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
Filing Receipt
The filing receipt mailed 10/02/2024 does not state earlier priority to any applications. The effective filing date is 05/25/2023.
Information Disclosure Statement
The information disclosure statement filed 09/05/2023 has been considered.
Restriction/Species Election
Applicant’s election of Group I, claims 1-15, without traverse is acknowledged.
Applicant’s election of the following is also acknowledged:
Luteolin, botanical agent.
Silymarin, additional compound.
Claim 8 is hereby withdrawn being drawn to a non-elected species. Claims 16-20 are hereby withdrawn being drawn to a non-elected invention.
Rejections
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.
Claim 6-7 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 6 contains the trademark/trade name Senactive® senolytic supplement. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an additional compound and/or composition and, accordingly, the identification/description is indefinite.
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) 1-7, 9-10, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Qualia (Qualia, Qualia Senolytic Product page, url=https://www.qualialife.com/shop/qualia-senolytic, accessed 03/02/2026) as evidenced Kelly (Qualia, Qualia Senolytic Ingredients, url=https://www.qualialife.com/the-formulator-s-view-of-the-qualia-senolytic-ingredients, accessed 03/02/2026, dated 5/15/2022).
Qualia discloses a composition comprising fisetin, quercetin, piperlongumine, luteolin, and silymarin (as milk thistle extract). See ingredients information shown below.
Qualia Senolytic Product Ingredients
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Qualia also discloses a form of the composition comprising a powder within a capsule, shown below.
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Regarding claims 10, the limitation “wherein the composition is formulated for a prescribed administration protocol” in claim 10 is considered an intended use. The limitation are considered an intended use, which does not give patentable weight, because the limitations do not significantly change the form of the composition. Claim 10 does not specify how the composition’s form is altered to be formulated for a prescribed administration protocol.
Qualia does not disclose a date prior to the effective filing date. As evidenced by Kelly, the product above would have had to have been for sale or was at least publicly available as of 2022.
Kelly, dated May 15, 2022, discusses the product above. Qualia on p. 3, sec. What is Qualia Senolytic? states “Qualia Senolytic contains a combination of nine vegan ingredients that were carefully selected to support healthy aging in an area called “cellular senescence.” Kelly continues by listing the components which include quercetin (as Quercefit® quercetin phytosome), fisetin, luteolin, piperlongumine, and silymarin (as milk thistle extract).
Considering the disclosure from Kelly, the composition in Qualia would have at least been publicly available on or before the May 15, 2022 date.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-7, 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qualia (Qualia, Qualia Senolytic Product page, url=https://www.qualialife.com/shop/qualia-senolytic, accessed 03/02/2026) as evidenced Kelly (Qualia, Qualia Senolytic Ingredients, url=https://www.qualialife.com/the-formulator-s-view-of-the-qualia-senolytic-ingredients, accessed 03/02/2026, dated 5/15/2022).
Discussion regarding claims 1-7, 9-10, and 12-15 from the 102 ejection above is incorporated here.
Regarding claim 11, which is drawn to an embodiment of claim 10 requiring an administration protocol comprising administration of the claimed composition once daily for a period of at least two ays but not more than four days followed by a period of at least twelve days but no more than thirteen weeks without treatment and with the administration repeated following the same dosing protocol, Qualia teaches taking 6 capsules per day, in two consecutive days. While this does not anticipate claim 11, claim 11 is made obvious in view of this teaching.
The MPEP, 2144.05, subsection II states, “
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Determining the optimized dosing regiment is within the skillset of one of ordinary skill in the art. Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill to have modified the dosing regimen taught by Qualia to read on the instant claims. One of ordinary skill would be motivated to make the modification in efforts to optimize administration.
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624