DETAILED ACTION
The amendment filed on 02/17/2026 has been entered. No new matter was added/
Claims 1 is amended in the claim set filed on 02/17/2026.
Claims 1, 6-7, 9, 12, 21-23, 27-28, 32-34, 37, and 40 in the claim set filed on 02/17/2026 are currently under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Priority
This application claims the benefit of U.S. Provisional Application No. 63/145,201 filed
on February 3, 2021. Accordingly, the priority date of claim set filed on February 1, 2026, is determined to be February 3, 2021.
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, 6-7, 9, 12, 21-23, 27-28, 32-34, 37 and 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/mathematical relationship of creating a matched filter and abstract idea/mental process of comparing and constructing based on the comparing, without significantly more. The claims recite abstract ideas. These judicial exceptions are not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims provide no specific limitations that provide significantly more.
Claim analysis
The instant claim 1 is directed towards “A method of genotyping a segment of DNA, the method comprising: obtaining a signal derived from an image of the DNA segment that is indicative of a nucleotide composition of the DNA segment, wherein the image comprises one or more signals of photon energy emitted from the DNA at one or more wavelengths; obtaining at least one reference signal derived from images of different reference samples of DNA, the at least one reference signal being based on a trajectory of at least one strand of the different reference samples of DNA; creating at least one matched filter from the at least one reference signal; comparing the signal to the at least one reference signal, the comparing being based on an amplitude of at least one output value generated from applying the at least one matched filter to the signal; and constructing, based on the comparing, a nucleotide sequence of the DNA segment, the constructing comprising identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype block corresponds to the at least one output value.
The “creating at least one matched filter from the at least one reference signal” is interpreted as an abstract idea relating to the mathematical relationship.
The “comparing the signal to the at least one reference signal” step is interpreted as an abstract idea relating to data comparisons that can be performed mentally or analogous to human mental work.
The “constructing, based on the comparing, a nucleotide sequence of the DNA segment, the constructing comprising identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype block corresponds to the at least one output value” step is interpreted as an abstract idea relating to organizing or analyzing information that can be performed mentally or analogous to human mental work.
Dependent claims set forth further limitations about the haplotype block, comparison of signal, signal, nucleotide assignment, methods of screening, method of detecting chromosomal instability and treating.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract ideas. With regard to claim 1, the claim recites “A method of genotyping a segment of DNA, the method comprising: obtaining a signal derived from an image of the DNA segment that is indicative of a nucleotide composition of the DNA segment, wherein the image comprises one or more signals of photon energy emitted from the DNA at one or more wavelengths; obtaining at least one reference signal derived from images of different reference samples of DNA, the at least one reference signal being based on a trajectory of at least one strand of the different reference samples of DNA; creating at least one matched filter from the at least one reference signal; comparing the signal to the at least one reference signal the comparing being based on an amplitude of at least one output value generated from applying the at least one matched filter to the signal; and constructing, based on the comparing, a nucleotide sequence of the DNA segment, the constructing comprising identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype block corresponds to the at least one output value”. The “creating at least one matched filter from the at least one reference signal” step is an abstract idea relating to the mathematical relationship. The “comparing the signal to the at least one reference signal” step is an abstract idea relating to data comparisons that can be performed mentally or analogous to human mental work. The “constructing, based on the comparing, a nucleotide sequence of the DNA segment, the constructing comprising identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype block corresponds to the at least one output value” step is an abstract idea relating to organizing or analyzing information that can be performed mentally or analogous to human mental work.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, there are no additional elements that are significantly more than the judicial exceptions.
Regarding claim 1, the claim requires a method of genotyping a segment of DNA similar to that of Rabinowitz et al. (“Rabinowitz”, US Patent App. Pub. US 2017/0166971, June 15, 2017).
