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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 2022/0288258) in view of Follman (US 2018/0256880).
Regarding claim 1, Gardner (US 2022/0288258) discloses –
A cap configured to engage different types of female connectors (Fig. 18, disinfectant cap 810), comprising:
a housing (cap body 812) comprising
a closed bottom (bottom wall 818), an open top (top opening 820), and a sidewall extending between the top and the bottom (sidewall 816) comprising
threads on an inner surface of the sidewall (the sidewall is threaded 819; par. 84);
a sleeve disposed in the housing comprising threads (threadable insert 814) engaged to the threads of the housing configured to rotate relative to the housing, thereby moving the sleeve through the housing (par. 84 discloses the insert 814 being threaded into the body 812 and therefore rotating relative thereto). The cap disclosed by Gardner is well capable of receiving and engaging different types of female connectors, see MPEP 2114, II.
Gardner teaches the threadable insert 814 utilizes a friction fit, but appears to be silent with regards to a gripper and an absorbent support disposed in the gripper as claimed.
Follman (US 2018/0256880) teaches an antimicrobial cap (title) including an inner component 200 (see figs. 4-5 and 11C) that engages a portion of a medical device (par. 70), including at least one flexible leg that would be pressed radially inward when inserted into the body (pars. 77-79 disclose the attaching), further including an absorbent support disposed in the gripper configured to clean and/or disinfect portions of a female connector (pad 300 containing an antimicrobial element, see fig. 7; par. 78). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Gardner such that it includes the component 200 (a gripper) for retaining the medical device via a friction fit as desired such that the at least one flexible leg that would be pressed radially inward when inserted into the body, the gripper including an absorbent support as taught by Follman to arrive at the claimed invention. One would have been motivated to do so to more securely and engage the medical device for cleaning and disinfecting purposes according to means known in the art. The combination of familiar prior art elements, including coupling members and disinfecting caps, for the same purpose together as separate according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A)-(B).
Regarding claim 2, modified Gardner further teaches a cap sized such that is well capable of performing the claimed function of receiving female connectors having different thread configurations and dimensions, see MPEP 2114, II.
Regarding claim 3, modified Gardner appears to be silent with regards to the size of the female connectors received.
However, the modification of the cap to be sized to receive female connectors having threads with a width at a crest of from about 0.3 mm to about 1.0 mm and a width at a root of the crest from about 0.5 mm to 1.2 mm would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention. One would have been motivated to do so as a recitation of relative dimension or proportion is not sufficient to distinguish a claimed invention from the prior art MPEP 2144.04(IV)(A), and the selection of a size of thread would only be the product of routine experimentation, see MPEP 2144.05(II).
Regarding claim 4, modified Gardner further teaches a cap that is well capable of receiving a female connector comprising a threaded outer surface, and wherein, when the female luer connector is inserted into the housing, the threaded outer surface of the female luer connector contacts the at least one leg of the gripper, see MPEP 2114, II.
Regarding claim 5, modified Gardner further teaches a cap that is well capable of cleaning and/or disinfect at least the threaded outer surface of the female luer connector, see MPEP 2114, II.
Regarding claim 6, modified Gardner further teaches the housing, sleeve, and gripper comprise a rigid thermoplastic polymer comprising at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene (par. 48 of Gardner discloses that cap and its parts are made from polypropylene).
Regarding claim 7, modified Gardner further teaches an inwardly extending protrusion on an inner surface of the sleeve (Fig. 18 annular ledge 836) positioned to contact an outer surface of the gripper (the gripper taught by Follman, 200, would be or at least be capable of being in contact with the protrusion of the sleeve).
Regarding claim 8, modified Gardner further teaches an inner surface of the sleeve is tapered, such that an inner diameter of the sleeve increases from a top of the sleeve to a bottom of the sleeve (Fig. 18, shows annular ledge 836, and the inner diameter increases from the portion 834 to the opposite end, the designation of top and bottom being arbitrarily defined, as claimed).
Regarding claim 9, modified Gardner further teaches he sleeve further comprises at least one axially extending tab extending axially from a top of the sleeve beyond the open top of the housing (Fig. 18, the portion of the insert 814 that is most proximate opening 820 extends from the base at ledge 836 and is positionable to extend from a top of the sleeve though opening 820, the sidewall of the insert 814 in this configuration reading on the limitation of a tab).
Regarding claim 10, modified Gardner further teaches the gripper comprises an annular base and the at least one leg extending axially from the annular base (Figs. 5a-b of Follman best show the base 200 with legs 202, 204, 206, 208 extending axially away from it).
