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 .
Election/Restrictions
Applicant's election of Group I, claims 1-9 and 11 in the reply filed on November 14, 2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14-20, 25, 27 and 30-31 are withdrawn as being drawn to non-elected invention.
Claims 1-9 and 11 are under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 6, 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Present claim 2 recites: The vaccine composition of claim 1, wherein the recombinant Zika virus envelope protein is one in which a polypeptide consisting of an amino acid sequence of SEQ ID NO: 4 is fused.
The claim is indefinite because it is not clear, where the polypeptide consisting of an amino acid sequence of SEQ ID NO: 4 is fused to. Is SEQ ID NO: 4 fused to SEQ ID NO: 1? or is the recombinant Zika virus further comprising SEQ ID NO: 4 fused with the nucleic acid encoding the recombinant Zika virus? Additionally, the metes and bounds of the claimed fusion are unclear. Applicant is suggested to amend the claims to recite that the recombinant Zika virus comprising SEQ ID NO: 1 further comprises SEQ ID NO: 4 covalently attached/fused with the nucleic acid encoding SEQ ID NO:1.
Present claim 3 recites: The vaccine composition of claim 1, wherein the recombinant Zika virus envelope protein is one in which a polypeptide consisting of an amino acid sequence of SEQ ID NO: 6 is fused.
The claim is indefinite because it is not clear, where the polypeptide consisting of an amino acid sequence of SEQ ID NO: 6 is fused to. Is SEQ ID NO: 6 fused to SEQ ID NO: 1? or is the recombinant Zika virus further comprising SEQ ID NO: 4 fused with the nucleic acid encoding the recombinant Zika virus? Additionally, the metes and bounds of the claimed fusion are unclear.
Present claim 4 recites: The vaccine composition of claim 3, wherein the recombinant Zika virus envelope protein is one in which a polypeptide consisting of an amino acid sequence of SEQ ID NO: 8 is further fused. The claim is indefinite because it is not clear, where the polypeptide consisting of an amino acid sequence of SEQ ID NO: 8 is fused to. Is SEQ ID NO: 8 fused to SEQ ID NO: 1, SEQ ID NO: 4 or SEQ ID NO: 6? Additionally, the metes and bounds of the claimed fusion are unclear.
Correction is required.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Petsch et al. (US Patent 11,723,967).
Petsch et al. disclose a vaccine composition comprising a recombinant Zika virus envelope protein comprising an amino acid sequence identical with present SEQ ID NO: 1 and an adjuvant selected from alum or monophosphoryl lipid A (MPL) (see SEQ ID NO: 760 in Petsch et al, and a sequence alignment below, Example 3, Example 7, column 3, lines 12-42, column 12, lines 11-52, column 15, lines 25-44, columns 139-140).
Thus, by this disclosure Petsch et al. anticipate the present claims.
Present SEQ ID NO: 1 and SEQ ID NO: 760 in Petsch)
Query Match 100.0%; Score 2416; Length 687;
Best Local Similarity 100.0%;
Matches 454; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 IRCIGVSNRDFVEGMSGGTWVDVVLEHGGCVTVMAQDKPTVDIELVTTTVSNMAEVRSYC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 184 IRCIGVSNRDFVEGMSGGTWVDVVLEHGGCVTVMAQDKPTVDIELVTTTVSNMAEVRSYC 243
Qy 61 YEASISDMASDSRCPTQGEAYLDKQSDTQYVCKRTLVDRGWGNGCGLFGKGSLVTCAKFA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 244 YEASISDMASDSRCPTQGEAYLDKQSDTQYVCKRTLVDRGWGNGCGLFGKGSLVTCAKFA 303
Qy 121 CSKKMTGKSIQPENLEYRIMLSVHGSQHSGMIVNDTGHETDENRAKVEITPNSPRAEATL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 304 CSKKMTGKSIQPENLEYRIMLSVHGSQHSGMIVNDTGHETDENRAKVEITPNSPRAEATL 363
Qy 181 GGFGSLGLDCEPRTGLDFSDLYYLTMNNKHWLVHKEWFHDIPLPWHAGADTGTPHWNNKE
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 364 GGFGSLGLDCEPRTGLDFSDLYYLTMNNKHWLVHKEWFHDIPLPWHAGADTGTPHWNNKE 423
Qy 241 ALVEFKDAHAKRQTVVVLGSQEGAVHTALAGALEAEMDGAKGRLSSGHLKCRLKMDKLRL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 424 ALVEFKDAHAKRQTVVVLGSQEGAVHTALAGALEAEMDGAKGRLSSGHLKCRLKMDKLRL 483
Qy 301 KGVSYSLCTAAFTFTKIPAETLHGTVTVEVQYAGTDGPCKVPAQMAVDMQTLTPVGRLIT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 484 KGVSYSLCTAAFTFTKIPAETLHGTVTVEVQYAGTDGPCKVPAQMAVDMQTLTPVGRLIT 543
Qy 361 ANPVITESTENSKMMLELDPPFGDSYIVIGVGEKKITHHWHRSGSTIGKAFEATVRGARR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 544 ANPVITESTENSKMMLELDPPFGDSYIVIGVGEKKITHHWHRSGSTIGKAFEATVRGARR 603
Qy 421 MAVLGDTAWDFGSVGGALNSLGKGIHQIFGAAFK 454
||||||||||||||||||||||||||||||||||
Db 604 MAVLGDTAWDFGSVGGALNSLGKGIHQIFGAAFK 637
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-4, 6-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Petsch et al. (US Patent 11,723,967) as applied to claim 1 and further in view of Mason et al. (US Patent Application Publication US 2014/0127749), Karin et al. (US Patent 8,211,852), and Christou et al. (US Patent Application Publication US2002/0078472).
