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 .
DETAILED ACTION
Applicant’s Requests for Reconsideration dated May 1, 2026 is acknowledged.
Claims 1-5, 8 and 9 are pending.
Claims 6, 7 and 10-18 are cancelled.
Claim 1 is currently amended.
Claims 1-5, 8 and 9 as filed on May 1, 2026 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim objections are withdrawn, all previous claim rejections under 35 USC 101 are withdrawn, and all previous claim rejections under 35 USC 112(b) are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Patent Prosecution Highway
The Patent Prosecution Highway (PPH) is a framework in which an application whose claims have been determined to be patentable by an Office of Earlier Examination (OEE) is eligible to go through an expedited examination of corresponding claims in a corresponding patent application pending in a second patent office. Applicant’s statement in the Remarks filed May 1, 2026 that claim 1 as amended reverts to the scope of claim 1 in the OEE application (WO 2023/228079) is acknowledged.
Maintained Grounds of Rejection: 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Giuliani et al. (US 2015/0337005, published November 26, 2015, of record) in view of Kang et al. (US 2008/0160110, published July 3, 2008, of record); Suzuki et al. (US 5,314,877, published May 24, 1994, of record); and Kim et al. (KR 2020-0029193 A, published March 18, 2020, as evidenced by the Google translation, of record).
The rejections have been updated to delete reference to cancelled claims
Giuliani teaches cosmetic compositions comprising, in a cosmetically acceptable carrier, an ester of glycyrrhetinic acid with (poly)glycerol sorbitol having the formula (title; abstract; claims, in particular 1-6):
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wherein n is an integer from 1 to 3, Sorb represents a moiety of sorbitol, and Polygly represents a moiety of glycerol or polyglycerol having polymerization degree of 1.5 to 10. Glycyrrhetinic acid is a pentacyclic triterpenoid insoluble in water and oils and having lenitive or anti-inflammatory activity (paragraphs [0008]-[0010], also [0005], [0015], Example 6, [0179]). The introduction of sorbitol in the (poly)glycerol chain increases the water solubility of the ester (abstract; paragraphs [0016], [0029]).
Giuliani further teaches a use of the ester as an anti-aging agent in the topical treatment of the skin (paragraphs [0020], [0065], [0075]-[0077]).
Giuliani further teaches the compositions may be in liquid form such as inter alia a solution or in a solid or semi-solid form such as inter alia an ointment (paragraph [0066]). The compositions may contain about 1 to 99.9 wt% water (paragraph [0068]). The compositions may further comprise ingredients inclusive of skin protecting agents and solubilizing agents (paragraph [0063]).
Giuliani does not teach a pentacyclic triterpene and a highly branched cyclic dextrin as required by claims 1, 8.
Giuliani does not teach the pentacyclic triterpene is selected from inter alia oleanolic acid as required by claim 2.
Giuliani does not teach the pentacyclic triterpene is maslinic or/and oleanolic acid as required by claims 3, 9.
Giuliani does not teach the maslinic or/and oleanolic acid are contained in or obtained from an olive tree fruit extract as required by claims 4, 9.
Giuliani does not teach the plant extract is an Olea europaea fruit extract as required by claim 5.
These deficiencies are made up for in the teachings of Kang, Suzuki and Kim.
Kang teaches an anti-aging cosmetic composition comprising Hibiscus esculentus extracts and at least one selected from the group consisting of oleanolic acid, ursolic acid, glycyrrhetinic acid and retinol (title; abstract; claims), as required by instant claims 2, 3, 9. Active agents selected from oleanolic acid, ursolic acid, glycyrrhetinic acid and retinol improve skin wrinkles generated by aging (paragraphs [0006], [0013]).
Suzuki teaches water soluble pentacyclic triterpene compositions (title; abstract; claims). Pentacyclic triterpenes include oleanolic acid (abstract; claim 3), as required by instant claims 2, 3, 9. Oleanolic acid can be found in olives (Olea europaea as evidenced by page 8, line 22 of the instant specification) (column 1, lines 28-31), as required by instant claims 4, 5, 9. Regarding obtaining the maslinic and/or oleanolic acid from an olive tree fruit extract as required by instant claim 4, although Suzuki renders obvious sourcing from olives as instantly claimed, this claim is reasonably construed as product-by-process claims which is met by the disclosure of oleanolic acid per se. See MPEP 2113. The insoluble pentacyclic triterpenes are made water soluble by including within cyclodextrins inclusive of branching type cyclodextrins (abstract; column 2, line 23; column 3, lines 12-25, 34-60).
