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 .
Preliminary Amendment and Status of the Claims
The preliminary amendment filed 11/12/2025, in which claims 38, 40 were amended, is acknowledged and has been entered.
Election Restrictions
Applicant’s election without traverse of Group I, claims 1, 5, 26-36, 38, 40, 45, 47 drawn to a polypeptide, in the reply filed on 11/12/2025 is acknowledged.
Further, Applicant’s election of the following species:
SEQ ID NOs: 1 in claim 1
SEQ ID NOs: 3 in claim 5
SEQ ID NOs: 13 in claim 32
SEQ ID NOs: 23 in claim 35
SEQ ID NOs: 10 in claim 38
SEQ ID NOs: 29 in claim 40
SEQ ID NOs: 32 in claim 47
in the reply filed on 11/12/2025 is acknowledged.
It is noted that claims 38, 40, and 47 as amended and submitted on 11/12/2025 read on a multimer comprising different species of polypeptides and are not considered to read on the polypeptide of Group I. Specifically, claims 38, 40, and 47 require a plurality of nucleic acids encoding different species of polypeptides (SEQ ID NO: 10 in claim 38, SEQ ID NO: 29 in claim 40 and SEQ ID NO: 32 in claim 47, per Applicant’s species election). It is further noted that independent claim 1 is directed to a single polypeptide species of Applicant’s elected species of SEQ ID NO: 1. As indicated previously, (SEQ ID NOs:) sequences encoding different proteins are structurally distinct chemical compounds and are unrelated to one another. These sequences are thus deemed to constitute independent and distinct inventions within the meaning of 35 U.S.C. § 121. Absent evidence to the contrary, each such nucleotide sequences are presumed to represent independent and distinct inventions, subject to a restriction requirement pursuant to 35 U.S.C. § 121 and 37 CFR 1.141 et seq. (MPEP § 803.04). Accordingly, claims 38, 40, 47 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 12, 16, 38, 40, 47, 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1, 5, 26-36, 45, are under examination on the merits.
Priority
Applicant’s claim for domestic benefit of prior-filed provisional application No. 63/069,573 filed on 08/24/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/14/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 02/17/2023. The drawings are objected to because the labels should read “Fig.” instead of “Figure”. Further, the resolution in Figure 2 is too low and some of the text is barely legible.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is defective because the size of the ASCII text file is in kilobytes instead of bytes.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112 - Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 26-36, 45, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
The instant claims require a polypeptide having an amino acid sequence of a receptor binding domain (RBD) of SEQ ID NO: 1 and a multimerization domain having the ability to induce multimerization to display the RBD polypeptide at the surface. The instant claims alternatively require a polypeptide having an amino acid sequence of a receptor binding domain (RBD) of SEQ ID NO: 1 wherein sequence alterations such as substitutions, additions, insertions, or deletions of one or more amino acids can be made anywhere in the amino acid sequence of SEQ ID NO: 1, including specific regions essential for receptor binding, provided that a polypeptide bears at least 70% sequence homology to SEQ ID NO: 1. Further, the instant claims require a multimerization domain of SEQ ID NO: 3, or a multimerization domain having an amino acid sequence wherein sequence alterations such as substitutions, additions, insertions, or deletions of one or more amino acids can be made anywhere in the amino acid sequence of SEQ ID NO: 3, including specific regions essential for multimerization, provided that a multimerization domain bears at least 70% sequence homology to SEQ ID NO: 3. However, the Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus as to establish a structure-function relationship with respect to receptor binding of an RBD and multimerization.
With respect to SEQ ID NO: 1 alone, e.g., is 194 amino acid residues long. The instant claims encompass any sequence having at least 70% sequence identity to SEQ ID NO: 1. An amino acid sequence sharing only 70% identity relative to SEQ ID NO: 1 could have anywhere from 1 to 58 substitutions, deletions, or additions in any combination along any length of SEQ ID NO: 1, which corresponds to a massive genus (2058 = 2.9 x 1075) comprising trillions upon trillions of sequences, with respect to SEQ ID NO: 1 alone.
