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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 June 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 17 June 2026 are acknowledged.
Claims 1, 4-10, and 28-32 are currently pending. Claims 2-3 and 11-27 have been cancelled. Claims 1, 4, 6, 8 and 10 are currently amended. Claims 28-32 are newly added. Claims 1, 4-10, and 28-32 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 17 June 2026 has been entered.
Modified/New Rejections
Claim Rejections – 35 U.S.C. 103
4. 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.
5. Claim(s) 1 and 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darouiche (U.S. Patent Application Publication No. 2007/0093894) in view of Li (U.S. Patent Application Publication No. 2012/0290100) and Neoh et al. (Surface Modification strategies for combating catheter-related complications: recent advances and challenges).
Darouiche teaches a method of coating a medical device by applying to a portion of the surface a bactericidal coating layer comprising a bactericidal agent (abstract and claim 1). The medical device includes catheter (claim 4). The bactericidal agent is a sulfonamide that includes sulfamethoxazole (claim 14). The step of forming the antimicrobial composition includes adding alkalizing agent to the composition in order to enhance the reactivity of the material of the medical implant (para 0049).
Darouiche does not teach sulfanilamide or grafting.
Li teaches medical devices that include catheters that include antimicrobial agents of sulfonamide that include sulfamethoxazole or sulfanilamide. See paragraph [0025] and abstract.
Neoh et al. teach catheter coatings and one of the surface modification strategies is coatings with surface-immobilized antimicrobial moiety. The covalent grafting of an antimicrobial agent onto surfaces is expected to provide longer term effects than the use of an eluting agent (abstract and page 2054 para 4.2.2).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one sulfonamide for another to yield predictable results because Li teaches the effectiveness of sulfanilamide as antimicrobial agents used in catheters. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to graft the sulfonamide to the catheter to provide longer term effects because Neoh et al. teach this is a result of grafting antimicrobial agents to surfaces of catheters. With respect to claim 1, which recites product-by-process limitations, the Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
6. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darouiche (U.S. Patent Application Publication No. 2007/0093894) in view of Li (U.S. Patent Application Publication No. 2012/0290100) and Neoh et al. (Surface Modification strategies for combating catheter-related complications: recent advances and challenges) as applied to claims 1 and 4-7 above and further in view of Bailey (US 20080306427).
Darouiche, Li and Neoh et al. do not teach a shaft.
Bailey teaches that catheter devices and components such as the shaft can be impregnated or coated with antimicrobial agents to minimized the risk of bacterial colonization of the catheter and catheter-related bacteremia during use (para 0037).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to attach an antimicrobial composition containing sulfonamides to any part of the catheter including the shaft for the purpose of minimizing the risks of bacterial colonization.
7. Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darouiche (U.S. Patent Application Publication No. 2007/0093894) in view of Li (U.S. Patent Application Publication No. 2012/0290100) and Neoh et al. (Surface Modification strategies for combating catheter-related complications: recent advances and challenges) as applied to claims 1 and 4-7 above and further in view of Stevens et al. (U.S. Patent Application Publication No. 2021/0277275).
Darouiche, Li and Neoh et al. do not a hydrophilic coating.
Stevens et al. teach having coatings functionalized with antimicrobial agents where the antibiotic is conjugated to the coating to decrease the risk of implant-related infections (para 02010). The coatings are used to coat a catheter and the antimicrobial properties can help reduce the risk of a pathogenic microbe interacting the implant and infecting the host (para 0213 and 0215). The coatings may be hydrophilic (para 0150). Antimicrobials such as cephalosporins are disclosed (para 0211). The devices include catheters (para 0207).
Darouiche teaches the antimicrobials may be cephalosporins or sulfonamide (para 0015) thus these are art recognized equivalent antimicrobials suitable for use with medical devices such as catheters.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to attach a sulfanilamide to a catheter via a hydrophilic polymer coating because Stevens et al. demonstrate this is an alternative strategy to provide antimicrobial properties to medical devices such as catheters. One would have been motivated to do so to immobilize the antimicrobial such that it is non-leaching in order to decrease the risk of implant-related infections and provide for longer term effects of the antimicrobial property.
8. Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karandikar et al. (U.S. Patent Application Publication No. 2009/0035342) in view of Neoh et al. (Surface Modification strategies for combating catheter-related complications: recent advances and challenges).
Karandikar et al. teach methods and compositions for antimicrobial devices comprising metal containing compositions wherein devices include catheters. See abstract. Antimicrobial active agents include dapsone (diaminodiphenyl sulfone), tetracycline, doxycycline, ciprofloxacin, etc. See paragraph [0171].
Karandikar et al. do not teach grafting.
Neoh et al. teach catheter coatings and one of the surface modification strategies is coatings with surface-immobilized antimicrobial moiety. The covalent grafting of an antimicrobial agent onto surfaces is expected to provide longer term effects than the use of an eluting agent (abstract and page 2054 para 4.2.2).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to graft the diaminodiphenyl sulfone to the catheter to provide longer term effects because Neoh et al. teach this is a result of grafting antimicrobial agents to surfaces of catheters. With respect to claim 28, which recites product-by-process limitations, the Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
9. Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karandikar et al. (U.S. Patent Application Publication No. 2009/0035342) in view of Neoh et al. (Surface Modification strategies for combating catheter-related complications: recent advances and challenges) as applied to claims 28-29 above and further in view of Bailey (US 20080306427).
Karandikar et al. and Neoh et al. do not teach a shaft.
Bailey teaches that catheter devices and components such as the shaft can be impregnated or coated with antimicrobial agents to minimized the risk of bacterial colonization of the catheter and catheter-related bacteremia during use (para 0037).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to attach an antimicrobial composition containing diaminodiphenyl sulfone to any part of the catheter including the shaft for the purpose of minimizing the risks of bacterial colonization.
10. Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karandikar et al. (U.S. Patent Application Publication No. 2009/0035342) in view of Neoh et al. (Surface Modification strategies for combating catheter-related complications: recent advances and challenges) as applied to claims 28-29 above and further in view of Stevens et al. (U.S. Patent Application Publication No. 2021/0277275).
Karandikar et al. and Neoh et al. do not teach a hydrophilic coating.
Stevens et al. teach having coatings functionalized with antimicrobial agents where the antibiotic is conjugated to the coating to decrease the risk of implant-related infections (para 02010). The coatings are used to coat a catheter and the antimicrobial properties can help reduce the risk of a pathogenic microbe interacting the implant and infecting the host (para 0213 and 0215). The coatings may be hydrophilic (para 0150). Antimicrobials such as cephalosporins are disclosed (para 0211). The devices include catheters (para 0207).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to attach a diaminodiphenyl sulfone to a catheter via a hydrophilic polymer coating because Stevens et al. demonstrate this is an alternative strategy to provide antimicrobial properties to medical devices such as catheters. One would have been motivated to do so to immobilize the antimicrobial such that it is non-leaching in order to decrease the risk of implant-related infections and provide for longer term effects of the antimicrobial property.
Response to Arguments
Applicants’ arguments filed 17 June 2026 have been fully considered but they are not persuasive.
11. Applicants argued, “Darouiche, Li, Neoh, Stevens, and Bailey do not teach grafting a sulfanilamide to a surface via reduction of a diazonium sulfanilamide salt.”
In response to applicants’ arguments, the claims are directed to a product, not a process of making. The Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The prior art of Darouiche, Li, and Neoh make obvious a catheter comprising sulfanilamide grafted to the surface. The prior art of Karandikar et al. and Neoh make obvious a catheter comprising a diaminodiphenyl sulfone grafted to the surface.
Thus this rejection is maintained.
Correspondence
12. No claims are allowed at this time.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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