Kim teaches a carnosic acid – highly branched cyclic dextrin complex having improved water solubility; highly branched cyclic dextrin is produced through a cyclization reaction of a branching enzyme from amylopectin (highly branched cyclic dextrin as defined at pages 10-11 of the instant specification) (title; abstract; claims; page 2, 12th full paragraph and last full paragraph on page). Carnosic acid is a component in rosemary extract that is phenolic diterpene having very low solubility in aqueous solution (abstract; page 2, 4th and 6th paragraphs). Although cyclodextrin is frequently used for encapsulation, the highly branched cyclic dextrin complex improves upon the low solubility of the existing complexes (page 2, 7th – 10th paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cosmetic compositions of Giuliani comprising the ester of glycyrrhetinic acid with poly(glycerol) sorbitol to further comprise at least one selected from the group consisting of oleanolic acid, ursolic acid, glycyrrhetinic acid and retinol as taught by Kang because they improve skin wrinkles generated by aging. There would be a reasonable expectation of success because Giuliani embraces the presence of further ingredients inclusive of skin protecting agents and one would be motivated to do so because Giuliani, as a whole, is drawn to anti-aging topical treatments of the skin.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cosmetic compositions of Giuliani in view of Kang comprising the oleanolic acid to further comprise a cyclodextrin inclusive of branching type cyclodextrins as taught by Suzuki or/and inclusive of highly branched cyclic dextrin as taught by Kim in order improve the solubility of the oleanolic acid. There would be a reasonable expectation of success because Giuliani embraces the presence of further ingredients inclusive of solubilizing agents and one would be motivated to do so because Giuliani, as a whole, is drawn to anti-aging topical treatments of the skin which may be in liquid form comprising 1 to 99.9 wt% water.
Claims 1-5, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Giuliani et al. (US 2015/0337005, published November 26, 2015, of record) in view of Kang et al. (US 2008/0160110, published July 3, 2008, of record); Suzuki et al. (US 5,314,877, published May 24, 1994, of record); and Kim et al. (KR 2020-0029193 A, published March 18, 2020, as evidenced by the Google translation, of record) as applied to claims 1-5, 8 and 9 above, and further in view of Santoyo Gonzalez et al. (WO 2012/017108 A1, published February 9, 2012, as evidenced by the Google translation, of record).
Giuliani is applied herewith under a different interpretation of the extracts of claims 4, 5, 9 in the interest of compact prosecution
The teachings of Giuliani, Kang, Suzuki and Kim have been described supra.
They do not specifically teach an Olea europaea fruit extract / an olive tree fruit extract as required by claims 4, 5, 9.
This deficiency is made up for in the teachings of Santoyo.
Santoyo teaches a method for obtaining maslinic acid and oleanolic acid from olive-pressing waste comprising the steps of extraction from the skin of an olive (fruit); the maslinic acid and oleanolic acid are obtained in highly pure form (title; abstract; claims, in particular 1, 5, 6; page 2, second full paragraph under “Description of the Invention”). Maslinic and oleanolic acid are triterpenic acids; maslinic acid is used in the cosmetic industry to remove skin blemishes and wrinkles (page 2, first 6 full paragraphs under “Background of the Invention”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to source the oleanolic acid in the compositions of Giuliani in view of Kang, Suzuki and Kim as an extract from the skin of an olive (fruit) as taught by Santoyo because said extract comprises oleanolic acid in highly pure form.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
At page 8 of the Remarks filed July 31, 2025, Applicant disagrees with the rejection because the instant specification aims at topical controlled release. This is unpersuasive because 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). The rejected claims are broadly drawn to compositions.
Applicant further disagrees because the compositions of claims 1 and 8 aim to solubilize pentacyclic triterpene. This is unpersuasive because there is no claim limitation reciting this feature. Nonetheless, the logic of the rejection renders this feature prima facie obvious because it is known in the art to solubilize actives within dextrins (e.g., Suzuki, Kim).
Applicant cites to Kang (e.g., paragraphs [0008]-[0009]) and concludes Kang does not teach oleanolic acid per se but rather oleanolic acid plus Hibiscus extracts. This is unpersuasive because the narrative of the rejection of record acknowledges Kang as teaching oleanolic acid plus Hibiscus extracts, however, Kang also teaches oleanolic acid per se is an active ingredient “which improve[s] skin wrinkles by aging” (e.g., paragraph [0006] as referenced in the rejection).
Applicant states the claimed oleanolic acid is not simply topically administered. This is unpersuasive because the rejected claims are drawn to compositions, not to methods of use thereof, and because the rejected claims (e.g., claim 1) expressly recite a limitation of a “composition to topically deliver”. Applicant’s statements lack nexus with the rejected claims. Applicant’s further statement regarding the unexpected delivery of oleanolic acid through the epidermis is unpersuasive because the there is no basis within the instant specification to substantiate this allegation and because Giuliani teaches the ester thereof penetrates into the deepest layers of the epidermis (e.g., paragraphs [0014]-[0015]). It seems expected that additional or/and alternative pentacyclic triterpenes would also possess this property.
