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
1. The applicant’s response to the office action filed on February 23, 2026 is acknowledged.
Status of the Application
2. Claims 1-5, 7-10 and 12 are pending under examination. New claims 57-63 are added. Claims 13 and 15 are previously withdrawn from further consideration as being drawn to non-elected group. Claims 6, 11, 14 and 16-56 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part.
Response to Arguments:
3. With reference to the objection to the specification, the Applicant’s arguments and the amendment have been fully considered and found unpersuasive. The objection has been maintained because the amendment did not address the generic names of the fluorophores (FITC, Iowa black, Tex615, 6-FAM).
4. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Meagher et al. has been withdrawn in view of the amendment.
New Rejections Necessitated by the Amendment
Claim Rejections - 35 USC § 103
5. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.2. Ascertaining the differences between the prior art and the claims at issue.3. Resolving the level of ordinary skill in the pertinent art.4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A. Claims 1-5, 7-10, 12 and 57-62 are rejected under 35 U.S.C. 103 as being unpatentable over Martineau et al. (US 2019/0177784) in view of Stratagene Catalog (Stratagene Catalog, page 39, 1988).
Martineau et al. teach a loop-mediated amplification reaction of claim 1, 12, 59, 60, comprising: a loop primer nucleic acid molecule configured for loop-mediated isothermal amplification (LAMP), the loop primer nucleic acid molecule (SNP FIP-tag primer for SNP (loop back primer) comprising: a targeting sequence complementary to a target portion of a target nucleic acid sequence; and an adapter sequence (tag sequence); a displacement nucleic acid probe (tag fluorophore) comprising: a fluorophore adapter sequence; and the adapter sequence; and a fluorophore adapter (tag quencher) complement nucleic acid molecule complementary to the fluorophore adapter sequence, wherein the fluorophore adapter sequence or the fluorophore adapter complement nucleic acid molecule is coupled to a fluorophore;
an internal amplification control primer nucleic acid molecule (wild-type FIP-tag primer (loop back primer)), wherein the loop primer nucleic acid and internal amplification primer nucleic acid molecules are configured to compete with each other for amplification (Fig. 7, para 0054-0057, 0012-0015, 0027-0032).
With reference to claim 2-3, Martineau et al. teach that the fluorophore adapter sequence or the fluorophore adapter complement nucleic acid molecule is not coupled to the fluorophore is coupled to a quencher configured to quench fluorescence of the fluorophore and wherein whichever of the fluorophore adapter sequence or the fluorophore adapter complement nucleic acid molecule is not coupled to the fluorophore is coupled to a second fluorophore configured to receive energy from the fluorophore by Forster resonance energy transfer (para 0054-0057).
With reference to claim 4, Martineau et al. teach that the fluorophore adapter sequence is configured to form a hairpin structure and further comprises a quencher positioned to be proximal to the fluorophore when the fluorophore adapter sequence is in the hairpin structure and configured to quench fluorescence of the fluorophore (para 0027-0028, Fig. 7).
With reference to claim 5, 7, 57, 60, Martineau et al. teach further comprising a second loop primer (additional SNP FIP-tag primer) nucleic acid molecule configured for LAMP, the second loop primer nucleic acid molecule (LF/LB primer) comprising: a second targeting sequence complementary to a second target nucleic acid sequence; and the adapter sequence and a second loop primer nucleic acid molecule complementary to a second portion of the target nucleic acid sequence, wherein the second portion of the target nucleic acid sequence is different than the target portion of the target nucleic acid sequence (para 0054-0057, 0036, 0046-0048, claim 1).
