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 .
Status of Claims
This office action is in response to the Amendments filed on February 20, 2025, claims 1, 15, 19, and 26 are amended; claims 27, 31, 35-37, 40, 42, 44, 45, 47, 51, 53, and 54 are cancelled; claims 59-66 are newly added. It is noted that although claims 19 and 26 are not indicated as being currently amended, the claims have been amended and thus, are considered to be currently amended. Appropriate clarification is required in subsequent responses. Currently, claims 1-3, 5, 7-9, 11, 15 17, 19, 21, 22, 26, and 59-66 are now pending and further examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19, 21, 22, 26, and 59-62 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 19, the recitation of “the permitted location” on line 15 is confusing because it is unclear what the antecedent basis for the recitation is. It is unclear whether the recitation referring to the at least one permitted location of lines 13-14; one of the at least one permitted location of lines 13-14; or another permitted location different from the at least one permitted location of lines 13-14. However, as best understood for the purpose of continuous examination, the recitation is interpreted as referring to the at least one permitted location of lines 13-14 and thus, is suggested to be recited as --the at least one permitted location-- to avoid the confusion. However, if applicant intends to require another different permitted location, appropriate clarifications is required.
Claims 21, 22, 26, and 59-62 are rejected for incorporating the above confusion through their respective claim dependencies.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, 11, 17, 63, and 64 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Zeibol (US Pat. No. 10,525,250 B1), or in the alternate, under 35 U.S.C. 103 as being obvious Zeibol (US Pat. No. 10,525,250 B1) in view of Ofek (US Pub. No. 2020/0000972 A1).
Claim 1. Zeibol discloses a catheter extender-lengthener, comprising:
a first connector (16), said first connector being suitable to engage with a corresponding connector of a catheter or a catheter extension set (Fig. 2C);
at least one catheter extender-lengthener tube (21) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of tube 21); and
a second connector (i.e., second connector) proceeding from said catheter extender-lengthener tube (col. 16, lines 61-65);
Moreover, since Zeibol further discloses that delivering an antimicrobial composition into a medical tube (col. 6, lines 1-16) and that the antimicrobial composition includes an antimicrobial agent and a hydrophilic water-soluble polymer (col. 23, lines 10-14), it follows that Zeibol discloses that said catheter extender-lengthener tube wall comprises a polymer and at least one antibiotic since the catheter extender-lengthener tube wall is the wall of a tube.
Examiner notes that the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113. As such, the limitations of the specifics of forming by melt processing of said polymer and said at least one antibiotic are being treated as functional limitations. Only structure of said polymer and said at least one antibiotic form the catheter extender-lengthener tube wall are being considered positively claimed. Applicant is required to identify non-obvious differences in structure between a catheter extender-lengthener tube wall comprising a polymer and at least one antibiotic formed by melt processing said polymer and said at least one antibiotic as described by the product-by-process limitations and a catheter extender-lengthener wall with a polymer and at least one antibiotic as disclosed by Zeibol, since the catheter extender-lengthener tube wall of Zeibol comprises a polymer and at least one antibiotic.
Alternatively, even if forming by melt processing requires a structural difference from the catheter extender-lengthener tube wall of Zeibol, it is noted that Ofek also discloses a catheter extender-lengthener with a connector (19) and a catheter extender-lengthener tube (18) having a catheter extender-lengthener tube wall (i.e., wall of tube 18), wherein said catheter extender-lengthener tube wall comprises a polymer ([0085]; i.e., polyurethane, silicone, polyvinyl chloride) and at least one antibiotic (i.e., antimicrobial) ([0086]), wherein the at least one antibiotic may be applied as a coating (42) or alternatively being extruded (90) ([0098]). Therefore, since both Zeibol and Ofek are drawn to catheter extender-lengtheners with antimicrobial, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the catheter extender-lengthener tube of Zeibol with the feature of the catheter extender-lengthener tube wall being formed by melt processing a polymer and an at least one antibiotic to form the catheter extender-lengthener tube wall comprising the polymer and the at least one antibiotic as disclosed by Ofek since Ofek discloses that a catheter tube wall comprising a polymer with an antimicrobial being applied as a coating or being extruded are known suitable alternative manners for including an antimicrobial material to the catheter extender-lengthener tube ([0098] of Ofek).
Claim 2. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, but both do not explicitly disclose that said at least one antibiotic is present in said catheter extender-lengthener tube wall at a concentration of at least 2% by weight. First, it is noted that the instant [00102] discloses the claimed concentration range as one of many possible ranges, the instant disclosure does not provide criticality for the claimed specific range. Second, it is noted that one of ordinary skill in the art would have known to adjust the concentration of the microbial agent to provide the desired effect including strength and duration. Moreover, Zeibol also discloses to provide a sufficient concentration of antimicrobial agent to the fluid path so as to kill microbes and prevent ingrowth of microbes wherein the concentration depends on the type of antimicrobial agent and the desired effect (col. 24, line 46 until col. 25, line 37). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Zeibol or Zeibol in view of Ofek to be an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including a concentration of at least 2% by weight, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Claim 3. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, wherein Zeibol or Zeibol in view of Ofek further discloses that said polymer and said at least one antibiotic 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 (col. 23, lines 10-14 of Zeibol and ([0098], [0113] of Ofek).
Claim 7. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, wherein Zeibol further discloses said at least one antibiotic is selected from the group consisting of: minocycline (col. 7, line 62); other members of the tetracyclines class of antibiotics; rifampicin (col. 7, line 62); other antimycobacterial drugs; ciprofloxacin; other fluoroquinolones; vancomycin; other glycopeptides; cephalosporins; penicillins; gentamicin; other aminoglycosides; sulfonamides; macrolides; carbapenems; linezolid; other oxazolidinones; daptomycin; other lipopeptides; and immunosuppressants.
