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
2. This Office Action is responsive to Applicant’s Remarks, filed March 2, 2026. The Remarks, filed March 2, 2026, contains no amendment to the claims.
Claims 1 – 5, 7 – 8, 10 – 11, 14 – 15, 17 – 18, 20 – 22, 24, 28 – 29, 32, 34, and 36 – 39 are pending in this application, wherein claims 1 – 5, 7 – 8, 10 – 11, 14 – 15, 17 – 18, 20 – 22, and 36 – 37 are withdrawn and claims 6, 9, 12 – 13, 16, 19, 23, 25 – 27, 30 – 31, 33, and 35 are canceled.
Claims 24, 28 – 29, 32, 34, and 38 – 39 are examined on the merits herein.
Priority
3. This application is a national stage application of PCT/EP2020/066314, filed June 12, 2020, which claims benefit of foreign priority document GB1908528.1, filed June 13, 2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Rejections
4. The rejection of claims 24, 28 – 29, and 38 in the previous Office Action, mailed October 29, 2025, under 35 U.S.C. 102(a)(1) as being anticipated by Michon et al. with evidence provided by Jermyn has been considered and is withdrawn in view of Applicant’s Remarks because Michon et al. only show XI comprises a β-1,4 bond between the reducing end sugar and the linear chain of rhamnose moieties.
The rejection of claims 24, 28 – 29, 32, 34, and 38 – 39 in the previous Office Action, mailed October 29, 2025, under 35 U.S.C. 103 as being unpatentable over Michon et al. with evidence provided by Jermyn in view of Faridmoayer et al. has been considered and is withdrawn in view of Applicant’s Remarks because Michon et al. only show XI comprises a β-1,4 bond between the reducing end sugar and the linear chain of rhamnose moieties.
The following are new grounds of rejection necessitated by Applicant’s Remarks, filed March 2, 2026, wherein no claims have been amended. Previously and newly cited references are used to establish the new grounds of rejection.
New Claim Rejections - 35 USC § 102
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 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.
Claims 24, 28, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Beek (Utrecht University, 2018, Reference included with PTO-892).
a. Independent claim 24 is directed to a synthetic streptococcal polysaccharide, the polysaccharide having a non-reducing end comprising a linear chain of rhamnose moieties and a reducing end comprising a hexose monosaccharide, wherein the linear chain of rhamnose moieties comprises a repeating unit consisting of rhamnose-galactose, wherein the polysaccharide comprises a α-1,3 bond or a α-1,2 bond between the hexose monosaccharide and the linear chain of rhamnose moieties, and the hexose comprises galactose. Dependent claim 28 is directed to the polysaccharide, wherein the polysaccharide comprises a polysaccharide, or a fragment, or a variant that are Group G carbohydrates. Dependent claim 38 is directed to the polysaccharide, wherein each or any repeating unit and/or rhamnose moiety includes one or more side groups.
van der Beek teaches making an breaking streptococcal rhamnose polysaccharides (SRPs) (Title), wherein the SRPs may be produced via SRP biosynthesis pathway (page 13, para. 2). Group G carbohydrate contains a backbone of [α-1,2 galactose α-1,3 rhamnose]n and a GalNAc-rhamnose side chain linked to the rhamnose backbone reside (page 9, para. 2; page 10, Figure 1A):
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van der Beek teaches a streptococcal polysaccharide, specifically Group G carbohydrate, having a backbone of [α-1,2 galactose α-1,3 rhamnose]n. Claim 24 recites that the linear chain of rhamnose moieties may comprise a repeating unit consisting of rhamnose-galactose. Thus, van der Beek teaches the recited linear chain. Further the disclosed backbone includes α-1,2 galactose, thereby meeting (ii) of claim 24, which require a α-1,2 bond between the hexose monosaccharide and the linear chain of rhamnose moieties, wherein the hexose comprises galactose. Under the broadest reasonable interpretation, the disclosed polysaccharide necessarily possesses terminal residues. The terminal galactose residue, having a free anomeric carbon, constitutes the claimed reducing end hexose monosaccharide, while the opposite terminal rhamnose residue constitutes the non-reducing end.
