DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/27/2026 has been entered.
Status of Claims
Claims 4-5 and 14-15 are cancelled.
Claims 1-3, 6-13 and 16-20 are pending and are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of CHINA application 202110495855.6, filed 05/07/2021 is acknowledged
Withdrawn Rejections/Objections
The rejection to claims 1-20 under 35 U.S.C. 112(b) in the Office action posted 1/28/2026 is withdrawn in view of claim amendments and Applicant’s persuasive Remarks (pages 11-12) both filed 4/27/2026.
The rejection to claims 1 and 11 under 35 U.S.C. 103 in the Office action posted 1/28/2026 is withdrawn in view of claim amendments filed 4/27/2026.
Regarding the 35 35 U.S.C. 102/103:
The claims are free of the analogous art at least because close art, e.g. as cited on the 1/28/2026 Office Action and those cited on the 10/05/2021, 8/24/2022 IDSs as well as art found in the search histories, either individually or in obvious combination, does not teach the following claim elements recited in both claims 1 and 11:
in response to the at least one local maximum value being greater than the first threshold and the part of the first derivative values adjacent to the at least one local maximum value being all positive, using the at least one local maximum value, which corresponds to an inflection point of the growth type curve, as a target maximum value;
in response to the at least one local maximum value being not greater than the first threshold or the part of the first derivative values adjacent to the at least one local maximum value being not all positive, using one of the first derivative values after a predetermined effective cycle number as the target maximum value, wherein the one of the first derivative values corresponds to a gray zone of the growth type curve;
The combination of these claim limitations is not taught by any art, and is not obvious. Additionally, the interview held on 07/14/2026 and Applicant's Remarks filed 04/27/2026 at pages 16-21 supports the withdrawal of the 102/103 rejections.
Claim Rejections - 35 USC § 101
This rejection is maintained from the 1/28/2026 Office action. Modifications are necessitated by claim amendments filed 4/27/2026.
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 1-3, 6-13, and 16-20 are rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-3 and 6-10 are directed to a process, here a "method," with functional steps like “calculating,” “searching,” “determining,” “obtaining”, “deriving”, “adjusting”, and “calculating”.
Claims 11-13 and 16-20 are drawn to a machine and manufacturer, here an “apparatus", with structural components of a memory and a processor.
Step 2A Prong One: Identification of Abstract Ideas
The claims recite:
Calculating a plurality of first derivative values corresponding to the data points (claims 1 and 11);
This step recites mathematical calculations explicitly with data points as input and a plurality of first derivative values as output, which equates to an abstract idea of mathematical concepts.
Searching at least one local maximum value from the first derivative values;
This step recites a judgement activity (identify at least one local maximum value) based on data observation (“from the first derivative values”), which equates to an abstract idea of mental processes.
Determining whether the at least one local maximum value is greater than a first threshold, and
This step recites a judgement activity based on data comparison, which equates to an abstract idea of mental processes.
Determining whether a part of the first derivative values adjacent to the at least one local maximum value are all positive;
This step recites a judgement activity based on data comparison, which equates to an abstract idea of mental processes.
In response to the at least one local maximum value being greater than the first threshold and the part of the first derivative values adjacent to the at least one local maximum value being all positive, using the at least one local maximum value, which corresponds to an inflection point of the growth type curve, as a target maximum value;
This step recites a decision-making activity based on data comparisons, which equates to an abstract idea of mental processes.
In response to the at least one local maximum value being not greater than the first threshold or the part of the first derivative values adjacent to the at least one local maximum value being not all positive, using one of the first
This step recites a decision-making activity based on data comparisons, which equates to an abstract idea of mental processes.
Obtaining a target cycle number corresponding to the target maximum value;
This step recites defining a parameter based on an existing data, which can be achieved in human mind. Hence this step equates to an abstract idea of mental processes.
Deriving a basic cycle number according to the first derivative value corresponding to the target cycle number;
This step recites defining a parameter based on an existing data, which can be achieved in human mind. Hence this step equates to an abstract idea of mental processes.
Adjusting the data points according to the basic cycle number to form a baseline of the growth type curve; and
This step recites data manipulation (adjusting the data points) based on an existing data, which can be achieved in human mind. Hence this step equates to an abstract idea of mental processes.
Calculating a fitting function of the adjusted growth type curve and using the fitting function to derive a first cycle of quantification (Cq) value.
This step recites mathematical calculations explicitly with adjusted growth type curve as input and a first Cq as output, which equates to an abstract idea of mathematical concepts.
