DETAILED ACTION
Applicant’s response, filed 08 Sept. 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Status of Claims
Claims 1-8 are pending.
Claims 1-8 are rejected.
Priority
Acknowledgment is made of applicant’s claim for foreign priority to App. No. JP2023-003703 filed 13 Jan. 2023 under 35 U.S.C. 119 (a)-(d).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
The objection to claims 1-2 and 5-6 in the Office action mailed 10 June 2026 has been withdrawn in view of claim amendments received 08 Sept. 2026.
Claim Interpretation
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.
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 limitations are:
“an analysis device configured to measure a temperature.. and an absorbance…” in claim 1;
“an analysis device…to supply a control target value of temperature…” in claim 5;
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Applicant’s specification at para. [0020]-[0021] and FIG. 1 discloses the structure for the analysis device. The analysis device comprises a photometric unit of an ultraviolet and visible spectrophotometer, an operation unit that is a keyboard or pointing device, a display, a first control device including a CPU and memory (i.e. a computer) that performs computational and control processing, and a sample unit that includes a multi-cell, temperature sensors (#36 in FIG. 1) a temperature controller, and a heating and cooling unit.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. This rejection is newly recited and necessitated by claim amendment.
Claim 1 recites “the control device is configured to: acquire the data by controlling the analysis device to supply a control target value of temperature…”. Claim 5 recites “acquiring by the control device, data indicating a relationship…by controlling the analysis device to supply a control target value of temperature…”. Claims 1 and 5 then recite “the control device” performs the analysis of the acquired data of “set/setting a boundary point…”, “set/setting a minimum temperature…”, etc., to detect the melting temperature. However, Applicant’s specification does not provide support for a single control device that both controls the analysis device to supply temperature and to then perform the analysis of the data to determine the melting temperature.
Applicant’s specification at para. [0021]-[0022] and FIG. 1 discloses the analysis device includes a first control device that controls operations of the sample unit (which includes the temperature controller) of the analysis device. Applicant’s specification at para. [0026] and FIG. 1 discloses a second control device, different than the first control device, that analyzes the data from the analysis device to create a melting curve and ultimately determine a melting temperature. However, Applicant’s specification does not provide support for a single control device for performing both functions, as claimed.
For the reasons discussed above, the specification does not provide a sufficient disclosure of the limitation above of claims 1 and 5, and claims dependent therefrom, to demonstrate to one of ordinary skill in the art that the inventor possessed the invention at the time the application was filed. THIS IS A NEW MATTER REJECTION. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
Claim Rejections - 35 USC § 112(b)
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 1-8 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, or for pre-AIA the applicant regards as the invention. Any newly recited portion is necessitated by claim amendment.
Claims 1 and 5, and claims dependent therefrom, are indefinite for recitation of “set/setting, as a first straight line, the straight line calculated from the first data that maximizes K1….in the first data is denoted by K1, a temperature difference…of the first data, and a gradient…from the first data…”. Claims 1 and 5 previously recite “calculates/calculating a straight line…using data in a range between the first start point and the first end point, while moving a range of the first data….repeat/repeating calculating the straight line using each of the first data after the moving”. Accordingly, claims 1 and 5 involve moving a range of the first data, such that there are multiple first data (e.g. “each of the first data after the moving”, and calculate the straight line using each first data (i.e. there are multiple approximate straight lines). As a result, it is not clear which first data is intended to correspond to the parameters for K1, W1, and r1. It is similarly unclear which line, “the straight line calculated from the first data that maximizes…”, is referring to given the parameters of the equation being maximized are not clear. Dependent claims 2-3 and 6-7 also recites “the first data” and “the second data”, and are indefinite for the same reason. To overcome the rejection, the claims can be amended to recite “set/setting, as a first straight line, the straight line of the straight lines calculated from each of the first data that maximizes…, wherein a first constant…in the respective first data is denoted by K1, a temperature difference…of the respective first data is denoted by W1, and a gradient…from the respective first data is denoted by r1”.
