DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amendment submitted on July 1st, 2026 has been entered. Claims 1-2, 4-12, 14-18, and 41-42 are currently pending and under consideration. Claims 1 and 11 have been amended. Claims 41-42 have been newly added. Claims 3 and 13 have been newly cancelled. Claims 19-40 have been cancelled.
Response to Arguments
Applicant's arguments filed July 1st, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument pertaining to Farrel not disclosing that the moisture control layer is substantially free of water with the examiner’s assertion resting on an argument from silence, this argument is not found to be persuasive as the disclosure of ¶0022 as pointed to in the previous rejection specifically states that the moisture control layer is deposited on the surface and “dried off” such that the moisture control layer is a thin film or molecular monolayer (a layer that is one molecule thick), this act of drying the layer to form a molecular monolayer is seen to result in a layer that would inherently be substantially free of water as the layer has been “dried” and further did not substantially include water in the preparation process as hexadecanol and PEG both inherently present insolubility in water solution due to their amphiphilic in nature further indicating that any drying of the layer would result in substantially no water. Farrell further discloses the hydrophilic regions of the layer, the region that would exhibit hygroscopic tendencies as indicated by the applicant, faces the hydrophilic material of the medical device (¶0018 faces the hydrophilic material) and further discloses the hydrophilic material being substantially dry ¶0024 which would lead the hygroscopic natured portion of the device substantially dry which is how applicant has defined the terminology of substantially free of water (¶0060 the solid state of the lubricant is advantageously clean and free from mess in that it can adopt a relatively dry, particulate form over the hydrophilic coating wherein the lubricant is substantially free of water. Absent any other limitations defining the terminology of “substantially free of water” the broadest reasonable interpretation of substantially free of water is determined to be in line with substantially dry as detailed by Farrel. Applicants argument pertaining to the packaging containing water is not found to be persuasive as the disclosure of Farrel has expressly disclosed the hydrophilic portion of the layer being toward the substantially dry hydrophilic coating and preventing further ingress as stated in ¶0024 and showing that the hydrophilic region remains in the substantially dry state even after the package has been sealed thus disclosing that the moisture control layer remains itself substantially free of water even in the presence of water in the packaging due to its amphiphilic nature.
As such these arguments absent any other further defining limitations of “substantially free of water” such as those seen in the newly added dependent claim language of claim 41 is not found to be persuasive.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 7, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell (U.S. Publication 2020/0282177) in view of Carleo (U.S. Publication 2012/0179144), as evidenced by Tosatti (U.S. Publication 2008/0086008).
Regarding claims 1 and 11, Farrell discloses an intermittent catheter comprising:
a catheter tube 12;
a hydrophilic coating 14 disposed over a surface (Fig. 1 shows element 14 disposed over outer surface of catheter tube 12);
a lubricant (16, see below functional language regarding lubricant) the lubricant being substantially free of water (¶0022 moisture control layer comprises 1% hexadecanol and spreading agent polyethylene glycol once ethanol is dried off), disposed over a surface of at least a distal portion (¶0022 substantially covers the entire surface of the hydrophilic material) of the catheter tube (¶0017 moisture control layer 16 overlies/covers/is deposited on hydrophilic coating, the lubricant configured to transition from a solid state to a liquid state upon insertion into a urethra of a patient or user (¶0020 when device is inserted into the body, the moisture control layer melts); and
a funnel coupled to a proximal portion of the catheter tube (see illustrative diagram of Figure 2 below).
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Illustrative diagram of Fig. 2 of Farrell.
While Farrell does not expressly disclose element 16 being a lubricant, the limitation of “lubricant” is considered functional language (lubricant defined as a substance capable of reducing friction, heat, and wear when introduced as a film between solid surfaced, Merriam-Webster LUBRICANT Definition & Meaning - Merriam-Webster; thus the term defines the function of reducing friction, heat, and wear; for voiding urine describes function of urine flowing through the catheter and out of the funnel when used as a urinary catheter in a patient). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant application, the moisture control layer of Farrell discloses all the structure as claimed, and further comprises Polyethylene glycol (¶0022 of Farrell polyethylene glycol) which is a known lubricant (¶0046 of Tosatti, lubricant selected from the group consisting of polyethylene glycol). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a lubricant).
Farrell does not expressly disclose the catheter tube being made of a polymeric material, the extent to which the hydrophilic material/lubricant coats the catheter tube, or the funnel including an opening in a proximal end of the funnel for voiding urine.
