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 .
DETAILED ACTION
Disposition of Claims
Claims 1-20 remain pending. Amendments to claims 4, 11, 13, 15-17, and 19-20 are acknowledged and entered. Claims 1-20 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230323488A1, Published 10/12/2023.
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.
The examiner of your application in the Patent and Trademark Office has been reassigned. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Rachel Gill, Art Unit 1671.
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.
Response to Arguments
Applicant's arguments filed 02/20/2026 regarding the previous Office action dated 11/25/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Specification
(Objection withdrawn.) The objection to the specification is withdrawn in light of the amendments to the specification.
Drawings
(Objection withdrawn.) The objection to the drawings in the specification is withdrawn in light of the amendments to the specification.
(Objection withdrawn.) The objection to the color drawings in the specification is withdrawn in light of the amendments to the specification.
Claim Objections
(Objection withdrawn.) The objection to claims 4, 11, 13, 16, 17, and 19 is withdrawn in light of the amendments to the claims.
(New objection.) Claims 1, 3-6, and 9-11 are objected to because of the following informalities: “bioaerosol particles” should be “bioaerosol particles” to place the claims in better form. Appropriate correction is required.
(New objection.) Claim 11 is objected to because of the following informalities: the definition of the abbreviations “RNA” and “SARS CoV-2” is not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name (i.e. … ribonucleic acid (RNA)…severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2)...).
Appropriate correction is required.
Claim Rejections – 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The objection to Claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre–AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(New rejection.) Claims 1 and 15 and dependent claims 2-14 and 16-20 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 “defined area” in claim 1 and the term “defined space” in claim 15 are relative terms which renders the claims indefinite. The term “defined area/space” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “defined area” or “defined space” is unclear as the claim and the specification fails to define what is, and what is not, within the parameters or confines of such an area or space. For instance, these terms could mean a room, an entire building, a specific volume of air, a controlled environment (such as a hospital ward), or a spatial boundary (which is further unclear without defining the boundary physically and/or functionally). As there is no objective boundary for the “defined area” or “defined space”, and no clear criteria for what does, or does not, qualify as such an area/space, a skilled artisan would not be able to determine if they are infringing upon the claimed methods.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant claims 1 and 15 are rejected on the grounds of being indefinite. Claims 2-14 and 16-20 are also rejected since they depend from claims 1 or 15, but do not remedy these deficiencies of claims 1 or 15.
(New rejection.) Claim 1 and dependent claims 2-14 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 of collecting bioaerosol particles of a suspected virus in a defined area, the method comprising: positioning a dehumidifier in the defined area; collecting the bioaerosol particles in the condensate of the dehumidifier; and concentrating the condensate to isolate any captured bioaerosol particles for further analysis. However, the term “suspected virus” fails to provide objective boundaries for the claimed virus. It is unclear what makes a virus “suspected”, including whether the term refers to a virus suspected by a scientist before sampling, a virus that may be present in the defined area, a virus later detected in the condensate from the humidifier, a specific virus (e.g. SARS CoV-2), or any other airborne virus that would be capable of being collected in a condensate. As this term is not clearly defined, the metes and bounds of what is, and what is not, a “suspected virus” is unclear.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant claim 1 is rejected on the grounds of being indefinite. Claims 2-14 are also rejected since they depend from claim 1, but do not remedy these deficiencies of claim 1.
(New rejection.) Claims 4 and 13 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 4 is drawn to the method of claim 1 “further comprising analyzing the captured bioaerosol particles for coronavirus (CoV) biomarkers selected from coronavirus disease 2019 (COVID-19) or mutants or variants thereof.” Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “coronavirus disease 2019 (COVID-19)” in claim 4 is used by the claim to mean “severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2),” while the accepted meaning is “disease caused by SARS CoV-2.” The term is indefinite because the specification does not clearly redefine the term.
Additionally, the phrase “mutants or variants thereof” lacks a clear antecedent and objective basis for comparison for determining what is, and what is not, a “mutant” or a “variant”, because without providing a baseline virus strain/sequence, genomic strain/sequence, protein strain/sequence, or the like, it is unclear how one of skill in the art can determine if the analyzed biomarker or virus is a “mutant” or a “variant” compared to what they are looking for.
Claim 13 is rejected for similar reasoning.
For at least these reasons, claims 4 and 13 are rejected on the grounds of being indefinite.
(New rejection.) Claim 5 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.
The terms “about” and “several” in claim 5 are relative terms which renders the claim indefinite. The terms “about” and “several” are 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. It is suggested that a specific range be utilized in the claims to clearly define the time frame for claim 5 (e.g. “…wherein the collecting of the bioaerosol particles in the condensate is for at least 10 minutes up to 7 days.”)
For at least these reasons, the metes and bounds of claim 5 are unclear.
(New rejection.) Claims 10 and 18 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 “about” in claims 10 and 18 is a relative term which renders the claims indefinite. The term “about” 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. It is suggested that a specific range be utilized in the claims to clearly define the humidity (and temperature for claim 10) conditions.
For at least these reasons, the metes and bounds of claims 10 and 18 are unclear.
