DETAILED ACTION
Applicant’s response, filed Oct 8 2025, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Claim Status
Claims 1-3 and 5-21 are pending.
Claim 4 is canceled.
Claim 21 is newly added.
Claims 3, 11, and 13 are objected to.
Claims 1-2, 5-12, and 14-21 are rejected.
Claims 3 and 13 are allowed.
Priority
The instant Application claims domestic benefit to US provisional application 62/645,021, filed Mar 19 2018. As set forth in previous Office Actions, the provisional application does not support all of the limitation of claims 6-9 and 11-20.
Applicant's claim for the benefit of a prior-filed application, PCT/US2019/022913, filed Mar 19 2019, is acknowledged.
Accordingly, each of claims 1-3, 5, and 10 are afforded the effective filing date of Mar 19 2018 and each of claims 6-9 and 11-21 are afforded the effective filing date of Mar 19 2019.
Claim Objections
The outstanding objections to the claims are withdrawn in view of the amendments submitted herein.
The claims are objected to because of the following informalities. The instant objection is newly stated and is necessitated by claim amendment.
Claim 11, 7th limitation, recites on the 2nd to last line “a human reference population”, which should be amended to recite “the human reference population” because the limitation previously recites a human reference population on line 2.
Claim Rejections - 35 USC § 101
The outstanding rejection from the previous Office Action for claim 20 as being directed to non-statutory subject matter is withdrawn in view of the amendment of a “non-transitory computer readable medium”.
The outstanding rejection from the previous Office action for claims 3 and 13 are withdrawn in view of the amendments and arguments submitted herein. Specifically, claims 3 and 13 recite a lateral flow assay test strip which comprises a plurality of zones which comprise immobilized compounds configured to bind to the plurality of human subject biomarkers comprising salivary alpha amylase (AMY1), Flt3 ligand (FLT3L), and monocyte chemotactic protein 1 (MCP1), which an unconventional additional element at Step 2B that provides for significantly more than the recited judicial exceptions.
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 1-2, 4-12, and 14-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more. Any newly recited portions are necessitated by claim amendment.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, 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
Step 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:
Step 1
With respect to Step 1: yes, claims 1-2, 4-12, and 14-21 are directed to a method and an apparatus, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
The claims also recite a law of nature or a natural phenomenon. The MPEP at 2106.04(b) further explains that laws of nature and natural phenomena include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) as well as a law of nature or a natural phenomenon are as follows:
Independent claim 1: determining… based on the plurality of human subject biomarker concentration values for the plurality of human subject biomarkers, a human subject test statistic by standardizing and weighing each of the plurality of human subject concentration values and determining a sum across the plurality of human subject concentration values as standardized and weighted; and
comparing… the human subject test statistic to a test statistic threshold, wherein the test statistic threshold is derived based in part on non-human primate (NHP) subject data, wherein the NHP subject data is from an NHP source population including NHP subjects having the condition, and wherein standardizing respective ones of the plurality of human subject concentration values comprises determining a standardized value (Z i) by evaluating Zi = (Li - Mi)/Si, for a human reference population, where the human reference population comprises human subjects not having the condition, wherein Li, for each human subject biomarker concentration value (Ci) of the plurality of human subject biomarker concentration values, is a natural log transformation (ln(Ci)), Mi represents a mean value of a natural log of biomarker concentrations in the human reference population, and Si represents a standard deviation of the natural log of biomarker concentrations in the human reference population.
Independent claim 11: convert, for each zone of the plurality of zones, a respective light intensity measurement of the plurality of light intensity measurements into a human subject concentration value for the biomarker of the plurality of human subject biomarkers associated with a respective zone of the plurality of zones;
determine, based on the plurality of human subject biomarker concentration values for the plurality of human subject biomarkers, a human subject test statistic by standardizing and weighing each of the plurality of human subject concentration values and determining a sum across the plurality of human subject concentration values as standardized and weighted;
compare the human subject test statistic to a test statistic threshold, wherein the test statistic threshold is derived based on non-human primate (NHP) subject data, wherein the NHP subject data is from an NHP source population including NHP subjects having the condition and wherein standardizing respective ones of the plurality of human subject concentration values comprises:
determining a standardized value (Z i) by evaluating Zi = (Li - Mi)/Si, for a human reference population, where the human reference population comprises human subjects not having the condition and wherein Li, for each human subject biomarker concentration value (Ci) of the plurality of human subject biomarker concentration values, is a natural log transformation (ln(Ci)), Mi represents a mean value of a natural log of biomarker concentrations in a human reference population, and Si represents a standard deviation of the natural log of biomarker concentrations in the human reference population.
