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 1-4, 6-9, 11-13, 15, 17 and 18 in the reply filed on February 17, 2026 is acknowledged.
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.
Claim 6 recites the limitation "the predicted viral proteome" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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) 1-4, 6-9, 11-13, 15, 17 and 18 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Weiss (US 2020/0291428).
Regarding claim 1, Weiss teaches engineered HSV-1 vectors comprising a cell or tissue infected with a herpesvirus (paragraph [0147]), an extract from a cell or tissue infected with a herpesvirus (paragraph [0147]); or a protein preparation from a cell or tissue infected with a herpesvirus and determining abundance level of a plurality of herpesvirus proteins in the sample using parallel reaction monitoring (PRM) to quantify signature peptide(s) corresponding to the herpesvirus proteins; wherein the herpesvirus is HSV-1 and the signature peptides comprise a sequence selected from one of SEQ ID NOs: 1-219 (paragraph [0010]); or the herpesvirus is HCMV and the signature peptides comprise a sequence selected from one of SEQ ID NOs: 220-453; or the herpesvirus is KSHV and the signature peptides comprise a sequence selected from one of SEQ ID NOs: 454-606.
Regarding claim 2, at least one herpesvirus protein (detectable molecule) for which the abundance level is determined, at least two signature peptides are quantified. (paragraph [0116])
Regarding claim 3, determining the abundance level of the plurality of herpesvirus proteins using PRM comprises subjecting the sample to liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). (paragraph [0116])
Regarding claim 4, the plurality of herpesvirus proteins comprises at least one herpesvirus protein from each temporal class of viral replication for that herpesvirus; and/or the cell or tissue infected with the herpesvirus is a human cell or human tissue. (paragraph [0147])
Regarding claim 6, the plurality of herpesvirus proteins constitutes approximately 30-70% of the predicted viral proteome, or 50-80% of the predicted viral proteome. (Tables 1 and 2)
Regarding claim 7, repeating the assay of claim 1 a plurality of times, where for each repetition the sample is obtained at a different timepoint in a time course. (paragraph [0185])
Regarding claim 8, the different timepoints are: different times post infection of the cell or tissue with the herpesvirus; different times post exposure of the cell or tissue to a compound variable; or different times post exposure of the cell or tissue to an environmental variable. (paragraph [0185])
Regarding claim 9, the different times after infection of the cell or tissue with the herpesvirus include at least one time from each state of a replication cycle of the herpesvirus. (paragraph [0185])
Regarding claim 11, a plurality of times, where for each repetition the sample is obtained from a cell or tissue that has been exposed to a different compound or condition or a different dosage of a compound or a condition. (paragraph [0197])
Regarding claim 12, the different compounds comprise one or more of known antiviral compounds, proposed antiviral compounds, test compounds, small molecule drugs or drug candidates, or siRNAs or other biologically active non-coding RNAs. (paragraph [0197])
Regarding claim 13, the known antiviral compounds comprise one or more of acyclovir, ganciclovir, another nucleoside, penciclovir, famciclovir, valacyclovir, valganciclovir, cidofovir, another nucleotide phosphonate, fomivirsen, foscarnet, or honokiol. (paragraph [0197])
Regarding claim 15, the different exposures comprise one or more of genetic modification of the cell or tissue, genetic modification of the herpesvirus, environmental conditions, or cell or tissue growth or harvesting conditions. (paragraph [0038])
Regarding claim 17, subjecting a cell sample or cell extract from a cell infected with a herpesvirus to parallel reaction monitoring (PRM) to generate abundance data; analyzing the abundance data to quantify signature peptide(s) corresponding to at least one herpesvirus protein from each of at least two temporal classes of viral replication; and providing the quantified peptide(s) results from the analyzing to a database, a computer memory, a display, a printer, or another output device; wherein the herpesvirus is HSV-1 and one or more of the signature peptides comprise a sequence selected from one of SEQ ID NOs: 1-219; or the herpesvirus is HCMV and one or more of the signature peptides comprise a sequence selected from one of SEQ ID NOs: 220-453; or the herpesvirus is KSHV and one or more of the signature peptides comprise a sequence selected from one of SEQ ID NOs: 454- 606. (Refer to rejection of claims 1-4)
Regarding claim 18, screen a drug candidate as a modulator of viral infection (tumor bearing mice example); analyze a stage of infection at which a test compound acts; determine what functional family(s) of viral proteins are affected by a drug or drug candidate; characterize viral and/or host responses to viral infection; characterize viral and/or host responses to drug treatment; or characterize viral and/or host responses to genetic manipulation of either the viral genome or the host genome. (Refer to paragraphs [0188-0194])
Conclusion
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/JYOTI Mutreja/ Primary Examiner, Art Unit 1798
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