(New rejection.) Claim 11 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 11 is drawn to the method of claim 1, wherein the bioaerosol particles comprise virus particles or biomarkers and wherein the captured virus particles or biomarkers are analyzed using ribonucleic acid (RNA)- based analysis employing commercially available Loop-Mediated Isothermal Amplification of RNA (RT- LAMP), reverse-transcription polymerase chain reaction (RT-PCR) kits, or a nano-sensing platform using lanthanide-doped carbon nanoparticles (LCNPs), to provide a distinct fluorescence response in the presence of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). The claim recites that the captured virus particles or biomarkers are analyzed using commercially available methods to “provide a distinct fluorescence response in the presence of SARS CoV-2”. It is unclear if the phrase “provide a distinct fluorescence response” modifies only the nano-sensing platform using LCNPs, or whether it modifies each of the recited alternatives, including RT-LAMP and RT-PCR, as these two methods can employ detection methods which are not fluorescence-based (e.g. RT-LAMP can use fluorescence, colorimetric detection, turbidity, or lateral flow detection).
Additionally, the term “distinct” in claim 11 is a relative term which renders the claim indefinite. The term “distinct” 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. While it appears as though the specification may provide some guidance as to what a skilled artisan is looking for with the LCNP method, it remains that this term is relative and it is unclear what would, and would not, be a “distinct” fluorescence response.
For at least these reasons, claim 11 is rejected on the grounds of being indefinite.
(New rejection.) Claims 12 and 20 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 “stabilize” in claim 12 is a relative term which renders the claim indefinite. The term “stabilize” 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. Stabilize is a term of degree because the claim does not identify what level of stabilization is required, for how long the virus must be “stabilized”, or what measurable endpoint determines if the virus is “stabilized.” It is unclear if this term is meant to preserve infectivity, to preserve viral nucleic acid/genome/virions, to preserve other viral proteins or antigens, to prevent degradation of the sample relative to not using VTM, or the like. This distinction is even more relative with respect to the guidance provided by the specification, which focused only on detection of RNA viruses and stabilizing said enveloped RNA viruses (namely SARS CoV-2) in the VTM, while the claim is more broadly drawn to stabilizing “any collected virus”, which includes non-RNA-based viruses and any enveloped/non-enveloped viruses.
Claim 20 is rejected for similar reasoning.
For at least these reasons, the metes and bounds of claims 12 and 20 are unclear.
(New rejection.) 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.
The term “increase” in claim 14 is a relative term which renders the claim indefinite. The term “increase” 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. It is unclear if this “increase” is relative to the ambient moisture level before performing the claimed method, or if the “increase” is relative to the moisture level in the “area” or within the dehumidifier itself, or if the “increase” is relative to a predetermined humidity level or other reference point. The claim also fails to state how the “increase” is detected and what degree of “increase” is required.
For at least these reasons, the metes and bounds of claim 14 are unclear.
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 of collecting bioaerosol particles of a suspected virus in a defined area, the method comprising: positioning a dehumidifier in the defined area; collecting the bioaerosol particles in the condensate of the dehumidifier; and concentrating the condensate to isolate any captured bioaerosol particles for further analysis.
Further limitations on the method of claim 1 are wherein the method is further comprising removing condensate from the dehumidifier prior to concentration of said condensate (claim 2); wherein the bioaerosol particles comprise virus particles or biomarkers (claim 3); further comprising analyzing the captured bioaerosol particles for coronavirus (CoV) biomarkers selected from CoV that is the causative agent of coronavirus disease 2019 (COVID-19) or mutants or variants thereof (claim 4); wherein the collecting of the bioaerosol particles in the condensate is for about 10 minutes to several days (claim 5); wherein the bioaerosol particles comprise virus particles or biomarkers and wherein the captured virus particles or biomarkers are analyzed to determine virus type and quantity (claim 6); wherein the dehumidifier is a low-grain refrigerant (LGR) dehumidifier (claim 7); wherein concentration of the condensate to isolate virus particles or biomarkers in the condensate is effectuated using an affinity microcolumn (claim 8); wherein the bioaerosol particles comprise virus particles or biomarkers and wherein the captured virus particles or biomarkers are analyzed using rapid flow enzyme- linked immunosorbent assay (ELISA)(claim 9); wherein collecting the bioaerosol particles in the condensate of the dehumidifier is conducted under humidity conditions ranging from about 40-60% at about room temperature (claim 10); wherein the bioaerosol particles comprise virus particles or biomarkers and wherein the captured virus particles or biomarkers are analyzed using ribonucleic acid (RNA)- based analysis employing commercially available Loop-Mediated Isothermal Amplification of RNA (RT- LAMP), reverse-transcription polymerase chain reaction (RT-PCR) kits, or a nano-sensing platform using lanthanide-doped carbon nanoparticles (LCNPs), to provide a distinct fluorescence response in the presence of SARS-CoV-2 (claim 11); wherein the dehumidifier further comprises viral transport medium (VTM) in a condensate container to stabilize any collected virus (claim 12); wherein the concentrated condensate is analyzed for RNA or spike protein (S-protein) from the virus which causes COVID-19 or mutants or variants thereof (claim 13); and wherein a humidifier is positioned in the defined area to increase moisture content in the defined area (claim 14).
