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 .
Response to Arguments
Claim Interpretation
Applicant's arguments filed 08/21/2025 have been fully considered. Applicant argues that the amended claims no longer recite terms that invoke 112(f) and therefore the interpretation should be withdrawn. In response to Applicant’s argument and the amendments, the claim interpretations under 112(f) are withdrawn.
Rejection Under 112
Applicant's arguments filed 08/21/2025 have been fully considered. Applicant argues that the claim amendments resolve the 112 issues and the rejection should be withdrawn. In response to Applicant’s argument and the amendments, the rejection under 112(a) and (b) are withdrawn, however, due to the amendments new issues have come up that necessitated a new 112(a) rejection. See the updated rejection for further clarification.
Rejection Under 101
Applicant's arguments filed 08/21/2025 have been fully considered. Applicant argues that the amended claims recite a practical application of any alleged concept including executing control to inform a recommendation of suggestions for improving a health condition to the user. In response to Applicant’s argument, the claims do not recite a practical application since the additional elements do not amount to anything more than invoking computers as a tool to perform the abstract idea. Additionally, the limitation at issue is part of the abstract idea and not considered an additional element. See the updated rejection for further clarification.
Rejection Under 103
Applicant's arguments filed 08/21/2025 have been fully considered. Applicant argues that the amended claims are not taught by the prior art. Additionally, the combination of Cykinso and Konica would not have suggested the combinations of limitations recited in the amended claims, specifically the executing a second determination that determines a type of gut microbiota the user applies… executing a recommendation…. In response to Applicant’s argument, the argument appears to be directed toward the amendment and is therefore moot. Cykinso and Konica do teach the newly amended limitations. See the updated rejection below.
Claim Objections
Claims 2 and 6 are objected to because of the following informalities: the claims recite multiple different DB’s throughout the claims. Applicant’s drawing in Fig. 6 shows three DB’s within storage unit 18. However, the abbreviation “DB” is not defined in the specification. Examiner is construing “DB” to mean database, since one of ordinary skill in the art would understand DB stands for database. Applicant is advised to clarify that DB is abbreviated for database. Appropriate clarification is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and similarly with the other independent claims, the claim recites “executing a second determination that determines a type to which gut microbiota of the user applies, among a plurality of enterotypes regardless of the score on the basis of the gut bacteria data.” The specification does not appear to have sufficient support for determining a type from among a plurality of enterotypes regardless of the score. The specification at [0078] and similarly at [0105] seem to indicate that the determination of a type is not regardless of the score of gut health. The dependent claims are also rejected for inheriting the issues of their corresponding independent claims. Appropriate correction is required.
Regarding claim 2, the claim recites “a proposal DB” in the fifth line of the amended claims. However, there does not appear to be a proposal DB mentioned in the specification. The specification only mentions three DB’s: a subject DB181, a classification DB182, and a suggestion DB183 (see [0047]). For this claim, Examiner is interpreting the proposal DB to be a typo and the claim instead to be a first information managed by the classification DB and a second information managed by the suggestion DB. 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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-3, 6-7 are drawn to a device, which is within the four statutory categories (i.e. process). Claim 4 is drawn to a method, which is within the four statutory categories (i.e. apparatus). Claim 5 is drawn to a non-transitory computer readable medium, which is within the four statutory categories (i.e. manufacture).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 1 (and substantially similar with independent claims 4, 5) recites:
An information processing device for managing recommendations corresponding to groups to which subjects including a user belong, comprising:
a processor coupled to a storage unit, having control instructions stored thereon, which, when executed by the processor, causes the information processing device to perform a control process comprising:
acquiring gut bacteria data for each subject including the user;
executing a first determination that determines a score that indicates a health level of a gut microbiome for each subject including the user on a basis of the gut bacteria data;
executing a second determination that determines a type to which gut microbiota of the user applies, among a plurality of enterotypes regardless of the score on the basis of the gut bacteria data;
classifying each of the subjects including the user into any one of a plurality of groups to which the subjects belong according to a combination of a result of the first determination and a result of the second determination;
managing the recommendations to be proposed for each of the groups; and
executing control to inform a recommendation including suggestions for improving a health condition of the user to the user on the basis of the group to which the user belongs.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behaviors or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the processing device, processor coupled to a storage unit, non-transitory computer readable medium storing a program, the limitations of the claim encompass following steps to make determinations of a patient’s gut health and then provide health recommendations for them to improve their conditions. If a claim limitation, under its broadest reasonable interpretation, covers personal behaviors or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-3, 6-7 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 1 (and substantially similar with independent claims 4, 5) recites:
An information processing device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) for managing recommendations corresponding to groups to which subjects including a user belong, comprising:
