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 .
Election/Restrictions
The restriction requirement mailed 19 March 2026 between Group I, claims 1-4 and Group II, claims 5-8 has been withdrawn because a search burden does not exist.
Status of Claims
Claims 1-8 are pending.
Claims 1-8 are rejected.
Claims 1-2 and 5-6 are objected to.
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.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 31 Dec. 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner.
Drawings
The drawings received 31 Dec. 2023 are accepted.
Claim Objections
Claims 1-2 and 5-6 are objected to because of the following informalities:
Claim 1 recites “…comprising: a control device; and a storage device…and the control device…”, which is grammatically incorrect and should recite “…and a storage device…, wherein the control device…”.
Claims 1 and 5 recite “sets/setting a first straight line…when a first constant…” and “sets/setting a second straight line…when a second constant…”, which should be amended to recite “…wherein wherein
Claim 2 recites “detects, as the melting temperature, the temperature…” (including the entire limitation), which is redundant with the final limitation of claim 1 and should be removed.
Claim 6 recites “detecting, as the melting temperature, the temperature…” (including the entire limitation), which is redundant with the final limitation of claim 5 and should be removed.
Claim 4 recites “executes the setting processing of the second straight line…” which should be amended to recite “executes the setting of the second straight line…” to use consistent language with claim 1, which recites “sets a second straight line”.
Appropriate correction is required.
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.
Claim 1, and claims dependent therefrom, recite “the detection device comprising: a control device; and a storage device…, and the control device sets…., sets…, calculates…, sets…, sets…, and detects… “ It is unclear if the phrase “the control device sets…” (etc.) is intended to merely set forth the manner in which the control device is intended to be employed, or if the phrase is intending to specify how the control device is programmed. See MPEP 2114. II. Clarification is requested. For purpose of examination, the phrase is interpreted to mean the control device is programmed to perform the recited functions. If Applicant agrees with this interpretation, the claim can be amended to recite “…wherein the control device is configured to set[[s]]…, set[[s]]…, calculate[[s]]…” (etc.). Dependent claims 2-4 recite similar limitations (e.g. the control device repeats…, the control device ends…, the control device executes), which are indefinite for the same reasons discussed above for claim 1.
Claims 1 and 5, and claims dependent therefrom, are indefinite for recitation of “…setting/sets a boundary point dividing the data stored 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…”. It is not clear if the step of setting a boundary is intended to be contingent on the data being expressed as the melting curve or if the setting of a boundary point dividing the data is required to be performed in accordance with the temperature while the data is expressed as the melting curve. Given the subsequent steps utilize the result of setting the boundary point, it is similarly unclear if these steps are contingent upon the boundary point being set or if the claims require the setting of a boundary point. Clarification is requested. For purpose of examination and in the interest of compact prosecution, the claims are interpreted to mean setting a boundary point dividing the data expressed as a melting curve into a front region and a rear region in accordance with the temperature of the nucleic acid.
Claims 1 and 5 are indefinite for recitation of “…calculates/calculating an approximate straight line..” and “…repeats setting/repeating setting processing of the approximate straight line”. The term “approximate straight” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As a result it is unclear in what embodiments a line may be considered an “approximate straight” line, as opposed to a not straight line. For purpose of examination, the limitation will be interpreted to a mean a straight line is calculated.
Claims 1 and 5, and claims dependent therefrom, are indefinite for recitation of “repeats setting/repeating setting processing of the approximate straight line…” and “repeating setting processing of the approximate straight line…” respectively. The metes and bounds of “setting processing” are not clear, particular because the phrases uses two verbs simultaneously. It is not clear if the claims intend to require repeating of calculating the approximate straight line, or just initializing (setting) of the processing/calculating of the straight line. Dependent claims 2-4 also recite “the setting processing” and are indefinite for the same reasons. For purpose of examination, the limitation is interpreted to mean repeats/repeating calculating of the approximate straight line.
Claims 1 and 5 are indefinite for recitation of “sets/setting a first straight line…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”. Claims 1 and 5 previously recite “calculates/calculating an approximate 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….repeats setting/repeating setting processing of the approximate 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 approximate straight line using each first data (i.e. there are multiple approximate straight lines). As a result, it is not clear which first data and which approximate straight line is being referenced in the setting of the first straight line. For purpose of examination, the limitation is interpreted to mean that the approximate straight line calculated from the first data that maximizes the recited equation is set as the first straight line in light of Applicant’s specification at Fig. 7. Clarification is requested.
