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 amendments and arguments filed on 05/20/2026.
Claims 1 and 15 have been added.
Claims 27 and 28 have been added.
Claims 8, 10, 14, 18-21, 24 and 26 have been cancelled. Accordingly, claims 1-7, 9, 15, 16, 22, 23, 25, 27 and 28 are pending and presented for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/20/2026 was noted 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.
Applicant’s arguments, see page 6, filed 05/20/2026, with respect to the rejection(s) of claim(s) 1-7, 9, 15, 16, 22, 23, and 24 under 103 rejection have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as follow.
Response to Declaration Under C.F.R. §1.132
The Declaration under 37 CFR 1.132 filed 03/20/2026 is sufficient to overcome the rejection of claims 1-7, 9, 15, 16, 22, 23 and 24 based upon 103 rejection.
In view of the amendments and remarks made herein, the rejection of claims 1-7, 9, 15, 16, 22, 23 and 24 under 103 rejection have been withdrawn. However, upon further consideration a new grounds of rejection is made as follow.
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.
Claim(s) 1-7, 9, 15, 16, 22-23, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Maitland et al. (US 2019/0192743) in view of Ling Sun et al. (Appl. Mater. Interfaces, 8, 10499-10512, 2016) 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-triiodoisophthalid 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) covalently bonded SMP foam and GBCA including between 1 and 10 eq % gadopentetic acid (GPA).
Ling Sun discloses preparation of stimuli-responsive biodegradable hyperbranched polymer-gadolinium conjugates as efficient and biocompatible nanoscale magnetic resonance imaging contrast agents (Title). Ling Sun discloses that gadolinium [Gd(III)] based dendritic macromolecules with well-defined and tunable nanoscale sizes are excellent candidates as multivalent MRI contrast agents. Ling Sun discloses novel preparation of functional hyperbranched poly(oligo-(ethylene glycol) methacrylate)-gadolinium conjugates (HB-POEGMA-Gd and HB-POEGMA-cRGD-Gd) (would read Gd covalently bonded to polymer) and evaluated their potential efficacy and safety as nanoscale contrast agents for tumor diagnosis (Scheme 1 and Figure 1).
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Additional disclosure includes that conjugate-based nanoscale systems had three-fold more T1 relaxivity compared to clinical agent diethylenediaminepentaacetic acid (DTPA)-Gd and animal studies with the nanoscale system offered greater tumor accumulation and enhanced signal intensity (SI) in mouse U87 tumors of which the greatest activity was conferred by cRGDyK moiety functionalized hyperbranched conjugate (abstract).
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., lohexol); 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 a person of ordinary skill in the art at the time the invention was made to modify the preparation of method of Mitland ( preparation of polyurethane shape memory polymer (SMP) foam by reversible addition-fragmentation chain transfer (RAFT) polymerization and click chemistry as taught by Ling Sun because it would have been expected to provide an efficient and biocompatible nanoscale magnetic resonance imaging contrast agents gadolinium [Gd(III)] based dendritic macromolecules with well-defined and tunable nanoscale sizes are excellent candidates as multivalent MRI contrast agents (abstract) and reasonably would have expected success because the design strategy for multifunctional Gd(III)-labeled biodegradable dendritic macromolecules may have significant potential as future efficient, biocompatible polymeric nanoscale MRI diagnostic contrast agent for cancer.
Claim(s) 25 are rejected under 35 U.S.C. 103 as being unpatentable over Maitland et al. (US 2019/0192743) in view of Ling Sun et al. (Appl. Mater. Interfaces, 8, 10499-10512, 2016) and Domb et al. (US 2016/0151124) as applied to claims 1-7, 9, 15, 16, 22- 23, 27 and 28 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 with 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.
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 JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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