Rabinowitz discloses “method for increasing the fidelity of measured genetic data, for making allele calls, and for determining the state of aneuploidy, in one or a small set of cells, or from fragmentary DNA, where a limited quantity of genetic data is available. Poorly or incorrectly measured base pairs, missing alleles and missing regions are reconstructed using expected similarities between the target genome and the genome of genetically related individuals. In accordance with one embodiment, incomplete genetic data from an embryonic cell are reconstructed at a plurality of loci using the more complete genetic data from a larger sample of diploid cells from one or both parents, with or without haploid genetic data from one or both parents. In another embodiment, the chromosome copy number can be determined from the measured genetic data, with or without genetic information from one or both parents.” (Abstract)
Dependent claims require haplotype block length, comparison of signal, signal, nucleotide assignment, methods of screening, method of detecting chromosomal instability and treating which are all routine and conventional based on Rabinowitz et al. (“Rabinowitz”, US Patent App. Pub. 2017/0166971, June 15, 2017) in view of Wang et. al. (“Wang”; (2005). Normalization of multicolor fluorescence in situ hybridization (M‐FISH) images for improving color karyotyping. Cytometry Part A: The Journal of the International Society for Analytical Cytology, 64(2), 101-109.), Gal-Yam et al. (“Gal-Yam”, WO Patent App. Pub. 2017/025970, February 16, 2017) and Arora et al. ("Arora", WO Patent App. Pub. 2018/152154, August 23, 2018).
Response to Arguments
Applicants' argument: “In particular, the claim recites ''creating at least one matched filter from the at least one reference signal," and ''constructing...a nucleotide sequence of the DNA segment, the constructing comprising identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype block corresponds to the at least one output value," which cannot be practically performed by the human mind or using pen and paper. In other words, the human mind is not equipped to perform this claim element or any of the other recited claim elements individually or in combination ”(Pg. 13).
Response: Applicant’s arguments filed 02/17/2026 have been fully considered and found unpersuasive because applicants amendments do not overcome the lack of patentably matter under U.S.C. 35 101. The amended claims recite abstract ideas requiring a creating a matched filter (mathematical relationship), comparing the signal to the at least one reference signal (mental process related to data comparison), constructing based on the comparing (mental process related to organizing or analyzing information) and routine and conventional limitations requiring a general haplotype block length, comparison of signal, signal, nucleotide assignment, methods of screening, method of detecting chromosomal instability and treatment. The judicial exceptions are not integrated into a practical application because the claim limitations do not appear to improve the current technology or technical field beyond well-understood, routine, conventional activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims provide no specific limitations that provide significantly more.
Claim Rejections - 35 USC § 103
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, 6-7, 9, 21-23, 27-28, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over by Rabinowitz et al. (“Rabinowitz”, US Patent App. Pub. US 2017/0166971, June 15, 2017) in view of Wang et. al. (“Wang”; (2005). Normalization of multicolor fluorescence in situ hybridization (M‐FISH) images for improving color karyotyping. Cytometry Part A: The Journal of the International Society for Analytical Cytology, 64(2), 101-109.).
Rabinowitz discloses “method for increasing the fidelity of measured genetic data, for making allele calls, and for determining the state of aneuploidy, in one or a small set of cells, or from fragmentary DNA, where a limited quantity of genetic data is available. Poorly or incorrectly measured base pairs, missing alleles and missing regions are reconstructed using expected similarities between the target genome and the genome of genetically related individuals. In accordance with one embodiment, incomplete genetic data from an embryonic cell are reconstructed at a plurality of loci using the more complete genetic data from a larger sample of diploid cells from one or both parents, with or without haploid genetic data from one or both parents. In another embodiment, the chromosome copy number can be determined from the measured genetic data, with or without genetic information from one or both parents.” (Abstract)
Regarding claim 1, Rabinowitz teaches methods comprising “Karyotyping, … and fluorescence in situ hybridization (FISH)” (Para. 32). Karyotyping reads on “signal derived from an image of the DNA segment that is indicative of a nucleotide composition of the DNA segment”; “fluorescence in situ hybridization (FISH)” reads on “signal derived from an image of the DNA segment that is indicative of a nucleotide composition of the DNA segment”.