Dependent claims further recite abstract ideas in the mental processes grouping and the mathematical concepts grouping.
Step 2A Prong Two: Consideration of Practical Application
The claims results in outputting a test result of the object under test using the first Cq value, which reads on an insignificant extra-solution activity of data outputting. The claims do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
Outputting a test result of the object under test using the first Cq value (claims 1 and 11);
A memory (claim 11); and
A processor (claim 11).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is routine and conventional to output data. Other elements of the method include a memory and a processor, which is a recitation of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
The conventionality of recited subject matter, when considered as a whole, can further be witnessed by the following references:
Liu, Meile, Claudia Udhe‐Stone, and Chetan T. Goudar. "Progress curve analysis of qRT‐PCR reactions using the logistic growth equation." Biotechnology progress 27.5 (2011): 1407-1414.
Ramakers, Christian, et al. "Assumption-free analysis of quantitative real-time polymerase chain reaction (PCR) data." Neuroscience letters 339.1 (2003): 62-66.
Yuan, Joshua S., et al. "Statistical analysis of real-time PCR data." BMC bioinformatics 7.1 (2006): 85.
Pryor, Robert J., and Carl T. Wittwer. "Real-time polymerase chain reaction and melting curve analysis." Clinical applications of PCR. Totowa, NJ: Humana Press, 2006. 19-32.
Liu, Weihong, and David A. Saint. "A new quantitative method of real time reverse transcription polymerase chain reaction assay based on simulation of polymerase chain reaction kinetics." Analytical biochemistry 302.1 (2002): 52-59.
The titles of above listed references clearly demonstrated that claimed methods are conventionally pursued for many years before the instant application is filed. Computers as assistant tools, are used in these studies.
Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
Applicant's arguments filed 27 April 2026 have been fully considered but they are not persuasive. Particularly:
In the Remarks filed 4/27/2026, Applicant argued (page 13, 2nd para through page 14, 1st para) that “the claimed feature does not set forth any mathematical formula, equation, or specific mathematical relationship. Instead, it recites a functional step of utilizing a fitting function within a technical process for analyzing biological amplification data.”
In response, Applicant’s argument is not persuasive. In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989) "It is of no moment that the algorithm is not expressed in terms of a mathematical formula. Words used in a claim operating on data to solve a problem can serve the same purpose as a formula."
Hence, classifying elements like "Calculating a fitting function of the adjusted growth type curve and using the fitting function to derive a first cycle of quantification (Cq) value" into mathematical concepts is reasonable.
In the Remarks, Applicant argued (page 13, last para through page 14, 1st para) that “similar to the claimed method in Thales Visionix, Inc. V. United States, the claimed feature applies these techniques in a specific technological context to improve the determination of a critical physical parameter (i.e., the Cq value) in real-time PCR analysis. The focus of the claim 1 is not on the mathematical concept, but on a particular method of processing biological amplification data to achieve a more accurate result of nucleic acid testing.”
In response, Applicant’s argument is not persuasive. In Thales Visionix, Inc. V. United States, the solution is applied to a specific technological improvement, not merely to the abstract idea or natural law itself. However, for the instant claim, the solution is applied to the Cq value analysis. There is no improvement to the real-time PCR. Further, as discussed above over the 101 analysis, claim 1 is not only directed to mathematical concepts, claim 1 also recites abstract ideas in the mental processes grouping. Therefore, claim 1 does recite abstract ideas at Step 2A/Prong one.
In the Remarks, Applicant argued (page 14, 3rd para through page 15, last para) that “claimed features of claim 1 recite and implement the above technical solution and reflect the corresponding technical improvements in the technical field of nucleic acid testing. Moreover, claim 1 is directed to a concrete nucleic acid testing process that processes biological amplification data and generates a test result for a biological object, rather than merely performing abstract data analysis.”
In response, Applicant’s argument is not persuasive. Claims as a whole, read on data analysis, or “data in, data out”. There is no additional elements that apply, capture and reflect the technical merits rooted in data analysis of the PCR curves. The claims recite only three additional elements: A memory; a processor; and an output. The memory and processor are generic computing components which merely provide a computing environment for processing abstract ideas (MPEP §2106.05(f)). The technical merits rooted in the judicial exceptions is not applied to the computing components, the computing components do not capture or reflect the technical merits rooted in the judicial exceptions. Data outputting is classified into insignificant extra-solution activities. The argued technical solution is merely better data analysis. There is no improvement to a technical field at Step 2A/Prong two of the 101 analysis.
Hence, the 101 rejection is maintained.
Conclusion
No claims are allowed.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635
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