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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/12/2026 has been entered.
Status of Application
Applicants' arguments/remarks filed 02/12/2026 are acknowledged. Claim 1 is currently amended. Claims 12, 15-20 were previously withdrawn. Claim 21 is newly added. Claims 1, 4-8 10-11 and 21 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicant's amendments and with respects to applicant's arguments and remarks filed 09/03/2025:
the 35 U.S.C. § 103 rejection of Claims 1, 4-8 and 10-11 over McClain et al., Antoni et al., CN 107286793A, CN 102526813A, Vyacheslav et al., Yang and Ralf et al. has been withdrawn in view of the amendment of claim 1;
Modified Rejections
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 non-obviousness.
Claim(s) 1, 4-8, 10-11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClain et al. (CA 2797110 A1) in view of Antoni et al. (WO 2014118382 Al) and further in view of CN 107286793A, CN 102526813A, Vyacheslav et al. (CN 101790568 A), Yang (WO 2011084326 A2), Ralf et al. (WO 9008786 A1) and Raval et al. (US 20160151545A1).
Claims 1 and 4-8, and 21,
McClain et al. teach coated implantable medical device (0058). Devices comprising a stent; and a coating on said stent comprising a polymer and an active agent, wherein the active agent comprises at least one of: extracellular matrix and an extracellular matrix component. (Abs). A device comprising a substrate; and a coating on said substrate comprising a first polymer and an active agent, wherein the active agent comprises a macrolide immunosuppressive drug in crystalline form. (pg. 106, Claim 1). In some embodiments, the extracellular matrix comprises hyaluronic acid. (0007). In some embodiments, the durable polymer comprises at least one of a polyester, polyamide, polyamide, polyvinyl alcohol, (0008), which are hydrophilic polymers. In some embodiments, at least two of said first polymer, said second polymer and said third polymer are the same polymer. (0017). In some embodiments, at least one of said first polymer, said second polymer and said third polymer is a durable polymer. In some embodiments, the durable polymer comprises at least one of a polyester. (0019). In some embodiments, at least two of said first polymer, said second polymer and said third polymer are different polymers. (0020).
McClain et al. teach coating on stent are crosslinked polymers comprising polymethylmethacrylate, poly( ethylmethacrylate/n-butylmethacrylate), but do not teach that coating hydrophilic polymers comprises a graft polymer containing photo-cross-linking groups. monomer of acrylate, acrylamide or methacrylate.
Antoni et al. teach a substrate with a surface having a hydrophilic coating comprising cross-linked copolymers of components A and B, and optional components C and D; wherein component A comprises one or more C2-C16 hydrophilic monomers each bearing one or more alkene and/or alkyne groups; component B comprises one or more hydrophilic polymers each bearing two or more alkene and/or alkyne groups; component C, if present, comprises one or more beneficial agents each bearing one or more alkene or alkyne groups; and component D, if present, comprises one or more low molecular weight cross-linking agents each bearing two or more functional groups independently selected from thiol, alkene and alkyne groups; wherein the crosslinked copolymer is formed by radical polymerization involving the alkene and/or alkyne groups of components A, B and C (if present) and involving the functional groups of component D (if present); wherein the hydrophilic coating optionally comprises component E which comprises one or more beneficial agents, wherein component E does not form a copolymer with components A, B, C (if present) and D (if present); and wherein the hydrophilic coating is covalently attached to the surface of the substrate. (Abs). Specific examples of component A include but are not limited to acrylic acid, methacrylic acid, polyethyleneglycol acrylate, oligoetyleneglycol acrylate, 2-hydroxyethyl methacrylate (HEMA), acrylamide, methacrylamide, glycidyl acrylate, glycidyl methacrylate. In one embodiment, component A is acrylic acid. In another embodiment, component A is methacrylic acid. In a further embodiment, component A comprises and suitably consists of acrylic acid and/or methacrylic acid. (pg. 9, lines 24-30). Component B, contains hydroxy, carboxyl or amino group, and comprises and suitably consists of one or more hydrophilic polymers each bearing two or more alkene and/or alkyne groups, wherein the hydrophilic polymer is independently selected from the group consisting of polyether derivative (e.g. polyethylene glycol (PEG), polypropylene glycol (PPG) or a polypropylene glycol (PPG) derivative, polyvinyl alcohol. (pg. 12 lines 40-44-pg. 13, lines 1-2). In one embodiment, component B comprises polymethacrylic acid derivative, polymethacrylamide, a polymethacrylamide derivative, a polyacrylamide, polyacrylamide derivative. (pg. 12, lines 20-38). In one embodiment, component A comprises and suitably consists of one or more C2-C16 hydrophilic monomers. (pg. 8, lines 15-16). The hydrophilic character of the monomer may derive from the functional groups. (pg. 8, line 27). in one embodiment component A comprises and suitably consists of one or more C2-C16 hydrophilic monomers each bearing one or more alkene and/or alkyne groups, and also one or more groups selected from ester, ether, carboxyl, hydroxyl, amino, groups. (pg. 8, lines 32-35). Hydrophilic monomers can be straight chain, cyclic or branched. (pg. 9, line 4).
