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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Applicant’s amendment of 04/17/2026 is acknowledged. Claims 1 and 8 are amended, and claims 2 and 12 are cancelled. Claims 1 and 3-11 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/JP2021/010029 filed on 03/12/2021 and
claims foreign priority to JP-2020-043014 filed on 03/12/2020 as reflected in the filing
receipt dated on 11/29/2022. Receipt is acknowledged of certified copies of papers
required by 37 CFR 1.55.
Declaration Under 37 CFR 1.132
Masaki Fujita provided a Declaration under 37 CFR 1.132, filed 04/17/2026. The Declaration meets the formal requirements. In the most relevant part, the Declaration presents results of an antithrombogenicity test comparing Copolymer a and Copolymer b, which are within the scope of the claimed invention, with Copolymer x and Copolymer z, which each comprise a unit A monomer outside of the instant claimed scope. A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art, 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)), 4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)), and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The Declaration under 37 CFR 1.132 filed 04/17/2026 is insufficient to overcome the rejection of the instant claims as set forth in the last Office action for the following reasons: The relevant criterion here is No. 3, whether the Declaration is commensurate in scope of the claims. The Examiner has carefully reviewed the Declaration, including the data presented in the Declaration. The data which demonstrate the allegedly superior antithrombogenicity of copolymers of the present invention are not commensurate in scope with the instant claims, which broadly claim a copolymer comprising: a monomer unit A consisting of alkylalkoxysilyl groups in which one or more C1-C3 alkyl groups and one or more C1-C3 alkoxy groups are bound to a silicon atom and polyhedral oligomeric silsesquioxane; a monomer unit B corresponding to any vinyl carboxylate; and a monomer unit C containing any hydrophilic group. The data presented demonstrate the antithrombogenicity of copolymers containing only two species of monomer unit A (3-(methyldimethoxysilyl)propyl methacrylate or polymethacryl-heptaisobutyl-polyhedral oligomeric silsesquioxane), only one species of monomer unit B, and only one species of monomer unit C. However, the instant claims reflect that a copolymer having any combination of monomer units within the scope of A, B, and C as claimed will achieve the same superior effect. If the monomer unit B and/or monomer unit C, which encompass an extremely broad number of monomeric units, is changed, is the same performance observed? Do the relative quantities of each monomer within the copolymer affect its antithrombogenic behavior? In Applicant’s Copolymer a, the mole% of monomer units A, B, and C with respect to the total amount of copolymer is 36%, 24%, and 40%, respectively, whereas in Copolymer b, the mol% of monomer unit A with respect to the total amount of copolymer is 53% and the relative amounts of monomer units B and C are unknown. Thus, one of ordinary skill in the art would not expect that all combinations of monomer units A, B, and C, which could further include additional unrecited units encompassed by the open claim language “comprising”, at any proportion would achieve the same level of antithrombogenicity.
Thus, the Declaration does not overcome the prior art rejections of record at this time because the results demonstrated are still not commensurate in scope with the claims. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Previous Rejections/Objections
Applicant’s arguments filed 04/17/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied as necessitated by Applicant’s amendment to the claims. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicant’s arguments insofar as they pertain to the present grounds of rejections and/or objections are addressed herein.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
Claims 1 and 8 each recite the limitation “consisting of alkylalkoxysilyl groups in which one or more C1-C3 alkyl groups and one or more C1-C3 alkoxy groups are bound to a silicon atom and polyhedral oligomeric silsesquioxane”. To clarify that the alkyl and alkoxy groups are bound to a silicon atom only and not to a polyhedral oligomeric silsesquioxane, the Examiner suggests inserting commas around the clause “in which one or more C1-C3 alkyl groups and one or more C1-C3 alkoxy groups are bound to a silicon atom”.
Appropriate correction is 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ushiro et al. (WO2018061916A1; 04/05/2018; PTO-892 of 02/12/2025) in view of Ding et al. (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025).
Ushiro teaches a copolymer that is capable of being immobilized on a base material while maintaining a high antithrombotic property persistently without having to introduce heparin or an anticoagulant drug to the surface thereof; and a medical material using same (Abstract). The copolymer comprises a monomer unit A, a monomer unit B, and a monomer unit C represented by the following general formula (I):
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wherein the monomer unit A, the monomer unit B, and the monomer unit C are arranged randomly (Claim 3).
