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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Withdrawn Objections/Rejections
The objection to claim 19 is withdrawn in response to the amendments.
The rejection of claims 1-3 and 16-19 under 112b is withdrawn in response to the arguments and amendments; namely the new limitation, “a sample collection device”, provides sufficient structure to the 112(f) claim interpretation of “the system further configured to…”; and the remark that the recited “LFA” is “is a known device” (page 8 para. 5) clarifies the scope of the term.
The rejection of claims 1-4 and 16-20 under 102 are withdrawn in response to the amendments. However, new grounds of rejection are set forth below under 103.
Priority
The present application claims benefit under 35 U.S.C. 119(e) to provisional application 63/480,238 filed on 1/17/2023.
Status of the Claims
Claims 1-4 and 16-20 are pending; claims 1, 16 and 19-20 are amended, claims 5-15 are canceled. Claims 1-4 and 16-20 are examined below
New Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“the system configured to: collect a sample from the hydrogen storage reservoir using the sample collection device; add one or more biomarker indicators to the sample using the biomarker indicator addition device, wherein the one or more biomarkers target specific proteins/enzymes unique to hydrogenotrophic microorganisms; and analyze the sample using the testing device to determine whether the sample contains one or more deleterious microorganisms” in claim 1. The generic placeholder is the “system”, the functional language is “configured to” and the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function (collecting, adding and analyzing).
“prepare the sample for spectrophotometry; analyze the prepared sample using the spectrophotometer; and determine whether the sample contains the one or more deleterious microorganisms based on a result from the spectrophotometer” in claim 3. The generic placeholder is the “system” (recited in claim 1), the functional language is “configured to” (recited in claim 1) and the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function (preparing, analyzing and determining).
“responsive to determining that the sample contains the one or more deleterious microorganisms, determine an amount of the one or more deleterious microorganisms in the sample” in claim 4. The generic placeholder is the “system” (recited in claim 1), the functional language is “configured to” (recited in claim 1) and the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function (determining).
“the system further configured to: collect a sample from the hydrogen reservoir using the sample collection device; apply a first portion of the sample to the sandwich LFA to test the sample; receive a first result from the sandwich LFA; add one or more biomarker indicators to a remaining portion of the sample using the biomarker indicator addition device, wherein the one or more biomarkers target specific proteins/enzymes unique to hydrogenotrophic microorganisms; analyze the remaining portion of the sample using the testing device to determine a second result of whether the sample contains one or more deleterious microorganisms; and combine the first result from the sandwich LFA and the second result from the testing device to form a comprehensive test result” in claim 16. The generic placeholder is the “system”, the functional language is “configured to” and the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function (collecting, adding, analyzing and combining).
“prepare the remaining portion of the sample for spectrophotometry; analyze the prepared remaining portion of the sample using the spectrophotometer; and determine whether the remaining portion of the sample contains the one or more deleterious microorganisms based on a result from the spectrophotometer” in claim 18. The generic placeholder is the “system” (recited in claim 16), the functional language is “configured to” (recited in claim 16) and the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function (preparing, analyzing and determining).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding claim 1,
The system’s structure configured to collect a sample from a hydrogen storage reservoir is interpreted as a drill-type device that extends into the subsurface to probe a sample, disclosed as “a sample collection device 204” (para. 20). The general description is shown in Figure 2.
The system’s structure configured to add one or more biomarkers indicators to the sample using the biomarker indicator addition device, wherein the one or more biomarkers target specific proteins/enzymes unique to hydrogenotrophic microorganisms is interpreted as a pipette-type device (“In some embodiments, biomarker addition 320 may be an automated biomarker addition device. In some other embodiments, biomarker addition 320 may be a manual process. In yet some other embodiments, biomarker addition may be by any suitable device or method as would be known to a person of skill in the art” para. 24).
The systems’ structure configured to analyze the sample using the testing device to determine whether the sample contains one or more deleterious microorganisms is interpreted as a optical-based reader (“testing device 330” see Figure 3).
Regarding claim 3, the system’s structure configured to prepare the sample for spectrophotometry; analyze the prepared sample using the spectrophotometer; and determine whether the sample contains the one or more deleterious microorganisms based on a result from the spectrophotometer” is interpreted as being inherent from the optical-based reader. In other words, an optical-based reader prepares the sample for analysis and delivers a result.
