Prosecution Insights
Last updated: October 25, 2026
Application No. 18/003,614

DETECTION OF PANCREATIC CANCER BY COMBINING DETECTION OF PANCREATIC CANCER-SPECIFIC GENE EXPRESSION PATTERN AND MEASUREMENT OF CA19-9

Final Rejection §101§102§112
Filed
Dec 28, 2022
Priority
Sep 05, 2022 — nonprovisional of PCTJP2022033204
Examiner
DHARITHREESAN, NIDHI
Art Unit
1686
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kubix Inc.
OA Round
2 (Final)
40%
Grant Probability
Moderate
3-4
OA Rounds
1y 0m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 40% of resolved cases
40%
Career Allowance Rate
22 granted / 55 resolved
-20.0% vs TC avg
Strong +33% interview lift
Without
With
+33.1%
Interview Lift
resolved cases with interview
Typical timeline
4y 11m
Avg Prosecution
29 currently pending
Career history
91
Total Applications
across all art units

Statute-Specific Performance

§101
24.6%
-15.4% vs TC avg
§103
24.8%
-15.2% vs TC avg
§102
16.2%
-23.8% vs TC avg
§112
24.6%
-15.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 55 resolved cases

Office Action

§101 §102 §112
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 . Applicant Response Applicant's response, filed 07/02/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Claim Status Claims 2-5 are canceled. Claims 1, and 6-8 are pending and under examination herein. Claims 1 and 6-8 are rejected Priority The instant application is a National Stage entry of PCT/JP2022/033204 , International Filing Date: 09/05/2022. As such, the effective filing date assigned to each of claims 1 and 6-8 is 09/05/2022. Drawings The drawings filed 12/28/2022 were accepted by the examiner in the office action mailed 04/08/2026. Specification The objection to the disclosure is withdrawn in view of amendments to the specification filed 07/02/2026. The objection to the abstract is withdrawn in view of amendments to the abstract filed 07/02/2026. Claim Objections The objections of claims 4-5 are withdrawn in view of cancelation of the claims in the claim amendments filed 04/08/2026. Claim 1 is objected to because of the following informalities: the steps and sub-steps of the claim are not separated by a line indentation, and there are spacing issues within the steps (e.g. step (iv) contains a line break in the middle of the sentence). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. See MPEP 608.01(i). Appropriate correction is required. This objection is newly recited and necessitated by claim amendments. Claim Rejections - 35 USC § 112 The rejections of claims 2-3 and 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph are withdrawn in view of cancelation of the claims in the claim amendments filed 04/08/2026. The rejections of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of the claim amendments filed 04/08/2026. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 6 remains rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Newly recited portions are necessitated by claim amendments. Claim 6 recites the limitation " The method for detecting pancreatic cancer according to claim 5" in line 5. There is insufficient antecedent basis for this limitation in the claim, as claim 5 has been canceled. Claim 6 should depend from claim 1. Response to Applicant’s Arguments Applicant’s arguments have been fully considered but they do not address the issue discussed above. Claim Rejections - 35 USC § 101 The rejections of claims 2-5 under 35 U.S.C. 101 are withdrawn in view of cancelation of the claims in the claim amendments filed 04/08/2026. Claims 7-8 appear to be free from a rejection under 35 U.S.C. 101, as the claims recite statutory subject matter (Step 1: YES) and the claims do not recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1:NO). 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 and 6 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Newly recited portions are necessitated by claim amendments. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea and/or law of nature or natural phenomenon: Claim 1 recites assisting detection of pancreatic cancer based on an expression level of 56 genes in a 56-gene set A listed below and a measured value of CA19-9 in a subject; standardizing it with a Ct value of a housekeeping gene such as GAPDH to obtain a standardized Ct value ; (iv) a step of calculating a value for assisting in determining whether it is positive or negative for pancreatic cancer from the standardized Ct value obtained in step (ii) using a discriminant formula I described below, Discriminant formula I: P = intercept + I (beta i x Xi) wherein intercept is a constant, beta i is a coefficient for the i-th gene of the 56 genes in the gene set A, and X i indicates the standardized Ct value of the i-th gene of 56 genes in the gene set A, and I indicates summing the beta x X of each gene of the 56 genes in the gene set A; and (b) a step of setting the measured value of CA19-9 obtained in step (iii) as a C value and assigning the P value and the C value to a discriminant formula II described below to obtain a final determination value Z, Discriminant formula II: Z = -2.9448 + (0.0090864 x P) + (0.9329593 x Log C) These recitations equate to steps of collecting information, analyzing data and making observations, evaluations and judgements that can be carried out in the human mind. Specifically, standardizing and calculating values