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
Examiner acknowledges the reply filed 02/10/2026. Claim 1 was amended. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardner et al (U.S. Pat. 10,695,550 B2, hereinafter “Gardner”).
Regarding claim 1, Gardner discloses a cap configured to engage a needleless connector (col. 1, lines. 10-25; Fig. 1), the cap comprising:
a housing (combination of 1710, 1762 and 1764) comprising a first portion 1713 (see Fig. 16B) hingedly connected to a second portion 1719 (see Figs. 16A and 16B; the first and second portions are connected by a hinge 1768), wherein the first portion and the second portion of the housing each comprise first ends (near the indentations 1723; see Fig. 16B) that are connected together forming a hinge 1768 (see Fig. 16A); separated second ends (near protrusions 1715 and 1721; see Fig. 16B) that define an opening of the housing (see Figs. 16AB and 16B; the opening accepts the connector injection site 14); and arcuate walls extending between the first end and the second end of the first and second portions of the housing (see Fig. 16A, showing the arcuate shape of the hinge 1768);
at least one absorbent member 1710 disposed in the housing configured to contain a cleaning solution for cleaning and/or disinfecting portions of the needleless connector engaged to the cap (an absorbent sponge material within the member 1710; various figures, such as Fig. 1B, show absorbent sponge material 30; see also col. 5, lines 15-20 disclosing this material as being an absorbent material, such as a sponge);
a first arm 1711 (see Figs. 16A and 16B) connected to the first portion of the housing (arm 1711 is integral with first portion 1713) and a second arm 1717 (see Figs. 16A and 16B) connected to the second portion of the housing (arm 1711 is integral with second portion 1719; see Fig. 16B);
wherein the first arm and the second arm each include a textured area forming a grip configured to be contacted by a practitioner for manipulating the first arm and the second arm (shown, but not labeled, in Fig. 16A as a 3-rowed textured area on both arms 1711 and 1717; see also Fig. 20A, showing this area in greater relief; and see various figures, such as Fig. 14C, showing analogous textured areas, e.g., 1415),
the arms are configured such that applying a pressing force against the first arm and/or the second arm causes the first portion of the housing to pivot away from the second portion of the housing thereby increasing an area of the opening defined by the second ends of the first portion and the second portion of the housing (when the arms 1711 and 1717 are squeezed together, the ends—where protrusions 1715 and 1721 are located—move apart from each other, thereby increasing the area of the opening defined by these ends in order to provide sufficient clearance to remove the cap from, or apply the cap to, the injection site 14; see col. 12, line 63 to col. 13, line 3).
Regarding claim 2, Gardner discloses the cap of claim 1, wherein the needleless connector comprises a male luer connector or a female luer connector (see col. 16, lines 65-67).
Regarding claim 3, Gardner discloses the cap of claim 2, wherein its device is suitable for engaging to a "conventional access connector" (see col. 5, lines 45-8). Therefore, a skilled artisan would have recognized that the device of Gardner was capable of receiving a female luer connector with the dimensions claimed).
Regarding claim 4, Examiner notes that the claimed invention does not positively recite the connector, but rather, a cap "configured to engage a needleless connector", and so claim 4 covers the function of the invention that has no structural bearing on the claimed device; the cap of the Gardner would be able to be used with the female luer connector described in claim 4.
Regarding claim 5, Examiner notes that the claimed invention does not positively
recite the connector, but rather, a cap "configured to engage a needleless connector", and so claim 4 covers the function of the invention that has no structural bearing on the claimed device; the cap of the Gardner would be able to be used with the female luer connector described in claim 5.
Regarding claim 6, Gardner discloses the cap of claim 1, wherein the housing is configured to move between a closed position when no force is applied to the first arm and/or the second arm and an open position when force is applied to the first arm and/or the second arm, such that an area of the opening of the housing in the closed position is less than an area of the opening when the housing is in the open position (when the arms 1711 and 1717 are squeezed together, the ends—where protrusions 1715 and 1721 are located—move apart from each other, thereby increasing the area of the opening defined by these ends in order to provide sufficient clearance to remove the cap from, or apply the cap to, the injection site 14; see col. 12, line 63 to col. 13, line 3).
Regarding claim 7, a cap "configured to engage a needleless connector", and so claim 4 covers the function of the invention that has no structural bearing on the claimed device; even so, Gardner discloses that when the housing is in a closed position, the housing would be form an interference and/or friction engagement with the needleless connector by use of the engagement portions 1715 and 1721 which engage corresponding portions of the connector 14; see Fig. 16A).
