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Claims 6-7, 25 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-5, 8-10, 14-19, 21 and 23 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Sequence Compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR § 1.821 through 1.825 for the following reasons. The instant claims contain sequences that are not properly identified (see claims 6-8). Note that (a) 37 CFR § 1.821(a) states that an unbranched sequence of four or more amino acids or an unbranched sequence of ten or more nucleotides requires a sequence identifier. In case these sequences are not in the current "Sequence Listing,” applicant must provide a substitute computer readable form (CRF) copy of a Sequence Listing which includes all of the sequences that are present in the instant application and encompassed by these rules, a substitute paper copy of that Sequence Listing, an amendment directing the entry of that paper copy into the specification, and a statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. §§ 1.821(e) or 1.821(f) or 1.821(g) or 1.825(b) or 1.825(d). The instant specification will also need to be amended so that it complies with 37 C.F.R. § 1.821(d) which requires a reference to a particular sequence identifier (SEQ ID NO:) be made in the specification wherever a reference is made to that sequence.
Applicant is advised to review the entire text of the instant specification for compliance with sequence rules. Applicant is required to address this in the response to this Office action or the claims will be considered as non-compliant.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, www. See pages 60-63 and 66. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code, www. See MPEP § 608.01.
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 1-5, 8-10, 14-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bearat et al., 2013 (instant PTO-892) in view of Cappello et al., US2016/0176949 (instant 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 2-3, 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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Poursaid Thesis 2016 (instant PTO-892) teaches SELPs in the use of cancer treatment and also discusses treatment of aneurysms.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675