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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Europe on 09/07/2023. It is noted, however, that applicant has not filed a certified copy of the EP 23195883 application as required by 37 CFR 1.55.
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 1-18 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “polyolefin”, and the claim also recites “at least one of polyethylene or polypropylene” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-18 are rejected as indefinite by virtue of their dependence on claim 1, and if the indefiniteness rejection of claim 1 is overcome, so will those of claims 2-18.
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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 8-12, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lundahl et al. (US 2019/0224384 A1) in view of Yang et al. (US 2006/0173123 A1).
Regarding claim 1, Lundahl discloses a urinary catheter (Fig. 1, feat. 1; ¶0054) comprising a catheter shaft (3) and a discharge element (2), a lumen extending between drainage eyelets (4) at a proximal insertion end of the catheter shaft (5) and an opposite discharge end at the discharge element (2; ¶0054), the catheter shaft comprising a substrate and a hydrophilic coating provided on the substrate (¶0065-0070: the catheter tubing material comprises a base, or substrate layer, and a hydrophilic polymer coating).
Lundahl does not disclose that the substrate is formed of a material comprising a blend of 70-99 wt% of a plastomer and 1-30 wt% of polyolefin, the polyolefin being at least one of polyethylene or polypropylene.
Yang teaches low melt viscosity polyethylene compositions (¶0003 and 0020-0021) comprising a blend of 50-99.99 wt% of an ethylene polymer (¶0044-0045), 0.01-50 wt % of a liquid modifier (¶0045-0046), and less than 50 wt% of a propylene homopolymer (¶0048 and 0183), such as polypropylene. The ethylene polymer (¶0136-0168) may be an ethylene based plastomer, such as an ethylene-alpha olefin copolymer in which the alpha olefin is 1-butene, 1-hexene, or 1-oxtene (¶0159-0161). The plastomer proportion of Yang of 50-99.99 wt% overlaps the claimed plastomer proportion of 70-99 wt%, and the polypropylene proportion of Yang of less than 50 wt% overlaps the claimed polypropylene proportion of 1-30 wt%. Therefore, a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Yang teaches that such compositions are suitable for manufacturing catheters (¶0194) and have enhanced softness and flexibility (¶0368). Yang further teaches that the low melt viscosity of the polyethylene compositions results in improved melt flowability, which makes it easier to fabricate articles from the compositions (¶0368-0374). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter disclosed by Lundahl so that the substrate is formed of a material comprising a blend of 70-99 wt% of a plastomer and 1-30 wt% of polyolefin, the polyolefin being at least one of polyethylene or polypropylene in order to make it easier to manufacture the catheter and enhance the softness and flexibility of the catheter as taught by Yang.
Regarding claims 2-3, Lundahl in view of Yang suggests the catheter of claim 1. As discussed above, Yang teaches a composition comprising, among other things, a blend of 50-99.99 wt% of an ethylene based plastomer (¶0044-0045 and 0159-0161) and less than 50 wt% of polypropylene (¶0048 and 0183). The plastomer proportion of 50-99.99 wt% overlaps the claimed ranges of 70-90 wt% of claim 2 and 75-85 wt% of claim 3, and the polypropylene proportion of less than 50 wt% overlaps the claimed ranges of 10-30 wt% of claim 2 and 15-25 wt% of claim 3. Therefore, a prima facie case exists for the claimed ranges. Please see MPEP §2144.05(I). As discussed above, Yang teaches that such a composition makes it easier to manufacture articles and enhances the softness and flexibility of the manufactured articles (¶0368-0374). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter suggested by Lundahl in view of Yang so that the substrate is formed of a material comprising a blend of 70-90 wt% of plastomer and 10-30 wt% of polyethylene and/or polypropylene, with respect to claim 2, or so that the substrate is formed of a material comprising a blend of 75-85 wt% of plastomer and 15-25 wt% of polyethylene and/or polypropylene, with respect to claim 3.
