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 .
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.
Claim(s) 7 is/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 7 recites “wherein the second patient information includes third patient information about the patient that was not recorded when the patient was examined.” It is unclear how “third patient information” is included if it is “not recorded”? Per broadest reasonable definition in light of the specification, to “examine” means “to look at, inspect, or study something very closely in order to learn the facts, find errors, or understand how it works.” It seems as though any patient information must be recorded when the patient is examined. Does Applicant intend for the conditional limitation to be “when the patient was undergoing a physical or medical examination at a doctor’s office”? Appropriate clarification is requested for the proper interpretation of the claim limitations, as the ambiguity renders the metes and bounds of the claim unclear.
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(s) 1-8 is/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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a device which is within the four statutory categories (i.e., machine). Claim 7 is drawn to a method which is within the four statutory categories (i.e., method). Claim 8 is drawn to a non-transitory computer-readable storage medium storing a program which is within the four statutory categories (i.e., method).
Independent claim 1 (which is representative of independent claims 7-8) recites… receives a question for a patient from a medical professional, and answers on behalf of the patient using a [model] that reproduces a condition of the patient, …receive the question; acquire at least medical condition information representing a medical condition of the patient; update the [model] based on the medical condition information; use the [model] to output answer information representing the answer to the received question; and generate display data for presenting the answer information...
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output accordingly (i.e., page 2 of the specification describes “evaluation (analysis and consideration)” performed by “doctors” as human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., A medical information processing device comprising processing circuitry; a digital twin; wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model; cause a display device to display the display data). Claim 7 recites additional elements (i.e., a computer of a medical information processing device; a digital twin; wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model; causing a display device to display the display data). Claim 8 recites additional elements (i.e., A non-transitory computer-readable storage medium storing a program; a computer of a medical information processing device; a digital twin; wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model; causing a display device to display the display data). Looking to the specifications, a computing device having processing circuitry, non-transitory computer-readable storage medium storing a program is described at a high level of generality (pages 18-20), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “a digital twin” and “wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model” is described at a high level of generality without placing any limits or including details on how it actually functions (i.e., no description of the mechanism for accomplishing the result), such that using the trained AI model amounts to no more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, and only generally links the use of a judicial exception to a particular technological environment or field of use (i.e., artificial intelligence), which does not impose meaningful limits on the scope of the claim. Also, the claims add “cause a display device to display the display data” only invokes the display device merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent), and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computing device having processing circuitry, non-transitory computer-readable storage medium storing a program) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “a digital twin” and “wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model” is described at a high level of generality without placing any limits or including details on how it actually functions (i.e., no description of the mechanism for accomplishing the result), such that using the trained AI model amounts to no more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, and only generally links the use of a judicial exception to a particular technological environment or field of use (i.e., artificial intelligence), which does not impose meaningful limits on the scope of the claim. Also, the claims add “cause a display device to display the display data” only invokes the display device merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent), and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-6 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-6 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
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 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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2021/0124465 A1 (hereinafter referred to as "Sahu") in view of International Pub. No. WO 2026/026949 A1 (hereinafter referred to as "ZHANG").
Regarding claim 1, Sahu teaches a medical information processing device (Sahu: ¶ 0056; ¶ 0132) that receives a question for a patient from a medical professional (Sahu: ¶ 0057, i.e., “The example processor 130 can receive a request, query, and/or other trigger via the communication interface 110” from “a user”; ¶ 0060, i.e., “a query of patient medications can be processed by an AI model of the digital twin 140 to identify a reaction (or likelihood of reaction) among the current and/or proposed medications in the query with respect to the particular patient modeled by the digital twin 140”; ¶ 0077, i.e., “a user” includes “healthcare practitioner (e.g., doctor, nurse, technician, administrator, etc.), other provider”), and answers on behalf of the patient using a digital twin (Sahu: ¶ 0061, i.e., “access information from the digital twin 140…to answer a query”) that reproduces a condition of the patient (Sahu: ¶ 0044),
the medical information processing device comprising processing circuitry (Sahu: ¶ 0056; ¶ 0129; ¶ 0132-0133) configured to:
receive the question (Sahu: ¶ 0057, i.e., “The example processor 130 can receive a request, query, and/or other trigger via the communication interface 110” from “a user”; ¶ 0060, i.e., “a query of patient medications can be processed by an AI model of the digital twin 140 to identify a reaction (or likelihood of reaction) among the current and/or proposed medications in the query with respect to the particular patient modeled by the digital twin 140”; ¶ 0118);
acquire at least medical condition information representing a medical condition of the patient (Sahu: ¶ 0119);
update the digital twin based on the medical condition information (Sahu: ¶ 0120);
use the digital twin to output answer information representing the answer to the received question (Sahu: ¶ 0122-0123); and
generate display data for presenting the answer information and cause a display device to display the display data (Sahu: ¶ 0125).
