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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 & 2, in the reply filed on 02/03/2026 is acknowledged. Group II, claims 4 & 5, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A first office action on the merits of claims 1 & 2 is set forth herein and claims 4 & 5 are withdrawn from consideration.
Information Disclosure Statement
Only the abstracts of the references in the IDS submitted on 08/25/2023 that are lined through, under the foreign patent documents section, were considered because an English copy of the full documents were not provided.
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 & 2 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Regarding claim 1, the recitation “measuring a light emission intensity at the spots of the microarray to measure the light emission intensity of the hybridized nucleic acid” in lines 11-12 of the claim is unclear an is generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. In addition, the claim recites the limitations “the amount of extracted nucleic acid” and “the amount of microorganisms” in lines 13 & 15 of the claim and there is insufficient antecedent basis. In addition, it is unclear if the recitation of “the extracted nucleic acid” in line 13 of the claim and “the nucleic acid in lines 14 of the claim is meant to refer back to “the hybridized nucleic acid” from the previous step or not. In addition, the recitation of “estimating the amount of the extracted nucleic acid based on the measured value of light intensity” in lines 13-14 of the claim is unclear what the relationship is between the measured value of light intensity and estimating an amount of an extracted nucleic acid is. Do certain thresholds of measured values of light intensity indicate particular amounts of extracted nucleic acids? In addition, the recitation of “calculating the amount of microorganisms in the test sample based on the estimated amount of the extracted nucleic acid” in lines 15-16 of the claim is unclear what the relationship is between the amount of microorganisms and the estimated amount of extracted nucleic acids. How does an estimated amount to extracted nucleic acid relate back to an amount of microorganisms.
Regarding claim 2, the claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
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.
Claim(s) 1 & 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersen (United States Application Publication US 2018/0223339 A1, August 2018), as cited on the IDS dated 01/06/2025.
Regarding claim 1, Andersen teaches a method of detecting the presence, relative abundance, and quantity of microorganisms with operational taxon unit (OTU) specific probes that are attached to a substrate forming a microarray comprising collecting a sample and concentrating and filtering (purifying) microorganisms in the sample (concentrating and purifying the microorganisms in the test sample), detecting microorganisms in the sample based on the selective hybridization of a plurality of probes hybridized with fluorescent molecules to nucleic acids isolated from the microorganisms to be detected (extracting a nucleic acid from the concentrated and purified microorganisms and performing a hybridization reaction such that the extracted nucleic acid is capturable at spots of a microarray where probes modified with fluorescent molecules are fixed), and after hybridization of isolated (extracted) nucleic acids to fluorescent probes on a microarray measuring fluorescent emission signal (light emission intensity) to detect and quantify isolated (extracted) nucleic acids in the sample enabling detection and quantification od microorganisms in the sample (measuring light emission intensity at spots of the microarray to measure the light emission intensity of the hybridized nucleic acid, estimating the amount of extracted nucleic acid based in the measured value of light emission intensity, and calculating the amount of the microorganism in the test sample based on the estimated amount of the extracted nucleic acid) (abstract lines 1-14; paragraph [0006] lines 1-23; paragraph [0010] lines 1-14; paragraph [0030] lines 1-13; paragraph [00159] lines 1-5; paragraph [0163] lines 1-18; paragraph [0166] lines 1-8; paragraph [0170] lines 1-18; paragraph [0171] lines 1-20; paragraph [0173] lines 1-17; paragraph [0174] lines 1-26; paragraph [0175] lines 1-18; paragraph [0176] lines 1-15; paragraph [0301] lines 1-11; paragraph [0399] lines 1-8). In addition, Andersen teaches the hybridization reaction comprises use of MES hybridization buffer (hybridization reaction solution containing salts and surfactant necessary for the hybridization reaction of the extracted nucleic acids) (paragraph [0356] lines 15-24).
Regarding claim 2, Andersen teaches that the hybridization signal obtained from measuring fluorescent emission signal to detect and quantify hybridized isolated (extracted) nucleic acids comprises comparing to background signal or hybridization signal from known mismatch probes to the target nucleic acids in order to measure the target hybridized and isolated (extracted) nucleic acids (when estimating the amount of extracted nucleic acids concentration of the nucleic acid in the test sample is estimated based on the luminance values (hybridization signal obtained from measuring fluorescent emission signal) for a reference nucleic acid of know concentrations (nucleic acid mismatch probes to target nucleic acids) obtained in advance after an arbitrary hybridization reaction and calibration curve of nucleic acid concentration) (paragraph [0158] lines 1-24).
Conclusion
Claims 1 & 2 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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