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 .
Election/Restrictions
Applicant's election with traverse of Group I and the species where monomer A is formula 1 with Z1 = oxygen, monomer B is formula 2 with Z2 = -NH- and X = -SO3H, and monomer C is a benzophenone containing group selected from 4-(meth)acryloyloxybenzophenone (MBP), 4-(meth)acryloyloxyethoxybenzophenone, 4-(meth)acryloyloxy-4'-methoxybenzophenone, 4-(meth)acryloyloxyethoxy-4'-methoxybenzophenone in the replies filed on July 21, 2025 and December 1, 2025 is acknowledged. The traversal is on the ground(s) that there is no serious search burden. While the claims embrace a wide array of polymers based upon the recitation of the polymer itself or its monomers with functional language (e.g., photoreactive group and hydrophilic copolymer) as well as the recitation of required monomers based upon the presence of a single substituent (e.g., sulfonic acid group (-SO3H), a sulfuric acid group (-OSO3H), a sulfurous acid group (-OSO2H), and salt groups thereof); consideration of the disclosure and search of the prior art shows that the hydrophilic copolymers of instant claim 1 are known. As a result the restriction requirement is hereby withdrawn.
In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
Claims 2-3, 6, and 11-12 are objected to because of the following informalities: the claims recite [Chem. 1], [Chem. 2], [Chem. 3], and [Chem.4], but they are associated with different compounds than when recited in the specification. For example [Chem. 1] is recited as a label for formula 1; however the specification lists a series of compounds that are not formula 1 as the compounds of [Chem. 1] (see paragraph 62). Instead the specification labels formula 2 as [Chem. 1]. Appropriate correction is required.
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 10 recites a polyelectrolyte as a component. A polyelectrolyte is a an ionizable organic polymer comprising at least one repeat unit bearing an acid or base functionality (see Kim et al. US PGPub No. 2010/0041292 paragraph 58). However, claim 15 recites options for the “polyelectrolyte” and the vast majority of them are polymers. The recitation of options is inconsistent with the moniker “polyelectrolyte” since most are missing the “poly-“ aspect of the term. Thus the scope of compounds embraced by the term “polyelectrolyte” is unclear. In regard to claim 15, it is unclear if its polyelectrolyte is to contain one of the recited compounds, be a homopolymer, or some other configuration. 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.
Clam 15 also recites “3-acrylamide-3-methylbutanoic acid, AMBA polyacrylic acid,”. It is not clear if the “AMBA” is supposed to paired with the “3-acrylamide-3-methylbutanoic acid” as its abbreviation or if is an undefined variety of polyacrylic acid, given that the meaning of AMBA is not provided.
Claims that re rejection but are not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity,
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 1-20 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 – see IDS) in view of Ding (US PGPub No. 2006/0067908).
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 onto a substate layer of the device (see paragraphs 94 and 102; 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). 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 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).
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 Kuramoto et al. in light of Ding. 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, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), or dextrin 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. Therefore claims 1-20 are obvious over Kuramoto et al. in view of Ding.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuramoto et al. in view of Ding as applied to claims 1-20 above, and further in view of Shah et al. (US Patent No. 6,387,450).
Kuramoto et al. in view of Ding render obvious the product and methods of instant claims 1-20, where hyaluronic acid can be present along with the instantly claimed hydrophilic polymer as part of a coating on a catheter.
Shah et al. teach that the addition of hyaluronic acid to a surface coating polymer increases the slipperiness (lubricity) of the coating layer (see abstract column 2 lines 35-48 and examples 7 and 10). They detail its inclusion as useful for coating medical devices, such as catheters, where low friction is important for their intended use (see column 1 lines 18-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include hyaluronic acid, in particular, in the modified coating of Kuramoto et al. so as to increase the lubricity already desired in the coating. This choice would have been additionally supported by Shah et al. who detail the increase in lubricity that the addition of hyaluronic acid achieves. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-20 are obvious over Kuramoto et al. in view of Ding and Shah et al.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Beavers et al. (US PGPub No. 2003/0096131).
Beavers et al. teach a lubricious and durable coating for medical devices (see abstract). Here the device is envisioned as a catheter or guide wire that is inserted into a patient’s blood vessel and traverses a circuitous path to a desired treatment location in a patient (see paragraph 85). Treatment of restenosis (lesion) with a stent is also envisioned as is accessing of remote internal locations via catheter or guidewire without major surgery (see paragraph 2). The medical device is provided with a base layer (substrate layer) to which a coating composed of a hydrophilic polymer or polymer blend is applied (see abstract and paragraph 68). Hyaluronic acid is envisioned and exemplified as a hydrophilic polymer in combination with the hydrophilic polymer polyacrylic acid (see example 15 and claim 15). While a full example of each embodiment that follows from the teachings of Beavers et al. is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ their exemplified coating embodiment that includes hyaluronic acid and polyacrylic acid on a catheter, guidewire, or stent that is fed through a patient’s blood vessels (lumen) to a treatment/lesion site because they suggest these utilities. Therefore claims 19 and 20 are obvious over Beavers 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 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. 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. Therefore claims 1-14 are unpatentable over claims 1-20 of U.S. Patent No. 12,054,564.
