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 .
Claim Objections
Claim 34 is objected to because of the following informalities:
Claim 34 line 2 “the elastomeric sealing ring” should read “the elastic sealing ring”. This suggestion is to help maintain similarity between the claims and how the limitation was first introduced.
Appropriate correction is required.
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.
Claim(s) 1-3, 5, 7-8, 10, 13-14 and 18-21, 32-33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bedoe et al. (US Patent Pub. 20170050013 hereinafter “Bedoe”) in view of Faulkner (WO 2015174953) and Chiu et al. (US 20170232121 hereinafter “Chiu”).
Regarding Claim 1, Bedoe teaches (figs 1-4) a device for connection to a medical connector, the device comprising:
a cap (1002) comprising an integral body, a closed end, an annular wall (outer wall of 1002) having a length LC extending from the closed end (bottom of Fig 3) to an open end (top of fig 3) and defining a chamber (1008,1010), the open end defining an end face, the open end defining an engagement surface, the chamber comprises a first portion (1010) adjacent the closed end having a first portion inner diameter (see [0081]) and a second portion (1008) adjacent the open end having a second portion inner diameter (see [0081]), the first portion and second portion in fluid communication with each other and the first portion inner diameter being less than the second portion inner diameter (see [0081] "a second cavity of smaller diameter 1010 extends from a base 1012 of the first cavity 1008.");
the annular wall having an exterior wall surface and an interior wall surface (outer and inner surfaces of cap 1002);
a peripheral ledge (1012) extending radially between the interior wall surface of the second portion (1008; interior wall surface is inner surface of 1006 in 1008) to the interior wall surface of the first portion (1010; interior wall is surface where 1018 points to);
a ring (1014) having a top surface and a bottom surface, the bottom surface disposed on the peripheral ledge (1012; see Fig 3), the ring extending radially inward from the interior wall surface (See Fig 3), the ring having opening therethrough sized and adapted to receive a male luer connector, a female luer connector and a hemodialysis connector, the male luer connector rests on the peripheral ledge upon being fully inserted in into the chamber (the examiner notes that the male luer connector, female luer connector and hemodialysis connectors are not positively recited in the claim and as such this limitation is considered a functional/intended use limitation; since Bedoe teaches all the structural elements of the cap, annular wall and ring it is interpreted that it would be functional to receive a male luer connector, a female luer connector and a hemodialysis connector, the male luer connector rests on the peripheral ledge upon being fully inserted in into the chamber; the examiner also notes Bedoe [0083-0084] teaches that the cap may receive a female port, therefore, the ring and cap is sized to fit a connector);
the interior wall surface comprising internal threads (1020) adjacent to the closed end, the internal threads disposed adjacent the closed end and partially extend from the closed end to the peripheral ledge (see Fig 3), the internal threads positioned within the chamber (See Fig 3, threads 1020 are within chamber 1008, 1010) and sized to engage a female luer connector, wherein when a male luer connector, a female luer connector and a hemodialysis connector is inserted through the dilatable opening, the absorbent material and the disinfectant or the antimicrobial agent contact the male luer connector, a female luer connector and a hemodialysis connector (the examiner notes that the male luer connector, female luer connector and hemodialysis connectors are not positively recited in the claim and as such this limitation is considered a functional/intended use limitation; since Bedoe teaches all the structural elements of the cap, annular wall, ring and threads it is interpreted that it would be functional to receive/engage a female luer connector, wherein when a male luer connector, a female luer connector and a hemodialysis connector is inserted through the dilatable opening, the absorbent material and the disinfectant or the antimicrobial agent contact the male luer connector, a female luer connector and a hemodialysis connector; the examiner notes that Bedoe teaches in [0083] that the threads on a female connector interact with the threads 1020 within the cap).
Bedoe does not specify the chamber containing an absorbent material and disinfectant or antimicrobial agent or a peelable seal on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber.
Faulkner teaches (Fig 1-2) a cap with a chamber (110) containing an absorbent material (116) and disinfectant or antimicrobial agent (Pg. 9 lines 20-32) and a peelable seal (104) on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber (Pg. 8 lines 3-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap of Bedoe such that it includes an absorbent material and disinfectant or antimicrobial agent, and a peelable seal on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber as taught by Faulkner. One of ordinary skill in the art would have been motivated to do so in order to partially seal a volume of fluid within the cap (Faulkner Pg. 8 lines 3-8).
The combination does not specify the ring being an elastic sealing ring having a dilatable opening, the dilatable opening sized to frictionally engage a male luer connector.
