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 .
Claims 1-26 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 7/24/2023, 11/15/2023, and 2/12/2025 have been considered. Signed copies are enclosed.
Specification
The use of the terms TWEEN and multiple others on at least pages 44, and 50-51, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
It is noted that the cited occurrences of improper use are only exemplary and applicant should review the specification to correct any other use of trademarks.
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 8-9, 12, and 17 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8-9 and 12 recite broad recitations followed by a narrower limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 17 is indefinite because it is not clear how it fits into the parent claim. The parent claim requires a prebiotic component comprising at least one punicalagin but claim 17 requires that the prebiotic component consist essentially of a polyphenolic pomegranate derivative or extract that comprises the punicalagin. It is not clear what components are required or prevented by the term “consist essentially of”. Further, it is not clear how the component can “consist essentially of” an extract that “comprises” punicalagin since the extract is open by virtue of the “comprising” language.
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.
Claims 1-26 are rejected 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).
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). Further, “treating” is defined as including ameliorating symptoms of disease and delaying onset of a disease that has not occurred yet (see page 18). Therefore, administration of the synbiotic as directed in the Seed Health reference necessarily treats 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).
Conclusion
No claim is allowed.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached at 571-272-0835. 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