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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/15/2026 has been entered.
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 1, 3, 5, 7, 9-12, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansour et al. (PG PUB 2011/0130724).
Re claim 1, Mansour discloses a needleless connector 750 (seen assembled in Fig 7E; all reference characters cited below refer to Fig 7A-7E unless otherwise noted), comprising: a housing 700+740+730 comprising a cavity 704, a proximal fluid port 702 in fluid communication with the cavity (as seen in Fig 9), and a distal fluid port 734 in fluid communication with the cavity (as seen in Fig 9); and a flexible valve element 710 disposed within the cavity (as seen in Fig 7E-11) and comprising a valve diaphragm 720+722, the valve diaphragm comprising a retention edge 722 and a diaphragm body 720 that extends from the retention edge towards the distal fluid port (when the valve diaphragm is expanded, as seen in Fig 9), wherein the valve diaphragm is configured to expand when a luer is inserted into the proximal fluid port (as seen in Fig 9; Para 62) to permit flow between the proximal fluid port and the distal fluid port (as seen in Fig 9) and retract when the luer is removed from the proximal fluid port (as seen in Fig 10; Para 64).
Re claim 3, Mansour discloses that the flexible valve element comprises a cone 714 coupled to the valve diaphragm and extending toward the proximal fluid port (as seen in Fig 7E).
Re claim 5, Mansour discloses that the valve diaphragm defines a flat portion (connecting the tapered proximal portion to the retention edge 722; seen in Fig 7E and labeled in annotated Fig A below).
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Re claim 7, Mansour discloses that at least a portion of the retention edge is captured within the housing (as seen in Fig 7E; Para 61).
Re claim 9, Mansour discloses that the flexible valve element comprises a valve tail 724 extending into the cavity (as seen in Fig 7E), wherein the valve tail deflects to selectively permit flow between the proximal fluid port and the distal fluid port (as seen in Fig 9; Para 57).
Re claim 10, Mansour discloses that the valve tail comprises a plurality of bends 726 (as seen in Fig 7B).
Re claim 11, Mansour discloses that the valve tail is configured to minimize insertion force of a luer to permit flow between the proximal fluid port and the distal fluid port (one of ordinary skill in the art would recognize that this limitation is met since insertion force is “minimized” by valve tail 724 in comparison to a valve tail having different dimensions or made of a harder material).
Re claim 12, Mansour discloses that the housing comprises a proximal portion 700 and a distal portion 730, wherein the proximal portion and the distal portion are coupled together (as seen in Fig 7E; Para 60).
Re claim 18, Mansour discloses that the housing defines at least one flow channel 708 in fluid communication with the proximal fluid port and the distal fluid port (as seen in Fig 9; Para 56).
Re claim 20, Mansour discloses a needleless connector 750 (seen assembled in Fig 7E; all reference characters cited below refer to Fig 7A-7E unless otherwise noted), comprising: a housing 700+740+730 comprising a proximal portion 700; a distal portion 730, wherein the proximal portion and the distal portion are coupled together to cooperatively define a cavity 704 (as seen in Fig 7E; Para 60); a proximal fluid port 702 in fluid communication with the cavity (as seen in Fig 9); and a distal fluid port 734 in fluid communication with the cavity (as seen in Fig 9); and a flexible valve element 710 comprising: a truncated, substantially conical shape (at shoulder 718, as seen in Fig 7B) and extending toward the proximal fluid port (as seen in Fig 7E); a retention edge 722, wherein at least a portion of the retention edge is captured within the housing (as seen in Fig 7E; Para 61); a valve diaphragm 720 comprising a diaphragm body 720 that extends from the truncated, substantially conical shape towards the distal fluid port (when the valve diaphragm is at rest, as seen in Fig 7E) and extends from the retention edge towards the distal fluid port (when the valve diaphragm is expanded, as seen in Fig 9), wherein the valve diaphragm is configured to expand when a luer is inserted into the proximal fluid port (as seen in Fig 9, Para 62) to permit flow between the proximal fluid port and the distal fluid port (as seen in Fig 9) and retract when the luer is removed from the proximal fluid port (as seen in Fig 10; Para 64); and a valve tail 724 extending into the cavity (as seen in Fig 7E), wherein the valve tail deflects to selectively permit flow between the proximal fluid port and the distal fluid port (as seen in Fig 9; Para 57).
