DETAILED ACTION
Claims 135-160 are currently pending. Claims 135-138, 140-154, 156, 158-160 are currently under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/21/2026 has been entered.
Withdrawn Rejections
The prior rejection of claims 136, 140, 149 and 156 under 112(b) is withdrawn in light of Applicant amending the claims to clearly state the monomers present in the guest polymer and providing proper antecedent basis for tubular body structure, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 04/21/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04/21/2026, it is noted that claims 135-136, 140, 147, 149-151, 153, 159 are amended and claim 160 is newly added. No new matter or claims have been added.
Modified Rejection:
The following rejection is modified based on newly added claim 160.
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.
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.
Claim(s) 135-138, 142, 144-146 and 158-159 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104 (Applicant provided), US 2010/0040870 (Applicant provided) and US 2008/0181861 (previously applied).
Regarding claim 135, 138 and 158-159, the limitation of a medical tubular device comprising a body structure extending from a first end to a second end of the medical tubular device and having a luminal surface and an external surface, wherein said body structure comprises an interpenetrating polymer network (IPN) comprising a host polymer matrix and at least one hydrogel guest polymer domain of a guest polymer comprising a plurality of interconnected paths of the guest polymer, which is interpenetrating the host polymer matrix, said at least one hydrogel polymer domain comprises a luminal surface guest polymer domain comprising at least one part of the luminal surface, wherein the plurality of the paths of the guest polymer coincide and form at least a part of said luminal surface is met by the ‘104 publication teaching medical device such as a catheter (page 1, first paragraph) wherein in innermost wall surface, wherein at least a section of the inner wall surface constitutes an inner surface of the delivery membrane and comprises an interpenetrating polymer network substrate comprising a host polymer and a guest polymer, wherein the guest polymer is interpenetrating the host polymer to form substantially continuous pathways within the host polymer (page 2, middle of the page). The delivery membrane has an outer surface opposite to the inner surface of the delivery membrane. Substantially continuous pathways of the guest polymer within the host polymer extends from the inner surface to the outer surface of the delivery membrane (page 2, third last paragraph).
Regarding claim 136, 144 and 146, the limitation of wherein said guest polymer comprises a hydrogel comprising a cross-linked network polymerized monomers comprising of one or more type of monomers is met by the ‘104 publication teaching guest polymer comprises homopolymer or copolymers, preferably polymerized from acrylate monomer including functionalized acrylates such as HEMA and PEGylated (meth)acrylates including PEGMEA (page 4, bottom half).
Regarding claim 142, the limitation of wherein the host polymer comprises a crosslinked elastomer is met by the ‘104 publication teaching the host polymer is a cross-linked polymer, such as crosslinked rubber including silicone (page 3, middle of page).
The ‘104 publication does not specifically teach a tubular body structure extending from a first open end to a second open end of the medical tubular device wherein the body structure had an elongate hollow structure (claim 135). The ‘104 publication does not specifically teach an interpenetrating polymer network comprising a tubular host polymer matrix extending in an entire length of the body structure (claim 135).
The ‘104 publication does not specifically teach wherein said luminal surface comprises zwitterionic moieties, said zwitterionic moieties being covalently bonded to said guest polymer (claim 135, 158), specifically sulfobetaines (claim 137, 145).
The ’861 publication teaches super low fouling sulfobetaine and carboxybetaine material, super low fouling surfaces and method of making such surfaces (abstract). IPN films are taught to be formed of sulfobetaine methacrylate, 2-hydroxyethyl methacrylate (HEMA) monomer [0026]. Sulfobetine methacrylate is taught to be used to resist protein adsorption [0100].
