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 .
Preliminary Amendment
The preliminary amendment dated 06/02/2023 has been entered. Claims 12-20 are pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest possible effective filing date for the instant claims is December 4, 2020 based on the filing date of the provisional application IN202011053106.
Information Disclosure Statement
The submitted Information Disclosure Statement(s) (IDS) have been considered by the examiner.
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 12 and dependent claims 13-14 and 19 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.
1. Claim 12 recites the limitation " A process for detecting SARS-CoV2 and other viruses in a sample, the process comprising:(a) collecting, storing, and transporting the sample from a collection center to a testing center, wherein the sample is in single-layer packing, wherein the sample is in a dry form, and wherein the sample is free from viral transport media and any other liquid media; (b) extracting the sample of (a) with….”. Part (a) requires collecting, storing, and transporting the sample and part (b) requires extracting the sample of (a) in buffer. Part (a) specifically is without liquid while part (b) is obviously with liquid (in the buffer). Clarification is needed regarding what happens at the testing center, because parts (a) and (b) could reasonably happen all at the same time which is inconsistent with the fact that the sample is to be dry and when it should be wet.
2. The term “single-layer packing” in claim 12 and 14 is a relative term which renders the claim indefinite. The term “single-layer packing” 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. The term “single-layer packing” does not seem to be readily clear in the art, especially as it could be dependent on the sample.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 12 is rejected on the grounds of being indefinite. Claims 13-14 and 19 are also rejected since they depend from claim12, but do not remedy these deficiencies of claim XX.
Appropriate correction is required.
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.
1. Claims 12-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 12-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method to detect SARS-CoV-2 in a sample obtained from nasopharyngeal and/or oropharyngeal swabs and a kit for detecting SARS-CoV-2, does not reasonably provide enablement for the claimed limitation “detecting SARS-CoV-2 and other viruses” (that, is any DNA or RNA virus), especially when the method involves qRT-PCR (claims 12, 13 and 19) and RNA isolation (claims 14, 15 and 20) (these limitations read on a method for detecting only RNA viruses (which need a reverse transcriptase (RT) enzyme for PCR) and therefore DNA viruses are excluded), does not reasonably provide enablement for the analysis of any type of virus in any type of sample, and the kit contains in-vitro transcribed RNA from SARS-CoV-2 genes and primers directed to those SARS-CoV-2 genes (claims 16-18), which can only detect SARS-CoV-2 and no other virus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The specification discloses the use of direct RT-PCR for SARS-CoV-2 Virus diagnosis using VTM extract as a template for RT- PCR (example 1). Direct RT-PCR from the TE buffer extract of dry nasopharyngeal and/or oropharyngeal swabs (examples1-4) for SARS-CoV2 Virus diagnosis with or without Proteinase K (examples 2 and 3). RT-PCR for SARS-CoV2 Virus diagnosis after RNA extraction from the TE+ proteinase K buffer extract using the extracted RNA as a template for RT-PCR (example 4). It does not provide any information on how to use these assays for any DNA virus or how to optimize these assays for any other RNA virus with the exception of SARS-CoV-2. In addition, it does not provide any information on how to test in any kind on sample (type of fluid, tissue, or cells, such as blood, urine, saliva, stool, tissue biopsies, bone marrow, hair, nail clippings, cerebrospinal fluid (CSF), semen, breast milk, bronchoalveolar lavage (BAL), etc.
In addition, the specification does not disclose how to obtain a dry sample for the detection of any virus and the method to dry the sample (e.g. spray freeze, lyophilization, etc.) nor how the sample is stably stored in the packaging (room temperature, 40C, etc.). if it can be exposed to high or low temps, how long the sample is kept in a “dried” state before extraction, whether or not the extraction buffer would work on any other type of virus aside from SARS CoV-2. The conditions for heat inactivation are not enable for any other virus other than SARS_CoV-2 since different viruses have different thermal inactivation points and require specific temperature and time combinations.
One cannot extrapolate the teachings of the specification to the enablement of the claims because the specification does not provide examples or guidance for detecting any virus aside from SARS CoV-2.
