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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claim(s) 21-36 and the election of species for claim 36 (irritated skin) in the reply filed on March 09, 2026 is acknowledged.
Claim(s) 37-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claim(s) 21-36 are examined on the merits.
Claim Objections
Claim 29 is objected to because of the following informalities:
In claim 29, “comprises at most at most 0.3%” should read “comprises at most 0.3%”
Appropriate correction is required.
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(s) 21-34 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 21 is indefinite because it is unclear what “cosmetic method” means; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim 26 recites the limitation "the vegetal" in the second line. There is insufficient antecedent basis for this limitation in the claim, since claim 25 from which claim 26 depends refers to a vegetable oil.
All other claims depend directly or indirectly from the rejected claim 21 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 103
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.
Claim(s) 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Zelkha (WO 2016084068 A1) in view of Yun-Jeong (KR 101508622 B1 – English translation provided), Naumoska et al (Journal of Chromatography A, (Year:2015), vol. 1381, issue. 13, pp. 229-238), Martelanc et al (Journal of Chromatography A, (Year: 2009), vol. 1216, issue. 38, pp. 6662-6670), Gallo et al (Journal of Investigative Dermatology, (Year: 1998), vol. 111, issue. 5, pp. 739-743) and Matthews (AU 2014203112 A1).
Zelkha teaches a reduced-lycopene tomato-derived composition, comprising lycopene, wherein the concentration of said lycopene is in the range of 0.3% to 2% (weight/weight) (page 2). Zelkha teaches a reduced-lycopene tomato-derived composition [wherein] said composition further comprises phytosterols (page 2). Zelkha teaches that the product [has been used] extensively and successfully [to prevent or treat] skin conditions (page 1). Zelkha teaches the tomato product used as the starting material comprises tomato peels (page 4). Zelkha teaches the extraction of the tomato product (claim 9). Zelkha teaches that the composition of the present invention [is a] topical medicament [that is] a cosmetic or cosmeceutical preparation, and may be prepared in the form of a cream, lotion, ointment, gel and so on (page 5). Zelkha teaches that the composition of the present invention can be used as a medicament for oral delivery (page 6). Zelkha teaches for oral administration, the compounds can be formulated by combining the active compounds with pharmaceutically acceptable carriers known in the art. The compositions can be formulated in any solid or liquid dosage form known in the art, including but not limited to, tablet, caplet, capsule, microcapsule, pellet, pill, powder, syrup, gel, slurry, granule, suspension, dispersion, emulsion, liquid, solution, dragee, bead and beadlet (page 8). Zelkha teaches [that] for liquid formulations, pharmaceutically acceptable carriers may be aqueous or nonaqueous solutions, suspensions, emulsions or oils [such as] mineral oil, vegetable oil, olive oil, sunflower oil (pages 8-9). Zelkha teaches suitable excipients for solid formulations include lactose, mannitol, potato starch, polyethylene glycols, ascorbic acid, thiosorbitol (pages 9-10).
Zelkha does not teach a lipophilic Solanum lycopersicum fruit (e.g. tomato) peel extract. Zelkha does not teach that the lipophilic tomato peel extract comprises at least 5% by weight of amyrins and at least 1.5% by weight of sterols. Zelkha does not teach that the oral or topical administration of the lipophilic tomato peel extract soothes the skin. Zelkha does not teach that the lipophilic tomato peel extract induces the expression of antimicrobial peptides (AMPs). Zelkha does not teach that the vegetal (e.g. vegetable) oil is obtained by simultaneous or separate extraction(s) of tomato byproducts. Zelkha does not teach that the lipophilic tomato peel extract comprises at most 0.1% by weight, of lycopene. Zelkha does not teach that the lipophilic tomato peel extract comprises amyrins (e.g. α-amyrin, β-amyrin and/or δ-amyrin) at the specified concentrations stated within the claims of the present invention. Zelkha does not teach that the lipophilic tomato peel extract contains atleast 1% by weight of β-sitosterol and stigmasterol. Zelkha does not teach the lipophilic tomato peel extract that contains a weight content from 0.01% to 30% (that would include lycopene, amyrins and sterols combined). Lastly, the Zelkha reference does not teach that the lipophilic tomato peel extract treats irritated skin.
Yun-Jeong teaches a cosmetic composition comprising a green tomato extract (abstract). Yun-Jeong teaches [that the] green tomato extract is effective in improving wrinkles and skin elasticity, moisturizing skin, alleviating skin inflammation and stimulation, and regenerating skin cells (abstract). Yun-Jeong teaches the cream composition containing the green tomato extract of the present invention was superior in skin irritation mitigating effect (page 9).
