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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 2, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “to cause radical polymerization of the antifungal monomer and ionic binding monomer to form a copolymer coating with antifungal moieties grafted to the medical device surface and form the antifungal coating possessing passive antifungal activity, which in the absence of an antimicrobial substance, produces at least a 4-log reduction in Candida albicans biofilm formation relative to an uncoated medical device surface”. Here antifungal monomer and ionic binding monomer are recited to form a copolymer which “produces at least a 4-log reduction in Candida albicans biofilm formation relative to an uncoated medical device surface”. There is no correspondence between a particular degree of log reduction and a copolymer of antifungal monomer and ionic binding monomer in the disclosure. None of the polymers tested for antimicrobial efficacy contained an ionic binding monomer and there is no general discussion of ionic monomer containing copolymers and the log reduction that is now recited. Therefore the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as currently claimed at the time of filing.
This is a new matter rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “exposing the medical device surface to a monomer solution comprising an antifungal monomer” where an ionic binding monomer is not listed as a component. Subsequently, the claim also recites “irradiating the photoinitiator with UV light to cause radical polymerization of the antifungal monomer and ionic binding monomer to form a copolymer coating with antifungal moieties grafted to the medical device surface”. The requirement for the presence of the ionic binding is not clear, given that it is recited as a participant in polymerization, but was not previously recited in the claim as part of the monomer solution nor is it mentioned amongst the moieties that the claim recites to be grafted to the medical device surface via the irradiating step. Thus it is unclear if the ionic binding monomer is required in the polymer that forms on the medical device surface. Consequently, it is also unclear which monomers are present in the polymer that yields an antifungal coating “which in the absence of an antimicrobial substance, produces at least a 4-log reduction in Candida albicans biofilm formation relative to an uncoated medical device surface”.
In addition, there is no recited contact time over which the recited reduction in Candida albicans biofilm formation occurs upon contact with the bacteria. Biofilm reduction is a time dependent process such that depending on the duration of exposure, a coated medical device could be both inside and outside the scope of claim in regard to log reduction in Candida albicans biofilm formation.
Both an ionic binding monomer and an antifungal monomer selected from tricyclodecane dimethanol diacrylate, 4-tert-butylcyclohexyl acrylate, neopentyl glycol diacrylate, trimethylcyclohexyl methacrylate, and mixtures thereof are recited in the polymerization process and a copolymer is recited as forming a coating on the device surface. Thus for the sake of compact prosecution and the application of prior art, a process that provides such a polymer on a medical device that has a photoinitiator containing surface and is polymerized via UV exposure will be deemed sufficient to meet the limitations of the “irradiating” stanza of instant claim 1. Further, the claim does not state that an antimicrobial substance is absent from the coating. Instead, the claim recites a function when an antimicrobial substance is absent. This conditional recitation does not constrain the components in the product that is made because the method embraces additional unrecited steps (e.g., the loading of an antimicrobial substance) due to its open claim construction. In addition, the “irradiating” step recites irradiating the photoinitiator and does not explicitly recite the presence of monomers; however, due to the recited outcome of causing “radial polymerization of the antifungal monomer and ionic binding monomer”, the recitation is being interpreted as occurring while the monomers are also present on the medical device surface. Clarification is still required.
Claims that are rejected, but are not explicitly elaborated upon, are also indefinite because they depend from an indefinite claim and do not add clarity.
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.
Claims 1, 4, 7, 11, 13-14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. (previously cited) in view of Kangas (previously cited).
