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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1-30-2023 has been entered.
The amendment filed on 1-30-2026 is acknowledged. Claim 19 has been amended. Claims 19-28 and 37-38 are pending. Claims 25, 27-28 and 37-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 19-24 and 26 are currently under examination. It should be noted that claims 37 and 38 have improper claim status indicators. Claims are either “withdrawn” or “previously presented”. Said identifiers need to be corrected in order for any response to this action to be considered fully responsive.
Claim Rejections Withdrawn
The rejection of claims 19-21, 23-24 and 26 under 35 U.S.C. 102(a)(2) as being anticipated by Banci et al. (WO 2011/051893 – IDS filed on 6-23-2025) is withdrawn in light of the amendment thereto.
The rejection of claims 19-23 and 26 under 35 U.S.C. 103 as being unpatentable over Murphy et al. (Journal of Infectious Disease Vol. 200, pages 379-389 – IDS filed on 6-23-2025) is withdrawn in lieu of the rejection set forth below.
Claim Rejections Maintained
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claims 19-23 under 35 U.S.C. 102(a)(2) as being anticipated by Murphy et al. (Journal of Infectious Disease Vol. 200, pages 379-389 – IDS filed on 6-23-2025) is maintained for reasons of record.
Applicant argues:
1. The cited reference doesn’t disclose, teach or suggest a polypeptide with at least 85% sequence identity to SEQ ID NO:47.
With regard to Point 1, given that the claims limit the recitation of the percentage to 2 places the cited reference does disclose a sequence with 85% sequence identity when properly rounded (as is standard within the art).
As outlined previously, Murphy et al. disclose vaccines comprising Neisseria meningitidis Factor H Binding Proteins with at least 85% sequence identity to the sequence of SEQ ID NO:47 and a variant with the L123R substitution; a serine at residue 32 and a glutamate at residue 240 (see the alignment below). Consequently, Murphy et al. anticipates all the limitations of the rejected claims.
RESULT 228
RA Murphy E., Andrew L., Lee K.L., Dilts D.A., Nunez L., Fink P.S.,
RA Ambrose K., Borrow R., Findlow J., Taha M.K., Deghmane A.E., Kriz P.,
RA Musilek M., Kalmusova J., Caugant D.A., Alvestad T., Mayer L.W.,
RA Sacchi C.T., Wang X., Martin D., von Gottberg A., du Plessis M.,
RA Klugman K.P., Anderson A.S., Jansen K.U., Zlotnick G.W., Hoiseth S.K.;
RT "Sequence diversity of the factor H binding protein vaccine candidate in
RT epidemiologically relevant strains of serogroup B Neisseria meningitidis.";
RL J. Infect. Dis. 200:379-389(2009).
RN [2] {ECO:0007829|PDB:7NRU}
Query Match 84.6%; Score 1049.5; Length 255;
Best Local Similarity 82.7%;
Matches 205; Conservative 19; Mismatches 23; Indels 1; Gaps 1;
Qy 1 VAADIGAGLADALTAPLDHKDKSLQSLTLDQXVRKNEKLKLAAQGAEKTYGNGDSLNTGK 60
|||||||||||||||||||||| ||||||||:||||||||||||||||||||||||||||
Db 8 VAADIGAGLADALTAPLDHKDKGLQSLTLDQSVRKNEKLKLAAQGAEKTYGNGDSLNTGK 67
Qy 61 LKNDKVSRFDFIRQIEVDGQLITLESGEFQIYKQDHSAVVALQIEKINNPDKIDSLINQR 120
|||||||||||||||||||:||||||||||:||| |||: ||| |:: : : :: :|
Db 68 LKNDKVSRFDFIRQIEVDGKLITLESGEFQVYKQSHSALTALQTEQVQDSEDSGKMVAKR 127
Qy 121 SFXVSGLGGEHTAFNQLP-DGKAEYHGKAFSSDDAGGKLTYTIDFAAKQGHGKIEHLKTP 179
|:: : ||||:|::|| | | | | || |||||||||||||||||||||||||||||
Db 128 QFRIGDIAGEHTSFDKLPKGGSATYRGTAFGSDDAGGKLTYTIDFAAKQGHGKIEHLKTP 187
Qy 180 EQNVELAAAELKADEKSHAVILGDTRYGSEEKGTYHLALFGDRAQEIAGSATVKIGEKVH 239
|||||||:|||||||||||||||||||| |||||||||||||||||||||||||| ||||
Db 188 EQNVELASAELKADEKSHAVILGDTRYGGEEKGTYHLALFGDRAQEIAGSATVKIREKVH 247
Qy 240 XIGIAGKQ 247
:|||||||
Db 248 EIGIAGKQ 255
New Grounds of Rejection
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19-23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al. (Journal of Infectious Disease Vol. 200, pages 379-389 – IDS filed on 6-23-2025) and Pizza et al. (U.S. Patent Application Publication 2011/0020390).
