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 .
Specification
The amended abstract filed 3/16/2026 is acceptable and overcomes the objection set forth in the last Office Action.
Claim Objections
Claim 22 is objected to because of the following informalities: Line 3 has been amended to recite “the plurality of of catheter components”; one occurrence of the term “of” in this phrase should be removed in order to be grammatically correct. Appropriate correction is required.
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.
Claims 1, 6-11, 13-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sansoucy (PG PUB 2012/0083750) in view of Shevgoor et al. (PG PUB 2015/0231307).
Re claim 1, Sansoucy discloses an antimicrobial catheter 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 2 unless otherwise noted), comprising: a catheter tube 14; a catheter hub 12, a proximal-end portion of the catheter tube coupled to the catheter hub (as seen in Fig 1); one or more extension legs 16,18, a distal-end portion of each extension leg of the one-or-more extension legs coupled to the catheter hub (as seen in Fig 1); one or more extension-leg fittings 100a,100b, a proximal-end portion of each extension leg of the one-or-more extension legs coupled to a respective extension-leg fitting of the one-or-more extension-leg fittings (as seen in Fig 1); and one or more polymeric inserts 130+140 including an antimicrobial filler (in layer 130, Para 32) and a hydrophilic base polymer (in layer 140, Para 33), each polymeric insert of the one or more polymeric inserts providing at least a portion of a luminal surface in a catheter component selected from the catheter tube, the catheter hub, the one or more extension legs, and the one or more extension-leg fittings (as seen in Fig 2, the inserts provides a portion of a luminal surface of the fitting 100a,100b), and each polymeric insert of the one or more polymeric inserts configured to elute one or more antimicrobial metal species 136a (Fig 7; Para 34) therefrom upon contact with a liquid (Para 13). Sansoucy does not explicitly disclose that the antimicrobial filler forms a filled polymer with the base polymer or that the one or more polymeric inserts is molded from the filled polymer.
Shevgoor, however, teaches an antimicrobial catheter 200 (Fig 2A) including a polymeric insert 201 (Fig 2A) that is molded (Para 49) from a filled polymer including an antimicrobial filler (“antimicrobial agent”, Para 41) in a base polymer (“base material”, Para 41; “the base material comprises a hydrophilic polymer”, Para 45) and that is configured to elute one or more antimicrobial species therefrom upon contact with a liquid (Para 9); Shevgoor teaches that molding the insert from a filled polymer that includes both the antimicrobial filler and the base polymer (as opposed to the antimicrobial filler and the base polymer being in different layers as in Sansoucy) easing and reducing the cost of manufacturing (Para 63). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sansoucy to include the one or more polymeric inserts such that they are molded from a filled polymer including an antimicrobial filler in a base polymer (as opposed to forming the inserts by stacking a layer having an antimicrobial filler on a layer having a base polymer), as taught by Shevgoor, for the purpose of easing and reducing the cost of manufacturing (Para 63). To reiterate, the modification being made is simply to provide the insert of Sansoucy with the antimicrobial filler in the base polymer, instead of separated therefrom in a different layer; the type of polymer used and antimicrobial filler used is not changed.
Re claim 6, Sansoucy discloses that each extension-leg fitting of the one-or-more extension-leg fittings includes at least one polymeric insert of the one-or-more polymeric inserts (as seen in Fig 2).
Re claim 7, Sansoucy discloses that the filled polymer of a respective polymeric insert of the one or more polymeric inserts includes a same base polymer as that of the catheter component including the polymeric insert (Para 33 and Para 40 disclose that PET can be the base polymer of the insert and the polymer of the catheter component).
Re claim 8, Sansoucy discloses that the filled polymer of a respective polymeric insert of the one or more polymeric inserts includes a different base polymer than that of the catheter component including the polymeric insert (Para 33 sets forth that a base polymer of the insert can be polytetramethylene while Para 40 sets forth that the catheter component can include polyaryletherketone).