Ditizio et al. teach preparing lubricious antimicrobial surfaces by coating the surface with a photoinitiator, then incubating the coated surface in a solution of monomers able to undergo radical polymerization along with a photoinitiator, followed by irradiating the surface with ultraviolet light to polymerize the monomers (see abstract and paragraph 15). The coating is then loaded with an antimicrobial agent envisioned as silver via incubation in a solution of the agent (see paragraphs 13 and 51; instant claims 1 and 7). The coating is negatively charged and holds the silver ionically, when present, but not in a manner that saturates the available negative charge sites so as to insure that lubricity (hydrophilicity) is maintained (see paragraphs 66-67; instant claims 5 and 11). The loaded silver is released over time from the coating.(see paragraph 70). Ditizio et al. further teach that the coating is effective against bacterial and fungal infection and illustrate the effectiveness against Pseudomonas aeruginosa and Staphylococcus aureus (see paragraph 13 and figure 8; instant claims 7 and 14). Medical devices are envisioned as a surface to be provided with their coating (see paragraph 43). The coating is a stable acrylate coating that may include monomers in combination (see paragraphs 11-14 and 54). They further teach benzophenone as an envisioned photoinitiator and acrylic acid as a preferred monomer (see paragraphs 53-54 and example 2; instant claims 6 and 14). Examples employed to make the coating for a catheter or stent are detailed with acrylic acid (see examples 2 and 4). A neopentyl glycol diacrylate monomer is not explicitly detailed as present.
Kangas teaches lubricious coatings for devices envisioned as catheters that includes a hydrophilic polymer (see abstract and paragraphs 8-9). They detail the inclusion of ethylenically unsaturated monomers and an initiator to permit curing under UV light (see paragraphs 7, 39, and 41). Polyethylene glycol diacrylate and neopentyl glycol diacrylate are detailed in this role as crosslinkable compounds in the lubricious coating (see paragraph 43, examples 1 and 2, and claim 53). The crosslinking helps to retain the hydrophilic polymer on the surface of the device (see paragraph 42-43). They note that the presence of the crosslinking monomers increased lubricity and the duration of lubricity for a lubricity inducing polymer also present on the surface (see paragraph 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add neopentyl glycol diacrylate to the acrylic acid containing monomer mixture of Ditizio et al. prior to polymerization in light of Kangas. This choice would have been obvious so as to provide the added durability conferred by crosslinking. The modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The functional limitation of anti-fungal activity against Candida albicans is provided by the claimed monomers, such as neopentyl glycol diacrylate, according to the instant specification (see paragraph 16 and figure 1; instant claims 1 and 7). Thus the ability of the polymer coating with the recited antifungal monomers to reduce Candida albicans biofilm formation in the absence of an antimicrobial substance is a feature connected to the fact that the monomers are present. In addition, MPEP 2145II notes that the mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore claims 1, 4, 7, 11, 13-14, and 19 are obvious over Ditizio et al. in view of Kangas.
Claims 1, 4, 7, 11, 13-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Kangas as applied to claims 1, 4, 7, 11, 13-14, and 19 above, and further in view of Schachter (previously cited).
Ditizio et al. in view of Kangas render obvious the limitations of instant claims 1, 4, 7, 11, 13-14, and 19. Ditizio et al. teach and exemplify catheters as particular medical devices to which their method of coating applies. They are silent in regard to whether both the intraluminal (interior) and extraluminal (exterior) surfaces are coated.
Schachter teaches an antimicrobial coating for medical devices such as catheters (see abstract). They go on to teach that both the interior and exterior surfaces of the catheter could be coated and that this was preferred for catheters, in particular (see paragraph 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the coating method and coating of Ditizio et al. in view of Kangas to the intraluminal (interior) and extraluminal (exterior) surfaces of the envisioned catheter in light of Schachter. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 4, 7, 11, 13-15, and 19 are obvious over Ditizio et al. in view of Kangas and Schachter.
Claims 1, 4, 6-7, 11, 13-14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Kangas as applied to claims 1, 4, 7, 11, 13-14, and 19 above, and further in view of Dudnik et al. (previously cited).