can be practically performing the human mind as claimed, since the mind can read data and make mathematical calculations as claimed and are similar to the concepts of collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011) and collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) that the courts have identified as concepts that can be practically performed in the human mind. Therefore, each of the above recited limitations fall under the “Mental Processes” grouping of abstract ideas. Furthermore, the steps of standardizing and calculating values using equations equate to organizing information and manipulating information through mathematical correlations and reciting a mathematical equation, similar to the concepts of taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Therefore, these limitations fall under the “mathematical concepts” grouping of abstract ideas. Furthermore, the claims recite a correlation between the levels of biomarkers (i.e. expression levels of genes) present in the subject and the biological state of the subject, such as the subject having pancreatic cancer. This is similar to the concept of a correlation between the presence of myeloperoxidase in a bodily sample and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017) that the court identified as a law of nature or natural phenomenon. Claim 6 further qualifies the judicial exceptions. As such, claims 1 and 6 recite an abstract idea, and a law of nature or natural phenomenon (Step 2A, Prong 1: YES). Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology, applies or uses the recited judicial exception to affect a particular treatment for a condition, implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effects a transformation or reduction of a particular article to a different state or thing or applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Rather, the instant claims recite additional elements that amount to mere data gathering. Specifically, the claims recite the following additional elements: Claim 1 recites (i) a step of extracting mRNA from the peripheral blood cells collected from the subject; (ii) a step of amplifying the 56 genes in the gene set A by PCR to obtain a Ct (Cycle threshold) value; (iii) a step of measuring CA19-9 in a biological sample collected from the subject; the gene set A being (1) Abhydrolase domain containing 3 (ABHD3) (2) Abl-interactor 1 (ABI1) (3) Acyl-CoA synthetase long-chain family member 3 (ACSL3) (4) Aldo-keto reductase family 1, member B 1 (aldose reductase) (AKR1B 1) (5) ATPase, Class VI, type 11B (ATP11B) (6) UDP-GlcNAc:betaGal beta-1,3-N-acetylglucosaminyltransferase 5 (B3GNT5) (7) BTB and CNC homology 1, basic leucine zipper transcription factor 1 (BACH1) (8) Chromosome 11 open reading frame 2 (Cllorf2) (9) Chromosome 2 open reading frame 81 (C2orf81) (10) Cyclin Y-like 1 (CCNYL1) (11) Centromere protein N (CENPN) (12) Complement factor H-related 3 (CFHR3) (13) C-type lectin domain family 4, member D (CLEC4D) (14) Collagen, type XVII, alpha 1 (COL17A1) (15) Cytochrome b5 reductase 4 (CYB5R4) (16) DENN/MADD domain containing 1B (DENND1B) (17) Enoyl CoA hydratase domain containing 3 (ECHDC3) (18) Ectonucleoside triphosphate diphosphohydrolase 1 (ENTPD1) (19) Family with sequence similarity 198, member B (FAM198B) (20) Family with sequence similarity 49, member B (FAM49B) (21) Fatty acyl CoA reductase 1 (FARI) (22) Fibrinogen-like 2 (FGL2) (23) Fibronectin type III domain containing 3B (FNDC3B) (24) Fucose-1-phosphate guanylyltransferase (FPGT) (25) UDP-N-acetyl-alpha-D-galactosamine:polypeptide N-acetylgalactosaminyltransferase 4 (GalNAc-T4) (GALNT4) (26) HEAT repeat containing 5A (HEATR5A) (27) HIV-1 Tat interactive protein 2, 30kDa (HTATIP2) (28) Interferon gamma receptor 1 (IFNGR1) (29) IKBKB interacting protein (IKBIP) (30) Lactate dehydrogenase A (LDHA) (31) Lysophosphatidic acid receptor 6 (LPAR6) (32) Membrane-bound transcription factor peptidase, site 2 (MBTPS2) (33) Minichromosome maintenance complex binding protein (MCMBP) (34) Mesoderm induction early response 1 homolog (Xenopus laevis) (MIER1) (35) Nuclear factor (erythroid-derived 2) -like 2 (NFE2L2) (36) Oligonucleotide/oligosaccharide-binding fold containing 2A (OBFC2A) (37) Oxysterol binding protein-like 8 (OSBPL8) (38) Peptidylprolyl isomerase H (cyclophilin H) (PPIH) (39) Protein phosphatase 1, regulatory (inhibitor) subunit 13 like (PPP1R13L) (40) PR domain containing 5 (PRDM5) (41) Protein tyrosine phosphatase, receptor type, C (PTPRC) (42) RAB 10, member RAS oncogene family (RAB 10) (43) Ribosomal protein, large, P1 (RPLP1) (44) Ras-related GTP binding D (RRAGD) (45) Solute carrier family 22, member 15 (SLC22A15) (46) Solute carrier family 44, member 1 (SLC44A1) (47) Schlafen family member 12 (SLFN12) (48) S1 RNA binding domain 1 (SRBD1) (49) Tet oncogene family member 2 (TET2) (50) Transducin-like enhancer of split 2 (E(spl) homolog, Drosophila) (TLE2) (51) Ubiquitin-conjugating enzyme E2W (putative) (UBE2W) (52) Ubiquitination factor E4A (UBE4A) (53) Ubiquitin specific peptidase 15 (USP15) (54) WD repeat and SOCS box containing 1 (WSB 1) (55) Zinc finger E-box binding homeobox 2 (ZEB2) (56) Zinc metallopeptidase (STE24 homolog, S. cerevisiae) (ZMPSTE24); the method using a reagent comprising a nucleotide consisting of a nucleotide sequence of the genes in the 56-gene set A of (1) to (56) or a nucleotide comprising a partial nucleotide sequence thereof for detecting pancreatic cancer and a reagent for measuring CA19-9 by immunoassay. Claim 1 recites steps for gathering data and is similar to determining the level of a biomarker in blood, which the courts determined to be an insignificant extra-solution activity in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968 and PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012). These limitations equate to mere data gathering activity to obtain the data necessary for the mental evaluations and judgements (see MPEP 2106.05(g)). There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, claims 1-6 are directed to an abstract idea (Step 2A, Prong 2: NO). Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). Further analyzing the additional elements under step 2B, the additional elements as described above do not rise to the level of significantly more than the judicial exception. As set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s). With respect to the instant claims under the 2B analysis, the instant specification discloses methods for extracting mRNA, and measuring expression levels using quantitative PCR are well-understood, routine and conventional in the art, and further discloses using commercially available kits (para 0019-0026; para 0046-0051). The prior art to Dai et al. (Frontiers in Cell and Developmental Biology 2022, 10, p.855474; newly cited) reviews nucleic acid drug discovery and targeted therapy in pancreatic cancer (PC) and discloses numerous genetic and epigenetic alterations could be detected within PC and correlate with the dysregulation of mRNA translation and that Yoshio Sakai designed one PCR-based detecting strategy to monitor the dysregulated genes related to PDAC with a high sensitivity of more than 70% independent of the stage of pancreatic ductal adenocarcinoma (PDAC). The prior art to Sakai discloses developing a blood mRNA PDAC screening system using real‐time detection PCR to detect the expression of 56 genes of the instant claims, to discriminate PDAC from noncancer subjects (abstract; section 2.4; Table 1; fig 2). Furthermore, the courts have found that limitations for determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)), using polymerase chain reaction to amplify and detect DNA (Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)) and amplifying and sequencing nucleic acid sequences ( University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)) are well-understood, routine and conventional. Therefore, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1 and 6 are not patent eligible under 35 U.S.C. 101. Response to Applicant’s Arguments Applicant states claims 1 and 6 have been amended to recite the limitations directed towards an inventive reagent as recited in claims 7 and 8, which were found to be free of the art, and provides significantly more, similar to claims 3-4 of example 29, and request withdrawal of the rejection (Applicant’s Arguments, p 13, para 9-p 14, para 5). It is respectfully submitted that this is not persuasive. Claims 7-8 free found free from a rejection under 35 U.S.C. 101 because the claims recite statutory subject matter (Step 1: YES) and the claims do not recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1:NO). Furthermore, claims 3-4 of example 29 were found to be eligible because prior to applicant’s invention, and at the time the application was filed, , there is no evidence that porcine antibodies were routinely or conventionally used to detect human proteins such as JUL-1 and antibody mAb-D33 was not routinely or conventionally used to detect human proteins such as JUL 1. In contrast, with respect to the instant claims under the 2B analysis, the instant specification discloses methods for extracting mRNA and measuring expression levels using quantitative PCR are well-understood, routine and conventional in the art, and further discloses using commercially available kits (para 0019-0032; para 0046-0051). The prior art to Dai et al. (Frontiers in Cell and Developmental Biology 2022, 10, p.855474; newly cited) reviews nucleic acid drug discovery and targeted therapy in pancreatic cancer (PC) and discloses numerous genetic and epigenetic alterations could be detected within PC and correlate with the dysregulation of mRNA translation and that Yoshio Sakai designed one PCR-based detecting strategy to monitor the dysregulated genes related to PDAC with a high sensitivity of more than 70% independent of the stage of pancreatic ductal adenocarcinoma (PDAC). The prior art to Sakai discloses developing a blood mRNA PDAC screening system using real‐time detection PCR to detect the expression of 56 genes of the instant claims, to discriminate PDAC from noncancer subjects (abstract; section 2.4; Table 1; fig 2). Furthermore, the courts have found that limitations for determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)), using polymerase chain reaction to amplify and detect DNA (Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)) and amplifying and sequencing nucleic acid sequences ( University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)) are well-understood, routine and conventional. Therefore, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO), and the rejections are maintained. Claim Rejections - 35 USC § 102 The rejections of claims 2-4 under 35 U.S.C. 102(a)(1) are withdrawn in view of cancelation of the claims in the claim amendments filed 04/08/2026. The rejections of claim 1 35 U.S.C. 102(a)(1) as being anticipated by Sakai et al. (02/14/2023 IDS NPL #1; hereafter referred to as Sakai) is withdrawn in view of the claim amendments filed 04/08/2026, as Sakai does not appear to teach or suggest the steps for obtaining the final Z value by discriminant formula II. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 7-8 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakai et al. (02/14/2023 IDS NPL #1; hereafter referred to as Sakai), as evidenced by Komura et al. (Cancer science 2015, 106(6), 672-686, pages; hereafter referred to as Komura). Newly recited portions are necessitated by claim amendments. With respect to claim 7-8, Sakai discloses developing a blood mRNA PDAC screening system using real‐time detection PCR to detect the expression of 56 genes, to discriminate PDAC from noncancer subjects (abstract; section 2.4; Table 1; fig 2). Sakai discloses gene expression analysis by RTD-PCR for candidate genes selected from cDNA microarray data (including the 56 disclosed by the instant claim)was undertaken as described previously in Komura and CA19‐9 measurement by the standard chemiluminescent enzyme immunoassay (Table 1; Section 2.2; section 2.4). Komura discloses a PCR primer consisting of a nucleotide sequence of the genes of interest (Komura “Doc S1. Supporting Materials and Methods.”, section “RNA isolation and real-time detection polymerase chain reaction.”) Response to Applicant’s Arguments Applicant states Sakai does not describe the detection of pancreatic cancer using a combination of the expression level of the 56 genes and CA 19-9 measurements and combining them to determine a final determination value Z, and therefore the reagent of claim 7 is novel over Sakai (Applicant’s Arguments, p 15, para 4-p 16, para 2). It is respectfully submitted that this is not persuasive as the claims do not recite detection of pancreatic cancer using the expression levels of the genes and CA 19-9 measurements in the equation, but rather recites a reagent that can be used for detecting pancreatic cancer. And as discussed above, Saki discloses developing a blood mRNA PDAC screening system using real‐time detection PCR to detect the expression of 56 genes, to discriminate PDAC from noncancer subjects (abstract; section 2.4; Table 1; fig 2). Sakai also discloses gene expression analysis by RTD-PCR for candidate genes selected from cDNA microarray data (including the 56 disclosed by the instant claim) was undertaken as described previously in Komura and CA19‐9 measurement by the standard chemiluminescent enzyme immunoassay (Section 2.2; section 2.4). Komura discloses a PCR primer consisting of a nucleotide sequence of the genes of interest (Komura “Doc S1. Supporting Materials and Methods.”, section “RNA isolation and real-time detection polymerase chain reaction.”) Therefore, Sakai as evidenced by Komura teaches the limitations of claims 7-8 and the rejections are maintained. Prior Art Claims 1 and 6 appear to be free from prior art, as the closest prior art to Sakai et al. (02/14/2023 IDS NPL #1; hereafter referred to as Sakai) does not appear to teach or suggest the steps for obtaining the final Z value by discriminant formula II, as disclosed by claim 1, or that the intercept value is -298.018, with the coefficients are the specific values disclosed by claim 6. With respect to claim 1 and 6, Sakai discloses equation for PDAC diagnosis using the weighted linear sum of each gene's expression level: Sum- value =intercept + a1 ∗ gene1 + a2 ∗ gene2 + … … + a56 ∗∗ gene56, where an is a coefficient value for each gene, a1*gene 1 + a2*gene 2 + ……… + a56**gene 56” was determined based on Fisher's linear discriminant, and its intercept value was set as −209.018, in the equation, and that sum-values 0 or higher and less than 0 were taken as positive and negative for PDAC, respectively. (p 1382, col 2, para 1-2). However, Sakai does not disclose the step of obtaining the final Z value by discriminant formula II, as disclosed by claim 1, or that the intercept value is -298.018, with the coefficients are the specific values disclosed by claim 6. Conclusion No claims allowed. THIS ACTION IS MADE FINAL. 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. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI DHARITHREESAN whose telephone number is (571)272-5486. The examiner can normally be reached Monday - Friday 9:00 - 5:00. 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, Larry D Riggs II can be reached at (571) 270-3062. 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. /N.D./Examiner, Art Unit 1686 /Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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Prosecution Timeline

Dec 28, 2022
Application Filed
Apr 08, 2026
Non-Final Rejection mailed — §101, §102, §112
Jul 02, 2026
Response Filed
Oct 06, 2026
Final Rejection mailed — §101, §102, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
40%
Grant Probability
73%
With Interview (+33.1%)
4y 11m (~1y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 55 resolved cases by this examiner. Grant probability derived from career allowance rate.

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