Claim 15 is drawn to a system for detecting aerosolized virus particles or biomarkers in an atmosphere within a defined space, the system comprising: a dehumidifier for collecting the aerosolized virus particles or biomarkers, wherein collected aerosolized virus particles or biomarkers are contained in a condensate of the dehumidifier; a collection system for removing the condensate from the dehumidifier; an affinity microcolumn for concentrating the collected aerosolized virus particles or biomarkers in the removed condensate; and a detection system for analyzing the concentrated aerosolized virus particles or biomarkers.
Further limitations on the system of claim 15 are wherein the dehumidifier is a LGR dehumidifier (claim 16); wherein the detection system comprises a rapid flow ELISA (claim 17); wherein collecting the aerosolized virus particles or biomarkers in the condensate of the dehumidifier is conducted under humidity conditions ranging from about 40-60% at room temperature (claim 18); wherein the detection system comprises a RNA based analysis device employing commercially available RT-LAMP system, or a nano-sensing platform using LCNPs (claim 19); and wherein the dehumidifier further comprises VTM in a condensate container to stabilize any collected virus (claim 20).
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.
(New rejection.) 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 methods of collecting bioaerosol particles of a suspected virus in a defined area, the method comprising: positioning a dehumidifier in the defined area; collecting the bioaerosol particles in the condensate of the dehumidifier; and concentrating the condensate to isolate any captured bioaerosol particles for further analysis. The claims are not limited to a particular subset of bioaerosol particles of any virus, so the breadth includes any enveloped or non-enveloped virus, any RNA or DNA virus, or any particle thereof. As set forth in the 35 USC 112b rejections supra, the area for collection is extremely broad and undefined, and is not limited to a particular room of any particular size, or a building of a certain amount of square feet. The sampling duration is broad, and while further dependent claims narrow the sampling rate, it is still largely indistinct and undefined. It is not clear how much condensate can or should be collected before it is concentrated and sampled, nor do the independent claims specify that a specific detection method be used. Further dependent claims narrow the methods, but are specifically focused on RNA-based analysis, which may not be useful depending on the virus or the type of biological sample that is present in the condensate.
While the invention relates to bioaerosol sampling, virus collection in dehumidifier condensate, the concentration of said condensate through a variety of means, and downstream detection of biological materials related to said virus (e.g. proteins, nucleic acids, virions, etc.), all of these steps or conditions are highly affected by the airborne particle size, the viral load, the humidity and/or air flow/exchange of the environment or area being tested, the amount of condensate collected in the time allotted, the stability of the virus or the viral components, and the sensitivity of the detection methods or assays used on the concentrated condensate. Taking everything into consideration, the scope of the claims and the nature of the claimed invention is significantly broader than the actual working examples within the specification.
State of the prior art/Predictability of the art. The prior art recognized that atmospheric condensate could be used to collect and analyze airborne contaminants, including biological agents. Pycke et. al. (US20160041138A1) teaches generating atmospheric condensate from air using HVAC cooling coils or a heat exchange module, wherein the condensate can be collected and analyzed for the presence of contaminants such as microorganisms in whole or in part, including viruses, bacteria, yeasts, fungi, Archaea, prions, DNA, RNA, organelles, eukaryotic cells, and natural and genetically modified cells (entire document; see abstract; reference claim 8; ¶[0004]). Pycke further teaches that these biological agents may be assayed from indoor condensate using methods available to those skilled in chemical and biological monitoring (¶0046]).
The prior art also recognized that virus sampling from air is technically difficult and dependent on sampler performance. Pan et. al. (Pan M, et. al. J Appl Microbiol. 2019 Dec;127(6):1596-1611. Epub 2019 Jun 26.) describes air sampling technologies for detecting aerosolized viruses and discusses limitations, factors affecting performance, and research needs for airborne virus sampling and detection. Pan explains that sampling devices are needed that can collect a wide size range of virus-containing aerosols and maintain viability, indicating that air sampling for viruses was not a routine matter of merely placing a collector in a room. Pan shows that depending on droplet size, the particle may not be able to travel a large distance (Fig. 1), that filters can be used to collect viruses but they often inactivate the virus, and that appropriate liquids must be used for viral collection to maintain viability for later testing. Pan discusses water-based condensation to detect aerosolized virus (p. 1602-3), but these devices were often limited to breathalyzer type devices and were not as effective for sampling airborne infectious viruses. Pan notes that an emerging virus aerosol sampler, the water-based laminar-flow condensational growth tube collector (GTC) showed promise in monitoring for aerosolized viruses, but that the limitations were that said devices were bulky and required specialized skills to operate and maintain.
With respect to viruses in environmental water samples, the prior art noted that viruses are often present at low concentrations and require further concentration before accurate detection. Farkas et. al. (Farkas K, et. al. Methods Protoc. 2018 Sep 10;1(3):35.) details methods involving a tangential flow ultrafiltration step that reduces the sample volume of 1–10 L to approximately 50 mL, followed by secondary precipitation using polyethylene glycol 6000, which reduces the volume to 1–4 mL, and can be used across a wide range of water sample types. However, the teachings of Farkas highlight how the concentration method, sample volume, and recovery affect whether viruses can be detected in aqueous samples; for example, Farkas shows how filters cannot be used in samples where other particulates may clog the filter or affect the surface charge of the filter.
