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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/23/26 has been entered.
Claims 1-33 and 36-46 are pending.
Claims 1-3, 7-11, 13-15, 17, 18, 24, 26, 27, 36, 38, and 43-45 have been amended by Applicant.
Claims 1-33 and 36-46 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Action contains New Rejections Necessitated by Amendments.
Rejections Withdrawn
The rejection of claims under 35 U.S.C. 103 as being unpatentable over Deshmukh et al (Molecular Cancer, 2016, 15(69): 1-10), Wang et al (Angew Chem, 2016, 55: 1773-1776; 3/14/22 IDS), Vlashi et al (Breast Cancer Res Treat, 2014, 146: 525-534), and Fiorillo et al (Aging, 2016, 8(8): 1593-1606) and Sotgia et al (Cell Cycle, 2018,17(17): 2091-2100) is withdrawn.
The rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
The rejection under 35 U.S.C. 102(a)(1) is withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
Claims 1-5, 7-31, and 33 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Deshmukh et al (Molecular Cancer, 2016, 15(69): 1-10) in view of Wang et al (Angew Chem, 2016, 55: 1773-1776; 3/14/22 IDS), and Vlashi et al (Breast Cancer Res Treat, 2014, 146: 525-534).
Deshmukh et al teaches ATP content is known to be elevated in breast cancer CSCs as compared to non-CSCs (left column on page 4, in particular). Deshmukh et al further teaches CSCs are known to possess a high efflux system that disable chemotherapeutic drug activity using ABC transporters that are highly dependent on ATP generation and inhibitors of such ABC transporters can render cancer cells sensitive to chemotherapeutic drugs (left column on page 5, in particular). Deshmukh et al further teaches CSCs of various tumors exhibit particular surface markers, such as: CD133+/CXCR4+ for pancreatic cancer; and CD24-/CD44+ for breast cancer (paragraph spanning columns on page 3, in particular). Deshmukh et al further teaches ALDH1 is a marker of CSCs (right column on page 3, in particular). Deshmukh et al further teaches CSCs are known to remain in the GO phage of the cell cycle (left column on page 3, in particular).
Deshmukh et al does not specifically teach generating a composition comprising CSCs expressing a fluorescent signal in response to a fluorescent ATP imaging probe. However, these deficiencies are made up in the teachings of Wang et al and Vlashi et al.
Wang et al teaches a method of detecting increased ATP levels in a population of cells comprising staining the cells with ATP-Red-1, which is a fluorescent probe that selectively detects intracellular concentrations of ATP (Abstract, in particular). Wang et al further teaches flow cytometry can be used to detect ATP levels with ATP-Red-1 (right column on page 1775 and Figurer S19, in particular).
Vlashi et al teaches fluorescence activated cell sorting (FACS) as a well-known means of sorting cells based on fluorescent signal (left column on page 527, in particular). Vlashi et al further teaches cancer stem cells (BCSCs) have higher ATP content than their differentiated progeny (Abstract and Figure 2, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to identify CSCs that possess a high efflux system that disables chemotherapeutic drug activity of Deshmukh et al in a tumor biopsy tissue sample from a human subject with cancer in order to sensitize CSCs to chemotherapeutic drugs by inhibiting ATP-dependent ABC transporters of the CSCs by performing a combined method comprising treating cells of the tumor biopsy tissue sample with ATP-Red-1 and detecting those cells with elevated levels of fluorescence by performing FACS flow cytometry comprising measuring the fluorescence signals of the cells and comparing the fluorescence signals of the cells with a threshold (such as the top 5% or 10% of the fluorescence signals) wherein those cells above the threshold are sorted into a subpopulation indicative of being CSCs of Deshmukh et al because Deshmukh et al teaches CSCs exhibit elevated levels of ATP and are known to possess a high efflux system that disable chemotherapeutic drug activity using ABC transporters that are highly dependent on ATP generation and inhibitors of such ABC transporters can render cancer cells sensitive to chemotherapeutic drugs, Vlashi et al teaches fluorescence activated cell sorting (FACS) as a well-known means of sorting cells based on fluorescent signal, and Wang et al teaches ATP-Red-1 as a probe for ATP levels that is detected by flow cytometry. Such sorting results in the recited “purified composition”.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein the CSCs of the combined method with elevated ATP are further sorted based on the presence of other known biomarkers for CSCs of the tumor of interest (such as CD133+/CXCR4+ surface markers of Deshmukh et al for pancreatic cancer), wherein the sample is first treated and sorted with ATP-Red-1 (by detecting fluorescence from the ATP-Red-1 ) and then sorted with stains for said other known biomarkers (by detecting stains of the other known biomarkers), in order to confirm the sorted CSCs with elevated ATP of the combined method are actual CSCs of said tumor.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein cell cycle progression is further measured with the cells sorted as CSCs in order to confirm the sorted CSCs of the combined method are actual CSCs of said tumor because Deshmukh et al teaches CSCs are known to remain in the GO phage of the cell cycle.
