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 .
DETAILED ACTION
The instant application having Application No. 17271628 has a total of 13 claims pending in the application, of which claims 9, 11 and 14 have been cancelled.
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, 10, and 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 1 is a process type claim. Claim 13 is a Therefore, claims 1-8, 10, and 12-13 are directed to either a process, machine, manufacture or composition of matter.
As per claim 1,
2A Prong 1:
“Preparing a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms” A user mentally or with pencil and paper calculates the parameters to be used to extract peak information from a wave form.
“associating the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” The user mentally or with pencil and paper determines which parameter set to use with the different waveforms.
“determining a first similarity between the first chromatogram waveform and the analysis target chromatogram waveform and determining a second similarity between the second chromatogram waveform and the analysis target chromatogram waveform” The user mentally or with pencil and paper determines the similarity between the various waveforms and the target analysis waveform.
“comparing the first similarity and the second similarity” The user mentally or with pencil and paper compares the two similarities.
“Extracting peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracting peak information from the analysis target chromatogram waveform using the second parameter set when the second similarity is higher than the first similarity” The user mentally or with pencil and paper uses the parameter set with the most similarity to the target analysis waveform.
2A Prong 2: This judicial exception is not integrated into a practical application.
Additional elements:
“A chromatograph analyzing device”, (mere instructions to apply the exception using a generic computer component);
“Preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device, wherein each of the first chromatogram waveform and second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample”, “measuring an analysis target sample by a chromatograph analyzing device to obtain an analysis target chromatogram waveform” (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)).
“storing the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)).
2B: The claim does not include additional elements individually or in combination that are sufficient to amount to significantly more than the judicial exception.
Additional elements:
“A chromatograph analyzing device”, (mere instructions to apply the exception using a generic computer component)
“Preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device, wherein each of the first chromatogram waveform and second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample”, “measuring an analysis target sample by a chromatograph analyzing device to obtain an analysis target chromatogram waveform” (MPEP 2106.05(d)(II) indicate that merely “Sending and receiving data” is a well‐understood, routine, conventional function when it is claimed in a merely generic manner (as it is in the present claim). Thereby, a conclusion that the claimed preparing and measuring steps are well-understood, routine, conventional activity is supported under Berkheimer).
“storing the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” (MPEP 2106.05(d)(II) indicate that merely “storing and retrieving data from memory” is a well‐understood, routine, conventional function when it is claimed in a merely generic manner (as it is in the present claim). Thereby, a conclusion that the claimed storing step is well-understood, routine, conventional activity is supported under Berkheimer).
As per claim 2, this claim contains similar mental steps to claim 1 and is rejected for similar reasons.
2A Prong 2: This judicial exception is not integrated into a practical application.
Additional elements:
“a learning model by performing machine learning” (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f) – Examiner’s note: Claims contain a generic machine learning model with no additional detail or limitations that make it more than a generic, off the shelf machine learning model.
2B: The claim does not include additional elements individually or in combination that are sufficient to amount to significantly more than the judicial exception.
Additional elements:
“a learning model by performing machine learning” (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f) – Examiner’s note: Claims contain a generic machine learning model with no additional detail or limitations that make it more than a generic, off the shelf machine learning model.
As per claim 3, this claim contains similar generic machine learning models similar to claim 2, and is rejected for similar reasons.
As per claim 4, this claim contains similar mental steps and generic machine learning models for claim 2, and is rejected for similar reasons.
As per claim 5-8, 10, and 12 , this claim contains similar mental steps to claim 1, and is rejected for similar reasons.
As per claim 13,
2A Prong 1:
“Preparing a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms” A user mentally or with pencil and paper calculates the parameters to be used to extract peak information from a wave form.
“associating the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” The user mentally or with pencil and paper determines which parameter set to use with the different waveforms.
“determining a first similarity between the first chromatogram waveform and the analysis target chromatogram waveform and determining a second similarity between the second chromatogram waveform and the analysis target chromatogram waveform” The user mentally or with pencil and paper determines the similarity between the various waveforms and the target analysis waveform.
“comparing the first similarity and the second similarity” The user mentally or with pencil and paper compares the two similarities.
