DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 6 is objected to because of the following informalities: the claim recites an “ionic binding monomer”, but the listing includes methyl acrylate which is an ester with a neutral charge. It is not clear that this titling of compounds embraces this compound since it has no available charges to bind ionically. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 21 is 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.
The claim recites that the “copolymer coating produced a 4-log reduction” [emphasis added]. The claim is drawn to product; thus it recites no actions occurring with the product that could have “produced” any outcome. No circumstances or conditions are recited under which a log reduction could be attained. Thus the scope of the claim is unknown since the structural limitations implied by its functional recitation cannot be discerned.
For the sake of application of prior art, the claim limitations will be deemed met when the recited structural limitations are met.
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, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. (previously cited) in view of Kangas (US PGPub No. 2007/0078388).
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, 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 (see paragraph 13). Medical devices are envisioned as a surface to be provided with their coating(see paragraph 43). They teach benzophenone as an envisioned photo initiator and acrylic acid as a preferred ionic 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 as well as with acrylic acid in a mixture of monomers that include polyethylene glycol diacrylate (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 (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 alternatives, as crosslinkable compounds, and as components that may be employed in combination in the lubricious coating (see paragraph 43, examples 1 and 2, and claim 53). They note that the presence of the crosslinking monomers increased lubricity and the duration of duration of lubricity (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 example 2 of Ditizio et al. prior to polymerization or to in place of the polyethylene glycol diacrylate in light of Kangas. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). Here two diacrylate compounds are known for use in the same capacity in a catheter coating. In addition, the substitution of one diacrylate for the other is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. It alternatively would have been obvious to add neopentyl glycol as a crosslinking monomer to the coating composition of example 4 of Ditizio et al. prior to polymerization in light of Kangas. Ditizio et al. already demonstrate the contemplation of including a crosslinking glycol diacrylate monomer along with the acrylic acid monomer via example 2. Thus the modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement where the particular glycol diacrylate is substituted based upon the teachings of Kangas. The functional limitation of passive anti-fungal activity is provided by the claimed monomers according to the instant specification (see paragraph 16 and figure 1). Therefore claims 1, 5-7, 11, 13-14, and 19 are obvious over Ditizio et al. in view of Kangas.
Claims 1, 4, 7, 11, 13-15, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Kangas as applied to claims 1, 5-7, 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, 19, and 21. 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, 19, and 21 are obvious over Ditizio et al. in view of Kangas and Schachter.
Claims 1, 4, 6-7, 11, 13-14, 19, and 21 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, 19, and 21 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, 19, and 21. Ditizio et al. teach and exemplify catheters as particular medical devices to which their method of coating applies. While they exemplify coatings with acrylic acid alone as a polymerized monomer or in combination with other monomers, they do not detail methyl acrylate amongst them.
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.
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 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, 19, and 21 are obvious over Ditizio et al. in view of Kangas, and Dudnik et al.
Claims 1, 4, 6-9, 11, 13-14, 16-17, 19, and 21 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, 19, and 21 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, 19, and 21. 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 claim 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, 19, and 21 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, 18-19, and 21 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, 19, and 21 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, 18-19, and 21 are obvious over Ditizio et al. in view of Kangas, Ryan et al., and Godfroid et al.
Claims 1, 4, 7, 11-14, and 19-21 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, 19, and 21 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 1-2, 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 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).
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 19-21 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 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ditizio et al. in view of Krongauz et al. (US PGPub No. 2011/0212152).
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, 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 (see paragraph 13). Medical devices are envisioned as a surface to be provided with their coating (see paragraph 43). They teach benzophenone as an envisioned photo initiator and acrylic acid as a preferred ionic 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 as well as with acrylic acid in a mixture of monomers that include polyethylene glycol diacrylate (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). 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 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 Krongauz et al. suggest the combination of similar diacrylate monomers with acrylic acid that are polymerized into an antimicrobial coating and they are alternatives for a particular diacrylate included in an antimicrobial coating prepared from polymerizing acrylic acid. The modifications are obvious as the application of the same technique to a similar product in order to yield the same improvement or the simple substitution of one known element for another in order to yield a predictable outcome. The functional limitation of passive anti-fungal activity is provided by the claimed monomers according to the instant specification (see paragraph 16 and figure 1). Therefore claims 1, 3-4, 7, 11, 13-14, 19, and 21-22 are obvious over Ditizio et al. in view of Kangas.
Response to Arguments
Applicant's arguments filed October 15, 2025 have been fully considered. In light of the amendment to the claims, the previous grounds of rejection under 35 USC 102 and 35 USC 103 are hereby withdrawn. New grounds of rejection are detailed in their place to address the new combination of required components. The applicant’s amendment addressed the object to claim 14 but not the object to claim 6. In contrast to the applicant’s assertion, the amendment to claim 6 does correct the fact that a nonionic monomer is classified as an ionic monomer in the claim.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615