a processor coupled to a storage unit, having control instructions stored thereon, which, when executed by the processor, causes the information processing device to perform a control process comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
acquiring gut bacteria data for each subject including the user;
executing a first determination that determines a score that indicates a health level of a gut microbiome for each subject including the user on a basis of the gut bacteria data;
executing a second determination that determines a type to which gut microbiota of the user applies, among a plurality of enterotypes regardless of the score on the basis of the gut bacteria data;
classifying each of the subjects including the user into any one of a plurality of groups to which the subjects belong according to a combination of a result of the first determination and a result of the second determination;
managing the recommendations to be proposed for each of the groups; and
executing control to inform a recommendation including suggestions for improving a health condition of the user to the user on the basis of the group to which the user belongs.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of processing device, acquisition unit, first determination unit, second determination unit, and information unit, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0036], [0046], [0094], see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim 2 recites making suggestions on intake of dietary supplements, which amounts to furthering the abstract idea; claim 3 recites making a suggestion with a score and type together, which amounts to furthering the abstract idea; claim 6 recites storing information in a subject DB and the classification is performed based on results of the first and second determination and the data of health conditions, thus amounting to furthering the abstract idea and also invoking computers as a tool to perform the abstract idea; claim 7 recites where the data on the health conditions is obtained through a questionnaire thus furthering the abstract idea; and claims 2-3, 6-7 recite additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using processing device, acquisition unit, first determination unit, second determination unit, and information unit, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0046]); using a processor (see 112(f) claim interpretation), processing device, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, amounts to furthering the abstract idea, the other recited additional elements, as discussed above with respect to integration of the abstract idea into a practical application are mere instructions to apply an exception and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
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 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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over CYKINSO INC. (JP 2020/078273) in view of KONICA MINOLTA INC. (WO 2020/202738).
Regarding claim 1, Cykinso discloses an information processing device for managing recommendations corresponding to groups to which subjects including a user belong, comprising:
a processor coupled to a storage unit, having control instructions stored thereon, which, when executed by the processor, causes the information processing device to perform a control process comprising: ([0043] The information processing device 10 is a server type computer including a CPU, a ROM, a RAM, an input/output interface, and the like. [0048] The information processing device 10 includes an information acquisition unit 101, a scoring item extraction unit 102, and a determination reference value setting function unit that is realized by a program stored in a ROM or placed in a RAM in cooperation with a CPU)
acquiring gut bacteria data for each subject including the user; ([0046]-[0049] information acquisition unit 101 acquires information from the user including intestinal bacteria information)
executing a first determination that determines a score that indicates a health level of a gut microbiome for each subject including the user on a basis of the gut bacteria data; ([0054] the intestinal flora score calculation unit 105 determines and calculates the intestinal flora score [0044] the score is for determining whether the target user has intestinal dysbiosis based on the data used to calculate the score)
executing a second determination that determines a type to which gut microbiota of the user applies, among a plurality of enterotypes regardless of the score on the basis of the gut bacteria data; and ([0010] The system according to (8), wherein the diarrhea constipation-related index is enterotype. (14) The determination reference value is set based on a comparison of the inspection value distributions of the determination reference value setting population of each item included in the index [0054]-[0058] determination unit 106 determines the intestinal dysbiosis in the target user based on the predetermined criteria of scores and ranges for which the user belongs. The enterotypes results are then transmitted to the user device of the user for display)
classifying each of the subjects including the user into any one of a plurality of groups to which the subjects belong according to a combination of a result of the first determination and a result of the second determination; ([0055] and [0063] The enterotypes results are then transmitted to the user device of the user for display where the types were determined based on the score and type)
managing the recommendations to be proposed for each of the groups; ([0055] and [0063] The enterotypes results are then transmitted to the user device of the user for display)
executing control to inform the user on the basis of the group to which the user belongs. ([0055] and [0063] The enterotypes results are then transmitted to the user device of the user for display where the types were determined based on the score and type {construed as the user’s group})
Cykinso does not appear to disclose the following, however, Konica teaches it would be well known in the art of healthcare data processing to make:
a recommendation including suggestions for improving a health condition of the user ([0050] control unit 31 outputs advice relating to the improvement of the intestinal flora based on the test results).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Cykinso to incorporate suggestions for improving a health condition of the user, as taught by Konica, in order to provide advice to the user to help improve their gut health based on their gut bacteria data. See Konica [0050].