“Extracting peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracting peak information from the analysis target chromatogram waveform using the second parameter set when the second similarity is higher than the first similarity” The user mentally or with pencil and paper uses the parameter set with the most similarity to the target analysis waveform.
2A Prong 2: This judicial exception is not integrated into a practical application.
Additional elements:
“A device”, “A processor”, “A chromatograph analyzing device”, (mere instructions to apply the exception using a generic computer component);
“Preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device, wherein each of the first chromatogram waveform and second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample”, “measuring an analysis target sample by a chromatograph analyzing device to obtain an analysis target chromatogram waveform” (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)).
“storing the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)).
2B: The claim does not include additional elements individually or in combination that are sufficient to amount to significantly more than the judicial exception.
Additional elements:
“A device”, “A processor”, “A chromatograph analyzing device”, (mere instructions to apply the exception using a generic computer component)
“Preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device, wherein each of the first chromatogram waveform and second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample”, “measuring an analysis target sample by a chromatograph analyzing device to obtain an analysis target chromatogram waveform” (MPEP 2106.05(d)(II) indicate that merely “Sending and receiving data” is a well‐understood, routine, conventional function when it is claimed in a merely generic manner (as it is in the present claim). Thereby, a conclusion that the claimed preparing and measuring steps are well-understood, routine, conventional activity is supported under Berkheimer).
“storing the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” (MPEP 2106.05(d)(II) indicate that merely “storing and retrieving data from memory” is a well‐understood, routine, conventional function when it is claimed in a merely generic manner (as it is in the present claim). Thereby, a conclusion that the claimed storing step is well-understood, routine, conventional activity is supported under Berkheimer).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 10, and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per claim 1, this claim calls for “preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device, wherein each of the first chromatogram waveform and the second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample. This limitation calls for a single sample to be put into the system, and TWO corresponding chromatogram waveforms to be produced. The claim then goes on to have these chromatogram waveforms be different, having different parameters, different similarity comparisons with the analysis target, and other distinctions that clearly make these two different waveforms. However, the specification at no time describes TWO waveforms being made from a single sample.
The closest paragraph is 0032, which measures multiple samples with the gas chromatograph spectrometer, and outputs pieces of GCMS data, but there is no discussion of a single sample producing multiple waveform results.
Paragraph 0033 similarly denotes multiple biological samples being processed and getting corresponding 32 pieces of GCMS data. There is no discussion of a single sample producing multiple waveform results.
Paragraph 0034 and associated figure 3A/B show the GCMS data for each sample, including the TICC waveform created for the sample. There is no discussion of a single sample producing multiple waveform results.
This causes the limitation of a single sample producing two separate waveforms to be new matter, and therefore leading to claim 1 being rejected under U.S.C. 112(a).
As per claims 2-8, 10, and 12, these claims are rejected as being dependent on a claim rejected under U.S.C. 112(a) for new matter.
As per claim 13, this claim calls for “preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device, wherein each of the first chromatogram waveform and the second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample. This limitation calls for a single sample to be put into the system, and TWO corresponding chromatogram waveforms to be produced. The claim then goes on to have these chromatogram waveforms be different, having different parameters, different similarity comparisons with the analysis target, and other distinctions that clearly make these two different waveforms. However, the specification at no time describes TWO waveforms being made from a single sample.
The closest paragraph is 0032, which measures multiple samples with the gas chromatograph spectrometer, and outputs pieces of GCMS data, but there is no discussion of a single sample producing multiple waveform results.
Paragraph 0033 similarly denotes multiple biological samples being processed and getting corresponding 32 pieces of GCMS data. There is no discussion of a single sample producing multiple waveform results.
Paragraph 0034 and associated figure 3A/B show the GCMS data for each sample, including the TICC waveform created for the sample. There is no discussion of a single sample producing multiple waveform results.
This causes the limitation of a single sample producing two separate waveforms to be new matter, and therefore leading to claim 13 being rejected under U.S.C. 112(a).
As per claim 4, this claim calls for “using the analysis target chromatogram waveform for which the peak information is extracted as the first chromatogram waveform and the second chromatogram waveform.” However, this is not supported by the specification. The specification at no time discloses using an incoming analysis target chromatogram waveform to replace the previously looked at first chromatogram waveform or the second chromatogram waveform, let alone both with the same analysis target waveform. This cases the claim to be new matter, and therefore rejected under U.S.C. 112(a).