Chiu teaches a cap (20) with an elastic sealing ring (30; see [0048] teaching 30 is comprised of an elastic material), the elastic sealing ring (30) having a dilatable opening (opening within 30) therethrough sized and adapted to receive various shapes of different inserted device ports (see [0048] “Furthermore, the membrane 30 may comprise an elastic material to enable the membrane to adapt to the specific shapes of different inserted device ports”; also see annotated Fig 3 below showing the modification).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ring of Bedoe with the elastic sealing ring having a dilatable opening, the dilatable opening sized to frictionally engage a various device ports taught by Chiu. One of ordinary skill in the art would have been motivated to do so in order to create a tight seal that would isolate the disinfecting agent, as well as enable the membrane to adapt to various shapes of different device ports (Chiu [0048]).
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Annotated Fig 3 (Bedoe)
Regarding Claim 2, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the female luer connector is selected from the group consisting of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors (See Bedoe [0002] teaching a variety of medical implements including luer ports and needle free valves; also see Faulkner Pg. 5 lines 28-32; the examiner notes that female luer connector is not positively recited in the claim and as such this limitation is considered a functional/intended use limitation; since Bedoe teaches all the structural elements of the cap, annular wall, ring and threads it is interpreted that it would be functional to receive any female luer connector).
Regarding Claim 3, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the male connector is an intravenous tubing end, stopcock or male lock luer (See Bedoe [0002] teaching a variety of medical implements including luer ports and tubing; also see Faulkner Pg. 5 lines 28-32; the examiner notes that the male luer connector, is not positively recited in the claim and as such this limitation is considered a functional/intended use limitation; since Bedoe teaches all the structural elements of the cap, annular wall, ring and threads it is interpreted that it would be functional to receive any male luer connector).
Regarding Claim 5, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. Chiu teaches the elastic sealing ring may adapt to specific shapes of different inserted device ports (see [0048]). However, the combination does not specify the dilatable opening has a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm.
The instant disclosure describes the parameter of the dilatable opening has a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the dilatable opening has a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the dilatable opening has a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 7, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the male luer connector frictionally engages the dilatable opening via a press-fit connection upon insertion into the chamber (See Chiu [0064] teaching that the slits 33 in base 31 may maintain a tight close-fit seal around the external surface of the inserted device port; the examiner also notes that this is considered a functional/intended use limitation as the male luer connector is not positively recited in claim 1; since the modified Bedoe teaches all structural elements of the cap, it is interpreted that the modified Bedoe would meet the functional limitation of frictionally engaging a male luer connector).
Regarding Claim 8, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the open end of the interior wall surface is sized and adapted to receive an elastic sealing ring in a press-fit connection (See Chiu [0072] teaching the membrane 30 may be coupled to the reservoir by fitting the entirety of the membrane within the reservoir).
Regarding Claim 10, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the elastic sealing ring comprises an elastomeric material (See Chiu [0048] teaching various elastomeric materials).
Regarding Claim 13, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. Bedoe further teaches the device herein the annular wall (outer wall of 1002) of the cap is frusto-conically shaped (See Fig 3).
Regarding Claim 14, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. Bedoe further teaches the device wherein the exterior wall surface includes a plurality of grip members (1022; see [0081]).
Regarding Claim 18, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the absorbent material (Faulkner 116) compresses toward the closed end of the chamber upon connection to the female luer connector or the male luer connector (Faulkner Pg. 9 lines 18-32 and Fig 6).
Regarding Claim 19, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 18 as described above. The combination further teaches the device wherein compression of the absorbent material disinfects the female luer connector or the male luer connector (Faulkner Pg. 9 lines 18-32 and Fig 6).
Regarding Claim 20, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches wherein the absorbent material (Faulkner 116) is under radial compression by the internal threads (Faulkner 118) to retain the absorbent material in the chamber (Faulkner Pg. 9 lines 18-32 teaches the antimicrobial substance 116 is partially compressible such that it fits within the housing 102, and that protrusions 118 are on the inner surface of 102; therefore with the modification, the same compression would occur with the internal threads 1020 of Bedoe).
Regarding Claim 21, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches wherein the disinfectant or antimicrobial agent (Faulkner 116) is isopropyl alcohol or ethanol (Faulkner Pg. 5 lines 5-14).
Regarding Claim 32, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the elastic sealing ring extends between the peripheral ledge and the open end (See annotated Fig 3 above; with the modification the elastic sealing ring will be between the ledge 1012 and open end just similar to Bedoe ring 1014)
Regarding Claim 33, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the elastic sealing ring extensa from the peripheral ledge to the open end (See annotated Fig 3 above; with the modification the elastic sealing ring will be between the ledge 1012 and open end just similar to Bedoe ring 1014).
