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 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claim 1 (system) in the reply filed on 6/23/2026 is acknowledged.
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 3-22 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No.12,220,502. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 3 and 5 comprise the same substrate, coating and shape memory polymer foam as claim 1 of US Patent No. 12,220,502. Instant claim 4 is the same as claim 16 of US Patent No. 12,220,502. Instant claims 8-12 are identical to claims 5-9 of US Patent No. 12,220,502.
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.
Claims 3-8, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Singhal et al. (US Patent Application No. 2013/0317541) in view of Bezwada (US Patent Application No. 2012/0158127).
Regarding claims 3 and 4, Singhal et al. teach a system comprising a PFO device (a substrate of a medical device) (abstract, page 1, paragraph [0007], page 4, paragraphs [0046], [0055]); a thermoset polyurethane shape memory polymer foam (a monolithic thermoset polyurethane shape memory polymer foam) (page 4, paragraph [0055], page 5, paragraph [0059], claim 4). Thermally actuated shape memory polymers (SMP) have the ability to transform from a stable “secondary” shape to a predetermined “primary” when heat or otherwise activated (page 1, paragraph [0013]). Singhal et al. teach a thermoset polyurethane shape memory polymer foam and therefore teaches wherein the SMP foam has a primary state and a programmed secondary state (page 1, paragraph [0013], page 4, paragraph [0055], page 5, paragraph [0059], claim 4). The SMP foam is compressed and therefore is in the primary state (page 1, paragraph [0013], page 4, paragraph [0055]). The SMP foam surrounds the PFO device (substrate) (page 4, paragraph [0055]).
Singhal et al. fail to teach wherein the system comprises an un-foamed, thermoplastic, aliphatic coating fixedly attached to the substrate. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 5, Singhal et al. teach wherein the SMP foam (monolithic SMP foam) includes polymerized monomers, the monomers including triethanolamine (TEA) and hexamethylene diisocyanate (HDI) (page 5, paragraphs [0059], [0060]).
Regarding claim 6, Singhal et al. fail to teach wherein the coating does not include polymerized monomers that include TEA. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]), wherein the coating does not include polymerized monomers that include TEA (entire document).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 7, Singhal et al. teach wherein a short axis is orthogonal to the long axis and intersects the substrate (page 1, paragraph [0013], page 3, paragraph [0038], page 4, paragraphs [0042], [0055], page 5, paragraph [0059]), and first and second portions of the monolithic SMP foam that are respectively on opposing sides of the substrate (page 4, paragraphs [0042], [0055]).
Singhal et al. do not disclose wherein the first portion of the monolithic foam is no more than 2 mm thick measured along the short axis. However, where in the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in thickness involve only routine skill in the art, absence a showing of criticality. MPEP 2144.05 II. One would have been motivated to modify the thickness of Singhal et al. in order to achieve a complete seal starting immediately after deployment of the device (Singhal et al., page 3, paragraph [0034]).
Singhal et al. fail to teach wherein the system comprises an un-foamed, thermoplastic, aliphatic coating fixedly attached to the substrate. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 8, Singhal et al. fail to teach wherein the coating is less hydrophobic than polytetrafluoroethylene (PTFE). However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]).
Bezwada et al. do not disclose wherein the coating is less hydrophobic than polytetrafluoroethylene (PTFE). However, where in the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in hydrophobic nature involve only routine skill in the art, absence a showing of criticality. MPEP 2144.05 II. One would have been motivated to modify the hydrophobic nature of the coating within a range in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 16, Singhal et al. teach wherein the SMP foam (monolithic SMP foam) includes polymerized monomers, the monomers including N,N,N’,N’-tetrakis (2-hydroxypropyl)ethylenediamine (HPED) (page 5, paragraph [0059]).
Regarding claim 17, Singhal et al. fail to teach wherein the coating includes the polymerized monomers. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to polymerize the monomers of Singhal et al. in the coating of Bezwada in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 18, Singhal et al. fail to teach wherein the coating is porous. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]), wherein the coating is porous (page 15, paragraph [0148]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Claims 9-15, 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Singhal et al. (US Patent Application No. 2013/0317541) in view of Bezwada (US Patent Application No. 2012/0158127), in further view of Wilson et al. (US Patent Application No. 2012/0158034).
Singhal et al. and Bezwada are relied upon as disclosed above.
Regarding claims 9 and 10, Singhal et al. fail to teach wherein the substrate includes a metal. However, Wilson et al. teach a system comprising a substrate for a medical device (page 2, paragraphs [0027], page 6, paragraph [0078]), wherein the substrate includes a metal wire (page 6, paragraph [0079]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use the substrate of Wilson et al. in the system of Singhal et al. in order to allow pre-loaded of compressed expandable implant (Wilson et al., page 6, paragraph [0075]).
Regarding claim 11, Singhal et al. fail to teach wherein the substrate includes a polymer. However, Wilson et al. teach a system comprising a substrate for a medical device (page 2, paragraphs [0027], page 6, paragraph [0078]), wherein the substrate includes a polymer (page 6, paragraph [0079]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use the substrate of Wilson et al. in the system of Singhal et al. in order to allow pre-loaded of compressed expandable implant (Wilson et al., page 6, paragraph [0075]).
Regarding claim 12, Singhal et al. fail to teach wherein the coating directly contacts the substrate. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 13, Singhal et al. fail to teach wherein the coating has a chemical composition unequal to a chemical composition of the monolithic SMP foam. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]), wherein the coating has a chemical composition unequal to a chemical composition of the monolithic SMP foam (page 4, paragraph [0029], page 5, paragraph [0052]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claims 14 and 15, Singhal et al. fail to teach wherein the substrate includes a stent graft. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]), wherein the substrate includes a stent graft, wherein the substrate includes an exterior surface of the stent graft (page 11, paragraph [0109])
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 19, Singhal et al. fail to teach wherein the substrate includes a polymer. However, Wilson et al. teach a system comprising a substrate for a medical device (page 2, paragraphs [0027], page 6, paragraph [0078]), wherein the substrate includes a polymer (page 6, paragraph [0079]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to use the substrate of Wilson et al. in the system of Singhal et al. in order to allow pre-loaded of compressed expandable implant (Wilson et al., page 6, paragraph [0075]).
Regarding claim 20, Singhal et al. fail to teach wherein the coating directly contacts the substrate. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 21, Singhal et al. fail to teach wherein the substrate includes an exterior surface of a stent graft. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]), wherein the substrate includes an exterior surface of the stent graft (page 11, paragraph [0109])
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Regarding claim 22, Singhal et al. fail to teach wherein the coating has a chemical composition unequal to a chemical composition of the monolithic SMP foam. However, Bezwada teaches a system comprising a substrate of a medical device (page 11, paragraph [0109], page 14, paragraph [0144]) and polyurethane coating (an unfoamed, thermoplastic aliphatic coating) fixedly attached to the substrate (page 4, paragraph [0029], page 5, paragraph [0052], page 14, paragraph [0144]), wherein the coating has a chemical composition unequal to a chemical composition of the monolithic SMP foam (page 4, paragraph [0029], page 5, paragraph [0052]).
It would have been obvious to a person of the ordinary skill in the art before the effective filing date of the claimed invention to fixedly attach the coating of Bezwada to the substrate of Singhal et al. in order to provide biodegradability and biocompatibility (Bezwada, page 4, paragraph [0027]).
Conclusion
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/Chinessa T. Golden/Primary Examiner, Art Unit 1788 8/20/2026
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