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-8 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As per claim 6, this claim refers to “in associating the parameter set.” There is insufficient antecedent basis for this limitation. In addition, it is unclear which parameter set this is referring to, as the parent claim has a first parameter set and a second parameter set. This causes the claim to be confusing and rejected under U.S.C. 112(b) for failing to particularly point out and claim the intended invention
As per claims 7-8 and 10, these claims are rejected as being dependent on a claim rejected under U.S.C. 112(b) for failing to particularly point out and claim the intended invention.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-8, 10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Belglovskly et al, hereinafter “Bel” (US 20060255257 A1) in view of Barcaru et al (“Bayesian Approach to peak deconvolution and library search for high resolution gas chromatography – Mass spectrometry”).
As per claim 1, Bel discloses, “A method for analyzing waveform data comprising steps of: preparing a first chromatogram waveform and a second chromatogram waveform” (pg.5-6, particularly paragraph 0054; EN: this denotes taking in multiple samples that will be measured by the system. Pg.5, particularly paragraph 0058; EN: This denotes looking at peaks of the output signal, which is being interpreted as the waveforms of the samples). “by measuring a sample using a chromatograph analysis device” (pg. 5, particularly paragraph 0049; EN: this denotes the use of a high performance liquid chromatography system). “wherein each of the first chromatogram waveform and the second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample” (Pg.5, particularly paragraph 0058; EN: this denotes the peaks of the sample).
“preparing a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms” (Pg.6, particularly paragraph 0065 and Figure 4; EN: this denotes the parameter sets that were used to extract the peaks).
“associating the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” (Pg.6, particularly paragraph 0065 and Figure 4; EN: this denotes the parameter sets that were used to extract the peaks and the discussion of optimizing/adjusting them to resolve the peaks).
“storing the first parameter set in relation to the first chromatogram waveform and the second parameter set in relation to the second chromatogram waveform” (pg.4-5, particularly paragraph 0046 and 0050-0051;; EN: this denotes storing the results of the system and creating an expert system for future use).
“Measuring an analysis target sample by a chromatograph analyzing device to obtain an analysis target chromatogram waveform” (Pg.6, particularly paragraph 0078; EN: This denotes using the information in subsequent runs of the devices).
However, Bel fails to explicitly disclose, “determining a first similarity between the first chromatogram waveform and the analysis target chromatogram waveform and determining a second similarity between the second chromatogram waveform and the analysis target chromatogram waveform”, “comparing the first similarity and the second similarity”, ”extracting peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracting peak information from the analysis target chromatogram waveform using the second waveform using the second parameter set when the second similarity is higher than the first similarity”
Barcaru discloses, “determining a first similarity between the first chromatogram waveform and the analysis target chromatogram waveform and determining a second similarity between the second chromatogram waveform and the analysis target chromatogram waveform” ” (Pg.79, particularly section 2.3.2; EN: This denotes taking the input spectra and comparing it to the spectra of the library. When combined with the Bel reference, this denotes using the expert system from the Bel reference to find matching data).
“Comparing the first similarity and the second similarity” (Pg.79, particularly C2, the “Extracting” and “keeping” sections; EN: this denotes ranking the various similarity comparisons and comparing them to see which one is superior).
”extracting peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracting peak information from the analysis target chromatogram waveform using the second waveform using the second parameter set when the second similarity is higher than the first similarity” (Pg.88, C2, First and second paragraph; Pg. 89, particularly C1, First and second paragraph; EN: this denotes taking in new data and using the algorithm to resolve the peaks via matching with the library and ranking).
Bel and Barcaru are analogous art because both involve mass spectrometry.
Before the effective filing date it would have been obvious to one skilled in the art of mass spectrometry to combine the work of Bel and Barcaru in order to find matching data to inputs when using a library for mass spectrometry.
The motivation for doing so would be to make use of “a probabilistic library search [to] comput[e] the spectral match with a high resolution library” (Barcaru, Abstract) or in the case of Bel, allow the system to use the Expert system disclosed by Bel in order to match future inputs to known previous inputs of the system in order to benefit from previous optimizations.