Dependent claim 2: converting… for each zone of the plurality of zones, the intensity of light into a respective human subject concentration value of the plurality of human subject concentration values and for a respective biomarker of the plurality of human subject biomarkers associated with a respective zone of the plurality of zones.
Dependent claims 5-7, 9-10, 12, 14-16, and 18-19 recite further steps that limit the judicial exceptions in independent claims 1 and 11 and, as such, also are directed to those abstract ideas. For example, claims 5-7, 10, 14-16, and 19 further limit determining the human subject test statistic; claim 10 further limits the test statistic threshold; claim 12 further limits the human subject biomarkers to MCP1 and the test statistic threshold; and claim 18 further limits standardizing the respective ones of the plurality of human subject concentration values.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually determine whether a subject has a condition based on their biomarker levels. Without further detail as to the methodology involved in “converting”, “determining”, and “comparing”, under the BRI, one may simply, for example, use pen and paper to convert a light intensity measurement into a human subject concentration value for the biomarker, determine a human test subject statistic based on the concentration value, compare the test statistic to a threshold derived from non-human primate subject data, and determine that the subject has the condition. Some of these steps, including determining a human subject test statistic and the test statistic threshold, and those recited in the dependent claims require mathematical techniques as the only supported embodiments, as is disclosed in the specification at: [0025-0029; 0038-0052; 0076-0077].
The claims also recite a natural relationship between a human subject’s biomarker concentration and the condition the subject has. Therefore, the claims recite a law of nature or a natural phenomenon.
Therefore, claims 1 and 11 and those claims dependent therefrom recite an abstract idea and a law of nature/natural phenomenon [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions 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 judicial exceptions are 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 exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 1: determining, via an optical reader and data analyzer of an apparatus, a plurality of human subject biomarker concentration values associated with a plurality of human subject biomarkers and a human subject based on intensity of light reflected from a lateral flow assay test strip received by a housing of the apparatus, wherein the plurality of human subject biomarkers is associated with a condition without an accessible human reference population; and
outputting an indication, by the data analyzer and based on the human subject test statistic exceeding the test statistic threshold, predictive of the human subject having the condition.
Independent claim 11: receiving a test strip that supports lateral flow of a fluid sample along a lateral flow direction and comprises a plurality of zones wherein each of a plurality of human subject biomarkers is associated with one zone of the plurality of zones, and wherein a control is associated with at least one zone of the plurality of zones, wherein the plurality of human subject biomarkers are associated with a condition without an accessible human reference population;
obtain a plurality of light intensity measurements from the plurality of zones of the test strip; and
output an indication, based on the human subject test statistic exceeding the test statistic threshold, predictive of the human subject having the condition.
Dependent claim 2: measuring, by the optical reader of the apparatus, the intensity of light reflected from each of a plurality of zones of a lateral flow assay test strip using optoelectronic components of the optical reader, wherein each of the plurality of human subject biomarkers is associated with one zone of the plurality of zones, and wherein a control is associated with at least one zone of the plurality of zones.
Dependent claim 8: one or more of the test statistic threshold, Mi, Si, the coefficient Ai, the coefficient Bi, the concentration minimum, the concentration maximum, or the upper threshold value is received by the data analyzer via a radio frequency identification (RFID) tag affixed to a cartridge containing the lateral flow assay test strip.
Dependent claims 9 and 18: outputting the indication that the human subject has the condition to a display. Claim 9 also further limits the later flow assay strip to comprising a plurality of zones which comprise immobilized compounds.
Dependent claim 17: receive at least one of the test statistic threshold, Mi, Si, the coefficient Ai, the coefficient Bi, the concentration minimum, the concentration maximum, and the upper threshold value by the RFID reader via a radio frequency identification (RFID) tag affixed to a cartridge containing the lateral flow assay test strip, the apparatus comprising the cartridge.
