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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2025 has been entered.
Priority
This application claims benefit of priority to Provisional Application 63/238,782 filed on 08/31/2021. However, support for the instant claims is not found in the Provisional Application. The only limitation the Provisional Application provides support for is delaying skin aging in claim 8. Thus, as priority is granted per claim not per limitation, the effective filing date of all claims is the initial filing date, 08/31/2022.
Information Disclosure Statement
The Information Disclosure Statement filed on 07/10/2025 is acknowledged and has been considered.
Drawings
The Drawings filed on 11/29/2022 are accepted by the Examiner.
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 6 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huang et al. (CN 112402333 A, 02/26/2021) (Of Record).
Regarding claim 6, Huang et al. disclose a red rice fermentation extract prepared by using Lactobacillus plantarum as a fermentation strain (Abstract). Huang et al. further disclose the red rice fermentation extract is used in the preparation of cosmetics (Claim 1), wherein the red rice is an active ingredient for anti-aging or for repairing/maintaining the micro-ecology of the skin surface (Claim 2). More specifically, the red rice fermented extract restores/maintains the skin surface micro-ecology by down regulating S.a/S.e (Staphylococcus aureus) (Staphylococcus epidermis) values and provides anti-aging effects through skin repair activity via promotion of fibroblast and epidermal cell proliferation (Claim 4).
It is noted instant claim 6 is a product claim, not a method claim. More specifically, instant claim 6 is a product-by-product claim. While Huang et al. do not explicitly disclose the exact steps utilized in the instant method of producing a red rice ferment, there do not appear to be any discernable differences in the resultant product of the methods. The steps recited in instant claim 1 are very broad, the claim recites mixing red rice and water, adding a 1% amylase solution, extracting, adding a 1% saccharifying enzyme solution and then fermenting with S. cerevisiae, L. plantarum and A. aceti. At the end of the first step, all you have is water and red rice, with the water making up a greater portion than the red rice. Regarding the amylase, the claim does not tell you the activity of the amylase and the extraction could simply be for 30 minutes. The claim does not provide any insight into how saccharified the red rice is after only 30 minutes, and as 30 minutes is a rather short span of time, the rice could be barely saccharified at all. The second saccharification step, utilizing a ‘1% saccharification enzyme solution’ is also very broad, this step could essentially do nothing further to saccharify the red rice. Lastly, the fermentation step, does not provide for how the composition was changed after the fermentation or what the fermentation step accomplished.
Huang et al. utilize a similar method. Huang et al. clean the red rice, pulverize the red rice into a powder, mix the red rice powder with water wherein the red rice powder is 1 to 5 % by weight red rice powder and the rest water, inoculate with Lactobacillus plantarum and allow to culture for 36 hours at 35 to 40°C (Example 1, Paragraphs 1-2).
Though Huang et al. do not disclose the use of amylase or a saccharifying enzyme solution, it is known that bacteria, such as L. plantarum, naturally produce enzymes, including amylase enzymes. Additionally, the claim does not recite what fermenting with three microbes does to the extract that one microbe alone cannot accomplish.
As such, there appears to be little material difference in the product of the instant claim and the product of the prior art disclosed by Huang et al. If there are differences, the differences are not claimed. Therefore, the product of the instant claim does not appear to be patentably distinct from the red rice fermentation extract of the prior art.
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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112402333 A, 02/26/2021) (Of Record).
The teachings of Huang et al. are disclosed above.
Regarding claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the composition of Huang et al. for improving a skin condition as the composition is drawn to a skin care composition as discussed above
Regarding claims 8-9, Huang et al. do not explicitly disclose the red rice extract is for alleviating skin redness or skin roughness, firming skin, minimizing pores or a combination thereof.
However, Huang et al. do disclose the red rice fermentation extract as an active ingredient of anti-aging, whereby the anti-aging occurs from enhancing skin repair activity (Page 3, Paragraph 1). Further, the red rice fermentation extract repairs unbalanced skin surface microecology, maintains the steady state of the skin surface microflora and enhances skin repair activity (Page 3, Paragraph 2).
Huang et al. doesn’t explicitly state alleviating skin redness or skin roughness, firming skin or minimizing pores, as claimed.
However, Huang et al. do disclose anti-aging, repairing unbalanced skin surface microecology, maintaining the steady state of the skin surface microflora and enhancing skin repair activity, which would necessarily lead to alleviating skin redness and roughness and firming skin, as-claimed. Therefore, alleviating skin redness and roughness and firming skin as-claimed is inherent to anti-aging, repairing unbalanced skin surface microecology, maintaining the steady state of the skin surface microflora and enhancing skin repair activity, thus, meeting the limitations of instant claims 8-9.
Claims 1, 6-7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (CN 111956707 A, 11/20/2020) (Of Record) and Cho et al. (WO 2022098210 A1, 05/12/2022) (Of Record).
Regarding claim 1, He et al. disclose a method for fermenting plants comprising, extracting a plant with water to obtain a plant extract, mixing the plant extract with Saccharomyces cerevisiae, Lactobacillus plantarum and Acetobacter aceti for fermentation to obtain a plant fermentation product (Page 3, Paragraph 3). The weight ratio of the plant and water is 1: 5 to 10 (Page 4, Sentence 5) and the temperature of the extraction is between 50 and 100°C and the extracting time is between 0.5 and 1.5 hours (Page 4, Sentence 6). The fermentation time of the microorganisms is: Saccharomyces cerevisiae 1 to 2.5 days, Lactobacillus plantarum 1 to 3 days and Acetobacter aceti 3 to 10 days (Page 4, Sentence 3). The concentration of the microorganisms is: Saccharomyces cerevisiae 0.01 to 0.5% (v/v), Lactobacillus plantarum 0.01 to 0.25% (v/v) and Acetobacter aceti 3 to 10% (v/v) (Page 4, Sentence 4). The plant fermentation product is used for the preparation of a skin care composition (Page 4, Sentence 10). More specifically, the skin care composition is for improving anti-oxidation ability of the skin, improving anti-glycation activity of skin and promoting elastin hyperplasia (Page 4, Sentence 11).
