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 Species I in the reply filed on 02/27/2026 is acknowledged.
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 1-20 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 lines 4-5 recite the limitation “a shaft comprising a first end and a second end opposite the first end, which is connected to the closed second end of the base.” It is unclear from this limitation what is “connected to the closed second end of the base,” the shaft, the first end, or the second end. Appropriate correction and/or clarification 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.
Claims 1, 5, 9-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Coyle (USPGPub 2022/0040469) in view of Erekocanski et al. (USPGPub 2019/0308006).
Re Claim 1, Coyle teaches a universal cap (Coyle Figs. 6A-11) configured to engage at least a first connector and a second connector of different types, comprising: an inner housing (30) comprising a base (34) comprising an open first end, a closed second end, a sidewall extending therebetween, and a shaft (31) comprising a first end and a second end opposite the first end, which is connected to the closed second end of the base (34) (as seen in Coyle Fig. 6A); an outer housing (20, 40) positioned around the shaft (31) of the inner housing (30) comprising an open first end, an open second end, and a sidewall extending therebetween, wherein an inner surface of the sidewall of the outer housing comprises threads (25) configured to engage corresponding threads (74) of the first connector or the second connector (Coyle ¶ 0055), and wherein the shaft (31) of the inner housing (30) is configured to move through the outer housing (20, 40) toward the first connector or the second connector (Coyle Figs. 8B-9C).
Coyle teaches the use of at least one absorbent member but fails to explicitly show an absorbent member (Coyle ¶ 0009-0010). Therefore, Erekocanski fails to explicitly teach wherein at least one absorbent member is connected to the first end of the shaft configured to contact portions of the first connector or the second connector, when the first connector or the second connector is inserted through the open first end of the outer housing. Erekocanski teaches an inner housing (102) comprising a shaft (132) (Erekocanski Figs. 1-2; ¶ 0118), wherein at least one absorbent member (114) is connected to a first end of the shaft (132) configured to contact portions of a first connector or a second connector, when the first connector or the second connector is inserted through the open first end of the outer housing (102), wherein the at least one absorbent member comprises a disinfectant or antimicrobial agent for disinfecting and sterilizing male or female Luer fittings (Erekocanski ¶ 0002, 0118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the shaft of Coyle wherein at least one absorbent member is connected to the first end of the shaft configured to contact portions of the first connector or the second connector, when the first connector or the second connector is inserted through the open first end of the outer housing as disclosed by Erekocanski, wherein the at least one absorbent member comprises a disinfectant or antimicrobial agent for disinfecting and sterilizing male or female Luer fittings (Erekocanski ¶ 0002, 0118).
Re Claim 5, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle further teaches wherein the second connector (70) is a female needleless connector (Coyle Fig. 10A), and wherein the threads (25) on the inner surface of the outer housing (20, 40) are configured to engage corresponding threads (74) of the female needleless connector for securing the female needleless connector to the cap (Coyle ¶ 0037; Fig. 10A).
Re Claim 9, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle further teaches wherein the shaft (31) comprises at least one protrusion (32) configured to rotatably engage the threads (67) of the outer housing (20, 40), such that rotation of the inner housing (30) relative to the outer housing (20, 40) draws the shaft (31) of the inner housing (30) through the outer housing (20, 40) (Coyle ¶ 0047).
Re Claim 10, Coyle in view of Erekocanski teach all of the limitations of Claim 9. Coyle further teaches wherein the at least one protrusion (32) comprises a plurality of lugs configured to rotatably engage the threads (67) on the inner housing (30) of the sidewall of the outer housing (20, 40).
Re Claims 11 and 12, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle further teaches the cap further comprising an annular seal (62) about the shaft (31) of the inner housing (30) configured to seal against the inner surface of the sidewall of the outer housing (20, 40) preventing cleaning solution from passing through the open second end of the outer housing (20, 40). Coyle fails to teach wherein the seal is integral with an outer surface of the shaft. The use of a one piece construction instead of the structure disclosed in Coyle would be merely a matter of obvious engineering choice. See MPEP 2144.04-V-A.
Re Claim 13, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle further teaches wherein the outer housing (20, 40) is configured to move from an initial position, in which the open second end of the outer housing (20, 40) is closer to the open first end of the base (34) than to the closed second end of the base (34), and a final position, in which the open second end of the outer housing (20, 40) is closer to the closed second end of the base (34) than to the open first end of the base (34) (Coyle Figs. 9A-9C).
Re Claim 15, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle fails to teach wherein the at least one absorbent member is positioned to cover an opening of the first connector or the second connector when the first connector or the second connector is inserted through the open first end of the outer housing. Erekocanski teaches wherein the at least one absorbent member (114) is positioned to cover an opening of the first connector or the second connector when the first connector or the second connector is inserted to contact the absorbent material (114) (Erekocanski Figs. 1-2; ¶ 0118), wherein the at least one absorbent member comprises a disinfectant or antimicrobial agent for disinfecting and sterilizing male or female Luer fittings in contact with said absorbent material (Erekocanski ¶ 0002, 0118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the at least one absorbent member of Coyle in view of Erekocanski to be positioned to cover an opening of the first connector or the second connector when the first connector or the second connector is inserted through the open first end of the outer housing, wherein Erekocanski teaches the at least one absorbent member comprises a disinfectant or antimicrobial agent for disinfecting and sterilizing male or female Luer fittings in contact with said absorbent material (Erekocanski ¶ 0002, 0118).
