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 .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 16-31, Species A: Figures 1-4, and Species 2A: Figures 1-7B in the reply filed on 1/8/2026 is acknowledged.
Claims 32-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102 / Claim Rejections - 35 USC § 103
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.
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 16-21, 23-26, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brandenburger et al. (US 2009/0054865; hereinafter “Brandenburger 2009”), or in the alternative, under 35 U.S.C. 103 as obvious over Brandenburger 2009 in view of Brandenburger (US 2018/0092807; hereinafter “Brandenburger 2018”).
With respect to Claim 16, Brandenburger teaches a cap 1 for a fluid container 33 (Figures 1-5; Abstract), the cap 1 comprising:
a body (2, 3) comprising a container connection part 4 adapted to be tightly connected to a container opening of a container body 33 (paragraph [0035]);
a first port 7 comprising a first port housing (the area surrounding first port 7) that has a first opening 9 (Figures 1-4);
a second port 6 comprising a second port housing (the area surrounding second port 6) that has a second opening 8 (Figures 1-4; paragraph [0037]);
the first port 7 comprising a first seal member 11 that is elastic, the first seal member 11 being accommodated in the first port housing and sealing the first opening 9 (paragraph [0037]);
the first seal member 11 further being formed as a pierceable septum (paragraphs [0037-0046]);
the first seal member 11 comprising an outer surface that is essentially flush or entirely flush with an edge surface of the first opening (see Figure 4);
the second port 6 further comprising a second seal member 10 that is elastic, the second seal member being accommodated in the second port housing and sealing the second opening 8 (paragraph [0037]); and
the second seal member 10 comprising a valve opening configured to provide a fluid-tight connection with a fluid manipulation device (seal member 10 comprises a pre-slit that allows easy piercing with a spike; the second seal member is a self-sealing membrane, such that it will automatically reseal upon removal of the spike, thereby functioning as a valve; see Abstract and paragraphs [0023] and [0037-0046]).
However, in the event that Applicant does not clearly envisage Brandenburger 2009’s second seal 10 as comprising a valve opening configured to provide a fluid-tight connection with a fluid manipulation device, Brandenburger 2018 teaches a similar connector for a fluid container comprising a female luer connector self-sealing member 4 disposed (Figures 5-12B; paragraphs [0031-0032]). The self-sealing member 4 comprises a slit 45 (Figures 11-12B) that opens the valve upon insertion of a luer tip, thereby providing a fluid-tight connection for allowing fluid to flow. This configuration provides an art-established means for creating a stable, fluid-tight connection by holding the connector in place as a male connector pierces through the sealing element (paragraphs [0032] and [0077]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Brandenburger 2009’s connector cap such that the second port comprises a self-sealing member comprising a slit valve opening thereon, as suggested by Brandenburger 2018, in order to provide an well-known, alternate sealing configuration for creating a stable, fluid-tight connection between the container and an attached fluid manipulation device.
With respect to Claim 17, Brandenburger 2009 teaches that the first port 7 is capable of being used as an administration port (paragraphs [0037] and [0046]), and the second port 6 is a needle-free port (the port is configured to receive the spike of a fluid transfer device, which is differentiated from a needle/cannula by Brandenburger 2009; see paragraphs [0044-0046]). Additionally, or in the alternative, Brandenburger 2018 reasonably suggests that the second port may be a needle-free port.
With respect to Claim 18, Brandenburger 2009 teaches that the first sealing member 11 and second sealing member 10 may be welded and/or glued within the first and second port housings, respectively. See paragraph [0014].
With respect to Claim 19, Brandenburger 2009 teaches that the outer surface of the first seal member has a concave portion 11c indicating a piercing location (Figure 1; paragraphs [0039] and [0046]).
With respect to Claims 20 and 21, Brandenburger 2009 teaches that the first seal member 7 and second seal member 6 may comprise rubber or a thermoplastic elastomer [0037].
With respect to Claim 23, Brandenburger 2009 teaches that the body (2, 3) of the cap 1 comprises a polyolefin [0034].
