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 .
Claim(s) 21-23 and 25-36 are pending.
Election/Restrictions
Applicants’ election without traverse of Group I, claim(s) 21-23 and 25-36 and the election of species for claim 36 (irritated skin) in the reply filed on March 09, 2026 is acknowledged. Claim(s) 37-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Newly submitted claim(s) 39-41 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim(s) 39-41 are drawn to a method of making the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 39-41 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim(s) 21-23 and 25-36 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 02, 2026 are being considered by the examiner.
The signed IDS form are attached with the instant office action.
Withdrawn Rejections
Applicants’ arguments filed July 07, 2026 have been fully considered.
In regard to the rejection under 35 U.S.C. 112(b) for indefiniteness, applicant has amended claim 26 as appropriate. Thus, the rejection of claim 26 under 35 U.S.C. 112(b) has been withdrawn.
Pending Rejections:
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) 21-23 and 25-34 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.
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.
The rejection of claim 21 is maintained because although in applicants’ arguments the applicant provides an explanation for a “cosmetic method”, the explanation given does not overcome the fact that the term itself “cosmetic method” is unclear. “Cosmetic method” is not clearly defined with applicants’ specification and the locations within the specification namely page 5, line 21 and page 19, lines 18-21 does not overcome the indefiniteness issue and one skilled in the art would render “cosmetic method” as unclear because that term can refer to something else and the examiner is not allowed to put forth his or her own interpretations which is why the applicant is reminded to either 1) provide a location within the specification where “cosmetic method” is appropriately defined or amend the language within the claim.
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) 21-23 and 25-36 are rejected under 35 U.S.C. 103 as being unpatentable over Zelkha (WO 2016084068 A1) in view of Offer (WO 2021070184 A1), 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 that in one preferred embodiment of the above-disclosed composition the phytosterol concentration is at least 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 (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 explicitly teach a lipophilic CO2 supercritical extract of Solanum lycopersicum fruit (e.g. tomato) peel (as stated within claim 21 of the present invention). Zelkha does not teach that the lipophilic tomato peel extract comprising at most 0.5% by weight of lycopene, at least 5% by weight of amyrins and at least 1.5% by weight of sterols, in relation to the total weight of the extract and wherein the CO2 supercritical extract of Solanum lycopersicum fruit peel promotes the expression of antimicrobial peptides (AMPs) in the skin (also stated within claim 21 of the present invention). Zelkha does not teach that wherein the oral or topical administration of the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel reinforces skin barrier function, and/or maintains or increases the resistance or the tolerance of the skin against an external aggression or stress, and/or prevents or treats a non-pathological alteration of the skin caused by an external aggression or stress, and/or improves or restores skin comfort and/or restores and/or maintains a healthy skin microbiome (as stated within claim 22 of the present invention). Zelkha does not teach that the oral or topical administration of the lipophilic CO2 supercritical extract of tomato peel extract soothes the skin (as stated within claim 23 of the present invention). Zelkha does not teach wherein the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel is administered in combination with a vegetable or mineral oil, and/or with Solanum lycopersicum seed oil (as stated within claim 25 of the present invention). Zelkha does not teach the cosmetic method of claim 25, wherein the weight ratio of the lipophilic CO₂ supercritical extract of Solanum lycopersicum fruit peel to the vegetable or mineral oil is from 1:2 to 1:70 (as stated within claim 26 of the present invention). Zelkha does not teach the cosmetic method of claim 25, wherein the vegetable oil and the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel extract are obtained by simultaneous or separate extraction(s) of tomato byproducts (as stated within claim 27 of the present invention). Zelkha does not teach the cosmetic method of claim 21, wherein the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel comprises at most 0.3% by weight of lycopene, in relation to the total weight of the extract (as stated within claim 28 of the present invention). Zelkha does not teach the cosmetic method of claim 28, wherein the lipophilic CO₂ supercritical extract of Solanum lycopersicum fruit peel comprises at most 0.1% by weight, of lycopene, in relation to the total weight of the extract (as stated within claim 29 of the present invention). Zelkha does not teach the cosmetic method of claim 21, wherein the amyrins are α-amyrin, ß-amyrin and/or δ-amyrin (as stated within claim 30 of the present invention). Zelkha does not teach The cosmetic method of claim 21, wherein the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel extract-comprises at least 1.5% by weight of α-amyrin, at least 1% by weight of ß-amyrin and at least 2.5% by weight of δ-amyrin, in relation to the total