Therefore before the effective filing date it would have been obvious to one skilled in the art of mass spectrometry to combine the work of Bel and Barcaru in order to find matching data to inputs when using a library for mass spectrometry.
As per claim 2, Bel discloses, “Creating a learning model by performing machine learning in which the first parameter set associated with the first chromatogram waveform and the second parameter set associated with the second chromatogram waveform are used as learning data” (pg.4-5, particularly paragraph 0046; EN: this denotes using data processed by the system to create an expert system, a type of learning model).
Barcaru discloses, “wherein the learning model compares the first similarity and the second similarity” (Pg.79, particularly C2, the “Extracting” and “keeping” sections; EN: this denotes ranking the various similarity comparisons and comparing them to see which one is superior).
“The learning model extracts peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracts peak information from the analysis target chromatogram waveform using the second parameter set when the second similarity is higher than the first similarity” (Pg.88, C2, First and second paragraph; Pg. 89, particularly C1, First and second paragraph; EN: this denotes taking in new data and using the algorithm to resolve the peaks via matching with the library and ranking).
As per claim 4, Bel discloses, “updating the learning model by performing the machine learning using the analysis target chromatogram waveform for which the peak information is extracted as the first chromatogram waveform and the second chromatogram waveform” (pg.4-5, particularly paragraph 0046; EN: this denotes using data processed by the system to create an expert system, a type of learning model).
As per claim 5, Bel discloses, “the first chromatogram waveform, the second chromatogram waveform, and the analysis target chromatogram waveform are mass chromatograms, total ion current chromatograms, mass spectra, or spectroscopic spectra” (Pg.3, particularly paragraph 0035; EN: this denotes the use of chromatograms).
As per claim 12, Barcaru discloses, “the first chromatogram waveform or the second chromatogram waveform is associated only when the first similarity or the second similarity is equal to or higher than a predetermined standard” (pg.83, particularly C2, second paragraph; EN: this denotes requiring the data be above a certain threshold).
As per claim 13, Bel discloses, “a device that analyzes waveform data comprising” (Pg.5, particularly paragraph 0058; EN: this denotes looking at peaks of a waveform).
“A processor performing” (pg.4, particularly paragraph 0040; EN: this denotes the use of a processor).
“Preparing a first chromatogram waveform and a second chromatogram waveform” (pg.5-6, particularly paragraph 0054; EN: this denotes taking in multiple samples that will be measured by the system. Pg.5, particularly paragraph 0058; EN: This denotes looking at peaks of the output signal, which is being interpreted as the waveforms of the samples). “by measuring a sample using a chromatograph analysis device” (pg. 5, particularly paragraph 0049; EN: this denotes the use of a high performance liquid chromatography system). “wherein each of the first chromatogram waveform and the second chromatogram waveform include one or more peaks derived from a plurality of substances contained in the sample” (Pg.5, particularly paragraph 0058; EN: this denotes the peaks of the sample).
“preparing a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms” (Pg.6, particularly paragraph 0065 and Figure 4; EN: this denotes the parameter sets that were used to extract the peaks).
“associating the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform” (Pg.6, particularly paragraph 0065 and Figure 4; EN: this denotes the parameter sets that were used to extract the peaks and the discussion of optimizing/adjusting them to resolve the peaks).
“storing the first parameter set in relation to the first chromatogram waveform and the second parameter set in relation to the second chromatogram waveform” (pg.4-5, particularly paragraph 0046 and 0050-0051;; EN: this denotes storing the results of the system and creating an expert system for future use).
“Measuring an analysis target sample by a chromatograph analyzing device to obtain an analysis target chromatogram waveform” (Pg.6, particularly paragraph 0078; EN: This denotes using the information in subsequent runs of the devices).
However, Bel fails to explicitly disclose, “determining a first similarity between the first chromatogram waveform and the analysis target chromatogram waveform and determining a second similarity between the second chromatogram waveform and the analysis target chromatogram waveform”, “comparing the first similarity and the second similarity”, ”extracting peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracting peak information from the analysis target chromatogram waveform using the second waveform using the second parameter set when the second similarity is higher than the first similarity”
Barcaru discloses, “determining a first similarity between the first chromatogram waveform and the analysis target chromatogram waveform and determining a second similarity between the second chromatogram waveform and the analysis target chromatogram waveform” ” (Pg.79, particularly section 2.3.2; EN: This denotes taking the input spectra and comparing it to the spectra of the library. When combined with the Bel reference, this denotes using the expert system from the Bel reference to find matching data).