Regarding claim 4-5, Lundahl in view of Yang suggests the catheter of claim 1. As discussed above, Yang teaches that the plastomer may be an ethylene-alpha olefin copolymer in which the alpha olefin is 1-butene, 1-hexene, or 1-oxtene (¶0159-0161). Therefore, Lundahl in view of Yang further suggests that the plastomer comprises an ethylene-alpha olefin copolymer, with respect to claim 4, and that the alpha olefin comprises at least one of 1-butene, or 1-hexene and 1-octene.
Regarding claim 8, Lundahl in view of Yang suggests the catheter of claim 1, and Lundahl further discloses that the hydrophilic coating comprises a hydrophilic polymer or a polyvinylpyrrolidone (¶0065-0070). Regarding claim 9, Lundahl further discloses that the hydrophilic coating comprises polyvinylpyrrolidone (¶0070).
Regarding claims 10-12, Lundahl in view of Yang suggests the catheter of claim 1. Yang further teaches that the blend may further include a slip additive present in the range of 0.001 to 1 wt% (¶0176-0177). The slip additive proportion of 0.001 to 1 wt% overlaps the claimed range of 0.01-3 wt% of claim 11 and the claimed range of 0.01-0.5 wt% of claim 12. Therefore, a prima facie case exists for the claimed ranges. Therefore, Lundahl in view of Yang further suggests that the material of the substrate further comprises a slip agent, with respect to claim 10, that the material of the substrate comprises the slip agent in the range of 0.01-3 wt%, with respect to claim 11, and that the material of the substrate comprises 0.01-0.5 wt% of slip agent, with respect to claim 12.
Regarding claim 19, , Lundahl discloses a urinary catheter (Fig. 1, feat. 1; ¶0054) comprising a catheter shaft (3) and a discharge element (2), a lumen extending between drainage eyelets (4) at a proximal insertion end of the catheter shaft (5) and an opposite discharge end at the discharge element (2; ¶0054), the catheter shaft comprising a substrate and a hydrophilic coating provided on the substrate (¶0065-0070: the catheter tubing material comprises a base, or substrate layer, and a hydrophilic polymer coating).
Lundahl does not disclose that the substrate is formed of a material comprising at least 80 wt% of plastomer.
Yang teaches low melt viscosity polyethylene compositions (¶0003 and 0020-0021) comprising a blend of 50-99.99 wt% of an ethylene polymer (¶0044-0045), 0.01-50 wt % of a liquid modifier (¶0045-0046), and less than 50 wt% of a propylene homopolymer (¶0048 and 0183), such as polypropylene. The ethylene polymer (¶0136-0168) may be an ethylene based plastomer, such as an ethylene-alpha olefin copolymer in which the alpha olefin is 1-butene, 1-hexene, or 1-oxtene (¶0159-0161). The plastomer proportion of Yang of 50-99.99 wt% overlaps the claimed plastomer proportion of at least 80%.Therefore, a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Yang teaches that such compositions are suitable for manufacturing catheters (¶0194) and have enhanced softness and flexibility (¶0368). Yang further teaches that the low melt viscosity of the polyethylene compositions results in improved melt flowability, which makes it easier to fabricate articles from the compositions (¶0368-0374). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter disclosed by Lundahl so that the substrate is formed of a material comprising at least 80 wt% of plastomer in order to make it easier to manufacture the catheter and enhance the softness and flexibility of the catheter as taught by Yang.
Regarding claims 20-21, Lundahl in view of Yang suggests the catheter of claim 19. As discussed above, Yang teaches a composition comprising, among other things, a blend of 50-99.99 wt% of an ethylene based plastomer (¶0044-0045 and 0159-0161). The plastomer proportion of 50-99.99 wt% overlaps the claimed range of at least 90 wt% of claim 20 and at least 99 wt% of claim 21. Therefore, a prima facie case exists for the claimed ranges. Please see MPEP §2144.05(I). As discussed above, Yang teaches that such a composition makes it easier to manufacture articles and enhances the softness and flexibility of the manufactured articles (¶0368-0374). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter suggested by Lundahl in view of Yang so that the substrate is formed of a material comprising at least 90 wt% of plastomer, with respect to claim 20, or so that the substrate is formed of a material comprising at least 99 wt% of plastomer, with respect to claim 21.