Claim 11. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, wherein Zeibol further discloses that said catheter extender-lengthener tube wall comprises an inner layer (i.e., interior surface) and an outer layer (i.e., exterior surface), wherein said inner layer comprises said polymer and said at least one antibiotic and said outer layer does not contain any of said at least one antibiotic (col. 6, lines 1-16 and col. 23, lines 10-14 of Zeibol), or wherein said catheter extender-lengthener tube comprises, for a first portion of its length, a first material that comprises said polymer and said at least one antibiotic, and comprises, for a second portion of its length, a second material that does not comprise any of said at least one antibiotic.
Claim 17. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, Zeibol further discloses that the catheter extender-lengthener being usable in combination with a cap (i.e., cap) that is mateable to said second connector (col. 16, lines 63-65 of Zeibol), wherein said cap being capable of releasing an antimicrobial substance (col. 19, lines 4-5 of Zeibol).
Claims 63 and 64. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, wherein Zeibol does not explicitly disclose that the melt processing comprises molding (as per claim 63) or extrusion (as per claim 64). However, these limitations are only further limits a product-by-process limitation since the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall, see above for additional details. Therefore, since Zeibol discloses the structures required as explained above, Zeibol discloses the required structures for the claimed catheter extender-lengthener.
Alternatively, Zeibol in view of Ofek further discloses molding and extrusion ([0098] of Ofek).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zeibol (US Pat. No. 10,525,250 B1) in view of Ofek (US Pub. No. 2020/0000972 A1).
Claim 5. Zeibol discloses the catheter extender-lengthener of claim 1, wherein Zeibol further discloses that said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube (col. 23, lines 3-27) but does not explicitly disclose for at least 30 days. However, Ofek further discloses that catheters left in patient for extended time could result in bacterial colonization causing catheter-related sepsis ([0002]), therefore the desired level of antimicrobial efficacy for the antimicrobial depends on the indwelling time among other factors ([0090]). Ofek also explicitly disclose that antimicrobial surface providing a therapeutic effect even after an extended period such as 31 days or more ([0106]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Zeibol with the feature of said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days as disclosed by Ofek so as to prevent catheter-related sepsis ([0002]) for therapy requiring extended indwelling time of the catheter extender-lengthener.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Zeibol (US Pat. No. 10,525,250 B1) in view of Naheed (US Pub. No. 2017/0020941 A1), or alternatively, over Zeibol (US Pat. No. 10,525,250 B1) in view of Ofek (US Pub. No. 2020/0000972 A1) further in view of Naheed (US Pub. No. 2017/0020941 A1).
Claim 8. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, wherein Zeibol and Zeibol in view of Ofek does not explicitly disclose that said polymer is selected from the group consisting of: ethylene vinyl acetate; silicone; polyurethane; polyvinylpyrrolidone; polytetrafluoroethylene; polyvinyl chloride; rubber; latex rubber and elastomers. However, it is noted that Naheed also discloses polymeric coatings for medication delivery including minocycline ([0030]) wherein the polymers include ethylene vinyl acetate ([0020]); silicone ([0020]); polyurethane ([0262]); polyvinylpyrrolidone ([0262]); polytetrafluoroethylene ([0239]); polyvinyl chloride ([0020]); rubber ([0020]); latex rubber and elastomers ([0216]). Therefore, since both Zeibol and Zeibol in view of Thiagarajan and Naheed are drawn to catheters with antimicrobial agent, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the polymer of Zeibol and Zeibol in view of Ofek with a polymer selected from the group consisting of: ethylene vinyl acetate; silicone; polyurethane; polyvinylpyrrolidone; polytetrafluoroethylene; polyvinyl chloride; rubber; latex rubber and elastomers as disclosed by Naheed since Naheed discloses that these polymers are suitable for controlling delivering antimicrobial agent including minocycline ([0030] of Naheed).
Claim 9. Zeibol or Zeibol in view of Ofek discloses the catheter extender-lengthener of claim 1, wherein Zeibol or Zeibol in view of Ofek does not explicitly disclose that said polymer comprises ethylene vinyl acetate and a release modifying material comprising polyethylene glycol or polycaprolactone or both. However, it is noted that Naheed also discloses polymeric coatings for medication delivery including minocycline ([0030]) wherein the polymeric layers including ethylene vinyl acetate ([0020]), a release modifying material comprising polyethylene glycol ([0216]) or polycaprolactone ([0217]) or both. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the polymer of Zeibol and Zeibol in view of Ofek with ethylene vinyl acetate and a release modifying material comprising polyethylene glycol or polycaprolactone or both as disclosed by Naheed since Naheed discloses that these polymers are suitable for controlling delivering antimicrobial agent including minocycline ([0030] of Naheed).
Claim 1, 3, 5, 17, 63, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1) or Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1) and Ofek (US Pub. No. 2020/0000972 A1).
Claim 1. Scherich discloses a catheter extender-lengthener, comprising:
a first end (36), said first end being suitable to engage with a corresponding connector (32) of a catheter or a catheter extension set ([0031]; Fig. 1B);
at least one catheter extender-lengthener tube (34) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of extension tube 34 with inner surface 48 and outer surface 46) (Fig. 1B; [0038]); and
a second connector (40) proceeding from said catheter extender-lengthener tube ([0031]; Fig. 1B),
wherein said catheter extender-lengthener tube wall comprises a polymer ([0012]) and at least one antibiotic ([0018], [0036]-[0037]); and wherein said polymer and said at least one antibiotic form said catheter extender-lengthener tube wall ([0012]; [0018]).
