The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 8-3-2026 is acknowledged. Claims 34-53 are pending. Claims 36-38 and 44-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 34-35 and 39-43 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 12-16-2026 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 34 and 42 are objected to for reciting language drawn to non-elected inventions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 34-35 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Choi et al. (U.S. Patent Application Publication US 2002/0061545) and Nordlund et al. (Biochemistry Journal, Vol. 392, pages 485-491 – IDS filed on 12-16-2024).
Choi et al. disclose the Streptococcus pneumoniae SP012 protein having the amino acid sequence of SEQ ID NO:209 (see SEQ ID NO:18 and alignment below) and their use in immunological compositions.
Choi et al. differs from the instant invention in that they don’t explicitly disclose the use of a biotin-binding protein (e.g. avidin, streptavidin or neutravidin) in a fusion protein.
Nordlund et al. disclose the use of scAvd (tetravalent single-chain avidin) as a stable scaffold providing four independent binding sites (see page 485). Moreover, Nordlund et al. disclose that said scAvd could be used in a fusion protein since it provides a unique, oligomeric structure which is fully functional with four high-affinity binding sites (see abstract and page 489).
It would have been obvious for one of ordinary skill in the art to utilize the scAvd of Nordlund et al. in conjunction with the protein of Choi et al. in order to take advantage of the four high-affinity biotin binding sites which would allow the presentation of ligands/antigens in the same molecule.
One would have had a reasonable expectation of success as Nordlund et al. disclose that their scAvd would make a good fusion partner.
ALIGNMENT:
Query Match 100.0%; Score 1305; Length 258;
Best Local Similarity 100.0%;
Matches 252; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 7 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 66
Qy 61 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 67 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 126
Qy 121 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 127 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 186
Qy 181 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 187 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 246
Qy 241 EDVATKEVKEGQ 252
||||||||||||
Db 247 EDVATKEVKEGQ 258
Claims 34-35 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Choi et al. (U.S. Patent Application Publication US 2002/0061545) and Malley et al. (WO 2012/155007 – IDS filed on 12-6-202).
Choi et al. disclose the Streptococcus pneumoniae SP012 protein having the amino acid sequence of SEQ ID NO:209 (see SEQ ID NO:18 and alignment below) and their use in immunological compositions.
Choi et al. differs from the instant invention in that they don’t explicitly disclose the use of a biotin-binding protein (e.g. avidin, streptavidin or neutravidin) in a fusion protein.
Malley et al. disclose the use of affinity binding pairs for increased antigen presentation (see abstract and paragraph [000154]). Malley et al. further disclose that said affinity binding pairs can comprise biotin binding proteins such as rhizavidin (see paragraph [000155]).
It would have been obvious for one of ordinary skill in the art to utilize the antigen of Choi et al. in conjunction with the binding proteins of Malley et al. in order to take advantage of the increased immunogenicity of the resulting compositions.
One would have had a reasonable expectation of success as Malley et al. disclose that their binding proteins can be used with a myriad of antigens (see paragraph [00059]).
ALIGNMENT:
Query Match 100.0%; Score 1305; Length 258;
Best Local Similarity 100.0%;
Matches 252; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 7 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 66
Qy 61 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 67 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 126
Qy 121 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 127 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 186
Qy 181 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 187 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 246
Qy 241 EDVATKEVKEGQ 252
||||||||||||
Db 247 EDVATKEVKEGQ 258
Claims 34-35 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Choi et al. (U.S. Patent 6,573,082) and Nordlund et al. (Biochemistry Journal, Vol. 392, pages 485-491 – IDS filed on 12-16-2024).
Choi et al. disclose the Streptococcus pneumoniae SP012 protein having the amino acid sequence of SEQ ID NO:209 (see SEQ ID NO:18 and alignment below) and their use in immunological compositions.
Choi et al. differs from the instant invention in that they don’t explicitly disclose the use of a biotin-binding protein (e.g. avidin, streptavidin or neutravidin) in a fusion protein.
Nordlund et al. disclose the use of scAvd (tetravalent single-chain avidin) as a stable scaffold providing four independent binding sites (see page 485). Moreover, Nordlund et al. disclose that said scAvd could be used in a fusion protein since it provides a unique, oligomeric structure which is fully functional with four high-affinity binding sites (see abstract and page 489).
It would have been obvious for one of ordinary skill in the art to utilize the scAvd of Nordlund et al. in conjunction with the protein of Choi et al. in order to take advantage of the four high-affinity biotin binding sites which would allow the presentation of ligands/antigens in the same molecule.
One would have had a reasonable expectation of success as Nordlund et al. disclose that their scAvd would make a good fusion partner.
ALIGNMENT:
Query Match 100.0%; Score 1305; Length 258;
Best Local Similarity 100.0%;
Matches 252; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 7 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 66
Qy 61 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 67 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 126
Qy 121 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 127 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 186
Qy 181 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 187 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 246
Qy 241 EDVATKEVKEGQ 252
||||||||||||
Db 247 EDVATKEVKEGQ 258
Claims 34-35 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Choi et al. (U.S. Patent 6,573,082) and Malley et al. (WO 2012/155007 – IDS filed on 12-6-202).
