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 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) 1-11, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aalto et al (US 4,597,758) in view of Solomon et al (US 2012/0039764).
Regarding claim 1, Aalto discloses a cap 34 comprising: a housing comprising a top wall 38, a sidewall having an inner surface defining a cavity (fig 2), an open bottom 40 formed by said cylindrical sidewall with an opening to the cavity within said housing (fig 2) for receiving a hub of a male luer connector (fig 5); an outer thread 42 (fig 5) on said outer surface of the cylindrical sidewall, said outer thread being sufficient to interlock with a mating feature of said male luer connector (fig 5); a ball 36 (Col.3 ll 43) disposed within the cavity (fig 2).
While Aalto substantially discloses the invention as claimed, it does not disclose a disinfectant or antimicrobial agent.
Solomon discloses a disinfecting cap which has an elastomeric foam (¶120; including silicone which Aalto’s ball is made of) which also has an antiseptic (¶121).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Aalto such that in includes a disinfectant or antimicrobial agent in the ball as taught by Solomon to disinfect an inserted male luer connector.
Regarding claim 2, wherein when a hub of said male luer connector is received within said inner surface of said cavity (fig 5), said hub is secured within said inner surface of said cavity by interlocking at least a portion of said outer thread 42 with a mating feature 24 on said hub of said male luer connector (fig 5).
Regarding claim 3, wherein said cavity extends essentially from an inner surface of said top wall toward said open bottom of said housing (fig 5).
Regarding claims 4 and 5, while Aalto substantially discloses the invention as claimed, it does not disclose wherein the thread has an inclined thread pattern or a helical-shaped thread pattern.
Solomon discloses luer connectors, similar to Aalto, but the female connector has an inclined/helical-shaped thread 114 pattern (fig 5).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Aalto such that the thread has an inclined thread pattern or a helical-shaped thread pattern as taught by Solomon as the threads of Solomon are more robust than the threads of Aalto (the threads of Aalto being very small). Further, it is now well settled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F2d 846, 205 USPQ 1069, CCPA 1980, in the instant case using the threads from one cap on a different cap flows logically from them both being luer connectors.
Regarding claim 6, while Aalto substantially discloses the invention as claimed, it does not disclose a removable cover sealing said opening of the cavity to seal said ball and disinfectant or antimicrobial agent within said cavity prior to use of said cap.
Solomon discloses a removable cover 1034 sealing said opening of the cavity (fig 10) to seal the disinfectant or antimicrobial agent within said cavity prior to use of said cap (fig 10; ¶123 of Solomon).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Aalto such that it includes a removable cover sealing said opening of the cavity to seal said ball and disinfectant or antimicrobial agent within said cavity prior to use of said cap as taught by Solomon to prevent the disinfectant or antimicrobial agent from evaporating and maintain the sterility of the cap until use.
Regarding claim 7, wherein an exterior wall surface of the sidewall of the housing includes a plurality of grip members 58 (fig 5).
Regarding claim 8, wherein the upper portion of the sidewall is tapered outward toward the top wall and the lower portion of the sidewall is cylindrical (fig 1).
Regarding claim 9, wherein the upper portion of the sidewall includes a slanted surface (fig 1).
Regarding claim 10, wherein the slanted surface includes one or more finger grips 58.
Regarding claim 11, while Aalto substantially discloses the invention as claimed, it does not disclose the one or more finger grips are made of an elastomeric material.
Solomon discloses its finger grips may have an elastomeric coating having a relatively high coefficient of friction (¶117).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Aalto such that the one or more finger grips are made of an elastomeric material as taught by Solomon to allow it be gripped with decrease likelihood of slipping.
Regarding claims 14 and 15, while Aalto substantially discloses the invention as claimed, it does not disclose the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.
See the combination in claim 1 adding an antiseptic to Aalto via Solomon. Solomon discloses the use of chlorhexidine gluconate (¶113) as an antiseptic.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aalto et al (US 4,597,758) in view of Solomon et al (US 2012/0039764) and Bedoe et al (US 10,828,484).
The examiner notes that there are multiple interpretation for “further comprising an absorbent material”. While one is that it is claiming a separate structure such as in Applicant’s fig 12B (and is treated as so below) as the examiner believes that is what Applicant intended, it is not considered an unreasonable interpretation to interpret the that any of the materials of the structures already claimed could also meet the limitation (for example the ball being made of an absorbent material).
Regarding claim 12, while Aalto substantially discloses the invention as claimed, it does not disclose further comprising an absorbent material disposed within the cavity.
Bedoe discloses a foam ring 1014 (fig 3; which is an absorbent material) that is infused with a disinfecting solution (Col.5 ll 28-33). Said foam ring will disinfect the exterior surface of the inserted connector.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Aalto such that it further comprises an absorbent material disposed within the cavity as taught by Bedoe to disinfect the exterior surface of the connector.
Regarding claim 13, see claim 12 above, the absorbent material of Bedoe is a foam and when compressed by an inserted male luer connector (which is tapered) will compress both radially and toward the top wall of the housing upon connection to the male luer connector.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,975,168. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally broader claims and any differences are obvious in view of the references used in the art rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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