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 .
Applicant Response
Applicant's response, filed 07/23/2025, 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
Claim Status
Claims 3-4, 11-12 and 17-18 are canceled.
Claims 1-2, 5-10 and 13-16 are pending and under examination herein.
Claims 1-2, 5-10 and 13-16 are rejected.
Priority
The instant application, filed 01/27/2021, is a National Stage entry of PCT/JP2018/029093 , International Filing Date: 08/02/2018. As such, the effective filing date assigned to each of claims 1-2, 5-10 and 13-16 is 08/02/2018.
Claim Interpretation
The instant specification defines the following variables in para 0031 – para 0032:
s (p, t): an electropherogram signal by each divided wavelength band detected
f (q, t): a fluorescence intensity from a labeled fluorescent substance during electrophoresis
n (r, t): an intensity of an electrophoresed fluorescent noise
b (p,t): a background intensity for each divided wavelength band
x (q, p): a fluorescence profile of a labeled fluorescent substance
y (r, p): a fluorescence profile of a set noise
As “Q” and “R” are defined as integers of one or more with the in claims, under broadest reasonable interpretation, “Q+R” is interpreted an integer representing the sum of Q and R.
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 1-2, 5-10 and 13-16 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). Newly recited portions are necessitated by claim amendments.
In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recites setting a profile of Q type(s), wherein Q is an integer of one or more, of labeled fluorescent substance used in the sample; setting a profile of a non-labeled fluorescent substance as R type(s), wherein R is an integer of one or more, of fluorescent substance different from the labeled fluorescent substance; and identifying Q+R types of fluorescent substances using the fluorescence intensity, the profile of the Q type(s) of labeled fluorescent substance, and the profile of the R type(s) of non-labeled fluorescent substance; wherein a detection intensity per divided wavelength band is s (p, t), the profile of the Q type of labeled fluorescent substance is x (q, p), the profile of the R type of non-labeled fluorescent substance is y (r, p), a background intensity during a measurement is b (p, t), a fluorescence intensity from the labeled fluorescent substance is f (q, t), and a fluorescence intensity from the non-labeled fluorescent substance is n (r, t), the Q+R types of fluorescent substances are identified from the following formula:
PNG
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402
774
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wherein, t is time, p is a number of the divided wavelength band (p = 0, 1, ..., P-1), q is a number of a labeled fluorescent substance type (q = 0,1, ..., Q-1), and r is a number of the non-labeled fluorescent substance (r = 0, 1, ..., R-1); and determining a component of the biopolymer based on the profile of the Q type(s) of labeled fluorescent substance.
Claim 2 recites further comprising analyzing the biopolymer from data of the identified Q type of fluorescent substance.
Claims 5 and 13 recite wherein f (q, t) is computed by the formula, and the Q type(s) of fluorescent substance is identified.
Claims 6 and 14 recites computing n (r, t) by the formula and subtracting a signal intensity caused by the n (r, t) from the s (p, t) to compute a detection intensity per divided wavelength band from which the non- labeled fluorescent substance is removed; and identifying the Q type(s) of fluorescent substance.
Claim 8 recites further comprising evaluating a degree of reliability of a measurement result by the predetermined measurement method by determining whether at least one of an appearance frequency of the R type(s) of non-labeled fluorescent substance and an intensity of the non-labeled fluorescent substance is equal to or more than a preliminarily set threshold or not.
Claim 9 recites reads the profile of the Q type(s) of labeled fluorescent substance and the profile of the R type(s) of non- labeled fluorescent substance from the memory, and identifies Q+R types of fluorescent substances using the detection intensity, the profile of the Q type of labeled fluorescent substance, and the profile of the R type of non-labeled fluorescent substance; wherein a detection intensity per divided wavelength band is s (p, t), the profile of the Q type of labeled fluorescent substance is x (q, p), the profile of the R type of non-labeled fluorescent substance is y (r, p), a background intensity during a measurement is b (p, t), a fluorescence intensity from the labeled fluorescent substance is f (q, t), and a fluorescence intensity from the non-labeled fluorescent substance is n (r, t), the Q+R types of fluorescent substances are identified from the following formula:
PNG
media_image1.png
402
774
media_image1.png
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wherein, t is time, p is a number of the divided wavelength band (p = 0, 1, ..., P-1), q is a number of a labeled fluorescent substance type (q = 0,1, ..., Q-1), and r is a number of the non-labeled fluorescent substance (r = 0, 1, ..., R-1); and determining a component of the biopolymer based on the profile of the Q type(s) of labeled fluorescent substance.
Claim 10 recites further analyzes the biopolymer from data of the identified Q type(s) of fluorescent substance.
Claim 15 recites a function to evaluate a degree of reliability of a measurement result by the predetermined measurement method by determining whether at least one of an appearance frequency of the R type of non-labeled fluorescent substance and an intensity of the non-labeled fluorescent substance is equal to or more than a preliminarily set threshold or not.