The ’870 publication teaches methods of producing article comprising an interpenetrating polymer network (IPN) and an IPN article. A polymer substrate, e.g. shaped to provide the desired article and applying it in a reaction chamber, providing at least one monomer for an interpenetrating polymer, exposing said polymer substrate in said reaction chamber to said at least one monomer in the presence of an impregnations solvent and polymerizing and optionally crosslinking said at least one monomer to form an interpenetrating polymer (abstract, [0080]). The interpenetrating polymer may be e.g. crosslinked [0018]. The substrate is taught to be a polymer formed from materials such as silicone ([0019]-[0021]). The outer surface layer (a coating) applied onto the substrate and interpenetrating polymer at least in a layer of the substrate and extending to the desired depth [0031], reading on claim 159. Monomers used for the interpenetrating polymer include HEMA, MPC, betaine and methacrylate [0037]. The interpenetrating polymer may be e.g. crosslinked to form a network [0098]. The article comprises a body formed of a rubber substrate and an interpenetrating non-rubber polymer and an outer surface layer on at least part of the surface of said non-rubber polymer. Silicone rubber is taught. The silicone rubber substrate is taught to produce implants such as catheters and stents [0101].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form the device taught by the ‘104 publication into a stent as the ‘104 publication teaches medical device formed of silicone containing an interpenetrating network and the ‘870 publication teaches a silicone stent with an interoperating network polymer. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘870 publication teaches the interchangeability of a stent and catheter structure. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘104 publication and the ‘870 publication are both directed to silicone medical device containing acrylate interpenetrating networks.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use poly(sulfobetaine methacrylate) as taught by the ‘861 publication in the guest copolymer taught by the ‘104 publication because the ‘104 publication teaches the desire for antifouling and the ‘861 publication teaches the poly(sulfobetaine methacrylate) provides antifouling properties. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘104 publication teaches the guest polymer comprising methacrylic derivatives and the ‘861 publication teaches poly(sulfobetaine methacryate) to be used in IPN networks and to have anti-fouling properties. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘870 publication teaches the use of betaines in interpenetrating polymers in a silicone medical device structure, thus providing a reasonable expectation of success in using the poly(sulfobetaine methacrylate) taught by the ‘861 publication in the guest polymer of the interpenetrating network of the ‘104 publication.
Claim(s) 147, 156 and 159 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104, US 2010/0040870 and US 2008/0181861 as applied to claims 135-138, 142, 144-146 and 158-159 above, and further in view of Salamone (Salamone, J.C., et al., Polymer, 1977, Vol 18, October, previously applied).
As mentioned in the above 103 rejection, all the limitations of claims 135-138, 142, 144-146 and 158-159 are taught by the combination of the ‘104 publication, the ‘870 publication and the ‘861 publication.
Regarding claim 160, the limitation of wherein said guest polymer comprises a hydrogel comprising a cross-linked network polymerized monomers comprising of one or more type of monomers is met by the ‘104 publication teaching guest polymer comprises homopolymer or copolymers, preferably polymerized from acrylate monomer including functionalized acrylates such as HEMA and PEGylated (meth)acrylates including PEGMEA (page 4, bottom half).
The combination of references does not specifically teach wherein the at least one guest polymer domain comprises a clot promoting domain and/or a cell proliferation promoting located at the external surface of the body structure and/or located at an intermediate guest polymer domain which does not comprise the luminal surface or the external surface (claim 147).
The combination of references does not specifically teach wherein the at least one zwitterionic monomer is selected from the list which includes the elected 1-Ethenyl-3-(4-sulfonatobuty)-1H-imidazol-3-ium (claim 156, 159).
Salamone teaches preparation and properties of ampholytic polymers. Synthesis of monomeric vinylimidazolium sulphobetaines, a class of aromatic inner salt monomers, their free radial polymerization and properties resulting from the polymers. The ampholytic polymers prepared were shown to have hydrogel characteristics (abstract). Preparation of zwitterionic sulphobetaine monomers derived from the ring-opening of a sulfone by nucleophilic vinylimidazole, followed by their free radical polymerization to the corresponding poly(vinylimidazolium sulphobetaines).
PNG
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346
627
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Greyscale
wherein R is H and n = 4 is the elected compound (page 1060, first column).
Regarding one guest polymer domain comprises a clot promoting domain and/or a cell proliferation promoting located at the external surface of the body structure and/or located at an intermediate guest polymer domain which does not comprise the luminal surface or the external surface, the combination of references teaches the elected monomers PHEMA-co-PEGMEA, sulfobetaine and CK1573, and thus would have the claimed properties absent factual evidence to the contrary.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the zwitterionic monomers taught by Salamone in the guest polymer taught by the ‘104 publication because the ‘104 publication teaches the guest copolymer may include imidazole derivatives and Salamone specifically teaches an imidazole compound. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to include the compound of Salamone in the guest copolymer of the ‘104 publication because Salmone teaches zwitterionic monomers which are specific sulfobetaine and the ‘861 publication teaches sulfobetaine methacrylate to resist protein adsorption.