The prior art was also aware that recovery of specific types of viruses from aqueous samples was method-dependent, as evidenced by the teachings of Ahmed et. al. (Ahmed W, et. al. Sci Total Environ. 2020 Oct 15;739:139960. Epub 2020 Jun 5.) Ahmed evaluated seven concentration methods: (A–C) adsorption-extraction with three different pre-treatment options, (D–E) centrifugal filter device methods with two different devices, (F) polyethylene glycol (PEG 8000) precipitation, and (G) ultracentrifugation, with the most efficient methods being adsorption-extraction methods with MgCl2 pre-treatment (Method C), and without pre-treatment (Method B). Ahmed notes that the recovery efficiencies for an enveloped virus such as SARS-CoV-2 can be different from those of nonenveloped enteric viruses because of significant structural differences between enveloped viruses and nonenveloped enteric viruses, and that a previous study highlighted the differences between detection of an enveloped virus and a nonenveloped virus in lake water, with such discrepancies potentially leading lead to large errors in the estimated presence and/or concentration of virus in an aqueous sample. La Rosa et. al. (La Rosa G, et. al. Water Res. 2020 Jul 15;179:115899. Epub 2020 Apr 28.) reviews detection of coronaviruses (CoVs) in water environments and discusses concentration methods for CoVs and other enveloped viruses. La Rosa describes that environmental detection depends on persistence, sample type, and concentration approach, notably that i) CoV seems to have a low stability in the environment and is very sensitive to oxidants, like chlorine; ii) CoV appears to be inactivated significantly faster in water than non-enveloped human enteric viruses with known waterborne transmission; iii) temperature is an important factor influencing viral survival (the titer of infectious virus declines more rapidly at 23C-25C than at 4C); iv) there is no current evidence that human coronaviruses are present in surface or ground waters or are transmitted through contaminated drinking-water; v) further research is needed to adapt to enveloped viruses the methods commonly used for sampling and concentration of enteric, non-enveloped viruses from water environments (abstract.) These data support that concentration and detection of coronavirus from liquid environmental samples was unpredictable and depended highly on the selected method.
Level of Skill in the Art. One of skill in the art at the time of filing would have been familiar with methods for using commercially-available dehumidifiers, collecting and concentrating condensate from dehumidifiers, and basic molecular biology techniques for analysis of the concentrated condensate. The specification leaves the skilled artisan to determine, through empirical testing, which combinations of sampling conditions, concentration methods, and assays will successfully detect not only SARS CoV-2 but any other virus in different defined areas. The ability to prepare and test samples from concentrated condensates does not establish that one skilled in the art would have known how to overcome the lack of guidance provided for in where to use the dehumidifier and how to collect and test the sample from the dehumidifier.
Working examples. The working example disclosed in the specification was limited and dealt with four portable dehumidifiers placed in select locations in a hospital ward, wherein condensate was collected at 24 or 48-hour intervals over about a week in viral transport medium (VTM), 50 mL samples were processed, and the samples were analyzed for SARS CoV-2 related spike (S) protein or RNA (¶[0052-0080]). The example was limited to one type of environment, one type of dehumidifier, and one “suspected” virus (SARS CoV-2). The reported results were not consistent. Some samples were shown to be positive by protein ELISA or LCNP nano-sensing, while RT-LAMP or RT-PCR failed to detect any SARS CoV-2 viral nucleic acid in the condensate samples. The specification states that RNA was detected in many samples after VTM was used, but RT-PCR and RT-LAMP still did not detect viral RNA. The specification also states that all samples were deactivated in a water bath set at 65° C. for 30 min, following which they were either stored at 4° C. for protein detection using a protein enzyme-linked immunosorbent assay (ELISA) kit or aliquoted and freeze-dried for RNA-based analysis employing commercially available RT-LAMP and reverse-transcription polymerase chain reaction (RT-PCR) kits (¶[0054]); it is unclear if this length of heat-inactivation possibly affected the stability of the viral proteins and/or RNA. Applicant suggests that their methods did not yield predictable results because of the extensive dilution of SARS CoV-2 beyond the limit of detection (LOD) of the assay used (¶[0060-0062][0072]).
The working examples only tested for the presence of SARS CoV-2 from one environment using one humidifier. No other locations were tested, no other humidifiers were used, no other viruses were sampled for in the condensates. It was unclear how factors affected the ability to detect any virus, as it does not appear as though control environments were tested for, nor were any other variables known to affect the outcome tested (e.g. closed rooms where a known amount of virus was introduced into the air, testing for enveloped vs. non-enveloped viruses, determining how air flow or exchange affected the ability for the virus to be tested, determining if different humidifiers produced different results, different VTMs, etc.) The working examples fail to provide reproducible methods for any of the claimed methods, even if the virus is limited to only SARS CoV-2, as there is insufficient guidance as to how to test for and control these variables that affect the outcome.