Rabinowitz teaches methods comprising “build an idealized matching signal, or matched filter, corresponding to each of the possible noise-free signals, and to correlate this matched signal with the received noisy signal. Rabinowitz teaches a method of detecting whether chromosomes, or segments of DNA, are present or absent in a sample and extended to many scenarios of aneuploidy and sex determination, or detecting insertions and deletions in the chromosomes of embryos, fetuses or born children. Rabinowitz also teaches the concept of matched filtering can be applied to a wide range of quantitative and qualitative genotyping platforms (Para. 297). Rabinowitz teaches a method wherein a related individual may refer to any individual who is genetically related, and thus shares haplotype blocks with the target individual (Para. 365); “corresponding to each of the possible noise-free signals” reads on “from the at least one reference signal”
Rabinowitz teaches methods comprising “use of the expected similarities between the genetic data of the target individual and the genetic data of related individuals, to clean the noise in the target genome. This is done by determining which segments of chromosomes of related individuals were involved in gamete formation and, when necessary, where crossovers may have occurred during meiosis, and therefore which segments of the genomes of related individuals are expected to be nearly identical to sections of the target genome. In certain situations this method can be used to clean noisy base pair measurements on the target individual, but it also can be used to infer the identity of individual base pairs or whole regions of DNA that were not measured. It can also be used to determine the number of copies of a given chromosome segment in the target individual” (Para. 60); “use of the expected similarities between the genetic data of the target individual and the genetic data of related individuals” reads on “constructing based on the comparing”; “determining which segments of chromosomes of related individuals were involved” reads on “identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype block corresponds to the at least one output value''”
Thus, Rabinowitz suggests a method comprising obtaining a signal derived from an image of the DNA segment that is indicative of a nucleotide composition of the DNA segment, creating at least one matched filter from the at least one reference signal; comparing the signal to the at least one reference signal the comparing being based on an amplitude of at least one output value generated from applying the at least one matched filter to the signal; and constructing, based on the comparing, a nucleotide sequence of the DNA segment, the constructing comprising identifying at least one haplotype block from a nucleotide sequence of the different reference samples of DNA, wherein the at least one haplotype corresponds to the at least one output value.
Rabinowitz does not explicitly teach the limitations (i) “wherein the image comprises one or more signals of photon energy emitted from the DNA at one or more wavelengths” and (ii) “obtaining at least one reference signal derived from images of different reference samples of DNA, the at least one reference signal being based on a trajectory of at least one strand of the different reference samples of DNA”
Wang discloses “Pixel misclassification errors result from different factors. These include uneven hybridization, spectral overlap among fluors, and image misregistration. Effective preprocessing of M-FISH images can decrease the effects of those factors and thereby increase pixel classification accuracy. The data normalization steps described in this report, such as image registration and background flattening, can significantly improve subsequent classification accuracy. An improved classifier in turn would allow subtle DNA rearrangements to be identified in genetic diagnosis and cancer research.” (Abstract-conclusion)
Regarding the limitation (i) recited in claim 1, Wang teaches a method comprising “six-channel image sets recorded at different wavelengths” (Pg. 103, M-FISH Image Database, Para. 1; Figure 1). Thus, Rabinowitz and Wang suggest a method wherein the image comprises one or more signals of photon energy emitted from the DNA at one or more wavelengths.
Regarding the limitation (ii) recited in claim 1, Wang teaches a method comprising “A database consisting of 200 M-FISH–labeled human chromosome spread images has been established by Advanced Digital Imaging Research (ADIR)” and “The database contains 200 spreads from 33 slides from five different laboratories. The specimens include 74 normal male spreads, 8 normal female spreads, 99 abnormal spreads, and 17 more that are of low specimen quality” (Pg. 103, M-FISH Image Database, Para. 1). Wang also teaches that “This comprehensive image database is a valuable source for M-FISH studies. In addition, the database includes a classification map, stored as an image file, that was established by experienced cytogeneticists” (Pg. 103, M-FISH Image Database, Para. 1). Thus, Rabinowitz and Wang suggest a method comprising obtaining at least one reference signal derived from images of different reference samples of DNA, the at least one reference signal being based on a trajectory of at least one strand of the different reference samples of DNA.