Claim(s) 140-141 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104, US 2010/0040870 and US 2008/0181861 as applied to claims 135-138, 142, 144-146 and 158-159 above, and further in view of US 2015/0273117 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 135-138, 142, 144-146 and 158-159 are taught by the combination of the ‘104 publication, the ‘870 publication and the ‘861 publication.
The ‘117 publication teaches drug coated catheters which preferably includes anti-inflammatory drugs and antiproliferative drugs including rapamycin or paclitaxel (abstract).
It would have been obvious to one of ordinary skill in the art to substitute a first medicinal agent, rapamycin, as taught by the ‘104 publication with a second medicinal agent, paclitaxel, as taught by the ‘117 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in substituting paclitaxel as taught by the ‘117 publication for the active agent such as rapamycin as taught by the ‘104 publication because the ‘117 publication teaches the interchangeability of rapamycin and paclitaxel in drug coated medical devices and the ‘104 publication is directed to an active agent containing medical device including rapamycin.
Claim(s) 148-150 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104, US 2010/0040870 and US 2008/0181861 as applied to claims 135-138, 142, 144-146 and 158-159 above, and further in view of US 2009/0018501 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 135-138, 142, 144-146 and 158 are taught by the combination of the ‘104 publication, the ’870 publication and the ‘861 publication.
The combination of references does not specifically teach wherein the host polymer comprises two or more guest polymer domains, wherein the two or more guest polymer domains comprises a luminal surface guest polymer domain comprising at least a part of the luminal surface and an external surface guest polymer domain comprising at least part of the external surface, wherein two or more guest polymer domains are separated by a polymer portion essentially free of guest polymer (claim 148), wherein the body structure is layered body structure comprising two or more layers, wherein at least one of said layers comprises the IPN (claim 149).
The combination of references does not specifically teach wherein at least one layer without an IPN is PTFE (claim 150).
The ‘501 publication teaches drug coated balloon catheters for treating a luminal system of a patient. The catheter is taught as flexible membrane capable of delivering a therapeutic agent (abstract). The catheter may be constructed of any suitable material including PTFE [0048]. The inner and outer shafter membranes may be further coated with any materials and techniques to enhance performance if desired. The possible coating material include lubricous materials such as silicone and hydrogel materials [0051]. The therapeutic agent is taught to include antiproliferative agents including rapamycin and paclitaxel [0063]. The ‘501 publication teaches various modifications of the device may be made including a different medical device such as a vascular graft [0096].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use PTFE for the medical device construction with inner and outer coating layers of the IPN network as the ‘104 publication teaches a catheter medical device wherein the delivery device comprises coating on the inner and outer surface of the part or parts of the device and the ‘501 publication teaches a catheter device formed of PTFE containing a coating containing an active agent. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention that it was known to form catheters of PTFE comprising drug releasing coatings and the IPN network taught by the ‘104 publication is taught to be a drug releasing layer and the use of inner and outer coating on the device is taught. It would be obvious to one of ordinary skill in the art at the time the invention was made that alternative medical devices such as grafts and stents may be used to form the device as the ‘501 publication teaches the device may be modified and includes grafts and the 870 publication teaches implants include catheters, stents, medical articles for use in humans, thus teaching interchangeability of the medical devices between catheter and stents.
Claim(s) 154 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104, US 2010/0040870 and US 2008/0181861 as applied to claims 135-138, 142, 144-146 and 158-159 above, and further in view of US 7,459,438 (previously applied).
As mentioned in the above 103 rejection, all the limitations of claims 135-138, 142, 144-146 and 158-159 are taught by the combination of the ‘104 publication, the ‘870 publication and the ‘861 publication.
The combination of references does not specifically teach the elected dialysis graft (claim 154).
The ‘438 patent teaching coatings on medical devices (abstract). Medical devices are taught to be selected from the group including catheter and dialysis graft (claim 16). The medical devices are taught to contain a hydrogel coating comprising a methacrylic polymer (claims 1-7).
It would have been obvious to one of ordinary skill in the art to substitute a first medical device as taught by the ‘104 publication with a second medicinal, i.e. dialysis graft, as taught by the ‘438 patent with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. One of ordinary skill in the art would have a reasonable expectation of success as the ‘438 patent teaches the interchangeability of dialysis grafts and catheters as medical devices.