Claims 1 and 5, and claims dependent therefrom, are indefinite for recitation of “sets/setting, as a second straight line, the straight line calculated from the second data that maximizes K2….in the second data is denoted by K2, a temperature difference…of the second data, and a gradient…from the second data…”.”. These limitations are indefinite for the same reasons discussed above in the limitation of setting a “first straight line”. To overcome the rejection, the limitation can be amended consistent with the suggested amendment for the first straight line.
Claims 2 and 6, and claims dependent therefrom, is indefinite for recitation of “repeat/repeating calculating the first straight line by decreasing the number of data of the first data…; repeat/repeating calculating the second straight line by decreasing the number of data of the second data….”. However, claims 1 and 5 recite “set/setting, as a first straight line, the straight line calculated from the first data that maximizes…; set/setting, as a second straight line, the straight line calculated from the second data that maximizes…” K*W + 1/r (for each of the first and second line), but claims 1 and 5 do not require calculating the first/second straight line. As a result, is not clear if the first/second straight line used for detecting the melting temperature is required to be the straight line calculated from the first/second data that maximizes the equation that was set in claims 1 and 5 (i.e. one of the lines calculated by moving a range of the first/second data and repeat calculating the straight line using each of the first/second data after moving), or if the first/second straight line is the line calculated by decreasing the number of data in the first/second data and changing W in accordance with the number of data decreased (which would not correspond to one of the lines calculated from the first/second data in claim 1). Clarification is requested. In light of Applicant’s specification at para. [0034]-[0036] and FIG. 7, it appears the claims intend to further limit how the straight lines from the first data and the second data are calculated by requiring the temperature range (i.e. number of data) decreases in addition to moving.
Response to Arguments
Applicant's arguments filed 08 Sept. 2026 regarding 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
Applicant remarks applicant amended the claims to address indefiniteness and therefore the rejection should be withdrawn (Applicant’s remarks at pg. 12, para. 3).
This argument is not persuasive for the reasons set forth above in the outstanding rejection.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portion is necessitated by claim amendment.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claims 1 and 5 being representative) is directed a device and method for determining a melting temperature. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claims 1 and 5 recite the following steps which fall under the mathematical concepts and/or mental processes groupings of abstract ideas:
sets/setting a boundary point dividing the data stored in the storage device into a front region and a rear region in accordance with the temperature of the nucleic acid when the data is expressed as the melting curve (mental process);
sets/setting a minimum temperature as a first start point and a maximum temperature as a first end point on first data defined by a predetermined number of data continuously changing in accordance with the temperature of the nucleic acid among the data in the front region (mental process);
calculate/calculating a straight line by a least squares method by using data in a range between the first start point and the first end point (mental process and mathematical concept);
while moving a range of the first data in a direction of the boundary point until the first end point reaches the boundary point, repeat/repeating calculating the straight line using each of the first data after the moving (mental process and mathematical concept);
set/setting a maximum temperature as a second start point and a minimum temperature as a second end point on second data defined by a predetermined number of data continuously changing in accordance with the temperature of the nucleic acid among the data in the rear region (mental process);
calculate/calculating a straight line by the least squares method by using data in a range between the second start point and the second end point (mental process and mathematical concept);
while moving a range of the second data in a direction of the boundary point until the second end point reaches the boundary point, repeat/repeating calculating of the straight line using each of the second data after the moving (mental process and mathematical concept);
set/setting, as a first straight line, the straight line calculated from the first data that maximizes K1 x W1 + 1/r wherein a first constant preset on the basis of a plot interval of adjacent data in the first data is denoted by K1, a temperature difference between the first start point and the first end point of the first data is denoted by W1, and a gradient of the approximate straight line calculated from the first data is denoted by r (mental process and mathematical concept);
set/setting, as a second straight line, the straight line calculated from the second data that maximizes K2 x W2 + 1/r, wherein a second constant preset on the basis of a plot interval of adjacent data in the second data is denoted by K2, a temperature difference between the second start point and the second end point of the second data is denoted by W2, and a gradient of the approximate straight line calculated from the second data is denoted by r (mental process and mathematical concept);
