Prosecution Insights
Last updated: October 04, 2026
Application No. 18/280,801

COMPOSITION FOR DIAGNOSING PANCREATIC CANCER

Final Rejection §101§103§112
Filed
Sep 07, 2023
Priority
Mar 08, 2021 — RE 10-2021-0029877 +2 more
Examiner
JOHANNSEN, DIANA B
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Acurasysbio Co. Ltd.
OA Round
2 (Final)
53%
Grant Probability
Moderate
3-4
OA Rounds
12m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allowance Rate
269 granted / 506 resolved
-6.8% vs TC avg
Strong +43% interview lift
Without
With
+42.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
33 currently pending
Career history
549
Total Applications
across all art units

Statute-Specific Performance

§101
18.0%
-22.0% vs TC avg
§103
25.3%
-14.7% vs TC avg
§102
12.2%
-27.8% vs TC avg
§112
37.6%
-2.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 506 resolved cases

Office Action

§101 §103 §112
FINAL ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the Amendment filed 24 June 2026. Claims 22 and 24-31 have been amended and claims 23 and 32-33 have been canceled. All prior rejections applied against claims 23 and 32-33 are moot in view of the cancelation of those claims. Claims 24, 26-27, 30, and 34-35 are withdrawn (see also paragraphs 6-10 below), and claims 22, 25, 28-29, and 31 are under consideration herein. It is noted that the substitute specification filed 24 June 2026 (correcting issues related to missing sequence identifiers) has also been entered. Applicant’s amendments and arguments have been thoroughly reviewed, and have overcome the following objections/rejections set forth in the prior Office action: Several rejections of claims under 35 USC 112(b) in view of Applicant’s clarifying amendments; and The rejections of claims under 35 USC 103, in view of the amendment of independent claim 22 to require measuring expression levels “in peripheral blood mononuclear cells (PBMCs) isolated from a blood sample obtained from a subject” (although it is noted that the amended claims are rejected under 35 USC 103 for the reasons given below). Claims 22, 25, 28-29, and 31 remain rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendments. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL. It is again noted that while a certified copy of the foreign priority document is present in the application file, a certified translation has not been provided; accordingly, the effective filing date for purposes of comparing the claimed invention to the prior art remains 08 March 2022. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Election/Restrictions and Claim Status Applicant’s election without traverse of Group I in the reply filed on 23 February 2026 is again acknowledged. Claims 34-35 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 February 2026. Applicant’s election without traverse of the species of “a combination of PLD4, ID3, and IL-7R” and “a gene encoding the protein” in the reply filed on 23 February 2026 is also again acknowledged. Claims 26-27 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 February 2026. Additionally, in view of the amendment of claims 24 and 30 to recite non-elected species (specifically, NR4A1 and KLRF1), and the fact that the prior art continues to apply against the claims as directed to the elected species, claims 24 and 30 are also now withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. The present status of the claims is: claims 22, 25, 28-29, and 31 under consideration as directed to the elected species; claims 24, 26-27, 30, and 34-35 withdrawn. Notice of Improper Information Disclosure Statement The discussion of a reference and the provision of that reference as an Exhibit incorporated into Applicant’s Reply is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office. Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Interpretation With regard to claim 31, it is noted that the recitation of the limitation “the step of 2)” is interpreted as referring to “2)” of claim 22 (as this is the only reasonable interpretation of the claim language, i.e., the fact that the term “step” is no longer employed in claim 22 does not render the claims indefinite). Claim Rejections - 35 USC § 112(b)/second paragraph THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS: Claims 22, 25, 28-29, and 31 remain 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. Claims 22, 25, 28-29, and 31 are indefinite because while the language of independent claim 22 makes reasonably clear how “diagnosing pancreatic cancer and treating pancreatic cancer” is achieved “when the measured expression levels” as specified in 2) of claim 22 meet the specified conditions, it is unclear what else is encompassed by the claims. Some persons of skill in the art would interpret the claims as requiring “diagnosing” and “treating” both in instances when the conditions of 2) are met and when they are not (given the recitation of “diagnosing…and treating” in the claim preamble), while others might interpret the claim as limited to the specific outcome of 2) (despite the use of the conditional term “when” therein), and still others would – in view of the recitation of a conditional/contingent limitation at 2), and the guidance of MPEP 2111.04 (“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”) - interpret the claims as only requiring the “measuring” of 1) of claim 22 (with the “diagnosing” and “treating” only occurring