These recitations equate to steps of collecting information, analyzing data and making observations, evaluations and judgements that can be carried out in the human mind. Specifically, setting profiles, identifying types of fluorescent substances using the fluorescence intensity and profiles, computing n (r, t) by the formula and subtracting a signal intensity caused by the n (r, t) from the s (p, t) to compute a detection intensity per divided wavelength band from which the non- labeled fluorescent substance is removed, evaluating a degree of reliability of a measurement result by comparing the appearance frequency and intensity to a preliminarily set threshold, reading the profiles of labeled and unlabeled fluorescent substances, analyzing biopolymer data from data of the identified Q type of fluorescent substance and determining a component of the biopolymer based on the profile of the Q type(s) of labeled fluorescent substance can be practically performing the human mind as claimed and are similar to the concepts of collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011) and collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) that the courts have identified as concepts that can be practically performed in the human mind. Therefore, each of the above recited limitations fall under the “Mental Processes” grouping of abstract ideas. Furthermore, the steps as claimed for identifying types of fluorescent substances using the fluorescence intensity and profiles, identifying Q=R types using the formulars, computing n (r, t) by the formula and subtracting a signal intensity caused by the n (r, t) from the s (p, t) to compute a detection intensity per divided wavelength band from which the non- labeled fluorescent substance is removed also equate to organizing information and manipulating information through mathematical correlations and reciting a mathematical equation, similar to the concepts of taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Therefore, these limitations also fall under the “Mathematical Concepts” grouping of abstract ideas. Claims 5 and 13-15 further qualify the judicial exceptions. As such, claims 1-2, 5-10 and 13-16 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere data gathering, and mere instructions to implement the abstract idea in a generic computing environment. Specifically, the claims recite the following additional elements:
Claim 1 recites detecting a fluorescence intensity from the sample at a specified time using a detection mechanism unit comprising a fluorescence condenser lens, a grating, a focus lens, and a two-dimensional detector; wherein in the detecting of the fluorescence intensity from the sample, a detection wavelength range of a predetermined width is set, and the detection wavelength range is divided into P, wherein P is a positive integer, wavelength bands and detected.
Claim 7 recites comprising electrophoresing the sample in a capillary or sequentially reacting the sample.
Claim 9 recites a detection mechanism unit that detects the fluorescence intensity from the sample at a specified time, wherein the detection mechanism unit comprising a fluorescence condenser lens, a grating, a focus lens, and a two-dimensional detector; a memory that stores a profile of Q type(s), wherein Q is an integer of one or more, of labeled fluorescent substance used in the sample and a profile of a non-labeled fluorescent substance as R type, wherein R is an integer of one or more, of fluorescent substance different from the labeled fluorescent substance; and a data processing unit; wherein the measurement unit divides a preset detection wavelength range of a predetermined width into P, wherein P is a positive integer, wavelength bands and detects.
Claim 16 recites further comprising an electrophoretic apparatus that electrophoreses the sample or a sequential reaction apparatus, wherein the sequential reaction apparatus detects a base sequence of the biopolymer by sequentially reacting a fluorescent substance and a base of the biopolymer.
Claims 2, 5-6, 8, 10, and 13-15 do not recite elements in addition to the recited judicial exceptions. Claims 1, 7, 9, and 16 recites limitations for gathering data, including a detection mechanism unite for gathering fluorescence intensity data. Claim 16 also recites steps for storing data. These limitations equate to mere data gathering and selecting a particular data source or type of data to be manipulated, and data outputting, which the courts have found to be insignificant extra-solution activity (see MPEP 2106.05(g)). The limitations for receiving information, storing data and sending data also equate to steps of data gathering and outputting over a network that the courts have identified as insignificant extra-solution activity in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015). Claim 16 also merely recite using generic computing systems and computer program products to carry out instructions to implement an abstract idea on a computer. The computer system and computer program product as claimed fails to recite details of how a solution to a problem is accomplished and only recites the idea of a solution or outcome. There are no limitations that indicate that the claimed steps require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. 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 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). There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, claims 1-2, 5-10 and 13-16 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). Further analyzing the additional elements under step 2B, the additional elements as described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either 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 under the 2B analysis, as discussed above, claims 1, 7, 9 and 16 recites limitations for gathering data for use in the claimed process of biopolymer analysis amounts to a pre-solution activity to gather data to perform the mental and mathematical steps, and therefore amounts to an insignificant extra-solution activity. Furthermore, the prior art to Krylov and Dovichi (Anal. Chem. 2000, 72, 12, 111–128; previously cited) reviews capillary electrophoresis for the analysis of biopolymers, and discloses capillary electrophoresis with laser-induced fluorescence detection has become a dramatically successful analytical tool with widespread application in the biological sciences and large-scale capillary array electrophoresis instruments have been marketed by numerous companies (p 111R, col 1, para 2). Krylov and Dovichi further discloses wavelength-resolved emission detection allows for identification of different molecules with different detection limits and discloses detecting at different wavelength bands for different molecules (p118R, col 2, para 5-p 119R, col 1, para 1; p 119R, col 1, para 4; p 124R, col 2, para 5). Furthermore, the prior art to Lin et al. (Genomic Medicine, Biomarkers, and Health Sciences 2011, 3(1), pp.27-38; newly cited) reviews high-throughput fluorescence detections in microfluidic systems discloses the use of a detection unit with a fluorescence condenser lens, grating, focus lens and CCDs (i.e. two-dimensional detector) in capillary electrophoresis is well-known in the art (abstract; p 30, col 2, para 2-p 34, col 2, para 1). The courts have found the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional (Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)). As such, activities such as data gathering do not provide a non-conventional or unconventional step.
