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 § 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 10-18 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.
Claim 15 recites “a structural unit derived from a monomer selected from the group consisting of “ but lists a mixture of monomers and polymers as options from which to choose (e.g., acrylic acid, polyacrylic acid, polyglutamic acid). For the sake of compact prosecution and the application of prior art, a polymer compound able to be produced from a recited compound of claim 15 will be deemed sufficient to meet is limitations. Clarification is still required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kuramoto et al. (WO 2018/038063 – US PGPub No. 2019/0185776 relied upon as English equivalent – previously cited) in view of Ding (previously cited).
Kuramoto et al. teach a set of copolymers employed as a lubricous coating on the surface of medical devices (see abstract and paragraph 105). The envisioned devices include stents and catheters and the coating is detailed as a lubricious coating layer applied via a coating liquid with 10 wt% of the polymer onto a substrate layer of the device (see paragraphs 94 and 102 and example 1-2; instant claims 5, 7-9, and 14). They go on to teach the copolymer as a terpolymer composed of three monomers, where a preferred example provides a sulfobetaine containing monomer (monomer A) as [2-(methacryloyloxy)ethyl] dimethyl-(3-sulfopropyl) ammonium hydroxide, a sulfonic acid containing monomer (monomer B) as 2-acrylamido-2-methyl-1-propanesulfonic acid, and a photoreactive group containing monomer (monomer C) as 4-methacryloyloxybenzophenone (see production example 1, example 1-2, and figure 4 example 1-2; instant claims 1, 4, 10, and 13). These compounds fulfill monomer A as formula 1 with Z1 = oxygen, monomer B as formula 2 with Z2 = -NH- and X = -SO3H, and monomer C as a benzophenone containing group selected from 4-(meth)acryloyloxybenzophenone (MBP), 4-(meth)acryloyloxyethoxybenzophenone, 4-(meth)acryloyloxy-4'-methoxybenzophenone, 4-(meth)acryloyloxyethoxy-4'-methoxybenzophenone (see instant claims 2-3, 6, and 11-12). The copolymer is more generically composed of a monomer with a sulfobetaine structure, a monomer with a sulfonic acid groups, and a monomer with a photoreactive group (see abstract). Additional envisioned benzophenone (photoreactive) containing monomers include 4-(meth)acryloyloxyethoxybenzophenone, 4-(meth)acryloyloxy-4'-methoxybenzophenone, 4-(meth)acryloyloxyethoxy-4'-methoxybenzophenone (see paragraph 70). The polymers are designed such that after application to a substrate an drying, light irradiation chemically bonds the polymer to the substrate surface via the photoreactive groups (see paragraph 117). Kuramoto et al. also detail the utility of their coatings on catheters to permit access to peripheral lesions via insertion into and movement through a lumen of a living body (see paragraph 3; instant claims 19-20). The presence of hyaluronic acid, an instantly claimed polysaccharide, nonionic polymer, or polyelectrolyte in the coating is not detailed.
Ding teaches a methacrylate based polymer envisioned as a coating for medical implants (see abstract). They teach the polymer to include hydrophilic monomers and for the coating to include a physical mixture of biobeneficial agents to confer features such as non-fouling properties, anti-thrombogenic properties, anti-inflammatory properties, and hemocompatibility (see paragraphs 20 and 31). Sulfonic acid group containing monomers are named as hydrophilic monomers (see paragraph 20). The biobeneficial agents may be included individually or in combination and are envisioned to include hyaluronic acid as well as a poly(vinyl pyrrolidone), dextran, and polyacrylic acid (see paragraphs 31-32).