While Scherich discloses the first end (36) being coupled to connector of side port 32 (Fig. 1A) or alternatively may be integrally formed with side port 32 ([0031]), but does not explicitly disclose that the first end comprises a connector. However, it is noted that Zeibol also discloses an infusion deice with antimicrobial properties with a catheter extender-lengthener, comprising: a first connector (16), said first connector being suitable to engage with a corresponding connector of a catheter or a catheter extension set (Fig. 2C); at least one catheter extender-lengthener tube (21) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of tube 21); and a second connector (i.e., second connector) proceeding from said catheter extender-lengthener tube (col. 16, lines 61-65). Zeibol further discloses that connectors such as luer connectors are known suitable coupling for infusion devices (col. 16, lines 43-65; col. 15, lines 11-31). Therefore, since both Scherich and Zeibol are drawn to catheter assemblies with connectors, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first end of Scherich with a connector as disclosed by Zeibol for coupling the first end with at the side port and since Zeibol discloses that coupling with connectors are well known in the art for connections between parts of a catheter system (col. 1, lines 46-57 of Zeibol).
Again, examiner notes that the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113. As such, the limitations of the specifics of forming by melt processing of said polymer and said at least one antibiotic are being treated as functional limitations. Only structure of said polymer and said at least one antibiotic form the catheter extender-lengthener tube wall are being considered positively claimed. Applicant is required to identify non-obvious differences in structure between a catheter extender-lengthener tube wall comprising a polymer and at least one antibiotic formed by melt processing said polymer and said at least one antibiotic as described by the product-by-process limitations and a catheter extender-lengthener wall as disclosed by Scherich in view of Zeibol, since the catheter extender-lengthener tube wall of Scherich also comprise of a polymer and at least one antibiotics.
Moreover, it is noted that Scherich also further discloses that an anti-thrombogenic material and a polymer form structures of a catheter assembly including the catheter extender-lengthener tube wall (34), wherein the anti-thrombogenic material may be applied as a coating or the anti-thrombogenic material is extruded through a die ([0017]; [0032]-[0034] for additional details of extruding; and [0038] for coating) and wherein the antimicrobial coating or compound being on surfaces of catheter assembly 10 in a similar manner as the anti-thrombogenic coating 45 or compounds ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich in view of Zeibol so as to apply the antimicrobial material to the catheter assembly via a coating or extrusion as disclosed by Scherich for the anti-thrombogenic coating since both coating and extruding are suitable manners to applying the antimicrobial to the surfaces of the catheter assembly 10 as for anti-thrombogenic ([0036] of Scherich).
Alternatively, even if forming by melt processing requires a structural difference from the catheter extender-lengthener tube wall of Scherich, it is noted that Ofek also discloses a catheter extender-lengthener with a connector (19) and a catheter extender-lengthener tube (18) having a catheter extender-lengthener tube wall (i.e., wall of tube 18), wherein said catheter extender-lengthener tube wall comprises a polymer ([0085]; i.e., polyurethane, silicone, polyvinyl chloride) and at least one antibiotic (i.e., antimicrobial) ([0086]), wherein the at least one antibiotic may be applied as a coating (42) or alternatively being extruded (90) ([0098]). Therefore, since both Scherich and Ofek are drawn to catheter extender-lengtheners with antimicrobial, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the catheter extender-lengthener tube of Scherich in view of Zeibol with the feature of the catheter extender-lengthener tube wall being formed by melt processing a polymer and an at least one antibiotic to form the catheter extender-lengthener tube wall comprising the polymer and the at least one antibiotic as disclosed by Ofek since Ofek discloses that a catheter tube wall comprising a polymer with an antimicrobial being applied as a coating or being extruded are known suitable alternative manners for including an antimicrobial material to the catheter extender-lengthener tube ([0098] of Ofek).
Claim 3. Scherich in view of Zeibol or Scherich in view of Zeibol and Ofek discloses the catheter extender-lengthener of claim 1, wherein both Scherich and Ofek discloses that said polymer and said at least one antibiotic 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 ([0036]-[0037] of Scherich; [0098] of Ofek).
Claim 5. Scherich in view of Zeibol or Scherich in view of Zeibol and Ofek discloses the catheter extender-lengthener of claim 1, wherein while Scherich discloses that the catheter may be used for indwelling time of more than one day ([0005]) and that the catheter used as a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter ([0029]), Scherich does not explicitly discloses said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days. However, Ofek further discloses that catheters left in patient for extended time could result in bacterial colonization causing catheter-related sepsis ([0002]), therefore the desired level of antimicrobial efficacy for the antimicrobial depends on the indwelling time among other factors ([0090]). Ofek also explicitly disclose that antimicrobial surface providing a therapeutic effect even after an extended period such as 31 days or more ([0106]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich with the feature of said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days as disclosed by Ofek so as to prevent catheter-related sepsis ([0002]) for therapy requiring extended indwelling time of the catheter extender-lengthener.
Claim 17. Scherich in view of Zeibol or Scherich in view of Zeibol and Ofek discloses the catheter extender-lengthener of claim 1, but Scherich does not explicitly discloses that the catheter extender-lengthener being usable in combination with a cap that is mateable to said second connector, wherein said cap being capable of releasing an antimicrobial substance. However, it is noted that Ofek further discloses a threaded cap for removably covering a threaded end of a luer connector, wherein the cap may include the antimicrobial coating to prevent microbial contamination ([0101]). Therefore, since Scherich discloses second connector being a luer connector (40) ([0031]) and Ofek discloses a cap for covering a luer connector ([0101]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Scherich in view of Zeibol or Scherich in view of Zeibol and Ofek with the feature of a cap that is mateable to said second connector, wherein said cap being capable of releasing an antimicrobial substance as disclosed by Ofek to prevent microbial contamination of the luer connector due to relatively extensive physical contact by users ([0101]).
