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 without traverse of Group 1 (claims 1-13) in the reply filed on 3/2/2026 is acknowledged. The examiner confirmed with the attorney of record, John DiMaio, that claim 14 belongs to Group 2.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-41 are pending.
Claims 14-41 are withdrawn for being drawn to non-elected inventions (i.e., Group 2-3).
Claims 1-13 are under consideration.
Priority
The instant application is a 371 of PCT/US21/52907 filed on 9/30/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 3/29/2023 and 11/26/2024 have been considered.
Claim Objections
Claims 1 and 10 is objected to because of the following informalities: claim 1 is objected for the use of an abbreviated phrase (SARS-CoV-2) and claim 10 is objected for the use of an abbreviated phrase (QS21), which should be described for the first time followed by an abbreviated form placed in a bracket.
. Appropriate correction is required.
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 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.
Claim(s) 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lovell et al. (IDS, US Pub. No. 2018/0085473) in view of Babb et al. (IDS, US Patent No. 10,787,501).
The instantly claimed invention is broadly drawn to a method for generating neutralizing antibodies against SARS-CoV-2 virus in subject comprising administering to the subject a vaccine composition comprising: a) liposomes comprising i) a bilayer, wherein the bilayer comprises phospholipid, and porphyrin having cobalt coordinated thereto forming cobalt-porphyrin; and ii) a polyhistidine- tagged amino acid sequence of receptor-binding-domain (RBD) of Spike protein from SARS- CoV-2, wherein at least a portion of the polyhistidine tag resides in the hydrophobic portion of the bilayer and one or more histidines of the polyhistidine tag are coordinated to the cobalt in the cobalt-porphyrin, and wherein at least a portion of the amino acid sequence is exposed to the outside of the liposome; and b) a pharmaceutical carrier(claim 1), wherein the RBD has a sequence depicted as SEQ ID NO: 1 or a variant thereof which has at least 90% identity with the sequence of SEQ ID NO: 1 (claim 2), wherein the cobalt porphyrin is conjugated to a phospholipid to form a cobalt porphyrin-phospholipid conjugate (claim 3), wherein the cobalt porphyrin-phospholipid conjugate makes up from 0.1 to 25 mol % of the bilayer (claim 4), wherein the cobalt porphyrin-phospholipid conjugate makes up from 5 to 10 mol % of the bilayer (claim 5), wherein the bilayer further comprises cholesterol (claim 6), wherein the polyhistidine-tag comprises 6 to 10 histidine residues (claim 7), wherein size of the liposome is 50 nm to 200 nm (claim 8), wherein the liposomes further comprise one or more adjuvants (claim 9), wherein the one or more adjuvants are attenuated lipid A derivatives, phosphorylated hexaacyl disaccharides, and/or QS21 (claim 10). The method of claim 1, further comprising one or more adjuvants which are not associated with the liposomes (claim 11). The method of claim 1, wherein the subject is a human (claim 12), and wherein the composition is administered multiple times (claim 13).