Regarding the term “hyper-proliferative” CSCs of claim 1, the cited references do not describe CSCs of the combined method exhibiting elevated ATP levels as “hyper-proliferative; however, said CSCs exhibiting elevated ATP levels of the combined method appear to be the same as claimed. Further, the examiner takes the position that being “hyper-proliferative” is not a property having a significance greater than the combined method having the property of identifying CSCs as being targetable by inhibitors of ABC transporters to render the CSCs sensitive to chemotherapeutic drugs. Therefore, recitation that CSCs are “hyper-proliferative” is not sufficient to rebut obviousness of the combined method that is expected to have the equal or greater property of expected therapeutic benefit from identifying CSCs as being targetable by inhibitors of ABC transporters to render the CSCs sensitive to chemotherapeutic drugs. See MPEP 716.02(c). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results. Further, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991), where the court held that the fact that another advantage would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
Response to Arguments
In the Reply of 3/23/26, Applicant cites Vlashi et al as teaching using "an imaging system recently developed by our laboratory to sort BCSCs from non-tumorigenic cells using fluorescence activated cell sorting" (Vlashi at p. 527, right column), states Vlashi's approach "allows for detection of BCSCs without the need for additional staining, which could potentially perturb metabolic function." (Vlashi at p. 527 right column), and argues Vlashi using an imaging system based on lack of 26S proteasome activity for FACS having the benefit of not requiring any staining “teaches away” from using any staining (such as with ATP-Red-1) for separating cells using FACS. Applicant further argues a proposed combination and/or modification of Vlashi would impermissibly change Vlashi’s mode of operation because Vlashi’s use of FACS relied on a novel imaging system that beneficially allowed “for detection of BCSCs without need for additional staining, which could perturb metabolic function.”
The amendments to the claims and the arguments found in the Reply of 3/23/26 have been carefully considered, but are not deemed persuasive. In regards to the citation of Vlashi using an imaging system based on lack of 26S proteasome activity for FACS having the benefit of not requiring any staining “teaches away” from using any staining (such as with ATP-Red-1) for separating cells using FACS, the examiner disagrees. Vlashi et al teaches detection of BCSCs by detecting accumulation of a fusion protein of ZsGreen and cODC without the need for additional staining and postulates such additional staining “could potentially perturb metabolic function.” Vlashi et al does not teach staining of the combined method (such as with ATP-Red-1) actually perturbs metabolic function. Rather, Vlashi et al characterizes accumulation of a fusion protein of ZsGreen and cODC as a desirable alternative to other staining techniques. Further, Wang et al teaches fluorescent probes for monitoring mitochondrial ATP levels (taught by Deshmukh et al to be elevated in breast cancer CSCs) are “essential and highly desired” and that ATP-Red is such a fluorescent probe that “selectively and rapidly responds to intracellular concentrations of ATP” and describes ATP-Red as “a useful tool for investigating ATP-relevant biological processes” (Abstract of Wang et al, in particular). The test for obviousness is what the combined teachings of cited references would have suggested to one of ordinary skill in the art and all teachings must be considered to the extent that they are in analogous arts. Where the teachings of two or more prior art references conflict, the examiner must weigh the power of each reference to suggest solutions to one of ordinary skill in the art, considering the degree to which one reference might accurately discredit another. See MPEP 2143.01. Here, the cited prior art, as a whole, suggests desirability of using ATP-Red to detect elevated ATP levels in CSCs (as taught by Deshmukh et al) due to Wang et al teaching ATP-Red as a fluorescent probe that “selectively and rapidly responds to intracellular concentrations of ATP” and describes ATP-Red as “a useful tool for investigating ATP-relevant biological processes” (Abstract of Wang et al, in particular). While Vlashi et al characterizes accumulation of a fusion protein of ZsGreen and cODC as a desirable alternative to other staining techniques, Vlashi et al does not teach ATP-Red as unable to detect elevated ATP levels in CSCs.
Claim Rejections - 35 USC § 103
Claim(s) 1-31 and 33 remain rejected under 35 U.S.C. 103 as being unpatentable over Deshmukh et al (Molecular Cancer, 2016, 15(69): 1-10), Wang et al (Angew Chem, 2016, 55: 1773-1776; 3/14/22 IDS), and Vlashi et al (Breast Cancer Res Treat, 2014, 146: 525-534) as applied to claims 1-5, 7-31, and 33 above, and further in view of Liu et al (Nature Protocols, 2015, 10(10): 1612-1624) and Huang et al (Chinese Journal of Cancer, 2013, 32(11): 582-593).
Teachings of Deshmukh et al, Wang et al, and Vlashi et al are discussed above.