Claim(s) 143 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104, US 2010/0040870 and US 2008/0181861 as applied to claims 135-138, 142, 144-146 and 158-159 above, and further in view of US 2017/0027682 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 135-138, 142, 144-146 and 158-159 are taught by the combination of the ‘104 publication, the ‘870 publication and the ‘861 publication.
The combination of references does not specifically teach the claimed shore A hardness, tera strength and stress (claim 143).
The ‘682 publication teaches elastomeric tube including an inner and outer diameter (abstract). Elastomeric materials that have high temperature stability and thus can withstand high temperatures without melting are preferred. For example, silicone has the properties, among others, of high temperature stability, low volatile content, being capable of varying its hardness or softness and chemical inertness that make it useful. Elastomeric tubes are taught to include silicone that have mechanical properties of shore hardness from 15 to 25 Shore A, Tensile strength in the range of 4.8 MPA to 9.7 MPa, stress at 200% strain of 0.8 to 0.72 MPa and a tear strength of 22.9 kN/m [0121].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the elastomer taught by the ‘682 publication for the host polymer taught by the ‘104 publication because the ‘104 publication teaches the use of silicone elastomers for forming a medical device and the ‘682 publication teaches specific silicone elastomers known to form medical devices. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the polymers of the ‘682 publication for the device of the ‘104 publication because the ‘682 publication teaches high temperature stability and optimizable of varying hardness.
Claim(s) 151-153 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/025104, US 2010/0040870, US 2008/0181861 and US 2009/0018501 as applied to claims 135-138, 142, 144-146, 148-150 and 158-159 above, and further in view of US 2004/0043052 (previously applied).
As mentioned in the above 103 rejection, all the limitations of claims 135-138, 142, 144-146, 148-150 and 158-159 are taught by the combination of the’104 publication, the ’870 publication and the ‘861 publication.
Regarding claim 151, the limitation of a tubular support structure located concentrically with the body structure, wherein the support structure being of a polymer material comprising PTFE is met by the ‘501 publication teaches catheter formed of PTFE.
The combination of references does not specifically teach wherein the support structure comprises a cuff close-fitting to the external surface of the body structure (claim 151) wherein the cuff comprises an IPN material loaded with one or more drugs selected from cell proliferating promoting drugs (claim 152), wherein the internal diameter of from about 2mm to about 6cm and/or a compliance of from about 1 to about 10.
The ‘052 publication teaches medical implants (abstract) comprising catheters [0029] wherein catheter cuffs are taught [0095]. Subcutaneous “cuff” around the catheter [0124] or stents ([0019], [0096]). The coating is taught to be applied over the subcutaneous “cuff” around the insertion site ([0169], [0270]). Catheters is taught to include diameters of 3mm [0356]. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. Regarding the compliance, the combination of references teaches the catheter formed of the elected host and guest polymeric materials and thus would have the compliance absent factual evidence to the contrary.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include a cuff on the external surface of the device taught by the ‘104 publication because the ‘104 publication teaches a catheter and the ‘052 publication teaches cuff around a catheter wherein coating is taught to be applied over the cuff ([0029], [0095]). One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘052 publication teaches it was known to use cuffs on catheters and the ‘104 publication teaches a drug coated catheter.
Response to Arguments:
Applicant’s arguments have been fully considered and not deemed to be persuasive.
103: The ‘104 publication (Thomsen), the ‘870 publication (Alm) and the ‘861 publication (Jiang)
Applicant argues the ‘104 publication describes a balloon catheter in which at least a portion for the wall of the balloon is of an IPN material. In all cases the membrane of the balloon is highly flexible and is fully collapsed when not filled with the filling fluid. The ‘870 publication describes producing an article of an IPN comprising polymer substrate and a second interpenetrating polymer made from monomers which in a long list comprise methacrylates. The body is taught as formed of rubber and an interpenetrating non-rubber polymer. The ordinarily skilled artisan would have appreciated that the whole purpose of a stent is to provide constant internal pressure in an artery or similar to keep the artery open. The stent is typical mesh. The ‘870 publication does not disclose any interchangeability between a stent and a catheter structure. The ‘870 publication does not disclose which part of the various material could produce to comprise the polymer substrate with second polymer forming the interpenetrating polymer. There is not teaching how to form the flexible membrane of the balloon into a stent or how such stent formed form such membrane would work to keep an artery open.
