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 .
Response to Amendment
This office action is responsive to the amendment filed on January 7, 2026. As directed by the amendment: claims 1, 9, 12, and 18 have been amended. Thus, claims 1-16, 18-21, and 23-24 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed October 15, 2025.
Response to Arguments
Applicant’s arguments, filed January 7, 2026, with respect to the rejection(s) of claim(s) 1, 9, and 18 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to Guala not teaching or disclosing the wall having the claimed disproportionate cross-sectional thickness at different locations around its perimeter. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claims 1, 9, and 18 are objected to because of the following informalities: the claims should be amended to recite “…around its perimeter forming [[having]] an asymmetric shape…” to correct for grammar. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 5-10, 12-16, and 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansour (US 20140276463).
Regarding claim 1, Mansour discloses a needleless connector (fig. 1) comprising:
a housing (body portion 200 and base portion 300 in fig. 1 form the “housing”) comprising a central longitudinal axis (central longitudinal axis 501 in fig. 2A), a housing body portion (body portion 200 in fig. 1), and a base portion (base portion 300 in fig. 1), wherein:
the housing body portion comprises an inner surface forming an internal cavity (fig. 7B shows an inner surface forming a cavity 242), and a first port forming a first fluid passage to the internal cavity (first passage 252 in fig. 7A); and
the base portion comprises a top section (see below) including a valve seal support (valve mount 355 in fig. 9A), and a bottom section (see below) including a second port forming a second fluid passage to the internal cavity (second port 382 in fig. 9A); and
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an asymmetrically-shaped valve disposed in the internal cavity (compressible valve 100 in fig. 4A; paragraph 60 and 63 discloses the notches 114a/b and dimples 180a/b being of different sizes so that the valve is asymmetrically shaped) and comprising a head portion (see below), a flange portion (see below), a valve body portion extending from the head portion to the flange portion (see below), and a wall (cylindrical wall 131 in fig. 4A) having an inner surface (interior wall 132 in fig. 4A) forming a valve cavity (air space 134 in fig. 4A), the wall comprising a disproportionate cross-sectional thickness at different locations around its perimeter forming having an asymmetric shape of the cavity when the head portion is positioned in the first port to obstruct the first fluid passage (fig. 4A shows disproportionate wall thickness at the location designated below), wherein the asymmetrically- shaped valve is coupled with the housing such that the flange is coupled to the top section (fig. 10), the inner surface of the asymmetrically-shaped valve at the valve body portion is seated and radially supported on the valve seal support (fig. 10 shows the bottom portion of the valve body portion designated below radially seated on the valve mount 355), and a primary seal portion is formed by an outer surface of the valve body portion (primary seal portion 120 in fig. 4A).
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Regarding claim 2, Mansour discloses the valve is coupled with the housing such that the top section of the base portion is disposed in the valve cavity with the inner surface of the valve at the valve body portion being seated and radially supported on the valve seal support (fig. 10 shows the valve mount 355 positioned in the bottom portion of the valve cavity).
Regarding claim 3, Mansour discloses the top section of the base portion comprises a head and a stem longitudinally extending from the head (see below), the head comprising a ramp surface for engaging and radially supporting the inner surface of the valve (see below from fig. 9A; fig. 10 shows the inner surface of the valve engaged to the surface below).
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Regarding claim 5, Mansour discloses an outer surface of the head portion of the valve forms a secondary seal portion (circumferential lip 115 in fig. 4A; paragraph 59), and wherein the primary seal portion is spaced apart from the secondary seal portion (fig. 4A).
Regarding claim 6, Mansour discloses the primary seal portion is configured to engage against the inner surface of the housing body portion to form a primary seal therebetween (fig. 10), and the secondary seal portion is configured to engage against the inner surface of the housing body portion to form a secondary seal therebetween (paragraph 59).
Regarding claim 7, Mansour discloses the inner surface of the housing body portion comprises a sealing edge between the first port and the top section of the base portion (sealing edge 254 in fig. 10), the primary seal portion configured to engage against the sealing edge to form the primary seal (fig. 10; paragraph 76).