The claims also include non-abstract sample processing and computing elements. For example, independent claim 1 includes a reader and a data analyzer, independent claim 11 includes an apparatus comprising a housing comprising a port, a reader, and a data analyzer, dependent claim 17 includes an RFID reader, dependent claim 18 includes a display, dependent claim 20 includes a non-transitory computer readable medium with computer-readable instructions for carrying out the method of claim 1, and dependent claim 21 further includes that the optical reader is arranged within the housing and comprises optoelectrical components comprising lights sources and light detectors configured to emit light toward each of the plurality of zones of the test strip and capture light in response thereto which corresponds to the plurality of light intensity measurements.
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “determining, via a reader and data analyzer of an apparatus, a plurality of human subject biomarker concentration values associated with a human subject based on intensity of light reflected from a lateral flow assay test strip received by a housing of the apparatus” data in claims 1, 8, and 17, “receiving a test strip” in claim 11, and “measuring” or “obtaining” light intensity measurements by a reader in claims 2 and 11, and to data outputting, such as “outputting” an indication in claims 1, 9, 11, and 18, perform functions of collecting and outputting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Further steps directed to additional non-abstract elements of the sample processing and computing elements do not describe any specific sample processing or computational steps by which the physical components of the device perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, and therefore the claim does not integrate that judicial exceptions into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc.… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (MPEP 2106.05(f)).
The specification does not provide a clear explanation for how the additional elements provide these improvements. Therefore, the additional elements do not clearly improve the functioning of a computer, or comprise an improvement to any other technical field. Further, the additional elements do not clearly affect a particular treatment; they do not clearly require or set forth a particular machine; they do not clearly effect a transformation of matter; nor do they clearly provide a nonconventional or unconventional step (MPEP2106.04(d)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: 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 claims, the prior art review to Vashist et al. (Analytical Bioanalytical Chemistry, 2014, 406:3263-3277; previously cited) discloses that using a lateral flow assay test strip to measure an intensity of light is a data gathering element that is routine, well-understood and conventional in the art. Said portions of the prior art are, for example, Table 1 and p. 3267, col. 2, par. 3 through p. 3269, col. 2, par. 1. The courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)(i), Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362; TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)). The courts have also found that determining the level of a biomarker by any means is a well-understood, routine, conventional activity in the life science arts when claimed in a merely generic manner (see MPEP 2106.05(d)(II)(i), Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)), and the specification as published describes performing immunosassays using commercially available kits, peptides, and antibodies [0134-0135; 0148]. As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claim 11 and those claims dependent therefrom, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, which the courts have found to not provide significantly more when recited in a claim with a judicial exception (see MPEP 2106.06(A)). The specification as published also notes that computer processors and systems, as example, are commercially available or widely used at [0014; 0112]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the judicial exceptions (see MPEP 2106.05(b)I-III).
With respect to claim 11 and those claims dependent therefrom, the prior art review to Vashist et al. (Analytical Bioanalytical Chemistry, 2014, 406:3263-3277; previously cited) and Juntunen (University of Turku: Turku, Finland, 2018, p. 1-97; previously cited) disclose that apparatuses for measuring light intensity from a lateral flow assay with a plurality of zones for a plurality of biomarkers, comprising a housing and optoelectrical components, a port, a reader, a data analyzer, and an RFID reader, are commercially available (see at least Table 1, Fig. 1-4, and p. 3267, col. 2, par. 3 through p. 3269, col. 2, par. 1 of Vashist and Section 2.4, Table 3, and p. 48, par. 5 of Juntunen). Therefore, the claims simply append well-understood, routine, conventional devices for analyzing lateral flow assays previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)), and do not provide an inventive step.
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, instant claims 1-2, 5-12, and 14-21 are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Response to Applicant Arguments
At p. 10-12, Applicant summarizes the analysis to determine patent eligibility under 35 USC 101. At p. 12-15, Section I.A. and p. 21-24, , Section II.A.,, Applicant submits that the apparatus and method claims are not directed to an abstract idea because the rejection does not consider a substantive part of the claim limitations because the claims have not been considered as a whole. Applicant submits that the conclusion in the rejection that the claims are directed to a judicial exception ignores the remaining limitations at Step 2A, Prong 1 and 2. Applicant submits that when the claims are considered their entirety, the claims are not directed to an abstract idea but a particular apparatus that improves the relevant technology and provides meaningful limitations, similarly to PowerBlock Holdings, Inc. v. iFit, Inc. Applicant submits that claim 11 is directed to an improved analyzer apparatus when considered in its entirety. Applicant submits that claim 1 is directed to a particular method implemented by a particular apparatus which improves the relevant technology and provides meaningful limitations. Applicant submits that the additional elements of the claim apply the judicial exceptions in a meaningful way and do not generally link their use to a particular technological environment. Applicant submits that the claims provide an improvement by addressing challenges in assessing a human subject having a condition that does not have a readily available human population, resulting in an improvement to an apparatus similarly to Ex Parte Desjardins.
