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) 1-4, 6, 8-10, 12-14, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eddy (US 2014/0276456 A1).
With regard to claim 1, Eddy discloses A needleless access connector ([0017]) having a valve comprising an antimicrobial agent (Fig. 1 and 2; [0004], [0017]), wherein the valve has a porous top surface that includes the antimicrobial (opening of valve at 25a, [0022]).
With regard to claim 2, Eddy discloses wherein a top surface of the valve comprises a silicone elastomer ([0004], [0022], [0026], [0027]).
With regard to claim 3, Eddy discloses wherein the valve includes an insert (36 or 24 could be considered the insert) near the porous top surface of the valve, wherein the insert comprises an antimicrobial coating thereon which includes the antimicrobial agent ([0022]).
With regard to claim 4, Eddy discloses wherein the insert has a top surface (40b) that is flat and near the porous top surface of the valve.
With regard to claim 6, Eddy discloses wherein the insert is rigid (element 24 is a rigid insert) and comprises a rigid polymeric material ([0020]).
With regard to claim 8, Eddy discloses wherein the valve has a series of groves (43) or textured pattern containing an antimicrobial formulation including the antimicrobial agent (element 36 contains the antimicrobial).
With regard to claim 9, Eddy discloses wherein the valve has an antimicrobial coating including the antimicrobial agent on a hydrophilic surface of the valve ([0022], entire valve may be wiped, sprayed, or dipped in the antimicrobial material).
With regard to claim 10, Eddy discloses wherein the valve is made of a material that includes the antimicrobial agent (0022], [0023]).
With regard to claim 12, Eddy discloses wherein the valve material includes the antimicrobial agent by injecting an antimicrobial formulation into a top surface of the valve (this is being a considered a product by process claim as the process the of injecting the antimicrobial appears to be a method of manufacturing type step., Therefore, the claim must only teach the structure recited of a top surface of the valve having the antimicrobial [0022], [0023]).
With regard to claim 13, Eddy discloses wherein the antimicrobial formulation is a sustained release antimicrobial formulation ([0024], [0025], the antimicrobial resists being rubbed off during use and therefore continues to provide continual protection against contamination for a long duration).
With regard to claim 14, Eddy discloses wherein the sustained release antimicrobial formulation comprises a biodegradable polymer, a mesh forming polymer, a temperature/pH sensitive polymer ([0022]) or combinations thereof ([0024], [0025]).
With regard to claim 18, Eddy discloses A needleless access connector (Fig. 1 and 2, [0017]) having a valve comprising an antimicrobial agent ([0004], [0017]), wherein the valve is the only component of the needleless access connector including an antimicrobial agent (see Fig. 2), and wherein the valve is the only component of the needleless connector including the antimicrobial agent (the entire device of Fig. 1 is the valve of the connector and thus this is the only part considered to have antimicrobial agent. [0004], [0006], Eddy describes the connector as being the valve itself and therefore the entire structure shown in Fig. 1 is the valve. The claims also don’t recited any separate structure between the valve and the needleless connector, thus the only component of the needleless connector is the valve).
Claim(s) 1, 3, 5, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leinsing et al. (US 2003/0209681 A1).
With regard to claim 1, Leinsing discloses A needleless access connector (Fig. 2) having a valve comprising an antimicrobial agent ([0048]) wherein the valve has a porous top surface (top surface 54 includes opening 64 making it porous).
With regard to claim 3, Leinsing discloses wherein the valve includes an insert (38) near the porous top surface of the valve, wherein the insert comprises an antimicrobial coating thereon which includes the antimicrobial agent ([0048]).
With regard to claim 5, Leinsing discloses wherein the insert has a top surface (fig 6, at 68) that includes pockets or crevices (75, 74) and the antimicrobial coating is included in the pockets or crevices ([0048]).
With regard to claim 7, Leinsing discloses wherein the valve has a series of tunnels or bores (64 then through to 74 and 75) within the top surface of the valve and the tunnels and/or bores contain an antimicrobial formulation including the antimicrobial agent ([0048]).
Claim(s) 18, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crawford et al. (US 2007/0293822 A1).
With regard to claim 18, Crawford discloses A needleless access connector (ex, Fig. 10) having a valve comprising an antimicrobial agent ([0008]), wherein the valve is the only component of the needleless access connector including an antimicrobial agent (Fig. 10) and wherein the valve is the only component of the needleless connector including the antimicrobial agent (the entire device of Fig. 10 is the valve of the connector and thus this is the only part considered to have antimicrobial agent. [0008], Crawford describes the connector as being the valve itself and therefore the entire structure shown in Fig. 10 is the valve. The claims also don’t recited any separate structure between the valve and the needleless connector, thus the only component of the needleless connector is the valve)..
With regard to claim 19, Crawford discloses wherein only a top surface of the valve includes the antimicrobial agent ([0008, top surface of septum is swapped with a pad containing antimicrobial agent).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eddy (US 2014/0276456 A1) in view of Nelson (US 2006/0287722 A1).
With regard to claim 11, Eddy discloses the valve material comprising silicone elastomer and antimicrobial agent ([0022]).
However, Eddy does not disclose the use of a fluoropolymer.
Nelson teaches a valve that may be made with a silicone elastomer, antimicrobial and a fluoropolymer ([0050], [0070]).
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 materials of Eddy to include a fluoropolymer as taught by Nelson because the substitution of one material for another is well known in the art and would not affect the overall function of the device.
Claim(s) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eddy (US 2014/0276456 A1) in view of Waller et al. (US 2020/0214900 A1).
With regard to claim 15 and 20, Eddy discloses the claimed invention except for the use of cyanoacrylate.
Waller teaches the use of cyanoacrylate for its antimicrobial properties (Abstract).
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 materials of Eddy to cyanoacrylate as taught by Waller for the purpose of its antimicrobial properties (abstract). Further a simple substitution of one delivery agent for another is well known in the art and would not alter the overall function of the device.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eddy (US 2014/0276456 A1) in view of Ziebol et al. (US 2020/0139104 A1).
With regard to claim 16, Eddy discloses the claimed invention except for the use of chlorohexidine salt.
Ziebol teaches the use of chlorhexidine salt as part of the antimicrobial agent ([0245]).
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 materials of Eddy with the chlorohexidine salt as taught by Ziebol for the purpose of controlling release of the antimicrobial agent ([0245]). Further a simple substitution of one delivery agent for another is well known in the art and would not alter the overall function of the device.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eddy (US 2014/0276456 A1).
With regard to claim 17, Eddy discloses the use of an antimicrobial agent in a coating on the valve ([0022], [0024], [0025]).
However, Eddy does not explicitly disclose the agent comprising 0.5 to about 50 parts by weight compared to 100 parts by weight of a formulation to form the coating.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention for Eddy to optimize the ratio between the antimicrobial agent and the formulation as doing so is well known in the art and would not alter the overall function of the device.
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 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,029,835 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 and 18 of the present invention is a broader version of claim 1 of U.S. Patent No. 12,029,835 B2 including the limitations of a needless access connector having a valve comprising an antimicrobial agent, the valve having a porous top that includes the antimicrobial agent.
Further dependent claims of the present invention recite similar subject matter as that of the dependent claims of U.S. Patent No. 12,029,835 B2 as outlined below:
Present Invention
U.S. Patent No. 12,029,835 B2
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Conclusion
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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