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 .
Applicant’s preliminary amendment filed on September 15, 2025 is acknowledged. Claims 56-67 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 5, 2024 has been considered by the examiner.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
Claims 56-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,980,661. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO: 1, An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:2 and An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:3.
The claims of the US Patent 11,980,661 are drawn to A method for immunizing a subject, comprising: administering a composition comprising a recombinant influenza virus, wherein the recombinant influenza virus comprises SEQ ID NO:1, SEQ ID NO:2, and SEQ ID NO:3.
The present claims and the claims of the US Patent 11,980,661 are drawn to An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:2 and An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:3. Thus the present claims are obvious over the claims of the US Patent 11,980,661.
Claims 56-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,040,098. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO: 1, An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:2 and An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:3.
The claims of the US Patent 11,040,098 are drawn to A host cell comprising a heterologous nucleotide sequence that encodes an influenza A virus comprising a nucleotide sequence selected from the group consisting of: (i) the nucleotide sequence set forth in SEQ ID NO: 1; (ii) the nucleotide sequence set forth in SEQ ID NO: 2; (iii) the nucleotide sequence set forth in SEQ ID NO: 3; (iv) a nucleotide sequence that encodes a polypeptide having the amino acid sequence set forth in SEQ ID NO: 6; (v) a nucleotide sequence that encodes a polypeptide having the amino acid sequence set forth in SEQ ID NO: 7; and (vi) a nucleotide sequence that encodes a polypeptide having the amino acid sequence set forth in SEQ ID NO: 8.
The present claims and the claims of the US Patent 11,040,098 are drawn to An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:2 and An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:3. Thus the present claims are obvious over the claims of the US Patent 11,040,098.
Claims 56-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,284,533. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO: 1, An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:2 and An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:3.
The claims of the US Patent 9,284,533 are drawn to A recombinant influenza virus comprising SEQ ID NO:1, SEQ ID NO:2, or SEQ ID NO:3, wherein the virus comprises a mutant M gene.
The present claims and the claims of the US Patent 9,284,533 are drawn to An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:2 and An influenza virus having a mutant M gene, wherein said mutant M gene comprises SEQ ID NO:3. Thus the present claims are obvious over the claims of the US Patent 9,284,533.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
Prosecution Insights