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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/17/2025 has been entered.
3. Applicant’s amendment and response of 10/17/2025 are acknowledged. Claims 1 and 55 have been amended. Claims 3-9, 20 and 30-42 have been canceled. New claims 56-57 have been added.
Claim Status
4. Claims 1-2, 10-19, 21-29 and 43-57 are pending. Claims 1 and 55 have been amended. Claims 3-9, 20 and 30-42 have been canceled. New claims 56-57 have been added. Claims 3-7, 8, 20, 31-35 have been canceled by previous amendment. Claims 10-15, 22-29 and 43-54 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/202. Claims 1, 2, 6-19, 21 and 55-57 are under consideration.
Information Disclosure Statement
5. Applicants’ information disclosure statement filed 10/172025 has been considered. Initialed copy of 1449 is enclosed.
Double Patenting Rejection Moot
6. Rejection of claim 9 on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,147,864 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is moot in view of applicants’ cancelation of said claim.
7. Rejection of claim 9 on the ground of non-statutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,241,489 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is moot in view of applicants’ cancelation of said claim.
8. Rejection of claim 9 on the ground of non-statutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,123,417 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is moot in view of applicants’ cancelation of said claim.
9. Rejection of claim 9 provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 11, 22-32 of co-pending Application No. 1750071611 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is moot in view of applicants’ cancelation of said claim.
Claim Rejections - 35 USC § 102 Moot
10. Rejection of claim 9, under 35 U.S.C. 102(a)(2) as being anticipated by Burki et al. WO 2018064444 A1 (Filed 9/29/2017. Art of record 1449), is moot in view of applicants’ cancelation of said claim.
Claim Rejections - 35 USC § 103 Moot
11. Rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over of Schultz (US 20030099672 A1) in view Siber et al. (US 20140322263 A1), and Martens et al. (BMC Infectious Diseases, 4, 21, 2004), is moot in view of applicants’ cancelation of said claim.
Double Patenting Rejection Withdrawn
12. Rejection of claims 1, 2, 16-19 and 21 provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 11, 22-32 of co-pending Application No. 1750071611 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is withdrawn in view of applicants’ amendment of 10/17/2025.
Claim Rejections - 35 USC § 102 Withdrawn
13. Rejection of claim(s) 1, 2, 16-19 and 21 under 35 U.S.C. 102(a)(2) as being anticipated by Burki et al. WO 2018064444 A1 (Filed 9/29/2017. Art of record 1449), is maintained, is withdrawn in view of applicants’ amendment of 10/17/2025.
Claim Rejections - 35 USC § 103 Withdrawn
14. Rejection of claim(s) 1, 9, 16-19 and 21 under 35 U.S.C. 103 as being unpatentable over of Schultz (US 20030099672 A1) in view Siber et al. (US 20140322263 A1), and Martens et al. (BMC Infectious Diseases, 4, 21, 2004), is withdrawn in view of applicants’ amendment of 10/17/2025.
Double Patenting Rejection Maintained
15. Rejection of claims 1, 2,16-19, 21 and new claims 55-57 on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,147,864 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is maintained.
The rejection is as stated below:
Claims 1, 2, 9, 16-19, 21 and new claims 55 -57 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,147,864 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant amended claims are drawn to:
A multivalent pneumococcal conjugate composition, comprising 22-27 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11lA, 12F, 14, 15A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B, wherein the protein carrier comprises CRM197 and tetanus toxoid, and wherein the capsular polysaccharides conjugated to tetanus toxoid comprise at least two of serotypes 1, 3, 5, 15B, and 22F.
The U.S. Patent No. 11,147,864 patented claims are drawn to mixed carrier multivalent pneumococcal conjugate compositions and vaccine. The claims of instant application and the patent are not patentably distinct and there are minor differences in said compositions both recite multivalent pneumococcal conjugate compositions comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
See U.S. Patent No. 11,147,864 claims specially claim 1, abstract, columns 2,3,6 and summary. U.S. Patent No. 11,147,864 claim 1 is recited below.
Claim 1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9\7, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F,wherein the protein carrier is CRM197 or tetanus toxoid, and wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are selected from the group consisting of serotypes 1, 3, and 5.
