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 .
Election/Restrictions
Applicant’s election of Group I, claims 1, 6-7, 11-15, 17-21, 24, and 26-27 in the reply filed on August 22, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
CLAIMS
1. Claims 1, 6-7, 11-15, 17-21, 24, and 26-27 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of claims 1, 6-7, 11-15, 17-21, 24, and 26-27 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Streptococcus polysaccharide serotypes VI, VII, VII, and IX are all mutually exclusive structures.
Serotype VI:
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326
694
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Serotype VII:
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123
550
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Serotype VIII:
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106
390
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Serotype IX:
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171
572
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Additionally, each of these distinct structures elicit distinct immune responses.
Accordingly, none of group B streptococcus capsular polysaccharides share a “single structural similarity.”
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
1. Claim(s) 1, 6-7, 11-15, 17-21, 24, and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bagle et al.
The claims are directed to an immunogenic composition comprising a polysaccharide-protein conjugate comprising a group B streptococcus (GBS) capsular polysaccharide selected from serotypes VI, VII, VIII, and IX and a carrier protein.
Bagle et al (WO 2018/087635) disclose of immunogenic compositions comprising capsular polysaccharides from Streptococcus agalactiae, commonly referred to as group B streptococcus, conjugated to a carrier protein. (See abstract). Bagle et al further disclose of serotypes VI, VII, VIII and IX. (See claim 1). Bagle et al further disclose of additional serotypes Ia, Ib, II, III, IV and V. (See claim 4). Bagle et al further disclose of sialic acid levels greater than 95% or .95 mM sialic acid per mM of polysaccharide. (See page 14). Bagle et al further disclose of the polysaccharide having a molecular weight of between about 5 kDa and about 1000 kDa. (See page 19). Bagle et al further disclose of the polysaccharides having between 0% and about 40% O-acetylation. (See pages 14-15). Bagle et al further disclose 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). Bagle et al further disclose of the carrier protein CRM197. (See Figure 1). Bagle et al further disclose of HEPES buffer, polysorbate and starch in combination with the polysaccharide conjugate. (See pages 53, 66, Figure 13).
Accordingly, Bagle et al disclose of each and every limitation of the instantly filed claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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 Nickol can be reached at 571 272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 October 16, 2025
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