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
This action is in reference to the communication filed on 1 APRIL 2024
Claims 1-10 are present and have been examined.
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 1-10 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-10 the independent claim(s) 1, 9, 10 recite(s) an apparatus, method, and non-transitory computer readable storage medium, each of which fall into a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-10 the independent claim(s) (claims 1, 9, 10 as shown in exemplary claim 1 below) is/are directed, in part, to:
An information processing apparatus comprising:
acquire designation information for designating a plurality of derivation methods to derive record information to be recorded in at least one record item related to a patient;
derive the record information by applying a derivation method, which is selected according to a preset priority order from among the plurality of derivation methods designated through the designation information, based on patient information related to the patient, for the record item; and
generate medical document data in which the derived record information is recorded in the record item.
These claim elements are considered to be abstract ideas because they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Acquiring information, deriving information from the information, using that information to derive health information, and generating a report, are all examples of mental processes as identified above. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
The claims are further directed to mathematical concepts – i.e. mathematical relationships, formulas, equations, and/or calculations. The derivation as best understood is an example of a mathematical concept or relationship as identified above. If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, formulas, equations, and/or calculations, then it/they falls/ fall into the “mathematical processes” category.
Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional element(s). Claim 1 requires at least one processor, as does claim 9, and claim 10 requires a non-transitory computer readable storage medium controlling a processor. The processors in each of these claims, as well as the non-transitory computer readable medium in claim 10, are recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Examiner finds no improvement to the functioning of the computer or any other technology or technical field as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e).
Examiner notes that claims 1, 9, 10 each recite a “record”, which as claimed is appropriately classified in the abstract idea. However, in the interest of compact prosecution, Examiner notes that “recording” if interpreted as “saving or storing” is generally found to be an addition of insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g).
Accordingly, this/these additional element(s) do(es) 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.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: claim 1 requires at least one processor, as does claim 9, and claim 10 requires a non-transitory computer readable storage medium controlling a processor. When considered individually, the above identified claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0038] The RAM 102 is a work memory for the CPU 101 to execute a process. The CPU 101 loads the document creation program 110 stored in the non-volatile memory 103 to the RAM 102 and executes a process according to the document creation program 110. The CPU 101 is an example of a “processor” in the disclosed technology. The determination/classification rule 111 is an example of a “predetermined rule” in the disclosed technology. The determination/classification model 112 is an example of a “trained model” according to the disclosed technology.
[0081] One processing unit may be configured by one of the various processors or may be configured by a combination of the same or different kinds of two or more processors (for example, a combination of a plurality of FPGAs or a combination of the CPU and the FPGA). Further, a plurality of processing units may be configured by one processor.
[0082] As an example in which a plurality of processing units are configured by one processor, first, there is a form in which one processor is configured by a combination of one or more CPUs and software as typified by a computer, such as a client or a server, and this processor functions as a plurality of processing units. A second example thereof is a form of using a processor that realizes the function of the entire system including the plurality of processing units by one integrated circuit (IC) chip, as represented by a system on chip (SoC) or the like. In this way, various processing units are configured by one or more of the above-described various processors as hardware structures.
[0083] Furthermore, as the hardware structure of the various processors, more specifically, an electrical circuit (circuitry) in which circuit elements such as semiconductor elements are combined can be used.
[0084] Moreover, in the above-described embodiment, an aspect has been described in which the document creation program 110 is stored (installed) in advance in the non-volatile memory 103, but the disclosed technology is not limited to this. The document creation program 110 may be provided in a form recorded in a recording medium such as a compact disc read only memory (CD-ROM), a digital versatile disc read only memory (DVD-ROM), and a universal serial bus (USB) memory. In addition, the document creation program 110 may be configured to be downloaded from an external device via a network. That is, the program (program product) described in the present embodiment may be provided by a recording medium or may be distributed from an external computer.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-8:
Dependent claims 2-8 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as additional clarification of the mental processes and/or types of mathematical relationships considered. The claims discuss different types of input, as well as rules for the ranking of the input sources, and the model(s) used. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
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) 1-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mitsumori (US 20200342997 A1).