Re claim 9, Sansoucy discloses that the polymeric insert is overmolded in the catheter component (Para 30).
Re claim 10, Sansoucy discloses that the polymeric insert is inserted into the catheter component (Para 31).
Re claim 11, Sansoucy discloses that an antimicrobial filler (“zeolite materials 136”, Fig 7; Para 34) of the filled polymer includes a carrier (“zeolite materials 136”, Fig 7) of the one or more antimicrobial metal species (Para 34).
Re claim 13, Sansoucy discloses that the carrier is a zeolite 136 (Fig 7; Para 34) and the one or more antimicrobial metal species include antimicrobial cations selected from silver, copper, and zinc electrostatically held at ion-exchange sites of the zeolite (“ions 136a selected from the group including silver, copper, zinc”, Para 34).
Re claim 14, Sansoucy discloses that the liquid includes dissolved cations selected from sodium and potassium for ion exchange with the antimicrobial cations at the ion-exchange sites of the zeolite (it is noted that the “liquid” is not a part of the claimed invention and the claim only requires the antimicrobial cations be capable of ion exchanging with cations of sodium or potassium; this limitation is met in view of Para 19).
Re claim 15, Sansoucy discloses an antimicrobial catheter 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 2 unless otherwise noted), comprising: one or more polymeric inserts 130+140 including an antimicrobial filler (in layer 130, Para 32) and a hydrophilic base polymer (in layer 140, Para 33), each polymeric insert of the one or more polymeric inserts providing at least a portion of a luminal surface in a catheter component (as seen in Fig 2, the insert provides a portion of a luminal surface of the fittings 100a,100b) selected from a catheter tube 14, a catheter hub 12, one or more extension legs 16,18, and one or more extension-leg fittings100a,100b, and each polymeric insert of the one or more polymeric inserts configured to elute one or more antimicrobial metal cations 136a (Fig 7; Para 34) therefrom upon contact with a liquid including dissolved cations (Para 13, 19). Sansoucy does not explicitly disclose that the antimicrobial filler forms a filled polymer with the base polymer or that the one or more polymeric inserts is molded from the filled polymer.
Shevgoor, however, teaches an antimicrobial catheter 200 (Fig 2A) including a polymeric insert 201 (Fig 2A) that is molded (Para 49) from a filled polymer including an antimicrobial filler (“antimicrobial agent”, Para 41) in a base polymer (“base material”, Para 41; “the base material comprises a hydrophilic polymer”, Para 45) and that is configured to elute one or more antimicrobial species therefrom upon contact with a liquid (Para 9); Shevgoor teaches that molding the insert from a filled polymer that includes both the antimicrobial filler and the base polymer (as opposed to the antimicrobial filler and the base polymer being in different layers as in Sansoucy) easing and reducing the cost of manufacturing (Para 63). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sansoucy to include the one or more polymeric inserts such that they are molded from a filled polymer including an antimicrobial filler in a base polymer (as opposed to forming the inserts by stacking a layer having an antimicrobial filler on a layer having a base polymer), as taught by Shevgoor, for the purpose of easing and reducing the cost of manufacturing (Para 63). To reiterate, the modification being made is simply to provide the insert of Sansoucy with the antimicrobial filler in the base polymer, instead of separated therefrom in a different layer; the type of polymer used and antimicrobial filler used is not changed.
Re claim 16, Sansoucy discloses that each polymeric insert of the one or more polymeric inserts is overmolded in the catheter component (Para 30) or inserted into the catheter component (Para 31).
Re claim 17, Sansoucy discloses that the antimicrobial filler (“zeolite material 136”, Fig 7; Para 34) of the filled polymer includes a carrier (“zeolite material 136”, Fig 7; Para 34) of the one-or-more antimicrobial metal cations (Para 34), the carrier being a zeolite (Para 34) and the one-or-more antimicrobial cations selected from silver, copper, and zinc electrostatically held at ion-exchange sites of the zeolite (“ions 136a selected from the group including silver, copper, zinc”, Para 34) for ion exchange with sodium, potassium, or a combination thereof for the dissolved cations (Para 19).
