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
Claim Status
Claims 1-4, 7-8, 12-15, 25, 69, 74-76 and 78-79 are pending. Claim 77 has been canceled. Claims 1-4, 8, 12-14, 25 and 76 have been amended. In the response to the restriction requirement, Applicants elected of Group II, SEQ ID NO: 30 (heterologous polypeptide), and SEQ ID NO: 6 (polypeptide).
Applicants elected species (i.e. a fusion protein comprising SEQ ID NOs: 6 and 30) was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that anticipated it. As a result, claims 4, 7-8 and 69 have been examined and claims 1-3, 12-15, 25 and 74-79 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Response to Arguments
In the response filed on 3/3/2026, Applicant argues that claims 75-79 fall within the scope of elected Group II, thus they should be rejoined and examined for patentability.
Applicant’s arguments are not persuasive because, as discussed above, in accordance with Markush Practice, once the elected species is deemed to be free of the prior art, the search is extended to the Markush group/independent claim, and the prior art search will NOT be extended unnecessarily to cover all nonelected species (see MPEP 803.02).
For the reasons stated above, the withdrawal of claims 75-79 is proper.
Claim Objections
Claim 69 is objected to because of the following informalities: Claim 69 should be rewritten to recite “A pharmaceutical composition comprising the fusion protein of claim 4”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The rejection of claims 4, 7-8 and 69 under 35 U.S.C. 102(a)(1) as being anticipated by Berti et al. is withdrawn in view of the amendments to the claims
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.
This is a new rejection.
Claims 4, 7-8 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Berti et al. (WO 2016/020413) in view of Zhu et al. (Hum Vaccin Immunother. 2014 Nov 17;10(9):2761–2774).
With respect to claims 4 and 7-8, Berti et al. teach a conjugate comprising an antigen and a carrier molecule, wherein the carrier molecule comprises a Streptococcus agalactiae BP-2a polypeptide and a Streptococcus agalactiae spb1 polypeptide (claim 1), wherein the spb1 polypeptide comprises the amino acid sequence of SEQ ID NO: 206 (claim 2), wherein the carrier molecule comprises 2 or more BP-2a polypeptides derived from different Streptococcus agalactiae strains as a single polypeptide chain (claim 4), and wherein the polypeptide chain is of the formula NH2-A-{-X-L-}n-B-COOH, wherein: A is an optional N-terminal amino acid sequence; Bis an optional C-terminal amino acid sequence; n is an integer of 2 or more (e.g. 2, 3, 4, 5, 6, etc.); each X is an amino acid sequence of a BP-2a polypeptide or a spb1 polypeptide, wherein at least one X is an BP-2a polypeptide and at least one X is an spb1 polypeptide; and L is an optional linker amino acid sequence (claim 6).
Berti et al. also teach that the antigen is linked to the carrier molecule via a linker (para bridging pages 30-31).
Please note that SEQ ID NO: 206 (depicted below) comprises instantly claimed SEQ ID NO: 43 (bolded)
MKKKMIQSLLVASLAFGMAVSPVTPIAFAAETGTITVQDTQKGATYKAYKVFDAEIDNANVSDSNKDGASYLIPQGKEAEYKASTDFNSLFTTTTNGGRTYVTKKDTASANEIATWAKSISANTTPVSTVTESNNDGTEVINVSQYGYYYVSSTVNNGAVIMVTSVTPNATIHEKNTDATWGDGGGKTVDQKTYSVGDTVKYTITYKNAVNYHGTEKVYQYVIKDTMPSASVVDLNEGSYEVTITDGSGNITTLTQGSEKATGKYNLLEENNNFTITIPWAATNTPTGNTQNGANDDFFYKGINTITVTYTGVLKSGAKPGSADLPENTNIATINPNTSNDDPGQKVTVRDGQITIKKIDGSTKASLQGAIFVLKNATGQFLNFNDTNNVEWGTEANATEYTTGADGIITITGLKEGTYYLVEKKAPLGYNLLDNSQKVILGDGATDTTNSDNLLVNPTVENNKGTELPSTGGIGTTIFYIIGAILVIGAGIVLVARRRLRS
Therefore, the conjugate of Berti et al. comprises SEQ ID NO: 43 and an antigen.
Berti et al. do not teach the claimed heterologous polypeptide (i.e. a polypeptide subunit of a self-assembling protein nanoparticle).