Regarding claim 8, using an alternative interpretation of claims 1 and 5, Mansour discloses a housing (body portion 200 and base portion 300 in fig. 1 form the “housing”) comprising a central longitudinal axis (central longitudinal axis 501 in fig. 2A), a housing body portion (body portion 200 in fig. 1), and a base portion (base portion 300 in fig. 1), wherein:
the housing body portion comprises an inner surface forming an internal cavity (fig. 7B shows an inner surface forming a cavity 242), and a first port forming a first fluid passage to the internal cavity (first passage 252 in fig. 7A); and
the base portion comprises a top section (see below) including a valve seal support (valve mount 355 in fig. 9A), and a bottom section (see below) including a second port forming a second fluid passage to the internal cavity (second port 382 in fig. 9A); and
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an asymmetrically-shaped valve disposed in the internal cavity (compressible valve 100 in fig. 4A; paragraph 60 and 63 discloses the notches 114a/b and dimples 180a/b being of different sizes so that the valve is asymmetrically shaped) and comprising a head portion (see below), a flange portion (see below), a valve body portion extending from the head portion to the flange portion (see below), and a wall (cylindrical wall 131 in fig. 4A) having an inner surface (interior wall 132 in fig. 4A) forming a valve cavity (air space 134 in fig. 4A), the wall comprising a disproportionate cross-sectional thickness at different locations around its perimeter forming having an asymmetric shape of the cavity when the head portion is positioned in the first port to obstruct the first fluid passage (fig. 4A shows disproportionate wall thickness at the location designated below in the dotted line), wherein the asymmetrically- shaped valve is coupled with the housing such that the flange is coupled to the top section (fig. 10), the inner surface of the asymmetrically-shaped valve at the valve body portion is seated and radially supported on the valve seal support (fig. 10 shows the bottom portion of the valve body portion designated below radially seated on the valve mount 355), and a primary seal portion is formed by an outer surface of the valve body portion (see corner designated below; fig. 10 shows the primary seal portion designated as abutting the inner surface of the housing body portion so to form a seal);
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an outer surface of the head portion of the valve forms a secondary seal portion (circumferential lip 115 in fig. 4A; paragraph 59), and wherein the primary seal portion is spaced apart from the secondary seal portion (fig. 4A).
Further regarding claim 8, using the alternative interpretation of claims 1 and 5, Mansour discloses a longitudinal extent of the elongate head portion comprises a first length and a longitudinal extent of the valve body portion comprises a second length (see annotated figure above), the first length being greater than the second length (see annotated figure above, the length of the designated head portion is greater than the length of the designated body portion).
Regarding claim 9, Mansour discloses a needleless connector (fig. 1) comprising:
a housing (body portion 200 and base portion 300 in fig. 1 form the “housing”) comprising a central longitudinal axis (central longitudinal axis 501 in fig. 2a), a housing body portion (body portion 200 in fig. 1), and a base portion (base portion 300 in fig. 1), wherein:
the housing body portion comprises an inner surface forming an internal cavity (fig. 7B shows an inner surface forming a cavity 242), and a first port forming a first fluid passage to the internal cavity (first passage 252 in fig. 7A); and
the base portion comprises a top section (see below) including a valve seal support (valve mount 355 in fig. 9A), and a bottom section (see below) including a second port forming a second fluid passage to the internal cavity (second port 382 in fig. 9A); and
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an asymmetrically-shaped valve disposed in the internal cavity (compressible valve 100 in fig. 4A; paragraph 60 and 63 discloses the notches 114a/b and dimples 180a/b being of different sizes so that the valve is asymmetrically shaped) and comprising an elongate head portion (see below), a flange portion (see below), a valve body portion extending from the elongate head portion to the flange portion (see below), and a wall having an inner surface (interior wall 132 in fig. 4A) forming a valve cavity (air space 134 in fig. 4A), the wall comprising a disproportionate cross-sectional thickness at different locations around its perimeter forming having an asymmetric shape of the cavity when the head portion is positioned in the first port to obstruct the first fluid passage (fig. 4A shows disproportionate wall thickness at the location designated below), wherein
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the wall defines a radially-inward extending ledge (see below), the top section further comprises a radially-outward extending ledge which abuts the radially-inward extending ledge of the of the valve to prevent the valve from being displaced into the first port (see below), and an outer surface of the valve body portion forms a primary seal portion configured to engage against the inner surface of the housing body portion to form a primary seal therebetween (primary seal portion 120 in fig. 4A).
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Regarding claim 10, Mansour discloses the valve cavity comprises an upper valve cavity and a lower valve cavity and the radially-inward extending ledge is disposed between the upper and lower valve cavities (see below).
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Regarding claim 12, using a different interpretation of claim 9 above, Mansour discloses a housing (body portion 200 and base portion 300 form the “housing”) comprising a central longitudinal axis (axis 501 in fig. 1), a housing body portion (body portion 200 in fig. 10), and a base portion (base portion 300 in fig. 10), wherein:
an asymmetrically-shaped valve disposed in the internal cavity (compressible valve 100 in fig. 4a) and comprising an elongate head portion (see below), a flange portion (see below), a valve body portion extending from the elongate head portion to the flange portion (see below), and a wall having an inner surface (interior wall 132 in fig. 4a) forming a valve cavity (space 134 in fig. 4A), the wall comprising a disproportionate cross-sectional thickness at different locations around its perimeter forming having an asymmetric shape of the cavity when the head portion is positioned in the first port to obstruct the first fluid passage (fig. 4A shows disproportionate wall thickness at the location designated below in the dotted line), wherein:
the wall defines a radially-inward extending ledge (see below), the top section further comprises a radially-outward extending ledge which abuts the radially-inward extending ledge of the of the valve to prevent the valve from being displaced into the first port (see below), and an outer surface of the valve body portion forms a primary seal portion configured to engage against the inner surface of the housing body portion to form a primary seal therebetween (see corner designated below; fig. 10 shows the primary seal portion designated as abutting the inner surface of the housing body portion so to form a seal).
