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 .
DETAILED ACTION
Restriction/Election
Applicant’s election of Group I (claims 226-234 and 498-506) in the reply filed on 09/14/2026 is acknowledged. In response to species election requirement, Applicant elected (i) an ActRIIB fusion protein of SEQ ID NO: 402; (ii). ALK7 domain of SEQ ID NO: 406.
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 226-234 and 498-507 are pending. Claims 226-234 and 498-506 are currently under consideration. Claim 507 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed on 04/14/2026 and 05/21/2024 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Drawings
4. The drawings filed on 08/21/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
5. Basis for nonstatutory double patenting:
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/ guidance/eTD-info-I.jsp.
6. Claims 226-234 and 498-506 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-29 of US Patent No. 10,227,392 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-29 of US Patent No. 10,227,392 B2 are drawn to a soluble recombinant heteromultimer comprising an ALK7 polypeptide and an ActRIIB polypeptide, wherein the ALK7 polypeptide comprises an amino acid sequence that is at least 90% identical to amino acids 28-92 of SEQ ID NO: 9, and wherein the ActRIIB polypeptide comprises an amino acid sequence that is at least 90% identical to amino acids 29-109 of SEQ ID NO: 1, wherein the amino acid position in the ActRIIB polypeptide corresponding to L79 of SEQ ID NO: 1 is not an aspartic acid (D); wherein the ALK7 and/or ActRIIB polypeptide is a fusion protein further comprising a heterologous domain, and wherein the heteromultimer binds to activin B.
On the other hand, claims 226-234 and 498-506 of the instant application are drawn to a recombinant heteromultimer comprising ALK7 fusion protein comprising an ALK7 domain and a heterologous domain, and an ActRIIB fusion protein comprising an ActRIIB domain and a heterologous domain.
Claims 1-29 of US Patent No. 10,227,392 B2 and claims 226-234 and 498-506 of the instant application vary in scope and are obvious over each other.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
7. The following is a quotation of the first paragraph of 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.
8. Claims 226-234 and 498-506 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent 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. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claims 226-234 and 498-506 are drawn to a recombinant heteromultimer comprising an ALK7 fusion protein comprising an ALK7 domain and a heterologous domain and an ActRIIB fusion protein comprising an ActRIIB domain and a heterologous domain. The claims do not require that the ALK7 fusion protein and the ActRIIB fusion protein possess any particular biological activity, nor any particular conserved structure, nor other disclosed distinguishing feature. The claims do not require that the recombinant heteromultimer possess any biological activity. The specification states that the term “ALK7 polypeptide” includes polypeptides comprising any naturally occurring polypeptides of an ALK7 family members as well as any variants thereof (including mutants, fragments, fusions, and peptidomimetic forms) that retain a useful activity (page 113, the 2nd paragraph). The specification also states that the term “ActRIIB polypeptide” includes polypeptides comprising any naturally occurring polypeptides of an ActRIIB family member as well as any variants thereof (including including mutants, fragments, fusions, and peptidomimetic forms) that retain a useful activity (page 59, the 3rd paragraph). Thus, the claims are drawn to an enormous genus of recombinant heteromultimers without any structural and functional features.
The specification discloses a human ActRIIB precursor protein set forth in SEQ ID NO: 1, the mature extracellular ActRIIB polypeptide set forth in SEQ ID NO: 2, variants comprising the amino acid sequences of SEQ ID NOS: 3-6, and Fc fusion proteins thereof (pages 60-61; Table on page 388). The specification also discloses human ALK7 isoforms 1-4 proteins sequences and their mature extracellular ALK7 polypeptide sequences (pages 113-119), and recombinant a heteromultimer comprising ActRIIB-Fc:ALK7-Fc (Table on page 389). However, such an instant disclosure does not adequately support the broad scope of the claimed recombinant heteromultimer comprising an ALK7 fusion protein comprising an ALK7 domain and a heterologous domain and an ActRIIB fusion protein comprising an ActRIIB domain and a heterologous domain.
Vas-Cath Inc. v Mahurkar, 19 USPQ2d 1111 (Fed. Cir.1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purpose of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Adequate written description requires more than a mere statement that it is part of the invention are reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir.1991).
An adequate written description of a chemical invention “requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir.2004); Regents of the Univ. of Cal. V. Eli Lilly & Co., Inc., 119 F.3d 1559, 1556 (Fed. Cir.1997); Fiers v. Revel, 984F.2d 1164, 1171 (Fed. Cir.1993). “A description of what a material does, rather than of what it is, usually does not suffice.” Rochester, 358F.3d at 923; Eli Lilly, 119 F.3d at 1568. In addition, possession of a genus “may be achieved by means of a recitation of a representative number of [compounds]…falling within the scope of the genus.” Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 f. 3d at 927.
Due to the breadth of the genus of the recombinant heteromultimers comprising comprising an ALK7 fusion protein comprising an ALK7 domain and a heterologous domain and an ActRIIB fusion protein comprising an ActRIIB domain and a heterologous domain and lack of the definitive structural and functional features of the genus, one skilled in the art would not recognize from the disclosure that Applicant was in possession of the genus of the recombinant heteromultimers.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
9. The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claim 226 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 226 recites “an ALK7 domain” and “an ActRIIB domain”. It is unclear what the metes and bounds of the limitation are, rendering the claim indefinite.
Claim Rejections under 35 USC § 103(a)
11. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
12. Claims 226-234 and 498-506 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tsuchida et al. (Cell Communication and Signaling 75, 2009).
Tsuchida et al. teach a heteromultimer comprising an ALK7 polypeptide and an ActRIIB polypeptide (Figure 1). The ALK7 polypeptide would comprise an amino acid sequence that is at least 90% to a polypeptide comprising amino acids 21-133 of SEQ ID NO: 38, whereas ActRIIB polypeptide would comprise an amino acid sequence that is at least 90% to a polypeptide comprising amino acids 20-134 of SEQ ID NO: 1.
Tsuchida et al. do not teach a recombinant heteromultimer comprising an ALK7-Fc fusion polypeptide and an ActRIIB-Fc polypeptide.
However, it would have been obvious for one skilled in the art to make a recombinant heteromultimer comprising an ALK7 polypeptide and an ActRIIB polypeptide with a reasonable expectation of success. It would also have been obvious for one skilled in the art to make a recombinant heteromultimer comprising an ALK7 polypeptide and an ActRIIB polypeptide, wherein ALK7 polypeptide and/or ActRIIB polypeptide is a fusion protein and comprises an IgG Fc with or without a linker, with a reasonable expectation of success. One would have been motivated to do so because such a recombinant heteromultimer comprising an ALK7 polypeptide and an ActRIIB polypeptide would be useful for studying the signal transduction of the ActRIIB and/or ALK7 polypeptide and making a fusion protein comprising an IgG Fc is well known in the art.
Conclusion
13. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 October 4, 2026