Claims 1 and 5, and claims dependent therefrom, are indefinite for recitation of “sets/setting a second straight line….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”. These limitations are indefinite for the same reasons discussed above in the limitation of setting a “first straight line”. That is, it is not clear which second data and which approximate straight line is being referenced in the setting of the second straight line. For purpose of examination, the limitation is interpreted similarly to the setting of the first straight line above.
Claims 1 and 5, and claims dependent therefrom, are indefinite for recitation of “sets a second straight line….the approximate straight line calculated from the second data is denoted by r”. The claims previously recite “the approximate line calculated from the first data is denoted by r”. As a result, it is not clear if the variable “r” denotes the approximate straight line calculated from the first or second data. Clarification is requested via claim amendment. To overcome the rejection, Applicant may amend each variable “r” to be “r1” and “r2” for the first line and second line, respectively.
Claim 5, and claims dependent therefrom, are indefinite for recitation of “the data stored” in line 10. There is insufficient antecedent basis for this limitation in the claim because while claim 5 recites “data indicating a relationship…”, claim 5 does not require that the data is stored. As a result it is not clear if “the data stored” is referring to the data indicating a relationship or some other data. Clarification is requested. For purpose of examination, the limitation is interpreted to mean “the data”.
Claims 4 and 8 are indefinite for recitation of “the plot position set” in lines 6 and 4 respectively. There is insufficient antecedent basis for “the plot position set” because claims 4 and 8 do not previously recite a plot position set, and instead only recite “a plot position”. As a result, it is unclear if “the plot position set” is intended to refer to the plot position, or if the plot position set is a set of plot positions. Clarification is requested.
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.
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);
calculates/calculating an approximate 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, repeats setting/repeating setting processing of the approximate straight line using each of the first data after the moving (mental process and mathematical concept);
sets/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 an approximate 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, repeats/repeating setting processing of the approximate straight line using each of the second data after the moving (mental process and mathematical concept);
set/setting a first straight line that maximizes K1 x W1 + 1/r when 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);
sets/setting a second straight line that maximizes K2 x W2 + 1/r when 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);
detects/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 claim 1 include:
a control device; and
a storage device that stores the data 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.
The additional elements of a control device 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 claim 1 include:
a control device; and
a storage device that stores the data 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.
The additional elements of a control device 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 applicant is directed generally to the MPEP § 2106.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shimadzu, Thermal Stability Analysis of Nucleic Acid Drugs by TMSPCTM-8 Tm Analysis System, 2020, Shimadzu Corporation, pg. 1-3.
Conclusion
No claims are allowed.
Claims 1-8 are free of the prior art.
The closest prior art of record is Shamdzu (2020). Shimadzu discloses a method for analyzing melting temperature (Tm) of nucleic acids. Shimadzu discloses data is represented by a melting curve in which the absorbance of the nucleic acid increases with temperature in the form of a plot, with temperature on the x-axis and absorbance on the y-axis (pg. 1, col 1., para. 4; Fig. 1). Shimadzu discloses setting a boundary dividing the data expressed as a melting curve into a pre-transition region and a post-transition region (i.e. a front and rear region) (Fig. 1; Fig. 5). Shimadzu discloses setting a region start and region end indicating start and end temperatures for each of the pre-transition and post-transition regions (i.e. a minimum temperature as a first and second start point and a second maximum temperature as a second and first end point) (Fig. 5). Shimadzu discloses calculating a straight line in the form of y=Ax+B using data between the first start and end point (Fig. 5) and a straight line in the form of y=Ax+B using data between the second start and second end point in the post-transition region (Fig. 5). Shimadzu detects, as the melting temperature, the temperature of the nucleic acid where the melting curve intersects a line connecting the median (i.e. intermediate values) of the absorbance of the nucleic acid in which the temperature is the same for the first and second straight line (pg. 2, col. 1, para. 1).
Therefore, Shimadzu discloses the process of setting a boundary point between a front and rear region, setting start and end times for each of a front and rear regions, calculating a straight line for each region by fitting data between the start and end points of the respective region, and assigning a melting temperature as the temperature corresponding to the intersection, as claimed. However, Shimadzu does not disclose repeating the calculation of the approximate straight lines in the first and second data by moving a range of the first and second data until the first and second endpoint reach the boundary point, and then setting first and second lines that maximize the recited equations using a gradient of the approximate straight lines calculated from each of the first and second data, as claimed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (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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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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