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 .
The amendment filed 7/16/26 has been considered and entered. Claims 1-28,36 and 42 have been canceled. Claims 29-35,37-41 and 43-48 are the only claims remaining in the application for prosecution thereof.
Considering the amendment filed 7/16/26, the 35 USC 112,102 and 103 rejections have been withdrawn. However, the following rejections have been necessitated by the amendment.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 29-36,37-41 and 43-48 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (2018/0325649) in view of Rooijmans (2010/0198168) further in combination with either Leon et al. (2012/0016050) or JP 4503116.
Wu et al. (2018/0325649) discloses a coat including a copolymer of a first tetrahydrofurfuryl acrylate monomer and a second monomer including at least one functional group amenable to further derivatization and the polymer is prepared by polymerizing tetrahydrofurfuryl acrylate or derivatives thereof and a second monomer containing an amine, a carboxylic acid, or N hydroxyl group [0014].
Wu et al. (2018/0325649) does not specifically disclose a topcoat polymer containing more than two reactive moieties per molecule or a thermoplastic surface being coated by the base coat.
Rooijmans (2010/0198168) discloses a layered coating, comprising a base and topcoat [0058], as well as a topcoat polymer containing more than two reactive moieties per molecule [0022],[0026]. Rooijmans (2010/0198168) further discloses plastic surface for coating thereon which would be inclusive of thermoplastic [0050] and a catheter tubing comprising a thermoplastic Pebax 7233 is an inherently thermoplastic material [0069].
Therefore, it would have been obvious to one having ordinary skill in the art to combine the teachings of Wu et al. (2018/0325649) and Rooijmans (2010/0198168) and design the said tetrahydrofurfuryl acrylate copolymer formulation, as disclosed in Wu et al. (2018/0325649) while implementing a base-top type coating with polymer containing more than two reactive moieties per molecule, as disclosed in Rooijmans (2010/0198168), in order to reduce thrombogenicity of the coated medical devices and, thus, better treat the patients in need Wu et al. (2018/0325649) [0049].
Wu et al. (2018/0325649) in view of Rooijmans (2010/0198168) fail to teach the incorporation of 2-isocyanatoethyl acrylate in the base layer.
Leon et al. (2012/0016050) teaches a monoisocyanate-acrylate useful for coatings and as base resins [0001] which produce urethane acrylate oligomers with much lower viscosity [0009].
JP 4503116 teaches a antimicrobial coating for biomedical devices including catheters whereby isocyanato ethyl methacrylate is used as a hydrophilic monomer [0006],[0007],[0018].
Therefore, it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to have modified Wu et al. (2018/0325649) in view of Rooijmans (2010/0198168) catheter coating to include 2-isocyanatoethyl acrylate in the base layer as evidenced by either Leon et al. (2012/0016050) or JP 4503116 with the expectation of producing a base hydrophilic coating for biomedical devices having lower visosity.
Regarding claim 29, the claimed base coating is met by the coating being applied to the substrate as the term “base” is not limited to any specific coating, but a coating applied to a surface. Rooijmans (2010/0198168) further discloses wherein the top coat is atop the base coat [0058]-[0060].
Regarding claim 30, Wu et al. (2018/0325649) further discloses wherein the surface is cleaned before applying the coat [0033].
Regarding claim 31, Wu et al. (2018/0325649) further discloses wherein the surface is plasma treated before applying the coat [0035],[0037].
Regarding claim 32, Wu et al. (2018/0325649) further discloses wherein the coat is applied by dipping [0046] and Rooijmans (2010/0198168) further discloses the base coat (pare [0058]). Regarding the topcoat being applied by dipping the Examiner takes the position that this would be suggestive since the base coat is applied by dipping that success would be garnered by dipping the topcoat as well.
Regarding claim 33, Rooijmans (2010/0198168) further discloses wherein the base coat is exposed to ultraviolet radiation [0041], [0065], [0077].
Regarding claim 34, Rooijmans (2010/0198168) further discloses wherein the ultraviolet radiation is at a wavelength ranging from about 250nm to about 400 nm [0077].
Regarding claim 35, Rooijmans (2010/0198168) further discloses wherein the base coat cures for about 0.25 minutes [0077] and the primer coating was exposed for 15 seconds while the topcoat was exposed 360 seconds to the UV light. Whereas neither Wu et al. (2018/0325649) nor Rooijmans (2010/0198168) specifically discloses wherein the base coat cures for about 0.5 to about 10 minutes (i.e., specific range of the irradiation exposure time), in view of the above disclosure, it would have been obvious for the person of ordinary skill in the art to adjust the said irradiation exposure time to be within the specified range, in the course of routine experimentation, in order to enhance the quality of the manufactured coating, e.g., by adjustment of the cross-linking of the formed polymers.