“Comparing the first similarity and the second similarity” (Pg.79, particularly C2, the “Extracting” and “keeping” sections; EN: this denotes ranking the various similarity comparisons and comparing them to see which one is superior).
”extracting peak information from the analysis target chromatogram waveform using the first parameter set when the first similarity is higher than the second similarity, and extracting peak information from the analysis target chromatogram waveform using the second waveform using the second parameter set when the second similarity is higher than the first similarity” (Pg.88, C2, First and second paragraph; Pg. 89, particularly C1, First and second paragraph; EN: this denotes taking in new data and using the algorithm to resolve the peaks via matching with the library and ranking).
Bel and Barcaru are analogous art because both involve mass spectrometry.
Before the effective filing date it would have been obvious to one skilled in the art of mass spectrometry to combine the work of Bel and Barcaru in order to find matching data to inputs when using a library for mass spectrometry.
The motivation for doing so would be to make use of “a probabilistic library search [to] comput[e] the spectral match with a high resolution library” (Barcaru, Abstract) or in the case of Bel, allow the system to use the Expert system disclosed by Bel in order to match future inputs to known previous inputs of the system in order to benefit from previous optimizations.
Therefore before the effective filing date it would have been obvious to one skilled in the art of mass spectrometry to combine the work of Bel and Barcaru in order to find matching data to inputs when using a library for mass spectrometry.
Claim Rejections - 35 USC § 103
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Belglovskly et al, hereinafter “Bel” (US 20060255257 A1) in view of Barcaru et al (“Bayesian Approach to peak deconvolution and library search for high resolution gas chromatography – Mass spectrometry”) and further in view of Ulintz et al (“Improved Classification of Mass Spectrometry Database Search Results using Newer Machine Learning Approaches”).
As per claim 3, Bel fails to explicitly disclose, “the machine learning uses deep learning, a support vector machine, or adaboost.”
Ulintz discloses, , “the machine learning uses deep learning, a support vector machine, or adaboost” (Pg.499 C1-C2; EN: this denotes using adaboost as well as SVM for classification of mass spectrometry data; Pg.501-502, particularly the results and discussion section; EN: this denotes using the SVM/Adaboost for classification of mass spectrometry data).
Ulintz and Bel modified by Barcaru are analogous art because both involve mass spectrometry.
Before the effective filing date it would have been obvious to one skilled in the art of mass spectrometry to combine the work of Ulintz with Bel modified by Barcaru in order to use machine learning to identify mass spectrometry data.
The motivation for doing so would be because “Boosting and random forest approaches … improve the discrimination of true hits from false positive identifications in the results of mass spectrometry database search engines” (Ulintz, Abstract) or in the case of Bel modified by Barcaru, allow the system to use adaboost or other machine learning algorithms to better match the incoming data to known data of the Expert system of Bel.
Therefore before the effective filing date it would have been obvious to one skilled in the art of mass spectrometry to combine the work of Ulintz with Bel modified by Barcaru in order to use machine learning to identify mass spectrometry data.
Claim Rejections - 35 USC § 103
Claim 6-8 and 10 is rejected under 35 U.S.C. 103 as being unpatentable over Belglovskly et al, hereinafter “Bel” (US 20060255257 A1) in view of Barcaru et al (“Bayesian Approach to peak deconvolution and library search for high resolution gas chromatography – Mass spectrometry”) and further in view of Teshima (US 20070110144 A1).
As per claim 6, Bel fails to explicitly disclose, “in associating the parameter set, the first parameter set and the second parameter set are determined for some or all of first divided chromatogram waveforms and second divided chromatogram waveforms obtained by dividing the first chromatogram waveform and the second chromatogram waveform.”
Teshima discloses, “in associating the parameter set, the first parameter set and the second parameter set are determined for some or all of first divided chromatogram waveforms and second divided chromatogram waveforms obtained by dividing the first chromatogram waveform and the second chromatogram waveform” (pg.3, particularly paragraph 0038; EN: this denotes dividing up spectrum waveforms).
