Prosecution Insights
Last updated: October 04, 2026
Application No. 17/796,830

METHODS AND COMPOSITIONS FOR IDENTIFYING CASTRATION RESISTANT NEUROENDOCRINE PROSTATE CANCER

Non-Final OA §101§103
Filed
Aug 01, 2022
Priority
Feb 11, 2020 — provisional 62/975,009 +2 more
Examiner
BUCHANAN, BAILEY CHEYENNE
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Universita’ Degli Studi Di Trento
OA Round
3 (Non-Final)
43%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allowance Rate
12 granted / 28 resolved
-17.1% vs TC avg
Strong +57% interview lift
Without
With
+57.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
51 currently pending
Career history
87
Total Applications
across all art units

Statute-Specific Performance

§101
14.3%
-25.7% vs TC avg
§103
37.1%
-2.9% vs TC avg
§102
16.2%
-23.8% vs TC avg
§112
23.7%
-16.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 28 resolved cases

Office Action

§101 §103
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 . 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered. Claims Status Claims 124 & 128-146 filed on 02/25/2026 are pending. Claim 124 is currently under examination directed to the elected species of iv) hypomethylation of at least one genomic site listed in Table 1D and INSM1 (see response dated 04/07/2025). The cancellation of claims 41-45, 49, & 125 and the new claims 132-146 in the reply filed on 02/25/2026 are acknowledged. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant application. Response to Applicant’s argument follow. This action is Non-FINAL. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action. Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims. Claim Rejections - 35 USC § 101 Claims 124 & 128-146 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. 35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010). Claims Analysis: As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1). The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention. The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. The claimed invention recites a method for assessing whether a subject is afflicted with or at risk of developing CRPC-NE through the presence of methylation and mutations to DNA methylation. This recitation is a natural correlation between presence of genomic sites with hypomethylation, hypermethylation, and mutations and afflicted with or at risk of developing CRPC-NE. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites “identified as having been afflicted with or at risk of developing castration-resistant neuroendocrine prostate cancer (CRPC-NE)” which is a recitation of an abstract idea because it encompasses conclusions and determinations which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions. The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)]. The claims recite steps of a method for treating a subject wherein a subject has been identified as developing CRPC-NE by criteria comprising mutations, hypomethylation, and hypermethylation, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method. Although the claims recite “administering an immunotherapy and/or a cancer therapy” to the patient, this step is conditional as it is dependent on whether the subject has been identified as having been afflicted with CRPC-NE or at risk for developing CRPC-NE. Accordingly, these generally recited elements are considered nothing more than instructions to apply the law of nature because no particular conditions are required by the step of assessing the presence or absence of one or more genomic or epigenomic features. As such, the “administering” step is merely a generalized “treat” limitation with no particularity that integrates the judicial exception into a practical application. The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294. In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B). In the instant situation, the steps of mutation, hypomethylation, and hypermethylation criteria are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter. Response to Arguments The response traverses the rejection. The response asserts that a method of treatment has been determined by USPTO to comprise patent-eligible subject matter (see 2014 Interim Guidance on Subject Matter Eligibility examples, especially example 29), irrespective of whether the administering step is a generalized “treat” limitation and that a claim directed to a treatment method is not a judicial exception. Further, the response asserts that applicant has amended claim 124, from which the remaining claims depend, to more clearly recite a treatment method