DETAILED ACTION
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 .
2. The office action of September, 2 2025 has been vacated. Claims 1, 9-11, 17-18, 22-23 and 26-30 are under consideration.
Continued Examination Under 37 CFR 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/27/2025 has been entered.
4. Applicants’ response of 5/27/2025 is acknowledged. No claims have been amended.
Claim Status
5. Claims 1 and 9-30 are pending in this application. Claims 1, 9-11, 17-18, 22-23 and 26-30 are under consideration. Claims 2-8 have been canceled. Claims 12-16, 19-21 and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/2024.
Rejections Withdrawn
Double Patenting
6. Rejection of claims 1, 9-11, 17-18, 22-23 and 26-30 on the ground of non-statutory double patenting as being unpatentable over claims 1-19 of co-pending Application No. 18,074,884 (reference application has not been published), is now withdrawn in view of abandonment of Application No. 18,074,884 on 2/26/2026
Rejections Maintained
Double Patenting
7. Rejection of claims 1, 9-11, 17-18, 22-23 and 26-30 on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,547,752 B2, is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The amended claims are instant application are drawn to:
Claim 1. A 24 valent pneumococcal conjugate vaccine composition comprising a capsular polysaccharide from serotypes of Streptococcus pneumoniae conjugated to a carrier protein, wherein the serotypes comprise 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197.
Claim 2. The 24 valent pneumococcal conjugate vaccine composition of claim 1, wherein the carrier protein is selected from CRM)197 of. a combination of CRMi97 and PsaA a combination of CRMis97 and Tetanus toxoid combination of PsaA and Tetanus toxoid and or a combination of CRM197, PsaA and Tetanus toxoid.
U.S. Patent No. 11,547,752 B2 claims recite:
Claim 1. A multivalent pneumococcal vaccine composition comprising:
(a) carrier proteins consisting of pneumococcal surface adhesion protein A (PsaA) and CRM197; and (b) capsular pneumococcal polysaccharides of two or more serotypes, wherein each of the capsular pneumococcal polysaccharides are individually conjugated to a carrier protein selected from PsaA and CRM197, wherein at least one capsular pneumococcal polysaccharide 1s conjugated to PsaA, wherein at least one capsular pneumococcal polysaccharide is conjugated to CRM197, and wherein the at least one capsular pneumococcal polysaccharide conjugated to PsaA has a serotype different from a serotype of the at least one capsular pneumococcal polysaccharide conjugated to CRMi97, and wherein the PsaA lacks the wild-type hydrophobic N-terminal leader peptide.
Claim 2. The multivalent pneumococcal vaccine composition of claim 1, wherein the pneumococcal vaccine composition is a 10 valent, 13 valent, 14 valent, 15 valent, 17 valent, 18 valent, 19 valent, 20 valent, 22 valent, 23 valent, 24 valent or 25 valent pneumococcal vaccine compositions.
Claim 3. The multivalent pneumococcal vaccine composition of claim 1, the two or more serotypes are selected from the group consisting of 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.
The claims of the patent and the instant application recite the same 24 valent conjugate vaccine and same limitations. The cited patented claims make obvious the cited pending claims. The dependent claims also recite most of the same limitations.
Applicants’ Arguments
8. Applicant's arguments filed 5/27/2025 have been fully considered but they are not persuasive. Applicants argue:
Claims 1-16 of U.S. Patent No. 11,547,752 do not recite any of the features in claim 1 emphasized above, and the Office Action has provided any explanation of why a person of ordinary skill in the art would "at once envisage" the claimed arrangement from claims 1-16 of U.S. Patent No. 11,547,752. The Office Action also provided no analysis of independent claims 28-30. Therefore, the Office Action has not sufficiently shown that claims 1-16 of U.S. Patent No. 11,547,752 anticipate claims 1 and 28-30.
The Office Action also did not explain why independent claims 1 and 28-30 are obvious over claims 1-16 of U.S. Patent No 11,547,752. To reject a claim as obvious, Office personnel must resolve the Graham factual inquiries:
determining the scope and content of the prior art;
ascertaining the differences between the claimed invention and the prior art;
resolving the level of ordinary skill in the pertinent art; and
evaluating objective evidence (also referred to as "secondary considerations") relevant to the issue of obviousness.
