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 .
Applicants Amendment
Applicant’s amendment filed 9/29/2025 has been received and entered. Claims 1, 4, 6, 16-19 have been amended, claims 21-26 have been added.
Claims 1-26 are pending.
Election/Restriction
Applicant's election with traverse of Group I in the reply filed on 3/28/2025 was acknowledged. In the previous action, upon initial search and review, it did not appear that it would not be an undue burden to search both methods together. Accordingly, the restriction requirement was withdrawn.
Newly added claims 21-26 appear consistent with the examined invention.
Claims 1-26, drawn to a method of treating cancer suing a database to finding an effective treatment and to a method of treating cancer using sequencing to detect cancer are currently under examination.
Priority
This application filed 8/21/2020 is a continuation of 15/431395 which is a continuation of PCT/US2015/067717 filed 12/18/2015 which claims benefit to US provisional applications 62/155763 filed 5/1/2015 and 62/098426 filed 12/31/2014; and
Is related as a parent to 17/462906 filed 8/31/2021, 17/699968 filed 3/21/2022 and 17/818944 filed 8/10/2022; and to 29/768979 filed 2/2/2021 as a design patent.
No comment on the summary of priority is provided in Applicants response.
Information Disclosure Statement
The two information disclosure statements (IDS) submitted 10/1/2025 and 10/30/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
It is noted that several of the cited references are Office actions. It is noted that for review of these, the pending claims that were reviewed in these actions were not provided, but for completeness and clarity of the record the cited references when provided in this prosecution were not considered in light of the instant claims.
It was noted that the listing of references in the specification is not a proper information disclosure statement, indicating [0095] for example.
Applicants have not complimented on this, and the IDS provided do not appear to provide the citation.
37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Response to Applicants arguments
Applicants acknowledge the rejections and request that the rejections be held in abeyance.
In response, a rejection can not be held in abeyance. Since no specific arguments are made, and in review of the amendments, the basis of the rejections are updated to address the amendments and maintained for the reasons of record.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 15/431395 (parent, final office action mailed 4/18/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims broadly encompass the claims of ‘395 which provides more specific probes and steps for the analysis, but would provide the same information about variants/mutations observed and affects of treatment when the observations are informative. A copy of the independent claim 43 pending 1/17/2025 is provided for comparison to the instant claims.
43. (Currently Amended) A method for generating a tumor response map indicating changes over time in genetic information from a tumor, comprising:
a) obtaining or having obtained a biological sample from the subject, wherein the biological sample comprises cell-free deoxyribonucleic acid (cfDNA) molecules;
b) ligating molecular barcodes to a plurality of the cfDNA molecules in the biological sample to generate tagged parent polynucleotides;
amplifying a plurality of tagged parent polynucleotides to generate amplified progeny polynucleotides and wherein the molecular barcodes are configured to generate an at least bi- partite encoded sequence read of a particular polynucleotide and/or original single cell-free nucleic acid molecule;
c}[[b)]] sequencing a plurality of polynucleotides derived from the plurality of tagged cell-free nucleic acid molecules from the samples to generate a set of sequence reads, wherein the set of sequencing reads comprises sequences of the molecular barcodes and sequences of the plurality of polynucleotides are decoded to identify correspondence
comprise a polynucleotide that combine with the diversity of the sequence of the plurality of polynucleotides to identify the particular polynucleotide and/or original single cell-free nucleic acid molecule;
d[[c)]] determining, by a computer, a quantitative measure of each of a plurality of genetic variants among the panel from each of the samples from the set of sequence reads; and generating a tumor response map, comprising:
i) normalizing the quantitative measure of each of the plurality of genetic variants for rendering across serial time points; and
ii) applying a scaling factor to the normalized quantitative measure of each of the plurality of genetic variants;
e[[d)]] collapsing, by a computer, the plurality of sequence reads to generate consensus calls for bases in each parent polynucleotide, wherein the plurality of sequence reads are collapsed to generate consensus calls by grouping, by a computer, the sequence reads into families based at least on sequence information from the molecular barcodes, and further wherein the tumor response map is a graphical representation of relative quantities of each of the plurality of genetic variants at each of the serial time points for somatic mutations present at a non-zero quantity and at least one of the serial time points.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/462906 filed 8/31/2021 (con of instant application, nonfinal office action mailed 5/29/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims broadly encompass the claims of ‘906 which provides more specific probes and steps for the analysis to determine CNV as a specific type of mutation that might be present, but would provide the same information about variants/mutations observed and affects of treatment when the observations are informative. A copy of the independent claim 1 pending 9/6/2024 is provided for comparison to the instant claims.
