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 .
The amendments filed 8/21/25 overcome the rejection set forth over Li alone in the office action mailed 5/19/25, but not the rejection set forth over Li in view of Chmielewski, which has been updated in light of the claim amendments and maintained below. A separate rejection for claim 2, citing an evidentiary reference in order to more explain the rejection, has been set forth below, and the office action is accordingly made non-final. The double patenting rejection is also maintained below.
Claim Rejections - 35 USC § 103
Claims 1, 3-6, 9, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. PG Pub. No. 2011/0200828) in view of Chmielewski (U.S. PG Pub. No. 2007/0270515).
In paragraphs 14 and 18 Li discloses a medical device having a bilaminar coating, where the bilaminar coating includes a base coat that firmly adheres to the substrate and a top coat that is chemically grafted to the base coat, where the top coat is hydrophilic and lubricious. In paragraph 59 Li discloses that the base coat can be a polyurethane, meeting the limitations of the base coating layer of claim 1. In paragraph 49 Li discloses that the top coat comprises a hydrophilic polymer which can be poly(methylvinyl ether-maleic anhydride) and salts thereof. A salt of poly(methylvinyl ether-maleic anhydride) meets the limitations of the lubricative polymer of claims 1 and 4-5. In paragraph 51 Li discloses that the top coat also comprises a cross-linker, leading to a lubricative polymer at least partially crosslinked, meeting the limitations of claim 6. In paragraph 59 Li discloses that the top coat polymers are grated to the base coat polymer, meeting the limitations of claim 8. In paragraph 101 Li discloses that the polymer salt used in the top coat can be a sodium salt, meeting the limitations of the monovalent salt of claim 9.
Li does not specifically disclose the combination of the poly(methylvinyl ether-maleic anhydride) polymer with an acrylate polymer in the top coat.
In paragraph 2 Chmielewski discloses a toughened polymeric material, in particular a toughened thermoplastic material. Methyl vinyl ether/maleic anhydride copolymers, as disclosed by Li, are thermoplastic. In paragraphs 32-33 and 44 Chmielewski discloses that the toughening agent can be various copolymers comprising acrylate or methacrylate units, meeting the limitations of the toughening polymer of claim 1, and the poly(methacrylate) of claim 3, noting that paragraph 39 of the current specification defines a poly(methacrylate) as comprising methacrylate monomers, indicating that other monomers can also be present, and paragraph 24 further defines poly(methyl methacrylate) as also including copolymers comprising other comonomers. Since the maleic anhydride copolymer in the top coat of Li is crosslinked, and the toughening polymer of Chmielewski is not crosslinked, the polymers will form a semi interpenetrating network, as recited in amended claim 1. Curing the coating top coat of Li and Chmielewski in accordance with the heating step described paragraphs 55 and 96 of Li will lead to a semi-interpenetrating network where only the lubricative polymer is chemically bonded to the base coating layer, as recited in amended claim 1, noting that as discussed above, Li teaches that the lubricative polymers are grafted to the base coating layer, and the temperature range and duration of curing disclosed in paragraphs 55 and 96 of Li in line with that disclosed for the curing step described in paragraph 42 of the current specification. Since the toughening polymer of Li and Chmielewski meets the limitations of the claimed toughening polymer, and the coating composition is cured under conditions consistent with those disclosed in the current application, and there is no evidence to the contrary, the toughening polymer of Li and Chmielewski would not be chemically bonded to the base coating layer.
