DETAILED ACTION
Notice of Pre-AIA or AIA Status
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/27/2025 has been entered.
Claim Status
Applicant’s amendment of 08/27/2025 is acknowledged. Claims 1 and 8 are amended; claim 2 remains cancelled; and claim 12 is new. Claims 1 and 3-12 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.
Withdrawn Objections and Rejections
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of rejection presented herein under 103 and nonstatutory double patenting. Thus, the previous rejections under 103 and nonstatutory double patenting are hereby withdrawn in favor of the new/revised grounds of rejection presented herein. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites the limitation “wherein the substrate is made of a material containing an olefinic polymer” in line 12. However, the claim already recites this limitation in lines 8-9. Therefore, the second recitation of this limitation as it appears in line 12, which appears to be a typographical error, is redundant and should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 is 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 12 recites the limitation "the coating agent" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 12 does not recite a coating agent, making it unclear to which coating agent “the” coating agent refers. Therefore, the scope of the claim is indefinite.
Claim Interpretation
As defined in Applicant’s instant specification, the term “alkylalkoxysilyl group” recited in claims 1, 8, and 12 is interpreted to mean a group in which at least one or more each of alkyl groups and alkoxy groups are bound to a silicon atom. With no limiting definition of the term “alkyl groups” provided in Applicant’s instant specification or claims, the Examiner is interpreting the term broadly to include linear, branched, and cyclic hydrocarbon groups, which may be substituted or unsubstituted.
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 3-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ushiro et al. 2013 (WO2018061916A1; 04/05/2018; PTO-892 of 02/12/2025) in view of Ding (US9580558B2; 02/28/2017; PTO-892 of 06/30/2025) as evidenced by Ueno (JP4888559B2; published: 02/29/2012; PTO-892 of instant action).
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.
Regarding claim 12: As discussed above, Ushiro teaches a medical material comprising: a substrate made of a material containing an olefinic polymer, and a layer formed on the surface of the substrate by a coating agent comprising a copolymer comprising the instantly claimed unit B and unit C monomer units.
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 and polyhedral oligomeric silsesquioxane groups as recited in claims 1 and 8, or wherein the monomer unit contains a group selected from the group consisting of alkylalkoxysilyl groups, dialkylsiloxane groups, and polyhedral oligomeric silsesquioxane groups as recited in claim 12. Further, Ushiro does not explicitly teach that the medical material is a hollow fiber membrane as recited in claim 12.
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).
Regarding the instantly claimed monomer unit containing a Si-O bond as recited in claims 1, 8, and 12: Given the small group of siloxane substituents taught by Ding, one of ordinary skill in the art could readily envision a siloxane monomer wherein R1 and R2 are each a C1-C10 alkyl (or, alternatively, a C3-C10 cycloalkyl, a substituted C1-C10 alkyl, or a haloalkyl); 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. One of ordinary skill in the art would have been motived to combine the siloxane monomer with Ushiro’s Copolymer A because Ding teaches that the siloxane monomer imparts flexibility to polymers that are used for medical applications, such as coating implantable devices (Col. 1, lines 55-61).
Regarding an alternative species of claim 12 wherein the instantly claimed monomer unit containing a Si-O bond contains a dialkylsiloxane group: The Examiner notes that in some embodiments Ding exemplifies dimethylsiloxane as the siloxane monomer of choice (Col. 13-14, Examples 1-3). For the same reasons as discussed above, it would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to, alternatively, modify the Copolymer A taught by Ushiro by further adding the dimethylsiloxane monomer taught by Ding.
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.
Regarding the hollow fiber membrane recited in claim 12: Ushiro further directs the reader’s attention to patent document JP4888559B2, hereinafter Ueno, to show that copolymers comprising vinylpyrrolidone and a vinyl carboxylate are known in the art to be successfully immobilized on the surface of a hollow fiber membrane to form coated medical devices, like stents and catheters, with antithrombogenic properties (Paragraphs 0005 and 0009). Ueno, incorporated by reference in Ushiro, teaches that said hollow fiber membrane is made of a hydrophobic polymer material, and lists polypropylene as a specific example of said material (Page 37). Therefore, 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 medical material taught by the combination of Ushiro and Ding by using the polypropylene hollow fiber membrane taught by Ushiro as evidenced by Ueno, rather than a polypropylene plate, as the substrate to form a coated hollow fiber membrane suitable for use as a medical device. One of ordinary skill in the art would have been motivated to apply the copolymer of Ushiro and Ding to the surface of a hollow fiber membrane in order to improve upon existing medical devices, which Ushiro teaches are more susceptible to thrombus formation and/or deterioration of their antithrombogenic properties (Paragraph 0009).