Antoni et al. teach a hydrophilic coating comprising a cross-linked copolymers of each bearing one or more alkene and/or alkyne groups, which are photo-crosslinking group, but they are not inherently the same as polymers grafting dedicated photo-cross-linking groups, though they often serve the same purpose (photo-cross-linking), so they do not teach polymers grafting photo-cross-linking monomers.
CN 107286793 A teaches the medical coating mainly includes reactant and hydrophilic polymer, which contains two or more photosensitive group to answer agent (pg. 1, Claim 1). X is photosensitive group, which can be a small molecule or macromolecule can be connected to the polymer chain Y by chemical bond. (pg. 1, Claim 2). The hydrophilic polymer includes poly-lactam (like PVP, polyvinyl alcohol, polyvinyl ether, maleic anhydride base co-polymer, polyvinylamine, polyethyleneimine, PEO, polyCarboxylic acid). One of which or two or more mixing in polyamide, heparin, dextran, cellulose (like methylcellulose, carboxymethyl cellulose, hydroxymethyl cellulose or hydroxypropyl cellulose); the polypeptide (like collagen, fibrin or elastin laminin); the polysaccharide (like chitosan, hyaluronic acid, alginic acid, gelatin or chitin); Polyester (like polylactide, PGA or polycaprolactone). (pg. 1, Claims 5-6). As mass fraction, the content of each component is in medical coating:Reactant 1~35%, hydrophilic polymer 65~99%. (Claim 7). The photosensitive monomers chemical bonded to first polymers are considered as grafting photosensitive groups.
CN 107286793 A does not teach grafting acrylate, acrylamide and methacrylate as the photo-cross-linking monomers.
CN 102526813A teaches the photosensitive group, or the monomer is 2-hydroxyethyl methacrylate or oligoethylene glycol methacrylate. which are photosensitive groups. a surface-modified metal stent with the initiator fixed on the surface, the monomer undergoes free radical polymerization to obtain a polymer modified metal stent. The surface of the metal stent is covered with an ε-lysine grafted inert polymer layer; hydrophilic inert polymer is polymethacrylic acid-2-hydroxyethyl ester or polyglycol methacrylate. (Claim 1, pg. 1). It would be obvious that polyglycol methacrylate, acrylate and methacrylate are closely related derived from monomer acrylate.
CN 102526813A does not teach the photo-cross-linking monomer is selected from at least one of acrylate, acrylamide and methacrylate.
Yang teaches acrylamide monomer is grafted onto chitosan. (pg. 5, line 29).
Ralf et al. teach Japanese patent application 55-161 806 also describes hydrophilic polymers grafted with acrylate monomers. (pdf pg. 3, 5th par.).
Vyacheslav et al. teach a composition, a method forming a coating on the medical material (pg. 2, 2nd par.). The coating composition of the invention can be used for processing all kinds of medical materials, processing represented by coating or dipping. the medical materials can be chosen from but not limited to hydrophilic material and polymeric material. (0057). A polymer such as a polyurethane, polyamide, polyester, polyether, of all polymeric matrix comprises cellulose fibres, such as chitosan carbohydrate material and proteins, such as gelatin, collagen comprises a combination of polymer, a carbohydrate and a protein. (0059). The method specifically comprises using long wavelength UV radiation (300nm to 400nm) and containing, for example, a photoinitiator solution of methanone (BP), the hydrophilic copolymer derived from such as methacrylate monomer with a carboxylic acid-containing monomer is added to the surface of the inert substrate, (0060), which are the product of crosslinking of monomer like methacryate crosslinking to the hydrophilic polymer backbone like gelatin, chitosan.
