DETAILED ACTION
Claims 1-27 are currently pending. Claims 1-21 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 .
Withdrawn Rejections
The prior rejection of claims 1, 5-6 and 19-21 under 35 U.S.C. 103 as being unpatentable over US 2011/0244016 is withdrawn in light of Applicant’s amendment to specify the anti-microbial coating consisting of a plurality of polyene antimycotic molecules coupled to the medical device ‘016 publication does not teach as the ‘016 publication requires the use of an additional active agent.
Examiner’s Note
Applicant's amendments and arguments filed 12/03/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 12/03/2025, it is noted that claims 1 and 5 have been amended and no new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5-6 and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alves (Alves, Diana et al., Frontiers in Chemistry, June 2019, Volume 7, Article 431, pgs. 1-9).
Regarding claims 1, 5-6 and 19-21, the limitation of an anti-microbial substrate comprising a medical grade polymer material forming at least a surface of the substrate and an anti-microbial coating consisting of plurality of polyene antimycotic molecules coupled to the medical grade polymer on the substrate surface is met by Alves teaching urinary catheters with antifungal coatings. Liposomal amphotericin B is immobilized on polydimethylsiloxane surface wherein PDMS is immersed in dopamine solution to form a thin adherent film called polydopamine (pDA) which allowed the incorporation of LAmB afterwards (abstract, Figure 1, page 2, last paragraph) wherein PDMS is taught as a material used for urinary catheters (page 2, second column, 3rd paragraph). The liposome and pDA are interpreted as coupling agents for the antimycotic and thus meets the limitation for consisting of.
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) 1, 5-6, 12 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0121661 in view of US 2006/0088666 and Alves (Alves, Diana et al., Frontiers in Chemistry, June 2019, Volume 7, Article 431, pgs. 1-9).
Regarding claims 1, 5 and 19, the limitation of an anti-microbial substrate comprising a medical grade material forming at least a surface of the substrate and an anti-microbial coating consisting of a plurality of polyene antimycotic molecules coupled to the medical grade material on the substrate surface is met by the ‘661 publication teaching phosphorous based coating having a plurality of phosphate moieties, a plurality of phosphonate moieties or both covalently bonded to an oxide surface of an implantable substrate (abstract). When desired an active agent can be bound to the derivation surface to accomplish a variety of goals [0127]. The active agent can include one or more active ingredient such as antifungals including amphotericin B or nystatin ([0137], claim 22).
Regarding claim 12, the limitation of wherein the polyene antimycotic molecules are in an amount of form about 0.5 nmol/cm2 to about 5.0 nmol/cm2 is met by the ‘661 publication teaches the surface phosphorous containing group density of the coated regions of the substrate is at least about 0.1 nmol/cm2 (abstract), wherein the active agent is attached to the phosphorous containing groups. 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 claims 20-21, the limitation of wherein the medical device is a catheter, specifically urinary catheter is met by the ‘661 publication teaches implantable devices has at least one oxide surface and may comprise coating urological devices such as catheters [0196].
The ‘661 publication does not specifically teach a medical grade polymer (claim 1) where the medical grade polymer is a silicone (claim 6).
The ’666 publication siloxane substrate surface is treated suing a combination of ozone and UV radiation to render the siloxane surface more hydrophilic and subsequently a functional coating is applied in situ over the surface of the siloxane substrate (abstract). The device is taught to be an implant [0003]. The coatings are taught to be chemically bonded to a medical device surface [0010]. Hemocompatible polyethylene glycol films on silicone are taught wherein PEG organosilicon derivatives are reacted with hydroxylated groups on silicon surfaces [0024]. PEG is taught to be deposited on device such as catheters [0071]. PDMS substrate surface is taught which is treated with ozone ([0094]-[0095]) wherein PDMS is poly(dimethylsiloxane) ([0043]-[0044], [0072]) wherein PEG is taught as attached to ozone/UV/oxygen plasma treated substrate [0235].
Alves teaching urinary catheters with antifungal coatings. Liposomal amphotericin B is immobilized on polydimethylsiloxane surface wherein PDMS is immersed in dopamine solution to form a thin adherent film called polydopamine (pDA) which allowed the incorporation of LAmB afterwards (abstract, Figure 1, page 2, last paragraph) wherein PDMS is taught as a material used for urinary catheters (page 2, second column, 3rd paragraph). Amphotericin B is taught to be immobilized on PDMS, a material commonly used for urinary catheters manufacture to impart with the ability to resist Candida albicans colonization (page 2, second column, 3rd paragraph).
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 PDMS to form the medical device taught by the ‘661 publication because the ‘661 publication teaches a medical device such as a catheter with a material which contains surface modification and the Alves teaches PDMS is a known catheter material. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ’661 publication teaches modification on the surface through attachment to hydroxyl groups and the ‘666 publication teaches hydroxyl groups free for modification on silicone materials. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use silicone as it is a known material to be used for catheters with the desire for reduction in infections and the ‘661 publication teaches methods of modifying substrates such as catheters wherein ingredients wherein antifungals are taught to be attached to the surface. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to attached AmB to the catheter taught by the ‘661 publication because Alves teaches the desire to use AmB on silicone catheters to prevent Candida Albian colonization on the catheter during use.
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0121661, US 2006/0088666 and Alves as applied to claims 1, 5-6 and 19-21 above, and further in view of WO 2018/112405 (Applicant provided).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 5-6 and 19-21 are taught by the ‘661 publication, the ‘666 publication and the ‘465 publication.
The combination of references does not specifically teach wherein the medical grade polymer is the elected polydimethylsiloxane (claim 6).
