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
Priority
This application claims priority under 35 U.S.C. § 119(e) of provisional applications U.S. Serial No. 62/582,050 filed November 6, 2017, U.S. Serial No. 62/596,508 filed December 8, 2017, and U.S. Serial No. 62/599,401 filed December 15, 2017, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 08/06/2024 is acknowledged. Claims 20-40 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Claim Objections
Claims 21-27 and 37 are objected to for the following informalities:
Claims 21-27 and 37 are objected to as being dependent
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 Langi, 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.
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The actual 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 20 and 28-35 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11311616 (‘616) in view of Harris et al. “Harris” (US PGPUB 20130064839, IDS of record dated 08/05/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The patented claims are directed to:
1. An immunogenic composition comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle that encodes a feline leukemia virus (FeLV) glycoprotein (gp85) that comprises an amino acid sequence comprising at least 95% identity with the amino acid sequence of SEQ ID NO: 2 (instant claims 20 and 35).
2. An immunogenic composition comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle that encodes an antigenic fragment of a feline leukemia virus (FeLV) glycoprotein (gp85) that comprises an amino acid sequence comprising at least 95% identity with the amino acid sequence of SEQ ID NO: 4 (instant claim 35).
3. A vaccine to aid in the prevention of disease due to FeLV comprising the immunogenic composition of claim 1, and a pharmaceutically acceptable carrier (instant claim 20).
4. The vaccine of claim 3, wherein an antibody is induced in a feline when said feline is immunized with the vaccine (instant claims 20 and 29).
5. The vaccine composition of claim 3 that further comprises at least one non-FeLV antigen for eliciting protective immunity to a non-FeLV feline pathogen (instant claims 29 and 30).
6. The vaccine of claim 5, wherein the non-FeLV feline pathogen is selected from the group consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline pneumovirus (FPN), feline parvovirus (FPV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus, borna disease virus (BDV), feline influenza virus, feline panleukopenia virus (FPLV), feline coronavirus (FCoV), feline rhinotracheitis virus (FVR), Chlamydophila felis, and any combination thereof (instant claim 30).
7. The vaccine of claim 6, wherein the non-FeLV antigen is a killed or attenuated non-FeLV antigen selected from the group of killed or attenuated non-FeLV antigens consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline pneumovirus (FPN), feline parvovirus (FPV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus, borna disease virus (BDV), feline influenza virus, feline panleukopenia virus (FPLV), feline coronavirus (FCoV), feline rhinotracheitis virus (FVR), Chlamydophila felis, and any combination thereof (instant claim 31).
8. The vaccine of claim 7, wherein the attenuated non-FeLV antigen is a modified live feline pathogen selected from the group consisting of a modified live Chlamydophila felis, a modified live feline rhinotracheitis Virus (FVR), a modified live feline calicivirus (FCV), a modified live feline panleukopenia virus (FPL), a modified live feline herpesvirus (FHV), a modified live feline pneumovirus (FPN), a modified live feline parvovirus (FPV), a modified live feline infectious peritonitis virus (FIPV), a modified live feline immunodeficiency virus, a modified live borna disease virus (BDV), a modified live feline coronavirus (FCoV), and a modified live feline influenza virus (instant claim 32).
9. The vaccine composition of claim 3, that further comprises an alphavirus RNA replicon particle comprising a nucleotide sequence encoding at least one protein antigen or an antigenic fragment thereof that originates from a non-FeLV antigen (instant claim 33).
10. The vaccine of claim 9, wherein the protein antigen or an antigenic fragment thereof that originates from a non-FeLV feline pathogen selected from the group consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline pneumovirus (FPN), feline parvovirus (FPV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus, borna disease virus (BDV), feline influenza virus, feline panleukopenia virus (FPLV), feline coronavirus (FCoV), feline rhinotracheitis virus (FVR), Chlamydophila fells, and any combination thereof (instant claim 34).
11. The vaccine composition of claim 3, that is a nonadjuvanted vaccine (instant claim 28).
12. A method of immunizing a feline against a pathogenic FeLV comprising administering to the feline an immunologically effective amount of the vaccine of claim 11 (instant claims 20 and 28).
13. The vaccine of claim 3, further comprising a modified live feline calicivirus (FCV), a modified live feline panleukopenia virus (FPLV), a modified live feline rhinotracheitis virus (FVR), and an attenuated live strain of Chlamydophila felis (instant claims 31-32).
