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 .
Acknowledgments
In the reply, filed on February 18, 2026, Applicant amended claims 5, 14-15, 18, and 21.
In the non-final rejection of November 18, 2025, Examiner rejected claims 2-21 under 35 U.S.C. 112(a). Applicant amended claim 21. Rejection is withdrawn.
Examiner rejected claims 5, 14-15, and 18 under 35 U.S.C. 112(b). Applicant amended claims 5, 14, and 18. Rejection is withdrawn.
Information Disclosure Statement
The listing of references in the specification (paragraph [0003]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Figures 1A-1B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
In line 1, “Connector and disinfecting cap system” should be changed to “A connector and a disinfecting cap system”
In line 1, “disinfectant solution” should be changed to “a disinfectant solution”
In line 2, “the exposure time” should be changed to “an exposure time”
In line 2, “cap system” should be changed to “the cap system”
In line 3, the first recitation of “connector” should be changed to “the connector”
In line 3, the second recitation of “connector” should be changed to “the connector”
In lines 3-4, “Connector and cap system” should be changed to “The connector and the cap system”
In line 4, “connector” should be changed to “the connector”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The Cross-Reference to Related Applications section does not state that the application is a 371 of PCT/US2019/063233, filed 11/26/2019.
Appropriate correction is required.
Claim Objections
Claims 1, 14-15, and 21 are objected to because of the following informalities:
In regards to claim 1, line 2, “a surface” should be changed to “said surface”.
In regards to claim 14, line 1, “said first” should be changed to “said first open area”.
In regards to claim 14, line 2, “second open areas” should be changed to “said second open area”.
In regards to claim 15, line 2, “optimized configuration” should be changed to “an optimized configuration”.
In regards to claim 21, line 14, “said opening of said connector” should be changed to “said opening into said connector”.
In regards to claim 21, line 21, “said opening of said connector” should be changed to “said opening into said connector”.
Appropriate correction is required.
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 14-15 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.
In regards to claim 14, line 2 recites “second open areas” which is understood as “said second open area”. There is insufficient antecedent basis for this limitation in the claim. Claim 15 is rejected by virtue of being dependent upon claim 14.
In regards to claim 15, lines 2-3 recite “said pivot connection”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-6, 9-10, 12-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al (US 7,682,561).
In regards to claim 21, Davis et al teaches a system (Figures 4-6) comprising:
a cap housing (34) comprising
a reservoir (labeled in Figure 4 below) for storing a disinfecting solution (column 3, lines 62-63: disinfectant pad 38 is located in the cowl 34)
an open end with an opening (labeled in Figure 4 below) into said reservoir, said open end comprising a contoured open end surface (labeled in Figure 4 below) on said open end
a connector (16) comprising
a tip (20) with an opening (labeled in Figure 5 below) into said connector
a contoured actuation surface (labeled in Figure 5 below) on said tip of said connector
a contoured external surface (labeled in Figure 4 below) on a side of said connector
wherein:
said cap housing is pivotally attached to said connector to selectively open (Figure 5) or close said opening into said connector (Figures 4, 6)
to close said opening of said connector
said contoured open end surface on said open end of said cap housing is pivoted to interface with said contoured actuation surface on said tip of said connector such that said contoured open end surface on said open end of said cap housing does not interface with said contoured external surface on said side of said connector (Figure 5 to Figure 4)
to open said opening of said connector
said contoured open end surface on said open end of said cap housing is pivoted to interface with said contoured external surface on said side of said connector such that said contoured open end surface on said open end of said cap housing does not interface with said contoured actuation surface on said tip of said connector (Figure 4 to Figure 5)
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In regards to claim 2, Davis et al teaches wherein said cap housing comprises:
a continuous sidewall (Figures 4-6)
a top wall (Figures 4-6)
a closed end formed by said top wall (Figures 4-6)
wherein:
said reservoir comprises a cavity within said cap housing formed by interior surfaces of said top wall and said sidewall, said open end is formed by a rim of said sidewall, and a surface of said rim forms said contoured open end surface of said cap housing (Figures 4-6)
In regards to claim 3, Davis et al teaches wherein said connector is an IV needleless connector (16).
In regards to claim 4, Davis et al teaches wherein said cap housing is configured to pivot about one or more axes (Figures 4-5).
