DETAILED ACTION
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/5/2026 has been entered.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been filed for review.
Claim Rejections - 35 USC § 101
3. 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 1-4, 6, 8-13 and 16-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims are directed to a lipstick composition comprising at least one natural oil, at least one fatty alcohol wax and particles of at least one natural filler.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The invention recited in claims 1-4, 6-13 and 16-22 are drawn to a composition of matter, in this case a composition that reads on using natural ingredients. The composition is formulated of active ingredients that include fatty alcohols and filler of mica of which are naturally occurring. Step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirement set forth in the composition are naturally occurring ingredients. The composition is formulated of all naturally occurring ingredients such as natural oils, mica, and fatty alcohols.
The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in 1-4, 6-13 and 16-22, the answer is no. There is not a practical application of the law of nature because the composition recited is encompassed by the combination of all naturally occurring ingredients.
Lastly, step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from a natural product. Reciting the intended use does not amount to significantly more than the judicial exception. The components recited in the rejected claims do not chemically react with one another or otherwise combine together in a particular way that creates a structural difference than what exists in nature. Even if the claimed subject matter recites specific amounts or ratios, the claims are still patent ineligible because each naturally occurring ingredient in the product would still be structurally identical to what exists in nature. The test is not whether if said ingredients are all found combined together in nature but rather if they are a combination of naturally occurring ingredients. The claim as a whole recites nothing more than naturally occurring ingredients combined into a lipstick. Claim 1 has recites at least one coloring agent and at least one fatty alcohol wax consists of a fatty alcohol component containing from 8 to 30 carbon atoms, and optionally a natural component of one or more natural oils however, coloring agents are inclusive of natural ingredients such as annatto and the fatty alcohol wax reads on waxes such as beeswax. Beeswax is an ester formed from fatty acid and 30 carbon chain. As such, the claim recites natural product.
The product as a whole does not do significantly more than what is in nature. With regards to the hardness alleged by applicants and the teachings of Example 3, it is noted that this example is not commensurate in scope with the claim. The claim recites natural oil, fatty alcohol wax, additional wax, coloring agent, particles of at least one natural filler, is in the form of a lipstick, and wherein the at least one fatty alcohol wax is present form 2 to 10 % by weight with respect to the entire weight of the composition, wherein the weight ratio of additional waxes to fatty alcohol waxes is at least 2:1, wherein the at least one fatty alcohol wax consists of a fatty alcohol component containing from about 8 to 30 carbon atoms and has a melting point of at least 40 ˚C. Example 3 specifically states particles of naturally fillers are cellulose or mica from 0.5 to 5 %. From this Example it is not clear what the specific test composition was. Claim 1 does not recite any amounts or the type of natural fillers. While mica particles and cellulose particles are disclosed at 1.5 %, 3 % and 5 %, it is not clear what the rest of the compositional components were tested for the compositions thus it is not clear if identical compositions were tested with varying the natural filler particles. Paragraph 00113 of the specification disclose “hardness of all compositions prepared was tested using the two testing procedures set forth in the earlier application” and it is not clear what earlier application this references or what the test compositions were for the rest of the ingredients. Example 1 varies all the amounts of each ingredient so it is not clear if identical compositions were tested with just varying the mica or cellulose. Furthermore, the hardness was tested without filler and compositions with the natural filler. Pharmaceutical fillers are added to increase volume and add bulk. Fillers also increase hardness of a tablet as it is directly related to how much pressure is needed to crush it which is influenced by the type of filler and amount. The combined components do not change any characteristic of any of the naturally occurring ingredients. The structure and function of the naturally occurring filler is not changed by mixing with the ingredients of the instant lipstick as claimed. Applicants have not demonstrated that the filler has an unexpected property that does not exist in nature. There is no evidence that the mica has altered properties. The comparative composition merely alleges comparison to adding mica vs no mica but does not provide evidence that the properties of mica or cellulose are altered when mixed in the composition versus what is found in nature. It is not significantly more or unexpected in the cosmetic and pharmaceutical arts that adding filler would lead to a harder tablet. Applicants can overcome the 101 rejection by amending to recite a non-naturally occurring ingredient.
As such, the claims fail to recite subject matter that is patent eligible, and thus the claims do not amount to significantly more than the judicial exception. In order to overcome the rejection, the claim needs to require a synthetic non-natural ingredient or demonstrate synergy.
Claim Rejections - 35 USC § 103
4. 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 1-4, 6, 8-13 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable Goppel et al. (EP1342463), Pinzon et al. (US 20020122781) and Dumousseaux et al. (US Patent 9,114,076), “Alcohol in Cosmetics: The Good, the Bad, and the Ugly”, Knip et al. “Diagnosing lanolin contact allergy with lanolin alcohol and Amerchol L101”, as evidenced by SpecialChem Lanolin Alcohol, further evidenced by “Campaign for Safe Cosmetics Mica”, and Carnauba wax”.
