DETAILED ACTION
Applicant's response, filed 04/02/2026 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Herein, "the previous Office action" refers to the Non-Final rejection of 12/02/2025.
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 .
Claim Examination Status
Claims 1-4, 7, and 21-25 are currently pending and under exam herein.
Claims 5-6 and 8-20 are cancelled
Claims 1-4, 7, and 21-25 are rejected.
Priority
As previously discussed for the benefit of priority, all claims 1-4, 7, and 21-25 are examined for effective filing date 05/06/2020. In future actions, the effective filing date of one or more claims may change, due to claim amendments, or further analysis of the disclosure(s) of the priority application(s).
Claim Objections
Instant claim 1, filed 04/02/2026, is amended improperly. According to the MPEP 1.121( c)(2)), amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled… (2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of "currently amended," and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived.
Prior claim version, filed 06/17/2025, claim 1 recites:
displaying the first layer and the second layer independently of each other on a layer associated with the map of the region, such that a user may toggle the layers independently of each otherin order to identify areas of high risk for a potential outbreak based on the viral load
Instant claim 1 recites:
may be displayed independently of each other on a layer associated with the map of the region[[,]] to identify locations where the likelihood of a potential outbreak based on the viral load information is increased.
Applicant should review the instant claim set relative to the immediate prior version of the claims and amend the claims with proper markings to indicate all claim changes. .
Withdrawn Rejections/Objections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn in view of the amendments, filed 04/02/2026.
The 112b rejection regarding claim 1, the limitation “conveying, with the Point of Care device…” with the disclosed display, “at least one suspected pathogen”, “diagnostic analysis”, and the intended use limitation “to perform” is withdrawn.
On further consideration, new rejections/portions are recited below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 7, and 21-25 are rejected under 35 U.S.C. 101, because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture, or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, the claims are directed to a method of using wastewater to detect pathogens, therefore the answer is "yes".
With respect to step (2A)(1), the claims recite abstract ideas. To determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon, MPEP at 2106.03 teaches abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships, and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (see MPEP 2106.04(a)(2)). In the instant application, the claims recite the following limitations that equate to an abstract idea with mental steps.
With respect to the instant claims, under the step (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular steps for conveying…taking into account…taking into account…generating… generating… determining risk and viral load information).
The claims directed to abstract ideas are as follows:
Mental processes:
Claim 1 recites determining, with the Point of Care device: viral load information associated with the sample of waste water; and a risk assessment based on the viral load information and the location information;… to identify areas of high risk for locations where the likelihood of a potential outbreak based on the viral load information is increased.
Claim 2 recites taking into account a dilution of the sample of waste water when performing the diagnostic analysis.
Claim 3 recites taking into account a time that has passed since stool in the sample of waste water has been excreted.
Claim 7 recites determining, with the Point of Care device, a risk for spread of infection of the region based on the viral load information
Claim 21 recites … identifying, with the Point of Care device, gaps in testing based on a reconciliation between the demographic information and the viral load information; and communicating, with the Point of Care device, the gaps in testing to a user.
Claim 22 recites identifying gaps in testing based on a reconciliation between the demographic information and the viral load information… determining, with the Point of Care device, a location-based model based on sampling information from that location, demographics, and infection rate; determining, with the Point of Care device, a predicted infection rate for the location by inverting the location-based model; and comparing the predicted infection rate to the demographic information about confirmed cases associated with the viral load.
Claim 23 recites … in order to determine whether to pass the sample of waste water onto targeted sequencing diagnostics.
Hence, the claims explicitly recite elements that, individually and in combination, constitute abstract ideas.
With respect to step (2A), under the broadest reasonable interpretation (BRI), the instant claims recite a method using wastewater to detect pathogens. Instant independent claim 1, and therein dependent claims, are therefore directed to the judicial exceptions of abstract groupings with mental processes (conveying…taking into account…taking into account…generating… generating…determining).
Because the claims do recite judicial exceptions, direction under step (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exception, the claim is said to fail to integrate into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements considered for practical application:
Claim 1 recites configuring a portable Point of Care device to comprise an assay cartridge comprising an extraction chamber for placement thereon of a sample of waste water that includes at least one suspected viral pathogen; and a module comprising a microcontroller that, upon receipt of the assay cartridge therein, (i) acquires location information corresponding to a sampling site of the sample of waste water and (ii) performs diagnostics on the sample of waste water, upon receipt of the sample of waste water and the location information… conveying, with the Point of Care device, at least one of the risk assessment and the viral load information to a display to show a dashboard comprising over a map associated with the region, the map comprising by: generating a first layer associated with the viral load information[[;]] and generating a second layer associated with population information such that ; and displaying the first layer and the second layer may be displayed independently of each other on a layer associated with the map of the region…
Claim 4 recites performing real-time Polymerase chain reaction; and performing targeted sequencing based on a genome of a virus associated with the viral load.
Claim 7 recites displaying, with the Point of Care device, the risk for spread of infection of the region.
Claim 21 recites obtaining, with the Point of Care device, demographic information about confirmed cases associated with the viral load
Claim 22 recites sampling information from that location, demographics, and infection rate
Claim 23 recites using results obtained from a real-time polymerase chain reaction diagnostics performed on the sample of waste water
Claim 24 recites determining the viral load information further comprises generating a test result corresponding to cells of the suspected viral pathogen that have been lysed by the assay cartridge.
Claim 25 recites outputting, using the Point of Care device, the test result to a portable electronic device.