Bel and Teshima are analogous art because both involve chromatographs.
Before the effective filing date it would have been obvious to one skilled in the art of chromatographs to combine the work of Bel and Teshima in order to divide up waveforms patterns.
The motivation for doing so would be so “the pattern is divided up into regions that have typical peaks A, B, and C from among the spectrum waveform and that are respectively referred to as region A, region B, and region C” (Teshima, Pg.3, particularly paragraph 0038) or in the case of Bel, allow the system to break up the waveforms in order to make the pieces easier to refer to and identify.
Therefore before the effective filing date it would have been obvious to one skilled in the art of chromatographs to combine the work of Bel and Teshima in order to divide up waveforms patterns.
As per claim 7, Barcaru discloses, “identifying a substance corresponding to the peak information extracted from the analysis target chromatogram waveform by collating the extracted peak information with a database of known substances” (Pg.79, particularly section 2.3.2; EN: This denotes taking the input spectra and comparing it to the spectra of the library. When combined with the Bel reference, this denotes using the expert system from the Bel reference to find matching data).
As per claim 8, Barcaru discloses, “a degree of matching with peak information stored in the database regarding the identified substance is obtained for the extracted peak information included in the analysis target chromatogram waveform” (Pg.79, particularly section 2.3.2; EN: This denotes taking the input spectra and comparing it to the spectra of the library. When combined with the Bel reference, this denotes using the expert system from the Bel reference to find matching data).
As per claim 10, Barcaru discloses, “… analysis target chromatogram waveforms are compared with the first … chromatogram waveforms and the second … chromatogram waveforms” (Pg.79, particularly section 2.3.2; EN: This denotes taking the input spectra and comparing it to the spectra of the library. When combined with the Bel reference, this denotes using the expert system from the Bel reference to find matching data).
Teshima discloses, “the analysis target chromatogram waveform is divided based on a predetermined standard to create a plurality of divided analysis targe chromatogram waveforms” (pg.3, particularly paragraph 0038; EN: this denotes dividing up spectrum waveforms).
“first divided chromatogram waveform and the second divided chromatogram waveforms” (pg.3, particularly paragraph 0038; EN: this denotes dividing up spectrum waveforms).
Response to Arguments
In pg.6-7, the Applicant argues in regards to the rejection under U.S.C. 101,
Applicant respectfully submits that the present claims do not cover an abstract idea because the feature "preparing a first chromatogram waveform and a second chromatogram waveform by measuring a sample using a chromatograph analyzing device" cannot be performed by human mind. The elements recited by Applicant's independent claims integrate any allegedly abstract idea into a practical application. As described in paragraph [0022] of the specification as originally filed, the sequential features recited in amended claim 1 ,reflect technical improvement that "[[i]]t is possible to easily obtain the appropriate analysis result by using a data analyzing method, a data analyzing device, or a learning model creating method for data analysis according to the present invention when analyzing various kinds of data such as measurement data, obtained by measuring the sample using the analyzing device, using the analysis parameters." As explicitly recited in amended claim 1, the measurement data is a chromatograph waveform obtained by measuring a sample using a chromatograph analyzing device, and analyzing the chromatogram waveform integrates the alleged abstract idea into a practical application. The present claims recite significantly more than the abstract idea itself by reciting a specific and complex approach to increase accuracy in analysis result by preparing a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms, associating the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform and storing the first parameter set in relation to the first chromatogram waveform and the second parameter set in relation to the second chromatogram waveform to extract peak information which is not taught by the recited references as discussed below. Taking all the additional elements individually, and in combination, claims as a whole amount to significantly more than the abstract idea. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the above rejection in view of the arguments as set forth above.
The aspect of preparing wave forms out of a generic chromatograph device is not considered a mental step, it is the use of generic hardware in order to receive a type of data input, in this case a waveform out of the chromatograph device. There is no requirement that receiving data from a generic device to be a mental step, and merely using generic hardware to implement extrasolutionary activity like receiving input data or storing that data is not enough to be significantly more than the abstract idea. Merely stating that it is “easy to obtain the appropriate analysis result” is not considered an improvement to the chromatograph itself or to any other piece of hardware, it is an improvement to the abstract idea of selecting appropriate parameters for interpreting a waveform input. Therefore the rejection is maintained as shown above.