Regarding claim 2, Cykinso-Konica teaches the information processing device according to claim 1, and Cykinso further discloses: further comprising: a classification DB and a suggestion DB provided in one region of the storage unit, a first information about the group managed by the classification DB (Cykinso [0048] storage unit 110 includes an intestinal bacterium database (DB) 111, a scoring item information database (DB) 112, and a determination reference database. (DB) 113 is included [0052] At least one index selected from the group or a scoring item included in the index is extracted and stored in the scoring item information DB 112. Further, in step S2, the determination reference value setting unit 103 sets the determination reference value and the determination score for each scoring item from the information stored in the scoring item information DB 112, and stores them in the determination reference DB.)
And Konica further teaches:
a second information about the recommendation managed by a proposal DB are associated with each other for each group; and the recommendation includes information about the supplements that are suggested for intake and purchase (Konica [0036] The storage unit 33 is composed of a hard disk, a nonvolatile semiconductor memory, or the like, and stores various processing programs, parameters and files necessary for executing the programs, and the like. The storage unit 33 stores an inspection result management DB (Database) 331, an attribute information DB 332, a question information table 333, a countermeasure product table 334, and the like. [0042] a recommendation of a food or countermeasure product to ingest for the improvement goal can be a supplement suggestion).
The combination of references was discussed above in the rejection of claim 1 and is incorporated herein.
Regarding claim 3, Cykinso-Konica teaches the information processing device according to claim 1, and Cykinso further discloses: wherein the executing control to inform to the user includes executing control to inform of the score and the type (Cykinso [0055] and [0063] The enterotypes results are then transmitted to the user device of the user for display where the types were determined based on the score and type)
And Konica further teaches:
Informing of at least one feature of the results. (Konica [0050] control unit 31 outputs advice relating to the improvement of the intestinal flora based on the test results).
The combination of references was discussed above in the rejection of claim 1 and is incorporated herein.
Regarding claim 4, the claim recites similar limitations as those already addressed in the rejection of claim 1, and, as such, is rejected for similar reasons as given above.
Regarding claim 5, the claim recites similar limitations as those already addressed in the rejection of claim 1, and, as such, is rejected for similar reasons as given above.
Regarding claim 6, Cykinso-Konica teaches the information processing device according to claim 2, and Cykinso further discloses: further comprising a subject DB provided in one region of the storage unit, wherein in the subject DB, the gut bacteria data and data on health conditions are associated with information that can uniquely identify each subject, and are managed, and wherein the classification is performed based on a combination of the result of the first determination, the result of the second determination, and the data on health conditions. (Cykinso [0050] Upon receiving the intestinal bacterium data of the user, the information acquisition unit 101 stores the intestinal bacterium information DB 111 in association with the user identification information. The intestinal bacterium information DB 111 stores intestinal bacterium data thus collected from a plurality of users. The intestinal bacterium information DB 111 includes user identification data and questionnaire information data. When the information acquisition unit 101 receives the user questionnaire data, the information acquisition unit 101 stores it in the scoring item DB 112 in association with the user identification information [0054] the intestinal flora score calculation unit 105 determines and calculates the intestinal flora score [0044] the score is for determining whether the target user has intestinal dysbiosis based on the data used to calculate the score [0010] The system according to (8), wherein the diarrhea constipation-related index is enterotype. (14) The determination reference value is set based on a comparison of the inspection value distributions of the determination reference value setting population of each item included in the index [0054]-[0058] determination unit 106 determines the intestinal dysbiosis in the target user based on the predetermined criteria of scores and ranges for which the user belongs. The enterotypes results are then transmitted to the user device of the user for display).
Regarding claim 7, Cykinso-Konica teaches the information processing device according to claim 6, and Cykinso further discloses: wherein the data on health conditions is based on at least one of information about health conditions obtained through a questionnaire given to each of the subjects including the user and any information on a health not based on the questionnaire. (Cykinso [0049] The information acquisition unit 101 acquires various types of information from the user device 30 and/or the inspection organization 40 via the network 20, and causes the storage unit 110 to store the information. The information received from the user device 30 and/or the inspection organization 40 includes intestinal bacterial data of the user, information (questionnaire data) regarding answers to questions (questionnaire) to the user, and user identification information (name and birth date of the user). The date, address, telephone number, mail address used by the user, ID set by the user, etc.) are included. The user identification information may include the identifier of the user device 30 used by the user. [0050] Upon receiving the intestinal bacterium data of the user, the information acquisition unit 101 stores the intestinal bacterium information DB 111 in association with the user identification information. The intestinal bacterium information DB 111 stores intestinal bacterium data thus collected from a plurality of users. The intestinal bacterium information DB 111 includes user identification data and questionnaire information data. When the information acquisition unit 101 receives the user questionnaire data, the information acquisition unit 101 stores it in the scoring item DB 112 in association with the user identification information).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached at (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA R. COVINGTON/Examiner, Art Unit 3686 /JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686