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
Applicant’s election without traverse of Group I, as well as the species election of 1) the CD80-Fc fusion immunomodulatory protein of SEQ ID NO: 2732, 2) amino acid modifications E35D/M47L/A71G, and 3) the Fc region of SEQ ID NO: 1714 in the reply filed on 03/16/2026 is acknowledged.
Claims 1, 8, 12, 24, 29, 32, 38, 45, 49, 54, 55, 58, 61, 66, 69, 74, 75, and 147-151 are pending.
Claim 75 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2026.
Claims 148, 149, and 151 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 03/16/2026.
Claims 1, 8, 12, 24, 29, 32, 38, 45, 49, 54, 55, 58, 61, 66, 69, 74, 147, and 150 are under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 8, 12, 24, 29, 32, 38, 45, 49, 54, 55, 58, 61, 66, 69, 74, 147, and 150 have an effective filing date of 03/16/2017.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/25/2024 and 03/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Notes on the Prior Art
At the effective filing date of the invention, CD80-Fc fusion immunomodulatory proteins were known in the art. For example at p. 2704, second column, Ellis et al. (Journal of Immunology, 2700-2709, 1996) teach a CD80 variant expressed as an Ig fusion; however the prior art does not teach or suggest a CD80-Fc fusion immunomodulatory protein comprising a variant CD80 polypeptide and an Fc domain, wherein the variant CD80 polypeptide comprises the amino acid substitution A71G or A71D relative to: (i) the amino acid sequence set forth in SEQ ID NO:2 or (ii) a portion of (i) comprising the IgV domain, wherein the IgV domain is amino acids 35-141 of SEQ ID NO:1. The instantly claimed CD80-Fc fusion immunomodulatory protein is also not an obvious variant of any art-known CD80-Fc fusion immunomodulatory protein.
Claim Rejections
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 8, 12, 29, 32, 38, 45, 69, 74, 147, and 150 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1) claims 1-8 and 11 of U.S. Patent No. 11,230,588, 2) claims 1-7, 10, and 15 of U.S. Patent No. 11,117,948, 3) claims 1-8, 11, and 16 of U.S. Patent No. 11,117,949, and 4) claims 1-5, 8, and 10-13 of U.S. Patent No. 11,096,988.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims encompass a CD80-Fc fusion immunomodulatory protein comprising a variant CD80 polypeptide and an Fc domain, wherein the variant CD80 polypeptide comprises the amino acid substitution A71G or A71D relative to: (i) the amino acid sequence set forth in SEQ ID NO:2 or (ii) a portion of (i) comprising the IgV domain, wherein the IgV domain is amino acids 35-141 of SEQ ID NO:1, including a CD80-Fc fusion immunomodulatory protein that comprises the elected E35D/M47L/A71G substitutions.
The claims at issue are also not identical but not patentably distinct from each other, because the claims recite 1) CD80-Fc fusion immunomodulatory proteins having similar functional characteristics, 2) CD80-Fc fusion immunomodulatory protein homodimers, and 3) CD80-Fc fusion immunomodulatory proteins having similar linkers and Fc regions.
Claims 49, 54, 55, 58, 61, and 66 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1) claims 1-8 and 11 of U.S. Patent No. 11,230,588, 2) claims 1-7, 10, and 15 of U.S. Patent No. 11,117,948, 3) claims 1-8, 11, and 16 of U.S. Patent No. 11,117,949, and 4) claims 1-5, 8, and 10-13 of U.S. Patent No. 11,096,988, as applied to claims 1, 8, 12, 29, 32, 38, 45, 69, 74, 147, and 150, in view of Punnonen et al. (WO 2004029197, publication date: 04/08/2004).
The conflicting claims do not teach or suggest a conjugate molecule that comprises a CD80-Fc fusion immunomodulatory protein and a targeting moiety that binds to a molecule on the surface of a cell.
Punnonen et al. teach that novel costimulatory proteins may induce or inhibit a desired immune response, and in order to test the ability of a novel costimulatory protein to induce or inhibit a desired immune response, said novel costimulatory protein may be used in conjunction with T cell receptor/CD3 costimulation, for example, by administering an anti-CD3 antibody. See p. 47. The instant CD80-Fc fusion protein works by binding to CD80 receptors on T cells, i.e., CD28, and one of ordinary skill in the art would reason that T cell targeting could be improved by conjugating a CD80-Fc fusion protein of the invention to an anti-CD3 antibody. As such one of ordinary skill in the art would have had ample motivation to prepare a conjugate molecule that comprises a CD80-Fc fusion immunomodulatory protein and a targeting moiety (anti-CD3 antibody) that binds to a molecule on the surface of a cell (T cell). The invention of the conflicting claims and Punnonen et al. meets the structural limitations of claims 49 and 66.
With respect to claims 54, 55, 58, and 61, at p. 23 and 24, Punnonen et al. teach nucleic acids that encode polynucleotides of the invention, as well as associated vectors and cells transduced with said vectors. Based upon these teachings, one of ordinary skill in the art would have been motivated to prepare vectors that comprise nucleic acids that encode the CD80-Fc fusion immunomodulatory protein of the conflicting claims, because said vectors could be introduced in to host cells in order to produce CD80-Fc fusion immunomodulatory proteins for laboratory or clinical applications.
