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.
Election/Restrictions
Note that the restriction filed 11/19/2025 was made by a different Examiner from the current Examiner.
Applicant's election with traverse of Group I, claims 1-4 and 12-20 in the reply filed on 1/9/2026 is acknowledged. The traversal is on the ground(s) that "when reading page 3 of the Office Action, no such explanation exists of: (1) separate classification thereof; (2) separate status in the art when they are classifiable together; or (3) a different field of search, as required by the MPEP. Therefore, the Office Action failed to explain reasons why there would allegedly be a serious burden on the Examiner if the restriction is not required" (page 4 para. 3). This is not found persuasive because the restriction requires demonstrating serious search and/or .
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/9/2026.
Priority
The present application claims benefit under 35 U.S.C. 119(e) to provisional application 63/480,238 filed on 1/17/2023.
Information Disclosure Statement
The information disclosure statement filed 1/26/2024 is being considered by the examiner.
Claim Objections
Claims 12 and 19 are objected to because of the following informalities:
In claim 12 lines 11-13, and in claim 19 lines 10-12, “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” appears to be a typographical error, namely it is suggested that “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” read as “the test line and the control line are configured to bind a target antigen; and the test line and the control line are disposed to be visible through the sample port” (emphasis added).
Appropriate correction is required.
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: receive a sample; add one or more biomarker indicators to the sample using the biomarker indicator addition device; 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 (receiving, 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 a storage reservoir; 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 a remaining portion of the sample using the biomarker indicator addition device; 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” 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 (receiving, 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.
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 1-4 and 12-20 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 “the system configured to: receive a sample; add one or more biomarker indicators to the sample using the biomarker indicator addition device; and analyze the sample using the testing device to determine whether the sample contains one or more deleterious microorganisms” in claim 1, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to disclose what is meant by configuring the system to receive a sample, or to add indicators to the sample or to analyze the sample. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim limitation “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, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to disclose what is meant by configuring the system to prepare the sample, or to analyze the prepared sample, or to determine whether the sample contains deleterious microorganisms based on a result from the spectrophotometer. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
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.
Furthermore, regarding the 112f invocation of claim 4, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to disclose what is meant by configuring the system to analyze the sample using the testing device to determine whether the sample contains one or more deleterious microorganisms, further comprising responsive to determining that the sample contains one or more deleterious microorganisms determine an amount of the one or more deleterious microorganisms in the sample.
Claim limitation “the system further configured to: collect a sample from a storage reservoir; 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 a remaining portion of the sample using the biomarker indicator addition device; 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” in claim 16, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to disclose what is meant by configuring the system to collect a sample, or to apply a first portion of the sample to the LFA, or to receive a first result from the LFA, or to add one or more biomarker indicators, or to analyze the remaining portion of the sample or to combine the first result from the LFA and the second result from the testing device to form a comprehensive test result. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim limitation “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, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to disclose what is meant by configuring the system 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. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 15 recites “liquid flow of the sample wicks the target-antigen complexes to the test line and the control line”. However, it is not clear what is meant by “liquid flow of the sample wicks to the target-antigen complexes to the test line and the control line”. The term “wicks” in claim 15 appears to be used by the claim to mean the transporting or moving of the complexes to the test/control line via a wicking effect, i.e. through capillary fluid flow. Therefore, it is not clear how liquid flow wicks because these refer to the same action of fluid movement. The limitation “wicks” can also be interpreted as another term entirely, not defined by the specification. For these reasons, a person having ordinary skill in the art would not recognize the metes and bounds of the claim.
Claim 16 recites “A system for detecting deleterious microbial activity in hydrogen reservoirs, the system comprising:…a Lateral Flow Assay (LFA)…apply a first portion of the sample to the LFA to test the sample; receive a first result from the LFA…and combine the first result from the LFA and the second result from the testing device to form a comprehensive test result”. However, it is not clear what is meant by an “LFA”. The specification discloses that an LFA is a detection method (“detection methods, such as lateral flow assays (LFA)” para. 31). However, the claim language suggests that LFA refers to an LFA device such as instant Fig. 4. Given these multiple possible interpretations, a person having ordinary skill in the art would not be able to recognize the metes and bounds of the claim. Claim 16 further recites “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”. The limitation “a second result of whether the sample contains one or more deleterious microorganisms” in lines 13-14 lacks antecedent basis. It is not clear what is being referred to by “to determine a second result of whether the sample contains one or more deleterious microorganisms” because a determined first result is not previously recited. Note that although the claim recites “receive a first result from the LFA” (line 10), this is not the same as a determined result as recited in lines 13-14. For these reasons, the claim is indefinite.