Rabinowitz and Wang are both considered to be analogous to the claimed invention because they are in the same field of genotyping. Rabinowitz suggests that “It should be obvious to one skilled in the art how to extend any of the methods described herein to detect for any of these abnormalities” (Para. 117). The skilled artisan would have been motivated to modify the method of Rabinowitz detect any DNA segment modification of interest, especially when it would help identify the unknowns of DNA segments. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of genotyping a segment of DNA as taught by Rabinowitz to incorporate the method wherein the image comprises one or more signals emitted from the DNA at one or more wavelengths and obtaining at least one reference signal derived from images of different reference samples of DNA wherein the at least one reference signal is based on a trajectory of at least one strand of the different reference samples of DNA as taught by Wang and provide a method of matching haplotype blocks to determine the sequences of nucleotides that are present in the cell, copy number and /or aneuploidy status in the cell. It would be obvious to the ordinary artisan to determine unknown nucleotide sequence (noisy characteristics) using phased data by comparison with references with some similarity as suggested by Rabinowitz and incorporate the known elements of the imaging and methods for obtaining reference signals as suggested by Wang with a reasonable expectation of success, because the claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claim 1. Doing so would allow for identification of haplotype blocks for phasing of DNA segments which could be used to identify causative variants in diseases such as cancer or aneuploidy.
The teachings of Rabinowitz and Wang are documented above in the rejection of claim 1 under 35 U.S.C. 103. Claim 6-7, 9, 21-23 27-28, and 32-34 depend on claim 1. Claim 32 depends on claim 28, which depends on claim 1. Claim 34 depends on claim 33 which depends on claim 1.
Regarding claim 6, Rabinowitz teaches a method wherein a section of a chromosome on the haplotype block can range in size from one base pair to the entire chromosome and as such would encompass haplotype blocks of at least 100 kb (entire chromosome) (Para. 73 and 78-81).
Regarding claim 7, Rabinowitz teaches a method wherein a measurement is created by differencing the data and the reference signal (Para. 337). Rabinowitz also teaches there are more embodiments that may implement one or more of the systems, methods, and features, disclosed herein (Para. 360).
Regarding claim 9, Rabinowitz teaches a method wherein a measurement is created by differencing the data and the reference signal (Para. 337). Rabinowitz also teaches methods wherein there are more embodiments that may implement one or more of the systems, methods, and features, disclosed herein (Para. 360). Rabinowitz teaches a method wherein unordered genetic data is pooled data derived from measurements on two or more chromosomes in a diploid or polyploid genome, both the maternal and paternal copies of a chromosome in a diploid genome. (Para. 84). Rabinowitz teaches a method wherein data from an embryonic cell is analyzed at multiple positions on the embryonic DNA (Abstract, Para. 9).
Regarding claim 21, Rabinowitz teaches the methods are equally applicable to any live or dead human, animal, or plant that inherits or inherited chromosomes from other individuals. (Para.369).
Regarding claim 22, Rabinowitz teaches a method to measure haplotypes by sequencing single DNA molecules or clonal populations of DNA molecules. The basis for this method is to use any sequencing method to directly determine haplotype phase by direct sequencing of a single DNA molecule or clonal population of DNA molecules (Para. 372).
Regarding claim 23, Rabinowitz teaches a method of cleaning of incomplete or noisy genetic data using secondary genetic data as a source of information, and also the determination of chromosome copy number using said genetic data (Para. 35).
Regarding claim 27, Rabinowitz teaches methods that make use of knowledge of the genetic data of the mother and the father such as diploid tissue samples, sperm from the father, and haploid samples from the mother or other embryos derived from the mother's and father's gametes. (Para. 36).
Regarding claim 28, Rabinowitz teaches method wherein adult haploid single egg cells can be isolated in the context of egg harvesting during IVF procedures (Para. 283.).
Regarding claim 32, Rabinowitz teaches a method used to in conjunction with embryo screening or prenatal testing procedures (Para. 373).
Regarding claim 33, Rabinowitz teaches methods that make use of knowledge of the genetic data of the mother and the father such as diploid tissue samples, sperm from the father, and haploid samples from the mother or other embryos derived from the mother's and father's gametes. (Para. 36).
