DETAILED ACTION Disposition of Claims Claims 1-20 are pending. Examiner’s Note All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240150854A1 , Published 05/09/2024 . Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice . Optional Authorization to Initiate Electronic Communications The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization. Claim Rejections - 35 USC § 112 (b); Second Paragraph 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 appl icant regards as his invention. Claims 1, 3, 5, and 17 and dependent claims 2, 4, 6-16, and 18- 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. Claim 1 is drawn to a method for detecting a presence of a non-variola Orthopoxvirus in a subject comprising: (a) obtaining a sample from the subject; (b) detecting a first nucleic acid sequence specific to the non-variola Orthopoxvirus; and (c) detecting a second nucleic acid sequence that serves as a control. However, from the method steps claimed, it is unclear as to what item the “detecting” portions of parts (b) and (c) should be testing/detecting. Further, as part (c) is generically reciting any nucleic acid sequence and said sequence is to serve as a control, it is unclear as to the nature of this “control” as it is unclear what is being tested and why it would serve as a control in this method. To place the claim in better form, it is suggested the claim be amended along the lines of the following to ensure that the detection is performed on the sample obtained in part (a) of the claim, and that the “control” is a positive and/or negative control (e.g. positive control being a protein native to the subject, negative control being a protein/sequence native to a variola Orthopoxvirus.) “1. A method for detecting a presence of a non-variola Orthopoxvirus in a subject comprising: (a) obtaining a sample from the subject; (b) detecting a first nucleic acid sequence specific to the non-variola Orthopoxvirus in the sample of part (a) ; and (c) detecting a t least one second (other possible wording: at least one additional) nucleic acid sequence that serves as a positive or negative control in the sample of part (a) . ” Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim (s) 1, 3, 5, and 17 are rejected on the grounds of being indefinite. Claims 2, 4, 6-16, and 18-19 are also rejected since they depend from claim 1, 3, 5, or 17 , but do not remedy these deficiencies of claim 1, 3, 5, or 17 . Claims 1, 3, 5, and 17 and dependent claims 2, 4, 6-16, and 18- 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. The term “ specific ” in claim s 1, 3, 5, and 17 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 the method appears to be drawn to performing nucleic acid detection through the use of probes, it is suggested that accepted terms such as “hybridize”, “bind”, or “anneal” be utilized as they are art-accepted terms that do not have varying degrees of function with respect to their target nucleic acids. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim (s) 1, 3, 5, and 17 are rejected on the grounds of being indefinite. Claims 2, 4, 6-16, and 18-19 are also rejected since they depend from claim 1, 3, 5, or 17 , but do not remedy these deficiencies of claim 1, 3, 5, or 17 . Claim 12 and dependent claim 13 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. Claim 12 is drawn to the method of claim 1, wherein multiple individual samples are processed simultaneously. It is not clear what is meant by “multiple individual samples”, as claim 1 only refers to obtaining one sample (“a sample”) from a single subject. It is unclear if the “multiple individual samples” refers to multiple samples taken from multiple, different subjects, or if the “multiple individual samples” refers to multiple samples taken from the same subject (e.g. blood, urine, sputum, etc.) 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. Claim 13 is also rejected since it depend s from claim 12 , but do es not remedy these deficiencies of claim 12 . Claim 14 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. Claim 14 recites the limitation "the E9L gene… sequences" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, as claim 14 depends upon claim 5, and claim 5 only references sequences to human RNaseP genes and vaccinia virus sequences. One suggestion is to have claim 5 depend upon the method of claim 3, that way the antecedent basis for all three limitations in claim 14 is clear. For at least this reason, claim 14 is rejected on the grounds of being indefinite. Claim 16 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. Claim 16 recites the limitation "the solid substrate" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. One suggestion is to have claim 16 depend upon claim 6, which provides clear antecedent basis for this limitation. For at least these reasons, claim 16 is rejected on the grounds of being indefinite. 