DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments/remarks filed 6/25/2026 are acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 101
4. 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, 8-12 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, 6-12 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.
RESPONSE TO ARGUMENTS
5. Applicants’ arguments have been fully considered.
Applicant argues that with regards to the 101 rejection, as demonstrated in example 3, claimed compositions containing all the identified ingredients and natural filler particles in the identified amounts have significantly improved harness properties as compared to comparative compositions of similar ingredients in different amounts.
In response, the Examiner respectfully submits that this argument is not found persuasive because independent claim 1 is not commensurate in scope with the showing of the hardness. Example 3 states cellulose or mica from 0.5 to 5 %, and harness testing of the composition showed that mica at 1.5 % had poorer hardness properties than the control composition. Claim 1 does not require the filler to be cellulose or mica just that if mica were to be present it should be about 3 %. The additional waxes included were candelilla and sunflower seed however, claim 1 does not require these nor does it state the relationship of its absence. Therefore, the properties are not found to be commensurate in scope. There is no showing that 0.5 % mica or cellulose had improved hardness properties which would not be predictable given that the 1.5 % mica showed poorer results.
Applicants argue that Example 4 of Goppel requires 5 % beeswax. In response, the Examiner respectfully submits the argument is not found persuasive because beeswax is not excluded by independent claim 1. Example 5 omits beeswax and applicants argue that the lanolinol and lanlinalkohol contain a total amount of 9 %. This argument is not found persuasive because the fatty alcohol wax of claim 1 can be up to 10 %. The claims now require that if mica is present it must be at 3 % which is not taught by Goppel.
CONCLUSION
6. 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.
CORRESPONDENCE
7. 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
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