Regarding claim 8, Gardner discloses the cap of claim 7, wherein moving the housing to an open position removes the friction engagement between the housing and the needleless connector (as previously noted, increasing the area of the opening defined by these ends provides sufficient clearance to remove the cap from the injection site 14; see col. 12, line 63 to col. 13, line 3).
Regarding claim 9, Gardner discloses the cap of claim 6, wherein the housing is biased to the closed position (Fig. 16B shows the position when no squeezing force is applied to the top portions 1711 and 1717).
Regarding claim 10, Gardner discloses the cap of claim 6, further comprising a biasing member (hinge 1768) applying a biasing force to the first portion and/or the second portion of housing that biases the housing to the closed position, wherein the biasing member comprises a resilient annular member positioned about outer surfaces of the arcuate walls of the first portion and the second portion (as shown in Fig. 16A, the hinge 1768 is positioned circumferentially about the first and second portions and connects them together).
Regarding claim 11, Gardner discloses the cap of claim 10, wherein the force applied to the first arm and/or the second arm overcomes the biasing force of the biasing member to move the housing from the closed position to the open position (as noted above, squeezing the two arms together provides sufficient clearance to remove the cap from the injection site 14; applying such squeezing overcomes the implicit bias force of the hinge 1768 when the cap is opened).
Regarding claim 12, Gardner discloses the cap of claim 1, wherein the housing comprises a living hinge between the first end of the first portion and the first end of the second portion (the hinge 1768 is integral with the portions 1762 and 1764, which meets the reasonable definition of a living hinge as a flexure bearing made from the same material as the two pieces it connects).
Regarding claim 13, Gardner discloses the cap of claim 1, wherein the at least one absorbent member 1710 comprises a closed first end contacting the first ends of the first and/or second portion of the housing (the top end of the member 1710 is closed; see Fig. 16B), an open second end accessible through the opening of the housing (the bottom end of the member 1710, closer to the protrusions 1715 and 1721, has an open end to accept the top of the connector 14; see Fig. 16B), and an annular sidewall extending therebetween (portion 1710 has an annular shape; see Fig. 16B).
Regarding claim 14, Gardner discloses the cap of claim 1, further comprising the cleaning solution absorbed by the at least one absorbent member, wherein the cleaning solution comprises Isopropyl Alcohol (IPA) and/or chlorhexidine gluconate (see col. 5, lines 45-55, disclosing isopropyl alcohol fluid absorbed within the absorbent material).
Regarding claim 15, Gardner discloses the cap of claim 1, wherein the first portion of the housing, the second portion of the housing, the first arm and the second arm are integral (see Fig. 16B); the limitation "formed as a single molded part" is considered a product-by-process limitation that does not connote specific structure or physical characteristics that distinguish over the prior art).
Regarding claim 16, Gardner discloses the cap of claim 1, wherein the first arm and the second arm comprise proximal ends integral with the arcuate wall of the first portion or the second portion of the housing and free distal ends opposite the proximal ends (see Fig. 16A and 16B, showing the first and second arms and the arcuate walls being integral with each other).
Regarding claim 17, Gardner discloses the cap of claim 16, wherein the distal ends of the first arm and the second arm are axially spaced apart from and above the first ends of the first portion and the second portion (see Figs. 16A and 16B).
Regarding claim 18, Gardner discloses the cap of claim 1, wherein the first arm is spaced apart from the second arm by about 180 degrees about a longitudinal axis of the housing, and wherein the pressing force applied to the first arm is applied in a first direction and the pressing force applied to the second arm is applied in a second direction which is substantially opposite the first direction (see Figs. 16A and 16B).
Regarding claim 19, Gardner discloses the cap of claim 1, further comprising a protective cover over the opening of the housing (see Figs. 18-20, showing various protective covers over the opening of the housing, such as 1930, 2030 and 2150).
Regarding claim 20, Gardner discloses the method for attaching the cap of claim 1 to the needleless connector (see col. 2, lines 36-43), the method comprising:
pressing the first arm and/or the second arm radially inward to move the housing to an open position, inserting a distal end of the needleless connector through the opening of the housing, with the housing is in the open position; releasing the first arm and/or the second arm, thereby causing the housing to move to a closed position, in which the at least one absorbent member forms an interference and/or friction engagement with the needleless connector (Gardner discloses a "method of applying the cap to a connector injection site and allowing the cap to remain on and cover the connector"; in order for this to occur, the above-steps would be carried out as described in col. 12, line 63 to col. 13, line 3).
Response to Arguments
Applicant's arguments have been fully considered, but are moot in view of the new grounds of rejection necessitated by the amendment.
Conclusion
THIS ACTION IS MADE FINAL. 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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 03/26/2026
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