Regarding claim 4, the system’s structure configured to determine an amount of the one or more deleterious microorganisms in the sample is interpreted as being inherent to the optical-based reader. In other words, the result of the optical-based reader provides the amount determination claimed.
Regarding claim 16,
The system’s structure configured to collect a sample from the hydrogen reservoir using the sample collection device is interpreted as a drill-type device that extends into the subsurface to probe a sample, disclosed as “a sample collection device 204” (para. 20) see Figure 2.
The system’s structure configured to apply a first portion of the sample to the sandwich LFA to test the sample microorganisms is interpreted as a pipette-type device (para. 24).
The systems’ structure configured to receive a first result from the sandwich LFA is interpreted as a type of result window in test strip devices (“The top section 402A also includes a result window 408” see Figure 4)
The systems’ structure configured to add one or more biomarker indicators to a remaining portion of the sample using the biomarker indicator addition device, wherein the one or more biomarkers target specific proteins/enzymes unique to hydrogenotrophic microorganisms is interpreted as a pipette-type device (para. 24).
The systems’ structure configured to analyze the remaining portion of the sample using the testing device to determine a second result of whether the sample contains one or more deleterious microorganisms; and combine the first result from the sandwich LFA and the second result from the testing device to form a comprehensive test result is interpreted as being inherent from the optical-based reader. In other words, the optical-based reader would combine the result from the test strip and the result from its optical-based reading of the test strip in order to form a comprehensive test result.
Regarding claim 18, the system’s structure configured to prepare the remaining portion of the sample for spectrophotometry; analyze the prepared remaining portion of the sample using the spectrophotometer; and determine whether the remaining portion of the sample contains the one or more deleterious microorganisms based on a result from the spectrophotometer is interpreted as being inherent from the optical-based reader. In other words, an optical-based reader prepares the sample for analysis and delivers a result.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 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.
Claim limitation “responsive to determining that the sample contains the one or more deleterious microorganisms, determine an amount of the one or more deleterious microorganisms in the sample” in claim 4, is unclear. The limitation can be interpreted in multiple ways. The limitation may be interpreted as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Specifically, “responsive to determining that the sample contains the one or more deleterious microorganisms” can be interpreted to be referring to the system configuration of claim 1 lines 10-11. However, the limitation “responsive to determining that the sample contains the one or more deleterious microorganisms” may be interpreted as separate from the system configuration of claim 1 lines 6-11 given that there is no “wherein” clause linking the limitation to the system configuration as in claim 3. Therefore, for at least this reason, the claim is indefinite because a person having ordinary skill in the art would not be able to recognize the metes and bounds of the claim.
Claim 4 recites “[t]he system of claim 2, further comprising: responsive to determining that the sample contains the one or more deleterious microorganisms, determine an amount of the one or more deleterious microorganisms in the sample”. The limitation “determine an amount of the one or more deleterious microorganisms in the sample” reads on a method step. Given that claim 4 is to a system, i.e. a product, and recites method steps, the claim is indefinite. “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)” (MPEP 2173.05(p)II.). A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim because it is not clear if the claim is a product or a process.
Claim 20 recites “wherein the sandwich LFA further comprises: a panel of targets, wherein the panel of the targets comprises a plurality of sandwich LFAs, and wherein each sandwich LFA of the plurality of sandwich LFAs contains a different target than each other sandwich LFA of the plurality of sandwich LFAs”. However, it is not clear what is meant by “the panel of the targets”. This limitation seems to refer to the “panel of targets” however, “the panel of the targets” can also be interpreted as referring to individual targets and their “panel”, which is not clear. Furthermore, it is not clear how an LFA can comprise a panel of targets wherein the panel of the targets comprises a plurality of LFAs. How can an LFA device comprise a plurality of LFA devices? A person having ordinary skill in the art would be confused by the language of claim 20, and would not recognize the metes and bounds of the claim.
New Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Propper et al. (US 20130280698 A1)-Cite No. A of PTO-892 4/28/2026 (“Propper”) in view of Schwab et al. (2022) Int. J. Hydrog. Energy 47 (47), 20684 – 20694 http://dx.doi.org/10.1016/j.ijhydene.2022.04.170 (“Schwab”).
Regarding claim 1, Propper teaches “rapid multiplex lateral flow assay device” (Title). Propper further teaches a system for detecting deleterious microbial activity in hydrogen reservoirs (“Disclosed herein are devices, systems and methods for simultaneously conducting multiple assays on a liquid sample for the presence of, and/or quantification of, analytes in the liquid sample” Abstract, “ The cartridge device, system and method of the invention may be used in a variety of situations wherein a rapid diagnostic panel of tests that relies on testing liquids is desirable” para, 17, “Non-limiting examples of situations or environments wherein such rapid diagnostics are desirable include water testing in the field … such as to monitor industrial processes” para. 20, “Non-limiting examples of analytes which may be tested using devices, systems and methods of the invention include…water…For example, an environmental water sample obtained from a natural body of water, tap water, a water treatment facility, etc. may be tested for various components and/or conditions, such as pH, chemicals, microbes e.g., algae, bacteria, fungi , viruses), hormones,…” para. 21). Note that the limitation of “for detecting deleterious microbial activity in hydrogen reservoirs” merely describes the intended purpose of the claimed system and thus does not impart a limiting effect to the claimed system. Therefore, this limitation is not required to be explicitly taught by Propper in order to anticipate the claim. Nevertheless, it is expected that the system taught by Propper, would be capable of detecting deleterious microbial activity in hydrogen reservoirs given that Propper teaches that the system may detect microbes in water reservoirs and in industrial processes. Propper further teaches the system comprising: a sample storage device (“natural body of water…a water treatment facility, etc.” para. 21). Note that although Propper fails to use the language “sample storage device” the teaching of a “natural body of water” and/or “water treatment facility” inherently provides a sample storage device because a body of water is reasonable interpreted as a device that stores water and a water treatment facility contains water tanks, i.e. a sample storage device, for the treatment of the water. Note that the specification fails to clearly define a sample storage device, thus using the broadest reasonable interpretation in light of the specification, the “natural body of water” and/or the “water treatment facility” inherently anticipates the sample storage device claimed. Note also that the specification suggests that a sample storage device is a natural reservoir or an industrial treatment facility (“Geological, or subsurface, storage facilities store inventory of liquid or gaseous fuels underground under pressure. The most common storage facilities are depleted reservoirs located at natural gas and oil fields, saline aquifers, and subterranean salt caverns. Geological storage is a possible option to store large quantities of hydrogen” para. 4, “Currently hydrogen storage is in early stages of exploration” para. 12, “hydrogen in storage facilities” para. 19). Propper further teaches a biomarker indicator addition device (“The liquid sample may be introduced using a pipette” para. 59). Note that although Propper fails to use the language “a biomarker indicator addition device” the teaching of a pipette inherently provides a biomarker indicator addition device because a pipette is capable of adding biomarker indicators. Note that the specification fails to define a biomarker indicator addition device. Given that the specification suggests that “enzymes” are an example of biomarker indicators (“the biomarker indicators specific to the biomarkers such as enzymes” para. 27), the pipette taught by Propper effectively anticipates the biomarker indicator addition device because a pipette is an adequate tool for adding enzymes. Propper further teaches a testing device (“The assay results may be identified via viewing with the human eye, or via an optical image collected from the reader device. The reader device can be any type of automated reader, but is preferably a opto-electronic reader. Still more preferably, the reader device is hand-held and portable” para. 5. “a reader for use with the devices (cartridges) of the invention. The reader is a portable electronic assay reader data logger, and interpretation interface. The technology platform is designed to provide the user with a near real-time, cost-effective method for water sample analysis for multiple analytes, database building, and contaminant areal mapping” para. 88). Propper teaches the system further configured to: add one or more biomarker indicators to the sample using the biomarker indicator addition device, wherein the one or more biomarkers target specific proteins/enzymes unique to hydrogenotrophic microorganisms (“The liquid sample may be introduced using a pipette” para. 59); and analyze the sample using the testing device to determine whether the sample contains one or more deleterious microorganisms (para. 5, “The invention provides a way for the user to simultaneously test a single sample of whatever fluid is to be analyzed, via multiple assays. The assays used will depend upon the particular chemicals, biological components (e.g., antibodies), etc. that the user is seeking to determine whether the sample contains” para. 17 and para. 21). Propper further teaches that the system can be used for “environmental monitoring, contamination site management decision, remediation technology performance monitoring, and multiple site/multiple remediation technology comparisons” (para. 4 and 20-21).