and since claim 124 is directed to a treatment method, which is not a judicial exception, withdrawal is requested. This argument has been thoroughly reviewed but was not found persuasive as the administration of a cancer therapy is very broad and encompasses a wide range of possible treatments and therefore are not meaningful constraints on the administration such that a particular treatment consideration would apply because it is not limited to any particular cancer therapy (see example 49 of 2024 Guidance Update on Patent Subject Matter Eligibility). Further, it is noted that example 29 of 2014 Interim Guidance on Subject Matter Eligibility as discussed by the response is directed to particular methods of treatments comprising TNF antibodies. Further, as discussed above, example 49 of 2024 Guidance Update on Patent Subject Matter Eligibility discusses administering of a broad and not a particular treatment being ineligible and as amended claim 124 is broad and does not comprise administering a particular cancer treatment the particular treatment consideration would not apply. For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims. Claim Rejections - 35 USC § 103 Claim(s) 124, 128-139, & 143-146 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beltran (Beltran et al.; Nature Medicine, Vol. 22, Pages 298-309, March 2016), as cited in the IDS dated 09/30/2022, in view of Quinn (Quinn et al.; Urologic Oncology, Vol. 33, pages 245-260, October 2014). Regarding amended claim 124, Beltran teaches a method of genome-wide methylation analysis that revealed marked epigenetic differences between CRPC-NE tumors and CRPC-Adeno through evaluating CpG methylation on a genome-wide scale by single-cytosine-resolution DNA methylation analysis (abstract lines 14-16; pg.301-302 paragraph bridging pg. 301 & pg. 302 lines 2-10 & 18-23; pg. 307-308 paragraph bridging pg. 307 & pg. 308 lines 1-28). Beltran also teaches detection of mutations of TP53, RB1, and CYLD, mutation of AR, the hypomethylation genomic sites on chromosome 1 position 202039152, on chromosome 14 position 100039424, on chromosome 18 position 866097, on chromosome 18 position 14917015, on chromosome 18 position 25442245, on chromosome 2 position 89530056, on chromosome 20 position 20,421,461, on chromosome 20 position 21563920, on chromosome 21 position 46885291, on chromosome 3 position 193490472, on chromosome 5 position 36521978, on chromosome 5 position 39390554, on chromosome 5 position 168573592, on chromosome 7 position 2006578, on chromosome 7 129912397, on chromosome 8 position 61990389, on chromosome 8 position 69087226, on chromosome 8 position 133070960, on chromosome 8 position 141458925, and on chromosome 9 position 134913163, and the hypermethylation genomic sties on chromosome 1 position 241206097, chromosome 18 position 47258088, chromosome 21 position 32546325, chromosome 5 position 1548486, chromosome 5 position 71146893, chromosome 5 position 142194122, chromosome 7 position 7799017, chromosome 7 position 127841627, chromosome 8 position 53499559, chromosome 8 position 73479989, chromosome 8 position 73849053, chromosome 8 position 140727997, chromosome 8 position 141994083, chromosome 8 position 142367953, chromosome 8 position 143395943, chromosome 9 position 37648432, chromosome 9 position 38437313, chromosome 9 position 93792387, chromosome 9 position 133769512, and chromosome 9 position 138719303 (all of the criteria listed in (a)-(d) in claim 124 of instant application as currently amended), as showing strong epigenetic segregation between the CRPC-NE and CRPC-Adeno subtypes (pg.301-302 paragraph bridging pg. 301 & pg. 302 lines 2-10 & 18-23; Figure 1d; Supplementary Table 3; Supplementary Table 7; Supplementary Table 8). Finally, Beltran teaches that this approach is amenable to metastatic prostate cancer biopsies with limited tissue availability and paves the way for future studies this method to samples types such as circulating tumor DNA (sample comprising whole blood, serum, or plasma) (pg. 304 column 1 1st full paragraph lines 10-17). Beltran does not teach administering an immunotherapy and/or a cancer therapy. Quinn teaches treating subjects with castration-resistant prostate cancer with a variety of immunotherapy methods comprising cancer vaccines, immune-checkpoint inhibitors, and immunosuppressive cells (cell-based) (see claims 128 & 130) (abstract background paragraph lines 1-4; abstract results paragraph lines 1-7; abstract conclusion paragraph lines 1-4; pg. 247 column 1 1st full paragraph lines 1-14; pg. 258 paragraph bridging column 1 & 2 