Regarding claim 34, Rabinowitz teaches a method wherein the embryos and fetuses are obtained by in vitro fertilization (Para. 373).
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but are unpersuasive. To clarify some instances argued in the response filed 02/17/2026 see responses to each argument made by Applicant below:
Applicant’s argument:
“Rabinowitz and Wang fail to disclose or even suggest all claim elements.””
Response: Applicant’s arguments have been fully considered and found unpersuasive because Rabinowitz and Wang do disclose and/or suggest all claim elements. Please see revised 35 USC 103 rejection above in the Non-Final Office action Pg. 7-11.
Applicant’s argument: “No reasonable expectation of success.”
Response: Applicant’s arguments have been fully considered and found unpersuasive because there would be reasonable expectation of success for the ordinary artisan. Please see revised 35 USC 103 rejection above in the Non-Final Office action Pg. 7-11.
Claim 1 and 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rabinowitz et al. (“Rabinowitz”, US Patent App. Pub. 2017/0166971, June 15, 2017) in view of Wang et. al. (“Wang”; (2005). Normalization of multicolor fluorescence in situ hybridization (M‐FISH) images for improving color karyotyping. Cytometry Part A: The Journal of the International Society for Analytical Cytology, 64(2), 101-109.) and Gal-Yam et al. (“Gal-Yam”, WO Patent App. Pub. 2017/025970, February 16, 2017).
The teachings of Rabinowitz and Wang are documented above in the rejection of claims 1, 6-7, 9, 21-23, 27-28, and 32-34 under 35 U.S.C. 103. Claim 12 depend on claim 1.
However, Rabinowitz does not explicitly teach the limitation of claim 12 “wherein comparing the signal to one or more reference signals with matched filtering comprises convolving the signal with conjugated reversed versions of each of the one or more reference signals”.
Gal-Yam discloses a method and system for processing at least two M-dimensional data-measurements (DMs) of a physical-property for detecting one or more new-objects and/or a transition of one or more known objects, in complex constant -background DMs, using at least one processor and at least one memory element, the method comprising: generating a filtered-new-DM by match-filtering a new-DM, respective to impulse response of a reference-DM; generating a filtered-reference-DM by match-filtering the reference-DM, respective to impulse response of the new-DM; generating an M-dimensional object-indicator (O1) by subtracting the filtered-reference-DM from the filtered-new-DM, or vice versa; and generating an M-dimensional data score (DS) from the M-dimensional O1, where each of the scores is a probe for existence of an object at a specific M-dimensional location (abstract).
Regarding claim 12, Gal-Yam teaches a method wherein "match filtering" refers to correlating a known signal, or template, with an unknown signal to detect the presence of the template in the unknown signal. Gal-Yam teaches this is equivalent to convolving/convoluting (convolution) the unknown signal with a conjugated reversed version of the template. (Para. 73; Para. 24; Fig. 1). Gal-Yam also teaches a method wherein "convolving", "convoluting" , or similarities thereof, refer to a mathematical operation on two functions / and g, producing a third function that is typically viewed as a modified version of one of the original functions, giving the area overlap between the two functions as a function of the amount that one of the original functions is translated (Para. 74; Para. 39). Thus, Gal-Yam teaches a method wherein comparing the signal to one or more reference signals with matched filtering comprises convolving the signal with conjugated reversed versions of each of the one or more reference signals.
Rabinowitz and Gal-Yam are both considered to be analogous to the claimed invention because they are in the same field of computing arrangements based on specific computational models . Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include convolving the signal with conjugated reversed versions of each of the one or more reference signals of Gal-Yam to the method of evaluating segments of DNA within a single strand or chromosome using matched filtering as taught by Rabinowitz to have yielded the predictable result of reducing the noise of the matched data. It would be obvious to the ordinary artisan to apply conjugated versions of reference signals to match filtered data of Gal-Yam, to match filtering of Rabinowitz with the reasonable expectation of cleaning noisy genetic data.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been considered but are not persuasive. Please see response to arguments documented above in the rejection of claims 1 under 35 U.S.C. 103.
