DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 09/09/2025.
Claims 12-23 previously presented. claim 13 is currently canceled.
Claims 12, 14-23 are pending and subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Rejections - 35 USC § 102
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 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 12, 14-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2020007293 (hereinafter JP ‘293, abstract provided by IDS filed 04/10/2023, and the office previously provided a machine translation of the full document), as evidenced by the article by Ratanasumarn et al. (“Cosmetic potential of lignin extracts from alkaline-treated bagasse: Optimization of extraction conditions using response surface methodology”, IDS filed 04/10/2023).
Claim 12 is directed to a method for improving skin condition, the method comprising:
administering an effective amount of a composition for improving skin condition to a subject in need thereof,
wherein the composition comprises a bagasse-derived polyphenol composition as an active ingredient,
wherein the bagasse-derived polyphenol composition is obtained through a method
including:
pretreating bagasse using at least one alkaline solution selected from the group consisting of an aqueous sodium hydroxide solution, an aqueous potassium hydroxide solution, and an aqueous ammonia solution to obtain a pretreatment solution;
adjusting a pH of the pretreatment solution to be from 1.5 to 4.5 with hydrochloric acid, and then filtering the pretreatment solution to recover a filtrate; and
passing the filtrate without adjusting pH through a column filled with an aromatic synthetic
adsorbent and eluting a component adsorbed onto the above-described aromatic synthetic adsorbent with a mixed solvent of ethanol and water to obtain an eluted fraction as the polyphenol composition.
Note that the claims are directed to a process of using a product and, similar to product by process, the process of using the product claims are not limited to the recited steps of making the product, only the steps of method of using the product and the product structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), wherein the product-by-process claim was rejected because the end product, in both the prior art and the claimed product were the same. The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Since the claimed product appears to be substantially identical to that of the prior art, the burden is shifted to applicant to show an unobvious difference between the claimed product and the prior art product and to come forward with evidence establishing an unobvious difference. The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974); In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983); Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989). It has been held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
However, for completeness of record, the process of making the product used in the method of use will be addressed.
JP ‘293 discloses antiaging agent contains decomposition extract of bagasse as an active ingredient. The decomposition extract of bagasse is rich in polyphenols as evidenced by Ratanasumarn that teaches lignin extracted from sugarcane bagasse has high polyphenol. The reference discloses alkaline treatment of bagasse to extract polyphenol using aqueous solution of sodium hydroxide in amount of 0.1-50%, e.g. 0.5%, and aqueous solution of ammonia. The reference uses heat above 40 oC. to 100 oC. for shortening the decomposition time. The reference used acid treatment, and synthetic adsorbent, e.g. styrene-divinylbenzene, and use solvent of ethanol and water. The extract is liquid or powder. The extract used in cosmetic in combination with oil, fat, surfactant, vitamins, etc. The antiaging composition comprises 0.5-50% of the bagasse extract depending on the purpose of use (see the entire reference, and in particular the abstract and ¶¶ 0007, 0016, 0022, 0025-0027, 0030, 0033-0035, 0038, 0042, 0047, 0057-0068, 0072-0092, claims).
All the limitation of the claimed method for improving skin condition as claimed by claim 12 are met by the reference.
Regarding the claimed steps of producing the bagasse derived polyphenol heating using sodium hydroxide, using acid, and using aromatic synthetic adsorbent as claimed by the process of claim 12, all disclosed by the reference.
Regarding the temperature between 60 and 100 oC. as claimed by claim 14, the reference discloses 100 oC.
Regarding aqueous hydroxide solution claimed by claim 15, it is discloses by the reference.
Regarding concentration of sodium hydroxide of 0.1-1% as claimed by claim 16, the reference discloses 0.5%.
Regarding aromatic synthetic adsorbent claimed by claim 17, the reference discloses the claimed styrene-divinylbenzene.
Regarding skin conditions as claimed by claim 18 selected from the group consisting of improving skin smoothness, reducing skin wrinkles, suppressing skin pigmentation, and increasing skin moisture content, the reference discloses treating skin aging.
Regarding additional ingredients in the agent claimed by claim 19, the reference discloses surfactant, vitamins and oils.
Regarding the agent is solid or liquid as claimed by claim 20, the reference discloses bagasse extract can be liquid or solid powder form.
Regarding human subject as claimed by claim 21, the reference discloses cosmetic that implies a human user.
Regarding application to the skin as claimed by claim 22, the reference discloses topical cosmetic application.
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.
Claims 12, 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of any of Mitchell et al. (US 2020/0215145) or the article by Ratanasumarn et al. (Cosmetic potential of lignin extracts from alkaline-treated bagasse: Optimization of extraction conditions using response surface methodology) each combined with JP ‘489.