Claims 63 and 64. Scherich in view of Zeibol or Scherich in view of Zeibol and Ofek discloses the catheter extender-lengthener of claim 1, wherein although the limitations that the melt processing comprises molding (as per claim 63) or extrusion (as per claim 64) are considered as only further limiting the product-by-process limitation since the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall, see above for additional details. Therefore, since Scherich discloses the structures required as explained above, Scherich discloses the required structures for the claimed catheter extender-lengthener.
Alternatively, Scherich in view of Zeibol and Ofek further discloses molding and extrusion ([0098] of Ofek and [0032]-[0034], [0036] of Scherich as explained above).
Claims 1, 3, 8, 11, 63, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1) or Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1) and Labib (US Pub. No. 2011/0300202 A1).
Claim 1. Scherich discloses a catheter extender-lengthener, comprising:
a first end (36), said first end being suitable to engage with a corresponding connector (32) of a catheter or a catheter extension set ([0031]; Fig. 1B);
at least one catheter extender-lengthener tube (34) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of extension tube 34 with inner surface 48 and outer surface 46) (Fig. 1B; [0038]); and
a second connector (40) proceeding from said catheter extender-lengthener tube ([0031]; Fig. 1B),
wherein said catheter extender-lengthener tube wall comprises a polymer ([0012]) and at least one antibiotic ([0018], [0036]-[0037]); and wherein said polymer and said at least one antibiotic form said catheter extender-lengthener tube wall ([0012]; [0018]).
While Scherich discloses the first end (36) being coupled to connector of side port 32 (Fig. 1A) or alternatively may be integrally formed with side port 32 ([0031]), but does not explicitly disclose that the first end comprises a connector. However, it is noted that Zeibol also discloses an infusion deice with antimicrobial properties with a catheter extender-lengthener, comprising: a first connector (16), said first connector being suitable to engage with a corresponding connector of a catheter or a catheter extension set (Fig. 2C); at least one catheter extender-lengthener tube (21) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of tube 21); and a second connector (i.e., second connector) proceeding from said catheter extender-lengthener tube (col. 16, lines 61-65). Zeibol further discloses that connectors such as luer connectors are known suitable coupling for infusion devices (col. 16, lines 43-65; col. 15, lines 11-31). Therefore, since both Scherich and Zeibol are drawn to catheter assemblies with connectors, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first end of Scherich with a connector as disclosed by Zeibol for coupling the first end with at the side port and since Zeibol discloses that coupling with connectors are well known in the art for connections between parts of a catheter system (col. 1, lines 46-57 of Zeibol).
Again, examiner notes that the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113. As such, the limitations of the specifics of forming by melt processing of said polymer and said at least one antibiotic are being treated as functional limitations. Only structure of said polymer and said at least one antibiotic form the catheter extender-lengthener tube wall are being considered positively claimed. Applicant is required to identify non-obvious differences in structure between a catheter extender-lengthener tube wall comprising a polymer and at least one antibiotic formed by melt processing said polymer and said at least one antibiotic as described by the product-by-process limitations and a catheter extender-lengthener wall as disclosed by Scherich in view of Zeibol, since the catheter extender-lengthener tube wall of Scherich also comprise of a polymer and at least one antibiotics.
Moreover, it is noted that Scherich also further discloses that an anti-thrombogenic material and a polymer form structures of a catheter assembly including the catheter extender-lengthener tube wall (34), wherein the anti-thrombogenic material may be applied as a coating or the anti-thrombogenic material is extruded through a die ([0017]; [0032]-[0034] for additional details of extruding; and [0038] for coating) and wherein the antimicrobial coating or compound being on surfaces of catheter assembly 10 in a similar manner as the anti-thrombogenic coating 45 or compounds ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich in view of Zeibol so as to apply the antimicrobial material to the catheter assembly via a coating or extrusion as disclosed by Scherich for the anti-thrombogenic coating since both coating and extruding are suitable manners to applying the antimicrobial to the surfaces of the catheter assembly 10 as for anti-thrombogenic ([0036] of Scherich).
Alternatively, it is noted that Labib also discloses material composition with polymer and at least one antibiotic suitable for long term antibacterial effect for medical devices via forming the useful articles through standard methods of plastics processing such as extrusion, compression, or injection molding ([0022]) including for catheters ([0050]), wherein Labib discloses various suitable polymers and antibiotic concentrations to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]). Therefore, since both Scherich in view of Zeibol and Labib, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich in view of Zeibol with the feature of the catheter extender-lengthener being formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener wall as disclosed by Labib since Labib discloses that that these are standard methods of plastics processing for forming useful articles containing the antibiotic ([0022]) including for catheters ([0050]).
Claim 3. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein both Scherich and Labib discloses that said polymer and said at least one antibiotic 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 ([0036]-[0037] of Scherich; [0135] or [0141] of Labib).
Claim 8. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein Scherich and Labib both discloses that said polymer is selected from the group consisting of: ethylene vinyl acetate; silicone; polyurethane; polyvinylpyrrolidone; polytetrafluoroethylene; polyvinyl chloride; rubber; latex rubber and elastomers ([0033]; i.e., polyurethane or silicone elastomer of Scherich; [0085] of Labib).