It is respectfully submitted that this is not persuasive. The above and previous rejection clearly considers the additional elements of claims 1 and 11 at Step 2A, Prong 2, alone and in combination with the judicial exceptions (i.e., as a whole) and find them to be elements which act in a data gathering function to provide data for the performance of the judicial exception (an optical reader determining human biomarker concentration values in claim 1; housing comprising a port; a reader configured to obtain light intensity measurements in claim 11), or are generic computer parts (data analyzer) which merely apply the judicial exceptions to a computer environment. It is noted that only those limitations which are considered to recite a judicial exception are considered at Step 2A, Prong 1, which is why these elements are not considered there in the above rejection. It is maintained that the rejection appropriately considers each of the limitations at the appropriate steps of the analysis.
Regarding PowerBlock Holdings, Inc. v iFit, Inc., it is noted that the instant claims are not analogous to those at issue in PowerBlock, which did not recite an abstract idea at Step 2A, Prong 1, because it recites a particular type of dumbbell. The methods for automatically selecting the dumbbell had real-world effects on the automatic stacking of the dumbbells. However, as discussed above, the instant claims recite judicial exceptions at Step 2A, Prong 1, and include only additional elements which gather data or apply the judicial exceptions to a computer at Step 2A, Prong 2.
It is maintained that the claims are found to be directed to predicting whether a human subject has a condition, as submitted by Applicant at p. 14, par. 1, which is not patent eligible subject matter. The claims are considered as a whole and found that determining biomarker values via an optical reader in claim 1 and the apparatus as recited in claim 11 include features for gathering the optical data from a lateral flow assay which are used by the judicial exceptions to produce an output or condition prediction, and are therefore found to function in a data gathering capacity at Step 2A, Prong 2. The additional elements of the apparatus, besides the data analyzer, do not apply the judicial exceptions at all as they merely provide data for the judicial exceptions. It is further noted that the data gathering step and the apparatus as recited are considered to be conventional at Step 2B. Nothing in the claims suggests an improvement in the actual analyzer apparatus or the data gathering step recited in the claims. The performance of the judicial exceptions leave the apparatus and the data gathering step unchanged; therefore the claims are not analogous to those examined in Ex Parte Desjardins. The purported improvement by Applicant regarding the addressing challenges in assessing a human subject having a condition that does not have a readily available human population is not convincing because such an improvement is provided by the judicial exceptions rather than the additional elements. While the analysis at Step 2A, Prong 2, considers the claims as a whole, i.e., the additional elements in combination with the judicial exceptions (see MPEP 2106.05(a)), the integration or improvement provided in the claim must flow from the additional elements and not the judicial exceptions to be considered persuasive.
At p. 15-17, Section I.A.i. and p. 24-25, Section II.A.i., Applicant submits that the apparatus and method claims does not preempt any analyzer apparatus because, as discussed above, the invention includes non-abstract components of the housing comprising a port for receiving a test strip, an optical reader, and the data analyzer.
It is respectfully submitted that this is not persuasive. While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility (Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016)). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible (Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981); “We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection”; see MPEP 2106.04). The apparatus recited in the claims is considered as an additional element which, however, does not provide a practical application at Step 2A, Prong 2, or significantly more at Step 2B, as discussed above.
At p. 17, Section I.A.ii. and at p. 25-27, Section II.A.ii., Applicant submits that the apparatus and method claims as a whole cannot be performed mentally.
