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 .
This office action is in response to the amendment received on July 23rd, 2026.
The applicant has cancelled claims 2 and 6.
Claims 1, 3-5, 7, and 8 are pending and were examined on the merits.
Any objections or rejections not reiterated below are hereby withdrawn.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed July 23rd, 2026, with respect to the objection to the specification have been fully considered and are persuasive. The applicant has amended the specification to correctly recite trademarks and tradenames. The objection to the specification has been withdrawn.
Applicant’s arguments, filed July 23, with respect to the objection to claims 1, 3, and 4 over a punctuation informality have been fully considered and are persuasive. The applicant has amended claims 1, 3, and 4, to correct the punctuation informality regarding separating items in a list a comma. The objection to claims 1, 3, and 4 has been withdrawn.
The objection to claim 2 has been withdrawn, this claim having been cancelled by the applicant.
The objection to claim 6 has been withdrawn, this claim having been cancelled by the applicant.
Applicant’s arguments, filed July 23rd, 2026, with respect to the objection to claim 5 regarding completing a list using the term "or" have been fully considered and are persuasive. The applicant has added the term “or” to complete a list of alternative forms of the cosmetic composition. The objection to claim 5 has been withdrawn.
Applicant’s arguments, filed July 23rd, 2026, with respect to the have been fully considered and are persuasive. The applicant has amended claims 1, 5, 7, and 8, removing the term “characterized” and instead reciting the physical form, components, and intended use of the composition in the affirmative. The rejection of claims 1, 5, 7, and 8 under 35 U.S.C. 112(b) has been withdrawn
The rejection of claim 6 under 35 U.S.C. 112(b) has been withdrawn, this claim having been cancelled by the applicant.
Applicant’s arguments, filed July 23rd, 2026, with respect to the rejection of claim 8 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The applicant has amended claim 8, removing the term “preventing”. The previous rejection of claim 8 under 35 U.S.C. 112(a) has been withdrawn, however a new rejection of claim 8 under 35 U.S.C. 112(a) is made in view the applicant’s amendment to independent claim 1, from which claim 8 depends.
The rejection of claim 2 under 35 U.S.C. 101 has been withdrawn, this claim having been cancelled by the applicant.
The rejection of claim 6 under 35 U.S.C. 101 has been withdrawn, this claim having been cancelled by the applicant.
Applicant’s arguments, filed July 23rd, 2026, with respect to the rejection of claims 1, 3-5, 7, and 8 under 35 U.S.C. 103 have been fully considered. Upon further consideration, the applicant’s disclosure and the prior art does not enable a person of skill in the art to make the claimed invention, so the invention is non-obvious. The rejection of claims 1, 3-5, 7, and has been withdrawn.
The rejection of claim 2 under 35 U.S.C. 103 has been withdrawn, this claim having been cancelled by the applicant.
The rejection of claim 6 under 35 U.S.C. 103 has been withdrawn, this claim having been cancelled by the applicant.
Pending Objections and Rejections
Drawings
The drawings are objected to because in Figure 5, the shades of gray representing Groups 1 and 2 are so close in appearance that they are difficult to distinguish. Using more distinct shading to represent Groups 1 and 2 is recommended. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Table 1 (page 12 of the full specification, received on November 14th, 2023) recites concentration percentages without indication of these concentrations as weight/weight, weight/volume, or volume/volume percent for the following samples: Wild sage + Brazilian pepper tree + Lactobacillus, and Wild sage + Brazilian pepper tree + Brazilian copal + Lactobacillus.
Appropriate correction is required.
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 1, 3-5, 7, and 8 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 combining the extracts of Casearia sylvestris, Schinus terebinthifolius, and Hymenaea courbaril, does not reasonably provide enablement for obtaining the extracts of Casearia sylvestris, Schinus terebinthifolius, and Hymenaea courbaril. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a cosmetic composition comprising extracts of Casearia sylvestris and Schinus terebinthifolius; an extract, oil, or butter of Hymenaea courbaril; and Lactobacillus. Thus, the claims taken together with the specification imply a cosmetic composition comprising any extract of Casearia sylvestris; any extract of Schinus terebinthifolius; any extract, oil, or butter of Hymenaea courbaril; and Lactobacillus.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
De Oliveira et al. (BR-112019009838-A2) recites Casearia sylvestris and Hymenaea courbaril each reducing the apparent senescence markers p21 and p16 in an in vitro cell model (paragraphs [0016] - [0025]). However, De Oliveira does not recite the steps of preparing the Casearia sylvestris and Hymenaea courbaril in terms of the parts of the plant they are derived from and what extraction solvents were used (if any) and does not recite the bioactive chemical components from Casearia sylvestris and Hymenaea courbaril which resulted in the anti-senescence effects of each extract.
Estevão et al. (Acta Cir Bras. 2017, 32 (9), 726-735) recites treating an excisional wound model with Schinus terebinthifolius Raddi leaves oil (abbreviated STRO) (Abstract). The STRO-treatment increased collagen fibers deposition compared to a control group subject to vehicle solution.
Since the bioactive chemical component(s) of Casearia sylvestris and Hymenaea courbaril resulting in the reported anti-senescence effects remain largely unsolved by De Oliveira et al., and the means of obtaining the Casearia sylvestris and Hymenaea courbaril substances used to produce these effects is not disclosed, means for making a cosmetic composition comprising extracts of Casearia sylvestris and Schinus terebinthifolius; an extract, oil, or butter of Hymenaea courbaril; and Lactobacillus is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Estevão et al. investigated the effect of a specific part of the Schinus terebinthifolius plant, the oil of the leaves, on an excisional wound model and reported increased collagen fibers deposition.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided combining the extracts of Casearia sylvestris, Schinus terebinthifolius, and Hymenaea courbaril (Example 1). However, the specification does not provide the means for obtaining these extracts, in terms of extraction solvents and plant parts used as source materials; and does not recite an example using an oil or butter of Hymenaea courbaril, or a reason to expect the same cosmetically useful bioactive components in the same concentrations in an extract, oil, or butter of Hymenaea courbaril. Furthermore the specification does not provide indication of certain percentages of ingredients in Table 1 as weight/weight, weight/volume, or volume/volume percent for the following samples: Wild sage + Brazilian pepper tree + Lactobacillus, and Wild sage + Brazilian pepper tree + Brazilian copal + Lactobacillus.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by De Oliveira et al. and Estevão et al. and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to make a cosmetic composition comprising extracts of Casearia sylvestris and Schinus terebinthifolius; an extract, oil, or butter of Hymenaea courbaril; and Lactobacillus.
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.
Claims 1, 3-5, 7, and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to materials from recited plants and bacteria (instant claim 1) without significantly more.
Applicant's arguments filed July 23rd, 2026 have been fully considered but they are not persuasive. T Furthermore, the form of Hymenaea courbaril used in the experiment to obtain the unexpected result is thought to be an extract (instant specification, Example 1), whereas claim 1 recites the forms of an extract, oil, or butter, extending the breadth of the claimed form of Hymenaea courbaril beyond that used to obtain the unexpected result. Furthermore, claim 1 does not recite how the extracts are obtained, in terms of plant part(s) used as source materials and extraction solvent(s). Reciting how the extracts were obtained would contribute to distinguishing the claimed invention as that corresponding to the disclosed unexpected result. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility) (MPEP § 2106.04(c) II. B.).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground 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 Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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