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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 29, 2025 has been entered.
Applicant’s claim amendments have overcome the rejection of record under 35 USC § 103.
Applicant is convincing that Ahl et al. (WO 2019/212846, of record) do not anticipate the weight of each saccharide having a molecular weight of 20-4000 kDa. However, an updated search in the prior art found pertinent teachings addressing this limitation.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 29, 2025 has been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: The abbreviated “S.”, recited in independent claims 1-3 should be spelled out prior to first use. Appropriate correction is required.
Claim 21 remains objected to because of the following informalities: the claim should be spaced below claim 20. This objection was not addressed in applicant’s reply. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 8-12, and 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ahl et al. (WO 2019/212846, of record) and Smith et al. (USPgPub 2019/0192648).
On page 23, lines 13-20 Ahl et al. teach an immunogenic composition containing one or more antigens conjugated to one or more carrier proteins. On page 10, line 20 to page 11, line 24 and claim 18, Ahl et al. teach an immunogenic composition comprising at least one glycoconjugate comprising at least two Streptococcus pneumoniae capsular polysaccharide antigens from different serotypes covalently linked to the same carrier protein. Claim 30 of Ahl et al. recites that the at least two conjugated polysaccharides are S. pneumoniae serotypes 8, 10A, 11A, 12F, 15A, 15B, 22F, 23A, 23B, 33F, and 35B. These teachings satisfy the corresponding limitations required by instant claims 1-4, 11, 16, and 21. Page 22, lines 12-14 of Ahl et al. includes adjuvants, as required by instant claim 12. Claim 31 of Ahl et al. requires that the carrier protein is CRM197, anticipating instant claims 8, 9, 18, 19, 23, and 24. Page 35, line 8 to page 36, line 5 of Ahl. et al. teach that the glycoconjugate is prepared using reductive amination, as required by instant claims 10, 20, and 25. Claim 26 of Ahl et al. list the ratio (weight/weight) of saccharide to carrier protein between 0.7 to 2.0 as required by instant claims 5, 17, and 22.
Ahl et al. do not teach the molecular weight of 20 kDa to 4000 kDa corresponding to “each” polysaccharide, conjugated to the same carrier protein, as required in instant claims 1-3.
Smith et al. teach size reduction and oxidation of S. pneumoniae polysaccharide (Ps) serotypes 8, 10A, 11A, 12F, 15A, 15B, 22F, 23A, 23B, 33F, and 35B, and resulting molecular weights in the first column, “Oxidized Ps Mn/Mw” of each of the following Tables:
Table 5: Ps 8 Mw = 128 kD;
Tables 7 and 8: Ps 10A Mw = 111 and 130 kD, respectively;
Table 9: Ps 11A Mw = 2804 kD;
Table 10: Ps 12F Mw = 73 kD;
Tables 11-13: Ps 15A Mw = 200kD, 154 kD, and 231 kD, respectively;
Table 14: Ps 15B Mw = 252 kD;
Table 24: Ps 22F Mw = 196 kD;
Table 26: Ps 23A Mw = 175 kD;
Table 27: Ps 23B Mw = 179 kD;
Table 32: Ps 33F Mw = 220 kD; and
Tables 33 and 34: Ps 35B Mw = 82 kD and 82kD, respectively.
Therefore, Smith et al. teach the molecular weight of each Ps within the range recited, 20 kDa to 4000 kDa.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have reduced the size of each S. pneumoniae Ps serotype of Ahl et al. to the molecular weights, taught by Smith et al., to enhance covalent associations between the polysaccharide and the protein and enhance immunogenicity of the glycoprotein conjugates in paragraphs [0068, 0120, 0347, 0353, 0362, and 1050] of Smith et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have reduced the size of each of the S. pneumoniae Ps serotype of Ahl et al. to the molecular weights, taught by Smith et al., because both Ahl et al. and Smith et al. size-reduce Ps prior to conjugation to carrier proteins by reductive amination, see page 26, lines 12-29, page 35, line 8 to page 36, line 5, Example 2, of Ahl et al. and the paragraphs bridging the Tables cited above and paragraphs [0021, 0068, and [0351] of Smith et al.
Response to Arguments
In reply to the rejection of record, applicant argues that Ahl et al. do not disclose the specific arrangement of the S. pneumoniae serotypes recited in the instant claims.
Applicant’s arguments have been fully considered, but are found unpersuasive since there is no specific arrangement of the S. pneumoniae serotype polysaccharides implied in the instant claims. A search in the instant specification for “order”, “arrangement”, “location”, “position”, “display”, “placement”, or “locus” of a specific arrangement of the at least two S. pneumoniae serotype polysaccharide conjugation to the carrier protein in the instant disclosure cannot be not located. Since the S. pneumoniae serotype polysaccharides recited in claims 1-3 are selected from “…at least two…selected from the group consisting of…”, any two saccharides, in any order recited, is encompassed by the scope of the claims. The specific arrangement of the S. pneumoniae serotype polysaccharides recited appear to be in numerical and alphabetical order, which is the order also recited by Ahl et al.
Applicant states that instant claim 1 recites a subset consisting of 4 serotypes and instant claims 2 and 3 each recite a subset consisting of 5 serotypes. Applicant calculates that if any four subtypes were selected from the 96 recited in claim 30 of Ahl et al., 3,321,960 combinations would result and if any five serotypes from the same list were selected, 61,124,064 combinations would result. Applicant argues that the skilled artisan could not have at once envisaged the particular combinations recited in the small Markush group instantly recited.
Applicant’s arguments have been fully considered, but are found unpersuasive. Ahl et al. clearly names all of the species of S. pneumoniae polysaccharide serotypes recited even though additional S. pneumoniae polysaccharide serotypes are named. See MPEP § 2131.02 (II). Therefore, the skilled artisan is not required envisage a polysaccharide serotype that is only alluded to, but not expressly taught by Ahl et al. The instant composition “comprising”, encompasses any two of the S. pneumoniae serotype polysaccharides recited in claims 1-3, respectively, in addition to any others not recited. See MPEP § 2111.03 (I). Paragraph [1382-1383] of the instant published disclosure, USPgPub 2022/0016229, exemplifies other serotypes that are encompassed by the instant glycoconjugates, i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, and 23F. The skilled artisan would be able to at once envisage any number of combinations of at least two saccharides recited in instant claims 1-3 in any order, which encompasses any S. pneumoniae polysaccharide serotype not recited, and probably exceeds 3,321,960 combinations since only two from the list recited in claims 1-3, respectively, are required. The claims would only exclude other unrecited polysaccharides from instant claims 1-3 if the glycoconjugate “consisted” of only the saccharides recited. See MPEP § 2111.03 (II). Amendments to the claims drawn to specific 4- or 5-member saccharide conjugates is encouraged if this is the subject matter intended to be claimed.
Applicant points out that Ahl et al. do not teach the molecular weights recited in instant claims 1-3.
Applicant’s arguments are persuasive. However, Smith et al. teach the molecular weights recited in instant claims 1-3, with motivation to modify the sizes of S. pneumoniae saccharide serotypes of Ahl et al., with a reasonable expectation of success, absent evidence to the contrary.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kapre et al. (USPgPub 2018/0353591) claim an immunogenic composition comprising bivalent and/or multivalent S. pneumoniae capsular saccharides with molecular weights ranging from 10 kDa to 300 kDa conjugated to a CRM197carrier protein with a ratio of 1:1. See claims 1, 4, 5, 7, 10, 12, 14-17, and 23.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671