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 .
Objection to Specification
The disclosure is objected to because page 16, line 3; page 17, line 16; page 18, line 20; page 19, line 24; page 20, line 40; page 21, lines 11, 22, 32; page 22, lines 3, 17, 26, 36; page 23, lines 7, 18, 30; page 24, 1, 12, 21, 33 of the specification contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction filed on June 29, 2026. No claims amendment are made in the response filed on 06/29/2026.
Claims 1, 3-4, 7-8, 12-15, 17-18 and 21-22 are pending, with claims 8, 15 and 17-18 withdrawn.
Claims 1, 3-4, 7, 12-14 and 21-22 are under consideration. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 3-4, 7-8, 12-14 and 21-22) in the reply filed on June 29, 2026 is acknowledged 1.
Applicant’s election without traverse of the following species in the reply filed on June 29, 2026 is acknowledged:
Species of measuring biomarker expression: A) measuring RNA-based expression levels (Claim 21; specification page 16, lines 12-14);
Species of Biomarker Type : C) nucleic acids isolated from tumor tissue sample (claim 4, 18; see specification page 33, lines 4-9);
Species of additional biomarker: F) CD3G and ITGAL (claim 7) 2.
Claims 8, 15 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Examination on the merits commences on claims 1, 3-4, 7, 12-14 and 21-22.
Priority
For the instant claims 1, 3-4, 7, 12-14 and 21-22 in this U.S. Application, the applicant claims priority of Foreign Application EP 21187175.1, which has a filling date on July 22, 2021.
Claim Objections
Claims 1, 14, and 21 are objected to because of the following informalities:
In claim 1, lines 1-2, "A method for determining the response or resistance to treatment … " should read
"A method for determining [[the]]a response or resistance to treatment… "
In claim 14, lines 3-4, "a method according claim 1" should read
"[[a]]the method according to claim 1."
In claim 21, lines 2-4, should read: "wherein the biomarkers [[is]]are[[a]] protein coding genes, or wherein the expression level of the biomarkers is the RNA-based expression level of the protein coding genes" to properly refer back to multiple biomarkers introduced in base claim 1.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, regarding claim 1, it recites a method "for determining the response or resistance to treatment with an immunotherapeutic agent that is an immune checkpoint inhibitor or a combination of immune checkpoint inhibitors" in the preamble, this claim language is interpreted as descriptive language that does not distinguish the claimed method from prior art methods that disclose all the claimed steps, applied to a sample of a subject diagnosed with cancer.
MPEP§ 2111.04 states: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Here, the claim body does not include any step of administering treatment to a subject or determining treatment response. In fact, the body only requires a single step of determining expression level of markers. In other words, the phrases describing determining the response or resistance to a treatment in the preamble at most states a potential applicability or intended purpose of the claimed method and makes no manipulative difference. Therefore, the claimed method does not distinguish itself from prior art that discloses the determining step.
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”) (i.e. claim 13) 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.
In claim 13, line 3, the limitation “means for measuring… ” has been interpreted under 112(f) as a means plus function limitation because of the combination of a non-structural term “means” and functional language “for measuring the expression level of the biomarkers CD247, LAX1, and IKZF3 in a sample of the subject” without reciting sufficient structure to achieve the function.
The specification provides the following relevant description regarding structures that support the recited function:
"The expression level of the protein coding genes disclosed herein may be assessed by any method known in the art suitable for determination of specific gene expression levels in a sample. Such methods are well-known and routinely implemented in the art. Gene expression analysis can for example be performed by reverse transcriptase real-time quantitative PCR, gene expression arrays, TruSeq gene expression analysis, in-situ hybridization, dye sequencing, pyrosequencing, CRISPR-Cas-based or any other form of transcriptome sequencing (total RNA-Seq, mRNA-Seq, gene expression profiling)." (page 16, lines 14-21)
The broadest reasonable interpretation of a claim limitation that invokes 35 U.S.C. 112(f) is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act, (see MPEP 2181).
In this case, the BRI for the recited "means for measuring … " is interpreted in light of the specification3 to encompass the assay reagents and materials associated with reverse transcriptase real-time quantitative PCR, gene expression arrays, TruSeq gene expression analysis, in-situ hybridization, dye sequencing, pyrosequencing, CRISPR-Cas-based, transcriptome sequencing, or equivalents thereof, for measuring expression level of CD247, LAX1, and IKZF3.
Claim Rejections - 35 USC § 112(b)
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.
Claim 14 is rejected under 35 U.S.C. 112(b), 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 14, it recites:
A method of treating a subject diagnosed with cancer with an immunotherapeutic agent, the method comprising determining the response of the subject to the immunotherapeutic agent by a method according claim 1, and administering to the subject the immunotherapeutic agent.