lines 1-3; Table 2). In addition, Quinn teaches that castration-resistant prostate cancer can also be treated with a variety of cancer therapies comprising radiotherapy, combination of immunotherapy with chemotherapy or radiation therapy, and combination of immunotherapy with platinum-based chemotherapy (see claims 128 & 129) (pg. 246 column 1 1st full paragraph lines 1-11; pg. 256-257 paragraph bridging pg. 256 & pg. 257 lines 1-4; pg. 257 column 1 1st full paragraph lines 1-7). Finally, Quinn teaches that immunotherapies and combination of immunotherapies and cancer therapies can prolong survival and identification of patients at high-risk for castration-resistant prostate cancer (pg. 258 paragraph bridging column 1 & 2 lines 1-3; pg. 258 column 2 1st full paragraph lines 7-12). Beltran and Quinn are considered to be analogous to the claimed invention because they are all in the same field of detection and treatment prostate cancer. 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 have modified the method of detecting a subject afflicted with or at risk for developing CRPC-NE and CRPC-Adeno tumor tissue samples comprising detecting the mutations, hypomethylation, and hypermethylation of the genomic sites in CRPC-NE tumor tissue samples in Beltran to incorporate the treatment of the subject with or at risk for castration-resistant prostate cancer with an immunotherapy or cancer therapy as taught in Quinn because Quinn teaches that doing so would prolong the subjects survival and aid in the detections of patients at high-risk for castration-resistant prostate cancer. Regarding claims 128 & 130, Quinn teaches treating subjects with castration-resistant prostate cancer with a variety of immunotherapy methods comprising cancer vaccines, immune-checkpoint inhibitors, and immunosuppressive cells (cell-based) (abstract background paragraph lines 1-4; abstract results paragraph lines 1-7; abstract conclusion paragraph lines 1-4; pg. 247 column 1 1st full paragraph lines 1-14; pg. 258 paragraph bridging column 1 & 2 lines 1-3; Table 2). Regarding claims 129 & 131, Quinn teaches that castration-resistant prostate cancer can also be treated with a variety of cancer therapies comprising radiotherapy, combination of immunotherapy with chemotherapy or radiation therapy, and combination of immunotherapy with platinum-based chemotherapy (pg. 246 column 1 1st full paragraph lines 1-11; pg. 256-257 paragraph bridging pg. 256 & pg. 257 lines 1-4; pg. 257 column 1 1st full paragraph lines 1-7). Regarding new claim 132, Quinn teaches treating subjects with castration-resistant prostate cancer with a variety of immunotherapy methods comprising cancer vaccines, immune-checkpoint inhibitors, and immunosuppressive cells (cell-based) (subject is administered with a cancer therapy other than an AR-targeted therapy) (abstract background paragraph lines 1-4; abstract results paragraph lines 1-7; abstract conclusion paragraph lines 1-4; pg. 247 column 1 1st full paragraph lines 1-14; pg. 258 paragraph bridging column 1 & 2 lines 1-3; Table 2). Regarding new claim 133, Beltran teaches the method of genome-wide analysis that revealed marked epigenetic differences between CRPC-NE tumors and CRPC-Adeno comprises whole-exome sequencing (WES) (the deletion, mutation, or gain is detected by WES) (pg. 299 column 1 1st full paragraph lines 1-4). Regarding new claim 134, Beltran teaches the mutation is a missense mutation (the mutation is a non-synonymous single-nucleotide variant (SNV)) (Supplementary Table 3). Regarding new claim 135, Beltran teaches detection mutation of AR (Figure 1d). Regarding new claim 136, Beltran teaches detection mutation of AR comprising the mutation of AR is L702H (Figure 1d). Regarding new claim 137, Beltran teaches differentially methylated (hypermethylation or hypomethylation) are defined by increased and decreased methylation levels from a tissue-based threshold (pg. 306 column 1 1st full paragraph lines 1-6; pg. 307-308 paragraph bridging pg. 307 & 308 lines 19-28; Supplementary Table 8). Regarding new claim 138, Beltran teaches a method of genome-wide methylation analysis that revealed marked epigenetic differences between CRPC-NE tumors and CRPC-Adeno through evaluating CpG methylation on a genome-wide scale by single-cytosine-resolution DNA methylation analysis (abstract lines 14-16; pg.301-302 paragraph bridging pg. 301 & pg. 302 lines 2-10 & 18-23; pg. 307-308 paragraph bridging pg. 307 & pg. 308 lines 1-28). Beltran also teaches detection of mutations of TP53, RB1, and CYLD, mutation of AR, the hypomethylation genomic sites, and