Applicant Claims
Claim 12 is directed to a method for improving skin condition, the method comprising:
administering an effective amount of a composition for improving skin condition to a subject in need thereof,
wherein the composition comprises a bagasse-derived polyphenol composition as an active ingredient,
wherein the bagasse-derived polyphenol composition is obtained through a method
including:
pretreating bagasse using at least one alkaline solution selected from the group consisting of an aqueous sodium hydroxide solution, an aqueous potassium hydroxide solution, and an aqueous ammonia solution to obtain a pretreatment solution;
adjusting a pH of the pretreatment solution to be from 1.5 to 4.5 with hydrochloric acid, and then filtering the pretreatment solution to recover a filtrate; and
passing the filtrate without adjusting pH through a column filled with an aromatic synthetic
adsorbent and eluting a component adsorbed onto the above-described aromatic synthetic adsorbent with a mixed solvent of ethanol and water to obtain an eluted fraction as the polyphenol composition.
Note that the claims are directed to a process of using a product and similar to product by process, the process of using the product claims are not limited to the recited steps of making the product, only the steps of method of using the product and the product structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), wherein the product-by-process claim was rejected because the end product, in both the prior art and the claimed product were the same. The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Since the claimed product appears to be substantially identical to that of the prior art, the burden is shifted to applicant to show an unobvious difference between the claimed product and the prior art product and to come forward with evidence establishing an unobvious difference. The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974); In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983); Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989). It has been held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
However, for completeness of record, the process of making the product used in the method of use will be addressed.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Mitchell teaches treating skin aging or skin pigmentation conditions, e.g. skin wrinkles and dark spots, and providing skin moisturization by topical application of polyphenols. Polyphenol is obtained from bagasse of sugarcane. Polyphenol is included in topical composition and administered daily (abstract; ¶¶ 0015-0034, 0089, 0094-0096, 0098-0101, 0254; claims). The composition is used for human (¶ 0084). Bagasse extract can be liquid or solid powder form (¶¶ 0149, 0150). The extract is included in topical composition in the form of emulsion, cream, serum, lotion, etc. (¶¶ 0192, 0196). The composition comprises excipients, e.g. thickeners, surfactants, moisturizers, oils, etc. (¶¶ 0203, 0206, 0209, 0213). The specific dosage level of polyphenol derived from bagasse and frequency of dosage for any particular patient may be varied and will depend upon a variety of factors including the activity of the specific extract derived from sugar cane employed, the metabolic stability and length of action of that extract derived from sugarcane, the age, body weight, general health, sex, diet, mode and time of administration, rate of excretion, drug combination, the severity of the particular condition, and the subject undergoing therapy (¶¶ 0224-0227).
Ratanasumarn teaches that lignin extracted from sugarcane bagasse has high polyphenol content and provides antiaging skin and skin whitening effects. Bagasse can be included in cosmetic compositions. The extract produced by alkaline hydrolysis and dried by lyophilization (see the entire document; in particular the abstract; pages 139, 141; and conclusion).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Mitchell does not explicitly teach the claimed method of producing the bagasse derived polyphenols. While Ratanasumarn teaches alkaline hydrolysis of bagasse from sugarcane to obtain polyphenol, the reference does not teach the steps of the method as instantly claimed by claims 12.
The method of making the claimed composition is taught by JP ‘489 as previously discussed in this office action.
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to treat skin aging using bagasse derived polyphenol as taught by any of Mitchell or Ratanasumarn, and produce the polyphenol from bagasse using the process taught by JP ‘489. One would have been motivated to do so because JP ‘489 teaches that such a process of producing polyphenol is extremely efficient and allows the production of polyphenol from bagasse from pretreated waste liquid generated in the process of producing sugar liquid from bagasse. One would reasonably expect producing polyphenol from bagasse by extremely efficient economic process.
Regarding all the steps of the using the composition and all ingredients of the composition, and production method claimed by claim 12, all the steps of using and making the product are taught by JP ‘489.
Regarding temperature of the alkaline solution as claimed by claim 14, JP ‘489 teaches the same temperature of 60-100 oC.
Regarding the alkaline solution is an aqueous solution as claimed by claim 15, JP ‘489 teaches aqueous sodium hydroxide solution.
Regarding the concentration of the aqueous alkaline solution of 0.1-1.0% as claimed by claim 16, this is taught by JP ‘489.
Regarding the aromatic synthetic adsorbent styrene-divinylbenzene claimed by claim 17, it is taught by JP 489.
Regarding skin conditions as claimed by claim 18 all the cited references teach treating skin aging and pigmentation including skin wrinkles and dark spots, and providing skin moisturization.
Regarding additional ingredients in the composition claimed by claim 19, Mitchell discloses thickeners, surfactants, moisturizers, and oils; and JP ‘489 teaches surfactant, vitamins and oils.
Regarding the composition is solid or liquid as claimed by claim 20, Mitchell discloses bagasse extract can be liquid or solid powder form.
Regarding human subject as claimed by claim 21, this is taught by all the cited references.
Regarding application to the skin as claimed by claim 22, this is taught by all the cited references.
