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 7 July 2026 in response to the non-final rejection mailed 7 April 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 7 July 2026 replaces all prior versions and listings of the claims.
Claims 1, 2, 4-15 and 17-22 are pending. Claim 3 has been cancelled by applicant’s amendment. Claims 4-9, 11, 12, 14, 15, and 17-22 are amended. Claims 1, 2, 4-15 and 17-22 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to the specification have overcome the specification objection in regards to minor informalities. The objection to the specification has thus been withdrawn.
Applicant’s amendments to the claims have overcome the claims objection in regards to minor informalities of Claims 6-14, 21, and 22. The objection to Claims 6-14, 21, and 22 has thus been withdrawn.
Applicant’s arguments and amendments, on page 9 of the reply filed 7 July 2026 with respect to the rejection of Claims 1-15 and 17-22 under 35 USC § 112(b) have been fully considered. The rejections of Claims 1-15 and 17-22 are withdrawn due to amendment of the claims.
Claim Objections
Claims 4 and 5 are objected to because “isomeric of citric acid” should instead read --isomer of citric acid--.
Appropriate correction is required.
Allowable Subject Matter
Claims 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-11 and 19-22 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 1-11 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:
Claims 1-11 are drawn to compositions (for the intended use as a cosmetic active ingredient, see e.g., [0018]; for the intended use of treating the skin for a skin anti-aging effect) formed entirely from natural ingredients (as disclosed in paragraphs [0008]-[0012] and [0024]-[0035] of the instant specification) including a hydroglycolic extract of Hibiscus sinensis flowers comprising N-(1-deoxy-1-fructosyl)-proline or sarmentosin epoxide, and in some embodiments further comprising citric acid, carbohydrates, minerals, and proteins (obtainable via any solvent other than ethanol, see e.g., [0044]). Additional embodiments include forms such as solid and liquid. The claimed composition is not markedly different from its naturally-occurring counterpart (e.g., Hibiscus sinensis flowers which comprise all of the claimed compounds and are solid in form; or Hibiscus sinensis flowers in a hydroglycolic solvent) because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterpart (including the natural compounds found therein, e.g., N-(1-deoxy-1-fructosyl)-proline or sarmentosin epoxide). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitation of “cosmetic active ingredient” merely refers to molecules which have an effect when applied on the skin (see [0018]), and the limitations of “cosmetic composition” and “cosmetic product” refer to solid and liquid forms which may be applied to the skin.
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials in broad amounts. While Claims 1, 5-7, 10, 11, 19, and 20 require certain amounts of components in the active ingredient or composition, there is no indication that the amounts claimed result in a markedly different characteristic for the composition as compared to components found in nature. Finally, while Claim 21 discloses assumption of the form of a gel, emulsion, or cream in the alternative, this does not exclude the mucilage of Hibiscus flowers (e.g., gel) and thus does not integrate the composition into a distinguishing practical application.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
Double Patenting
(grounds modified as necessitated by amendment)
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, 2, 5-11, 15, and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-11 and 20 of U.S. Patent No. 12,485,086 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant Claim 1 discloses the intended use of the composition as a “cosmetic active ingredient,” the broad comprising language does not exclude the extract from damaged parts from a Moringaceae genus disclosed in the broad comprising Claim 1 of the ‘086 reference patent, and there is no indication that a cosmetic active ingredient is markedly different from a composition. While ‘086 Claim 1 requires that the composition be in the form of an emulsion, the identical active ingredient of the instant claims - an extract from Hibiscus sinensis comprising at least 2 ppm of N-(1-deoxy-1-fructosyl)-proline and/or at least 145 ppm of sarmentosin epoxide - is also provided as an emulsified composition of instant Claims 19 and 21, which recite a composition comprising the same Hibiscus sinensis extract as that of ‘086 Claim 1. Additionally, the Hibiscus sinensis extract of the ‘086 patent is also provided as a hydroglycolic extract in ‘086 Claim 4.
Claims 2, 5, 6, 8, 9, 10, and 11 of the instant application are identical to ‘086 reference Claims 2, 4, 5, 7, 8, 9, and 10 respectively, of the ‘086 patent.
While Claim 7 of the instant application is dependent on the independent Claim 1 and Claim 6 of the ‘086 patent is dependent on Claim 5, these claims are not patentably distinct from one another as both require at least 30% by dry weight of carbohydrates. Claim 5 of the ‘086 patent requires at least 50% carbohydrates by dry weight of the extract, and all of these ranges of carbohydrates are overlapping.