For these reasons above, van der Beek anticipates the claimed invention.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
Claims 24, 28 – 29, 32, 34, and 38 – 39 are rejected under 35 U.S.C. 103 as being unpatentable over van der Beek (Utrecht University, 2018, Reference included with PTO-892) in view of Faridmoayer et al. (WO2019/016188A1, cited in the previous Office Action mailed December 26, 2024). Claims 24, 28, and 38 are rejected here because they have been rejected by the primary reference under 102.
b. Regarding claims 24, 28 – 29, 32, 34, and 38 – 39, van der Beek teaches making an breaking streptococcal rhamnose polysaccharides (SRPs) (Title), wherein the SRPs may be produced via SRP biosynthesis pathway (page 13, para. 2). Group G carbohydrate contains a backbone of [α-1,2 galactose α-1,3 rhamnose]n and a GalNAc-rhamnose side chain linked to the rhamnose backbone reside (page 9, para. 2; page 10, Figure 1A):
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van der Beek further teaches that current vaccines strategies have created incentive to use non-protein antigens for vaccine design and further teach that glycoconjugate vaccines consist of isolated polysaccharides covalently attached to a protein carrier. van der Beek also teach that the use of SRPs as vaccine antigens is of considerable interest (page 146, para. 1).
However, van der Beek does not teach an immunogenic composition or vaccine comprising the streptococcal rhamnose polysaccharide with a pharmaceutically acceptable excipient, wherein the composition further comprises an adjuvant.
Faridmoayer et al. teach a saccharide from Streptococcus pneumoniae that is used as an immunogenic compositions and vaccines, wherein the saccharide may be used either on its own or as a conjugate, coupled to a carrier protein (page 1, lines 5 – 10). In one embodiment, the immunogenic composition further comprises a pharmaceutically acceptable excipient (page 48, lines 33 – 34). In an embodiment, the immunogenic composition of the invention is administered in combination with an adjuvant (page 60, lines 34 – 35).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to use the group G streptococcal rhamnose polysaccharide taught by van der Beek in a glycoconjugate format covalently attached to a protein carrier, and to formulate the resulting conjugate in an immunogenic composition or vaccine further comprising a pharmaceutically acceptable excipient and an additional adjuvant because van der Beek teaches that glycoconjugate vaccines consist of isolated polysaccharides covalently attached to a protein carrier and that SRPs are of considerable interest as vaccine antigens, and Faridmoayer et al. teach immunogenic compositions comprising saccharides, pharmaceutical acceptable excipients, and an adjuvant. One would have been motivated to use the group G streptococcal rhamnose polysaccharide taught by van der Beek in a glycoconjugate format covalently attached to a protein carrier because van der Beek teaches that glycoconjugate vaccines consist of isolated polysaccharides covalently attached to a protein carrier and further teaches that the use of streptococcal rhamnose polysaccharides as vaccine antigens is of considerable interest. One would have been motivated to formulate the resulting glycoconjugate in an immunogenic composition or vaccine comprising a pharmaceutically acceptable excipient and an additional adjuvant because Faridmoayer et al. teach saccharide-based immunogenic compositions/vaccines. For the limitation “an acceptor” in claim 29, the specification recites “The acceptor may comprise a peptide or a protein” (page 28, line 12). Thus, the disclosure of van der Beek reads on the claimed limitation of “an acceptor”. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to use the group G streptococcal rhamnose polysaccharide taught by van der Beek in a glycoconjugate format covalently attached to a protein carrier because van der Beek teaches that glycoconjugate vaccines consist of isolated polysaccharides covalently attached to a protein carrier and further teaches that streptococcal rhamnose polysaccharides are of considerable interest as vaccine antigens and Faridmoayer et al. teach saccharide-based immunogenic compositions, including saccharides used either alone or as conjugates coupled to a carrier protein, and further teach formulations comprising a pharmaceutically acceptable excipient and an adjuvant. Thus, the cited art teach the same general vaccine format and use of polysaccharide-protein conjugates, such that one of ordinary skill in the art would have reasonably expected that the streptococcal rhamnose polysaccharide of van der Beek could be successfully incorporated into the known glycoconjugate vaccine platform and formulated into an immunogenic composition.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed March 2, 2026, have been fully considered and are found to be not persuasive.
