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, 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 and 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20200308440 A1) in view of Keating et al. (US 20210378676 A1).
Regarding claim 1, Cheng teaches a coated medical article comprising a substrate with a surface having reactive functional groups, a polymerization initiator chemically bonded to the substrate via reaction with the reactive functional groups on the surface of the substrate, and a polymeric coating layer (Cheng, Abstract, Par. 0003, 0015-0017, 0022, 0107-0111, 0114). Cheng teaches the polymeric coating layer has a thickness of at least about 100 nm (Cheng, Par. 0184), which overlaps the claimed range of greater than 10 nm and less than 2.5 µm and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I. Cheng teaches the polymeric coating layer is prepared from an aqueous monomer composition comprising a methacrylamide monomer having at least one ionic functional group (see zwitterionic) (Cheng, Par. 0089, 0101-0105, 0129, Claims 1 and 3-4). Cheng does not teach any other monomers are required and thus teaches the composition comprises 100 wt.% of the methacrylamide monomer which lies within the range of at least 50 wt.% and therefore satisfies the claimed range, see MPEP 2131.03. Cheng teaches the polymeric coating layer comprises a [3-(methacryloylamino)propyl]trimethylammonium chloride (Cheng, Par. 0101-0103), which is the same as the instant invention per the instant claim 11. Cheng teaches the polymeric coating layer is chemically bonded to and propagated from the polymerization initiator (Cheng, Abstract, Par. 0003, 0015-0017, 0022, 0107-0111, 0114). Cheng teaches an uncoated substrate has a water contact angle of 57° and that the coating of a zwitterionic polymer reduces the water contact angle due to the hydrophilicity (Cheng, Par. 0141). Cheng further teaches examples using a zwitterionic polymer wherein the coating has a water contact angle of under 2° (Cheng, Par. 0030 and 0152).
Cheng is silent regarding the polymeric coating layer demonstrating a water contact angle less than 10°, and wherein said coated article retains a contact angle of less than 10° after immersion in phosphate buffered aqueous saline solution at 22°C for a period of 28 days.
Keating teaches a coated medical article wherein the coating comprises a methacrylamide (Keating, Abstract, Par. 0045 and 0075). Keating teaches the coating may be hydrophilic with a water contact angle of less than 10° (Keating, Par. 0073), which is the same as the claimed range of less than 10° and therefore satisfies the claimed range, see MPEP 2131.03.
Cheng and Keating are analogous art as they both teach medical articles with a hydrophilic coating comprising a methacrylamide. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the polymeric coating layer of Cheng to have a water contact angle of less than 10°. This would allow for a very hydrophilic surface (Keating, Par. 0065 and 0073).
Regarding the limitation of the coated article retaining the contact angle after immersion in phosphate buffered aqueous saline solution at 22°C for a period of 28 days, modified Cheng teaches a coated article comprising the same polymeric coating layer with the same monomer and the same water contact angle as stated above for claim 1. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Therefore, absent objective evidence to the contrary, the coated article of modified Cheng would have inherently retained the claimed contact angle.
Regarding claims 3 and 19, modified Cheng teaches the substrate comprises stainless steel (Cheng, Par. 0117).
Regarding claim 4, modified Cheng teaches the substrate comprises reactive hydroxly groups (Cheng, Par. 0111, 0114, and 0139).
Regarding claims 5-8, 17, and 20, modified Cheng teaches the polymeric coating layer has a thickness of at least about 100 nm (Cheng, Par. 0184), which overlaps the claimed ranges and therefore establishes a prima facie case of obviousness over the claimed ranges, see MPEP 2144.05, I.
Regarding claims 9 and 18, modified Cheng teaches the polymeric coating layer demonstrates a water contact angle of less than 10° (Keating, Par. 0073) which overlaps the claimed range of less than 5° and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Regarding claims 10 and 16, modified Cheng teaches the substrate comprises a catheter (Cheng, Par. 0088).
