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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-15 and 21-24) in the reply filed on 10 August 2026 is acknowledged.
Claims 16-20 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 August 2026.
Claim Objections
Claims 1, 4, 6, 8, 17, and 25 are objected to because of the following informalities:
The clarity of claim 1 would be enhanced if lines 4-5 read as “…the OPG183 intergenic region of MPOX Clade II, or a combination thereof
In the last line of claim 4, “orthopoxvirus” should be plural.
Claim 8 line 4-5 should read as “…hybridizes to the OPG183 intergenic region…”
Claim 17 line 4 should read as “…and/or probes is present…”
Appropriate correction is required.
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.
Claims 2, 9, 15, 23, and 24 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.
Regarding claim 2, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 recites the limitation "…the primers and optional probe that selectively hybridizes to the DNA polymerase (E9L) gene…" in lines 8-11. However, these primers and probes were first introduced in claim 4, not in claim 1. As claim 9 depends from claim 1, there is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “…(CLIA)-compliant…”. However, the phrase “compliant” renders the claim indefinite because the rules and regulations regarding compliance can change over time to address new concerns and technologies. As a result, what is required for a cartridge to obtain CLIA-compliance status and its impact on the structure or function of the cartridge is unclear.
Claims 21 and 22 recite the limitation “…the cartridge facilitates detection…” within a set time. However, how these cartridges facilitate detection is not described as the claims do not recite any particular mechanism, process, structural feature, or other limitation by which the cartridge achieves the claimed effect. Accordingly, it is unclear what is required of the claimed cartridge to satisfy this limitation, rendering the metes and bounds of these claims indefinite.
Claims 23 and 24 recite the limitation “…the reaction vessel…”. However, these claims depend from 21 which depends from claim 12 which depends from claim 1. None of claims 1, 12, or 21 recite a reaction chamber; therefore, there is insufficient antecedent basis for this limitation in these claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 11-13, 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Subject Matter Eligibility Test (see MPEP § 2106):
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter?
Yes, the claims are directed towards a composition of matter.
Step 2A: Are the claims directed to a judicial exception?
Prong 1: Do the claims recite an abstract idea, law of nature, or a natural phenomenon?
Claim 1 is directed towards a set of primers and optional probe(s) (hereinafter referred to as primers) for the detection and/or identification of monkeypox (MPOX) Clade II virus in a sample. This set is designed to hybridize to conserved regions of the OPG153 gene of the Clade II virus, the OPG183 intergenic region of the Clade II virus, or both. However, primers and probes lack markedly different characteristics from nature as they are nothing more than strands of nucleic acids whose characteristics are innate to naturally occurring DNA and perform the same inherent function of their naturally occurring counterparts (see MPEP 2106.04(C).II.C.2; Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244). As described in MPEP 2106.04(c).II.C.2: In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction--a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here--the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself. Therefore, this claim recites a natural phenomenon (i.e., a product of nature).
Claims 2-13 and 21-24 depend from claim 1 and are thus similarly directed towards a natural phenomenon.
Prong 2: Do the claims recite additional elements that integrate the judicial exception into a practical application?
Claim 1 recites the limitation that the primers are present in a set. However, this does not integrate the judicial exception into a practical application because merely placing products of nature together in a set does not impose a meaningful limitation on the use of the claimed natural products beyond generally linking those products to a particular technological environment.
Claims 4-8 and 11 introduce limitations which require the set include primers for different targets. Similar to claim 1, the introduction of additional targets does not alter the product of nature itself. Rather, these limitations merely group products of nature together. Furthermore, the addition of a natural product to a natural product cannot integrate them into a practical application.
Regarding claim 11, the claim requires primers for either an exogenous control or an endogenous control. Paragraph 0146 of the instant specification describes the endogenous control as naturally occurring within the tested sample and includes RNA. Requiring that the target of these primers serves as a “sample adequacy control” does not alter the primers themselves, does not distinguish them from their natural counterparts, and can be construed as insignificant extra-solution activity. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP § 2106.05(g).
