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 with traverse of Group 1 in the reply filed on 1/5/26 is acknowledged. The traversal is on the ground(s) that a search burden wouldn’t be imposed if all inventions were examined. This is not found persuasive because the argument of whether or not a search burden would be an issue is not applicable to the instant application. The application is a national stage entry (371 application) and the Office action mailed on 11/7/25 is a Lack of Unity, which considered whether or not the claimed inventions provide a contribution over the prior art. Applicants have not identified any deficiencies of the prior art applied in the most recent Office action. Furthermore, search burden is not a factor considered when analyzing the claimed inventions in a Lack of Unity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 34, 76 and 99 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/5/26.
Claims 1, 2, 4, 6-8, 10-17, 19, 49 and 53 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/17/24; 10/28/24 and 5/29/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim- Rejections - 35 USC § 112
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 13 and 14 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventories), at the time the application -was filed, had possession of the claimed invention.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice... reduction to drawings...or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See BU Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 13 and 14 are rejected as lacking adequate descriptive support for a possession of a first and second binding agents having a Kd for the target analyte from between about 1:1000 to about 1000:1; and wherein the binding affinity of the first binding agent is weaker than the binding affinity of the second binding agent.
The binding agents are used in a system for detecting at least one target analyte in a biological sample.
In support of the claimed genus (binding agents with Kd for a target analyte from between about 1:1000 to about 1000:1 and wherein the first binding agent has a weaker binding affinity than the second binding agent), the application discloses one example in which an aptamer specific for the spike glycoprotein of SARS-CoV-2 and an antibody also specific this glycoprotein [see paragraph 627], however, there is no indication in the specification that the aptamer and antibody possess the claimed Kd or that one is weaker than the other with regard to binding affinity. No derivatives or variants or mutants thereof are disclosed that can achieve the claimed Kd binding values and that one binding agent is weaker than another. Thus, the application fails to provide examples of any species within the claimed genus.
Thus, in view of the above, there would have been significant uncertainty as to which binding agents possess the claimed Kd and also having different or weaker binding affinities between each other. In view of this uncertainty and the lack any examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Claims 10 and 11 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 detecting a SARS-CoV-2 spike glycoprotein with the antibody CR3022/47D11, does not reasonably provide enablement for detecting a generic analyte with a generic antibody. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The claimed invention is drawn a system for detecting at least one target analyte in a biological sample, wherein the system comprises (i) a two binding agent assay, wherein the assay contains a first and second binding agent capable of creating a detectable complex with the at least one target analyte; and (ii) a detection device for detecting the detectable complex, wherein the detection device is an oxidase-based amperometric sensor and the biological sample is present in sweat, saliva, serum, mucus, or blood;
wherein the first and second binding agents are selected from the group consisting of aptamers, antibodies, proteins, or a combination thereof; or
wherein the first binding agent is an aptamer and the second binding agent is an antibody, wherein the antibody is linked to glucose oxidase.
Thus, the claim is are directed to a broad class of antibodies, only defined by its function sequence identity relative to the entire variable domain. However, relative to the claimed identity percentage, the specification does not give one of ordinary skilled in the art enough information to choose candidate antigen binding structures from the vast number of options, and therefore required scientists to engage in a great deal of experimentation and failure. “That is not enablement”—it is a “hunting license.”
In Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). The Supreme Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the function of binding to specific amino acid residues on PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR. This decision reaffirmed the prior decision made by the Federal District Court in Amgen Inc. v. Sanofi, Aventisub LLC., 987 F.3d 1080 (Fed. Cir. 2021).
The Court clarified that the specification does not always need to "describe with particularity how to make and use every single embodiment within a claimed class." Id. at 610-11. However, "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class….The more one claims, the more one must enable." Id.
The specification may require a reasonable amount of experimentation to make and use the invention and what is reasonable will depend on the nature of the invention and the underlying art. For example, "it may suffice to give an example (or a few examples) if the specification also discloses some general quality … running through the class that gives it a peculiar fitness for the particular purpose" and "disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset." Id. at 611 (internal quotations omitted). However, the Supreme Court found that Amgen failed to enable all that it claimed, even if allowing for a reasonable degree of experimentation. Id. at 613; see also Baxalta Inc. v Genentech, Inc., 81 F.4th 1362, 1367, 2023 USPQ2d 1103 (Fed. Cir. 2023) ("[t]he facts of this case are more analogous to—and are, in fact, indistinguishable from—those in Amgen. We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors."). Moreover, "[w]e see no meaningful difference between Wands' ‘undue experimentation’ and Amgen's ‘[un]reasonable experimentation’ standards. Id. at footnote 4. See also Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024), which explains that regardless of the technology the Wands factors should be used when assessing enablement.