However, Carleo, in the same field of endeavor of urinary catheters, discloses a catheter tube 12 made of a polymeric material (¶0068 materials commonly used to make the member 12 include silicones), that comprises a hydratable coating on at least a distal portion of the catheter tube (¶0036 coating arranged at least on an outer surface of the distal end) and a lubricious coating arranged at least on an outer surface of the distal portion of the catheter tube (¶0036 lubricious coating arranged at least on an outer surface of the distal end of the elongate member), and a funnel 18 including an opening in a proximal end (Fig. 2 shows opening in proximal end of 18) of the funnel for voiding urine (¶0063 flows into the catheter or member 12 and out of the funnel).
Regarding the catheter tube being made of a polymeric material, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the catheter shaft material of Farrell that performs the function of providing a urinary catheter shaft to be coated by a hydrophilic coating for the catheter shaft material of Carleo since these elements perform the same function of providing a catheter shaft for urinary catheters to be coated in hydrophilic material. Simply substituting one catheter shaft forming material means for another would yield the predictable result of providing a(n) a base catheter shaft material that can be coated. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the catheter shaft of Farrell out of silicone (polymeric material), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding the lubricant and hydrophilic coating being disposed over a surface of at least a distal portion of the catheter tube, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coatings of Farrell to be located at least at a distal portion of the catheter tube and therefore disposed over at least a distal portion of the catheter tube in view of Carleo since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of disposing a lubricant and hydrophilic material over a surface of at least a distal portion of the catheter tube would have yielded predictable results of applying the lubricant and hydrophilic material to the portion of the catheter that is intended to be inserted into the patient. This would result reduced friction of the inserted portion of the device such that the patient maintains greater comfort during the insertion process and is subject to less damaging forces occurring between the patient orifice walls and the catheter shaft. See MPEP 2143.
Regarding the funnel, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the funnel of Farrell to have included an opening at the proximal end of the funnel for voiding urine, as taught by Carleo, for the purpose of allowing fluid flowing into the urinary catheter to flow out of the funnel distally to the patient (proximal end is at distal end in reference to the patient when inserted; ¶0063 patient’s urine flow into the catheter and out of the funnel).
Regarding claims 2 and 12, Farrell in view of Carleo suggest the intermittent catheter of claims 1 and 11. Farrell further discloses the lubricant being in a particulate form of the lubricant (¶0022 solution applied by aerosol spraying which results in particulate formation of coating on applied surface).
Regarding claims 7, Farrell in view of Carleo suggest the intermittent catheter of claim 1. Carlos further suggests the polymeric material being silicone (¶0068 materials commonly used to make the member 12 include silicones). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the catheter shaft material of Farrell that performs the function of providing a urinary catheter shaft to be coated by a hydrophilic coating for the catheter shaft material of Silicon of Carleo since these elements perform the same function of providing a catheter shaft for urinary catheters to be coated in hydrophilic material. Simply substituting one catheter shaft forming material means for another would yield the predictable result of providing a(n) a base catheter shaft material that can be coated. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the catheter shaft of Farrell out of silicone (polymeric material), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell (U.S. Publication 2020/0282177) in view of Carleo (U.S. Publication 2012/0179144), as evidenced by Tosatti (U.S. Publication 2008/0086008) and further in view of Tosatti (U.S. Publication 2020/0086008).
Regarding claim 4 and 14, Farrell in view of Carleo suggest the intermittent catheter of claims 1 and 11. Farrell further discloses tuning or adjusting the melting point of the lubricant to the desired application (¶0020) and being about 37°C (i.e. 98.6°F, however neither Farrell or Carleo disclose or suggest the lubricant having a melting point between 70°F and 95°F (Claims 4 and 14)
However, Tosatti, in the same field of endeavor of lubricating medical devices such as urinary catheters (¶0057 urinary catheters), teaches a Polyethylene glycol (¶0046) lubricant provided on a surface (¶0030 on the surface of the coating) of a hydrophilic coating that has a melting point between 20°C and 50°C equating to 68°F and 122°F).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lubricant of Farrell to have had a melting point between 70°F and 95°F as Tosatti shows that the material disclosed by Farrell of Polyethylene glycol has the ability to be formulated with a melting point between 68°F and 122°F and Farrell teaches tuning or adjusting the melting point of the lubricant to the desired application (¶0020) as well as having the lubricant melt during application to a patient which would require that the material have a melting point of above room temperature in order to not melt prior to application and below/at a normal patient body temperature which is 98.6°F and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Farrell would not operate differently with the claimed range and specifically discloses the use of a material capable of being adjusted to within the claimed range as well as disclosing tuning and adjusting the melting point to a desired application. Further, applicant places no criticality on the ranged claimed, indicating simply that “The foregoing lubricant can be a fat such as a natural fat, a semisynthetic fat, a synthetic fat, or a combination thereof having a melting point between 70°F and 95°F” (¶0061 of applicants’ specification).
Claim(s) 1, 5-6, 8, 11, 15-16, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (U.S. Publication 2017/0007802) in view of Tosatti (U.S. Publication 2020/0086008).
