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 .
Priority
This application is a National Stage entry of PCT/US2022/074178, filed 07/27/2022, and claims priority from Provisional Application 63203592, filed 07/27/2021.
Claim Status
Receipt of remark/amendments filed on 7/16/2026 is acknowledged. Claims 1-6, 9, 11, 13-14, 16-17, 19-23 are currently pending and under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Note: This is a second non-final office action that is prompted by further consideration of the instant claims and the prior art.
Specification
The use of the terms KinetiSol® and Soluplus® (see e.g. pages 3 and 5-6), which is a trade name or a mark used in commerce, has been noted in this application. These terms are used throughout the specification besides the pages pointed to above. The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Response to Arguments
Applicant in the remarks stated substitute specification containing the appropriate trademark indicators have been submitted.
In response, as discussed supra, the terms should be accompanied by the generic terminology. However, the substitute specification do not provide the terms accompanied by the generic terminology.
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.
Claims 1-6, 9, 13-14, 16-17, 19-20, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Behrend et al. (US 2018/0028451 A1; Feb. 1, 2018).
Behrend throughout the reference teaches a process for the preparation of a tablet comprising antihypertensive telmisartan active ingredient.
Regarding claim 1, 5 and 23, Behrend teaches a process for the preparation of a tablet composition comprising telmisartan, a basic agent, and a polymeric matrix excipient to form an amorphous solid dispersion with the active agent telmisartan, i.e., telmisartan is embedded into the polymeric matrix. As disclosed in instant specification, telmisartan is a poorly water soluble and a weakly acidic drug. Thus, Behrend teaches providing an API that is a weak acid. Behrend teaches processing telmisartan and a basic agent together with a polymeric matrix excipient and the processing comprises hot melt extrusion. The basic agent is selected from alkali metal hydroxides, basic amino acids, meglumine, NaOH, KOH, NaHCO3, KHCO3, Na2CO3, K2CO3, Na2HPO4 and K2HPO4. As such, Behrend teaches contacting the active (telmisartan) with a polymeric carrier and a strong base because NaOH and KOH disclosed by Behrend are strong bases as disclosed in the claims and specification. As disclosed in the instant specification and claims, NaOH and KOH are water soluble bases. Behrend teaches the composition comprises 5-15 wt. % of the basic agent (e.g., NaOH) and 0-30 wt. % of the polymer.
Regarding claim 2, as disclosed in the instant specification, telmisartan exhibits high melting point, thermal and shear sensitivity and exhibit low and pH dependent solubility by thermal and/or high energy mixing process.
Regarding claim 3, as discussed supra, Behrend teaches processing telmisartan and a basic agent together with a polymeric matrix excipient and the processing comprises hot melt extrusion (thermal process).
Regarding claim 4, as disclosed in the instant specification, water solubility of API being less than 1 mg/mL includes telmisartan.
Regarding claim 6, as discussed supra, Behrend teaches the basic agent is selected from alkali metal hydroxides, basic amino acids, meglumine, NaOH, KOH, NaHCO3, KHCO3, Na2CO3, K2CO3, Na2HPO4 and K2HPO4.
Regarding claim 9, as discussed supra, Behrend teaches processing telmisartan and a basic agent together with a polymeric matrix excipient and the processing comprises hot melt extrusion. Behrend does not teach contacting telmisartan, the basic agent and the polymer before the hot melt extrusion and thus reads on wherein the steps b and c occur simultaneously.
Regarding claim 13, Behrend teaches the composition comprises 5-15 wt. % of the basic agent (e.g., NaOH) and 0-30 wt. % of the polymer.
Regarding claim 14, Behrend teaches the polymeric matrix excipient comprises polyvinylpyrrolidone, which is water soluble as disclosed in the instant specification.
Regarding claim 19, Behrend teaches 5 to 30 wt. % of telmisartan and 0 to 30 wt. % of the polymer, which overlaps a ratio of 1:1 recited in the claim.
Regarding claim 20, Behrend teaches processing telmisartan, basic agent and polymer by hot melt extrusion at a temperature of 120-180 C.
(see e.g. Abstract; Claims; para 0016; 0022-0031; Examples; Entire Document).
The teachings of Behrend have been set forth above.
