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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 April 2026 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 2 April 2026 wherein Claims 9, 13, and 15 are amended, Claim 20 is cancelled, and no claims are newly added. Therefore Claims 1 – 19 are currently pending within the Application.
The Applicant’s amendment to the Claims dated 2 April 2026 has overcome each Claim Rejection set forth under 35 U.S.C. § 112(b) within the Final Rejection dated 23 January 2026. Therefore, each Claim Rejection set forth under 35 U.S.C. § 112(b) within the Final Rejection dated 23 January 2026 is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 1 – 2, filed 2 April 2026, with respect to the rejection(s) of independent claim 13 and its dependent claims under 35 U.S.C. § 103 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 Therefore, the rejection has been withdrawn.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 Hoang et al. (US 2012/0016318 A1), Goral et al. (US 2016/0220762 A1), and Hoang et al. (US 2007/0112333 A1).
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.”
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 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoang et al. (US 2012/0016318 A1; hereinafter referred to as “Hoang ’318”), Goral et al. (US 2016/0220762 A1; hereinafter referred to as “Goral”), and Hoang et al. (US 2007/0112333 A1; hereinafter referred to as “Hoang ’333”).
Hoang ’318 and Goral are cited in the Notice of References Cited dated 23 January 2026.
With regards to claim 13, Hoang ’318 discloses (see Figs. 3 – 6) a catheter system (see Fig. 3), comprising:
a catheter adapter (60) (see [0035]), comprising a distal end (see Examiner annotated Fig. 4 below hereinafter referred to as “Fig. A”), a proximal end (see Fig. A below), and a lumen (see Fig. A below) extending through the distal end of the catheter adapter and the proximal end of the catheter adapter;
a catheter tube (see Fig. A below at the annotated “Catheter”) extending distally from the distal end of the catheter adapter;
an end cap (50) (see [0035]) proximal to the catheter adapter and comprising an outer surface (see at 52 in Fig. 5); and
a swab holder (40) (see [0034]) coupled to a proximal end (52) (see [0035]) of the end cap (see Fig. 4)
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However, Hoang ’318 is silent with regards to the catheter system comprising :
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;
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 Goral, which is within the analogous art of needle assemblies with site preparation provisions (see abstract and title), teaches the catheter system (see Figs. 1 – 4 and 16) comprising:
a needle hub (120) (see [0040] and Fig. 16);
an introducer needle (122) (see [0038] and Fig. 16) extending from the needle hub and distally through the catheter tube (see Figs. 3 and 16), wherein the introducer needle comprises a sharp distal tip (132) (see [0042] and Fig. 16).
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 Hoang ’318 in view of a teaching of Goral such that the catheter system further comprises a needle hub and an introducer needle extending from the needle hub and distally through the catheter tube, wherein the introducer needle comprises a sharp distal tip. One of ordinary skill in the art would have been motivated to make this modification because Goral teaches that incorporating an insertion needle and needle hub enables for fluid to flow from the patient’s vein into a flash chamber thereby indicating successful venipuncture (see [0039] of Goral). Next the catheter may be threaded into the vasculature of the patient and the insertion needle may be retracted into the needle hub (see [0038] and Figs. 1 – 2 of Goral). The catheter being properly positioned within the patient’s vasculature allows for medicament infusion while the needle being retracted into the needle hub prevents for inadvertent needle sticking (see [0003], [0036], and Figs. 1 – 2 of Goral).
Here, the distal end of the needle hub of Goral would be coupled to the proximal end of the catheter adapter of Hoang ’318 such that the introducer needle extends from the needle hub and distally through the catheter tube. The distal end of the end cap of Hoang ’318 would then be attached to the proximal end of the needle hub. The distal end of the swab holder of Hoang ’318 would then be attached to the proximal end of the end cap of Hoang ’318. This coupling configuration is taught by Figure 16 of Goral. This configuration allows for the successful over-the-needle positioning of the catheter thereby allowing for successful venipuncture and then retraction of the needle within the needle hub (see [0005] and Figs. 1 – 4 of Goral).
The catheter system of Hoang ’318 modified in view of a teaching of Goral will hereinafter be referred to as the catheter system of Hoang ’318 and Goral.
Neither Hoang ’318 nor Goral teaches the following:
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 ’333, 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 replace the swab holder of the catheter system of Hoang ’318 and Goral for the swab holder of Hoang ’333 such that 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. One of ordinary skill in the art would have been motivated to make this replacement because Hoang ’333 teaches that this swab holder can be repeatedly used ([0036] Hoang ’333). Additionally, this swab holder aids in the maintaining of antiseptic conditions for the catheter system (see Abstract and [0023] of Hoang ’333). The swab holder of Hoang ’333 is better than the swab holder of Hoang ’318 because it incorporates a dry pad 24 and a wet pad 22 to maintain the antiseptic conditions of the catheter system.
The catheter system of Hoang ’318 and Goral modified in view of a teaching of Hoang ’333 will hereinafter be referred to as the catheter system of Hoang ’318, Goral, and Hoang ’333.
With regards to claim 14, the catheter system of Hoang ’318, Goral, and Hoang ’333 teaches the claimed invention of claim 13, however, Hoang ’318 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 ’333, 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 Hoang ’318, Goral, and Hoang ’333 in view of a further teaching of Hoang ’333 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 ’333).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoang ’318, Goral, and Hoang ’333 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 Hoang ’318, Goral, and Hoang ’333 teaches the claimed invention of claim 14, and the catheter system of Hoang ’318, Goral, and Hoang ’333 further teaches the swab holder (10) (see [0017] of Hoang ’333) or the film (20) (see [0019] of Hoang ’333) comprises a thermoplastic or pressure sensitive material (see [0018] and [0019] of Hoang ’333).
However, none of Hoang ’318, Goral, and Hoang ’333 teaches 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 Hoang ’318, Goral, and Hoang ’333 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 Hoang ’318, Goral, and Hoang ’333 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 Hoang ’318, Goral, and Hoang ’333 teaches the claimed invention of claim 13, and, the catheter system of Hoang ’318, Goral, and Hoang ’333 teaches wherein the swab holder (10) (see [0017] of Hoang ’333) comprises a flange (see at 16a in Fig. 2 of Hoang ’333) surrounding and contacting the swab (22) (see [0020] and Fig. 2 of Hoang ’333).
However, none of Hoang ’318, Goral, or Hoang ’333 teaches 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 Hoang ‘318, Goral, and Hoang ’333 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).
Conclusion
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.
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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
05/14/2026
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