However, while the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class which included "a ‘vast’ number of additional antibodies" that Amgen had not described by their amino acid sequences. Id. at 613. The Court found that Amgen sought to monopolize an entire class by their function, even though that class was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. Id. at 613.
In Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed, the Federal Circuit explicitly applied the Wands factors to assess whether the specification of Amgen’s patent provided sufficient enablement, for purposes of 35 U.S.C. 112(a), to make and use the full scope of the claimed invention. The court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Id. at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. See also the following cases across various technology areas: McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019).
Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification. The two processes, the “roadmap” and “conservative substitution” did not save Amgen. According to the Court, these amounted to “little more than two research assignments” which forced scientists to conduct “painstaking experimentation” to see what worked. (citing Incandescent Lamp). The Court therefore held that Amgen’s specification did not enable the claims.
This case is akin to the issue in Amgen Inc. v. Sanofi, Aventisub LLC, in which the court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Sanofi-Aventisub at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. While the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class that included “a ‘vast' number of additional antibodies” that Amgen had not described by their amino acid sequences. Id. at 1256. The Supreme Court found that Amgen sought to monopolize an entire class of antibodies by their function, which was much broader than the 26 exemplary antibodies disclosed by their amino acid structure.
The instant claims are directed to a class of antibodies that include “a ‘vast’ number of antibodies specific for a generic analyte present in a biological sample, in view of teachings for the specification. It would be necessary to first generate and then screen each candidate antibody and fragments thereof, with the recited function) to determine whether it met the functional limitations of “binding to a target analyte”. The Federal Circuit concluded that there was a lack of enablement, which was affirmed by the Supreme Court in Amgen.
The instant claims simply direct skilled artisans to engage using antibodies for detecting an target analyte and that “[u]nder Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Id. at *8, *10.
The Supreme Court’s 2023 decision in Amgen v. Sanofi, which mainly involves the enablement requirement, states that “where a patentee purports to invent an entire genus, it must enable the entire genus”; “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies – and it is the latter that petitioners claim as their invention”; S. Ct.
The specification does not reasonably provide enablement to make the invention of claims 10 and 11 as it is currently written. The specification does reasonably provide enablement to make and use the invention of antibody CR3022/47D11 as discussed above.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
In addition, any CDR mutation, which can happen when you recombine all these CDRs into different species is not predictable. This is evidenced by the fact that even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff (Proc Natl Acad Sci USA 1982 Vol 79 page 1979). Rudikoff teaches that the alteration of a single amino acid in a single CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (entire article, Abstract).) Thus, all claims rejected above, which read on shark monoclonal nanobody with mixed and matched CDRs, which are mutated CDR sets, or nanobodies recited by percent identity without all parental CDRs being fixed, are rejected here as failing the enablement requirement.
Moreover, claims not containing elements critical or essential to the practice of the invention, such as antibodies or antibody fragments not having all of the relevant functional complementarity determining regions (CDRs) in the proper site on an appropriate antibody heavy or light chain framework, are not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
Note that an enabling disclosure for the preparation and use of only a few analogs of a product does not enable all possible analogs where the characteristics of the analogs are unpredictable. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. (18 USPQ 2d 1027 (CAFC 1991)).
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, 8, 14 and 17 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 2 recites, “wherein the amperometric sensor is an oxidase-based, a hydrogenase-based, or dehydrogenase-based amperometric sensor.” However, claim 1 states that the amperometric sensor is oxidase-based, therefore, it is unclear if the sensor is oxidase-based, a hydrogenase-based, or dehydrogenase-based, which are different.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “sugar”, and the claim also recites “glucose” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 recites, “wherein the binding affinity of the first binding agent is weaker than the binding affinity of the second binding agent.” However, the claims nor the specification provide a definition or specific example of what the metes and bounds of “weaker” are relative to this claim.
Claim 17 recites the limitation "target coronavirus" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites, “the hemagglutinin protein”, however, coronaviruses do not possess hemagglutinin proteins. Therefore, it is unclear which hemagglutinin the claim is referring to.