Claims 2, 3, and 9 describe the sequence identity and hybridization selectivity of said primers. However, these limitations do not impart any structural changes which would distinguish them from their natural counterparts. In fact, these limitations further demonstrate the similarity between these products and their intended target(s).
Claims 12 and 13 introduce limitations which place the claimed natural products into cartridge(s). As described by these claims, the cartridges appear to be a housing for the storage of the claimed natural product. Placing a natural product into a container is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product of nature to a particular technological environment. While claims 21-24 introduce limitations which indicate that these cartridges facilitate detection of the MPOX clade II virus within certain time frames, how these cartridges facilitate detection is not described and does not appear to impact the structure of the claimed natural products themselves, merely specifying a desired result.
In summary, the additional limitations introduced by claims 1-9, 11-13, 21-24 do not integrate the judicial exception into a practical application.
Claim 10 introduces limitations requiring that at least one of the primers be detectably labeled. This does integrate the claimed natural products into a practical application as this alters the structure of the product in such a way as to facilitate detection of the primer, as well as detection of an amplification product generated through use of the claimed primers.
The limitations introduced by claims 14 and 15 are directed towards a machine (i.e. a cartridge) that applies the judicial exception. Claims 14 and 15 describe the structure of the claimed cartridge with sufficient particularity such that the cartridge integrates the natural product into a practical application. For example, claim 14 describes a plurality of chambers and the manner in which they are coupled. Thus, while claims 12 and 13 merely recite a “cartridge” that could broadly encompass any housing for the natural product, claim 14 recites a particular arrangement of features that provides functionality beyond merely housing the natural product.
Therefore, because the additional limitations of claims 10, 14, and 15 integrate the natural product into a practical application, these claims contain eligible subject matter and are not rejection under 35 U.S.C. § 101.
Step 2B: Do the claims recite additional elements that amount to significantly more than the judicial exception?
The additional limitations, individually and in combination, recited by claim 1-9, 11-13, and 21-24 are either judicial exceptions themselves or represent insignificant extra-solution activity, and do not recite an unconventional arrangement or other meaningful limitation beyond the product of nature. As a result, they do not amount to significantly more than the judicial exception such that claims 1-9, 11-13, 21-24 do not contain eligible subject matter.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The cartridge of claim 14, with the exception of the primers of claim 1, is described by the combined teachings of Dority [US 8048386 B2] and Chang [US 10871498 B2]. A similar cartridge was also used to detect Monkeypox by Li [Li D, et al. The American journal of tropical medicine and hygiene. 2017 Feb 8;96(2):405, IDS reference.]. Multiple, non-cartridge-based methods exist for the detection of Monkeypox which are capable of discriminating between MPOX Clade 1 and 2 and could have been adapted for use on the cartridges of Dority/Chang and Li (e.g., Dai [CN 114752711 A]). Additionally, as Monkeypox and certain STIs exhibit common physical symptoms which complicate diagnosis and treatment, motivation existed for the development of a test capable of detecting and differentiating between Monkeypox, HSV, VZV, and Syphilis [PRNewswire. “Cepheid and BioGX Announce Collaboration to Develop Monkeypox PCR Test for the GeneXpert® System”. Cepheid. 27 June 2022.]
While designing primers for a well-characterized genomic region is not typically sufficient by itself to confer patentability, in the case of the instant application the record does not establish a motivation that would have led a skilled artisan to develop primers targeting the OPG153 gene, the OPG 183 intergenic region, or a combination thereto, for the detection of Monkeypox.
Therefore, although the record provides motivation to develop a cartridge capable of detecting and differentiating Monkeypox clades, as well as differentiating Monkeypox from other pathogens, the record does not provide a reason for why a skilled artisan would have selected primers targeting the claimed genomic regions for incorporation into the cartridge of claim 14.
Conclusion
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/K.N.K./ Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681
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