Regarding claim 11, Cheng teaches a coated medical article comprising a substrate with a surface having reactive functional groups, a polymerization initiator chemically bonded to the substrate via reaction with the reactive functional groups on the surface of the substrate, and a polymeric coating layer (Cheng, Abstract, Par. 0003, 0015-0017, 0022, 0107-0111, 0114). Cheng teaches the polymeric coating layer has a thickness of at least about 100 nm (Cheng, Par. 0184), which overlaps the claimed range of greater than 10 nm and less than 2.5 µm and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I. Cheng teaches the polymeric coating layer is prepared from an aqueous monomer composition comprising a methacrylamide monomer having at least one ionic functional group (see zwitterionic) (Cheng, Par. 0089, 0101-0105, 0129, Claims 1 and 3-4). Cheng does not teach any other monomers are required and thus teaches the composition comprises 100 wt.% of the methacrylamide monomer which lies within the range of at least 50 wt.% and therefore satisfies the claimed range, see MPEP 2131.03. Cheng teaches the polymeric coating layer is chemically bonded to and propagated from the polymerization initiator (Cheng, Abstract, Par. 0003, 0015-0017, 0022, 0107-0111, 0114). Cheng teaches the polymeric coating layer comprises a [3-(methacryloylamino)propyl]trimethylammonium chloride (Cheng, Par. 0101-0103). Cheng teaches an uncoated substrate has a water contact angle of 57° and that the coating of a zwitterionic polymer reduces the water contact angle due to the hydrophilicity (Cheng, Par. 0141). Cheng further teaches examples using a zwitterionic polymer wherein the coating has a water contact angle of under 2° (Cheng, Par. 0030 and 0152).
Cheng is silent regarding the polymeric coating layer demonstrating a water contact angle less than 10°, and wherein said coated article retains a contact angle of less than 10° after immersion in phosphate buffered aqueous saline solution at 22°C for a period of 28 days.
Keating teaches a coated medical article wherein the coating comprises a methacrylamide (Keating, Abstract, Par. 0045 and 0075). Keating teaches the coating may be hydrophilic with a water contact angle of less than 10° (Keating, Par. 0073), which is the same as the claimed range of less than 10° and therefore satisfies the claimed range, see MPEP 2131.03.
Cheng and Keating are analogous art as they both teach medical articles with a hydrophilic coating comprising a methacrylamide. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the polymeric coating layer of Cheng to have a water contact angle of less than 10°. This would allow for a very hydrophilic surface (Keating, Par. 0065 and 0073).
Regarding the limitation of the coated article retaining the contact angle after immersion in phosphate buffered aqueous saline solution at 22°C for a period of 28 days, modified Cheng teaches a coated article comprising the same polymeric coating layer with the same monomer and the same water contact angle as stated above for claim 1. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Therefore, absent objective evidence to the contrary, the coated article of modified Cheng would have inherently retained the claimed contact angle.
Regarding claim 12, modified Cheng teaches the polymeric coating layer comprises a homopolymer of [3-(methacryloylamino)propyl]trimethylammonium chloride (Cheng, Par. 0070 and 0101-0103).
Regarding claim 13, modified Cheng teaches the polymeric coating layer may include a copolymer including a hydrophilic monomer (Cheng, Par. 0070, 0081, and 0101-0103).
Modified Cheng is silent regarding the polymeric coating layer including a block copolymer.
Keating teaches a coated medical article comprising a coating which comprises a block copolymer, wherein the block copolymer comprises a hydrophilic monomer and a binding monomer (Keating, Abstract and Par. 0113-0117).
Modified Cheng and Keating are analogous art as they both teach coated medical articles comprising a coating with a copolymer including a hydrophilic monomer. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formed the copolymer of modified Cheng to be a block copolymer with a binding block. This would allow for a hydrophilic copolymer with binding properties (Keating, Par. 0113-0117).
Regarding claim 14, modified Cheng teaches the polymeric coating layer is prepared via a controlled radical polymerization process (see ATRP) (Cheng, Par. 0115). Alternatively, the limitation of the polymeric coating layer being prepared via a CRP process is a product by process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113). The polymeric coating layer structure of the prior art discloses a product which reasonably appears to be either identical or substantially identical to the claimed product-by-process polymeric coating layer structure subjected to the process steps of controlled radical polymerization and therefore absent any objective evidence showing to the contrary, the addition of the process limitations of claim 14 does not provide a patentable distinction over the prior art.
