DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Aug 18 2025 has been entered.
Applicant’s response, filed Aug 18 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 1-6, 8, 10-14, and 18-20 are pending.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, as set forth in the Non-Final Office Action dated 9/01/2022.
Claims 7, 9, and 15-17 are canceled.
Claims 1-6, 8, 10-11, 14, and 18-20 are rejected.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. KR10-2015-0135386, filed Sep 24 2015. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant's claim for the benefit of a prior-filed application, PCT/KR2016/010708, filed Sep 23 2016, is acknowledged.
Accordingly, each of claims 1-6, 8, 10-11, 14, and 18-20 are afforded the effective filing date of the Sep 24 2015.
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 1-6, 8, 10-11, 14, and 18-20 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, the claims are directed to a method and a device, 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).
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) are as follows:
Independent claims 1 and 18-20: (c) or (iii) applying predefined thresholds to the two or more different datasets, thereby obtaining two or more determinative factors, wherein each of the thresholds is predefined for each type of the datasets, wherein the predefined threshold is for differentiating between a positive sample and a negative sample and wherein the determinative factor represents whether the dataset used to obtain the determinative factor indicates the presence or absence of the target analyte in the sample; and
(d) or (iv) determining the obtained two or more determinative factors as positive determinative factors, whereby the target analyte is determined to be present in the sample, wherein each of the positive determinative factors represents a probability of the presence of the target analyte.
Dependent claims 6, 8, 10-11, and 14 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claims 6, 8, and 10-11 further limit the determinative factors; and claim 14 further limits the determination of the presence or absence of the target analyte.
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 the presence or absence of a target analyte in a sample. Without further detail as to the methodology involved in “applying” and “determining”, under the BRI, one may simply, for example, use pen and paper to apply predefined criteria to multiple datasets and use the results to determine the presence or absence of a target analyte. Some of these steps and those recited in the dependent claims require mathematical techniques as the only supported embodiments, including determinative values representing a probability of the presence of the target analyte, as is supported in the specification as published at least at [0102-0108].
Therefore, claims 1, 18-20, and those claims dependent therefrom recite an abstract idea [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:
Claim 1: (a) performing an amplification reaction for the target analyte; and
(e) providing the result indicating the presence of the target analyte in the sample when the obtained two or more determinative factors are positive determinative factors.
Claims 18-20: (a) or (i) receiving an outcome of an amplification reaction for the target analyte.
Claims 1 and 18-20: (b) or (ii) obtaining two or more different datasets each representing an outcome of the amplification reaction, wherein each of the two or more different datasets comprises a plurality of data points, each data point having a pair of coordinate values comprising a cycle and a signal value at the cycle.
Dependent claims 2-5 recite steps that further limit the recited additional elements of claim 1. For example, claim 2 further limits the type of target analyte; claim 3 further limits the amplification reaction to being PCR or real-time PCR performed using a PCR machine; claims 4 and 5 further limit the obtained datasets to a raw dataset and one or more mathematically processed datasets thereof.
Independent claim 18 includes a non-transitory computer readable storage medium containing instructions to configure a processor to perform a method. Independent claim 19 includes a device for determining a presence of a target analyte in a sample by a multiple dataset analysis (MDA), the device comprising: (a) a computer processor; and (b) a computer readable storage medium coupled to said computer processor, wherein the computer readable storage mediums contains instructions to configure a processor to perform a method. Independent claim 20 includes a non-transitory computer program to be stored in a computer readable storage medium containing instructions to configure a processor to perform a method.
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 “performing an amplification reaction” using a PCR device and “receiving” and “obtaining” data, and to data outputting, such as “providing” results, perform functions of collecting and outputting the data needed to carry out the judicial exceptions. Data gathering and outputting does 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 recited computing elements do not describe any specific computational steps by which the “computer parts” 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 discloses that one of the characteristics of the present invention lies in the fact that the presence or absence of the target analyte can be finally determined, even using determinative factors expressed simply as a yes/no type indication, with more improved accuracy than conventional methods at p. 23, lines 20-21, but 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 effect 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 to Kurnik (US 2015/0186598 A1, IDS reference) discloses that performing an amplification reaction relies on commercially available equipment (i.e., a PCR machine) and is routine, well-understood and conventional in the art. Said portions of the prior art are, for example, [0002-0003], and [0043]. Further, 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 Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)). 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 claims 18-20, 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 also notes that computer processors and systems, as example, are commercially available or widely used at [0043] and [0090-0096]. 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).
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].