Propper fails to teach a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings and the system further configured to: collect a sample from the hydrogen storage reservoir using the sample collection device.
Schwab teaches “[s]tructural analysis of microbiomes from salt caverns used for underground gas storage” (Title). Schwab further teaches that hydrogen reservoirs are needed to store energy surplus from sustainable solar and wind plants (“Power to gas, the electrochemical conversion of excess energy from solar and wind plants into hydrogen (H2), is a promising concept that requires large-scale underground gas storage (UGS)” page 4 para. 1, “This study was conducted to investigate the microbiomes of five different salt caverns which are used for natural gas storage, but regarded as potential storage site for green H2. Various eco-physiologically different microorganisms can consume H2 as an energy source [36]. It is therefore essential to study the microbiome inhabiting the storage site, as this allows for assessment of possible biogeochemical effects during H2 storage. In the following sections the characteristics of salt caverns as a microbial habitat and their microbiome itself are discussed” page 14 para. 2). Schwab further teaches that salt caverns are used to store hydrogen and that indigenous hydrogenotrophic microbes need to be studied to evaluate possible deleterious activity (“More research on the structure and putative functions of indigenous microbiomes of underground reservoirs is important to assess the prospects and challenges of future H2 UGS” bridge paragraph pages 4-5, “Salt caverns are considered as promising option for storing large quantities of hydrogen in the underground due to their specific geological conditions and inertness to chemical reactions as well as for economic reasons (Zivar et al., 2020). Notably, cell numbers as well as structures and functions of microbiomes of subsurface salt formations are poorly investigated; such information is essential to evaluate possible biogeochemical effects caused by microorganisms in salt caverns upon long-term hydrogen storage” page 18 para. 2). Schwab further teaches a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings and the system further configured to: collect a sample from the hydrogen storage reservoir using the sample collection device (“a high-pressure air lock (Figure 1A) was installed for measurements and sampling. …The sampling device was inserted with the valves closed. After immersion into the brine the bottles were opened, left there for roughly 60 minutes to be flooded with brine and slowly recovered, the valves still being open…The liquid was transferred to N2 flushed bottles and sealed” page 6). Schwab further teaches analyzing the sample using a testing device to determine whether the sample contains one or more deleterious microorganisms (“Determination of total cell counts Microbial cell numbers were determined immediately after sampling by staining with 4’6-diamidino-2-phenylindole (DAPI)…analyzed using Imager.Z2 (Carl Zeiss Microscopy GmbH, Jena, Germany)” bridge paragraph pages 7-8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Propper to include a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings and to configure the system to collect a sample from the hydrogen storage reservoir using the sample collection device taught by Schwab because Schwab teaches that this enables the testing for deleterious microbial activity of hydrogenotrophic microorganisms in natural reservoirs and Proper is interested in analyzing microbes from environmental samples such as natural reservoirs. One would be motivated to make such a modification because Schwab suggests that hydrogen storage reservoirs and their proper maintenance is important for green energy storage and for economic reasons. A person having ordinary skill in the art would have had a reasonable expectation of success because both Proper and Schwab teach systems configured to analyze microbes in liquid samples for environmental monitoring of natural reservoirs.
Regarding claim 2, Propper in view of Schwab teach the system of claim 1 as discussed above.
Propper in view of Schwab further teach wherein the testing device further comprises a spectrophotometer (“via color change in the visible light spectrum” para. 19 of Propper, “instances, the assay results are not visible to the naked eye, and therefore must be "read" using a reader machine, such as one that picks up fluorescent signals, infrared signals, etc.” para. 79 of Propper, “camera, which takes a high resolution color image of the assay strips” para. 81 of Propper). Note that although Propper fails to use the language “spectrophotometer” the teaching of using a reader to analyze the color change in the visible spectrum using a color image and signals from different parts of the electromagnetic spectrum, inherently provides a spectrophotometer because a spectrophotometer measures light at different colors. Note that Schwab also suggests wherein the testing device further comprises a spectrophotometer (“concentrations were determined by spectral photometry” page 8 para. 2).