the hypermethylation genomic sties, as showing strong epigenetic segregation between the CRPC-NE and CRPC-Adeno subtypes (threshold for each genomic site is a predetermined threshold that discriminates between CRPC-Adeno and CRPC-NE tissues) (pg.301-302 paragraph bridging pg. 301 & pg. 302 lines 2-10 & 18-23; Figure 1d; Supplementary Table 3; Supplementary Table 7; Supplementary Table 8). Regarding new claim 139, Beltran teaches the sample comprises tumor tissue samples (pg. 306 column 1 1st full paragraph lines 1-6). Regarding new claim 143, Beltran teaches the sample comprises tumor tissue samples (the genomic DNA isolated from a tumor tissue is used for determining the criteria (pg. 306 column 1 1st full paragraph lines 1-6). Regarding new claim 144, Beltran teaches the subject is resistant to AR-directed therapy (abstract lines 1-22). Regarding new claims 145 & 146, Beltran teaches the tumor tissue samples are from human patients (subject is mammal human) (pg. 306 column 1 1st full paragraph lines 1-6). Claim(s) 140-142 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beltran (Beltran et al.; Nature Medicine, Vol. 22, Pages 298-309, March 2016), as cited in the IDS dated 09/30/2022, in view of Quinn (Quinn et al.; Urologic Oncology, Vol. 33, pages 245-260, October 2014), as applied to claims 124, 128-139, & 143-146 above, and further in view of Strand (Strand, Orntoft, & Sorensen; International Journal of Molecular Sciences, Vol. 15, pages 16544-16576, September 2014). The teachings of Beltran and Quinn with respect to claims 124 & 139 are discussed above. Regarding new claim 140, Beltran and Quinn does not teach wherein the body fluid is selected from whole blood, serum, or plasma. Strand teaches that DNA methylation of cell-free DNA is detectable in body fluids, including whole blood, plasma, and serum in prostate cancer samples and that this sample type enables the detection of tumor-specific epigenetic aberrations with non-invasive testing and can be monitored repeatedly allowing for real-time monitoring of disease progression and therapy response (abstract lines 1-11; pg. 16562 3rd full paragraph lines 1-10). Beltran, Quinn, and Strand are considered to be analogous to the claimed invention because they are all in the same field of detection and treatment prostate cancer. 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 have modified the method of detecting the mutations, hypomethylation, and hypermethylation of the genomic sites in CRPC-NE tumor tissue samples in Beltran to incorporate the detection of methylation in prostate cancer samples comprising whole blood, serum, or plasma as taught in Strand because Strand teaches that doing so would provide a non-invasive testing method for detection of tumor-specific epigenetic aberrations and real-time monitoring of disease progression and therapy response. Regarding new claim 141, Strand teaches that DNA methylation of cell-free DNA is detectable in body fluids, including whole blood, plasma, and serum in prostate cancer samples (abstract lines 1-11; pg. 16562 3rd full paragraph lines 1-10). Regarding new claim 142, Strand teaches that DNA methylation of cell-free DNA is detectable in body fluids, including whole blood, plasma, and serum in prostate cancer samples (cfDNA isolated from plasma used for determining the criteria) (abstract lines 1-11; pg. 16562 3rd full paragraph lines 1-10). Response to Arguments The response traverses the rejection. The response asserts that amended claim 124, from which the remaining rejected claims depend, recite treatment methods for a subject that has been identified as having been afflicted with or at risk of developing CRPC-NE by criteria comprising 4 genomic features and 20 epigenomic features and such a surprisingly accurate determination of CRPC-NE or risk of developing CRPC-NE would not have been obvious based on Beltran since Beltran does not teach or suggest the recited combination comprising 4 genomic features and 20 epigenomic features. Further, the response asserts that Beltran does not provide reasonable guidance regarding the selection of the particular combination of features recited in the pending claims as, for example, Beltran discloses about 85,000 methylation sites (see Beltran, Supplementary Table 8) which is practically an unlimited number of epigenomic features and even if a person of ordinary skill were to select 20 out of 85,000 methylation sites, such a selection would amount to a practically unlimited number of possible combinations. Further, the response asserts that Beltran does not indicate which site or