Applicant’s conclusion that Kang motivates the inclusion of a Hibiscus extract is acknowledged. That the prior art renders obvious additional compositions is acknowledged. Notably, a Hibiscus extract is embraced by the rejected claims. Applicant’s conclusion that there is no motivation to only add oleanolic acid is unpersuasive because the actual rejection articulates a rationale to include at least one selected from the group of Kang which are taught to improve skin wrinkles generated by aging because Guiliani, as a whole, embraces anti-aging agents.
Applicant concludes the reliance on Kim is hindsight. This is not found persuasive because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Kim renders obvious art recognized alternatives to Suzuki for solubilizing terpenes within dextrins. 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). To the extent Applicant appears to argue the disclosed composition delivers the pentacyclic triterpenic compounds and not to solubilize the enoxolone, it is not clear what point Applicant intends to make. Furthermore, there are no limitations within the rejected claims which require solubilization of any compound, rendering the argument moot.
Applicant cites to Examples 15-20 and Table 1 of the specification in support of the argument of unexpected and improved results. This is not found persuasive because the examples have limited nexus with the broad genus of compositions claimed. Furthermore, it is not seen how the apparent UV vis comparison to 0.08% maslinic acid dissolved in ethanol is meaningful because the amount of Olea europeaea fruit extract is only disclosed in Example 19. Presumably the negative control and the composition of Example 19 should be characterized by the same absorbance because that the absorbance appears to be employed by Applicant as a proxy for concentration. That they are not suggests the data lack significance. Applicant is reminded that the mere submission of data does not mandate a conclusion of patentability and that the burden of establishing the significance of any proffered results in a manner commensurate in scope with the claims and in comparison to the closest prior art is borne entirely by Applicant. See generally MPEP 716 for information regarding allegations of unexpected results.
Therefore, the rejections are properly maintained and made again.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,394,335 in view of Kang et al. (US 2008/0160110, published July 3, 2008, of record); Suzuki et al. (US 5,314,877, published May 24, 1994, of record); and Kim et al. (KR 2020-0029193 A, published March 18, 2020, as evidenced by the Google translation, of record).
The instant claims are drawn to compositions comprising (a) a pentacyclic triterpene, a mixture of biologically active components containing a pentacyclic triterpene, or a plant extract containing a pentacyclic triterpene, (b) a poly-n-glyceryl-sorbitol enoxolone having the following structural formula:
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wherein n is an integer from 1 to 3, Sorb denotes a sorbitol residue and Polygly denotes a glycerol or polyglycerol with a degree of polymerization from 1.5 to 10, (c) a highly branched cyclic dextrin and optionally (d) a cosmetically acceptable carrier. The triterpene may be selected from groups inclusive of oleanolic acid which may be obtained from an olive tree or the triterpene may be present within an Olea europaea fruit extract.
The conflicting Patent claims are drawn to a cosmetic composition comprising at least one cosmetically acceptable carrier and at least one glycyrrhetinic ester having the formula:
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wherein n is an integer from 1 to 3, Sorb represents a moiety of sorbitol, and Polygly represents a moiety of glycerol or polyglycerol having polymerization degree of 1.5 to 10.
The instant claims differ from the Patent claims with respect to the pentacyclic triterpene / oleanolic acid, the sourcing of the triterpene / oleanolic acid from olives, and the highly branched cyclic dextrin. However, these differences are obvious in view of Kang, Suzuki and Kim as elaborated supra. It would have been obvious to one of ordinary skill in the art that the glycyrrhetinic acid ester of the cosmetic compositions of the Patent claims is an anti-winkle agent because Kang teaches such and it would have been obvious to combine the glycyrrhetinic acid ester with additional anti-wrinkle agents inclusive of oleanolic acid as taught by Kang because “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06. In view of Suzuki, it would have been obvious to one of ordinary skill in the art that oleanolic acid is an insoluble pentacyclic triterpene found in olives, the water solubility of which can be improved by including within cyclodextrins inclusive of branching type cyclodextrins. Therefore, it would have been obvious to one of ordinary skill in the art to modify the compositions of the Patent claims in view of Kang to further comprise cyclodextrins inclusive of branching type cyclodextrins so that the oleanolic acid would have improved solubility. In view of Kim, it would have been obvious to one of ordinary skill in the art to employ a highly branched cyclic dextrin as the cyclodextrin because highly branched cyclic dextrin provides the best water solubility of otherwise insoluble plant extracts in comparison to other known cyclodextrins. The instant claims are therefore an obvious variant of the Patent claims in view of the prior art.
Response to Arguments: Double Patenting
Applicant’s arguments do not specifically address the double patenting rejection, rather, they assert that the rejection is hindsight and should be withdrawn. This line of argument is unpersuasive. As noted in MPEP 2145 “Applicants may argue that the examiner’s conclusion of obviousness is based on improper hindsight reasoning. However, ‘[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.’ In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).“ Therefore, the rejection is properly maintained.
Conclusion
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 ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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