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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application filed on 07/01/2024 is a CIP of 17/974,680 filed on 10/27/2022 which claims priority to US provisional 63/293,901 filed on 12/27/2021.
It is noted that the specification for US provisional 63/293,901 filed on 12/27/2021 recites an oral dosage form comprising a therapeutically effective amount of cis-resveratrol.
However, US provisional 63/293,901 does not expressly teach the claimed amounts of cis-resveratrol (at least 200 mg or between 10 and 150 mg), not more than 200 mg of trans-resveratrol, the dosage form being a capsule, the total size of the dosage being 700 mg or less, the dosage form being a food or beverage, or the dosage form providing the claimed plasma or blood Cmax value as required by claims 1-10.
It is noted that support for claims 1-10 is found in the specification of the instant application, 18/761,018.
Therefore, all claims (1-10) of the instant invention have benefit to the priority date of 07/01/2024.
Claim Objections
Claims 9 is objected to because of the following informality:
Claim 9 should read, “wherein the dosage form provides a cis-resveratrol…” Appropriate correction is 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 1 is rejected under 35 U.S.C. 102 as being as being anticipated by Donnelly et al. (US 6,878,751 B1).
Claim 1 is anticipated because Donnelly discloses orally administering to the patient a pharmaceutical formulation that comprises a therapeutically effective amount of an active agent, wherein the active agent is cis-resveratrol (abstract; claim 1; claim 3). Donnelly discloses that the resveratrol is administered in stereoisomerically pure form (i.e., only the cis form and no trans form is present) (Col 4, lines 24-26).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being as being obvious over Donnelly et al. (US 6,878,751 B1).
Regarding claim 1, Donnelly discloses orally administering to the patient a pharmaceutical formulation that comprises a therapeutically effective amount of an active agent, wherein the active agent is cis-resveratrol (abstract; claim 1; claim 3). Donnelly discloses that the resveratrol is administered in stereoisomerically pure form (i.e., only the cis form and no trans form is present) (Col 4, lines 24-26).
Donnelly is believed to be anticipatory as described above, but in the interest of completeness of prosecution, purely arguendo, and for the purposes of this ground of rejection only, Donnelly will be interpreted as if it is not anticipatory.
In that case, Donnelly could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose cis-resveratrol as the active agent, disclosed at claim 3 within the pharmaceutical formulation (abstract and claim 1).
In that case, claim 1 is rendered prima facie obvious over the teachings of Donnelly, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., cis-resveratrol as the active agent) were known in the prior art (e.g., Donnelly) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., an oral dosage form) to one of ordinary skill in the art. MPEP 2143.A.
Claims 2-5 are rendered prima facie obvious because Donnelly discloses the dose of active agent is in the range of about 0.015 to about 135 mg per kg per day for oral administration (col 12, lines 21-24; col 15, lines 20-27). The average adult weights around 62 kg. Therefore, Donnelly discloses administering around 0.96 to 8,370 mg of active agent, wherein cis-resveratrol is disclosed as the active agent (claim 3) administered in stereoisomerically pure form (i.e., 100% cis-resveratrol) (Col 4, lines 24-26). Regarding the amount of cis-resveratrol, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claim 6 is rendered prima facie obvious because Donnelly discloses the dosage form may be a capsule formulation encapsulating resveratrol in solid form (Col 15, lines 21-23; Col 7, lines 45-54).
Claim 7 is rendered prima facie obvious because Donnelly discloses total sizes of the oral dosage form of 50 or 500 mg (Col 15, lines 25-26).
Examiner’s note: “A daily serving” of a food or beverage is not defined as a specific amount in the instant specification. “A daily serving” is being interpreted as any amount of any food or beverage component because a daily serving varies broadly by the person, dietary needs, and dietary guidelines.
Claim 8 is rendered prima facie obvious because Donnelly discloses the oral dosage form include foods such as sucrose, lactose or starch (Col 7, lines 48-50).
Regarding claim 9, While the dosage form providing the claimed plasma or blood Cmax is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches an oral dosage form with the same components (i.e., cis-resveratrol in its stereoisomerically pure form in amounts overlapping with that claimed), the properties the applicant discloses and/or claims (providing a plasma or blood Cmax of from 10 to 50 µM) are reasonably expected to be necessarily present. Furthermore, the desired plasma or blood Cmax would be achieved through routine experimentation following the teachings of Donnelly. Donnelly teaches that the dose of active agent is in the range of about 0.015 to about 135 mg per kg per day for oral administration and that an optimal dosing regimen for any particular patient, i.e., the number and frequency of doses, can be ascertained using conventional course of treatment determination tests (col 12, lines 21-36; col 15, lines 20-27). Where 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. See MPEP 2144.05(II)(A). In this case, the general condition of the dose of active agent (i.e., cis-resveratrol) and varying the optimal dosage for a particular patient’s needs has been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum dosage of cis-resveratrol via routine experimentation to achieved the claimed cis-resveratrol plasma or blood Cmax value.
Claim 10 is rendered prima facie obvious because Donnelly discloses the oral dosage form is a capsule formulation encapsulating resveratrol in solid form (Col 15, lines 21-23; Col 7, lines 45-54) and the dose of active agent is in the range of about 0.015 to about 135 mg per kg per day for oral administration (col 12, lines 21-24; col 15, lines 20-27). The average adult weights around 62 kg. Therefore, Donnelly discloses administering around 0.96 to 8,370 mg of active agent, such as cis-resveratrol (claim 3) which is administered in stereoisomerically pure form (i.e., 100% cis-resveratrol) (Col 4, lines 24-26). A prima facie case of obviousness exists because of overlap, as previously discussed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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