Guidance in the specification. The specification provides insufficient guidance for practicing the full scope of the claims. The specification identifies a preferred humidity range, a preferred room temperature, a preferred dehumidifier (LGR), and one hospital ward example. However, it fails to provide sufficient guidance for selecting dehumidifier size, number, or placement across different defined areas. It also does not provide sufficient guidance for determining minimum viral load, minimum condensate volume, required sampling time, or the assay sensitivity needed to detect SARS CoV-2 or different viruses. The specification fails to teach a skilled artisan how to reasonably adapt the system for use in other environments (e.g. school, home, office building, etc.) for detection of other viruses. The reliability of the methods claimed is questionable, as there is insufficient guidance how to adjust the operating parameters to achieve reliable virus detection across the full scope of the claims. It is unclear if a negative result means no virus was present, the virus was not captured, or if the virus was diluted below the assay LOD, as the appropriate controls were not performed. The unpredictability of the art is shown by Applicant’s explanation that actual condensate samples may have been too dilute for the methods of detection, even though spiked samples could be detected. This demonstrates that successful practice of the claimed method requires more than simply using a dehumidifier and testing the concentrated condensate.
Amount of experimentation necessary. Additional research is required in order to determine how effective the full scope of the methods would be in detecting any virus from any dehumidifier, wherein the condensate from any dehumidifier is concentrated in any fashion and then analyzed using any means. The undue experimentation a skilled artisan would have to undertake would minimally involve determining the appropriate dehumidifier type, number, and placement, determining what qualifies as an “area” and how often to test for samples in said area, determine what condensate volume should be collected and how it should be concentrated, determining whether VTM or another type of stabilization media or solution is needed, determining the recovery efficiency for each virus or biomarker, determining the proper detection assay, determining the limit of detection in the dehumidifier condensate, and validating the overall performance of detection in the defined analysis area.
The specification need not describe how to make and use every individual embodiment within the claimed scope. However, the specification must enable one skilled in the art to make and use the full scope of the claimed invention without undue experimentation. Amgen Inc. v. Sanofi, 598 U.S. 594, 610-13 (2023). In the instantly claimed invention, the sheer number of possible viruses that can be detected alone makes the amount of experimentation that is required to enable these claimed methods undue. Factor in the additional areas noted supra which require experimental and empirical testing, and the amount of work that a skilled artisan would have to undertake to enable the scope of the present claims is very large and extraordinarily undue.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
(New rejection.) 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), 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 Eli 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 1-20 are rejected as lacking adequate descriptive support for any method of collecting any bioaerosol particles with any dehumidifier, and collecting and concentrating the dehumidifier condensate to analyze said concentrate for the presence of any virus.
In support of the claimed genera (any virus, any bioaerosol particle, any dehumidifier, any method of timing/sampling/collection/concentration/detection, any location of collection), the application discloses one example in which a hospital ward is equipped with a specific type of humidifier and the condensate from said humidifiers is collected, concentrated, and analyzed using different means of detection. The methods have been summarized supra with the 35 USC 112a enablement rejection, and the scope of the claimed methods is beyond the methods, viruses, and locations which are encompassed by the scope of the broadly claimed genera. No other viruses aside from SARS CoV-2 were tested for using the method claimed. No other types of dehumidifiers were used, nor were any controls implemented to determine what variables should be controlled for with respect to the specific virus being detected. The claims are not merely limited to only hospital wards, but to any other perceivable area that could have a dehumidifier reasonably placed in said area. No specific viral load was tested for, nor was a particular volume of condensate or concentrated condensate optimized for in the claimed methods. None of the methods tested for appeared optimized for detection of SARS CoV-2 or any other virus.
The specification only generally states that any dehumidifier may be used to collect any airborne virus in any dehumidifier condensate and that samples from said condensate may be concentrated and analyzed for any viral biomarkers, including virions, viral nucleic acid, or viral proteins. However, as detailed supra, the specification only described placing four specific types of portable humidifiers in a specific hospital ward and testing for the presence of SARS CoV-2 using ELISA, LCNP nano-sensing, RT-LAMP, and RT-PCR.
The specification does not reasonably convey possession of collecting and detecting bioaerosol particles of any suspected virus from any defined area. The only pathogen tested for was SARS CoV-2. The specification does not provide representative examples from other viruses, including other coronaviruses, non-coronaviruses, other RNA viruses, other enveloped viruses, DNA viruses, or non-enveloped viruses, or any other virus reasonably considered to be aerosolized (e.g. influenza virus, respiratory syncytial virus, adenovirus, etc.) and possibly detected through such a method. The specification also does not provide representative examples for environments other than hospital wards, such as schools, residences, transportation modalities (e.g. trains, buses, airplanes, etc.), commercial facilities, shops, restaurants, outdoor areas, places of worship, or other mass-gathering locations.
The specification also does not reasonably convey possession of the claimed scope involving virus particles or biomarkers generally. The examples tested only looked at SARS CoV-2 S protein and SARS CoV-2 RNA. However, the breadth of the claims reasonably covers any biomarker of any virus, such as any viral genome, any viral protein, and any viral particle. The specification does not identify a representative number of biomarkers across the claimed genus, does not describe conserved structural features (e.g. protein affinity, charge, virion charge, virion size, virion stability, etc.) that would permit collection and detection of such biomarkers across the scope of the claims, and does not provide a correlation showing that capture of a SARS CoV-2 S protein or RNA in one hospital setting is representative of capture and analysis of other virus particles or biomarkers.
