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 .
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20210341480A1, Published 11/04/2021. Amendments to the specification presented on 01/31/2025 are acknowledged and entered.
Disposition of Claims
Claims 1-5, 7-14, 22-23, and 25-28 were pending. Claims 6, 9, 15-21, 23-24, and 29 are cancelled. Amendments to claims 1, 7, 10, and 25 are acknowledged and entered. Claims 1-5, 7-8, 10-14, 22, and 25-28 will be examined on their merits.
Response to Arguments
Applicant's arguments filed 02/20/2026 regarding the previous Office action dated 11/24/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(New rejection – necessitated by amendment.) Claim 1 and dependent claims 2-5, 7-8, 10-14, 22, and 25-28 thereof 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 term “specific” in claim 1 is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As set forth in previous Office actions (See e.g. non-final rejection 02/14/2025, final rejection 11/01/2024), the use of “specific” in relation to antibody binding is not defined by the art or the specification.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant claim 1 is rejected on the grounds of being indefinite. Claims 2-5, 7-8, 10-14, 22, and 25-28 are also rejected since they depend from claim 1, but do not remedy these deficiencies of claim 1.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1-5, 7-14, 22-23, and 26-28 under 35 U.S.C. 101 is withdrawn in light of the amendments to the claims.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1 is drawn to a method of detecting a respiratory virus infection, the method comprising:
1) obtaining a saliva sample from an individual, wherein the sample is self-collected by the individual;
2) performing a first assay comprising nucleic acid amplification on a first portion of the saliva sample to quantify viral nucleic acid from the respiratory virus using one or more primers that bind to the viral nucleic acid; and
3) performing a second assay comprising an immunoassay on a second portion of the saliva sample to quantify IgA and IgG antibodies which bind to a component of the respiratory virus.
Further limitations on the method of claim 1 are wherein the sample was obtained within 3 days after onset of symptoms (claim 2); wherein the respiratory virus is a member selected from the group consisting of paramyxoviridae, picornaviradae, coronaviridae, parvoviridae, and enteroviridae (claim 3); wherein the respiratory virus is a virus causative of severe acute respiratory syndrome (SARS)(claim 4); wherein the virus c is severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2)(claim 5); wherein first assay is a polymerase chain reaction (PCR) (claim 7); wherein the first assay is PCR using primers that target one or more of the SARS CoV-2 nucleocapsid (N), open reading frame 1ab (ORF1ab), and envelope (E) genes (claim 8); wherein the first assay is quantitative PCR (qPCR) (claim 10), further comprising determining severity of the infection based on quantification of viral nucleic acid (claim 13); wherein the PCR is digital PCR (dPCR)(claim 11), wherein the dPCR is droplet digital PCR (ddPCR)(claim 12); further comprising comparing the respiratory viral nucleic acid quantities in a plurality of saliva samples obtained from the patient at successive time points and determining disease progression based on increases or decreases in the respiratory viral nucleic acid quantities over time (claim 14); further comprising normalizing the quantities of IgA and IgG antibodies produced by an immune response to the respiratory virus against total IgA and IgG antibodies in the saliva sample (claim 22); wherein the immunoassay is an enzyme-linked immunosorbent assay (ELISA), bead-based assay, a luminescent assay, a metal-linked immunosorbent assay, or a point-of-care immunochromatographic assay (claim 25); wherein the saliva sample is collected in a sterile container (claim 26), further comprising sealing the sterile container and transferring the container to a laboratory (claim 27); and wherein the saliva sample is collected using an at-home kit and/or simple packaging (claim 28).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1, 3-5, 23, and 25-28 under 35 U.S.C. 102(a)(2) as being anticipated by Muthukumar (US20210325380A1; Priority 04/20/2020; hereafter “Muthukumar”) is withdrawn in light of the amendments to the claims.
(New rejection – necessitated by amendment.) Claims 1, 3-5, 7-8, 10, 13-14, and 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan et. al. (Sullivan PS, et. al. JMIR Public Health Surveill. 2020 Apr 24;6(2):e19054.; hereafter “Sullivan”.)