Regarding Claim 35, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination further teaches the device wherein the elastic sealing ring is disposed completely within the second portion (See annotated Fig 3 above, with the modification the elastic sealing ring will be within the second portion 1008 similar to ring 1014).
Claim(s) 26-27, 29 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bedoe (US Patent Pub. 20170050013) in view of Faulkner (WO 2015174953) and Chiu (US 20170232121) as applied to claim 1 above, and further in view of Solomon (US Patent Pub. 20160144118)
Regarding Claim 26, the combination of Bedoe, Faulkner and Chiu teaches all elements of claim 1 as described above. The combination does not specify the elastic sealing ring having one or more undercuts on the surface of the elastic ring facing the peripheral ledge.
Solomon (Fig 7) teaches an elastic ring (20) that comprises an undercut (21). While the undercut (21) is not on a surface facing the peripheral ledge, Solomon does teach that the undercut (21) helps guide a device into the chamber (see [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastic sealing ring of Bedoe such that it include an undercut on the surface of the elastic ring facing the peripheral ledge. Solomon teaches that beveled edges/undercuts help guide and engage two surfaces together (Solomon [0055]). One of ordinary skill in the art would have been motivated to add the undercut of Solomon to the bottom surface of the sealing ring of Bedoe in order to better guide and engage the sealing ring to the inner surface and ledge of the cap of Bedoe.
Regarding Claim 27, the combination of Bedoe, Faulkner, Chiu teaches all elements of claim 1 as described above. The combination does not specify the device wherein the elastic sealing ring has one or more undercuts and/or tapered surfaces are disposed on the surface of the elastic sealing ring facing the dilatable opening.
Solomon (Fig 7) teaches an elastic sealing ring (20) one or more undercuts and/or tapered surfaces (Solomon 21) are disposed on the surface of the elastic sealing ring (Solomon 20) facing the dilatable opening (See Solomon Fig 7, the taper (21) of the elastic sealing ring (20) is towards the opening 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastic sealing ring of Bedoe such that the elastic sealing ring has one or more undercuts and/or tapered surfaces are disposed on the surface of the elastic sealing ring facing the dilatable opening as taught by Solomon. One of ordinary skill in the art would have been motivated to do so in order to help guide a port/NIS into the chamber of the cap (Solomon [0055]).
Regarding Claim 29, the combination of Bedoe, Faulkner, Chiu teaches all elements of claim 1 as described above. The combination does not specify the device wherein the one or more undercuts and/or tapered surfaces are disposed on the surface of the elastic sealing ring facing the dilatable opening and on the surface of the elastic sealing ring facing the peripheral ledge.
Solomon (Fig 7) teaches an elastic sealing ring (20) one or more undercuts and/or tapered surfaces (Solomon 21) are disposed on the surface of the elastic sealing ring (Solomon 20) facing the dilatable opening (See Solomon Fig 7, the taper (21) of the elastic sealing ring (20) is towards the opening 14). While Solomon does not specify an undercut (21) on a surface facing the peripheral ledge, Solomon does teach that the undercut (21) helps guide a device into the chamber (see [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastic sealing ring of Bedoe such that it include an undercut disposed on the surface of the elastic sealing ring facing the dilatable opening and on the surface of the elastic sealing ring facing the peripheral ledge. Solomon teaches that beveled edges/undercuts help guide and engage two surfaces together (Solomon [0055]). One of ordinary skill in the art would have been motivated to do so in order to help guide a port/NIS into the chamber of the cap (Solomon [0055]). Additionally, one of ordinary skill in the art would have been motivated to add the undercut of Solomon to the bottom surface of the sealing ring of Bedoe in order to better guide and engage the sealing ring to the inner surface and ledge of the cap of Bedoe.
Regarding Claim 34, the combination of Bedoe, Faulkner, Chiu teaches all elements of claim 1 as described above. The combination does not specify the device wherein an initial diameter of the dilatable opening of the elastomeric sealing ring is at least as large as the first portion diameter.
Solomon teaches (Fig 7) an elastic sealing ring (20) with an initial diameter of the opening 14 at least as large as the first portion diameter (See annotated Fig 7).
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Annotated Fig 7 (Solomon)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastic sealing ring of Bedoe such that an initial diameter of the dilatable opening of the elastomeric sealing ring is at least as large as the first portion diameter as taught by Solomon. One of ordinary skill in the art would have been motivated to do so as it would have been an obvious matter of design choice to change the initial diameter of the sealing ring since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Response to Arguments
Applicant’s arguments, see Pg. 8-9, filed 11/13/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 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 Bedoe et al. (US Patent Pub. 20170050013 hereinafter “Bedoe”) in view of Faulkner (WO 2015174953) and Chiu et al. (US 20170232121 hereinafter “Chiu”).
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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783