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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Sep. 25, 2023. Claims 1-20 are pending and currently examined.
Claim Objections
Claims 1-3, 5, 7-12, 17 and 20 are objected to because of the following informalities:
The base claim 1 recites that “…the presence of SARS-CoV-2 nsp8 gene in a sample comprising or consisting of a nucleic acid sequence SEQ ID NO:4; SEQ ID NO:5, SEQ ID NO:5, SEQ ID NO:7, and SEQ ID NO:8…”, where SEQ ID NO: 5 is listed twice. In addition, the phrase “…comprising or consisting of a nucleic acid sequence SEQ ID NO: 4…” should be recited as “…comprising or consisting of the nucleic acid sequence SEQ ID NO: 4…”.
For claim 2 recites “(a)” twice at “…comprising (a) a Cas/sgRNA pair, and (b) one or more fluorescent reporters, one or more quenchers, or a combination thereof, (a) a phosphate buffer …”.
For claim 3, a space is needed in the phrase “…claim 1comprising…”.
For claim 5, it recites “…wherein the salt is selected from the group consisting of KCl, NaCl, MgCh, MgSQ4, (NH4)2SQ4)”, where the “and” is needed between “MgSQ4, (NH4)2SQ4)”.
For claims 7-8, the cited “any of the foregoing” should be deleted.
For claim 9, it recites “(a) contacting the sample with a composition comprising the composition of claim 1 under conditions sufficient for amplification of the nsp8 gene of SARS-Co V-2, wherein the set of RT-LAMP primers and”. Here, part (a) is incomplete.
For claims 10-11, the phrase “wherein the primers comprise…” should be rewritten as: “wherein the RT-LAMP primers comprise…”.
For claim 12, a word “and” is needed to replace the “or” between “…serum, or whole blood”.
For claim 17, it recites a sentence at “A Kit the presence of SARS-CoV-2 nsp8 gene in a sample comprising the composition of claim lin one or more containers”, where ““A Kit the presence of SARS-CoV-2 nsp8...” need to be rewritten and a space is needed between “claim 1in”.
For claim 20, the “on” in the cited phrase “except primers at the bottom on a container” should be “of a container”.
Applicant is required to make proper corrections.
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 8-9, 12, 14 and 16 are 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.
Claim 8 recites “the reporter nucleic acid” in reference to claim 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “the set of RT-LAMP primers” in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “the RT-LAMP primers” in reference to claim 11. There is insufficient antecedent basis for this limitation in the claim.
Also, claim 12 recites (e.g., biopsy material) that renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention See MPEP § 2173.05(d).
Claim 14 recites the “primer” in reference to claim 13. There is insufficient antecedent basis for this limitation in the claim. Also, claim 14 recites the “RT-LAMP reaction” in reference to claim 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites “the RT-LAMP reaction” in line 1. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 112
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 1-7 and 9-20 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 base claim 1 and the claim 11 are drawn to a nucleic acid composition or a primer comprising having at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 90% sequence identity to the SEQ ID NO: 4-8.
The claim 7 is directed to the sgRNA comprising SEQ ID NO: 1 or a nucleic acid sequence having at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity to any of the foregoing.
The written description rejection is made because the claims are interpreted as being drawn to a composition/nucleic acid sequences recited as being “at least 90% identity” to the instant claimed SEQ ID NOs 4-8 (claim 11), or being “at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity to the SEQ ID NO: 4-8” (claim 1) or being “at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity to SEQ ID NO: 1” (claim 7). This means that up to 10% or 30% nucleic acid sequences as the primers can vary.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
For the nucleic acid composition for detecting the presence of SARS-CoV-2 nsp8 gene (claim 1 and 11), the instant specification discloses that sequences for detection of SARS-CoV-2 are provided and can comprises any of SEQ ID NOs:4-8, a sequence having at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity thereto, a nucleic acid sequence having 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 nucleic acid substitution(s), addition(s), deletion(s), or a combination thereof relative thereto, or the reverse complement of any of the foregoing. The sequences are useful for amplifying the SARS-CoV-2 nsp8 gene in a sample, using Reverse Transcriptional Loop Mediated Isothermal Amplification (RT-LAMP) and it is preferably used in combination with a Cas enzyme/sgRNA pair and a reporter nucleic acid (See [0008]). However, the specification does not indicate which portions of the claimed SEQ ID NOs 4-8 are essential to retain the ability to be a primer for detecting the SARS-COV-2 NSP8 gene or which portions of SEQ ID NOs: 4-8 can be modified or altered up to 10% or 30% and still retain the ability for amplifying the target genes using the RT-LAMP.
For the sgRNA, the instant specification discloses a SARS-COV-2 -NSP8-gRNA SEQ ID NO: 1 and states that the composition of any one of paragraphs 2-9, wherein the sgRNA comprises SEQ ID NO: 1 or a nucleic acid sequence having at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity to any of the foregoing (See, [0098], Table 5 and [0137]). However, the specification does not indicate which portions of the claimed SEQ ID NO: 1 is essential to retain the ability for specifically targeting the RT-LAMP amplicons of nsp8 or altered up to 30% and still retain the ability for targeting the amplicons as claimed.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.). As discussed above, the skilled artisan cannot envision the detailed sequence structure of the encompassed SRAS-COV-2 NSP8 gene and the sgRNA that are " at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical” to the SEQ ID NOs as claimed. Therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Allowable Subject Matter
The nucleic acid sequence SEQ ID NOs: 7 is free of prior art.
The nucleic acid sequence having at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% sequence identity to SEQ ID NO: 7 is free of prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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/RUIXUE WANG/ Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672