MPEP 2164.03 states that
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention.
MPEP 2164.03 further states that
The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. …
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.
MPEP 2164.08(b) states that
The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).
Although, typically, inoperative embodiments are excluded by language in a claim (e.g., preamble), the scope of the claim may still not be enabled where undue experimentation is involved in determining those embodiments that are operable. A disclosure of a large number of operable embodiments and the identification of a single inoperative embodiment did not render a claim broader than the enabled scope because undue experimentation was not involved in determining those embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ 214, 218 (CCPA 1976). However, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative.
Given the disclosure of the specification and the teachings in the art that indicates that qRT-PCR reactions are very sensitive and highly specific, one skilled in the art could not predictably detect any virus under conditions suitable for detecting SARS-CoV-2, especially when the design of primers is directed to SARS-CoV-2 genes and the breadth of samples includes any sample type of tissue, cell, or fluid obtained by any means.
Further, in light of the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) (hereafter Amgen), updated guidelines were provided regarding the assessment of enablement (Federal Register, pp. 1563-1566; Pub. Jan. 10, 2024.) In Amgen, the Supreme Court unanimously affirmed that a genus of monoclonal antibodies were not enabled because when a range within a genus is claimed, there must be reasonable enablement of the scope of the range. The Court found in Amgen that due to the large number of possible candidates within the scope of the claims and the specification's corresponding lack of structural guidance, it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionality. In the instantly claimed invention, the breadth of the different genera claimed, including the breadth of possible viruses to be tested, the breadth of possible qRT-PCR procedures, and the breadth of possible samples comprising said virus(es), would cause a skilled artisan to have to perform an undue amount of experimentation on the extremely large amount of possible permutations encompassed by said claims in order to determine if the method as claimed is enabled.
Therefore, in view of the breadth of the claims, lack of guidance in the specification, the absence of working examples for detecting any virus that is not SARS-CoV-2, and the state of the art, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
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.
2. Claims 12-15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over ICMR (Indian Council of Medical Research, "Advisory on use of Dry Swab RNA Extraction Free RTPCR Method", 26 November 2020 (26/11/2020 IDS citation NPL 11) in view of Srivatsan (bioRxiv preprint, April 23, 2020, pages 1-11, IDS citation NPL 10) and Thermoscientific (Proteinase k (recombinant), PCR grade. Thermoscientific User guide. August 2, 2019) and Stanford (Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 test EUA Summary. Updated November 24, 2020)
ICMR teaches an RNA extraction free, dry swab method for RT-PCR based detection of SARS-CoV-2 (bullet 1). The collection of a VTM-less (free from viral transport media and any other liquid media, dry oropharyngeal/nasopharyngeal swab from suspect SARS-CoV-2 patients (bullet 2), (limitations of instant claims 12(a), 14(i) and 20(i)) - and a collected sample would also need to be stored before transportation). Bullet 2 further discloses that the swab is transported to the lab (that is, transportation from the collection center to the testing center (limitation of instant claims 12(a), 14(i) and 20(i))). Tris-EDTA (aka TE buffer) with Proteinase K (instant claims 12-15) buffer is added (limitation of instant claims 12(b), 14(ii) and 20(ii)), and the sample is incubated for 30 minutes at room temperature. The sample is then subjected to heat inactivation at 98oC for 6 minutes (limitation of instant claims 12(c), 14(iii) and 20(iii)). The extract is then used for RT-PCR. (limitation of instant claims 12(d), 14(v) and 20(v)). ICMR also teaches that the dry swab variant method can be used as a screening tool only in settings where automated RNA extraction is not available (bullet 5) because the sensitivity of the dry swab variant method is 79% and specificity is 99% when compared with the gold standard, the RT-PCR test (bullet 4). This is interpreted as indicating that the dry swab variant method sensitivity and specificity can be improved when the RNA can be isolated from the extracted sample ((limitation of instant claims 14 (iv), and 20(iv)). ICMR also teaches adding to the dry tube 400 µl of TE-proteinase K buffer (limitation of instant claims 12(b), 14(ii) and 20(ii)), (figure on page 3).
