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 .
Response to Amendment
Applicant's amendment and argument filed 02/16/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-3, and 5-20 are pending of which claims 10-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/01/2025.
Claims 1-3, 5-9, and 16-20 are being examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 depends on cancelled claim 4.
Claim Rejections - 35 USC § 101
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.
Claim(s) 1-3, 5-9, and 16-20 is/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.
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 to a product of nature. In this case, applicant’s claim recites a cosmetic active agent comprising a Gardenia fruit extract and a solvent, wherein the solvent is a eutectic solvent having a pH of at least 5 (as disclosed in claim 1 of the instant application). In some embodiments, the invention further comprises a cosmetic active agent wherein the components of the eutectic solvent are of natural origin (e.g. betaine, glycerol and water) (see instant claims 3, 4 and claims dependent thereto). Thus, the claim(s) do recite a product 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, a composition comprising Gardenia fruit extract comprises naturally occurring products, whereby as claimed, the instant invention may comprise a composition comprising Gardenia fruit extract and a eutectic solvent having a pH of at least 5 wherein the eutectic solvent is of natural origin and comprises betaine, glycerol and water which are known in combination in the art to be biologically sourced from natural sources (see Skulcova, et al. "The pH behavior of seventeen deep eutectic solvents," BioRes. 13(3), 5042-5051. (2018)). There is no evidence or reason to expect that any new compounds are formed from the extraction process. Similarly, the eutectic solvent may be of natural origin (e.g. plants). There is no evidence or reason to expect that any new compounds are formed in the production of the solvent components from natural sources. The instant broadly claimed composition is a mixture of the naturally occurring plant components from the Gardenia plant and the plants from which the solvent is derived. Thus, while extraction of the Gardenia and/or production of the solvent components alters the structure of the cell(s) the result is still a mixture of components which are naturally found i.e., the components are not inventive or “man-made.” Thus, the claimed mixture 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, in some embodiments, Applicant’s claim is directed to a cosmetic active agent comprising a Gardenia fruit extract and a solvent, wherein the solvent is a eutectic solvent having a pH of at least 5 is with an intended use for an anti-ageing skin care composition (see instant claim 9). MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. 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. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and/or the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
In addition, applicant’s intended use of an anti-aging composition is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant's arguments filed 02/16/2026 have been fully considered but they are not persuasive. The applicant argues that the claimed composition does not naturally exist and therefore is not a product of nature. The components claimed are products of nature and the applicant has claimed them together in a composition. Each of the compounds found existing in plants are judicial exceptions and these components are what is being compared to their natural counterparts. The applicant argues that the claimed product has unpredictable and unexpected properties because when the extract is combined with the three solvents in the claimed ratios there is an advantage with storage stability. Optimizing solvents and pH is routine and conventional in the art especially for preserving actives in cosmetic formulations. Adjusting pH levels is common practice for optimizing control of acidic and basic environments which can have negative effects on active ingredients. This does not show any change to the components which are extracted from the Gardenia plant. Allowing active compounds to exist in specific pH environments is known to speed up or slow down the process of degradation. Adjusting pH is expected to have an effect on how quickly the extracted components are degraded when contained in solution. This does not show any change to those active components or allow them any functional change in characteristics.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-9 & 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rongjun, et al. (CN109602671) in view of Skulcova, et al. "The pH behavior of seventeen deep eutectic solvents," BioRes. 13(3), 5042-5051. (2018).
The instant claim(s) is/are of record, drawn to the following: a cosmetic active agent comprising a Gardenia fruit extract and a solvent, wherein the solvent is a eutectic solvent having a pH of at least 5 is with an intended use for an anti-ageing skin care composition, in some embodiments, further comprising naturally sourced eutectic solvent and/or the eutectic solvents betaine, glycerol and water.
Rongun, et al. teaches the preparation of a Gardenia volatile component, a skin cream containing the Gardenia volatile component, and preparation method of the skin cream (see Abstract). Rongun, et al. teaches Gardenia species (e.g. Gardenia jasminoides) as having known medicinal properties (e.g. protective role against oxidative damage to cells and tissues) (see Specification, [0004]-[0005]) (broadly teaching anti-ageing skin care composition, as required in the instant claim 9). Rongun, et al. teaches Gardenia contains crocin which has antioxidant properties (see Specification, [0006]). Rongun, et al. teaches a method for obtaining the volatile component of Gardenia comprising forming a Gardenia jasminoides extract (see Specification, [0016]-[0020]) (broadly teaching a Gardenia fruit extract as required in the instant claim 1). Rongun, et al. teaches a skin care cream composition comprising an oily and aqueous phase: Gardenia jasminoides extract (1.0%), betaine (1.0%-3.0%), deionized water, glycerin (i.e. glycerol) (3.0%-8.0%) (see Specification, [0020]-[0025]) (teaching the composition comprising Gardenia fruit extract and a eutectic solvent as required in the instant claims 1-3, 5-9, & 16). Rongun, et al. further teaches the skin care cream may also contain other raw materials such as moisturizers and/or preservatives (see Specification, [0026]) (teaching a cosmetically acceptable excipient as required in the instant claim 8).