Ditizio et al. in view of Kangas render obvious the limitations of instant claims 1, 4, 7, 11, 13-14, and 19. Ditizio et al. teach and exemplify catheters as particular medical devices to which their method of coating applies and that the coating releases an ionic antimicrobial active (see paragraph 13). While they exemplify coatings with acrylic acid alone as a polymerized monomer or suggest it in combination with other monomers, they do not detail methyl acrylate amongst them (see paragraph 54).
Dudnik et al. teach an antimicrobial coating applied to medical devices (see abstract). The coating is generated from a hydrophilic (lubricious) coating made the copolymerization of vinyl monomers in the presence of an initiator coated device surface and UV light that are subsequently coated with antimicrobial silver and dye (see paragraph 60 and example 3). Example 5 provides a hydrophilic coating made by coating a catheter with a benzophenone, drying the coating, then immersing it in a solution of acrylic acid and methyl acrylate and irradiating with UV light. The coated catheter is subsequently coated with a mixture of silver and crystal violet where the latter may alternatively be ethyl violet (see paragraph 79).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the modified coating of Ditizio et al. that contains neopentyl glycol diacrylate and acrylic acid, where methyl acrylate is also included, in light of Dudnik et al. This modification would have been obvious because Dudnik et al. exemplify a similar acrylic acid containing coating for a similar purpose explicitly with the combination of methyl acrylate and acrylic acid, indicating their recognized utility and contemplation together as a intraluminal coating to release an ionic antimicrobial active. Therefore claims 1, 4, 6-7, 11, 13-14, and 19 are obvious over Ditizio et al. in view of Kangas, and Dudnik et al.
Claims 1, 4, 6-9, 11, 13-14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Kangas, and Dudnik et al.as applied to claims 1, 4, 6-7, 11, 13-14, and 19 above, and further in view of Rosenblatt et al. (previously cited).
Ditizio et al. in view of Kangas, and Dudnik et al. render obvious the limitations of instant claims 1, 4, 6-7, 11, 13-14, and 19. Dudnik et al. also teach that methylene blue and ethyl violet are cationic dyes that can be employed in antimicrobial coatings on catheters that also include silver as an antimicrobial active (see abstract, paragraph 7 and example 5). Ditizio et al. do not name ethyl violet and methylene blue as antimicrobial actives useful in addition to the cationic silver that is exemplified.
Rosenblatt et al. teach silver as well as ethyl violet and methylene blue as individual or combination options for antimicrobial actives in an antimicrobial catheter coatings (see abstract and paragraphs 17-18 and claims 1 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select ethyl violet or methylene blue as the antimicrobial agent loaded via ionic interaction into the coating of Ditizio et al. in view of Kangas, and Dudnik et al. These choices would have been obvious in light of Rosenblatt et al. because they are known as alternatives to silver as antimicrobial actives for catheters. Further, they are known to be cationic in light of Dudnik et al. and therefore able to interact ionically with the polymer similar to the interaction between silver and the ionic polymer in Ditizio et al. These choices are also obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 4, 6-9, 11, 13-14, 16-17, and 19 are obvious over Ditizio et al. in view of Kangas, Dudnik et al., and Rosenblatt et al.
Claims 1, 4, 7, 10-11, 13-14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Kangas as applied to claims 1, 4, 7, 11, 13-14, and 19 above, and further in view of Ryan et al. (previously cited) and Godfroid et al. (previously cited).
Ditizio et al. in view of Kangas render obvious the limitations of instant claims 1-2, 5-7, 11, 13-14, and 19. Ditizio et al. teach and exemplify catheters as particular medical devices to which their method of coating applies. They do not name chlorhexidine diacetate as an antimicrobial active useful in addition to the cationic silver that is exemplified.
Ryan et al. teach silver as well as chlorhexidine diacetate as an antimicrobial active for antimicrobial materials in medical devices (see abstract and paragraphs 5 and 34).
