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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/14/2026 is acknowledged.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
When there are drawings, there shall be a “brief description of the several views of the drawings” (See 37 C.F.R. 1.74.).
The section heading “brief description of the several views of the drawings” as set forth in 37 C.F.R. 1.74 is missing. Please correct.
Claim Objections
Claim 6 is objected to because of the following informalities: a semicolon “;” is missing after the word “status” in line 13. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: a semicolon “;” is missing after the word “diabetes” in line 21. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: a period “.” Instead of a semicolon “;” is after the word “vaccine” in line 23. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: a semicolon “;” is missing after the word “status” in line 13. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: a semicolon “;” is missing after the word “diabetes” in line 21. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: a period “.” Instead of a semicolon “;” is after the word “vaccine” in line 23. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a semicolon “;” is missing after the word “status” in line 13. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a semicolon “;” is missing after the word “diabetes” in line 21. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a period “.” Instead of a semicolon “;” is after the word “vaccine” in line 23. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a semicolon “;” is missing after the word “status” in line 13. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a semicolon “;” is missing after the word “diabetes” in line 21. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: a period “.” Instead of a semicolon “;” is after the word “vaccine” in line 23. Appropriate correction is required.
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.
Claims 1-8 and 10 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.
The phrase “determining the gut microbiome status” in Claim 1, line 3 is vague and indefinite as it is unclear how “determining … status” is possible without taking a biological sample of material from a subject. It appears a person could be eating an excellent diet which may be indicative of a healthy microbiome, however, the person’s microbiome status may be poor due to unknown medical condition.
Furthermore, the mere “determining” without carrying out any physical/biological step on a subject does appear to provide any status.
Applicant is advised to consider setting forth specific method steps connecting “determining” to “status”.
The phrase “providing recommendations … in said subject” in Claim 1, line 4 is vague and indefinite as it is unclear how recommendations further limit the method of “determining … status” as providing recommendations is something that may be done after one determines that one’s status is not desirable and needs to be corrected.
Claim 2 recites the limitation "the microbiome activity" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating “microbiome activity".
The phrase “determination of microbiome status is by questionnaire” in Claim 2, lines 1-2 is vague and indefinite as it is unclear how it is possible without taking a biological sample of material from a subject. It appears a person could be eating an excellent diet which may be indicative of a healthy microbiome, however, the person’s microbiome status may be poor due to unknown medical condition.
The phrase “wherein said method is computer-implemented” in Claim 4, line 2 is vague and indefinite as it is unclear how determining status can be “computer-implemented” when determining status appears to require obtaining a biological sample.
Claim 6 recites the limitation "the feature parameters" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating “feature parameters".
Claim 6 recites the limitation "the location of exercise" in line 14. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “location of exercise".
Claim 7 recites the limitation "said feature parameters" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating “feature parameters".
Claim 8 recites the limitation "a subject" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the subject".
Claim 8 recites the limitation "the same geographic region" in line 6. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “a same geographic region ".
Clarification and/or correction required.
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)(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.
Claim(s) 1-4, 6, 7, 8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dominianni et al., Sex, Body Mass Index, and Dietary Fiber Intake Influence the Human Gut Microbiome (2015).
The claims are interpreted as being directed to a method for determining the gut microbiome status.
Claim 1 is not interpreted as having any method steps as no biological sample is collected.
Claim 1 is not interpreted as a method where anyone eats any food.
Claim 2 is not interpreted as having any method steps as asking questions does provide status as there is no connection between asking questions and a status.
Claim 4 is not interpreted as having any method steps as implementing a computer does not provide status.
Claim 6 is not interpreted as having any method steps as asking questions does provide status as there is no connection between answering questions and a status.
Claim 7 is not interpreted as having any method steps as asking questions does provide status as there is no connection between answering questions and a status.
Claim 8 is not interpreted as having any method steps as no biological sample is collected.
Claim 10 is not interpreted as having any method steps directed to the method for determining gut microbiome status as informing a subject is for a different method.
Regarding Claims 1, 2, 4, 6, 7, 8 and 10, Dominianni (2015) teaches a method of determining the microbiome status including ethnicity (See Abs., p. 2, last paragraph to p. 3, first paragraph, FIG-4, Table 4 where diets with fiber are evaluated for determining status.).
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Regarding Claim 3, Dominianni (2015) teaches wherein a biological sample of a subject is taken to determine microbiome status (See p. 2, para. 3+.).
Claim Rejections - 35 USC § 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, 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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dominianni et al., Sex, Body Mass Index, and Dietary Fiber Intake Influence the Human Gut Microbiome (2015).
Regarding Claim 5, Dominianni (2015) teaches the method discussed above, however, fails to expressly disclose wherein said method involves evaluation of feature parameters related to gut microbiome status as Low, Medium or High.
Applicant does not set forth any non-obvious unexpected results for selecting one status over another. It would have been foreseeable and obvious prior to the earliest effective filing date to select any subjective status, including the claimed scheme, one desires to evaluate status. The selection of status scheme would have been within the skill set of a person having ordinary skill in the art to provide a scheme for analyzing status.
Double Patenting
Claims 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/577,113 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because neither claim 1 in this application or claim 1 in copending Application No. 18/577,113 teach any steps of determining the effects of eating any food. The claim in this application refers to determining status while application 18/577,113 effects of food on. The mere reference to food are not process steps and do not further limit the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 2 of copending Application No. 18/684,723 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because neither claim 1 in this application or claims 1 and 2 in copending Application No. 18/684,723 teach any steps of determining the effects of eating any food. The claims in this application refer to The claim in this application refer to determining status while application 18/684,723 refers to types of polyphenols. The mere reference to fibers and polyphenols are not process steps and do not further limit the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T O'HERN whose telephone number is (571)272-6385. The examiner can normally be reached M-Th 5:00 am - 3:30 pm.
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/BRENT T O'HERN/ Primary Examiner, Art Unit 1793
January 17, 2026