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 .
DETAILED ACTION
1. Applicant’s response filed on January 21, 2026 is acknowledged. Claims 1, 11-15, 17-18, 20-21, 24, 26, 27, and 31-39 are currently pending. Claim 1 has been amended. Claims 6-7 and 19 have been canceled. Claims 37-39 have been added. Claims 31-36 were previously withdrawn. Claims 1, 11-15, 17-18, 20-21, 24, 26-27, and 37-39 are currently under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on January 21, 2026 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.
Rejections Withdrawn
3. In view of Applicant’s amendments, the rejection of claims 1, 6-7, 11-15, 17-21, 24, and 26-27 on the basis that it contains an improper Markush grouping of alternatives is withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
The following has been updated to reflect Applicant’s claim amendments
4. The rejection of claim(s) 1, 6-7, 11-15, 17-21, 24, 26-27, and newly added claims 37-39 under 35 U.S.C. 102(a)(1) as being anticipated by Bagle et al, WO 2018/087635; Published: 05/17/18 is maintained for the reasons set forth in the previous office action.
Independent claim 1 is drawn to an immunogenic composition comprising polysaccharide-protein conjugates comprising capsular polysaccharides from group B streptococcus (GBS) serotypes Ia, Ib, II, III, IV, V and VI and a carrier protein, wherein the carrier protein comprises CRM197 or Streptococcal C5a peptidase (SCP).
Bagle et al., disclose immunogenic compositions comprising capsular polysaccharides from Streptococcus agalactiae, commonly referred to as group B streptococcus, conjugated to a carrier protein (see abstract). Bagle discloses that the conjugates comprises serotype Ia, Ib, II, III, IV, V, VI, VII, VIII, and IX (see page 43, lines 10-29; meeting claims 1 and 37-39).
Bagle et al. further disclose that said polysaccharide has sialic acid levels greater than 95% or .95 mM sialic acid per mM of polysaccharide (see page 14; meets claims 11-12). Bagle et al. further disclose that the polysaccharide has a molecular weight of between about 5 kDa and about 1000 kDa (see page 19; meets claims 13-14). Bagle et al. further disclose that the polysaccharides have between 0% and about 40% O-acetylation (see pages 14-15; meets claim 15). Bagle et al. further disclose that the capsular polysaccharide has at least about 0.4 mM acetate per mM saccharide of repeating unit or less than about .05 mM O acetate per mM saccharide repeating unit (see page 15; meets claims 17-18). Bagle et al. further disclose of the carrier protein CRM197 as well as C5a peptidase from Streptococcus (see Figure 1 and page 42, lines 9-14; meets claim 1).
In another aspect, the invention relates to a composition including at least one of any polysaccharide described herein and a pharmaceutically acceptable excipient, buffer, stabilizer, adjuvant, a cryoprotectant, a salt, a divalent cation, a non-ionic detergent, an inhibitor of free radical oxidation, a diluent or a carrier, or mixture thereof. The immunogenic composition optionally comprises one or more physiologically acceptable buffers selected from, but not limited to HEPES, PIPES, MES, Tris (trimethamine), phosphate, acetate, borate, citrate, glycine, histidine and succinate. In a preferred embodiment, the buffer is histidine or phosphate. The surfactant is selected from polysorbate-20, polysorbate-40, polysorbate-40 amongst others. Excipients include, but aren’t limited to, starch, glucose, lactose, sucrose, dextran (see page pages 53-66, Figure 13; meets claim 20-21, 24, 26-27).
Lastly, since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Applicant argues that:
1) The cited art does not specifically disclose the combination of capsular polysaccharides from GBS serotypes Ia, Ib, II, III, IV, V and VI conjugated to carrier proteins CRM197 or SCP and therefore does not anticipate the present claims.
Applicant’s argument have been considered, but is not found persuasive.
As it pertain to point 1, contrary to Applicant’s response, Bagle does anticipate the invention as now claimed. Specifically, Bagle et al., disclose immunogenic compositions comprising capsular polysaccharides from Streptococcus agalactiae, commonly referred to as group B streptococcus, conjugated to a carrier protein. Said serotypes can include Ia, Ib, II, III, IV and V. In one embodiment the conjugates comprise serotype Ia, Ib, II, III, IV, V, VI, VII, VIII, and IX (see page 43, lines 10-29; meeting claims 1 and 37-39). Lastly, Bagle discloses that the carrier protein is CRM197 as well as C5a peptidase from Streptococcus (See Figure 1 and page 42, lines 9-14; meets claim 1). Therefore, the rejection is maintained for the reasons set forth previously.
New Grounds of Objection and Rejection Necessitated by Amendment
Claim Objections
5. Claims 1 and 21 are objected to because of the following informalities:
As it pertains to claim 1, on first sight, CRM should be accompanied by ‘Cross-Reacting Material’.
As it pertains to claim 21, on first sight acronyms such as HEPES should be accompanied by its meaning, i.e. 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES) or 1,4-Piperazinediethanesulfonic acid (PIPES).
Appropriate correction is required.
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.
6. Claims 1, 11-15, 17, 20-21, 24, 26-27, and 37-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-17, and 26-32 of U.S. Patent No. 10,226,525. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to an immunogenic composition comprising polysaccharide-protein conjugates comprising capsular polysaccharides from group B streptococcus (GBS) serotypes Ia, Ib, II, III, IV, V and VI and a carrier protein, wherein the carrier protein comprises CRM197 or Streptococcal C5a peptidase (SCP).
Meanwhile, the combination of the following patented claims are drawn to:
1. An immunogenic composition comprising polysaccharide-protein conjugates, wherein the conjugates comprise capsular polysaccharides from group B streptococcus (GBS) serotypes Ia, Ib, II, III, IV and V, and wherein at least one of the capsular polysaccharides has a sialic acid level of greater than about 60%.
26. An immunogenic composition comprising polysaccharide-protein conjugates from group B streptococcus (GBS) serotype IV and at least five additional serotypes selected from the group consisting of serotypes Ia, Ib, II, III, V, VI, VII, VIII, and IX.
27. An immunogenic composition comprising polysaccharide-protein conjugates comprising at least six GBS capsular polysaccharides selected from the group consisting of serotypes Ia, Ib, II, III, IV, V, VI, VII, VIII, and IX.
28. The immunogenic composition of claim 27, wherein the composition comprises GBS capsular polysaccharide serotype V.
29. The immunogenic composition of claim 28, wherein the composition does not have immune interference.
30. An immunogenic composition according to claim 26 or 27, wherein the protein is CRM197 or tetanus toxoid.
31. An immunogenic composition according to claim 30, wherein the protein is CRM197.
The combination of claims 1, 26-31 anticipate and/or makes obvious the pending claims and invention.
Conclusion
7. No claims are allowed.
8. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
9. 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.
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, 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 July 29, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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