Response to Applicant Arguments
At p. 7-9, par. 1, Applicant submits that the claims, when taken as an ordered combination, rather than by disregarding the allegedly abstract steps, involve more than well-understood, routine, and conventional activities. Applicant submits that the finding of novelty and nonobviousness supports the unconventionality of the claims. Applicant submits that the claims are similar to CardioNet v. InfoBionic for these reasons. Applicant submits that also similarly to CardioNet, the instant claims focus on a specific means or method that improves target analyte detection where the analysis of the data produces the improvement.
It is respectfully submitted that this is not persuasive. As set forth in MPEP 2106.05, it is the additional elements which are examined at Step 2B for an inventive concept, and not the combination of the additional elements and the judicial exceptions. Those steps which recite abstract activities are not disregarded at Step 2B, they just are not examined at this step as per the guidelines outlined in the MPEP. The judicial exceptions are considered in combination with the additional elements at Step 2A Prong 2 when the claims are examined as a whole. However, at Step 2A, Prong 2, the improvement or integration must flow from the additional elements, and at Step 2B, the inventive concept must come from the additional elements.
In the instant claims, the additional element of obtaining multiple datasets is routine, well-understood, and conventional. It is further submitted that the generation of those datasets is not present in the claims as currently recited, because the claims recite only “obtaining” datasets. Obtaining data or datasets is a conventional operation of a generic computer which does not provide for an inventive concept at Step 2B. The data being obtained does not change the act of obtaining the data or contribute to the unconventionality of the step in anyway because data is, simply, data. If the claims were to recite the action of generating those datasets, those limitations would be considered to recite judicial exceptions and would also not be considered at Step 2B. The use of those datasets (steps (c) and (d) in claim 1, for example) recite a judicial exception and cannot provide the inventive concept at Step 2B. It is considered that the improvement (analyzed at Step 2A, Prong 2) as submitted by Applicant in reducing false-positive errors arises from the use of the datasets in steps (c) and (d) of claim 1. In other words, it is the analysis of those datasets which provides the results and supposed improvement at Step 2A, Prong 2.
In summary, the additional elements of the claims are only those recited in steps (a), (b), and (e) of claim 1, for example, which are routine data gathering and outputting actions of performing an amplification and obtaining and providing data. Those additional elements therefore do not provide for significantly more at Step 2B, or an improvement at Step 2A, Prong 2.
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.
Regarding Applicant’s comments about CardioNet, it is not considered that the claims are analogous because the courts found that the claims at issue in CardioNet were actually directed to a patent-eligible improved cardiac monitoring device. In other words, the data analysis, as alleged by Applicant, improved the actual cardiac monitoring device. In the instant claims, the improvement argued by Applicant of reducing false-positive errors is an improvement only in the data analysis of an amplification reaction. The performance of the judicial exceptions does not result in an improvement in any of the additional elements in the claim. There is no improvement in the actual amplification reaction itself or the obtaining and providing of data, and therefore does not constitute an improvement to a field of technology.
At p. 9, par. 2, Applicant submits that the claims are similar to those in Thales Visionix v. US because, in both cases, data is obtained via sensor sand calculations are performed through novel and unconventional processes to provide a result in the reduction of errors.
It is respectfully submitted that this is not persuasive. In Thales, the court found that the claims resulted in an improvement because the particular method of using the data from the sensors was used to produce a particular configuration of sensors. Therefore, the claims in Thales recite an additional element (the position of the sensors) which integrated the judicial exceptions into a practical application at Step 2A, Prong 2. As discussed above, the claims do not recite any additional elements which provide a practical application of the judicial exceptions. Therefore, the cases are not analogous.
At p. 9, par. 3 through p. 10, Applicant submits that because claim 1 recites limitations which cannot practically be performed in the human mind, such as (a) performing an amplification reaction, the claim is not directed to a mental process. Applicant submits that the Office Action disregarded this step as merely “data gathering”, improperly ignoring the meaningful limitation the step places on the claim. Applicant submits that the claim cannot be performed without this step, which is a complex technical procedure on a physical sample. Applicant submits that the high-level abstraction of designating the limitation as “data gathering” runs afoul of guidance by the Supreme Court. Applicant submits that whether the amplification reaction is conventional or known is not relevant because questions of novelty and nonobviousness apply to 35 USC 102 and 103, and not 101. Applicant submits that because “performing an amplification reaction” cannot be performed entirely in a human’s mind, the claims should be eligible.