Claim 11. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein Scherich further discloses said catheter extender-lengthener tube wall comprises an inner layer (48) and an outer layer (46), wherein said inner layer comprises said polymer and said at least one antibiotic and said outer layer does not contain any of said at least one antibiotic, or wherein said catheter extender- lengthener tube comprises, for a first portion of its length, a first material that comprises said polymer and said at least one antibiotic, and comprises, for a second portion of its length, a second material that does not comprise any of said at least one antibiotic ([0036]; i.e., when one or more portions of inner surface is coated but not the outer surface or when only selected portions the inner and outer surfaces are coated and the other selected portions that are not coated by the antimicrobial coating).
Claims 63 and 64. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein the limitations of the melt processing comprises molding (as per claim 63) or extrusion (as per claim 64) are only further limits a product-by-process limitation since the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall, see above for additional details. Therefore, since Scherich in view of Zeibol discloses the structures required as explained above, Scherich in view of Zeibol discloses the required structures for the claimed catheter extender-lengthener.
Alternatively, Scherich in view of Zeibol and Labib further discloses molding and extrusion ([0022] of Labib).
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1).
Claim 19. Scherich discloses a catheter extender-lengthener for use with a catheter, said catheter extender-lengthener comprising:
a first end (36), said first end being suitable to engage with a corresponding connector (32) of a catheter or a catheter extension set ([0031]; Fig. 1B);
a catheter extender-lengthener tube (34) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of extension tube 34 with inner surface 48 and outer surface 46) (Fig. 1B; [0038]) comprising a polymer ([0012]; polyurethane or silicone elastomer) and at least one antibiotic ([0036]; i.e., antimicrobial) that is safe for exposure to a patient's bodily fluids, wherein the at least one antibiotic is distributed throughout the catheter extender-lengthener tube wall ([0036]-[0037]; i.e., distributed throughout the inner and/or outer surfaces including proximate all of fluid path 44); and
a second connector (40) proceeding from said catheter extender-lengthener tube ([0031]; Fig. 1B),
said first connector, said catheter extender-lengthener tube, and said second connector defining a lumen (i.e., lumen through distal end 36, extension tube 34, and luer adapter 40 at proximal end 38) extending therethrough,
further comprising a clamp (i.e., clamp not labeled, but illustrated in Figs. 1A, 1B) disposed on said catheter extender-lengthener tube having at least one permitted location on said catheter extender-lengthener tube (Figs. 1A, 1B; i.e., illustrated position),
wherein when said clamp is in the permitted location on said catheter extender- lengthener tube, fluid inside said lumen on one side of said clamp is exposed to said polymer and said at least one antibiotic substance, and fluid inside said lumen on an opposite side of said clamp is exposed to said polymer and said at least one antibiotic substance ([0036]-[0037]; i.e., antimicrobial distributed throughout the inner and/or outer surfaces including proximate all of fluid path 44, therefore, the antimicrobial is applied to both the side of clamp closer to distal end 32 and also on the opposite side of the clamp closer to proximal end 38).
While Scherich discloses the first end (36) being coupled to connector of side port 32 (Fig. 1A) or alternatively may be integrally formed with side port 32 ([0031]), but does not explicitly disclose that the first end comprises a connector. However, it is noted that Zeibol also discloses an infusion deice with antimicrobial properties with a catheter extender-lengthener, comprising: a first connector (16), said first connector being suitable to engage with a corresponding connector of a catheter or a catheter extension set (Fig. 2C); at least one catheter extender-lengthener tube (21) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of tube 21); and a second connector (i.e., second connector) proceeding from said catheter extender-lengthener tube (col. 16, lines 61-65). Zeibol further discloses that connectors such as luer connectors are known suitable coupling for infusion devices (col. 16, lines 43-65; col. 15, lines 11-31). Therefore, since both Scherich and Zeibol are drawn to catheter assemblies with connectors, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first end of Scherich with a connector as disclosed by Zeibol for coupling the first end with at the side port and since Zeibol discloses that coupling with connectors are well known in the art for connections between parts of a catheter system (col. 1, lines 46-57 of Zeibol).
Claim 21. Scherich in view of Zeibol discloses the catheter extender-lengthener of claim 19, wherein while Scherich further discloses that the antimicrobial being chlorhexidine and silver, or other suitable antimicrobial ([0036]), Scherich does not explicitly disclose that said at least one antibiotic substance comprises minocycline and rifampin. However, Zeibol further discloses that minocycline and rifampin are known suitable antimicrobial as an alternative to chlorhexidine and silver for catheter systems (col. 7, lines 55-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich with the feature of said at least one antibiotic substance comprises minocycline and rifampin since Zeibol discloses that such antibiotics are known to be suitable antimicrobials (col. 7, lines 55-62 of Zeibol).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1) further in view of Lucchino (US Pub. No. 2016/0235893 A1).
Claim 26. Scherich in view of Zeibol discloses the catheter extender-lengthener of claim 19, while Scherich further discloses that the catheter extender-lengthener tube having an internal surface (48) but does not further disclose that said catheter extender-lengthener tube has texturing on an internal surface thereof, suitable to increase its internal surface area compared to that of a smooth surface. However, Lucchino discloses antimicrobial catheters wherein an internal surface of the catheter may be roughened to alter the intrinsic characteristics of the catheter ([0114]-[0115]). Therefore, since both Scherich in view of Zeibol and Lucchino are drawn to medication delivery catheters, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the internal surface of Scherich in view of Zeibol with the feature of an internal surface but does not further disclose that said catheter extender-lengthener tube has texturing on an internal surface thereof, suitable to increase its internal surface area compared to that of a smooth surface as disclosed by Lucchino to control the intrinsic characteristics of the internal surface and thereby the resistance or lack thereof to cell/microorganism adhesions ([0114] of Lucchino).