Said steps that are “in addition” to the recited judicial exception in the instant claims represent those of mere instructions or field of use limitations (receiving a sample of waste water…performing diagnostics/diagnostic analysis on the sample of waste water… performing real-time Polymerase chain reaction…performing targeted sequencing… generating a test result corresponding to cells of the suspected pathogen that have been lysed by the assay cartridge) to implement in the recited judicial exception and do not impart meaning to said recited judicial exception, such that is applied in a practical manner. Further with respect to the additional elements in the instant claims, in combination these steps direct to mere data gathering and handling (sampling information from that location, demographics, and infection rate…obtaining/conveying demographic/viral load information over a map…displaying the layer(s) of the viral load information/risk…) to carry out the abstract idea without imposing any meaningful limitation on the abstract idea. Thereby, in combination, these steps are insignificant extra-solutions activity steps and are insufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g). Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
As such, the claims are lastly evaluated using the step (2B) analysis, wherein it is determined that because the claims recite abstract ideas which do not integrate the abstract ideas into a practical application, the claims also lack a specific inventive concept. The judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering, instructions, and field of use limitations described above do not rise to the level of significantly more than the judicial exception. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represent well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant recitations, the claims recite the following additional elements considered for inventive concepts:
Claim 1 recites configuring a portable Point of Care device to comprise an assay cartridge comprising an extraction chamber for placement thereon of a sample of waste water that includes at least one suspected viral pathogen; and a module comprising a microcontroller that, upon receipt of the assay cartridge therein, (i) acquires location information corresponding to a sampling site of the sample of waste water and (ii) performs diagnostics on the sample of waste water, upon receipt of the sample of waste water and the location information… conveying, with the Point of Care device, at least one of the risk assessment and the viral load information to a display to show a dashboard comprising over a map associated with the region, the map comprising by: generating a first layer associated with the viral load information[[;]] and generating a second layer associated with population information such that ; and displaying the first layer and the second layer may be displayed independently of each other on a layer associated with the map of the region…
Claim 4 recites performing real-time Polymerase chain reaction; and performing targeted sequencing based on a genome of a virus associated with the viral load.
Claim 7 recites displaying, with the Point of Care device, the risk for spread of infection of the region.
Claim 21 recites obtaining, with the Point of Care device, demographic information about confirmed cases associated with the viral load
Claim 22 recites sampling information from that location, demographics, and infection rate
Claim 23 recites using results obtained from a real-time polymerase chain reaction diagnostics performed on the sample of waste water
Claim 24 recites determining the viral load information further comprises generating a test result corresponding to cells of the suspected viral pathogen that have been lysed by the assay cartridge.
Claim 25 recites outputting, using the Point of Care device, the test result to a portable electronic device.
These additional elements do not contribute significantly more to well-known and conventional testing to assess viral genetic information in a biological sample (in this case wastewater which contains stool samples from an area’s population of subjects), which can be routinely collected, tested for pathogens, and managed by a healthcare worker with ordinary skill in the art of as of the effective filing date and present in the prior art:
Further, data (e.g. viral genetic information) remain merely measured and manipulated data in abstract mental processes (conveying…taking into account…taking into account…generating… generating…determining…) which can be annotated with pen on a paper map, to be used in the judicial exception. Generic recitations of well-understood and conventional steps for utilizing any task appropriate cloud/online platform [0075], mobile or cellular device, or smartphone, are recited in the specification without any particularity or specificity, as recited in the specification below:
Further aspects of the present disclosure provide a rapid, and easy to use method for sample collection and diagnostics, which can interface with biosurveillance networks and physicians, e.g., via online connections, to best determine if someone should self-isolate, seek medical care, or take other action. Examples of biosurvelliance are described in a non-limiting manner herein, e.g., in the context of wastewater treatment plant screening. Moreover, because a smartphone is utilized in some embodiments, cellular, wifi and related technologies can link to cloud-based data source to compile accurate, near-real time counts of uses, diagnostic results, etc. As such, trends can be tracked and predicted, accurate infection counts can be made, etc. Moreover, while doing so, homebased diagnostics protect our frontline healthcare workers, as they do not have to be exposed during sample collection [0075].
The MPEP 2106.05(a) provides evidence to the routine nature of applying the judicial exception with computers or devices to perform or automate an existing process, and constitute insignificant extra-solution activity, as recited: “Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential).”
With respect to the instant claims, the steps (processing and displaying viral load data on map) and additional elements (real-time Polymerase chain reaction; and performing targeted sequencing, diagnostics) involving automated mental steps do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-4, 7, and 21-25 are not patent eligible.
Response to 101 Remarks
Applicant's remarks (p1-5), filed 04/02/2026 have been fully considered and are not persuasive for the previously stated reasons in the previous Office Action, with additions necessitated by claim amendments. The Applicant asserts instant claim limitations are:
microcontroller-based components and their associated activities cannot practically be applied in one’s mind through the mental or manual use of human logic. Specifically, there is no evidence that the human implementation of such logic is capable of the totality of (among other things) microcontroller-based performance of diagnostics on the sample of waste water and performing a risk assessment based on location and viral load information, then conveying one or both of the risk assessment and viral load information to a device where such information may be displayed as a dashboard using a multilayered map.
Applicant asserts, “microcontroller-based components and their associated activities cannot practically be applied in one’s mind…” recitations cannot practically be performed in one’s mind. However, the argument presented is not persuasive. First, the mere presence of physical steps in the claim with the judicial exception does not guarantee eligibility (see As the Supreme Court explained in Alice Corp., mere physical or tangible implementation (microcontroller-based components) of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point"). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis are not "sufficient" to render claim 1 patent eligible merely because they are physical steps). In MPEP 2106.04(d)(I)). Ultimately physical steps such as the said wet laboratory steps performed within an assay cartridge (microcontroller-based performance of diagnostics on the sample of waste water) constitute field of use limitations/extra-solution steps, which were necessary to provide the data used in the judicial exception/abstract idea/mental process of one skilled in the art of laboratory result analysis. The output of viral load information with the associated location information can be evaluated by an epidemiologist, who can surmise an elevated viral load in wastewater from county X indicates and elevated risk of disease Y, and can diagram the viral load data on a map with location and/or population information to activate public health interventions, such as social distancing or mask wearing.