U.S. Patent No. 11,147,864 teach 21 conjugates and does not specifically state 22-27 pneumococcal capsular -protein conjugates.
However, Burki et al. WO 2018064444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
It would be prima facie obvious to one ordinary skilled in the art to combine the teachings of U.S. Patent No. 11,147,864 and Burki et al. to obtain 22-27 valent pneumococcal capsular -protein conjugates. Because the U.S. Patent No. 11,147,864 patented claims are drawn to mixed carrier 21 multivalent pneumococcal conjugate compositions and vaccine and teach serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The only difference between the patent and instant claims are only serotype 35B. Burki et al teach serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45. And U.S. Patent No. 11,147,864 teach while one or more exemplary embodiments have been described in the specification, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the inventive concept. Therefore, it would be obvious to ordinary skill in the art to add serotype 35B taught by Burki et in U.S. Patent No. 11,147,864 patented to obtain instant invention.
The depended claims are also not patentably distinct.
Applicants’ Arguments
16. Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive. Applicants mainly argue:
1- Claims of US. Patent No. 11,147,864 are directed to a multivalent pneumococcal conjugate comprising 21 serotypes and do not suggest 22-27 serotypes.
2- Burki teach 22,24 valent vaccine (see 0080-0088).
3- Burki does not teach tetanus toxoid.
Office Response
17. Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive.
In response to applicants’ arguments that the claims are still unpatentable over claims 1-20 of U.S. Patent No. 11,147,864 in view of Burki et al. WO 2018064444 A1.
The claims of instant application and the patent are not patentably distinct and there are minor differences in said compositions both recite multivalent pneumococcal conjugate compositions comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. See U.S. Patent No. 11,147,864 claims specially claim 1, abstract, columns 2,3,6 and summary. U.S. Patent No. 11,147,864 claim 1 is recited below.
Claim 1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9\7, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F,wherein the protein carrier is CRM197 or tetanus toxoid, and wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are selected from the group consisting of serotypes 1, 3, and 5.
Burki et al. WO 2018064444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
Burki et al. teach amended limitations of claim 1, protein carriers such as CRM197 and Tetanus toxoid see claims7, 19-21, 24, 34, 36-37 and para 0018, 0019, 0023, 0024, 0033, Burki et al. teach limitations of new claims 55-57, serotypes 15B and 22F. Burki et al. teach serotypes 6A, 14, 18C, 19A, 19F, 23F conjugated to CRM197 and Tetanus toxoid (see para 0009, 0019, 0020, 0023, 0037).
It would be prima facie obvious to one ordinary skilled in the art to combine the teachings of U.S. Patent No. 11,147,864 and Burki et al. to obtain a 22-27 valent pneumococcal capsular -protein conjugates.
Double Patenting Rejection Maintained
18. Rejection of claims 1, 2, 16-19, 21 and new claims 55-57 on the ground of non-statutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,241,489 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is maintained.
The rejection is as stated below:
Claims 1, 2, 16-19, 21 and new claims 55-57 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,241,489 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to a multivalent pneumococcal conjugate composition comprising 22-27 pneumococcal capsular -protein conjugates.
The instant amended claims are drawn to:
A multivalent pneumococcal conjugate composition, comprising 22-27 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B, wherein the protein carrier comprises CRM197 and tetanus toxoid, and wherein the capsular polysaccharides conjugated to tetanus toxoid comprise at least two of serotypes 1, 3, 5, 15B, and 22F.
The U.S. Patent No. 11,241,489 patented claims are drawn to mixed carrier multivalent pneumococcal conjugate compositions and vaccine. Claim 1 recite:
1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising 20 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, wherein the protein carrier is CRM197 or tetanus toxoid, wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, and wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are selected from the group consisting of serotypes 1, 3, and 5.
The claims of instant application and the patent are not patentably distinct and there are minor differences in said compositions both recite multivalent pneumococcal conjugate compositions comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Additionally, abstract and columns 2, 3 and 5 recites capsular polysaccharides conjugated to tetanus of at least two serotypes of 1, 3,5, 15B and 22 F.
