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 .
Specification
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
The disclosure is objected to because of the following informalities: please also insert the WIPO publication number and date after the application number cited.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 23 recites the limitations “means for flowing the cell culture medium” and “means for circulating said cell culture medium”.
The instant Specification states that “means for flowing the cell culture medium” may be a “pump”.
However, no discussion of the structure is recited in the instant Specification with regard to “means for circulating said cell culture medium”.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “each hollow fiber” on line 5 can be rewritten as “each of the hollow fibers” to indicate that it refers to the “plurality of hollow fibers” more clearly. 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.
Claims 1, 13, 25, 29, 38, 43, 44, 53 and their dependent claims 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 1 recites the limitation “the walls thereof” on lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “it” on line 8. It is not clear to what limitation “it” refers, such as “the liquid” or “waste materials” or more. Examiner interprets “it” to be “the liquid”.
Claim 13 recites the limitation “passage of waste materials” on line 2. It is not clear if this limitation is the same as “passage of waste materials” as in Claim 1, or not. Examiner interprets it to be the same.
Claim 25 recites the limitation “the flow of said cell culture medium”. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation “said receptacle” on line 4. It is not clear if this limitation is the same as “said at least one receptacle” as in Claim 23, or not.
Claim 25 recites the limitation “the content” on line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation “two or more receptacles”. It is not clear if this limitation is part of the previously recited “said at least one receptacle” in Claim 23, or if it is a limitation separate from the earlier recited group of receptacles. Examiner interprets them to be part of the same group.
Claim 38 recites the limitation “a cell culture container” on lines 3 & 3-4 of the claim. It is not clear if these limitations are the same as “a cell culture container” already recited on line 2 of the claim, or if they are all different. Examiner interprets them to be the same.
Claim 43 recites the limitation “the walls thereof” on line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation “it” on line 2. It is not clear to what limitation “it” refers, such as “said cell culture medium” or more, in Claim 43. Examiner interprets “it” to be “said cell culture medium”.
Claim 53 recites the limitations “a cell culture medium”, “nutrients”, or “waste molecules” but it is not clear once the limitations from Claim 43 are imported into the claim, if the limitations recited in Claim 43 are the same as the limitations recited above in Claim 53, or not.
Claim limitation “means for circulating said cell culture medium” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7, 9, 13 & 19 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Flieg et al., (“Flieg”, US 2015/0320924).
Claims 1, 7, 9, 13 & 19 are directed to a receptacle, an apparatus or device type invention group.
Regarding Claims 1, 7, 9, 13 & 19, Flieg discloses a receptacle for filtering a liquid, (See Abstract), said receptacle comprising:(1) a plurality of hollow fibers extending the length of said receptacle, (Hollow Fibers 3 in Housing 2 as part of Module 1, See Figure 2 & 5, See paragraph [0012], [0023]); and (2) at least one solid absorbent material occupying a space between said plurality of hollow fibers, (Filtrate Space 4 between Fibers 3 in Housing 2 as part of Module 1, See Figure 2 & 5, See paragraphs [0014]-[0016], [0023]), wherein each hollow fiber comprises at least one opening and a lumen formed by the walls thereof, (Hollow Fibers 3 inherently have opening and lumen respectively, See Figures 2 & 5, See paragraph [0012], [0023]), said walls having a porosity profile selective to passage of waste materials contained in the liquid from the lumen to the at least one solid absorbent material, (See paragraph [0023]), thereby filtering the liquid when it flows along the lumen, (See paragraph [0023]).
Additional Disclosures Included:
Claim 7: The receptacle of claim 1, wherein said liquid is a cell culture medium comprising blood cells, mammalian cells, chicken cells, crustacean cells, or fish cells, (See paragraph [0020], [0021]; See paragraph [0051] or [0052]).
Claim 9: The receptacle of claim 1, wherein said waste materials are selected from the group consisting of ammonia, lactate, toxins and sodium salts, (See paragraph [0053] or [0055]).
Claim 13: The receptacle of claim 1, wherein said porosity profile is configured to provide an average pore size and pore density that permits passage of said waste materials, (See paragraph [0023] or [0053]-[0055]; fibers have pores large enough for passage of toxins that are then adsorbed by particulates).
Claim 19: The receptacle of claim 1, wherein said at least one solid absorbent material is a microporous aluminosilicate material, an activated carbon, an ion-exchange resin, a charged polymer, a silica gel, a clay material, a resin material, or a combination thereof, (See paragraphs [0038], [0041], [0042]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 10, 23, 25, 27, 29, 36, 37, 40, 43, 44, & 50-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flieg et al., (“Flieg”, US 2015/0320924), in view of Nahmias, (US 2020/0080050 A1; The earlier publication date of January 18, 2018 of WO 2018/011805, its earlier publication, is relied upon), as also evidenced by “pH of blood: What to know”, Medical News Today, published 05/22/2020, obtained from Web on Oct. 10, 2025, <https://www.medicalnewstoday.com/articles/ph-of-blood>, 10 total pages).