Naumoska et al teaches the extraction of the vegetable cuticular waxes (pg. 230). Naumoska et al teaches that the cuticular waxes [on the skin of the] plant organs are composed of triterpenoids and phytosterols (pg. 229). Naumoska et al teaches the presence of β-sitosterol, stigmasterol, α-amyrin and β-amyrin [(e.g. amyrins are triterpenoids)] (table 3, pg. 237).
Martelanc et al teaches δ-Amyrin isolated from the tomato surface extract could be separated from other amyrins only by HPLC (abstract).
Gallo et al teaches that antimicrobial peptides are part of the host defense systems of mammals (abstract). Gallo et al teaches that the presence of these peptides in the skin forms a barrier for innate host protection against microbial pathogenesis (abstract).
Matthews teaches a topical composition that is useful in a method of treating skin irritation (abstract). Matthew teaches the composition can comprise tomato seed oil [and that the tomato seed oil or olive oil may be extracted from plants by chemical or physical extraction] (paragraph 0038).
The tomato peel extract as taught by Zelkha can be modified to include that the cosmetic composition can be used to improve wrinkles, skin elasticity, a skin moisturizer, stimulating skin, promoting skin cells [and treating] irritated skin as taught by Yun-Jeong along with additional knowledge that the extract of the skin of tomatoes contain molecules such as α-amyrin, β-amyrin, β-sitosterol, stigmasterol as taught by Naumoska et al and δ-Amyrin as taught by Martelanc et al. One skilled within molecular biology would reasonably expect that a cosmetic composition that contains tomato peel extracts as taught by Zelkha or a tomato extract itself, as taught by Yun-Jeong has the ability to intrinsically induce the presence of antimicrobial peptides that are naturally found within the skin that act as protection against microbes as taught by Gallo et al. In addition, one would reasonably expect that the use of a green tomato extract would not differ significantly than just the tomato peel extract itself. Tomatoes are tomatoes and, in this case, either red or green tomatoes, they both possess the same scientific name, Solanum lycopersicum and also it is very likely for the tomato extract in Yun-Jeong’s reference to include the skin of the tomato, thus possessing components indicated by the other references that would function to help improve the skin. Additionally, given that Yun-Jeong’s composition can improve skin elasticity, one would reasonably expect that skin weakness can be attributed to deficiencies in skin elasticity in which, deficiencies in skin elasticity is known to be contributed to by genetic factors, external stresses, etc. Furthermore, one would reasonably expect that the modified cosmetic composition would have an intended use to treat and/or have a desired outcome on all of the skin functions and/or features that are stated within claim(s) 22-23 and 34-36 of the claims of the present invention. Lastly, one would reasonably expect that Solanum lycopersicum (e.g. tomato) is naturally a lipophilic fruit, therefore, a person skilled in the art would know that a tomato would be considered a lipophilic product due to its natural and significant presence of carotenoids and sterols.
Regarding claim 25, one of ordinary skill in the art would reasonably expect to administer the tomato seed oil within Zelkha’s composition in order to treat skin.
Regarding claim(s) 26-27, one of ordinary skill in the art would reasonably expect to administer olive oil within Zelkha’s composition in order to treat skin. In addition, one of ordinary skill in the art knows that a vegetal oil like olive oil as taught by Matthews that is obtained through olives can only be obtained through an extraction.
The references do not specifically teach the percentages of the components of the lipophilic tomato peel extract together (e.g. at most 0.1% of lycopene, atleast 1.5% of α-amyrin, atleast 1% of β-amyrin, atleast 2.5% of δ-amyrin, and atleast 1% of β-sitosterol and stigmasterol), the weight content from 0.01% to 30% of the tomato peel extract and the ratio of the lipophilic tomato peel extract to the vegetal or mineral oil (from 1:2 to 1:70) in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references combined teach the use of each of the components within a lipophilic tomato peel extract that is within a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the components produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
One of ordinary skill in the art would be motivated to combine the aforementioned references in order to remedy the deficiencies within Zelkha in order to achieve a cosmetic method that comprises a Solanum lycopersicum fruit (e.g. tomato) peel extract that contains all of the components: lycopene, amyrins and sterols at optimal concentrations in relation to the total weight of the extract that can also be administered with a vegetal, mineral or tomato seed oil or can be administered with a cosmetically acceptable excipient either through oral or topical administration to a subject that would allow the subject to exhibit skin enhancing qualities.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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