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 .
This office action is in response to the amendment filed on April 22, 2025 and June 30, 2025. Claims 8-15 are currently pending and are under examination.
Any objections or rejections not reiterated below are hereby withdrawn.
Pending Objections and Rejections
Claim Objections
Claims 8-11 are objected to because of the following informalities: the identifier is recited as SEQ ID No. and should be identified as SEQ ID NO: based on the sequence rules. Appropriate correction is required.
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.
(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.
Claim(s) 8-15 stand rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Niespodziana et al. (US 2014/0193450 A1).
The rejection was explained in the office action mailed on October 22, 2024. Niespodziana et al. disclose a polypeptide comprising at least four peptide fragments consisting of 20 to 50 consecutive amino acid residues of a wild-type allergen fused to the N- and C-terminus of a surface polypeptide of a virus of a hepadnaviridae family or a fragment of the surface polypeptide. The virus of the hepadnaviridae family is Hepatitis B virus. The surface polypeptide of the virus of the hepadnaviridae family is PreS. The polypeptide is a vaccine formulation. The polypeptide can be formulated to comprises at least one adjuvant, pharmaceutical acceptable excipient and/or preservative. The formulation can be administered to an individual in amount of 0.01 µg/kg body weight to 5 mg/kg body weight, preferably 0.1 µg/kg body weight to 10 µg/kg body weight (see claims 1-4 and 22, [0316], and [0319]).
Response to Remarks
Applicants state that Niespodziana et al. do not contain any (experimental) evidence at all showing that fusion proteins comprising a viral capsid flanked by at least two allergen fragments at the N-terminal end and at least two allergen fragments at the C-terminal end are able to induce the formation of antibodies binding to said capsid protein. Niespodziana et al. show only that such fusion proteins may induce the production of antibodies binding specifically to the flanking allergen fragments. This means that the inventors of Niespodziana et al. had no proof that the fusion proteins disclosed therein can be used as a potential vaccine for hepadnaviruses at the filing date of said document. Hence, Niespodziana et al. cannot be considered as novelty destroying for the subject matter claimed in the present patent application. Applicants further state that there is no direct and unambiguous disclosure of the subject mater of claim 1 in Niespodziana et al.
Applicant's arguments filed April 22, 2025 have been fully considered but they are not persuasive. Niespodziana et al. disclose a polypeptide comprising at least four peptide fragments consisting of 20 to 50 consecutive amino acid residues of a wild-type allergen fused to the N- and C-terminus of a surface polypeptide of a virus of a hepadnaviridae family or a fragment of the surface polypeptide. The virus of the hepadnaviridae family is Hepatitis B virus. The surface polypeptide of the virus of the hepadnaviridae family is PreS. The polypeptide is a vaccine formulation. The polypeptide can be formulated to comprises at least one adjuvant, pharmaceutical acceptable excipient and/or preservative. The formulation can be administered to an individual in amount of 0.01 µg/kg body weight to 5 mg/kg body weight, preferably 0.1 µg/kg body weight to 10 µg/kg body weight (see claims 1-4 and 22, [0316], and [0319]).
SEQ ID NO: 16 has 100% identity to SEQ ID NO: 6 of the instant application.
US-14-124-925A-16
; Sequence 16, Application US/14124925A
; Patent No. 9308251
; GENERAL INFORMATION
; APPLICANT: Biomay AG
; TITLE OF INVENTION: Peptide carrier fusion proteins as allergy vaccines
; FILE REFERENCE: 425829US58PCT
; CURRENT APPLICATION NUMBER: US/14/124,925A
; CURRENT FILING DATE: 2013-12-09
; PRIOR APPLICATION NUMBER: EP 11169365.1
; PRIOR FILING DATE: 2011-06-09
; PRIOR APPLICATION NUMBER: PCT/EP2012/061040
; PRIOR FILING DATE: 2012-06-11
; NUMBER OF SEQ ID NOS: 152
; SOFTWARE: PatentIn version 3.5
; SEQ ID NO 16
; LENGTH: 307
; TYPE: PRT
; ORGANISM: Artificial Sequence
; FEATURE:
; OTHER INFORMATION: Synthetic Peptide
US-14-124-925A-16
Query Match 100.0%; Score 1619; DB 7; Length 307;
Best Local Similarity 100.0%;
Matches 307; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MEAAFNDAIKASTGGAYESYKFIPALEAAVKAEEVKVIPAGELQVIEKVDAAFKVAATAA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MEAAFNDAIKASTGGAYESYKFIPALEAAVKAEEVKVIPAGELQVIEKVDAAFKVAATAA 60
Qy 61 NAAPANDKGGWSSKPRKGMGTNLSVPNPLGFFPDHQLDPAFGANSNNPDWDFNPIKDHWP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NAAPANDKGGWSSKPRKGMGTNLSVPNPLGFFPDHQLDPAFGANSNNPDWDFNPIKDHWP 120
Qy 121 AANQVGVGAFGPGLTPPHGGILGWSPQAQGILTTVSTIPPPASTNRQSGRQPTPISPPLR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 AANQVGVGAFGPGLTPPHGGILGWSPQAQGILTTVSTIPPPASTNRQSGRQPTPISPPLR 180
Qy 181 DSHPQAMQWNSTAFHQALQDPRVRGLYFPAGGSSSGTVNPAPNIASHISSISARTGDPVT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DSHPQAMQWNSTAFHQALQDPRVRGLYFPAGGSSSGTVNPAPNIASHISSISARTGDPVT 240
Qy 241 NADLGYGPATPAAPAAGYTPATPAAPAEAAPAGKATTEEQKLIEKINAGFKAALAAAAGV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 NADLGYGPATPAAPAAGYTPATPAAPAEAAPAGKATTEEQKLIEKINAGFKAALAAAAGV 300
Qy 301 QPADKYR 307
|||||||
Db 301 QPADKYR 307
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. It is recognized that structure will lead to functional effect. Since the structure is disclosed the composition will necessarily have the functional effect as currently claimed.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 10:30-9:30 EST.
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/ANAND U DESAI/Primary Examiner, Art Unit 1656