DETAILED ACTION
Applicant’s response, filed May 4 2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Claims 1 and 3-20 are pending.
Claim 2 is canceled.
Claims 1, 5-6, 11, 13, 16-18, and 20 are objected to.
Claims 1 and 3-20 are rejected.
It is noted that claims 3 and 10 as currently recited are not completely identical. However, if the below 35 USC 112(b) rejection of claim 10, which was previously applied to claims 3 and 10 but addressed only in claim 3, is addressed in a similar manner as in claim 3, then claims 3 and 10 will be substantial duplicates as the claim dependency has changed in the current amended claim set.
Priority
Applicant's claim for the benefit of a prior-filed application, PCT/CN2020/134810, filed Dec 9 2020, is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. CN202010084107.4, filed Feb 10 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should the applicant desire to obtain the benefit of foreign priority under 35 USC 119(a)-(d), a certified English translation of the foreign priority application must be submitted. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, each of claims 1 and 3-20 are afforded the effective filing date of Feb 10 2020.
Drawings
The replacement drawing sheets submitted May 4 2026 are accepted and the outstanding objections from the previous Office Action are withdrawn.
Claim Interpretation
Contingent Claiming
In the interest of compact prosecution, the instant claims are examined to consider all claim limitations. However, the claims contain recitations of intended use and contingent claim language that affect the scope of the claims, as listed below. The courts have stated that claims must be given their broadest reasonable interpretation (BRI) consistent with the specification (see MPEP § 2111).
The instant claims include a recitation of contingent claim language.
With respect to contingent claiming, said contingencies as claimed require that the claims are interpreted as provided for in the MPEP at 2111.04 (II), wherein: “the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met). For example, assume a method claim requires step A, if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B”.
In the instant claims, the following is a “contingent” recitation:
Claim 3 and 10: “selecting an optimal mass spectrum with the most anchor peaks from the plurality of mass spectra when the plurality of mass spectra have different calibration coefficients”; and “summing an absolute intensity or a square intensity of a mass spectrum with an absolute intensity or a square intensity of another mass spectrum only when a calibration coefficient of the mass spectrum and a calibration coefficient of the optimal spectrum meet a condition”. As these limitations are interpreted to be substeps of the step of “synthesizing the plurality of mass spectra by using a self-weighted average method” (see the below 35 USC 112(b) rejection), the entirety of claims 3 and 10 are interpreted to be contingent.
Claims 6, 11, 13, and 17: “step S136… when there is no overlapping peak, fitting a single Gaussian peak by Levenberg- Marquardt algorithm to find specified parameters to minimize a tuning function”.
With respect to the interpretations above, it is suggested that the claims be amended to recite alternative language so as to avoid interpretation of contingent claiming.
Response to Applicant Arguments
At p. 14, Applicant submits that the claims reciting the contingent limitation “in a case where” have been amended to recite “when” to avoid interpretation of contingent claiming, as suggested in the previous Office Action.
It is respectfully submitted that this is not persuasive. The recitation of “when” is also interpreted as contingent claiming, and the interpretation is maintained. It is noted that the previous Office Action did not suggest to amend the claim language to recite “when”.
Claim Objections
Unless otherwise stated, the outstanding objections to the claims are withdrawn in view of the amendments submitted herein.
The claims are objected to because of the following informalities. The instant objection is newly stated and is either necessitated by claim amendment or based upon further consideration of the claims, or is maintained from the previous Office Action.
The claims recite multiple limitations which include a plurality of steps. As set forth in 37 CFR 1.75, where a claim sets forth a plurality of steps, each step of the claim should be separated by a line indentation (see MPEP 608.01(i)). The objection is maintained from the previous Office Action. Such limitations include:
Claim 1: “step S14: finally selecting…, steps of finding…, matching…, and only selecting…”; and
Claim 1: “step S15: performing…, calculating…”.
The text should not begin on the lines after the recitations of step S…, as occurs in step S1, step S4, step S12, step S14, and step S15 of claim 1 and Step S136 in claims 6, 11, 13, and 17.
Claim 1, step S4, should end with a semicolon after “detection point”.
Claim 1 recites “wherein the step S1, recalibrating the single mass spectrum comprises:” should begin on a new line after step S4.
Claim 1, step S11, 1, should be amended to recite “a peak value of a reference peak of the group of reference peaks” to maintain consistent claim language. The objection is newly stated based upon further consideration of the claims.