Regarding claim 37, Wu et al. (2018/0325649) further discloses wherein the coat is applied by dipping [0046] and Rooijmans (2010/0198168) further discloses the base coat (pare [0058]). Regarding the topcoat being applied by dipping the Examiner takes the position that this would be suggestive since the base coat is applied by dipping that success would be garnered by dipping the topcoat as well.
Regarding claim 38, Rooijmans (2010/0198168) further discloses wherein the top coat is exposed to ultraviolet radiation [0041], [0065], [0077].
Regarding claim 39, Rooijmans (2010/0198168) further discloses wherein the ultraviolet radiation is at a wavelength ranging from about 10 nm to about 400 nm [0077].
Regarding claim 40, Rooijmans (2010/0198168) further discloses wherein the base coat cures for about 0.25 minutes [0077] and the primer coating was exposed for 15 seconds while the topcoat was exposed 360 seconds to the UV light. Whereas neither Wu et al. (2018/0325649) nor Rooijmans (2010/0198168) specifically discloses wherein the base coat cures for about 0.5 to about 10 minutes (i.e., specific range of the irradiation exposure time), in view of the above disclosure, it would have been obvious for the person of ordinary skill in the art to adjust the said irradiation exposure time to be within the specified range, in the course of routine experimentation, in order to enhance the quality of the manufactured coating, e.g., by adjustment of the cross-linking of the formed polymers.
Regarding claim 41, Wu et al. (2018/0325649) further discloses wherein the polymer has a molecular weight between about 16,000 g/mole and about 150,000 g/mole [0031].
Regarding claim 43, Rooijmans (2010/0198168) further discloses wherein the topcoat is a hemocompatible topcoat [0053],[0058]; stents, shunts, vascular graft, vascular access port, heart valve are inherently hemocompatible).
Regarding claim 44, Rooijmans (2010/0198168) further discloses wherein the top cost polymer [0068] is a hemocompatible and includes a small molecule, protein [0037], polysaccharide [0037], glycosaminoglycan [0037], hyaluronic acid), or polymer derivatized with at least one (e.g., at least two, or more than two) polymerizable group [0026].
Regarding claim 45, Rooijmans (2010/0198168) further discloses wherein the top-coat polymer [0058] is an albumin [0037], a heparin [0037], a phosphorylcholine, a poly(alkoxyalkyl(meth)acrylate), a zwitterionic polymer, a nitric oxide releasing polymer, an extremely hydrophillic polymer, an extremely hydrophobic polymer, or a combination thereof.
Regarding claim 46, Rooijmans (2010/0198168) further discloses wherein the topcoat polymer [0068] has a molecular weight between about 500 g/mol to about 100,000 g/mol ([0026], [0031]).
Regarding claim 47, Wu et al. (2018/0325649) and Rooijmans (2010/0198168) disclose coating medical devices with lubricious hydrophilic coatings Wu et al. (2018/0325649) [0020]-[0022] and Rooijmans (2010/0198168) [0043],[0052]-[0055].
Regarding claim 48, Rooijmans (2010/0198168) further discloses providing increased lubricity [0025] or hemocompatibility to a medical device [0052]-[0054] and further discloses wherein the medical device is a catheter [0053]-[0054]. Wu et al. (2018/0325649) teaches catheters [0008].
Response to Amendment
Applicant’s arguments with respect to claims 29-35,37-41 and 43-48 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argued the combination of Wu et al. (2018/0325649) in view of Rooijmans (2010/0198168) is an unsuitable combination and no motivation to combine the references.
The Examiner disagrees. As detailed in the rejection, Rooijmans (2010/0198168) teaches a base and top coating for a catheter tubing while Wu et al. (2018/0325649) teaches advantages of the base coating and hence the combination would be suggestive to take advantage of the base coating with the combination base/top coating of Rooijmans (2010/0198168).
Applicant argued the inclusion of 2-isocyanatoethyl acrylate in the base layer is not taught in the rejections based upon Wu et al. (2018/0325649) in view of Rooijmans (2010/0198168).
The Examiner agrees and has applied Leon et al. (2012/0016050) or JP 4503116 as detailed above.
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 BRIAN K TALBOT whose telephone number is (571)272-1428. The examiner can normally be reached Monday -Friday 7-4PM.
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/BRIAN K TALBOT/Primary Examiner, Art Unit 1712
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