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. Claim 18 is drawn to the system of claim 17 , wherein the system is further comprising a component for self-collection of the sample . However, it is unclear if the “self-collection” is performed by the subject, or the “self” is considered to be another person, such as the person performing the analysis on the sample. From the guidance provided for in the specification, it appears the “self-collection” is performed by “the subject” of claim 17, so it is suggested claim 18 be amended to read along the lines of “…wherein the system is further comprising a component for self-collection of the sample by the subject.” For at least these reasons, claim 18 is rejected on the grounds of being indefinite. Claim Rejections - 35 USC § 112(d); Fourth Paragraph The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 is drawn to t he method of claim 2, wherein the first nucleic acid sequence comprises sequences specific to the E9L gene of the non-variola Orthopoxvirus . However, since claim 3 depends upon claim 2, and claim 2 is drawn to the method of claim 1 , wherein the non-variola Orthopoxvirus is monkeypox (Mpox), the use of “non-variola Orthopoxvirus” is seen as a broadening of the limitations of the claim upon which it depends as it should refer back to the species of monkeypox (Mpox) and not the broader genus of “non-variola Orthopoxvirus”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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 for detecting a presence of a non-variola Orthopoxvirus in a subject comprising: (a) obtaining a sample from the subject; (b) detecting a first nucleic acid sequence specific to the non-variola Orthopoxvirus in the sample of part (a) ; and (c) detecting a second nucleic acid sequence that serves as a control in the sample of part (a ) . Further limitations on t he method of claim 1 are wherein the non-variola Orthopoxvirus is monkeypox (Mpox) (claim 2) , wherein the first nucleic acid sequence comprises sequences specific to the E9L gene of monkeypox (claim 3) , wherein the second nucleic acid comprises sequences specific to the human RNase P gene and/or a vaccinia virus (claim 5) , further comprising multiplex qPCR for at least two of the E9L gene, the human RNase P gene or the vaccinia virus sequences (claim 14) ; wherein detecting the first nucleic acid sequence comprises the step of real-time PCR (claim 4); wherein detecting the first nucleic acid sequence comprises isolation of the non-variola Orthopoxvirus from a solid substrate (claim 6) , wherein isolation of the non-variola Orthopoxvirus from the solid substrate comprises a multi-well extraction procedure (claim 7) , wherein the solid substrate comprises a dry swab (claim 8) , wherein the dry swab is a synthetic tip swab with an aluminum shaft or a synthetic tip swab with a plastic shaft (claim 9); wherein the step of obtaining the sample comprises self- collection of the sample by the subject (claim 10) ; further comprising purification of the first nucleic acid sequence by binding the nucleic acid to silica beads (claim 11) ; wherein multiple individual samples are processed simultaneously (claim 12) , wherein at least 20 samples are processed simultaneously (claim 13) ; wherein detecting the first nucleic acid sequence comprises isolation of the non-variola Orthopoxvirus from a sample submitted in liquid viral media (NB: definition of “liquid viral media” is per ¶[0049]; claim 15) , and wherein isolation of the non-variola Orthopoxvirus from the solid substrate comprises a multi-well extraction procedure (claim 16). The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 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. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a component for” recited numerous times in claim 17. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim 17 is drawn to a system for detecting a presence of a non-variola Orthopoxvirus in a sample from a subject comprising: (a) a component for isolation of the non-variola Orthopoxvirus from a solid substrate comprising the sample using a multi-well procedure; (b) a component for purification of a nucleic acid sequence specific to the non- variola Orthopoxvirus; (c) a component for PCR amplification of the nucleic acid sequence specific to the non-variola Orthopoxvirus; and (d) a component to output results indicating a presence or absence of the nucleic acid sequence specific to the non-variola Orthopoxvirus. Further limitations on the system of claim 17 are wherein the system is further comprising a component for self-collection of the sample by the subject (claim 18); and wherein at least one of the components is controlled by a computer (claim 19). Claim 20 is drawn to a kit for self-collection of a sample for determining the