detect/detecting, as the melting temperature, the temperature of the nucleic acid corresponding to an intersection between the melting curve and a line connecting intermediate values of the absorbance of the nucleic acid at which the temperature of the nucleic acid is the same on the first straight line and the second straight line ((mental process and mathematical concept);
The identified claim limitations falls into one of the groups of abstract ideas of mathematical concepts and/or mental processes for the following reasons. Setting a boundary point dividing data into two regions can be practically performed in the mind by analyzing the entire region of the data and assigning a boundary point in the middle of the x-axis of the data, thus considering the data in the first half of the data and the second half of the data. Setting a minimum temperature and maximum temperature as a start and end point for each of the first and second data as claimed can be practically performed in the mind by determining a number of the data is increasing with temperature and picking a start and end point around this region. Calculating an approximate straight line by a least squares method for each of the first and second data can be practically performed in the mind aided with pen and paper by calculating and minimizing residual errors in the data. This limitation further recites a mathematical concept because it recites a mathematical algorithm (a least squares algorithm) that is a textual equivalent to performing mathematical calculations. Repeating the calculating of an approximate straight line with a moving range of the first data and the second data recites a mental process and mathematical concept for the same reasons discussed for calculating the approximate straight line above, and given it involves just repeating that same mental process/mathematical concept. The steps of setting a first straight line and a second straight line that maximizes the recited formulas can be practically performed in the mind because the human mind is equipped to carry out multiplication, addition, and division; the limitation further recites the mathematical concept of a mathematical formula (K1*W1 + 1/r and K2*W2+1/r) and a mathematical calculation because the claim requires computing/maximizing the recited formulas. Other than reciting the limitations in claim 1 are carried out by a control device, nothing in the claims precludes the steps from being practically performed in the mind. Therefore, these limitations recite an abstract idea of a mental process and/or mathematical concept as identified above.
Dependent claims 2-4 and 6-8 further recite an abstract idea and/or are part of the abstract idea identified above. Dependent claims 2 and 6 further limit the mental process and mathematical concept of setting the first and second line to involve decreasing the number of the data by a predetermined number for each of the first and second data. Dependent claims 3 and 7 further recites the mental process of determining to end the setting of the first and second line when the number of data reaches a predetermined lower limit for each of the first and second data. Dependent claims 5 and 8 further recites the mental process and mathematical concept of inverting a plot position of data to rotate the melting curve in point symmetry with respect to the boundary, and then inverting the plot position of the second straight line again. Therefore, claims 1-8 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
Claims 2-8 do not recite any elements in addition to the judicial exception, and therefore are part of the judicial exception.
The additional elements of claims 1 and 5 include:
a control device; (claims 1 and 5);
an analysis device (claim 5) configured to measure a temperature of the nucleic acid and an absorbance of the nucleic acid corresponding to ultraviolet light (claim 1)
a storage device that stores data indicating a relationship between the temperature and the absorbance form the analysis device, wherein the data is represented by a melting curve in which the absorbance of the nucleic acid increases as the temperature of the nucleic acid increases when the data is plotted with the temperature of the nucleic acid on a horizontal axis and the absorbance of the nucleic acid on a vertical axis (claim 1);
storing, in the storage device, data indicating a relationship between the temperature and the absorbance form the analysis device, wherein the data is represented by a melting curve in which the absorbance of the nucleic acid increases as the temperature of the nucleic acid increases when the data is plotted with the temperature of the nucleic acid on a horizontal axis and the absorbance of the nucleic acid on a vertical axis (claim 5);
acquire/acquiring the data by controlling the analysis device to supply a control target value of temperature to a temperature controller that controls power supplied to a heating and cooling unit such that a temperature detected by a temperature sensor becomes the control target value, and to measure the temperature of the nucleic acid and the absorbance while changing the temperature of the nucleic acid (claims 1 and 5).
The additional element of acquiring the data by controlling the analysis device to control a temperature and to measure the temperature of the nucleic acid and the absorbance while changing the temperature of the nucleic acid is not sufficient to integrate the recited judicial exception into a practical application because the limitation only served to generate the necessary data for use by the abstract idea, which amounts to insignificant extra-solution activity. See MPEP 2106.05(g).