Goppel et al. (EP1342463) (hereinafter Goppel et al.) teach compositions that include:
Goppel et al. Table, Ex 5 Lipstick
Claim 1
Candelilla Cera (additional wax) 6 %
At least one additional wax
Cera Carnauba (additional wax) 2.5 %
At least one additional wax
Lanolin alcohol 2 % (fatty alcohol wax)
At least one fatty alcohol wax
Jojoba oil (natural oil)
At least one natural oil
Mica
Particles of least one natural filler
The weight ratio of the additional waxes to fatty alcohol waxes are at least 2:1 (8.5/2). Lanolin alcohol has the chemical formula C48H69NO and a melting point of >56, (see evidence reference SpecialChem Lanolin Alcohol). The composition contains at least one colorant (e.g., Cl (77491, 77492, 77499, 77891, 77120, 42090, 17200)). The composition is a lipstick thus in stick form. The composition does not contain water (anhydrous) and does not contain beeswax. The composition does not contain volatile oil, silicone oil or silicone waxes. Examples 4-5 are lipsticks. Goppel et al. are drawn to lip treatment products that contain UV agents and these compositions are drawn to coloring. The reference contains dye and color pigments for use in the lip products. The reference also discloses “lip contour sticks” and decorative lipsticks containing dyes and pigments. These would provide color to the lips. By definition a lipstick is a cosmetic product used to apply color and texture to the lips.
Example 4 discloses cetearyl alcohol (fatty alcohol wax) at 7 %, cera carnauba (additional wax) at 1.5 % and mica (filler) at 1.5 %. The natural oils consist of jojoba oil, almond oil, avocado oil and castor oil. The filler is mica at 1.5 %. As evidenced by Campaign for Safe Cosmetics, Mica is a naturally occurring mineral dust (e.g., particles). Octyldodecanol is disclosed.
Goppel et al. does not disclose the fatty alcohol behenyl alcohol.
Pinzon et al. (US 20020122781) (hereinafter Pinzon et al.) disclose lipstick compositions that contain fatty alcohols such as behenyl alcohol (para 0146-0147). The fatty alcohols can be present form 0.1 to 15 % and Pinzon et al. disclose that the skilled artisan may be able to cure a stability defect by the addition of at least one fatty alcohol to the composition. For example, the addition of at least one fatty alcohol may improve stick structure, minimize syneresis, and generally improve application properties without interfering with stick transparency, as compared to a composition that does not contain at least one fatty alcohol. It would have been prima facie obvious to one of ordinary skill in the art to further include a fatty alcohol such as behenyl alcohol in overlapping amounts in the lipsticks of Goppel et al anywhere from 0.1 to 15 %. One would have been motivated to do so to improve stick structure and application properties. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The ratio of fatty alcohol (0.1 to 15 % of Pinzon) to the carnauba wax is at least 4:1 (e.g., 7/1.5). A ratio of a fatty alcohol wax (behenyl) to particle of filler (mica) is at least 1:1. A ratio of natural oils to a fatty alcohol wax (castor oil + lanolin oil+ avocado oil+ jojoba oil) to behenyl is inclusive of at least 2:1. When taking into consideration fatty alcohol can be anywhere 0.1 to 15 %. Thus, the combined teachings disclose amounts that overlap the ratio. Example 4. Natural oils are merely optional.
A ratio of a fatty alcohol wax (behenyl) to particle of filler (mica) is 1:1 (6/6). A ratio of natural oils to a fatty alcohol wax (avocado oil+ jojoba oil) (3+2) to behenyl can fall for example (5/2) or a ratio of at least 2:1 as behenyl alcohol is taught in overlapping amounts.
Goppel et al disclose Mica is taught at 6 % which could be construed as about 5 %. Furthermore, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). It would have been prima facie obvious to one of ordinary skill in the art to optimize the mica. As taught by Goppel, Mica is a color pigment (para 0035-0038). Thus, one of ordinary skill in the art would optimize the amount of mica for the purpose of providing a pigment for color effects.
Goppel et al. does not disclose cellulose as the natural filler.
Dumousseaux et al. (US Patent 9,114,076) (hereinafter Dumousseaux et al. disclose solid anhydrous compositions comprising fillers which are understood as colorless or white solid particles of any form, which are in an insoluble and dispersed form in the medium of the composition, irrespective of the temperature of which the composition is manufactured (abstract and col. 28, lines 42-.col. 29., line 25).It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute on known filler for another. Both cellulose and mica are art recognized equivalents as suitable fillers for use in anhydrous compositions.
Goppel et al. disclose Lanolin alcohol and does not specifically disclose that the composition is devoid of animal derived ingredients.
The reference “Alcohol in Cosmetics: The Good, the Bad, and the Ugly” discloses that good alcohols include lanolin alcohol and cetyl alcohol. Knip et al. “Diagnosing lanolin contact allergy with lanolin alcohol and Amerchol L101” disclose that lanolin can cause contact allergy. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the lanolin alcohol for the cetyl alcohol as both are recognized as suitable alcohols for use and it would be obvious to one of ordinary skill in the art to avoid lanolin alcohol in order to avoid the contact allergy to wool as it is a known skin irritant.
RESPONSE TO ARGUMENTS
5. Applicants argue that in Natural Alternatives, not only were the method claims directed to specific methods of treatment using dietary supplements to satisfy the 101, the product claims were found to because they had different characteristics of what is found in nature. Applicants state that the characteristics that are different to nature are improved hardness when formulated together as a lipstick however do not provide evidence that the hardness is any different to nature. Claim 1 recites waxes which occur in nature and waxes provide a hardness. The claims are directed to a naturally occurring composition and there is no evidence of record that the ingredients have different characteristics that occur in nature. The Examiner disagrees with Applicants that the claims are directed to non-naturally occurring manufacture of a composition of matter.
Applicants argue that Goppel disclose Lanolin which is animal derived from sheep wool.
In response, while this argument is noted, the prior art recognizes that lanolin alcohol may cause skin irritation thus providing motivation to substitute this fatty alcohol for another.
CORRESPONDENCE
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615