Godfroid et al. teach that chlorhexidine diacetate is a cationic antimicrobial active (see claim 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select chlorhexidine diacetate as the antimicrobial agent loaded via ionic interaction into the coating of Ditizio et al. in view of Kangas These choices would have been obvious because it is known as an alternative to silver as an antimicrobial actives for medical devices in light of Ryan et al. Further, it is known to be cationic in light of Godfroid et al. and thus able to interact ionically with the polymer like silver. This choice is also obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 4, 7, 10-11, 13-14, and 18-19 are obvious over Ditizio et al. in view of Kangas, Ryan et al., and Godfroid et al.
Claims 1, 4, 7, 11-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Kangas as applied to claims 1, 4, 7, 11, 13-14, and 19 above, and further in view of Reo et al. (previously cited) and Wilcox et al. (previously cited).
Ditizio et al. in view of Kangas render obvious the limitations of instant claims 1, 4, 7, 11, 13-14, and 19. Ditizio et al. teach and exemplify catheters as particular medical devices to which their method of coating applies. They do not name cecropin as an antimicrobial active useful in addition to the cationic silver that is exemplified.
Reo et al. teach silver as well as cecropin A as an antimicrobial active for providing an antimicrobial surface on a medical device (see abstract and paragraph 43; instant claim 12).
Wilcox et al. teach that cecropins are cationic antimicrobial peptide actives known for use in antimicrobial coatings for medical devices (see abstract, paragraph 5, and table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select chlorhexidine acetate as the antimicrobial agent loaded via ionic interaction into the coating of Ditizio et al. in view of Kangas These choices would have been obvious because it is known as an alternative to silver as an antimicrobial actives for medical devices in light of Reo et al. Further, it is known to be cationic in light of Wilcox et al. and thus able to interact ionically with the polymer like silver. This choice is also obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 4, 7, 11-14, and 19-20 are obvious over Ditizio et al. in view of Kangas, Reo et al., and Wilcox et al.
Claims 1, 3-4, 7, 11, 13-14, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Krongauz et al. (previously cited).
Ditizio et al. teach preparing lubricious antimicrobial surfaces by coating the surface with a photoinitiator, then incubating the coated surface in a solution of monomers able to undergo radical polymerization along with a photoinitiator, followed by irradiating the surface with ultraviolet light to polymerize the monomers (see abstract and paragraph 15). The coating is then loaded with an antimicrobial agent envisioned as silver via incubation in a solution of the agent (see paragraphs 13 and 51; instant claims 1 and 7). The coating is negatively charged and holds the silver ionically, when present, but not in a manner that saturates the available negative charge sites so as to insure that lubricity (hydrophilicity) is maintained (see paragraphs 66-67; instant claims 5 and 11). The loaded silver is released over time from the coating.(see paragraph 70). Ditizio et al. further teach that the coating is effective against bacterial and fungal infection and illustrate the effectiveness against Pseudomonas aeruginosa and Staphylococcus aureus (see paragraph 13 and figure 8; instant claims 7 and 14). Medical devices are envisioned as a surface to be provided with their coating (see paragraph 43). The coating is a stable acrylate coating that may include monomers in combination (see paragraphs 11-14 and 54). They further teach benzophenone as an envisioned photoinitiator and acrylic acid as a preferred monomer (see paragraphs 53-54 and example 2; instant claims 6 and 14). Examples employed to make the coating for a catheter or stent are detailed with acrylic acid (see examples 2 and 4). The presence of trimethyl cyclohexyl methacrylate neopentyl glycol diacrylate monomer is not explicitly detailed.