1. (Currently Amended) A method for analyzing nucleic acids from disease cells from a subject, the method comprising:
(a) providing a population of nucleic acids from disease cells from at least a bodily fluid sample from the subject, wherein a plurality of the nucleic acids in the bodily fluid sample comprise cell-free deoxyribonucleic acid (cfDNA) molecules;
(b) performing biomolecular analysis of a plurality of the nucleic acids from the population of nucleic acids, wherein the biomolecular analysis comprises genomic and epigenetic analysis, wherein at least the genomic analysis comprises analyzing by a computer sequence reads from at least 1 million nucleic acid molecules derived from the cfDNA molecules, wherein the sequence reads correspond to a plurality of genomic regions of a human genome, wherein the sequence reads are generated by DNA sequencing, wherein the sequencing reads comprise sequences of molecular barcodes that identify a particular polynucleotide and/or original single cell-free nucleic acid molecule;
(c) determining and quantifying biomolecular variants comprising copy number variation (CNV) mutant allele frequencies and methylation mutant allele frequencies based on the biomolecular analysis and adjusted using measurement of replication origin CNV (ROCNV);
(d) developing a profile of disease cell heterogeneity in the subject based on the determining and quantifying of step (c), wherein the disease cells comprise cancer cells; and
(e) using a computer configured to access a database to identify an effective therapeutic intervention for the subject based on the profile of disease cell heterogeneity, wherein the database includes, for each of a plurality of subjects having cancer, tumor genomic testing data, including somatic alterations, collected at two or more time intervals per subject, one or more therapeutic interventions administered to each of the subjects at one or more times and efficacy of the therapeutic interventions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/699968 filed 3/21/2022 (con in line of the instant application, nonfinal office action mailed 5/12/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims broadly encompass the claims of ‘968 which provides more specific probes and steps for the analysis to determine CNV as a specific type of mutation that might be present, but would provide the same information about variants/mutations observed and sets forth in the preamble that the treatment is immunotherapy when the observation and diagnosis is informative.
A copy of the independent claim 1 pending 8/28/2024 is provided for comparison to the instant claims.
1. (Currently Amended) A method for treating a subject having cancer with an immunotherapy,the method comprising:
(a) determining a genetic profile of a tumor from the subject, the genetic profile providing an indication that the subject is likely to respond to the immunotherapy, by:
(i) obtaining or having obtained a biological sample from the subject, wherein the biological sample comprises cell-free deoxyribonucleic acid (cfDNA) molecules;
(ii) performing a diagnostic assay on the biological sample to determine the genetic profile of the tumor from the subject, wherein the diagnostic assay comprises: (A) ligating molecular barcodes to a plurality of the cfDNA molecules in the biological sample to generate tagged parent polynucleotides;amplifying a plurality of tagged parent polynucleotides to generate amplified progeny polynucleotides and wherein the molecular barcodes are configured to generate an at least bi-partite encoded sequence read of a particular polynucleotide and/or original single cell-free nucleic acid molecule;sequencing a plurality of the amplified progeny polynucleotides to generate the set of sequence reads, wherein the set of sequence reads comprises sequence information corresponding to a polynucleotide derived from the plurality of cfDNA molecules and sequence information from the molecular barcodes that were ligated to the cfDNA molecules and wherein sequencing is with a machine with up to a 5% error rate;
{_B}are decoded to identify correspondence
{_} and wherein the quantitative measure is above a noise threshold that is less than or equal to the machine error rate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/818944 filed 8/10/2022 (con in line of the instant application, RCE filed, nonfinal office action mailed 4/10/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims broadly encompass the claims of ‘944 which provides more specific probes and steps for the analysis to determine CNV as a specific type of mutation that might be present, but would provide the same information about variants/mutations observed and sets forth in the preamble that the treatment is immunotherapy when the observation and diagnosis is informative.