The disclosure is also inconsistent with possession of the claimed scope because the RNA-based methods did not detect SARS CoV-2 viral RNA in actual dehumidifier condensate samples. The specification states that RT-LAMP and RT-PCR did not detect viral RNA from actual condensate samples, even after addition of VTM, and attributes this to extensive dilution and/or sensitivity limitations. Accordingly, the disclosure fails to show that the inventors possessed a broadly applicable method for collecting, concentrating, and analyzing virus bioparticles or biomarkers from dehumidifier concentrate across the full scope of the claims.
Thus, in view of the above, there would have been significant uncertainty as to applicant being in possession of the full scope of the claimed invention at the time of filing.
Claim Rejections – 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1-20 under 35 U.S.C 103 as being unpatentable over Call, C., et. al. (US 20100255560; Published 10/07/2010) and Ensor, D. S., et. al. (US 20150024379; Published 01/22/2015), and in further view of McDevitt, J. J., et. al., (2013), Development and Performance Evaluation of an Exhaled–Breath Bioaerosol Collector for Influenza Virus, Aerosol Science and Technology, 47:4, 444–451 (Published 01/25/2013), hereby referred to as McDevitt, J. J., et. al. and Prather, K. A., et. al., (2020), Reducing Transmission of SARS–CoV–2, Science, 368, 1422–1424 (Published June 26, 2020; Cited in Applicant’s IDS submitted on 11/30/2023), hereby referred to as Prather, K. A., et. al., is withdrawn in light of the new rejection set forth herein.
(New rejection.) Claims 1-6, 8, 10-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Berger et. al. (US20220061823A1, Priority 08/31/2020; hereafter “Berger”); in view of
Pycke et. al. (US20160041138A1, Pub. 02/11/2016; hereafter “Pycke”);
Lednicky et. al. (Lednicky JA, et. al. Int J Infect Dis. 2020 Nov;100:476-482. Epub 2020 Sep 16.; hereafter “Lednicky”);
Moore et. al. (Moore B, Robinson R, Lisabeth K. “Member Blog: Condensate Recapture for Cannabis Cultivation Facilities – Making Informed Decisions to Save Resources and Improve Efficiency.” National Cannabis Industry Association (NCIA). https://thecannabisindustry.org/member-blog-condensate-recapture-for-cannabis-cultivation-facilities-making-informed-decisions-to-save-resources-and-improve-efficiency/. Pub. 01/27/2020; hereafter “Moore”); and
Guzman (US20150093304A1, Pub. 04/02/2015; hereafter “Guzman”).
The Prior Art
Berger teaches methods for collecting respiratory droplets and their contents from moisture, exhaled air, circulating air, and ambient air (entire document; see abstract, ¶[0012]). Berger teaches that the sources are aerosolized droplets trapped from the environment and the biological material can be adsorbed and concentrated, wherein an aqueous buffer can then be used to elute the droplets from the article to recover the aerosolized droplets for analysis (¶[0004]). Berger further teaches that a device of the invention may be a face mask or a filter in an air distribution system, dehumidifier, fan and the like (¶[0006]) and that the article may be shaped to filter air in an air purification system or an air conditioning system, such as a humidifier, dehumidifier, air exchanger, air cleaner, or HVAC system (¶[0076]).
Berger teaches that the material used may be any known material capable of collecting respiratory droplets (¶[0043]) and that the material may collect moisture directly from air so that respiratory droplets in the air are collected and recovered for analysis (¶[0043]). Berger teaches silica gel as an adsorbent or adsorbent material (¶[0043-0044]). Berger further teaches that the contents of respiratory droplets may be recovered from the material by elution using an aqueous buffer, such as saline or phosphate-buffered saline, and that the recovered droplets are coalesced into an aqueous phase for subsequent analysis (¶[0079]). Berger teaches that the detection system may be RT-PCR, or that isothermal methods of amplification, such as rolling circle amplification (RCA) or loop-mediated isothermal amplification (LAMP), may be used (¶[0087-0088][0100]; instant claims 11, 19). These detection methods can amplify the nucleic acid sequence of the virus, such as RNA (¶[0048][0087-0092]; instant claim 13). Berger teaches that the aerosolized droplets may comprise viral particles or biomarkers of viruses, such as biomarkers from SARS CoV-2 (¶[0038][0080][0094][0100-0101]; instant claims 3-4). Berger teaches the sensitivity of a given analytic method can be increased by increasing the amount of time the article is in contact with the source of droplets to be analyzed, leading to increased accumulation of the infectious agent and an opportunity to both detect the presence of the agent and/or to determine the rate and quantity of the infectious agent in the source of the droplets over time (¶[0042]; instant claims 5-6) and that quantitative PCR can provide the identity and copy number of the identified pathogen (¶[0087]).
While Berger teaches that bioparticles may be collected and analyzed using a dehumidifier, and teaches detection of SARS CoV-2 viral proteins and RNA using methods such as LAMP and RT-PCR, Berger does not expressly teach collecting the bioaerosol particles, especially particles in condensate of the dehumidifier. However, such methods were known in the art, as evidenced by the teachings of Pycke, Lednicky, Moore, and Guzman.