It is respectfully submitted that this is not persuasive. As set forth in MPEP 2106.04(II), Step 2A is a two-prong inquiry, in which examiners determine in Prong 1 whether a claim recites a judicial exception. MPEP 2106.04(I) sets forth that when determining whether a claim recites a judicial exception, it is sufficient to identify the claimed concept which aligns with at least one judicial exception, or, in other words, the specific claim limitations that the examiner believes may recite an exception. That the claim recites limitations which are in addition to those which recite judicial exceptions (i.e., additional elements) does not alter the analysis to determine whether a claim recites a judicial exception performed at Step 2A, Prong 1 (see MPEP 2106.04(II)(A)(1)). Those additional elements are examined at Step 2A, Prong 2, to determine whether the claim is directed to the judicial exceptions (see MPEP 2106.04(II)(A)(2)), which is discussed further below. As set forth in the above rejection, those limitations which are considered to recite a judicial exception are identified at Step 2A, Prong 1, and why they are considered to recite a judicial exception is explained, as is required by the eligibility analysis as outlined in MPEP 2106.04.
As discussed in the above rejection, “performing an amplification reaction” is considered to recite an additional element at Step 2A, Prong 2. Therefore, the step is not disregarded or improperly assigned to the judicial exception category, as alleged by Applicant. It is submitted that Applicant is conflating the analysis of the additional elements in the claim as a whole at Step 2A, Prong 2, with the analysis to identify judicial exceptions at Step 2A, Prong 1. Similarly, Applicant’s argument that high-level abstraction of claim elements as data gathering also conflates the designation of elements as judicial exceptions at Step 2A, Prong 1, and the analysis of additional elements in the claim as a whole at Step 2A, Prong 2. The court actually explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has cautioned ‘‘to tread carefully in construing this exclusionary principle lest it swallow all of patent law.’’(Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (citing Mayo, 566 US at 71, 101 USPQ2d at 1965). The designation of an additional element as serving a data gathering function in the claim does not align with such an warning from the court, which warns of over-characterizing limitations as judicial exceptions.
It is submitted that the above rejection correctly identifies the step of performing an amplification reaction as an additional element (or, as submitted by Applicant, patent eligible subject matter) at Step 2A, Prong 2, and proceeds to examine how this additional element functions in the claim as a whole. The step produces the data that is required by the judicial exceptions for their performance, as submitted by Applicant. MPEP 2106.05(g) discusses the role of additional elements which recite insignificant extra-solution activity in the claims, which are activities that are incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity, and an example of pre-solution activity is a step of gathering data for use in a claimed process. MPEP 2106.05(g) goes on to describe that with necessary data gathering, all uses of the recited judicial exception require such data gathering. It is pointed out that Applicant’s argument that claim 1 cannot be performed without performing an amplification reaction aligns exactly with the MPEP’s description of data gathering.
Regarding Applicant’s assertion that conventionality of the amplification reaction is not relevant, such an argument is applicable only to Step 2A, Prong 2. While the additional elements are not analyzed for conventionality at this step, that conventionality is examined at Step 2B. The above rejection accordingly only analyzes the conventionality of the additional elements at Step 2B. Ultimately, the analysis finds that the claims recite judicial exceptions at Step 2A, Prong 1, and that the additional element of performing an amplification reaction does not provide a practical application at Step 2A, Prong 2, or significantly more at Step 2B.
At p. 11, Applicant submits that claim 3 satisfies the SiRF Tech criteria for a particular machine because a PCR machine is a particular machine designed specifically to carry out PCR reactions, which provides a meaningful limit on the claim scope to exclude other forms of amplification reactions. Applicant submits that claim 3 ties the allegedly abstract steps of claim 1 to a concrete, specific, practical application.
It is respectfully submitted that this is not persuasive. MPEP 2106.05(b) sets forth that while the application of a judicial exception with, or by use of, a particular machine may integrate a judicial exception into a practical application in Step 2A Prong Two or recite significantly more than a judicial exception in Step 2B, this requires that the particular machine apply the judicial exception. MPEP 2106.05(b)(III) sets forth that if the use of a machine contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step), it would not integrate a judicial exception or provide significantly more. In the instant claims, the PCR machine does not apply the recited judicial exceptions of claim 1. The PCR machine functions in the claims to perform the amplification reactions. Therefore, the PCR machine applies only an additional element, and serves the same function in the claim as a whole as that additional element. Therefore, at Step 2A, Prong 2, the PCR machine serves a data gathering function which does not provide a practical application. Further, the PCR machine is found to be conventional at Step 2B, and therefore does not provide significantly more. It is further noted that the specification as published provides only the examples of a thermocycler, PCR machine or DNA amplifier for performing PCR [0063]. It is submitted that one of ordinary skill in the art would consider each of those examples as describing the same machine. Therefore, the recitation of a “PCR machine” does not place a meaningful limit on the claims, as submitted by Applicant.
Conclusion
No claims are allowed.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANNA NICOLE SCHULTZHAUS whose telephone number is (571)272-0812. The examiner can normally be reached on Monday - Friday 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached on (571)272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.N.S./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685