presence of a non-variola Orthopoxvirus in a subject comprising: a swab for collection of the sample from the subject; a transport container; a biohazard bag; optionally, external packaging for the subject to mail the sample to a laboratory for testing; and instructions for use. Claim Rejections - 35 USC § 112 (a); First Paragraph 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. Claims 1-20 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. The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows: Nature of the invention/Breadth of the claims . The claims are drawn to method s, systems, and kits for detecting a presence of a non-variola Orthopoxvirus in a subject comprising: (a) obtaining a sample from the subject; (b) detecting a first nucleic acid sequence specific to the non-variola Orthopoxvirus in the sample of part (a) ; and (c) detecting a t least one second nucleic acid sequence that serves as a positive or negative control in the sample of part (a) . The breadth of “non-variola Orthopoxvirus” includes any virus that is not a Variola virus (smallpox) in the Orthopoxvirus genus, including monkeypox (Mpox Virus or MPXV), Vaccinia virus (VACV), Cowpox (CPXV), Camelpox (CMLV), Alaskapox (AKPV), Ectromelia virus (mousepox), Raccoonpox , Volepox , Skunkpox , Taterapox , and Uasin Gishu/ Horsepox ( Institute of Medicine (US) Committee on the Assessment of Future Scientific Needs for Live Variola Virus. Assessment of Future Scientific Needs for Live Variola Virus. Washington (DC): National Academies Press (US); 1999. 2, Variola Virus and Other Orthopoxviruses. Available from: https://www.ncbi.nlm.nih.gov/books/NBK230917/ ) . The breadth of “sample” includes any type of sample that may be taken from the subject, which includes blood (whole blood, serum, plasma), urine, sputum, stool, saliva, saliva-based oral fluids, vaginal fluids, bile, bone marrow aspirate, breast milk, cerebral spinal fluid (CSF), vitreous humor, synovial fluid, sweat, cell/ tissue biopsies, protein lysates, and nucleic acid ( DNA/RNA ). In light of the 35 USC 112b rejection supra , a nucleic acid sequence that aligns with, hybridizes to, binds to, or anneals to a sequence from said non-variola Orthopoxvirus would be any sequence that is found only in said non-variola Orthopoxvirus and is not conserved amongst Orthopoxviruses. The breadth of nucleic acid detection is quite large in claim 1, as it is broadly drawn to any method of nucleic acid detection, and real-time PCR is not provided for until later, dependent claims. Claims 17 provides for components for PCR amplification, but does not specify what type. Claim 20 is simply drawn to a kit for collecting a sample that can be used to determine the presence of NVO in a sample, and the “determining the presence” is not limited to any specific type of determination (e.g. any reasonable method of detecting virus from the sample can be performed – immunological, nucleic acid testing, viral titer assays, etc.) With respect to the breadth of “PCR”, this can include standard/end-point PCR, quantitative real-time PCR, reverse-transcription PCR, multiplex PCR, hot start PCR, digital PCR, digital droplet PCR, high-fidelity PCR, nested PCR, assembly PCR, inverse PCR, asymmetric PCR, and long-range PCR. Real-time PCR, as provided for in dependent claim 4, can include SYBR Green I dye based qPCR that detects any dsDNA in the reaction, or probe-based qPCR that is sequence specific that uses such detection reagents as TaqMan probes or Molecular Beacons. Multiplex qPCR as in dependent claim 14 can be duplex (e.g. detects two targets at the same time), high-order (detection of 3-5 or more targets simultaneously), TaqMan probe-based multiplexing, or intercalating dye multiplexing. State of the prior art/Predictability of the art. The Poxviridae family includes a number of diverse double-stranded (ds) DNA viruses with large genomes, ranging in length from ∼ 135 to ∼ 350 kbp . Poxviruses infect a wide spectrum of hosts, including insects, birds, reptiles, and mammals . The Poxviridae family is divided into two subfamilies, Chordopoxvirinae and Entomopoxvirinae , for viruses that infect vertebrates and invertebrates, respectively. Chordopoxviruses are further classified into 18 genera , and a mong these, the Orthopoxvirus genus comprises several viruses of great medical relevance, including variola virus (VARV), the causative agent of smallpox, and vaccinia virus (VACV), which was used in the smallpox eradication campaign. Additional orthopoxviruses with zoonotic potential such as monkeypox virus (MPXV) and cowpox virus (CPXV), are increasingly reported as a cause of human disease, possibly because of waning population immunity caused by discontinuation of routine smallpox vaccination. In addition to viruses that have been known for decades, recent years have also witnessed the