In regards to claim 5, Davis et al teaches one or more arms (40) extending from said cap housing and fixed with respect to said cap housing, and pivotally connected to an exterior surface of said connector (Figures 4-6).
In regards to claim 6, Davis et al teaches at least one disinfection sponge (38) configured within said reservoir.
In regards to claim 9, Davis et al teaches wherein said connector comprises a hub (20) having said tip, and said contoured actuation surface forming said tip of said hub (Figure 5).
In regards to claim 10, Davis et al teaches wherein said contoured external surface is essentially axially perpendicular to said hub comprising said contoured actuation surface (Figure 4).
In regards to claim 12, Davis et al teaches wherein said contoured open end surface of said cap housing interfaces with said contoured actuation surface of said connector such that a first open area between said contoured open end surface and said contoured actuation surface is minimized (Figures 4, 6).
In regards to claim 13, Davis et al teaches wherein said contoured open end surface of said cap housing interfaces with said contoured external surface on said side of said connector such that a second open area between said contoured open end surface and said contoured external surface is minimized (Figure 5).
In regards to claim 14, Davis et al teaches wherein at least one of said first and second open areas are minimized by an optimized configuration of said cap housing with respect to said connector (Figures 4-6).
In regards to claim 15, Davis et al teaches wherein said optimized configuration comprises optimized configuration of said pivot connection of said cap housing to said connector (Figures 4-6).
In regards to claim 16, Davis et al teaches wherein said connector is an IV needleless connector (16).
In regards to claim 17, Davis et al teaches wherein said cap housing pivots in one or more axes in reference to said connector (Figures 4-5).
In regards to claim 18, Davis et al teaches one or more arms (40) extending from said cap housing and fixed with respect to said cap housing, and pivotally connected to an exterior surface of said connector (Figures 4-6).
In regards to claim 19, Davis et al teaches at least one disinfection sponge (38) configured within said reservoir.
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.
Claims 7, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al, as applied to claims 2 and 21 above, and further in view of Hoang et al (US 8,740,864).
In regards to claim 7, Davis et al is silent about a removable cover configured on said contoured open end surface sealing said opening into said reservoir. Hoang et al teaches a system (Figure 10A) comprising a removable cover (74a) configured on a contoured open end surface sealing an opening into a reservoir (of 74). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Davis et al, with a removable cover, as taught by Hoang et al, as such will provide a moisture barrier for a wet disinfection sponge and the disinfecting solution prior to contact between the wet disinfection sponge and the connector (column 6, lines 56-58).
In regards to claim 11, Davis et al is silent about wherein a removable cover is configured on said contoured open end surface by attachment to a surface of said rim of said sidewall of said cap housing. Hoang et al teaches a system (Figure 10A) wherein a removable cover (74a) is configured on a contoured open end surface by attachment to a surface of a rim of a sidewall of a cap housing (74). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Davis et al, with a removable cover, as taught by Hoang et al, as such will provide a moisture barrier for a wet disinfection sponge and the disinfecting solution prior to contact between the wet disinfection sponge and the connector (column 6, lines 56-58).
In regards to claim 20, Davis et al is silent about a removable cover configured on said contoured open end surface sealing said opening into said reservoir. Hoang et al teaches a system (Figure 10A) comprising a removable cover (74a) configured on a contoured open end surface sealing an opening into a reservoir (of 74). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Davis et al, with a removable cover, as taught by Hoang et al, as such will provide a moisture barrier for a wet disinfection sponge and the disinfecting solution prior to contact between the wet disinfection sponge and the connector (column 6, lines 56-58).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al, as applied to claim 21 above, and further in view of Mobassery et al (US 2015/0374969).
In regards to claim 8, Davis et al is silent about wherein said cap housing comprises a clear portion enabling view of a fill level of said disinfecting solution within said reservoir. Mobassery et al teaches a system (Figures 1-7) wherein a cap housing (18) comprises a clear portion enabling view of a fill level of a disinfecting solution within a reservoir (paragraph [0049]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said cap housing, of the system of Davis et al, to comprise a clear portion, as taught by Mobassery et al, as such will allow a practitioner to see through the cap housing to determine when the disinfecting solution is low in volume (paragraph [0049]).
Response to Arguments
Applicant’s arguments with respect to claims 2-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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