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 .
Claim Status
Claims 1-9 are pending and examined herein.
Claims 1-9 are rejected.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claims 1-9 are interpreted as receiving the claim to the benefit of priority to Foreign application KR10-2022-0038857 filed 29 March 2022. Thus, the effective filling date of claims 1-9 is 29 March 2022.
Information Disclosure Statement
The information disclosure statement (IDS) was received on 22 March 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings received 22 March 2023 are objected to for the reason provided below.
The drawings are objected to because Fig. 1, Fig. 2, Fig. 3… Fig. 10 should read FIG. 1, FIG. 2, FIG. 3… FIG. 10. The MPEP states that the view numbers must be preceded by the abbreviation “FIG.” (see MPEP 608.02(V) and 37 C.F.R. 1.84(u)(1)). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
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 1-9 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.
Claim 1 recites “selecting segments necessary for cancer diagnosis predictions from CpG site information for a human reference genome” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what types of segments are encompassed as being “necessary for cancer diagnosis” or what characteristics are encompassed in the differentiation between segments which are necessary for cancer diagnosis that are selected and segments which are not necessary for cancer diagnosis that are not selected. Dependent claims 3-9 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, this limitation will be interpreted as selecting segments from CpG site information for a human reference genome. It is noted that claim 2 is not rejected in this rejection due to providing conditions for this selection process.
Claim 1 recites “applying a methylation pattern fraction feature, among the whole-genome methylation sequencing information for cfDNA obtained in step b), to the segments selected in step a), and additionally applying, to the segments, at least one feature selected from the group consisting of a copy number ratio and a fragment size ratio, thereby extracting feature data” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what constitutes as applying a methylation pattern fraction feature, applying a copy number ratio, or applying a fragment size ratio (e.g., does this mean determining a methylation pattern fraction feature, determining a copy number ratio, and determining a fragment size ratio of the data which is located at the selected segments or does this mean using an already determined methylation pattern fraction feature, already determined copy number ratio and already determined fragment size ratio to process the data through operations such as filtering data, normalizing the data, scaling the data). The specification does not provide a clear and precise definition of the limitation, nor would one skilled in the art recognize the metes and bounds of said limitation. Dependent claims 2-9 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, the this limitation will be interpreted as determining a methylation pattern fraction feature and determining at least one feature selected from the group consisting or a copy number ratio and a fragment size ratio.
Claim 1 recites “applying… among the whole-genome methylation sequencing information for cfDNA obtained in step b), to the segments selected in step a), and additionally applying, to the segments, at least one feature selected from the group consisting of a copy number ratio and a fragment size ratio, thereby extracting feature data” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear if the features are being determined from the whole-genome methylation sequencing information which is located at the segments for the human reference genome or if this is meant to mean that these features are determined separately for the whole-genome methylation sequencing information and the segments. Dependent claims 2-9 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, the this limitation will be interpreted as determining a methylation pattern fraction feature and determining at least one feature selected from the group consisting or a copy number ratio and a fragment size ratio for the segments selected in a) utilizing the whole-genome methylation sequencing information located at the segments selected in a).
Claim 2 recites “the average sequencing depth of the segments in 90% or more, excluding lower 10% in healthy persons, exceeds 3” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what “the segments” is referring to due to claim 2 reciting conditions for selecting “a segment” and it is unclear what this condition requires to be met for “a segment” to be selected as being necessary for cancer diagnosis. For the sake of furthering examination, this limitation will be interpreted as the average sequencing depth for the segment exceeds three.
Claim 3 recites “wherein the liquid biopsy sample is blood from a healthy person or a cancer patient” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear which liquid biopsy sample of the “two or more liquid biopsy samples” (in claim 1) that “the liquid biopsy sample” is referring to. For the sake of furthering examination, this limitation will be interpreted as wherein the two or more liquid biopsy samples are blood from a healthy person or a cancer patient.
