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 (i.e., changing from AIA to pre-AIA ) 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 1-5, 9, 10 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen; Niels Joergen et al. (US 20090012208 A1) in view of Calcote; Robert W. et al. (US 5453235 A).
Regarding claim 1, Madsen discloses an intermittent catheter (¶ [0018] The term "medical device" should be interpreted in a fairly broad sense … catheters (such as urinary catheters), endoscopes, laryngoscopes, tubes for feeding, tubes for drainage; ¶ [0156] According to a preferred embodiment of the invention, the medical device according to the invention is a catheter, suitably a urinary catheter);
comprising a hollow polymeric tubular body (¶ [0079], Both extrusions and co-extrusion are suitable ways of preparing tube formed medical devices, such as catheters; ¶ [0150], the medical device for example a catheter, may be made by injection moulding of the coating composition as described in WO 03/002325. Extrusion is also a possibility; ¶ [0153] Injection moulding of more than one layer … Co-extrusion also represents a possibility);
comprising a base polymer (¶ [0025], the medical device or the part of the medical device carrying the hydrophilic coating and the coating composition is made from different materials or different polymer compositions; ¶ [0026], the medical device or the part of the medical device having a hydrophilic coating may be formed from any material conventionally used for making such medical devices, see below, and the coating composition is thereafter applied to the medical device; ¶ [0146] Medical devices … may be formed from a variety of basic materials, such as plastic … other polymer materials including … ethylene-vinyl-acetate copolymers(EVA), polyethylene (PE) metallocene-catalyzed polyethylene and copolymers of ethylene and propylene or mixtures thereof); and
a layer comprising a lubricious additive on or comprising a surface of the body (¶ [0035] Preferably, the hydrophilic polymer is a polymer forming a physically cross-linked matrix in the coating composition, e.g. an amphiphilic block copolymer comprising hydrophilic and hydrophobic blocks; ¶ [0079] An advantage of amphiphilic block copolymers which are cross linked by physical cross links, is that they are thermoplastic, which allow the coating composition to be heated and formed into articles e.g. by extrusion, injection moulding etc.);
wherein the lubricious additive comprises an amphiphilic molecule (¶ [0035], The hydrophilic coating is suitably formed from a thermoplastic coating composition comprising an amphiphilic block copolymer forming a physically cross-linked matrix in the coating composition; ¶ [0039], Suitably, the amphiphilic block co-polymer is a diblock AB or a triblock ABA, and most preferred the amphiphilic block co-polymer is a triblock copolymer ABA; ¶ [0056] Monomers useful for preparing the hydrophilic B block are for example …; ¶ [0057] Suitable, the hydrophilic B block(s) in the amphiphilic block copolymers are PEG …; ¶ [0058] The hydrophilic B block(s) in the amphiphilic block copolymers may also be prepared from different monomers …; ¶ [0105], the coating composition comprises: 60-90% w/w, suitably 60-80% w/w or more preferred 70-80% w/w of an amphiphilic polyurethane);
wherein the layer comprising a lubricious additive comprises the surface of the body and comprises a co-extruded layer (¶ [0079], amphiphilic block copolymers … are thermoplastic, which allow the coating composition to be heated and formed into articles e.g. by extrusion, injection moulding etc. and allows the coating composition to be applied on the medical device e.g. by co-extrusion. Both extrusions and co-extrusion are suitable ways of preparing tube formed medical devices, such as catheters); and
wherein the base polymer comprises at least one of polypropylene and polyethylene (¶ [0146] Medical devices … may be formed from a variety of basic materials, such as plastic … other polymer materials including … ethylene-vinyl-acetate copolymers(EVA), polyethylene (PE) metallocene-catalyzed polyethylene and copolymers of ethylene and propylene or mixtures thereof).