Claim 14 is indefinite because the metes and bounds of "the immunotherapeutic agent" used for treating the subject are unclear. Claim 14 recites treating a subject "an immunotherapeutic agent," while claim 1 also recites an immunotherapeutic agent and more narrowly describes it as "an immune checkpoint inhibitor or a combination of immune checkpoint inhibitors."
Therefore, it is unclear whether "the immunotherapeutic agent" in the administering step in claim 14 is limited to "an immune checkpoint inhibitor or a combination of immune checkpoint inhibitors," recited in claim 1, or whether it encompasses a broader class of immunotherapeutic agents.
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, 3-4, 7, 12-14 and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 recites:
A method for determining the response or resistance to treatment with an immunotherapeutic agent that is an immune checkpoint inhibitor or a combination of immune checkpoint inhibitors in a subject diagnosed with cancer,
the method comprising:
determining the expression level of the biomarkers CD247, LAX1, and IKZF3 in a sample of the subject wherein the sample contains or is suspected to contain tumor cells.
Therefore, under BRI claim 1 is drawn to a method comprising a single step of determining gene expression level in a sample of a subject.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Step 1 - Whether the Claim is to a Statutory Category : YES. The claims are drawn to a method, therefore to one of the four statutory categories.
Step 2A Prong 1 - Whether the Claim Recite an Abstract idea, Law of Nature, or Natural Phenomenon: Yes.
The claim relies on the natural phenomenon of gene expression pattern of a subject and its correlation with a phenotype, and broadly recites a determining step to observe this phenomenon.
As stated in MPEP 2106.04(b)(I), laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
A biological sample comprising genes CD247, LAX1, and IKZF3 in its transcriptome, which naturally possesses an expression level is classified as naturally occurring principles/relations.
In conclusion, the claims recite laws of nature and natural phenomena.
Step 2A Prong 2- Whether the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application: No. The claim does not integrate the judicial exception into a practical application. For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must “transform the nature of the claim” into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981.
While claim 1 broadly recites a step of determining expression level of biomarkers, the step is recited at a high level of generality and reflect extra-solution activities for data gathering, without any additional elements that impose a meaningful limit on the judicial exception (i.e., the naturally occurring gene expression of genes comprising CD247, LAX1, and IKZF3). See MPEP §2106.04(d). Thus, the method step merely observes the judicial exception and do not integrate it into a practical application.
It is now well settled under Federal Circuit case law that the use of conventional techniques in a standard way to observe nucleic acids in a biological sample is not eligible for patentability under 35 U.S.C. § 101. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1377 (Fed. Cir. 2022). Therefore, to impose a meaningful limit, a claim must do more than simply apply the natural law with methods/approaches that are known in the art.
Although the preamble recites a method "for determining the response or resistance to treatment with an immunotherapeutic agent," as noted in the claim interpretation section, this descriptive language does not make a manipulative difference in the claimed method because the method does not require any treatment step. Therefore, the preamble does not meaningfully limit the claimed method nor does it integrate the judicial exception into a practical application. See MPEP §2106.04(d)
Claim 14 further recites a method of treating a subject with an immunotherapeutic agent:
A method of treating a subject diagnosed with cancer with an immunotherapeutic agent, the method comprising determining the response of the subject to the immunotherapeutic agent by a method according claim 1, and administering to the subject the immunotherapeutic agent.
The treating step fails to transform the claimed method into patent-eligible subject matter because it does not recite a treatment that is sufficiently particular.
MPEP 2106.04(d)(2) states the following regarding consideration for particular treatment in Step 2A Prong Two:
"In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. "
"The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s)."
Here, claim 14 further recites a mental analysis step of determining the response of the subject to the immunotherapeutic agent by a method according claim 1, and administering to the subject the immunotherapeutic agent.
Related to the 112(b) issue identified above, claim 14 broadly recites administering an "immunotherapeutic agent," without clearly limiting this term to the narrower "immune checkpoint inhibitor" described in claim 1. According to the application's disclosure, "immunotherapeutic agent" encompasses a wide range of therapeutics known in the art and is not particular to the "immune checkpoint inhibitor" recited in claim 1:
"In a further embodiment, the immunotherapeutic agent comprises a checkpoint inhibitor, a chimeric antigen receptor T-cell therapy, an oncolytic vaccine, a cytokine agonist or a cytokine antagonist, or a combination thereof, or any other immunotherapy available in the art. The activating immunotherapy may further comprise the use of checkpoint inhibitors. Checkpoint inhibitors are readily available in the art and include, but are not limited to, a PD-1 inhibitor, PD-L1 inhibitor, PD-L2 inhibitor, a CTLA-4 inhibitor, or a combination thereof." (specification, page 35, lines 30-35)
Therefore, the administering step in claim 14 does not integrate the observed natural correlation and the mental determination step of claims 1 and 14 into a practical application. However, if claim 1 were amended to recite an active and particular treatment step requiring a PD1/PD-L1 inhibitor or its combinations with CTLA4 inhibitor (specification, page 34, lines 1-2), which are described in the specification as particularly related to gene expression for markers CD247, LAX1, and IKZF3 (specification, page 40, lines 24-25), such an amendment could potentially overcome the presently set forth rejection under 35 U.S.C. 101.