Regarding Claim 10, Flieg discloses the receptacle of claim 1, wherein said liquid is a cell culture medium, (See paragraph [0020] or [0051]), but does not disclose wherein the cell culture medium contains tissues cultured for antibody production, growth factor production, or cultured meat production and wherein said waste materials are removed from said cell culture medium, while produced antibodies, produced growth factors, and produced cultured meat are retained in said cell culture medium.
Nahmias discloses wherein the cell culture medium contains tissues cultured for antibody production, growth factor production, or cultured meat production and wherein said waste materials are removed from said cell culture medium, while produced antibodies, produced growth factors, and produced cultured meat are retained in said cell culture medium, (See paragraphs [0053]-[0055] and [0156], Nahmias).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the receptacle of Flieg by incorporating wherein the cell culture medium contains tissues cultured for antibody production, growth factor production, or cultured meat production and wherein said waste materials are removed from said cell culture medium, while produced antibodies, produced growth factors, and produced cultured meat are retained in said cell culture medium as in Nahmias in order to provide “a cell growing technique that outperforms”, (See paragraph [0154], Nahmias), “many cell cultures” in which “such culture techniques are incredibly wasteful”, (See paragraph [0150], Nahmias), in which it can provide “cells…for cellular therapy or for protein…production” or “tissue transplantation…and a cultured meat”, (See paragraph [0156], Nahmias).
Regarding Claims 23, 25, 27, 29, 36, 37 & 40, Flieg discloses a system for filtering a cell culture medium, (See Abstract and See Figure 5, Flieg), said system comprising: (1) at least one receptacle according to claim 1, (See rejection of Claim 1 with Flieg above); (2) means for flowing the cell culture medium through the plurality of hollow fibers in said at least one receptacle, (Pump QRez, See Figure 5, See paragraph [0026], Flieg); (3) means for circulating said cell culture medium, (Pump QBin See paragraph [0026], Flieg), but does not disclose (4) a bioreactor.
Nahmias discloses creating a cell culture medium with (4) a bioreactor, (System 1000 and Bioreactor 300, See Figure 1A, See paragraph [0157], Nahmias). Additional features of this embodiment are included as part of the overall combination and are claim mapped to in the Additional Disclosures section below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the receptacle of Flieg by incorporating creating a cell culture medium with (4) a bioreactor as in Nahmias in order to provide “a cell growing technique that outperforms”, (See paragraph [0154], Nahmias), “many cell cultures” in which “such culture techniques are incredibly wasteful”, (See paragraph [0150], Nahmias), in which it can provide “cells…for cellular therapy or for protein…production” in which “polypeptides….can be purified using a variety of standard protein purification techniques, such as…chromatography”, (See paragraph [0482], Nahmias), as in Flieg, (See paragraph [0020], Flieg).
Additional Disclosures Included:
Claim 25: The system of claim 23, wherein the means for flowing the cell culture medium is a pump, (Pump QRez, See Figure 5, See paragraph [0026], Flieg), and the system further comprising at least one sensor configured to record values of at least one parameter related to the flow of said cell culture medium through said receptacle and/or the content of said cell culture medium, (See paragraph [0304], Nahmias), and a controller electrically connected to the pump and the at least one sensor, wherein said controller is configured to activate the pump based on signals received from the at least one sensor, (See paragraph [0305] & [0304] and See paragraphs [0160] & [0161], Nahmias).
Claim 27: The system of claim 23, further comprising at least one flow adaptor configured to fluidically connect said at least one receptacle to a recycling system, wherein said recycling system is an alternating tangential flow (ATF) system, a Tangential Flow Filtration (TFF) system, (See paragraph [0086], Flieg), a fed-batch culturing system, (See paragraph [0152], Nahmias), or a variation thereof.
Claim 29: The system of claim 27, wherein two or more receptacles are fluidically connected to a recycling system, wherein the two or more receptacles are configured to treat different waste materials, (Dialyzer 20 and Filter 24, fluid is recirculated, See Figure 1A, and See paragraph [0170], Nahmias).
Claim 36: The system of claim 23, further comprising a passive flow receptacle, (Dialyzer 20, See Figure 1A, See paragraph [0157] & [0270], Nahmias).
Claim 37: The system of claim 36, wherein said passive flow receptacle is configured to recycle the cell culture medium by osmosis or diffusion, (Dialyzer 20, See Figure 1A, See paragraph [0157], [0170], & [0270], Nahmias; fluid is recirculated).
Claim 40: The system of claim 23, wherein said cell culture medium is a suspension containing animal cells, (See paragraph [0157], [0170], Nahmias), said suspension being perfused into the plurality of hollow fibers of said at least one receptacle by a pump, (Pump QRez, See Figure 5, See paragraph [0026], Flieg), wherein said pump is a positive displacement pump that pushes the suspension through the plurality of hollow fibers or alternates between pushing the suspension into the plurality of hollow fibers and drawing the suspension out into the bioreactor, (See paragraph [0079], Flieg or See paragraph [0170], Nahmias; peristaltic pumps are positive displacement pumps).