Regarding Michon et al., Applicant argues that Michon et al. does not anticipate the subject matter of independent claim 24 as the structure shown in XI comprises a β-1,4 bond between the reducing end sugar and the linear chain of rhamnose moieties and Michon et al. does not disclose a synthetic streptococcal polysaccharide comprising the features of claim 24.
Regarding Jermyn, Applicant further argues that Jermyn merely notes “D-glucitol is a known effective acceptor” and does not disclose a synthetic polysaccharide comprising the combination of features recited in claim 24.
Regarding Faridmoayer et al., Applicant argues that Faridmoayer et al. teach an unrelated polysaccharide, which does not comprise the features of instant claim 24. Thus, the skilled person in the art would not , and could not, have arrived at the subject matter of the instant claims by combining the teachings of Faridmoayer et al.
However, Applicant’s arguments directed to Michon et al., Jermyn, and Faridmoayer et al. are moot because the new rejection is no longer based on Michon et al. with Jermyn in view of Faridmoayer et al. The new rejection is relied upon the combination of van der Beek and Faridmoayer et al. van der Beek teaches a Group G SRP having a backbone of [α-1,2 galactose α-1,3 rhamnose]n, which reads on claim 24 because claim 24 encompasses a linear chain of rhamnose moieties comprising a repeating unit consisting of rhamnose-galactose, and the disclosed α-1,2 galactose satisfies the recited hexose/linkage relationship. van der Beek further teaches that glycoconjugate vaccines consist of isolated polysaccharides covalently attached to a protein carrier and teaches that SRPs are of considerable interest as vaccine antigens, thereby supporting the claimed conjugate/vaccine context. Faridmoayer et al. is not relied upon to supply the core SRP structure of claim 24, but to teach known immunogenic composition features, including saccharide conjugates coupled to a carrier protein, pharmaceutical acceptable excipients, and formulations comprising an additional adjuvant. Therefore, the new combination of references renders the claimed invention obvious.
Furthermore, Applicant argues that the present inventors have devised the claimed synthetic polysaccharides, which may be easily synthesized for use in various applications rather than relying on existing labor-intensive chemical or enzymatic extraction methods from native bacteria. Applicant further points to Figures 1 and 2 as allegedly demonstrating that an exemplary synthetic rhamnose polysaccharide triggers an antibody response and binds to multiple group A Streptococcus serotypes. These arguments are not persuasive. The alleged ease of synthesis and avoidance of extraction from native bacteria are not the recited limitations of the pending claims. The claims are directed to the structural subject matter of the synthetic SRP and compositions comprising the same, rather than to any particular manufacturing efficiency or extraction-free preparation method. Moreover, the data relied upon by Applicant are not commensurate in scope with the pending claims. The figures appear to relate to a specific exemplary construct in a particular conjugated immunization format, whereas the pending claims are not limited to that specific construct. Also, the data do not establish that the results are unexpected relative to the closest prior art. The cited data show that the exemplary construct is immunogenic and useful in a vaccine-related context, which would not have been surprising in view of the teachings of van der Beek that SRPs are of considerable interest as vaccine antigens and that glycoconjugate vaccines consist of isolated polysaccharides covalently attached to a protein carrier, together with the teachings of Faridmoayer et al. regarding saccharide-based immunogenic compositions and vaccines. Furthermore, Applicant has not provided a direct comparison showing that the claimed invention exhibits superior or unexpected properties over the SRPs disclosed in the closest prior art.
Conclusion
No claim is found to be allowable.
THIS ACTION IS MADE NON-FINAL.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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