Yet, Sahu does not explicitly teach, but ZHANG teaches, in the same field of endeavor,
wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model (ZHANG: ¶ 00018, i.e., “Building digital twins with large language models”; ¶ 00081, i.e., “LLMs refer to deep neural networks trained on vast amounts of text with billions of parameters that can understand and generate human-like text… answering health questions to clinical diagnostics and mortality prediction”),
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the digital twin is an Al model trained by adding information on the patient to at least a large language model, as taught by ZHANG, within the system of Sahu, with the motivation to “enhance the ability to make informed decisions in scenarios where the underlying mechanisms are not clear” (ZHANG: ¶ 00081).
Regarding claim 2, Sahu and ZHANG teach the medical information processing device according to claim 1,
wherein the processing circuitry is configured to:
determine whether the answer to the received question can be provided using the current digital twin (Sahu: ¶ 0119, i.e., “external information needed and/or otherwise associated with a response to the input is identified…[only] some information can be modeled within the digital twin 140”);
extract missing information that is missing to answer the question if it is determined that the answer to the question cannot be provided (Sahu: ¶ 0119, i.e., “external information needed and/or otherwise associated with a response to the input is identified. For example, patient records, image data, scheduling/availability information, etc., located eternal to the digital twin 140 can be identified”);
acquire new medical condition information corresponding to the patient if the missing information is extracted (Sahu: ¶ 0119, i.e., “other information can be retrievable from another element of the apparatus 100 and/or an external source such as an EMR, PACS, RIS, CVIS, HIS, LIS, etc. At block 1030, the identified additional information is retrieved and/or otherwise accessed by the digital twin 140”); and
update the digital twin to include the new medical condition information (Sahu: ¶ 0120).
Regarding claim 3, Sahu and ZHANG teach the medical information processing device according to claim 2,
wherein the processing circuitry is configured to:
extract a difference between previous medical condition information of the patient and the new medical condition information of the patient (Sahu: ¶ 0119, i.e., “external information needed and/or otherwise associated with a response to the input is identified. For example, patient records, image data, scheduling/availability information, etc., located eternal to the digital twin 140 can be identified. As such, some information can be modeled within the digital twin 140 and other information can be retrievable from another element of the apparatus 100 and/or an external source such as an EMR, PACS, RIS, CVIS, HIS, LIS, etc.”); and
update the digital twin to include the new medical condition information if the difference between the previous medical condition information and the new medical condition information is extracted (Sahu: ¶ 0120).
Regarding claim 4, Sahu and ZHANG teach the medical information processing device according to claim 1, wherein the medical condition information includes patient information recorded when the patient was examined (Sahu: ¶ 0039, i.e., “a patient record provides identification information, allergy and/or ailment information, history information, orders, medications, progress notes, flowsheets, labs, images, monitors, summary, administrative information, and/or other information”; ¶ 0119), and examination information representing results of examination performed on the patient (Sahu: ¶ 0119, i.e., “image data” represents results of imaging, or examination, performed on the patient).
Regarding claim 5, Sahu and ZHANG teach the medical information processing device according to claim 4, wherein the patient information includes first patient information that is the patient information recorded when the patient was examined (Sahu: ¶ 0039, i.e., “image data” is recorded when the patient is imaged, or examined, during an imaging session), and second patient information that is the patient information based on living records output by a collection device that collects living conditions of the patient (Sahu: ¶ 0033, i.e., “A patient electronic medical record (EMR), electronic health record (EHR), and/or other record include a medical history for a patient and include data with time stamps (or times and dates at which data was collected or entered). Types of data can include…imaging acquisition”; ¶ 0035; ¶ 0039, i.e., “a patient record provides…history information”).
Regarding claim 6, Sahu and ZHANG teach the medical information processing device according to claim 5, wherein the second patient information includes third patient information about the patient that was not recorded when the patient was examined (Sahu: ¶ 0033, i.e., “test result” is recorded after the patient is examined).
Regarding claim 7, claim 7 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 7 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding claim 8, claim 8 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 8 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2024/0161913 A1 teaches responding to a search query for biological information specific to a patient by using a digital twin.
“Concepts and applications of digital twins in healthcare and medicine” teaches creating a digital twin of a patient by feeding the model with data and interactions.
WO 2021/030637 A1 teaches generating a digital twin of the patient’s metabolic health including machine learning models and updated data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571) 272-8317. The examiner can normally be reached on M-Th 7-4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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