Krongauz et al. teach an antimicrobial coating that includes vinyl monomers and a metal salt that are polymerized into a coating (see abstract and claim 4). The metal salt is the antimicrobial active and envisioned as silver salts (see paragraphs 2 and 10). Here acrylic monomers are included to promote adhesion of the contained antimicrobial active to the treated surface (see paragraphs 8 and 20). These monomers are envisioned to include acrylic acid, 1,6-hexandiol diacrylate, neopentyl glycol diacrylate, trimethylcyclohexyl methacrylate, and their combinations (see paragraph 48; instant claims 1, 3, , 7, 14, and 22). They exemplify diacrylate monomers such as polyethylene glycol diacrylate and 1,6-hexandiol diacrylate in combination with acrylic acid in the coating (see example 1). Catheters are envisioned as substrates to which the coating is applied (see claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include neopentyl glycol diacrylate and/or trimethylcyclohexyl methacrylate in a catheter coating of Ditizio et al. made like that of example 2 or 4, prior to polymerization, in view of Krongauz et al. These modifications would have been obvious because, like Ditizio et al., Krongauz et al. suggest antimicrobial coatings with acrylic acid monomers and metal antimicrobial actives, then further include diacrylate monomers to generate the coating. This similarity in utility and composition render the use of the monomer mixture of Krongauz the simple substitution of one known element for another in order to yield a predictable outcome. The functional limitation of anti-fungal activity against Candida albicans is provided by the claimed monomers, such as neopentyl glycol diacrylate, according to the instant specification (see paragraph 16 and figure 1; instant claims 1 and 7). Thus the ability of the polymer coating with the recited antifungal monomers to reduce Candida albicans biofilm formation in the absence of an antimicrobial substance is a feature connected to the fact that the monomers are present. In addition, MPEP 2145II notes that the mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore claims 1, 3-4, 7, 11, 13-14, 19, and 22 are obvious over Ditizio et al. in view of Krongauz et al.
Claims 1, 3-4, 13-14, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Krongauz et al. in view of Minagawa (US PGPub No. 2013/0203883) and Minagawa et al. (US PGPub No. 2016/0008520 – henceforth Minagawa B) as evidenced by Ditizio et al.
Krongauz et al. teach an antimicrobial coating that includes multifunctional acrylic monomers, adhesion promoting vinyl monomers as well as a metal salt that are polymerized into a coating (see abstract and claim 4). The metal salt is the antimicrobial active and envisioned as silver salts (see paragraphs 2 and 10). Ditizio et la detail that silver released from a coating is efficacious against Pseudomonas aeruginosa and Staphylococcus aureus (see paragraph 13 and figure 8; instant claim 14). Here adhesion promoting acrylic monomers are included to promote adhesion of the contained antimicrobial active to the treated surface and are envisioned to include acrylic acid, trimethylcyclohexyl methacrylate, and their combinations (see paragraphs 8, 20, and 48; instant claims 1, 3, 7, 14, and 22). The multifunctional acrylic monomers are taught to include neopentyl glycol diacrylate, polyethylene glycol diacrylate, and 1,6-hexandiol diacrylate and their combinations where these options are also envisioned as adhesion promoting monomers (see paragraphs 37 and 48; instant claims 1, 3, 7, 14, and 22). Krongauz et al. exemplify diacrylate monomers such as polyethylene glycol diacrylate and 1,6-hexandiol diacrylate in combination with acrylic acid and a silver ion (antimicrobial substance) in the coating (see example 1). They also teach preparing the coated medical device by applying a mixture of the desired monomers in combination with a photoinitiator on the device surface and then exposing the surface to UV irradiation (see example 1; instant claims 1, 14, and 19). The envisioned photoinitiators include benzophenones as well as other ketones (see paragraphs 56-57). Krongauz et al. teach catheters are envisioned as device substrates to which the coating is applied (see claim 10). Further, medical device surfaces are envisioned as elastomers, plastic, and glass (see paragraph 22). The presence of an initiator on the surface of the medical device.