Regarding claim 1: Because the copolymer of Ushiro is capable of being immobilized on a base material, it reads on the limitation “coating agent”. Ushiro further teaches an exemplary embodiment wherein vinylpyrrolidone, vinyl propanoate (also called vinyl propionate), and allylamine are mixed to obtain a vinylpyrrolidone/vinyl propanoate/allylamine random copolymer, referred to as Copolymer A (Paragraph 0135, Copolymer A). Vinyl propanoate reads on the instantly claimed monomer unit B. Vinylpyrrolidone reads on the monomer unit C containing a hydrophilic group as evidenced by instant claim 9.
Regarding claim 3: The vinyl propionate of Ushiro’s Copolymer A reads on a species of the unit B as instantly claimed.
Regarding claim 4: The vinylpyrrolidone of Ushiro’s Copolymer A comprises an amide group, as evidenced by its chemical structure, and thus meets the claim.
Regarding claim 5: Ushiro explicitly teaches that the monomer units of Copolymer A are arranged randomly and thus meets the claim.
Regarding claim 6: Ushiro further teaches a medical material comprising the copolymer and a substrate bonded to the copolymer (Claim 6). In Ushiro’s Example 9, a polypropylene plate was used as the substrate, and the surface of the plate was subjected to plasma treatment to form carboxy groups, then immersed in an aqueous solution comprising Copolymer A in order to covalently bind Copolymer A to the carboxy groups on the surface of the polypropylene plate (Paragraph 0149). Thus, a layer of Copolymer A was formed on the surface of the substrate, as instantly claimed.
Regarding claim 7: Polypropylene reads on the instantly claimed olefinic polymer as recognized by the instant specification (Page 30).
Regarding claim 8: As discussed above, Ushiro’s Copolymer A reads on the unit B and unit C monomer units of the instantly claimed copolymer.
Regarding claim 9: The vinyl propionate of Ushiro’s Copolymer A reads on a species of the unit B as instantly claimed, and the vinylpyrrolidone of Ushiro’s Copolymer A reads on a species of the unit C as instantly claimed.
Regarding claims 10 and 11: Ushiro explicitly teaches that the monomer units of Copolymer A are arranged randomly and thus meets the claim.
Ushiro does not expressly teach that the copolymer comprises a monomer unit containing a Si-O bond, wherein the monomer unit contains a group selected from the group consisting of alkylalkoxysilyl groups in which one or more C1-C3 alkyl groups and on or more C1-C3 alkoxy groups are bound to a silicon atom and polyhedral oligomeric silsesquioxane groups as recited in claims 1 and 8.
Ding teaches a polymeric material useful for medical application such as for coating an implantable device like a stent (Col. 1, lines 15-20). In some embodiments, the polymer blend includes a polymer that has siloxane monomers and at least one other biocompatible polymer, like vinyl esters and vinyl pyrrolidone (Col. 5, lines 55-61 and from Col. 7, line 65 to Col. 9, line 11). The siloxane monomers can be any siloxanes capable of polymerization, preferably those of the general formula shown below (Col. 4, lines 48-67 and Col. 5, lines 1-3):
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wherein R1 and R2 are independently H, halo groups, C1-C10 alkyl, C3-C10 cycloalkyl, substituted C1-C10 alkyl, haloalkyl, substituted phenyl, or substituted aryl, and Z1 and Z2 are independently absent or oxygen (O). Other biocompatible polymers include polyvinyl esters and n-vinyl pyrrolidone, among others (from Col. 7, line 65 to Col. 9, line 11). Ding teaches that the siloxane monomer component imparts flexibility to the polymers (Col. 1, lines 55-61).
Regarding the instantly claimed monomer unit containing a Si-O bond as recited in claims 1 and 8: Given the small group of siloxane substituents specifically contemplated by Ding, an ordinarily skilled artisan could readily prepare a siloxane monomer wherein R1 and R2 are each a C1 alkyl or a C3 cycloalkyl; Z1 is O; and Z2 is absent, which reads on the instantly claimed alkylalkoxysilyl group. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Copolymer A taught by Ushiro by further adding the alkylalkoxysilyl group-containing siloxane monomer taught by Ding according to known methods to yield the predictable result of a copolymer with improved flexibility that is suitable for coating medical devices. Combining prior art elements according to known methods to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. V. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
There is a reasonable expectation of success in building the copolymer because Ding teaches that the siloxane monomers may be used in combination with biocompatible polymers like vinyl esters (i.e., vinyl propanoate) and vinyl pyrrolidone to build random copolymers (Col. 1, lines 55-61), and Ushiro teaches that additional components may be copolymerized with the exemplary monomers. Regarding the antithrombogenic properties of the Copolymer A of Ushiro, Ding teaches that the combination of siloxanes with materials such as n-vinyl pyrrolidone allows retention of biobeneficial characteristics, including non-thrombogenicity (from Col. 10, line 60 to Col. 11, line 40). Thus, the resulting copolymer suggested by the combination of Ushiro and Ding would introduce a new property to the coating agent while retaining its antithrombogenic activity. Additionally, one of ordinary skill in the art would reasonably expect that the copolymer would be suitable for producing a medical material by forming a layer on the surface of a substrate because both Ushiro and Ding teach that copolymers comprising these monomers are suitable for coating medical devices.