Claim 19 recites “wherein the LFA further comprises: a case, the case further comprising: a bottom section; a top section; and a sample port and a result window disposed in the top section; a test strip disposed within the case, the test strip further comprising: a primary detector; a test line; and a control line, 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”. However, similar to claim 16, it is not clear what is meant by “LFA”. The recited LFA can be interpreted as a method (“detection methods, such as lateral flow assays (LFA)” para. 31 of spec.) or as a device. For this reason, a person having ordinary skill in the art would not recognize the metes and bounds of the claim.
Claim 20 recites “wherein the LFA further comprises: a panel of targets, wherein the panel of the targets comprises a plurality of LFAs, and wherein each LFA of the plurality of LFAs contains a different target than each other LFA of the plurality of LFAs”. However, similar to claims 16 and 19, it is not clear what is meant by “LFA”. The recited LFA can be interpreted as a method (para. 31 of spec.) or as a device. Furthermore, 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 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 comprise a plurality of LFAs? Furthermore, it is not clear how the plurality of LFAs contains a different target than each other LFA of the plurality of LFAs. 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.
Claims 2, 13-14 and 17 are included in this rejection because they depend from a rejected claim but fail to clarify the scope of patent protection sought.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 12 and 16-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Propper et al. (US 20130280698 A1) (“Propper”).
Regarding claims 1 and 16, although the claims are indefinite (see 112b rejection above), in the interest of compact prosecution, the 112(f) limitations (limitations after “the system further configured to” lines 6-11 of claim 1, and lines 7-16 of claim 16) 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. Furthermore, the “LFA” recited in claim 16 is interpreted as a test strip.
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…” 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 (“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 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). Note that, although not explicitly required in order to anticipate the claim (112f limitations are interpreted as inherently provided), Propper teaches the system further configured to: receive a sample (“(b) an inlet in the housing for introducing the liquid sample into the housing” para. 28); analyze the sample using the testing device to determine whether the sample contains one or more deleterious microorganisms (“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), collect a sample from a storage reservoir (paras. 20-21); apply a first portion of the sample to the LFA to test the sample; receive a first result from the LFA; 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” para. 4 and 20-21).
Regarding claims 2 and 17, Propper further teaches wherein the testing device further comprises a spectrophotometer (“via color change in the visible light spectrum” para. 19, “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, “camera, which takes a high resolution color image of the assay strips” para. 81). 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.
Regarding claims 3 and 18, 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.
Nevertheless, Propper further teaches 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); 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, para 21). .
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.
Nevertheless, Propper further teaches 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).
Regarding claim 12, Propper teaches an apparatus for detecting deleterious microbial activity in hydrogen reservoirs (Abstract, paras. 17 and 20-21). Note that “for detecting deleterious microbial activity in hydrogen reservoirs” merely describes the intended purpose of the claimed apparatus and thus does not impart a limiting effect to the claimed apparatus. Propper further teaches the apparatus comprising: a case (“In this embodiment, the cartridge device is comprised of the following components:” para. 35 “a housing” para. 36), the case further comprising: a bottom section; a top section (“The housing 3 is comprised of a top piece 70 and bottom piece 75” para. 42); and a sample port (“an inlet 2 in the housing for introducing the liquid sample into the housing” para. 37) and a result window disposed in the top section (“Each assay chamber 30 may further comprise an assay viewing window 4 in the housing” para. 47); a test strip disposed within the case (“The cartridge device 1 has multiple assay chambers 30, and within each chamber 30 is a particular assay strip” para. 56), the test strip further comprising: a primary detector (“This type of detection system is commonly used in strip tests such as home pregnancy tests. This conjugate will be dried into a conjugate application fleece” para. 104); a test line (“which analyzes the strips for the control lines and intensity of the data test lines” para. 81); and a control line (para. 81), 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 (“The first line or "test" line will be a known concentration of an E2-BSA mixture. The BSA (bovine serum albumin) is present to make the estradiol adhere to the nitrocellulose. The second zone, the "control" line, will be a known concentration of goat anti-mouse antibody. The application of a negative sample (zero concentration E2) will result in a high concentration of the colloidal gold-mouse anti-E2 binding to the E2 on the test line, with the remainder binding at the control line. When E2 is present in the sample, the free E2 will bind to the anti E2 antibody-colloidal gold conjugate, preventing the conjugate from binding at the test line. This complex will pass through the test line and will be bound by the anti-mouse antibodies at the control line” para. 104, para. 47, see Figures 10 and 13).
