DETAILED ACTION
Applicant's response, filed 06/17/2025, 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 Final rejection of 01/28/2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/17/2025 has been entered.
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.
Claim 5 is newly cancelled. Claims 6 and 8-20 were previously cancelled.
Claims 24-25 are newly added.
Claims 1-4, 7, and 21-25 are rejected.
Election/Restrictions
Election was made without traverse, in the reply filed on 06/13/2024, is acknowledged. Applicant elected Group (I) (claims 1-7: a method using wastewater to detect pathogens) in response to the 04/17/2024 Restriction/Election requirement. Claims 8-20 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, in response to restriction, there being no allowable generic or linking claim. Claims 8-20 are further cancelled in the 06/17/2025 Remarks.
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).
Withdrawn Rejections/Objections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn in view of the amendments filed 06/17/2025. On further consideration, new rejections/portions are recited below.
The objection of claim 1 limitation “census in information ” is hereby withdrawn; its cancellation moots the rejections.
All rejections of claim 5 are hereby withdrawn; its cancellation moots the rejections.
The rejection under 35 U.S.C. 112(b) - is withdrawn with respect to claim 23 limitation term “gate keeper” in view of instant application amendments. The previous rejection of claims 2 and 3 remains.
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 conveying, with the Point of Care device, the viral load information over a map associated with the region by: generating a first layer associated with the viral load information; generating a second layer associated with population information;…in order to identify areas of high risk for a potential outbreak based on the viral load of the samples and the census in information..
Claim 2 recites taking into account for a dilution of the sample…
Claim 3 recites taking into account for a time that has passed since stool in the sample has been excreted.
Claim 7 recites determining a risk for spread of infection of the region based on the viral load information…
Claim 21 recites …identifying gaps in testing … and communicating the gaps in testing to a user.
Claim 22 recites determining a location-based model … determining a predicted infection rate for the location by inverting the location-based model; and comparing the predicted infection rate …
Claim 23 recites …in order to determine whether to pass the sample 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 that, upon receipt o
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 the risk for spread of infection of the region…
Claim 21 recites obtaining demographic information and the viral load information
Claim 22 recites sampling information from that location, demographics, and infection rate
Claim 23 recites using real-time polymerase chain reaction diagnostics … sample ..targeted sequencing diagnostics.
Claim 24 recites generating a test result corresponding to cells of the suspected 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) represents 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 that, upon receipt o
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 the risk for spread of infection of the region…
Claim 21 recites obtaining demographic information and the viral load information
Claim 22 recites sampling information from that location, demographics, and infection rate
Claim 23 recites using real-time polymerase chain reaction diagnostics … sample ..targeted sequencing diagnostics.
Claim 24 recites generating a test result corresponding to cells of the suspected 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 arguments (p1-5), filed 06/17/2025, 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:
not directed to an abstract idea/judicial exception (“claim 1 as amended recites that it is the portable Point of Care device that determines, generates and conveys viral load information associated with a particular sample, where a microcontroller that makes up a portion of the Point of Care device is particularly recited. These individual recitations cannot practically be applied in one’s mind in order to perform diagnostics on the sample of waste water, determine a corresponding viral load and then convey corresponding viral load information over a map associated with the region by generating multiple map layers and displaying the results. As such, none of the individual elements identified by the Examiner recite any mental steps on amended claim 1) and
a technological solution to a technological problem (“potentially dangerous exposure of healthcare workers and other citizens to such pathogens, such as those seen recently with the SARS-CoV-2 and COVD-19 outbreaks. Some of the same passages from the original specification further describe how previous efforts may lead to shortages of testing reagents, as well as often requiring expensive, complex analysis instruments. The technological solution by the current 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… high risks for a potential outbreak based on the viral load information that is generated by the Point of Care device can be readily displayed…[so] viral load information associated with the region in order to identify areas of high risk for a potential outbreak based on the viral load information) take place within or by the presently-recited Point of Care device”).
However, the arguments presented are not persuasive for the following reasons:
Regarding intended use limitations, the exemplary steps in independent claim 1 are considered intended use limitations: “to perform diagnostics on the sample of waste water, determine a corresponding viral load” and “in order to identify areas of high risk”. Applicant can consider changing to an active method step of “performing” and “identifying” respectively, to address intended use phrasing. Further, “the technological solution by the current claims is that by using a portable Point of Care device to perform molecular-based virus testing on a patient, in-home… without having to unduly expose the patient or others to certain pathogens” is not claimed and also constitutes an intended use.
As discussed above, it is agreed that “to perform diagnostics on the sample of waste water, determine a corresponding viral load” recitations cannot practically be performed in one’s mind. Rather, this exemplary limitation regarding physical testing steps/diagnostics was examined as an element in addition to the judicial exception/abstract idea/mental process which may provide practical integration, then inventive concept. 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 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 constitute field of use limitations/extra-solution steps, which were necessary to provide the data used in the judicial exception/abstract idea/mental process.