14. The vaccine composition of claim 13, that is a nonadjuvanted vaccine (instant claim 28).
15. A method of immunizing a feline against a pathogenic FeLV comprising administering to the feline an immunologically effective amount of the vaccine of claim 13 (instant claims 20 and 32).
16. A vaccine to aid in the prevention of disease due to FeLV comprising the immunogenic composition of claim 2, and a pharmaceutically acceptable carrier (instant claim 20).
17. A method of immunizing a feline against a pathogenic FeLV comprising administering to the feline an immunologically effective amount of the vaccine of claim 16 (instant claim 20).
18. The vaccine of claim 3, further comprising a modified live feline pathogen selected from the group consisting of a modified live feline viral rhinotracheitis virus (FVR), a modified live feline panleukopenia virus (FPLV), a modified live feline calicivirus (FCV), and a modified live Chlamydophila felis, and any combination thereof, and a pharmaceutically acceptable carrier (instant claim 32).
19. A method of immunizing a feline against a pathogenic FeLV comprising administering to the feline an immunologically effective amount of the vaccine of claim 18 (instant claim 32).
20. A method of immunizing a feline against a pathogenic FeLV comprising administering to the feline an immunologically effective amount of the vaccine of claim 3 (instant claims 20 and 29-30).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 11311616 discloses administering a vaccine to a feline subject comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle (RP) that encodes a first feline leukemia virus (FeLV) glycoprotein 85 (gp85) or an antigenic fragment thereof, and a first pharmaceutically acceptable carrier.
‘616 does not explicitly teach administering a primer vaccine and a booster vaccine comprising the composition of ‘616.
Harris, however, discloses nucleic acid vaccines that can be safe and produced quickly; whereby such vaccine are produced using alphavirus replicon vectors that express heterologous proteins (para [0061]; and alphavirus replicon particles that include Venezuelan equine encephalitis virus (VEE (para [0063] that is useful in vertebrate animals including feline (para [0105] and claim 14 of Harris), particularly, feline leukemia virus (FeLV) (para [0105]). Harris also teaches embodiments whereby the method is administering a prime/boost to the subject (para [0178] and Table 4).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method of administering a primer vaccine and a booster vaccine to a feline subject comprising an alphavirus RNA replicon particle that encodes a feline leukemia virus (FeLV) antigen as disclosed by Harris to the VEE alphavirus RNA replicon of ‘616. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the knowledge of Harris that nucleic acid vaccines provide safe and quick production of vaccines using alphavirus replicon vectors that express very high levels of heterologous proteins; and given the knowledge that Delbert explicitly states "the method of the present invention is useful in vertebrate animals including feline" (see paragraph [0105]) including feline leukemia virus (FeLV) (see paragraph [0105]).
Thus, the composition of the methods with the immunogenic composition would be prima facia obvious over 18/794,860 since the ‘616 patent in view of Harris, since Harris teaches the prime/boost method of a VEE alphavirus RNA replicon given the knowledge of the VEE RNA replicon encoding a FELV gp85 of ‘616. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 20 and 28-36 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12076392 (’392) in view of Harris et al. “Harris” (US PGPUB 20130064839, IDS of record dated 08/05/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The patented claims are directed to:
1. A vaccine to aid in the prevention of disease due to FeLV comprising an immunogenic composition comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle that encodes a feline leukemia virus (FeLV) antigen, wherein the FeLV antigen is a FeLV glycoprotein (gp85) or an antigenic fragment thereof, and a pharmaceutically acceptable carrier (instant claim 20).
2. The vaccine of claim 1, wherein an antibody is induced in a feline when said feline is immunized with the vaccine (instant claims 20 and 29).
3. The vaccine composition of claim 1 that further comprises at least one non-FeLV antigen for eliciting protective immunity to a non-FeLV feline pathogen (instant claims 29 and 30).
4. The vaccine of claim 3, wherein the non-FeLV feline pathogen is selected from the group consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline pneumovirus (FPN), feline parvovirus (FPV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus, borna disease virus (BDV), feline influenza virus, feline panleukopenia virus (FPLV), feline coronavirus (FCOV), feline rhinotracheitis virus (FVR), Chlamydophila felis, and any combination thereof (instant claim 30).
5. The vaccine of claim 4, wherein the non-FeLV antigen is a killed or attenuated non-FeLV antigen selected from the group of killed or attenuated non-FeLV antigens consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline pneumovirus (FPN), feline parvovirus (FPV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus, borna disease virus (BDV), feline influenza virus, feline panleukopenia virus (FPLV), feline coronavirus (FCOV), feline rhinotracheitis virus (FVR), Chlamydophila felis, and any combination thereof (instant claim 31).