The additional elements of a control device, input devices, a display, and a storage device storing data are generic computer components and/or functions. The control device is merely used as a tool to carry out the abstract idea, while the storage device is used in its ordinary capacity to store information for use by the abstract idea. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
Therefore, the additionally recited elements amount to mere instructions to apply the exception on a computer, and as such, the claims as a whole do no integrate the abstract idea into practical application. Thus, claims 1-8 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
Claims 2-8 do not recite any elements in addition to the judicial exception, and therefore are part of the judicial exception.
The additional elements of claims 1 and 5 include:
a control device; (claims 1 and 5);
an analysis device (claim 5) configured to measure a temperature of the nucleic acid and an absorbance of the nucleic acid corresponding to ultraviolet light (claim 1)
a storage device that stores data indicating a relationship between the temperature and the absorbance form the analysis device, wherein the data is represented by a melting curve in which the absorbance of the nucleic acid increases as the temperature of the nucleic acid increases when the data is plotted with the temperature of the nucleic acid on a horizontal axis and the absorbance of the nucleic acid on a vertical axis (claim 1);
storing, in the storage device, data indicating a relationship between the temperature and the absorbance form the analysis device, wherein the data is represented by a melting curve in which the absorbance of the nucleic acid increases as the temperature of the nucleic acid increases when the data is plotted with the temperature of the nucleic acid on a horizontal axis and the absorbance of the nucleic acid on a vertical axis (claim 5);
acquire/acquiring the data by controlling the analysis device to supply a control target value of temperature to a temperature controller that controls power supplied to a heating and cooling unit such that a temperature detected by a temperature sensor becomes the control target value, and to measure the temperature of the nucleic acid and the absorbance while changing the temperature of the nucleic acid (claims 1 and 5).
The additional element of acquiring the data by controlling the analysis device to control a temperature and to measure the temperature of the nucleic acid and the absorbance while changing the temperature of the nucleic acid is well-understood, routine, and conventional. This position is supported by Kulkarni et al. (Advances in continuous-flow based microfluidic PCR devices- a review, 2020, Eng. Res. Express, 2, pg. 1-21; newly cited). Kulkarni reviews various polymerase chain reaction (PCR) devices (Abstract), and discloses PCR and microfluidic devices for PCR has been extensively and vigorously implemented (Abstract). Kulkarni discloses various PCR devices (i.e. analysis device) which control temperatures of the nucleic acid in various zones during nucleic acid amplification (Figures 2 and 4; pg. 3, para. 2) and further measures absorbance of the nucleic acid during the process (Table 1; pg. 10, para. 3 to pg. 11, para. 2). Kulkarni further discloses PCR devices may be connected to a computer for intensity analysis (pg. 15, para. 3 to pg. 16, para. 1), demonstrating the conventionality of PCR devices in combination with computers.
Furthermore, the additional elements of a control device, input device, display, and a storage device storing data are conventional computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Therefore, 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]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Response to Arguments
Applicant's arguments filed 09 Sept. 2026 regarding 35 U.S.C. 101 have been fully considered but they are not persuasive.
Step 2A, Prong 2:
Applicant remarks the claims are directed to a concrete analysis system and method that acquires physical measurement data of a nucleic-acid sample, and then automatically processes the resulting data in the form of a melting curve using a defined sequence of operations to determine a melting temperature, and that the claims expressly require acquiring data by controlling an analysis device to supply a control temperature to a temperature controller and to measure temperature and absorbance of the nucleic acid, and thus the data processing is closely integrated with a controlled physical measurement step of the nucleic acid sample and is applied to a particular physical measurement process rather than being performed on data in the abstract (Applicant’s remarks at pg. 8, para. 7 to pg. 9, para. 2). Applicant remarks the Office only identifies a control device and storage device as additional elements, which does not account for the amended limitations which define a controlled physical measurement operation that generates a melting curve, and thus the abstract idea is integrated into a practical application (Applicant’s remarks at pg. 9, para. 3).