in particular instances as specified in the claim). As there are a variety of reasonable interpretations of the claim language that impart different boundaries on what is claimed, further clarification is required. Dependent claim 31 as amended is also indefinite for reasons related to and similar to those noted above regarding the language of independent claim 22. Claim 25 (from which claim 31 depends) clearly requires an additional step “of measuring an expression level of IL7R protein or a gene encoding IL7R in the PBMCs from the subject, however claim 31 states “wherein in the step of 2), the subject is diagnosed with the pancreatic cancer when the expression level of IL7R or the expression level of the gene encoding IL7$ is higher than that of a control”. Given the lack of the language of claim 22, there are multiple possible ways in which claim 31 might further limit what is claimed. Additionally, while some persons of skill in the art might interpret claim 31 as setting forth an additional condition that must be present (in addition to conditions required by claim 22, which would render claim 31 a proper dependent claim), the claim as presently worded is ambiguous, stating that that the subject “is diagnosed…when” a further condition (related to IL7R) is met; this language thus suggests that the conditions specified in claim 22 are not in fact required, or are not necessarily required, and also suggests that different conditions (not referenced in claim 22) may be relied upon to achieve pancreatic cancer diagnosis (such that the language claim 31 is both confusing on its own, and suggestive of alternative interpretations of claim 22, only some of which claim 31 is properly further limiting of). Clarification is therefore required to ensure that the boundaries of the claims are clear (both with regard to independent claim 22 and dependent claim 31). Claim 28 is indefinite over the recitation of the limitation ‘the agent for measuring the expression level of the gene encoding PLD4 or ID3 comprises….”, because there is insufficient antecedent basis for this limitation in claim 22, and because it is unclear how claim 28 further limits claim 22. Claim 22 as amended and directed to the elected species recites the activity “measuring…expression levels of genes encoding PLD4 and ID3” in “ PBMCs “isolated from a blood sample obtained from a subject”. There is no prior reference to an “agent for measuring the expression level of the gene encoding PLD4 or ID3”; rather, claim 22 recites “measuring expression levels” of both genes, without referencing an “agent” (for use in measuring either one or both genes). Thus, clarification is required with regard to how claim 28 further limits claim 22, as well as whether such further limitation applies to the “measuring” of both genes, of one gene, etc. Claim 29 is indefinite over the recitation of the limitation “wherein the measuring the expression level of the gene encoding PLD4 or ID3 is performed by…”, because there is insufficient antecedent basis for this limitation in claim 22. Again, claim 22 as amended recites “measuring….expression levels of genes encoding PLD4 and ID3”; there is no single “measuring” that pertains to one gene or the other. It is thus not clear whether claim 29 is further limiting of the activity of “measuring expression levels” of the two genes specified in claim 22 (given the reference to “the measuring the expression level”), or whether the claim is only further limiting of the measuring of one gene. As there are multiple reasonable interpretations that differ in how they further limit claim 22, clarification is required. Claim Rejections - 35 USC § 103 This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS: Claim(s 22, 25, 28-29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kandimalla et al (Clinical Cancer Research 26(14):3641 [July 2020; online 31 March 2020]; previously cited) in view of Lee et al (Molecular Cancer Research 9(6):782 [2011]; previously cited) and Heo et al (Journal of Clinical Medicine 10:4157 [15 Sept 2021]; cited herein). It is noted that the authorship of the Heo et al reference overlaps the inventorship of the present application; however, the Heo et al reference also includes additional co-authors that are not named as inventors on the application. Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. It is also reiterated that the claims are indefinite for the reasons given above, and that – particularly given the conditional language of the “diagnosing” of 2) of independent claim 22 – the claims may reasonably be interpreted as encompassing methods only requiring the “measuring” of 1) of claim 22 (see MPEP 2111.04(II), which states that the broadest reasonable interpretation of claims reciting conditional/ contingent limitations “requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”). Additionally, given the language of amended claims 25 and 31, the claims as directed to the elected species reasonably encompass methods in which genes encoding all of PLD4, ID3, and IL7R are measured in PBMCs, with elevated IL7R (as recited in dependent claim 31) being relied upon as a diagnostic marker for pancreatic cancer. Kandimalla et al teach a 15 gene signature that significantly associates with pancreatic ductal adenocarcinoma (PDAC) survival, which signature includes the elected gene PLD4; see entire reference, particularly the Abstract, the “Translational