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
Claims 23-27 are withdrawn. Claims 23-32 are pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. This application is a 371 of PCT/JP2022/003385, filed on 01/28/2022.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. §119 (a)-(d). The certified copies of JP2021-012817, 01/29/2021, and JP2021-126318, 07/30/2021 were submitted on 27 July 2023.
Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
Claims 28-32 have the effective filing date of 30 July 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 July 2023 and 21 January 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Restriction/Election
Applicant's election with traverse of Group II (Claims 28-32), in the reply filed on 17 November 2025, is acknowledged. The traversal is on the grounds that even if the prior art describes the relationship between Allobaculum's occupancy rate and obesity, this is a separate matter from the number of bacterial species belonging to the Erysipelotrichaceae family and the prior art does not destroy novelty regarding the "number of bacterial species." However, the claimed subject matter does not describe any specific number of bacterial species with regard to the functions of the various system 'means' as instantly-claimed (e.g., reception means for receiving data). In addition, in order to determine that Allobaculum is (or is not) associated with obesity, the prior art reference does show specific numbers (i.e., numerical values) of Allobaculum bacteria. Therefore, this argument is not found to be persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Group I, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement mailed on 15 September 2025 in the reply filed on 17 November 2025.
Claims 28-32 are rejected.
Claim Objections
Claims 23-28 are objected to because of the following informalities:
Claims 23-27 show incorrect status identifiers. Applicant is reminded that claims 23-27 should be labeled: “(Withdrawn)”; remaining claims should be identified appropriately (MPEP 714 (II)(C)(A)) (See 37 CFR 1.121 (c)). Applicant is required to provide a new claim set showing correct status identifiers in the response to this Office Action.
Claim 28 recites: "A system for predicting obesity in an animal, comprising: reception means for receiving data on the number of bacterial species...belonging to a predetermined bacterial family regarding bacteria present in the body of an animal or in a sample isolated from the animal; and determination means for predicting whether or not the animal will become obese from data on the number of bacterial species...belonging to a predetermined bacterial family regarding bacteria present in the body of an animal or in a sample isolated from the animal", which should read, for the purpose of clear antecedent basis: "A system for predicting obesity in an animal, comprising: reception means for receiving data on the number of bacterial species or occupancy rate of bacteria belonging to a predetermined bacterial family regarding bacteria present in the body of an animal or in a sample isolated from the animal; and determination means for predicting whether or not the animal will become obese from the data on the number of bacterial species...belonging to the predetermined bacterial family regarding bacteria present in the body of the animal or in the sample isolated from the animal."
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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 28-32 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. The judicial exception is not integrated into a practical application, and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The instant claims were analyzed for eligibility pursuant to the Patent Subject Matter Eligibility Guidance as presented in MPEP 2106. The instant claims are drawn to a system for predicting obesity.
As such, the instant claims are drawn to a machine, which is a statutory category of invention. (STEP 1: YES).
The claimed system for predicting obesity comprises: 1) a reception means for receiving data on the number of bacterial species or occupancy rate of bacteria belonging to a predetermined bacterial family; and 2) a determination means for predicting whether or not the animal will become obese from data on the number of bacterial species or occupancy rate of bacteria belonging to a predetermined bacterial family.
The broadest reasonable interpretation of the function of the reception means is that it receives or gathers data. The broadest reasonable interpretation of the determination means is that it falls within the mental process groupings of abstract ideas, because it covers concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04 (a)(2)(III).
As such, claim 28 recites a judicial exception (abstract ideas) in the form of a system for predicting obesity comprising a reception means and a determination means (STEP 2A, PRONG ONE: YES).
The instant claims are drawn to a system for predicting obesity which is a judicial exception (i.e., abstract ideas). The claims do not improve the functioning of a computer or other technology.
Claims 29 and 30 cite specific bacterial families considered to be the predetermined bacterial families. Claims 31 and 32 describe a proposal means for recommending food according to a prediction result.
These claims also recite aspects of the data gathering or mental process functions of the system. That is, there are no additional elements recited in the claimed subject matter beyond the judicial exception. See MPEP 2106.04 (d).
As such, the instant claims do not recite additional elements that integrate the judicial exception(s) into a practical application of the exception(s) (STEP 2A, PRONG TWO: NO).
The claims as a whole does not describe significantly more than the recited judicial exception (i.e., an abstract idea). The function of the reception means to receive data is considered to be an extra-solution activity performed to gather data, and is considered to be well-understood, routine and conventional. The function of the determination means for predicting whether or not the animal will become obese is considered to be a mental process See MPEP 2106.05 (d)(II).
As noted above, claims 29 and 30 cite specific bacterial families considered to be the predetermined bacterial families. Claims 31 and 32 describe a proposal means for recommending food.
As such, the instant claims as a whole do not describe significantly more than the recited judicial exception (Step 2B: NO).
In summary, the claimed subject matter describes a judicial exception which is not integrated into a practical application, and, as individual elements and as a combination of elements, does not recite ‘significantly more’ than the judicial exception. See Example 6: <http://www.uspto.gov/sites/default/files/documents/abstract_idea _ examples.pdf>.
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 U.S.C. § 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.
Claims 31 and 32 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 pre-AIA the applicant regards as the invention.
Claims 31 and 32 recite the limitation "the prediction result" in line 2. There is insufficient antecedent basis for this limitation in the claim.
35 U.S.C. §112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. §112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph, is invoked.
Claim 28 recites: "A system for predicting obesity in an animal, comprising: reception means for receiving data...; and determination means for predicting whether or not the animal will become obese..."
Claims 31 and 32 recite: "..., further comprising proposal means for recommending food..."
