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 .
Claim Status
Applicant’s remarks and amendments, filed 24 March 2026 in response to the non-final rejection mailed 24 September 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 24 March 2026 replaces all prior versions and listings of the claims.
Claims 1-23 are pending. Claims 19-23 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 8, 12, and 14 are amended. Claims 1-18 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to Claims 8, 12, and 14 have overcome the claims objection in regards to minor informalities. The objection to Claims 8, 12, and 14 has thus been withdrawn.
Applicant’s arguments and amendments, on page 6 of the reply filed 24 March 2026 with respect to the rejection of Claims 14-16 under 35 USC § 112(b) have been fully considered. The rejections of Claims 14-16 are withdrawn due to amendment of Claim 14.
Claim Rejections - 35 USC § 101
(maintained)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-17 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, applicant’s claims recite an extract from the plant Swertia chirata, hyaluronic acid which is naturally found in various tissues, and retinoid, or Vitamin A, which is naturally found in meat products. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, extraction only concentrates and portions the naturally occurring compounds which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the organism and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a combination of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the matter away from the naturally-occurring ingredients, the result of extraction is still a combination of ingredients which are naturally-found in or obtainable from the material; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a combination of the naturally occurring compounds found in the particular organisms. Combining the extracts from the individual organisms leads to a combination of the naturally occurring compounds from each of the organisms and the claims are therefore drawn to combinations of naturally occurring products.
There is no indication that combining the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a combination of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a combination of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that combining the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed combination as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are not directed to a specific intended use. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. The instant claims do not recite an intended use of the claimed composition. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
(maintained)
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 1, 8-10, 12, 13, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lintner et al. (WO 2021/013973 A1).
The instant claims are as of record, drawn to a cosmetic composition comprising a Swertia chirata extract, hyaluronic acid, and retinoid.
Lintner et al. however anticipates the claims by teaching cosmetic compositions comprising Swertia chirata extract, hyaluronic acid, water, (Lintner et al., page 2, lines 14-35), and antioxidants such as Vitamin A (retinoid) and derivatives thereof such as retinaldehyde (retinal) and Vitamin C and derivatives thereof such as ascorbic acid (Lintner et al., page 8, lines 22-30; as required for instant Claims 1, 8, 9, 12, 13, and 17). The hyaluronic acid includes both low and high molecular weight hyaluronic acid (mixture of hyaluronic acids of different molecular weights; Lintner et al., pages 4-5; as required for instant Claim 10). Additionally, the composition may be formulated as a cream or a serum (Lintner et al., page 14, lines 26-31; as required for instant Claim 18).
Claims 1, 2, 4, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bezivin (FR 3018191 A1, translation, 14 pages).
The instant claims are as of record, drawn to a cosmetic composition comprising a Swertia chirata extract, hyaluronic acid, and retinoid.
Bezivin however anticipates the claims by teaching cosmetic compositions comprising the Swertia chirata plant extract swertiamarine in an amount of 0.0001 to 10% by weight of the total composition (Bezivin, page 2; as required for instant Claims 1, 2, and 5-7); hyaluronic acid as an additional active ingredient in an amount of 0.0001 to 10% by weight of the total composition (Bezivin, page 6; as required for instant Claims 1 and 4-7); Vitamin A (retinoid; Bezivin, page 7; as required for instant Claim 1); and thermal water as an excipient in an amount of 80 to 99.9% by weight of the total composition (at least 60 wt%; Bezivin, page 8; as required for instant Claim 17). The compositions can be in the form of a cream or a serum (Bezivin, pages 8-9; as required for instant Claim 18).
Claim Rejections - 35 USC § 103
(maintained)
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 1-7, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bezivin (FR 3018191 A1, translation, 14 pages) as applied to Claims 1, 2, 4, 17, and 18 above.
The instant claims and teachings of Bezivin are as of record.
Bezivin teaches cosmetic compositions comprising the Swertia chirata plant extract swertiamarine in an amount of 0.0001 to 10% by weight of the total composition (Bezivin, page 2; as required for instant Claims 1, 2, and 5-7); hyaluronic acid as an additional active ingredient in an amount of 0.0001 to 10% by weight of the total composition (Bezivin, page 6; as required for instant Claims 1 and 4-7); Vitamin A (retinoid; Bezivin, page 7; as required for instant Claim 1); and thermal water as an excipient in an amount of 80 to 99.9% by weight of the total composition (at least 60 wt%; Bezivin, page 8; as required for instant Claim 17).
It would have been obvious to a person of ordinary skilled in the art prior to the effective filing date of the instant application to provide the retinoid Vitamin A in the amount of 0.005 to 1.00% by weight because it is an agent that promotes the regeneration of the epidermis (Bezivin, page 7), thereby providing skin beneficial effects. A skilled artisan could therefore modify the weight of retinoid present in the composition by percentage in order to arrive at the claimed invention with a reasonable expectation of success. If not expressly taught by Bezivin, based upon the overall beneficial teaching provided by this reference with respect to Vitamin A in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable weight percentage ranges of Claims 3 and 5-7), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1, 8-13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lintner et al. (WO 2021/013973 A1) as applied to Claims 1, 8-10, 12, 13, and 18 above, and further in view of Mazzucco (Int J Chem Res, 2019, 13-18).
The instant claims and teachings of Lintner et al. are as of record.
Lintner et al. do not teach at least three hyaluronic acids of different molecular weights.
Mazzucco teaches hyaluronic acids with high, medium, and low molecular weight and mixtures thereof comprising hyaluronic acids weighing from 50-2,500 kDa (at least three hyaluronic acids of different molecular weights; Mazzucco, page 15; as required for instant Claim 11).