The Prior Art
Sullivan teaches detection of SARS CoV-2 RNA and antibodies in diverse samples, such as home-collected blood, saliva, and oropharyngeal samples (entire document; see abstract.) Sullivan teaches that due to limitations in supplies during the SARS CoV-2 pandemic, alternate options for SARS CoV-2 screening were necessary, and included self-collection of specimens at home with kits and reagents while being observed through a telehealth portal by a healthcare provider (abstract, p. 5 “Saliva Self-Collection”). Sullivan teaches that the sample will them be subjected to isolation of viral RNA and reverse transcription of said RNA to DNA, with the resulting DNA subjected to quantitative polymerase chain reaction (qPCR)(p. 6, “Testing: RNA-PCR”). The sample will also be subjected to enzyme immunoassay serology tests with antibodies that bind to SARS CoV-2 antigens to analyze for IgG, IgM, and IgA antibodies (p. 7, “Serology Tests”). Sullivan therefore teaches every aspect of instant claims 1, 3-5, 7, 10, 25, and 28.
Sullivan notes these protocols and kits will allow for follow-up monitoring for viral shedding without the need for return office visits (p. 7, “Discussion”, ¶ bridging cols.; instant claim 14). Sullivan teaches that RNase P will be used as an internal amplification control and to quantify the nucleic acid content of the specimen (p. 6, “Specimen Sufficiency for RNA-PCR”). Sullivan teaches the reverse-transcribed DNA will undergo qPCR with primers and probes targeting N, S, and ORF1 of the SARS CoV-2 genome (p. 6, “Testing: RNA-PCR”; instant claim 8). Sullivan teaches the interpretation of the qPCR results will be made based on Ct values and positive identification of the nucleic acid, and these methods allow them to monitor the infection status of the patient while reducing burden on the medical supply chain and clinician’s office (p. 6, “Testing: RNA-PCR”; p. 7, “Discussion”; instant claim 13). Sullivan teaches the saliva will be tested for IgG, IgM, and IgA and would follow the manufacturer’s guidelines for reaction conditions, data interpretation, and internal controls (p. 7, “Serology Tests”.) Sullivan teaches that the saliva collection device was in a sealed container, which, absent evidence to the contrary, would be a sterile container used for collection of the saliva sample, which then after collection would be placed in a biohazard bag, sealed, and sent to a laboratory for testing (Fig. 3; instant claims 26-27).
For at least these reasons, Sullivan directly or inherently teaches every aspect of instant claims 1, 3-5, 7-8, 10, 13-14, and 25-28, and anticipates the invention encompassed by said claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 2, 7-14, and 25 under 35 U.S.C. 103 as being unpatentable over Muthukumar as applied to claims 1, 3-5, 23, and 25-28 above, and further in view of Rothberg et. al. (US20210292825A1; Priority 03/17/2020; CITED ART OF RECORD; hereafter “Rothberg”);
McDevitt et. al. (US20210311055A1, Priority 03/25/2020; CITED ART OF RECORD; hereafter “McDevitt”) as evidenced by Kojima et. al. (Kojima N, et. al. medRxiv 2020.04.11.20062372; 04/15/2020.; CITED ART OF RECORD; hereafter “Kojima”);
Wyatt et. al. (US20130217071A1, Pub. 08/22/2013; CITED ART OF RECORD; hereafter “Wyatt”); and
Chen et. al. (Chen Z, et. al. J AIDS Clin Res. 2016 Jan;7(1):540. Epub 2016 Jan 31.; CITED ART OF RECORD; hereafter “Chen”) is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 22 under 35 U.S.C. 103 as being unpatentable over Muthukumar Rothberg, McDevitt (as evidenced by Kojima), Chen, and Wyatt as applied to claims 1-5, 7-14, 23, and 25-28 above, and further in view of Lai et. al. (US20150284451A1, Pub. 10/08/2015; CITED ART OF RECORD; hereafter “Lai”) is withdrawn in light of the amendments to the claims.
