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 October 22, 2025 is acknowledged.
Status of the Application
2. Claims 1-3 and 5-19 are pending under examination. Claim 4 is cancelled. New claim 21 is added. Claim 20 is previously withdrawn from further consideration as being drawn to nonelected group. The Applicant’s arguments have been fully considered and found persuasive in-part for the following reasons.
Objection to the Specification-maintained
3. The disclosure is objected to because of the following informalities:
The use of the term (fluorescent dyes such as BHQ in para 0057, 0082-0083) which is a trade name or a mark used in commerce, has been noted in this application.
The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The fluorescent dyes are not followed by generic names. Appropriate correction is required.
Response to Arguments:
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 because the amendment did not provide generic names of the fluorescent labels (BHQplus, BHQ-1).
Claim Rejections - 35 USC § 112-Withdrawn
4. The rejection of claims under 35 USC 112(a) has been withdrawn in view of the amendment.
5. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 102-Withdrawn
6. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Cabannes et al. has been withdrawn in view of the amendment.
7. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Petrillo et al. has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103-withdrawn
8. The rejection of claims under 35 USC 103 as being unpatentable over Petrillo et al. in view of Rothberg et al. and Lowe et al. has been withdrawn in view of the amendment. However, the references teach newly cited seq Id Nos and applied to a new combination of references.
New Rejections necessitated by the Amendment
Claim Rejections - 35 USC § 112
9. 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.
Claim 18 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. The claim 18 recites ‘amounts of human host DNA and viral RNA’. The limitations ‘human host DNA’ are unclear and indefinite because claim 11 requires animal host DNA and it is not clear if the claim 18 refers to animal host DNA or optional limitation of human host DNA, which is optional.
Claim Rejections - 35 USC § 102
10. 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 11, 13-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piralla et al. (J Clin Virology, Vol. 107, page 6-10, (2018)).
Piralla et al. teach a method of claim 11, for performing a quantitative viral determination comprising:
separately isolating, purifying and concentrating RNA and DNA from a sample obtained from human subject (page 7, paragraphs under section 3.1 to 3.2 section: indicating isolation, purification of the viral RNA and host DNA from sample as evidenced by the cross references in section 3.1 to 3.2);
amplifying a viral RNA from the isolated RNA (page 7, paragraph 2 under section 3.1);
amplifying an animal host DNA from the isolated DNA (page 7, paragraph 1 under section 3.2);
quantitating concentrations of the amplified viral RNA and the amplified animal host (page 7, paragraphs under section 3.1 and 3.2: indicating quantitation of animal host DNA and viral RNA); and
normalizing amount of viral RNA by comparison with the amount of host DNA to obtain the number of viral copies/ng of host DNA (page 7, paragraphs under section 3.3 and 3.4 and paragraphs under section 4).
With reference to claims 13-14, Piralla et al. teach that the sample is a nasopharangeal sample and is placed in universal transport medium (page 7, paragraph under the subheading ‘objectives’, paragraphs under 3.1, paragraph 1 under ‘results’ section).
With reference to claims 15-16, Piralla et al. teach that each amplification comprises PCR wherein each comprises separately mixing extracted viral RNA and animal host DNA with two or more primers (page 7, paragraphs under section 3.1- 3.2).
With reference to claim 18, Piralla et al. teach that host DNA and viral RNA are isolated separately and amount are quantitated (page 7, paragraphs under 3.1-3.4). For all the above the claims are anticipated.
Claim Rejections - 35 USC § 103
11. 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 1-3, 5-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (PLOS ONE, Vol. 15(5): e0233085, page 1-20, (2020)) in view of Petrillo et al. (Microorganisms, Vol. 8, 1064, p. 1-10, (2020, published online July 2020), Rothberg et al. (US 2021/0292825) and Lowe et al. (Nucleic Acids Research, Vol. 18, No. 7, page 1757-1761, 1990).
Long et al. teach a method of claims 1, 11, for performing a quantitative viral determination comprising separately isolating, purifying and concentrating RNA and DNA from a sample obtained from an animal (page 14-15, paragraphs under materials and methods section): indicating isolation, purification of the viral RNA and host DNA from sample);
amplifying a viral RNA from the isolated RNA (page 14-16 paragraphs under materials and methods section: indicating qRT-PCR);
amplifying an animal host DNA from the isolated DNA (page 14-16 paragraphs under materials and methods section: indicating qPCR);
detecting the presence of the virus by analyzing the nucleic acid amplification products of the RT-qPCR and qPCR assay (page 14-16, paragraphs under materials and methods section).