Regarding claim 19, Propper further teaches wherein the LFA further comprises: a case (Title, paras. 35-36), the case further comprising: a bottom section; a top section (para. 42); and a sample port (para. 37) and a result window disposed in the top section (para. 47); a test strip disposed within the case (para. 56), the test strip further comprising: a primary detector (para. 104); a test line (para. 81); and a control line (para. 81), 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).
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 further teaches wherein the LFA further comprises: a panel of targets, wherein the panel of the targets comprises a plurality of LFAs, and wherein each LFA of the plurality of LFAs contains a different target than each other LFA of the plurality of 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).
Claims 12-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ohta et al. (US 11648562 B2) ("Ohta").
Regarding claim 12, Ohta teaches an apparatus for detecting deleterious microbial activity in hydrogen reservoirs (“apparatus…for anonymized diagnosis using lateral flow assays” Abstract). Note that the limitation “for detecting deleterious microbial activity in hydrogen reservoirs” describes the mere intended purpose of the claimed apparatus and thus fails to impart any limiting-effect to the apparatus. Ohta further teaches the apparatus comprising: a case, the case further comprising: a bottom section; a top section; and a sample port and a result window disposed in the top section; a test strip disposed within the case (“Referring now to FIG. 4… The sample receiving zone 402 (e.g., a sample pad), the labeling zone 404 (e.g. , a conjugate pad), the detection zone 406 ( e.g., a reaction membrane), and the absorbent zone 408 (e.g., a wicking pad) are typically fixed to the substrate 410 (e.g., an inert backing material) and housed within a plastic casing with a sample port open to the sample receiving zone 402 and a reaction window showing the detection zone 406” col. 9 lines 9 and 23-29, see Figure 4 showing both the sample port and the window on the top side), the test strip further comprising: a primary detector (“The labeling zone 404 may be provided in the form of a conjugate pad containing one or more labeling substances with antibodies that are specific for the one or more target analytes and that are conjugated to labeling particles” col. 9 line 49-52, see Figure 4), a test line; and a control line, 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 (“The detection zone 406 may be provided in the form of a membrane ( e.g., a nitrocellulose membrane or a cellulose acetate membrane) onto which antibodies are immobilized in lines… that define one or more test patterns…and one or more control patterns. In each test pattern, antibodies specific for the one or more target analytes are immobilized in a line,… each control pattern, antibodies specific for the conjugate antibodies of the one or more labeling substances are immobilized in a line” col 10 lines 4-20, see Figure 4).
Regarding claim 13, Ohta further teaches further comprising: primary antibodies disposed on the primary detector (col. 9 line 49-52); secondary capture antibodies disposed on the test line; and species detection antibodies disposed on the control line (col 10 lines 4-20).
Regarding claims 14-15, although claim 15 is indefinite (see 112b rejection above), in the interest of compact prosecution, the claim is interpreted as reciting “capillary liquid flow of the sample transports the target-antigen complexes to the test line and the control line”.
Ohta further teaches wherein: target antigens from a sample are bound to the primary antibodies to form target-antigen complexes, wherein: liquid flow of the sample wicks the target-antigen complexes to the test line and the control line; and the target-antigen complexes are bound to the secondary capture antibodies on the test line and the species detection antibodies on the control line (“The absorbent zone 408 may be provided in the form of a wicking pad that draws the test sample by capillary action from the sample receiving zone 402 and across the labeling zone 404 and the detection zone 406 and collects the drawn portion of the sample” col. 11 lines 17-21, “The labeled target analyte complexes, the labeled nontarget analyte complexes, along with excess quantities of the labeling substance 510, are carried along the lateral flow assay 400 into the test pattern 412, which contains immobilized compounds 520 that are capable of specifically binding the target analyte 504…immunoglobulins that specifically bind the labeled target…immobilized compounds 524 in the control pattern 416 bind and retain the labeling substance 510… the control pattern 416 may contains… anti-immunoglobulin antibodies specific for the antibody of the labeling substance” col. 12 lines 1-6, 13 and 36-41).
Conclusion
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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