See MPEP § 2141(11) (citing Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)).
The Office Action provided no rationale for why independent claims 1 and 28-30 were obvious. AA at 5 ("The cited patented claims anticipate and/or make obvious the cited pending claims."). Because the Office Action has not shown that claims 1-16 of U.S. Patent No. 11,547,752 anticipate or make obvious claims 1 and 28-30, the double patenting rejection is improper. Claims 9-11, 17, 18, 22, 23, 26, and 27 depend from and incorporate each and every feature of independent
claim 1. Applicant requests withdrawal of the double patenting rejection of claims 1, 9-11, 17, 18, 22, 23, and 26-30 over claims 1-16 of U.S. Patent No. 11,547,752.
Response to Arguments
9. In response to applicants’ arguments the amendment limitations do not obviate the rejection, claim 1 of U.S. Patent No. 11,547,752 B2 also recite that each of the capsular pneumococcal polysaccharides are individually conjugated to a carrier protein selected from PsaA and CRM197. The claims of the patent and the instant application recite the same 24 valent conjugate vaccine and same limitations. The cited patented claims make obvious the cited pending claims. The dependent claims also recite most of the same limitations. The instant claim 1 and claims 1 and 3 of U.S. Patent No. 11,547,752 B2 both recite the serotypes comprise 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197. Therefore, the claims of U.S. Patent No. 11,547,752 B2 makes the instant claims obvious and are not patently distinct.
As to applicants arguments about analysis of independent claims 28-30, it is the examiner’s position that claims 1 and 3 of U.S. Patent No. 11,547,752 B2 both recite the serotypes comprise 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B and claims 10 and 13 of U.S. Patent No. 11,547,752 B2 also recite the amounts of CRM 197 and Psa A conjugated to the polysaccharides. Therefore, the claims of U.S. Patent No. 11,547,752 B2 makes the instant claims obvious and are not patently distinct.
Therefore, the rejection is maintained.
filed 5/27/2025 have been fully considered but they are not persuasive. Applicants argue:
The Office Action also rejected claims 1, 9-11, 17-18, 22-23 and 26-30 on the grounds of non-statutory double patenting as allegedly unpatentable over claims 1-19 of co-pending Application No. 18/074,884. OA at 6. This rejection is improper for the same reasons as recited above for the double patenting rejection over claims 1-16 of U.S. Patent No. 11,547,752. Applicant requests withdrawal of the double patenting rejections of claims 1, 9-11, 17-18, 22-23 and 26-30 over claims 1-19 of co-pending Application No. 18/074,884.
Reinstated Rejection
10. While the advisory action mailed May 8, 2025 withdrew the rejection under 102(a)(2) as anticipated by Matur et al., upon review and reconsideration, the rejection is being reinstated for the reasons set forth below.
Claim Rejections - 35 USC § 102
11. 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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Rejection of claims 1,9-11, 17-18, 22-23 and 26-30 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Matur et al., (US 20190224295 published 2019-07-55 with priority to 9/30/2016), is being reinstated.
The rejection as stated below:
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The claims are instant application are drawn to:
Claim1. A 24 valent pneumococcal conjugate vaccine composition comprising a capsular polysaccharide from serotypes of Streptococcus pneumoniae conjugated to a carrier-protein to form a capsular-polysaccharide carrier-protein conjugate, wherein the serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, IOA, I IA, 12F, 14, ISA, l8C, 19A, l9F, 22F,
23A, 23B, 23F, 24F, 33F and 35B, wherein the capsular-polysaccharide carrier-protein conjugates constituting the 24 valent pneumococcal conjugate vaccine composition are selected from the group consisting of:
capsular polysaccharide from serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F are individually conjugated to CRM197 and the capsular polysaccharide from serotypes 3, 6A, 8, IOA, I IA, 12F, ISA, 23A, 23B, 24F and 35B are individually conjugated to PsaA;
the capsular polysaccharide from serotypes of Streptococcus pneumonia I, 3, 4, 5, 6A, 6B, 7F, 8, 9V, IOA, I IA, 12F, 14, ISA, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and
35B are individually conjugated to CRM197; and
capsular polysaccharide from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F are individually conjugated to CRM197 and the capsular polysaccharide from serotypes 6A, 8, IOA, I IA, 12F, ISA, 23A, 23B, 24F and 35B are individually conjugated to PsaA.