Response to Arguments
Applicant’s arguments submitted on 04/17/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that there is no motivation to specifically select the alkylalkoxysilyl group (where only Z1 is oxygen) or a PSS group over the dimethylsiloxane (Z1 and Z2 are both absent) primarily disclosed in the examples of Ding. This argument was not found to be persuasive. Ding’s use of dimethylsiloxane in its non-limiting examples does not criticize, discredit, or otherwise discourage use of any of its other disclosed siloxane monomers. See In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Further, MPEP 2123(II) states, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)”. It is within the skillset of an ordinary artisan to optimize the structure of the siloxane monomer within the scope disclosed by Ding in order to impart a desired level of flexibility to the copolymer of Ushiro. Though Applicant argues that narrowing claims 1 and 8 to recite “in which one or more C1-C3 alkyl groups and one or more C1-C3 alkoxy groups are bound to a silicon atom” further distances the claimed invention from Ding’s siloxane monomers, Ding explicitly contemplates the use of C1 alkyl groups and C3 cycloalkyl groups, as discussed in the prior art rejections of record.
Applicant further asserts that it is difficult to perceive that prior art combination would yield the unexpected effect of improved antithrombogenicity and that the Examiner’s allegation is based on hindsight reasoning. This argument was not found to be persuasive. The motivation to modify the copolymer of Ushiro by incorporating any of the disclosed siloxane monomers contemplated by Ding is based solely on the prior art’s teaching that such monomers are known to impart improved flexibility to copolymers within the scope of Ushiro’s invention. Thus, a prima facie case of obviousness has been properly established based solely on the prior art teachings and not Applicant’s own disclosure as asserted by Applicant.
Regarding Applicant’s argument of unexpected results, while Applicant’s data do appear to demonstrate that Copolymer a and Copolymer b achieve improved antithrombotic performance compared to Copolymer x and Copolymer z, which are outside of the scope of the claimed invention, the data are still not commensurate in scope with the instant claims for at least the reasons discussed above in response to Applicant’s Declaration filed 04/17/2026. Briefly, Applicant’s comparative tests demonstrate the antithrombogenicity of copolymers comprising only two species of unit A, only one species of unit B, and only one species of unit C. Further, the relative amounts of each monomer unit appear to vary substantially between examples. In contrast, Applicant’s instant claims encompass copolymers comprising a wide array of possible monomeric units, combinations, and proportions that can differ vastly in chemical structure from those provided in the data supporting Applicant’s allegedly unexpected results. As such, one of ordinary skill in the art could not ascertain that any copolymer within the scope of the instant invention would possess superior antithrombotic performance. Thus, the data are insufficient to overcome the prior art rejections of record at this time because the results demonstrated are still not commensurate in scope with the claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. Therefore, the prior art rejections of record are maintained.
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, 4-5, 8, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10,308,745 B2 in view of Ding et al. (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025).
U.S. ‘745 claim 1 recites a copolymer comprising a hydrophilic unit and a hydrophobic unit, wherein the hydrophobic unit includes at least one vinyl carboxylate unit, and the vinyl carboxylate unit has 2 or more and 7 or less carbon atoms at a side chain terminal thereof, wherein the hydrophilic unit includes a vinylpyrrolidone unit. U.S. ‘745 claim 4 further limits the copolymer such that the hydrophilic unit and the hydrophobic unit are arranged randomly or alternately.
The claims of U.S. ‘745 differ from the instant claims in that they do not recite a monomer unit containing a Si-O bond, wherein the monomer unit contains a group selected from the group consisting of alkylalkoxysilyl groups and polyhedral oligomeric silsequioxane groups as recited in instant claims 1 and 8.