Step 2B- Whether a Claim Amounts to Significantly More: No. In this instant case, the claims, when considered as a whole, do not recite any inventive concept with additional elements that amount to significantly more than the judicial exception.
Claim 1 recites a step of determining expression level of biomarkers at a high level of generality and reflect extra-solution activities for data gathering.
According to the instant application's own disclosure, methods for determining gene expression levels for the disclosed gene markers are "are well-known and routinely implemented in the art"(page 16, lines 14-21).
The claims do not appear to add markedly different characteristics that significantly modify or use the naturally occurring correlation in a manner that is not naturally occurring.
The dependent claims 3-4, 7, 12-14 and 21-22 do not recite additional elements that amount to significantly more than the judicial exception, as they either further describe the judicial exception or represent mere general linkage of the judicial exception to the additional elements in the claims (MPEP § 2106.05(h)).
As discussed above, the administering step in claim 14 does not amount to significantly more, because the recited "immunotherapeutic agent," as indicated in the specification, encompass agents that are well-known and readily available in the art (specification, page 35, lines 30-35).
In conclusion, the claims are not patent eligible under 35 U.S.C. 101.
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.
Claims 1, 3-4, 7, 12-14 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (Huang et al. A single dose of neoadjuvant PD-1 blockade predicts clinical outcomes in resectable melanoma. Nat Med. 2019 Mar;25(3):454-461. doi: 10.1038/s41591-019-0357-y. Epub 2019 Feb 25. PMID: 30804515; PMCID: PMC6699626.), as evidenced by
NCBI (Gene Expression Omnibus Series GSE123728, GPL25929 NanoString nCounter gene expression platform; Public on Feb 11, 2019) and
Newcastle (Newcastle NanoString; Newcastle University; research.ncl.ac.uk/nanostring/nanostringtechnology; Archived November 26, 2020 on WaybackMachine)
Huang teaches methods for predicting clinical outcomes of neoadjuvant PD-1 blockade in treating melanoma (Abstract). Specifically, Huang teaches gene expression markers that are associated with clinical benefit (Abstract, lines 16-19; page 458).
Regarding claim 1, Huang teaches “determining the expression level of the biomarkers CD247, LAX1, and IKZF3 in a sample of a subject diagnosed with cancer wherein the sample contains or is suspected to contain tumor cells,” by teaching isolating RNA from FFPE tumor biopsy samples from melanoma patients and gene expression analysis using the NanoString nCounter system. (p. 462, left-hand col, para 1; p. 463, left-hand col, para 1-2).
Huang teaches determining the expression level of CD247, LAX1, and IKZF3 using NanoString nCounter system, as evidenced by NCBI’s Gene Expression Omnibus in Platform GPL25929, disclosing the gene panel of the NanoString assay used in Huang, comprising CD247 (ID#111), LAX1 (ID#452), and IKZF3 (ID#374).
Regarding claim 3, it is anticipated by Huang because it does not further limit the claimed method.
Claim 3 recites: “wherein the immunotherapeutic agent is selected from the group consisting of a PD-1 targeting agent, a PD- L1 targeting agent, a CTLA-1 targeting agent, and a combination thereof. ”
Per MPEP 2111.04, a wherein clause can limit a method claim if it contributes meaning and purpose to the manipulative steps.
In this instant case, the wherein clause does not limit the method claim because the base claim 1 does not recite any step that requires using an immunotherapeutic agent.
As such, this clause merely describes an element that is not required in any of the steps, without modifying any step of the claimed method. Therefore, this claim language is interpreted as descriptive statement without any associated active steps and do not distinguish the claims from the prior art.
Regarding claim 4, Huang teaches tumor tissue sample (p. 463, left-hand col, para 1, FFPE sample; see also Fig. 4, analyzing gene expression of pre- versus treatment tumor).
Regarding claim 7, Huang as evidenced by NCBI teaches determining expression level of CD3G and ITGAL in the sample of the subject.
Huang teaches gene expression analysis using the NanoString nCounter system. (p. 463, left-hand col, para 1-2).
