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
Preliminary amendment filed on May 23, 2024 has been acknowledged. According to this amendment, claims 1, 7-14 were amendment, claims 2-6 and 15 was canceled and new claims 16-17 were added. Claims 1, 7-14 and 16-17 are pending.
Claim Objections
Claim 9 is objected to because of the following informalities: a complete full name of BAC needs to be spell out and then followed by BAC put into a bracket. Appropriate correction is required.
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.
The term “derived” in claims 1, 8, 12, is a relative term which renders the claim indefinite. The term “derived” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Please make a proper amendment in order to overcome the rejection. This rejection affect all dependent claims.
Claim 7 recites the limitation "the protein three times " in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the gene or the full-length cDNA and the equivalent regions as well as the cDNA fragment" in claim 1 or the instant case. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the DNA sequence" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the DNA sequence" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the DNA sequence , the protein, and the supernatant" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the gene, the Delta variant and the Omicron variant" in claim 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the variant " in claim 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the S gene, the protein S, and the delta variant and the omicron variant" in claim 12. There is insufficient antecedent basis for this limitation in the claim.
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 8 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. In the instant case, the claim itself lacks of further limitaiton defined itself, i.e. the totally deleted 5 genes cited in the following citation are cited with only 3 genes. Please check the specification on page 3 and then make a proper amendment if that description in the specification is correct one. 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 12-14, and 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using the particular genetically modified SARS-Cov virus mutant of SARS-CoV-2-A [3,E,6,7,8] which is a replication component replicon, wherein the SARS-Cov-2 defective replicon that comprises the total five genes of 3,E,6,7,8 deleted mutations to induce a protective immune response to compact the SARS-Cov-2 wt virus infection, does not reasonably provide enablement for having a vaccine to induce a protect any protective immune response to any or all SARS-Cov-2 mutants with any or all kind of SARS-Cov-2 mutants.. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The test of an enablement or scope of enablement is whether one skilled in the art could make and use the claimed invention from the disclosure in the application coupled with information known in the art would render undue experimentation (See United States v. Theketronic Inc., 8USPQ2d 1217 (fed Cir. 1988). Whether undue experimentation is required is not based upon a single factor but rather a conclusion reached by weighting many factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in re Wands, 8USPQ2d 1400 (Fed. Cir. 1988), which are set forth below: 1). Nature of invention; 2). Scope of claims; 3). State of art; 4). Unpredictability; 5). Level of skill in the art; 6). Number of working examples and 7). Amount of guidance presented in the specification.
The nature of invention is directed toa method for making a recombinant replication component SARS-Cov-2 replicon, While several kinds of mutations of the SRAS-Cov-2 viruses have been made, however, it is only one mutant of SARS-Cov-2 with total five genes of 3,E,6,7,8 complete deletion mutations and using said SARS-Cov-2 replicon to induce a protective immune response, particularly wt. type SARS-Cov-2 infection. However, the specification does not provide sufficient evidence to support any or all claimed SARS-Cov-2 mutants are able to induce a protective immunity against any or all protective immune response.
SRAS-Cov-2 as a RNA viruses have been mutated several times since its pandemic in 2019. Because it has a high tendency to be mutated any time . So, it is very unpredictable using the SARS-Cov-2 replicon that comprises the total five genes of 3,E,6,7,8 deleted mutations
Because the specification fails to provide sufficient evidence to support the broad scope of claimed invention, given the above analysis of the factors which the courts have determined are critical in asserting whether a claimed invention is enabled, it must be considered that the skilled artisan would have to conduct undue and excessive experimentation in order to practice the claimed invention.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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