Claims 1, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinowitz et al., (“Rabinowitz”, US Patent App. Pub. 2017/0166971, June 15, 2017) in view of Wang et. al. (“Wang”; (2005). Normalization of multicolor fluorescence in situ hybridization (M‐FISH) images for improving color karyotyping. Cytometry Part A: The Journal of the International Society for Analytical Cytology, 64(2), 101-109.) and Arora et al. ("Arora", WO Patent App. Pub. 2018/152154, August 23, 2018).
The teachings of Rabinowitz and Wang are documented above in the rejection of claims 1, 6-7, 9, 21-23, 27-28, and 32-34 under 35 U.S.C. 103. Claim 40 depends on claim 37, which depends on claim 1.
Regarding claim 37, Rabinowitz further teaches methods of evaluating segments of DNA within a single strand or chromosome using matched filtering as required by claim 1. Rabinowitz teaches a method allowing more effective identification of genetic variations, specifically aneuploidy and disease linked genes (Para. 3). Rabinowitz teaches a method of testing for chromosomal abnormalities (Para. 7). Chromosomal instability is interpreted as a chromosomal abnormality. Rabinowitz teaches it is possible to use the method disclosed herein in the context of cancer genotyping and/or karyotyping, where one or more cancer cells (Para. 368).
Rabinowitz does not teach a method wherein “treating the cancer or tumor cell or a subject from which the cell was obtained for cancer based on whether chromosomal instability has been indicated” (claim 37) or “the treatment comprises administering poly ADP ribose polymerase (PARP) inhibitors or platinum-based chemotherapeutics if chromosomal instability is indicated” (claim 40).
Arora discloses methods that relate generally to the field of cancer diagnosis and treatment. More particularly, the disclosure relates to methods for diagnosing a subject as a candidate for removal of a solid tumor without preoperative chemoradiation therapy, and to methods for treating patients having solid tumors, who have one or more of genomic instability, elevated double stranded DNA breaks, elevated gamma- H2AX foci, or elevated replication stress and/or double stranded break- signaling (DSB-signaling) biomarkers in peripheral blood lymphocytes (PBLs) (Pg. 4 ln 4-9).
Regarding claim 37 and 40, Arora teaches a method wherein genomic instability may be detected, for example, from a metaphase spread or a karyotype (Pg. 12 ln 32-33). Arora teaches methods for treating a subject having a solid tumor comprising: detecting the presence or absence of genomic instability ( Pg. 2 ln 25-26) and treating the subject with preoperative chemoradiation therapy ( Pg. 2 ln 31-32) Thus, Arora teaches a method wherein “treating the cancer or tumor cell or a subject from which the cell was obtained for cancer based on whether chromosomal instability has been indicated” and the treatment comprises administering chemotherapeutics if chromosomal instability is indicated.
Rabinowitz and Arora are both considered to be analogous to the claimed invention because they are in the same field of Genotyping/Karyotyping. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include treating the subject with indicated chromosomal instability with a chemoradiation therapy of Arora to the method of detecting chromosomal instability taught by Rabinowitz to have yielded the predictable result of treating the cancer or tumor cell or a subject from which the cell was obtained for cancer based on whether chromosomal instability has been indicated. It would be reasonable for the ordinary artisan to optimize the type of treatment for the cancer, tumor cell or subject with indicated chromosomal instability. The ordinary artisan would be motivated to include treatment of detected cancer based on chromosomal instability of Arora, to detection of chromosomal instability of Rabinowitz with the reasonable expectation of a subject, tumor or cancer cell possibly benefiting from the treatment. (pg. 13 ln 13)
Response to Arguments
Applicant's arguments filed 02/17/2026 have been considered but are not persuasive. Please see response to arguments documented above in the rejection of claims 1 under 35 U.S.C. 103.
Conclusion
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENDRA R VANN-OJUEKAIYE whose telephone number is (571)270-7529. The examiner can normally be reached M-F 9:00 AM- 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KENDRA R VANN-OJUEKAIYE/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
Prosecution Insights