However, while the claims are drawn to a genus that comprises innumerable sequences, the Specification has only adequately described and successfully reduced to practice the full-length of SEQ ID NO: 10 (which is comprised in formulation termed VX3025r, Specification Examples 1, 2) which shares 97.2% sequence identity with SEQ ID NO: 1 and SEQ ID NO: 29 which shares 97.2% sequence identity with SEQ ID NO: 1 (Specification, Examples 3, 4). This is not representative of the extremely large genus of sequences claimed.
At best, the Specification contemplates the use of BLAST to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement.
Moreover, Friedberg (“Automated protein function prediction--the genomic challenge”. Brief Bioinform. 2006;7(3):225-242.) teaches that homology-based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that sequence-based tools are just not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (page 228, first full paragraph).
Thorton (“Structural genomics takes off.” Trends Biochem Sci. 2001;26(2):88-89.) teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thorton further describes examples of little correlation between specific binding function and overall protein structure (page 992, right column, at lines 2-10). Thus, when taken with the teachings of Friedberg and Thorton, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples, the Specification must at least describe the structural features that are required for the claimed function, in this case receptor binding of an RBD and multimerization. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to receptor binding of an RBD and multimerization.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
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.
Claims 1, 5, 26-28, are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US PGPub 20230090422 A1 to Zhang et al. PCT filed on 03/11/2020. See PTO-892: Notice of References Cited.
See claims 1, 5, 26-28, as submitted on 11/12/2025.
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Regarding claim 1, Zhang et al. disclose polypeptides comprising fusion proteins comprising a binding domain (RBD) from SARS-CoV-2 connected to a multimerization domain, for example a Lumazine Synthase domain (LS) so as to achieve antigen multimerization. Zhang et al. further disclose such an embodiment can overcome the defect of insufficient immunogenicity of an RBD monomer by significantly increasing the level of a neutralizing antibody against a virus in a host (Abstract, ¶¶ [0007-0008], [0019]-[0024], [0056]). Zhang et al. further disclose an RBD sequence which shares 100% identity with instant SEQ ID NO: 1. See alignment below (Qy is instant SEQ ID NO: 1; Db is Zhang et al.’s SEQ ID NO: 1.)
With respect to the recitation of “capable of generating multimers comprising at least 60 copies of the polypeptide”, it is noted that this recitation does not impart any additional structural features to the polypeptide as recited in claim 1, therefore this recitation is considered to flow from the features already present in the polypeptide as recited in claim 1. Therefore, any polypeptide in the prior art having the all of the structural limitations recited in claim 1 would be capable of generating multimers comprising at least 60 copies of the polypeptide.
Regarding claim 5, Zhang et al. further disclose a multimerization domain which shares 100% identity with instant SEQ ID NO: 3. See alignment below (Qy is instant SEQ ID NO: 3; Db is Zhang et al.’s SEQ ID NO: 8.)
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Regarding claims 26-28, Zhang et al. further disclose nucleic acid molecules encoding the polypeptide of claim 1, recombinant vectors comprising the nucleic acid encoding the polypeptide of claim 1 operatively linked for expression, and recombinant cells comprising the nucleic acid encoding the polypeptide of claim 1 for expression (¶¶ [0060]-[0064]).
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.
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.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (previously cited), as applied to claims 1, 5, 26-28 above, in view of US patent No. 11,382,968 B2 to Georges et al. See PTO-892: Notice of References Cited.
See claim 29 as submitted on 11/12/2025.
Regarding claim 29, Zhang et al. teach the polynucleotide of claim 1 and the nucleic acid encoding said polynucleotide as recited in claim 26.
Zhang et al. do not tech a nucleic acid comprising mRNA.