particular piece of structure with which to perform such detection (specific way through a particular arrangement and cooperation of computer-based components with which to use a particular set of rules to solve a particular problem, in this case improving the operation of a real-time system) as well as to output the results of pathogen testing. McRO Inc. v. Bandai Namco Games America Inc….a]n improvement in the functioning of a computer, or an improvement to other technology ( use of a computerized Point of Care device to perform real-time surveillance of pathogens in a novel and non-obvious way to precisely address the problems to the technical field of determining whether waste water is infected) “the Ex Parte Desjardins decision analyzed eligibility in terms of whether the claims were directed to an improvement in the functioning of a computer, or an improvement to other technology or technical field under longstanding Federal Circuit precedent in Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) and McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016). See also MPEP §§ 2106.04(d)(l) and 2106.05(a).” technological solution enabled by the presently-amended claims is that by using a portable Point of Care device to perform molecular-based virus testing on a patient, in-home, rapid diagnostics are enabled without having to unduly expose the patient or others to certain pathogens. FIGS. 1 and 3 depict a particular embodiment of the Point of Care device while FIGS. 9 through 18 shows a technical effect achieved by the Point of Care device in the form of an output of a diagnostic analysis.
Applicant asserts a “particular piece” of structure/arrangement of computer components/configuration rules in the use of a computerized Point of Care device to perform real-time surveillance of pathogens… [in order to] address the problems to the technical field of determining whether waste water is infected, and thereby providing an improvement in the functioning of a computer/other technology. This argument is not persuasive because the judicial exception of abstract idea (determining…conveying real time infection of a region) in the instant limitations applies to laboratory technology/devices (Point of Care device) but does not solve a problem rooted in or arising from the use of a particular technology to allow a function that said Point of Care device was not previously capable of performing, and ultimately, the limitations are only generally linking the use of the abstract idea to a broad technological environment (i.e. portable assay analyzers) In SiRF Tech., Inc. v. Int’l Trade Comm ’n, 601 F.3d 1319,1333 (Fed. Cir. 2010) (holding that: In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly, i.e., through the utilization of a computer for performing calculations). The claimed POC device is performing diagnostics/diagnostic analysis based on assay cartridges, which does not distinguish it from the state of the art to establish improvement. Applicant can consider incorporating asserted unique aspects of the POC device [0039-0052] rooted in the instant specification which can distinguish the Point of Care device as well as provide the minimally sufficient and necessary system components for the claimed invention to perform the claimed diagnostics, such as buffers/reagents, a PCR module, a sequencing module, display module, a communication module connected to a database of viral references/map/population data, which are not disclosed in the cited FIGs 1-3 nor the FIGS. 9 through 18. The disclosed portable Point of Care device for home use does not appear to be equipped to allow all of these diagnostic functions in the field, only claiming an assay cartridge/extraction chamber and a microcontroller/computer processer. No other particular features distinguishes said POC and instant claims do not recite the minimally sufficient and necessary components to provide the pathogen data, and therefore, cannot provide practical integration of the judicial exceptions.
One approach to clearly placing an improvement argument on the record is to show that: 1) a particular improvement is identified (assertion of general "improvement" cannot suffice); 2) there is a clear difference, apparent through comparison with the most relevant conventional technology (since there can be no "improvement" without a difference); and 3) any improvement is either explicitly recited or is inherent to the claims, but in either case must apply to all claimed embodiments within the recited claim scope. As further examples, argument may explain cause and effect leading to improvement or may include evidence comparing a claimed result to conventional results. Arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim.
With respect to the instant claims, the steps (obtaining, processing, and displaying viral load data on map) and additional elements (POC device, real-time Polymerase chain reaction; and performing targeted sequencing, diagnostics) involving automated mental steps do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-4, 7, and 21-25 are not patent eligible.
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.
Claims 1-4, 7, and 21-25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The dependent claims 2-4, 7, and 21-25, are also rejected because they depend on and/or do not remedy the deficiencies inherited by their parent claims. Any newly applied rejection/portion is necessitated by instant application amendment.
Regarding claim 1, the limitation “a risk assessment based on the viral load information and the location information” is indefinite because it does not recite active steps for combining the location information with the viral load to give a risk assessment without which one of ordinary skill in the art would be unable to determine the risk.
Regarding claim 1, the relative limitation of “likelihood…increased” as in “ to identify locations where the likelihood of a potential outbreak based on the viral load information is increased.…” is a relative term which renders the claim indefinite. There is no clear definition or comparison to any type of reference for the basis of increased likelihood of a potential outbreak. The specification does not provide a standard for ascertaining the requisite degree of risk (e.g. a viral load threshold), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention (See MPEP at 2173.05(b)).
Regarding claim 1, the term “population information” in ”generating a second layer associated with population information” remains indefinite as to what population is being referenced in said second layer, whether human, fish, pathogens, or microbes.
Regarding claims 2 and 3, the term “taking into account” in “comprises taking into account a dilution of the sample” and “comprises taking into account a time that has passed since stool in the sample has been excreted” remain indefinite. The term “taking into account” has no standard definition or active steps for a one of ordinary skill in the art for taking into account for a dilute sample or time from stool excretion. Instant specification discloses [0097]: waste water itself is a combination of human waste, water, tissue paper, food waste, and other items flushed down drains. Further, there is a lag between the time stool is excreted to when the stool reaches a waste water treatment plant. Thus, the viral load may fluctuate based on an amount of time between excretion and sampling/diagnosis, which should be taken into account when detecting a viral load within the sample. During that time, the stool is diluted and mixed with the other items listed above. Thus, when detecting a viral load within a sample, the dilution of the sample must be factored into any calculation. Clearer claim language with active steps to accomplish the intended method is requested.
Appropriate correction is required.
Response to 112 Remarks
Applicant's arguments (Remarks p5), filed 04/02/2026, have been fully considered and are not persuasive for the previously stated reasons in the previous Office Action, with additions necessitated by claim amendments. While instant claim amendments to improve the claim clarity, several 112b rejections from the prior action are maintained as the rejection was not addressed by amendment or argued on its merits.
