DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to the response filed 20 April 2026, on an application filed 7 February 2025, which claims foreign priority to a Japanese application filed 16 February 2024.
Claims 1, 7 and 8 have been amended.
Claim 4 has been canceled.
Claims 1-3 and 5-8 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 7 and 8 recite the step of generating summary text of the explanatory text with use of a large language model with the explanatory text used as an input. The patent application does not provide an adequate formula or algorithm explaining how the summary text is generated. For example, the specification, in paragraph [0031] states the system uses a large language module to generate summary text. The specification does not, however, disclose an adequate formula or algorithm for generating summary text. Therefore, one skilled in the art of healthcare intervention, upon reading the specification, would not conclude that the inventor had possession of the claimed inventions on the day the application was filed.
Claims 1, 7 and 8 recite the step of inferring, based on the summary text and the medical information, a symptom candidate for the symptom in the patient. The patent application does not provide an adequate formula or algorithm explaining how the symptom candidate is inferred. For example, the original specification, in paragraph [0037] states the system uses a large language module to infer a symptom candidate. The specification does not, however, disclose an adequate formula or algorithm for inferring a symptom candidate. Therefore, one skilled in the art of healthcare intervention, upon reading the specification, would not conclude that the inventor had possession of the claimed inventions on the day the application was filed.
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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.
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.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1, 7 and 8 recite the limitation in such a manner that … . As written, it is unclear whether the limitation following this phrase is required by the claim; accordingly the metes and bounds of the claims are unclear.
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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 1-8 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.
Step 1
Claims 1-3 and 5-8 are within the four statutory categories. Claims 1-6 are drawn to a symptom understanding assist apparatus, which is within the four statutory categories (i.e. machine). Claim 7 is drawn to a symptom understanding assist method, which is within the four statutory categories (i.e. process). Claim 8 is drawn to a computer-readable non-transitory recording medium having recorded thereon a symptom understanding assist program for causing a computer to function as a symptom understanding assist apparatus, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1 recites: A symptom understanding assist apparatus, comprising
at least one processor, the at least one processor carrying out:
an explanation acquiring process of acquiring explanatory text of an explanation made by a patient about a symptom in the patient;
a summary generating process of generating summary text of the explanatory text with use of a large language model with the explanatory text and text information instructing generation of a summary of the explanatory text used as an input;
a medical information acquiring process of acquiring medical information regarding the patient;
a symptom inferring process of inferring, with use of an inference model with a combination of the summary text and the medical information used as an input, a symptom candidate for the symptom in the patient, the inference model being a model generated by machine learning; and
an outputting process of making displaying equipment display outputting the summary text and the symptom candidate inferred, wherein the medical information acquiring process is carried out in parallel with the summary generating process before carrying out the symptom inferring process.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea a certain method of organizing human activity because they recite a process that comprise managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case the use of patient data to infer a diagnosis based thereon – a process performed in a patient encounter.), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 7 and 8 are identical as the abstract idea for claim 1, because the only difference between claims 1, 7 and 8 is that claim 1 recites an apparatus, whereas claim 7 recites a method and claim 8 recites a non-transitory computer-readable media.
Dependent claims 2, 3, 5 and 6 include other limitations, for example claims 2, 5 and 6 recite further details regarding the medical information or symptom candidate information and claim 3 recites data conversion, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2, 3, 5 and 6 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-6 are nonetheless directed towards fundamentally the same abstract idea as independent claim 1.
Prong 2 of Step 2A
Claims 1-3 and 5-8 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of LLM and the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph 55 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to medical data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2, 3, 5 and 6 include other limitations, but these limitations also amount to no more than mere instructions to apply the exception (e.g. claim 4 presents a trained model generated by machine learning), and/or do not include any additional elements beyond those already recited in independent claims 1, 7 and 8, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1-3 and 5-8 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the structural components of the computer), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Paragraph 55 of the Specification discloses that the additional elements (i.e. the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data ) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 2, 3, 5 and 6 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 7 and 8, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. claim 4 presents a trained model generated by machine learning), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-3 and 5-8 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 102(e) as being anticipated by Kannan et al. (U.S. PG-Pub 2019/0311814 A1), hereinafter Kannan.
