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 § 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.
Claim(s) 1-5, 11-14, 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Solomon et al. (US 2011/0213341 A1).
With regard to claim 1, Solomon discloses a cap (see Fig. 18, 19a, element 502) configured to engage at least a first connector and a second connector of different types (the configured to language implies functional language and therefore the first and second connector are not positively recited and do not need to be taught by the prior art as long as the cap would be capable of being used with a first and second connector. In this case the connector is 302), the cap comprising: a housing (body of 510 and 512) comprising a first end (513), an open second end (at 530), and a sidewall (see body of 510 and 512) extending between the first end and the second end; an absorbent support (532) positioned in the housing configured to contact portions of the first connector or the second connector inserted into the housing (as shown in Fig. 19b); and a seal (541) mounted to a portion of the absorbent support configured to cover an opening of the first connector or the second connector when one of the first connector or the second connector is inserted into the housing (see Fig. 19b), wherein the cap is configured to be secured to the first connector by an engagement between a first axial portion (see annotated Fig below) of an inner surface of the sidewall of the housing and the first connector (302) and to the second connector by an interference engagement between a second portion of the inner surface of the sidewall of the housing and an outer surface of the second connector (the cap and connector are in engagement via the threaded inner surface of the cap and the outer surface of the connector as shown in Fig. 19a and 19b. The claim language “configured” indicates functional language such that the prior art would only need to be capable of connecting at two different axial points between two different connectors. Because the cap of the prior art teaches multiple axial portions depending on how far in the connect is screwed the cap is capable of an interference fit at two different axial points between two different connectors. It is suggested the claims further provide structure to the first and second axial portions in order to overcome the current rejection).
With regard to claim 2, Solomon discloses wherein the first connector is a female luer connector (see 302) comprising a threaded outer surface that engages the inner surface of the sidewall of the housing (see distal end of 302 threads cooperate with the threaded inner surface of the cap as shown in Fig. 19a and 19b).
With regard to claim 3, Solomon discloses the claimed invention including the inner surface of the sidewall (510/512) with threads (531). The limitations regarding the female luer are not required to be taught by the prior art because the female connector is not positively claimed.
With regard to claim 4, Solomon discloses wherein the second connector comprises a male luer connector comprising a stem configured to be inserted into the absorbent support, such that the opening of the male luer connector is sealed by the seal mounted to the absorbent support ([0102], the first and second connector are not required to be taught in the prior art as they were not positively recited. However, Solomon does teach that the connector 302 could be of other types of ports and connectors thus suggesting a male connector).
With regard to claim 5, Solomon discloses the claimed invention. The limitations regarding the male luer are not required to be taught by the prior art because the first and second connector are not positively claimed.
With regard to claim 11, Solomon discloses wherein the housing is a single-molded part, comprising a rigid thermoplastic polymer comprising at least one of polyester, polycarbonate ([0121]), polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
With regard to claim 12, Solomon discloses wherein the absorbent support comprises a cylindrical member sized to be received within a substantially cylindrical cavity defined by a portion of the inner surface of the sidewall of the housing (see 532 inside the housing 510 as shown in Fig. 18).
With regard to claim 13, Solomon discloses wherein the absorbent support comprises a porous foam comprising a thermoplastic elastomeric material ([0061]).
With regard to claim 14, Solomon discloses wherein insertion of the first or second connector into the cap causes the connector to contact the absorbent support (shown in Fig. 19b), and wherein contact between the connector and the absorbent support mechanically removes objects from an outer surface of the connector ([0120], 533 is the antiseptic in the support member. This is better described in [0042] with regard to a different embodiment however the antiseptic applies to the embodiment of Fig. 18 and 19a as well).
With regard to claim 16, Solomon discloses wherein the seal comprises a closed cell foam ([0064], while this is in description of a sealing member from a different embodiment, the materials used also apply to the embodiment of Fig. 18. Silicone is a closed cell foam).
With regard to claim 17, Solomon discloses further comprising a removable protective cover (1086, Fig. 24, [0137] teach packaging of the caps in the previous embodiments and shows a removable cover 1086) attached to the open second end of the housing for protecting an interior of the housing and the absorbent support prior to use.