Claims 2, 5, 7, 9, 59-62, 65, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich (US Pub. No. 2021/0228781 A1) in view of Zeibol (US Pat. No. 10,525,250 B1) further in view of Labib (US Pub. No. 2011/0300202 A1).
Claim 2. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein Scherich in view of Zeibol does not explicitly disclose that said at least one antibiotic is present in said catheter extender-lengthener tube wall at a concentration of at least 2% by weight. However, Scherich discloses that said catheter extender-lengthener tube wall comprises antimicrobial ([0037]-[0037]) and providing a sufficient antimicrobial agent to provide antimicrobial effect such as via multiple antimicrobial compounds ([0036] of Scherich) but does not explicitly disclose that said at least one antibiotic in an amount of at least 2% by weight. However, it is noted that the instant [00102] discloses the claimed concentration range as one of many possible ranges, the instant disclosure does not provide criticality for the claimed specific range. Second, it is noted that one of ordinary skill in the art would have known to adjust the concentration of the microbial agent to provide the desired effect including strength and duration. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol or Scherich in view of Zeibol and Labib to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 2% by weight, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Alternatively, it is noted that Labib also discloses material composition with polymer and at least one antibiotic suitable for long term antibacterial effect of medical devices ([0022]) including for catheters ([0050]) wherein Labib discloses various suitable polymers and antibiotic concentrations to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]) including specifically 6% ([0135]) or 15% ([0141]) of ciprofloxacin. Therefore, since Scherich further discloses that the antimicrobial may be other suitable antimicrobial compound ([0036]) and Labib discloses that ciprofloxacin is a broad spectrum antimicrobial agent suitable for long term release in a medical device ([0123]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify said at least one antibiotic of Scherich in view of Zeibol or Scherich in view of Zeibol and Labib with the feature of an antibiotic in an amount of at least 2% by weight as disclosed by Labib ([0135] or [0141]) so as to prevent the formation of a biofilm and thereby preventing infections during use. Moreover, it is also noted that while Labib discloses values within the claimed range, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol and Labib to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 2% by weight, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Claim 5. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein while Scherich discloses that the catheter may be used for indwelling time of more than one day ([0005]) and that the catheter used as a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter ([0029]), Scherich does not explicitly discloses said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days. However, Labib also further discloses long term ([0022]) releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days (Figs. 6-8; i.e., continuous increase in cumulative % released). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Scherich in view of Zeibol or Scherich in view of Zeibol and Labib with the feature of said catheter extender-lengthener tube wall is capable of releasing a therapeutic amount of said at least one antibiotic, to a fluid contained within said catheter extender-lengthener tube, for at least 30 days as disclosed by Labib to provide antimicrobial for sufficient time required for extended indwelling time of the catheter extender-lengthener.
Claim 7. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein Scherich discloses chlorhexidine, silver, or other suitable antimicrobial ([0036]) but does not explicitly disclose that said at least one antibiotic is selected from the group consisting of: minocycline; other members of the tetracyclines class of antibiotics; rifampicin; other antimycobacterial drugs; ciprofloxacin; other fluoroquinolones; vancomycin; other glycopeptides; cephalosporins; penicillins; gentamicin; other aminoglycosides; sulfonamides; macrolides; carbapenems; linezolid; other oxazolidinones; daptomycin; other lipopeptides; and immunosuppressants. However, it is noted that both Zeibol and Labib discloses at least one of the antibiotic from the claimed group including minocycline, rifampicin (col. 7, lines 60-62 of Zeibol and [0094] of Labib) and additional others ([0092]-[0095] of Labib) such as ciprofloxacin ([0095], [0135], [0141]). Therefore, since Scherich further discloses that the antimicrobial may be other suitable antimicrobial compound ([0036]) and Zeibol and Labib both discloses various known antibiotics from the claimed group as being suitable for medical devices, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one antibiotic of Scherich in view of Zeibol or Scherich in view of Zeibol and Labib with the feature of said at least one antibiotic is selected from the claimed group as disclosed by Zeibol or Labib since Scherich further discloses that the antimicrobial may be other suitable antimicrobial compound ([0036]).
Claim 9. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein Scherich in view of Zeibol does not explicitly disclose that said polymer comprises ethylene vinyl acetate and a release modifying material comprising polyethylene glycol or polycaprolactone or both. However, it is noted that Labib discloses thermoplastic polymer material consisting of ethylene-vinyl acetate and polyethylene glycol ([0086]-[0088], [0134], [0165]) as a suitable material to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]) including for catheters ([0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Scherich in view of Zeibol or Scherich in view of Zeibol and Labib with the feature of the polymer comprises ethylene vinyl acetate and a release modifying material comprising polyethylene glycol as disclosed by Labib since Labib discloses that such material composition being suitable for forming catheters with long term antibiotic release ([0022], [0086]-[0088] of Labib).