identification of novel orthopoxviruses in humans and other animals. Thus, Akhmeta (AKMV) and Alaska (AKPV) viruses have been sequenced in the last 15 years from people living in Georgia and Alaska, whereas orthopoxvirus Abatino (OPVA) was first isolated in Italy during an outbreak in captive macaques in 2015. To date, 12 orthopoxvirus species have been officially recognized by the ICTV . Phylogenetically, orthopoxvirus genomes form two major clades of viruses sampled in the Old World and in the New World. Diagnosing non-variola orthopoxviruses (e.g., mpox, cowpox) is challenged by atypical clinical presentations, such as rashes lacking typical vesicular features. Common issues include, but are not limited to, cross-contamination, which can cause false-positive results, low viral loads, the need for specialized laboratory equipment, and the risk of mistaking the infection for varicella, measles, or sexually transmitted infections . While PCR is the preferred method for diagnostic testing , results can sometimes be inconclusive, especially in the early or late stages of the disease . False negatives can occur due to inadequate specimen collection ( e.g. low viral load, improper swab sites) or improper transport/storage, such as not refrigerating samples within one hour. The high sensitivity of PCR can cause false-positive results if specimens are contaminated during handling. The CDC advises re-extracting and re-testing specimens with high Ct values (e.g., ≥34) to confirm positive results. (Minhaj FS, et. al ; CDC Monkeypox Emergency Response Team; CDC Monkeypox Emergency Response Team. Orthopoxvirus Testing Challenges for Persons in Populations at Low Risk or Without Known Epidemiologic Link to Monkeypox - United States, 2022. MMWR Morb Mortal Wkly Rep . 2022 Sep 9;71(36):1155-1158. Online 2 Sept 2022.) Orthopoxviruses ( OPXV) possess highly conserved sequences within the central ~100 kbp region of their linear double-stranded DNA genomes, which encodes approximately 100-120 proteins essential for viral replication, morphogenesis, and virion assembly. While the terminal regions of the genome (responsible for host range and immune evasion) are highly variable, the central core shows strict conservation, with roughly 49-123 genes conserved across all members, depending on the scope of the comparison. Those conserved sequences generally include those important for DNA replication (e.g. DNA polymerase (E9L), DNA polymerase processivity factor (A20R), single-stranded DNA-binding protein (D5R) ), t ranscription (e.g. Early transcription factor (A7L, D6R), RNA polymerase subunit (J6R, A24R), mRNA capping enzyme (D1R) ), v irion s tructure/ a ssembly (e.g. Major core protein (A10L), membrane protein L1R (highly conserved, 99.34%+) ), and virion assembly/morphogenesis (e.g. H7 protein (crescent membrane formation), F12 (egress), E6R ( viroplasm packaging))( Molteni C, et. al . Virus Res . 2023 Jan 2;323:198975. Epub 2022 Oct 21.). Sequences that would be useful for diagnostic of non-variola orthopoxviruses (NVOs) would be those genetic sequences or single nucleotide polymorphisms (SNPs) which are not conserved amongst the whole genus of Orthopoxviruses. Key regions that are known in the art as useful for diagnostic assays often include the rpo18 gene (RNA polymerase 18kDa subunit), the VETF g ene (Vaccinia Early Transcription Factor) , A13L gene, crmB gene (cytokine response modifier B), and VCP (vaccinia complement control protein)( Nitsche A, et. al . J Clin Microbiol . 2004 Mar;42(3):1207-13.; Lapa S, et. al . J Clin Microbiol . 2002 Mar;40(3):753-7.; Uvarova EA, et. al . Virus Res . 2001 Dec 4;81(1-2):39-45. ) PCR testing for viral infections uses various human samples ( e.g. swabs, blood, saliva) to offer rapid, highly specific detection of viral nucleic acids. Major pros include high sensitivity for early detection and the ability to use less invasive, non-invasive, or rapid-testing samples, while cons include high costs (especially for specialized, non-routine tests) , the need for specialized laboratory equipment, and potential false negatives if viral load is low (e.g. sample may be taken too early, too late, or improperly) . As PCR is sensitive, minimal cross-contamination in the lab may cause false-positives, and PCR can detect viral remnants long after a person is no longer infectious. Certain biological samples naturally comprise interfering components that can inhibit PCR by degrading DNA or blocking polymerases. For instance, hemoglobin and IgG in blood can bind to DNA and/or interfere with Taq polymerase, while bile salts, bilirubin, and complex polysaccharides in feces/stool can inhibit polymerase activity. Certain biological samples therefore require specialized handling and isolation during collection and/or before PCR may be performed on the sample. With respect to a person who