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 .
Claims 1-28 filed on 3/24/2023 are pending and under examination.
Information Disclosure Statement
The information Disclosure Statement filed on 8/22/2023 (2) have been considered by the examiner. The crossed-out references do not have a publication year.
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 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11,643,446. Although the claims at issue are not identical, they are not patentably distinct from each other because a progranulin variant comprising an amino acid sequence having at least 90% identity to SEQ ID NO:2 and an amino acid sequence defined by XiX2X3 at the positions corresponding to amino acid residues 574 to 576 of SEQ ID NO:2, wherein XiX2X3 is selected from the group consisting of: PIL, PFL, PPL, PYL, QRL, and QHL, wherein XiX2X3 is PIL, wherein the progranulin variant comprises the sequence of any one of SEQ ID NOS:13, 15, and 17-20. The fusion protein of claim 1, wherein the progranulin variant comprises an amino acid sequence having at least 90% identity to SEQ ID NO:2 and an amino acid sequence defined by XiX2X3 at the positions corresponding to amino acid residues 574 to 576 of SEQ ID NO:2, wherein XiX2X3 is selected from the group consisting of: PIL, PFL, PPL, PYL, QRL, and QHL (claim 4), wherein XiX2X3 is PIL, wherein the progranulin variant comprises the sequence of any one of SEQ ID NOS:13, 15, and 17-20 (claim 7), wherein the Fc polypeptide is linked to the progranulin variant, wherein the Fc polypeptide is linked to the progranulin variant by a polypeptide linker comprising G4S (SEQ ID NO:90) or (G4S)2 (SEQ ID NO:91), wherein the C-terminus of the Fc polypeptide is linked to the N-terminus of the progranulin variant. The Fc fusion polypeptide of claim 4, wherein the Fc polypeptide specifically binds to a transferrin receptor (claim 10). A pharmaceutical composition comprising the progranulin variant of claim 1 and a pharmaceutically acceptable carrier (claim 11). A pharmaceutical composition comprising the Fc fusion polypeptide of claim 4 and a pharmaceutically acceptable carrier (claim 12). A method of treating a subject having a neurodegenerative disease, atherosclerosis, a disorder associated with TDP-43, age-related macular degeneration (AMD), or a progranulin- associated disorder, the method comprising administering the progranulin variant of claim 1 to the subject (claim 13), wherein the subject has a neurodegenerative disease selected from the group consisting of frontotemporal dementia (FTD), neuronal ceroid lipofuscinosis (NCL), Niemann-Pick disease type A (NPA), Niemann-Pick disease type B (NPB), Niemann-Pick disease type C (NPC), C90RF72-associated amyotrophic lateral sclerosis (ALS)/FTD, sporadic AL S, Alzheimer's disease (AD), Gaucher's disease, and Parkinson's disease. A method of treating a subject having a neurodegenerative disease, atherosclerosis, a disorder associated with TDP-43, age-related macular degeneration (AMD), or a progranulin- associated disorder, the method comprising administering the Fc fusion polypeptide of claim 4 to the subject (claim 15), wherein the subject has a neurodegenerative disease selected from the group consisting of frontotemporal dementia (FTD), neuronal ceroid lipofuscinosis (NCL), Niemann-Pick disease type A (NPA), Niemann-Pick disease type B (NPB), Niemann-Pick disease type C (NPC), C90RF72-associated amyotrophic lateral sclerosis (ALS)/FTD, sporadic ALS, Alzheimer's disease (AD), Gaucher's disease, and Parkinson's disease. A polynucleotide comprising a nucleic acid sequence encoding the progranulin variant of claim 1 (claim 17). A polynucleotide comprising a nucleic acid sequence encoding the Fc fusion polypeptide of claim 4 (claim 18). A vector comprising the polynucleotide of claim 17. A vector comprising the polynucleotide of claim 18. A host cell comprising the polynucleotide of claim 17. A host cell comprising the polynucleotide of claim 18. A host cell comprising the vector of claim 19. A host cell comprising the vector of claim 20. A method for producing a progranulin variant, comprising culturing the host cell of claim 21 under conditions in which the progranulin variant encoded by the polynucleotide is expressed (claim 25). A method for producing an Fc fusion polypeptide, comprising culturing the host cell of claim 22 under conditions in which the Fc fusion polypeptide encoded by the polynucleotide is expressed (claim 26). A method for producing a progranulin variant, comprising culturing the host cell of claim 23 under conditions in which the progranulin variant encoded by the vector is expressed (claim 27), and a method for producing an Fc fusion polypeptide, comprising culturing the host cell of claim 24 under conditions in which the Fc fusion polypeptide encoded by the vector is expressed (claim 28) are taught in claims 1-38 of U.S. Patent No. 11,643,446.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674