A copy of the independent claim 1 pending 6/27/2025 is provided for comparison to the instant claims.
(Currently Amended) A computer-implemented method comprising:
partitioning one or more loci of a reference genome into a plurality of non-overlapping windows of uniform length that is less than a median spacing between mammalian replication origins, and wherein the plurality of non-overlapping windows comprises at least one window that overlaps at least one origin-of- replication (ORI) locus under analysis;
b) ]]for the plurality of non-overlapping windows, determining a baseline measure of copies of control deoxyribonucleic acid (DNA) molecules of one or more control samples and calculating a baseline replication-origin copy-number- variation (ROCNV) statistic comprising a measure of statistical dispersion of the baseline measures across the plurality of non-overlapping windows, wherein the control DNA molecules each contain DNA from cells in a resting state
[[c) ]] for the plurality of non-overlapping windows, determining a test measure of copies of test DNA molecules of a test sample and calculating a test ROCNV statistic comprising a measure of statistical dispersion of the test measures across the plurality of non-overlapping windowsand
[[d) ]]comparing the test ROCNV statistic ROCNV statisticROCNV statistic the baseline ROCNV statistic that DNA in the test sample derives from cells dividing faster than those that provided the DNA in the one or more control samples
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
For completeness of the record, an updated review of the inventors and claim amendments, the design patent applications 29/768979 filed 2/2/2021 is noted, and while any display of the data would be appear to be obvious, that is mutations over time and in response to treatment, the present claims do not require any specific output that would lead the skilled artisan to provide for the display as provided in ‘979.
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 1-20 stand and newly added claims 21-26 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.
Claim analysis
Independent claim 1 has been amended and still is generally directed to identifying somatic changes which are detected in analyzing data representing cfDNA from a subject that has a tumor and correlating changes that are associated with treatment or therapeutic intervention over time. More specifically, the claims have been updated so that the sequence data that was obtained has ‘complementary strand identifiers enabling duplex consensus error correction’, ‘defining tumor burden based on alterations in cfDNA’ and from the data ‘generating a feedback based dosing schedule’ based on tumor burden. Newly added claims provide that the data represents various timepoints for observing variants and levels of detection of clones and possible modification of treatment based on the observations. The claims as amended use a database and do not appear to require any of the steps necessary to obtain the data in the database, and the generation of the therapy appears to be instructions based on the data given any type of intervention.
Claim has deleted that the cfDNA from ‘at least 50 subjects’ and provides broadly a ‘plurality’, which comprise read data be obtained wherein the data is obtained over time and after intervention, then the data is assessed to observe changes in the read data that can be correlated to the effect of the treatment. The basis of the invention is based on the observation that subjects with cancer have cfDNA that originates from the tumor and that mutations present in the tumor/cancer can be observed in the analysis of cfDNA, and that the presences of the mutated read data can be used to measure the presence, absence or general change in tumor/cancer cells present in the subject before and after treatment.
Dependent claims provide for possible result interpretation of types of mutations that may be observed, such as the effectiveness of a treatment and the number of patients screened. Generally, the specification provides for analysis by ‘generating a tumor response map” by normalizing and applying a scaling factor to provide for a graphical representation in review of the specification for the requirements of this step, at paragraph [00124] teaches a graphical map is:
“FIG. 9B shows an exemplary process to generate genetic reports, including a tumor response map and associated summary of alterations. A tumor response map is a graphical representation of genetic information indicating changes over time in genetic information from a tumor, e.g., qualitative and quantitative changes. Such changes can reflect response of a subject to a therapeutic intervention.”
