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 .
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.
Priority
This application is a U.S. National Stage (371) application of PCT/US2022/036857 filed on 07/12/2022 which claims priority to U.S. Provisional Application Nos. 63/248,207 filed on 09/24/2021, 63/241,467 filed on 09/07/2021 and 63/220,810 filed on 07/12/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed U.S. provisional application No. 62/746,001 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-5 of the instant application recite “an inhibitor to caspase 4 (CASP4)” and claims 6-8 recite measuring the level of “CASP4” to directly correlate with the severity of SARS-CoV-2 infection in a subject. These inventive concepts were not described in the U.S. provisional application Nos. 62/746,001 and hence this application is not entitled to priority of 07/12/2021.
Similarly, the disclosure of the prior-filed U.S. provisional application Nos. 63/241,467 filed on 09/07/2021 and 63/248,207 filed on 09/24/2021 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Therefore, this application is not entitled to the priority date of 09/07/2021 nor of 09/24/2021.
The invention was fully described in application PCT/US2022/036857 which was filed on 07/12/2022. Thus, for purposes of applying prior art, claims 1-8 are subject to a priority date of 07/12/2022.
Should applicant disagree with the examiner’s factual determination above, applicant should provide evidence that the provisional application provide support for the invention now claimed in the manner required by 35 USC 112, first paragraph. This could be accomplished, for example, by pointing to the specific page and line numbers within the provisional application which disclose each limitation of the claimed invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/12/2024 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and all references are considered except where they were lined through.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification of the instant application does not reasonably provide enablement for treating a coronaviral infection, the coronaviral infection’s symptoms or the coronaviral infection’s disease state with any inhibitor of caspase 4 (CASP4). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Furthermore, the current disclosure does not satisfy the enablement requirement for directly correlating the GASP4 levels with the severity of a SARS-CoV-2 infection. The specification does not provide enough support for an artisan to perform the assay without undue additional experimentation as described in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998) as appropriate. See also MPEP § 2164.01(a) and § 2164.04.
The breadth of the claims:
The claims are recited at a high level of generality in which the method of treating a coronaviral infection with any inhibitor of CASP4 that comprises any antibody, siRNA, shRNA, protein or small molecule. Claim 6 also recites directly correlating the measured GASP4 level with the severity of a SARS-CoV-2 infection without specifying a reference level of GASP4 that is associated with a severe SARS-CoV-2 infection. Thus, the claims are recited at a high level of generality.
The nature of the invention:
The invention is about a first method of treating a coronaviral infection, the symptoms or disease state thereof comprising administering to a subject with a coronaviral infection an inhibitor of caspase 4 (CASP4) that comprises any antibody, siRNA, shRNA, protein or small molecule. The invention is also about a second method of assessing the severity of a SARS-CoV2 infection by measuring the level of CASP4 expression from a pulmonary tissue sample from a subject and directly associating the level of CASP4 with the severity of SARS-Cov2 infection.
The state of the prior art:
Although there have been reports about assessing the severity of SARS-CoV-2 infection in a subject as noted by Durand et al. (US 2023/0400464 A1, priority to Nov. 3, 2020, Abstract, [0017]), there is no prior art that describes using the level of CASP4 expression from a pulmonary tissue sample of a subject with SARS-Co-V2 infection to assess the severity of SARS-CoV2 infection. Although Durand provides a severity score to which levels of biomarkers are compared to (Abstract), there have not been reports of establishing reference values for CASP4 to directly correlate with severe SARS-CoV2 infection. While there have been dramatic improvements in the diagnosis and monitoring of SARS-CoV2 infections it remains a challenge for all clinicians due to the sudden onset of the disease and clinical implications including cytokine storm, thrombosis, pneumonia, inflammation, and tissue damage that leads to death if not treated as noted by Jacotot et al. (US 2023/0372292 A1, priority to 10/07/2020, Abstract; [0016]; [0023]; [0037]; [0181]).
Moreover, although there has been reports of treating a coronaviral infection with an inhibitor of CASP4 as noted by Jacotot et al. (Abstract; [0044]; [0054]), there is no prior art that teaches treating a subject with SARS-CoV2 infection with any inhibitor of CASP4. Furthermore, in re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims of the instant application.
The level of one of ordinary skill:
Based on the lack of prior art that describes using the level of CASP4 expression from a pulmonary tissue sample of a subject with SARS-Co-V2 infection to assess the severity of SARS-Co-V2 infection and on the lack of prior art that teaches treating SARS-CoV2 with any inhibitor of CASP4, the level of a person having ordinary skill in the art is not high enough to assess the severity of SARS-CoV2 infection by using the level of CASP4 expression and to treat a subject with such an infection with any inhibitor of CASP4. Specifically, although Durand teaches assessing the severity of SARS-CoV-2 infection in a subject, Durand does not teach using the level of CASP4 expression from a pulmonary tissue sample of a subject with SARS-CoV2 infection to assess the severity of SARS-Co-V2 infection. And Jacotot does not teach treating SARS-CoV2 with any inhibitor of CASP4.
