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, claims 1-2, 5, 16-17, 19-22, 24-25, 27-29, 31, 33, 37 and Cas 13 in the reply filed on 03/27/2026 is acknowledged.
Claims 34-35 and 39-43 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/27/2026.
Claims 1-2, 5, 16-17, 19-22, 24-25, 27, 31, 33, and 37 are under examination. Claim 29 is under examination with respect to Cas13a.
Claim Rejections - 35 USC § 112(b)
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 28-29 and 31 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.
Claim 28 recites the method comprises transcribing a copied and/or amplified templated nucleic acid synthesis target using any primer inserted promoter. Claim 28 depends from claim 27 and claim 1. Neither claim 27 nor claim 1 require transcribing a copied or amplified templated nucleic acid synthesis target or any primer inserted promoter. Claim 1 requires a primer that comprises a T7 promoter sequence element but does not require any primer inserted promoter. It is unclear what is encompassed by claim 28, it is unclear if claim 28 is requiring an additional step of transcribing a target using any primer inserted promoter or requiring transcribing a target using the primers that include a T7 promoter sequence elements. The primers required for transcribing the target is indefinite and it is unclear the scope of the claim. Additionally the recitation of any primer inserted promoter is indefinite, it is unclear if the claim requires a primer that has a promoter sequence or if the claim is requiring an entire promoter sequence with a primer sequence inserted at any place within the promoter. The metes and bounds of the claim are indefinite and one of ordinary skill in the art would not be apprised of what is encompassed by the claims. Claims 29 and 31 depend from claim 28 and are indefinite for the reasons applied to claim 28.
Claim Rejections - 35 USC § 112(d)
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 28 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 28 recites the method comprises transcribing a copied and/or amplified templated nucleic acid synthesis target using any primer inserted promoter. Claim 28 depends from claim 27 and claim 1. Neither claim 27 nor claim 1 1 require transcribing a copied or amplified templated nucleic acid synthesis target or any primer inserted promoter. Claim 1 requires a primer that comprises a T7 promoter sequence element but does not require any primer inserted promoter. Claim 27 further limits the CRISPR-Cas detection composition. Claim 28 does not further limit the CRISPR-Cas detection composition nor does claim 28 further limit claim 1. Claim 28 appears to be broader in scope than claim 1 as claim 1 requires primers that include a T7 promoter sequence element and claim 1 does not require transcribing nor using any primer inserted promoter. While claim 1 uses a primer that includes a portion of a T7 promoter sequence this is not any promoter and is not any promoter that has a primer inserted into the sequence, as appears to be required for claim 28. 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 § 102
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 1-2, 16-17, 19-22, 24, 25, 27-29, 33, 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agrawal (medRxiv preprint 12/16/2020, pp. 1-19).
With regard to claim 1, Agrawal teaches LAMP using nine primer sets targeting distinct regions across SARS-CoV-2 genome (see fig 2C). Agrawal teaches incorporating T7 promoter sequences into LAMP primer sequences to enable transcription and Cas13 detection (claim 28) (see pg. 6, primer table). Agrawal teaches primer sets comprising FIP, Bloop and F loop comprising T7 promoters (see N gene set 1), FIP, BIP, F loop and B loop comprising T7 promoter (See RNAse P gene set). Agrawal teaches in vitro transcription with T7 RNA polymerase (See pg. 7) (claim 28). Agrawal teaches contacting amplified nucleic acids with CRISPR-Cas detection composition and detecting amplified nucleic acid (see pg. 9). Additionally it is noted the claim does not require an entire T7 promoter sequence only a sequence element which can encompass any smaller nucleotide portion of the T7 promoter including any two or more nucleotides. Each of the primers taught by Agrawal comprise a portion of the T7 promoter sequence element. Additionally the claim does not require that each of the plurality of primers are used in the same amplification reaction as such the analysis of amplification of plurality of primers comprising T7 promoter sequence elements as taught by Agrawal meets the limitations of the claims.
With regard to claim 2, Agrawal teaches the primers are complementary to the hybridization site (see primer table).
With regard to claim 16, Agrawal teaches at least one primer that comprises at least two T7 promoter sequence elements. Agrawal teaches T7 sequence at two different locations of FIP and BIP. Additionally Agrawal teaches primers with a T7 sequence and additional nucleotides that encompass any two or more sequence elements of T7. For example Rnase P FIP M T7 comprises two sequence elements of T7 promoter as it comprises the entire T7 promoter and the claim only requires at least two T7 promoter sequence elements. Additionally, The N gene Set the B3 primer comprises TAGG which is T7 promoter sequence element and BIP with T7 promoter in middle comprises a TAAT and TAAT twice in the primer sequence and thus comprises at least two T7 promoter element (see primer table).
With regard to claim 17-20, Agrawal teaches primers with T7 promoter elements in the forward loop primer, backward loop primer, forward inner primer, backward inner primer (see primer table). The primers for gene set N gene set 1, N gene set 2, and N gene set 3 encompasses these limitations. It is noted the claims do not require all of the primers to comprise a T7 promoter as the claims recites “and/or”.
With regard to claim 22, 24-25, Agrawal teaches LAMP and amplification is detected via fluorescence (See fig 1).
With regard to claim 27-29, 31, 33, 36-37, Agrawal teaches a detection system that comprises a guide polynucleotide, labeled nucleic acid reporter construct, Cas13 protein. Agrawal teaches detecting at least two target sequences of interest and primer that flank the two sequences, see fig 4.
Claims 1-2, 5, 22, 24, 25, 27-29, 33, 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (Biosensor and Bioelectronics, 2021, 172, 112766, pp 1-7 and supplemental data)
With regard to claim 1 and 28, Wang teaches PCR amplification of a S gene sequence in a plasmid by incubating the template nucleic acid target with a plurality of primers that comprise T7 promoters (see T7 primer). Wang teaches incorporating T7 promoters into sequence to enable transcription (see s2) (claim 28). Wang teaches contacting the amplified target sequence with a CRISPR-Cas detection composition and detecting the amplified nucleic acid (see fig 1). Wang teaches T7 primers for S gene transcription. The T7-FP primer contains the entire T7 promoter while the T7-RP contains a T7 promoter element, for example the sequence TAA. The claim does not require the entire T7 promoter sequence and recites only a T7 sequence element which could encompass any portion of the T7 promoter sequence. Wang further teaches LAMP primers. Each of the LAMP primers taught by Wang comprise a portion of the T7 promoter sequence element.
With regard to claim 2, Wang teaches the primers are complementary to the hybridization site (see nucleic acid sequences used, supplementary data).
With regard to claim 5, Wang teaches the RNA template was isolated from a sample (see materials).
With regard to claim 16, Wang teaches at least one primer that comprises at least two T7 promoter sequence elements. Wang teaches T7 sequence for transcription. The T7 sequence for transcription further comprises AAAT, which is a portion of T7 sequence element and therefore this primer comprises at least two T7 promoter sequence elements.
With regard to claim 17, 19-21, Wang teaches primers with T7 promoter elements in the forward loop primer, backward loop primer, forward inner primer, backward inner primer (see primer table). The primers for RT-LAMP primers each comprise a portion of T7 and encompasses these limitations. It is noted the claims do not require all of the primers to comprise a T7 promoter as the claims recites “and/or”.
With regard to claim 22, 24-25, Wang teaches in vitro transcription followed by LAMP and amplification is detected via fluorescence (See fig 1).
With regard to claim 27-28, 33, Wang teaches a detection system that comprises a guide polynucleotide, labeled nucleic acid reporter construct, Cas12a protein, see fig 1 and 2.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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