Behrend does not expressly exemplify wherein the basic agent used is a strong base (e.g., NaOH or KOH). However, as discussed supra, Behrend teaches the basic agent is selected from alkali metal hydroxides, basic amino acids, meglumine, NaOH, KOH, NaHCO3, KHCO3, Na2CO3, K2CO3, Na2HPO4 and K2HPO4. Behrend teaches NaOH and KOH (strong bases) as one of the basic agent utilized. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). It would have been obvious to one of ordinary skill in the art to try and substitute the bases taught by the reference as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding claim 16 and 17, Behrend teaches the same composition and method of preparation along with a strong base recited in the claims and therefore would necessarily result in the increased drug loading recited in these claims.
Regarding the claimed limitation wherein XRD shows no peaks noting the presence of crystallinity, Behrend teaches amorphous solid dispersion of the active agent telmisartan and specifically that the composition comprises amorphous telmisartan according to analysis by X-ray powder diffraction. (see e.g. claim 14; para 0015, 0051). As such, amorphous solid dispersion of the active agent telmisartan would show no peaks noting presence of crystallinity because amorphous drug is solubilized and not in crystalline form.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Behrend et al. (US 2018/0028451 A1; Feb. 1, 2018) as applied to claims 1-6, 9, 13-14, 16-17, 19-20, 23 above and further in view of Giri et al. (Pharmaceuticals, January 18, 2021, 14, 73), Almotairy et al. (J. Drug Deliv. Sci. Technol. Author manuscript; June 29, 2021), Dressman et al. (European Journal of Pharmaceutics and Biopharmaceutics 103 (2016) 95-103) and Helgi (Tropical Journal of Pharmaceutical Research, September 2018; 17 (9): 1685-1691).
The teachings of Behrend et al. have been set forth above.
Behrend does not teach wherein the composition comprises a strong acid and specifically the acids recited in claim 11. However, Giri, Almotairy, Dressman and Helgi cure this deficiency.
Giri also teaches hot melt extruded amorphous solid dispersion for solubility, stability and bioavailability enhancement of telmisartan (TEL). Giri teaches TEL is categorized as a BCS Class II molecule because of its low aqueous solubility (0.09 µg/mL) with dissolution rate-limited absorption. Additionally, TEL is highly ionizable (pKa 4.45 ± 0.09) and shows pH-dependent solubility behavior, i.e., sparingly soluble in strongly acidic media but readily soluble at strong alkaline conditions. (see e.g. Abstract; Introduction; Entire Document).
Almotairy teaches effect of pH modifiers on the solubility, dissolution rate, and stability of telmisartan solid dispersions produced by hot-melt extrusion technology. An important approach to improve the solubility of pH-dependent, poorly soluble drugs is pH adjustment. Incorporating a pH-modifying material into formulations or tablets is a promising way to create a suitable microenvironment pH that leads to improved solubility and the release of pH-dependent drugs. For example, poorly soluble weakly basic drugs can solubilize more when using acidifiers and vice versa. (see e.g. Abstract; Introduction; Results and discussion; Entire document).
Dressman discloses precipitation kinetics of weak base drugs. Weak base drugs generally have pH-dependent aqueous solubility and are often highly soluble only under acidic pH conditions. The weak base drugs (ketoconazole and dipyridamole) were dissolved in hydrochloric acid which is water soluble. (see e.g. Abstract; Introduction; section 2.2.4; Entire document).
Helgi teaches amlodipine is a long acting calcium channel blocker used for treatment of hypertension, coronary artery disease and chest pain. Amlodipine is a weak base with a pKa value of about 9.0 at 25 ºC. The reported aqueous solubility is 0.774 mg/mL. In relation to amlodipine besylate, solubility values at pH 1.2, 4.5 and 6.8 are 0.38 ± 0.017, 0.31 ± 0.005 and 0.110 ± 0.002 mg/mL respectively (abstract; introduction; entire document).