The level of predictability in the art:
There is a high level of unpredictability in assessing the severity of SARS-CoV2 infection in a subject without the presence of a severity score as taught by Durand. Specifically, although Durand teaches assessing the severity of SARS-CoV-2 infection in a subject with a severity score, Durand does not teach using the level of CASP4 expression from a pulmonary tissue sample of a subject with SARS-CoV2 infection to assess the severity of SARS-Co-V2 infection. And Jacotot does not treat a subject with coronaviral infection with any inhibitor to CASP4. Furthermore, claim 8 covers a broad panel of inhibitors of CASP4, von Willebrand factor (vWF), IL-1β or Cxcl1 without a specific example for each of the species listed which makes the level of unpredictability even higher.
The amount of direction provided by the inventor:
As discussed above, prior art does not describe using the level of CASP4 expression from a pulmonary tissue sample of a subject with SARS-CoV2 infection to assess the severity of such an infection nor does teach treating a subject for SARS-CoV2 with any inhibitor of CASP4, and thus the inventor needs to show how the method of the instant application will enable a skilled artisan to assess the severity of SARS-CoV2 using the level of CASP4 expression from a pulmonary sample and to show how to treat subject for a SARS-Co-V2 infection with any inhibitor to CASP4.
The specification only gives one example that does not show a direct correlation between the level of CASP4 expression and severe SARS-CoV2 infection (Pages 29-45). Specifically, Example 1 of the specification teaches that Caspase-4/11 exacerbates disease severity in SARS-CoV2 infection by promoting inflammation and thrombosis (Page 29). While the specification teaches that the level of CASP4 expression is increased in subjects with severe SARS-CoV2 infection, it fails to provide a cutoff value or a reference level at which the severity of the SARS-CoV2 infection is assessed.
Furthermore, Example 1 does not describe a specific inhibitor to use to treat a subject for a coronaviral infection. Thus, the specification of the instant application fails to address a method for assessing the severity of SARS-CoV2 infection in a subject and treating it with any inhibitor to CASP4 and is not commensurate in scope with the broad claims of the instant application.
Last, there is no structure-function correlation for any of the inhibitors that are claimed by the instant invention to treat a subject for a SARS-CoV2 infection (i.e., species of claim 2 or of claim 8).
The existence of working examples:
There is only one example in the specification as noted above (Page 29, Example 1). Example 1 of the specification is about the effect of Caspase-4/11 on disease severity in SARS-CoV-2 infection by promoting inflammation and thrombosis (Page 29)
Example 1 is only directed to high expression of CASP4 in the pulmonary tissue sample of a subject with severe SARS-CoV2, but it does not provide a cutoff value nor a reference level, to which the level of CASP4 expression is compared to, for assessing the severity of SARS-CoV2 infection in a subject.
Furthermore, there is no indication from example 1 of the specification of the instant application that the broadly claimed method would work with any inhibitor to CASP4 and with any measurement assay without a reference value to compare to because example 1 is only teaching the high expression of CASP4 without the comparison. Thus, the specification does not provide guidance with respect to assessing the severity of SARS-CoV2 infection in a subject and treating with any CASP4 inhibitor.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
With the lack of teaching in prior art in regards to assessing the severity of SARS-CoV2 by directly correlating CASP4 expression level to the severity of SARS-CoV2 to treat with any inhibitor to CASP4, the PHOSITA is expected to face an unreasonable amount of experimentation. Furthermore, the recent onset of SARS-CoV2 with clinical implications in an individual add another challenge to a PHOSITA or to a clinician.
Thus, the specification of the instant application does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claims of the instant application. Consequently, claims 1-8 are rejected under 35 U.S.C. 112(a) because the specification does not reasonably provide enablement for treating a coronaviral infection, the coronaviral infection’s symptoms or the coronaviral infection’s disease state with any inhibitor of caspase 4 (CASP4) nor does it allow to assess the severity of a SARS-CoV2 infection with CASP4 levels.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data from which the applicant or doctor will be able to assess the severity of SARS-CoV-2 infection. Such an inference is not sufficient to transform the abstract idea of a mental process (assessing the severity of a SARS-CoV-2 infection) and a law of nature (directly correlating the level of CASP4 with the severity of infection) into a patentable application.
The claims are ineligible because the claims recite at least one judicial exception, i.e., abstract idea of a mental process (assessing the severity of a SARS-CoV-2 infection) and a law of nature (directly correlating the level of CASP4 with the severity of infection). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?)
