DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 4, 6, 8, 9, 11, 14-19, 21, 22, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gravesen; Per Otto Børresen et al. (US 20120219742 A1) in view of Rolf; David et al. (US 20140141048 A1).
Regarding claim 1, Gravesen discloses an intermittent catheter comprising a hollow polymeric tubular body (¶ [0017] The article may be any medical hollow tube article … a urine catheter; ¶ [0022] The invention also relates to the use of a medical article … the urethra; ¶ [0031] FIG. 3 shows a first example of a medical article);
comprising a polymer being a derivative of at least one polyolefin material (¶ [0008] Thus, a medical article is provided, comprising a thermoplastic polymer as a basis material and an amphiphilic block copolymer possessing both hydrophilic and lipophilic properties and comprising a main block being hydrophobic and another block being hydrophilic; ¶ [0037] FIG. 1 … a first polymer acting as a basis material 4 … The thermoplastic basis material 4 may be selected from the group of Polyolefin, Polyvinylchloride (PVC) … or a combination thereof; ¶ [0041] In a hydrophobic basis polymer, such as polyolefin, SEBS-, SIS- and SBC-elastomers as a first polymer; ¶ [0048] The thermoplastic base material 4 could for instance be Accurel.TM., Styroflex.TM., Styrolux.TM., Mediprene.TM., Meliflex.TM. or Estane.TM., which are all thermoplastic polymers commercially available);
wherein the catheter further comprises at least one amphiphilic additive (¶ [0007], the amphiphilic block copolymer may be a hydrocarbon chain block of the formula CH3CH2(CH2CH2).sub.a where "a" is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25, and a B-block, said B-block being hydrophilic; ¶ [0045], amphiphilic block copolymer 2, 3; ¶ [0046] The amphiphilic block copolymer 2, 3 could be either Irgasurf.TM. or Unithox.TM., which are both commercially available copolymers);
wherein the polymer and at least one amphiphilic additive are in the form of a mixture (¶ [0012] By mixing the first polymer with an amphiphilic block copolymer, an article having an inherent lubricious property is obtained; ¶ [0024] mixing a granulate blend of a first polymer being a thermoplastic or thermo-curing polymer and a second polymer being an amphiphilic copolymer; ¶ [0037] FIG. 1 … The polymer mixture comprises a second polymer being an amphiphilic copolymer 2, 3 which is mixed in a first polymer acting as a basis material 4).
Although Gravesen describes the embodiment of Fig. 3 as an airway tube or suction catheter (¶ [0049]), Fig. 3 shows a catheter that more closely resembles an intermittent urinary catheter. Fig. 3 appears to have been mislabeled. The catheter of Fig. 3 includes a proximal funnel or handle, an elongate tubular body with a lumen and a distal tip with inlet holes. These features apply to an intermittent urinary catheter instead of an airway tube, which appears in Fig. 4.
Gravesen is silent whether the polymer is negatively charged or becomes negatively charged when wetted with an aqueous medium having a pH greater than 2. Rolf discloses hydrophilic coatings for medical devices (¶ [0004], [0012], [0034], FIG. 5, a coating of an anion-containing species (a coating of a carboxyl-containing species 120 is shown) may be provided on a medical device substrate 110);
comprising an intermittent catheter comprising a hollow polymeric tubular body (¶ [0037], catheters including urological catheters);
comprising a polymer that is negatively charged or that becomes negatively charged when wetted with an aqueous medium having a pH greater than 2 (¶ [0032] Other techniques … argon plasma treatment may be employed to create sulfate and carboxylate groups on substrate surfaces. See, e.g., J. P. Lens et al., "Preparation of heparin-like surfaces by introducing sulfate and carboxylate groups on poly(ethylene) using an argon plasma treatment," J. Biomater. Sci. Polymer Edn., vol. 9, pp. 357-373, 1998; ¶ [0034], This coating 120 may then be ionically crosslinked to a sulf(on)ated species 210);
said polymer being a derivative of a polyolefin material (¶ [0042], Specific examples of organic materials include polymers (biostable or bioerodable) and other high molecular weight organic materials … and polyether ether ketones, polyolefin homopolymers and copolymers, including polyalkylenes such as polypropylene, polyethylene, polybutylenes (such as polybut-1-ene and polyisobutylene), polyolefin elastomers (e.g., santoprene)).