(New rejection – necessitated by amendment.) Claims 2 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan as applied to 1, 3-5, 7-8, 10, 13-14, and 25-28 above, and further in view of:
McDevitt et. al. (US20210311055A1, Priority 03/25/2020; CITED ART OF RECORD; hereafter “McDevitt”) as evidenced by Kojima et. al. (Kojima N, et. al. medRxiv 2020.04.11.20062372; 04/15/2020.; CITED ART OF RECORD; hereafter “Kojima”); and
Wyatt et. al. (US20130217071A1, Pub. 08/22/2013; CITED ART OF RECORD; hereafter “Wyatt”).
The Prior Art
The teachings of Sullivan have been set forth supra. While Sullivan teaches the self-collection of blood, oropharyngeal swabs, and saliva at home for testing using both PCR and serology tests against SARS CoV-2 antigens and nucleic acid, Sullivan is silent as to the specific onset of symptoms prompting the self-collection of samples. While Sullivan teaches that the PCR on saliva may be qPCR, Sullivan fails to specifically teach that other types of PCR may be performed on the sample, such as digital PCR or digital droplet PCR (dPCR and ddPCR, respectively). However, the art was apprised to different devices that could perform multiple tests, and rationales for performing different types of tests, as evidenced by the teachings of McDevitt (as evidenced by Kojima) and Wyatt. Additionally, testing after a specific time frame following onset of SARS CoV-2 symptoms would be obvious to a skilled artisan, as evidenced by the teachings of McDevitt (as evidenced by Kojima) and Wyatt.
McDevitt teaches portable bio-nano-chip assays, methods and compositions for diagnosing and assessing pathogen-mediated diseases or infections at point-of-care (POC) or home settings using biological samples. The assays, methods and compositions provide in a more convenient, less expensive, and less time-consuming sampling and analysis (entire document; see abstract.) McDevitt teaches the sample tested may include saliva (¶[0053][0062][0079][0133][0135][0153][0193][0196][0196][0217]), such as self-collected saliva from the patient (¶[0217]), and the saliva can be tested using immunoassay and RT-PCR formats to detect SARS CoV-2 antigens and antibodies (¶[0196][0218]), such as IgG antibodies against SARS CoV-2 (¶[0196]; instant claims 3, 5, 25). The testing can lead to grading the severity of infection, such as Tier-1 or Tier-2 (¶[0116-0126]), wherein the more severe would be noted for close monitoring, hospitalization, intensive care, ventilators, or therapeutic agents (¶[0067]). As evidenced by Kojima, which is incorporated by reference in its entirety into McDevitt, saliva was collected from a symptomatic individual within 2 days (Kojima, Figure; instant claim 2). In addition to using the testing methods of McDevitt on SARS CoV-2 infections, said methods may detect other respiratory viral infections, such as SARS, Middle East respiratory syndrome coronavirus (MERS CoV), respiratory syncytial virus (RSV), rhinovirus, adenovirus, and parainfluenza virus (¶[0033]; instant claim 4). McDevitt teaches point of care (POC) diagnostics for pathogens and pathogen-mediated infection or disease, devices containing biomarker specific reagents, portable devices for use as analyzers or drivers with same, software to evaluate and report test results, and the overall diagnostics and reporting system as a whole (¶[0034]), which include detection and quantitation of one or more biomarkers and then assessing a clinical course of treatment based on said quantitation (¶[0037][0065][0070][0098][0101-0102]). McDevitt teaches the biomarkers may include IgM and/or IgG antibodies which bind to SARS CoV-2 components, or SARS CoV-2 proteins, such as spike (S), nucleocapsid (N), hemagglutinin esterase protein, or envelope (E), and can be tested via immunoassay and followed with RT-PCR (¶[0102][0194]). The primers and probes can be labeled to detect a PCR product (¶[0050]) instant claims 7-8). McDevitt teaches that multiple samples were taken, allowing them to track disease progression over time (¶[0170-0171}; instant claim 14).