may have a NVO infection, the sample collected may be limited to whether or not they are presenting symptoms. The preferred sample collection method would be to have swabs from active skin lesions, but if a person is not having outward skin lesions, throat or anal swabs may be considered. Sterile, dry, synthetic swab s (including but not limited to polyester, nylon, rayon, or Dacron) with plastic , wood, or aluminum shaft s were recommended for NVO collection as cotton-tipped swabs were shown to inhibit PCR test methods, and many submissions for RT-PCR testing required storage at or below 4 deg C without the use of viral or universal transport media , as the media is noted for interfering with PCR tests (“Monkey pox Testing Instructions FAQ.” Commonwealth of Virginia, Dept. of General Services, Richmond, VA. 08/ 01 /2022 . https://www.vdh.virginia.gov/content/uploads/sites/13/2022/08/Monkey-pox-Testing-Instructions-FAQ.pdf . ; NETEC (National Emerging Special Pathogens Training & Education Center). “How to Collect an Mpox Specimen for Diagnostic Testing.” 07/26/2022; https://netec.org/2022/07/26/how-to-collect-a-monkeypox-specimen-for-diagnostic-testing/ . ) In general, while the art was apprised to the use of PCR techniques to determine the presence of NVOs in samples, there were and remain a variety of controls, conditions, and sample collection techniques that must be utilized, along with optimization of the isolation and extraction of nucleic acid from the sample to perform the NVO PCR-based testing. Working examples. The working example disclosed in the specification utilized n on-variola Orthopoxvirus (NVO) Real-Time PCR primers and probes as well as RNase P Real Time PCR primers and probes obtained from CDC (CDC KT00035A; KT0068) , as well as commercially-available samples of Human Genomic DNA from human blood (buffy coat) and Vaccinia virus (e.g., Vaccinia (MVA) Genomic )(¶[0084]). The isolation of viral nucleic acid was performed with MAGNA PURE®, which lyses the sample material and binds the nucleic acid to magnetic glass particles, with the viral samples taken from dry swabs stored at 2-8°C (it was noted duplicate swabs could be collected in universal transport media (UTM) or viral transport media (VTM) , but said liquid samples were for follow-up testing to be performed by the CDC or other public health laboratories and were not to be used in the PCR method)(¶[0085-0091]). Multiple swabs were processed simultaneously using the Promega SLICPREP™ followed by the MAGNAPURE® kit (¶[0096-009 8 ]) . Swabs were also processed using the swab extraction tube system (SETS) tube protocol before following with the MAGNAPURE® kit (¶[0099-0100]) or swabs were placed in either UTM or VTM before following with the MAGNAPURE® kit (¶[0101]). Real-time PCR was performed on the samples and amplified for E9L and human RNase P, which serves as a sample-specific internal control (IC). It is not explicitly stated in the specification, but the only provided E9L primers/probes disclosed are those at ¶[0042] for SEQ ID NOs: 1-3 with the RNase P primers/probes listed as SEQ ID NOs: 4-6. It is noted that these primers should not detect Variola virus because “ the probe has 3 base pair mismatches within the corresponding Variola virus sequence ”, but from the wording of the specification, it is not clear that this refers to the E9L primers (¶[0043]). An NCBI BLAST of SEQ ID NOs:1-2 against Variola sequences shows 100% identity (See attached NCBI BLAST for SEQ IDNOs: 1-2) and two mismatches with SEQ ID NO:3 (probe; see attached NCBI BLAST for SEQ ID NO: 3). No actual RT-PCR data on any of the samples acquired was provided, and it is not clear what type of PCR method was performed (real-time PCR, PCR, and qPCR are all provided for in the claims) , nor are other conditions for said PCR amplification clear, such as what specific primers/probes must be used (oligo (dT) primers for mRNA, gene-specific primers, sequences of said primers/probes, what genes may/may not be targeted, etc.), what intercalating dyes or probes should be used (e.g. SYBR Green, EvaGreen , TaqMan Probes, Molecular Beacons, Dual Hybridization Probes, Scorpion Primers, etc.), and/or what amplifying/cycling conditions are required. In Example 4 starting at ¶[0114], it was described as to how one could collect specimens at home via sampling of lesions using swabs. While a variety of swabs appear to have been described as to how said viral DNA may be processed, it is unclear where said swabs were sampled on the subject, nor were any other non-swab collected samples (e.g. blood, urine, sputum, etc.) tested via PCR for their determination of NVOs. No data was provided to show the specificity of primers for NVOs, specifically monkeypox, over variola, nor was data provided to show the baseline IC of RNase P or any other internal control. In