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of Behrend, Giri, Almotairy, Dressman and Helgi and replace or combine telmisartan with amlodipine and use a strong acid such as hydrochloric acid in the method and composition of Behrend. One would have been motivated to do so because Behrend teaches telmisartan is used as an antihypertensive agent and Helgi teaches amlodipine is a long acting calcium channel blocker used for treatment of hypertension. Thus, it would have been obvious to replace or combine telmisartan with amlodipine because both are taught to treat hypertension. Further, as discussed supra, Giri teaches Telmisartan is highly ionizable (pKa 4.45 ± 0.09) and shows pH-dependent solubility behavior, i.e., sparingly soluble in strongly acidic media but readily soluble at strong alkaline conditions. Almotairy teaches incorporating a pH-modifying material into formulations or tablets is a promising way to create a suitable microenvironment pH that leads to improved solubility and the release of pH-dependent drugs. For example, poorly soluble weakly basic drugs can solubilize more when using acidifiers and vice versa. Dressman teaches weak base drugs generally have pH-dependent aqueous solubility and are often highly soluble only under acidic pH conditions wherein the weak base drugs (ketoconazole and dipyridamole) were dissolved in hydrochloric acid which is water soluble. Helgi teaches amlodipine is a weak base with a pKa value of about 9.0 at 25 ºC. The reported aqueous solubility is 0.774 mg/mL. In relation to amlodipine besylate, solubility values at pH 1.2, 4.5 and 6.8 are 0.38 ± 0.017, 0.31 ± 0.005 and 0.110 ± 0.002 mg/mL respectively. The combination of Giri, Almotairy, Dressman and Helgi suggest that a weakly basic active ingredient can solubilize more when using acidifiers such as hydrochloric acid. Thus, it would have been obvious to one skilled in the art to use a strong acid such as hydrochloric acid when the active ingredient in the composition is weakly basic such as amlodipine.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Behrend et al. (US 2018/0028451 A1; Feb. 1, 2018) as applied to claims 1-6, 9, 13-14, 16-17, 19-20, 23 above and further in view of Medline (MedlinePlus; 02/15/2021; https://medlineplus.gov/druginfo/meds/a692051.html#:~:text=Lisinopril%20is%20used%20alone%20or,survival%20after%20a%20heart%20attack.).
The teachings of Behrend et al. have been set forth above.
Behrend does not teach wherein the composition comprises a second API. However, Medline cures this deficiency.
Medline teaches lisinopril is used alone or in combination with other medications to treat high blood pressure. (see entire document).
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of Behrend and Medline and further include lisinopril in the composition of Behrend. One would have been motivated to do so because Behrend teaches telmisartan is used as an antihypertensive and Medline teaches lisinopril is used alone or in combination with other medications to also treat high blood pressure. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Behrend et al. (US 2018/0028451 A1; Feb. 1, 2018) as applied to claims 1-6, 9, 13-14, 16-17, 19-20, 23 above and further in view of Schittny (Journal of Controlled Release 320 (2020) 214-225).
The teachings of Behrend et al. have been set forth above.
Behrend does not teach wherein the composition comprises a surfactant. However, Schittny cures this deficiency.
Schittny discusses effect of surfactant on oral bioavailability of amorphous solid dispersions (ASD). Results indicated improvement of dissolution and in vivo results support a positive effect of addition of surfactant on the performance of the formulation. Based on the results in this study, we hypothesize that surfactants can be used to fine-tune the dissolution behavior and particle formation from ASDs and therefore further enhance bioavailability. (see e.g., Abstract; Introduction Conclusion; Entire document).
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of Behrend and Schittny and further include a surfactant in the composition of Behrend. one would have been motivated to do so because similar to Behrend, Schittny discloses amorphous solid dispersions and discusses effect of surfactant on oral bioavailability of amorphous solid dispersions (ASD). Results indicated improvement of dissolution and in vivo results support a positive effect of addition of surfactant on the performance of the formulation. Based on the results in this study, we hypothesize that surfactants can be used to fine-tune the dissolution behavior and particle formation from ASDs and therefore further enhance bioavailability. Thus, it would have been obvious to one skilled in the art to include a surfactant in the composition of Behrend.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant argued Behrend only exemplifies the use of amine base, which is a weak base, in significant amounts (at least 20%) to process the active ingredient. The claims require less than 15% of strong base/acid.
In response, Behrend teaches processing telmisartan and a basic agent together with a polymeric matrix excipient and the processing comprises hot melt extrusion. The basic agent is selected from alkali metal hydroxides, basic amino acids, meglumine, NaOH, KOH, NaHCO3, KHCO3, Na2CO3, K2CO3, Na2HPO4 and K2HPO4. As such, Behrend teaches contacting the active (telmisartan) with a polymeric carrier and a strong base because NaOH and KOH disclosed by Behrend are strong bases as disclosed in the claims and specification. Behrend specifically teaches the composition comprises 5-15 wt. % of the basic agent (e.g., NaOH). Further, the rejection is made under 103 and does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123.