Zhu et al. teach that “[T]he antigen sensing and uptake of a particulate form by APCs are superior to those for small soluble proteins. Therefore, antigens bound to or encapsulated in nanoparticles can be more efficiently internalized compared with free antigens” (page 2763, left column, 1st para).
Zhu et al. also teach that “[A]nother advantage of nanocarriers for delivery is that their surface chemistry can be easily manipulated. For example, antigen uptake can be further enhanced by altering the nanocarrier’s surface charge, hydrophobicity and functional groups for APC targeting (page 2763, right column, 2nd para).
It would have been obvious to one of ordinary skill in the art to link a polypeptide subunit of a self-assembling protein nanoparticle to the conjugate of Berti et al. in order to obtain a nanocarrier which can be more efficiently internalized.
The skilled artisan would have had a reasonable expectation of success because Zhu et al. teach that antigens bound to nanoparticles can be more efficiently internalized compared with free antigens, and further teach that the surface chemistry of nanocarriers can be easily manipulated, thus enhancing antigen uptake.
With respect to claim 69, Berti et al. teach a pharmaceutical composition comprising the conjugate in combination with a pharmaceutically acceptable carrier (claim 12).
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.
This is a new rejection.
Claims 4, 7-8 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10245310 in view of Zhu et al. (Hum Vaccin Immunother. 2014 Nov 17;10(9):2761–2774).
With respect to claims 4 and 7-8, ‘310 teaches a conjugate comprising an antigen and a carrier molecule, wherein the carrier molecule comprises BP-2a polypeptides derived from different Streptococcus agalactiae strains and a Streptococcus agalactiae spbl polypeptide as a single polypeptide chain, said polypeptide chain having an amino acid sequence at least 70% identity to SEQ ID NO:276 (claim 1).
‘310 also teaches that the antigen is linked to the carrier molecule via a linker (column 27, lines 13-15). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
Please note that SEQ ID NO: 206 (depicted below) comprises instantly claimed SEQ ID NO: 43 (bolded)
MKKKMIQSLLVASLAFGMAVSPVTPIAFAAETGTITVQDTQKGATYKAYKVFDAEIDNANVSDSNKDGASYLIPQGKEAEYKASTDFNSLFTTTTNGGRTYVTKKDTASANEIATWAKSISANTTPVSTVTESNNDGTEVINVSQYGYYYVSSTVNNGAVIMVTSVTPNATIHEKNTDATWGDGGGKTVDQKTYSVGDTVKYTITYKNAVNYHGTEKVYQYVIKDTMPSASVVDLNEGSYEVTITDGSGNITTLTQGSEKATGKYNLLEENNNFTITIPWAATNTPTGNTQNGANDDFFYKGINTITVTYTGVLKSGAKPGSADLPENTNIATINPNTSNDDPGQKVTVRDGQITIKKIDGSTKASLQGAIFVLKNATGQFLNFNDTNNVEWGTEANATEYTTGADGIITITGLKEGTYYLVEKKAPLGYNLLDNSQKVILGDGATDTTNSDNLLVNPTVENNKGTELPSTGGIGTTIFYIIGAILVIGAGIVLVARRRLRS
Therefore, the conjugate of ‘310 comprises SEQ ID NO: 43 and an antigen.
‘310 does not teach the claimed heterologous polypeptide (i.e. a polypeptide subunit of a self-assembling protein nanoparticle).
Zhu et al. teach that “[T]he antigen sensing and uptake of a particulate form by APCs are superior to those for small soluble proteins. Therefore, antigens bound to or encapsulated in nanoparticles can be more efficiently internalized compared with free antigens” (page 2763, left column, 1st para).
Zhu et al. also teach that “[A]nother advantage of nanocarriers for delivery is that their surface chemistry can be easily manipulated. For example, antigen uptake can be further enhanced by altering the nanocarrier’s surface charge, hydrophobicity and functional groups for APC targeting (page 2763, right column, 2nd para).
It would have been obvious to one of ordinary skill in the art to link a polypeptide subunit of a self-assembling protein nanoparticle to the conjugate of ‘310 in order to obtain a nanocarrier which can be more efficiently internalized.
The skilled artisan would have had a reasonable expectation of success because Zhu et al. teach that antigens bound to nanoparticles can be more efficiently internalized compared with free antigens, and further teach that the surface chemistry of nanocarriers can be easily manipulated, thus enhancing antigen uptake.
With respect to claim 69, ‘310 teaches a pharmaceutical composition comprising the conjugate in combination with a pharmaceutically acceptable carrier (claim 8).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658