Claim 5 recites “calculating the ratio of methylated CpGs that are opposite to the predefined methylation pattern of healthy persons for the segments selected in step a)” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what “the ratio” and “the predefined methylation pattern of healthy persons” is referring to in the claims. It is further unclear what is encompassed by methylated CpGs that are opposite to predefined methylation patterns of healthy persons (e.g., does this mean calculating a ratio of the number of methylated CpGs in a sample to the number of unmethylated CpGs in healthy persons from sequencing data in the segments or does this mean calculating a ratio for a segment with methylated CpGs of a sample that have differing methylation patterns than methylation patterns of healthy persons for the segments). For the sake of furthering examination this limitation will be interpreted as calculating a ratio for a segment with methylated CpGs of a sample that have differing methylation patterns than methylation patterns of healthy persons for the segments.
Claim 6 recites “the subject sample” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what “the subject sample” is referring to in the claim. For the sake of furthering examination, this limitation will be interpreted as a sample.
Claim 7 recites “calculating the number of the first segments and the number of the second segments as a log ratio” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear which segments and what number that “the number of the first segments” and “the number of the second segments” is referring to. It is further unclear what is being calculated as a log ratio due to which segments and what numbers are being referred to. For the sake of furthering examination, this claim will be interpreted as wherein the fragment size ratio is determined by classifying fragments, mapped to each of the segments selected in step a), into first fragments of 100 bp to 150 bp and second fragments of 150 bp to 220 bp.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
(Step 1)
Claims 1-9 fall under the statutory category of a process.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. The instant claims further recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations.
Independent claim 1 recites mental processes of selecting segments from CpG site information for a human reference genome.
Independent claim 1 recites mathematical concepts of determining a methylation pattern fraction using the whole-genome methylation sequencing information located at the selected segments, additionally determining at least one feature selected from the group consisting of a copy number ratio and a fragment size ratio using the sequencing information located at the selected segments, and generating a cancer diagnosis prediction model through machine learning using at least one of the feature data extracted.
Claim 9 recites a mathematical concept of detecting the presence or absence of cancer and/or cancer-derived tissue by applying the whole-genome methylation sequencing information for cfDNA obtained in step a) to the multi-analytical prediction model for cancer diagnosis prepared through the method of claim 1.
The claim recites mental processes of organizing data and making judgments based on data as selecting segments from CpG site information for a human reference genome. The human mind is capable of analyzing CpG site information for a human reference genome to select segments based on criteria. Further the claim recites mathematical concepts of mathematical calculations as determining methylation pattern fraction of sequencing information at a segment (which encompasses calculating a ratio utilizing a mathematical equation shown in instant disclosure [0053]), determining a copy number ratio at a segment (which encompasses calculating a ratio utilizing fragment reads at a location) and a fragment size ratio of fragments at a segment (which encompasses calculating a ratio utilizing a mathematical equation shown in instant disclosure [0063]), generating a model utilizing these metrics through machine learning (which encompasses generating a linear regression model or logistic regression model which defines the mathematical relationship between numerical data representing these metrics and a numerical output which represents a cancer indication which is a series of mathematical calculations), and using this model to make a prediction (which encompasses a mathematical calculation of generating a numerical output utilizing a linear regression or logistic regression model). Dependent claims 2-8 further limit the mental process/mathematical concept recited in the independent claim but do not change their nature as a mental process/mathematical concept.
(Step 2A Prong 2)
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). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional element in claim 1 of obtaining whole-genome methylation sequencing information for cfDNA from two or more liquid biopsy samples and the additional element in claim 9 of obtaining whole-genome methylation sequencing information for cfDNA from a liquid biopsy sample of a subject patient do not integrate the judicial exceptions into a practical application because these steps are insignificant extra solution activity of data gathering. These additional elements constitute as extra solution activity of data gathering because these additional elements only interact with the judicial exceptions by providing data to be analyzed with the abstract ideas.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1-9 are directed to the abstract idea.