combination of sites would provide an accurate determination of CRPC-NE, let alone with a low P value of P=0.00044, which indicates high statistical significance and, accordingly, there would have been no motivation for a person of ordinary skill to select 4 genomic features and 20 epigenomic features recited in the pending claims out of 85,000 epigenomic features in Beltran, and there would have been no reasonable expectation of success in arriving at the pending claims based on the practically unlimited combination disclosed in Beltran and since Beltran does not disclose a finite number of predictable solutions, Beltran does not render the pending claims obvious. This argument has been thoroughly reviewed but was not found persuasive. First, Beltran does teach detection of mutations of TP53, RB1, and CYLD, mutation of AR, the hypomethylation genomic sites on chromosome 1 position 202039152, on chromosome 14 position 100039424, on chromosome 18 position 866097, on chromosome 18 position 14917015, on chromosome 18 position 25442245, on chromosome 2 position 89530056, on chromosome 20 position 20,421,461, on chromosome 20 position 21563920, on chromosome 21 position 46885291, on chromosome 3 position 193490472, on chromosome 5 position 36521978, on chromosome 5 position 39390554, on chromosome 5 position 168573592, on chromosome 7 position 2006578, on chromosome 7 129912397, on chromosome 8 position 61990389, on chromosome 8 position 69087226, on chromosome 8 position 133070960, on chromosome 8 position 141458925, and on chromosome 9 position 134913163, and the hypermethylation genomic sties on chromosome 1 position 241206097, chromosome 18 position 47258088, chromosome 21 position 32546325, chromosome 5 position 1548486, chromosome 5 position 71146893, chromosome 5 position 142194122, chromosome 7 position 7799017, chromosome 7 position 127841627, chromosome 8 position 53499559, chromosome 8 position 73479989, chromosome 8 position 73849053, chromosome 8 position 140727997, chromosome 8 position 141994083, chromosome 8 position 142367953, chromosome 8 position 143395943, chromosome 9 position 37648432, chromosome 9 position 38437313, chromosome 9 position 93792387, chromosome 9 position 133769512, and chromosome 9 position 138719303 (all of the criteria listed in (a)-(d) in claim 124 of instant application as currently amended), as showing strong epigenetic segregation between the CRPC-NE and CRPC-Adeno subtypes (pg.301-302 paragraph bridging pg. 301 & pg. 302 lines 2-10 & 18-23; Figure 1d; Supplementary Table 3; Supplementary Table 7; Supplementary Table 8). Therefore, Beltran does teach the recited combination comprising 4 genomic features and 20 epigenomic features. Further, the claim is a comprising (open) claim and therefore encompasses the criteria of genomic and epigenomic features recited and not recited in the newly amended claim and does not exclude the criteria of other epigenomic features. Therefore, Beltran teaches the recited combination comprising 4 genomic features and 20 epigenomic features with a reasonable expectation of success. The response also asserts that Strand and Quinn does not cure the deficiencies as Strand and Quinn does not teach or suggest 4 genomic features and 20 epigenomic features according to the pending claims and, accordingly, Beltran, Strand, and Quinn, either alone or in combination, do not render the pending claims obvious. This argument has been thoroughly reviewed but was not found persuasive for the reasons set forth above. For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims. Conclusion Claims 124 & 128-146 are rejected. 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 BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET. 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 on (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. /BAILEY BUCHANAN/Examiner, Art Unit 1682 /JEHANNE S SITTON/Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Aug 01, 2022
Application Filed
May 19, 2025
Non-Final Rejection mailed — §101, §103
Aug 29, 2025
Response Filed
Nov 25, 2025
Final Rejection mailed — §101, §103
Feb 25, 2026
Response after Non-Final Action
Mar 30, 2026
Request for Continued Examination
Apr 01, 2026
Response after Non-Final Action
Sep 16, 2026
Non-Final Rejection mailed — §101, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
43%
Grant Probability
99%
With Interview (+57.1%)
3y 9m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 28 resolved cases by this examiner. Grant probability derived from career allowance rate.

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