One of ordinary skill in the art would reasonably expect success in modifying the medical material taught by the combination of Ushiro and Ding, as evidenced by Ueno, 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 08/27/2025 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 Ushiro and Ding do not disclose or suggest a copolymer comprising a monomer unit that contains a group selected from the group consisting of alkylalkoxysilyl groups and polyhedral oligomeric silsesquioxane groups. This argument was not found to be persuasive. As discussed in detail in the prior art rejections above, Ding discloses several species of siloxane monomer that read on Applicant’s instantly claimed species of a monomer unit containing a Si-O bond, wherein the monomer contains an alkylalkoxysilyl group. Because an ordinarily skilled artisan would be reasonably motivated to add the alkylalkoxysilyl group-containing siloxane monomer of Ding to the Copolymer A of Ushiro to impart flexibility to the polymer while retaining its antithrombogenic properties, the instantly claimed invention(s) are prima facie obvious in view of the prior art.
Regarding Applicant’s alleged unexpected results, the provided comparison is not commensurate in scope with Applicant’s invention as defined in claims 1 and 3-11 because the limitation “dialkylsiloxane groups” was removed from the claims. Therefore, the alleged unexpected results are irrelevant to those claims. To the extent that the argument of unexpected results applies to the alternative species of Applicant’s claim 12, wherein the monomer unit containing a Si-O bond contains a dialkylsiloxane group, the provided data do not appear demonstrate the criticality of the Si-O bond type in unit A on antithrombotic performance in a context that is commensurate in scope with Applicant’s claimed invention. For example, in Applicant’s Table 1 (Page 6 of Remarks filed 08/27/2025), each example appears to comprise a copolymer wherein unit C comprises vinyl propionate. However, the unit C in Applicant’s claimed copolymer is a monomer unit containing a hydrophilic group, such as vinylpyrrolidone, vinylacetamide, or acrylamide. While this appears to be an error in view of Applicant’s provided syntheses, the data reported make the comparison unclear—particularly in view of the prior art, which teaches a copolymer comprising both vinyl propionate and vinylpyrrolidone. Nevertheless, it appears that Applicant’s data attempt to demonstrate that copolymers comprising the dialkylsiloxane groups of claim 12 are actually inferior to those comprising alkylalkoxysilyl groups and polyhedral oligomeric silsesquioxane groups, despite including the limitation in the claims. Lastly, in order to establish that the properties of Applicant’s claimed invention are in fact unexpected and unobvious, Applicant must demonstrate that the data provided are statistically significant compared to the closest prior art. No such demonstration was provided.
Overall, Applicant fails to provide sufficient evidence to establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance" as per MPEP 716.02(b). In view of the foregoing, 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 (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, or alternatively the dimethylsiloxane monomer, taught by Ding. One of ordinary skill in the art would have been motived to add a siloxane monomer because Ding teaches that the siloxane monomer imparts flexibility to polymers that are used for medical applications, such as coating implantable 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 3-12 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 (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. 2013 (WO2018061916A1; PTO-892) as evidenced by Ueno (JP4888559B2; published: 02/29/2012; PTO-892 of instant action).
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 and 12.
The teachings of Ushiro as evidenced by Ueno 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, 7, and 12: 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 or the polypropylene hollow fiber membrane taught by Ushiro as evidenced by Ueno, 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 (US9580558B2; 02/28/2017; PTO-892 of 08/27/2025).
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, or alternatively the dimethylsiloxane monomer, taught by Ding. One of ordinary skill in the art would have been motived to add a siloxane monomer because Ding teaches that the siloxane monomer imparts flexibility to polymers that are used for medical applications, such as coating implantable 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. 10,9128,68 B2 in view of Ding (US9580558B2; 02/28/2017; PTO-892 of 08/27/2025), as applied to claims 1, 4, and 8 above, and further in view of Ushiro et al. 2013 (WO2018061916A1; PTO-892).
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 3-12 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 (US9580558B2; 02/28/2017; PTO-892 of 08/27/2025) and Ushiro et al. 2013 (WO2018061916A1; 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) as evidenced by Ueno (JP4888559B2; published: 02/29/2012; PTO-892 of instant action).
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 and 12.
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 as evidenced by Ueno are as set forth above and further incorporated herein.
Regarding claims 6, 7, and 12: 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.
Regarding the hollow fiber membrane recited in claim 12: 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 medical material taught by the combination of U.S. ‘868 claims, Ding, Wan, and Ushiro by incorporating the polypropylene membrane in the form of a hollow fiber, as taught by Ushiro as evidenced by Ueno, in order to produce a medical material with improved antithrombogenicity that is suitable for use as a stent or catheter.
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 08/27/2025 with 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.
Conclusion
No claim is allowed.
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/SARAH C WISTNER/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616