Madsen is silent regarding the additive layer’s thickness. The additive layer thickness is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The additive layer thickness affects the catheter’s lubricity and durability through routine experimentation. For example, Madsen cites Tanghoj, Allan et al. (US 20030018293 A1) (¶ [0150], the medical device for example a catheter … in WO 03/002325). Tanghoj describes a catheter and its cross-sectional area (¶ [0015] The outer cross-sectional shape … a cross-sectional area in the range of 0.5 mm2 - 30 mm2; ¶ [0016], a cross-sectional area in the range of 0.5 mm2 - 30 mm2 or a hydraulic radius in the size of 0.2-1.5 mm).
Given an outer cross-section of 0.5 mm2 - 30 mm2, the catheter’s outer radius is between 0.399 - 3.090 mm. (Radius =
r
=
A
/
π
).
Given an inner diameter or hydraulic radius in the size of 0.2-1.5 mm, the catheter’s wall thickness is expressed as (outer diameter - inner diameter) = (0.399 - 0.2) to (3.090-1.5) mm = 0.199 to 1.590 mm.
A skilled artisan would have been able to adjust Madsen’s additive layer thickness within the constraints of the wall thickness.
Too thin
Additive layer will erode or wear off too quickly
Optimized range
Additive layer will adequately lubricate the catheter and resist wear or erosion
Too thick
Additive layer will excessively weaken or soften the catheter
Additive layer is costly
Therefore, it would have been obvious to adjust the additive layer thickness in order to adequately lubricate the catheter while maintaining its structural integrity. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Madsen is also silent whether the additive layer is melded or physically entangled with the body. Calcote discloses a vascular graft and a method for making a vascular graft (col. 1, lines 5-10; col. 3, lines 5-20; col. 4, lines 10-20, vascular graft 20);
comprising a hollow polymeric tubular body (col. 4, lines 10-15, vascular graft 20 is tubular and can have any desired length, internal diameter, and wall thickness);
comprising a base polymer and (col. 4, lines 20-25, Vascular graft 20 includes inner surface 28 of expanded PTFE material having a first porosity, and outer surface 30 of expanded PTFE material having a second porosity different from that of inner surface 28);
a layer on or comprising a surface of the body (col. 4, lines 20-25, Vascular graft 20 includes inner surface 28 of expanded PTFE material having a first porosity, and outer surface 30 of expanded PTFE material having a second porosity different from that of inner surface 28);
wherein the layer comprises the surface of the body and comprises a co-extruded layer which is melded with or is physically entangled with the body (col. 5, lines 35-40, FIG. 4 illustrates an extrusion die 34 for melding separate billets 29 and 31, aligned concentrically on shaft 32, into a tube with the result that, as shown in FIG. 2, the original, separate billets are inseparable and visually indistinguishable; col. 5, lines 55-60, In operation, shaft-supported concentrically aligned billets 29 and 31 are loaded into a ram extruder (not shown) attached to die 34, and the billets are forced through die 34, thereby merging or melding the two billets into extrudate 42; col. 6, lines 5-10, Extrusion speed can be varied in the range of about 3-6 inches extrudate per second to control the melding of the two billets).
Calcote demonstrates how to manufacture a catheter with a co-extrusion technique. One would be motivated to modify Madsen with Calcote’s melded or entangled coextruded layer since Madsen calls for co-extruding the catheter (¶ [0079], Both extrusions and co-extrusion are suitable ways of preparing tube formed medical devices, such as catheters; ¶ [0152], where the coating composition is a thermoplastic material coating is suitably carried out by co-extrusion). Therefore, it would have been obvious to modify Madsen with Calcote’s melded or entangled coextruded layer in order to construct a catheter via co-extrusion.