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 provide the composition of Lintner et al. with the hyaluronic acids of Mazzucco to arrive at the instantly claimed application. Combining high, medium, and low molecular weight hyaluronic acids takes advantage of moisturizing and anti-wrinkle properties (Mazzucco, page 15) and the combination triggers a better cellular response (Mazzucco, page 17). A skilled artisan would therefore be motivated to provide hyaluronic acids of various molecular weights and could do so with a reasonable expectation of success.
Claims 1, 8-10, 12-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lintner et al. (WO 2021/013973 A1) as applied to Claims 1, 8-10, 12, 13, and 18 above, and further in view of Carola et al. (EP 1508327 B1, translation, 20 pages).
The instant claims and teachings of Lintner et al. are as of record.
Lintner et al. do not teach a chromene of formula (I) or wherein the chromene is dihydroxy methylchromene (Specification, [0058], compound 1):
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Carola et al. teach formula la (dihydroxy methylchromene; image from original document, Carola et al., [0030], line 20; as required for instant Claims14 and 16):
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for the prophylaxis or reduction of skin irregularities such as wrinkles, fine lines, rough skin, and large pores, preventing dry skin, wrinkling, pigmentary disorders, and reduction or prevention of UV damage (Carola et al., translation, page 3).
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 composition of Lintner et al. with the compound of Carola et al. to arrive at the instantly claimed invention. A skilled artisan would be motivated to include dihydroxy methylchromene due to the positive teachings of skin prophylaxis effects as described above and could do so with a reasonable expectation of success. If not expressly taught by Carola et al., based upon the overall beneficial teaching provided by this reference with respect to the skin-beneficial properties of dihydroxy methylchromene in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable weight percentage ranges of Claim 15), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
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.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “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).
Response to Arguments
Applicant's arguments filed 24 March 2026 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 1-17 under 35 USC § 101, applicant argues (pg. 6-7 of remarks) that the instant claims are drawn to a man-made composition which does not exist in nature and exhibits markedly different characteristics relative to any naturally occurring counterpart. First, it is noted that “cosmetic” merely refers to a product which is applied to the body to improve or enhance appearance and does not require any particular form. The rejected claims do not recite any particular dosage form which would require formulation (e.g., the cream or serum of Claim 18) and thus are drawn to any combination of the three naturally occurring ingredients, such as a mixture. Regarding markedly different characteristics, the applicant references synergism, however this is not recited in the claims, nor are there comparisons between the claimed composition formulated as a serum and the naturally occurring Swertia chirata, hyaluronic acid, and retinoid to reach the conclusion of markedly different characteristics. The rejection of Claims 1-17 under 35 USC § 101 is therefore maintained.
Applicant argues that because Lintner et al. (pg. 7-8 of remarks) and Bezivin do not disclose single specific embodiments which is identical to the instantly claimed composition, anticipation cannot be established.
MPEP §2123(I), however, states that “"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component).
Since both Lintner et al. and Bezivin disclose each and every component of the instantly rejected claims as described in the 35 USC § 102(a)(1) rejection as described above, this rejection is maintained.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant additionally argues that there is no articulation as to why a skilled artisan would select the specific three ingredients of the instant claims from those listed in Bezivin, however it is noted that the compositions of the instant claims are “comprising” compositions. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP § 2111.03(I)).
Regarding the prior art of Mazzucco, applicant argues that selecting and formulating high, medium, and low molecular weight hyaluronic acids into a single topical composition is not taught and that there is no articulated reasoning or rational underpinning for providing a mixture of at least three hyaluronic acids of different weights as required of instant Claim 11. Mazzucco, however, teaches a “second generation” hyaluronic acid with molecular weights ranging from 50-2500 kDa, which encompasses the instant claims. It is noted that the instant claims do not require any particular molecular weights (e.g., low molecular weight of less than about 50 kDa, mid-molecular weight range of 50-1000 kDa, or high molecular weight of greater than about 1000 kDa, at [0038]) and that the broadest interpretation of “at least three hyaluronic acids of different molecular weights” would encompass a mixture of single molecule of hyaluronic acid with a molecular weight of 50 kDa, single molecule of hyaluronic acid with a molecular weight of 200 kDa, and a single molecule of hyaluronic acid with a molecular weight of 2500 kDa, which is also encompassed by the teaching of Mazzucco. Finally, a skilled artisan would be motivated to use the combination of Mazzucco due to the skin beneficial effects of moisturizing and anti-wrinkle properties (Mazzucco, page 15) and triggering of a better cellular response (Mazzucco, page 17).
Finally, regarding the prior art of Carola et al., applicant argues that this prior art teaches away from combining the dihydroxy methylchromenone of Carola et al. with the retinol-containing composition of Lintner et al. because Carol et al. teach away from retinoid-containing preparations. Carola et al., however, merely disclose that retinol is may have a skin irritating effect and overdose must be avoided such that an alternative, such as dihydroxy methylchromenone, is desired. Carola et al. also disclose that retinol is used for the prophylaxis and treatment of many skin conditions. The composition of Carola et al. merely preferably does not include retinol; there is no teaching that the combination of the two is detrimental.
MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) and “The court held that the prior art anticipated the claims even though it taught away from the claimed invention. ‘The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.' ” Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
A skilled artisan would be motivated to include the dihydroxy methylchromenone of Carola et al. in a cosmetic composition due to its skin beneficial effects and lessened skin-irritating effect, which would allow for inclusion of retinol at a lower dose while obtaining the benefits of both.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., synergy, potentiation of retinoid topical efficacy) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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