Relevance” on page 3642 (left column), and the Results at pages 3644-3646, particularly the disclosure of genes on page 3644, right column). Kandimalla et al disclose methods including measuring expression levels of their disclosed genes in FFPE PDAC specimens via qRT-PCR analysis of total RNA isolated from the specimens (see “Materials and Methods” on page 3642, right column, and the Results at page 3645, right column, first full paragraph). Kandimalla et al thereby teach methods meeting the requirements of claim 22 with respect to PLD4, other than the type of sample tested (as amended independent claim 22 requires measuring expression levels “in peripheral blood mononuclear cells (PBMCs) from a blood sample obtained from a subject”). Kandimalla et al do not teach measuring expression level of the ID3 gene or IL7R gene, and do not teach measuring expression in PBMCs isolated from a blood sample. Lee et al teach that Id3 (the protein encoded by ID3) is “pervasively expressed in neoplastic lesions in human PDA in situ”, and was also found to be expressed in pancreatitis, suggesting that Id3 “might induce cell cycle entry in ducts” (see entire reference, particularly the Abstract, and the Discussion on page 789, left column, first full paragraph). Lee et al also suggest that this pattern observed with Id3 “as an early and sustained feature of ductal pathogenesis” may provide a “potential therapeutic target for intervention in pancreatitis and PDA” (see the Abstract, and see also the Discussion at page 788, first paragraph in the left column). Lee et al teach that ID3 RNA may – like the signature genes of Kandimalla et al – be detected via qRT-PCR (see page 783, right column, last paragraph bridging to the top of the left column on page 784). Heo et al teach identifying and characterizing “the distinct subset of blood cell population elevated in peripheral blood mononuclear cells (PBMC) of pancreatic cancer to evaluate the potential markers for diagnosis of pancreatic cancer” (see entire reference, particularly the Abstract), and report finding “PMBC from pancreatic cancer patients expressed elevated IL-7R mRNA compared to healthy control individuals” (see entire reference, particularly the Abstract; pages 5-6, section 3.1; page 10, last paragraph). Like Kandimalla et al and Lee et al, Heo et al employ a qPCR methodology in their methods (see, e.g., page 3, section 2.3.1), and Heo et al state that IL-7R expression in PMBC “rapidly emerged from the onset of early pancreatic tumor formation” allowing it to be used as a biological marker “for early events of pancreatic cancer development” (see again the Abstract and page 10, last paragraph). Heo et al also teach that pancreatic cancer typically has low survival rates at time of diagnosis because diagnosis occurs too late for effective treatment, as a result of which “earlier stage diagnosis…is required for clinically significant improvement”, including by facilitating more effective treatment/therapy for disease (see page 1 bridging to page 2). Heo et al thus make clear that an intended benefit of their early diagnostic method is to provide an opportunity for successful treatment of pancreatic cancer. In view of teachings of Kandimalla et al, Lee et al, and Heo et al, 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 performed measurement of gene expression levels of all of PLD4, ID3, and IL-7R in PBMCs isolated from blood samples of a subject, including via the quantitation of expressed RNA via qRT-PCR/qPCR, and thereby to have performed methods meeting the requirements of independent claim 22, as well as dependent claims 28-29 (given the disclosure in the references of the use of primers targeting the elected genes in qRT-PCR/qPCR), and claims 25 and 31 (reciting the requirement for the third marker of the elected species, IL-7R). All three references pertain to measurement of expression levels of genes exhibiting altered expression patterns in association with PDAC, with the signature of Kandimalla et al (which includes PLD4) being taught as providing a benefit in determining prognosis and diagnosis, the teachings regarding ID3 of Lee et al indicating a possible benefit in early disease detection/diagnosis and therapeutic intervention, and Heo et al explicitly teaching measurement of elevated IL-7R gene expression in PBMCs as an early diagnostic marker of PDAC. Based on these teachings, an ordinary artisan would have recognized that measurement of expression of all of these genes is potentially informative with regard to PDAC diagnosis (as well as identification of a need for treatment of PDAC when diagnosed); further, given the benefits of PBMCs disclosed by Heo et al, an ordinary artisan would have been motivated to have selected that sample type for testing for the benefit of earlier measurement of gene expression levels indicative of PDAC, and thus earlier diagnosis of PDAC (as well as the additional benefit of improved likelihood of treatment success that flows from such earlier diagnosis). While it is noted that the Kandimalla et al and Lee et al employ different (non-PBMC) sample types, as already noted the BRI of the instant claims embraces methods simply requirement performing the “measuring expression levels” of the claims, such that the teachings of the cited art are clearly sufficient to suggest the claimed method (as the claims embrace any potential outcome of the “measuring”). For