Re claim 18, Sansoucy discloses a method of making antimicrobial catheters (Para 29-31), comprising: molding (“co-extruded”, Para 30) a plurality of polymeric inserts 130+140 (Fig 2) including a filled polymer (in layer 130, Para 33) and a hydrophilic base polymer (in layer 140, Para 33), each polymeric insert of the plurality of polymeric inserts configured to elute one or more antimicrobial metal species 136a (Fig 7; Para 34) therefrom upon contact with a liquid (Para 13); molding (“co-extruded”, Para 30) a plurality of catheter components of at least one type of catheter component selected from a catheter tube 14 (Fig 1), a catheter hub 12 (Fig 1), an extension leg 16,18 (Fig 1), and an extension-leg fitting 100a,100b (Fig 1), each catheter component of the plurality of catheter components having a luminal surface (as seen in Fig 2) and at least a portion of the luminal surface provided by one or more polymeric inserts of the plurality of polymeric inserts (as seen in Fig 2); and assembling the antimicrobial catheters from the catheter components (Para 30,31). Sansoucy does not explicitly disclose that the antimicrobial filler forms a filled polymer with the base polymer or that the one or more polymeric inserts is molded from the filled polymer.
Shevgoor, however, teaches an antimicrobial catheter 200 (Fig 2A) including a polymeric insert 201 (Fig 2A) that is molded (Para 49) from a filled polymer including an antimicrobial filler (“antimicrobial agent”, Para 41) in a base polymer (“base material”, Para 41; “the base material comprises a hydrophilic polymer”, Para 45) and that is configured to elute one or more antimicrobial species therefrom upon contact with a liquid (Para 9); Shevgoor teaches that molding the insert from a filled polymer that includes both the antimicrobial filler and the base polymer (as opposed to the antimicrobial filler and the base polymer being in different layers as in Sansoucy) easing and reducing the cost of manufacturing (Para 63). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sansoucy to include the one or more polymeric inserts such that they are molded from a filled polymer including an antimicrobial filler in a base polymer (as opposed to forming the inserts by stacking a layer having an antimicrobial filler on a layer having a base polymer), as taught by Shevgoor, for the purpose of easing and reducing the cost of manufacturing (Para 63). To reiterate, the modification being made is simply to provide the insert of Sansoucy with the antimicrobial filler in the base polymer, instead of separated therefrom in a different layer; the type of polymer used and antimicrobial filler used is not changed.
Re claim 20, Sansoucy discloses that the antimicrobial filler includes a zeolite 136 (Fig 7; Para 34), the one or more antimicrobial metal species including antimicrobial cations selected from silver, copper, and zinc electrostatically held at ion-exchange sites of the zeolite (“ions 136a selected from the group including silver, copper, zinc”, Para 34).
Re claim 21, Sansoucy discloses that the molding of the plurality of catheter components includes overmolding each catheter component over its one or more polymeric inserts (Para 30).
Re claim 22, Sansoucy discloses inserting the one or more polymeric inserts in their respective catheter component after the molding of the plurality of catheter components (Para 31).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sansoucy (PG PUB 2012/0083750)/Shevgoor et al. (PG PUB 2015/0231307) in view of Ofek et al. (PG PUB 2020/0000972).