In reference to claim 1, 9, 10:
Mitsumori teaches: An information processing apparatus comprising: at least one processor, wherein the processor is configured to:
An information processing method executed by at least one processor included in an information processing apparatus, the method comprising:
And a non-transitory computer readable storage medium storing an information processing program causing at last one processor included in an information processing apparatus to execute a process, comprising:
acquire designation information for designating a plurality of derivation methods to derive record information to be recorded in at least one record item related to a patient (at least [fig 2, 9 and related text] “For example, when “Finding 1” is set by the finding setting function 152, the first extraction function 153 searches for and extracts, for each of the four extraction conditions associated with “Finding 1”, the first medical data satisfying the extraction condition... he second extraction function 156 extracts, from among medical data (hereinafter referred to as second medical data) of the subject managed at the other medical facility (medical facility system 10), the second medical data related to a finding set by the finding setting function 152. ” see also [fig 5 and related text]):
derive the record information by applying a derivation method, which is selected according to a preset priority order from among the plurality of derivation methods designated through the designation information, based on patient information related to the patient, for the record item (at least [figs 2, 9 and related text] “Specifically, the first extraction function 153 extracts, based on the above-described extraction condition information 121, medical data satisfying the extraction condition on a finding set by the finding setting function 152 from among medical data of a subject managed at the own medical facility…When no medical data satisfying the extraction condition has been found, the second determination function 155 determines that no medical data satisfying the lacked extraction condition is available. When medical data satisfying the extraction condition has been found, the second determination function 155 determines that medical data satisfying the lacked extraction condition is available at the other medical facility. In this case, the second determination function 155 may notify the second extraction function 156 of the storage destination of the medical data satisfying the extraction condition.”); and
generate medical document data in which the derived record information is recorded in the record item (at least [figs 2, 5-8, 9, and related text] display control function displays the findings as shown in figs 5-8, see also [0024] “ In addition, the radiation department system 300 generates report data related to image examination performed on the subject and stores the generated report data in the storage in the system. For example, the radiation department system 300 includes picture archiving and communication systems (PACS) or the like. The image examination includes examination using a CT image captured by an X-ray computed tomography (CT) device, examination using an MR image captured by a magnetic resonance imaging (MRI) device, examination using an ultrasonic wave image captured by an ultrasonic wave diagnostic device, and examination using an X-ray image captured by an X-ray diagnostic device. Then, the radiation department system 300 transmits the image data and the report data stored in the storage to the integrated data server 500. The image data and the report data each include an examination result and a report of the subject and the like as well as a patient ID for identifying the subject.”)
In reference to claim 2:
Mitsumori further teaches: wherein the processor is configured to, in a case where the record information is not capable of being derived by using a derivation method where a relatively high priority order is set among the plurality of derivation methods, derive the record information by using a derivation method where a relatively low priority order is set (at least [fig 3 and related text] “For example, the finding estimation function 151 may select a predetermined number (for example, three) of findings with highest validities…For example, as for the extraction conditions for “Finding 1” illustrated in FIG. 3, when the data type of the first medical data extracted by the first extraction function 153 is D1, D3, and D5, the first determination function 154 determines that medical data satisfying the extraction condition on the data type D2 is lacked. For example, as for the extraction conditions for “Finding 2”, when the data type of the first medical data extracted by the first extraction function 153 is D1, D6, and D7, the first determination function 154 determines that medical data satisfying the extraction condition on the data type D9 is lacked… When it is determined that medical data of the diagnosis target subject is available in the medical data managed at the integrated data server 500 of the other medical facility system 10, the second determination function 155 searches the medical data of the subject for medical data satisfying the lacked extraction condition. When no medical data satisfying the extraction condition has been found, the second determination function 155 determines that no medical data satisfying the lacked extraction condition is available. When medical data satisfying the extraction condition has been found, the second determination function 155 determines that medical data satisfying the lacked extraction condition is available at the other medical facility. In this case, the second determination function 155 may notify the second extraction function 156 of the storage destination of the medical data satisfying the extraction condition.”).
In reference to claim 3:
Mitsumori further teaches: wherein at least one of the plurality of derivation methods is
a first derivation method of deriving the record information by diversion from the patient information (at least [fig 2 and related text] “The first extraction function 153 extracts, from among medical data (hereinafter referred to as first medical data) of a diagnosis target subject managed at the integrated data server 500 of the own medical facility, the first medical data related to a finding set by the finding setting function 152. Specifically, the first extraction function 153 extracts the first medical data satisfying a condition on the finding set by the finding setting function 152 from among the first medical data of the subject managed at the own medical facility based on extraction condition information 121 in which a condition on medical data as a display target is defined for each finding.”),
a second derivation method of deriving the record information by performing determination or classification based on a predetermined rule regarding the patient information (at least [fig 2 and related text] “The second extraction function 156 extracts, from among medical data (hereinafter referred to as second medical data) of the subject managed at the other medical facility (medical facility system 10), the second medical data related to a finding set by the finding setting function 152. Specifically, when the second determination function 155 has determined that medical data satisfying the lacked extraction condition is available at the other medical facility, the second extraction function 156 extracts the second medical data satisfying the lacked extraction condition from among the second medical data of the subject managed at the other medical facility.”), or
a third derivation method of deriving the record information by performing determination or classification using a trained model regarding the patient information (at least [fig 2 and related text] “n function 151 may estimate a finding by using an estimation model such as a machine learning model obtained by learning the relation between medical data of each of a plurality of subjects and a diagnosis result (finding) or a simulator. In this case, the finding estimation function 151 inputs medical data of a subject as a diagnosis target into the estimation model and acquires, as a finding, a diagnosis result output from the estimation model.”), and
the trained model is a model that uses the patient information as an input and that uses the record information as an output (at least [043] “Alternatively, for example, the finding estimation function 151 may estimate a finding by using an estimation model such as a machine learning model obtained by learning the relation between medical data of each of a plurality of subjects and a diagnosis result (finding) or a simulator. In this case, the finding estimation function 151 inputs medical data of a subject as a diagnosis target into the estimation model and acquires, as a finding, a diagnosis result output from the estimation model.”).