Regarding the application amount per day as claimed by claim 23, JP ‘293 teaches concentration based on the desired purpose of use. Further, Mitchell teaches the specific dosage level of polyphenol derived from bagasse and frequency of dosage for any particular patient may be varied and will depend upon a variety of factors including the activity of the specific extract derived from sugar cane employed, the metabolic stability and length of action of that extract derived from sugar cane, the age, body weight, general health, sex, diet, mode and time of administration, rate of excretion, drug combination, the severity of the particular condition, and the subject undergoing therapy (¶¶ 0224-0227). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to determine the daily amount of polyphenol derived from bagasse in ng/cm2 from within the concentrations taught by Mitchell, Ratanasumarn and JP ‘293 that is required for specific skin condition and based on the factors taught by Mitchell. One would reasonably expect effectively treated specific skin conditions.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 09/09/2025 have been fully considered but they are not persuasive.
Pending Claims Are Not Anticipated by JP ‘489
Applicant argues that JP ‘489 describes an extraction process that significantly differs from that of the pending claims. For example, after alkaline treatment, the pH is adjusted to 6 before column purification in JP293, whereas pending claim 12 describes adjusting the pH of the pretreatment solution to 1.5 to 4.5. The difference in pH during purification necessarily leads to a different polyphenol composition, which is not disclosed in JP293.
In response to this argument, it is argued that the present claims are directed to method of using a composition, and the method of making the composition and conditions of method do not impart patentability to claims directed to a composition or method of its use, as set forth in this office action, absent evidence to the contrary. The reference disclosed the claimed method of treating the claimed conditions using the claimed product. If the prior art meets the structure recited, the properties must be met or Applicant's claim is incomplete. This is in line with In re Spada, 15 USPQ 2d 1655 (1990) which holds that products of identical chemical composition cannot have mutually exclusive properties. Regardless how the product is produced, the cited reference disclosed the claimed method of treating skin condition. It has been held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). This is applicable on claims directed to process of using the product.
Pending Claims Are Not Obvious
First, Applicant argues that the substance of claim 13 is incorporated into claim 12, does not render the claims obvious. First, the claimed invention states, among others, adjusting the pH of the pretreatment solution to 1.5 to 4.5 and proceeding directly to column purification without adjusting PH, i.e., maintaining the same pH for the column purification. To the contrary, Mitchell fails to disclose passing the filtrate through a column at the claimed pH range.
In response to this argument, the examiner reiterate the argument above regarding the method of making claims. The process of making a product and conditions of the process do not impart patentability to claims directed to product, and similarly claims directed to process of using the product, unless the process of making the product materially affect the product and its method of use. The process of making the bagasse derived-polyphenol composition disclosed by JP ‘489 delivered a product that treats the claimed conditions. The ultimate results obtained from the prior art is a composition that is identical to the claimed composition that is used in an identical process. Applicants not claiming pH of he composition or its effect on the claimed method of use.
Second, applicant argues that a person of ordinary skill in the art (“POSITA”) would not have been motivated to combine Mitchell with JP ‘489 because Mitchell specifically teaches to avoid extreme pH conditions and to adjust pH to 4-7.5. See Mitchell at [0111]. Accordingly, a POSITA would not have had any motivation to adjust the pH of Mitchell to the claimed range of 1.5 to 4.5 regardless of whether JP489 teaches any such pH range. For the same reason, a POSITA would not have had any expectation of success from the combination.
In response to this argument, it is argued that no pH of the composition is not claimed and applicants did not show its input on the claimed method of using the composition. The pH claimed in the method of making the composition, is not even the final pH of the composition, it is only a condition in one step in the process of making the final composition used to treat skin conditions. It is well established that the claims are given the broadest interpretation during examination. A conclusion of obviousness under 35 U.S.C. 103 (a) does not require absolute predictability, only a reasonable expectation of success; and references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969). The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
Third, applicant argues that a POSITA would not have been motivated to combine Ratanasumarn with JP489. Ratanasumarn optimizes alkaline extraction conditions to maximize polyphenol content, antioxidant activity and ability for protecting from sunlight. Adopting an entirely different purification method of JP ‘489 into Ratanasumam would likely result in loss of these optimized effects, providing a disincentive to combine the teachings.
In response to this argument, the argument above regarding steps of making the composition and its conditions are hereby repeated.
Moreover, applicant argues that because claims 14-17, 19, and 23 depend on pending claim 12, they are not rendered obvious for the reasons that pending claim 12 is not obvious.
In response to this argument, it is argued claim 12 as amended is obvious as set forth in this office action. All the limitations of claims depending on claim 12 are taught either explicitly or implicitly by the cited references as discussed above. And the claims are obvious.
In the light of the foregoing discussion, the Examiner’s ultimate legal conclusion is that the subject matter defined by the claims would have been obvious within the meaning of 35 U.S.C. 103 (a).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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