U.S. Patent No. 11,241,489 does not teach 22-27 pneumococcal capsular -protein conjugates.
However, Burki et al. WO 2018064444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
It would be prima facie obvious to one ordinary skilled in the art to combine the teachings of U.S. Patent No. 11,241,489 and Burki et al. to obtain 22-27 valent pneumococcal capsular -protein conjugates. Because The U.S. Patent No. 11,241,489 patented claims are drawn to mixed carrier 20 multivalent pneumococcal conjugate compositions and vaccine and teach serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The only difference between the patent and instant claims are only serotype 9N and 35B. Burki et al teach serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45. And U.S. Patent No. 11,241,489 teach while one or more exemplary embodiments have been described in the specification, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the inventive concept. Therefore, it would be obvious to ordinary skill in the art to add serotypes 9N and 35B taught by Burki et in U.S. Patent No. 11,241,489 patented to obtain instant invention.
The depended claims are also not patentably distinct.
Applicants’ Arguments
19. Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive. Applicants mainly argue:
1- Claims of US. Patent No. 11,247,489 are directed to a multivalent pneumococcal conjugate comprising 20 serotypes and do not suggest 22-27 serotypes.
2- Burki teach 22,24 valent vaccine (see 0080-0088).
3- Burki does not teach tetanus toxoid.
Office Response
20. Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive.
In response to applicants’ arguments that the claims are still unpatentable over claims 1-8 of U.S. Patent No. 11,241,489 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017).
The claims of instant application and the patent are not patentably distinct and there are minor differences in said compositions both recite multivalent pneumococcal conjugate compositions comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
The U.S. Patent No. 11,241,489 patented claims are drawn to mixed carrier multivalent pneumococcal conjugate compositions and vaccine. Claim 1 recite:
1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising 20 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, wherein the protein carrier is CRM197 or tetanus toxoid, wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, and wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are selected from the group consisting of serotypes 1, 3, and 5.
Additionally, abstract and columns 2, 3 and 5 recites capsular polysaccharides conjugated to tetanus of at least two serotypes of 1, 3,5, 15B and 22 F
Burki et al. WO 201806444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
Burki et al. teach amended limitations of claim 1, protein carriers such as CRM197 and Tetanus toxoid see claims7, 19-21, 24, 34, 36-37 and para 0018, 0019, 0023, 0024, 0033, Burki et al. teach limitations of new claim 55, serotypes 15B and 22F. Burki et al. teach serotypes 6A, 14, 18C, 19A, 19F, 23F conjugated to CRM197 and Tetanus toxoid.
It would be prima facie obvious to one ordinary skilled in the art to combine the teachings of U.S. Patent No. 11,241,489 and Burki et al. to obtain 22-27 valent pneumococcal capsular -protein conjugates.
Double Patenting Rejection Maintained
21. Rejection of claims 1, 2, 9, 16-19, 21 and new claims 55-57 on the ground of non-statutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,123,417 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017), is maintained.
The rejection is as stated below:
Claims 1, 2, 9, 16-19, 21 and new claims 55-57 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,123,417 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to a multivalent pneumococcal conjugate composition comprising 22-27 pneumococcal capsular -protein conjugates.
The instant amended claims are drawn to:
A multivalent pneumococcal conjugate composition, comprising 22-27 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B, wherein the protein carrier comprises CRM197 and tetanus toxoid, and wherein the capsular polysaccharides conjugated to tetanus toxoid comprise at least two of serotypes 1, 3, 5, 15B, and 22F.
The U.S. Patent No. 11,123,417 patented claims are drawn to mixed carrier multivalent pneumococcal conjugate compositions and vaccine. Claim 1 recite:
1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F,
wherein the protein carrier is CRM197 or tetanus toxoid, and wherein four of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, wherein the four capsular polysaccharides that are conjugated to tetanus toxoid are serotypes 15B, 22F and the other two serotypes are selected from the group consisting of serotypes 1, 3, and 5.
The claims of instant application and the patent are not patentably distinct and there are minor differences in said compositions both recite multivalent pneumococcal conjugate compositions comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
U.S. Patent No. 11,123,417 does not 22-27 pneumococcal capsular -protein conjugates.
