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 I in the reply filed on 9/30/2025 is acknowledged.
Accordingly, claims 9-18 are withdrawn from consideration for being directed to non-elected subject matter. Claims 1, 5-8 are currently under examination.
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/PatentLegalFramework), 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 – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specially, paragraph [0032] Table 2, page 13-22).
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 sequence identifiers, 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.
Specification
The use of the term “Quick,” “Trelief,” “Endo-Free,” “Lipofectamine,” “EasyGeno,” “Q5,”which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 depends on claim 1 (which recites a stem cell), but claims stem cell selected from a group that comprises embryonic kidney cell, which is not a stem cell. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
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(s) 1, 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al (CN1990042, IDS), in view of Zhang (CN111228475, IDS) and Tomchuck (IDS).
Claim 1 is drawn to a cell-mediated sars-cov-2 vaccine, comprising stem cells comprising vector containing the nucleic acid encoding S protein, M protein and N protein of SARS-COV-2.
He et al. teach according to research results of other coronaviruses, the spike (S) protein, the nucleocapsid (N) protein and membrane (M) all can induce immune effects, so the S, M and N proteins can be used in the research of anti-SARS coronavirus vaccines. He et al. teach anti-SARS coronavirus cellular vaccine can be prepared using the cDNA encoding the SARS coronavirus S, M and N protein (paragraph [0059]). He et al. teaches eukaryotic expression vector pDNA3.1 can be used to express the target gene (paragraph [0149]). He et al. further teaches said vector maybe transfected into 293 cells (paragraph [0134]), or B cells (paragraph [0153]).
The teaching from He differs from claim 1 that it does not teach S, M and N protein of SARS-COV-2, or specially a stem cell that comprises said vector encoding S, M and N protein.
Zhang teaches that COVID19 (SARS-CoV-2) is an enveloped positive strand RNA virus with a genome length of 29.9Kbp, which comprises S, N and M protein (paragraph [0015] and Figure 1). Zhang teaches expressing both S and N protein in HEK293 cells (paragraph [0029]).
Tomchuck et al. teach mesenchymal stem cells (MSCs) has the ability to stimulate antigen-specific antibody production in vivo (page 4, 1st col-2nd col., bridging paragraph, and Figure 3 and legend). Tomchuck et al. teach also teaches MSCs can promote adaptive immunity (page 5, Table 1). Tomchuck et al. teach MSC may be used as a vaccination platform generating protective immunity because it can deliver vaccine antigens that are highly immunogenic and a more immunostimulatory phenotype of the MSC (page 6, 1st col., 2nd paragraph, lines 1-10).
It would have been obvious to an ordinary skilled in the art that SARS-CoV-2 virus is closely related to SARS-CoV coronavirus based on the nucleotide sequence. The ordinary skilled in the art trying to develop a vaccine for SARS-CoV-2 would be motivated to follow the teaching from He to develop a cell based vaccine that comprises vectors expressing S, N and M protein using SARS-CoV-2 nucleotide sequence encoding S, N and M (taught by Zhang) because He demonstrated the strategy for expressing multiple antigenic peptide for safe and effective vaccine for SARS-CoV. It would have been obvious to an ordinary skilled in the art to use MSCs transfected with vectors expressing S, N and M protein of SARS-CoV-2 to prepare a vaccine composition based on the teaching from Tomchuck et al., because Tomchuck et al. teach MSC produces antigen that are highly immunogenic in vivo. Following combined teaching from He, Zhang and Tomchuck, an ordinary skilled in the art would have reasonable expectation of success to replace the sequence of SARS-CoV S, N and M protein taught by He, with the SARS-CoV-2 S, N and M protein taught by Zhang, and transfect the vector into a MSC following teaching from Tomchuck. Therefore, the claimed invention of claims 1 and 5 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 5, the claim also recites the stem cells is human embryonic kidney cells. It would have been obvious to an ordinary skilled in the art that SARS-CoV-2 virus is closely related to SARS-CoV coronavirus based on the nucleotide sequence. The ordinary skilled in the art trying to develop a vaccine for SARS-CoV-2 would be motivated to follow the teaching from He to develop a cell based vaccine that comprises vectors expressing S, N and M protein using SARS-CoV-2 nucleotide sequence encoding S, N and M because He demonstrated the strategy for expressing multiple antigenic peptide for safe and effective vaccine for SARS-CoV. The ordinary skilled in the art would recognize that HEK293 cells (human embryonic kidney cells) are well known in the art for expressing the viral protein such as S, N and M as demonstrated by both He and Zhang. Therefore, the claimed invention of claim 5 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claims 6 and 7, He teaches a eukaryotic expression vector pcDNA 3.1 for expressing the cDNA (paragraph [0149]).
Regarding claim 8, He teaches expressing cDNAs together in the eukaryotic expression vector (paragraph [0129]).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/Primary Examiner, Art Unit 1637