In paragraph 33 Chmielewski discloses that the block copolymer toughening agent is present in an amount of “at least about 4% or less” of the toughened thermoplastic material. While this teaching is somewhat ambiguous, even if the range of Chmielewski is taken to be at least about 4%, this range will lead to a ratio of toughening agent to the remainder of the polymeric material of at least about 4:96. Li, in paragraphs 52-54, discloses that the top-coat comprises a minimum of 0.25% chromium (III) ion, which leads to a minimum concentration of chromium-containing compound as low as about 1% when the chromium compound is provided as one of the compounds disclosed in paragraph 52 of Li, for example chromium (III) phosphate. The ratio of block copolymer toughening agent to lubricative polymer when the toughening agent of Chmielewski is included in the top-coat of Li is therefore at least about 4:95 (about 4.21:100). It is the examiner’s position that this range overlaps the ranges recited in amended claims 1 and 13, since both Chmielewski and the amended claims use “about” language in defining the endpoint of the claimed/disclosed ranges, and there is no evidence that a ratio of 4.21:100 leads to compositions having different properties such that one of ordinary skill in the art would not consider about 4.21:100 to overlap about 4:100. Furthermore, given the “or less” language in paragraph 33 of Chmielewski and both Chmielewski and newly added claims 21-22 use “about language”, the range of Chmielewski also leads to a weight ratio of toughening polymer to lubricative polymer overlapping the ranges recited in claims 21-22. It is also noted that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
The inclusion of the acrylate or methacrylate containing toughening agents of Chmielewski in the top coat of Li therefore meets the limitations of the coating of claims 1, 3-6, 9, and 21-22.
It would have been obvious to one of ordinary skill in the art to add the toughening agent of Chmielewski to the top coat of the coating and medical device of Li, since Chmielewski in order to impart at least one of the advantageous properties disclosed in paragraphs 3, 5, 43, and 47-49 of Chmielewski.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Chmielewski as applied to claims 1, 3-6, 9, and 21-22 above, and further in light of the evidence provided by Lelkes (U.S. PG Pub. No. 2013/0018454).
The discussion of Li and Chmielewski in paragraph 3 above is incorporated here by reference. Li and Chmielewski disclose a coating meeting the limitations of amended claim 1, where the base coat can be a polyurethane, but does not explicitly disclose a polyether-based polyurethane.
In paragraph 46, Li discloses suitable polyurethane base coats, including NeoRez R600. Lelkes, in paragraph 141, provides evidence that Neorez R600 is an aliphatic polyether polyurethane, as recited in claim 2. Claim 2 is therefore rendered obvious by Li and Chmielewski in light of the evidence provided by Lelkes.
Claims 10 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Chmielewski as applied to claims 1, 3-6, 9, and 21-22 above, and further in view of Kohama (U.S. PG Pub. No. 2016/0175492).
The discussion of Li in view of Chmielewski in paragraph 3 above is incorporated here by reference. Li and Chmielewski disclose a coating meeting the limitations of claim 1 and medical device meeting the limitations of claim 11, where the top coat comprises a chromium crosslinker meeting the limitations of claim 14, a poly(methacrylate) meeting the limitations of claim 19, and a maleic anhydride polymer meeting the limitations of claim 20, and the salt is a monovalent salt as recited in claim 16. In paragraph 77 Li discloses a method of coating a medical device with the base coat and the top coat, followed by curing the top coating layer, meeting the limitations of the first three steps of claim 13. Li does not specifically disclose coating the forming the top coating layer with a polymer comprising a saltable monomer followed by activating the top coating layer after curing, and does not disclose converting the monovalent salt to a divalent salt.
In paragraph 12 Kohama discloses a medical device having a resin coating layer that includes a maleic acid polymer substance. In paragraphs 20-21 including structures (a′) and (a′′) of Chemical formula 1, Kohama discloses that the maleic acid polymer can be a monovalent (alkali metal) or divalent (alkali earth metal) salt. In paragraph 23 Kohama discloses that the maleic acid can be copolymerized with comonomers including methyl vinyl ether, as in the coating of Li. In paragraphs 46-58 Kohama discloses a method of coating a medical device similar to the method disclosed by Li, and in paragraph 59 Kohama further discloses a step of alkali treatment to convert to carboxyl groups of the maleic acid to a carboxylate salt, where the salt can be monovalent or divalent. Preparing the salted maleic acid copolymer in the top coat of Li by the method of Kohama meets the limitations of claims 13-17 and 19-20. Using a divalent metal, as disclosed by Kohama, as the cation in the salted polymer of Li, meets the limitations of claim 10.
Kohama further discloses in paragraphs 67-68 that following the alkali treatment, a cleaning step may be performed, where the cleaning liquid has a low concentration of calcium. Kohama discloses in paragraph 68 that the presence of calcium can lead to substitution of monovalent sodium with divalent calcium, as recited in claim 18. While Kohama discloses that this is undesirable, Kohama does teach that some level of calcium can be present in the cleaning fluid, which will lead to some amount of conversion, noting that claim 18 does not recite a minimum for the amount of conversion.