Claim Interpretation - 35 U.S.C. 112(f)
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 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. This newly applied interpretation is necessitated by instant application amendment.
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 is: “module comprising a microcontroller …. in claim 1 is being interpreted under 35 U.S.C. 112(f) with module and microcontroller as generic placeholders for means, and “therein acquires…and performs diagnostics…” for the corresponding functional language. The module/microcontroller is being interpreted to cover the corresponding structure (specification FIGs 1-3: user held digital droplet point of care device, [0007-0010; 00109-00111]) as performing the claimed function, and equivalents thereof. The “microcontroller” is being interpreted to cover the corresponding structure (specification [0047: the droplet module comprises a small durable processor (e.g., microcontroller) and an extraction and dropmaking (ED) module. The module may also include any other necessary hardware, e.g., microfluidic chip(s), heating elements, pumps, valves, tubing, hydrophobic filters, buffer and lyophilized reagent storage reservoirs,]), as performing the claimed function, and equivalents therefore. Furthermore, neither the term “module” nor “microcontroller” has sufficiently definite meaning for a person of ordinary skill in the art to glean the scope of structures included in “module” and “microcontroller” (see MPEP 2181.I.A).
Because this/these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and § 103 (or as subject to pre-AIA 35 U.S.C. § 102 and § 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
Note on formatting: citations from the instant application are italicized in the following section.
Claims 1-3, 7, and 21-22 are rejected under 35 U.S.C. § 103 as being unpatentable over Farkas et al. (IDS cited; herein Farkas), in view of Fuernkranz et al. (WO-2006116455 A2; System for genetic surveillance and analysis; 11-02-2006, newly PTO 892 cited), and in view of Barrett et al. (IDS cited, herein Barrett) and in further view of Rogan et al (Rogan PK et al (US20210057109A1, IDS cited, herein Rogan).
Regarding instant claim 1, instant application recites a method using wastewater to detect pathogens:
A process for using waste water to determine in real time infection of a region, the process comprising: configuring a portable Point of Care device to comprise thereon of a that includes at least one suspected viral pathogen that, upon receipt of the assay cartridge therein, (i) acquires location information corresponding to a sampling site of the sample of waste water and (ii) performs diagnostics on the sample of waste water; upon receipt of the sample of waste water and the location information, determining, with the Point of Care device: of waste water; and a risk assessment based on the viral load information and the location information; and conveying, with the Point of Care device, at least one of the risk assessment and the viral load information to a display to show a dashboard comprising , the map comprising and such that may be displayed independently of each other on a layer associated with the map of the region[[,]] to identify locations where the likelihood of a potential outbreak based on the viral load information is increased.
The prior art to Farkas teaches viral load surveillance in human wastewater systems for public health monitoring (Abstract):
a method to evaluate diurnal and seasonal patterns in wastewater viral loads.
3-day sampling campaigns with bihourly sample collection to quantify (determine viral load) enteric viruses (namely NoVGI, NoVGII, SaVGI, HAV, HEV and AdV) in untreated influent and treated effluent (waste water) over three seasons at Llanrwst and Betws-y-Coed (North Wales, U.K.) wastewater treatment plants (location information) [Abstract and FIG.1].
viral nucleic acids were extracted 2 × 0.5 mL of the concentrate… the final volume of the nucleic acid solution was 0.1 mL. Viral RNA quantified using two triplex TaqMan one-step qRT-PCR assays [p.33393 Col 1].
However, Farkas does not teach infection determination in real time…configuring a portable Point of Care device that, upon receipt of receiving a sample of waste water that, wherein the sample includes (i) at least one suspected pathogen and (ii) location information corresponding to a sampling site of the waste water, performs a diagnostic analysis of the waste water, the Point of Care device comprising: an assay cartridge comprising an extraction chamber for placement of at least a portion of the sample of waste water thereon; and a module comprising a microcontroller configured to perform performing diagnostics on the sample of waste water; to determine viral load information associated with the sample; determining, with the Point of Care device, viral load information associated with the sample… conveying the viral load information over a map associated with the region and generating a first layer associated with the viral load information; generating a second layer associated with population information; and displaying the first layer and the second layer independently of each other on a layer associated with the map of the region, such that a user may toggle the layers independently of each other; and identifying areas of high risk for a potential outbreak based on the viral load of the samples and the census in information.
The prior art to Fuernkranz teaches:
…occurrence of biological contaminants in environmental (upon receipt of receiving a sample of waste water) or biological samples, may be a feature of many infectious and non-infectious diseases, as well as diseases known to be associated with microorganisms or pathogens (at least one suspected pathogen). Identifying the frequency of a particular disease as being excessive may be developed by following its frequency over time, by comparing its frequency in different places, or by comparing its frequencies among subgroups in a single population at a particular time. Such identification may include identifying the excessive frequency that comes about in a short period of time and in a narrowly defined geographic area [0037] ((i) at least one suspected pathogen and (ii) location information corresponding to a sampling site… performs a diagnostic analysis of the waste water).
The system supports a plurality of reader-analyzer instruments of different sizes and capabilities, including portable multi-cartridge units (a portable instrument 54) to small, shirt-pocket- sized units such as handheld instruments... (an assay cartridge comprising an extraction chamber for placement of at least a portion of the sample of waste water thereon…). The reader-analyzer instruments 176 analyze samples, whether taken from a patient or from the environment… implemented using any one of a variety of different reader-analyzer instruments, such as genetic assay analysis platforms including the model 7500 fast real-time PCR system. The handheld instrument …. can include an embedded internal controller so that no external computer (microcontroller) is required. Any instrument that can provide data on the analysis of pathogens such as identifying a strain of bacteria, fungi, virus, and the like, may be integrated into the genetic surveillance and analysis system [0039-0042] (teach infection determination in real time…configuring a portable Point of Care device… and a module comprising a microcontroller configured to perform…).
