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 .
Receipt is acknowledged of Applicant’s Arguments and Request for Continued Examination filed on 10/13/2025.
Claims 8, 10, 14 and 18-21 have been cancelled.
Claims 24-26 have been added. Accordingly, claims 1-7, 9, 15, 16 and 22-26 are pending and presented for examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/01/2025 was considered and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of amendments and arguments filed on 10/13/2025. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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.
Claim(s) 1-7, 9, 15, 16 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Maitland et al. (US 2019/0192743) in view of Weems A.C et al. (Acta Biomaterial, 54, 45-57, 2017) and Domb et al. (US 2016/0151124).
Maitland discloses a polyurethane shape memory polymer (SMP) foam that functions as an effective embolization device with favorable healing responses and relatively low friction during delivery due to the shape memory effect (abstract and 0012). In one embodiment include radiopaque SMP foam formulations designed for X-ray visibility, as well as alternative means of visualizing the entire foam length (0013). In one embodiment, includes a system comprising: a thermoset shape memory polymer (SMP) foam that is covalently bonded to iodine; wherein (a) the SMP foam is configured to expand from a compressed secondary state to an expanded primary state in response to thermal stimulus, and (b) the SMP foam is a poly(urethane-urea-amide) (0050 and Example ia). The system of example 1a wherein the SMP foam is radiopaque (0051 and Example 2a). Example 3a includes the system of example 2a wherein the iodine is included in a triiodobenzene monomer (0052). Example 4a-6a includes the system of example 3a wherein the triiodobenzene monomer includes at least one of (a) 5-amino-2,4,6-triiodoisophthalic acid (ATIPA), (b) diatrizoic acid, (c) iohexol, and (qd) triiodophenol (0053-0055). Example 10a the backbone includes a majority % of polymer and a minority % of metal (0061). Example 17a includes the method of example 12a wherein the first member is ATIPA and the ATIPA constitutes between 20 and 30% MW of the first and second members (0069). Example 12a includes the method of example 11a wherein: triiodobenzene monomer includes a first member selected from the group consisting of 5-amino-2,4,6-triiodoisophthalic acid (ATIPA), the aliphatic monomer includes a second member selected from the group consisting of 1,2,6-hexanetriol (HT); the diisocyanate includes a third member selected form the group consisting of hexamethylene diisocyanate (HDI); trimethylhexa-methylene diisocyanate (TMHDI) (0063). Maitland discloses SMP foam is formed by the reaction product of triethanolamine (TEA), hydroxypropyl ethylenediamine (HPED), hexamethylene diisocyante (HDI), isophorone’ diisocyanate (IPDI) (0130-0132). Additional disclosure includes that expandable polyurethane foam is used in embodiments due to their excellent acute thrombogenicity, long term biocompatibility, tunable pore size, and favorable healing response.
Maitland fails to disclose a gadolinium-based contrast agent (GBCA) chemically bonded SMP foam and GBCA including between 1 and 10 eq % gadopentetic acid (GPA).
Weems discloses a methodology for the development of MR and X-ray visible shape memory polymers (SMPs) using either a chemically loaded or physical loaded modifying agent during polymer synthesis (abstract). In one embodiment discloses a method for enhancing the MR-visibility of SMPs through the use of iron nanoparticles or gadolinium chelates (Gd) incorporated into the polymer backbone (page 46). A traditional two-step polyurethane foaming process was used for synthesis. Triethanolamine (TEA), 2-hydroxypropyl ethylenediamine (HPEDP, and trimethyl hexamethylene diisocyanate (TMHDI) were reacted to form a prepolymer prior to foaming. The prepolymer was then added to an alcohol premix, consisting of the remaining alcohols, surfactants, catalysts and blowing agents. The Gd (Diethylenetriaminepentaacetic acid gadolinium (Ill) dihydrogen salt dehydrate) (reads on gadopentetic acid, GPA) were added to the alcohol premix during the second step of the foaming process and were dispersed/dissolved using high speed shear mixing (page 46, 2.2). Additional disclosure includes that the incorporation of Gd compared with Fe allows for tunable shape recovery profiles, although this does not alter the total recoverable strain or volume. Both methods enhance X-ray density and MR-visibility without significantly altering the degradation rates, and more importantly, without a significant amount of Fe or Gd released into the bold stream over a one-month period (page 46).
