Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. Applicant’s preliminary amendment filed on April 10, 2024 is acknowledged. Claim 1 has been canceled. Claims 2-19 are currently pending and under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on February 28, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
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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3. Claims 2-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,918,636. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to:
2. A method of eliciting an immune response in a subject comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by at least 3 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I) in an amount of 200-2000 μg of CFA/I;
inactivated E. coli expressing Coli surface antigen 3 (CS3) in an amount of 500-10000 μg of CS3;
inactivated E. coli expressing Coli surface antigen 5 (CS5) in an amount of 100-2000 μg of CS5;
inactivated E. coli expressing Coli surface antigen 6 (CS6) in an amount of 20-600 μg of CS6;
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 1-200 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.
9. A method of immunizing a subject against enterotoxigenic E. coli (ETEC)-induced diarrhea, comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by at least 3 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I) in an amount of 200-2000 μg of CFA/I;
inactivated E. coli expressing Coli surface antigen 3 (CS3) in an amount of 500-10000 μg of CS3;
inactivated E. coli expressing Coli surface antigen 5 (CS5) in an amount of 100-2000 μg of CS5;
inactivated E. coli expressing Coli surface antigen 6 (CS6) in an amount of 20-600 μg of CS6;
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 1-200 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration, and wherein the vaccine is formulated in a solution to neutralize gastric acidity upon ingestion.
16. A method of immunizing a subject against enterotoxigenic E. coli (ETEC)-induced diarrhea, comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by 3-60 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I);
inactivated E. coli expressing Coli surface antigen 3 (CS3);
inactivated E. coli expressing Coli surface antigen 5 (CS5);
inactivated E. coli expressing Coli surface antigen 6 (CS6);
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 1-200 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.
Moreover, the patented claims are drawn to the following:
1. A method of eliciting an immune response in a subject comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by at least 3 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I);
inactivated E. coli expressing Coli surface antigen 3 (CS3);
inactivated E. coli expressing Coli surface antigen 5 (CS5);
inactivated E. coli expressing Coli surface antigen 6 (CS6);
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein) in an amount of 500-1500 μg per unit dose; and
a double mutant heat-labile toxin (dmLT) protein at 8-30 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.
7. A method of immunizing a subject against enterotoxigenic E. coli (ETEC)-induced diarrhea, comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by at least 3 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I);
inactivated E. coli expressing Coli surface antigen 3 (CS3);
inactivated E. coli expressing Coli surface antigen 5 (CS5);
inactivated E. coli expressing Coli surface antigen 6 (CS6);
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 8-30 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration, and wherein the vaccine is formulated in a solution to neutralize gastric acidity upon ingestion.
14. A method of immunizing a subject against enterotoxigenic E. coli (ETEC)-induced diarrhea, comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by 7-10 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I);
inactivated E. coli expressing Coli surface antigen 3 (CS3);
inactivated E. coli expressing Coli surface antigen 5 (CS5);
inactivated E. coli expressing Coli surface antigen 6 (CS6);
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 8-30 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.
The pending claims are anticipatory and/or obvious over the patented claims.
4. Claims 2-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 9, 12-15 of U.S. Patent No. 10,548,961. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to:
2. A method of eliciting an immune response in a subject comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by at least 3 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I) in an amount of 200-2000 μg of CFA/I;
inactivated E. coli expressing Coli surface antigen 3 (CS3) in an amount of 500-10000 μg of CS3;
inactivated E. coli expressing Coli surface antigen 5 (CS5) in an amount of 100-2000 μg of CS5;
inactivated E. coli expressing Coli surface antigen 6 (CS6) in an amount of 20-600 μg of CS6;
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 1-200 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.
Meanwhile, the combination of the following patented claims anticipated and/or make obvious the pending claims:
12. A method of eliciting an immune response in a subject comprising orally administering the composition according to claim 1 to the subject on at least two separate occasions separated in time by at least 3 days.
1. An immunogenic composition, comprising inactivated Escherichia coli (E. coli) cells expressing:
enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I) in an amount of 415-1245 μg per unit dose;
inactivated E. coli expressing Coli surface antigen 3 (CS3) in an amount of 1485-4455 μg per unit dose;
inactivated E. coli expressing Coli surface antigen 5 (CS5) in an amount of 255-765 μg per unit dose; and
inactivated E. coli expressing Coli surface antigen 6 (CS6) in an amount of 60-180 μg per unit dose;
a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein,
wherein the immunogenic composition comprises less than 1013 cells per unit dose and said immunogenic composition is formulated for oral administration.
8. The composition according to claim 1, comprising per unit dose
LCTBA-protein in an amount of 500-1500 μg.
9. The composition according to claim 8, comprising per unit dose:
a) inactivated E. coli expressing CFA/I in an amount of 747-913 μg of CFA/I;
b) inactivated E. coli expressing CS3 in an amount of 2673-3267 μg of CS3;
c) inactivated E. coli expressing CS5 in an amount of 459-561 μg of CS5;
d) inactivated E. coli expressing CS6 in an amount of 108-132 μg of CS6; and
e) LCTBA-protein in an amount of 900-1100 μg.
The composition of the patented claims is identical to that of the pending claims, absent evidence to the contrary, after oral administration the method would necessarily be effective against ETEC induced diarrhea.
Conclusion
5. No claim is allowed.
6. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carlin WO 00/37106.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 April 25, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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