Regarding claim 11, modified Gardner further teaches the at least one leg comprises an inner surface and an outer surface, and wherein at least a portion of the outer surface is sloped towards the annular base of the gripper (Figs. 5a-b of Follman best show inner and outer surfaces of the legs, and the outer surface of legs 202, 204, 206, 208 slope toward the base).
Regarding claim 12, modified Gardner further teaches the gripper comprises a plurality of the flexible legs extending from the annular base (Fig. 5a of Follman shows this) about a circumference of the annular base, and wherein the plurality of legs define a substantially cylindrical space that receives the absorbent support (Figs. 5a-b and 7 illustrate the space where the pad 300 is received, the space being substantially cylindrical).
Regarding claim 13, modified Gardner further teaches the at least one leg comprises an inwardly extending protrusion for pressing against the female connector (Fig. 5A shows inwardly projecting protrusions on legs 206 and 208, which are well capable of pressing against the female connector), thereby securing the cap to the female connector.
Regarding claim 17, modified Gardner further teaches a cleaning solution absorbed by the absorbent support comprising isopropyl alcohol (par. 101).
Regarding claim 18, modified Gardner further teaches the cleaning solution comprises from about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA (par. 101).
Regarding claim 19, modified Gardner further teaches a protective cover over the open top of the housing (par. 84 discloses a film over the top opening 820).
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 2022/0288258) in view of Follman (US 2018/0256880) as applied to 1 and 19 above and further in view of Marici (US 10,871,246).
Regarding claim 16, modified Gardner discloses the absorbent support comprises a foam (claim 21 of Follman) but appears to be silent with regards to the foam being open cell or comprising a thermoplastic elastomer.
Marici (US 10,871,246) discloses a cap cleaner (title) with an absorbent support comprising a foam that is a sponge or a thermoplastic elastomer (Col. 11 lines 26-35 discloses a sponge or polyurethane foam). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Gardner such that the absorbent support comprises a sponge or thermoplastic elastomer as taught by Marici to arrive at the claimed invention. One would have been motivated to do so to construct the sponge according to known-effective materials to arrive at a successful device. The combination of familiar prior art elements according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Regarding claim 20, modified Gardner is set forth above with regards to claim 19 but appears to be silent with regards to a heat seal.
Marici further teaches a peelable seal that is heat sealed to the housing (Col. 11 lines 20-25). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Gardner such that the seal is attached by heat sealing to arrive at the claimed invention. One would have been motivated to do so to successfully secure the seal to the housing in a cheap and conventional manner. The combination of familiar prior art elements according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Prior Art
The prior art, alone or in combination, fails to teach or fairly suggest each and every limitation of claims 14 and 15.
The prior art considered to be the closest prior art is Gardner in view of Follman. Gardner in view of Follman teach a rotatable sleeve and a gripper in contact therewith (see the rejection of claim 1 above), but modified Gardner fails to teach or fairly suggest the sleeve contacting the gripper to move the gripper radially inward. Gardner is further silent with regards to an additional seal disposed in the housing over the gripper, the seal comprising an annular seal comprising a non-porous foam.
Response to Arguments
Applicant's arguments filed 2/4/26 have been fully considered but they are not persuasive.
Applicant remarks on page 7 arguing Follman fails to teach a sleeve disposed in a sleeve and the gripper disposed partially in the sleeve, which is not persuasive. Follman teaches a gripper 200 that is at least partially disposed in a sleeve 100.
Applicant further argues on pages 7-8 that there is no motivation to combine the gripper and absorbent pad of Follman with the sleeve of Gardner, which is further not persuasive. The rejection does not rely on the incorporation of the foam absorbent pad, it incorporates specifically the component 200 for advantageously providing the friction fit that Gardner teaches but lacks a specific structure for (see par. 85 of Gardner, teaching a friction fit as opposed to a threaded one). This would have the advantage of retaining the device to be treated according to a known retention mechanism type set forth by Follman. An ordinary artisan would look to the prior art from Gardner to seek an appropriate friction-based retention mechanism and could readily incorporate the teachings of Follman into Gardner as set forth in the rejection above.
The courts have held that there is an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical— there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. See MPEP 2144(II). In this case, Gardner suggests and desires permutations of the cap 810 that includes a fit other than the threaded on illustrate in fig. 18, such as a friction fit, and Follman provides this teaching. The rejection of claim 1 is therefore maintained.
The remaining claims remain rejected similarly.
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.
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/BRENDAN A HENSEL/Examiner, Art Unit 1758