Chabrecek et al. teach a coating composed of surface bound hydrophilic polymers with entangled hydrophilic polymers to confer hydrophilicity and lubricity to devices envisioned to include catheters (see abstract and paragraphs 1 and 161). They employ (meth)acrylic and (meth)acrylamide hydrophilic monomers to generate the surface bound polymer (see paragraphs 7 and 63 and examples C-1 though C-3). Chabrecek et al. teach a hydrophilic polymer dissimilar from that bound to the surface as the entrapped polymer that are envisioned to include polyacrylic acid, polyvinyl pyrrolidone, and polysaccharides such as hyaluronic acid and dextran (see paragraphs 147-152 and examples D-2 through D-6 and E1 and E-7). Hyaluronic acid is a preferred choice (see paragraph 152). They exemplify hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 100 (as calculated by the examiner from coating solution providing about 3.25 g bound polymer and 0.03 g hyaluronic acid) (see examples D-6 and E-7; instant claims 1 and 10). Another example provides hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 55 (as calculated by the examiner from coating solution providing about 1.1 g bound polymer and 0.02 g hyaluronic acid) (see examples D-5 and E-4; instant claims 1 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hydrophilic polymer as a biobeneficial agent in the polymer coating of Kuramoto et al. in light of Ding and Chabrecek et al. This modification would have been obvious so as to confer the added or enhanced properties these components provide to the (meth)acrylate based polymer coating and as the application of the same technique to a similar product in order to yield the same improvement. Specifically, the addition of hyaluronic acid, polyacrylic acid, poly(vinyl pyrrolidone), or dextran at a proportion envisioned by Chabrecek et al. to the 10 wt% coating solution would have been obvious. The application of the coating on a catheter as detailed and the process of reaching a peripheral lesion site as envisioned by inserting it into and through a lumen of a living body would then follow. While the sliding resistance of the resulting coating is not explicitly detailed, the coating concentration of polymer is higher than that instantly exemplified as resulting in 40% or less sliding resistance as compared to the coating without hyaluronic acid (see instant example 1 and comparative example 1 and instant figure 4). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Since the instantly claimed components are present at the instantly claimed proportions and at a coating level that exceeds that instantly exemplified, the coating would have the instantly claimed functionality, absent evidence to the contrary. Therefore claims 1-22 are obvious over Kuramoto et al. in view of Ding and Chabrecek et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,054,564.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a medical device with a lubricious coating composed of hyaluronic acid in combination with a hydrophilic copolymer composed of the same monomer A, monomer B, and monomer C as instantly claimed. The claims also both recite a medical device with a lubricious coating composed of a polyelectrolyte, a polysaccharide, or a nonionic polymer in combination with the same hydrophilic copolymer. The ratio of hyaluronic acid (polysaccharide) to hydrophilic copolymer is 1:more than 5 to 500. The concentration of the hydrophilic polymer in a coating solution to product the coating ranges from 0.1 to 4.5 wt%. A catheter, stent, and guidewire are recited particular devices in both sets of claims. A method of making the coated devices by applying a coating liquid comprising the respective polymer blends to the device is recited by both sets of claims. The patented claims additionally recite a substrate layer and adhesive layer beneath the lubricious layer; however, the instant disclosure envisions its substrate layer to have a core layer and surface layer (see instant specification paragraph 36 and figure 2). Thus the patented substrate layer and adhesive layer constitute a multi-layered embodiment of the instant substrate layer. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the hyaluronic acid and hydrophilic copolymer at a ration within the recited range because the claims state to do so. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). The range of ratios of hyaluronic acid to hydrophilic copolymer overlap with the instantly claimed ranges, thereby rendering them obvious. While the sliding resistance of the resulting coating is not explicitly detailed, the coating concentration of polymer is about the same as that instantly exemplified as resulting in 40% or less sliding resistance as compared to the coating without hyaluronic acid (see instant example 1 and comparative example 1 and instant figure 4). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Since the instantly claimed components are present at the instantly claimed proportions and at a coating level that exceeds that instantly exemplified, the coating would have the instantly claimed functionality, absent evidence to the contrary. Therefore claims 1-14 and 22 are unpatentable over claims 1-20 of U.S. Patent No. 12,054,564.
Claims 1-18 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,054,564 as applied to claims 1-14 and 22 above, and further in view of Ding.
Claims 1-20 of U.S. Patent No. 12,054,564 teach the limitations of instant claims 1-14 and 22. Particular nonionic polymer, polyelectrolytes, and instantly claimed polysaccharides are not detailed.
Ding teaches a methacrylate based polymer envisioned as a coating for medical implants (see abstract). They teach the polymer to include hydrophilic monomers and for the coating to include a physical mixture of biobeneficial agents to confer features such as non-fouling properties, anti-thrombogenic properties, anti-inflammatory properties, and hemocompatibility (see paragraphs 20 and 31). Sulfonic acid group containing monomers are named as hydrophilic monomers (see paragraph 20). The biobeneficial agents may be included individually or in combination and are envisioned to include hyaluronic acid as well as a poly(vinyl pyrrolidone), dextran, and polyacrylic acid (see paragraphs 31-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a biobeneficial agent in the polymer coating of the patented claims that fulfill the polysaccharide, polyelectrolyte or non-ionic polymer categories in light of Ding. This modification would have been obvious so as to confer the added or enhanced properties these components provide and fulfill the requirements of the patented claims. The modification is also obvious as the application of the same technique to a similar product in order to yield the same improvement. Specifically, the selection of polyacrylic acid, poly(vinyl pyrrolidone), or dextran would have been obvious. Therefore claims 1-18 and 22 are obvious over claims 1-20 of U.S. Patent No. 12,054,564 in view of Ding.