weight of the extract (as stated within claim 31 of the present invention). Zelkha does not teach the cosmetic method of claim 21, wherein the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel extract comprises at least 1% by weight of ß-sitosterol and stigmasterol, in relation to the total weight of the extract (as stated within claim 32 of the present invention). Zelkha does not teach the cosmetic method of claim 21, said method comprising the topical administration to a subject of a cosmetic composition comprising the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel in a weight content from 0.01% to 30%, in relation to the total weight of the composition, said composition comprising at least one cosmetically acceptable excipient (as stated within claim 33 of the present invention). Zelkha does not teach the cosmetic method of claim 21, wherein the subject is a healthy subject having sensitive skin, dry skin, aged-skin, blemish-prone skin, acne-prone skin, atopic-prone skin or skin weakened by an external insult or stress (as stated within claim 34 of the present invention). Zelkha does not teach a method for treating a skin disease characterized by an altered or unbalanced innate immune response comprising the oral or topical administration to a subject in need thereof of a composition comprising a lipophilic CO₂ supercritical extract of Solanum lycopersicum fruit peel extract-comprising at most 0.5% by weight of lycopene, at least 5% by weight of amyrins and at least 1.5% by weight of sterols, in relation to the total weight of the extract, as an active ingredient and wherein the extract promotes the expression of antimicrobial peptides (AMPs) in the skin (as stated within claim 35 of the present invention). Zelkha does not teach the method of claim 35, wherein the skin disease is eczema, psoriasis, rosacea, acne, dermatitis, atopic dermatitis, or irritated skin (as stated within claim 36 of the present invention).
Offer teaches [a method of] supercritical CO2 extraction of Solanum lycopersicum (par. 00131). Offer teaches [that the composition is for] treating skin-related conditions, including collagen loss (par. 0002).
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 ß-sitosterol, stigmasterol, α-amyrin and ß-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 the supercritical CO2 method of extraction of Solanum lycopersicum (tomato) as taught by Offer, can further include that the composition as taught by Zelkha 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 which would intrinsically mean that the composition would also help to maintain, balance or reinforce the natural defenses of the skin. Zelkha’s composition can also include additional knowledge that the extract of the skin of tomatoes contains molecules such as α- amyrin, ß-amyrin, ß-sitosterol, stigmasterol as taught by Naumoska et al and δ-amyrin as taught by Martelanc et al.
One skilled within molecular biology and the art would reasonably expect that a cosmetic composition that contains a CO2 supercritical extract of S. lycopersicum as taught by Offer has the ability to intrinsically induce the presence of antimicrobial peptides (AMPs) that are already naturally found within the skin that act as protection against microbes as taught by Gallo et al. Given that the Yun-Jeong reference teaches the use of a green tomato extract, regardless of the color of the tomato, tomatoes are tomatoes and, in this case, either red or green tomatoes, they both possess the same scientific name, Solanum lycopersicum and the Yun-Jeong reference can be used as an additional reference that teaches the preparation of an extract of S. lycopersicum within a cosmetic composition. Thus, based on the combination of Zelkha, Offer and Yun-Jeong, that would enable one skilled in the art to infer that the cosmetic compositions that contain a CO2 supercritical extract of S. lycopersicum can have a large range of beneficial effects on and within the skin. Thus, with the additional aforementioned references in combination with Zelkha, Offer and Yun-Jeong, it would be obvious to use the combination of the aforementioned references to meet all of the claim limitations of the present invention.
Additionally, given that Yun-Jeong's composition can improve skin elasticity, one would reasonably expect that if Offer’s CO2 supercritical extraction method of S. lycopersicum is used within Zelkha, one would be motivated to create a cosmetic composition that is geared towards treating skin weakness which 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 as taught by Matthews with Zelkha's composition in order to have beneficial effects on the skin.
Regarding claim 27, one of ordinary skill in the art would reasonably expect to administer Matthews olive oil within Zelkha's composition in order to have beneficial effects on the skin. In addition, one of ordinary skill in the art knows that a vegetable oil like olive oil as taught by Matthews that is obtained through olives that are obtained through an extraction.
Regarding claim(s) 21, 26, 28, 29, 31-33 and 35, the combined aforementioned references do not specifically teach most of the percentages of the components of the lipophilic CO2 supercritical extract of Solanum lycopersicum fruit peel in the amounts as claimed by the 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 was subjected to a CO2 supercritical extraction method 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 vegetable, 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.
Response to Arguments
Applicants’ arguments filed July 07, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 103 for obviousness are found to be non-persuasive.