general, the specification provides only prophetic guidance towards the collection of samples via swabs, isolation of viral DNA from said swabs, and PCR analysis of the isolated DNA. Guidance in the specification . The specification provides prophetic guidance towards the collection of swabs from lesions of suspected NVO origin, how said swabs may be processed, and how said nucleic acid acquired from said swabs may be subjected to PCR for analysis. No specifics on the actual PCR method that should be used, primers/probes that should be used, or cycle metrics of the PCR method have been provided. Dependent claims provide that the RNase P should serve as an IC while E9L is the NVO sample control, but specific primer/probes are not claimed for each gene. As the art has noted E9L is conserved amongst Orthopoxviruses, the amplified region should be carefully chosen to avoid false-positives . Amount of experimentation necessary. Additional research is required in order to determine how effective the methods, systems, and kits as claimed would be in collecting any sample from any subject and subjecting said sample to any type of analysis to determine the presence of NVO, specifically through nucleic acid based analysis, especially any PCR-based analysis. 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 d ue 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 NVO claimed, the breadth of the open reading frames (ORFs) which may be tested, the breadth of the samples which may be collected and tested, and the breadth of the actual nucleic acid/PCR analysis of said samples is so large that the permutation of the different factors within each limitation makes the experimentation large and undue, especially in light of the uncertainty noted in the prior art. For the reasons discussed above, it would require undue experimentation for one skilled in the art to make and/or use the claimed methods and products . 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-7, 11-17, and 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Quest Diagnostics (Quest Diagnostics. Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR Emergency Use Authorization (EUA) Summary. Ver. September 15, 2022. Earlier version of EUA accessed via WayBack Machine https://www.fda.gov/media/161457/download .; hereafter “Quest Diagnostics”.) The Prior Art Quest Diagnostics teaches a monkeypox virus qualitative real-time PCR assay (entire document; see EUA abstract.) Quest Diagnostics teaches qualitative detection of DNA from monkeypox virus (West African clade; clade II) and non-variola Orthopoxvirus in lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) in universal viral transport media (UTM) from individuals suspected of monkeypox virus infection by their healthcare provider (p. 1, “Intended Use”; instant claims 2, 4, 15 ). Quest Diagnostics teaches the multiplexed targets detected are RNaseP as the internal endogenous control, E9L, TNF, and an internal processing control (IPC) (pp. 2-3, “Device Description and Test Principle: Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR”; instant claims 1-5 , 14 .) Quest Diagnostics teaches the viral nucleic acid is isolated from a swab of the lesion , wherein the isolation comprises a 96-well extraction system (p. 2, “Device Description and Test Principle: Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR”; instant claim s 6 -7, 12-13, 15-17 .) Quest Diagnostics teaches the use of the MAGNA PURE® system, which inherently comprises the use of magnetic glass particles for binding the nucleic acid within the sample (p. 2, “Device Description and Test Principle: Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR”; instant claim 11 .) The instrumentation for performing the real-time PCR ( ABI 7500 Real-Time PCR or ABI 7500 Fast Real-Time PCR instruments ) comprises the use of a computer interface (p. 2, “Device Description and Test Principle: Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR”; instant claim 19 .) For at least these reasons, Quest Diagnostics teaches the limitations of instant claims 1-7, 11-17, and 19 , and anticipates the invention encompassed by the claims. 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. 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. 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. Claims 8-10, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Quest Diagnostics as applied to claims 1-7, 11-17, and 19 above, and further in view of Springer et. al. (US20230248338A1; Priority 08/30/2020; hereafter “Springer”) , LabCorp (LabCorp. SPECIMEN COLLECTION GUIDE: Mpox (Orthopoxvirus), DNA, PCR Collection Instructions. 