and for the steps that result in the response map at paragraph [00134] it teaches:
“Next, a tumor response map is generated. To generate the map, the process can comprise normalizing the quantities for each gene alteration for rendering across all test points and then generates a scaling factor (34). As used herein, the term "normalize" generally refers to means adjusting values measured on different scales to a notionally common scale. For example, data measured at different points are converted/adjusted so that all values can be resized to a common scale. As used herein, the term "scaling factor" generally refers to a number which scales, or multiplies, some quantity. For example, in the equation y = Cx, C is the scale factor for x. C is also the coefficient of x, and may be called the constant of proportionality of y to x. The values are normalized to allow plotting on a common scale that is visually-friendly.”
and appears to provide for how the graph is presented for a ‘visually-friendly’ presentation of the data, and does not appear to necessarily change the data and given the broad general nature of the steps appears dependent on the data for what normalization would or could encompass or generally be done, as well as the need for a scaling factor.
In review of the guidance of the specification, none of the new limitations appear to affect the data per se and are consistent with known methods previously used to tag and track nucleic acids to a sample, and for the resulting data may provide for a means to simply interpret the data in graphical form which may be easier to read in a common scale. Overall, the limitations required of the claims do not appear to have affected the scope of the claims with respect to a requirement that a plurality of tagged cfDNA sequences being provided/sequenced over time for analysis except the number initially provided by sequencing; and require providing a series of tagged/barcoded samples containing cfDNA over time, sequencing the cfDNA in the samples, and determining with a computer implemented method any somatic change or variant within the reads over time and representing the results graphically if present. Dependent claims have been amended to correct grammatical issues, and still provide for what the quantitative measure is and how the information from the analysis is presented, as well as the source of the cfDNA being in the blood, plasma or serum and how it is tagged for preparation of sequencing.
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a process.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of accessing sequence read data for possible sequence changes over time and determination of possible changes and graphically presenting the information in a normalized and a scaled presentation if present. The claims encompass and provide the step where a quantitative measure is determined, and now the determination is displayed as a normalized and scaled representation of the step. The step of determining given the guidance of the specification and art of record, requires the step of aligning and comparing sequence to arrive at the identification of possible changes in the read sequences are considered instructional steps. The claim requires computing similarity scores based for potential differences, and thus determine a potentially somatic sequence changes. The judicial exception is a set of instructions for analysis of sequence data and falls into the category of a mental processes, that is concepts performed in the human mind (including an observation, evaluation, judgment, opinion). In review of the specification and the requirement of the claims, the importance of 50 subjects and what it represents relative to the data analyzed does not suggest a complexity rather simply an amount of reads to be analyzed, and could represent copies of an amplified locus of interest or random reads which are not necessarily informative to the analysis steps. Further, the specification teaches that the plurality can be interpreted as read data, and suggests that alignment and quantification of the types and number of variants at a specific allele/locus of interest would be a simple matter of observation. Given the plain meaning and general guidance of the specification, the plurality can be of one target of interest, making the alignment and comparison straightforward. In view of the guidance of the specification would target sequencing a limited number of specific genes (supported in the explanation and figure 10D for example). Comparison and analysis of specific sequences can be performed by observation in one’s mind or on paper, and can be represented with a simple graph with any choice of colors of any changes if observed in the data.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims have an additional element which is directed to obtaining the read data that is subsequently analyzed in the judicial exception and does not appear to be a practical application of the judicial exception. This judicial exception requires steps recited at high level of generality and are only stored on a non-transitory, and is not found to be a practical application of the judicial exception as broadly set forth. Dependent claims set forth further indication of how the results are presented and that over the time period the patient was being treated. With respect to treatment, it is noted that this is prior to the sample be analyzed, and the method as a whole is broader than this requirement and in this embodiment simply analyzes samples to observe possible changes or correlations to the presences of detectable cfDNA within a sample.