Wyatt teaches fast, sensitive, and accurate nucleic acid-based detection methods, especially for the detection of pathogenic infections (entire document; see abstract, ¶[0196-0216]). Wyatt teaches methods to quantify specific and large numbers of mRNAs are known in the art, as well as the detection and quantification of patterns of expression of known and unknown genes (¶[0003]). Wyatt teaches the sample tested may be a clinical sample (¶[0116]), such as saliva (¶[0115]). Wyatt teaches the virus detected may be a SARS coronavirus (¶[0202]) or other respiratory viruses, such as other coronaviruses (¶[0202]), orthomyxoviruses (influenza A, B, and C viruses)(¶[0203], paramyxoviruses (¶[0201][0212]), picornaviruses (¶[0204-0205]), or enteroviruses (¶[0205]). Wyatt teaches the PCR detection method used to identify these viruses may be a digital PCR reaction, such as a droplet digital PCR reaction (¶[0010-0011]; instant claims 11-12), and are an excellent way of amplifying low-levels of RNAs (¶[0002]) as well as quantitating the amount of mRNA in the sample (¶[0024-0025][0058][0122][0140][0145]; Figs. 1-2).
Given the teachings of Sullivan, one of skill in the art would be apprised to self-collecting saliva for use in testing for respiratory viral infections, such as SARS CoV-2 infections, wherein said saliva could be subjected to both nucleic acid and serological tests. As shown by Wyatt, dPCR and ddPCR methods for detection and quantification of respiratory virus nucleic acid, such as coronaviruses, from saliva samples was known in the art at the time of filing, and would be an obvious species of the broader qPCR tests of Sullivan. Given the teachings of Sullivan, Wyatt, and McDevitt, it would be obvious to include the use of PCR to detect coronaviruses in a saliva sample, and it would be obvious to a skilled artisan that a number of different nucleic acid amplification technologies were available in the art, such as qPCR and ddPCR. Further, given the teachings of McDevitt, it would be obvious to test a subject in a certain amount of time after onset of symptoms. Given what was known in the art at the time of filing, the limitations of instant claims 2 and 11-12 would be obvious, especially given the teachings of Sullivan, McDevitt (as evidenced by Kojima), and Wyatt.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Sullivan in order to utilize a specific type of PCR assay, such as ddPCR or qPCR, thereby allowing one to determine if the infection was active and potentially the viral load and severity of the infection, especially over time, in addition to the immunoassays to detect viral and host biomarkers to aid in determining the stage of infection. One would have been motivated to do so, given the suggestion by McDevitt that the saliva samples collected could be tested using immunoassays or PCR and could allow for the assessment of disease progression over time, and would be useful to test using both nucleic acid and serological tests in a subject soon after showing signs or symptoms of infection to potentially determine the stage of infection. There would have been a reasonable expectation of success, given the knowledge that the assays that could test viral nucleic acids and antigens in a sample were known and used in the art in home, POC, and clinical settings, as taught by McDevitt and Sullivan, and also given the knowledge that samples could be taken soon after onset and taken successively over time to track disease progression, as taught by McDevitt. There would have been further expectation of success as methods to determine the presence of viral nucleic acid in a sample were well-known in the art at the time of filing, such as dPCR, and ddPCR, as evidenced by the teachings of Wyatt. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
(New rejection – necessitated by amendment.) Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Sullivan as applied to 1, 3-5, 7-8, 10, 13-14, and 25-28 above, and further in view of Lai et. al. (US20150284451A1, Pub. 10/08/2015; CITED ART OF RECORD; hereafter “Lai”.)
The Prior Art
The teachings of Sullivan have been set forth supra. Sullivan teaches assessing the levels of IgG, IgA, and IgM in a self-collected saliva sample using ELISA-based methods, but fails to teach normalizing the levels to the overall levels of said antibodies. However, such optimizations were known and commonly practiced in the art, especially with respect to ELISAs, and would be obvious to a skilled artisan, as evidenced by the teachings of Lai.
Lai teaches assessment of antibodies that bind to a pathogen, such as a virus (entire document; see abstract, reference claims 1, 5). Lai teaches the antibodies assessed may be against respiratory viruses, such as influenza (including influenza A, B, and C), coronaviruses such as SARS CoV, RSV, adenovirus, and human rhinovirus (¶[0063]). Lai teaches taking the clinical sample, which may be saliva (¶[0137][0139]), and subjecting the sample to a whole-virus ELISA assay to determine the entire antibody content (¶[0171]), wherein the ELISA determines the total amount of IgG, IgA, and IgM, and compares it to the IgG, IgA, and IgM in the sample which is specific to the virus (Table 2). Lai teaches there is approximately a 50:50 ratio of IgG:IgA in respiratory mucus secretions, and that IgA is found throughout the gastrointestinal tract (¶[0053]). Therefore, as shown by Lai, it is common in the art to determine total antibody amounts of each isotype using ELISA assays to normalize the antibody within the sample, and then to compare the amount of each antibody isotype which binds to the pathogen of interest to the total amount of each antibody isotype.