Claims 2-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Coyle (USPGPub 2022/0040469) in view of Erekocanski et al. (USPGPub 2019/0308006) as applied to Claim 1 above, and further in view of Gardner et al. (USPGPub 2013/0197485).
Re Claims 2-4, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle further teaches wherein the first connector is a male needleless connector (Coyle Fig. 10B). However, Coyle in view of Erekocanski fail to teach wherein the shaft of the inner housing is configured to be secured to the male needleless connector by an interference or friction engagement between the shaft and an outer surface of the male needleless connector; wherein the male needleless connector is a male luer connector comprising a stem having a tapered outer surface, and wherein the shaft of the inner housing comprises a tapered cavity sized to receive the stem of the male luer connector for securing the male luer connector to the cap; and wherein the male luer connector further comprises an annular shield extending about the stem, and wherein an open end of the annular shield contacts the open first end of the outer housing as the stem of the male luer connector is inserted through the open first end of the outer housing.
Garner teaches a cap (810) comprising an inner housing (830) comprising a shaft (811), an outer housing (828), and wherein the shaft (811) of the inner housing (830) is configured to be secured to a male needleless connector (12) by an interference or friction engagement between the shaft (811) and an outer surface of the male needleless connector (12) (Gardner Fig. 13); wherein the male needleless connector (12) is a male luer connector comprising a stem (22) having a tapered outer surface (as seen in Garner Fig. 13), and wherein the shaft (811) of the inner housing (830) comprises a tapered cavity sized to receive the stem (22) of the male luer connector (12) for securing the male luer connector (12) to the cap (810) (as seen in Gardner Fig. 14); and wherein the male luer connector (12) further comprises an annular shield (18) extending about the stem (22), and wherein an open end of the annular shield (18) contacts the open first end of the outer housing (828) as the stem (22) of the male luer connector (12) is inserted through the open first end of the outer housing (828) (Gardner ¶ 0085-0089), the configuration for securing the male needleless connector to both the inner housing and the outer housing (as seen in Gardner Fig. 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the shaft of the inner housing of Coyle in view of Erekocanski to be secured to the male needleless connector by an interference or friction engagement between the shaft and an outer surface of the male needleless connector; wherein the male needleless connector is a male luer connector comprising a stem having a tapered outer surface, and wherein the shaft of the inner housing comprises a tapered cavity sized to receive the stem of the male luer connector for securing the male luer connector to the cap; and wherein the male luer connector further comprises an annular shield extending about the stem, and wherein an open end of the annular shield contacts the open first end of the outer housing as the stem of the male luer connector is inserted through the open first end of the outer housing, the configuration as disclosed by Gardner for securing the male needleless connector to both the inner housing and the outer housing (as seen in Gardner Fig. 14).
Re Claim 6, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle in view of Erekocanski fail to teach wherein the inner housing and/or the outer housing comprise a rigid thermoplastic polymer, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. Gardner teaches wherein the inner housing and the outer housing comprise a rigid thermoplastic polymer, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene (Gardner ¶ 0049). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Re Claim 7, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle fails to teach wherein the shaft comprises a tapered cavity extending inwardly from the first end of the shaft sized to receive a stem of a male luer connector. Gardner teaches a cap (810) comprising an inner housing (830) comprising a shaft (811), wherein the shaft (811) comprises a tapered cavity extending inwardly from the first end of the shaft (811) sized to receive a stem (22) of a male luer connector (12) (Gardner Fig. 14), the configuration for creating a friction fit between the stem of the male Luer connector and the shaft (as seen in Gardner Fig. 14). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the shaft of the inner housing of Coyle in view of Erekocanski to comprise a tapered cavity extending inwardly from the first end of the shaft sized to receive a stem of a male luer connector as disclosed by Gardner for creating a friction fit between the stem of the male Luer connector and the shaft (as seen in Gardner Fig. 14).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Coyle (USPGPub 2022/0040469) in view of Erekocanski et al. (USPGPub 2019/0308006) as applied to Claim 1 above, and further in view of Madsen (USPGPub 2021/0308443).
Re Claim 8, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle in view of Erekocanski fail to teach wherein the inner housing comprises a substantially opaque polymer material. Madsen teaches connectors comprising an inner housing (28) (Madsen Figs. 12-15) wherein the inner housing comprises a substantially opaque polymer material for aiding in sterilization using UVC light (Madsen ¶ 0045). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inner housing of Coyle in view of Erekocanski to comprise a substantially opaque polymer material as disclosed by Madsen for aiding in sterilization using UVC light (Madsen ¶ 0045).