In response, the ‘104 publication teaches a medical device such as a catheter (page 1, first paragraph). The host polymer is taught to include rubber and silicone (page 3, last paragraph). The guest polymer is taught to be acrylate monomers such as HEMA (page 4). The ‘870 publication teaches interpenetrating polymer network (title, abstract) wherein the polymer substrate is taught to include rubber and silicone rubber [0021]. The interpenetrating polymer is taught to include HEMA [0037]. The rubber substrates and interpenetrating non-rubber polymer are taught to be devices such as stents and catheters [0101]. Thus the ‘104 publication and the ‘870 publication are both directed to the same host polymer, rubber/silicone, and contain the same interpenetrating polymer such as HEMA, thus it would have been prima facie obvious that the IPN taught by the ‘104 publication could be used to form a stent as taught by the ’870 publication as both are directed to overlapping substrate/guest polymers and the ’870 publication teaches the IPN can be used to form both stents and catheters and the ’104 publication is directed to catheters.
Applicant argues impermissible use of the claimed invention as an instruction manual or template.
In response, as for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Applicant argues the hypothetical proposed modification of the balloon in the ‘104 publication to form a stent would not even produce a tubular body structure extending from a first open end to a second open end of the medical tubular device wherein the body structure has an elongate hollow structure with a luminal surface as claimed.
In response, the ‘870 publication teaches the rubber substrates and interpenetrating non-rubber polymer are taught to be devices such as stents and catheters [0101], thus the ‘870 publication teaches the IPN forming the stent structure.
Applicant argues the ‘861 publication provides super-low fouling surfaces of a coating comprising sulfobetaine and carboxybetaine materials. The coating is applied I the form of so-called IPN material. The teaching of the so-called IPN fil is that is should be a very thin coating of segmented polyurethane film with interpenetrating crosslinked HEMA and sulfobetaine methacrylate. This not a true IPN comprising a continuous covalently crosslinked elastomer matrix of a host polymer matrix and hydrogel guest polymer domain of a guest polymer comprising a plurality of interconnected paths of the guest polymer. The office can not pick and choose some aspects of a prior art reference and ignore and exclude other aspects. Applicant argues the IPN of the ‘861 publication is very thin film, wherein it is explicitly taught to apply thin anti-fouling layers to a surface provided as a property of a bulk material of the device.
In response, the ‘861 publication teaches sulfobetiane and carboxybetiane material are super low fowling and may be used in IPN films with HEMA monomers ([0026], [0100]). The ‘870 publication teaches a stent structure formed of rubber substrate which forms an IPN with the non-rubber polymer [0101]. Thus the ‘870 publication teaches forming an IPN into a medical device such as a stent and the ‘861 publication teaches a motivation to use sulfobetaine in the device, for its super low fouling properties. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use poly(sulfobetaine methacrylate) as taught by the ‘861 publication in the guest copolymer taught by the ‘104 publication because the ‘104 publication teaches the desire for antifouling and the ‘861 publication teaches the poly(sulfobetaine methacrylate) provides antifouling properties. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘104 publication teaches the guest polymer comprising methacrylic derivatives and the ‘861 publication teaches poly(sulfobetaine methacryate) to be used in IPN networks and to have anti-fouling properties. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘870 publication teaches the use of betaines in interpenetrating polymers in a silicone medical device structure, thus providing a reasonable expectation of success in using the poly(sulfobetaine methacrylate) taught by the ‘861 publication in the guest polymer of the interpenetrating network of the ‘104 publication.
Applicant argues impermissible hindsight. The cited art would not have led to the ordinary skilled artisan beyond applying a thin layer of the outer surface.
In response, the ‘861 publication teaches sulfobetiane and carboxybetiane material are super low fowling and may be used in IPN films with HEMA monomers ([0026], [0100]). The ‘870 publication teaches a stent structure formed of rubber substrate which forms an IPN with the non-rubber polymer [0101]. Thus the ‘870 publication teaches forming an IPN into a medical device such as a stent and the ‘861 publication teaches a motivation to use sulfobetaine in the device, for its super low fouling properties.