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
Example 43 of 2019 Revised Patent Subject Matter Eligibility Guidance (PEG) is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims (Subject matter eligibility | USPTO).
Regarding claim 1 of example 43 of PEG and per Step 1, the claim is directed to a process, which is one of the statutory categories of invention as the claim recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
Similarly, claim 6 of the instant application is also directed to a statutory class of a method for assessing the severity of SARS-CoV-2 infection as it recites “a) obtaining a pulmonary tissue sample from the subject … b) measuring the level of CASP4 expression in the sample … wherein the level of CASP4 directly correlates with severity of infection” (Step 1: YES).
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?)
Regarding claim 1 of example 43 of PEG and per Step 2A, prong 1, the claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” and according to broadest reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of PEG recites “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. The grouping of “mathematical concepts” in PEG includes “mathematical calculations” as an exemplar of an abstract idea. PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in PEG, and a law of nature), and the analysis must therefore proceed to Step 2A Prong Two.
Similarly, claim 6 of the instant application recites a judicial exception of an abstract idea of a mental process of assessing the severity of a SARS-CoV-2 infection “A method of assessing the severity of a SARS-CoV-2 infection”, and a law of nature of directly correlating the level of CASP4 with the severity of a SARS-CoV-2 infection “wherein the level of CASP4 directly correlates with severity of infection”.
Accordingly, claim 6 of the instant application recites two judicial exceptions of a mental process and a law of nature, and the analysis must therefore proceed to Step 2A Prong Two.
(Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?)
Regarding claim 1 of example 43 of PEG and per Step 2A, prong 2, the claim as a whole does not integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, claim 1 of example 43 of PEG recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s
phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of PEG fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of PEG does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similarly, claim 6 of the instant application does not have additional elements that would integrate the judicial exceptions cited above into a practical application. The claim has steps of obtaining a pulmonary tissue sample from the subject and measuring the level of CASP4 expression in the sample to directly correlate with the severity of SARS-CoV2 infection, and these steps do not integrate the judicial exceptions into a practical application because they are data gathering steps to use in assessing the severity of a SARS-Co V-2 infection, which do not add a meaningful limitation to the method as they are insignificant extra-solution activity. These steps do not integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d).
Therefore, claim 6 does not integrate the judicial exceptions into a practical application.
(Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?)
Regarding claim 1 of example 43 of PEG and per Step 2B, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, claims 6 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as measuring the level of expression of CASP4 in human lung by single-cell RNA sequencing (scRNAseq) (Specification, page 29, lines 18-22). Furthermore, the claim itself is recited at a high level of generality in which any assay can be used as the measurement method for claim 6.
Thus, claim 6 is not eligible and is rejected under 35 USC 101.
Regarding claim 7, the claim teaches a list of different methods to measure the CASP4 expression level which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 8, the claim teaches a general treatment method of an inhibitor to different entities without specifying what type of an inhibitor to use which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Claim Rejections - 35 USC § 102
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)(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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jacotot et al. (US 2023/0372292 A1, priority to 10/07/2020).
Claim 1 recites:
“A method of treating a coronaviral infection or the symptoms or disease state thereof comprising administering to a subject with a coronaviral infection an inhibitor of
caspase 4 (CASP4)”.
Regarding claim 1, Jacotot teaches a method of treating a coronaviral infection or the symptoms or disease state (Abstract; [0044]; [0054]). Jacotot further teaches administering to a subject with a coronaviral infection an inhibitor of caspase 4 (CASP4) ([0044]; [0100]).
Regarding claim 2, Jacotot teaches that the inhibitor of CASP4 comprises a small molecule [0044]. Regarding claim 3, Jacotot teaches that the coronaviral infection is a SARS-CoV2 infection (Abstract, [0044], [0053]). Regarding claim 4, Jacotot teaches that the disease state is COVID-19 (Abstract; [0044]). Regarding claim 5, Jacotot teaches that the symptoms comprise thrombosis, pneumonia, inflammation, and tissue damage ([0016], [0037]; [0181]).
Conclusion
No claims are allowed.
Claims 6-8 are free of prior art because there is no prior art that teaches or suggests assessing the severity of SARS-CoV2 infection in a subject by directly correlating the measured GASP4 levels in a pulmonary tissue sample with the severity of a SARS-CoV-2 infection.
The closest prior art is:
Durand et al. (US 2023/0400464 A1, priority to Nov. 3, 2020) teaches the assessing the severity of SARS-CoV2 infection in a patient with a severity score that is determined by biomarkers (Abstract, [0017]). Durand does not teach nor suggest assessing the severity of SARS-CoV2 infection in a subject by directly correlating the measured GASP4 levels in a pulmonary tissue sample with the severity of a SARS-CoV-2 infection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR RAMADAN whose telephone number is (571)270-0754. The examiner can normally be reached Monday-Friday 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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