Claims 1-14, 19-20, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,054,564 as applied to claims 1-14 and 22 above, and further in view of Umeno et al. (previously cited).
Claims 1-20 of U.S. Patent No. 12,054,564 teach the limitations of instant claims 1-14 and 22. The patented claims also teach a method of inserting a coated medical device into lumen of a patient and moving it within the lumen. A particular destination is not detailed.
Umeno et al. teach a vascular catheter that is inserted into a patient vessel lumen and moved to a lesion site to perform a desired treatment (see column 1 lines 11-19). They detail coating the catheter with a lubricious coating composed of a hydrophilic polymer (see column 5 line 66-column 6 line 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of the patented claims such that the catheter embodiment is inserted and moved in a blood vessel to a lesion for treatment. This modification would have been obvious in light of Umeno et al. who detail this purpose for the insertion of a lubricious catheter into a patient lumen. Therefore claims 1-14, 19-20, and 22 are obvious over claims 1-20 of U.S. Patent No. 12,054,564 in view of Umeno et al.
Claims 1-18 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,377,512 in view of Ding and Chabrecek et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a medical device with a lubricious coating composed of a hydrophilic copolymer composed of the same monomer A, monomer B, and monomer C as instantly claimed. The claims also both recite a medical device with a lubricious coating composed of a polyelectrolyte, a polysaccharide, or a nonionic polymer in combination with the same hydrophilic copolymer. A catheter, stent, and guidewire are recited particular devices in both sets of claims. The presence of hyaluronic acid, an instantly claimed polysaccharide, nonionic polymer, or polyelectrolyte in the coating is not detailed.
Ding teaches a methacrylate based polymer envisioned as a coating for medical implants (see abstract). They teach the polymer to include hydrophilic monomers and for the coating to include a physical mixture of biobeneficial agents to confer features such as non-fouling properties, anti-thrombogenic properties, anti-inflammatory properties, and hemocompatibility (see paragraphs 20 and 31). Sulfonic acid group containing monomers are named as hydrophilic monomers (see paragraph 20). The biobeneficial agents may be included individually or in combination and are envisioned to include hyaluronic acid as well as a poly(vinyl pyrrolidone), dextran, and polyacrylic acid (see paragraphs 31-32). Ding also teaches the preparation of the coated devices by applying a coating liquid comprising the desired polymers/components (see example 2).
Chabrecek et al. teach a coating composed of surface bound hydrophilic polymers with entangled hydrophilic polymers to confer hydrophilicity and lubricity to devices envisioned to include catheters (see abstract and paragraphs 1 and 161). They employ (meth)acrylic and (meth)acrylamide hydrophilic monomers to generate the surface bound polymer (see paragraphs 7 and 63 and examples C-1 though C-3). Chabrecek et al. teach a hydrophilic polymer dissimilar from that bound to the surface as the entrapped polymer that are envisioned to include polyacrylic acid, polyvinyl pyrrolidone, and polysaccharides such as hyaluronic acid and dextran (see paragraphs 147-152 and examples D-2 through D-6 and E1 and E-7). Hyaluronic acid is a preferred choice (see paragraph 152). They exemplify hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 100 in a coating solution with 10 wt% of the bound polymer components (as calculated by the examiner from coating solution providing about 3.25 g bound polymer and 0.03 g hyaluronic acid) (see examples D-6 and E-7; instant claims 1 and 10). Another example provides hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 55 (as calculated by the examiner from coating solution providing about 1.1 g bound polymer and 0.02 g hyaluronic acid) (see examples D-5 and E-4; instant claims 1 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hydrophilic polymer as a biobeneficial agent in the polymer coating of the patented claims in light of Ding and Chabrecek et al. This modification would have been obvious so as to confer the added or enhanced properties these components provide to the (meth)acrylate based polymer coating and as the application of the same technique to a similar product in order to yield the same improvement. Specifically, the addition of hyaluronic acid, polyacrylic acid, poly(vinyl pyrrolidone), or dextran at a proportion and coating density envisioned by Chabrecek et al. would have been obvious. The application of the coating on a catheter as detailed and the process of reaching a peripheral lesion site as envisioned by inserting it into and through a lumen of a living body would then follow. Application of the coating from a liquid would then follow. While the sliding resistance of the resulting coating is not explicitly detailed, the coating concentration of polymer is higher than that instantly exemplified as resulting in 40% or less sliding resistance as compared to the coating without hyaluronic acid (see instant example 1 and comparative example 1 and instant figure 4). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Since the instantly claimed components are present at the instantly claimed proportions and at a coating level that exceeds that instantly exemplified, the coating would have the instantly claimed functionality, absent evidence to the contrary. Therefore claims 1-18 and 22 are obvious over claims 1-12 of U.S. Patent No. 11,377,512 in view of Ding.