Choi et al. disclose the Streptococcus pneumoniae SP012 protein having the amino acid sequence of SEQ ID NO:209 (see SEQ ID NO:18 and alignment below) and their use in immunological compositions.
Choi et al. differs from the instant invention in that they don’t explicitly disclose the use of a biotin-binding protein (e.g. avidin, streptavidin or neutravidin) in a fusion protein.
Malley et al. disclose the use of affinity binding pairs for increased antigen presentation (see abstract and paragraph [000154]). Malley et al. further disclose that said affinity binding pairs can comprise biotin binding proteins such as rhizavidin (see paragraph [000155]).
It would have been obvious for one of ordinary skill in the art to utilize the antigen of Choi et al. in conjunction with the binding proteins of Malley et al. in order to take advantage of the increased immunogenicity of the resulting compositions.
One would have had a reasonable expectation of success as Malley et al. disclose that their binding proteins can be used with a myriad of antigens (see paragraph [00059]).
ALIGNMENT:
Query Match 100.0%; Score 1305; Length 258;
Best Local Similarity 100.0%;
Matches 252; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 7 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 66
Qy 61 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 67 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 126
Qy 121 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 127 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 186
Qy 181 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 187 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 246
Qy 241 EDVATKEVKEGQ 252
||||||||||||
Db 247 EDVATKEVKEGQ 258
Claims 34-35 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Doucette-Stamm et al. (U.S. Patent 7,051,530) and Nordlund et al. (Biochemistry Journal, Vol. 392, pages 485-491 – IDS filed on 12-16-2024).
Doucette-Stamm et al. disclose the Streptococcus pneumoniae SP012 protein having the amino acid sequence of SEQ ID NO:209 (see SEQ ID NO:3397 and alignment below) and their use in immunological compositions.
Doucette-Stamm et al. differs from the instant invention in that they don’t explicitly disclose the use of a biotin-binding protein (e.g. avidin, streptavidin or neutravidin) in a fusion protein.
Nordlund et al. disclose the use of scAvd (tetravalent single-chain avidin) as a stable scaffold providing four independent binding sites (see page 485). Moreover, Nordlund et al. disclose that said scAvd could be used in a fusion protein since it provides a unique, oligomeric structure which is fully functional with four high-affinity binding sites (see abstract and page 489).
It would have been obvious for one of ordinary skill in the art to utilize the scAvd of Nordlund et al. in conjunction with the protein of Doucette-Stamm et al. in order to take advantage of the four high-affinity biotin binding sites which would allow the presentation of ligands/antigens in the same molecule.
One would have had a reasonable expectation of success as Nordlund et al. disclose that their scAvd would make a good fusion partner.
ALIGNMENT:
Query Match 100.0%; Score 1305; Length 278;
Best Local Similarity 100.0%;
Matches 252; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 27 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 86
Qy 61 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 87 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 146
Qy 121 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 147 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 206
Qy 181 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 207 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 266
Qy 241 EDVATKEVKEGQ 252
||||||||||||
Db 267 EDVATKEVKEGQ 278
Claims 34-35 and 39-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Doucette-Stamm et al. (U.S. Patent 7,081,530) and Malley et al. (WO 2012/155007 – IDS filed on 12-6-202).
Doucette-Stamm et al. disclose a Streptococcus pneumoniae protein having the amino acid sequence of SEQ ID NO:209 (see SEQ ID NO:3397 and alignment below) and their use in immunological compositions.
Doucette-Stamm et al. differs from the instant invention in that they don’t explicitly disclose the use of a biotin-binding protein (e.g. avidin, streptavidin or neutravidin) in a fusion protein.
Malley et al. disclose the use of affinity binding pairs for increased antigen presentation (see abstract and paragraph [000154]). Malley et al. further disclose that said affinity binding pairs can comprise biotin binding proteins such as rhizavidin (see paragraph [000155]).
It would have been obvious for one of ordinary skill in the art to utilize the antigen of Doucette-Stamm et al. in conjunction with the binding proteins of Malley et al. in order to take advantage of the increased immunogenicity of the resulting compositions.
One would have had a reasonable expectation of success as Malley et al. disclose that their binding proteins can be used with a myriad of antigens (see paragraph [00059]).
ALIGNMENT:
Query Match 100.0%; Score 1305; Length 278;
Best Local Similarity 100.0%;
Matches 252; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 27 TSGDNWSKYQSNKSITIGFDSTFVPMGFAQKDGSYAGFDIDLATAVFEKYGITVNWQPID 86
Qy 61 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 87 WDLKEAELTKGTIDLIWNGYSATDERREKVAFSNSYMKNEQVLVTKKSSGITTAKDMTGK 146
Qy 121 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 147 TLGAQAGSSGYADFEANPEILKNIVANKEANQYQTFNEALIDLKNDRIDGLLIDRVYANY 206
Qy 181 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 207 YLEAEGVLNDYNVFTVGLETEAFAVGARKEDTNLVKKINEAFSSLYKDGKFQEISQKWFG 266
Qy 241 EDVATKEVKEGQ 252
||||||||||||
Db 267 EDVATKEVKEGQ 278
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 August 21, 2026
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