Regarding the rejection under 35 U.S.C. § 103 for obviousness, based on applicants’ remarks, examiner has included an additional art within the 35 U.S.C. § 103 rejection, namely, Offer; Offer does teach a CO2 supercritical extraction of S. lycopersicum in which, it would be obvious that the tomato extracted would also include the skin of the tomato. Thus, Zelkha’s extraction method can be modified to use Offer’s CO2 supercritical extraction method of the tomato. Throughout applicants’ arguments on pages 11-16, applicant states that each of the references does not teach or suggest the preparation of the lipophilic CO2 supercritical tomato peel extract that is currently claimed in the present invention. More specifically beginning on page 11 of applicants’ arguments, applicant states “that the CO2 supercritical tomato peel extract of the invention upregulates the expression of genes encoding antimicrobial peptides (AMPs) such as psoriasin (S100A7), koebnerisin (S100A7A), lactotransferrin (LTF), and Calcium binding protein (S100B) in a human skin explant model…[in addition applicant states] In addition to the upregulation of AMP expression, the CO2 supercritical tomato peel extract of the invention induces a strong inhibition of genes involved in inflammation (mainly CXCL8, IL6, CXCL2), in oxidative stress (PTGS2, GPX3, HMOX1), and in terminal keratinocyte differentiation (KRT17, SPRR1A, TGM1, several LCE, EREG, CDSN). These effects were confirmed in vivo, as evidenced by Examples 5 and 6 of the as-filed application”. Based on applicants’ additional information regarding the CO2 supercritical tomato peel extract upregulating the expression of genes encoding antimicrobial peptides (AMPs), what the applicant is arguing is not commensurate in scope; in other words, what the applicant is arguing within the remarks is more detailed than that of the claim itself. In addition, to help remedy the deficiencies proposed due to Zelkha not conducting a CO2 supercritical extraction method, Offer is able to remedy that deficiency. Moving towards the bottom of page 12 of applicant arguments, applicant states that “Zelkha does not teach or suggest maintaining, balancing or reinforcing natural defenses of the skin”. Within the Zelkha reference, Zelkha does discuss that the composition can be used to prevent or treat skin conditions and therefore Zelkha’s teaching combined with the other aforementioned references would enable one skilled in the art to reasonably expect that Zelkha’s composition can help to maintain, balance or reinforce the natural defenses of the skin as a result of using Offer’s method in regard to the CO2 supercritical extraction of Solanum lycopersicum. Additionally, if the Zelkha reference teaches preventing or treating skin conditions, that teaching could go hand-in-hand with maintaining, balancing or reinforcing natural defenses of the skin as a result of assisting a subject in need that has a skin condition and thus helping that subject heal from that skin condition. Moreover, on pages 13-16, applicant delves into further detail of the references cited by examiner in the Non-final Office action dated April 07, 2026 that does not explicitly teach the CO2 supercritical extraction method of S. lycopersicum. Additionally, on page 14, applicant discusses that Yun-Jeong “exemplifies the preparation of an aqueous tomato extract and not of a lipophilic tomato extract”; it is known within the art 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. Therefore, the extraction of S. lycopersicum would continue to be lipophilic. Moving towards page 15 of applicants’ arguments, applicant states “Gallo is silent as to a composition comprising a tomato extract… [and that] Matthews is silent about a tomato extract, let alone a tomato peel extract, and CO2 supercritical extraction”. The Gallo et al reference is included in order to provide additional information in regard to AMP’s being a natural component within the skins defense system. In addition, the Matthews reference was provided by the examiner in order to discuss tomato seed oil which is known in the art to undergo extraction processes in order to be achieved. Lastly, on page 16 of applicants’ arguments, applicant states “Zelkha is not analogous art for the present invention and a skilled artisan, seeking to develop an extract for maintaining, balancing or reinforcing the natural defenses of the skin or mucous membranes would not have consulted Zelkha”. Based upon applicants’ explanation of the importance of a CO2 supercritical extraction method of S. lycopersicum, the addition of the Offer reference along with the additional aforementioned references within the 35 U.S.C. § 103 rejection above would enable one skilled in the art to use Offer’s CO2 supercritical extraction method of S. lycopersicum within Zelkha’s composition in order to achieve specific components and compounds within that of the S. lycopersicum extract that can be used for maintaining, balancing or reinforcing the natural defenses of the skin or mucous membranes and that can be used for promoting the expression of antimicrobial peptides (AMPs) in the skin through the use of a topical or oral composition. Thus, based on applicants’ claim amendments and examiner’s additional art, namely Offer that is used in combination with Zelkha, Yun-Jeong, Naumoska et al, Martelanc et al, Gallo et al and Matthews effectively overcome the limitations of the present invention.
No claim(s) are allowed.
Conclusion
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.
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
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655