Additionally, confirmatory data may be generated after positive results are detected via PCR. Confirmatory data includes microbiology culture tests and genetic resequencing assays/instruments. After identification of an agent via a rapid biological assay such as real-time PCR, a confirmatory test can be performed using "gold standard" procedures such as viral/microbial cultures or Applied Biosystem's MicroSeq microbial identification system [00170].
The prior art to Barrett teaches a respiratory disease analytics system providing respiratory disease risk reports to a patient, provider, or third-party entity describing a patient's risk of experiencing a medication usage event (identifying areas of high risk for a potential outbreak based on the viral load of the sample) given data in a geographic region. Regional data, including demographic information and regional health conditions for a geographic region, are accessed from other sources and assigned based on event data recorded during a medicament usage event, as collected by sensors associated with the patient's medicament devices [FIG 4 and Abstract]. This method for conveying a respiratory disease risk and updating a user for a geographic region and its associated regional parameters. The dose-dependent respiratory risk from an environmental toxin [FIGs 7C-7G] is analogous to respiratory risk from an infectious exposure. In Barrett, the pathogen is an environmental toxic agent (i.e. instant claim communicable viral infection) causing respiratory disease risk (high risk for a potential outbreak) and measured by medicament usage events (i.e. instant claim viral load levels). The assessment of the geographic region at a given point in time incorporates local demographics, census tract data (census data) and environmental conditions within the region (Barrett at claim 1 and [0017-0021]). The user’s client device and medical sensor, in communication with an application server, receives these risk maps/reports [FIGs. 4-7G] (conveying the viral load information over a map associated with the region) through display modules 310, 440 (identifying areas of high risk for a potential outbreak based on the viral load of the samples). The maps can show diseased state and different parameters or risk factors on a map singly or in combination [0133: “FIGS. 7C-F illustrate the risk of rescue medication use across Jefferson County, according to one embodiment. FIGS. 7C, 7D, 7E, and 7F illustrate the respiratory disease risk estimated at the census tract level due to exposure to NO2, O3, and SO2, and a combination of the three, respectively”] (generating a first layer associated with the viral load information; generating a second layer associated with population information; and displaying the first layer and the second layer independently of each other on a layer associated with the map of the region, such that a user may toggle the layers independently of each other; and identifying areas of high risk for a potential outbreak based on the viral load of the samples and the census in information)
Neither Farkas nor Barret teach health risk with specific census information in the geographic region, however Rogan teaches identifying areas of high risk for a potential outbreak based on the viral load of the samples and the census in information. Rogan teaches an analogous method for identifying and quantifying populations exposed to environmental hazards including a radiation agent or a communicable infectious agent/COVID-19, with locations of hotspots (risk of infection of a region) across a geographic region [Abstract]. Rogan tracks point-to-point spatial interpolation of COVID-19 counts (generating a first layer associated with the viral load information; and further, reconstructs geographic incidence using disease-related count data against geographic boundaries and population data obtained from the census bureau when additional geographic resolution of hotspot predictions are needed [0039-0040] (generating a second layer associated with population information… potential outbreak based on the viral load of the samples and the census in information). Spatial and temporal information for case counts can be validated and separate data outliers on dedicated map layers with result annotations [0036-0037] (conveying the viral load information over a map associated with the region; generating a first layer associated with the viral load information; generating a second layer associated with population information; and displaying the first layer and the second layer independently of each other on a layer associated with the map of the region, such that a user may toggle the layers independently of each other; and identifying areas of high risk for a potential outbreak based on the viral load of the samples and the census in information).
Regarding instant claim 2, instant application recites
wherein the diagnostics of waste water when performing the diagnostic analysis.
The prior art to Farkas teaches: “where necessary, samples were diluted ten times prior to qRT-PCR to reduce inhibition” and controlled in virus isolate recovery… values showed little variation amongst virus types. [p.33393 Col 1-p.33394 Col 1].”
Regarding instant claim 3, instant application recites
wherein the diagnosticsof waste water has been excreted.
The prior art to Farkas teaches human viral surveillance in wastewater systems for public health monitoring (Abstract) by testing for specific enteric viral genotypes, especially human fecal adenovirus group F, which is used as a viral indicator because it is more persistent in the environment than the fecal indicator bacteria often used for water quality monitoring, due to human adenovirus extreme persistence (i.e. taking into account for time passed since stool[ing]).
Regarding instant claim 7, instant application recites
determining, with the Point of Care device, a risk for spread of infection of the region based on the viral load information; and displaying, with the Point of Care device, the risk for spread of infection of the region.
The prior art to Farkas teaches human viral pathogen surveillance in wastewater systems for public health monitoring (Abstract), however, Farkas does not teach relaying the infection risk information and a point of care/portable device, only transporting samples to a laboratory.
The prior art to Fuernkranz teaches portable POC testing of pathogens. The system supports a plurality of reader-analyzer instruments of different sizes and capabilities, including portable multi-cartridge units (a portable instrument 54) to small, shirt-pocket- sized units such as handheld instruments... (an assay cartridge comprising an extraction chamber for placement of at least a portion of the sample of waste water thereon…). The reader-analyzer instruments 176 analyze samples, whether taken from a patient or from the environment… implemented using any one of a variety of different reader-analyzer instruments, such as genetic assay analysis platforms including the model 7500 fast real-time PCR system. The handheld instrument …. can include an embedded internal controller so that no external computer (microcontroller) is required. Any instrument that can provide data on the analysis of pathogens such as identifying a strain of bacteria, fungi, virus, and the like, may be integrated into the genetic surveillance and analysis system [0039-0042] (teach infection determination in real time…configuring a portable Point of Care device… and a module comprising a microcontroller configured to perform…).
The prior art to Barrett teaches a method for conveying a respiratory disease risk (viral infection risk via viral load levels) assessment for a geographic region and its associated regional parameters characterizing the geographic region at a given point in time including local demographics, census tract data (census data) and environmental conditions within the region (Barrett at claim 1 and [0017-0021]). The user’s client device and medical sensor, in communication with an application server, receives these risk maps/reports [FIGs. 4-7G] to display 310, 440.