08/31/2022. https://www.labcorp.com/assets-media/2734 ; hereafter “LabCorp”), and Commonwealth of Virginia (“Monkey pox Testing Instructions FAQ.” Commonwealth of Virginia, Dept. of General Services, Richmond, VA. Rev. 2, Pub. 08/01/2022. https://www.vdh.virginia.gov/content/uploads/sites/13/2022/08/Monkey-pox-Testing-Instructions-FAQ.pdf .; hereafter “Commonwealth of Virginia”) as evidenced by LabCorp ( LabCorp. Mpox/Orthopoxvirus (Formerly Monkeypox) for Providers. https://www.labcorp.com/infectious-disease/mpox (Wayback Machine earliest capture 18 Dec 2022. ; hereafter “LabCorp -2022a ”) and CDC ( Centers for Disease Control and Prevention (CDC). " Labcorp to begin monkeypox testing today, doubling nationwide testing capacity." 07/06/2022. https://archive.cdc.gov/#/details?url=https://www.cdc.gov/media/releases/2022/s0706-monkeypox-labcorp.html . ; hereafter “CDC”.) The Prior Art The teachings of Quest Diagnostics has been set forth supra . While Quest Diagnostics teaches the majority of the instant claims, Quest Diagnostics has stated that their methods have not been tested on dry swabs, only swabs that have been provided/collected in transport media. Additionally, the instructions from Quest Diagnostics are for a medical professional and do not appear to suggest or teach self-collection by a non-medical professional, or kits that allow for self-collection of samples by the subject who is experiencing symptoms. However, such limitations were known in the prior art for various reasons, as evidenced by the teachings of Springer and Commonwealth of Virginia. Commonwealth of Virginia provides a frequently asked question (FAQ) for monkeypox testing (entire document), and teaches that for each test, 2 swabs should be collected per lesion, and all lesions should be swabbed if they are in different body parts/areas (p. 1, “DCLS Testing”). Commonwealth of Virginia teaches that one should not use cotton swabs, as they interfere with PCR test methods, and swabs that are used should be nylon, polyester, or Dacron with plastic, wood, or aluminum shafts (p. 1, “DCLS Testing.” ; instant claim 9 ) Commonwealth of Virginia teaches that no viral or universal transport media should be used, and the swabs should be dry and left dry in separate dry, sterile tubes (Table, p. 1 ; p. 3, Item 6; instant claim 8 ). Note that Commonwealth of Virginia has shown that, via the CDC website, that LabCorp has initiated Monkeypox testing ( https://www.cdc.gov/media/releases/2022/s0706-monkeypox-labcorp.html , which links to https://archive.cdc.gov/#/details?url=https://www.cdc.gov/media/releases/2022/s0706-monkeypox-labcorp.html , which further links to https://www.labcorp.com/infectious-disease/mpox ). LabCorp teaches for monkeypox (Mpox) collection, two swabs are provided, along with universal transport medium (UTM) or viral transport medium (VTM) and must be used for the collection of mpox (Orthopoxvirus), DNA, PCR (“Collection Information”.) LabCorp teaches t he swabs may be made of polyester, rayon or Dacron (“Collection Information: Please note.”) After collection, the specimens must be placed in a biohazard bag (“Sample Submission.”) Springer teaches swabs that are automation compatible and kits and methods of use for said swabs (entire document; see abstract.) Springer teaches the swabs are compatible with dry or wet transport and self-swabbing at home (¶[0221][0224][0237][0239]; instant claim s 8 , 10, 18 ). Springer teaches the swabs would be made of material compatible for RT-PCR testing, especially automated testing, yet are comfortable for patients to self-administer at home (¶[ 0239] ) . Springer teaches kits which comprise the swabs useful for self-collection, which comprise the swab, transport container, instructions for use, and packaging for maintaining the temperature during transport (reference claim 46; ¶[0152-160] ). Given the teachings of Quest Diagnostics, Springer, LabCorp, and Commonwealth of Virginia , one would be apprised as to kits designed for collecting samples from suspected Mpox lesions, especially the use of non-cotton swabs for said collection. Given the teachings of Springer, one of skill in the art would be apprised as to the usefulness of having said kits be ready for home or self-collection, and the various components which would be in said kit. Given the teachings of Commonwealth of Virginia and Springer, one of skill in the art would be apprised that swab collection could be done with or without transport media, and in the case of Commonwealth of Virginia, said Mpox swabs were absolutely not to be submitted in any type of transport media. Given the teachings of LabCorp, it would be obvious to a skilled artisan that the swab samples should be collected in biohazard bags. Given the combined teachings of Quest Diagnostics, Springer, LabCorp, and Commonwealth of Virginia , arriving at the limitations of instant claims 8-10, 18, and 20 would be obvious to a skilled artisan. It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by Quest Diagnostics in order to take dry swab samples and/or hav