This argument is not persuasive. While it is acknowledged the claims were amended to recite a new additional element relating to using the analysis device to control temperatures and measure absorbance of a nucleic acid to provide the data being analyzed, this is not sufficient to integrate the recited judicial exception into a practical application because the limitation only serves to collect data for use by the abstract idea. See MPEP 2106.05(g). That is, the analysis device is only used to generate the melting curve which is subsequently analyzed by the abstract idea to determine a melting temperature.
Furthermore, while the amendment does tie the abstract idea to some physical measurement, It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. 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).
Applicant remarks the claims invention address a technical problem in nucleic acid measurement because in the conventional median method, a user manually and arbitrarily sets the start and end points for the analysis regions which is susceptible to noise and causes errors in determining the melting temperature, and the claimed solution sets a boundary points, repeatedly calculates straight lines for data ranges moved toward the boundary point, and determines the melting temperature from the resulting lines, which provides an automated and repeatable technique for selecting the fitting lines used in the measurement process (Applicant’s remarks at pg. 10, para. 1-2).
This argument is not persuasive. It is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. Furthermore, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP 2106.05(a).
In the instant case, the alleged improvement described by Applicant is merely an improved analysis of data from an already generated melting curve, which amounts to an improvement in the abstract idea rather than a technology. While Applicant states the fitting lines are “used in the measurement process” and the claimed invention solves a problem in nucleic-acid measurement, the abstract idea is not being applied to effect the actual measuring of the nucleic acid in anyway, such that the claims actually improve how the nucleic acid is being physically measured. Instead, the measuring has already been performed prior the steps of setting a boundary point, calculating straight lines, and determining a melting temperature. Therefore, the claims do not reflect an improvement to nucleic acid measurement technology, or any other technology.
Step 2B:
Applicant remarks the claimed invention applies a specific set of rules integrated with controlled operation of the analysis device, including calculating straight lines and selecting first and second straight lines, which eliminates the need for an operator to subjectively select data ranges and results in elimination of human trial-and-error and reliable analysis(Applicant’s remarks at pg. 10, para. 3 to pg. 11, para. 3). Applicant remarks that therefore the claimed invention provides a technical improvement in the nucleic-acid melting temperature measurement process (Applicant’s remarks at pg. 11, para. 4 to pg. 12, para. 1).
This argument is not persuasive. MPEP 2106.05 II states, in Step 2B, examiners should: Carry over their identification of the additional element(s) in the claim from Step 2A Prong Two; • Carry over their conclusions from Step 2A Prong Two on the considerations discussed in MPEP §§ 2106.05(a) - (c), (e) (f) and (h): Re-evaluate any additional element or combination of elements that was considered to be insignificant extra-solution activity per MPEP § 2106.05(g), because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and Evaluate whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP § 2106.05(d).
In the instant case, the claims do not reflect an improvement in the nucleic-acid melting temperature process for the reasons already set forth above under Step 2A, Prong 2. That is, the claims amount to an improvement in the abstract idea (i.e. analysis of a melting curve), rather than an improvement in a physical measurement of nucleic acid.
Furthermore, the additional elements of the claim are well-understood, routine, and conventional for the reasons set forth in the above rejection. Therefore, the additional elements are not sufficient to provide significantly more under Step 2B.
Applicant remarks the dependent claims further narrow this technical implementation and therefore confirm the claims are directed to a defined technical process rather than an abstract idea (Applicant’s remarks at pg. 12, para. 2).
This argument is not persuasive. The dependent claims do not recite any additional elements, and therefore are part of the abstract idea. Therefore, any details in the dependent claims further define the improvement in the abstract idea of the independent claims, which is not an improvement to technology.
Conclusion
No claims are allowed.
Claims 1-8 are free of the prior art for the reasons discussed in the Office action mailed 10 June 2026.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN L MINCHELLA whose telephone number is (571)272-6485. The examiner can normally be reached 7:00 - 4:00 M-Th.
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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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