It is respectfully submitted that this is not persuasive. As discussed above, Step 2A, Prong 1 considers whether the claim recites a judicial exception. Applicant is reminded that at Step 2A, Prong 1, the claims are examined limitation by limitation to identify whether the claimed concept (the specific claim limitation(s) that recite an exception) aligns with at least one judicial exception (see MPEP 2106.04(I)). That the claims recite limitations which are not considered to align with a judicial exception does not negate that the claim also recites other limitations which do align. Therefore, it is maintained that claims 1 and 11 recite a judicial exception. Those features which are recited in addition to the judicial exceptions (i.e., the additional elements recited in claims 1-2 and 11, as well as any other additional elements recited in other dependent claims), as pointed out by Applicant, and the claim as a whole are examined at Step 2A, Prong 2. The rejection above does not consider that the steps for measuring the intensity of light from biomarkers on a lateral flow assay and the associated apparatus for doing so recite a judicial exception.
At p. 17-21, Section I.B.-C. and at p. 27-30, Section II.B.-C., Applicant submits that the apparatus and method claims are directed to significantly more than the abstract idea because the apparatus involves an inventive concept over the prior art at least because such prior art analyzers do not include an (optical) reader configured to obtain a plurality of light intensity measurements across/in a plurality of zones of a test strip and/or a data analyzer that uses (e.g., converts, determines, compares) the plurality of light intensity measurements to provide the output as claimed, as is supported by the lack of prior art rejections. Applicant submits that the prior art used to demonstrate that a lateral flow assay test strip that measures intensity of light is a conventional feature only shows a test line and a control line, and not multiple lines for human subject biomarkers. Applicant submits that the application is similar to Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319 (Fed. Cir. 2020) and Exergen Corp. v. Kaz USA, Inc.
It is respectfully submitted that this is not persuasive. Applicant is reminded that the standard for assessing the conventionality of the additional elements at Step 2B of the 35 USC 101 analysis is separate and distinct from the standard for applying prior art under 35 USC 102 or 103 (see MPEP 2106.05(I)). Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. As discussed above, the only additional elements of the claims are considered to recite conventional features. Regarding Vashit, it is considered that a test line and a control line disclose a plurality of zones as instantly claimed. It is maintained that Vashit demonstrates that the housing comprising a port, an optical reader, and a data analyzer as instantly claimed are well-understood, routine, and conventional in the art. It is further noted that Step 2B requires examining only the additional elements, either alone or in combination with one another, for conventionality. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself (Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)). The limitations pointed to be Applicant and performed by the data analyzer to process the signal and produce the output are considered to recite a judicial exception as described above and are therefore not considered at Step 2B.
Applicant’s remarks regarding improvement to an apparatus at p. 19, par. 2, are found unconvincing for the same reasons as stated above.
The claims are not analogous to those in Illumina, Exergen, or Buysafe. In Illumina, the judicial exception recited in the claims was a natural phenomenon, but the claims were found patent eligible because they recite method steps which exploit the discovery of the natural phenomenon rather the natural phenomenon itself. The instant claims are dissimilar because they are directed towards using the natural phenomenon to make a diagnosis (i.e., “outputting an indication… predictive of the human subject having the condition”). The instant claims are different from those in Exergen because they do not recite additional elements which are unconventional and provide an inventive concept, as discussed above. Applicant is reminded that each application is examined on its own merits and the facts of the given examples do not match the facts as present in the instant application. Regarding Applicant’s comments about the physical realm and reference to Buysafe, outputting an indication does not encompass a physical action. The only physical steps and components of the claims are those involved in data gathering and applying the judicial exceptions on a computer, where the computer is the physical object. Such steps and components do not integrate the judicial exceptions at Step 2, Prong 2, or provide for significantly more at Step 2B, as discussed above.
At p. 30-33, Section III., Applicant claims that dependent claims 3, 9, and 12-13 recite an unconventional test strip.
It is respectfully submitted that this is partially persuasive. Claims 3 and 13 recite a lateral flow assay test strip which comprises a plurality of zones which comprise immobilized compounds configured to bind to the plurality of human subject biomarkers comprising salivary alpha amylase (AMY1), Flt3 ligand (FLT3L), and monocyte chemotactic protein 1 (MCP1), which an unconventional additional element at Step 2B that provides for significantly more than the recited judicial exceptions. However, claims 9 and 12 do not recite these features. The features of claims 9 and 12 are considered to recite well-understood, routine, and conventional elements as discussed above and in the rejection. It is further noted that the specification as published discusses the wide availability of lateral flow assay test kits [0084].
Conclusion
No claims are allowed.
Claims 3 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.N.S./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685