Regarding claims 1, 5-6, 11, 15-16, and 41, Clarke disclosed an intermittent catheter Fig. 1 comprising:
a catheter tube 10 made of a polymeric material (¶0175 polyvinyl alcohol, polyacrylic acids, polylactic acid, polyesters..), that comprises a hydrophilic lubricant coating (¶0176 non-aqueous lubricant include hydrophilic coating) substantially free of water (¶0176 nonaqueous, between about 5 wt% - 0 wt%) disposed over a surface on at least a distal portion of the catheter tube (¶0017 includes a catheter shaft having a proximal insertion end portion, a middle portion and a distal end portion; ¶0432 catheter shaft is lubricated; ¶0172 lubricious outer surface), and a funnel 22 coupled to a proximal portion of the catheter tube (see Fig. 1 shows coupling to end of catheter shaft 12), the funnel including a funnel opening in a proximal end of the funnel for voiding urine (¶0173 distal end portion may include drainage member 22, such as a funnel, associated therewith for fluidly connecting the flow path of catheter to a collection container or directing urine into a collection receptacle, opening illustrated in Fig. 33).
Clarke does not expressly disclose the lubricant being disposed over a hydrophilic coating (Claim 11), the lubricant configured to transition from a solid state into a liquid state upon insertion into a urethra of a patient or user (Claim 1 and 11), the lubricant being a natural fat, synthetic fat, or a combination thereof (Claims 5 and 15), the lubricant being coconut oil, cocoa butter, palm oil, shea butter, or a mixture thereof (Claims 6 and 16), the lubricant including less than 1% water (Claim 41), or the lubricant having antioxidant properties (Claim 42).
Regarding the lubricant including less than 1% water, Clarke discloses the lubricant including preferably between about 5 wt % - 0 wt % water ¶0176. While this range does not expressly disclose the claimed range of less than 1%, the disclosed range of Clarke includes the values associated with the range of less than 1 % within the disclosed range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the water content of Clarke to have been within the claimed range since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Clarke would not be seen to operate differently with the claimed ranged and applicant appears to have placed no criticality on the claimed ranged indicating simply that the lubricant is substantially free of water including less than 1 % water (¶0060 of applicants’ specification). As such the claimed range is seen to have been obvious to one of ordinary skill in the art.
Regarding the lubricant being disposed over the hydrophilic coating and being a natural fat of coconut oil, and the lubricant having antioxidant properties, however, Tosatti, in the same field of endeavor of lubricating medical devices such as urinary catheters (¶0057 urinary catheters), teaches a lubricant (¶0044 lubricant) disposed over a hydrophilic coating (¶0030 on the surface of the coating and thus disposed over) where the lubricant is a natural fat comprising coconut oil (¶0044 lubricant is selected from the group consisting of, a fat from plants; ¶0047 possible fats are listed as follows: oil of coconuts) for the purpose of providing lubrication in both wet and dry conditions ¶0024, defined by Tosatti to mean “in absence of water…encompasses also completely water free).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Clarke to have included a natural fat comprising coconut oil as a lubricant over a hydrophilic coating as taught by Tosatti for the purpose of providing lubrication in both wet and dry conditions ¶0024.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the coating and lubricant in a non-aqueous form substantially free of water, as Clarke, in the same field of endeavor of urinary catheters, further teaches that it is advantageous for the lubricant to be in non-aqueous form, i.e. low water content preferably between 5 wt % - 0 wt %, for the purpose of not dissolving or degrading the catheter during use ¶0176.
While Tosatti do not expressly suggest the lubricant being configured to transition from a solid state into a liquid state upon insertion into a urethra of a patient or user, the limitation of “configured to transition from a solid state into a liquid state upon insertion into a urethra of a patient or user” is considered functional language (describes the function of the device to have a lubricant capable of being melted upon insertion into a urethra). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Clarke in view of Tosatti discloses all the structure as claimed, and the lubricant is further made of coconut oil which has an inherent melting point of between 75-77°F and thus would be solid when the device is at room temperature and melt upon entering a patient’s urethra which would introduce the device to body temperature of 98.6°F. As such, it is capable of performing the functions as claimed (i.e. it is capable of melting upon insertion into a urethra of the patient).
Regarding claim 8, Clarke in view of Tosatti suggest the intermittent catheter of claim 1. Carleo in view of Tosatti do not expressly disclose the surface of the catheter tube being modified by a plasma treatment.
However, Tosatti, in the same field of endeavor of lubricating medical devices such as urinary catheters (¶0057 urinary catheters), teaches plasma treating (¶0114 plasma cleaned) a medical instrument to which a hydrophilic coating is to be applied (¶0114 plasma cleaned and coated according to any of the three coating strategies) for the purpose of cleaning the device before applying the coating (¶0114 plasma cleaned).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carleo in view of Tosatti to have the surface of the catheter tube be modified by a plasma treatment as taught by Tosatti for the purpose of cleaning the surface of the catheter tube prior to applying the hydrophilic coating.