Given the teachings of Sullivan, which teaches testing for the presence of anti-SARS CoV-2 IgA, IgG, and IgM antibodies using ELISA-based methods, and given that Lai shows that when looking at antibodies, especially antibody subtypes, it is a common practice in the art to look at more than one antibody subtype, and to also normalize the subtype-specific viral-binding antibody to the overall amount of subtype-specific antibody in the sample, it would therefore be obvious to arrive at the limitations of instant claim 22.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Sullivan in order to compare respiratory virus antibodies and their specific subtypes using immunoassays such as ELISAs. One would have been motivated to do so, given the suggestion by Lai that the method of comparing the target-specific antibodies to the overall number of the antibodies was a routine normalization performed in immunoassays, such as ELISAs. There would have been a reasonable expectation of success, given the knowledge that determining overall IgA, IgG, and IgM and comparing it to IgA, IgG, and IgM antibodies which bound to the respiratory virus of interest was a routine optimization, as taught by Lai, and also given the knowledge that Sullivan teaches the analysis of one or more antibody subtypes in the patient saliva sample. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 02/20/2026, with respect to the rejections over Muthukumar have been considered in light of the amendments to the claims and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of anticipation rejection are made utilizing the teachings of Sullivan, and further integrate the teachings of McDevitt, Wyatt, Chen, and Lai to show the obvious nature of the claims. Arguments regarding McDevitt, Wyatt, Chen, and Lai will be addressed as applicable herein in the interest of compact prosecution.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that McDevitt, Wyatt, Chen, and Lai fail to cure the deficiencies of Muthukumar. However, Muthukumar was not utilized in the instant rejections.
Applicant argues that McDevitt does not teach or suggest quantification of IgA antibodies specific to respiratory viruses such as SARS CoV-2, nor does McDevitt teach performing a nucleic acid amplification on the saliva sample. While McDevitt may not teach detection of IgA, this is not why McDevitt was cited, as Sullivan clearly teaches that IgA, IgM, and IgG antibodies can be detected in saliva samples. McDevitt also clearly teaches that the sample can be tested using nucleic acid amplification techniques, such as RT-PCR (¶[0026][0050][0162][0194]), and that one should test both nucleic acid levels and antibody levels to determine disease state and progression, as depending on the disease state, one assay may be negative while the other assay is positive (e.g. antibody tests can show that a person has been previously exposed, while the PCR would be negative, showing that a person had previous exposure and now has potential immunity.) McDevitt was cited not to show anything Applicant highlighted, but to show the time frame in which a subject may be tested. Therefore, the Office has different reasons for combining, and the arguments presented here regarding McDevitt are not persuasive.
Applicant argues that Wyatt does not teach or suggest quantification of IgA or IgG. The Office agrees. However, the teachings of Wyatt were incorporated for a different reason, namely to show that different PCR techniques for the detection of respiratory viruses, such as SARS coronaviruses, were known in the art, such as ddPCR. Therefore, the Office has different reasons for combining, and the arguments presented here regarding Wyatt are not persuasive.
Applicant argues that Lai does not teach or suggest nucleic acid amplification on the saliva, and only teaches ELISAs where the test amounts of IgG/IgA/IgM is normalized to the overall IgG/IgA/IgM in a sample. The Office agrees, which is why the teachings of Lai were utilized in the current rejection – specifically to show that normalization of total Ig in a sample to test Ig was known and practiced in the art. It would be an obvious optimization of the method of Sullivan, and is not a “different analytical approach” from those taught in Sullivan, as Sullivan teaches ELISA-based methods to test the saliva. Therefore, the Office has different reasons for combining, and the arguments presented here regarding Lai are not persuasive.
