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 .
Claims 1-21 are pending and under examination.
Information Disclosure Statement
The information disclosure statement filed 12/16/24 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the citation for non-patent literature cite number 2 (CD4 Spike.pdf) is incomplete and a copy has not been provided.
It has been placed in the application file, but the information referred to therein for non-patent literature cite number 2 (CD4 Spike.pdf) has not been considered as to the merits.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Title
The title of the invention is objected to because of the word "novel" which should not be included in the title. See MPEP 606 and 37 CFR 1.72.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE 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 missing, defective or incomplete.
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
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 4 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claim 4 is not clear. A restriction site is a nucleic acid sequence. The anti-spike glycoprotein nanobody is a protein.
In example 1 in the specification, restriction sites were incorporated throughout the plasmid backbone to allow modular modification of the construct. In paragraph 78 restriction enzymes were used to digest the plasmid.
Please clarify whether or not the anti-spike glycoprotein nanobody protein comprises a nucleic acid sequence for the restriction sites i.e. the protein comprises the nucleic acid sequence.
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.
Claim(s) 1-4 and 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamble et al. WO 2021/212122 10/21/2021 cited in IDS.
Claim 1: Kamble et al discloses a genetically modified bacterium (paragraph 4) having an outer membrane, the bacterium comprising one or more anti-spike glycoprotein nanobodies on the surface (outer membrane) of the bacterium (paragraph 4) comprising a heterologous nucleic acid, where the heterologous nucleic acid comprises a nucleic acid sequence encoding an anti-spike glycoprotein nanobody of a coronavirus the anti-spike glycoprotein nanobody appears on the surface of the probiotic bacteria (paragraph 4).
Claim 2: Kamble et al discloses the genetically modified bacterium of claim 1, wherein one or more of the anti-spike glycoprotein nanobodies have been fused with Intimin. See paragraph 0061.
Claim 3: Kamble et al discloses the genetically modified bacterium of claim 1, wherein one or more of the anti-spike glycoprotein nanobodies have been fused with Lpp-OmpA. See paragraph 0061.
Claim 4: Kamble et al discloses the genetically modified bacterium of claim 1, wherein one or more of the anti-spike glycoprotein nanobodies further comprise one or more restriction sites. See paragraph 68-69: The design, construction and cloning of pNKLab001-4 plasmids for nanobody expression using surface display signals Intimin and Lpp-OmpA in E. coli Nissle For the molecular cloning of COVID Nanobodies VHH72 and Ty1, Chloramphenicol resistant CJ23 plasmid was utilized For the construction of pNKLab001-Intimin-Ty1NE Nanobody CJ23 plasmids were digested overnight using EcoRI and PspXI and Bglll-PspXI restriction enzymes.
Claim 9: Kamble et al disclose the genetically modified bacterium of claim 1, wherein the genetically modified bacterium is a probiotic. See paragraph 4.
Claim 10: Kamble et al disclose the genetically modified bacterium of claim 1, wherein the bacterium that is modified is E. coli. See paragraph 4.
Claim 11: Kamble et al disclose the genetically modified bacterium of claim 1, wherein the bacterium that is modified is E. coli Nissle 1917. See paragraph 4.
Claim 12: Kamble et al disclose the a pharmaceutical composition comprising the genetically modified bacterium and a pharmaceutically acceptable excipient and the engineered probiotic bacterium and a pharmaceutically acceptable excipient. See paragraph 8.
Claim(s) 13-15 and 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al. WO 2021/207306 10/14/2021.
Claim 13: Gao et al disclose a genetically modified bacterium having an outer membrane corresponding to the surface of the bacteria, wherein the receptor-binding domain of the spike glycoprotein on SARS-CoV-2 (Spike-RBD) is expressed on the outer membrane (surface) of the bacterium at paragraph 225:
In some embodiments, the genetically engineered bacteria express peptides e.g. viral antigens, e.g., the receptor binding domain (RBD) of a spike protein of SARS-CoV-2 in the microbial cell wall (e.g., at the microbial cell surface) which binds to a cell surface receptor on a cell (e.g., a mammalian cell, e.g., a human cell).
See figure 2
Claim 14: Gao et al disclose the genetically modified bacterium of claim 13, wherein the Spike-RBD has been fused with Intimin. See paragraphs 517-518, 521 figure 4, figure 5
Claim 15: Gao et al disclose the genetically modified bacterium of claim 13, wherein the Spike-RBD has been fused with Lpp-OmpA. See paragraphs 517-518, 521, figure 8, figure 9,
16. The genetically modified bacterium of claim 13, wherein the Spike-RBD has a sequence of [SEQ ID NO: 6].
17. The genetically modified bacterium of claim 13, wherein the Spike-RBD has a sequence of [SEQ ID NO: 7].
Claim 18: Gao et al disclose the genetically modified bacterium of claim 13, wherein the genetically modified bacterium is a probiotic. See paragraph 9, 51, 165, 170, 193, 196, 215.
Claim 19: Gao et al disclose the genetically modified bacterium of claim 13, wherein the bacterium that is modified is E. coli. See paragraph 9, 51, 165, 170, 193, 196, 215.
Claim 20: Gao et al disclose the genetically modified bacterium of claim 13, wherein the bacterium that is modified is E. coli Nissle 1917. See paragraph 9, 51, 165, 170, 193, 196, 215.
Claim 21: Gao et al disclose the pharmaceutical composition comprising the genetically modified bacterium of claim 13 and a pharmaceutically acceptable excipient. See paragraphs 185, 186, 433, 448, 449, 450 and 461.
Double Patenting
Claims 1-4 and 9-12are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12605413 (‘413). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘413 claims disclose.
Claims 1-3: The ‘413 claims disclose an engineered probiotic bacterium comprising a heterologous nucleic acid, wherein the heterologous nucleic acid comprises a nucleic acid sequence encoding an anti-spike glycoprotein nanobody of a coronavirus and wherein the anti-spike glycoprotein is displayed on the surface of the engineered bacterium (corresponding to outer membrane) and wherein the anti-spike glycoprotein nanobody is fused to intimin or Lpp-OmpA via plasmid expression in the engineered bacterium wherein in the plasmid the nucleic acid encoding the anti-spike glycoprotein nanobody is in frame with the nucleic acid sequence encoding the intimin or Lpp-OmpA.
Claim 4: the plasmid sequence encoding the Nanobody comprises restriction site. SEQ ID NO: 5 in claim 1 identifies the DNA sequences for embodiments of the plasmids of the present invention and comprises a restriction site. See example 2 of the ‘413 specification.
Claims 9-11: The ‘413 claims disclose the engineered probiotic bacterium of claim 1, wherein the engineered probiotic bacterium is Escherichia coli Nissle 1917.
Allowable Subject Matter
Claims 5-8 and 16-17 are 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.
Status of Claims
Claims 1-4, 9-15 and 18-21 are rejected. Claims 5-8 and 16-17 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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