Claims 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-12 of U.S. Patent No. 12,642,892 in view of Chabrecek et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a medical device with a lubricious coating composed of a compound in combination with a hydrophilic copolymer composed of the same monomer A, monomer B, and monomer C as instantly claimed. The compound of the patented claims is a polymer with structural units made from acrylamide, a non-ionic monomer which yields the instantly claimed non-ionic polymer. A catheter, stent, and guidewire are recited particular devices in both sets of claims. The copending claims additionally recite a substrate layer to which the lubricious coating is applied. A ratio of the acrylamide polymer to the hydrophilic copolymer is not detailed.
Chabrecek et al. teach a coating composed of surface bound hydrophilic polymers with entangled hydrophilic polymers to confer hydrophilicity and lubricity to devices envisioned to include catheters (see abstract and paragraphs 1 and 161). They employ (meth)acrylic and (meth)acrylamide hydrophilic monomers to generate the surface bound polymer (see paragraphs 7 and 63 and examples C-1 though C-3). Chabrecek et al. teach a hydrophilic polymer dissimilar from that bound to the surface as the entrapped polymer that include polyacrylamide, polyacrylic acid, polyvinyl pyrrolidone, and polysaccharides such as hyaluronic acid and dextran (see paragraphs 147-152 and examples D-2 through D-6 and E1 and E-7). Hyaluronic acid is a preferred choice (see paragraph 152). They exemplify hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 100 with 10 wt% of the bound polymer components present in the coating solution (as calculated by the examiner from coating solution providing about 3.25 g bound polymer and 0.03 g hyaluronic acid) (see examples D-6 and E-7; instant claims 1 and 10). Another example provides hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 55 (as calculated by the examiner from coating solution providing about 1.1 g bound polymer and 0.02 g hyaluronic acid) (see examples D-5 and E-4; instant claims 1 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a proportion of entrapped polymer and coating solution concentration as detailed by Chabrecek et al. for the acrylamide polymer of the patented claims because it was known for a similar utility. Therefore claims 10-14 are unpatentable over claims 1 and 3-12 of U.S. Patent No. 12,642,892 in view of Chabrecek et al.
Claims 1-14 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-12 of U.S. Patent No. 12,642,892 in view of Chabrecek et al. as applied to claims 10-14 above, and further in view of Ding.
Claims 1 and 3-12 of U.S. Patent No. 12,642,892 in view of Chabrecek et al. teach the limitations of instant claims 10-14. Hyaluronic acid, other polysaccharides and polyelectrolytes are not explicitly recited in the patented claims.
Ding teaches a methacrylate based polymer envisioned as a coating for medical implants (see abstract). They teach the polymer to include hydrophilic monomers and for the coating to include biobeneficial agents to confer features such as non-fouling properties, anti-thrombogenic properties, anti-inflammatory properties and hemocompatibility (see paragraphs 20 and 31). Sulfonic acid group containing monomers are named as hydrophilic monomers (see paragraph 20). The biobeneficial agents may be included individually or in combination and are envisioned to include hyaluronic acid as well as polyacrylic acid, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), and dextrin (see paragraphs 31-32). Ding also teaches the preparation of the coated devices by applying a coating liquid comprising the desired polymers/components (see example 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a biobeneficial agent in the polymer coating of the modified patented claims in light of Ding. This modification would have been obvious so as to confer the added or enhanced properties these components provide and as the application of the same technique to a similar product in order to yield the same improvement. Specifically, the addition of hyaluronic acid as well as polyacrylic acid, poly(vinyl pyrrolidone), or dextran. While the sliding resistance of the resulting coating is not explicitly detailed, the coating concentration of polymer is higher than that instantly exemplified as resulting in 40% or less sliding resistance as compared to the coating without hyaluronic acid (see instant example 1 and comparative example 1 and instant figure 4). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Since the instantly claimed components are present at the instantly claimed proportions and at a coating level that exceeds that instantly exemplified, the coating would have the instantly claimed functionality, absent evidence to the contrary. Therefore claims 1-14 and 22 are obvious over claims 1 and 3-12 of U.S. Patent No. 12,642,892 in view of Chabrecek et al. and Ding.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/675565 (reference application) in view of Chabrecek et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a medical device with a lubricious coating composed of a compound in combination with a hydrophilic copolymer composed of the same monomer A, monomer B, and monomer C as instantly claimed. The compound of the copending claim is a polymer with structural units made from acrylamide, a non-ionic monomer which yields the instantly claimed non-ionic polymer. A catheter, stent, and guidewire are recited particular devices in both sets of claims. The copending claims additionally recite a substrate layer to which the lubricious coating is applied. A ratio of the acrylamide to polymer to the hydrophilic copolymer is not detailed.
