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 .
The Final Office action filed 06/26/2025 is hereby vacated. This Non-Final Office action replaces the vacated Final Office action dated 06/26/2025.
DETAILED ACTION
Priority
This PCT application claims the benefit under 35 USC § 119(e) to provisional U.S. application No. 62/370,611, filed on August 03, 2016 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 06/05/2025 is acknowledged. Claims 1-8, 10-11, 15-17, 19-21, 28-30, 36, 38 and 40-47 are pending and under examination. The restriction dated 08/21/2024 is withdrawn.
Election/Restrictions
The election/restriction requirement dated 08/21/2024 is hereby withdrawn. Claims 1-8, 10-11, 15-17, 19-21, 28-30, 36, 38 and 40-47 are pending and under examination. Based upon Applicant’s amendment to the claims dated 06/05/2025, the non-statutory double patenting rejection dated 01/15/2025 is maintained and includes previously withdrawn claims 36, 38 and 40-46. 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 claims at issue 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 claims at issue 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); 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. 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, 10-11, 15-17, 19-21, 28-30, 36, 38 and 40-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11701421. 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 claims of the present invention are directed to a lyophilized dengue virus composition comprising: live attenuated dengue virus; at least one of trehalose and sucrose; urea; a protein agent comprising human serum albumin (HAS); arginine; and at least one salt comprising sodium chloride (NaCl), sodium phosphate (Na2HPO4), potassium chloride (KCl) or potassium phosphate (KH2PO4); wherein the composition stabilizes the live attenuated dengue virus.
The patented claims are directed to
1. A flavivirus composition comprising: one or more live flaviviruses; at least one of trehalose and sucrose; urea; and a protein agent comprising serum albumin; wherein the composition stabilizes the one or more live flaviviruses; wherein the one or more live flaviviruses comprises dengue virus; and wherein the dengue virus comprises four dengue serotypes in the form of a dengue 1/2 chimera, a modified live attenuated dengue-2 virus, a dengue 3/2 chimera, and a dengue 4/2 chimera, wherein the dengue-2 virus as the backbone of the dengue 1/2 chimera, the dengue 3/2 chimera and the dengue 4/2 chimera is a PDK-53 dengue-2 strain (instant claims 1, 11).
2. The flavivirus composition according to claim 1, wherein the composition further comprises a base buffer, the base buffer comprises at least one of the following:
phosphate buffered saline (PBS), HEPES buffer, histidine buffer and Tris buffer (instant claim 2).
3. The flavivirus composition according to claim 1, comprising at least one salt selected from the group comprising sodium chloride (NaCl), sodium phosphate (Na2HPO4), potassium chloride (KCl) and potassium phosphate (KH2PO4) (instant claims 3, 32).
4. The flavivirus composition according to claim 3 wherein the at least one salt comprises NaCl at a concentration of 10 mM to 200 mM (instant claim 4).
5. The flavivirus composition according to claim 1 further comprising, mannitol (instant claims 5, 21, 31).
6. The flavivirus composition according to claim 1 further comprising, one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof (instant claims 6, 9, 33).
7. The flavivirus composition according to claim 6, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof comprises methionine, arginine, alanine or a combination thereof (instant claims 7, 23, 34).
8. The flavivirus composition according to claim 6, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof comprises monosodium glutamate (MSG) (instant claims 8, 29, 30, 35).
9. The flavivirus composition according to claim 1, wherein the one or more live flaviviruses comprises live, attenuated flaviviruses (instant claim 12).
10. The flavivirus composition according to claim 1, wherein the serum albumin comprises recombinant serum albumin, native albumin, human serum albumin (HSA), bovine serum albumin (BSA) or an albumin-like agent (instant claims 10, 14, 23, 25).
11. The flavivirus composition according to claim 1, wherein the composition does not contain magnesium chloride (MgCl2) (instant claim 15).
12. The flavivirus composition according to claim 1, wherein the protein agent has a concentration from 0.05% to 1.0% (w/v) (instant claim 17).
13. The flavivirus composition according to claim 1, wherein the trehalose, sucrose, or combination of trehalose and sucrose is present in the composition at a total concentration ranging from 5.0% to 15.0% (w/v) (instant claim 18).
14. The flavivirus composition according to claim 1, wherein the trehalose, sucrose, or combination of trehalose and sucrose is present in the composition at a total concentration of less than 10.0% (w/v) (instant claim 18).