Claims of the instant application is anticipated by Matur et al.
Matur et al., recite the limitations of the instant invention such as 24 valent pneumococcal conjugate vaccines comprising a capsular polysaccharide from serotypes, PsaA and CRM197 of Streptococcus pneumoniae conjugated to a carrier protein, multiple serotypes see para 0041,0057, 0065,0073.0074 and claims 1 of Matur et al. ( which recites multivalent pneumococcal vaccine composition comprising:(a) carrier proteins consisting of pneumococcal surface adhesion protein A (PsaA) and CRM197) and see para 0041,0057, 0065,0073.0074 and claim 2 of Matur et al. ( recites 24 valent vaccine) and see para 0042,0061, 0065,0066 .0067 and claim 3 of Matur et al. ( which recites serotypes are selected from the group consisting of 1, 3, 4, 5, 6A, 6B, 6C, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 18C, 19F, 19A, 22F, 23A, 23B, 23F, 24B, 24F, 33F and 35B).
Matur et al. recite the limitations of claims 9-11 various molecular weights see columns 9, 19, 21. Matur et al. recite the limitations of claims 17-18 pharmaceutically accepted carriers, diluents and adjuvants (see claims 11, 13). Matur et al. recite the limitations of claims 22-23 different dosages (see claim 10). Matur et al. recite the limitations of claim 27 preservative and 2-phenoxyethanol (see column 25). Matur et al. recite the limitations of claim 26 vials and syringes see claim 12. Matur et al. recite the limitations of claims 28-30 such as pharmaceutically acceptable diluent, buffer, preservative, stabilizer, adjuvant, and/or a lyophilization excipient. see claims 13-16. Different values would be inherent in teachings of Matur et al. recited by its claims 13-16.
As to amended limitation to claim 1, the Matur claim 1, recite A multivalent pneumococcal vaccine composition comprising:
(a) carrier proteins consisting of pneumococcal surface adhesion protein A (PsaA) and CRM197; and (b) capsular pneumococcal polysaccharides of two or more serotypes, wherein each of the capsular pneumococcal polysaccharides are individually conjugated to a carrier protein selected from PsaA and CRM197, wherein at least one capsular pneumococcal polysaccharide 1s conjugated to PsaA, wherein at least one capsular pneumococcal polysaccharide is conjugated to CRM197. And claim 3. Recite: The multivalent pneumococcal vaccine composition of claim 1, the two or more serotypes are selected from the group consisting of 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.
The above claims meet the limitations of wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197. Matur et al., anticipate the claimed invention.
Applicants’ Arguments and Office Response
13. Applicants have not argued this rejection in the response filed 5/27/2025.
However, Applicant's arguments filed 4/17/2025 have been fully considered but they are not persuasive.
It is the examiner’s position that as mentioned above the art anticipates the claimed invention. As to amended limitation to claim 1, the Matur para 0041,0042 ,0057 and claim 1, recite A multivalent pneumococcal vaccine composition comprising: (a) carrier proteins consisting of pneumococcal surface adhesion protein A (PsaA) and CRM197; and (b) capsular pneumococcal polysaccharides of two or more serotypes, wherein each of the capsular pneumococcal polysaccharides are individually conjugated to a carrier protein selected from PsaA and CRM197, wherein at least one capsular pneumococcal polysaccharide 1s conjugated to PsaA, wherein at least one capsular pneumococcal polysaccharide is conjugated to CRM197. Andpara 0042, 0057,0061, 0066 and claim 3. Recite: The multivalent pneumococcal vaccine composition of claim 1, the two or more serotypes are selected from the group consisting of 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. The multivalent pneumococcal vaccine composition is a 24 valent pneumococcal vaccine compositions. The serotype group recited by Matur teach each and every instantly claimed serotype. Matur also teach 24 valent conjugate vaccines where each serotype is individually conjugated to either PsaA or CRM197.