In reference to claim 4:
Mitsumori further teaches: wherein the processor is configured to, in a case where the third derivation method is applied, regarding the patient information, use exchange data, which indicates a correspondence relationship between an item name actually used and an item name used at a time of training of the trained model, to specify the patient information of the item name actually used corresponding to the item name used at the time of training, and derive the record information by inputting the specified patient information to the trained model (at least [029, 059-060] patient ID correspondence between multiple facilities, i.e. multiple sources of training information: “The patient ID may be common to the medical facilities or may be different among the medical facilities. However, in the latter case, for example, the patient IDs of an identical person at the medical facilities may be, for example, associated with one another so that the identical subject can be specified from the patient ID at each medical facility… With the above-described medical information system 1, when an identical subject is examined at a plurality of medical facilities, medical data of the subject is managed at each medical facility. ”).
In reference to claim 5:
Mitsumori further teaches: wherein the processor is configured to present the medical document data by associating information, which indicates the derivation method applied to derive the record information from among the plurality of derivation methods, with the record information (at least [fig 2, 3, 5/6 and related text] display control function 158 displays the medical report shown in fig 5/6 by using the extraction/determination functions in fig 2).
In reference to claim 6:
Mitsumori further teaches: wherein the processor is configured to present the medical document data by associating the patient information, which is used to derive the record information, with the record information model (at least [029, 059-060] patient ID correspondence between multiple facilities, i.e. multiple sources of training information: “The patient ID may be common to the medical facilities or may be different among the medical facilities. However, in the latter case, for example, the patient IDs of an identical person at the medical facilities may be, for example, associated with one another so that the identical subject can be specified from the patient ID at each medical facility… With the above-described medical information system 1, when an identical subject is examined at a plurality of medical facilities, medical data of the subject is managed at each medical facility. ” see also [fig 9, 4 and related text] for discussion of inputting patient ID of a subject in order to correlate the patient information to the records themselves).
In reference to claim 7:
Mitsumori further teaches: wherein the processor is configured to receive a designation input of the designation information (at least [fig 2 and related text] “For example, when “Finding 1” is set by the finding setting function 152, the first extraction function 153 searches for and extracts, for each of the four extraction conditions associated with “Finding 1”, the first medical data satisfying the extraction condition... he second extraction function 156 extracts, from among medical data (hereinafter referred to as second medical data) of the subject managed at the other medical facility (medical facility system 10), the second medical data related to a finding set by the finding setting function 152. ” see also [fig 5 and related text]).
In reference to claim 8:
Mitsumori further teaches: wherein the medical document data is data obtained by converting documents, which are related to hospital admission and discharge of the patient, into data (at least [fig 1 and related text] “The medical facility systems 10 includes, for example, a medical information processing apparatus 100, a sample examination system 200, a radiation department system 300, an electronic medical record system 400, and an integrated data server 500. The medical information processing apparatus 100, the sample examination system 200, the radiation department system 300, the electronic medical record system 400, and the integrated data server 500 are connected with each other to perform communication therebetween through an in-facility network N2 such as a local area network (LAN). The in-facility network N2 is connected with the inter-facility network N1 through a network instrument such as a router. The number of medical information processing apparatus 100 connected with the in-facility network N2 is not particularly limited.” And at [084] “… when pieces of the second medical data (numerical data) of an identical data type are displayed in a graph format or the like. In addition, for example, when the second extraction function 156 extracts the second medical data from other medical facilities different from each other or extracts a plurality of pieces of the second medical data of data types different from each other from an identical medical facility, the display control function 158 may display the display check information for each medical facility or each data type.”)
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20080275731 to Rao discloses mining patient data from multiple sources based on quality of the source.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687