McClain et al., Antoni et al., CN 107286793A, CN 102526813A, Vyacheslav et al.), Yang, and Ralf et al. do not teach on the polymer, the drug loaded implantable medical device, a dose of drug is in a range from 0.8 µg/mm2 to 1.0 µg/mm2, excluding 1.0 µg/mm2
Raval et al. teach a coated implantable medical device, comprising: a base layer comprising mTOR inhibitor, and at least one biodegradable polymer; a middle layer comprising mTOR inhibitor, and at least one biodegradable polymer; and a top layer selected from the group consisting of hydrophilic polymer, and combination of hydrophilic polymer and antioxidant, wherein the total mTOR inhibitor concentration over the medical device is in the range of 0.7 to 3.00 µg/mm2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare a drug load coated implantable medical device (0058). Devices comprising a stent; and a coating on said stent comprising hydrophilic polymers and an active agent, wherein the polymers comprise first polymer, second polymer or third polymer, taught by McClain, where the first polymer can be a hydrophilic polymer, with branches containing carboxyl, hydroxyl or amino functional groups, taught by Antoni et al., hydrophilic polymer having chemical bonding to photosensitive monomers, with ratio 1-35%:65-99% taught by CN 107286793 A, the photosensitive acrylate or acrylamide monomers are taught by Yang and Ralf et al. since they have provided different options of hydrophilic polymers can be drafted with photosensitive monomers with different ratios, to control and optimize the degree of crosslinking of polymer to optimize the physical properties of coating layers, to form products taught by Vyacheslav et al., and a coated implantable medical device, comprising combination of hydrophilic polymer and antioxidant, a base layer wherein the total mTOR inhibitor concentration over the medical device is in the range of 0.7 to 3.00 µg/mm2., taught by Raval et al., since they have proven it would be possible to do so.
With regard to claims 10,
McClain et al. teach about 5 microns of active agent. (00350, 00354).
With regard to claims 11,
McClain et al. teach preferably at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or 100% of the pharmaceutical agent is in crystalline or semi-crystalline form. (00201).
Response to Arguments
Claim Rejections Under 35 U.S.C. § 103
Applicant argues that "the hydrophilic coating is used as a carrier. Due to the existence of the
hydrophilic groups in the hydrophilic coating, more seed crystals may be formed, which is
beneficial to form crystalline drug particles with small size, thereby effectively avoiding a risk of
embolization. In addition, the introduction of hydrophilic groups may promote an interaction
between the carrier and the blood in human body, which is beneficial to promote the falling of
crystalline drug particles, so as to help achieve a target tissue concentration and avoid a poor
efficacy caused by an extremely low doses of drug. Moreover, the introduction of hydrophilic
groups may also effectively increase an anchoring effect between the carrier and the device
body, which may prevent the carrier from falling off and reduce toxic and side effects."
None of McClain, Antoni, Xu, Chen, Vyacheslav, Yang, and Ralf, taken alone or in
combination, discloses or suggests the same combination of features as recited in claim 1.
Applicant's arguments have been fully considered and are persuasive according to the previous office action, however, they are not persuasive according to this modified office action, where McClain et al. teach coated implantable medical device comprising a stent; and stent comprising a hydrophilic polymer and an active agent, wherein the active agent comprises a macrolide immunosuppressive drug in crystalline form. (pg. 106, Claim 1), which is obvious that the polymer carries the active agent. And Raval et al. teach a coated implantable medical device, comprising: a base layer comprising mTOR inhibitor, and at least one biodegradable polymer; a middle layer comprising mTOR inhibitor, and at least one biodegradable polymer; and a top layer selected from the group consisting of hydrophilic polymer, and combination of hydrophilic polymer and antioxidant, wherein the total mTOR inhibitor concentration over the medical device is in the range of 0.7 to 3.00 µg/mm2, a very low dose of drug. Also it would be obvious that these implantable medical devices with hydrophilic polymer coating would interact with tissues when they are implanted, however, this interaction and the prevention the carrier from falling off and reduce toxic and side effects are not the limitations in the claims 1, 4-8, 10-11 and 21.
Applicant argues that As admitted on page 4 of the Office Action "McClain ... do not teach that coating hydrophilic polymers comprises a graft polymer containing photo-cross-linking groups." McClain only generally discloses a stent and a coating on the stent, but fails to disclose or suggest that the first polymer is a hydrophilic polymer with a side chain containing at least one repeating functional group of hydroxyl group, carboxyl group, and amino group and that on the drug-loaded implantable medical device, a dose of drug is in a range from 0.8 µg/mm2 to 1.0 µg/mm2, excluding 1.0 µg/mm2, as recited in claim 1. None of Antoni, Xu, Chen, Vyacheslav, Yang, and Ralf cure the deficiencies of McClain with respect to claim 1. Applicant provides a list which Antoni, Xu, Chen, Vyacheslav, Yang and Raf teach something more and different from what applicant claims.
Applicant's arguments have been fully considered but they are persuasive according to previous office action regarding a dose of drug is in a range from 0.8 µg/mm2 to 1.0 µg/mm2, excluding 1.0 µg/mm2, however, they are not persuasive according to this modified office action, as explained above. Regarding hydrophilic polymer, and lists which Antoni, Xu, Chen, Vyacheslav Yang and Ralf teach something more and different from what applicant claims: applicant is reminded that this is 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. For example, McClain does not teach all hydrophilic polymers, but PVA is a hydrophilic polymer and Antoni teaches a substrate with a surface having a hydrophilic coating comprising cross-linked copolymers; CN 107286793 A teaches the medical coating mainly includes reactant and hydrophilic polymer.
Conclusion
No claim is allowed
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615