Claim 65. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 1, wherein Scherich discloses that said catheter extender-lengthener tube wall comprises antimicrobial ([0037]-[0037]) and providing a sufficient antimicrobial agent to provide antimicrobial effect such as via multiple antimicrobial compounds ([0036] of Scherich) but does not explicitly disclose that said at least one antibiotic in an amount of at least 5% (w/w). However, it is noted that the instant [00102] discloses the claimed concentration range as one of many possible ranges, the instant disclosure does not provide criticality for the claimed specific range. Second, it is noted that one of ordinary skill in the art would have known to adjust the concentration of the microbial agent to provide the desired effect including strength and duration. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol or Scherich in view of Zeibol and Labib to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 5% (w/w), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Alternatively, it is noted that Labib also discloses material composition with polymer and at least one antibiotic suitable for long term antibacterial effect of medical devices ([0022]) including for catheters ([0050]) wherein Labib discloses various suitable polymers and antibiotic concentrations to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]) including specifically 6% ([0135]) or 15% ([0141]) of ciprofloxacin. Therefore, since Scherich further discloses that the antimicrobial may be other suitable antimicrobial compound ([0036]) and Labib discloses that ciprofloxacin is a broad spectrum antimicrobial agent suitable for long term release in a medical device ([0123]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify said at least one antibiotic of Scherich in view of Zeibol or Scherich in view of Zeibol and Labib with the feature of an antibiotic in an amount of at least 5% (w/w) as disclosed by Labib ([0135] or [0141]) so as to prevent the formation of a biofilm and thereby preventing infections during use. Moreover, it is also noted that while Labib discloses values within the claimed range, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol and Labib to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 5% (w/w), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Claim 59. Scherich in view of Zeibol discloses the catheter extender-lengthener of claim 19, wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall because of the following:
First, examiner notes that the limitation “wherein the catheter extender-lengthener tube wall is formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall” is being interpreted as product-by-process limitation of the catheter extender-lengthener tube wall comprising said polymer and said at least one antibiotic made from the process of melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener tube wall. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113. As such, the limitations of the specifics of forming by melt processing of said polymer and said at least one antibiotic are being treated as functional limitations. Only structure of said polymer and said at least one antibiotic form the catheter extender-lengthener tube wall are being considered positively claimed. Applicant is required to identify non-obvious differences in structure between a catheter extender-lengthener tube wall comprising a polymer and at least one antibiotic formed by melt processing said polymer and said at least one antibiotic as described by the product-by-process limitations and a catheter extender-lengthener wall as disclosed by Scherich in view of Zeibol, since the catheter extender-lengthener tube wall of Scherich also comprise of a polymer and at least one antibiotics. However, it is noted that Scherich also further discloses that an anti-thrombogenic material and a polymer form structures of a catheter assembly including the catheter extender-lengthener tube wall (34), wherein the anti-thrombogenic material may be applied as a coating or the anti-thrombogenic material is extruded through a die ([0017]; [0032]-[0034] for additional details of extruding; and [0038] for coating). Moreover, Scherich also discloses that the antimicrobial coating or compound being on surfaces of catheter assembly 10 in a similar manner as the anti-thrombogenic coating 45 or compounds ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich in view of Zeibol so as to apply the antimicrobial material to the catheter assembly via a coating or extrusion as disclosed by Scherich for the anti-thrombogenic coating since both coating and extruding are suitable manners to applying the antimicrobial to the surfaces of the catheter assembly 10 as for anti-thrombogenic ([0036] of Scherich).
Alternatively, it is noted that Labib also discloses material composition with polymer and at least one antibiotic suitable for long term antibacterial effect for medical devices via forming the useful articles through standard methods of plastics processing such as extrusion, compression, or injection molding ([0022]) including for catheters ([0050]), wherein Labib discloses various suitable polymers and antibiotic concentrations to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]). Therefore, since both Scherich in view of Zeibol and Labib, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich in view of Zeibol with the feature of the catheter extender-lengthener being formed by melt processing said polymer and said at least one antibiotic to form the catheter extender-lengthener wall as disclosed by Labib since Labib discloses that that these are standard methods of plastics processing for forming useful articles containing the antibiotic ([0022]) including for catheters ([0050]).
Claim 60. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 59, wherein the melt processing comprises molding ([0022] of Labib and [0032]-[0034], [0036] of Scherich as explained above).
Claim 61. Scherich in view of Zeibol or Scherich in view of Zeibol and Labib discloses the catheter extender-lengthener of claim 59, wherein the melt processing comprises extrusion ([0022] of Labib and [0032]-[0034], [0036] of Scherich as explained above).
Claim 62. Scherich in view of Zeibol discloses the catheter extender-lengthener of claim 19, wherein Scherich discloses that said catheter extender-lengthener tube wall comprises antimicrobial ([0037]-[0037]) and providing a sufficient antimicrobial agent to provide antimicrobial effect such as via multiple antimicrobial compounds ([0036] of Scherich) but does not explicitly disclose that said at least one antibiotic in an amount of at least 5% (w/w). However, it is noted that the instant [00102] discloses the claimed concentration range as one of many possible ranges, the instant disclosure does not provide criticality for the claimed specific range. Second, it is noted that one of ordinary skill in the art would have known to adjust the concentration of the microbial agent to provide the desired effect including strength and duration. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 5% (w/w), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Alternatively, it is noted that Labib also discloses material composition with polymer and at least one antibiotic suitable for long term antibacterial effect of medical devices ([0022]) including for catheters ([0050]) wherein Labib discloses various suitable polymers and antibiotic concentrations to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]) including specifically 6% ([0135]) or 15% ([0141]) of ciprofloxacin. Therefore, since Scherich further discloses that the antimicrobial may be other suitable antimicrobial compound ([0036]) and Labib discloses that ciprofloxacin is a broad spectrum antimicrobial agent suitable for long term release in a medical device ([0123]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify said at least one antibiotic of Scherich in view of Zeibol with the feature of an antibiotic in an amount of at least 5% (w/w) as disclosed by Labib ([0135] or [0141]) so as to prevent the formation of a biofilm and thereby preventing infections during use. Moreover, it is also noted that while Labib discloses values within the claimed range, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol and Labib to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 5% (w/w), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Claim 66. Scherich discloses a catheter extender-lengthener, comprising:
a first end (36), said first end being suitable to engage with a corresponding connector (32) of a catheter or a catheter extension set ([0031]; Fig. 1B);
at least one catheter extender-lengthener tube (34) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of extension tube 34 with inner surface 48 and outer surface 46) (Fig. 1B; [0038]); and
a second connector (40) proceeding from said catheter extender-lengthener tube ([0031]; Fig. 1B),
wherein said catheter extender-lengthener tube wall comprising a polymer ([0012]; polyurethane or silicone elastomer) and at least one antibiotic ([0036]; i.e., antimicrobial) applied on said polymer ([0036]).