Minagawa teaches the application of coatings via radical polymerization to provide additional functional properties, such as antimicrobial activity and lubricity, to devices such as catheters (see abstract and paragraphs 9 and 37). They form initiation points on the surface of the device by adsorbing a desired photoinitiator to the device surface, prior to exposure to monomers of choice, and irradiation with UV light (see abstract and paragraphs 49 and 64). The photoinitiator, envisioned as a benzophenone, abstracts a hydrogen from the device substrate which permits bonding of the polymer to the surface during polymerization (see paragraphs 47, 50, and 64). Minagawa B teaches that this bonding improves the durability of the polymer coating while Minagawa teaches this surface bonding to yield a superior coating in regard to the functions it confers (see abstract and paragraph 8; Minagawa paragraphs 36, 99-103, and table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to also coat the device surface of Krongauz et al. with their photoinitiator as taught by Minagawa et al. prior to exposure to the monomer mixture. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g. superior functions and durability). It also would have been obvious to exchange neopentyl glycol diacrylate for a multifunctional acrylic monomer in the exemplified coating of example 1 in Krongauz et al. and/or include trimethylcyclohexyl methacrylate as an additional adhesion promoting monomer. These choices would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The functional limitation of anti-fungal activity against Candida albicans is provided by the claimed monomers, such as neopentyl glycol diacrylate, according to the instant specification (see paragraph 16 and figure 1; instant claims 1 and 7). Thus the ability of the polymer coating with the recited antifungal monomers to reduce Candida albicans biofilm formation in the absence of an antimicrobial substance is a feature connected to the fact that the monomers are present. In addition, MPEP 2145II notes that the mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore claims 1, 3-4, 13-14, 19, and 22 are obvious over Krongauz et al. in view of Minagawa and Minagawa B as evidenced by Ditizio et al.
Claims 1, 3-4, 13-15, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Krongauz et al. in view of Minagawa and Minagawa B as evidenced by Ditizio et al. as applied to claims 1, 3-4, 13-14, 19, and 22 above, and further in view of Schachter.
Krongauz et al. in view of Minagawa and Minagawa B as evidenced by Ditizio et al. render obvious the limitations of instant claims 1, 3-4, 13-14, 19, and 22. Krongauz et al. teach catheters as particular medical devices to which their method of coating applies. They are silent in regard to whether both the intraluminal (interior) and extraluminal (exterior) surfaces are coated.
Schachter teaches an antimicrobial coating for medical devices such as catheters (see abstract). They go on to teach that both the interior and exterior surfaces of the catheter could be coated and that this was preferred for catheters, in particular (see paragraph 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the coating method and coating of Krongauz et al. in view of Minagawa and Minagawa B to the intraluminal (interior) and extraluminal (exterior) surfaces of the envisioned catheter in light of Schachter. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3-4, 13-15, 19, and 22 are obvious over Krongauz et al. in view of Minagawa, Minagawa B, and Schachter as evidenced by Ditizio et al.
Response to Arguments
Applicant's arguments filed April 2, 2026 have been fully considered but they are not persuasive. In light of the amendment to the claims, new grounds of rejection are detailed to address the new claim limitations.
The amendment to the claim links a log 4 reduction in Candida albicans biofilm formation to an antimicrobial surface in claim 1. The claim is unclear in regard to the monomers that are present in the antimicrobial surface, as noted in the new grounds of rejection. Homopolymer coatings of antimicrobial monomers tricyclodecane dimethanol diacrylate, 4-tert-butylcyclohexyl acrylate, neopentyl glycol diacrylate, or trimethylcyclohexyl methacrylate as well as some copolymer pairings of these monomers with one another were shown to yield a log 4 reduction in Candida albicans over an undisclosed exposure duration. However, claim 1 confusingly seems to recite the polymerization of an antimicrobial monomer and an ionic binding monomer into a copolymer coating on a medical device which possesses antifungal activity that produces log 4 reduction in Candida albicans biofilm formation. The monomer solution exposed to the medical device prior to polymerization is not recited to include an ionic binding monomer. The applicant did not obtain log 4 reduction in Candida albicans biofilm formation with the copolymer the current method seems to recite. It is not clear what impact the presence of an ionic binding monomer has on Candida albicans biofilm formation or if the monomer is required to be present in claim 1. Thus the data in the disclosure is not sufficient to render the method of claim 1 non-obvious.
