DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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.
Claims 1-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuramoto et al. (US 2019/0185776) in view of Nielson et al. (US Pat. 5,846,558).
Considering Claims 1 and 2: Kuramoto et al. teaches a medical device (¶0002) comprising a substrate layer and a surface lubricious layer formed on at least part of the substrate layer (¶0097), where the surface lubricious layer comprises a hydrophilic copolymer comprising structural units derived from a polymerizable monomer having a sulfobetaine structure, structural units derived from a polymerizable monomer having at least one group from the groups consisting of a sulfonic acid group, a sulfuric acid group, a sulfurous acid group, and salts thereof, and structural units derived from a polymerizable monomer having a photoreactive group (¶0019).
Kuramoto et al. does not teach the coating layer as comprising a polymer containing units derived from acrylamide. However, Nielson et al. teaches adding polyacrylamide (5:1-10) to a coating comprising a zwitterionic polymer (2:62-3:43) for coating medical devices. Kuramoto et al. and Nielson et al. are analogous art as they are concerned with the same field of endeavor, namely hydrophilic zwitterionic coatings for medical devices. It would have been obvious to a person of ordinary skill in the art to have added the polyacrylamide of Nielson et al. to the coating of Kuramoto et al., and the motivation to do so would have been, as Nielson et al. suggests, to improve the viscosity and coatability of the coating composition (5:1-10).
Considering Claim 3: Kuramoto et al. teaches the sulfobetaine monomer as having the claimed formula (¶0034-37).
Considering Claim 4: Kuramoto et al. teaches the second monomer as having the claimed structure (¶0044-52).
Considering Claim 5: Kuramoto et al. teaches the third monomer as being a benzophenone monomer (¶0069).
Considering Claim 6: Kuramoto et al. teaches the third monomer as being a vinyl, acrylol, or allyl group (¶0062).
Considering Claim 7: Kuramoto et al. teaches the medical device as being a catheter, stent or guide wire (¶0101).
Considering Claim 8: Kuramoto et al. teaches the sulfobetaine monomer as having the claimed formula (¶0034-37). Kuramoto et al. teaches the second monomer as having the claimed structure (¶0044-52). Kuramoto et al. teaches the third monomer as being a benzophenone monomer (¶0069). Nielson et al. teaches adding polyacrylamide (5:1-10).
Considering Claim 9: Kuramoto et al. teaches the medical device as being a catheter, stent or guide wire (¶0101).
Considering Claims 10 and 11: Kuramoto et al. teaches coating a coating liquid comprising the polymer onto the substrate layer (¶0105).
Considering Claim 20: Nielson et al. teaches the amount of acrylamide as being less than 10 weight percent of the amount of zwitterionic polymer (5:1-10).
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 1-4, 6, 7, and 10 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 Nielson et al. (US Pat. 5,846,558).
Considering Claims 1 and 2: Claim 1 of Patent ‘558 teaches a medical device comprising a substrate layer and a surface lubricious layer formed on at least part of the substrate layer, where the surface lubricious layer comprises a hydrophilic copolymer comprising structural units derived from a polymerizable monomer having a sulfobetaine structure, structural units derived from a polymerizable monomer having at least one group from the groups consisting of a sulfonic acid group, a sulfuric acid group, a sulfurous acid group, and salts thereof, and structural units derived from a polymerizable monomer having a photoreactive group.
Patent ‘512 does not teach the coating layer as comprising a polymer containing units derived from acrylamide. However, Nielson et al. teaches adding polyacrylamide (5:1-10) to a coating comprising a zwitterionic polymer (2:62-3:43) for coating medical devices. Patent ‘512 and Nielson et al. are analogous art as they are concerned with the same field of endeavor, namely hydrophilic zwitterionic coatings for medical devices. It would have been obvious to a person of ordinary skill in the art to have added the polyacrylamide of Nielson et al. to the coating of Patent ‘512, and the motivation to do so would have been, as Nielson et al. suggests, to improve the viscosity and coatability of the coating composition (5:1-10).
Considering Claim 3: Claim 4 of Patent ‘512 teaches the claimed structure.
Considering Claim 4: Claim 1 of Patent ‘512 teaches the claimed structure.
Considering Claim 6: Claim 9 of Patent ‘512 teaches the third monomer as having an ethylenically unsaturated group.
Considering Claim 7: Claim 3 of Patent ‘512 teaches the medical device as being a catheter, stent or a guide wire.
Considering Claim 10: Patent ‘512 does not teach the method of applying the lubricous layer to the substrate. However, coating is a catch all term that would cover the known means of applying a layer to a substrate.
Claims 1-5 and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/675,063 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Considering Claims 1: Claim 1 of Application ‘063 teaches a medical device comprising a substrate layer and a surface lubricious layer formed on at least part of the substrate layer, where the surface lubricious layer comprises a acrylamide based polymer and a hydrophilic copolymer comprising structural units derived from a polymerizable monomer having a sulfobetaine structure, structural units derived from a polymerizable monomer having at least one group from the groups consisting of a sulfonic acid group, a sulfuric acid group, a sulfurous acid group, and salts thereof, and structural units derived from a polymerizable monomer having a photoreactive group.
Considering Claims 2-5: Claims 2 and 4-6 of Application ‘063 correspond to instant claims 2-5.
Considering Claim 7: Claim 8 of Application ‘063 corresponds to instant claim 7.
Considering Claim 8: Claim 9 of Application ‘063 corresponds to instant claim 8.
Considering Claim 9: Claim 12 of Application ‘063 corresponds to instant claim 9.
Considering Claims 10 and 11: Application ‘063 does not teach the method of applying the lubricous layer to the substrate. However, coating is a catch all term that would cover the known means of applying a layer to a substrate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed July 28, 2026 have been fully considered but they are not persuasive, because:
A) In response to applicant's argument that the claimed coating provides a more efficacious lubricating layer through providing hydration of the hydrophilic copolymer, the fact that the 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. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
B) In response to applicant's argument that Nielson et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Nielson et al. is analogous art as they are concerned with the same field of endeavor, namely hydrophilic zwitterionic coatings for medical devices. The reference contains disclosure on improving the coatability of the zwitterionic coatings, and thus would be reasonably pertinent to the teachings of Kuramoto et al.
C) In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to a person of ordinary skill in the art to have added the polyacrylamide of Nielson et al. to the coating of Kuramoto et al., and the motivation to do so would have been, as Nielson et al. suggests, to improve the viscosity and coatability of the coating composition (5:1-10).
D) In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the thickness of the coating) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIAM J HEINCER whose telephone number is (571)270-3297. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached at 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIAM J HEINCER/Primary Examiner, Art Unit 1767
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