As explained in MPEP 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph:
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 U.S.C. § 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 28-30 are rejected under 35 U.S.C. §102(a)(1)/(a)(2) as being anticipated by Turnbaugh et al. (Pub. No. WO 2008/076696 A2 in IDS 21 January 2025).
Prior art which shows a computer or computer-related apparatus which performs the functions of the reception means and/or the determination means as described in claim 28 and/or which performs the function of the proposal means as described in claims 31 and 32 will be considered to inherently show a reception means, a determination means, and/or a proposal means.
Regarding claim 28, Turnbaugh et al. teaches a method of predicting risk for obesity or an obesity-related disorder in a host (pg. 14, para. [0034]). Turnbaugh et al. further teaches that an obese subject typically has fewer Bacteroidetes and more Firmicutes compared to a lean subject (pg. 15, para. [0039]). The described invention provides tools utilizing the gut microbiome as a diagnostic or prognostic biomarker for obesity risk (pg. 16, cont. para. [0039]). The method comprises, in part, providing a microbiome profile from a host, and providing a plurality of reference microbiome profiles, then selecting the reference profile most similar to the host microbiome profile, such that if the host's microbiome is most similar to a reference obese microbiome, the host is at risk for obesity or an obesity-related disorder. The reference profiles may be stored on a computer-readable medium such that software known in the art and detailed in the examples may be used to compare the microbiome profile and the reference profiles (pg. 54, para. [0097]). A profile may be digitally-encoded on a computer-readable medium. The term "computer-readable medium" as used herein refers to any medium that participates in providing instructions to a processor for execution" (pg. 52, para. [0094]). A particular profile may be coupled with additional data about that profile on a computer readable medium (pg. 53, para. [0095]).
Regarding claims 29 and 30, pertaining to Ruminococcaceae, Turnbaugh et al. teaches that an obese subject typically has fewer Bacteroidetes and more Firmicutes compared to a lean subject (pg. 15, para. [0039]). Generally speaking, to promote weight loss, the relative abundance of bacteria within the Bacteroidetes division is increased and optionally, the relative abundance of bacteria within the Firmicutes division is decreased (pg. 16, para. [0040]). The relative abundance of Bacteroidetes may be altered by increasing or decreasing the presence of one or more Bacteroidetes species that reside in the gut. Non-limiting examples of Bacteroidetes and Firmicutes species are listed in Table A (pg. 16, para. [0041]; and pg. 17, Table A). Table A lists several Ruminococcus species (pg. 17, Table A, #8, #11, #12 and #30).
Claim Rejections - 35 U.S.C. § 103
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. §102(b)(2)(C) for any potential 35 U.S.C. §102(a)(2) prior art against the later invention.
Claims 31 and 32 are rejected under 35 U.S.C. §103 as being unpatentable over Turnbaugh et al. (Pub. No. WO 2008/076696 A2) in view of Ueda et al. (Pub. No. JP 2006048177 A; see NPL as English machine translation (EngMT) for page/para. numbers).
Turnbaugh et al. does not specifically teach a proposal means for recommending food according to the prediction result by the determination means, as part of the system [Claims 31 and 32].
Ueda et al. teaches a dietary management system that proposes a specific meal menu for improving a meal content when a comprehensive evaluation is performed and the overall evaluation is low (pg. 2, para. [0001]). One aspect of the described invention is an obesity level evaluation means for processing the personal information by the comprehensive evaluation scoring means, and a meal information evaluation means for processing the meal information (pg. 4, para. [0007]). The obesity level evaluation means extracts the height, weight, and body fat percentage stored in the dietary management database, calculates the obesity level from the height and weight, and acquires numerical values (pg. 4, para. [0009] [nexus to Turnbaugh et al.- predicting obesity in an animal]). As a result of comprehensive evaluation, a specific meal menu is proposed (pg. 8, para. [0016]). The meal menu proposing means of the dietary management system (1) has a total evaluation score of 56, and the obesity level, the nutrient satisfaction level, and the food group are among the evaluated items. In order to improve the ratio of the animal food and the vegetable food, the meal menu related to the ratio is searched and extracted from the meal menu for three days to determine the degree of nutrient satisfaction. The meal menu that, in part, uses less oil and fat is selected (pg. 22, para. [0047]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system for predicting obesity comprising a reception means and a determination means, as taught by Turnbaugh et al., to add a proposal means for recommending food, as taught by Ueda et al., because Ueda et al. shows a system which evaluates or predicts whether or not the subject is obese, which is the system shown by Turnbaugh et al. (MPEP 2143 (I)(G)). One of ordinary skill in the art would have been motivated to have made that modification, because Ueda et al. shows that the eating habit management system can be individualized according to the information provided by the specific subject. Ueda et al. shows an application of the system to the specific customer Koichi Mikami (pg. 21, para. [0046]). An individualized outcome would be considered to provide the optimal therapeutic approach to reducing the obesity in the specific subject. There would have been a reasonable expectation of success because Turnbaugh et al. shows that in addition to administration of a composition of the described invention for weight loss, a subject may also be placed on a restricted calorie diet. Restricted calorie diets are helpful for increasing the relative abundance of Bacteroidetes and decreasing the relative abundance of Firmicutes. Representative diets include a reduced fat diet, reduced protein, or a reduced carbohydrate diet (pg. 26, para. [0061]). Therefore, it would have been obvious to one of ordinary skill in the art of devising a system for predicting obesity to also include in the system a proposal means which would recommend foods according to the obesity level of the animal, because both Turnbaugh et al. and Ueda et al. teach this proposal (MPEP 2143 (I)(G)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON M PAPCIAK whose telephone number is (571)272-6235. The examiner can normally be reached M-F 8:30am-5:00pm.
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/SMP/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657