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 .
Election/Restrictions
Claims 65-88 are pending and are examined.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 08/01/2024, 01/16/2025, 04/24/2025, 11/13/2025, 02/18/2026, 04/30/2026 were considered by the examiner.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 65-86 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method of reducing a risk of telangiectasia when treating a patient with an ActRIIA fusion protein, the method comprising administering the ActRII fusion protein on a dosing regimen comprising:
(i) administering one or more doses of the ActRII fusion protein to a patient in an amount of 0.3 mg/kg once every 3 weeks for a period of 24 weeks; and
(ii) if the patient shows one or more symptoms or risk factors for developing telangiectasia administering one or more doses of the ActRII fusion protein to the patient in an amount that is reduced by at least half of the amount of the dose of (i);
wherein the ActRIIA fusion protein comprises (a) an ActRIIA polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence corresponding to residues 30-110 of SEQ ID NO: 1;
(b) an Fc domain of an immunoglobulin;
(c) a linker domain positioned between the ActRIIA polypeptide domain and the Fc domain of the immunoglobulin.
Further structural limitation are that the ActRIIa fusion protein is 95% identical to the amino acids sequence of SEQ ID NO:23.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). (emphasis added). See also MPEP 2163.04.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
In the instant case, the Specification does not disclose any working example of methods of treating telangiectasia. The Specification, in the examples section, describe the fusion proteins of SEQ ID NOs: 23 and 40. As to their use for treatment of any disease/condition: “A variety of ActRIIA variants that may be used according to the methods described herein are described in the International Patent Application published as WO2006/012627 (see, e.g., pp. 55-58), incorporated herein by reference in its entirety” ([0167]). It is noteworthy that the pages mentioned (55-58) do not contain any description of a method of treatment per se but the methods of obtaining the ACTRIIA fusion proteins (instant SEQ ID NOs: 23 and 40). The U.S. Pat. No.10,550,170 (having the same Assignee as the instant Application) contains SEQ ID NO: 32, which comprises SEQ ID NOs: 23 or 40 of the instant Application, discloses a method of reducing a risk of telangiectasia when treating macular telangiectasia in a patient with an ActRIIA fusion protein including dosing regimens.
However, the instant Application broadly claims treatment of telangiectasia with
(a) an ActRIIA polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence corresponding to residues 30-110 of SEQ ID NO: 1; (b) an Fc domain of an immunoglobulin; (c) a linker domain positioned between the ActRIIA polypeptide domain and the Fc domain of the immunoglobulin.
Given the fact that the amino acid sequence 90% of the SEQ ID NO:1 would mean that 8 amino acid residues would be substituted, inserted or deleted and the substitution would entail at least 19 natural amino acids for each position, a person of ordinary skill in the art would be left with the enviable position of testing this vast number of compounds. The skilled artisan would be inescapable driven to the conclusion that just 2 constructs (SEQ ID NOs: 23 and 40) do not represent a representative number of constructs to attest for the genus of treatment methods claimed.
Allowable Subject Matter
Claims 87-88 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed. Claims 65-86 are rejected and claims 87-88 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/ Primary Examiner, Art Unit 1647
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