For at least these reasons noted supra, Applicants arguments are either moot or unpersuasive, and the cited teachings remain relevant towards the obvious nature of the claims.
Double Patenting
The text regarding nonstatutory double patenting was presented in a previous Office action.
(Rejection withdrawn.) The rejection of Claims 1-5, 7-14, 22-23, and 25-28 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Pat. No. 12,344,889 in view of Muthukumar, Rothberg, McDevitt (as evidenced by Kojima), Chen (all supra), and Zhang et. al. (US20210292824A1, Priority 03/23/2020; CITED ART OF RECORD; hereafter “Zhang”) is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The provisional rejection of Claims 1-5, 7-14, 22-23, and 25-28 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending application 19/250,489 (reference application) in view of Muthukumar, Rothberg, McDevitt (as evidenced by Kojima), Chen (all supra), and Zhang et. al. (US20210292824A1, Priority 03/23/2020; CITED ART OF RECORD; hereafter “Zhang”) is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The provisional rejection of Claims 1-5, 7-14, 22-23, and 25-28 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16, 19-21, and 30-31 of copending Application No. 17/864,160 in view of Muthukumar, Rothberg, and McDevitt (as evidenced by Kojima), Chen (all supra), and Zhang et. al. (US20210292824A1, Priority 03/23/2020; CITED ART OF RECORD; hereafter “Zhang”) is withdrawn in light of the amendments to the claims.
(New rejection – necessitated by amendment.) Claims 1-5, 7-8, 10-14, 22, and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Pat. No. 12,344,889 in view of Sullivan, McDevitt (as evidenced by Kojima), Wyatt (all supra), and Zhang et. al. (US20210292824A1, Priority 03/23/2020; CITED ART OF RECORD; hereafter “Zhang”). Both the instant claims and the ‘889 claims are drawn to methods of amplifying viral nucleic acid from SARS CoV-2. Both sets of claims are drawn to primers which amplify SARS CoV-2 N, ORF1ab, and E genes, both claim quantifying the target viral nucleic acid. Both claim the use of qPCR, both claim the steps of taking saliva at multiple timepoints to assess onset and/or severity of disease progression. Both claim predicting disease treatment or outcomes based on viral nucleic acid. While the instant claims provide for an additional step of analyzing the saliva sample for antibodies or antigens, such a difference would be obvious, given the teachings of Sullivan, McDevitt, and Wyatt (detailed supra). To summarize, Sullivan, McDevitt, and Wyatt all teach testing saliva for the presence of viral nucleic acid and testing using antibodies for additional viral materials, with Sullivan teaches the saliva collection is a self-collection. Sullivan notes IgM, IgA, and IgG can be tested for from the saliva sample taken from a patient suspected of having a respiratory viral infection. Wyatt teaches nucleic acid amplification technologies, such as ddPCR, were known in the art at the time of filing and could be used to detect coronaviruses in a saliva sample. The ‘889 claims also note that the saliva is testing using an “extraction-free method”; however, extraction-free polynucleotide isolation was known in the art at the time of filing for extraction of SARS CoV-2 nucleic acid, as evidenced by Zhang (entire document; see abstract; ¶[0008]). Zhang teaches the extraction-free amplification can happen using saliva samples from the subject (Fig. 40; ¶[0056]). Therefore, the differences between the instant claims and the ‘889 claims would be obvious, given what was known in the art at the time of filing, and the claims are not patentably distinct.