15. The flavivirus composition according to claim 6, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives is present in the composition at a concentration ranging from 1.0 mM to 25.0 mM (instant claim 19).
16. The flavivirus composition according to claim 1, wherein the urea concentration in the composition is from 0.01% to 1.0% (w/v) (instant claim 20).
17. The flavivirus composition according to claim 1, wherein the composition comprises HSA (instant claim 14).
18. The flavivirus composition according to claim 17, wherein the HSA concentration is from 0.05% to 0.5% (w/v) (instant claim 24).
19. The flavivirus composition according to claim 1, wherein the protein agent comprises HSA and the composition further comprises arginine (instant claim 27).
20. The flavivirus composition according to claim 19, wherein the HSA concentration is from 0.05% to 0.5% (w/v); wherein the sucrose, trehalose or combination of sucrose and trehalose concentration is from 5.0% to 15.0% (w/v); wherein the arginine concentration is from 1.0 mM to about 20.0 mM; and wherein the urea concentration is from 0.1% to 0.3% (w/v) (instant claims 22, 26, 28).
21. A method for stabilizing live flaviviruses, the method comprising:
combining one or more live flaviviruses with a composition comprising:
at least one of trehalose and sucrose;
urea; and
a protein agent comprising serum albumin;
wherein the composition stabilizes the one or more live flaviviruses;
wherein the one or more live flaviviruses comprises dengue virus; and
wherein the dengue virus comprises four dengue serotypes in the form of a dengue 1/2 chimera, a modified live attenuated dengue-2 virus, a dengue 3/2 chimera, and a dengue 4/2 chimera, wherein the dengue-2 virus as the backbone of the dengue 1/2 chimera, the dengue 3/2 chimera and the dengue 4/2 chimera is a PDK-53 dengue-2 strain (instant claims 36, 38).
22. The method according to claim 21, wherein flavivirus composition is lyophilized (instant claim 40).
23. The method according to claim 22, wherein the lyophilized flavivirus composition is stored at 25° C. for extended periods (instant claim 40).
24. The method according to claim 22, further comprising partially or wholly rehydrating the composition prior to administration of the composition to a subject as part of an immunogenic composition (instant claim 41).
25. The method according to claim 21, further comprising a buffer (instant claim 42).
26. The method according to claim 21, wherein the protein agent is selected from the group consisting of a human serum albumin (HSA), a bovine serum albumin (BSA), a recombinant serum albumin, a bovine serum, and combinations thereof (instant claim 36).
27. The method according to claim 21 further comprising, one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof (instant claim 44).
28. The method according to claim 27, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof are selected from the group consisting of alanine, arginine, methionine, MSG or combinations thereof (instant claim 45).
29. The method according to claim 21, wherein the urea is present in the composition at a concentration ranging from 0.01% to 0.5% (w/v) (instant claim 46).
30. A kit for stabilizing live flaviviruses comprising: a composition according to claim 1; and at least one container (instant claim 47).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 11701421 discloses A flavivirus composition comprising: one or more live flaviviruses; at least one of trehalose and sucrose; urea; and a protein agent comprising serum albumin; wherein the composition stabilizes the one or more live flaviviruses; wherein the one or more live flaviviruses comprises dengue virus; and encompassing the limitations in the dependent claims of the present invention. 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 1-2, 4-8, 10-11, 15-17, 19-21, 28-30, 36, 38 and 40-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 10,835,597. 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 claims of the present invention are directed to a lyophilized dengue virus composition comprising: live attenuated dengue virus; at least one of trehalose and sucrose; urea; a protein agent comprising human serum albumin (HAS); arginine; and at least one salt comprising sodium chloride (NaCl), sodium phosphate (Na2HPO4), potassium chloride (KCl) or potassium phosphate (KH2PO4); wherein the composition stabilizes the live attenuated dengue virus.
The patented claims are directed to:
1. A flavivirus composition comprising: one or more live flaviviruses; at least one of trehalose in a concentration ranging from 5.0% to 15.0% (w/v) and sucrose in a concentration ranging from 5.0% to 15.0% (w/v); urea; mannitol; and human serum albumin (instant claim 1).
