claims are confined. The problem of healthcare providers workload and error reduction was not a problem cause by the computer, it is a problem that existed and/or exists regardless of whether a computer is involved in the process. At best, Applicant’s identified problem is a management / training / personnel / business problem. Because no technological problem is present, the claims do not provide a practical application.
Further, “The automatic control of the imaging modality reduces "the workload of medical staff and eliminate[s] or reduce[s] errors in the preparation of the examination process using technical systems." Is not reflected in the claim because the claim broadly recites “control the imaging modality to acquire a medical image of the patient based on the imaging protocol for examining the patient and adjust the action recommendation to update the imaging protocol to include at least one of a different contrast agent or updated image acquisition parameters during an imaging procedure performed by the imaging modality” Where there no indication of reduction in staff workload or reduction of errors.
Applicant argues pg. 11-12:
“ Further, the added step of "adjusting the action recommendation to update the imaging protocol to include at least one of a different contrast agent or updated image acquisition parameters during an imaging procedure performed by the imaging modality'' further integrates any alleged abstract idea of the pending claims into a practical application. This adjustment to the action recommendation is an "on the fly" adjustment that further improves the technical field of medical imaging and clearly provides a practical application of any alleged abstract idea within the pending claims.
The pending claims provide systems and methods that enable fully automatic inspection and evaluation of a patient. Specification, para. [0018]. A user may still be able to intervene at intermediate steps, but the user is not involved in any active steps of planning a workflow for examining a patient. Id. The pending claims therefore provide improved systems and methods for providing a patient-specific medical action recommendation. Accordingly, the pending claims provide a practical application of any alleged abstract idea.”
Examiner responds:
The Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, Applicant has not identified any technological problem that was caused by the technological environment to which the claims are confined. Applicant asserts “"on the fly" adjustment that further improves the technical field of medical imaging” and “automatic inspection and evaluation of a patient”, however no technological problem is identified in the technical field of medical imaging.
Applicant identifies on pg. 11 “automatic control of the imaging modality reduces "the workload of medical staff and eliminate[s] or reduce[s] errors in the preparation of the examination process using technical systems."” However, Examiner notes the above response in regards to these identified problem not being technological problem caused by the computer to which the claims are confined. Further, mere automation of manual processes may not be sufficient to show an improvement in computer functionality.
Response to Arguments Regarding U.S.C. 103 Rejection
Applicant argues Pg. 13:
“Caim 1 is amended to recite, in part, "adjusting the action recommendation to update the imaging protocol to include at least one of a different contrast agent or updated image acquisition parameters during an imaging procedure performed by the imaging modality.""”
Examiner responds:
In light of Applicant’s amendment, Examiner has applied new grounds of rejection. See claim 1, 10, 14 rejection above.
Applicant argues Pg. 13:
The Office Action alleges that paragraphs [0027]-[0029] of Zhao describe providing an action recommendation as recited in claim 1. The cited paragraphs of Zhao describe an evolving contextual clinical data (ECCD) technology that may display intelligence related to medical data. These paragraphs also describe that this ECCD technology may "provide intelligence and even diagnoses and recommend next steps/treatment." Zhao, paragraph [0028]. The cited portions of Zhao do not describe adjusting an action recommendation to update the imaging protocol to include at least one of a different contrast agent or updated image acquisition parameters during an imaging procedure performed by the imaging modality as recited in amended claim 1. Neither Olszewski nor Perrey remedies the above-described deficiencies of Zhao with respect to amended claim 1. For at least the reasons above, a prima facie case of obviousness cannot be established with regard to claim 1. Consequently, a primafacie case of obviousness cannot be established with regard to claims 2-4, 7-9, 12, 13, 15, 18, 19, 21, and 23, at least by virtue of their dependency from claim 1. Claims 10 and 14 are being amended similarly to claim 1. For at least the reasons above with respect to claim 1, aprimafacie case of obviousness cannot be established with regard to claims 10 or 14. Consequently, a primafacie case of obviousness cannot be established with regard to claims 11 and 17, at least by virtue of their dependency from claim 10..
Examiner responds:
In light of Applicant’s amendment, Examiner has applied new grounds of rejection. See claim 1, 10, 14 rejection above.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.K.T./Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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