The teachings of Ding are as set forth above and further incorporated herein.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the copolymer recited in U.S. ‘745 claim 4 by further adding the alkylalkoxysilylj group-containing siloxane monomer taught by Ding according to known methods to yield the predictable result of a copolymer with improved flexibility that is suitable for coating medical devices. One of ordinary skill in the art would have a reasonable expectation of success because Ding teaches that siloxanes may be used in combination with biocompatible polymers like vinyl esters (i.e. vinyl carboxylates) and vinyl pyrrolidone to build random copolymers.
Claims 1 and 3-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10,308,745 B2 in view of Ding et al. (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025), as applied to 1, 4-5, 8, and 10 above, and further in view of Ushiro et al. (WO2018061916A1; 04/05/2018; PTO-892 of 02/12/2025).
The combination of U.S. ‘745 claims and Ding teaches the invention(s) of instant 1, 4-5, 8, and 10 as discussed in detail above and further incorporated herein.
The combination of U.S. ‘745 claims and Ding differ from the instant claims in that they do not teach that the vinyl carboxylate unit is selected from the group recited in instant claims 3, 9, and ultimately required by claim 11, or the medical material recited in instant claims 6-7.
The teachings of Ushiro are as set forth above and further incorporated herein.
Regarding claims 3, 9, and 11: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vinyl carboxylate unit of the copolymer taught by the combination of U.S. ‘745 claims and Ding with the vinyl propanoate (also called vinyl propionate) taught by Ushiro (Copolymer A). One of ordinary skill in the art would have been motivated to use vinyl propanoate and there is a reasonable expectation of success because Ushiro teaches that it is a suitable vinyl carboxylate for use in a copolymer with vinylpyrrolidone.
Regarding claims 6 and 7: It would have been obvious to apply the copolymer taught by the combination of U.S. ‘745 claims, Ding, and Ushiro to the surface of a polypropylene substrate by forming a layer on the surface of the substrate, as taught by Ushiro, in order to improve the antithrombotic properties of the medical material. One of ordinary skill in the art would reasonably expect that the copolymer would be suitable for producing a medical material by forming a layer on the surface of a substrate, such as the polypropylene plate taught by Ushiro because Ding teaches that copolymers comprising siloxanes, vinyl esters, and vinylpyrrolidone can be applied to the surface of medical devices, such as stents, which are also taught by Ushiro as suitable medical devices or surfaces for producing a medical material.
Claims 1, 4, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of U.S. Patent No. 10,912,868 B2 in view of Ding et al. (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025).
U.S. ‘868 claim 1 recites a medical separation membrane, a blood circuit, a blood storage bag, a catheter, a stent, a contact lens or a biosensor in which a medical material is bonded or attached to a surface of a membrane including a hydrophobic polymer, wherein the medical material is a copolymer comprising a hydrophobic unit and a hydrophilic unit, the hydrophobic unit has a terminal alkyl group having 2 to 20 carbon atoms in a side chain, a static contact angle of water on the copolymer is 30 degrees or more and less than 70 degrees, and the copolymer has only one glass transition temperature of 45° C. or higher and lower than 90° C. U.S. ‘868 claim 2 further limits the hydrophobic unit of claim 1 to an alkyl carboxylic acid vinyl ester unit, U.S. ‘868 claim 3 further limits the hydrophilic unit of claim 1 to a vinylpyrrolidone unit, and U.S. ‘868 claim 8 further limits the hydrophilic unit of U.S. ‘868 claim 2 to vinylpyrrolidone.
The claims of U.S. ‘868 differ from the instant claims in that they do not recite a monomer unit containing a Si-O bond, wherein the monomer unit contains a group selected from the group consisting of alkylalkoxysilyl groups and polyhedral oligomeric silsequioxane groups as recited in instant claims 1 and 8.
The teachings of Ding are as set forth above and further incorporated herein.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the copolymer recited in U.S. ‘868 claim 8 by further adding the alkylalkoxysilylj group-containing siloxane monomer taught by Ding according to known methods to yield the predictable result of a copolymer with improved flexibility that is suitable for coating medical devices. One of ordinary skill in the art would have a reasonable expectation of success because Ding teaches that siloxanes may be used in combination with biocompatible polymers like vinyl esters and vinyl pyrrolidone to build random copolymers.