Pycke teaches generating an atmospheric condensate from air to be sampled, and collecting the atmospheric condensate in a collection vessel for subsequent use and analysis (entire document; see abstract.) Pycke teaches that the condensate may be generated through a heat exchange module, such as a cold trap or the cooling coils of an HVAC system (entire document; see abstract.) Pycke teaches the biological aerosols comprise at least one of the following: microorganisms in whole or in part, including viruses, bacteria, yeasts, fungi, Archaea, prions, DNA, RNA, organelles, eukaryotic cells, natural and genetically modified cells (reference claim 8; instant claim 3). Pycke teaches collecting the atmospheric condensate in a collection vessel and conducting an analysis of the atmospheric condensate (reference claim 1) wherein the clod trap that collects the atmospheric condensate may comprise solvent (reference claim 4) such as a buffered solution (reference claim 13). Pycke teaches sending the condensate to a laboratory for testing (¶[0040]; instant claim 2). Pycke teaches that the condensates were detected over the course of several days (¶[0037]; instant claim 5). Pycke teaches placing an optional preservative into the condensate (reference claims 23, 25) which would render obvious the use of preservative media known in the art, such as viral transport medium (VTM)(instant claims 12, 20).
Lednicky teaches collection and detection of airborne SARS CoV-2 from indoor air samples from a hospital room and demonstrates that viable virus and viral RNA may be recovered from aerosols present in occupied indoor environments (entire document; see abstract). Lednicky teaches that viable SARS-CoV-2 can be present in aerosols generated by a COVID-19 patient in a hospital room in the absence of an aerosol-generating procedure, and can thus serve as a source for transmission of the virus in this setting (p. 481, left col., ¶5). Lednicky teaches virus particles collected by various air samplers become inactivated during the air sampling process, and if such is the case for SARS-CoV-2, this partly explains why it had been difficult to prove that SARS-CoV 2 collected from aerosols is viable. Because when they previously attempted to collect SARS-CoV-2 from the air of a respiratory illness ward within a clinic but were unable to isolate the virus in cell cultures due to out-competition by other respiratory viruses, Lednicky sought to perform air sampling tests in a hospital room reserved for COVID-19 patients, to lessen the probability of collecting other airborne human respiratory viruses. Lednicky collected aerosols containing SARS-CoV-2 in a room housing COVID-19 patients using VIVAS air samplers that collect virus particles without damaging them, thus conserving their viability, wherein the samplers operate using a water vapor condensation mechanism (p. 477, rt. Col., ¶2). Lednicky teaches the samplings were taken every 3 hours (“Methods: Air samplers and sampling parameters”, p. 478; instant claim 5). SARS-CoV-2 genomic RNA (vRNA) was collected in collection media, and vRNA was extracted from virions in collection media and tested using RT-PCR (“Methods: SARS-CoV-2 genomic RNA (vRNA) in collection media vRNA was extracted from virions in collection media”, p. 478; instant claims 3-4, 11, 13, 19). Lednicky teaches the SARS CoV-2 genomes in the sample air were quantified (“Methods: Quantification of SARS-CoV-2 genomes in sampled air”; p. 478; instant claim 6).
Moore teaches condensate capture for reuse is an intriguing new application within the controlled environment horticulture space (¶1) and that with adequate monitoring and treatment, risks may be greatly reduced, maximizing the benefit of capturing and using condensate (item 3, ¶3). Moore teaches airborne bacteria, viruses, and fungal spores can be introduced to a condensate water system through its condenser plates (“Microbes and Organics”, ¶5). Moore therefore teaches that dehumidification systems generate condensate from processed air, and that condensate may serve as a collection medium for airborne particulates and biological materials present in the air stream, such as viruses. Moore further teaches recovery and analysis of materials present in the condensate generated by air-handling equipment (¶9). Moore teaches that dehumidification systems generate condensate water in controlled environment facilities. Conducting collection under ordinary indoor humidity and room-temperature conditions would have been obvious, especially noting Lednicky from above collecting samples from an occupied hospital room, and that Moore teaches condensate generation by dehumidification/HVAC systems in controlled indoor environments, therefore rendering the limitations of instant claims 10, 14, and 18 obvious.
Guzman teaches that affinity ligands or receptors can be immobilized directly to the surface of the inner cavity or channel of an analyte concentrator-microreactor device, and that the device can capture viruses or RNA present in small or large volumes of a biological fluid (entire document; see abstract; ¶[0029][0034][0048].) Guzman teaches affinity microcolumns as known analyte concentration devices that can be used in their devices (¶[0013]; instant claims 8, 15). Guzman further teaches analyte concentrator systems containing immobilized affinity ligands that facilitate isolation, enrichment, purification, concentration, detection, quantification, and characterization of analytes from biological fluids (¶[0003][0013-0014][0030]; instant claim 6).