In pg.7-8 the Applicant argues in regards to the rejection using the Bel reference under U.S.C. 103,
Applicant respectfully submits that none of the cited references fail to teach or suggest each and every element of claims 1 and 13. Bel merely discusses apparatus parameters for obtaining chromatogram data (i.e., gain). As described in paragraphs [0055]-[0064] of Bel, a gain is calculated in Step 7 which is performed after peaks are identified in Step 4. That is, the parameter of Bel is not used for extracting peak information from waveforms. Thus, Bell does not teach or suggest "a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms" recited in amended claim 1.
In response, the Examiner maintains the rejection as shown above. The Bel reference makes explicitly clear that peaks are examined (see paragraph 0058) in step 4, but it also states that the gain is adjusted, and the samples re-injected to return to step 2 (see Bel, paragraph 0062). Paragraph 0065 further describes the results of this re-injection in order to optimize the parameters in order to adequately resolve peaks.
“However, re-injection of the sample to acquire repeats used the already optimized gain parameters, thus the first gain setting of 1 was not repeated since it not result in an adequately resolved peak, whereas the two gains of 1000 and 5000 was repeated.” (Bel, pg.6, paragraph 0065).
This shows that the gain is being optimized to resolve the peaks, with gains sometimes NOT resolving peaks and not being used again in future re-injections. This shows that the parameters are used to extract peak information, and therefore the rejection is maintained as shown above.
Applicant further argues in pg.7-8 to the rejection under U.S.C. 103,
With respect to the feature of comparing as recited in claim 1, the office action argues that motivation for doing so would be to make use of "a probabilistic library search [to] comput[e] the spectral match with a high resolution library" (Barcaru, Abstract) or in the case of Bel, allow the system to use the Expert system disclosed by Bel in order to match future inputs to known previous inputs of the system in order to benefit from previous optimizations. See Pages 16-17 of the office action. Applicant, however, disagrees. Bel merely describes in paragraph [0046] that "controller 200 may include a database and/or a knowledgebase that can be accessed by processor 251. According to one embodiment of the present invention, the database may include a plurality of records, each record corresponding to a particular set of parameters for which both instruments 500 and 600 may be used to separate and quantitate the signal corresponding to the separated mixture." Thus, Bel does not teach or suggest a first parameter set and a second parameter set each of which includes one or more parameters used for extracting peak information from waveforms. In addition, the expert system of Bel stores data used to separate and quantitate the signal corresponding to the separated mixture. In contrast, the library disclosed in Barcaru stores standard spectrum data of known compounds and is far from Expert system of Bel. Therefore, a skilled person in the art cannot combine the above disclosures of Bel and Barcaru. Moreover, the features "associating the first parameter set with the first chromatogram waveform and the second parameter set with the second chromatogram waveform" and "storing the first parameter set in relation to the first chromatogram waveform and the second parameter set in relation to the second chromatogram waveform" are missing from Bel and Barcaru. The remaining references do not cure the deficiency of Bel and Barcaru.
In response, the Examiner maintains the rejection as shown above. The Applicant appears to be arguing that the parameters of the Bel reference is not something that can be used with the Barcaru reference because the Barcaru reference discloses matching the incoming spectra to known spectra in order to use the data associated with those known spectra. When combined with the Bel reference, which includes an expert system (i.e. a library) of parameters associated with these different types of spectra, it would be obvious to one of ordinary skill in the art at the time of filing to make use of a library system that matches the incoming waveforms to known waveforms in order to use the appropriate parameters stored in the Bel system in order to properly resolve the waveforms. Since this meets the broadest reasonable interpretation of the claims, the rejection is maintained as shown above.
Applicant's arguments with respect to claims 1-8, 10, and 12-13 have been considered but are either moot in view of the new ground(s) of rejection or repetitions of the above arguments and rejected for similar reasons.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEN M RIFKIN whose telephone number is (571)272-9768. The examiner can normally be reached Monday-Friday 9 am - 5 pm.
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/BEN M RIFKIN/Primary Examiner, Art Unit 2123
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