With respect to Claim 24, Brandenburger 2009 teaches that the second seal member 10 is elastomeric and self-sealing, thereby being configured to provide a fluid-tight connection with an inserted fluid manipulation device (paragraphs [0037-0045]).
With respect to Claim 25, Brandenburger 2009 teaches that a portion of the first port housing (the area surrounding first opening 9 of the first port 7; Figures 1-4) is formed monolithically with the body (2, 3). Specifically, the cap, including the port housings, is integrally formed via injection molding [0034].
With respect to Claim 26, Brandenburger 2009 does not teach at least one of:(a) the outer surface of the second seal member transitions essentially smoothly or entirely smoothly into the edge surface of the second opening, (b) the second opening has a chamfered edge surface, (c) the second port is formed as female connector, and (d) the second port housing comprises a thread structure.
However, Brandenburger 2018 further teaches a needle-less connector comprising a female luer connector with a thread structure 220 on the port housing (Figures 5-12B; paragraphs [0031-0032]). This configuration provides an art-established means for creating a stable, fluid-tight connection by holding the connector in place as a male connector pierces through the sealing element (paragraphs [0032] and [0077]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Brandenburger 2009’s connector cap to include a needle-less luer connector and thread structure for at least one of the fluid ports, as suggested by Brandenburger 2018, in order to provide an art-established means for creating a stable, fluid-tight connection by holding the connector in place as a male connector pierces through the sealing element.
With respect to Claim 30, Brandenburger 2009 teaches a fluid container (Figure 5) comprising a cap 1 according to claim 16 (see the rejection of Claim 16 above); and a container body 33 that is hollow and comprises an opening portion at the top thereof, wherein the body (2, 3) of the cap 1 is in fluid-tight connection with the opening portion (Figure 5; paragraph [0054]).
With respect to Claim 31, Brandenburger teaches that the container body 33 is at least partially filled with a fluid (Title, Abstract, and paragraph [0054]) and is semi-rigid (a bottle-shaped container; paragraph [0054]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Brandenburger 2009 and Brandenburger 2018 as applied to claim 16 above, and further in view of Russo (US 10,058,481).
With respect to Claim 22, Brandenburger 2009 and Brandenburger 2018 reasonably suggest the cap as claimed, wherein the second seal member comprises an elastic material [0037], but do not specifically teach that the elastic material of the second seal member has a hardness between 25-55 shore A.
Russo teaches a similar closure cap for a bottle, the cap comprising a port having an elastomeric stopper 10 disposed therein (Figures 1-11), the stopper 10 being configured to receive a syringe tip in a sealed manner to allow fluid transfer into or out of the container (Column 6, Line 23 through Column 7, Line 54). Specifically, the stopper is formed of a synthetic rubber injection molded thermoplastic elastomer material having a hardness of 40-50 shore A, which is completely within the claimed range (Column 8, Lines 27-30), which provides material properties that allow the stopper to have the performance characteristics of a self-sealing valve for use with a syringe tip (Column 7, Line 55 through Column 8, Line 65). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the cap of Brandenburger 2009 and Brandenburger 2018 such that the second seal member has a hardness of 40-50 shore A, in order to provide an art-established hardness range for an elastomeric seal member on a fluid container.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Brandenburger 2009 and Brandenburger 2018 as applied to claim 16 above, and further in view of Vancaillie et al. (US 2007/0299419).
With respect to Claim 27, Brandenburger 2009 and Brandenburger 2018 do not teach that the first port and the second port are in an angled arrangement.
Vancaillie teaches a connector assembly 28 for connecting fluid lines to a medical fluid container, the connector comprising an administration port 34 and a reconstitution port 36 (Figure 1). The reconstitution port 38 is disposed at an angle to the vertical axis, thereby preventing a vial connected to the reconstitution port from interfering with the administration port 34 and elements connected thereto (paragraph [0054]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Brandenburger 2009’s cap such that the first and second ports are in an angled arrangement, as suggested by Vancaillie, in order to prevent a vial connected to the reconstitution port from interfering with the administration port 34 and elements connected thereto (paragraph [0054]).