Therefore the claims are prima facie obvious over the conflicting claims in view of Punnonen et al.
Claims 1, 8, 12, 32, 45, 49, 54, 55, 58, 61, 66, 69, 74, and 147 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11/117,950, in view of Punnonen et al. (WO 2004029197, publication date: 04/08/2004).
The conflicting claims recite a variant CD80 polypeptide that comprises E35D/M47L/A71G mutations. The conflicting claims do not teach or suggest a protein-Fc conjugate molecule that comprises a CD80-Fc fusion immunomodulatory protein and a targeting moiety that binds to a molecule on the surface of a cell.
Punnonen et al. teach that medicinal proteins may be fused to Fc regions, because protein Ig fusion proteins are soluble, which expands their use as prophylactics or therapeutics, and stable, see p.164. Based upon these teachings, one of ordinary skill in the art would have been motivated to modify the variant CD80 polypeptide of the conflicting claim to produce a variant CD80 polypeptide-Fc fusion protein, as there would have been a reasonable expectation that the resultant CD80 polypeptide-Fc fusion protein is soluble, which expands their use as prophylactics or therapeutics, and stable. The invention of the conflicting claim and Punnonen et al. meets the limitations of claims 1, 8, 12, 69, and 74.
With respect to claim 32, at p. 234, Punnonen et al. teach protein-Ig fusion proteins that are homodimers.
With respect to claim 45, given that the invention of the conflicting claim and Punnonen et al. is structurally identical to the instantly claimed variant CD80 polypeptide-Fc fusion protein, one would expect the invention of the conflicting claim and Punnonen et al. to exhibit the same functional characteristics as the instantly claimed variant CD80 polypeptide-Fc fusion, such as the ability to exhibit PD-L1-dependent CD28 costimulation.
Punnonen et al. teach that novel costimulatory proteins may induce or inhibit a desired immune response, and in order to test the ability of a novel costimulatory protein to induce or inhibit a desired immune response, said novel costimulatory protein may be used in conjunction with T cell receptor/CD3 costimulation, for example, by administering an anti-CD3 antibody. See p. 47. The instant CD80-Fc fusion protein works by binding to CD80 receptors on T cells, i.e., CD28, and one of ordinary skill in the art would reason that T cell targeting could be improved by conjugating a CD80-Fc fusion protein of the invention to an anti-CD3 antibody. As such one of ordinary skill in the art would have had ample motivation to prepare a conjugate molecule that comprises a CD80-Fc fusion immunomodulatory protein and a targeting moiety (anti-CD3 antibody) that binds to a molecule on the surface of a cell (T cell). The invention of the conflicting claims and Punnonen et al. meets the structural limitations of claims 49 and 66.
With respect to claims 54, 55, 58, and 61, at p. 23 and 24, Punnonen et al. teach nucleic acids that encode polynucleotides of the invention, as well as associated vectors and cells transduced with said vectors. Based upon these teachings, one of ordinary skill in the art would have been motivated to prepare vectors that comprise nucleic acids that encode the CD80-Fc fusion immunomodulatory protein of the conflicting claims, because said vectors could be introduced in to host cells in order to produce CD80-Fc fusion immunomodulatory proteins for laboratory or clinical applications.
With respect to claim 147, at p. 164, Punnonen et al. teach that Ig protein fusion molecules may include a peptide linker.
Therefore the claims are prima facie obvious over the conflicting claims in view of Punnonen et al.
Claims 29 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11/117,950 and Punnonen et al. (WO 2004029197, publication date: 04/08/2004), as applied to claims 1, 8, 12, 32, 45, 49, 54, 55, 58, 61, 66, 69, 74, and 147, and further in view of Bonvini et al. (WO 2010/027797, 03/11/2010).
As indicated above based upon the teachings of Punnonen et al., one of ordinary skill in the art would have been motivated to modify the variant CD80 polypeptide of the conflicting claim to produce a variant CD80 polypeptide-Fc fusion protein, as there would have been a reasonable expectation that the resultant CD80 polypeptide-Fc fusion protein is soluble, which expands their use as prophylactics or therapeutics, and stable.
At [0025], Bonvini et al. teach that “[a]ntibodies that exhibit abrogated or reduced Fc effector function may find particular use in therapeutic applications wherein Fc region-mediated immune responses are not desired or are unnecessary…” In view of these teachings, one of ordinary skill in the art would have been motivated to modify the variant CD80 polypeptide-Fc fusion protein of the conflicting claim and Punnonen et al. to include an Fc region with reduced effector function, because the resultant variant CD80 polypeptide-Fc fusion protein would be useful in clinical applications where reduced effector function is desired.
Therefore the claims are prima facie obvious over the conflicting claims in view of Punnonen et al. and Bonvini et al.
Allowable Subject Matter
Claim 24 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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