Regarding Claims 43, 44 & 50, Flieg discloses a method for filtering a cell culture medium, (See Abstract, and See paragraph [0020], [0021]; See paragraph [0051] or [0052]), said method comprising: (1) flowing the cell culture medium through a receptacle, (Hollow Fibers 3 in Housing 2 as part of Module 1, See Figure 2 & 5, See paragraph [0012], [0023]), wherein said receptacle comprises a plurality of hollow fibers each having at least one opening and a lumen defined by the walls thereof, (See paragraph [0060] & [0061]), wherein said cell culture medium comprises waste molecules, (See paragraph [0023]); and (2) passing waste molecules through the walls of the plurality of hollow fibers to at least one solid absorbent material present outside the lumen and at a space between the plurality of hollow fibers, (See paragraph [0023]), thereby filtering the cell culture medium, (See paragraph [0023]), but does not disclose nutrients with the cell culture medium, retaining the nutrients in the lumen and wherein said at least one solid absorbent material is in a liquid environment having a pH > 7, (See paragraphs [0052] & [0053]; blood is treated which has a known pH of 7.35 to 7.45 according to “pH of blood”).
Nahmias discloses nutrients with the cell culture medium and retaining the nutrients in the lumen, (See paragraph [0171] & [0161], Nahmias).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the receptacle of Flieg by incorporating nutrients with the cell culture medium and retaining the nutrients in the lumen in order to provide “a cell growing technique that outperforms”, (See paragraph [0154], Nahmias), “many cell cultures” in which “such culture techniques are incredibly wasteful”, (See paragraph [0150], Nahmias), in which it can provide “cells…for cellular therapy or for protein…production” in which “polypeptides….can be purified using a variety of standard protein purification techniques, such as…chromatography”, (See paragraph [0482], Nahmias), as in Flieg, (See paragraph [0020], Flieg).
Additional Disclosures Included:
Claim 44: The method of claim 43, further comprising collecting said cell culture medium from said at least one opening and re-flowing it through the plurality of hollow fibers one or more times, thereby recycling the cell culture medium, (Fluid goes from Dialyzer 20 through loop to Filter 24 and back to Dialyzer 20 (recirculated), See Figure 1A, See paragraph [0170], Nahmias).
Claim 50: The method of claim 43, wherein the cell culture medium is used to grow cultured meat, (See paragraphs [0053]-[0055] and [0156], Nahmias).
Regarding Claims 51 & 52, modified Flieg discloses a method for producing cultured tissues, said method comprising: (1) culturing tissues in a cell culture medium comprising nutrients and waste molecules, (See paragraph [0171] & [0161], Nahmias); and (2) filtering the cell culture medium according to the method of claim 43, (See rejection of Claim 43 above), to reduce the amount of waste molecules from the cell culture medium, (See paragraph [0161], Nahmias).
Additional Disclosures Included:
Claim 52: The method according to claim 51, wherein the cultured tissues are used to produce cultured meat, (See paragraph [0082] & [0156], Nahmias).
Claim(s) 38 & 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flieg et al., (“Flieg”, US 2015/0320924), in view of Nahmias, (US 2020/0080050 A1; The earlier publication date of January 18, 2018 of WO 2018/011805, its earlier publication, is relied upon), in further view of Nordon et al., (“Nordon”, US 2008/0268538).
Regarding Claim 38, modified Flieg discloses the system of claim 36, but does not disclose wherein said passive flow receptacle is non-removably integrated with a cell culture container, or is removably placed inside a cell culture container or removably attached to an inner wall of a cell culture container.
Nordon discloses wherein said passive flow receptacle is non-removably integrated with a cell culture container, or is removably placed inside a cell culture container or removably attached to an inner wall of a cell culture container, (See paragraph [0025] & [0028], Nordon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the receptacle of modified Flieg by incorporating wherein said passive flow receptacle is non-removably integrated with a cell culture container, or is removably placed inside a cell culture container or removably attached to an inner wall of a cell culture container as in Nordon because “media degradation is accelerated in a recirculating system”, (See paragraph [0041], Nordon), so using “the proposed technical solution” will “scavenge unwanted by-products”, (See paragraph [0030], Norton), so that “media degradation can be reduced or prevented by selective removal of degradation products”, (See paragraph [0072], Norton).
Additional Disclosures Included:
Claim 39: The system of claim 38, wherein said cell culture container is a cell culture plate, a cell culture flask, or a cell culture bioreactor, (Bioreactor Chamber 300, See Figure 1A, See paragraph [0157] and [0158], Nahmias; or See paragraphs [0025], [0028], Nordon).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at 571-270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779