Additionally, or in the alternative, Brandenburger 2009’s cap is fully capable of having an administration device and a fluid manipulation device simultaneously connectable to the first and second ports. Applicant has not claimed any structural specifics of the administration device and fluid manipulation device, so it is unclear why simultaneous connection would not be possible.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Brandenburger 2009 and Brandenburger 2018 as applied to claim 16 above, and further in view of Domkowski (US 7,488,311).
With respect to Claim 28, Brandenburger 2009 and Brandenburger 2018 both teach twist-off covers (17/18 in Brandenburger 2009; 20 in Brandenburger 2018) that are configured to seal the ports prior to use to maintain sterility (paragraphs [0044-0046] of Brandenburger 2009), but do not teach at least one of:(a) a first peel-off foil is arranged atop the first seal member seen in a direction of insertion of an administration device, and (b) a second peel-off foil is arranged atop the second seal member seen in a direction of insertion of a fluid manipulation device.
Domkowski teaches a dual port arrangement for connecting to an intravenous fluid container, wherein the ports may be closed by either twist-off covers 44 (Figures 1-15) or by peel-off foil covers 122 (Figures 16-17; Column 10, Line 58 through Column 11, Line 7). The foil covers are configured to perform the same function as the twist-off covers in the embodiments of Figures 1-14, namely to cover the port and maintain sterility prior to use. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the cap of Brandenburger 2009 to use peel-off foil covers instead of twist-off covers, as suggested by Domkowski, in order to prove an art-established alternative arrangement for covering the ports prior to use.
Claims 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Brandenburger 2009 and Brandenburger 2018 as applied to claim 16 above, and further in view of Ding et al. (US 2017/0340517).
With respect to Claim 27, Brandenburger 2009 and Brandenburger 2018 do not teach that the first port and the second port are in an angled arrangement.
Ding teaches a dual-port cap for use with a fluid container, the cap comprising a first administration port 24 and a second port 26, wherein the administration port is configured to receive a needle or spike (Figures 5-8; paragraphs [0032-0035]). One or both ports may be disposed at an angle to the vertical axis, thereby further displacing the ports from each other to reduce the chances that the clinician will mistakenly access the wrong port, and prevent unwanted contact between the ports and connecters inserted therein (paragraph [0038]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Brandenburger 2009’s cap such that the first and second ports are in an angled arrangement, as suggested by Ding, thereby further displacing the ports from each other to reduce the chances that the clinician will mistakenly access the wrong port, and prevent unwanted contact between the ports and connecters inserted therein (paragraph [0038]).
Additionally, or in the alternative, Brandenburger 2009’s cap is fully capable of having an administration device and a fluid manipulation device simultaneously connectable to the first and second ports. Applicant has not claimed any structural specifics of the administration device and fluid manipulation device, so it is unclear why simultaneous connection would not be possible.
With respect to Claim 29, Brandenburger 2009 does not specifically teach a membrane arranged underneath the first seal member 11 as seen in the direction of insertion of an administration device, wherein the membrane is adapted to be pierced by a piercing device of the administration device.
Ding teaches a dual-port cap for use with a fluid container, the cap comprising a first administration port 24 and a second port 26, wherein the administration port is configured to receive a needle or spike (Figures 1-3; paragraphs [0032-0035]). The administration port 24 comprises a sealing member 24 and a membrane 32 disposed beneath the sealing member (Figure 3), the membrane being configured to seal the passageway until pierced by a suitable needle, syringe, or spike connector of an administration device [0035]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Brandenburger 2009’s cap to have a membrane under the first seal member that is configured to be pierced by a piercing device of an administration device, as suggested by Ding, in order to seal the passageway until pierced by a suitable needle, syringe, or spike connector of the administration device [0035].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brandenburger (US 2018/0055734), Brandenburger (US 9,095,500), and Brandenburger (US 8,585,674) all teach a multi-port caps for a medical fluid container.
Beine (US 2015/0069008) teaches a container cap with self-sealing elements bonded to teach port.
Derksen (US 5,678,713) teaches a dual-port cap with both ports sealed by a concave sealing element.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
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