Regarding claim 1, Lovell et al. teach a method for generating neutralizing antibodies against a virus in subject comprising administering to the subject a vaccine composition (claim 19 "A method for generating an immune response in a host individual comprising administering to the individual"; and paragraph [0125] - "Many of the monoclonal antibodies that broadly neutralize HIV viral entry, such as 2F5, Z13 and 4E10, target a conserved linear epitope in the membrane proximal external region (MPER) of the gp41 envelope protein, making the MPER a prime target for HIV peptide vaccines") comprising: a. liposomes (claim 19 "a composition comprising the liposomes
of claim 1"; claim 1 teaches "A liposome comprising i) a bilayer, wherein the bilayer comprises phospholipid, and porphyrin having cobalt coordinated thereto forming cobalt-porphyrin (claim 1 "a) a bilayer, wherein the bilayer comprises: i) phospholipid, and ii) porphyrin having cobalt coordinated thereto forming cobalt-porphyrin"); and b) a polyhistidine-tagged presentation molecule wherein at least a portion of the polyhistidine tag resides in the hydrophobic portion of the monolayer or the bilayer and one or more histidines of the polyhistidine tag are coordinated to the cobalt in the cobalt-porphyrin, wherein at least a portion of the polyhistidine-tagged presentation molecule is exposed to the outside of the liposome". Regarding claims 3-4, Lovell et al. teach cobalt- phospholipid conjugate that makes 1 to 25% of the monolayer or the bilayer (claims 2-3). Regarding claim 5, Lovell et al. teach that cobalt porphyrin-phospholipid conjugate makes up from 5 to 10% of the monolayer or the bilayer (see claim 4). Regarding claim 6, Lovell et at teach that phospholipid further comprises cholesterol (see claim 5) Regarding claim 7, Lovell et al teach having a polyhistidine-tag of 6-10 residues. Regarding claim 8, Lovell et al teach a liposome having a size of 50 to 200 nm (see claim 8). Regarding claim 9, Lovell et al. teach that bilayer further comprises an adjuvant comprises therein (see claim 19). Regarding claim 12, Lovell et al teach that subject is a human (see claim 18). Regarding claim 13, Lovell suggests that the administration of a composition can be a single administration or multiple administration (see paragraph [0075]). Lovel et al. do not teach that the neutralizing antibody is against SARS-CoV-2 virus, wherein the receptor binding-domain (RBD) of spike protein is histidine tagged, wherein at least a portion or the polyhistidine tag residues in the hydrophobic portion of the bilayer and one or more histidine of the polyhistidine tag are coordinating tag are coordinated to the cobalt in the cobalt porphyrin.
Babb et al. disclose antibodies and antigen-binding fragments thereof that bind specifically to a coronavirus spike protein and methods of using such antibodies and fragments for treating or preventing viral infections (abstract); comprising SARS-CoV-2 (claim 1 "An isolated antibody or antigen-binding fragment thereof that binds a SARS-CoV-2 spike protein") and amino acid sequence of receptor-binding-
domain (RBD) of Spike protein from SARS-CoV-2 (claim 1 "An isolated antibody or antigen-binding fragment thereof that binds a SARS-CoV-2 spike protein"; col 72, In 14-15 (see search results 10 below).
RESULT 10
US-16-912-678-829
(NOTE: this sequence has 5 duplicates in the database searched)
Sequence 829, US/16912678
Patent No. 10787501
GENERAL INFORMATION
APPLICANT: Regeneron Pharmaceuticals, Inc.
TITLE OF INVENTION: ANTI-SARS-COV-2-SPIKE GLYCOPROTEIN
TITLE OF INVENTION: ANTIBODIES AND ANTIGEN-BINDING FRAGMENTS
FILE REFERENCE: 10753US01
CURRENT APPLICATION NUMBER: US/16/912,678
CURRENT FILING DATE: 2020-06-25
NUMBER OF SEQ ID NOS: 850
SEQ ID NO 829
LENGTH: 251
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 100.0%; Score 1211; Length 251;
Best Local Similarity 100.0%;
Matches 223; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSASFSTFK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSASFSTFK 60
Qy 61 CYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNS 120
Qy 121 NNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQSYGFQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQSYGFQ 180
Qy 181 PTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVNF 223
|||||||||||||||||||||||||||||||||||||||||||
Db 181 PTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVNF 223
Therefore, it would have been prima facie obvious at the time of invention was made to use SARS-CoV-2 spike protein as taught by Babb et al to generate antibodies to generate an immune response in a host individual as taught by Lovell et al. Additionally, it would have been motivating to one of ordinary skill in the art because the SARS-CoV-2 spike protein of Babb et al would have been combined with the method of Lovell et al to provide a vaccine with greater efficacy than an antibody alone. Further, one would have a reasonable expectation of success in using an antigen having RBD polypeptide having amino acid sequence of 100% sequence identity to SEQ ID NO: 1 as taught by Babb et al to raise antibodies as a vaccine as taught by Lovell et al. Therefore, it would have been obvious to one ordinary skill in the art over the combined teachings of the prior art.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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