Regarding claim 3, the claim is interpreted as inherently provided by the system’s testing device and thus not required to be explicitly taught by the prior art in order to anticipate the claim (see 112(f) claim interpretation above).
Nevertheless, Propper in view of Schwab teach the system of claim 2 as discussed above.
Propper in view of Schwab further teach wherein analyze the sample using the testing device to determine whether the sample contains the one or more deleterious microorganisms further comprises: prepare the sample for spectrophotometry (“Then, the liquid to be analyzed (e.g., water, blood, urine, etc.) is introduced into the device 1 via the sample inlet 2. The liquid sample may be introduced using a pipette, dropper, syringe, or other suitable means. The liquid sample then travels to the diversion dam 10” para. 59 of Propper); analyze the prepared sample using the spectrophotometer; and determine whether the sample contains the one or more deleterious microorganisms based on a result from the spectrophotometer (“Data Collection: The reader uses a high resolution digital camera to capture assay results ( see below)” para. 94 of Propper, para 21 of Propper).
Regarding claim 4, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the 112(f) limitations (all the claim limitations) are interpreted as inherently provided by the system and thus not required to be explicitly taught by the prior art in order to anticipate the claim (see 112(f) claim interpretation above).
Nevertheless, Propper in view of Schwab teach the system of claim 2 as discussed above.
Propper in view of Schwab further teach responsive to determining that the sample contains the one or more deleterious microorganisms, determine an amount of the one or more deleterious microorganisms in the sample (“and/or quantification of, analytes in the liquid sample” Abstract of Propper).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Propper et al. (US 20130280698 A1)-Cite No. A of PTO-892 4/28/2026 (“Propper”) in view of Schwab et al. (2022) Int. J. Hydrog. Energy 47 (47), 20684 – 20694 http://dx.doi.org/10.1016/j.ijhydene.2022.04.170 (“Schwab”) and Cytiva “Sandwich or competitive format: which is right for your LFA?” May 2, 2022 (retrieved online https://www.cytivalifesciences.com/en/us/insights/lateral-flow-assay-format-sandwich-or-competitive on 9/15/2026).
Regarding claim 16, Propper teaches “rapid multiplex lateral flow assay device” (Title). Propper further teaches a system for detecting deleterious microbial activity in hydrogen reservoirs (Abstract, para, 17, para. 20, para. 21). Propper further teaches the system comprising: a sample storage device (para. 21). Propper further teaches a biomarker indicator addition device (para. 59). Propper further teaches a testing device (para. 88). Propper further teaches a Lateral Flow Assay (LFA) (Title, “A first embodiment of the device is a disposable cartridge comprising two or more different assays” para. 25, “Numerical information is extracted from the images of the individual test strips for analysis” para. 94). Propper teaches the system further configured to: apply a first portion of the sample to the LFA to test the sample; receive a first result from the LFA; add one or more biomarker indicators to the sample using the biomarker indicator addition device, wherein the one or more biomarkers target specific proteins/enzymes unique to hydrogenotrophic microorganisms (“Each assay chamber 30 may further comprise an assay viewing window 4 in the housing” para. 47, “The liquid sample may be introduced using a pipette” para. 59) analyze the remaining portion of the sample using the testing device to determine a second result of whether the sample contains one or more deleterious microorganisms; and combine the first result from the LFA and the second result from the testing device to form a comprehensive test result (“environmental monitoring, contamination site management decision, remediation technology performance monitoring, and multiple site/multiple remediation technology comparisons” paras. 4-5 and 20-21).
Propper fails to teach a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings, a sandwich LFA and the system further configured to: collect a sample from the hydrogen storage reservoir using the sample collection device.
