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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/11/2025 has been entered.
Claim Objections
Claim 19 is objected to because of the following informalities: Line 4 reading “a catheter” should read –the catheter--. 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, 3, 5, 8, 11, 19, 59-65, and 67-70 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich et al. (USPGPub 2021/0228781) in view of Fischer (USPGPub 2004/0068241).
Re Claim 1, Scherich teaches a catheter extender-lengthener (Scherich Figs. 1A-1B), comprising: a first connector (32), said first connector (32) being suitable to engage with a corresponding connector of a catheter or a catheter extension set (12) (Scherich ¶ 0031); at least one catheter extender-lengthener tube (34) proceeding from said first connector (32), said catheter extender-lengthener tube (34) having a catheter extender-lengthener tube wall (46, 48) (Scherich ¶ 0038); and a second connector (40) proceeding from said catheter extender-lengthener tube (34) (Scherich ¶ 0031), wherein said catheter extender-lengthener tube wall (46, 48) comprises a polymer and an antibiotic mixture (Scherich ¶ 0036-0037; Fig. 1B), wherein the antibiotic mixture is distributed throughout the catheter extender-lengthener tube wall (Scherich ¶ 0036-0037; Fig. 1B). However, Scherich fails to teach the antibiotic mixture comprising at least 2% by weight of minocycline and rifampin.
Fischer teaches tubing comprising a polymer and an antibiotic mixture comprising at least 2% by weight of minocycline and rifampin distributed throughout the tube (Fischer ¶ 0008, 0027, 0054) for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the antibiotic mixture distributed throughout the catheter extender-lengthener tube wall of Scherich comprise at least 2% by weight of minocycline and rifampin as disclosed by Fischer for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031). The limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said antibiotic mixture to form the catheter extender-lengthener tube wall” is being considered a product-by-process limitation. Patentability is assessed based on the product itself. If the product is identical or obvious in view of prior art, the claim is unpatentable, regardless of the process used to make it (See MPEP 2113).
Re Claim 3, Scherich in view of Fischer teach all of the limitations of Claim 1. The limitation “wherein said polymer and said antibiotic mixture exist together in said material by mixing at a molecular level, or in the form of particulate blended with surrounding material, or in the form of a co-continuous network, or in discrete phases” is being considered a product-by-process limitation. Patentability is assessed based on the product itself. If the product is identical or obvious in view of prior art, the claim is unpatentable, regardless of the process used to make it (See MPEP 2113).
Re Claim 5, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich fails to teach wherein said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said antibiotic mixture, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days. Fischer teaches wherein the tube wall is capable of releasing a therapeutic amount of said antibiotic mixture for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the catheter extender-lengthener tube wall of Scherich in view of Fischer be capable of releasing a therapeutic amount of said antibiotic mixture, to a fluid contained within said catheter extender-lengthener tube as disclosed by Fischer for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031). Furthermore, the limitation “for at least 30 days” is being determined to be an implicit disclosure in prior art Fischer which necessarily possesses the same time of releasing a therapeutic amount of said antibiotic mixture (See MPEP 2112).
Re Claim 8, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich teaches wherein said polymer is silicone (Scherich ¶ 0032-0033). Furthermore, examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Re Claim 11, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich fails to teach wherein said catheter extender-lengthener tube wall comprises an inner layer and an outer layer, wherein said inner layer comprises said polymer and said antibiotic mixture and said outer layer does not contain any of said antibiotic mixture, or wherein said catheter extender-lengthener tube comprises, for a first portion of its length, a first material that comprises said polymer and said antibiotic mixture, and comprises, for a second portion of its length, a second material that does not comprise any of said antibiotic mixture. Fischer teaches wherein said tubing wall comprises an inner layer (12) and an outer layer (14) (Fischer Fig. 1), wherein said inner layer comprises said polymer and said antibiotic mixture and said outer layer does not contain any of said antibiotic mixture (Scherich ¶ 0038-0040) for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections within a patient (Fischer ¶ 0030-0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the catheter extender-lengthener tube wall of Scherich in view of Fischer comprise an inner layer and an outer layer, wherein said inner layer comprises said polymer and said antibiotic mixture and said outer layer does not contain any of said antibiotic mixture as disclosed by Fischer for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections within a patient (Fischer ¶ 0030-0031).