Regarding claim 15, Cheng teaches a medical device comprising a substrate with a surface having reactive functional groups, a polymerization initiator chemically bonded to the substrate via reaction with the reactive functional groups on the surface of the substrate, and a polymeric coating layer (Cheng, Abstract, Par. 0003, 0015-0017, 0022, 0107-0111, 0114). Cheng teaches the polymeric coating layer has a thickness of at least about 100 nm (Cheng, Par. 0184), which overlaps the claimed range of greater than 10 nm and less than 2.5 µm and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I. Cheng teaches the polymeric coating layer is prepared from an aqueous monomer composition comprising a methacrylamide monomer having at least one ionic functional group (see zwitterionic) (Cheng, Par. 0089, 0101-0105, 0129, Claims 1 and 3-4). Cheng does not teach any other monomers are required and thus teaches the composition comprises 100 wt.% of the methacrylamide monomer which lies within the range of at least 50 wt.% and therefore satisfies the claimed range, see MPEP 2131.03. Cheng teaches the polymeric coating layer comprises a [3-(methacryloylamino)propyl]trimethylammonium chloride (Cheng, Par. 0101-0103), which is the same as the instant invention per the instant claim 11. Cheng teaches the polymeric coating layer is chemically bonded to and propagated from the polymerization initiator (Cheng, Abstract, Par. 0003, 0015-0017, 0022, 0107-0111, 0114). Cheng teaches an uncoated substrate has a water contact angle of 57° and that the coating of a zwitterionic polymer reduces the water contact angle due to the hydrophilicity (Cheng, Par. 0141). Cheng further teaches examples using a zwitterionic polymer wherein the coating has a water contact angle of under 2° (Cheng, Par. 0030 and 0152).
Cheng is silent regarding the polymeric coating layer demonstrating a water contact angle less than 10°, and wherein said coated article retains a contact angle of less than 10° after immersion in phosphate buffered aqueous saline solution at 22°C for a period of 28 days.
Keating teaches a coated medical article wherein the coating comprises a methacrylamide (Keating, Abstract, Par. 0045 and 0075). Keating teaches the coating may be hydrophilic with a water contact angle of less than 10° (Keating, Par. 0073), which is the same as the claimed range of less than 10° and therefore satisfies the claimed range, see MPEP 2131.03.
Cheng and Keating are analogous art as they both teach medical articles with a hydrophilic coating comprising a methacrylamide. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the polymeric coating layer of Cheng to have a water contact angle of less than 10°. This would allow for a very hydrophilic surface (Keating, Par. 0065 and 0073).
Regarding the limitation of the coated article retaining the contact angle after immersion in phosphate buffered aqueous saline solution at 22°C for a period of 28 days, modified Cheng teaches a coated article comprising the same polymeric coating layer with the same monomer and the same water contact angle as stated above for claim 1. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Therefore, absent objective evidence to the contrary, the coated article of modified Cheng would have inherently retained the claimed contact angle.
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. in view of Keating et al. as applied to claim 1 above, further in view of Atanasova et al. (US 20120184029 A1).
Regarding claim 2, modified Cheng teaches all of the elements of the claimed invention as stated above for claim 1. Cheng is silent regarding the polymerization initiator comprising alkyl halide functional groups.
Atanasova teaches a medical article comprising a substrate, a polymerization initiator, and a coating, wherein the polymerization initiator comprises alkyl halide functional groups (Atanasova, Abstract, Par. 0003, 0006-0007, 0146, and 0312).
Modified Cheng and Atanasova are analogous art as they both teach coated medical articles comprising a polymerization initiator. It would have been obvious to one of ordinary skill in the art before the effective filing date to have used a polymerization initiator comprising alkyl halide functional groups as the polymerization initiator of modified Cheng. This would allow for atom transfer radical polymerization to react with the substrate (Atanasova, Par. 0003, 0146, and 0312).
Conclusion
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/THOMAS J KESSLER/Examiner, Art Unit 1782
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