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 4 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 4 recites, “the biological sample is sweat, saliva, serum, mucus, or blood”, however, claim 1 recites these same options for the biological sample. 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 Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 4, 6, 7, 8 and 15-16 are rejected under 35 U.S.C. 102a1 as being anticipated by Zhang et al. (Angew Chem Int Ed, 2015, Vol. 54, pages 5929-5932).
The claimed invention is drawn to a system for detecting at least one target analyte in a biological sample, wherein the system comprises (i) a two binding agent assay, wherein the assay contains a first and second binding agent capable of creating a detectable complex with the at least one target analyte; and (ii) a detection device for detecting the detectable complex, wherein the detection device is an oxidase-based amperometric sensor and the biological sample is present in sweat, saliva, serum, mucus, or blood.
The target analyte is a whole virus or component thereof, such as an influenza virus.
The detection device is a glucose meter and that glucose meter comprises a glucose sensor having an output related to glucose in a biological sample on a test strip.
The biological sample is mixed with a sugar.
Zhang et al. teach the detection of influenza virus with a glucose meter possessing test strips. [see figure 1a] Zhang et al. teach that the use of binding agent SG1, which contains a glucose molecule, which in the presence of influenza A neuraminidase thereby achieving mixing of glucose with the sample suspected of having influenza, glucose is released and detected by the glucose meter, which requires a second binding agent. [see page 5930 and Figure 2] The glucose is measured amperometrically in the glucose meter, which is oxidase based. [see page 5930, right column] Zhang et al. teach the detection of influenza from nasal swabs, which would include nasal mucus. Therefore, Zhang et al.
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Claim(s) 1, 2, 4, 10-12 and 19 are rejected under 35 U.S.C. 102a1 as being anticipated by Dincer et al. (WO/19/134741).
The claimed invention is drawn to a system for detecting at least one target analyte in a biological sample, wherein the system comprises (i) a two binding agent assay, wherein the assay contains a first and second binding agent capable of creating a detectable complex with the at least one target analyte; and (ii) a detection device for detecting the detectable complex, wherein the detection device is an oxidase-based amperometric sensor and the biological sample is present in sweat, saliva, serum, mucus, or blood.
The target analyte is selected from the group consisting of IgG, IgM and IgA.
The first and second binding agents are selected from the group consisting of aptamers, antibodies, proteins or a combination thereof; or the first binding agent is an aptamer and the second binding agent is an antibody linked to glucose oxidase; or the first and second binding agents bind to different sites on the target analyte.
Dincer et al. teach in a preferred embodiment, the invention relates to a method for the measurement of multiple analytes from a single sample comprising the steps of
a) providing a system comprising
i. a common inlet configured to receive a fluid stream
ii. a single microfluidic channel
iii. a measurement cell
iv. a channel outlet
wherein the microfluidic channel comprises at least two immobilization areas and at least one spacer area that are arranged alternating, wherein only at the site of the immobilization areas biorecognition elements are immobilized that possess a binding affinity for an analyte
b) introducing the sample comprising at least two analytes into the microfluidic channel via the common inlet, whereby first analytes immobilize in a first immobilization area and second analytes immobilize in a second immobilization area
c) introducing a fluid comprising a reporter catalyst into the microfluidic channel via the common inlet, whereby the reporter catalyst immobilizes in the respective immobilization areas depending on the presence of analytes to form an analyte-dependent catalyst complex
d) introducing a fluid, containing a substrate for the reporter catalyst e) stopping the flow of the fluid stream for a stop interval such that in each immobilization area a catalytic reaction may take place to produce target molecules
f) initiating a flow of the fluid stream such that at the measurement cell the amount of target molecules produced in each immobilization area can be detected as separate peak signals. [see page 3]
The term "analyte" refers to a substance to be detected, quantified or otherwise assayed by
the method of the present invention. Typical analytes may include, but are not limited to proteins, peptides, nucleic acid segments, carbohydrates, lipids, antibodies (monoclonal or
polyclonal), antigens, oligonucleotides, specific receptor proteins, ligands, molecules, cells,
microorganisms and fragments and products thereof, or any substance for which attachment sites, binding members or receptors (such as antibodies) can be developed. [see page 15, paragraph 3]
In a preferred embodiment of the invention the biorecognition elements are selected from a
group consisting of nucleic acids, preferably RNA and/or DNA oligonucleotides, antibodies,
peptides, proteins, aptamers, molecularly-imprinted polymers or even whole cells. It is
particularly preferred that the biorecognition elements are chosen to exhibit a high specific
binding to the respective analytes. For instance, in case of an antigen as an analyte the
biorecognition element may refer to an antibody specific to the antigen. By immobilizing
different antigen-specific antibodies at each of the immobilization sites, multiple analytes
can be selectively captured. [see page 6, paragraph 5]
In a preferred embodiment of the invention, the reporter catalyst is a reporter enzyme
preferably selected from a group consisting of glucose oxidase, horseradish peroxidase,
alkaline phosphatase, Chloramphenicol acetyltransferase, ~-galactosidase and ~glucuronidase.