Secondly, the Applicant asserts instant amended claims with a POC device is a practical application under the consideration (MPEP 2106.04(d).I ) by an improvement to technology, which integrates the mental process steps. 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 abstract idea of the instant limitations is not confined to a particular technology or machine, not claiming limitations which solve a problem rooted in or arising from the use of a particular technology to allow a function that it previously was not 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). The generic POC is a portable tool for accomplishing an abstract idea, without evidence of transformation of the particular technology. 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. Incorporating asserted unique aspects of the POC device [0039-0052], such as the digital droplet modules, microfluidic chip, for identification via encapsulation of drops in ligation, RCA isothermal amplification, color changing dye, combinations with a smartphone reader would add particularity to a machine beyond a portable POC which accepts cartridges for nucleic acid quantification and data output.
It is the integration of the judicial exception with a practical application that takes a judicial exception into the realm of being patent-eligible. If the claim is sufficiently computer-related and/or improves its otherwise relevant field, at least the following Federal Circuit opinions may be relevant to an argument in this context: Enfish/TLI, McRO, BASCOM and Synopsys, but also see In re... Stanford (CAFC 3/11/2021, precedential). Since several of these opinions relate to inventions which were to some extent computer-related, arguments related to these opinions should clearly identify the particular field in which asserted improvement occurs in the claims. These arguments generally rely on there being an "improvement" clearly on the record and in the independent claims. 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. Any newly applied rejection/portion is necessitated by instant application amendment. 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.
Regarding claim 1, the term “at least one suspected pathogen” in “sample of waste water that includes (i) at least one suspected pathogen … determining, with the Point of Care device, viral load information associated with the sample …” is indefinite. The term pathogen is generic and broad, and does not require a virus to be present, which is the pathogen required to obtain a viral load. As claimed, said waste water sample limitation is a contingent limitation—contingent upon providing viral load information. The limitation is indefinite as to whether subsequent steps are performed if they utilize said viral load information and said pathogen is not a virus (see MPEP 2103.I.C.).
Regarding claims 1-4, and 23 use the term “diagnostic analysis” in “performs a diagnostic analysis of the waste water …” which is indefinite for whether it is the antecedent limitation for the term “diagnostics” used in claims 1, 23, as in “perform diagnostics on the sample of waste water …” and “comprises using real-time polymerase chain reaction diagnostics performed on the sample in order to determine whether to pass the sample onto targeted sequencing diagnostics.” Choosing one of the terms to consistently describe active testing steps is preferred, and for compact prosecution, diagnostic analysis will be interpreted as diagnostics. Further, the term diagnostics is generic and broad, and does not delineate active steps for one of ordinary skill in the art to accomplish said “diagnostics” on said sample (e.g. ELISA, PCR, hybridization…using real-time polymerase chain reaction diagnostics). Claim 1 does not set forth how diagnostics are identified or completed, nor whether diagnostics alone provide the viral load information without other calculating steps. Independent claim 1 does not appear to recite the minimally sufficient elements required for the instant method. Clearer claim language with active steps to accomplish the intended method is requested.
Regarding claim 1, the Point of Care device (POC) depicted in FIGs 1-3 do not appear to be equipped to convey…display…generating… said results over a map [0015-0024, FIGs. 9-18: wastewater dashboard/analysis panel] as claimed in “conveying, with the Point of Care device, the viral load information over a map associated with the region by: 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. The POC does not appear to claim the necessary elements required for these steps, such as transmitting POC results to a device capable of providing an analysis panel for displaying/conveying the aggregated information.
Regarding claim 1, the relative limitation of “high risk” as in “ to identify areas of high risk for a potential outbreak based on the viral load of the samples and the census in information…” 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 “high risk” of a potential outbreak. Further, it is indefinite the steps for combining the census information with the viral load to give a risk. The specification does not provide a standard for ascertaining the requisite degree of risk (e.g. 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, intended use limitation “to perform” as opposed to “performing” in “microcontroller configured to perform diagnostics…” is indefinite. Language that suggests but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation, raising a question as to its limiting effect (see MPEP 2103.I.C.). Clearer claim language with an active step to accomplish the intended method is requested.
Regarding claim 1, the limitation “conveying, with the Point of Care device, the viral load information over a map associated with the region” is indefinite as to active steps of applying information to a map. For compact prosecution, this term will be interpreted as conveying… information layered over a map for use with the disclosed display.
Regarding claim 1, the term “population information” in ”generating a second layer associated with population information” is 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 for a dilution of the sample.” and “comprises taking into account for a time that has passed since stool in the sample has been excreted.” remains 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.
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 configured to perform…. in claim 1 is being interpreted under 35 U.S.C. 112(f) with module and microcontroller as generic placeholders for means, and “configured to perform diagnostics on the sample of waste water…” 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 that, upon receipt othat(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 determining, with the Point of Care device, viral load information associated with the sample; and conveying, with the Point of Care device, the viral load information over a map associated with the region by: 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 otherin order to identify areas of high risk for a potential outbreak based on the viral load
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 indepe