Re Claim 19, Scherich teaches a catheter extender-lengthener (Scherich Figs. 1A-1B) for use with a catheter (20), said catheter extender-lengthener comprising: a first connector (32), said first connector (32) being suitable to engage with a corresponding connector of the catheter (20) or a catheter extension set (12) (Scherich ¶ 0031); a catheter extender-lengthener tube (34) proceeding from said first connector (32), said catheter extender-lengthener tube (34) having a catheter extender-lengthener tube wall (46, 48) comprising a polymer (Scherich ¶ 0038), and an antibiotic mixture, wherein the antibiotic mixture is distributed throughout the catheter extender-lengthener tube wall (46, 48) (Scherich ¶ 0036-0037; Fig. 1B); and a second connector (40) proceeding from said catheter extender-lengthener tube (34) (Scherich ¶ 0031); said first connector (32), said catheter extender-lengthener tube (34), and said second connector (40) defining a lumen (44) extending therethrough, further comprising a clamp disposed on said catheter extender-lengthener tube (34) having at a location on said catheter extender-lengthener tube (Scherich Fig. 1A showing clamp on extension tube 34), wherein when said clamp is in the location on said catheter extender-lengthener tube (34), fluid inside said lumen (44) on one side of said clamp is exposed to said polymer and said antibiotic mixture, and fluid inside said lumen (44) on an opposite side of said clamp is exposed to said polymer and said antibiotic mixture. However, Scherich fails to teach the antibiotic mixture comprising minocycline and rifampin.
Fischer teaches tubing comprising a polymer and an antibiotic mixture comprising minocycline and rifampin distributed throughout the tube (Fischer ¶ 0008, 0027, 0054) for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections, both gram positive and gram negative (Fischer ¶ 0030-0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the antibiotic mixture distributed throughout the catheter extender-lengthener tube wall of Scherich comprise minocycline and rifampin as disclosed by Fischer for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections, both gram positive and gram negative (Fischer ¶ 0030-0031).
Re Claims 59-61, Scherich in view of Fischer teach all of the limitations of Claim 19. The Claim 59 limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said antibiotic mixture to form the catheter extender-lengthener tube wall” is being considered a product-by-process limitation. Likewise, the Claim 60 and 61 limitations “wherein the melt processing comprises molding” and “wherein the melt processing comprises extrusion” are also being considered product-by-process limitations. Patentability is assessed based on the product itself. If the product is identical or obvious in view of prior art, the claim is unpatentable, regardless of the process used to make it (See MPEP 2113).
Re Claim 62, Scherich in view of Fischer teach all of the limitations of Claim 19. Scherich fails to teach wherein said catheter extender-lengthener tube wall comprises said antibiotic mixture in an amount of at least 5% (w/w). Fischer teaches tubing comprising a polymer and an antibiotic mixture comprises said antibiotic mixture in an amount of at least 5% (w/w) (Fischer ¶ 0008, 0027, 0054) for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the antibiotic mixture distributed throughout the catheter extender-lengthener tube wall of Scherich in view of Fischer comprise said antibiotic mixture in an amount of at least 5% (w/w) as disclosed by Fischer for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031).
Re Claims 63 and 64, Scherich in view of Fischer teach all of the limitations of Claim 1. The Claim 63 and 64 limitations “wherein the melt processing comprises molding” and “wherein the melt processing comprises extrusion” are being considered product-by-process limitations. Patentability is assessed based on the product itself. If the product is identical or obvious in view of prior art, the claim is unpatentable, regardless of the process used to make it (See MPEP 2113).
Re Claim 65, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich fails to teach wherein said catheter extender-lengthener tube wall comprises said antibiotic mixture in an amount of at least 5% (w/w). Fischer teaches tubing comprising a polymer and an antibiotic mixture comprises said antibiotic mixture in an amount of at least 5% (w/w) (Fischer ¶ 0008, 0027, 0054) for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the antibiotic mixture distributed throughout the catheter extender-lengthener tube wall of Scherich in view of Fischer comprise said antibiotic mixture in an amount of at least 5% (w/w) as disclosed by Fischer for the purpose of combination therapy for treatment, inhibition, and/or prevention of microbial infections (Fischer ¶ 0030-0031).
Re Claim 67, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich further teaches wherein the at least one catheter extender-lengthener tube comprises an inner wall (48) and an outer wall (46), and wherein one of the inner wall (48) or the outer wall (46) comprises the tube wall (46, 48) comprising the antibiotic mixture (Scherich ¶ 0036-0037; Fig. 1B).
Re Claim 68, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich further teaches wherein the at least one catheter extender-lengthener tube comprises segments (distal end, proximal end), and at least one of the segments comprises the tube wall (46, 48) comprising the antibiotic mixture (Scherich ¶ 0036-0037; Fig. 1B).