example, an ordinary artisan would have been motivated to have performed methods comprising testing of PMBCs for all three markers PLD4, ID3, and IL-7R) simply for the benefits of gaining information regarding what markers are present/absent, possible indicators of disease status, possible prognosis, etc., as well as for the potential benefit of earlier diagnosis, therapy/treatment and/or intervention (as suggested by the cited art). Further, an ordinary artisan would have recognized an additional benefit of efficiency and simplicity in testing PBMCs originating from blood samples for all three markers (as well as any other known PDAC markers of interest), which testing also provides the benefit of evaluating multiple markers in a common, single sample type. Additionally, given the detailed disclosures of all the cited references, an ordinary artisan would have had a reasonable expectation of success in performing such methods. Finally, to the extent that the claims are directed to embodiments in which the result of elevated IL-7R expression in PBMCs serves as a diagnostic marker and indicator to perform treatment (i.e., an embodiment alluded to in dependent claim 31), the teachings of Heo et al described above clearly suggest use of elevated IL-7R expression in PBMCs as an early diagnostic marker, and the cited art also discloses treatments of PDAC encompassed by the alternatives set forth in the “treating” of 3) of claim 22 (e.g., Heo et al refer to “resectable tumors” at the top of page 2, suggesting surgical removal of a diagnosed tumor in cases where it is resectable). Thus, the combined teachings of Kandimalla et al, Lee et al, and Heo et al render multiple embodiments embraced by claims 22, 25, 28-29, and 31 obvious. Applicant’s arguments regarding the prior rejection of claims under 35 USC 103 have been reviewed to the extent that they may apply to the new grounds of rejection above, but those arguments are not found persuasive. Applicant’s arguments focus on the failure of Kandimalla and Lee, as well as Xu et al, to “disclose or suggest pancreatic cancer” based on gene expression levels in PBMCs (which is a sample type newly recited in the amended claims); the Reply urges that “the expression profile of a biomarker in tumor tissue cannot be directly extrapolated to its expression profile in a blood-derived sample, such as PBMCs (Reply page 9). Applicant also refers to an (uncited) reference pertaining to differences in expression between blood and tissue samples from pancreatic cancer patients, which reference pertains to a different marker (PDX1) (Reply page 9 bridging to page 10). However, the current rejection above addresses the new limitation of PBMCs, and it is reiterated that the claims are indefinite with regard to whether they do or do not even require “diagnosing” (and “treating”). Further, methods simply requiring the “measuring” of the claims constitute one embodiment that is reasonably encompassed by the present claim language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Accordingly, Applicant’s arguments are non-persuasive with regard to nonobviousness of the claims presently under consideration. Claim Rejections - 35 USC § 101 THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS: Claims 22, 25, 28-29, and 31 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 22 as amended is drawn to a “method of diagnosing pancreatic cancer and treating pancreatic cancer” comprising “measuring expression levels” of genes encoding PLD4 and ID3 “in PBMCs isolated from a blood sample obtained from a subject, “diagnosing pancreatic cancer when” the measured expression level of PLD4 is lower than a control and that of ID3 higher than a control, and “treating the diagnosed pancreatic cancer” by an administering as recited in 3) of claim 22. As discussed above, the claims remain indefinite, and it is unclear whether the claims do/do not require a particular outcome for the “measuring” that necessitates performing the subsequently recited “diagnosing” and “treating” (and particularly in view of the language of amended claim 31, it appears that this “diagnosing” and “treating” may or may not ever occur). The activity of “diagnosing pancreatic cancer” as recited in this claim, while indefinite, appears to encompass activities such as thinking about and drawing conclusions regarding what the results of the “measuring” are, which is an activity that may be conducted entirely in the human mind, i.e., an abstract idea. Further, the “diagnosing” is written as a conditional/contingent limitation – the claim recites “diagnosing when” the specified outcome is present – such that the “treating” cannot be considered a required step based on the present claim language. The judicial exception is not integrated into a practical application because the “measuring expression levels” of the claims is a data gathering step that fails to implement/apply the abstract idea of the claims, i.e., it does not add a meaningful limitation to the method as it is insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the broadly and generally recited activity of “measuring expression levels” of a known gene or genes in a biological sample (including via various preferred methods as set forth in dependent claim 29) corresponds to the types of laboratory techniques/activities that the courts have recognized as well-understood, routine, and conventional activity in the life