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 .
Claims
Claims 3, 5-7, 11 and 17-19 are pending.
Examiner’s Note
When making amendments to the claims Applicant is advised to be careful and not add new matter. If Applicant believes that support is present in the Figures then Applicant is advised to consider amending the text of the Specification to capture the new limitations while being careful not to add new matter. Applicant is advised to precisely point out where in the disclosure as filed, not the PGPUB, support is present for any amendments.
WITHDRAWN OBJECTIONS
All objections of record in the Office Action mailed 11/7/2025 have been withdrawn due to Applicant’s amendments in the Paper filed 2/9/2026.
WITHDRAWN REJECTIONS
All rejections of record in the Office Action mailed 11/7/2025 have been withdrawn due to Applicant’s amendments in the Paper filed 2/9/2026.
NEW REJECTIONS
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Official Correspondence.
Claim Rejections - 35 USC § 112
Claims 3, 5-7, 11 and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is vague and indefinite as it is unclear how this claim further limits the claims of maintaining or improving a subject's gut microbiota diversity when no positive method is set forth but rather a general statement.
Claim 7 is vague and indefinite as it is unclear how this claim further limits the claims of maintaining or improving a subject's gut microbiota diversity when no positive method is set forth but rather a general statement.
The phrase “method for maintaining or improving a subject's gut microbiota diversity … gut microbiota diversity” in Claim 11, lines 1-9 is vague and indefinite as it is unclear how gut microbiota diversity can be maintained or improved when a subject’s microbiota diversity is not known, and a person is not required to eat anything.
The phrase “determining the potential ...” in Claim 11, lines 3-7 is vague and indefinite as it is unclear how potential further limits maintaining or improving a subject's gut microbiota diversity as no positive method step is set forth.
The phrase “adjusting the subject’s present diet …” in Claim 11, lines 8-9 is vague and indefinite as it is unclear how an unknown present diet when the specific diet is not set forth and the diet may already be far superior to what may be adjusted and already include 6 or 10 or 20 or 30 or more fibers.
Claim 17 recites the limitation "the effects" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating “effects”.
Claim 17 recites the limitation "the subject’s gut microbiota data" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating “subject’s gut microbiota data”.
Claim 17 is vague and indefinite as it is unclear what “data” is referring to and whether a sample of a subject’s gut microbiota is taken.
The phrase “relative abundance” in Claim 18, line 2 is vague and indefinite as it is unclear what the abundance is being compared to.
The phrase “absolute abundance” in Claim 18, line 2 is vague and indefinite as it is unclear whether this a mass or number or something else.
Claim 19 recites the limitation "the adjustment" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating “adjustment”.
The phrase “determining the effects” in Claim 19, line 2 is vague and indefinite as it is unclear what criteria is used to determine whether and what effects have occurred.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 3, 5-7, 11, 17-19 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 maintaining or improving a subject's gut microbiota.
Claim 11 is not interpreted as having any method steps of maintaining or improving.
The phrase “determining the potential …” in Claim 11, lines 3-7 is not a method step of maintaining or improving but rather a general statement regarding fiber.
The phrase “adjusting the subject’s present diet …” in Claim 11, lines 8-9 is not a method step of maintaining or improving but rather adjusting an unknown diet that may or not be excellent including already having 6 or 10 or 20 or 30 more fibers.
Claim 3 is not interpreted as having any method steps and thus does not further limit the claimed method. Claim 3 is merely a general conclusion about microbiota diversity.
Claim 5 is not interpreted as having any method steps and thus does not further limit the claimed method. Claim 5 is merely lists various fibers.
Claim 6 is not interpreted as having any method steps and thus does not further limit the claimed method. Claim 6 is merely to a dietary index.
Claim 7 is not interpreted as having any method steps and thus does not further limit the claimed method. Claim 7 is merely a general conclusion relating an index to microbiota.
Claim 17 is not interpreted as having any method steps of maintaining or improving.
Claim 18 is not interpreted as having any method steps of maintaining or improving.
Claim 19 is not interpreted as having any method steps of maintaining or improving.
Regarding Claims 11, 3, 5-7, and 17-19 Dominianni (2015) teaches a method of maintaining or improving a subject’s microbiota (See Abs., p. 2, last paragraph to p. 5, FIG-4, wherein sequence data is taken from subjects to evaluate how their microbiota responds to the various types of fibers.),
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Double Patenting
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 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 11 in this application or claims 1 and2 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 types of fibers 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.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/254,058 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 in this application and claims 1, 2 in Application No. 18/254,058 because the language in both sets of claims essentially state the same limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
ANSWERS TO APPLICANT’S ARGUMENTS
The limitations of the amended/new claims are discussed above.
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.
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 February 17, 2026