Re Claim 69, Scherich in view of Fischer teach all of the limitations of Claim 19. Scherich further teaches wherein the at least one catheter extender-lengthener tube comprises an inner wall (48) and an outer wall (46), and wherein one of the inner wall (48) or the outer wall (46) comprises the tube wall (46, 48) comprising the antibiotic mixture (Scherich ¶ 0036-0037; Fig. 1B).
Re Claim 70, Scherich in view of Fischer teach all of the limitations of Claim 19. Scherich further teaches wherein the at least one catheter extender-lengthener tube comprises segments (distal end, proximal end), and at least one of the segments comprises the tube wall (46, 48) comprising the antibiotic mixture (Scherich ¶ 0036-0037; Fig. 1B).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich et al. (USPGPub 2021/0228781) in view of Fischer (USPGPub 2004/0068241) as applied to Claim 1 above, and further in view of Naheed (USPGPub 2017/0020941).
Re Claim 9, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich in view of Fischer fail to teach wherein said polymer comprises ethylene vinyl acetate and a release modifying material comprising polyethylene glycol or polycaprolactone or both. Naheed discloses polymeric coatings for medication delivery including minocycline (Naheed ¶ 0030) wherein the polymeric layers include ethylene vinyl acetate (Naheed ¶ 0020), a release modifying material comprising polyethylene glycol (Naheed ¶ 0216) or polycaprolactone (Naheed ¶ 0217) or both where Naheed discloses that these polymers are suitable for controlling/delivering antimicrobial agents including minocycline (Naheed ¶ 0030). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the polymer of Scherich in view of Fischer comprise ethylene vinyl acetate and a release modifying material comprising polyethylene glycol or polycaprolactone or both as disclosed by Naheed where Naheed discloses that these polymers are suitable for controlling/delivering antimicrobial agents including minocycline (Naheed ¶ 0030).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich et al. (USPGPub 2021/0228781) in view of Fischer (USPGPub 2004/0068241) as applied to Claim 1 above, and further in view of Ziebol et al. (USPGPub 2021/0205596).
Re Claim 17, Scherich in view of Fischer teach all of the limitations of Claim 1. Scherich in view of Fischer fail to teach the catheter extender-lengthener in combination with a cap that is mateable to said second connector, said cap being capable of releasing an antimicrobial substance. Ziebol teaches tubing (22) in combination with a cap (30) that is mateable to a connector (40) (Ziebol Figs. 3A-4F’), said cap (30’) being capable of releasing an antimicrobial substance to inhibit and/or prevent microbial infections through the connector (Ziebol ¶ 0269-0276). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the catheter extender-lengthener of Scherich in view of Fischer be in combination with a cap that is mateable to said second connector, said cap being capable of releasing an antimicrobial substance, a similar configuration as disclosed by Ziebol for inhibiting and/or preventing microbial infections through the second connector (Ziebol ¶ 0269-0276).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich et al. (USPGPub 2021/0228781) in view of Fischer (USPGPub 2004/0068241) as applied to Claim 19 above, and further in view of Lucchino et al. (USPGPub 2016/0235893).
Re Claim 26, Scherich in view of Fischer teach all of the limitations of Claim 19. Scherich in view of Fischer fail to teach wherein said catheter extender-lengthener tube has texturing on an internal surface thereof. Lucchino teaches tubing having texturing on an internal surface thereof to contribute to the internal surfaces resistance (or lack thereof) to protein adsorption and/or cell/microorganism adhesion (Lucchino ¶ 0114-0115). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the catheter extender-lengthener tube of Scherich in view of Fischer have texturing on an internal surface thereof, as disclosed by Lucchino to contribute to the internal surfaces resistance (or lack thereof) to protein adsorption and/or cell/microorganism adhesion (Lucchino ¶ 0114-0115).
Allowable Subject Matter
Claims 15 and 22 are 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. The prior art neither anticipates nor makes obvious the Claim 15 limitation wherein said catheter extender-lengthener tube comprises 60% (w/w) of ethylene vinyl acetate, 10% of polyethylene glycol, 10% of polycaprolactone, 10% of the minocycline, and 10% of the rifampin. Likewise, the prior art neither anticipates nor makes obvious the Claim 22 limitation wherein said cap comprises said polymer and said antibiotic mixture, wherein said polymer and said antibiotic mixture are in a projection that is attached to or integral with said cap, and wherein when said cap is mated with said second connector, said projection extends through said clamp.
Response to Arguments
Applicant’s arguments filed 08/11/2025 with respect to 112 indefinite rejections have been fully considered and are persuasive. Due to clarifying amendments, all 112 indefinite rejections are hereinafter withdrawn.
Applicant’s arguments with respect to Claims 1, 3, 5, 8-9, 11, 17, 19, 26, 59-65 and 67-70 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/18/2026