Regarding instant claim 21, instant application recites:
obtaining, with the Point of Care device, demographic information about confirmed cases associated with the viral load; identifying, with the Point of Care device, gaps in testing based on a reconciliation between the demographic information and the viral load information; and communicating, with the Point of Care device, the gaps in testing to a user.
The prior art to Farkas teaches human viral surveillance in wastewater systems for public health monitoring (Abstract). However, Farkas does not teach data variance from demographic and viral load information and a point of care/portable device, only transporting samples to a laboratory.
The prior art to Fuernkranz teaches portable POC testing of pathogens. The system supports a plurality of reader-analyzer instruments of different sizes and capabilities, including portable multi-cartridge units (a portable instrument 54) to small, shirt-pocket- sized units such as handheld instruments... (an assay cartridge comprising an extraction chamber for placement of at least a portion of the sample of waste water thereon…). The reader-analyzer instruments 176 analyze samples, whether taken from a patient or from the environment… implemented using any one of a variety of different reader-analyzer instruments, such as genetic assay analysis platforms including the model 7500 fast real-time PCR system. The handheld instrument …. can include an embedded internal controller so that no external computer (microcontroller) is required. Any instrument that can provide data on the analysis of pathogens such as identifying a strain of bacteria, fungi, virus, and the like, may be integrated into the genetic surveillance and analysis system [0039-0042] (teach infection determination in real time…configuring a portable Point of Care device… and a module comprising a microcontroller configured to perform…).
The prior art to Barrett teaches a method for conveying a respiratory disease risk and updating a user for a geographic region and its associated regional parameters. The dose-dependent respiratory risk from an environmental toxin is analogous to respiratory risk of infection from an environmental agent/communicable pathogen with assayed viral load levels. The assessment of the geographic region at a given point in time incorporates local demographics, census tract data (census data) and environmental conditions within the region (Barrett at claim 1 and [0017-0021]). The user’s client device and medical sensor, in communication with an application server, receives these risk maps/reports [FIGs. 4-7G] through display modules 310, 440.
Neither Farkas nor Barrett teach identifying gaps in testing based on a reconciliation between the demographic information and the viral load information. However, Rogan teaches an analogous method for identifying and quantifying populations exposed to environmental hazards, including a radiation agent or communicable infectious agent/COVID-19 hotspots, such as locations of hotspots, across a geographic region [Abstract]. Rogan tracks point-to-point spatial interpolation of COVID-19 counts and further, reconstructs geographic incidence using disease-related count data against geographic boundaries and population data obtained from the census bureau when additional geographic resolution of hotspot predictions are needed [0039-0040] (obtaining demographic information about confirmed cases associated with the viral load). Data quality analysis compares and validates both case count spatial and temporal information, looking for missing and outlier data and for conveying on dedicated map layers with result annotations [0036-0037] (identifying gaps in testing based on a reconciliation between the demographic information and the viral load information)
Regarding instant claim 22, instant application recites:
wherein identifying gaps in testing based on a reconciliation between the demographic information and the viral load information further comprises: determining, with the Point of Care device, a location-based model based on sampling information from that location, demographics, and infection rate; determining, with the Point of Care device, a predicted infection rate for the location by inverting the location-based model; and comparing the predicted infection rate to the demographic information about confirmed cases associated with the viral load.
The prior art to Farkas teaches human viral surveillance in wastewater systems for public health monitoring (Abstract). However, Farkas does not teach location-based infection risk based on demographic/viral load information and a point of care/portable device, only transporting samples to a laboratory.
The prior art to Fuernkranz teaches portable POC testing of pathogens. The system supports a plurality of reader-analyzer instruments of different sizes and capabilities, including portable multi-cartridge units (a portable instrument 54) to small, shirt-pocket- sized units such as handheld instruments... (an assay cartridge comprising an extraction chamber for placement of at least a portion of the sample of waste water thereon…). The reader-analyzer instruments 176 analyze samples, whether taken from a patient or from the environment… implemented using any one of a variety of different reader-analyzer instruments, such as genetic assay analysis platforms including the model 7500 fast real-time PCR system. The handheld instrument …. can include an embedded internal controller so that no external computer (microcontroller) is required. Any instrument that can provide data on the analysis of pathogens such as identifying a strain of bacteria, fungi, virus, and the like, may be integrated into the genetic surveillance and analysis system [0039-0042] (teach infection determination in real time…configuring a portable Point of Care device… and a module comprising a microcontroller configured to perform…).
. The prior art to Barrett teaches a method for conveying a respiratory disease risk and updating a user for a geographic region and its associated regional parameters. The dose-dependent respiratory risk from an environmental toxin is analogous to respiratory risk of infection from an environmental/communicable pathogen with assayed viral load levels. The assessment of the geographic region at a given point in time incorporates local demographics, census tract data (census data) and environmental conditions within the region (Barrett at claim 1 and [0017-0021]) (location-based model based on sampling information from that location, demographics, and infection rate).
Neither Farkas nor Barrett teach comparing the predicted infection rate to the demographic information about confirmed cases associated with the viral load. However, Rogan tracks point-to-point spatial interpolation of COVID-19 counts and further, reconstructs geographic incidence using disease-related count data against geographic boundaries and population data obtained from the census bureau when additional geographic resolution of hotspot predictions are needed [0039-0040]. Data quality analysis uses both case count spatial and temporal information, including missing data, and separate outliers on dedicated map layers with result annotations [0036-0037] (comparing the predicted infection rate to the demographic information about confirmed cases associated with the viral load).
Regarding instant claim 24, instant application recites:
wherein determining the viral load information further comprises generating a test result corresponding to cells of the suspected viral pathogen that have been lysed by the assay cartridge.
The prior art to Farkas teaches human viral surveillance in wastewater systems for public health monitoring (Abstract). However, Farkas does not teach sample lysis.