The combination of references does not specifically teach wherein the medical grade polymer material is impregnated with a nitric oxide release agent (claim 7) specifically the elected S-nitroso-N-acetylpenicillamine (SNAP) (claims 8-9) wherein the NO release agent comprises about 0.1 to about 20% by weight of the medical grade polymer (claim 10) at a rate of 0.01x10-10 to about 4 x 10-10 mol/min-cm2 (claim 11).
The ‘405 publication teaches treated articles of tubing having anti-fouling characteristics. The tubing is impregnated with silicone oil and nitric oxide release agent (abstract). An article of tubing sequentially or simultaneously with silicone oil and a nitric oxide release agent to form a treated article of tubing (page 7, second last paragraph). S-nitroso-N-acetylpenicillamine (SNAP) into various medical grade polymers (page 8, second paragraph, page 10, last paragraph). The tubing can include an elastomer including a base polymer such as a thermoplastic polymer or silicone and can be used for catheters (page 11, second last paragraph). The nitric oxide rate of release from the tubing is about 0.01x10-10 to about 4 x 10-10 mol/min-cm2 (page 12, second paragraph). The nitric oxide releasing component is from about 1 to about 20% by weight (page 11, second paragraph). The silicone oil can include poly dimethyl siloxane (page 11, third paragraph). Nitric oxide releasing material have been shown to include strong bactericidal and antithrombotic activity. NO-releasing materials have been shown to significantly reduce thrombus formation and presence of viable bacterial in vivo (page 8, second paragraph).
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 silicone and NO-materials taught by the ‘405 in the device taught by the ‘661 publication because the ‘405 publication teaches implantable device material which reduces thrombus formation and the presence of bacteria. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘405 publication and the ’661 publication and the ‘465 publication are both directed to catheters formed of silicone material, thus there would be an expectation of success in using the materials of the ‘405 publication to form the device of the ‘’661 publication and the ‘465 publication as they are both known to form catheters.
Claim(s) 2-4 and 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0121661, US 2006/0088666, Alves and WO 2018/112405 as applied to claims 1, 5-11 and 19-21 above, and further in view of US 2010/0285561 (previously applied) and US 2003/0060663 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 5-11 and 19-21 are taught by the ‘661 publication, the ‘666 publication, the ‘465 publication and the ‘405 publication.
Regarding claims 16-18, the limitation of wherein the medical grade polymer material is impregnated with NO release agent, SNAP) is met by the ‘405 publication teaching an article of tubing sequentially or simultaneously with silicone oil and a nitric oxide release agent to form a treated article of tubing (page 7, second last paragraph). S-nitroso-N-acetylpenicillamine (SNAP) into various medical grade polymers (page 8, second paragraph, page 10, last paragraph).
The combination of references does not specifically teach wherein the polyene antimyotic agent are coupled to the surface of the medical grade polymer via a linker molecule conjugated to the surface of the medical grade polymer, the linker having free primary amines (claim 2) wherein the linker is aminopropyltriethoxysilane (APTMS) (claims 3-4) wherein the units are bonded as shown in formula 1 with R2 being propyl and y being a residue of amphotericin B (claims 13-15, 18).
The combination of references does not specifically teach wherein the polyene antimycotic molecules are in an amount of from about 0.5 nmol/cm2 to about 5.0 nmol/cm2 (claim 12).
The ‘561 publication teaches immobilizing biological molecule on a substrate comprising covalently attaching a substantially three dimensional polysilane polymer to a substrate and attaching a biological molecule onto and/or within the polymer (abstract). The medical device is taught to include implants [0001]. The use of aminopropyltriethoxysilane (APTES) for functionalizing silicone oxide substrates for the attachment of biological molecules are been discussed. The silane monolayer is covalently bonded to the substrate and acts as a crosslinker to which biological molecule may be covalently attached ([0011], [0038]-[0039]). The substrate may be contacted with a biological molecule for sufficient time and at suitable temperature to allow the biological molecule to become attached to the polysilane polymer [0054].
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The ‘663 publication teaches ligands covalently attached to a linker (framework) to provide multibinding compound (abstract). The antifungal agent amphotericine B is taught to complex [0067]. Nyastatin and Amphotericin are taught to treat fungal infections [0230]. Amphotericin is an antibiotic that is an active against fungal organism. Amphotericin B is a specifically taught polyene macrolide family of antifungal agents that also includes nystatin ([0385], Figure 19). The attachment is taught to be at the COOH group to react to an NH2 framework (Figure 21A).
It would have been prima facie obvious to one ordinary skill in the art before the filing date of the claimed invention to attach the active agent to the medical device through the use of APTES as the ‘561 publication teaches that it was known to attach active agents to medical devices containing silicone through the use of APTES. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to do so as the ‘661 publication teaches an active agent attached to an implantable medical device and the ‘561 publication teaches immobilization at a high density for high accuracy of the active agent [0004]. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘561 publication teaches attachment to the medical device resulting in a free NH2 group and the ’663 publication teaches modification of AmpB by reaching a COOH group with NH2. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the 661 publication and the ‘666 publication teach surface modification to a substrate for attachment to a medical device on a hydroxyl surface of the implant and the ‘561 publication teaches the use of APTES to attach to a silicone oxide on the substrate surface to attach an active agent. It would have been obvious to one of ordinary skill in the art to substitute a first attachment ligand as taught by the ‘661 publication with a second attachment ligand, APTES as taught by the ‘561 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.
Response to Arguments:
Applicant’s arguments have been fully considered.
Applicant argues the ‘016 publication (Gratz) teaches Nitrostatin not as an optional component and thus does not read on the amended claims with consisting of language. Applicant argues all other 102 rejection depend from the ‘016 publication and thus should also be withdrawn.
In response, the rejection over the ‘016 publication has been withdrawn based on Applicant’ claim amendments.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613