For step 2B of the 101 analysis, each of the independent claims recites additional elements and are found to be the steps of obtaining sequence data which were well known and conventional (see for example Forshew et al 2012 and Ding et al 2012). Additionally, steps for providing barcodes for sequencing or for tagging sequences for downstream processing were also known (see for example Schmitt et al, Vogelstein et al and Talasaz et al, as acknowledged in the specification in [0095]) and used for subsequent sequence read analysis. The data obtained from the steps considered the additional element are separate and appear to provide data for subsequent analysis and the judicial exception does not affect these steps, and as such, the claims do not provide for any additional element to consider under step 2B as a practical application or significantly more than analyzing possible changes within a sample as a whole. It is noted that in prosecution the method was amended so that the analysis is ‘by a computer’, however in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process."
As indicated in the summary of the judicial exception above and in view of the teachings of the specification, the steps are drawn to analysis of sequence data of cfDNA possibly present in sample. For implementing with a computer, while the instruction are stored on a medium and could be implemented on a computer, together the steps do not appear to result in significantly more than a means to compare sequences. The judicial exception of the method as claimed can be performed by hand and in light of the previous claims to a computer medium and in light of the teaching of the specification on a computer. In review of the instant specification the methods do not appear to require a special type of processor and can be performed on a general purpose computer.
Response to Applicants arguments
Applicants provide and overview for the 101 analysis. For step 2A prong 1, applicants argue that the claims do not recite a judicial exception and that the characterization of the claims is incorrect and directed to a method of treating a subject with cancer, also citing the teachings of the specification.
In response, the intent of the claims has been acknowledged and the additional element of treating has been addressed in step 2B. However, the claims clear start with ‘using a database’ and while the source of the data in the database is set forth in the claims, the claims do not require these steps and provide for analysis of cfDNA sequence reads. The claims have been amended to indicate that data represents a ‘clinical level’ however these are not terms of art relative to the claimed analysis, and appear in light of the specification observable differences that might be observed. Further, the generating step for dosing also appears to be broad and generic, with no specific intervention tied to any specific observable change encompassed by the claims. Contrary to Applicants arguments, the claims are primarily instructions for analyzing read data. Further, treatment of cancer patients is known, and in view of no specific guidance nor nexus between any observed ‘clinical level’ and particular ‘intervention’ these appear to be broad generic limitations that do not meaningful limit the claim except to analyze and identify effective therapeutic treatments.
For step 2A, prong 2, Applicants argue that the alleged judicial exception is integrated into a practical application, and improvement to the technology.
In response, there does not appear to be any evidence that there is an improvement or any specific practical application that flows from the claims. As discussed in prosecution, tumor burden was known and observed, and changes could be seen when the tumor was successfully treated or if the growth increased. In review of the specification and the claims as a whole, there is no specific or practical application for any intervention.
For step 2B, applicants argue that the claims amount to significantly more than just a judicial exception noting that the error correction enables a non-generic nature to measurements by grouping the sequences into consensus family of sequences.
In response, the amendments have been acknowledged, however they appear to fall within the judicial exception and not an additional element for consideration under step 2B. The only step found to be an additional element has been administering intervention, however this is found to be generic and in light of the evidence and guidance of the specification, there is no specific nexus between any observable change in tumor burden and any particular intervention to be considered a practical application consistent with cited decisions.
Therefor, for the reasons above and of record, the rejection is maintained.
As noted previously, one way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
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 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 1-20 rejected under 35 U.S.C. 103 as being unpatentable over Forshew et al (2012), Ding et al (2012), Fan et al (2008), Vogelstein et al (US Patent 9476095), Schmitt et al (US Patent 9752188) and Schmitt et al (PNAS 2012) is withdrawn.
While it was known that cancer cells represented a variety of genetic alterations, and sometimes the alterations resulted in specific characteristics such as relapse after treatment as evidenced by Ding et al who provide a detailed study of the clonal evolution in AML by whole genome sequencing over time, none of the references provide for ‘clinical levels of tumor burden’ and any specific dosing schedule of any intervention based on this data as required of the claims.
Conclusion
No claim is allowed.
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 Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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/Joseph Woitach/Primary Examiner, Art Unit 1687