Instant Claims 19 and 20 are not patentably distinct from ‘086 Claim 11 because the ranges of the amount of Hibiscus sinensis extract overlap, and the ‘086 patent specification discloses (at col. 2, ln. 14-16) that the composition may be in liquid or solid forms. A skilled artisan could therefor reasonably determine the appropriate amount of active ingredient for different dosage forms.
Instant Claims 15, 17, and 18 are not patentably distinct from ‘086 Claim 20 because while the claims are drawn to different intended uses (e.g., preventing and/or combatting skin aging and the effects of instant Claim 18 versus stimulating collagen synthesis in skin cells), the composition of ‘086 comprises the active ingredient of the instant claims - an extract from Hibiscus sinensis comprising at least 2 ppm of N-(1-deoxy-1-fructosyl)-proline and/or at least 145 ppm of sarmentosin epoxide - and requires the same single-step method of application to the skin (e.g., topically applying). Since the single-step method of administering the active ingredient is not different between the instant application and ‘086 patent, there is no structural difference and thus the properties of preventing and/or combatting skin aging, the effects of instant Claim 18, and stimulating collagen synthesis in skin cells are inherent absent 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 7 July 2026 have been fully considered but they are not persuasive.
Regarding the rejection under 35 USC § 101, applicant argues on pages 9-11 of the reply filed 7 July 2026 that because a hydroglycolic extract of Hibiscus sinensis flowers is not found in nature, the chemical composition of Claim 1 is markedly different than that found in nature. Applicant goes on to argue that N-(1-deoxy-1-fructosyl)-proline and sarmentosin epoxide are not present in Hibiscus sinensis flowers naturally, let alone in the dosages claimed, and that a hydroglycolic extract does not exist in nature. Finally, applicant argues that it is not possible to apply Hibiscus sinensis flowers to the skin and that Hibiscus sinensis flowers do not have the claimed effects of the composition when applied to the skin.
The instant disclosure states at [0011] that white to light pink Hibiscus sinensis flower have molecules which are present in small amounts or not at all in the red flowers: N-(1-deoxy-1-fructosyl)-proline and sarmentosin epoxide. It is therefore unclear how Hibiscus sinensis flowers would not comprise these compounds in nature and how the compounds therefore function differently upon extraction (e.g., functional properties of skin regeneration, etc.). In order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from the naturally occurring counterpart (MPEP § 2106.04(c).II.C). Additionally, it is unclear why it would not be possible to apply Hibiscus sinensis flowers, or the compounds contained therein, to the skin. It is well within the skill of an ordinary person to rub flowers upon their skin.
Additionally, it is noted that “hydroglycolic” merely describes the extract (versus e.g., contained within the hydroglycolic extraction solvent, thereby requiring the presence of said solvent) and does not, without evidence to the contrary, result in changes to the chemical composition of the claimed cosmetic active ingredient. As mentioned above, it is disclosed in the instant application that N-(1-deoxy-1-fructosyl)-proline and sarmentosin epoxide are naturally found in white to light pink Hibiscus sinensis flowers, and thus the extracted compounds are not markedly different from those found in nature. Finally, it is noted that modifying the concentration of the product and/or composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)).
Additionally, it is noted that while Claim 21 discloses assumption of the form of a gel, emulsion, or cream in the alternative, this does not exclude the mucilage of Hibiscus flowers (e.g., gel) and thus does not integrate the composition into a distinguishing practical application. Removing the gel limitation and adding the dosage forms of an emulsion or cream to instant Claim 1, or alternatively requiring an additional component in the gel form which is not naturally occurring would help overcome this rejection.
Regarding the nonstatutory double patent rejection, applicant argues on pages 11-12 of the reply filed 7 July 2026 that because ‘086 Claim 1 does not recite a hydroglycolic extract or a dosage form of an emulsion, it is patentably distinct from the claims of the instant application. As disclosed in the rejection above, however, it is noted that amended instant Claim 21 recites a dosage form of the cosmetic composition comprising the cosmetic active ingredient of at least 2 ppm of N-(1-deoxy-1-fructosyl)-proline or at least 145 ppm of sarmentosin epoxide, wherein the dosage form may be an emulsion. Additionally, the Hibiscus sinensis extract of the ‘086 patent is also provided as a hydroglycolic extract in ‘086 Claim 4. It is therefore well within the purview of a skilled artisan to provide a composition comprising a cosmetic active ingredient comprising a hydroglycolic extract of Hibiscus sinensis flowers with at least 2 ppm of N-(1-deoxy-1-fructosyl)-proline or at least 145 ppm of sarmentosin epoxide in the form of an emulsion.
Conclusion
Claims 1, 2, 4-11, 15, and 17-22 are presently rejected. Claims 12-14 are objected to.
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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 5:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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