Murphy et al. disclose vaccines comprising Neisseria meningitidis Factor H Binding Proteins with at least 85% sequence identity to the sequence of SEQ ID NO:47 and a variant with the L123R substitution; a serine at residue 32 and a glutamate at residue 240 (see the alignment below). Consequently, Murphy et al. anticipates all the limitations of the rejected claims.
Murphy et al. differs from the instant invention in that they don’t explicit the use of adjuvants in their compositions.
Pizza et al. disclose vaccine compositions comprising the fHbp protein of Neisseria meningitidis (see abstract and paragraph [0058] for example). Pizza et al. further disclose that their vaccines can be used in their compositions (see paragraph [0070]) and that said adjuvant can be aluminum phosphate (see paragraph [0072]).
It would have been obvious for one of ordinary skill in the art to utilize the adjuvants disclosed by Pizza et al. in the compositions of Murphy et al. in order increase the immunogenicity of the vaccine compositions.
One would have had a reasonable expectation of success as both Murphy et al. and Pizza et al. disclose vaccine compositions comprising the fHbp protein.
Moreover, given that it is well settled that adjuvants are used in a myriad of vaccine compositions (as evidenced by Pizza et al.), the addition of an adjuvant to the polypeptide compositions of Murphy et al. would have been obvious to one of ordinary skill in the art. Moreover, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Murphy et al. disclose the use of their fHbp in vaccine compositions and that the use of adjuvants in vaccine compositions is well established in the art, the use of adjuvants in the compositions of Murphy et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
RESULT 228
RA Murphy E., Andrew L., Lee K.L., Dilts D.A., Nunez L., Fink P.S.,
RA Ambrose K., Borrow R., Findlow J., Taha M.K., Deghmane A.E., Kriz P.,
RA Musilek M., Kalmusova J., Caugant D.A., Alvestad T., Mayer L.W.,
RA Sacchi C.T., Wang X., Martin D., von Gottberg A., du Plessis M.,
RA Klugman K.P., Anderson A.S., Jansen K.U., Zlotnick G.W., Hoiseth S.K.;
RT "Sequence diversity of the factor H binding protein vaccine candidate in
RT epidemiologically relevant strains of serogroup B Neisseria meningitidis.";
RL J. Infect. Dis. 200:379-389(2009).
RN [2] {ECO:0007829|PDB:7NRU}
Query Match 84.6%; Score 1049.5; Length 255;
Best Local Similarity 82.7%;
Matches 205; Conservative 19; Mismatches 23; Indels 1; Gaps 1;
Qy 1 VAADIGAGLADALTAPLDHKDKSLQSLTLDQXVRKNEKLKLAAQGAEKTYGNGDSLNTGK 60
|||||||||||||||||||||| ||||||||:||||||||||||||||||||||||||||
Db 8 VAADIGAGLADALTAPLDHKDKGLQSLTLDQSVRKNEKLKLAAQGAEKTYGNGDSLNTGK 67
Qy 61 LKNDKVSRFDFIRQIEVDGQLITLESGEFQIYKQDHSAVVALQIEKINNPDKIDSLINQR 120
|||||||||||||||||||:||||||||||:||| |||: ||| |:: : : :: :|
Db 68 LKNDKVSRFDFIRQIEVDGKLITLESGEFQVYKQSHSALTALQTEQVQDSEDSGKMVAKR 127
Qy 121 SFXVSGLGGEHTAFNQLP-DGKAEYHGKAFSSDDAGGKLTYTIDFAAKQGHGKIEHLKTP 179
|:: : ||||:|::|| | | | | || |||||||||||||||||||||||||||||
Db 128 QFRIGDIAGEHTSFDKLPKGGSATYRGTAFGSDDAGGKLTYTIDFAAKQGHGKIEHLKTP 187
Qy 180 EQNVELAAAELKADEKSHAVILGDTRYGSEEKGTYHLALFGDRAQEIAGSATVKIGEKVH 239
|||||||:|||||||||||||||||||| |||||||||||||||||||||||||| ||||
Db 188 EQNVELASAELKADEKSHAVILGDTRYGGEEKGTYHLALFGDRAQEIAGSATVKIREKVH 247
Qy 240 XIGIAGKQ 247
:|||||||
Db 248 EIGIAGKQ 255
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 June 23, 2026
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