Claim 1, step S11, 2, should be amended to recite “no other reference peak of the group of reference peaks, adjacent to the reference peak of the group of reference peaks” to maintain consistent claim language. The objection is newly stated based upon further consideration of the claims.
Claim 1, step S12, second limitation, includes a comma after “(-4, 0, 1, 2, 2, 2, 1, 0, -4)” which should be removed.
Claim 1, step S14, recites “finally selecting an anchor peak, by for a detected peak list”, where “by” should be removed.
Claim 1, step S15, recites “performing the recalibration operation by calculating a calibration coefficient by a nonlinear fitting method in combination with the anchor peak and an expected mass of the anchor peak, and a mapping function”. The limitation is interpreted as reciting a list of the combination of the anchor peak, an expected mass of the anchor, and a mapping function, and should be amended accordingly to recite “performing the recalibration operation by calculating a calibration coefficient by a nonlinear fitting method in combination with the anchor peak, [[and]] an expected mass of the anchor peak, and a mapping function”.
Claim 1 is missing an “and” before “t is a time period during which a signal appears in the mass spectrometer” in the final two lines.
In claims 5, 16, 18, and 20, “step S42: following features are recorded” should be amended to recite “steps S42: recording:”.
Applicant is advised that should claim 1 be found allowable, claims 4 and 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 1 be found allowable, claims 5 and 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Applicant Arguments
At p. 13, Applicant submits that the objections in the previous Office Action have been addressed.
It is respectfully submitted that this is not entirely the case. Many of the objections were addressed, but several remain to be addressed as set forth in the above objections.
Claim Rejections- 35 USC § 112
Unless otherwise noted, the outstanding rejections to the claims are withdrawn in view of the amendments submitted herein.
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 and 3-20 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, regards as the invention. The instant rejection is either newly stated and is necessitated by claim amendment or is maintained from the previous Office Action and updated based on amendment.
Claim 1, before step S11, recites “wherein in the steps S1, recalibrating the single mass spectrum comprises”. There is insufficient antecedent basis for the limitation because there is no previous recitation of a single mass spectrum or recalibrating a single mass spectrum. The claim previously recites recalibrating each of a plurality of mass spectra and synthesizing a unitary mass spectrum. It is assumed that the limitation before step S11 intends to further limiting each of a plurality of mass spectra as recited in step S1. The rejection may be overcome by clarifying the antecedent basis of the limitation. Claims 3-20 are rejected based on their dependence from claim 1.
Claim 1, step S14, recites “finally selecting an anchor peak, by for a detected peak list, steps of finding a cut-off signal-noise ratio, matching a peak in the detected peak list with a list of the reference peaks, and only selecting a peak whose mass is within a specific range of the candidate reference peak and whose signal-noise ratio is higher than the cut-off signal-noise ratio”. It is not clear whether the claim intends to recite the multiple steps of “selecting an anchor peak” and steps of “finding a cut-off signal-noise ratio”, “matching a peak…”, and “only selecting a peak…”, or if the steps of limitations following “steps of” are intended to recite substeps of “finally selecting an anchor peak, for a detected peak list”. For compact examination, it assumed that the steps of “finding a cut-off signal-noise ratio”, “matching a peak”, and “only selecting a peak” are intended to be substeps of “finally selecting an anchor peak”, which could be conveyed by removing the comma after “peak list” and adding “comprising” before “steps of:” or similar. Claims 3-20 are rejected based on their dependency from claim 1.
Claim 1, step S15, recites “performing the recalibration operation”. There is insufficient antecedent basis for the limitation because there is no previous recitation of a recalibration operation. It is noted that the claim previously recites “recalibrating” in Step S1. For compact examination, it is assumed that step S15 intends to refer to this recalibrating. The rejection may be overcome by clarifying the antecedent basis of the limitation. Claims 3-20 are rejected based on their dependency from claim 1.
Claim 1, step S15, recites “wherein the mapping function between a mass spectrometer and mass-to-charge ratio is a Bruker function…”. It is not clear whether the claim intended to recite “a mass spectrometer” or “a mass spectrum” or similar, because a mass spectrometer is the instrument which generates the mass spectra data and it is not clear what is meant by mapping mass-to-charge ratio to such an instrument. For compact examination, it is assumed that the claim intended to recite a mass spectrum or similar. The rejection may be overcome by clarifying what the wherein clause intends to limit. Claims 3-20 are rejected based on their dependency from claim 1. The rejection is maintained from the previous Office Action.