(New rejection – necessitated by amendment.) Claims 1-5, 7-8, 10-14, 22, and 25-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending application 19/250,489 (reference application) in view of Sullivan, McDevitt (as evidenced by Kojima), Wyatt (all supra), and Zhang et. al. (US20210292824A1, Priority 03/23/2020; CITED ART OF RECORD; hereafter “Zhang”). Both the instant claims and the ‘489 claims are drawn to methods of amplifying viral nucleic acid from SARS CoV-2. Both sets of claims are drawn to primers which amplify SARS CoV-2 N, ORF1ab, and E genes, both claim quantifying the target viral nucleic acid. Both claim the use of qPCR, both claim the steps of taking saliva at multiple timepoints to assess onset and/or severity of disease progression. Both claim predicting disease treatment or outcomes based on viral nucleic acid. While the instant claims provide for an additional step of analyzing the saliva sample for antibodies or antigens, such a difference would be obvious, given the teachings of Sullivan, McDevitt, and Wyatt (detailed supra). To summarize, Sullivan, McDevitt, and Wyatt all teach testing saliva for the presence of viral nucleic acid and testing using antibodies for additional viral materials, with Sullivan teaches the saliva collection is self-collection. Sullivan notes IgM, IgA, and IgG can be tested for from the saliva sample taken from a patient suspected of having a respiratory viral infection. Wyatt teaches nucleic acid amplification technologies, such as ddPCR, were known in the art at the time of filing and could be used to detect coronaviruses in a saliva sample. The ‘489 claims also note that the saliva is testing using an “extraction-free method”; however, extraction-free polynucleotide isolation was known in the art at the time of filing for extraction of SARS CoV-2 nucleic acid, as evidenced by Zhang (entire document; see abstract; ¶[0008]). Zhang teaches the extraction-free amplification can happen using saliva samples from the subject (Fig. 40; ¶[0056]). Therefore, the differences between the instant claims and the ‘489 claims would be obvious, given what was known in the art at the time of filing, and the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
(New rejection – necessitated by amendment.) Claims 1-5, 7-8, 10-14, 22, and 25-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 19-21, and 30-31 of copending Application No. 17/864,160 (NB: Said application was recently allowed) in view in view of Sullivan, McDevitt (as evidenced by Kojima), Wyatt (all supra), and Zhang et. al. (US20210292824A1, Priority 03/23/2020; CITED ART OF RECORD; hereafter “Zhang”). Both the instant claims and the ‘160 claims are drawn to methods of amplifying viral nucleic acid from SARS CoV-2. Both sets of claims are drawn to primers which amplify SARS CoV-2 N, ORF1ab, and E genes, both claim quantifying the target viral nucleic acid. Both claim the use of qPCR, both claim the steps of taking saliva at multiple timepoints to assess onset and/or severity of disease progression. Both claim predicting disease treatment or outcomes based on viral nucleic acid. While the instant claims provide for an additional step of analyzing the saliva sample for antibodies or antigens, such a difference would be obvious, given the teachings of Sullivan, Wyatt, and McDevitt (detailed supra). To summarize, Sullivan and McDevitt teach testing saliva for the presence of viral nucleic acid and testing using antibodies for additional viral materials, with Sullivan teaches the saliva is self-collected. Wyatt teaches nucleic acid amplification technologies, such as ddPCR, were known in the art at the time of filing and could be used to detect coronaviruses in a saliva sample. Sullivan notes IgM, IgA, and IgG can be tested for from the saliva sample taken from a patient suspected of having a respiratory viral infection. The ‘160 claims also note that the saliva is mixed with respiratory samples and is tested using an “extraction-free method”; however, extraction-free polynucleotide isolation was known in the art at the time of filing for extraction of SARS CoV-2 nucleic acid, as evidenced by Zhang (entire document; see abstract; ¶[0008]). Further, “mixing” of saliva and sputum happens naturally at points along the nasopharynx, so saliva samples or sputum samples would likely inherently be a mixture of these two. Zhang teaches the extraction-free amplification can happen using saliva samples from the subject (Fig. 40; ¶[0056]). Therefore, the differences between the instant claims and the ‘160 claims would be obvious, given what was known in the art at the time of filing, and the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 02/20/2026, with respect to the NSDP rejections have been fully considered. In light of the amendments to the claims, the previous NSDP rejections have been withdrawn. However, upon further consideration, new grounds of rejection utilizing the combined teachings of McDevitt (as evidenced by Kojima), Wyatt, and Zhang are made along with the teachings of Sullivan.
Applicant has requested that the non-statutory obviousness-type double patenting rejection be held in abeyance until allowable subject matter is indicated in the present application. However, said rejection must be maintained as a matter of record until the appropriate terminal disclaimers have been filed, or until the claims have been amended in such a way as to not claim patently identical subject matter.
Conclusion
No claims are allowed.
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 RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671
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