Applicant argues the office postulates without any support that PHEMA-co-PEGMEA, sulfobetaine and CK1573 have clot promoting and/or cell proliferation promoting properties. If the CK157 had any clot promoting and/or cell proliferation promoting properties, the grafts used in example 9 would evidently have closed completely within hours or days. As shown in the examples, the grafts in the form of tubular devices of embodiments of the invention remain open for more than 6 months.
In response, Applicant is arguing limitations not present in the instant claim. There are no limitations directed to grafts remining open for more than 6 months. Regarding one guest polymer domain comprises a clot promoting domain and/or a cell proliferation promoting located at the external surface of the body structure and/or located at an intermediate guest polymer domain which does not comprise the luminal surface or the external surface, the combination of references teaches the elected monomers PHEMA-co-PEGMEA, sulfobetaine and CK1573, and thus would have the claimed properties absent factual evidence to the contrary. Applicant elected the hydrogel guest polymer to include PHEMA-co-PEGMEA, sulfobetaine, luminal and CK1573 and reads on claims that include 147. Thus the combination of references teaching the elected monomers PHEMA-co-PEGMEA, sulfobetaine and CK1573 would meet the instant functional limitations absent factual evidence to the contrary.
Applicant argues the ‘501 publication (Yribarren) teaches the flexible membrane includes an inner surface and an outer surface. The therapeutic agent may be applied (coated) to the outer surface of the flexible membrane. There is no teaching or disclosure that a drug can be coated to the inner surface of the membrane. There is no teaching at all in the ‘501 publication that would have guided an ordinarily skilled artisan to modify the ‘104 publication by providing the at least one hydrogel guest polymer domains comprises a luminal surface hydrogel guest polymer domain comprising at least a part of the luminal surface and an external surface hydrogel guest polymer domain comprising at least a part of the external surface, wherein the two or more hydrogel guest polymer domains are separated by a polymer portion essentially free of guest polymer.
In response, the ‘501 publication teaches a catheter is taught as flexible membrane capable of delivering a therapeutic agent (abstract). The catheter may be constructed of any suitable material including PTFE [0048]. The inner and outer shafter membranes may be further coated with any materials and techniques to enhance performance if desired. The possible coating material includes lubricous materials such as silicone and hydrogel materials [0051]. The therapeutic agent is taught to include antiproliferative agents including rapamycin and paclitaxel [0063]. The ‘501 publication teaches various modifications of the device may be made including a different medical device such as a vascular graft [0096]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use PTFE for the medical device construction with inner and outer coating layers of the IPN network as the ‘104 publication teaches a catheter medical device wherein the delivery device comprises coating on the inner and outer surface of the part or parts of the device and the ‘501 publication teaches a catheter device formed of PTFE containing a coating containing an active agent. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention that it was known to form catheters of PTFE comprising drug releasing coatings and the IPN network taught by the ‘104 publication is taught to be a drug releasing layer and the use of inner and outer coating on the device is taught.
Applicant argues claim 159 is allowable for reasons similar to those pertaining to claim 135.
In response, Applicant’s arguments regarding claim 15 are addressed as first presented above.
Applicant argues the list o zwitterionic monomers of claim 160 comprises the guest polymers used in the IPNs of Figure 17, where the TAT values are lower than the three references G7, G9 and G10, a surprisingly high effect of suppressing the Thrombin-Anti-thrombin levels have been demonstrated for the entire scope of 160.
In response, Applicant points to Figure 17. The tested materials are silicone control samples compared to zwitterionic IPN samples containing PHEMA-co-PEGMEA-CO-zwitterionic monomer and a specific silicon host matrix. Therefore, the results presented are not commensurate in scope, as newly added claim 160 specified the zwitterionic monomer, however is broad regarding the host polymer and the one or more methacrylate monomers. Additionally, the samples tested demonstrate a wide variety of TAT levels, wherein those testing wherein the margin of error includes no advantage over the silicone control, e.g. 1573-G9 and 1582-G0 are included in the claimed zwitterionic monomers, thus not demonstrating superior results. Further the ‘861 publication teaches the use of zwitterionic monomers to limit protein absorption [0060], thus the inclusion of a zwitterionic monomer resulting in better TAT score is not unexpected.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
