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 .
Status of Claims
This office action is responsive to the amendment filed 30 June 2026.
Claims 9-16 and 20 are withdrawn without traverse.
Claims 1-8 and 17-19 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites the limitation “in the closed configuration, the second portion of the cavity comprises a first volume, and in the open configuration, the second portion of the cavity comprises a second volume, and wherein the second volume is greater than the first volume.” This limitation is in direct conflict with the drawings and the specification, which state “the second volume is less than the first volume” (Fig. 2 and 4 show that the volume of the second portion that exists between the skirt 260 and the cavity floor 130 decreases in size when moving from the closed to the open configuration; para. 0054).
For the purposes of examination, “the second volume is greater than the first volume” is interpreted as --the second volume is less than the first volume--.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jones et al. (US Patent No. 10780260 B2), hereinafter Jones.
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Regarding claim 1, Jones teaches a needle-free connector (Fig. 12A, connector 1255) comprising:
a housing (Fig. 12A above, housing A) comprising a first housing port (Fig. 12A above, first housing port E), a second housing port (Fig. 12A above, second housing port D), a cavity (Fig. 12A above, lumen of housing B between port E and floor F) extending through the first housing port (E) to a cavity floor (Fig. 12A above, cavity floor F), and a center-post (Fig. 12A above, center post B) extending into the cavity (lumen of B) and toward the first housing port (Fig. 12A above, center post B extends toward port E), the center-post (B) having an opening (Fig. 12A, opening C) and an inner surface forming a lumen (Fig. 12A, lumen of post B) extending between the opening (C) and the second housing port (D); and
a valve (Fig. 12A, comprising septum 1210 and member 1215) comprising a head (Fig. 12A, septum 1210) and a skirt (Fig. 12A, septum 1215), the head (1210) having an inner surface forming a passage (Fig. 12A, lumen of septum 1210) through the head (1210), and the skirt (1215) extending radially outward from the head (1210) to an outer end of the skirt (Fig. 12A above, member 1215 extends from the septum 1215 to the inner surface of housing A), the valve (1210 and 1215) disposed around the center-post (Fig. 12A above, septum 1210 and member 1215 are disposed around post B) with the head (1215) of the valve (1210 and 1215) longitudinally movable along the center-post (B) and relative to the outer end of the skirt (Fig. 12A to B, septum 1210 is shown moving longitudinally along post B relative to the outer end of member 1215), and the outer end of the skirt (1215) spaced apart from the cavity floor (Fig. 12A above, outer end of member 1215 is shown spaced from floor F) to fluidly separate the cavity of the housing (lumen of B) into a first portion of the cavity between the skirt and the first housing port (Fig. 12A, area of lumen B between member 1215 and port E), and a second portion of the cavity between the skirt and the second housing port (Fig. 12A, area of lumen of B between member 1215 and floor F, which is shown to be fluidly separate from the area between 1215 and E), the valve (1210 and 1215) having a closed configuration (Fig. 12A) wherein the inner surface of the valve (lumen of 1210) is engaged against the opening (Fig. 12A, lumen of 1210 is shown to be engaged against opening C) to resist movement of a fluid through the center-post (closed; col 8, ln 26-52), and an open configuration (Fig. 12B) wherein the head (1210) is biased away from the opening (Fig. 12A show above to B, septum 1210 is shown biased away from opening C) to permit movement of a fluid through the center-post (open; col 8, ln 26-52).
Regarding claim 2, Jones teaches the connector above, wherein the head (1210) of the valve (1210 and 1215) comprises a split septum (Fig. 12A, split septum 1210 is a split septum) forming a portion of the passage (lumen of 1210) that extends through a top end of the head (1210).
Regarding claim 3, Jones teaches the connector above, wherein, in the closed configuration (Fig. 12A), an inner surface of the housing (lumen of A) is engaged against the head (Fig. 12A, lumen of A is shown to be engaged against 1210) and a portion of the passage (lumen of 1210) through a top end of the head is obstructed (Fig. 12A above, top end of lumen of 1210 is shown to be obstructed), and in the open configuration (Fig. 12B), the inner surface of the housing (lumen of A) is spaced apart from the head (Fig 12B, lumen of A is shown to be spaced from lower surface of septum 1210) and the center-post (B) extends through the portion of the passage (lumen of 1210) through the top end of the head (Fig. 12B, post B is shown to extend through top of lumen of 1210).
