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 .
Applicant’s amendment and remarks filed on 4/1/2026 are acknowledged. Claims 1-5, 8-9, and 12 are amended. Claim 17 is cancelled. Claims 1-16 and 18-26 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 1/8/2026 has been considered. A signed copy is enclosed.
Objections Withdrawn
The objection to the use of the terms TWEEN and multiple others on at least pages 44, and 50-51, is withdrawn in light of applicant’s amendment thereto.
Claim Rejections Withdrawn
The rejection of claims 8-9, 12, and 17 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of applicant’s amendment thereto.
The rejection of claim 17 under 35 U.S.C. 102(a)(1) as being anticipated by Seed Health (https://web.archive.org/web/20190709011721/https://shop.seed.com/products/female-daily-synbiotic; 7/9/2019; accessed 9/27/2025) is withdrawn. The cancellation of the claim renders the rejection moot.
Claim Rejections Maintained
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.
The rejection of claims 1-16 and 18-26 under 35 U.S.C. 102(a)(1) as being anticipated by Seed Health (https://web.archive.org/web/20190709011721/https://shop.seed.com/products/female-daily-synbiotic; 7/9/2019; accessed 9/27/2025) is maintained for the reasons set forth in the previous office action. The rejection has been updated to reflect applicant’s claim amendments.
The instant claims are drawn to methods for treating disease in a human subject comprising administering a synbiotic composition.
Seed Health discloses a daily synbiotic composition comprising the 24 probiotic strains recited by the instant claims, along with punicalagins purified from pomegranate (see page 3 and 9-10). The synbiotic is administered to improve digestive health, thereby easing bloating and alleviating constipation, to promote heart health, to support healthy mitochondrial metabolism, and to support production of urolithin-A, among other benefits. Whiles the reference does not specifically mention all of the specific diseases recited in the claims, it is noted that the instant specification defines “disease” to include symptoms of said diseases (see page 17). The claims recite reducing the risk of acquiring or developing a disease, disorder, or condition. Therefore, administration of the synbiotic as directed in the Seed Health reference necessarily reduces the risk of acquiring or developing any and all diseases recited in the claims (assuming the method works as applicant claims). The synbiotic is administered as a swallowable capsule containing 190mg of prebiotic and 53.6 billion AFU of bacteria (see page 10). The dose is two capsules daily and each capsule comprises an inner capsule containing the probiotic and an outer capsule comprising the prebiotic (see pages 3-4). As the product appears to be the same product produced by the same company that is filing the instant claims, absent evidence to the contrary, it is assumed that the capsule meets the limitations of claim 12 regarding the proportion of cells and dissolution of the capsules. The product is provided for daily use as a 30 day supply, which is “at least about 7 days” (see page 1 and 4).
Applicant argues: That the claims have been amended to remove the recitation of “treating” a disease and the examiner’s logic is inapposite to the amended language.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons: The new language of “reducing the risk of acquiring or developing” a disease is anticipated for the same reasons set forth previously. In order for this to happen, the subject must not have the disease and, if the claimed method works as applicant suggests, then administration of the same composition to the same population would necessarily result in the same outcome.
Conclusion
No claim is allowed.
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 Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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