Claim 10 recites “wherein the step S2 comprises: synthesizing the plurality of mass spectra by using a self-weighted average method; selecting an optimal mass spectrum with the most anchor peaks from the plurality of mass spectra when the plurality of mass spectra have different calibration coefficients; initializing a mass spectrum synthesized by performing the self-weighted average method on the plurality of mass spectra with the optimal mass spectrum; summing an absolute intensity or a square intensity of a mass spectrum with an absolute intensity or a square intensity of another mass spectrum only when a calibration coefficient of the mass spectrum and a calibration coefficient of the optimal spectrum meet a condition”. It is not clear if the steps of “selecting an optimal mass spectrum”, “initializing a mass spectrum synthesized by performing the self-weighted average method” and “summing an absolute intensity or a square intensity” are substeps of performing the step of “synthesizing the plurality of mass spectra by using a self-weighted average method”, as one of the steps actually recites “initializing a mass spectrum synthesized by performing the self-weighted average method”, or if the steps are intended to be separate from “synthesizing the plurality of mass spectra by using a self-weighted average method”. For compact examination, it is assumed that the steps are intended to be substeps of “synthesizing the plurality of mass spectra by using a self-weighted average method”. The rejection may be overcome by clarifying the relationship between the limitations. The rejection is maintained from the previous Office Action. Claim 11 is rejected based on its dependency from claim 10.
Claims 11, 13, and 17, step S135, recites “masking a point, and further masking a point, having a signal-noise ratio… greater than a ratio given value and a noise greater than a noise given value”. It is not clear whether the claim requires two separate points to be masked, and if so, which point is being further limited by “having a signal-noise ratio… greater than a ratio given value and a noise greater than a noise given value”. For compact examination, it is assumed that just one point is required to be masked, and that the limitation regarding the signal-noise ratio and the noise further limits that one point. The rejection may be overcome by clarifying the relationship between the different terms in the limitation. The rejection is maintained from the previous Office Action.
Response to Applicant Arguments
At p. 14-15, Applicant submits that the rejections in the previous Office Action have been addressed.
It is respectfully submitted that this is not entirely the case. Many of the rejections were addressed, but several remain to be addressed as set forth in the above rejections.
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 and 3-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more. Any newly recited portions are necessitated by claim amendment.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to a method, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
Independent claim 1: step S1, recalibrating each of the plurality of mass spectra, wherein each mass spectrum of the plurality of mass spectra is recalibrated by using a group of anchor peaks; with an expected mass-to-charge ratio;
step S2, synthesizing the plurality of mass spectra, wherein on a basis of the step S1, the plurality of mass spectra corresponding to the different positions of the detection point are synthesized into a unitary mass spectrum of the detection point;
step S3: performing wavelet filtering on the unitary mass spectrum of the detection point, on a basis of the step S2, to eliminate high-frequency noise and a baseline through a wavelet- based digital filter; and
step S4: extracting a peak feature value, performing peak fitting to obtain a fitted curve of the unitary mass spectrum of the detection point on a basis of the step S3, and obtaining a peak height, a peak width, a peak area, a mass offset, and a signal-noise ratio based on a-the fitted curve of the unitary mass spectrum of the detection point;
wherein in the step S1, recalibrating the single mass spectrum comprises:
step S11: selecting a group of reference peaks, wherein selecting a group of reference peaks comprises selecting the group of reference peaks from all possible expected peaks according to following criteria: 1, a peak value of a reference peak being within a mass range of a specific interval; 2, no reference peak, adjacent to the reference peak, existing in the mass range of the specific interval;
step S12: positioning a peak,
applying a weight matrix convolution filter with a width of 9 to the single mass spectrum, wherein the weight matrix convolution filter is (-4, 0, 1, 2, 2, 2, 1, 0, -4), for a given point of the single mass spectrum, an intensity value of the given point after applying the weight matrix convolution filter is equal to a weighted sum of 9 values around the given point, and is expressed by a following formula:
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, wherein y’i represents a filtered intensity value of the given point, Ik represents a k-th intensity value among the 9 values of nine points surrounding the given point; yk represents a k-th value of the weight matrix convolution filter, i represents the intensity value of the given point, and the nine points surrounding the given point include four continuous points before the given point, four continuous points after the given point, and the given point itself,
decomposing the single mass spectrum into a plurality of specific point intervals based on filtered intensity values,
identifying a local noise for each specific point interval, and
identifying a peak with an intensity greater than or equal to four times the local noise and greater than or equal to a global minimum value as a reference peak, wherein the global minimum value is: 0.01 * a maximum local maximum value;
step S13: fitting a peak of the single mass spectrum;
step S14: finally selecting an anchor peak by for a detected peak list, steps of finding a cut-off signal-noise ratio, matching a peak in the detected peak list with a list of the reference peaks, and only selecting a peak whose mass is within a specific range of the reference peak and whose signal- noise ratio is higher than the cut-off signal-noise ratio; and
step S15: performing the recalibration operation by calculating a calibration coefficient by a nonlinear fitting method in combination with the anchor peak and an expected mass of the anchor peak, and a mapping function, wherein the mapping function between a mass spectrometer and mass-to-charge ratio is a Bruker function in a form of
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, wherein A, B, and C are calibration coefficients, m is a mass-to-charge ratio of a peak, t is a time period during which a signal appears in the mass spectrometer.