Claims 6 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lundahl in view of Yang and in further view of Sellers et al. (US 2021/0213175 A1).
Regarding claim 6, Lundahl in view of Yang suggests the catheter of claim 1, but does not disclose that the plastomer comprises polybutene-1.
Sellers teaches urinary catheters which advantageously include stable mechanical properties over a range of temperatures (¶0012). Sellers teaches that the catheters may be made from a blend of a thermoplastic elastomer (TPE), such as poly(1-butene) (also known as polybutene-1), and a polyolefin such as polypropylene or polyethylene (¶0017-0019). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter suggested by Lundahl in view of Yang so that the plastomer comprises polybutene-1 so that the catheter has stable mechanical properties over a range of temperatures as taught by Sellers.
Regarding claims 13-14, Lundahl in view of Yang suggests the catheter of claim 1, but does not disclose that the substrate is formed of a material comprising a blend of 70-90 wt% of polybutene-1 and 10-30 wt% of polypropylene, with respect to claim 13, or that the substrate is formed of a material comprising a blend of 75-85 wt% of polybutene-1 and 15-25 wt% of polypropylene, with respect to claim 14.
As discussed above, Sellers teaches urinary catheters which advantageously include stable mechanical properties over a range of temperatures (¶0012). Sellers teaches that the catheters may be made from a blend of a thermoplastic elastomer (TPE), such as poly(1-butene) (also known as polybutene-1), and a polyolefin such as polypropylene or polyethylene (¶0017-0019). Sellers further teaches that the blend may comprise the TPE, such as polybutene-1, in the amount between 5 wt% and 95 wt%, and the polyolefin, such as polypropylene, in the amount between 5 wt% and 95 wt% (¶0019). The polybutene-1 proportion of Sellers of between 5-95 wt% overlaps the claimed polybutene-1 proportion of 70-90 wt% of claim 13 and of 75-85 wt% of claim 14, and the polypropylene proportion of Sellers of between 5-95 wt% overlaps the claimed polypropylene proportion of 10-30 wt% of claim 13 and of 15-25 wt% of claim 14. Therefore, a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter suggested by Lundahl in view of Yang so that the substrate is formed of a material comprising a blend of 70-90 wt% of polybutene-1 and 10-30 wt% of polypropylene, with respect to claim 13, or that the substrate is formed of a material comprising a blend of 75-85 wt% of polybutene-1 and 15-25 wt% of polypropylene, with respect to claim 14 so that the catheter has stable mechanical properties over a range of temperatures as taught by Sellers.
Regarding claims 15-16, Lundahl in view of Yang suggests the catheter of claim 1. As discussed above, Yang teaches polymer blends comprising, among other things, 50-99.99 wt% of an ethylene based plastomer, such as an ethylene-alpha olefin copolymer, (¶0044-0045 and 0159-0161), with less than 50 wt% of a propylene homopolymer (¶0048 and 0183), such as polypropylene. Yang is silent with respect to blending ethylene-alpha olefin copolymers with polyethylene as claimed.