Rolf applies a low-friction coating to an existing polymeric catheter (¶ [0019] By virtue of their high negative (anionic) charge the preceding materials are very hydrophilic and can be used to form lubricious, bioerodible coatings; ¶ [0043], lubricious coatings for medical devices). A skilled artisan would have been able to modify Gravesen with Rolf’s negatively charged polymer by constructing Gravesen’s catheter and then applying Rolf’s argon plasma treatment and negatively charged coating. One would be motivated to modify Gravesen with Rolf’s negatively charged polymer since Gravesen calls for constructing the catheter from hydrophobic thermoplastics (¶ [0037], The thermoplastic basis material 4 may be selected from the group of Polyolefin, Polyvinylchloride (PVC), polyurethane (PUR), Polyolefin, Styrene-butadiene copolymer (SBC), Styrene-ethylene-butylene-styrene copolymer (SEBS) and thermoplastic elastomers, or a combination thereof). Therefore, it would have been obvious to modify Gravesen with Rolf’s negatively charged polymer in order to reduce friction on the catheter’s surface.
Regarding claim 21, Gravesen discloses an intermittent catheter comprising a hollow polymeric tubular body (¶ [0017] The article may be any medical hollow tube article … a urine catheter; ¶ [0022] The invention also relates to the use of a medical article … the urethra; ¶ [0031] FIG. 3 shows a first example of a medical article);
comprising a polymer, said polymer being a derivative of at least one polyolefin material (¶ [0008] Thus, a medical article is provided, comprising a thermoplastic polymer as a basis material; ¶ [0037] FIG. 1 … a first polymer acting as a basis material 4 … The thermoplastic basis material 4 may be selected from the group of Polyolefin, Polyvinylchloride (PVC), polyurethane (PUR), Polyolefin, Styrene-butadiene copolymer (SBC), Styrene-ethylene-butylene-styrene copolymer (SEBS) and thermoplastic elastomers, or a combination thereof; ¶ [0048] The thermoplastic base material 4 could for instance be Accurel.TM., Styroflex.TM., Styrolux.TM., Mediprene.TM., Meliflex.TM. or Estane.TM.);
wherein the catheter further comprises at least one amphiphilic additive that is an A-B block copolymer (¶ [0007], the amphiphilic block copolymer may be a hydrocarbon chain block … and a B-block, said B-block being hydrophilic; ¶ [0045], amphiphilic block copolymer 2, 3; ¶ [0046] The amphiphilic block copolymer 2, 3 could be either Irgasurf.TM. or Unithox.TM.);
comprising an A-block comprising a hydrocarbon chain block of the formula CH3CH-2(CH2CH2)a, where "a" is 9-25 (¶ [0007], the amphiphilic block copolymer may be a hydrocarbon chain block of the formula CH3CH2(CH2CH2).sub.a where "a" is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25, and a B-block, said B-block being hydrophilic); and
a hydrophilic B-block, wherein the B-block is a hydrophilic oligomer comprising between 2 and 10 monomer units derived from monomers selected from the group consisting of: alkylene oxides, alkylene glycols, epihalohydrins, unsaturated carboxylic acids, alkylene imines, lactones, vinyl alcohol, and vinyl alkanoates (¶ [0037], The hydrophilic B-block is a hydrophilic oligomer, i.e. a homo- or co-oligomer, consisting of between 2 and 10 monomer units derived from monomers selected from the group of ethylene oxide, propylene oxide, ethylene glycol, propylene glycol, epichlorhydrin, acrylic acid, methacrylic acid, ethylene imine, caprolactone, vinyl alcohol and vinyl acetate);
wherein the polymer and at least one amphiphilic additive are in the form of a mixture (¶ [0012] By mixing the first polymer with an amphiphilic block copolymer, an article having an inherent lubricious property is obtained; ¶ [0024] mixing a granulate blend of a first polymer being a thermoplastic or thermo-curing polymer and a second polymer being an amphiphilic copolymer; ¶ [0037] FIG. 1 … The polymer mixture comprises a second polymer being an amphiphilic copolymer 2, 3 which is mixed in a first polymer acting as a basis material 4).