Given the teachings noted supra, it would have been obvious to one of ordinary skill in the art to modify the aerosolized respiratory droplet system of Berger to collect airborne viral material in condensate generated by a dehumidifier, as taught by Pycke and Moore, and to analyze the collected viral material, as taught by Berger and Lednicky. It further would have been obvious to provide an affinity microcolumn for collecting and concentrating RNA, viral materials, or viral particles before analysis, as taught by Guzman, because affinity-based concentration was a known method for isolating, enriching, and purifying low-abundance analytes, including viruses, from fluid samples. This combination of teachings from Berger, Pycke, Moore, Lednicky, and Guzman therefore render obvious the limitations of instant claims 1-6, 8, 10-15, and 18-20.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Berger in order to collect and test the condensate from environmental manipulation systems, such as HVACs or dehumidifiers, thereby determining if a pathogen was present in the environment. One would have been motivated to do so, given the suggestion by Moore that dehumidifier condensate could be tested for the presence of viruses, and given that Lednicky teaches testing hospital rooms for the presence of airborne viruses, such as SARS CoV-2, and Pycke teaches testing condensates from environmental manipulation systems for the presence of viruses. There would have been a reasonable expectation of success, given the knowledge that isolation and concentration of viruses from liquid samples was known in the art, as taught by Guzman and Lednicky, and also given the knowledge that affinity microcolumns were used for such concentration, as taught by Guzman. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
(New rejection.) Claims 7, 9, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Berger, Pycke, Lednicky, Moore, and Guzman as applied to claims 1-6, 8, 10-15, and 18-20 above, and further in view of Dri-Eaz (Owner’s Manual EVOLUTION™ LGR Dehumidifier: 115v Model. https://manuals.interlinksupply.com/Dri-Eaz/EvolutionManual.pdf. 2007.; hereafter “Dri-Eaz”) and Daniels (US20210325279A1; Priority 05/23/2020; hereafter “Daniels”).
The Prior Art
The teachings of Berger, Pycke, Lednicky, Moore, and Guzman have been set forth supra. While in combination, these references teach the majority of the instant claims, they fail to teach the specific types of dehumidifiers that can be used or the use of rapid flow ELISA testing to detect an analyte in the sample (also known as lateral flow assays, LFAs, or Rapid Tests). However, such optimization steps were known in the art and would be obvious to a skilled artisan, as evidenced by the teachings of Dri-Eaz and Daniels.
Dri-Eaz teaches their LGR refrigerant dehumidifiers operate by pulling moist air in across a very cold evaporator core. The moisture condenses (freezes) on the coil. At intervals, the machine will go into defrost mode, warming the frost back to water. The water collects in a tray and leaves the unit through a drain hose or pump (p. 2). Dri-Eaz teaches their dehumidifiers warm the air as they remove moisture. Optimal drying temperatures range from 68-85° F (20-29° C) (p. 3). Dri-Eaz teaches that a contained receptacle can be used to collect the dehumidifier condensate (p. 3).
Daniels teaches a mask-based testing system for detecting a biomarker received from lungs and airways of a test subject includes an exhaled breath condensate (EBC) collector integrated into an inside of a face mask worn by the test subject (entire document; see abstract.) Daniels is therefore collecting airborne particles and testing fluid biosamples (entire document; see abstract.) Daniels teaches that lateral flow assays can be used to detect the target biomarker (¶[0007-0008][0157-0158][0171]; Figs. 1-2.)
Given the teachings of Dri-Eaz in view of the teachings of Berger, Pycke, Lednicky, Moore, and Guzman, it would be obvious to arrive at the limitations of instant claims 7 and 16 as Dri-Eaz teaches known types of portable humidifiers, such as LGR humidifiers, were known in the art and would be obvious to use, especially given the teachings of Moore or Berger. Given the teachings of Daniels in view of the teachings of Berger, Pycke, Lednicky, Moore, and Guzman, it would be obvious to arrive at the limitations of instant claims 9 and 17, as Berger, Moore, Pycke, Lednicky, and Guzman all teach known methods of detection of biological particles known in the art, and LFA were obvious assays to perform to rapidly detect protein, or even nucleic acid such as RNA in specific formats. Regardless, optimization of the teachings of Berger, Pycke, Lednicky, Moore, and Guzman to arrive at the limitations of instant claims 7, 9, and 16-17 would be routine, especially given the teachings of Dri-Eaz and Daniels.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Berger, Pycke, Lednicky, Moore, and Guzman in order to use specific types of detection assays or humidifiers. One would have been motivated to do so, given the suggestion by Dri-Eaz that their dehumidifier was portable and offered a variety of means to collect the condensate removed from the dehumidified area. There would have been a reasonable expectation of success in using LFA to detect the presence of viral proteins, given the knowledge that LFA were known and used in the art for viral detection, especially from respiratory aerosol liquids, as taught by Daniels. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and is listed below.
Sousan S, et. al. Am J Infect Control. 2022 Mar;50(3):330-335. Epub 2021 Oct 22. Post-filing art related to the technology of detection of aerosol pathogens, including viruses, in HVAC condensates.
Ratnesar-Shumate S, et. al. Aerosol Sci Technol. 2021 Apr 19;55(8):975-986. Teaches testing aerosols bearing infectious agents, namely SARS CoV-2. Post-filing art related to the instant invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN can be reached on 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RACHEL B GILL/
Primary Examiner, Art Unit 1671
Prosecution Insights