Chabrecek et al. teach a coating composed of surface bound hydrophilic polymers with entangled hydrophilic polymers to confer hydrophilicity and lubricity to devices envisioned to include catheters (see abstract and paragraphs 1 and 161). They employ (meth)acrylic and (meth)acrylamide hydrophilic monomers to generate the surface bound polymer (see paragraphs 7 and 63 and examples C-1 though C-3). Chabrecek et al. teach a hydrophilic polymer dissimilar from that bound to the surface as the entrapped polymer that include polyacrylamide, polyacrylic acid, polyvinyl pyrrolidone, and polysaccharides such as hyaluronic acid and dextran (see paragraphs 147-152 and examples D-2 through D-6 and E1 and E-7). Hyaluronic acid is a preferred choice (see paragraph 152). They exemplify hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 100 with 10 wt% of the bound polymer components present in the coating solution (as calculated by the examiner from coating solution providing about 3.25 g bound polymer and 0.03 g hyaluronic acid) (see examples D-6 and E-7; instant claims 1 and 10). Another example provides hyaluronic acid entrapped in the bound polymer at a weight ratio of about 1 to 55 (as calculated by the examiner from coating solution providing about 1.1 g bound polymer and 0.02 g hyaluronic acid) (see examples D-5 and E-4; instant claims 1 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a proportion of entrapped polymer and coating solution concentration as detailed by Chabrecek et al. for the acrylamide polymer of the copending claims because it was known for a similar utility. Therefore claims 10-14 are unpatentable over claims 1-17 of copending Application No. 17/675565 in view of Chabrecek et al.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/675565 in view of Chabrecek et al. as applied to claims 10-14 above, and further in view of Ding.
Claims 1-17 of copending Application No. 17/675565 in view of Chabrecek et al. teach the limitations of instant claims 10-14. The copending claims also recite a method of making the device by applying a coating liquid comprising the components to produce the lubricious coating to the device surface. Insertion of the device into a patient lumen and movement to a lesion site is also detailed in the copending claims. Hyaluronic acid, other polysaccharides and polyelectrolytes are not explicitly recited in the copending claims.
Ding teaches a methacrylate based polymer envisioned as a coating for medical implants (see abstract). They teach the polymer to include hydrophilic monomers and for the coating to include biobeneficial agents to confer features such as non-fouling properties, anti-thrombogenic properties, anti-inflammatory properties and hemocompatibility (see paragraphs 20 and 31). Sulfonic acid group containing monomers are named as hydrophilic monomers (see paragraph 20). The biobeneficial agents may be included individually or in combination and are envisioned to include hyaluronic acid as well as polyacrylic acid, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), and dextrin (see paragraphs 31-32). Ding also teaches the preparation of the coated devices by applying a coating liquid comprising the desired polymers/components (see example 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a biobeneficial agent in the polymer coating of the copending claims in light of Ding. This modification would have been obvious so as to confer the added or enhanced properties these components provide and as the application of the same technique to a similar product in order to yield the same improvement. Specifically, the addition of hyaluronic acid as well as polyacrylic acid, poly(vinyl pyrrolidone), or dextran. While the sliding resistance of the resulting coating is not explicitly detailed, the coating concentration of polymer is higher than that instantly exemplified as resulting in 40% or less sliding resistance as compared to the coating without hyaluronic acid (see instant example 1 and comparative example 1 and instant figure 4). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Since the instantly claimed components are present at the instantly claimed proportions and at a coating level that exceeds that instantly exemplified, the coating would have the instantly claimed functionality, absent evidence to the contrary. Therefore claims 1-22 are obvious over claims 1-17 of copending Application No. 17/675565 in view of Chabrecek et al. and Ding.
Response to Arguments
Applicant's arguments filed April 30 , 2026 have been fully considered. In light of the amendment to the claims the previous grounds of objection and rejection are withdrawn. New grounds of rejection are detailed to address the new claim limitations where some previously cited prior art is reapplied and modified by additional prior art.
It is noted that the applicant employs two different naming conventions for the same monomers (Chem. X and Formula A) and refers to them by both conventions simultaneously. The purpose of this dual naming is not clear in the claims, given that there are no instances where one convention is employed for a particular purpose and the other convention employed for another. It is suggested that the applicant choose one naming convention for the monomers in the claims (e.g., Formula A).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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