Gravesen lacks a negatively charged polymer. Rolf discloses hydrophilic coatings for medical devices (¶ [0004], [0012], [0034], FIG. 5, a coating of an anion-containing species … species 120);
comprising a hollow polymeric tubular body (¶ [0037], catheters including urological catheters);
comprising a polymer that is negatively charged or that becomes negatively charged when wetted with an aqueous medium having a pH greater than 2, said polymer being a derivative of at least one polyolefin material (¶ [0032] Other techniques … argon plasma treatment may be employed to create sulfate and carboxylate groups on substrate surfaces. See, e.g., J. P. Lens et al., "Preparation of heparin-like surfaces by introducing sulfate and carboxylate groups on poly(ethylene) using an argon plasma treatment," J. Biomater. Sci. Polymer Edn., vol. 9, pp. 357-373, 1998; ¶ [0034], This coating 120 may then be ionically crosslinked to a sulf(on)ated species 210; ¶ [0042], Specific examples of organic materials include polymers (biostable or bioerodable) and other high molecular weight organic materials … and polyether ether ketones, polyolefin homopolymers and copolymers, including polyalkylenes such as polypropylene, polyethylene, polybutylenes (such as polybut-1-ene and polyisobutylene), polyolefin elastomers (e.g., santoprene)).
Rolf reduces friction on a catheter surface by applying a negatively charged, hydrophilic coating (¶ [0019], [0043]). Regarding the rationale and motivation to modify Gravesen with Rolf’s negatively charged polymer, see the discussion of claim 1 above.
Regarding claims 2 and 14-16, Gravesen discloses an intermittent catheter wherein the polymer is or comprises a derivative of at least one material that is independently selected from the group consisting of: polyolefins, polyesters, polyacrylates, polyamides, polyether block amide, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, fluororubber, water disintegrable or enzymatically hydrolysable material, and combinations, blends or co-polymers of any of the above materials (¶ [0037], The thermoplastic basis material 4 may be selected from the group of Polyolefin, Polyvinylchloride (PVC), polyurethane (PUR), Polyolefin, Styrene-butadiene copolymer (SBC), Styrene-ethylene-butylene-styrene copolymer (SEBS) and thermoplastic elastomers, or a combination thereof);
the at least one additive is an A-B block copolymer comprising a hydrophobic hydrocarbon A-block and a hydrophilic B-block (¶ [0037] FIG. 1 … The amphiphilic block copolymer 2, 3 is a hydrocarbon chain block of the formula CH3CH2(CH2CH2).sub.a … and a hydrophilic B-block);
the at least one amphiphilic additive further comprises a hydrophobic hydrocarbon A-block that comprises a hydrocarbon chain block of the formula CH3CH2(CH2CH2)a where "a" is 9-25 (¶ [0007], the amphiphilic block copolymer may be a hydrocarbon chain block of the formula CH3CH2(CH2CH2).sub.a where "a" is 10 … 24 or 25; ¶ [0037], The amphiphilic block copolymer 2, 3 is a hydrocarbon chain block of the formula CH3CH2(CH2CH2).sub.a where "a" is 10 … 24 or 25);
the at least one amphiphilic additive further comprises a hydrophilic B-block that comprises a hydrophilic oligomer comprising between 2 and 10 monomer units optionally derived from at least one monomer independently selected from the group consisting of: alkylene oxides, alkylene glycols, epihalohydrins, unsaturated carboxylic acids, alkylene imines, lactones, vinyl alcohol, and vinyl alkanoates (¶ [0037], The hydrophilic B-block is a hydrophilic oligomer, i.e. a homo- or co-oligomer, consisting of between 2 and 10 monomer units derived from monomers selected from the group of ethylene oxide, propylene oxide, ethylene glycol, propylene glycol, epichlorhydrin, acrylic acid, methacrylic acid, ethylene imine, caprolactone, vinyl alcohol and vinyl acetate);
the at least one additive is homogenously distributed with the polymer (¶ [0023], a method for manufacturing a medical tube; ¶ [0024] mixing a granulate blend of a first polymer being a thermoplastic or thermo-curing polymer and a second polymer being an amphiphilic copolymer, and; ¶ [0025] injection moulding or extrusion of the medical article).
Regarding claims 17 and 18, Gravesen does not explicitly disclose that the additive comprises an outer surface layer. However, Gravesen discloses that the additive is mixed or blended with the main polymer before injection molding the catheter (¶ [0023], a method for manufacturing a medical tube; ¶ [0024] mixing … a first polymer … and a second polymer being an amphiphilic copolymer, and; ¶ [0025] injection moulding or extrusion of the medical article). This implies that the additive will extend homogenously through the entire structure of the body including its outer surface.