Regarding claim 15, Madsen discloses a method of manufacturing an intermittent catheter (¶ [0016] The invention also relates to a method for the preparation of a medical device having a wetted hydrophilic coating and medical devices obtainable by said method; ¶ [0018] The term "medical device" should be interpreted in a fairly broad sense … catheters (such as urinary catheters), endoscopes, laryngoscopes, tubes for feeding, tubes for drainage);
the method comprising the step of extruding a base polymer and a lubricious additive to form a hollow polymeric tubular catheter body comprising the base polymer, and a layer comprising a lubricious additive on or comprising a surface of the catheter body (¶ [0079], Both extrusions and co-extrusion are suitable ways of preparing tube formed medical devices, such as catheters; ¶ [0150], the medical device for example a catheter, may be made by injection moulding of the coating composition as described in WO 03/002325. Extrusion is also a possibility; ¶ [0153] Injection moulding of more than one layer … Co-extrusion also represents a possibility); and
wherein the base polymer comprises at least one of polypropylene and polyethylene (¶ [0146] Medical devices … may be formed from a variety of basic materials, such as plastic … other polymer materials including … ethylene-vinyl-acetate copolymers(EVA), polyethylene (PE) metallocene-catalyzed polyethylene and copolymers of ethylene and propylene or mixtures thereof).
Madsen is silent regarding the additive layer’s thickness. Regarding the rationale and motivation to optimize Madsen’s additive layer, see the discussion of claim 1 above.
Madsen is also silent whether the additive layer is melded or physically entangled with the body. Calcote discloses a vascular graft and a method for making a vascular graft (col. 1, lines 5-10; col. 3, lines 5-20; col. 4, lines 10-20, vascular graft 20);
wherein a layer comprises a surface of a body and comprises a co-extruded layer which is melded with or is physically entangled with the body (col. 5, lines 35-40, FIG. 4 illustrates an extrusion die 34 … FIG. 2, the original, separate billets are inseparable and visually indistinguishable; col. 5, lines 55-60, … the billets are forced through die 34, thereby merging or melding the two billets into extrudate 42; col. 6, lines 5-10, Extrusion speed can be varied in the range of about 3-6 inches extrudate per second to control the melding of the two billets).
Calcote describes how to co-extrude a tubular device from a pair of polymers. Regarding the rationale and motivation to modify Madsen with Calcote’s co-extrusion and melding technique, see the discussion of claim 1 above.
Regarding claims 2-4, 9-10 and 16-20, Madsen discloses an intermittent catheter and method wherein the surface comprises an outer surface of the body (¶ [0028] According to this embodiment of the invention, there is no separate step for application of a coating composition to the surface of the medical device or a part of the surface of the medical device; ¶ [0079], Both extrusions and co-extrusion are suitable ways of preparing tube formed medical devices, such as catheters);
wherein the layer comprising a lubricious additive is on or comprises at least 75% of the outer surface area of the body (¶ [0147] The surface of the medical device, to which the hydrophilic wetted coating is applied, may be the full surface of the medical device or a part thereof);
wherein at least 75% of the layer comprising a lubricious additive is the lubricious additive (¶ [0080] When preparing the coating composition, the amphiphilic block copolymer is suitably added in an amount of from 10 to 100%, suitably 10-90%, preferably 10-80% or most preferred 10-50% by weight of the total weight of the coating composition; ¶ [0105] In a particular embodiment of the invention, the coating composition comprises: 60-90% w/w, suitably 60-80% w/w or more preferred 70-80% w/w of an amphiphilic polyurethane);
wherein the layer comprising a lubricious additive is cross-linked (¶ [0035] Preferably, the hydrophilic polymer is a polymer forming a physically cross-linked matrix in the coating composition, e.g. an amphiphilic block copolymer comprising hydrophilic and hydrophobic blocks; ¶ [0038] The amphiphilic block copolymers forming the physically cross-linked matrix in the coating composition suitably consist of at least one non-polar polymeric chain (hydrophobic block) covalently linked to at least one polar polymeric chain (hydrophilic block); ¶ [0079] An advantage of amphiphilic block copolymers which are cross linked by physical cross links, is that they are thermoplastic);
wherein the amphiphilic additive is an amphiphilic A-B block copolymer comprising a hydrophobic hydrocarbon A-block and a hydrophilic B-block (¶ [0039] The amphiphilic block co-polymers may for instance be a diblock polymer having a structure AB, where A is a hydrophobic block and B is a hydrophilic block or a triblock having a linear structure ABA where A is a hydrophobic block and B is a hydrophilic block, or alternatively have the form of a multi block, or multi arm star-shaped copolymer structure, containing A and B blocks);
wherein the method comprises co- extruding the base polymer and the layer comprising a lubricious additive simultaneously; wherein the method comprises extrusion coating the lubricious additive on the surface of the catheter body(¶ [0028] According to this embodiment of the invention, there is no separate step for application of a coating composition to the surface of the medical device or a part of the surface of the medical device; ¶ [0079], Both extrusions and co-extrusion are suitable ways of preparing tube formed medical devices, such as catheters).