However, Burki et al. WO 2018064444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
It would be prima facie obvious to one ordinary skilled in the art to combine the teachings of U.S. Patent No. 11,123,417 and Burki et al. to obtain 22-27 valent pneumococcal capsular -protein conjugates. Because The U.S. Patent No. 11,123,417 patented claims are drawn to mixed carrier 20 multivalent pneumococcal conjugate compositions and vaccine and teach serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The only difference between the patent and instant claims are only serotype 9N and 35B. Burki et al teach serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45. And U.S. Patent No. 11,123,417 teach while one or more exemplary embodiments have been described in the specification, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the inventive concept. Therefore, it would be obvious to ordinary skill in the art to add serotypes 15A and 35B taught by Burki et in U.S. Patent No. 11,123,417 patented to obtain instant invention.
The depended claims are also not patentably distinct.
Applicants’ Arguments
22. Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive. Applicants mainly argue:
1- Claims of US. Patent No. 11,123,417 are directed to a multivalent pneumococcal conjugate comprising 20 serotypes and do not suggest 22-27 serotypes.
2- Burki teach 22,24 valent vaccine (see 0080-0088).
3- Burki does not teach tetanus toxoid.
Office Response
23. Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive.
In response to applicants’ arguments that the claims are still unpatentable over claims 1-21 of U.S. Patent No. 11,123,417 in view of Burki et al. WO 2018064444 A1 (Filed 9/29/2017).
The claims of instant application and the patent are not patentably distinct and there are minor differences in said compositions both recite multivalent pneumococcal conjugate compositions comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
The U.S. Patent No. 11,123,417 patented claims are drawn to mixed carrier multivalent pneumococcal conjugate compositions and vaccine. Claim 1 recite:
1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, wherein the protein carrier is CRM197 or tetanus toxoid, and wherein four of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, wherein the four capsular polysaccharides that are conjugated to tetanus toxoid are serotypes 15B, 22F and the other two serotypes are selected from the group consisting of serotypes 1, 3, and 5.
Burki et al. WO 2018064444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
Burki et al. teach amended limitations of claim 1, protein carriers such as CRM197 and Tetanus toxoid see claims7, 19-21, 24, 34, 36-37 and para 0018, 0019, 0023, 0024, 0033, Burki et al. teach limitations of new claim 55, serotypes 15B and 22F. Burki et al. teach serotypes 6A, 14, 18C, 19A, 19F, 23F conjugated to CRM197 and Tetanus toxoid.
It would be prima facie obvious to one ordinary skilled in the art to combine the teachings of U.S. Patent No. 11,123,417 and Burki et al. to obtain 22-27 valent pneumococcal capsular -protein conjugates.
New Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
24. Claims 1, 2, 16-19, 21 and 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Burki et al. WO 201806444 A1 (Filed 9/29/2017. Art of record 1449) in view of An et al. (WO 2019/152925 A1 published Aug 2019; priority to Feb 2018).
The instant amended claims are drawn to:
A multivalent pneumococcal conjugate composition, comprising 22-27 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B, wherein the protein carrier comprises CRM197 and tetanus toxoid, and wherein the capsular polysaccharides conjugated to tetanus toxoid comprise at least two of serotypes 1, 3, 5, 15B, and 22F.
Burki et al. discloses a 22-27-valent pneumococcal conjugate composition, comprising pneumococcal capsular polysaccharide-protein conjugates coupled to mixed carrier chosen among CRM197 or tetanus toxins ([109]). The serotypes are chosen among serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A,20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39 and 45 (103-104], [142-146], claims 1-3). The mixed conjugate composition is administered with alum (examples 3-4), methods of conjugation are also disclosed [154-155]. Burki et al. para 0103 recite in one embodiment, twenty pneumococcal), twenty-two pneumococcal polysaccharides (22 valent), twenty-three pneumococcal polysaccharides (23 valent), twenty-four pneumococcal polysaccharides (24 valent), twenty-five pneumococcal polysaccharides (25 valent), twenty-six pneumococcal polysaccharides (26 valent), twenty-seven pneumococcal polysaccharides (27 valent).