Deshmukh et al, Wang et al, and Vlashi et al do not specifically teach the CSCs sorted by the combined method as frozen. However, these deficiencies are made up in the teachings of Liu et al and Huang et al.
Liu et al teaches how to freeze stem cells sorted by FACS to provide a source for characterizing RNA of the cells (page 1620, in particular).
Huang et al teaches numerous studies are aimed at studying RNAs in cancer stem cells (page 585-587, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method wherein CSCs sorted by the combined method are frozen in order to provide a source of RNA for studies aimed at studying RNAs in CSCs because Huang et al teaches numerous studies are aimed at studying RNAs in cancer stem cells and Liu et al teaches how to freeze stem cells sorted by FACS to provide a source for characterizing RNA of the cells. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Response to Arguments
In the Reply of 3/23/26, Applicant repeats arguments that have been addressed above.
Claim Rejections - 35 USC § 103
Claim(s) 1-5 and 7-33 remain rejected under 35 U.S.C. 103 as being unpatentable over Deshmukh et al (Molecular Cancer, 2016, 15(69): 1-10), Wang et al (Angew Chem, 2016, 55: 1773-1776; 3/14/22 IDS), and Vlashi et al (Breast Cancer Res Treat, 2014, 146: 525-534) as applied to claims 1-5, 7-31, and 33 above, and further in view of Akbarzadeh et al (J Cell Physiol, 2019, 234: 14759-14772).
Teachings of Deshmukh et al, Wang et al, and Vlashi et al are discussed above.
Deshmukh et al, Wang et al, and Vlashi et al do not specifically teach the combined method wherein the further sorting based on the presence of other known biomarkers for CSCs of the tumor of interest (such as CD133+/CXCR4+ surface markers of Deshmukh et al for pancreatic cancer) is performed using antibody-coated magnetic beads instead of FACS. However, these deficiencies are made up in the teachings of Akbarzadeh et al.
Akbarzadeh et al teaches FACS and MACS (comprising using magnetic beads coated with antibodies against surface molecules of CSCs) can be used to isolate CSCs (Figure 1, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method wherein the further sorting based on the presence of other known biomarkers for CSCs of the tumor of interest (such as CD133+/CXCR4+ surface markers of Deshmukh et al for pancreatic cancer) is performed using magnetic beads coated with antibodies against surface molecules of CSCs as an alternative to FACS for said other known biomarkers because Akbarzadeh et al teaches FACS and MACS (comprising using magnetic beads coated with antibodies against surface molecules of CSCs) can be used to isolate CSCs (Figure 1, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Response to Arguments
In the Reply of 3/23/26, Applicant repeats arguments that have been addressed above.
Claim Rejections - 35 USC § 103
Claim(s) 1-5, 7-31, 33, and 36-40 remain rejected under 35 U.S.C. 103 as being unpatentable over Deshmukh et al (Molecular Cancer, 2016, 15(69): 1-10), Wang et al (Angew Chem, 2016, 55: 1773-1776; 3/14/22 IDS), and Vlashi et al (Breast Cancer Res Treat, 2014, 146: 525-534) as applied to claims 1-5, 7-31, and 33 above, and further in view of Fiorillo et al (Aging, 2016, 8(8): 1593-1606), Sotgia et al (Cell Cycle, 2018,17(17): 2091-2100), and Raghavan et al (Clin Cancer Res, 2017, 23(22): 6934-6945).
Teachings of Deshmukh et al, Wang et al, and Vlashi et al are discussed above.
Deshmukh et al, Wang et al, and Vlashi et al do not specifically teach the combined method wherein the CSCs of the subject are treated with a reagent such as Bedaquiline. However, these deficiencies are made up in the teachings of Fiorillo, Sotgia et al, and Raghavan et al.
Fiorillo et al teaches Bedaquiline is an FDA-approved antibiotic that inhibits ATP levels in cancer cells (Abstract and Figure 2, in particular) and halts the propagation of CSCs (Figure 7, in particular). Fiorillo et al further teaches a scheme of re-purposing Bedaquiline to eradicate CSCs by targeting mitochondrial metabolism (Figure 11, in particular).
Sotgia et al teaches mitochondrial-targeting FDA approved drugs that have successfully been used to eradicate CSCs include Bedaquiline, Doxcycline, Tigecycline, Azithromycin, Pyrvinium Pamoate, and Atovaquone (Table 1, in particular).