Petsch et al. disclose a vaccine composition comprising a recombinant Zika virus envelope protein comprising an amino acid sequence identical with present SEQ ID NO: 1 and an adjuvant selected from alum or monophosphoryl lipid A (MPL) (see SEQ ID NO: 760 in Petsch et al, and a sequence alignment below, Example 3, Example 7, column 3, lines 12-42, column 12, lines 11-52, column 15, lines 25-44, columns 139-140)
Regarding present claim 2. Mason et al. teach histidine tagged recombinant protein of HCV virus used in the construction of viral vectors (see paragraph [0307], SEQ ID NO: 1 in Mason).
Present SEQ ID NO: 4 and SEQ ID NO: 1 in Mason et al.
Query Match 100.0%; Score 63; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HHHHHHDEL 9
|||||||||
Db 1 HHHHHHDEL 9
It would have been prima facie obvious to provide the vaccine composition of Petsch comprising a recombinant Zika virus envelope protein comprising an amino acid sequence identical with present SEQ ID NO: 1 and further comprising Mason’s histidine tagged recombinant protein of HCV virus because Mason teaches using histidine tag in the construction of viral vectors (see paragraph [0307]).
Regarding present claim 3. Karin et al. teach a construction of chimeric proteins and the use a sequence identical with present SEQ ID NO: 6 (see SEQ ID NO: 22 in Karin). Karin teaches that the use of human IgG1 immunoglobulin set forth in SEQ ID NO:22, as a fusion partner sequence, provides a major advantage by allowing the protein be purified efficiently.
It would have been prima facie obvious to provide the vaccine composition of Petsch comprising a recombinant Zika virus envelope protein comprising an amino acid sequence identical with present SEQ ID NO: 1 and further comprising the sequence of Karin et al. because Karin teaches that that the use of human IgG1 immunoglobulin set forth in SEQ ID NO:22, as a fusion partner sequence, provides a major advantage by allowing the protein be purified efficiently (see Figure 1, columns 3-6).
Present SEQ ID NO: 6 and SEQ ID NO: 22 in Karin et al.
Query Match 100.0%; Score 1258; Length 231;
Best Local Similarity 100.0%;
Matches 231; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 60
Qy 61 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 120
Qy 121 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 180
Qy 181 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 231
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 231
Regarding present claim 4. Christou et al. teach that levels of antibody/protein expression can be enhanced by employing an endoplasmic reticulum (ER) retention signal, which is a peptide tag consisting of His Asp Glu Leu (HDEL)(SEQ ID NO: 4) identical with present SEQ ID NO: 8 (see sequence alignment below).
Present SEQ ID NO: 8 and SEQ ID NO: 4 in Christou et al.
Query Match 100.0%; Score 23; Length 4;
Best Local Similarity 100.0%;
Matches 4; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HDEL 4
||||
Db 1 HDEL 4
It would have been prima facie obvious to provide the vaccine composition of Petsch comprising a recombinant Zika virus envelope protein comprising an amino acid sequence identical with present SEQ ID NO: 1 and further comprising Christou et al. peptide tag consisting of His Asp Glu Leu (HDEL) (SEQ ID NO: 4) identical with present SEQ ID NO: 8 because Christou teach that levels of antibody/protein expression can be enhanced by employing an endoplasmic reticulum (ER) retention signal.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Regarding present claims 6-8. Petsch et al. disclose the recombinant Zika virus envelope protein to adjuvant ratio of adjuvant ration of 1:1 (see column 141, lines 45-67).
It would have been prima facie obvious to provide the vaccine composition of Petsch comprising a recombinant Zika virus envelope protein comprising an amino acid sequence identical with present SEQ ID NO: 1, wherein the ratio of envelope protein to alum is 1: 0.4. It would have been within the skill of the ordinary artisan to adjust/optimize the protein adjuvant ration to arrive at a composition suitable for immunization.
Regarding present claim 9, which recites wherein the vaccine composition is inoculated one to three times; and wherein the inoculation is performed at an interval of 14 to 28 days. It would have been prima facie obvious to provide the vaccine composition of Petsch comprising a recombinant Zika virus envelope protein and an adjuvant and to set an immunization schedule optimal for generation of desired immune responses.
Regarding present claim 11. The vaccine composition of claim 1, wherein the vaccine composition has protective ability against one or more selected from the group consisting of a Zika virus PRVABCS9 strain, a Zika virus MR766 strain and dengue virus type- 2, wherein the vaccine composition promotes the secretion of any one or more selected from the group consisting of interferon-gamma (IFN-y), interleukin-12 (IL- 12), and tumor necrosis factor-alpha (TNF-a); or wherein the vaccine composition induces the formation of a maternal antibody.
Petsch teaches Zika virus strain selected from the group consisting of ZikaSPH2015-Brazil, Z1106033-Suriname, MR766-Uganda and Natal RGN. In a preferred embodiment, the term ‘Zika virus’ as used herein refers to a Zika virus of strain Natal RGN, preferably corresponding to GenBank-ID KU527068.1. Thus, it would have been obvious and expected that the vaccine in Petsch induces immune responses against MR766 strain.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Claim Objection
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
SEQ ID NO: 10 and SEQ ID NO: 12 are free of prior art.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648