The prior art to Fuernkranz teaches the ISAP module can accept samples from the environment or from a patient, such as nasal, throat, and/or nasopharyngeal swabs… treats samples of liquid expressed from these swabs to facilitate lysis and ready the sample for purification. The nucleic acids produced are highly pure and free of cross-contamination [0060]. The RNA can be extracted from many cells, ideally from a single cell type, then converted to cDNA. In various embodiments, the cDNA may be amplified in quantity by PCR [00118].
Regarding instant claim 25, instant application recites:
further comprising outputting, using the Point of Care device, the test result to a portable electronic device.
The prior art to Farkas teaches human viral surveillance in wastewater systems for public health monitoring (Abstract). However, Farkas does not teach outputting, using the Point of Care device, the test result to a portable electronic device.
The prior art to Fuernkranz teaches an internal controller (microcontroller) can automatically coordinate transfer of data acquired by the handheld instrument (output) to another device for further analysis such as P2P communication to another handheld instrument, a portable instrument, a laboratory instrument 52, a local computer, a network, or a distant server. Further, Fuernkranz teaches a user interface module 625 communicates with the pathogen calculator module 607, the context acquisition module 609, and the local storage module 618. The user interface module 620 can include a display, a keypad, a touchscreen, a keyboard, a mouse, and/or any other suitable forms of input and output [00166]. The web server 640 allows for remote control and viewing of the database 636 and control of the analysis module 638, as described above. The web server 640 can include data visualization and summarization responses to queries, or can provide customizable real-time streaming of data and alerts or incorporate contextual data that further describes the environment in which the sample was taken or that the host existed in. This information includes environmental/climate data (such as that provided by the National Oceanic and Atmospheric Administration), demographic data (such as that provided by the U.S. Census Bureau) [00168-00169].
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Farkas’s viral load surveillance in human wastewater systems for public health monitoring (Abstract) to incorporate Fuernkranz’s portable POC testing and output device with Barrett’s geographic disease displays and Rogan’s additional statistical analysis of health risk levels against census data. Combining these prior art elements would have been obvious because Farkas’s teaching of viral wastewater surveillance with Fuernkranz’s portable POC testing, Barrett’s geographic disease, and Rogan’s statistical point-to-point spatial interpolation of COVID-19 counts (“spatial interpolation can more precisely define these locations of emerging hotspots compared to area-to-area approaches. The results of kriging and densification are displayed as a geostatistical layer, created using a kriging model with measurements at the existing locations” [0040]), improves recognition of specific regions that patients may avoid and inform health care providers or municipal decision makers about the regional risks associated with a tracked disease (Barrett at [0007]). One of ordinary skill in the art would predict combining Farkas, Barrett, and Rogan teachings with a reasonable expectation of success because said prior art are analogously applicable to local and regional analysis of disease patterns. Therefore, the invention is prima facie obvious.
Claims 4 and 23 are rejected under 35 U.S.C. § 103 as being unpatentable over Farkas et al. (IDS cited; herein Farkas), in view of Fuernkranz et al. (WO-2006116455 A2; System for genetic surveillance and analysis; 11-02-2006, newly PTO 892 cited), and in view of Barrett et al. (IDS cited, herein Barrett) and in further view of Rogan et al (Rogan PK et al (US20210057109A1, IDS cited, herein Rogan), as applied to claim 1 above, and in further view of Manor et al (IDS cited, herein Manor). Any newly applied rejection/portion is necessitated by instant application amendment.
Regarding instant claim 4, instant application recites
wherein diagnostic analysisreal-time Polymerase chain reaction; and performing targeted sequencing based on a genome of a virus associated with the viral load.
The prior art to Farkas teaches concentrations (viral loads) for targeted enteric genotypes (NoVGI, NoVGII, HAV, HEV, SaVGI and MgV) underwent two triplex TaqMan one-step qRT-PCR assays and human AdV DNA qPCR assay [p.33393 Col 1-p.33394 Col 1 para 2]. Neither Farkas, Barrett, nor Rogan specifically teach sequencing after PCR of a virus associated with the viral load.
However, the prior art to Manor teaches location-specific sewage (waste water) surveillance of wild type polio virus, via sequencing viral isolates quantified with qRT-PCR [Manor at p.3 Col 1 para 2, and FIG 1B, 2, and 4].
Regarding instant claim 23, instant application recites:
in order to determine whether to pass the sample onto targeted sequencing diagnostics. wherein the diagnostics using results obtained from a real-time polymerase chain reaction diagnostics performed on the sample of waste water in order to determine whether to pass the sample of waste water onto targeted sequencing diagnostics.
The prior art to Farkas teaches concentrations (viral loads) for targeted enteric genotypes (NoVGI, NoVGII, HAV, HEV, SaVGI and MgV) underwent two triplex TaqMan one-step qRT-PCR assays and human AdV DNA qPCR assay [p.33393 Col 1-p.33394 Col 1 para 2]. Neither Farkas, Barrett, nor Rogan specifically teach sequencing a virus associated with the viral load.
wherein the diagnosticsusing results obtained from a real-time polymerase chain reaction diagnostics performed on the sample of waste water in order to determine whether to pass the sample of waste water onto targeted sequencing diagnostics.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Farkas to incorporate Fuernkranz’s portable POC testing and output device with Barrett’s geographic disease displays, Rogan’s statistical analysis of viral and population data, and Manor’s sequencing technique. Combining these prior art elements would have been obvious because Farkas’s teaching of viral wastewater surveillance, Fuernkranz’s portable POC testing collections, and and Barrett’s geographic disease displays with Rogan’s statistical analysis, combined with Manor’s viral isolate sequencing technique, provides a more accurate detection of subclinical infections and enable early public health interventions [Manor at Abstract]. One of ordinary skill in the art would predict combining Farkas, Fuernkranz, Barrett, Rogan, and Manor’s teachings with a reasonable expectation of success because said prior art are analogously applicable to environmental surveillance in service of community health. Therefore, the invention is prima facie obvious.