The applicant also argues that the prior art did not recognize the impact of the claimed antifungal monomers on Candida albicans. They also argue that their disclosure does not teach that prior art monomers inherently achieve passive antifungal activity. However, paragraph 16 of the instant specification states that “[c]oatings incorporating antifungal monomers with moieties M1 to M5, shown in Fig. 1, have excellent passive resistance to clinically relevant Candida albicans yeast”. The cited prior art teaches moieties M3 and M4 in a polymerized coating on a medical device. Whatever “passive” properties the monomers carry is present in the prior art coatings as well (see MPEP 2112.01(I)-(II) and MPEP 2145II). Further, neopentyl glycol diacrylate is recognized as having some antimicrobial properties when polymerized, thus its ability to function an antimicrobial monomer was not fully unrecognized (see Xu et al. Angewandte Chemie International Edition 2019 58(31):10616-10620, page 10617 first column first paragraph). The degree to which biofilm formation is inhibited by claimed polymer coatings could occur at an unexpected level. However, only four claims recite or require a particular degree of antifungal efficacy. Additionally, the evidence of record does not indicate the expected outcome for copolymers of ionic binding monomers and claimed antifungal monomers such that a determination can be made as to whether the claimed coating has an unexpectedly superior function. The silence of the prior art in regard to functions identified by the applicant is not sufficient, in and of itself, to indicate non-obviousness.
While the applicant argues that Ditizio et al. and Kangas do not teach the instantly claimed antifungal monomers to have the property of producing a log reduction in Candida albicans biofilm formation, their combined teachings still render obvious a coating with the ionic binding monomer and particular monomers that are recited in the instant claims to be antifungal. The applicant notes that Kangas and Ditizio do not suggest the combination of passive antifungal activity and active antimicrobial activity as instantly claimed. This appears to be an argument that the only viable path to the combination of teachings in a prima facia case of obviousness is a teaching, suggestion, or motivation (TSM) explicitly provided by one of the source references. MPEP 2141(I) details that a reliance solely upon a TSM rationale is overly rigid and does not serve as the only route to a case of obviousness. Here the rationale based upon applying a known technique to a known device (method, or product) ready for improvement to yield predictable results, was employed to support the prima facia case of obviousness. This line of reasoning is explicitly detailed as a viable path to building a prima facie case of obviousness (see MPEP 2141(III)). The applicant argues there would not have been a reasonable expectation of success for the claimed products and methods. However, according to MPEP 2144 IV, “[t]he reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).” The artisan of ordinary skill would have had a reasonable expectation of success for generating a medical device with an antimicrobial coating because the cited prior art teaches to do so.
The applicant notes the recitation of the antimicrobial substance having activity against Pseudomonas aeruginosa and Staphylococcus aureus in claims 7 and 14. Ditizio et al. and Krongauz et al. teach silver loaded into their coatings and it has antimicrobial activity against these bacteria according to the instant claims and Ditizio et al.
The applicant also argues that Dudnik et al., Rosenblatt et al., Reo et la., Wilcox et al., Ryan et al., and Godfroid et al. each do not teach the functional limitations of the claimed coating polymer 1) having passive antifungal properties against Candida albicans, 2) achieving a log 4 reduction in its biofilm in the absence of an antimicrobial substance or 3) active antimicrobial activity against Pseudomonas aeruginosa and Staphylococcus aureus when an antimicrobial substance is present. These limitations were met by Ditizio et al. in view of Kangas as discussed above.
Further, the applicant argues that Ditizio et al. in view of Krongauz et al. do not met the limitations of the instant claims as they detailed in reference to Ditizio et al. in view of Kangas. The same response detailed above also applies and is similarly reiterated.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
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