(Step 2B)
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). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The additional element in claim 1 of obtaining whole-genome methylation sequencing information for cfDNA from two or more liquid biopsy samples and the additional element in claim 9 of obtaining whole-genome methylation sequencing information for cfDNA from a liquid biopsy sample of a subject patient is conventional as shown by Finkle et al. US20210398617A1, Valouev et al. US 20210065842 A1, and Legendre et al. Clin Epigenet 7, 100 (2015) which all show obtaining whole-genome methylation sequencing information for cfDNA for liquid biopsy samples.
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
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, 3-6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Finkle et al. (US 20210398617 A1) in view of Valouev et al. (US 20210065842 A1).
Claim 1 is directed to a method for preparing a multi-analytical prediction model for cancer diagnosis, the method comprising steps of: a) selecting segments from CpG site information for a human reference genome
Finkle et al. shows selecting segments as generating bins for a reference genome and that the bin sizes are variable according to some property of the genome of the species of the subject such as the density of possible methylation sites (Finkle et al. [0176]).
c) determining a methylation pattern fraction feature, among the whole-genome methylation sequencing information for cfDNA obtained in step b), to the segments selected in step a), and additionally applying, to the segments, at least one feature selected from the group consisting of a copy number ratio and a fragment size ratio, thereby extracting feature data
Finkle et al. shows determining bin-level methylation features such as ratios for a methylation pattern of one or more methylation sites (such as in a CpG dinucleotide) encompassed by the sequence reads assigned to a respective bin (Finkle et al. [0177]). Finkle et al. shows determining bin-level features relating to a fragmentation pattern of the cell-free DNA such as classifying the length of fragment sequences as long fragments or short fragments and then calculating a fragment length ratio for the bin (Finkle et al. [0186]). Finkle et al. further shows determining bin-level copy number ratios (Finkle et al. [0359]).
and d) generating a cancer diagnosis prediction model through machine learning using at least one of the feature data extracted in step c).
Finkle et al. shows generating and using an ensemble model which predicts a final circulating tumor fraction estimate for a sample utilizing the copy number variation, fragment length, and methylation pattern features derived from a whole genome methylation sequencing reaction (Finkle et al. [0511] and [0520]).
Finkle et al. does not explicitly show that the selection of segments is from CpG site information of a genome or obtaining whole-genome methylation sequencing information for cfDNA from two or more liquid biopsy samples.
Like Finkle et al., Valouev et al. shows obtaining methylation data from cfDNA and analyzing the methylation patterns utilizing bins to detect cancer as a tumor fraction of a sample. Valouev et al. shows obtaining a training dataset with a plurality of patients derived from a liquid sample of a respective reference subject along with performing whole genome bisulfite sequencing with an average coverage of at least 30x (Valouev et al. [0068], [0074], [0075], [0238], and [0249]). Valouev et al. shows utilizing CpG site information of a genome for the generation of bins when analyzing methylation patterns (Valouev et al. [0168]).
Claim 3 is directed to wherein the liquid biopsy samples are blood from a healthy person or a cancer patient.
Valouev et al. shows that the biological samples are blood samples and the reference subjects may be healthy reference subjects or reference subjects with a non-zero tumor fraction (Valouev et al. [0068], [0114], [0167], [0194], [0310], and [0318]).
Claim 4 is directed to wherein the methylation pattern fraction is determined by calculating the ratio of the number of methylated Cs among CpGs in all reads for the segments selected in step a).
Finkle et al. shows calculating a methylation pattern metric as a bin-level methylation ratio for all CpG sites that are methylated in the nucleic acid sequences assigned to a respective bin (Finkle et al. [0179]).
Claim 5 is directed to wherein the methylation pattern fraction is determined by calculating a ratio for a segment with methylated CpGs of a sample that have differing methylation patterns than methylation patterns of healthy persons for the segments.
Finkle et al. does not show calculating a ratio for a segment with methylated CpGs of a sample that have differing methylation patterns than methylation patterns of healthy persons for the segment.
Valouev et al. shows calculation bin values that correspond to ratios of abnormally methylated fragments versus fragments having a methylation status matching the methylation status for a healthy control group (Valouev et al. [0167] and [0194]).