He et al. do not disclose the method is for preparing a red rice ferment, adding a 1% (w/v) amylase solution to the plant extract or additionally adding a 1% saccharifying enzyme to the extract.
However, Cho et al. disclose a fermented red rice composition and preparation method thereof (Abstract). The preparation method includes culturing a mixture of red rice and yeast and performing alcohol fermentation, preparing a saccharified solution of red rice by mixing red rice, a saccharifying agent, and purified water, mixing the alcohol fermentation broth with the saccharified red rice solution and inoculating the mixed solution with acetic acid bacteria to perform acetic acid fermentation (Page 2, Paragraph 4). The red rice saccharification solution comprises the red rice, saccharifying agent and purified water in a weight ratio of about 1 to 3: 1: 3 to 6 (Page 3, Paragraph 11). The saccharifying agent used can be amylase (Page 3, Paragraph 9). Cho et al. further disclose the anti-inflammatory or antioxidant effect of the of the fermented red rice or composition comprising the red rice ferment may be significantly increased, as well as the stability in terms of odor quality and pH stability, when the above mentioned ratio is used (Page 3, Paragraph 11). Additionally, the saccharification efficiency in the step of preparing the saccharified red rice may vary depending on the saccharifying agent used, providing different contents of organic acids, polyphenols and flavonoids, resulting in varied anti-inflammatory or antioxidant effect and stability of the composition comprising the red rice ferment (Page 3, Paragraph 10).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used amylase in the method of He et al. because amylase is a known and effective saccharifying agent as taught by Cho et al. motivated by the desire to effectively saccharify the red rice for use in the fermented red rice composition.
Additionally, it would have been prima facie obvious to one of ordinary skill in the art to perform an additional saccharification comprising adding saccharifying enzyme solution to the first extract to further saccharify the rice and provide the optimal amount of organic acids, polyphenols and flavonoids motivated by the desire to create a pH stable skin care composition high in anti-inflammatory and antioxidant properties as taught by Cho et al.
Regarding the amount of saccharifying enzyme, including amylase, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges through routine experimentation.” See MPEP 2144.05(II)(A). See also, In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since the saccharifying enzyme solution, including amylase, is a result-effective variable, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal saccharifying enzyme solution amounts for the adequate saccharification of rice and it would have taken no more than the relative skills of an ordinary artisan through routine experimentation to have arrived at the claimed percentage motivated by the desire to adequately saccharify the rice and provide the optimal amount of organic acids, polyphenols and flavonoids motivated by the desire to create a pH stable skin care composition high in anti-inflammatory and antioxidant properties as taught by Cho et al.
Regarding claim 6, as the method steps are obvious, the product is also obvious. The product is an intrinsic occurrence of carrying out the obvious method.
Regarding claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the composition of He et al./Cho et al. for improving a skin condition as the composition is drawn to a skin care composition as discussed above.
Regarding claim 11, as discussed above regarding claim 1, Cho et al. disclose the use amylase. Amylase is a diastatic enzyme.
Regarding claim 12, Cho et al. disclose the red rice saccharified solution includes mixing the red rice, the saccharifying agent and the purified water at a temperature of about 60°C to about 70°C with standing or stirring for 6 to 24 hours (Page 4, Paragraph 11).
Cho et al. does not disclose the extraction occurring for 90 minutes.
“Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges through routine experimentation.” See MPEP 2144.05(II)(A). See also, In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Since the saccharifying enzyme solution, including amylase, is a result-effective variable, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal time periods for the saccharifying enzyme solution to adequately saccharify the rice and it would have taken no more than the relative skills of an ordinary artisan through routine experimentation to have arrived at the claimed time motivated by the desire to adequately saccharify the rice and provide the optimal amount of organic acids, polyphenols and flavonoids motivated by the desire to create a pH stable skin care composition high in anti-inflammatory and antioxidant properties as taught by Cho et al.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over He et al. (CN 111956707 A, 11/20/2020) (Of Record) and Cho et al. (WO 2022098210 A1, 05/12/2022) (Of Record) as applied to claims 1, 6-7 and 11-12 above, and further in view of Chan et al. (KR 20070062007 A, 06/15/2007) (Translation Provided).
The teachings of He et al. and Cho et al. are discussed above.
Regarding claim 2, neither He et al. nor Cho et al. disclose wherein the amylase is α-amylase, β-amylase, glucoamylase, isoamylase.
However, Chan et al. disclose a method of preparing a fermented extract of saccharified rice or glutinous rice wherein the rice is saccharified with a saccharifying enzyme and fermenting the saccharified product with lactic acid bacteria or yeast (Abstract). The saccharifying enzyme is koji, alpha-amylase or glucoamylase (Abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized alpha-amylase or glucoamylase in the method of He et al./Cho et al. as they are both known and effective saccharifying agents for saccharifying rice as taught by Chan et al.
The Supreme court acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The Examiner is therefore of the opinion that from the combined teachings of the references cited above, 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 would have been prima facie obvious to one of ordinary skill in the art especially in the absence of unexpected results.
Conclusion
Claims 1-2, 6-9 and 11-12 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653