ICMR does not teach either the Tris-EDTA buffer having a Tris concentration of 10 mM, an EDTA concentration of 0.1 mM, and a pH from 7.2 to 7.6, or the concentration of serine protease (proteinase k) to be added to the TE buffer to obtain an extracted sample (0.5 mg/ml to 5.0 mg/ml). It does not teach how to pack the sample.
Srivatsan teaches that dry swabs (limitation of instant claims 12(a), 14(i) and 20(i)) eluted directly into TE buffer [10 mM Tris pH-7.4, 0.1 mM EDTA], (page 7, Dry swab elution) can support molecular detection of SARS-CoV-2 via endpoint RT-qPCR (abstract), (RT-qPCR reads on qRT-PCR) ((instant claims 12(b)(d)(e), 14(ii) (v)(vi) and 20(ii)(v)(vi)). The RNA was isolated using the MagnaPure 96 RNA extraction platform (page 2, second paragraph), ((limitation of instant claims 14 (iv), and 20(iv)).
Srivatsan does not teach the use of serine protease (proteinase k) at the 0.5 mg/mL to 5.0 mg/ml dose range, to be added to the TE buffer to obtain an extracted sample In addition, It does not teach how to pack a sample.
Thermoscientific teaches that the recommended working concentration for Proteinase K is 0.05-1 mg/ml (note). Since this is a recommendation, the final concentration can be optimized as required by instant claim 12(b) and 15, please see below.
Stanford teaches that after the nasal swab specimen is collected, the swab is inserted, tip first, into the collection tube and the cap securely fastened. The tube is placed in the biohazard bag, and the bag is closed with the adhesive seal, which reads on a single-layer packing (packing limitation of instant claims 12(a), 14(i) and 20(i))
It would have been obvious to one of ordinary skill in the art to combine the teachings of ICMR, Srivatsan and Thermoscientific to develop an in-vitro (since the reactions are carried out in test tubes, instant claim 19) method for SARS-CoV-2 detection. The steps of this method being the collection and transportation of a dry form sample, sample extraction with a TE-Proteinase K buffer, heat inactivation step with optional RNA isolation and qRT-PCR. It would have been obvious to store samples prior to transportation if those samples are not transported immediately. It would also have been obvious that since the packaging and transportation of biological materials are subject to strict local, state, federal, and international regulations, the sample can be transported in a single layer packing if that form of transportation is in compliance with the regulation of a country. It would further have been obvious with that the concentration of proteinase K, Tris and EDTA (adjusting the pH as needed), and the volume of TE buffer, times and temperatures needed for heat inactivation, are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount and volume of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2. It would also have been obvious to follow the manufacturer’s instruction manual when using a commercial RT-PCR kit and interpret the results according to those instructions as required by instant claims 12(d)(e), 14(vi) and 20(vi)).
One of ordinary skill would have been motivated to do so because a method that can save time and reduce cost with a quick turn-around can help clinical or surveillance testing for SARS-CoV-2. There would be a reasonable expectation of success because the different steps of the method are known to work in different settings and labs.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
3. Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over ICMR, Srivatsan, Thermoscientific in view of Stanford, Helix (Accelerated Emergency Use Authorization (EUA) Summary, Helix COVID-19 Test (Helix OpCo, LLC), October 22,2020), Compass (Accelerated Emergency Use Authorization (EUA) Summary, Compass Laboratory Services SARS-COV2 ASSAY (Compass Laboratory Services, LLC) Priority date 07/13/2020 as found on website https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular) and Chen (US 12,297,425 B2. Priority date Apr. 28, 2020)
The teachings of ICMR, Srivatsan, Thermoscientific and Stanford have been discussed above and incorporated herein. In addition, Stanford teaches a FDA-approved (instant claim 17) SARS-CoV-2 RT PCR assay kit (title). This Assay kit enables the self-collection of nasal swab sample that is transported in dry conditions in a collection tube (page 3, 2nd paragraph), which reads on the limitation “first part comprising a collection tube and swabs” of instant claims 16 and 18. The assay is carried out on TE buffer for primers/probes (page 5), (second part of instant claims 16 and 18) and includes positive (ssDNA for SARS-CoV-2 E gene and negative controls. The E gene is the target gene for amplification (which reads on the assay utilizing primers and probes for the E gene), (page 7, section 2), (third part of instant claim 16 and fourth part of instant claim 18).