However, Scherich is silent to the first end comprising a first connector and that the at least one antibiotic being mixed with said polymer wherein the at least one antibiotic in an amount of at least 5% (w/w).
First, while Scherich discloses the first end (36) being coupled to connector of side port 32 (Fig. 1A) or alternatively may be integrally formed with side port 32 ([0031]), but does not explicitly disclose that the first end comprises a connector. However, it is noted that Zeibol also discloses an infusion deice with antimicrobial properties with a catheter extender-lengthener, comprising: a first connector (16), said first connector being suitable to engage with a corresponding connector of a catheter or a catheter extension set (Fig. 2C); at least one catheter extender-lengthener tube (21) proceeding from said first connector, said catheter extender-lengthener tube having a catheter extender-lengthener tube wall (i.e., wall of tube 21); and a second connector (i.e., second connector) proceeding from said catheter extender-lengthener tube (col. 16, lines 61-65). Zeibol further discloses that connectors such as luer connectors are known suitable coupling for infusion devices (col. 16, lines 43-65; col. 15, lines 11-31). Therefore, since both Scherich and Zeibol are drawn to catheter assemblies with connectors, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first end of Scherich with a connector as disclosed by Zeibol for coupling the first end with at the side port and since Zeibol discloses that coupling with connectors are well known in the art for connections between parts of a catheter system (col. 1, lines 46-57 of Zeibol).
Second, Scherich also further discloses that an anti-thrombogenic material and a polymer form structures of a catheter assembly including the catheter extender-lengthener tube wall (34), wherein the anti-thrombogenic material may be applied as a coating or the anti-thrombogenic material is extruded through a die ([0017]; [0032]-[0034] for additional details of extruding; and [0038] for coating). Moreover, Scherich also discloses that the antimicrobial coating or compound being on surfaces of catheter assembly 10 in a similar manner as the anti-thrombogenic coating 45 or compounds ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Scherich in view of Zeibol so as to mix the at least one antibiotic with the polymer via a coating or extrusion as disclosed by Scherich for the anti-thrombogenic coating since both coating and extruding are suitable manners to applying the antimicrobial to the surfaces of the catheter assembly 10 as for anti-thrombogenic ([0036]). Scherich further discloses that said catheter extender-lengthener tube wall comprises antimicrobial ([0037]-[0037]) and providing a sufficient antimicrobial agent to provide antimicrobial effect such as via multiple antimicrobial compounds ([0036] of Scherich) but does not explicitly disclose that said at least one antibiotic in an amount of at least 5% (w/w). However, it is noted that the instant [00102] discloses the claimed concentration range as one of many possible ranges, the instant disclosure does not provide criticality for the claimed specific range. Second, it is noted that one of ordinary skill in the art would have known to adjust the concentration of the microbial agent to provide the desired effect including strength and duration. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 5% (w/w), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Alternatively, it is noted that Labib also discloses material composition with polymer and at least one antibiotic suitable for long term antibacterial effect of medical devices ([0022]) including for catheters ([0050]) wherein Labib discloses various mixtures of suitable polymers and antibiotic concentrations to provide the desired antimicrobial effect of preventing biofilm formation on the medical device ([0174]) including specifically mixtures with 6% ([0135]) or 15% ([0141]) of ciprofloxacin. Therefore, since Scherich further discloses that the antimicrobial may be other suitable antimicrobial compound ([0036]) and Labib discloses that ciprofloxacin is a broad spectrum antimicrobial agent suitable for long term release in a medical device ([0123]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the polymer and the at least one antibiotic of Scherich in view of Zeibol with the feature of a mixture of a polymer and an antibiotic in an amount of at least 5% (w/w) as disclosed by Labib ([0135] or [0141]) so as to prevent the formation of a biofilm and thereby preventing infections during use. Moreover, it is also noted that while Labib discloses values within the claimed range, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the concentration of antibiotic present in Scherich in view of Zeibol and Labib to an amount suitable for the desired effect depending on the type of antimicrobial agent and the particular treatment requirement including any concentration of at least 5% (w/w), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 for additional details.
Allowable Subject Matter
Claim 15 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.
Claim 22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record does not singly or in combination disclose all of the specifics of the cap as required in the claim in combination the other limitations of claim 19 or the specific material composition required by claim 15. See PTO-892 for closest prior art of record.
Response to Arguments
With respect to the previous objection to the claim, the amendment to the claim is sufficient to clarifying the informality. Therefore, the previous objection to the claim is hereby withdrawn.
With respect to the previous 35 U.S.C. 112(b) rejections to the claims, the amendments to the claims are considered sufficient to clarifying the previously noted confusion. Therefore, the previous 35 U.S.C. 112(b) rejections to the claims are hereby withdrawn. However, the amendment to claim 19 also introduces new confusion and thus, is still rejected under 35 U.S.C. 112(b), see above for additional details.
Applicant’s arguments with respect to amended claims 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. In particular, it is noted that Ofek, Scherich, and Labib are relied upon for disclosing the newly added limitations as explained above.
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.
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/JENNA ZHANG/Primary Examiner, Art Unit 3783
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