Rongun, et al. is silent as to a eutectic solvent having pH of at least 5 and in some embodiments at least 5.5 (as required in claims 1-3, 5-9, & 16) and the percentage weight of the composition components (claims 5-7, & 19).
However, Skulcova, et al. teaches that Deep eutectic solvents (DESs) (i.e betaine, glycerol, water) are a specific category of solvents defined as a mixture of hydrogen bond donor and hydrogen bond acceptor (see Introduction, page 5042; Table 2, page 5045). Skulcova, et al. teaches because of their favorable properties, DESs are used in many industrial applications as an alternative to conventional organic solvents and have been introduced in many applications including extraction and for solubilizing biopolymers from lingocellulistic biomass (see Introduction, page 5042-43). Skulcova, et al. teaches it is very important to identify the relevant physical properties (i.e. pH) of the available solvent for every application (Introduction, page 5043). Skulcova, et al. further teaches temperature, molar ratio and the type of hydrogen bond donor could have significant influence on the pH of DESs. (Introduction, page 5043). Skulcova, et al. teaches that pH value of the green solvents in the context of hemicellulose solubility can have a significant effect on the composition and properties of extracted materials and should be taken into account at biomass treatment using DESs (see pages 5047-48).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have modified the composition comprising Gardenia fruit extract and eutectic solvent (e.g. betaine, glycerin (i.e. glycerol) and water) as taught by Rongun, et al. to manipulate the pH value of the solvent applying known properties of pH of eutectic solvents. It would have also been obvious to optimize the amount of the active ingredient which is the Gardenia extract to be in the amounts claimed because the extract has specific activity from antioxidant components isolated from gardenia and optimizing them is well within the purview of any skilled artisan. Also optimizing the solvents to be in the ranges claimed is well within the purview of a skilled artisan to preserve the stability of the antioxidant actives found within the Gardenia extract.
A person of ordinary skill in the art would have been motivated to combine the teachings of the references wherein glycerol, betaine and water are eutectic solvents generally known in the art to promote the stability of bioactive compounds as taught by Skulcova, et al. A person of ordinary skill in the art would have had a reasonable expectation of success in manipulating the pH of the eutectic solvents to obtain the extracted materials (i.e. crocins) with a desired composition and/or properties as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the adjustment of pH of the eutectic solvent and the percentage weight of the composition components) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
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 filed, 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 (including compositions within recited processes), 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 02/16/2026 have been fully considered but they are not persuasive. The applicant argues that Rongun’s composition is distinctly different than the instant composition because Rongun describes a volatile gardenia extract obtained by a process of steam distillation, which makes an oily composition. The applicant argues that the instant composition contains the water-soluble components of the Gardenia fruit extract however the applicant does not claim these and the claims are what is being examined. Also the composition itself is being examined and not the process of obtaining the composition. Rongun teaches skin care composition comprising of both an oily and aqueous phase and the instant claims are broadly directed to cosmetic compositions and do not require that merely only water-soluble components are found in the composition.
The applicant argues that Skulcova does not teach combining the three eutectic solvents together to arrive at the instant composition. Skulcova teaches of using green solvents for their stability of DES itself for thermal and chemical processes. Skulcova, et al. teaches that Deep eutectic solvents (DESs) (i.e betaine, glycerol, water) are a specific category of solvents defined as a mixture of hydrogen bond donor and hydrogen bond acceptor (see Introduction, page 5042; Table 2, page 5045). Skulcova, et al. teaches because of their favorable properties, DESs are used in many industrial applications as an alternative to conventional organic solvents and have been introduced in many applications including extraction and for solubilizing biopolymers from lingocellulistic biomass (see Introduction, page 5042-43). This teaching of stabilizing properties through hydrogen donor and acceptors makes obvious the use of these solvents for cosmetic formulations. Combining solvents is also common practice and conventional in the art. The applicant argues that since Skulcova does not specifically teach that the combined solvents exert the same properties of avoiding discoloration or improving stability it is not rendered obvious. Skulcova does not necessarily need to combine the solvents for the same purpose as why the instant applicant has combined them. One could combine them solely for the reasons described by Skulcova and from the basic knowledge of the artisan having ordinary skill. A skilled artisan would optimize solvents to arrive at compositions which would preserve well as Rongun specifically teaches of preservative raw materials (see claim 3). Adjusting pH is a well-known parameter to control for when considering preservation and so is the solvent in which to store the active components of the extract.
Conclusion
Currently no claims are allowed.
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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights