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 1-15 are being examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
At [0007], line 2, the phrase “Melatonin can promoted” should instead be --Melatonin production can be promoted-- or similar phrasing.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites that the longan flower extract is selected from the group consisting of longan flower extract, which is contradictory and also refers back to the longan flower extract of Claim 8. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
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, 2, 4-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Food Res Int, 2012, 444-449) in view of Ribas-Latre et al. (Mol Nutr Food Res, 2015, 865-878) as evidenced by Zhao et al. (Front Endocrin, 2019, 16 pages) and Walther and Bader (Biochm Pharm, 2003, 1673-1680).
The instant claims are as of record, drawn to methods for increasing melanin content in a subject or regulating gene expression of TPH, DDC, AANAT, and ASMT, comprising administering to a subject in need thereof a composition comprising an effective amount of longan flower extract obtained via solvent extraction.
Liu et al. teach a longan flower extract obtained from dried longan flowers using water (pharmaceutically acceptable carrier; as required for instant Claims 6 and 14) as a solvent which was fed (administered) to rats and analyzed for phytochemical content (Materials and Methods, page 445; Table 1, page 446; as required for instant Claims 1, 8, and 9). Rats were fed the longan flower extract as solution at a dose of 12.5 g/L or 25.0 g/L (at least 0.2 wt%; pharmaceutical composition; Liu et al., Animal and diets, page 445; as required for instant Claims 2, 5, 7, 13, and 15). The longan flower extract naturally comprises the proanthocyanidins catechin and epicatechin, which were provided to rats at the following doses: 8.4 mg/100 mL catechin and 17.7 mg/100 mL epicatechin in the 12.5 g/L longan flower extract solution and 16.6 mg/100 mL catechin and 37.9 mg/100 mL epicatechin in the 25.0 g/L longan flower extract solution (effective amount; Liu et al., Table 1, page 446; as required for instant Claims 1 and 8).
Liu et al. do not teach increasing melanin content in a subject or regulating gene expression of TPH, DDC, AANAT, and ASMT.
Ribas-Latre et al. teach that a grape seed proanthocyanidin extract comprising 58 μmol/g catechin and 52 μmol/g epicatechin administered to rats, including jet-lagged rats (subject in need thereof), resulted in increased melatonin levels during daylight (Ribas-Latre et al., Figure 1, page 869; as required for instant Claims 1 and 8). This increase in melatonin is either due to proanthocyanidins acting on the hypothalamic suprachiasmatic nucleus, which controls secretion of melatonin by the pineal gland, or by proanthocyanidins causing an increase in melatonin which then acts on the hypothalamic suprachiasmatic nucleus (Ribas-Latre et al., Discussion, page 875). Since melatonin biosynthesis in animals inherently occurs via a signal cascade comprising tryptophan hydroxylase (TPH), aromatic amino acid decarboxylase (DOPA decarboxylase), serotonin N-acetyltransferase (aralkylamine N-acetyltransferase), and N-acetylserotonin O-methyltransferase, an increase in melatonin biosynthesis would inherently increase (i.e., regulate) the expression of the corresponding genes, TPH, DDC, AANAT, and ASMT (Zhao et al., Figure 4, page 7 and page 9; as required for instant Claims 1 and 8). The specific gene TPH1 is expressed in the pineal gland and would inherently be the gene affected by proanthocyanidins (Walther and Bader, Abstract, page 1673; as required for instant Claim 10).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Liu et al. and Ribas-Latre et al. to arrive at the instantly claimed invention. A skilled artisan would be able to take the proanthocyanidin-rich longan flower extract of Liu et al. and apply it to a subject in need of improved insomnia, sleep quality, or sleep disturbance in order to increase melatonin production and thus expression of the genes controlling melatonin production with a reasonable expectation of success and would be motivated to do so because of the additional benefits of hepatoprotection and antioxidant properties (Liu et al., Abstract, page 444; Results and Discussion, page 447).
Liu et al. and Ribas-Latre et al. are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to proanthocyanidin activity and doses provided to rats and mice in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable longan flower extract concentration with which to perform such a method (as required for instant Claim 11)), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Food Res Int, 2012, 444-449) in view of Ribas-Latre et al. (Mol Nutr Food Res, 2015, 865-878) as evidenced by Zhao et al. (Front Endocrin, 2019, 16 pages) and Walther and Bader (Biochm Pharm, 2003, 1673-1680) as applied to Claims 1, 2, 4-11, and 13-15 above, and further in view of Wang et al. (Molec, 2017, 15 pages).
The claims and teachings of Liu et al. in view of Ribas-Latre et al. as evidenced by Zhao et al. and Walther and Bader are as of record.
Liu et al. in view of Ribas-Latre et al. as evidenced by Zhao et al. and Walther and Bader do not teach wherein the longan is hydrolyzed with a complex cellulase prior to solvent extraction.
Wang et al. teach that enzyme-assisted extraction using complex cellulase (hydrolyzed; Wang et al., Enzyme Pre-Treatment, page 10; as required for instant Claims 3 and 12) prior to solvent extraction increases the extraction yield of phenolics from plants (Wang et al., Abstract, page 1; Introduction, page 2).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Liu et al. and Ribas-Latre et al. with those of Wang et al. to arrive at the instantly claimed invention. Using cellulase enzyme-assisted extraction would increase the yield of the beneficial proanthocyanidins, and thus a skilled artisan could incorporate this extraction method into the claimed invention with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Relevant Prior Art Made of Record but not Relied Upon
Hsieh et al. (J Agric Food Chem, 2008, 7010-7016) teach that longan flower extracts comprise the major components epicatechin and proanthocyanidin A1.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655