Regarding claim 4, Jones teaches the connector above, wherein the outer end of the skirt (outer end of 1215) is positioned between the opening of the center-post (C) and the cavity floor (Fig. 12A above, member 1215 is shown to be positioned between opening C and floor F).
Regarding claim 5, Jones teaches the connector above, wherein, when the valve (1210 and 1215) moves from the closed configuration (Fig. 12A) toward the open configuration (Fig. 12B), the head (1210) of the valve (1210 and 1215) moves relative to the outer end of the skirt (Fig. 12A to B, septum 1210 is shown to move relative to outer end of member 1215 when moving to Fig. 12B).
Regarding claim 6, Jones teaches the connector above, wherein, in the closed configuration (Fig. 12A), the skirt (1215) extends outward from the head (1210) in a direction away from a top end of the head (Fig. 12A, member 1215 extends down and away from septum 1210), and in the open configuration (Fig. 12B), the skirt (1215) extends outward from the head (1210) in a direction toward a top end of the head (Fig. 12B, member 1215 extends up and towards top end of septum 1210).
Regarding claim 7, Jones teaches the connector above, wherein, in the closed configuration (Fig. 12A) and the open configuration (Fig. 12B), the skirt (1215) extends outward from the head (1210) in a direction toward a top end of the head (Fig. 12A and B, member 1215 takes on a concave shape, wherein it extends down away from the top of septum 1210, then toward top of septum 1210 simultaneously).
Regarding claim 8, Jones teaches the connector above, wherein, in the closed configuration (Fig. 12A), the second portion of the cavity (area of lumen of B between 1215 and F) comprises a first volume (Fig. 12A, volume 1 of lumen of B between 1215 and F), and in the open configuration (Fig. 12B), the second portion of the cavity (area of lumen of B between 1215 and F) comprises a second volume (Fig. 12B, volume 2 of lumen of B between 1215 and F), and wherein the second volume (volume 2) less than the first volume (Fig. 12A and B, volume 2 is shown to be less than volume 1).
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Regarding claim 17, Jones teaches a needle-free connector (1255) comprising: a housing (A) comprising a first housing port (E), a second housing port (D), an inner surface forming a cavity (lumen of A) extending to the first housing port (E), and a center-post (B) extending into the cavity (lumen of A) and toward the first housing port (E), the center-post (B) comprising an opening (C) and an inner surface forming a lumen (lumen of B) extending between the opening (C) and the second housing port (D); and a valve (1210 and 1215) comprising a head (1210) and a skirt (1215), the head (1210) disposed around the center-post (B), and the skirt (1215) extending radially outward from the head (1210) to an outer end of the skirt (outer end of 1215), wherein the valve (1210 and 1215) comprises a closed configuration (Fig. 12A) wherein an inner surface of the valve (lumen of 1210) is engaged against the opening of the center-post (C) to resists movement of a fluid therethrough (closed; col 8, ln 26-52), and an open configuration (Fig. 12B) wherein the head (1210) is displaced in a direction away from the first housing port (Fig. 12B above, septum 1210 is shown displaced away from port E) such that the inner surface of the valve (lumen of 1210) is spaced apart from the opening of the center-post (C) to permit movement of a fluid therethrough (open; col 8, ln 26-52), and the skirt (1215) comprises a skirt length (Fig. 12A and B, length of member 1215) from the head (1210) to the outer end of the skirt (outer end of 1215) that increases when the valve (1210 and 1215) moves from the closed configuration (Fig. 12A) toward the open configuration (Fig. 12B, member 1215 is elastically elongated when moved; col 8, ln 26-52).
Regarding claim 18, Jones teaches the connector above, wherein, when the valve (1210 and 1215) moves from the closed configuration (Fig. 12A) toward the open configuration (Fig. 12B), the head (1210) of the valve (1210 and 1215) moves relative to the outer end of the skirt (Fig. 12A to B, septum 1210 is shown to move relative to outer end of member 1215 when moving to Fig. 12B).
Regarding claim 19, Jones teaches the connector above, wherein, in the closed configuration (Fig. 12A), the skirt (1215) extends from the head (1210) in a direction away from a top end of the head (Fig. 12A, member 1215 extends down and away from septum 1210), and in the open configuration (Fig. 12B), the skirt (1215) extends from the head (1210) in a direction toward a top end of the head (Fig. 12B, member 1215 extends up and towards top end of septum 1210).
Conclusion
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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