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 .
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 14 August 2026 wherein Claim 13 is amended and no claims are newly added or cancelled.
Response to Arguments
Applicant’s arguments, see page 1, filed 14 August 2026, with respect to the 35 U.S.C. § 103 rejection of Claim 13 and its dependent claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Natesan et al. (US 2020/0016376 A1) and Hoang et al. (US 2007/0112333 A1).
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.
Claim(s) 13 – 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Natesan et al. (US 2020/0016376 A1) (hereinafter referred to as “Natesan”) and Hoang et al. (US 2007/0112333 A1) (hereinafter referred to as “Hoang”).
Hoang is previously cited within the Notice of References Cited form dated 18 May 2026.
With regards to claim 13, Natesan discloses a catheter system (20), comprising:
a catheter adapter (10), comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (see Figure 2F which shows the catheter adapter comprising a distal end, a proximal end, and a lumen extending through);
a catheter tube (12) extending distally from the distal end of the catheter adapter (see Figure 2F);
a needle hub (22);
an introducer needle (24) extending from the needle hub and distally through the catheter tube (see Figure 2C), wherein the introducer needle comprises a sharp distal tip (see [0032]);
an end cap (28) proximal to the catheter adapter and comprising an outer surface (see at 28 in Figure 2F), wherein fluid cannot pass the end cap such that the end cap closes a proximal end of the catheter system (see Figure 2F).
However, Natesan is silent with regards to the catheter system further comprising:
a swab holder coupled to a proximal end of the end cap, wherein the swab holder comprises a distal opening and a proximal end, wherein the proximal end of the swab holder comprises a pocket, wherein the proximal end of the end cap is inserted into the distal opening and secured via an interference or press fit between the outer surface of the end cap and the distal opening; and
a swab secured within the pocket of the swab holder and containing a disinfectant, wherein the pocket fluidically separates the disinfectant and the end cap.
Nonetheless Hoang , which is within the analogous art of patient fluid line access valve antimicrobial cap/cleaner (see abstract and title), teaches the following:
a swab holder (10) (see [0017]) coupled to a proximal end (see at A8 in Fig. 1) of the end cap (A4, A6), wherein the swab holder comprises a distal opening (see at 14b in Fig. 2) and a proximal end (see at 16b in Fig. 2), wherein the proximal end of the swab holder comprises a pocket (16b) (see [0020]), wherein the proximal end of the end cap (see at A4, A6 in Fig. 3) (see [0017]) is inserted into the distal opening (see Fig. 3) and secured via an interference or press fit between the outer surface (A4) (see [0024]) of the end cap (A4, A6) and the distal opening (see [0024] and the described interference or press fit via the threaded connection); and
a swab (22) (see [0020]) secured within the pocket of the swab holder (see Fig. 2) and containing a disinfectant (see [0023] and [0027] “Wet pad 22 is impregnated with a cleaning agent and optionally, an antimicrobial agent. Wet pad 22 may be made from materials similar to those described for dry pad 24”), wherein the pocket fluidically separates the disinfectant and the end cap (see Figs. 2 – 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter system of Natesan in view of a teaching of Hoang such that the catheter system further comprises a swab holder coupled to a proximal end of the end cap, wherein the swab holder comprises a distal opening and a proximal end, wherein the proximal end of the swab holder comprises a pocket, wherein the proximal end of the end cap is inserted into the distal opening and secured via an interference or press fit between the outer surface of the end cap and the distal opening; and a swab secured within the pocket of the swab holder and containing a disinfectant, wherein the pocket fluidically separates the disinfectant and the end cap. Here, the swab holder of Hoang would be coupled to the end cap of Natesan.
One of ordinary skill in the art would have been motivated to make this modification because Hoang teaches that it is beneficial to include a swab holder within a catheter system to maintain of antiseptic conditions. See Abstract and [0023] of Hoang. Hoang also teaches that this swab holder can be repeatedly used. See [0036] of Hoang.
The catheter system of Natesan modified in view of Hoang will hereinafter be referred to as the catheter system of Natesan and Hoang.
With regards to claim 14, the catheter system of Natesan and Hoang teaches the claimed invention of claim 13, however Natesan is silent with regards to the catheter system further comprising a film coupled to the swab holder and sealing the swab from an external environment.
Nonetheless Hoang, which is within the analogous art of patient fluid line access valve antimicrobial cap/cleaner (see abstract and title), teaches a film (20) (see [0019]) coupled to the swab holder (10) (see [0017]) and sealing the swab from an external environment (see [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter system of Natesan and Hoang in view of a further teaching of Hoang such that the catheter system further comprises a film coupled to the swab holder and sealing the swab from an external environment. One of ordinary skill in the art would have been motivated to make this modification because the lid completely seals the opening of the cleaning end of the swab holder. See [0019] of Hoang.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Natesan and Hoang as applied to claim 14 above, and further in view of Cordoba et al. (US 10,780,256 B2) (hereinafter referred to as “Cordoba”).
Cordoba is cited in the Notice of References Cited dated 2 October 2025.
With regards to claim 15, the catheter system of Natesan and Hoang teaches the claimed invention of claim 14, and the catheter system of Natesan and Hoang teaches to wherein the swab holder (10) (see [0017] of Hoang) or the film (20) (see [0019] of Hoang) comprises a thermoplastic or pressure sensitive material (see [0018] and [0019] of Hoang).