Burki et al. teach limitations of claim 2, 57 different pneumococcal capsular polysaccharide-protein conjugates from different serotypes selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, I0A, 11A, 12F, 14, I5A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B (see 0102).
Burki et al. teach limitations of claims 1 and 55-56 tetanus toxoid and conjugation of serotypes 1, 3, 5, 15B and 22F (see para 0009, 0019, 0020, 0023, 0097, 0109, 0115, 0116, 0117). Burki et al. teach limitations of claim 21 vaccine (see claims 21. 37, 118-121). Burki et al. teach limitations of claims 16-19 (adjuvants, aluminum-based adjuvant, aluminum phosphate, hydroxide, sulfate and pharmaceutically acceptable excipient) see abstract, claims 27, 29,33, 44, 45 and para 0070, 0077, 079, 0130, 0143, 0153.
Burki et al. WO 201806444 A1 recite in para [0041] that in one embodiment, the present disclosure provides a pneumococcal vaccine composition that is 20 valent, 22 valent, 23 valent, 24 valent, or 25 valent pneumococcal vaccine composition (26 valent), twenty-seven pneumococcal polysaccharides (27 valent) see [0103) also para [0042] recite that in another embodiment, the present disclosure provides a pneumococcal vaccine composition comprising pneumococcal polysaccharides that are each serotypes selected from pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, ?F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45.
Burki et al. teach amended limitations of claim 1, protein carriers such as CRM197 and Tetanus toxoid see claims 7, 19-21, 24, 34, 36-37 and para 0018, 0019, 0023, 0024, 0033, Burki et al. teach limitations of new claim 55, serotypes 15B and 22F. Burki et al. teach serotypes 6A, 14, 18C, 19A, 19F, 23F conjugated to CRM197 and Tetanus toxoid.
Additionally, an et al. teach a multivalent pneumococcal polysaccharide -protein conjugate vaccine composition (see title). An et al. recites
providing mixed carrier, multivalent pneumococcal conjugate compositions comprising mutliple different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of two of serotypes 1, 3, and 5 and one or both of serotypes 15B and22F are conjugated to TT and the remaining capsular polysaccharides are conjugated to CRM197, Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.
Also see claims specially claim 1, 5-8, 11 and pages 2-4.
An et al. teach limitations of claim 2, 57 different pneumococcal capsular polysaccharide-protein conjugates from different serotypes selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, I0A, 11A, 12F, 14, I5A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B (see abstract, claims 1-4).
An et al. teach limitations of claims 1 and 55-56 tetanus toxoid and conjugation of serotypes 1, 3, 5, 15B and 22F (see abstract, claim 1). An et al. teach limitations of claim 21 vaccine (see claim 11). An et al. teach limitations of claims 16-19 (adjuvants, aluminum-based adjuvant, aluminum phosphate, hydroxide, sulfate and pharmaceutically acceptable excipient) see claims 5-8 and 11). An et al. teach that serotypes 1.3.5.15B and 22F are conjugated to tetanus toxoid (see abstract, claim 1 and pages 3-4).
It would be prima-facie obvious at the time of the invention to modify the compositions Burki et al. with the teachings of An et al. in order to provide a multivalent pneumococcal conjugate composition to treat streptococcal infections. One of the skilled in the art would be motivated by the teachings of the references to obtain instant invention, because Burki et al. discloses a 22-27-valent pneumococcal conjugate composition, comprising pneumococcal capsular polysaccharide-protein conjugates coupled to mixed carrier chosen among CRM197 or tetanus toxins. The serotypes are chosen among serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A,20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39 and 45. And An et al. teach a multivalent pneumococcal polysaccharide -protein conjugate vaccine composition, wherein different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of two of serotypes 1, 3, and 5 and one or both of serotypes 15B and 22F are conjugated to TT.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses, "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known compositions and methods thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
25. No claims are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tue, Thurs-Fri 12pm-8pm.
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, Gary B. Nickol can be reached on 571-272-0835. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
/KHATOL S SHAHNAN SHAH/ Examiner, Art Unit 1645 October 31, 2025
/JANA A HINES/ Primary Examiner, Art Unit 1645