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Further regarding claim 12, using the alternative interpretation of claim 9 above, Mansour discloses a longitudinal extent of the elongate head portion comprises a first length and a longitudinal extent of the valve body portion comprises a second length (see annotated figure above), the first length being greater than the second length (see annotated figure above, the length of the designated head portion is greater than the length of the designated body portion).
Regarding claim 13, Mansour discloses the valve is coupled with the housing such that the top section of the base portion is disposed in the valve cavity with the inner surface of the valve at the asymmetrically-shaped valve body portion being seated and radially supported on the valve seal support (fig. 10).
Regarding claim 14, Mansour discloses an outer surface of the elongate head portion of the valve forms a secondary seal portion (circumferential lip 115 in fig. 4A; paragraph 59), and wherein the primary seal portion is spaced apart from the secondary seal portion (fig. 10).
Regarding claim 15, Mansour discloses the secondary seal portion is configured to engage against the inner surface of the housing body portion to form a secondary seal therebetween (fig. 10; paragraph 59).
Regarding claim 16, Mansour discloses the inner surface of the housing body portion comprises a sealing edge between the first port and the top section of the base portion (internal sealing edge 254 in fig. 10), the primary seal portion configured to engage against the sealing edge to form the primary seal (fig. 10; paragraph 57).
Regarding claim 18, Mansour discloses a needleless connector (fig. 10) comprising:
a housing (body portion 200 and base portion 300 form the “housing”) comprising a central longitudinal axis (axis 501 in fig. 1), a housing body portion (body portion 200 in fig. 10), and a base portion (base portion 300 in fig. 10), wherein:
the housing body portion comprises an inner surface (interior wall 132 in fig. 4A) forming an internal cavity (fig. 7B shows an inner surface forming a cavity 242), a first port forming a first fluid passage to the internal cavity (first passage 252 in fig. 7A); and
the base portion comprises a top section (see below) including a valve seal support (valve mount 355 in fig. 9A), and a bottom section (see below) including a second port forming a second fluid passage to the internal cavity (second port 382 in fig. 9A); and
an asymmetrically-shaped valve disposed in the internal cavity (compressible valve 100 in fig. 4a) and comprising an elongate head portion (see below), a flange portion (see below), a valve body portion extending from the elongate head portion to the flange portion (see below), and a wall having an inner surface (interior wall 132 in fig. 4a) forming a valve cavity (space 134 in fig. 4A), the wall comprising a disproportionate cross-sectional thickness at different locations around its perimeter forming having an asymmetric shape of the cavity when the head portion is positioned in the first port to obstruct the first fluid passage (fig. 4A shows disproportionate wall thickness at the location designated below in the dotted line), wherein:
an outer surface of the valve body portion comprising a primary seal portion (see corner designated below; fig. 10 shows the primary seal portion designated as abutting the inner surface of the housing body portion so to form a seal), and
an outer surface of the elongate head portion comprising a secondary seal portion spaced apart from the primary seal portion (circumferential lip 115 in fig. 4A; paragraph 59); and
the primary seal portion is located adjacent the base portion of the housing such that a distance between the primary seal portion and the base portion is smaller than a distance between the secondary seal portion and the primary seal portion (fig. 10; the primary seal portion below is adjacent a portion of the base).
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Regarding claim 19, Mansour discloses a longitudinal extent of the elongate head portion comprises a first length and a longitudinal extent of the valve body portion comprises a second length (see annotated figure above), the first length being greater than the second length (see annotated figure above, the length of the designated head portion is greater than the length of the designated body portion).
Regarding claim 20, Mansour discloses the primary seal portion is configured to engage against the inner surface of the housing body portion to form a primary seal therebetween (fig. 10 shows the primary seal portion designated above as engaging the inner surface of the housing body portion), and the secondary seal portion is configured to engage against the inner surface of the housing body portion to form a secondary seal therebetween (paragraph 59 and fig. 10).
Regarding claim 21, Mansour discloses the inner surface of the housing body portion comprises a sealing edge between the first port and a top section of the base portion (see below, the edge designated below is longitudinally between the top section and the first port), the primary seal portion configured to engage against the sealing edge to form the primary seal (fig. 10).
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Allowable Subject Matter
Claims 4, 11, 23, and 24 are 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 following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4, 11, and 23, the closest prior art is Mansour. Mansour discloses the top section of the base portion comprises a head and a stem longitudinally extending from the head (see below). However, as seen in fig. 10, the entirety of the top section is positioned within the lower cavity. As such, Mansour does not teach or disclose the head of the base portion being disposed in the upper valve cavity, and the stem being disposed in the lower valve cavity.
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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.
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783