Response to 103 Remarks
The Applicant's remarks [p.5-7], filed 04/02/2026 have been fully considered regarding the previous Office Action. The Applicant’s assertions, regarding independent claim 1 amendments, and its dependent claims, were not persuasive as set forth in the above rejection. Any newly recited portions, references, or rejections, as set forth above, are necessitated by instant application amendments. Applicant asserts:
[Examiner] combines the various references in a way that would not have been contemplated but for the Examiner looking backwards from the present specification in a manner that neglects the strictures set forth in Wesslau and W. L. Gore. With particular regard to Fuernkranz, there is no evidence that its large, network-based approach is compatible with the relatively autonomous approach of claim 1… As such, at Least Fuernkranz teaches away from these other references. Such teaching away is still recognized as negating any motivation… when the features that are missing from the primary reference to Farkas are being supplemented by the secondary reference to Fuernkranz, a strong presumption is created that the references teach away from one another, regardless of whether or not physical combinability is at issue. All told, the Applicants respectfully submit that a prima facie case of obviousness can no longer be supported.
However, Applicant asserts Fuernkranz, is a “large, network-based approach” and is not “compatible with the relatively autonomous approach of claim 1”. The prior art to Fuernkranz clearly demonstrates use of analogous Point of Care laboratory devices (handheld instrument/another handheld instrument) in a system which can be configured to communicate locally (with “another handheld instrument…local computer”… The handheld instrument …. can include an embedded internal controller so that no external computer (microcontroller) is required.[0039-0042]) and with a demographic/geographic database in order to correlate and display pathogen calculations with contextual data, as discussed in the above 103 rejection (p28-29):
The prior art to Fuernkranz teaches an internal controller (microcontroller) can automatically coordinate transfer of data acquired by the handheld instrument (output) to another device for further analysis such as P2P communication to another handheld instrument, a portable instrument, a laboratory instrument 52, a local computer, a network, or a distant server. Further, Fuernkranz teaches a user interface module 625 communicates with the pathogen calculator module 607, the context acquisition module 609, and the local storage module 618. The user interface module 620 can include a display, a keypad, a touchscreen, a keyboard, a mouse, and/or any other suitable forms of input and output [00166]. The web server 640 allows for remote control and viewing of the database 636 and control of the analysis module 638, as described above. The web server 640 can include data visualization and summarization responses to queries, or can provide customizable real-time streaming of data and alerts or incorporate contextual data that further describes the environment in which the sample was taken or that the host existed in. This information includes environmental/climate data (such as that provided by the National Oceanic and Atmospheric Administration), demographic data (such as that provided by the U.S. Census Bureau) [00168-00169]
Further, Applicant asserts that Examiner’s conclusion of obviousness is based on improper hindsight reasoning. However, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). "A factfinder should be aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning. . . . Rigid preventative rules that deny factfinders recourse to common sense, however, are neither necessary under our case law nor consistent with it." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007) (internal quotations omitted). The combination of two or more references is "hindsight" because "express" motivation to combine the references is lacking. However, there is no requirement that an "express, written motivation to combine must appear in prior art references before a finding of obviousness." Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See KSR, 550 U.S. at 402, 82 USPQ2d at 1389 ("The diversity of inventive pursuits and of modern technology counsels against confining the obviousness analysis by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasizing the importance of published articles and the explicit content of issued patents.") See also Uber Techs., Inc. v. X One, Inc., 957 F.3d 1334, 1339-40, 2020 USPQ2d 10476 (Fed. Cir. 2020) ("[W]e hold that the Board erred when it determined that a person of ordinary skill in the art would not have been motivated to combine the teachings of Okubo with Konishi's server-side plotting to render obvious the limitation ‘software ... to transmit the map with plotted locations to the first individual.’ This combination does not represent ‘impermissible hindsight’…. Rather, because Okubo's terminal-side plotting and Konishi's server-side plotting were both well known in the art, and were the only two identified, predictable solutions for transmitting a map and plotting locations, it would have been obvious to substitute server-side plotting for terminal-side plotting in a combination of Okubo and Konishi."). (see MPEP 2145.X.A). Analogously, one of ordinary skill in the art would predict combining Farkas’ wastewater surveillance of viral pathogens to incorporate Fuernkranz’s portable POC testing and output device with Barrett’s geographic disease displays, Rogan’s statistical analysis of viral and population data, and Manor’s sequencing technique has a reasonable expectation of success because said prior art are analogously applicable to environmental surveillance in service of community health, and supports a determination of prima facie obviousness.
Also, Applicant’s assertion that the cited prior art Fuernkranz reference "teaches away" from the claimed invention and thereby, does not support a determination of obviousness is unpersuasive. According to the MPEP, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (Claims were directed to an epoxy resin based printed circuit material. A prior art reference disclosed a polyester-imide resin based printed circuit material, and taught that although epoxy resin based materials have acceptable stability and some degree of flexibility, they are inferior to polyester-imide resin based materials. The court held the claims would have been obvious over the prior art because the reference taught epoxy resin based material was useful for the inventor’s purpose, applicant did not distinguish the claimed epoxy from the prior art epoxy, and applicant asserted no discovery beyond what was known to the art.). Furthermore, "the prior art’s mere disclosure of more than one alternative (Fuernkranz’s network vs. local device communication) does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) ("Although Oez [the prior art] used a white pigment with a cross-linking polymer, it does not discourage a skilled artisan from using the white pigment without a cross-linking polymer or lead the skilled artisan in a direction divergent from the path taken in the Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the Board's finding that Oez does not teach away from the proposed combination.") (see MPEP 2145.D.1.).
Conclusion
No claims are allowed.
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.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vy Rossi, whose telephone number is (703) 756-4649.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached on (571) 272-2249. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/VR/
Examiner
Art Unit 1685
/MARY K ZEMAN/Primary Examiner, Art Unit 1686
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