Applicant argued processing telmisartan with weak bases such as meglumine generally resulted in composition that exhibited some level of residual crystallinity.
In response, as discussed supra, the combination of Giri, Almotairy, Dressman and Helgi suggest that a weakly basic active ingredient can solubilize more when using strong acids and weakly acid active ingredient can solubilize more when using strong base. Thus, one skilled in the art would have an expectation that using a strong base to solubilize weak acid telmisartan would result in higher solubility and thus more amorphous drug and less crystallinity versus using a weak based with weak acid active.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6, 9, 13-14, 16-17, 19, 20, 22, 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12076328B2 in view of Behrend et al. (US 2018/0028451 A1; Feb. 1, 2018), Giri et al. (Pharmaceuticals, January 18, 2021, 14, 73), Almotairy et al. (J. Drug Deliv. Sci. Technol. Author manuscript; June 29, 2021) and Pardhi et al. (International Journal of Pharmaceutics 528 (2017) 202-214.
‘328 teaches a method of preparing a pharmaceutical composition comprising obtaining a pharmaceutically acceptable polymer, wherein the pharmaceutically acceptable polymer is a copolymer of polyvinyl pyrrolidone and polyvinyl acetate; a surfactant, and an active agent, wherein the active agent is niclosamide. Subjecting the pharmaceutically acceptable polymer, the surfactant, and the active agent to a hot melt extruder to obtain a pharmaceutical composition and the active agent is present in the amorphous form. The composition has been formulated through hot melt extrusion, wherein the hot melt extrusion is conducted at a temperature from about 100° C. to about 240° C. The composition comprises from about 5% w/w to about 90% w/w of the active agent and about 40% w/w to about 95% w/w of the pharmaceutically acceptable polymer. The composition further comprises an excipient. The pharmaceutical composition comprises from about 1% w/w to about 20% w/w of the further excipient.
‘328 does not teach niclosamide active component is poorly water soluble and a weak base/acid and wherein the API (e.g., niclosamide) is contacted/processed with a strong base (e.g., NaOH) or strong acid. However, Behrend, Giri Almotairy and Pardhi cure these deficiencies.
The teachings of Behrend, Giri Almotairy have been set forth above.
Pardhi teaches niclosamide is a weak acid and poorly water soluble (see entire document).
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of ‘328 and Behrend, Giri Almotairy and Pardhi and contact/process the API (e.g., niclosamide) with a strong base (e.g., NaOH). Pardhi teaches niclosamide is a weak acid and poorly water soluble. Almotairy teaches effect of pH modifiers on the solubility, dissolution rate, and stability of telmisartan solid dispersions produced by hot-melt extrusion technology. An important approach to improve the solubility of pH-dependent, poorly soluble drugs is pH adjustment. Incorporating a pH-modifying material into formulations or tablets is a promising way to create a suitable microenvironment pH that leads to improved solubility and the release of pH-dependent drugs. For example, poorly soluble weakly basic drugs can solubilize more when using acidifiers and vice versa. Almotairy, Giri and Behrend teach using NaOH as the strong base with weakly acid telmisartan. Therefore, it would have been obvious to further include a strong acid (e.g., NaOH) into the composition of ‘328 which comprises niclosamide, which was known to be a weakly acidic drug.
Regarding wherein XRD shows no peaks of crystallinity, ‘328 teaches the active agent is present in the amorphous form and as such would not have crystallinity.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to argument
Applicant argued the reference patent requires additional components not required by the present claims and is directed to pharmaceutical composition rather than methods.
In response, instant claims recite comprising language which does not exclude additional ingredients such as those in the reference patent. Further, the reference patent also claims a method of preparing pharmaceutical composition.
Applicant argued entire additional features that are not described in the claims of the reference patent cannot be added through secondary references.
In response, applicant have not provided any evidence (e.g. MPEP or elsewhere) that additional features not taught in the reference patent cannot be rendered obvious by utilizing a secondary reference. The rejection is a obviousness type double patenting rejection and does not require every instantly claimed feature to be claimed and anticipated by the reference patent.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616