2. The flavivirus composition according to claim 1, wherein the composition further comprises a base buffer, the base buffer comprises phosphate buffered saline (PBS), HEPES buffer, histidine buffer or Tris buffer (instant claim 1).
3. The flavivirus composition according to claim 1, comprising at least one salt comprising sodium chloride (NaCl), sodium phosphate (Na2HPO4), potassium chloride (KCl) or potassium phosphate (KH2PO4) (instant claim 1).
4. The flavivirus composition according to claim 3, wherein the at least one salt comprises NaCl at a concentration of 10 mM to 200 mM (instant claim 4).
5. The flavivirus composition according to claim 1 further comprising, one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof (instant claim 6).
6. The flavivirus composition according to claim 5, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof comprises methionine, arginine, alanine or a combination thereof (instant claim 1).
7. The flavivirus composition according to claim 5, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof comprises monosodium glutamate (MSG) (instant claim 8).
8. The flavivirus composition according to claim 5, wherein the one or more amino acids or salts, esters or amide derivatives thereof comprise alanine and methionine (instant claim 7).
9. The flavivirus composition according to claim 1, further comprising a protein agent comprising dextran, polyol polymer or gelatin (instant claim 10).
10. The flavivirus composition according to claim 1, wherein the one or more live flaviviruses is selected from the group consisting of dengue virus, West Nile virus, tick-borne encephalitis virus, yellow fever virus, Japanese encephalitis virus, Kunjin virus, St. Louis encephalitis virus, Murray Valley encephalitis virus, Zika virus, or any related flavivirus thereof (instant claim 1).
11. The flavivirus composition according to claim 1, wherein the one or more live flaviviruses comprises live, attenuated flaviviruses (instant claim 1).
12. The flavivirus composition according to claim 1, wherein the one or more live flaviviruses comprises dengue virus (instant claim 1).
13. The flavivirus composition according to claim 1, wherein the composition does not contain magnesium chloride (MgCl2) (instant claim 15).
14. The flavivirus composition according to claim 9, wherein the one or more protein agents have a concentration from 0.05% to 1.0% (w/v) (instant claim 16).
15. The flavivirus composition according to claim 1, wherein the trehalose, sucrose, or combination of trehalose and sucrose is present in the composition at a total concentration ranging from 5.0% to 15.0% (w/v) (instant claim 17).
16. The flavivirus composition according to claim 1, wherein the trehalose, sucrose, or combination of trehalose and sucrose is present in the composition at a total concentration of less than 10.0% (w/v) (instant claim 20).
17. The flavivirus composition according to claim 5, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives is present in the composition at a concentration ranging from 1.0 mM to 25.0 mM (instant claim 19).
18. The flavivirus composition according to claim 1, wherein the urea concentration in the composition is from 0.01% to 1.0% (w/v) (instant claim 20).
19. The flavivirus composition according to claim 1, wherein the composition further comprises alanine, methionine and MSG (instant claims 1, 7 and 8).
20. The flavivirus composition according to claim 19, wherein the HSA concentration is from 0.05% to 0.5% (w/v); wherein the sucrose, trehalose or combination of sucrose and trehalose concentration is from 5.0% to 15.0% (w/v); wherein the mannitol concentration is from 1.0% to 15.0% (w/v); wherein the alanine concentration is from 5.0 mM to 25.0 mM; wherein the methionine concentration is from 1.0 mM to 5.0 mM; wherein the MSG concentration is from 1.0 mM to 20 mM; and wherein the urea concentration is from 0.01% to 0.5% (w/v) (instant claim 30).
21. The flavivirus composition according to claim 1, wherein the composition comprises sucrose and alanine (instant claim 7).
22. The flavivirus composition according to claim 21, wherein the HSA concentration is from 0.05% to 0.5% (w/v); wherein the sucrose concentration is from 0.5% to 15.0% (w/v); wherein the alanine concentration is from 5.0 mM to 25.0 mM; and wherein the urea concentration is from 0.01% to 0.5% (w/v) (instant claim 29).
23. The flavivirus composition according to claim 1, wherein the composition comprises sucrose and methionine (instant claim 7).
24. The flavivirus composition according to claim 23, wherein the HSA concentration is from 0.05% to 0.5% (w/v); wherein the methionine concentration is from 1.0 mM to 5.0 mM; and wherein the urea concentration is from 0.01% to 0.5% (w/v) (instant claim 28).