The above claims meet the limitations of wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197.
As argument that claims 28-30 not anticipated by claims 13-16 of Matur et al. It is the examiner’s position that Matur et al. recite the limitations of claims 28-30 such as pharmaceutically acceptable diluent, buffer, preservative, stabilizer, adjuvant, and/or a lyophilization excipient. see claims 13-16. Different values would be inherent in teachings of Matur et al. recited by its claims 13-16.
Therefore, Applicants argument is not persuasive.
Reinstated Rejection
14. While the advisory action mailed May 8, 2025 withdrew the rejection under 102(a)(2) as anticipated by Burki et al., upon review and reconsideration, the rejection is being reinstated for the reasons set forth below.
Claim Rejections - 35 USC § 102
15. Rejection of claims 1, 9-11, 17-18, 22-23 and 26-30 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Burki et al., WO 2018064444 A1 published 4/5/2018 with priority to 9/30/2016), is being reinstated.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The claims are instant application are drawn to:
Claim 1. A 24 valent pneumococcal conjugate vaccine composition comprising a capsular polysaccharide from serotypes of Streptococcus pneumoniae conjugated to a carrier-protein to form a capsular-polysaccharide carrier-protein conjugate, wherein the serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, IOA, I IA, 12F, 14, ISA, l8C, 19A, l9F, 22F,
23A, 23B, 23F, 24F, 33F and 35B, wherein the capsular-polysaccharide carrier-protein conjugates constituting the 24 valent pneumococcal conjugate vaccine composition are selected from the group consisting of:
capsular polysaccharide from serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F are individually conjugated to CRM197 and the capsular polysaccharide from serotypes 3, 6A, 8, IOA, I IA, 12F, ISA, 23A, 23B, 24F and 35B are individually conjugated to PsaA;
the capsular polysaccharide from serotypes of Streptococcus pneumonia I, 3, 4, 5, 6A, 6B, 7F, 8, 9V, IOA, I IA, 12F, 14, ISA, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and
35B are individually conjugated to CRM197; and
capsular polysaccharide from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F are individually conjugated to CRM197 and the capsular polysaccharide from serotypes 6A, 8, IOA, I IA, 12F, ISA, 23A, 23B, 24F and 35B are individually conjugated to PsaA.
Claims of the instant application is anticipated by Burki et al.
Burki et al. recite the limitations of the instant invention such as 24 valent pneumococcal conjugate vaccines comprising a capsular polysaccharide from serotypes, PsaA and CRM197 of Streptococcus pneumoniae conjugated to a carrier protein, multiple serotypes see claims 1-4 and (para 0041,0065,0073, 0074, 0088 which recite 24 valent vaccine),
Burki et al. recite the limitations of claims 9-11 various molecular weights see para 0132, 0133, 0134, 0151, 0152. Burki et al. recite the limitations of claims 17-18 pharmaceutically accepted carriers, diluents and adjuvants (see claims 11, 13). Burki et al. recite the limitations of claims 22-23 different dosages (see abstract, claims 29-30). Burki et al. recite the limitations of claim 27 preservative and 2-phenoxyethanol (see abstract, para 0077, 0230, 0253, 0160 and claim 27). Burki r et al. recite the limitations of claim 26 vials and syringes see claim 28. Burki et al. recite the limitations of claims 28-30 see claims 31-36.
Burki and al. teach a pneumococcal vaccine composition, the composition comprising two or more capsular pneumococcal polysaccharide serotypes each individually conjugated to a carrier protein pneumococcal surface adhesion protein A (PsaA) or combination of PsaA and CRM197 as a carrier protein ( see claims 1 and 3 and para 0088, 0106, 0108, 0109)..
