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 22 December 2025 wherein Claims 1, 13, and 17 – 19 are amended, Claim 20 is cancelled, no claims are newly added, and Claims 17 – 19 are previously withdrawn. Therefore, Claims 1 – 19 are currently pending within the Application.
The Drawings dated 22 December 2025 has been fully considered and entered. The Drawings have overcome each Drawing Objection set forth in the Non-Final Rejection dated 2 October 2025 (hereinafter referred to as the “Non-Final Rejection”). Therefore each Drawing Objection set forth in the Non-Final Rejection is withdrawn.
The Specification dated 22 December 2025 has been fully considered and entered. The Specification has overcome each Specification Objection set forth in the Non-Final Rejection. Therefore, each Specification Objection set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 1 – 2, filed 22 December 2025, with respect to the rejection(s) of independent claim(s) 1 and 13 and their respective dependent claims under 35 U.S.C. §§ 102 and 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 Therefore, the rejection has been withdrawn.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) and Goral et al. (US 2016/0220762 A1).
Election/Restrictions
Claims 1 – 12 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 17 – 19, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between Groups I and II as set forth in the Office action mailed on 2 October 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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.
Claims 9 – 11 and 15 are 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.
Claim 1 recites “wherein the swab holder comprises a proximal opening and a flange distal to the proximal opening….wherein the flange forms a pocket having a second inner diameter…wherein the swab is seated within the pocket formed by the flange and extends across the second inner diameter.” Claim 9 recites “wherein the swab holder comprises a flange surrounding and contacting the swab, wherein the swab extends outwardly beyond the flange.” It is unclear if the “flange” recited in Claim 9 is the same “flange” recited in Claim 1. Therefore, Claim 9 is indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the “flange” is the same “flange” as recited in Claim 1. Nonetheless, the Examiner believes the “flange” recited in Claim 1 and Claim 9 is referring to the same flange. The Examiner suggests amending Claim 9 to recite “wherein the flange surrounds and contacts the swab, wherein the swab extends outwardly beyond the flange” to provide proper antecedent basis for the limitation pertaining to the flange.
Claims 10 – 11 are dependent upon Claim 9 and are therefore also rejected under 35 U.S.C. 112(b).
Claim 15 recites “wherein the swab holder or the film comprises a thermoplastic or pressure sensitive material, wherein the film is heat or pressure sealed to the swab holder.” There is a lack of antecedent basis for “the film.” The Examiner suggests amending Claim 15 to depend upon Claim 14 to provide the proper antecedent basis for the limitation reciting the film. This proposed change is consistent with how the Applicant has structured dependent claims 2 and 3.
Allowable Subject Matter
Claims 1 – 8, 12, and 17 – 19 are allowed.
Claims 9 – 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action.
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).
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 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”) and Goral et al. (US 2016/0220762 A1; hereinafter referred to as “Goral”).
Goral is cited in the Notice of References Cited form dated 2 October 2025.
With regards to claim 13, Hoang discloses (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) extending distally from the distal end of the catheter adapter;
an end cap (50) (see [0035]) proximal to the catheter adapter (see Fig. 4) and comprising an outer surface (see at 52 in Fig. 5);
a swab holder (10) (see [0035]) coupled to a proximal end of the end cap (52) (see [0035]), wherein the swab holder comprises a distal opening (see Examiner annotated Fig. 4 below hereinafter referred to as “Fig. B”), wherein the proximal end of the end cap is inserted into the distal opening (see Fig. 4 and [0036]) and secured via an interference or press fit between the outer surface of the end cap and the distal opening (see [0036] and Fig. 4); and
a swab (40) (see [0034]) secured within the swab holder and containing a disinfectant (see [0033] – [0034]).
PNG
media_image1.png
415
767
media_image1.png
Greyscale
PNG
media_image2.png
494
798
media_image2.png
Greyscale
However Hoang 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.
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]);
an introducer needle (122) (see [0038]) extending from the needle hub and distally through the catheter tube (see Fig. 3), wherein the introducer needle comprises a sharp distal tip (132) (see [0042]).
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 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, in view of Figure 16 of Goral the distal end of the needle hub of Goral is coupled to the proximal end of the catheter adapter of Hoang and the proximal end of the of the needle hub of Goral is coupled to the distal end of the end cap of Hoang. This coupling 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 in view of a teaching of Goral will hereinafter be referred to as the catheter system of Hoang and Goral.
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoang and Goral 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 form dated 2 October 2025.
With regards to claim 14, the catheter system of Hoang and Goral teaches the claimed invention of claim 13, however, Hoang 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 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) the catheter system (10) (see Col. 2, lines 55 – 56) further comprising a film (30) (see Col. 3, lines 21 – 34 “Outer sleeve 30 can be formed from a hard and rigid material such as polycarbonate. However, other materials such as foil or polyethylene could be used.”) coupled to the swab holder (see at 25 in Fig. 3) and sealing the swab from an external environment (see Col. 3, lines 21 – 34 and Fig. 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 Goral in view of a teaching of Chiappetta such that the catheter system further comprising 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 Chiappetta teaches that covering the swab located within the swab holder prevents evaporation of the drug (see Abstract of Chiappetta).
With regards to claim 16, the catheter system of Hoang and Goral teaches the claimed invention of claim 13, and Hoang further teaches wherein the swab holder (10) comprises a flange (see Fig. B reiterated below) surrounding and contacting the swab (40).
PNG
media_image2.png
494
798
media_image2.png
Greyscale
However, Hoang is silent with regards to the swab extending 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 and Goral 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).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoang and Goral as applied to claim 13 above, and further in view of Chiappetta and Cordoba et al. (US 10,780,256 B2 hereinafter referred to as “Cordoba”).
Chiappetta and Cordoba are cited in the Notice of References Cited form dated 2 October 2025.
With regards to claim 15, the catheter system of Hoang and Goral teaches the claimed invention of claim 13, however, Hoang is silent with regards to wherein the swab holder or the film comprises a thermoplastic or pressure sensitive material, wherein the film is heat or pressure sealed to the swab holder.
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 holder or the film (30) (see Col. 3, lines 21 – 34 “Outer sleeve 30 can be formed from a hard and rigid material such as polycarbonate. However, other materials such as foil or polyethylene could be used.” Wherein the disclosed foil or polyethylene is the film) comprises a thermoplastic or pressure sensitive material (see Col. 3, lines 21 – 34 “other materials such as foil or polyethylene” wherein this foil or polyethylene is a thermoplastic sensitive materials).
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 medical system of Hoang and Goral in view of a teaching of Chiappetta such that the swab holder or the film comprises a thermoplastic or pressure sensitive material. One of ordinary skill in the art would have been motivated to make this modification because Chiappetta teaches that covering the swab located within the swab holder prevents evaporation of the drug (see Abstract of Chiappetta).
The medical system of Hoang and Goral modified in view of a teaching of Chiappetta will hereinafter be referred to as the medical system of Hoang, Goral, and Chiappetta.
However, none of Hoang, Goral, nor Chiappetta 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, Goral, and Chiappetta 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). 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.
Conclusion
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.
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.
/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/21/2026