However, the catheter system of Natesan and Hoang is silent with regards to wherein the film is heat or pressure sealed to the swab holder.
Nonetheless Cordoba, which is within the analogous art of a system for integrating an antibacterial-element receptacle into an autoinjector cap (see abstract and title), teaches (Fig. 7) the film (5) is heat or pressure sealed to the swab holder (12) (see Col. 4, lines 36 – 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the film of the catheter system of Natesan and Hoang in view of a teaching of Cordoba such that the film is heat or pressure sealed to the swab holder. One of ordinary skill in the art would have been motivated to make this modification because Cordoba teaches that the heat seal is weak enough to allow the administrator to easily peel the cover lid off the removeable cover to access the contents sealed inside such as the dressing/swab. See Col. 4, lines 36 – 67 of Cordoba. Here, attaching the film to the swab holder via a heat seal would allow for easy access to the swab secured within the swab holder.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Natesan and Hoang as applied to claim 13 above, and further in view of Chiappetta (US 5,989,229 A1).
Chiappetta is cited in the Notice of References Cited dated 2 October 2026.
With regards to claim 16, the catheter system of Natesan and Hoang teaches the claimed invention of claim 13, and the catheter system of Natesan and Hoang teaches wherein the swab holder (10) (see [0017] of Hoang) comprises a flange (see at 16a in Fig. 2 of Hoang) surrounding and contacting the swab (22) (see [0020] and Figure 2 of Hoang).
However, the catheter system of Natesan and Hoang is silent with regards to wherein the swab extends outwardly beyond the flange.
Nonetheless Chiappetta, which is within the analogous art of needle cover assembly having self-contained drug applicator (see abstract and title), teaches (see Figs. 1 – 5) wherein the swab extends outwardly beyond the flange (see Figs. 2 – 4 wherein the flange is the annular structure holding the swab 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the swab of the catheter system of Natesan and Hoang in view of a teaching of Chiappetta such that the swab extends outwardly beyond the flange. One of ordinary skill in the art would have been motivated to make this modification because the swab extending outwardly beyond the flange facilitates the application of the drug to the patient or structure. See Col. 2, line 57 – Col. 3, line 3 of Chiappetta.
Allowable Subject Matter
Claims 1 – 12 and 17 – 19 are allowed.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claim 1 recites:
A catheter system, comprising:
a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter;
a catheter tube extending distally from the distal end of the catheter adapter;
a needle hub;
an introducer needle extending from the needle hub and distally through the catheter tube, wherein the introducer needle comprises a sharp distal tip;
a needle cover surrounding the catheter tube and the sharp distal tip, wherein the needle cover comprises an outer surface;
a swab holder coupled to a distal end of the needle cover, wherein the swab holder comprises a proximal opening and a flange distal to the proximal opening, wherein the distal end of the needle cover is inserted into the proximal opening and secured via an interference or press fit between the outer surface of the needle cover and the proximal opening, wherein the proximal opening has a first inner diameter, wherein the flange forms a pocket having a second inner diameter, wherein the second inner diameter is larger than the first inner diameter; and
a swab secured within the swab holder and containing a disinfectant, wherein the swab is seated within the pocket formed by the flange and extends across the second inner diameter.
The closest prior art to teach the invention of Claim 1 is the following:
Osei et al. (US 2003/0049069 A1), Yang (US 2005/0015055 A1), Mohiuddin (US 2006/0018701 A1), Cybulski et al. (US 2006/0072962 A1), Hoang et al. (US 2011/0066121 A1), Guzman et al. (US 2013/0156486 A1), Froimson (US 2013/0202482 A1), Frazier (US 2014/0003858 A1), Isaacson et al. (US 2016/0008538 A1), Cordoba et al. (US 2018/0264243 A), Lynch et al. (US 2021/0052825 A1), Mcginley et al. (US 2023/0321416 A1), Prasad et al. (US 2024/0165344 A1), Nalawade et al. (US 2024/0358296 A1), Gingras (US 3,270,743 A), Barrett (US 4,243,035 A), Chiappetta (US 5,989,229 A), Zelten et al. (US 8,535,257 B1), Zelten et al. (US 9,750,893 B1), Hoang et al. (US 2012/0016318 A1), Goral et al. (US 2016/0220762 A1), Haber (US 4,799,926 A), and Steube et al. (US 9,125,600 B2).
Each of prior art references in this list are cited in the Notice of References Cited form dated 23 January 2026.
However, none of the aforementioned prior art teaches a catheter system comprising a needle cover surrounding the catheter tube and the sharp distal tip, wherein the needle cover comprises an outer surface; a swab holder coupled to a distal end of the needle cover, wherein the swab holder comprises a proximal opening and a flange distal to the proximal opening, wherein the distal end of the needle cover is inserted into the proximal opening and secured via an interference or press fit between the outer surface of the needle cover and the proximal opening, wherein the proximal opening has a first inner diameter, wherein the flange forms a pocket having a second inner diameter, wherein the second inner diameter is larger than the first inner diameter in addition to the other limitations of Claim 1. Therefore Claim 1 is allowable.
Claims 2 – 12 and 17 – 19 are dependent upon or incorporate all of Claim 1 into the claim. Therefore, Claims 2 – 12 and 17 – 19 are allowable for the same rationale as Claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Natesan et al. (US 2021/0060307 A1).
Natesan et al. (US 2021/0386977 A1).
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 ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/01/2026
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