With reference to claims 5-6, Long et al. teach normalizing the viral load by comparison with human DNA and the sample comprises genomic DNA and mRNA (page 15-16, paragraphs under materials and methods section).
With reference to claims 15-16, Long et al. teach that the amplification utilizes PCR and each PCR comprises separately mixing RNA and animal host DNA sample with two primers (page 14-16, paragraphs under materials and methods section).
However, Long et al. did not teach SARS-Cov-2 virus and amplification primers and probes comprising the sequences of SEQ ID Nos. 7-12.
Petrillo et al. teach a method of claim 1-3, 5-19, 21, for performing a quantitative viral determination of SARS-cov-2 virus comprising:
amplifying viral RNA and animal host DNA (Rnase P gene) obtained from a nasal sample from an animal infected with Cov-2 virus with RNAse P gene primers comprising the sequences of SEQ ID NO:9-10 and a probe comprising sequence of SEQ ID NO:11 to produce an amplified sample, wherein the probe comprises a fluorescent dye and a quencher dye and incorporation of fluorescent dye in to the amplification products, monitoring and quantitating the fluorescence signal during amplification (page 2-3, section 2.1-2.4 under ‘materials and methods’ section and table 1 indicating the sequences of SEQ ID NO: 9-11 for amplifying RNAse P);
quantitating concentrations of the viral RNA and host DNA within the amplified sample (page 3-5, paragraphs under section 3.1-3.3).
Rothberg et al. teach a method for detecting SARS-Cov-2 in a sample, wherein Rothberg et al. teach detecting SARS Cov-2 virus in a sample wherein Rothberg et al teach nucleic acid sequence comprising the primer and probe sequences of SEQ ID NO: 7, 8 and 12 ((SEQ ID NO: 29 of Rothberg et al. comprises the sequences of SEQ ID NO; 7 and 8 and seq ID NO:38 of Rothberg et al. comprises the sequence of SEQ ID NO:12)
Lowe et al. teach a method for designing primers and evaluating their performance wherein Lowe et al. disclose a computer program for rapid selection of oligonucleotide primers for polymerase chain reaction, wherein the length of the primers designed to have 18 to 22 nucleotides or (paragraphs under subheading ‘computer program’ on page 1757-1758, abstract). Lowe et al. teach that all primers designed for over 10 gene products were experimentally tested and the results showed that all the amplification products specified by the primers are of the predicted size and also hybridize with the
appropriate cDNA or internal oligonucleotide probe (see page 1759-1760, col. 2, paragraph 1, table 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective date of the invention to modify the method for performing a quantitative viral determination as taught by Long et al. with the method of detecting SARS-Cov-2 virus using primers and probes as taught by Petrillo et al. to detect SARS-Cov-2 in a sample. Further, it would be obvious to combine the method with the nucleic acid sequence comprising primers and probes as taught by Rothberg et al. and obtaining primers/ probes from the known sequence as taught by Lowe et al. to improve the specificity of amplifying target get nucleic acid in a sample. The ordinary person skilled in the art would have motivated to generate primers and probes from the known sequence as taught by Lowe et al. and have a reasonable expectation of success that such primers/ probe generated using known sequence as taught by Rothberg et al. would amplify the target nucleic acid. The claimed primers /probe are functional equivalents of the primers sequence taught by Rothberg et al. in view of Lowe et al. because Lowe et al. explicitly taught that the primers/probe generated from a known sequence using the computer program would specifically amplify the target sequence and all primers designed for over 10 gene products from known sequences were experimentally tested and the results showed that all the amplification products specified by the primers are of the predicted size also hybridizes with the appropriate cDNA or internal oligonucleotide probe (see page 1760, col. 2, paragraph 1) and such a modification of the known sequences are considered obvious over the prior art. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim such as oligomer length and sequence, are disclosed in the prior art Petrillo et al., Rothberg et al. and Lowe et al.), it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that the selection of hybridization conditions performed was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art and such a modification of the method is considered obvious over the cited prior 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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