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 13 and 14 are rejected under 35 U.S.C. 103 as being obvious over Mansour et al. (PG PUB 2011/0130724).
Re claim 13, Mansour discloses all the claimed features except explicitly disclosing what material the proximal and distal portions are made of; therefore, Mansour does not disclose that at least one of the proximal and distal portions comprises polypropylene or polyethylene. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify at least one of the proximal and distal portions of the housing to include polypropylene or polyethylene since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Additionally, claim 13 has been rejected with art below.
Re claim 14, Mansour discloses all the claimed features except explicitly disclosing what material the proximal and distal portions are made of; therefore, Mansour does not disclose that at least one of the proximal and distal portions comprises polycarbonate or copolyester. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify at least one of the proximal and distal portions of the housing to include polycarbonate or copolyester since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Additionally, claim 14 has been rejected with art below.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mansour et al. (PG PUB 2011/0130724) in view of Aydin (PG PUB 2015/0129065).
Re claim 13, Mansour discloses all the claimed features except explicitly disclosing what material the proximal and distal portions are made of; therefore, Mansour does not disclose that at least one of the proximal and distal portions comprises polypropylene or polyethylene. Aydin, however, teaches a needleless connector 1 (Fig 1) comprising a flexible valve element 15 (Fig 1) and a housing 3+4 (Fig 1) comprising a proximal portion 3 (Fig 1) and a distal portion 4 (Fig 1) wherein each of the portions comprises polypropylene (Para 89) since this material tends to be dimensionally stable (Para 89). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mansour, to include at least one of the portions such that it comprises polypropylene, as taught by Aydin, for the purpose of ensuring that the housing is dimensionally stable (Para 89).
Re claim 14, Mansour discloses all the claimed features except explicitly disclosing what material the proximal and distal portions are made of; therefore, Mansour does not disclose that at least one of the proximal and distal portions comprises polycarbonate or copolyester. Aydin, however, teaches a needleless connector 1 (Fig 1) comprising a flexible valve element 15 (Fig 1) and a housing 3+4 (Fig 1) comprising a proximal portion 3 (Fig 1) and a distal portion 4 (Fig 1) wherein each of the portions comprises polycarbonate (Para 89) since this material tends to be dimensionally stable (Para 89). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mansour, to include at least one of the portions such that it comprises polycarbonate, as taught by Aydin, for the purpose of ensuring that the housing is dimensionally stable (Para 89).
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive. Applicant argues that Mansour’s diaphragm body 720 does not “extend from retention edge [722] towards the distal fluid port” as now recited in claim 1 and does not extend from a “truncated, substantially conical shape [of the flexible valve element] towards the distal fluid port and extends from the retention edge towards the distal fluid port” as now recited in claim 20. The Examiner respectfully disagrees. Each of these claims recite that the valve diaphragm is configured to expand and retract (see lines 7-9 in claim 1 and lines 19-22in claim 20) and do not recite in what configuration (expanded, retracted, at rest, or all the time) that the diaphragm body must extend in the manner claimed. As set forth above, the diaphragm 720 extends from the retention edge 722 towards the distal fluid port (as required by claims 1 and 20) when the diaphragm is expanded (as in Fig 9, Para 62) and extends from the truncated, substantially conical shape 718 towards the distal fluid port (as required by claim 20) when the diaphragm is at rest (as in Fig 7E, Para 61). If Applicant wishes for the claim to require the valve diaphragm to always extend toward the distal fluid port from the retention edge and/or the truncated substantially conical shape, then further amendment is needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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