Dependent claims 3-20 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claims 3 and 10 further limit synthesizing the plurality of mass spectra to being performed using a self-weighted average method; claims 4, 12, and 14 further limit performing wavelet filtering to obtain a filtered mass spectrum and then performing another round of recalibration; claims 5, 16, 18, and 20 further limit step S4 to fitting a peak and recording features of the peak; claims 6, 11, 13, and 17 further limit step S13 of claim 2 for fitting a peak; claims 7, 15, and 19 further limit the self-weighted average method of claim 3; claim 8 further limits step S131 of claim 6 for determining the expected line width to being determined by an equation; and claim 9 further limits the tuning function of step S136 of claim 6 to being determined by an equation.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually obtain descriptions of a mass spectrum peak based on a fitted curve of a unitary mass spectrum. Without further detail as to the methodology involved in “recalibrating”, “synthesizing”, “performing wavelet filtering”, “extracting a peak feature value”, “performing peak fitting to obtain a fitted curve”, and “obtaining” different parameters of the fitted curve, under the BRI, one may simply, for example, use pen and paper to recalibrate the single mass spectrum using a group of anchor peaks by selecting a group of reference peaks according to certain criteria, position a peak, apply a weight matrix convolution filter according to an equation to the single mass spectrum, decompose the single mass spectrum into a plurality of specific point intervals, identify a local noise for each specific point interval, identify a peak with a specific intensity, fit a peak of the single mass spectrum, and select an anchor peak by finding a cut-off signal-noise ratio, matching a peak to a list of reference peaks, and selecting a peak with a specific mass; synthesize mass spectra into a unitary mass spectrum; perform wavelet filtering on the unitary mass spectrum; extract a peak feature value; perform peak fitting to obtain a fitted curve of the unitary mass spectrum; and obtain peak parameters from the fitted curve. These steps as described in the independent and dependent claims also explicitly recite mathematical techniques and formulae and require mathematical techniques as the only supported embodiments, as is disclosed in the specification at: [0017-0039].
Therefore, claim 1 and those claims dependent therefrom recite an abstract idea [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 1: for each detection point of a sample on a sample plate of the mass spectrometer, obtaining a plurality of mass spectra corresponding to different positions of the detection point.
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “obtaining” data as in claim 1, perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
The specification discloses advantages of the method at [0011], including extracting reliable feature values, ameliorating the limitation of the prior art and improving the accuracy of nucleotide detection, and improving the credibility of nucleic acid mass spectrum data acquisition, but does not provide a clear explanation for how the additional elements provide these improvements. Therefore, the additional elements do not clearly improve the functioning of a computer, or comprise an improvement to any other technical field. Further, the additional elements do not clearly affect a particular treatment; they do not clearly require or set forth a particular machine; they do not clearly effect a transformation of matter; nor do they clearly provide a nonconventional or unconventional step (MPEP2106.04(d)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer or a person when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)). As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Response to Applicant Arguments
At p. 15, Applicant submits that the method of the present application is a method for further processing physical measurement data obtained by a mass spectrometer measuring nucleic acid samples on a sample plate, and such data are not abstract numbers. The processing object of the method of the present application is a nucleic acid sample, and the anchor peaks are specific to nucleic acid fragments. The method is a processing method dedicated to nucleic acid mass spectrometry, rather than a general data processing algorithm. The method of the present application can solve the problems of low conversion rate, uneven data, and the like existing in the mass spectrometry data acquisition process, and addresses practical technical problems in nucleotide detection. The method is a practical solution serving specific technical problems rather than abstract mathematical calculations.
