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
Status of Application
1. Applicants’ arguments/remarks filed 20 October 2025 are acknowledged. Claims 1 and 4-10 are currently pending. Claims 2-3 are cancelled. Claims 1, 4, 6, 8 and 10 are amended. Claims 1 and 4-10 are examined on the merits within.
Withdrawn Rejections
2. Applicants’ arguments, filed 20 October 2025, with respect to the 35 U.S.C. 112(b) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) Rejection of claim 6 has been withdrawn. The 35 U.S.C. 112(d) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(d) Rejection of claims 4-6 has been withdrawn. The 35 U.S.C. 102 Rejections have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) Rejection of claim 1 has been withdrawn. The 35 U.S.C. 103 Rejections of Darouiche in view of Li have been modified to incorporate the prior art of Neoh et al. The 35 U.S.C. 103 rejections of Darouiche in view of Li and further in view of Qu et al., Stevens et al., Neoh et al. and Bailey has been modified to Darouiche in view of Li and Neoh et al. as applied to claims 1 and 4-7 above and further in view of Bailey or Stevens.
New Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. 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.
5. 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.
6. 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.
Response to Arguments
Applicants’ arguments filed 20 October 2025 have been fully considered but they are not persuasive.
7. Applicants argued, “Darouiche, Li, Qu, Stevens, and Bailey do not teach antimicrobial grafting. Neoh does not teach sulfanilamide grafted to a surface of a medical device.”
In response to applicants’ arguments, each reference does not need to teach each and every limitation as long as the combination of references make obvious the claimed invention. In the instant case, the new rejection of Darouiche in view of Li and Neoh makes obvious grafting antimicrobials, including sulfanilamide, to catheters. The prior art of Neoh provides motivation to graft antimicrobial agents over various other methods of attachment.
Thus this rejection is maintained.
Conclusion
8. Applicants’ 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.
Correspondence
9. No claims are allowed at this time.
10. 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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