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 .
Applicant’s election without traverse of Group I, claims 18-33, in the reply filed on 29 December 2025 is acknowledged.
Claims 34-36 are withdrawn as being directed to a nonelected invention.
Claims 18-33 are presented for examination on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a cosmetic method for bleaching/lightening/homogenizing the skin by applying an extract of prepared according to a specific extraction method described in the specification as:
An essential oil and a hydrosol were produced by hydrodistillation of the flowering tops of Helichrysum italicum, then the hydrodistillation residue (distillation residue) was isolated and extracted using supercritical CO2 at a temperature of 60°C and a pressure of 285 bar. The unsaponifiable matter thus obtained was diluted in sunflower oil, and then subjected to a step of molecular distillation at 200°C and the resulting distillate was standardized by diluting it to 3-5% by weight in caprylic/capric triglycerides.
The polyphenol composition of this extract was compared with that of an oily extract of Helichrysum italicum obtained as follows:9% by weight of dried and ground plant powder (flowering tops) was mixed with 91% of an ultrasound-deodorized sunflower oil, in a container cooled to 10°C. Extraction was performed for 30 min, under ultrasound, with stirring at 500 rpm. Extraction was continued by microwave under a nitrogen flow of 0.4 L/min. The solid and liquid oily phases obtained were separated by decantation, then the oily phase was filtered and stored under an inert atmosphere, protected from light.
The extract according to the invention was prepared by dissolving 2 g of distillation residue extract in 1 mL of hexane. This oily solution was extracted three times with 2 mL of MeOH/H20 mixture (60/40). The MeOH/H20 phases were then pooled and diluted 12 in MeOH/H20 mixture (60/40).
However, the specification does not reasonably provide enablement for the claimed method employing any and all “oily” extracts of immortelle distillation residue of the Helichrysum italicum species. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
See Genentech v. Novo Nordisk, 108 F. 3d 1361, 1366 “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 86 S. Ct. 1033, 1042-43, 16 L. Ed. 2d 69, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to cosmetic use of oily extracts of immortelle distillation residue of the Helichrysum italicum species. However, the specification provides only one working example, prepared by a specific means of extraction. Regarding the extraction solvent used to obtain the extract of the claimed method of skin lightening, it is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his/her best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Oftentimes, unless the constituents in a particular natural product extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a natural product or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in an attempt to isolate particular ingredient(s) that have medicinal efficacy. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. For example, unpredictability with regard to natural extracts due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
Thus, the functional property of an extract Helichrysum italicum is not considered to be predictable because the type of extraction used to produce the extract would have a significant impact on the chemical characteristics of the extract.
The specification does not provide any specific guidance to show that any and all “oily” extracts of immortelle distillation residue of the Helichrysum italicum species have the claimed skin lightening functionality. An artisan would have to test every potential extraction technique with the virtually limitless number of solvents as well as every species of bee from every specific locale in order to determine if it is able to inhibit inflammation. This degree of experimentation clearly places an undue burden on the artisan of ordinary skill. The specification only provides testing data that the extract produced by the extraction procedures and variables disclosed could effectively lighten skin when used in a cosmetic preparation. Given the wide range of possible resulting extracts that could potentially result from various extraction methods, the presence of a single example of an extract that possesses skin lightening properties provides insufficient guidance to the person to practice the invention.
Consequently, given the unpredictability of the art, the lack of guidance from the specification and the quantity of experimentation needed to practice the claimed invention, the claims are not considered to be enabled for the full scope of the claims.
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.
Claims 18-33 are 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 18 is rendered vague and indefinite by the phrase “an oily extract of immortelle distillation residue of the Helichrysum italicum species”. Firstly, it is unclear what is meant by the use of the term “immortelle”, particularly since the proper botanical species name is also used, which would appear to make its use redundant. Does immortelle mean that the flowers specifically are being used? Aerial part of the plant?
Secondly, the term “oily” is a relative term which renders the claim indefinite. The term “oily” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term can be used to describe the solvent used to obtain the extract or the extract itself, that is there is some oil within the solvent or extract. But it is unclear how much oil is required to make it “oily”. Alternatively, does the term mean simply that the extract is the essential oil of plant species?
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
Note on claim interpretation: For purposes of examination the claims as drafted are given their broadest reasonable interpretation. When reading the preamble in the context of the entire claim, the recitation of an intended result of a method step such as skin lightening/bleaching etc, is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Furthermore, a description of an intended result of a positively recited step of a claimed method (e.g., “topically applying onto skin an oily extract of immortelle distillation residue of the Helichrysum italicum species”) also does not effectively limit the claimed method as such a intended result is deemed a result of the positively recited step. (see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) (a “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).
Thus absent language specifying that the amount of the extract is administered in “an effective amount”, the claims are directed a method comprising a step of topically applying onto skin an oily extract of immortelle distillation residue of the Helichrysum italicum species.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18-23 and 25-32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2019/180368A1.
The cited reference describes a cosmetic composition containing 0.1% essential oil of immortelle and 0.1% of an oily extract of immortelle curds. This example thus demonstrates that the combination according to the invention makes it possible to effectively fight against the aging of the skin and to reinforce the barrier function of the skin. Also taught is the non-therapeutic use of the composition to reduce the progression or decrease the intensity of the signs of skin aging, including wrinkles, sagging skin, loss of flexibility and / or elasticity of the skin, thinning of the skin, roughness of the skin and / or loss of radiance of the complexion; or to prevent or treat drying of the skin.
Thus, the cited reference is deemed to teach the claimed method of topically administering onto skin an oily extract of immortelle distillation residue of the Helichrysum italicum species.
In fact, the instant Specification states:
The oily extract of immortelle distillation residue advantageously represents from 0.01% to 1% relative to the total weight of the composition according to the invention.
Thus, topical application of the composition comprising the extract of the cited reference would have the effects of bleaching the skin and/or lightening the complexion and/or for homogenizing skin color and/or reducing or preventing the appearance of pigment spots, as the same extract is present in the same effect amounts as the cited reference.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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 5712720947. 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.
/RUSSELL G FIEBIG/ Examiner, Art Unit 1655