Claim 6 is directed to wherein the copy number ratio is determined by dividing the entire genome into bins, calculating a depth value for each bin, dividing the depth value for each bin of a sample by a reference value which is the median value of the depth for each bin from whole-genome methylation sequencing information for cfDNA of healthy persons, and then calculating a log value.
Finkle et al. shows determining the copy number ratio by dividing the entire genome into bins, calculating depths for each bin, calculating the log2 depths of an input sample and subtracting it by the log2 depth of a reference from whole-genome methylation sequencing information resulting in log 2 copy ratios (Finkle et al. [0363]). It is noted that subtracting the log2 depth of an input sample by the log2 depth of a reference value is the same as dividing the depth of the input sample by the depth of a reference value then taking the log2 of the resulting number.
Claim 8 is directed to wherein the cancer diagnosis prediction model detects the presence or absence of cancer and/or cancer-derived tissue.
Finkle et al. shows an ensemble model which detects the presence of cancer as a circulating tumor fraction estimate of a sample (Finkle et al. [0512]).
Claim 9 is directed to a method for providing information for cancer diagnosis, the method comprising steps of: a) obtaining whole-genome methylation sequencing information for cfDNA from a liquid biopsy sample of a subject patient
Finkle et al. shows obtaining whole-genome methylation sequence reads for cfDNA from a liquid biopsy sample of a test subject (Finkle et al. [0517], [0519], and claim 1).
and b) detecting the presence or absence of cancer and/or cancer-derived tissue by applying the whole-genome methylation sequencing information for cfDNA obtained in step a) to the multi-analytical prediction model for cancer diagnosis prepared through the method of claim 1.
Finkle et al. shows using a prediction model to detect the presence of cancer (a tumor fraction estimate) using the whole-genome methylation sequencing information for cfDNA obtained utilizing features of methylation pattern, copy number variation, and fragmentation features (Finkle et al. [0511], [0517], [0519], and claim 1).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the process of generating variable bins for a reference genome based on the density of possible methylation sites of Finkle et al. with the process of generating bins based on CpG site information of Valouev et al. because this would provide a particular pre-processing process of generating bins based on CpG site information and criteria for methylation analysis (Valouev et al. [0168] and [0182]) for the process of analyzing the methylation patterns of CpG sites within bins of a reference genome (Finkle et al. [0177]). It would have been further obvious to one of ordinary skill in the art before the effective filling date to have combined the generation of the machine learning cancer prediction model of Finkle et al. with the step of obtaining training datasets of whole-genome methylation data for reference subjects of Valouev et al. because this would provide labeled (i.e., tumor fraction) training data of liquid biopsy samples from reference subjects obtained from whole-genome methylation data (Valouev et al. [0068], [0074], [0075], and [0167]) for the generation of a machine learning model which intakes whole-genome methylation data for the prediction a tumor fraction. One would have a reasonable expectation of success because Finkle et al. shows analyzing methylation patterns from CpG sites within bins of a reference genome for the detection of cancer utilizing cfDNA derived from whole-genome methylation data while Valouev et al. shows a pre-processing process of generating bins based on CpG site information and criteria for methylation analysis of cfDNA derived from whole-genome methylation data.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Finkle et al. in view of Valouev et al. as applied to claim 1 above, and further in view of Finkle and Boulos et al. (NPJ Precision Oncology 5.1 (2021): 63).
Claim 2 is directed to wherein step a) comprises selecting a segment, which satisfies the following conditions, as a segment necessary for cancer diagnosis prediction: 1) the segment comprises CpG sites whose sequencing depth in healthy persons is 3 or more
Finkle et al. in view of Valouev et al. shows the reference subjects may be healthy reference subjects and performing whole genome bisulfite sequencing with an average coverage of at least 30x (Valouev et al. [0068], [0167], [0194], and [0310]) which shows that the reads at these bins which comprise CpG sites will have a sequencing dept in healthy persons of more than 3.
