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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/17/2025 has been entered.
Claims 1, 4-11, 14-20 are pending. Claims 2-3 and 12-13 have been cancelled.
The following rejections are newly applied.
This action is Nonfinal.
Withdrawn Rejections
The 35 USC 103 rejection made in the previous office action is withdrawn based upon amendments to the claims.
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, 4-11, 14-20 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
Upon review of the specification, the specification does not appear to provide support for the recitation of "the additional additive is a combination of formamide, SDS, and proclin 300, which has a final concentration of 0.03% (v/v) after being added to a PCR reaction solution".
However, the instant specification does not teach " the additional additive is a combination of formamide, SDS, and proclin 300, which has a final concentration of 0.03% (v/v) after being added to a PCR reaction solution ". Rather, page 6 teaches “the additional additive is SDS and Proclin 300, which has a final concentration of 0.01% to 0.05%”, which teaches a range but not the particular concentration recited. Further, the statement does not teach the three chemicals recited in the claim. On page 9 the specificaoin disclose 0.03% SNDS was used but in this example 2, does not disclose that the combination is a final concentration of 0.03% (v/v). Table 4 states that “additive group concentration is 0.03% v/v”, however, it is not clear which of the components are intended to be encompassed by “additive group”.
These amendments to the claims, therefore, constitute new matter.
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 1, 4-11, 14-20 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 1, 4-11, 14-20 contains the trademark/trade name proclin 300. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe chemicals and, accordingly, the identification/description is indefinite.
Modified Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-11, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al (US Patent Application Publication 2016/0326576 November 10, 2016) in view of Zhang et al. (US Patent Application Publication 20180163265 June 14, 2018), Nakamura et al. (US Patent Application 2019/0112638 April 18, 2019) and Hongo et al. (US Patent Application Publication 2013/0266973 October 10, 2013).
With regard to claim 1, Cook et al. teaches mixing upstream and downstream primer pairs, fluorescent probe and PCR amplification reagents and performing a fluorescent qPCR (para 3, 6, 257). Cook et al. teaches double quencher on the 3’ end and on a T base internal (para 10, 12). Cook et al. teaches that the quenchers can be 10 nucleotides (279). However, Cook et al. does not teach the additional additive of the combination of formamide, SDS, and proclin 300 or the final concentration.
With regard to claim 5, Cook et al. teaches that the fluorescent probe has a length of 20-30 bases (as such encompasses the length of 18-35 bp) (para 8).
With regard to claim 6, Cook et al. teaches a Tm value of 70 (para 8).
With regard to claim 7, Cook et al. teaches a probe that has a GC content not exceeding 60% (SEQ ID No. 3).
With regard to claim 9, Cook et al. teaches that the first and second quencher comprises the same quenching group of BHQ (para 402).
With regard to claim 10, Cook et al. teaches mixing upstream and downstream primer pairs, fluorescent probe and PCR amplification reagents and performing a fluorescent qPCR (para 3, 6, 257). Cook et al. teaches double quencher on the 3’ end and on a T base internal (para 10, 12). Cook et al. teaches that the quenchers can be 10 nucleotides (279). As Cook et al. does not teach purification or extraction steps in the “mixing” or “carrying out the fluorescent quantitative PCR”, Cook et al teaches the breadth of the claims. However, Cook et al. does not teach the additional additive of the combination of formamide, SDS, and proclin 300.
With regard to claim 11, Cook et al. teaches the compositions of an upstream and downstream primer pair, a fluorescent probe, and a PCR amplification reagent, wherein the fluorescent probe has two quenching groups, in which a first quenching group is located at a 3' end and a second quenching group is labeled on a T base and is 10-15 nt apart from the first quenching group (para 3, 6, 257, 279).
With regard to claim 15, Cook et al. teaches that the fluorescent probe has a length of 20-30 bases (as such encompasses the length of 18-35 bp) (para 8).
With regard to claim 16, Cook et al. teaches a Tm value of 70 (para 8).
With regard to claim 17, Cook et al. teaches a probe that has a GC content not exceeding 60% (SEQ ID No. 3).
With regard to claim 19, Cook et al. teaches that the first and second quencher comprises the same quenching group of BHQ (para 402).
With regard to claim 20, the term “kit” does not provide any additional structures. As such Cook et al. teaches all the components of the kit.
However, Cook et al. does not teach the additional additives and the components in the qPCR reaction mixture of polymerase and dNTPs.
With regard to claim 1 and 10, Zhang et al. teaches that PCR assays can included hybridization reactions assays for probe hybridization that includes formamide and SDS (para 372).
With regard to claim 1 and 10, Nakamura et al. teaches the addition of Proclin 300 in the PCR amplification mixture for preservation (para 222). Nakamura et al. suggests that samples of chlamydia can be treated with SDS (para 62). Therefore it would be obvious to one of ordinary skill in the art to use the SDS in the mixture with the sample of Cook et al. to disrupt cells prior to PCR amplification.
Nakamura et al. suggests that samples of chlamydia can be treated with SDS (para 62). Therefore it would be obvious to one of ordinary skill in the art to use the SDS in the mixture with the sample of Cook et al. to disrupt cells prior to PCR amplification. However, Nakamura et al does not teach the percentage or ph constraints of Proclin 300.
With regard to claim 8, 18, Nakamura et al. teaches polymerase, dNTPs and PCR buffer in a PCR mixture (paragraph 80 and 145, 160).
With regard to claims 3, 13, 4, and 14 Hongo et al. teaches that Proclin 300 used as a chemical in reagent conditions can include 0.05% and pH 7.4 (para 256).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method and composition of Cook et al. to use Proclin 300 and SDS of Nakamura to add known chemical components in a PCR mixture to add in the amplification of a target within a sample and further add formamide and SDS solution for the incubation of targets and probes as taught by Zhang. The ordinary artisan would be motivated to modify the method and composition of Cook et al. to include finite number of chemical components that are used in PCR amplification of a target with a reasonable expectation of amplification. Hongo et al. teaches the optimization of Proclin 300 wherein Hongo et al. teaches routine pH and amount levels of the chemical of Proclin 300 which is used in Nakamura et al. in a PCR amplification mixture. The combination of art does not teach the requirement for the final concentration. However, the combinations provide the same chemicals for PCR analysis. Absent secondary considerations it would be prima facie obvious to modify these known chemicals to design concentrations that would predictably amplify the target. Determining concentrations that would be used in PCR amplification would be considered equivalents to these concentrations of routine experimentation for concentrations that would amplify the target.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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