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 May 11, 2026 is acknowledged.
Status of the Application
2. Claims 57-77 are pending under examination. Claims 1-56 are canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part for the following reasons.
Claim Rejections - 35 USC § 102-maintained
3. 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.
Claims 57, 61-67 and 72-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayashi et al. (US 2006/0252058).
Hayashi et al. teach a method of claim 57, 67, comprising: providing a volume suspected of containing target nucleic acids; and conducting an isothermal nucleic acid amplification reaction in said volume in the presence of a modulator comprising an engineered or non-natural sequence-specific nuclease (engineered sequence specific mismatch binding protein), wherein said modulator modulates said isothermal amplification of said target nucleic acids by acting on said target nucleic acid within a
region located between amplification primers of said isothermal amplification (para 0081-0085, 0089, 0075-0076, 0107-0114, 0130).
With reference to claim 61-66, Hayashi et al. teach providing comprises providing a first volume comprising a first nucleic acid and a second volume comprising a second nucleic acid, wherein dispensing said first volume among a plurality of first areas and dispensing said second volume among plurality of second areas and performing amplification in said areas and detecting the amplification differences in said first and second target nucleic acid, said difference is diagnostic of said nucleic acids (para 0106-0110, 0120-0130, 0008-0011 indicating chip with plurality of reaction areas).
With reference to claim 67, Hayashi et al. teach that the said modulation comprises producing a difference in amplification efficiency (para 0084-0085).
With reference to claim 72, Hayashi et al. teach that the method further comprises comparing results of said isothermal amplification to results of a control isothermal amplification in (para 0114, 0130).
With reference to claim 73-74, Hayashi et al. teach that the isothermal amplification is a LAMP, NASBA or SDA (para 0050). For all the above the claims are anticipated.
Response to Arguments:
With reference to the rejection of claims under 35 USC 102(a)(1) as being anticipated by Hayashi et al., the Applicant’s arguments were fully considered and found unpersuasive. With reference to the Applicant’s arguments that the mismatch binding protein does not cleave DNA, degrade or modification of DNA, the arguments were found unpersuasive because the claims as presented do not require a modulator to cleave, degrade the amplicon. The broader scope of a modulator as presented in the claims do not exclude that the mismatch protein (modulator) binding to the mismatch comprising DNA and inhibit or suppress amplification of DNA comprising a mismatch as taught by Hayashi et al. wherein the property of a mismatch protein to inhibit or suppress of a mismatch containing DNA, and said property of the modulator is within the scope of the claims as presented. In addition, claim 67 supports the that the modulator modulates the efficiency of amplification, which is within the scope of the teaching of inhibit, suppress or modulation of amplification of a DNA comprising a mismatch as taught by Hayashi et al. Further, with reference to no teaching of modulator acting between primers, the arguments were found unpersuasive because the para 0084 indicates that the mismatch binding protein binds to double-stranded structure between primer and template nucleic acid, which is within the scope of the claims as presented. For all the above the rejection has been maintained and include the claims 61-66 and 74 that were rejected in the rejection but inadvertently omitted in the statute of rejected claims in the previous office action.
Claim Rejections - 35 USC § 103-Maintained
4. 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.
Claims 57-67 and 70-74 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al. (US 2006/0252058) in view of Ismagilov et al. (WO 2010/111265).
Hayashi et al. teach a method for isothermal amplification in the presence of a modulator as discussed above. However, Hayashi et al. did not teach distributing or partitioning a volume comprising a target nucleic acid into plurality of areas capable of generating digital nucleic acid amplification signals.
Ismagilov et al. teach a digital amplification method comprising a slipchip comprising multiple areas on a chip, wherein a volume suspected of containing target nucleic acids is dispensed in said areas (para 0359-0360, 0366-0368, 0427-0433, 0513-0514); and conducting an isothermal nucleic acid amplification reaction in said volume (para 0406, 0417, 0427-0433, 0515-0519, 0359-0360, 0366) wherein providing comprises dispensing said volume among a plurality of areas and conducting is performed in the dispended volume in said plurality of areas, wherein providing comprises comprise a first volume comprising a first nucleic acid and a second volume comprising a second nucleic acid at most one target and detecting a difference in said first and second target amplification and digitally detecting positive and negative amplification signals using positive and negative control for comparison (para 0427-0446, 0513-0519, 0175). With reference to claims 70-71, Ismagilov teach that the target nucleic acid comprises HCV nucleic acid and the method determining a detection signal of HCV genotype (para 0544, 0640).
It would have been prime facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method as taught by Hayashi et al. with a digital amplification method as taught by Ismagilov et al. to develop an improved sensitive method for detecting a target nucleic acid in a sample. The ordinary person skilled in the art would have motivated to modify the method of Hayashi et al. with the digital amplification as taught by Ismagilov et al. and have a reasonable expectation of success that the modification would result in an improved sensitivity of the amplification method because Ismagilov et al. explicitly taught that the method provides analysis of multiple samples in small- volume samples using multiple analysis methods with digital read out of results (para 0267, 0359, 0406, 0417) and such a modification of the method is considered obvious over the cited prior art.
Response to Arguments:
With reference to the rejection of claims 57-74 under 35 USC 103 as being obvious over Hayashi et al. in view of Ismagilov et al., the arguments were found persuasive in-part. With reference to the rejection of claims 57-67, 70-74, the Applicant’s arguments were found unpersuasive. As discussed above, Hayashi et al. teach the method of claim 57 and as discussed in the rejection it would be obvious to modify the method of Hayashi et al. with digital nucleic acid amplification as taught by Ismagilov to derive at the claimed method. The rejection of claims 68-69 is moot because the combination of the references did not teach digital amplification producing a difference in amplification efficiency that indicates positive amplification signal and the rejection claims 68-69 has been withdrawn. For all the above the rejection has been maintained and restated.
Allowable Subject Matter
6. Claims 68-69 and 75-77 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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