As per claims 1, 7 and 8, Kannan discloses a computer-readable non-transitory recording medium having recorded thereon a symptom understanding assist program for causing a computer to function as a symptom understanding assist apparatus, a symptom understanding assist method, and a symptom understanding assist apparatus (Kannan, see Figs. 1, 4, 10 and 16.), comprising
at least one processor, the at least one processor carrying out (Kannan, see Figs. 1, 4, 10 and 16.):
an explanation acquiring process of acquiring explanatory text of an explanation made by a patient about a symptom in the patient (Kannan, system acquires patient dialog information including information about symptoms, see paragraphs 72-76.);
a summary generating process of generating summary text of the explanatory text with use of a large language model with the explanatory text and text information instructing generation of a summary of the explanatory text used as an input (System processes patient dialog information to summarize and output determined symptoms, see Kannan Fig. 10. Kannan utilizes an LLM, see paragraph 137. User inputs text information regarding the summarization, see Fig. 10, wherein a user inputs “LOOKS GOOD” in order to provide instructions corresponding to generating and confirming the generated summary text of “Headache” and “General Malaise”.);
a medical information acquiring process of acquiring medical information regarding the patient (Kannan, paragraphs 17, 43, 66, 77, 102 and 111.);
a symptom inferring process of inferring, with use of an inference model with a combination of the summary text and the medical information used as an input, a symptom candidate for the symptom in the patient, the inference model being a model generated by machine learning (Kannan determines potential diagnosis based on symptom and patient medical records using a diagnosis algorithm, see paragraphs 95-100, 103 and 104. Model is generated via training a machine learned model, see paragraphs 98-100 and Fig. 12.); and
an outputting process of making displaying equipment display the summary text and the symptom candidate inferred, and the explanatory text which has not yet been summarized in such a manner that they can be contrasted with each other (See Kannan, paragraphs 95-99, 103 and 104; and Figs. 1 #101, 10, 13 and 14 #1470. Explanatory text shown in Fig. 10 can be temporally contrasted with secondary screen showing symptom candidates, see Fig. 13.),
wherein the medical information acquiring process is carried out in parallel with the summary generating process before carrying out the symptom inferring process (System acquires medical information in order to generate a summary thereof, i.e., in parallel, which occurs before symptoms are inferred, see Kannan, paragraphs 95-99, 103 and 104; and Figs. 1 #101, 10, 13 and 14 #1470.).
As per claims 2, 3, 5 and 6, Kannan discloses claim 1, discussed above. Kannan also discloses:
2. wherein the medical information includes at least one selected from the group consisting of personal information regarding the patient, information on findings shown by a medical examination performed on the patient, and medical history information regarding the patient (Kannan, paragraph 17, 43, 66, 77, 102 and 111.);
3. wherein in the explanation acquiring process, the at least one processor converts, into text data, a speech picked up in the medical examination performed on the patient (Kannan, paragraph 81.);
5. wherein the medical information includes a diagnosis target image of the patient (Kannan, paragraphs 134 and 139-141.); and
6. wherein the symptom candidate is information to be used in decision making on diagnosis of the patient (Kannan determines potential diagnosis based on symptom and patient medical records, see paragraphs 95-99, 103 and 104.).
Response to Arguments
Applicant’s arguments filed 20 April 2026 concerning the rejection of all claims under 35 U.S.C. 101, 112 and 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 112, Applicant argues on pages 5-6 that the claims satisfy the written description requirement because paragraph 37 provides support. The Office respectfully disagrees. As indicated above, paragraph 37 generically states use of a large language model to infer a symptom candidate, but there is no clear indication how or if the system can actually perform the contested limitations. Therefore, one skilled in the art of healthcare intervention, upon reading the specification, would not conclude that the inventor had possession of the claimed inventions on the day the application was filed.
Accordingly, the rejection is upheld.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 6-7 that the claims comprise statutory material because:
A. The claims are not directed to a method of organizing human activity;
B. The claims integrate the claimed subject matter into a practical application of inferring a symptom candidate due to recitation of various input data; and
C. The claims recite significantly more then the identified abstract idea as they provide “a technical improvement by reducing noises (sic) and errors associated with verbose explanation provided by a patient.”
The Office respectfully disagrees. Please see the statutory rejection of the claims, issued above, wherein the claims are shown to be directed to an abstract idea without significantly more.
Regarding A., 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 Office 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 to use patient data to infer a diagnosis based thereon – a process performed in a patient encounter. Furthermore, the Office submits that healthcare itself is inherently represents the organization of human activity. 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 use patient data to infer a diagnosis based thereon – a process performed in a patient encounter, the claimed invention is directed to an abstract idea.
Regarding B., the office notes that the various additional limitations do not amount to significantly more, as shown by the statutory rejection above.
Regarding C., 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, the Applicant’s argued problem is not a technological problem caused by the computing environment. The problem of summarizing patient information was not a problem cause by the computer, is it 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 business problem. Because no technological problem is present, the claims do not provide a practical application.
Accordingly, the rejection is upheld.
With regard to the rejection of the claims under 35 USC 103, Applicant argues on page 6 that the claims are distinguished from the prior art due to the inference model using summary text and medical information being used as a combined input.
The Office respectfully disagrees. As shown above, Kannan determines potential diagnosis based on symptom and patient medical records using a diagnosis algorithm, see paragraphs 95-100, 103 and 104. Model is generated via training a machine learned model, see paragraphs 98-100 and Fig. 12.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Kannan based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Action (2 February 2026), and incorporated herein.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
11 June 2026
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