NCBI’s Gene Expression Omnibus in Platform GPL25929, disclosing the gene panel of the NanoString assay used in Huang, comprising CD3G (ID#125) and ITGAL (ID#414).
Regarding claim 12, it is anticipated by Huang because it does not further limit the claimed method.
Claim 12 recites: “wherein the response is selected from the RECIST 1.1 response criteria.”
Per MPEP 2111.04, a wherein clause can limit a method claim if it contributes meaning and purpose to the manipulative steps.
In this instant case, the wherein clause does not limit the method claim because the base claim 1 does not recite any step that requires or rely on any “response.”
As such, this clause merely describes an element that is not required by any of the steps, without modifying any step of the claimed method. Therefore, this claim language is interpreted as descriptive statement without any associated active steps and do not distinguish the claims from the prior art.
Regarding claim 13, Huang teaches using a kit comprising means for measuring the expression level of the biomarkers CD247, LAX1, and IKZF3 in a sample of the subject by teaching gene expression analysis using the NanoString nCounter system. (p. 463, left-hand col, para 1-2), as evidenced by NCBI’s Gene Expression Omnibus in Platform GPL25929, disclosing the gene panel of the NanoString assay used in Huang, comprising CD247 (ID#111), LAX1 (ID#452), and IKZF3 (ID#374).
NanoString nCounter system is a gene expression array, as evidenced by Newcastle (see in Fig. "Schematic representation of NanoString nCounter expression array"). Thus, the NanoString nCounter system and its reagent components meets the limitation "means for measuring" under the current broadest reasonable interpretation, as discussed on the claim interpretation section above.
Regarding claim 14, Huang teaches determining the response of the subject to the immunotherapeutic agent by a method according to claim 1, and administering to the subject the immunotherapeutic agent (Abstract; lines 12, 16-19, administering single dose of anti-PD-1, “Transcriptional analysis demonstrated a pretreatment immune signature (neoadjuvant response signature) that was associated with clinical benefit”; see also Fig. 4; page 461, left-hand col, lines 1-9).
Regarding claim 21, Huang teaches the expression level of the biomarker is the RNA-based expression level of the protein coding gene (p. 463, left-hand col, para 1-2).
Regarding claim 22, Huang teaches the subject is diagnosed with melanoma (p. 462, left-hand col, para 1, “Patients were eligible for enrollment if they were 18 years of age or older… had measurable resectable clinical stage III or resectable stage IV melanoma”).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
CD247, LAX1, and IKZF3 are known biomarkers for immunotherapy response:
Xiong (Xiong et al. A gene expression signature of TREM2hi macrophages and γδ T cells predicts immunotherapy response. Nat Commun. 2020 Oct 8;11(1):5084. doi: 10.1038/s41467-020-18546-x. PMID: 33033253; PMCID: PMC7545100; cited as NPL#4 in IDS filed 01/19/2024) teaches gene signature comprising LAX1 as predictive for immunotherapy response in melanoma patients;
Gide (Gide et al., Distinct Immune Cell Populations Define Response to Anti-PD-1 Monotherapy and Anti-PD-1/Anti-CTLA-4 Combined Therapy. Cancer Cell. 2019 Feb 11;35(2):238-255.e6. doi: 10.1016/j.ccell.2019.01.003. PMID: 30753825; cited as NPL#2 in IDS filed 01/19/2024) teaches treating melanoma patients with anti-PD-1 monotherapy or combined anti-PD-1 and anti-CTLA-4, and gene signatures that relate to therapy response comprising CD247;
Hacohen (WO2021030627A1 - Methods for predicting outcomes of checkpoint inhibition and treatment thereof ; Published on 2021-02-18; cited as Foreign Pat Document #5 in IDS filed 01/19/2024) teaches a gene signature that relate to response to immunotherapy (e.g., anti-PD-1, anti-CTLA4), comprising IKZF3.
Conclusion
The specification is objected to; claims 1, 14, and 21 are objected to; claims 1, 3-4, 7, 12-14 and 21-22 are rejected. No claims are allowed.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Claims 15 and 17-18 are withdrawn as being drawn to non-elected group II
2 Claim 8 is withdrawn as being drawn to non-elected species G
3 Although the specification does not provide detailed reagent components, primer/probe sequences, or specific kit configurations, the specification identifies known gene expression analysis approaches that are well-known in the art and commercially available (e.g., real-time quantitative PCR, gene expression arrays, TruSeq gene expression analysis, in-situ hybridization, dye sequencing, pyrosequencing, etc.). Therefore, one of ordinary skill in the art would have understood the corresponding assay reagents and materials capable of performing the claimed measuring function.
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