Re claims 2, 4 and 5, Sansoucy discloses all the claimed features except explicitly disclosing that at least one polymeric insert (of the one or more polymeric inserts) is included in the catheter tube (as required by claim 2), the catheter hub (as required by claim 4), or each extension leg (of the one or more extension legs) (as required claim 5). Shevgoor teaches that inserts can be included in a variety of devices, including catheters (Para 39) but does not explicitly disclose placing the insert in the tube, hub or extension legs of catheters. Ofek, however, teaches providing an antimicrobial insert 90 (Fig 8; containing antimicrobial 42, Para 98) within various part a catheter 10 (Fig 1)(Para 78) including an extension leg fitting 19 (Fig 1,8; like in Sansoucy), an extension leg 18 (Fig 1), a catheter hub 16 (Fig 1) and a catheter tube 12 (Fig 1) (Para 78, 94-98) for the purpose of improving the ability of the catheter to resist microbial colonization (Para 78). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sansoucy/Shevgoor to include the polymeric insert in the catheter tube, the catheter hub and the extension leg in addition to the extension leg fitting, as taught by Ofek, for the purpose of improving the ability of the catheter to resist microbial colonization (Para 78).
Re claim 3, Sansoucy/Shevgoor discloses all the claimed features except that the catheter tube includes an antimicrobial compounded into the catheter tube different than the one or more antimicrobial metal species of the one or more polymeric inserts. Ofek, however, teaches using more than one antimicrobial compound in a catheter tube (Para 93), wherein one antimicrobial is compounded into the catheter tube and another antimicrobial is located on the interior surface of the catheter tube (Para 48) for the purpose of providing a wider range of antimicrobial protection (Para 93) and for providing protection to the outer surface of the catheter tube in addition to the inner surface (Para 48). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sansoucy/Shevgoor to include an antimicrobial compounded into the catheter tube that is different from that of the polymeric insert, as taught by Ofek, for the purpose of providing a wider range of antimicrobial protection (Para 93) and for providing protection to the outer surface of the catheter tube in addition to the inner surface (Para 48).
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sansoucy (PG PUB 2012/0083750)/Shevgoor et al. (PG PUB 2015/0231307) in view of Nishtala et al. (PG PUB 2010/0198195).
Re claim 12, Sansoucy discloses all the claimed features except that the antimicrobial filter is about 8-15% by weight of each polymeric insert of the one or more polymeric inserts. Shevgoor discloses that the antimicrobial filler can be between 0.1% - 40% by weight of the polymeric insert (Para 46), but does not disclose the more narrow range of about 8-15%. Nishtala, however, teaches that providing a polymeric insert with an antimicrobial filler (“oligodynamic metal salts”, Para 110) that is about 8-15% by weight of the polymeric insert (“between about 5% and about 15%”, Para 110) for the purpose of maintaining inhibition of microbial adherence on the surface of the polymeric insert while reducing the tissue exposure to the filler (Para 109). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the antimicrobial filter of Sansoucy/Shevgoor in an amount that is about 8-15% by weight of the polymeric insert, as taught by Nishtala, for the purpose of maintaining inhibition of microbial adherence on the surface of the polymeric insert while reducing the tissue exposure to the filler (Para 109).
Re claim 19, Sansoucy discloses compounding a base polymer with an antimicrobial filler for form the filled polymer (Para 30) but does not explicitly disclose that the antimicrobial filler is about 8-15% by weight of the filled polymer. Shevgoor discloses that the antimicrobial filler can be between 0.1% - 40% by weight of the polymeric insert (Para 46), but does not disclose the more narrow range of about 8-15%. Nishtala, however, teaches that providing a polymer filled with an antimicrobial filler (“oligodynamic metal salts”, Para 110) that is about 8-15% by weight of the polymeric insert (“between about 5% and about 15%”, Para 110) for the purpose of maintaining inhibition of microbial adherence on the surface of the filled polymer while reducing the tissue exposure to the filler (Para 109). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the antimicrobial filler of Sansoucy/Shevgoor in an amount that is about 8-15% by weight of the filled polymer, as taught by Nishtala, for the purpose of maintaining inhibition of microbial adherence on the surface of the polymeric insert while reducing the tissue exposure to the filler (Para 109).
Response to Arguments
Applicant’s arguments filed 3/16/2026 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. Specifically, the above-cited Shevgoor reference is utilized to teach the newly claimed feature that the one or more polymeric inserts are “molded form a filled polymer including an antimicrobial filler in a base polymer”.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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