Regarding claims 4, 6, 8, 9, 11, 19 and 22, Gravesen lacks a negatively charged polymer or ionisable moiety. Rolf discloses a catheter wherein the polymer is negatively charged or becomes negatively charged when wetted with an aqueous medium having a pH of greater than 2, at and/or on a surface, and preferably an outer surface of the body, more preferably at least 50% of the outer surface of the body (¶ [0032] Other techniques … argon plasma treatment may be employed to create sulfate and carboxylate groups on substrate surfaces. See, e.g., J. P. Lens et al., "Preparation of heparin-like surfaces by introducing sulfate and carboxylate groups on poly(ethylene) using an argon plasma treatment," J. Biomater. Sci. Polymer Edn., vol. 9, pp. 357-373, 1998; ¶ [0034], This coating 120 may then be ionically crosslinked to a sulf(on)ated species 210);
wherein the catheter polymer comprises at least one moiety that is negatively charged or becomes negatively charged when wetted with an aqueous medium having a pH of greater than 2. wherein the at least one moiety is present in the intermittent catheter polymer at a total concentration of at least 0.5 wt.% (¶ [0032] Other techniques … argon plasma treatment may be employed to create sulfate and carboxylate groups on substrate surfaces. See, e.g., J. P. Lens et al., "Preparation of heparin-like surfaces by introducing sulfate and carboxylate groups on poly(ethylene) using an argon plasma treatment," J. Biomater. Sci. Polymer Edn., vol. 9, pp. 357-373, 1998; ¶ [0033], anionic species may be held on the surface by other mechanisms including, cohesive mechanisms);
a method of manufacturing a catheter comprising the step of: incorporating a moiety into an intermittent catheter polymer comprising at least one polyolefin material, wherein the moiety is negatively charged or becomes negatively charged when wetted with an aqueous medium having a pH of greater than 2 (¶ [0006], methods of forming such devices; ¶ [0032] Other techniques … argon plasma treatment may be employed to create sulfate and carboxylate groups on substrate surfaces. See, e.g., J. P. Lens et al., "Preparation of heparin-like surfaces by introducing sulfate and carboxylate groups on poly(ethylene) using an argon plasma treatment," J. Biomater. Sci. Polymer Edn., vol. 9, pp. 357-373, 1998; ¶ [0033], anionic species may be held … cohesive mechanisms);
wherein the polymer comprises at least one ionisable moiety, preferably at least one deprotonatable moiety, that becomes negatively charged when wetted with an aqueous medium having a pH of greater than 2; wherein the polymer that is negatively charged or that becomes negatively charged when wetted with an aqueous medium having a pH greater than 2 is the polymer of the catheter body (¶ [0032], a carboxylated surface may be formed using a plasma treatment process … to functionalize a substrate surface with carboxyl groups).
Regarding the moieties being present on at least 50% of the outer surface area of the body and at least 50% of the moieties being on the outer surface of the body, Rolf discloses a treatment that applies negatively charged groups to the catheter’s outer surface (¶ [0032], argon plasma treatment may be employed to create sulfate and carboxylate groups on substrate surfaces).
Rolf also calls for reducing friction on the catheter’s surface (¶ [0043], due to the highly charged nature of the coatings the present disclosure, they are hydrophilic and thus suitable for use as lubricious coatings for medical devices). In order for the coating to serve as a lubricant, it must be present at a tissue contact surface, which includes the catheter’s outer surface. Therefore, a skilled artisan would have been motivated to apply Rolf’s moieties on at least 50% of the outer surface, and to apply at least 50% of the moieties on the outer surface.
Rolf reduces friction at a catheter’s outer surface by coating it with negatively charged molecules (¶ [0005], [0012], [0019], [0045], [0050]). Regarding the rationale and motivation to modify Gravesen with Rolf’s negatively charged polymer or ionisable moiety, see the discussion of claim 1 above.
Regarding claims 24 and 25, Gravesen discloses that the hollow polymeric tubular body is formed through melt-extruding or injection-moulding the mixture (¶ [0037], The sample is made of granulate comprising the first polymer 4 and the second polymer being the amphiphilic block copolymer 2, 3 in a suitable mixture and is delivered in granulate which, during a normal moulding or extrusion process, is heated and formed into the article in question; ¶ [0038] Thus, the first and the second polymer are mixed … Subsequently, the mixture is moulded or extruded into a tube-shaped article; ¶ [0039] The first and the second polymer are comprised in the same compound so that each granulate comprises both the first and the second polymer before moulding or extrusion of the article. Moulding or extruding the article from one mixture of the first and second polymer eliminates the subsequent process of coating the article).
Response to Arguments
The rejections of claims 14 and 15 under 35 USC § 112 are withdrawn in view of the amendments filed 24 August 2026.