Helix teaches a FDA-approved (instant claim 17) SARS-CoV-2 real time RT-PCR (page 1, Intended use, 1st paragraph). The kit consists of a swab and collection tube (page 2, Helix self-collection kit, 2nd paragraph), (first part of instant claims 16 and 18) and the assay includes primer and probe set(s) designed to detect simultaneously four targets: three SARS-CoV-2 viral targets, the N gene, the ORF1ab gene and the S gene, and one primer/probe set detecting MS2 phage RNA spiked into the reaction as an extraction and process control (page 3, Helix Covid19 test, 1st paragraph), ((third part of instant claim 16 and fourth part of instant claim 18). RNA extraction (RNA for all specimen types is performed using the MagMax Viral/Pathogen II
(MVP II) Nucleic Acid Isolation kit ((page 3, Helix Covid19 test, 4th paragraph) (third part of instant claim 18).
Compass teaches a FDA-approved (emergency use authorization (EUA) by the FDA) (instant claim 17) SARS-CoV-2 real time RT-PCR (page 1, Intended use, 1st paragraph). The primers and probe were selected from the ORF 1ab genome region. labelled with the FAM fluorophore. RNA extraction is performed using the MagMax Viral Pathogen Kit (page 2, Device description and test principle, 1sty paragraph), (third part of instant claims 16 and third and fourth part of instant claim 18)
Chen teaches a nucleic acid extraction composition, reagents and kits containing the same which can be used for biological reactions such as PCR (abstract). This kit includes: lysis buffer, wash buffer, an enhancer (proteinase K at 20 mg/ml), an elution buffer (1xTE buffer with pH of 10.0) and spin columns (example 1) (second part of instant claim 16 and second and third part of instant claim 18). The reagents can be used for obtaining nucleic acids of DNA and RNA viruses from various complex samples such as blood, throat swab, saliva and the like, and is very suitable for clinical and scientific research application (column 3 lines 28-35).
It would have been obvious to one of ordinary skill in the art to combine the teachings of ICMR, Srivatsan, Thermoscientific and Stanford for the development of an in-vitro method for SARS-CoV-2 detection and for designing of a kit capable of performing the steps of such a method. The kit would require the material and reagents for each step to detect SARS-CoV-2. The first part being the collection and transportation of a dry swab in a collection tube (as taught by Stanford and Helix). The second part being the extraction of the viral particles from the swab using a TE-Proteinase K buffer with an optional part being RNA extraction (as taught by Chen or an optimized version of the reagents, see below). And the last part comprising of running a FDA approved RT-PCR assay containing primers, probes, dyes, enzymes (DNA polymerase and Reverse Transcriptase are obviously necessary components of any RT-PCR kit), and RT-PCR buffer as taught by Stanford, Helix and Compass. All the Stanford, Helix and Compass assays include positive and negative controls such as ssDNA for the E gene and it would be obvious to use similar type of controls that would give the same kind of results like in vitro transcribed RNA for several SARS-CoV-2 genes. It would also be obvious to design primers and probes for any of the SARS-CoV-2 gene to detect the presence of the virus as they are part of the viral genome and even detect more than one gene simultaneously as taught by Helix. It would also be obvious to use fluorescence dyes such as FAM (as taught by Compass) or any other type of dye.
As mentioned above, it would further be obvious that the optimization of reagents, such as the TE-Proteinase K taught by Chen, are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount and volume of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2
One of ordinary skill would have been motivated to do so because the availability of a kit containing all the steps necessary for the easy and accurate detection of SARS-CoV-2 can help diagnosing the disease. There would be a reasonable expectation of success because other tests such as those describe above have been shown to be useful for diagnosis and have been authorized by the FDA for emergency use.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/RACHEL B GILL/Primary Examiner, Art Unit 1671