Schwab teaches “[s]tructural analysis of microbiomes from salt caverns used for underground gas storage” (Title). Schwab further teaches that hydrogen reservoirs are needed to store energy surplus from sustainable solar and wind plants (page 4 para. 1, page 14 para. 2). Schwab further teaches that salt caverns are used to store hydrogen and that indigenous hydrogenotrophic microbes need to be studied to evaluate possible deleterious activity (bridge paragraph pages 4-5, page 18 para. 2). Schwab further teaches a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings and the system further configured to: collect a sample from the hydrogen storage reservoir using the sample collection device (page 6). Schwab further teaches analyzing the sample using a testing device to determine whether the sample contains one or more deleterious microorganisms (bridge paragraph pages 7-8).
Cytiva teaches “Sandwich or competitive format: which is right for your LFA? (Title). Cytiva teaches that “There are two main formats…The first type of LFA assays is a non-competitive, or sandwich test. It’s used for macromolecular analytes with two antigen binding sites: it has binders that attach to the target and do not interfere with each other. If the target is present in the sample, there will be an increase in the signal at the test line. A well-known example of a sandwich test is a pregnancy test” (page 2 paras 6-7). Cytiva further shows “an Illustration showing how a sandwich LFA works” (Fig. 2 page 3). Cytiva further teaches that “The sandwich format is more favored towards larger molecular weight analytes, as experience shows it does not work as well for smaller molecular weight substances” (page 3 para. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Propper to include a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings and to configure the system to collect a sample from the hydrogen storage reservoir using the sample collection device taught by Schwab because Schwab teaches that this enables the testing for deleterious microbial activity of hydrogenotrophic microorganisms in natural reservoirs and Proper is interested in analyzing microbes from environmental samples such as natural reservoirs. One would be motivated to make such a modification because Schwab suggests that hydrogen storage reservoirs and their proper maintenance are important for green energy storage and for economic reasons. A person having ordinary skill in the art would have had a reasonable expectation of success because both Proper and Schwab teach systems configured to analyze microbes in liquid samples for environmental monitoring of natural reservoirs.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Propper in view of Schwab to rely on the sandwich LFA taught by Cytiva because Cytiva teaches that this type of LFA is optimal for larger analytes, and Propper in view of Schwab is interested in using LFA devices for analyzing larger analytes such as microbes. A person having ordinary skill in the art would have had a reasonable expectation of success because Cytiva teaches that the sandwich LFA technique is one of two types of LFA techniques available and shows a figure illustrating its principle.
Regarding claim 17, Propper in view of Schwab and Cytiva teach the system of claim 16 as discussed above.
Propper in view of Schwab and Cytiva further teach wherein the testing device further comprises a spectrophotometer (para. 19 of Propper, para. 79 of Propper, para. 81 of Propper). Note that Schwab also suggests wherein the testing device further comprises a spectrophotometer (page 8 para. 2).
Regarding claim 18, the claim is interpreted as inherently provided by the system’s testing device and thus not required to be explicitly taught by the prior art in order to anticipate the claim (see 112(f) claim interpretation above).
Nevertheless, Propper in view of Schwab and Cytiva teach the system of claim 17 as discussed above.
Propper in view of Schwab and Cytiva further teach wherein analyze the sample using the testing device to determine whether the sample contains the one or more deleterious microorganisms further comprises: prepare the sample for spectrophotometry (para. 59 of Propper); analyze the prepared sample using the spectrophotometer; and determine whether the sample contains the one or more deleterious microorganisms based on a result from the spectrophotometer (para. 94 of Propper, para 21 of Propper).
Regarding claim 19, Propper in view of Schwab and Cytiva teach the system of claim 16 as discussed above.
Propper in view of Schwab and Cytiva further suggest wherein the LFA further comprises: a case (Title, paras. 35-36 of Propper), the case further comprising: a bottom section; a top section (para. 42 of Propper); and a sample port (para. 37 of Propper) and a result window disposed in the top section (para. 47 of Propper); a test strip disposed within the case (para. 56 of Propper), the test strip further comprising: a primary detector (para. 104 of Propper); a test line (para. 81 of Propper); and a control line (para. 81 of Propper), wherein: the test line and the control line configured to bind a target antigen; and the test line and the control line disposed to be visible through the sample port (para. 104, para. 47, see Figures 10 and 13 of Propper).