Claims 1-18 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 18 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. 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 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 carboxylic acid bearing (polyelectrolyte) polymers such as polyacrylic acid, polysaccharides such as dextran, alginate (alginic acid), and dextrin, as well as hydroxyl containing polymers that are also nonionic such as hydroxy functional poly(vinyl pyrrolidone) (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, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), or dextrin would have been obvious. Therefore claims 1-18 are obvious over claims 1-20 of U.S. Patent No. 12,054,564 in view of Ding.
Claims 1-14 and 19-20 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 above, and further in view of Umeno et al. (US Patent No. 5,569,200).
Claims 1-20 of U.S. Patent No. 12,054,564 teach the limitations of instant claims 1-14. The patented claims also teach a method of inserting a the 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 and 19-20 are obvious over claims 1-20 of U.S. Patent No. 12,054,564 in view of Umeno et al.
Claims 1-18 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.
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 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 patented claims in light of Ding. 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, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), or dextrin 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. Therefore claims 1-18 are obvious over claims 1-12 of U.S. Patent No. 11,377,512 in view of Ding.
Claims 1-18 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 as applied to claims 1-18 above, and further in view of Shah et al.
Claims 1-12 of U.S. Patent No. 11,377,512 in view of Ding teach the limitations of instant claims 1-18, where hyaluronic acid can be present along with the instantly claimed hydrophilic polymer as part of a coating on a catheter.
Shah et al. teach that the addition of hyaluronic acid to a surface coating polymer increases the slipperiness (lubricity) of the coating layer (see abstract column 2 lines 35-48 and examples 7 and 10). They detail its inclusion as useful for coating medical devices, such as catheters, where low friction is important for their intended use (see column 1 lines 18-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include hyaluronic acid, in particular, in the modified coating of the patented claims so as to increase the lubricity already desired in the coating. This choice would have been additionally supported by Shah et al. who detail the increase in lubricity that the addition of hyaluronic acid achieves. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-18 are obvious over claims 1-12 of U.S. Patent No. 11,377,512 in view of Ding and Shah et al.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/675343 (reference application) in view of Peterson et al. (Journal of Chemistry 2013 587875:1-11).
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 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 hydroxyl group containing compound that holds water. A method of making the coated devices by applying a coating liquid comprising the blend of components to the device is recited by both sets of claims. Hyaluronic acid is not recited as the hydroxyl containing compound.
Petersen et al. teach of the recognized utility of the polysaccharide hyaluronic acid as a lubricious coating material for medical devices that holds water (see abstract and column 2 first partial paragraph). In addition, they detail its structure as containing hydroxyl groups along its length (see figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select hyaluronic acid as the hydroxyl group bearing, water retaining compound of the copending claims because it is within this category of compounds and was already known to be lubricious. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1-14 are obvious over claims 1-20 of copending Application No. 17/675343 in view of Peterson et al.
Claims 1-15 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/675343 (reference application) in view of Peterson et al. as applied to claims 1-14 above, and further in view of Ding as evidenced by Agulhon et al. (Biomacromolecules 2012 13:215−220).
Claims 1-20 of copending Application No. 17/675343 (reference application) in view of Peterson et al. teach the limitations of instant claims 1-14. Particular 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 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 polysaccharides such as alginate (alginic acid), and dextrin, as well as hydroxyl containing polymers that are also nonionic such as hydroxy functional poly(vinyl pyrrolidone) (see paragraphs 31-32). Alginate has hydroxyl moieties along its length (see Agulhon et al. figure 1).
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 that fulfills the hydroxyl containing compound category in light of Ding. This modification would have been obvious so as to confer the added or enhanced properties this component provides and fulfill the requirements of the copending 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 alginate (alginic acid) would have been obvious. Therefore claims 1-15 and 18 are obvious over claims 1-20 of copending Application No. 17/675343 in view of Peterson et al. in view of Ding as evidenced by Agulhon et al.
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).
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. Therefore claims 10-14 are unpatentable over claims 1-17 of copending Application No. 17/675565.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/675565 as applied to claims 10-14 above, and further in view of Ding.
Claims 1-17 of copending Application No. 17/675565 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 components.
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, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), or dextrin would have been obvious. Therefore claims 1-20 are obvious over claims 1-17 of copending Application No. 17/675565 in view of Ding.
Claims 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/675063 (reference application).
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 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 copending substrate layer and adhesive layer constitute a multi-layered embodiment of the instant substrate layer. Therefore claims 10-14 are unpatentable over claims 1-12 of copending Application No. 17/675063.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/675063 as applied to claims 10-14 above, and further in view of Ding.
Claims 1-12 of copending Application No. 17/675063 teach the limitations of instant claims 10-14. Hyaluronic acid, other polysaccharides and polyelectrolytes are not explicitly recited components.
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, hydroxy functional poly(vinyl pyrrolidone), dextran, alginate (alginic acid), or dextrin would have been obvious. Application of the coating from a liquid would then follow. Therefore claims 1-18 are obvious over claims 1-12 of copending Application No. 17/675063 in view of Ding.
Note to Applicant
The specification details a comparative analysis of the lubricity of a coating of a polymer of the invention in combination with hyaluronic acid and without hyaluronic acid. While the presence of hyaluronic acid reduces the friction of the coating, it is not evident that the difference is unexpected, given the recognized utility of hyaluronic acid as a friction reducing coating. In addition, the comparison does not speak to the other claimed embodiments that include a polyelectrolyte, nonionic polymer, or polysaccharide of a different structure than hyaluronic acid.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARALYNNE E HELM/ Examiner, Art Unit 1615