Regarding claim 5, Madsen and Calcote do not explicitly disclose that the layer comprising a lubricious additive comprises an additive concentration of greater than 5% by weight of the combination of base polymer and layer comprising a lubricious additive. However, the combined teachings of Madsen and Calcote comprise a co-extruded layer which is melded or entangled with the body, as discussed for claim 1 above. When Madsen’s base layer partially mixes with the outer additive layer, the resulting layer will combine the base polymer and the additive layer. Since the layers appear to blend along a gradient, some portion of the melded layer will contain greater than 5% of the combination of base polymer and lubricious additive.
Alternatively, the additive layer appears to comprise mainly a combination of base polymer and lubricious additive. Madsen formulates a coating layer mainly from amphiphilic block copolymer, with lesser amounts of plasticizer or other agents (¶ [0080] When preparing the coating composition, the amphiphilic block copolymer is suitably added in an amount of from 10 to 100% … or most preferred 10-50% by weight of the total weight of the coating composition; ¶ [0095] When preparing the coating composition of the invention, the plasticizer is suitably added in an amount of from 10-50% m more suitably from 20-50% by weight of the total weight of the coating composition; ¶ [0104], Thus, the coating composition suitably comprise: 10-100% w/w, or suitably 10-90% w/w, preferably 10-50% of an amphiphilic block copolymer, at least 5% w/w of a hydrophilic homopolymer or heteropolymer; 0-30% w/w of a plastiziser for the hydrophobic phase 0-50% w/w of a plastiziser for the hydrophilic phase).
Therefore, the additive layer will comprise an additive concentration of greater than 5% by weight of the combination of base polymer and layer comprising a lubricious additive.
Claims 11, 12, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen and Calcote in view of Gravesen; Per Otto Børresen et al. (US 20120219742 A1).
Regarding claims 11, 12, 21 and 22, Madsen further discloses that the amphiphilic additive is an A-B block copolymer (¶ [0039] The amphiphilic block co-polymers may for instance be a diblock polymer having a structure AB, where A is a hydrophobic block and B is a hydrophilic block or a triblock having a linear structure ABA).
Madsen and Calcote do not explicitly disclose an A-block of the formula CH3CH2(CH2CH2)a where "a" is 5-25. Gravesen discloses an intermittent catheter comprising a hollow polymeric tubular body (¶ [0017] The article may be … 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 base polymer (¶ [0008], [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., which are all thermoplastic polymers commercially available); and
a layer comprising a lubricious additive (¶ [0037], 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);
wherein the lubricious additive comprises an amphiphilic molecule (¶ [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 amphiphilic additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH3CH2(CH2CH2)a where "a" is 5-25 and a hydrophilic B-block (¶ [0037], The amphiphilic block copolymer 2, 3 is 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 hydrophilic B-block);
wherein the B-block is a hydrophilic oligomer comprising between 2 and 10 monomer units derived from one or more 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).