Domb discloses implants comprising polymers and contrast agents for marking and monitoring medical conditions (abstract). The implant may comprise a two-component solution, wherein a first component is a polymerizable or crosslinkable compound and a second component is a crosslinking or polymerization agent that is mixed with the first component (0041). In some embodiments, the polymer is a shape memory polymer being a material that has the ability to return from a deformed state (temporary shape) to its original (permanent) shape induced by an external stimulus, such as temperature change and to be designed with an optimum biodegradability and with adjusted recovery temperatures depending on the selection of the copolymer composition as understood by the person versed in the art. Some non-limiting examples of biodegradable shape memory polymers include PCL-PLA multi block copolymers, PCL-polyurethane block copolymers (0092). Non-limiting examples of contrast agents that can be used includes water soluble iodinated contrast agents (e.g., Iohexol); Magnetic Resonance Imaging (MRI) contrast agents (e.g. Gadolinium-based: Gadobenic acid, Gadopentetic acid, and other gadolinium salts and gadolinium complexes (0080). Polymers containing contrast agents were prepared by either melting of the polymer or by polymer dissolution in organic solvent followed by mixing with contrast agents followed by cooling or solvent evaporation respectively to prepare pellets using Teflon template. Sample with 1% and 5% w/w contrast agent were prepared for each polymer (0082 and claim 38). Additional disclosure includes the polymer and contrast agent that constitute the implant are mixed together to form an implant that is fabricated for delivery into a tissue, such that the contrast agent is maintained within the implant together with the polymer without leaching of the contrast agent to the surrounding tissue and thus enable the practitioner to distinguish the tissue carrying the implant (e.g. breast lesion) from neighboring tissue by a suitable imaging method.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate gadolinium-based contrast agent (GBCA) into Maitland’s polyurethane shape memory polymer (SMP) foam used in embolization devices. The person of ordinary skill in the art would have been motivated to make those modifications because Weems teaches that incorporation of Gd complex compared with Fe allows for tunable shape recovery profiles, although this does not alter the total recoverable strain or volume and both methods enhance X-ray density and MR- visibility without significantly altering the degradation rates, and more importantly, without a significant amount of Fe or Gd released into the bold stream over a one-month period (page 46) and reasonably would have expected success because Weems teaches that the methodology will allow for the development of minimally invasive medical devices for use in endovascular applications such as aneurysm occlusion or peripheral occlusion devices.
Claim(s) 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Maitland et al. (US 2019/0192743) in view of Weems A.C et al. (Acta Biomaterial, 54, 45-57, 2017) and Domb et al. (US 2016/0151124) as applied to claims 1-7, 9, 15, 16 and 22-24 above, and further in view of Nash et al. (WO 2018/102779).
The teachings of Maitland et al, Weems et al, and Domb et al, are delineated above. None of these teach amounts of ATIPA; MPD; BEP; and HT as instantly claimed.
Nash discloses a system comprising: an iodine containing thermoset shape memory polymer (SMP) foam that is X-ray visible , wherein the SMP foam is a poly(urethane-urea-amide) (abstract). Figure 9 discloses embodiment of ATIPA foam compositions and monomers listed by mole percent.
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It would have been obvious to one of ordinary skill in the art at the time of invention to incorporate mole percent of ATIPA; MPD; BEP; and HT into Maitland’s composition. The person of ordinary skill in the art would have been motivated to make those modifications because Nash teaches that the monomer combinations can be used to synthesize materials eith transitions relevant for body temperature actuation and further allow for tighter control of bulk thermomechanical properties, as determined by differential scanning calorimetry (0071) and reasonably would have expected success because an X-ray visible SMP material system with flexible structure-to-property relationships that can be tuned for characterization of a neurovascular embolization device.
Conclusion
No claims are allowed at this time.
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/J.R.S/Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618