Re Claim 14, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle in view of Erekocanski fail to teach wherein the outer housing comprises a transparent, substantially transparent, or translucent material, such that the inner housing can be seen through the transparent, substantially transparent, or translucent material of the outer housing. Madsen teaches connectors comprising an outer housing (26) comprising a transparent, substantially transparent, or translucent material, such that an inner housing (28) can be seen through the transparent, substantially transparent, or translucent material of the outer housing (26), the configuration for aiding in sterilization using UVC light (Madsen ¶ 0045). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inner housing and outer housing of Coyle in view of Erekocanski wherein the outer housing comprises a transparent, substantially transparent, or translucent material, such that the inner housing can be seen through the transparent, substantially transparent, or translucent material of the outer housing, the configuration as disclosed by Madsen for aiding in sterilization using UVC light (Madsen ¶ 0045).
Claims 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Coyle (USPGPub 2022/0040469) in view of Erekocanski et al. (USPGPub 2019/0308006) as applied to Claim 1 above, and further in view of Drmanovic (USPGPub 2018/0085568).
Re Claims 16 and 17, Coyle in view of Erekocanski teach all of the limitations of Claim 1. Coyle in view of Erekocanski fail to teach wherein the at least one absorbent member comprises a cylindrical absorbent member and a tubular absorbent member positioned around the cylindrical absorbent member; and wherein the shaft comprises a cavity extending inward from the first end of the shaft, wherein the cylindrical absorbent member is at least partially received within the cavity, and wherein the tubular absorbent member encloses the first end of the cavity and the cylindrical absorbent member, such that a portion of an inner surface of the tubular absorbent member contacts an outer surface of the shaft.
Drmanovic teaches connectors comprising an outer housing (103), an inner housing (107), and at least one absorbent member (105, 106), wherein the at least one absorbent member (105, 106) comprises a cylindrical absorbent member (106) and a tubular absorbent member (105) positioned around the cylindrical absorbent member (Drmanovic Figs. 3A-3B); and wherein the inner housing (107) comprises a shaft (as seen in Drmanovic Figs. 3A-3B), the shaft comprises a cavity (125) extending inward from the first end of the shaft, wherein the cylindrical absorbent member (106) is at least partially received within the cavity (125) (as seen in Drmanovic Figs. 3A-3B), and wherein the tubular absorbent member (105) encloses the first end of the cavity and the cylindrical absorbent member (106), such that a portion of an inner surface of the tubular absorbent member (105) contacts an outer surface of the shaft, the configuration for disinfecting both a distal end and circumferential end of a Luer (Drmanovic ¶ 0059).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the at least one absorbent member of Coyle in view of Erekocanski to comprise a cylindrical absorbent member and a tubular absorbent member positioned around the cylindrical absorbent member; and wherein the shaft comprises a cavity extending inward from the first end of the shaft, wherein the cylindrical absorbent member is at least partially received within the cavity, and wherein the tubular absorbent member encloses the first end of the cavity and the cylindrical absorbent member, such that a portion of an inner surface of the tubular absorbent member contacts an outer surface of the shaft, the configuration as disclosed by Drmanovic for disinfecting both a distal end and circumferential end of a Luer (Drmanovic ¶ 0059).
Re Claim 19, Coyle in view of Erekocanski as applied to Claim 1 above, and further in view of Drmanovic teach all of the limitations of Claim 16. Coyle in view of Erekocanski fail to teach wherein the cylindrical absorbent member and/or the tubular absorbent member comprise a porous foam comprising a thermoplastic elastomeric material. Drmanovic teaches wherein the cylindrical absorbent member (106) and the tubular absorbent member (105) comprise a porous foam comprising a thermoplastic elastomeric material (Drmanovic ¶ 0059). Examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Re Claim 20, Coyle in view of Erekocanski as applied to Claim 1 above, and further in view of Drmanovic teach all of the limitations of Claim 16. Coyle in view of Erekocanski fail to teach wherein insertion of the first connector through the open first end of the outer housing causes the first connector to contact the cylindrical absorbent member, and wherein contact between the first connector and the cylindrical absorbent member mechanically removes objects from outer surface(s) of the first connector, or wherein insertion of the second connector through the open first end of the outer housing causes the second connector to contact an outer surface of the tubular absorbent member, and wherein contact between the second connector and the tubular absorbent member mechanically removes objects from outer surface(s) of the second connector. The aforementioned limitation has been determined to be a functional limitation and an inherent characteristic of the prior art Coyle in view of Erekocanski as applied to Claim 1 above, and further in view of Drmanovic. The prior art structure of Coyle in view of Erekocanski as applied to Claim 1 above, and further in view of Drmanovic inherently possesses the functionally defined limitations of the claimed apparatus (See MPEP 2114-I).
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record fails to teach or disclose wherein the tubular absorbent member comprises at least one opening sized to receive a lug extending outward from the sidewall of the shaft
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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