Burki et al, teach pneumococcal vaccine composition of comprising pneumococcal polysaccharides include one or more serotypes selected from 1, 3, 4, 5, 6A, 6B,7, 8, 9V, 10A, 11A, 12F, 14, 18C, 19A, 22F,23A,23B,23F, ,24F,33, 35B,35F. Burki et al. meet the limitations of wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197.
As to claims 28-30 they are anticipated by claim 31 -37 of Burki et al. Burki et al. recite the limitations of claims 28-30 such as pharmaceutically acceptable diluent, buffer, preservative, stabilizer, adjuvant, and/or a lyophilization excipient. see claims 13-16. Different values would be inherent in teachings of Burki et al. recited by its claims 31-37. The prior art anticipates the claimed invention.
Applicants’ Arguments
16. Applicants have not argued this rejection in the response filed 5/27/2025.
However, Applicant's arguments filed 4/17/2025 have been fully considered but none of the arguments are persuasive. Applicants argue:
The Office Action relied on Burki for allegedly disclosing
[A] pneumococcal vaccine composition of claims I or 2 wherein each of the pneumococcal polysaccharides include one or more serotypes selected from 1,2, 3, 4, 5, 6A, 6B, 6C, 7 F, 8, 9N, 9V, I0A, 11 A, 12F, 14, ISA, 15B, 15C, 16F, l 7F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39 and 45.
Even if this characterization of Burki is true, which Applicant does not concede, Burki does not disclose the 24 valent pneumococcal conjugate vaccine compositions recited in claim 1 (i.e. claim l(a), (b), and (c)). Even if portions ofBurki's disclosure encompass the features of claim 1, which Applicant does not concede, Burki provides no disclosure that would allow "a person of skill in the art [to] 'at once envisage' the claimed arrangement or combination." Kennametal, 780 F.3d at 1376. Burki's disclosure contains the same preferred embodiments as Matur, (see, e.g. Burki Examples 3 and 4). Therefore, claim 1 is novel over Burki for the same reasoning as described in Section IA above for Matur.
The Office Action rejected independent claims 28-30 stating "Burki et al. recite the limitations of claims 28-30 see claims 31 -36," without providing any further rationale. OA at 11. These rejections are improper for the same reasoning as described in Section IA above-claims 31-36 of Burki do not disclose any of the features of claims 28-30.
Response to Arguments
17. It is the examiner’s position that as mentioned above the art anticipates the claimed invention It is the examiner’s position that as mentioned above the art anticipates the claimed invention.
Burki et al. recite the limitations of the instant invention such as 24 valent pneumococcal conjugate vaccines comprising a capsular polysaccharide from serotypes, PsaA and CRM197 of Streptococcus pneumoniae conjugated to a carrier protein, multiple serotypes see claims 1-4 and (para 0041,0065,0073, 0074, 0088 which recite 24 valent vaccine),
Burki et al. recite the limitations of claims 9-11 various molecular weights see para 0132, 0133, 0134, 0151, 0152. Burki et al. recite the limitations of claims 17-18 pharmaceutically accepted carriers, diluents and adjuvants (see claims 11, 13).
The above claims meet the limitations of wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197. The serotype group recited by Burki teach each and every instantly claimed serotype. Burki teach 24 valent conjugate vaccines where each serotype is individually conjugated to either PsaA or CRM197. The above claims meet the limitations of wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197.
As argument that claims 28-30 not anticipated by claim 31 of Burki et al. It is the examiner’s position that Burki et al. recite the limitations of claims 28-30 such as pharmaceutically acceptable diluent, buffer, preservative, stabilizer, adjuvant, and/or a lyophilization excipient. see claims 13-16. Different values would be inherent in teachings of Burki et al. recited by its claims 31-37.
Therefore applicant’s argument is not persuasive especially when Burki et al., meet the limitations of wherein the capsular polysaccharide from each serotype is individually conjugated to the carrier protein which is either PsaA or CRM197.
Therefore, Applicants argument is not persuasive and the rejection is maintained.
Conclusion
18. No claims are allowed.
19. 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.
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/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
March 23, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645