Furthermore, the computer system limitations of claim 16 are generically recited and 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, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-2, 5-10 and 13-16 are not patent eligible.
Response to applicant’s arguments
Applicant states that under Step 2A, Prong 1, the claims are not directed to an abstract idea, but are rather directed to a technological process that applies an abstract mathematical model in a specific, practical and physical context, distinguishing them from those at issue in Electric Power Group as the instant claims involves chemically and physically grounded measurement operations with real-world biological samples (Applicant’s Arguments, p 7, para 3 – p 8, para 3).
It is respectfully submitted that this is not persuasive. As discussed in MPEP 2106.04(I)(A), Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception. In other words, Step 2A, Prong 1 simply evaluates whether the claim recites any judicial exceptions, and the absence or presence of additional elements which are not judicial exceptions do not influence the evaluation. If any judicial exceptions are found to be recited by the claim under the analysis under Step 2A, Prong 1, the analysis then moves to Step 2A, Prong 2. And, as discussed above, the claims were found to recite judicial exceptions under Step 2A, Prong 1.
Applicant further asserts that under Step 2A, Prong 2, the instant claims go beyond merely stating and abstract idea and instructing its implementation on a generic computer and instead recite a specific, structured process for analyzing a biopolymer sample using quantified fluorescence intensity data across divided wavelength bans and mathematically resolving contributions from Q types of labeled and R types of non-labeled fluorescent substances, including detection, decomposition and inference steps that operate in a technically specific way, specifically the use of a detection wavelength range divided into P banded coupled with defined profiles and intensity variables to isolate and identify the constituent substance reflects more than generic data analysis (Applicant’s Arguments, p 8, para 4-p 9, para 2). Applicant also states that such claim limitations reflect an improvement to the technical field of biopolymer detection via fluorescence analysis, and therefore, when viewed as a whole, the claim recites significantly more than a mere abstract idea implemented on a generic computer (p 9, para 2-3).
It is respectfully submitted that this is not persuasive. It appear the improvement is solely by the judicial exceptions, specifically by identifying the different profiles and mathematically resolving contributions from Q types of labeled and R types of non-labeled fluorescent substances to determine a component of the biopolymer. However, as discussed in MPEP 2106.05(a), the judicial exception alone cannot provide the improvement and the improvement cannot be to the judicial exception itself. With respect to the instant claims, as discussed above, the claims recites limitations for gathering and storing data, including a detection mechanism unite for gathering fluorescence intensity data, which the courts have found to be insignificant extra-solution activity (see MPEP 2106.05(g)). Furthermore, 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 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). There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself.
Applicant further states that under Step 2B, given that the claims recite novel and non-obvious subject matter and the previous office actions contains no rejection under 35 U.S.C. 102 or 103, the unavoidable conclusion is that the currently-pending claims have been amended to recite significantly more than a fundamental economic practice and therefore the instant claims contain an inventive concept sufficient to transform an abstract idea into a patent-eligible application and the rejection under 35 U.S.C. 101 should be withdrawn (Applicant’s Arguments, p 9, para 4 – 5).
It is respectfully submitted that this is not persuasive. As discussed on MPEP2106.05, although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973. Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements.
As discussed in MPEP 2106.05, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and an inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. Therefore, only the additional elements of the claims are evaluated both individual and in combination to determine whether they amount to an inventive concept under step 2B. With respect to the instant claims, as discussed above, the additional elements of gathering data for use in the claimed process of biopolymer analysis amounts to a pre-solution activity to gather data to perform the mental and mathematical steps, and therefore amounts to an insignificant extra-solution activity. Furthermore, the prior art to Krylov and Dovichi and Lin et al. discloses these limitations to well-understood, routine and conventional in the art. The courts have found the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional (Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)). As such, activities such as data gathering do not provide a non-conventional or unconventional step.
Furthermore, the computer system limitations are generically recited and 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, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself, and the rejection is maintained.
Prior Art
Claims 1-2, 5-7, 10 and 13-16 appear free from prior art as the prior art to Sharaf and Roque-Biewer (US20020125136A1; previously cited) does not appear to teach or fairly suggest the formula, as recited in instant claims 1 and 9.
Conclusion
No claims 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.
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/N.D./ Examiner, Art Unit 1686
/Karlheinz R. Skowronek/ Supervisory Patent Examiner, Art Unit 1687