Raghaven et al teaches a personalized medicine method wherein CSCs of subjects are treated with candidate therapeutics and therapeutic effects of the candidate therapeutics are measured (Figure 3 and Figure 6, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method wherein CSCs obtained by the combined method are treated with any combination of known drugs to eradicate CSCs (including any of Bedaquiline, Doxcycline, Tigecycline, Azithromycin, Pyrvinium Pamoate, and Atovaquone) and therapeutic effects of the treated CSCs are measured because subjects with a disorder are not always therapeutically responsive to every reagent used to treat said disorder and Raghaven et al teaches treating CSCs of a subject with candidate therapeutics and measuring therapeutic effects of the candidate therapeutics provides an indication as to which drugs (or combinations thereof) a subject is therapeutically responsive. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Response to Arguments
In the Reply of 3/23/26, Applicant repeats arguments that have been addressed above.
Claim Rejections - 35 USC § 101
Claim 43 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. The rationale for this determination is explained below:
Claim 43 is directed to a natural phenomenon because the claims recite natural phenomenon (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is: “reagents”, which include PCR primers (not markedly different than naturally-occurring polynucleotides), for identifying upregulation of recited genes. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass kits/compositions that consist of polynucleotide primers that are not markedly different than polynucleotides found in nature encoding recited genes (“Step 2B”).
Response to Arguments
In the Reply of 3/23/26, Applicant argues this rejection should be withdrawn because there is no evidence that specific reagents for a unique gene signature exist in nature without other active ingredients.
The amendments to the claims and the arguments found in the Reply of 3/23/26 have been carefully considered, but are not deemed persuasive. In regards to the argument this this rejection should be withdrawn because there is no evidence that specific reagents for a unique gene signature exist in nature without other active ingredients, the examiner disagrees. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass kits/compositions that consist of polynucleotide primers that are not markedly different than polynucleotides found in nature encoding recited genes (“Step 2B”).
Claim Rejections - 35 USC § 101
Claims 45-48 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. Abstract ideas include mathematical concepts (including mathematical relationships, formulas, equations, and calculations), mental processes (including concepts performed in the human mind), and certain methods of organizing human activity (including managing personal behavior, relationships, or interactions between people). The rationale for this determination is explained below:
Claims 45-48 are directed to abstract idea and natural phenomenon because the claims recite natural phenomenon and an abstract idea (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is: levels of ABCA2, ATP51C, COX20, NDUFA2, UQCRB, and ATP are indicative of the presence of CTCs. The “abstract idea” is: the “indicating” step of claim 45 (a mental process). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional step of determining levels of ABCA2, ATP51C, COX20, NDUFA2, UQCRB, and ATP (“Step 2B”). Regarding determining levels of ATP, see Wang et al (Angew Chem, 2016, 55: 1773-1776; 3/14/22 IDS) using flow cytometry with ATP-Red-1 (right column on page 1775 and Figurer S19, in particular) that separates stained cells based on levels (including top 5% levels) of fluorescent signals. Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
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Here, the claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s). Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression and ATP levels. In regards to “indicating", it is further noted that merely presenting results of a process otherwise unpatentable under 35 U.S.C. 101 is insufficient to establish eligibility under the statute. See FairWarning IP, LLC v. Iatric Sys., Inc., No. 2015-1985, 2016 WL 5899185, at *3 (Fed. Cir. Oct. 11, 2016) (claim unpatentable under 35 U.S.C. 101 despite recitation of the step: “providing notification if [an] event has occurred”). Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…." Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Response to Arguments
In the Reply of 3/23/26, Applicant argues the recited separate populations of cells do not exist in nature and cells stained with ATP-labeling dye do not exist in nature. Applicant further argues a claimed approach to separating cell sub-populations using ATP-based fluorescent signals is patentable over prior art.
The amendments to the claims and the arguments found in the Reply of 3/23/26 have been carefully considered, but are not deemed persuasive. In regards to the arguments the recited separate populations of cells do not exist in nature and cells stained with ATP-labeling dye do not exist in nature, the examiner agrees.
In regards to the argument that a claimed approach to separating cell sub-populations using ATP-based fluorescent signals is patentable over prior art, this is not a prior art rejection.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
Claims 13-16 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.
Claims 13-16 are rejected because claim 13 recites “…wherein the cell sub-population….” There is insufficient antecedent basis for “the cell sub-population” in the claims.
Claim 15 is rejected for reciting “…and the separated cell sub-population….” There is insufficient antecedent basis for “the separated cell sub-population” in the claim.
Claim Rejections - 35 USC § 102
Claim(s) 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Swennenhuis et al (Expert Review of Molecular Diagnostics, 2016, 16(12): 1291-1305).
Swennenhuis et al teaches using the CellSearch kit/system, which isolates CTCs (left column on page 1292 and Figure 1, in particular). As a kit for isolating CTCs, said kit/system is a kit that consists essentially of reagents for identifying an upregulation of each of ABCA2, ATP51C, COX20, NDUFA2, and UQCRB in a biological sample by isolating CTCs for analysis.
Claim Objections
Claim 44 is objected to for being dependent upon a rejected claim.
Allowable Subject Matter
Claims 41-42 are allowed.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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