With regard to claim 18, Solomon discloses wherein the absorbent support is shaped to clean and/or disinfect a distal portion and outer surface of a female connector and a tip and outer surface of a stem and inner surface of an annular shield of a male connector (as shown in Fig. 19a and 19b).
With regard to claim 19, Solomon discloses further comprising at least one ramp protrusion (Fig. 18, see 531) extending inwardly from the inner surface of the housing positioned to contribute to the engagement between the second connector and the cap (shown in Fig. 19b).
With regard to claim 20, Solomon discloses a cap (Fig. 18, 19a, 19b, element 502) configured to engage at least a first connector and a second connector of different types (302), the cap comprising: a housing (510 and 512) comprising a first end (513), an open second end (at 530), a sidewall (510/512) extending between the first end and the second end, at least one prong (531) extending inwardly from an inner surface of the sidewall, and at least one axially-extending ramp protrusion extending inwardly from the inner surface of the sidewall (531, there are 4 threads shown in Fig. 18 and thus one of the threaded areas is a ramp protrusion that extends axially inward); an absorbent support (532) positioned in the housing configured to contact portions of the first connector or the second connector inserted into the housing; and a seal (541) mounted to a portion of the absorbent support configured to cover an opening of the first connector or the second connector when one of the first connector or the second connector is inserted into the housing (as shown in Fig. 19b), wherein the at least one prong is configured to rotationally engage threads of the first connector for securing the first connector to the cap (as shown in Fig. 19b), and the at least one ramp protrusion is configured to form a friction engagement with the second connector for securing the second connector to the cap (one of the other 4 threads, the first and second connector are not positively claimed and therefore not required to be taught by the prior art. Element 531 would be capable of being used to contact and first and second connector).
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solomon et al. (US 2011/0213341 A1).
With regard to claim 15, Solomon discloses further comprising a cleaning or disinfecting solution (533) absorbed by the absorbent support and includes chlorhexidine gluconate ([0062] and IPA ([0062]). While Solomon does not explicitly teach the specific amounts of each component, it would be prima facie obvious to optimize the specific concentrations of the disinfecting solution to be about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA as doing so would not alter the overall function of the device.
Claim(s) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solomon et al. (US 2011/0213341 A1) in view of Jarnagin et al. (WO 2007/103998 A2).
With regard to claim 6, Solomon discloses the claimed invention except for a flexible proximal portion on the housing.
Jarnagin teaches a cap for a luer member similar to that of Solomon (see Fig. 6 and 7) and further includes sidewalls (at 115) that flexible and configured to press against and deform to accommodate portions of the first connector or the second connector when the first or second connector is inserted into the housing ([0094], slits in the sidewall allow it to flex when engaging the luer).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Solomon to have flexible sidewalls as taught by Jarnagin for the purpose of providing secure attachment the connector element ([0094]).
With regard to claim 7, Solomon discloses the claimed invention except for the flexible portions.
Jarnagin teaches wherein the flexible portion of the sidewall (at 115) is configured to extend radially outwardly to accommodate portions of the first connector or the second connector having an outer diameter larger than an inner diameter of the sidewall in an unbiased state ([0094]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Solomon to have flexible sidewalls as taught by Jarnagin for the purpose of providing secure attachment the connector element ([0094]).
With regard to claim 8, Solomon discloses the claimed invention except for the flexible sidewalls.
Jarnagin teaches wherein the flexible portion deforms to form an interference engagement with the outer surface of the second connector ([0094]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Solomon to have flexible sidewalls as taught by Jarnagin for the purpose of providing secure attachment the connector element ([0094]).
With regard to claim 9, Solomon discloses wherein the sidewall further comprises a rigid portion that does not deform when the first connector or the second connector is inserted into the housing (cap walls 510 and 512 are not designed to flex out ward and are therefore considered to be rigid particularly at the closed end).
With regard to claim 10, Solomon discloses wherein the rigid portion comprises a threaded inner (531) surface configured to engage a corresponding threaded outer surface of the first connector.
Allowable Subject Matter
Claim 21 is 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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