6. The vaccine of claim 5, wherein the attenuated non-FeLV antigen is a modified live feline pathogen selected from the group consisting of a modified live Chlamydophila felis, a modified live feline rhinotracheitis Virus (FVR), a modified live feline calicivirus (FCV), a modified live feline panleukopenia virus (FPL), a modified live feline herpesvirus (FHV), a modified live feline pneumovirus (FPN), a modified live feline parvovirus (FPV), a modified live feline infectious peritonitis virus (FIPV), a modified live feline immunodeficiency virus, a modified live borna disease virus (BDV), a modified live feline coronavirus (FCOV), and a modified live feline influenza virus (instant claim 32).
7. The vaccine composition of claim 1, that further comprises an alphavirus RNA replicon particle comprising a nucleotide sequence encoding at least one protein antigen or an antigenic fragment thereof that originates from a non-FeLV antigen (instant claim 33).
8. The vaccine of claim 7, wherein the protein antigen or an antigenic fragment thereof that originates from a non-FeLV feline pathogen selected from the group consisting of feline herpesvirus (FHV), feline calicivirus (FCV), feline pneumovirus (FPN), feline parvovirus (FPV), feline infectious peritonitis virus (FIPV), feline immunodeficiency virus, borna disease virus (BDV), feline influenza virus, feline panleukopenia virus (FPLV), feline coronavirus (FCOV), feline rhinotracheitis virus (FVR), Chlamydophila felis, and any combination thereof (instant claim 34).
9. The vaccine composition of claim 1, that is a nonadjuvanted vaccine (instant claim 28).
10. A method of immunizing a feline against a pathogenic FeLV comprising administering to the feline an immunologically effective amount of the vaccine of claim 9 (instant claim 32).
11. The vaccine of claim 1, further comprising a modified live feline calicivirus (FCV), a modified live feline panleukopenia virus (FPLV), a modified live feline rhinotracheitis virus (FVR), and an attenuated live strain of Chlamydophila felis (instant claim 32).
12. The vaccine of claim 1, wherein the FeLV antigen is a FeLV glycoprotein (gp85) that comprises an amino acid sequence comprising at least 95% identity with the amino acid sequence of SEQ ID NO: 2 (instant claims 20 and 35).
13. The vaccine of claim 1, wherein the FeLV antigen is an antigenic fragment of the FeLV glycoprotein (gp85), and the antigenic fragment is FeLV (gp70) (instant claim 36).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 12076392 discloses administering a vaccine to a feline subject comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle (RP) that encodes a first feline leukemia virus (FeLV) glycoprotein 85 (gp85) or an antigenic fragment thereof, and a first pharmaceutically acceptable carrier.
‘392 does not explicitly teach administering a primer vaccine and a booster vaccine comprising the composition of ‘392.
Harris, however, discloses nucleic acid vaccines that can be safe and produced quickly; whereby such vaccine are produced using alphavirus replicon vectors that express heterologous proteins (para [0061]; and alphavirus replicon particles that include Venezuelan equine encephalitis virus (VEE (para [0063] that is useful in vertebrate animals including feline (para [0105] and claim 14 of Harris), particularly, feline leukemia virus (FeLV) (para [0105]). Harris also teaches embodiments whereby the method is administering a prime/boost to the subject (para [0178] and Table 4).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method of administering a primer vaccine and a booster vaccine to a feline subject comprising an alphavirus RNA replicon particle that encodes a feline leukemia virus (FeLV) antigen as disclosed by Harris to the VEE alphavirus RNA replicon of ‘392. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the knowledge of Harris that nucleic acid vaccines provide safe and quick production of vaccines using alphavirus replicon vectors that express very high levels of heterologous proteins; and given the knowledge that Delbert explicitly states "the method of the present invention is useful in vertebrate animals including feline" (see paragraph [0105]) including feline leukemia virus (FeLV) (see paragraph [0105]).
Thus, the composition of the methods with the immunogenic composition would be prima facia obvious over 18/794,860 since the ‘392 patent in view of Harris, since Harris teaches the prime/boost method of a VEE alphavirus RNA replicon given the knowledge of the VEE RNA replicon encoding a FELV gp85 of ‘392. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
Claims 38-40 are deemed free of the prior art. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
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.
/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
Prosecution Insights