As discussed above, Sellers teaches urinary catheters which advantageously include stable mechanical properties over a range of temperatures (¶0012). Sellers teaches that the catheters may be made from a blend of a thermoplastic elastomer (TPE), such as an ethylene based plastomer, and a polyolefin such as polyethylene (¶0017-0019). Because Sellers teaches that the catheter may be made from a blend of an ethylene based plastomer and polyethylene, and Yang teaches that ethylene based plastomers include ethylene-alpha olefin copolymers, Yang and Sellers together teach a blend comprising an ethylene-alpha olefin copolymer and polyethylene. Sellers further teaches that the blend may comprise the TPE, such as an ethylene-alpha olefin copolymer, in the amount between 5 wt% and 95 wt%, and the polyolefin, such as polyethylene, in the amount between 5 wt% and 95 wt% (¶0019). The ethylene-alpha olefin copolymer proportion of Yang and Sellers of between 5-95 wt% overlaps the claimed ethylene-alpha olefin copolymer proportion of 70-90 wt% of claim 15 and of 75-85 wt% of claim 16, and the polyethylene proportion of Sellers of between 5-95 wt% overlaps the claimed polyethylene proportion of 10-30 wt% of claim 15 and of 15-25 wt% of claim 16. Therefore, a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter suggested by Lundahl in view of Yang so that the substrate is formed of a material comprising a blend of 70-90 wt% of ethylene-alpha olefin copolymer and 10-30 wt% of polyethylene, with respect to claim 15, or that the substrate is formed of a material comprising a blend of 75-85 wt% of ethylene-alpha olefin copolymer and 15-25 wt% of polyethylene, with respect to claim 16 so that the catheter has stable mechanical properties over a range of temperatures as taught by Sellers.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lundahl in view of Yang and in further view of Triel et al. (US 2012/0136319 A1).
Regarding claim 7, Lundahl in view of Yang suggests the catheter of claim 1, and Lundahl further discloses that the discharge element has the form of a flared funnel (Fig. 1, feat. 2). Lundahl in view of Yang are silent with respect to the discharge unit being formed as an integrated, monolithic unit with the catheter shaft, and formed of the same material as the substrate.
Triel teaches a catheter (Figs. 6c, feat. 70; ¶0051) comprising a shaft (71) with a flared funnel connector (72). Triel teaches that the connector may be monolithic with the rest of the catheter, in order to allow the catheter and connector to be injection molded in a single cycle (¶0029). Making the connector or discharge element integral with the rest of the catheter so that it can be injection molded in the same cycle as the rest of the catheter would make it the same material as the rest of the catheter. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter suggested by Lundahl in view of Yang so that the discharge unit is formed as an integrated, monolithic unit with the catheter shaft, and formed of the same material as the substrate in order to allow the discharge unit to be injection molded with the rest of the catheter in a single cycle as taught by Triel.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lundahl in view of Yang and in further view of Panesar et al. (US 2023/0001132 A1).
Regarding claims 17-18, Lundahl in view of Yang suggests the catheter of claim 1. Lundahl further discloses a urinary catheter assembly (Fig. 2, feat. 20; ¶0057) comprising a urinary catheter (1) and a package accommodating the urinary catheter (21). Lundahl in view of Yang does not suggest that the package is made of a material comprising a polyolefin that of the same polyolefin type as in the urinary catheter, with respect to claim 17, or that the package is made of a material comprising at least one of polyethylene and polypropylene, with respect to claim 18.
Panesar teaches a urinary catheter assembly (Fig. 1, feat. 10; ¶0018) comprising a catheter (12) enclosed in a packaging sleeve (22; ¶0019). Panesar teaches that the packaging sleeve may be made of a polymer layer, such as a polyethylene or polypropylene layer, and an aluminum layer in order to make the packaging gas and liquid impermeable (¶0020 and 0035). Lundahl discloses that the packaging may comprise an aluminum layer to make it gas impermeable (Lundahl: ¶0057), but is silent with respect to any other materials used in the packaging. As discussed above, the catheter suggested by Lundahl in view of Yang comprises a substrate comprising a blend of, among other things, an ethylene based plastomer and polypropylene. Therefore, packaging comprising a propylene polymer layer and an aluminum layer as taught by Panesar would comprise a polyolefin that is the same as the polyolefin type in the catheter suggested by Lundahl in view of Yang. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter assembly suggested by Lundahl in view of Yang so that the package is made of a material comprising a polyolefin that of the same polyolefin type as in the urinary catheter, with respect to claim 17, and so that the package is made of a material comprising at least one of polyethylene and polypropylene, with respect to claim 18, so that the packaging is both gas and liquid impermeable as taught by Panesar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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