It is respectfully submitted that this is not persuasive. The first step of claim 1 recites “for each detection point of a sample on a sample plate of the mass spectrometer, obtaining a plurality of mass spectra corresponding to different positions of the detection point”. The subsequent method steps in the claim act on the obtained mass spectra, which are data obtained from a mass spectrometer. Therefore the subsequent method steps of the claim act on these data, and as many of these steps recited in the claims recite mathematical formula for processing the data, it is considered that the data encompass mathematical data. It is noted that the title of the application is “NUCLEIC ACID MASS SPECTRUM NUMERICAL PROCESSING METHOD”. Applicant’s statement that the data are not abstract numbers is not convincing. The claims do not recite the manipulation of nucleic acids, but merely obtaining mass spectrometry data generated from those nucleic acids, which reads on receiving or obtaining data which has already been generated. The claims therefore are not limited to any physical process that is performed on nucleic acids. That the data corresponds to nucleic acids does not alter the fact that the data is numerical data, and the actions performed on the numerical data recite abstract ideas, as described in the above rejection.
It is respectfully submitted that this is not persuasive. Applicant alleges that the method represents a practical application. However, steps S1-S4 that provide the supposed improvement (i.e., low conversion rate, uneven data, and the like existing in the mass spectrometry data acquisition process) in the instant claims are steps that are, themselves, the judicial exceptions and cannot therefore be a practical application of the judicial exception. The courts have made clear that a judicial exception is not eligible subject matter (Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)) if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, it is the additional elements (if any) in the claim that must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B. If there are no additional elements in the claim, then it cannot be eligible. It is submitted here that the instant claims do not include any additional elements that provide for a practical application. Rather, the “additional element” in the instant claims (see exemplary claim 1) includes only the step of “obtaining a plurality of mass spectra”. As set forth above, said steps operate in the claim as data gathering steps and do not integrate any of the recited judicial exceptions into a practical application, nor do the claims as a whole include any inventive concept beyond well-understood, routine and conventional steps.
It is further noted that the claims do not recite an active step of performing the mass spectrometry measurement of the nucleic acid. Therefore, Applicant’s arguments regarding an improvement in the mass spectrometry data acquisition process are not commensurate with the scope of the claims. However, even if the arguments were commensurate with the scope of the claims, it is noted that they would still not be convincing. The actual performance of the mass spectrometry data acquisition process would not be changed by the performance of the steps recited in the claims. Therefore, any improvements provided by the limitations identified as judicial exceptions in the above rejection would not provide an improvement to the actual mass spectrometry, but merely to the analysis of the data. As discussed above, a judicial exception cannot improve itself or another judicial exception to provide a practical application.
Claim Rejections - 35 USC § 102
The outstanding rejections from the previous Office Action are withdrawn in view of the amendments submitted herein. Specifically, Yang et al. (BMC Bioinformatics, 2009, 10(1):1-13; previously cited) does not teach performing a weight matrix convolution filter with the filter in claim 2.
Claim Rejections - 35 USC § 103
The outstanding rejections from the previous Office Action are withdrawn in view of the amendments submitted herein. Specifically, Yang et al. (BMC Bioinformatics, 2009, 10(1):1-13; previously cited) does not teach performing a weight matrix convolution filter with the filter in claim 2. Neither the closest prior art to Yang et al. (BMC Bioinformatics, 2009, 10(1):1-13; previously cited) nor any art identified in the indicated prior art searches appear to teach selecting a group of reference peaks with recited criteria and performing a weight matrix convolution filter with the filter in claim 1.
Conclusion
No claims are allowed.
The claims appear to be free of the prior art. Neither the closest prior art to Yang et al. (BMC Bioinformatics, 2009, 10(1):1-13; newly cited) nor any art identified in the indicated prior art searches appear to teach selecting a group of reference peaks with recited criteria and performing a weight matrix convolution filter with the filter in claim 1.
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.
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/JANNA NICOLE SCHULTZHAUS/Examiner, Art Unit 1685
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