These preferred enzymes are characterized by an efficient catalyzation of a
reaction yielding readily detectable target molecules upon provision of a solution
comprising a substrate. For instance, glucose oxidase as a reporter enzyme produces
gluconate and hydrogen peroxide upon provision of a substrate solution comprising
glucose. Herein, the target molecule hydrogen peroxide can be amperometrically detected
at a working electrode in an electrochemical cell. [see page 8, paragraph 4]
Dincer et al. further teach an amperometrtic signal detection using a glucose solution as a substrate solution for the immobilized reporter enzyme glucose oxidase in a stop-flow assay. [see page 27, example 3]
Dincer et al. also teach that the term "sample" as used herein refers to a solution comprising at least one analyte, preferably two or more analytes. Examples of samples include biological fluids such as serum, plasma, urine, tear, cells, cell mixtures, cell culture supernatants, or cell lysates containing one or more biological target molecules. Furthermore, samples can also comprise any conditioning reagents (e.g., permeablizing reagents) needed to render analytes soluble and accessible to detection and quantification. Such conditioning reagents may be added to the sample at any time before or after the sample is added to the devices of the present invention. [see page 15, paragraph 5]
Dincer et al. also teach that glucose oxidase can be attached to a detection antibody. [see page 2, 3rd paragraph and Figure 3]
Therefore, Dincer et al anticipate the instant invention.
Claim(s) 49 and 53 are rejected under 35 U.S.C. 102a1 as being anticipated by Dincer et al. (WO/19/134741).
The claimed invention also requires a test strip for use in the system, wherein the test strip comprises at least one of the following:
a substrate, at least one first and second binding agent and two or more electrodes;
the substrate both first and second binding agents and two or more electrodes;
at least one first and second binding agent and two or more electrodes; or
both first and second binding agents and two or more electrodes;
and a kit comprising the test strip.
Claim 49 also recites an intended use “for use in the system of claim 1”. MPEP § 2111.02 (II) recites, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the pre-amble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limita-tions, then the preamble is not considered a limitation and is of no significance to claim construction.”
Dincer et al. teach an assay that comprises a measurement cell that comprises one or more working electrodes [see page 9, first paragraph and figure 2e]
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Dincer et al. also teach use of biorecognition elements that include antibodies, which bind to analytes suspected of being in biological samples being assayed. [see page 6, paragraph 5 and page 7, paragraph 2] More specifically, the use of multiple analyte-specific binding partners are also taught. [see page 7, paragraph 3] While Dincer et al. do not specifically state a kit is part of their assay, the claimed kit only requires the products recited by claim 49. Therefore, Dincer et al. teach the claimed invention.
Claim(s) 1, 2, 4 and 15-17 are rejected under 35 U.S.C. 102a2 as being anticipated by Nazarian et al. (US PGPub 2021/0396703).
The claimed invention is drawn to a system for detecting at least one target analyte in a biological sample, wherein the system comprises (i) a two binding agent assay, wherein the assay contains a first and second binding agent capable of creating a detectable complex with the at least one target analyte; and (ii) a detection device for detecting the detectable complex, wherein the detection device is an oxidase-based amperometric sensor and the biological sample is present in sweat, saliva, serum, mucus, or blood.
The target analyte is a whole virus or component thereof, such as an SARS-CoV-2 spike protein, membrane protein or envelope protein.
Nazarian et al. teach an electrochemical based assay for detecting SARS-CoV-2 present in saliva. [see abstract and claims 1-18] Nazarian et al. also teach that glucose oxidase can be used as a redox agent with their electrochemical sensor as part of the assay and that the electrochemical sensor is configured for by measuring using amperometry. [see paragraph 11] The detection of SARS-CoV-2 is achieved by using antibodies, aptamers and angiotensin-converting enzyme 2 (ACE2), which are specific for the SARS-CoV-2 spike protein and created a detectable complex. [see paragraph 11 and claims 1-18] Therefore, Nazarian et al. anticipate the instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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