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 .
Election/Restrictions
Applicant’s election of species of a method treating an aneurysm and SELP SEQ ID NO: 23 in the reply filed on 10/15/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-7, 25 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/15/2025.
Claims 1-2, 4-5, 8-10, 14-19, 21 and 23 are under consideration in the instant Office Action.
Withdrawn Objections
The sequence compliance issue is withdrawn in view newly amended claims.
The objection of the specification because it contains an embedded hyperlink and/or other form of browser-executable code is withdrawn in view of the amended specification submitted on 5/1/2026.
Modified Rejection Necessitated by Amendments
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.
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 1-2, 4-5, 8-10, 14-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bearat et al., 2013 (11/4/2025 PTO-892) in view of Cappello et al., US2016/0176949 (11/4/2025 PTO-892).
The instant claims are towards a method of treating a subject with an aneurysm by administering silk-elastinlike protein polymer (SELP) wherein the SELP is SELP 815K, SEQ ID NO:23.
Bearat teaches treating a cerebral aneurysm by administering hydrogels, a liquid-to-solid embolic agent, into the aneurysms via catheters to produce embolization (see abstract and page 2515, 2nd column) as in instant claims 1, 5 and 14. While Bearat does not explicitly recite the diagnosis of an aneurysm, it is obvious that one needs to be diagnosed with an aneurysm to be able to treat said aneurysm as required in instant claim 4. Bearat teaches that liquid embolic agents have the advantage of conforming to the exact shape of the aneurysm and the possibility of better sealing large and giant aneurysms in cerebral aneurysms (see page 2516, top of 1st column and bottom of 2nd column; page 2518, “preliminary in vivo swine study”) as in instant claims 2, 10, 14-15. While Bearat teaches using a liquid-to-solid embolic agent to treat cerebral aneurysms, Bearat does not specifically teach using the hydrogel SELP of claim 1 or SELP 815K, SEQ ID NO:23 of instant claim 8.
Cappello teaches a chemo-embolic agent that is an injectable, recombinantly synthesized silk-elastin like protein copolymer and one or more therapeutic agent. Cappello teaches that upon injection, the embolic agent blocks the tumor vasculature, including the capillary bed, and releases therapeutic agents (see abstract) as in instant claims 1, 5, 10, 14, 16, 18, 23. Cappello teaches treating cancer by blocking tumor vasculature with a protein hydrogel embolic agent that includes therapeutic agents (see [0002]) as in instant claims 18 and 23. Cappello teaches that a protein hydrogel embolic agent is SELP-815K as in their Figure 1, SEQ ID NO:4 (see [0003]) which is the same amino acid sequence as instant SEQ ID NO:23 and same amino acid sequence of instant claim 8. Cappello teaches at ([00024-0029], [0034]) that embolization with SELPs offer important advantages over the use of existing embolic agents: SELPs are proteins composed solely of natural amino acids and they will ultimately degrade to their constituent amino acids, which are non-toxic and biocompatible; the SELP formulations, including SELP 815K , transition from liquids upon injection at room temperature (approximately 18–23°C) to elastic hydrogels at body temperature (approximately 37°C), forming stable biomaterials wherein the transition is not associated with any thermal release, nor is there a change of volume and meets the requirements of instant claims 1, 8-9, 17-18 and 23. Cappello teaches using endovascular catheters to selectively access the arteries in the tumor tissue under radiographic imaging (see [0031]) as required in instant claim 14. Cappello teaches that injection through finer catheters to deliver a SELP liquid embolic leads to a more selective embolization, which reduces collateral damage to the healthy tissue (see [0034]) as required in instant claims 16. Cappello teaches using contrast agents incorporated into SELP-815K (see [0049]) as in instant claims 19 and 21 since contrast agents are also visualization agents. Cappello does not teach using their liquid embolic agents to treat aneurysms.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Bearat and Cappello. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because Cappello teaches that injection through finer catheters to deliver a SELP liquid embolic leads to a more selective embolization, which reduces collateral damage to the healthy tissue (see [0034]). Therefore, one of ordinary skill in the art would be motivated to use the SELP hydrogel in the place of the hydrogels taught to treat aneurysms by Bearat. SELP is an liquid embolic agent that would perform as well if not better than other hydrogels since it is natural and does not have adverse reactions that can happen with other hydrogels. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Response to Arguments
Applicant's arguments filed 5/1/2026 have been fully considered but they are not persuasive. Applicant argues that the it would not be obvious to one of ordinary skill in the art to combine the references of Bearat in view of Cappello since they are towards different treatment types, treating aneurysms and treating cancer, respectively. The assertion that one of ordinary skill in the art would have had no expectation of success to use a cancer embolic for treatment of an aneurysm as the mechanisms of action are different cannot be accepted since the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). There is no evidence of record that supports this assertion.
This is not found persuasive because both of these references are towards method of treating issues involving the veins and arteries of the circulator system and how to apply treatments to these sites to modify the circulation. The prior art clearly has contemplated it and used the same techniques and treatments for different diseases with similar base problems. For example, the Poursaid Thesis 2016 (11/4/2026 PTO-892) teaches SELPs in the use of cancer treatment and also discusses treatment of aneurysms. The Poursaid Thesis teaches that one can treat both arteriovenous malformations, which include cerebral aneurysms, and hyper vascular tumors with embolization therapy. Therefore, this reference clearly speaks to the fact that the references of record can be combined and would motivate one of ordinary skill in the art to use the methods in cancer treatment in a cerebral aneurysm with a reasonable expectation of success.
Therefore, the arguments are not found persuasive and the rejection is maintained.
Conclusion
No claims are 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.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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