25. The flavivirus composition according to claim 1, wherein the composition comprises arginine (instant claim 1).
26. The flavivirus composition according to claim 25, wherein the HSA concentration is from 0.05% to 0.5% (w/v); wherein the sucrose, trehalose or combination of sucrose and trehalose concentration is from 5.0% to 15.0% (w/v); wherein the arginine concentration is from 1.0 mM to about 20.0 mM; and wherein the urea concentration is from 0.1% to 0.3% (w/v) (instant claim 28).
27. The flavivirus composition according to claim 1, wherein the composition further comprises MSG (instant claim 8).
28. The flavivirus composition according to claim 27, wherein the HSA concentration is from 0.05% to 0.5% (w/v); wherein the trehalose concentration is from 0.5% to 15.0% (w/v); wherein the MSG concentration is from 1.0 mM to 20 mM; and wherein the urea concentration is from 0.01% to 0.5% (w/v) (instant claims 21 and 28).
29. A flavivirus composition comprising, one or more live flaviviruses;
at least one of trehalose in a concentration ranging from 5.0% to 15.0% (w/v) and sucrose in a concentration ranging from 5.0% to 15.0% (w/v); at least one of mannitol or MSG; and human serum albumin (instant claim 17).
30. The flavivirus composition according to claim 29, wherein the flavivirus composition further comprises a base buffer, the base buffer comprises phosphate buffered saline (PBS), HEPES buffer, histidine buffer or Tris buffer (instant claim 2).
31. The flavivirus composition according to claim 29 further comprising, one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof (instant claim 1).
32. The flavivirus composition according to claim 31, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof comprises methionine, arginine, alanine or a combination thereof (instant claim 1).
33. The flavivirus composition according to claim 31, wherein the flavivirus composition comprises sucrose, methionine, alanine and MSG (instant claims1 and 8).
34. A method for stabilizing live flaviviruses, the method comprising:
combining one or more live flaviviruses with a composition comprising:
at least one of trehalose and sucrose; and urea;
wherein the composition stabilizes the one or more live flaviviruses (instant claim 36).
35. The method according to claim 34, wherein the one or more live flaviviruses are selected from the group consisting of dengue virus, West Nile virus, tick-borne encephalitis virus, yellow fever virus, Japanese encephalitis virus, Kunjin virus, St. Louis encephalitis virus, Murray Valley encephalitis virus, Zika virus, or any related virus thereof (instant claim 36).
36. The method according to claim 35, wherein the one or more live flaviviruses comprises dengue virus (instant claim 36).
37. The method according to claim 34, wherein flavivirus composition is lyophilized (instant claim 1).
38. The method according to claim 34, wherein the lyophilized flavivirus composition is stored at 25° C. for extended periods (instant claim 40).
39. The method according to claim 37, further comprising partially or wholly rehydrating the composition prior to administration of the composition to a subject as part of an immunogenic composition (instant claim 41).
40. The method according to claim 34, further comprising a buffer (instant claim 42).
41. The method according to claim 34, further comprising one or more protein agents selected from the group consisting of a serum albumin, a human serum albumin (HSA), a bovine serum albumin (BSA), a recombinant serum albumin, a bovine serum, gelatin, dextran, a polyol polymer, or combinations thereof (instant claim 43).
42. The method according to claim 34 further comprising, one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof (instant claim 44).
43. The method according to claim 42, wherein the one or more amino acids or derivatives thereof or salts, esters or amide derivatives thereof are selected from the group consisting of alanine, arginine, methionine, MSG or combinations thereof (instant claim 45).
44. The method according to claim 34, wherein the urea is present in the composition at a concentration ranging from 0.01% to 0.5% (w/v) (instant claim 46).
45. A kit for stabilizing live flaviviruses comprising: a composition according to claim 1; and at least one container (instant claims 1 and 47).
There is no patentable difference between the claimed composition and the patented composition and method in that the U.S. Patent No. 10,835,597 discloses a flavivirus composition comprising: one or more live flaviviruses; at least one of trehalose and sucrose; urea; and a protein agent comprising serum albumin; wherein the composition stabilizes the one or more live flaviviruses; wherein the one or more live flaviviruses comprises dengue virus; and encompassing the limitations in the dependent claims of the present invention. 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
No claims are allowed.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672