It would have been obvious to one of ordinary skill in the art to prepare the coating of Li and Chmielewski by the method of Kohama, in particular by converting the maleic acid polymer in the top coat of Li and Chmielewski to salts after curing, since Li discloses that it is a suitable method of forming a similar coated medical device comprising a top coat comprising a salted maleic acid copolymer. It would have been obvious to one of ordinary skill in the art to use a divalent metal as the cation in the salted polymer of Li and Chmielewski since Kohama discloses that it has equivalent use to monovalent metals in forming salts of maleic acid polymers in a top coat for a medical device.
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 1-6, 9-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,104,136. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1 and 9 of the ‘136 patent recite a medical device comprising a base coating layer comprising a polyurethane and a top coating layer comprising a toughening polymer comprising an acrylate polymer and a hydrophilic lubricative polymer, wherein the lubricative polymer comprises a salt monomer, meeting the limitations of the coating of claim 1 of the current application. While claims 1 and 9 of the ‘136 patent also recite a jacket coating between the body of the medical device and the base coating layer, the open-ended “comprising” language of claim 1 of the current application allows for the coating device to comprise additional layers, and the claim does not require the base coating layer to be disposed directly on the exterior surface of the body of the medical device. The toughening polymer and lubricative polymer of claim 1 of the ‘136 patent are present within the top coating layer as a semi-interpenetrating network in which only the lubricative polymer is chemically bonded to the base layer, as recited in claim 7 of the current application and also meeting the limitations of claim 8 of the current application. Claims 1 and 9-10 of the ‘136 patent also recite a ratio of toughening polymer to lubricative polymer wither matching or encompassing the ranges recited in claims 1 and 21-22 of the current application. Claims 2-6 of the ‘136 patent are analogous to claims 2-6 of the current application and claims 7-8 of the ‘136 patent are analogous to claims 9-10 of the current application.
Claim 1 of the ‘136 patent further recites that the medical device comprises a body having an exterior surface and a jacket coating disposed on the exterior surface, leading to a medical device meeting the limitations of claims 11-12 of the current application.
Allowable Subject Matter
Claims 11-12 would be allowable if the double patenting rejection set forth above were overcome. Claims 11-12 recite a medical device having a jacket coating disposed on the exterior surface of the body of the device, and a base coating disposed on the jacket coating. One of ordinary skill in the art would not have been motivated to modify Li and Kohama or Chmielewski to arrive at the medical device of claim 11, noting that Li teaches that the base coat is highly adherent to a medical device substrate, and interposing another coating, not taught by Li, between the body of the medical device and the base coat of Li could affect the adherency of the base coat. Dai (CN 105985720 A), discloses a medical device having a multilayer coating having a “primer” layer comprising polyurethane, which is again applied directly to the device without any disclosure of an intervening coating layer. The prior art does not disclose or render obvious a medical device meeting all the limitations of claims 11-12.
Response to Arguments
Applicant's arguments filed 8/19/25 have been fully considered but they are not persuasive. Applicant argues that Chmielewski does not teach a concentration of block copolymers (toughening polymer) sufficient to provide the ratio of toughening polymer to lubricative polymer. However, as discussed in the rejection, even if Chmielewski is interpreted to teach a lower bound of about 4%, the lower bound of the range of ratios of toughening polymer to lubricative polymer of Li and Chmielewski is about 4.21:100, and since both Chmielewski and the amended claims use “about” language in defining the endpoint of the claimed/disclosed ranges, and there is no evidence that a ratio of 4.21:100 leads to compositions having different properties such that one of ordinary skill in the art would not consider about 4.21:100 to overlap about 4:100. Applicant states that Chmielewski teaches that “more typically” the toughener concentration is higher, but this does not constitute a teaching away from the broader teaching of Chmielewski. Applicant’s argument on this point is therefore not persuasive. Similar arguments apply to newly added claims 21-22, and as noted in the rejection a prima facie case of obviousness also exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, in accordance with Titanium Metals. Applicant could overcome these rejections with a showing of the criticality of the claimed ranges in accordance with the requirements set forth in MPEP 716.02.
Conclusion
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/JAMES C GOLOBOY/Primary Examiner, Art Unit 1771