Regarding claim 20, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the claims is interpreted as reciting “wherein the system further comprises: thereby forming a panel of targets”.
Propper in view of Schwab and Cytiva teach the system of claim 16 as discussed above.
Propper in view of Schwab and Cytiva further suggest wherein the sandwich LFA further comprises: a panel of targets, wherein the panel of the targets comprises a plurality of sandwich LFAs, and wherein each sandwich LFA of the plurality of sandwich LFAs contains a different target than each other sandwich LFA of the plurality of sandwich LFAs (Title, “rapid diagnostic panel of tests” para. 17, “each cartridge device 11 is comprised of only one assay, and multiple cartridges 11 may be joined together ( either by the user or may be pre-joined together) to essentially create a custom analysis tool comprising multiple different types of assays to test for the presence of a variety of different analytes. In other words, each cartridge would have its own housing 33 contain an assay for a particular analyte, and two or more cartridges of the desired assays could be joined together to form a user-defined suite of tests.” para. 64, see cover Figure of Propper).
Response to Arguments
Applicant's arguments filed 8/21/2026 have been fully considered but they are not persuasive.
Regarding the 112b rejection of claims 4 and 20,
Applicant argues that “Dependent claims 2-4 ultimately depend from independent claim 1 and claims 17-20 ultimately depend from independent claim 16 and therefore, Applicant asserts that dependent claims 2-4 and 17-20 are allowable by virtue of their dependency on allowable independent claims” (page 9 para. 2).
However, although the claims are dependent from claims 1 and 16, the claims must still be definite. In this case, Applicant has not addressed the 112b issues of claims 4 and 20 specifically. Briefly, claim 4 is indefinite because it is unclear whether the claim invokes 112(f) or not, and because it reads on method steps. Claim 20 is indefinite because it recites sandwich LFAs comprising sandwich LFAs, which is unclear (see rejection above for the complete analysis).
Regarding the prior art rejections,
Applicant argues that “Applicant respectfully asserts that Propper does not disclose the features of claim 1…Notably, Propper does not appear to disclose, and makes no mention of, hydrogen reservoirs or biomarkers to target specific proteins/enzymes unique to hydrogenotrophic microorganisms. Further, nothing in Propper is drawn to collecting a sample from a hydrogen reservoir using a sample collection device” (page 9 para. 4 and page 10 para. 1).
However, new grounds of rejection are set forth above over Propper in view of Schwab. Schwab is relied upon for the teachings of a sample collection device configured to draw one or more samples from a hydrogen storage reservoir, wherein the one of more samples include at least one of a fluid sample or a rock cuttings. In this case, although Propper fails to use the language “hydrogen reservoirs”, given that Propper contemplates environmental monitoring of liquid samples, the system taught by Propper, in combination with the teachings of Schwab, addresses claim 1. Note that “biomarkers to target specific proteins/enzymes unique to hydrogenotrophic microorganisms” is a limitation directed to the biomarker indicator addition device’s configuration of the system, which is interpreted as being an inherent feature of the biomarker indicator addition device (see 112f claim interpretation above). In short, the claim invokes 112(f) and the structure, material or act that performs the given function of adding biomarker indicators to the sample using the biomarker indicator addition device is a pipette-type device as per the specification paragraph 24. Therefore, a pipette would be capable of adding any type of biomarker indicator to the sample, or enable the system’s configuration to add the biomarker indicators claimed, because a pipette functions by moving liquid samples that are capable of containing any type of biomarker indicator in it, including those that target specific proteins/enzymes unique to hydrogenotrophic microorganisms. Note also that the claimed system, as currently recited, is not limited to biomarker indicators. Therefore, Applicant’s arguments are not persuasive.
Applicant further argues that “Independent claim 16 presents subject matter similar to the subject matter presented in independent claim 1 and similarly distinguishes over Propper for at least the reasons stated above with respect to claim 1. Accordingly, Applicant asserts that claim 16 is also allowable” (page 10 para. 3).
However, new grounds of rejection are set forth above over Propper in view of Schwab and Cytiva. There are no deficiencies in the rejection of claim 16 and its dependent claims over Propper in view of Schwab and Cytiva. Therefore, Applicant’s argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