Gravesen selects commercially available monomers for a block copolymer. One would be motivated to modify Madsen and Calcote with Gravesen’s CH3CH2(CH2CH2)a formula since Madsen calls for a straight-chain alcohol as a block (¶ [0044] "(Meth)acrylic esters" is used in the present context to designate esters of acrylic acid and of methacrylic acid with optionally halogenated, e.g. chlorinated or fluorinated, C.sub.1-C.sub.30 straight or branched alcohols, preferably C.sub.1-C.sub.18 alcohols). Therefore, it would have been obvious to modify Madsen and Calcote with Gravesen’s CH3CH2(CH2CH2)a formula in order to make a coating with commercially available polymers.
Response to Arguments
Applicant’s arguments filed 10 February 2026 regarding the rejection of claims 1-5, 9-12 and 15-22 as amended, under 35 USC § 103 over Madsen, Calcote and Gravesen, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant notes that the cited portion does not identify polypropylene and/or polyethylene, and instead describes polyurethane and PVC. Nor does Calcote cure this deficiency (remarks p. 7). Examiner finds that Madsen explicitly describes at least three forms of polyethylene as acceptable materials for the base polymer (¶ [0146], other polymer materials including … ethylene-vinyl-acetate copolymers(EVA), polyethylene (PE) metallocene-catalyzed polyethylene and copolymers of ethylene and propylene or mixtures thereof).
Applicant asserts that the Office Action provides no evidence that either Tanghoj or Madsen recognizes the thickness of the additive layer as a result-effective variable. See MPEP 2144.05(III)(C). As such, it is respectfully submitted that the allegation of additive thickness being recognized as a result-effective variable relies on impermissible hindsight reasoning and cannot properly be said to establish obviousness with regard to claim 1 (remarks p. 7).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant contends that the claimed range of 50-300 µm is not arbitrary, and instead possesses criticality. Such a thickness range provides a balance between lubricity and mechanical integrity when applied to substrates formed of polypropylene and polyethylene (remarks p. 8). Examiner acknowledges that the claimed thickness range balances the catheter’s lubricity and mechanical integrity. However, optimizing the thickness would have been within the skill of a skilled artisan. Madsen specifies the amount of amphiphilic block copolymer and also the amounts of other additives (¶ [0080], the amphiphilic block copolymer is suitably added in an amount … most preferred 10-50% by weight of the total weight of the coating composition, i.e. before wetting with the wetting agent; ¶ [0089], the hydrophilic homopolymers or heteropolymers are suitable added in an amount from 5 to 80%, preferably 10-80% by weight of the total weight of the desired composition, i.e. before wetting; ¶ [0095], the plasticizer is suitably added in an amount of from 10-50% m more suitably from 20-50% by weight of the total weight of the coating composition, i.e. before wetting with the wetting agent).
Madsen suggests to obtain amphiphilic block copolymers from commercial sources (¶ [0077] Suitable amphiphilic block copolymers for the purpose of the present invention are a poly(styrene-b-acrylic acid-b-styrene) (such as P3000-SMS with Mn 2000-65000-2000), poly(methyl methacrylate-b-methacrylic acid-b-methyl methacrylate) (such as P1483-MMAMAAMMA) and poly(styrene-b-ethylene oxide-b-styrene) (such as P2525-SEOS with Mn at 9500-48000-9500) all available from Polymer Source 124 Avro Street, Montreal, Quebec H9P 2.times.8, Canada).
Table 1: excerpted prices for block copolymers from https://www.polymersource.ca/
poly(styrene)-b-poly(acrylic acid)
0.5 g
1 g
2 g
5 g
$300
$500
$800
$1,800
poly(methyl methacrylate)-b-poly(methacrylic acid)
0.5 g
1 g
2 g
5 g
$200
$300
$500
ask price
The online product listings from www.polymersource.ca describe prices for various block copolymers. Two of Madsen’s suggested copolymers, poly(styrene-b-acrylic acid-b-styrene) and poly(methyl methacrylate-b-methacrylic acid-b-methyl methacrylate) are costly. Controlling the additive layer’s cost would have further motivated the skilled artisan to optimize the layer’s additive thickness.
Conclusion
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