2) the distance between CpG sites is less than 100 bp, and the segment comprises at least 3 CpG sites
Finkle et al. in view of Valouev et al. shows each bin is defined when there is a separation between two adjacent CpG sites that exceeds a threshold amount (Voluev et al. [0168]). Valouev et al. further shows each the reference genome may be divided based on blocks of CpG sites such as 1 and 1000 CpG sites per bin (Valouev et al. [0182]).
3) the segment is divided when the segment length exceeds 1 kb
Finkle et al. in view of Valouev et al. shows when a respective bin is larger than a threshold size (such as 1000 bp) the respective bin is subdivided into windows of certain lengths (Valouev et al. [0168]).
and 5) the average sequencing depth for the segment exceeds three.
Finkle et al. in view of Valouev et al. shows the reference subjects may be healthy reference subjects and performing whole genome bisulfite sequencing with an average coverage of at least 30x (Valouev et al. [0068], [0167], [0194], and [0310]) which shows that the reads at these bins will have an average sequencing depth in healthy persons of more than 3.
Finkle et al. in view of Valouev et al. does not show sex chromosome segments are excluded.
Like Finkle et al. in view of Valouev et al., Finkle and Boulos et al. shows analyzing cfDNA from liquid biopsy samples detect the presence of cancer through tumor fraction. Finkle and Boulos et al. shows the exclusion of segments if it is on a contig that is historically difficult to sequence such as the sex chromosomes X and Y (Finkle and Boulos et al. page 10 left col.).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the segment selection of Finkle et al. in view of Valouev et al. to incorporate the process of filtering and excluding segments on sex chromosomes of Finkle and Boulos et al. because this provides a process which removes potential errors which arises from including data from areas of the genome that is recognized as being historically difficult to sequence (Finkle and Boulos et al. page 10 left col.). One would have a reasonable expectation of success because Finkle et al. in view of Valouev et al. and Finkle and Boulos et al. all show analyzing cfDNA of a liquid biopsy sample for detecting a tumor fraction utilizing a binning method to determine features for detecting a tumor fraction.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Finkle et al. in view of Valouev et al. as applied to claim 1 above, and further in view of Cristiano et al. (Nature 570, 385–389 (2019)).
Claim 7 is directed to wherein the fragment size ratio is determined by classifying fragments, mapped to each of the segments selected in step a), into first fragments of 100 bp to 150 bp and second fragments of 150 bp to 220 bp.
Finkle et al. in view of Valouev et al. shows determining a fragment length metric for a bin by comparing the length of each fragment to a predetermined threshold length and the fragment is classified either as a long fragment or a short fragment (Finkle et al. [0186]). Finkle et al. further shows calculating a fragment length ratio metric for the bin as a ratio of short to long fragments or vice versa (Finkle et al. [0186]).
Finkle et al. in view of Valouev et al. does not show first fragments of 100 bp to 150 bp and second fragments of 150 bp to 220 bp.
Like Finkle et al. in view of Valouev et al., Cristiano et al. shows analyzing cfDNA fragment lengths in the analysis of cancer. Cristiano et al. shows defining small cfDNA fragments as being 100 bp to 150 bp and larger fragments of 151 bp to 220 bp (Cristiano et al. page 386 right col.). Cristiano et al. shows that the median overall lengths of fragments of cfDNA from healthy individuals were larger than those from patients with cancer (Cristiano et al. page 386 right col.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted the predetermined threshold for classifying a fragment as a long fragment or a short fragment of Finkle et al. in view of Valouev et al. with the ranges of 100 bp to 150 bp for shorter cfDNA fragments and 151 bp to 220 bp for larger cfDNA fragments of Cristiano et al. because Finkle et al. in view of Valouev et al. and Cristiano et al. both show analyzing fragment lengths of cfDNA in the analysis of cancer and this would lead to predictable results of partitioning cfDNA fragment data based size ranges.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EDWARD HAYES whose telephone number is (571)272-6165. The examiner can normally be reached M-F 9am-5pm.
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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