Applicant’s arguments filed 24 August 2026 regarding the rejection of claims 1-2, 4, 6, 8-9, 11, 14-19, 21-22 and 24-25 as amended, under 35 USC § 103 over Gravesen and Rolf, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant submits that regardless of the merit of this position, the Office Action fails to cite any section of the references that teach or suggest a "polymer [that is negatively charged] and at least one amphiphilic additive are in the form of a mixture" as recited in claim 1 (remarks p. 3). Applicant reasons that rather, the Office Action points to an entirely additional step required by Rolf of adding a coating to an existing polymer (remarks p. 3).
Examiner responds that the specification describes a process for making a catheter including the following steps:
provide a polymer, namely a polyolefin derivative (¶ [0021], [0023], [0024], [0027], [0078]);
incorporate an ionizable moiety into the polymer so that it is negatively charged or becomes negatively charged when wetted with an aqueous medium having a pH greater than 2 (¶ [0078], [0080]-[0085]);
mix the polymer with an amphiphilic additive (¶ [0087]-[0089], [0100]-[0102]);
form the polymer-additive mixture into a catheter (¶ [0087]-[0089], [0100]-[0102]).
Steps 3 and 4 can be performed in combination via melt-extruding (¶ [0087]-[0089], [0096], [0099], [0101]).
In every case, an ionizable moiety alters the polymer so that it carries a negative charge or becomes negatively charged. The specification describes ionizable moieties where carboxylates are preferred (¶ [0036], [0114]-[0118], [0123], [0124]).
The specification describes two alternatives for introducing the ionizable moiety into the polymer, namely pre- or post-formation (¶ [0038] In some embodiments, at least one moiety is embedded within the catheter body. In some embodiments, at least one moiety is present at and/or on a surface of the body, preferably the outer surface. In some embodiments, the catheter polymer has a polymer brush outer surface containing at least one moiety; ¶ [0085] In some embodiments, the method comprises incorporating the moiety into the intermittent catheter polymer before formation of the intermittent catheter into a tubular catheter body. In some embodiments, the method comprises incorporating the moiety into the intermittent catheter polymer after formation of the catheter into the tubular catheter body).
The specification does not elaborate on pre-formation methods and instead offers multiple examples of post-formation methods. Ionizable moieties may be introduced to the catheter surface by various techniques including corona, plasma, flame or radiation treatments (¶ [0080], treating the intermittent catheter polymer … to introduce at least one moiety … corona treatment, plasma treatment, flame treatment, and radiation treatment (including treatment of the polymer with high energy ionising radiation, such as gamma rays, X-rays, or high speed electrons)).
Regarding claims 1 and 21, which describe devices, Gravesen discloses every feature except for a polymer that is negatively charged or becomes negatively charged when wetted with an aqueous medium having a pH greater than 2. Gravesen is silent whether the base polymer includes an ionizable moiety.
Rolf is cited as teaching a plasma treatment technique that incorporates an ionizable moiety into a polymer. Rolf applies a plasma treatment which incorporates sulfate and carboxylate groups on a catheter surface (¶ [0032], [0034]).
Applicant contends that the Office Action fails to establish where in the cited references teach or suggest a "polymer [that is negatively charged] and at least one amphiphilic additive are in the form of a mixture" as recited in claim 1 is set forth (remarks p. 3). Applicant submits that the Office Action fails to cite any sections of the cited references that teach or suggest "the polymer [that is negatively charged or that becomes negatively charged when wetted] and at least one amphiphilic additive are in the form of a mixture" as recited in previously presented claim 21 (remarks p. 4).
Examiner responds that claims 1 and 21 do not specify that an ionizable moiety is mixed throughout the tubular body’s entire thickness, or that an ionizable moiety is mixed with the polymer prior to forming the polymer into a tubular body. Instead, claims 1 and 21 specify only that the polymer is or becomes negatively charged.
Treating Gravesen’s catheter with Rolf’s plasma treatment yields a catheter comprising both a negatively charged / chargeable polymer and a mixed amphiphilic additive since Gravesen mixes in an additive and Rolf incorporates an ionizable moiety on the catheter’s surface. The entire thickness of the catheter will be mixed with an amphiphilic additive (due to Gravesen’s additive), and the polymer at the surface will include a negatively charged / chargeable polymer (due to Rolf’s surface treatment).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sasagawa, Masahiro et al. US 20040039128 A1
Igari; Naohiro et al. US 20190177517 A1
Kitagawa; Masaru US 20210001521 A1
Ichino; Hiroyuki et al. US 20220243050 A1
Tomoi; Shusaku US 20220325095 A1
THIS ACTION IS MADE FINAL. 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 extension fee 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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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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