With reference to claim 8-9, Martineau et al. teach that the further comprising: a forward outer primer nucleic acid molecule complementary to an upstream portion of the target nucleic acid sequence, wherein the upstream portion is upstream of the target portion of the target nucleic acid sequence; and a backwards outer primer nucleic acid molecule complementary to a downstream portion of the target nucleic acid sequence, wherein the downstream portion is downstream of the target portion; a forward inner primer nucleic acid molecule complementary to a second upstream portion of the target nucleic acid sequence, wherein the forward inner primer nucleic acid molecule further comprises a loop-forming portion complementary to a second downstream portion of the target nucleic acid sequence, wherein the second downstream portion is downstream of the downstream portion; and a backward inner primer complementary to a third downstream portion of the target nucleic acid sequence (para 0054-0057: indicating F3, B3, BIP, LF and LB primers).
With reference to claim 10, Martineau et al. teach that the kit further comprising internal amplification control primer nucleic acid molecules comprising: a control targeting sequence complementary to a control portion of a control target nucleic acid sequence; and a control adapter sequence; a control displacement nucleic acid probe comprising: a control fluorophore adapter sequence; and the control adapter sequence; and a control fluorophore adapter complement nucleic acid molecule complementary to the control fluorophore adapter sequence, wherein the control fluorophore adapter sequence or the control fluorophore adapter complement nucleic acid molecule is coupled to a control fluorophore (para 0027-0028, para 0057-0058).
With reference to claim 58, the fluorophore is configured to emit fluorescence in a first wavelength range, and control fluorophore emits a control fluorescence that is different than the first wavelength range (para 0029, 0055-0057, fig. 9).
With reference to claim 61, the concentration of the fluorophore is equal to the concentration of the quencher (para 0027, 0057, Fig.7).
With reference to claim 62, the control target sequence is derived from the target sequence and comprises an engineered sequence (tag modified sequence) in the control portion (para 0046-0058).
However, Martineau et al. did not teach packaging the composition into a kit format.
Stratagene Catalog teaches gene characterization kit which includes formatting kit components (see page 39).
Therefore, it would have been prima facie obvious to one of the ordinary person skilled in the art before e the effective filing date of the invention to combine the reaction composition as taught by Martineau et al. with a kit format as discussed by Stratagene catalog to develop a ready-to-use kit composition. The ordinary person skilled in the art would have been motivated to combine the reaction composition as taught by Martineau et al. into a kit format as taught by Stratagene catalog because Stratagene Catalog explicitly teaches assembling the components of gene characterizing components into a kit format which provides premixed ready to use reaction mixture, and saves money and resources for everyone by dramatically reducing waste (see page 39, col. 1, paragraph) and such a modification is considered obvious over the cited prior art.
B. Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Martineau et al. (US 2019/0177784) in view of Stratagene Catalog (Stratagene Catalog, page 39, 1988) as applied to claims 1-5, 7-10, 12 and 57-62 above, and further in view of Corman et al. (Euro Surveill, Vol. 25(3), page 1-8, January 2020).
Martineau et al. and Stratagene Catalog teach a kit for loop-mediated reaction. However, Martineau et al. and Stratagene Catalog did not teach target sequence as a SARS-CoV-2 nucleic acid sequence.
Corman et al. teach a diagnostic method for detecting a SARS-CoV-2 nucleic acid sequence (2019-nCov) in a sample, wherein the method comprises performing a real-time RT-PCR for detecting SARS-CoV-2 in a sample (page 1, abstract, paragraphs under Methods section on page 2-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the kit of Martineau et al. and Stratagene Catalog with the SARS CoV-2 target sequence as taught by Corman et al. to develop an improved amplification method for detecting SARS CoV-2 target nucleic acids in a sample. The ordinary person skilled in the art would have motivated to combine the kit of Martineau et al. and Stratagene Catalog with the target nucleic acid of SARS CoV-2 as taught by Corman et al. and have a reasonable expectation of success that the combination would result in an improved method for detecting SARS CoV-2 nucleic acid in a sample because Corman et al. explicitly taught diagnostic method for detecting the SARS CoV-2 in a sample (page 1, abstract) and such a modification of the ki is considered obvious over the cited art.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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