science arts when claimed a generic manner (as they are in the instant claims); see MPEP 2106.05(d)(II). It is also noted that measurement of expression of each of the genes of the elected species (including in the context of pancreatic cancer) was well-known, routine, and conventional as of Applicant’s effective filing date (see again Kandimalla et al, Lee et al, and Xu et al [all previously cited], and see Heo et al [cited above] with regard to measuring expression levels in PMBCs in the context of pancreatic cancer, including with regard to measurement of IL-7R); additionally, the occurrence of altered expression levels of such genes in biological samples of a subject with pancreatic cancer is a natural phenomenon, i.e., another JE, not something “more” than a JE. An inventive concept cannot be furnished by a judicial exception (i.e., a law of nature/natural phenomenon/abstract idea) itself (see MPEP 2106.05(I)). Thus, independent claim 22 is not directed to patent eligible subject matter. Regarding dependent claim 25, this claim recites the gathering of data regarding an additional gene, i.e., another type of insignificant extrasolution activity (rather than any type of application of a JE), and such “measuring” fails to add something “significantly more” for the same reasons noted above regarding the “measuring” of independent claim 22 (as even when these activities are considered in combination, such broadly recited “measuring” is a type of activity considered well-understood, routine, and conventional, and was also well-known in the prior art as exemplified by the teachings of Xu et al and Heo et al; further, any altered expression of IL7R in the context of cancer is also a natural phenomenon, i.e., a JE, rather than something “more” than a JE). Regarding claim 28, this claim embraces the use of a generally recited “agent” such as a primer or probe in data gathering; this is a further limitation on data gathering rather than any type of application/implementation of a JE, and such use of a generically recited primer/probe again corresponds to a laboratory technique/activity that the courts have recognized as well-understood, routine, and conventional activity in the life science arts (again see MPEP 2106.05(d)(II)). The analysis applied to claim 28 also applies to claim 29, as this claim recites broad categories of types of “measuring” that were well-known as of Applicant’s effective filing date. Claim 31 recites a further limitation that is conditional/contingent (as the claims specify activities that occur “when” a condition is met, with that condition not being required by the claims). As discussed in MPEP 2111.04(II), “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”; thus, the same analysis applied to claim 22 also applies to this claim. Accordingly, none of claims 22, 25, 28-29, and 31 is directed to patent eligible subject matter. The Reply of 24 June 2026 traverses the prior rejection of claims under 35 USC 101 on the following grounds. Applicant states that the amended claims are “directed to a practical application in which pancreatic cancer is diagnosed and then treated based on the diagnostic result” (Reply page 10). More particularly, Applicant argues that the invention “enables early diagnosis of pancreatic cancer by analyzing a blood sample, particularly a PBMC sample, and determining the expression levels of specific markers”, with the claims further integrating “the diagnostic marker into a specific medical treatment process” and applying the diagnostic result “to actual treatment of pancreatic cancer” (Reply page 10 bridging to page 11). These arguments have been thoroughly considered but are not persuasive because (as discussed above) the claims as presently written do not clearly require the limitations upon which Applicant’s arguments rely. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). While it is noted that the claims as written do clearly encompass the embodiments discussed in Applicant’s arguments, as discussed in MPEP 2106.03(II): “A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter”. Thus, the fact that the claims embrace embodiments requiring pancreatic cancer diagnosis based on recited expression levels of particular biomarkers in PBMCs followed by treatment in those instances is not sufficient to render the present claims patent eligible. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jang et al (Cancers 14:853 [8 Feb 2022]; cited herein) report further analysis and validation of the IL-7R marker in PBMCs isolated from PDAC patients (see entire reference, noting the discussion in Jang et al of the earlier work reported in Heo et al, which is cited and relied upon above). 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 DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST. 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, Wu-Cheng 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. /DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Sep 07, 2023
Application Filed
Mar 24, 2026
Non-Final Rejection mailed — §101, §103, §112
Jun 24, 2026
Response Filed
Sep 16, 2026
Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
53%
Grant Probability
96%
With Interview (+42.8%)
4y 0m (~12m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 506 resolved cases by this examiner. Grant probability derived from career allowance rate.

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