Claim(s) 9-10 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Carleo (U.S. Publication 2012/0179144), as evidenced by Tosatti (U.S. Publication 2020/0086008) as rejected in claim 1, and in view of Luo et al. (U.S. Publication 2018/0163152) and Cage et al. (U.S. Publication 2015/0132468).
Regarding claims 9-10 and 17-18, Farrell in view of Carleo suggest the intermittent catheter of claims 1 and 11. Farrell in view of Carleo do not expressly disclose or suggest a surface energy of the polymeric material at the surface of the catheter tube being at least 5 dynes/cm (Claim 9) or 10 dynes/cm (Claim 10) greater than that of the lubricant; or a surface energy of a surface of the hydrophilic coating being at least 5 dynes/cm (Claim 17) or 10 dynes/cm (Claim 18) greater than that of the lubricant.
However, Luo et al., in the same field of endeavor of lubricating coatings of medical devices ¶0003, teaches increasing the surface energy of a silicone substrate having a low surface energy using plasma treatment in order to better match the high surface energy of a hydrophilic coating for the purpose of promoting better adhesion of the hydrophilic material to the substrate surface during coating (¶0082 silicone elastomers are very hydrophobic, so it is difficult for a hydrophilic coating solution to spread on these surfaces spontaneously, need to modify the substrate in some way to increase the surface energy of the substrate surface…by using pretreatment, such as oxidation of the surface or plasma treatment to generate polar groups on the substrate surface).
Furthermore, Cage, in the same field of endeavor of coating medical devices (Title), teaches providing a difference of 10 dynes/cm greater surface energy between coating for the purpose of reducing adhesion between the coatings.
Farrell further discloses the lubricant layer being advantageously removable from the catheter through melting in order to expose the hydrophilic material below to the patient during use ¶0016.
As such it would have been obvious to one of ordinary skill in the art to have modified the polymeric material of Farrell in view of Carleo to have a surface energy as close to that of the hydrophilic material as possible as taught by Luo for the purpose of promoting better adhesion of the hydrophilic material to the substrate surface during coating, and further would have been obvious to have modified the hydrophilic coating of to have been at least 10 dynes/cm greater than the lubricant, as taught by Cage, for the purpose of allowing for reduced adhesion between the layers and thus greater removability of the layer in use to allow for greater exposure of the hydrophilic layer.
While Farrell in view of Carleo and further in view of Luo and Cage do not expressly disclose the range of at least 5 dynes/cm or whether the polymeric material specifically has at least 5 or 10 dynes/cm greater surface energy at its surface, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the layers to have the aforementioned range of at least 5 or at least 10 dynes/cm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and applicant appears to have placed no criticality on the claimed range (¶0062 the surface energy SE of the polymeric material at the surface of the catheter tube is at least 5 dynes/cm, 10 dynes/cm, 15 dynes/cm, or 20 dynes/cm greater than that of the lubricant). In the instant case, Farrell in view of Carleo and further in view of Luo and Cage would not operate differently with the claimed range and Cage has indicated that a difference between layers of greater than 10 dynes/cm would be advantageous where reduced adhesion is beneficial such as in the case of Farrell where the layer is intended to be removed from a lower layer during use. Further, applicant places no criticality on the ranged claimed, indicating simply that the surface energy of the polymeric material at the surface of the catheter is at least 5 dynes/cm, 10 dynes/cm, 15 dynes/cm, or 20 dynes/cm greater than that of the lubricant ¶0056 and that for exceptional spreading of the lubricant in its liquid state over the surface of the catheter tube it is desirable to have S greater than 10 ¶0062.
As such this limitations of the hydrophilic coating and the surface of the catheter having a surface energy that is greater than 10 dynes/cm is seen to have been obvious to one of ordinary skill in the art in light of Farrell in view of Carleo and further in view of Luo and Cage.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (U.S. Publication 2017/0007802) in view of Tosatti (U.S. Publication 2020/0086008) and further in view of Hunter (U.S. Publication 2004/0030301).
Regarding claim 42, Clarke in view of Tosatti suggest the intermittent catheter of claim 1. Clarke in view of Tosatti do not expressly disclose the lubricant having antioxidant properties.
However, in the same field of endeavor of coatings for urinary catheters (¶0001), Hunter teaches a coating incorporating antioxidants for the purpose of preventing injury to the epithelial tissues and promoting healing (¶0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lubricant suggested by Clarke in view of Tosatti to have incorporated an antioxidant as taught by Hunter, for the purpose of preventing injury to epithelial tissues and promoting healing (¶0011 of Hunter).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781