However, Georges et al. teach immunogenic compositions for preventing or treating COVID-19 related diseases caused by SARS-CoV-2, wherein the composition comprises SARS-CoV-2 spike protein receptor binding domain of S1 domain with conservative substitutions (col.3, lines 30-40, and col.6, lines 4-7). Georges et al. further teach that the immunogenic composition may comprise RNA immunogenic or vaccine composition that comprises a modified mRNA, a unmodified mRNA or a self-amplifying mRNA formulated in liposomes or lipid particles (col.87, lines 18-22). Georges et al. further teach such formulations comprising mRNA allow for antigen production by the epithelial cells of the host thereby inducing an immune response against the antigen as it occurs naturally when infection takes place (col. 12).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the teachings of Georges et al. about mRNA formulations into the polypeptide composition of Zhang et al. for the benefit of inducing an immune response against the SARS-CoV-2 virus as it occurs naturally when infection takes place. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating an mRNA formulation in the polypeptide composition of Zhang et al. given that the methods of formulating mRNA immunogens comprising viral antigens, for example SARS-CoV-2 antigens, are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, claim 29 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 30-36, 45 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. and Georges et al. (previously cited), as applied to claims 1, 5, 26-29 above, and US patent No. 10,918,740 B2 to Fotin-Mleczek, GenBank: FX016671 and GenBank: J00326. See PTO-892: Notice of References Cited.
See claims 30-34 as submitted on 11/12/2025.
Regarding claims 30-34, Zhang et al. and Georges et al. in combination teach the nucleic acid of claim 29.
Neither Zhang et al. nor Georges et al. teach the mRNA comprises a 5' cap, a poly(A) tail, a 5’ and 3’ untranslated region (UTR), 5’-CAP structure, and a poly A sequence.
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However, Fotin-Mleczek teaches RNA pharmaceutical compositions for treating diseases (Abstract). Fotin-Mleczek teaches the RNA composition comprises 5’ and 3’ UTR, 5’-CAP structure; a poly A sequence to provide stability to the mRNA molecule (col.137, lines 1-5). Fotin-Mleczek teaches poly A tail preferably comprises 50-250 adenosine nucleotides (col.145, lines 59-60), which overlaps with claimed range of 50-120 residues (relevant to instant claim 31). GenBank: FX016671 was cited for teaching a known sequence for a 5’-UTR which shares 100% sequence identity with instant SEQ ID NO: 13. See alignment below (Qy is instant SEQ ID NO: 13; Db is GenBank: FX016671).
Fotin-Mleczek further teaches an mRNA 3’ untranslated region that is required for producing mRNA for treatment of diseases (col.137, lines 1-5). GenBank: J00326 was cited for teaching a known sequence for a beta goblin 3’-UTR which shares 100% sequence identity with instant SEQ ID NO: 18. See alignment below (Qy is instant SEQ ID NO: 18; Db is GenBank: J00326).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the teachings of Fotin-Mleczek and the known sequences from GenBank: FX016671 and GenBank: J00326 into the polypeptide composition of Zhang et al. and Georges et al. for the benefit of providing stability to the mRNA molecule. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the teachings of Fotin-Mleczek and the known sequences from GenBank: FX016671 and GenBank: J00326 in the polypeptide composition of Zhang et al. and Georges et al. given that the methods of formulating stable mRNA molecules, are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 35-36, Zhang et al. and Georges et al. teach the polypeptide of claim 29. Zhang et al. further teach the polypeptide comprising an N-terminal signal peptide (¶ [0033]). Fotin-Mleczek teaches the polypeptide further comprising a signal peptide comprising a cytokine, wherein the cytokine is IL-2. Fotin-Mleczek teach a sequence for the IL-2 signal peptide that shares 100% identity with instant SEQ ID NO: 23. See alignment below (Qy is instant SEQ ID NO: 23; Db is Fotin-Mleczek’s SEQ ID NO: 4473).
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Regarding claim 45, Zhang et al. and Georges et al. in combination teach the nucleic acid of claim 29. Zhang et al. further teach a formulation diluted with physiological saline and emulsified with an adjuvant for immunization (¶ [0123]), which meets the limitations of the pharmaceutical composition comprising a cationic lipid carrier as recited in claim 45.
Accordingly, claims 30-36, 45 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672