Claims 1, 3-5, and 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of U.S. Patent No. 10,912,868 B2 in view of Ding et al. (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025), as applied to claims 1, 4, and 8 above, and further in view of Ushiro et al. (WO2018061916A1; 04/05/2018; PTO-892 of 02/12/2025).
The combination of U.S. ‘868 claims and Ding teaches the invention(s) of instant claims 1, 4, and 8 as discussed in detail above and further incorporated herein.
The combination of U.S. ‘868 claims and Ding differ from the instant claims in that they do not teach that the alkyl carboxylic viny ester unit is selected from the group recited in instant claims 3 and 9, or the limitation of instant claims 5, 10, and 11 wherein units A, B, and C are arranged randomly in the copolymer.
The teachings of Ushiro are as set forth above and further incorporated herein.
Regarding claims 3 and 9: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the alkyl carboxylic acid vinyl ester unit of the copolymer taught by the combination of U.S. ‘868 claims and Ding with the vinyl propanoate (also called vinyl propionate) taught by Ushiro (Copolymer A). One of ordinary skill in the art would have been motivated to use vinyl propanoate and there is a reasonable expectation of success because Ushiro teaches that it is a suitable vinyl carboxylate for use in a copolymer with vinylpyrrolidine in a medical material.
Regarding claims 5, 10, and 11: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the monomer units of the copolymer taught by the combination of U.S. ‘868 claims, Ding, and Ushiro in a random order because Ushiro teaches that such arrangement prevents partial bias in hydrophilicity or hydrophobicity, which could affect the polymer’s binding properties. There is a reasonable expectation of success because the copolymer taught by the combination of U.S. ‘868 claims, Ding, and Ushiro and the copolymer of Ushiro each comprise vinyl propanoate and vinylpyrrolidine monomers and are intended to bind medical materials.
Claims 1 and 3-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of U.S. Patent No. 10,912,868 B2 in view of Ding et al. (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025) and Ushiro et al. (WO2018061916A1; 04/05/2018; PTO-892 of 02/12/2025), as applied to claims 1, 3-5, and 8-11 above, and further in view of Wan et al. 2009 (PTO-892 of 02/15/2025).
The combination of U.S. ‘868 claims, Ding, and Ushiro teaches the invention(s) of instant claims 1, 3-5, and 8-11 as discussed in detail above and further incorporated herein.
The combination of U.S. ‘868 claims, Ding, and Ushiro differ from the instant claims in that they do not teach the medical material as recited in instant claims 6-7.
Wan teaches surface engineering strategies for macroporous polypropylene membranes, which are used in a variety of applications including bioseparation and medical devices (Abstract). One problem is the inherent hydrophobicity of polypropylene membranes because the membrane being used as a separator should be wetted easily by the electrolyte and should retain the electrolyte permanently (Page 14). Surface modification by coating and graft polymerization may be an approach for improving the surface wettability of the polypropylene membrane (Page 14).
The teachings of Ushiro are as set forth above and further incorporated herein.
Regarding claims 6 and 7: It would have been obvious to modify the hydrophobic polymer of the membrane recited in U.S. ‘868 claim 1 with the polypropylene taught by Wan and then bond or attach the copolymer taught by the combination of U.S. ‘868 claims and Ding to the surface of the membrane, as recited in the claims of U.S. ‘868, in order to produce a hydrophobic medical membrane with improved wettability, as taught by Wan. One of ordinary skill in the art would reasonably expect that the copolymer would be suitable for producing a medical material by forming a layer on the surface of a substrate, such as the polypropylene membrane taught by Wan, because Wan teaches polypropylene membranes can be improved by surface modification, such as polymer coating, and Ushiro supports that a copolymer comprising an alkyl carboxylic acid vinyl ester unit and a vinylpyrrolidone unit can also be applied to the surface of a polypropylene substrate.
One of ordinary skill in the art would reasonably expect success in modifying the claims of U.S. ‘868 claims with the prior art as proposed because the references teach that copolymers comprising these monomers are suitable for coating medical devices such as stents and catheters in order to impart antithrombogenic properties.
Response to Arguments
Applicant’s arguments submitted on 04/17/2026with respect to rejections on the ground of nonstatutory double patenting have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that each of the double-patenting rejections should be withdrawn for similar reasons discussed in relation to the prior art rejections. This argument is not persuasive for the same reasons as applied to the rejections of the claims under 103 as discussed in detail above. Therefore, the double patenting rejections of record are maintained.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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, Sue Liu can be reached at (571)272-5539. 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.
/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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