Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. Claims 1-15 are currently pending and under examination.
Information Disclosure Statement
2. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
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 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/apply/applying-online/eterminal-disclaimer.
3. Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 7,955,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a method for making an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide covalently linked to a carrier protein, the method comprising:
(a) reacting purified serotype 19A polysaccharide with an oxidizing agent resulting in an activated serotype 19A polysaccharide;
(b) compounding the activated serotype 19A polysaccharide with a carrier protein;
(c) co-lyophilizing the compounded activated serotype 19A polysaccharide and carrier protein;
(d) re-suspending the compounded activated serotype 19A polysaccharide and carrier protein in dimethyl sulfoxide (DMSO);
(e) reacting the compounded, activated serotype 19A polysaccharide and carrier protein with a reducing agent resulting in a serotype 19A polysaccharide:carrier protein conjugate; and
(f) capping unreacted aldehydes in the serotype 19A polysaccharide:carrier protein conjugate resulting in an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide covalently linked to a carrier protein.
Meanwhile, the patented claims are drawn to a method for making an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide covalently linked to a carrier protein, the method comprising:
(a) reacting purified serotype 19A polysaccharide with an oxidizing agent resulting in an activated serotype 19A polysaccharide;
(b) compounding the activated serotype 19A polysaccharide with a carrier protein;
(c) co-lyophilizing the compounded activated serotype 19A polysaccharide and carrier protein;
(d) re-suspending the compounded activated serotype 19A polysaccharide and carrier protein in dimethyl sulfoxide (DMSO):
(e) reacting the compounded, activated serotype 19A polysaccharide and carrier protein with a reducing agent resulting in a serotype 19A polysaccharide:carrier protein conjugate; and
(f) capping unreacted aldehydes in the serotype 19A polysaccharide:carrier protein conjugate resulting in an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide covalently linked to a carrier protein; wherein step (c) is performed after step (b) and before steps (d) and (e).
The pending claims are identical in scope and thus are anticipatory of the patented claims.
4. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,981,045 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a method for making an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide covalently linked to a carrier protein, the method comprising:
(a) reacting purified serotype 19A polysaccharide with an oxidizing agent resulting in an activated serotype 19A polysaccharide;
(b) compounding the activated serotype 19A polysaccharide with a carrier protein;
(c) co-lyophilizing the compounded activated serotype 19A polysaccharide and carrier protein;
(d) re-suspending the compounded activated serotype 19A polysaccharide and carrier protein in dimethyl sulfoxide (DMSO);
(e) reacting the compounded, activated serotype 19A polysaccharide and carrier protein with a reducing agent resulting in a serotype 19A polysaccharide:carrier protein conjugate; and
(f) capping unreacted aldehydes in the serotype 19A polysaccharide:carrier protein conjugate resulting in an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide covalently linked to a carrier protein.
Meanwhile, the patented claims are drawn to a method for making a single dose multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates, wherein said polysaccharide-protein conjugates consist essentially of individual Streptococcus pneumoniae capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, said method comprising:
(i) conjugating each capsular polysaccharide separately to CRM197 carrier protein, wherein at least one of said serotypes 6A, 6B, 19A or 19F is covalently linked to CRM197 carrier protein according to a method comprising:
(a) reacting purified serotype 6A, 6B, 19A, or 19F polysaccharide with an oxidizing agent resulting in an activated serotype 6A, 6B, 19A or 19F polysaccharide;
(b) compounding the activated serotype 6A, 6B, 19A or 19F polysaccharide with a carrier protein;
(c) co-lyophilizing the compounded activated serotype 6A, 6B, 19A or 19F polysaccharide and carrier protein;
(d) re-suspending the compounded activated serotype 6A, 6B, 19A or 19F polysaccharide and carrier protein in dimethyl sulfoxide (DMSO);
(e) reacting the compounded, activated serotype 6A, 6B, 19A or 19F polysaccharide and carrier protein with a reducing agent resulting in a serotype 6A, 6B, 19A or 19F polysaccharide:carrier protein conjugate; and
(f) capping unreacted aldehydes in the serotype 6A, 6B, 19A or 19F polysaccharide:carrier protein conjugate resulting in an immunogenic conjugate comprising Streptococcus pneumonia serotype 6A, 6B, 19A or 19F polysaccharide covalently linked to CRM197 carrier protein; and
wherein step (c) is performed after step (b) and before steps (d) and (e);
(ii) combining said polysaccharide-protein conjugates together with a physiologically acceptable vehicle; and
(iii) formulating said polysaccharide-protein conjugates and said physiologically acceptable vehicle into a single dose multivalent immunogenic composition.
The pending claims overlap in scope and thus are anticipatory of and/or obvious over the patented claims.
Conclusion
5. No claim is allowed.
6. 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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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 March 18, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645