NOTE: This action is responsive to the amendment of 11/25/2025 and supplemental to the action mailed 11/26/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on 11/13/25 and 11/25/25 have been entered.
Claims 7-10, 12-17, and 20-23 are pending.
Claim 9, 10, 12-17, and 20-23 remain withdrawn.
Claim 7 has been amended by Applicant.
Claim 7 is under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Withdrawn
The rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 101
Claim 7 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. Abstract ideas include mathematical concepts (including mathematical relationships, formulas, equations, and calculations), mental processes (including concepts performed in the human mind), and certain methods of organizing human activity (including managing personal behavior, relationships, or interactions between people). The rationale for this determination is explained below:
Claim 7 is directed to abstract idea and natural phenomenon because the claim recites natural phenomenon and an abstract idea (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is high expression levels of IL-7R and/or genes encoding IL-7R in biological samples from subjects correlate with the presence of pancreatic cancer occurrence. The “abstract idea” includes: the “determining” step of claim 7 (mental processes). It is noted claim 7 recites a curative treatment step; however, the claim encompasses methods where the curative treatment is not administered. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only required additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of measuring IL-7R or a gene encoding IL-7R in a biological sample from a subject (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. 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);
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Detecting levels of proteins and mRNAs in biological samples is well-understood, routine, and conventional (see page 1514 of Vudattu et al (Int J Cancer, 2007, 121: 1512-1519); page 375 of Motylewska et al (Cytokine, 2015, 75: 373-379); page 7390 of Rose et al (J Immunol, 2008, 182(12): 7389-7397); page 71199 of Birnbaum et al (Oncotarget, 2016, 7(44): 71198-71210); and acknowledgement at [0061] on page 16 of the instant specification that methods for measuring expression levels of recite biomarkers are “conventional”).
Here, the claim does not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claim does not amount to significantly more than the judicial exception(s). Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the required additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression. In regards to “determining” and “diagnosing", it is further noted that merely presenting results of a process otherwise unpatentable under 35 U.S.C. 101 is insufficient to establish eligibility under the statute. See FairWarning IP, LLC v. Iatric Sys., Inc., No. 2015-1985, 2016 WL 5899185, at *3 (Fed. Cir. Oct. 11, 2016) (claim unpatentable under 35 U.S.C. 101 despite recitation of the step: “providing notification if [an] event has occurred”). Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…." Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Response to Arguments
In the Reply of 11/13/25, Applicant submits a Declaration by Dong Ki Lee and indicates the claims are patent-eligible because the recited curative resection treatment step “practically applies” recited judicial exceptions.
The amendments to the claims, the Declaration, and the arguments found in the Reply of 11/13/25 have been carefully considered, but are not deemed persuasive. While limiting the claims to subjects that are diagnosed with pancreatic and treating the diagnosed subjects with a curative treatment could practically apply recited judicial exceptions, the claim is not limited to subjects diagnosed with pancreatic cancer (see the “when” in step “ii)” of the claim). Rather, the claim encompasses methods where treatment by curative resection is not performed (and judicial exceptions are not practically applied) when IL-7R is not higher than that in a normal control group.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a NEW MATTER rejection.
Claim 7 recites a method of treating a subject, by curative resection, wherein the subject is determined to have pancreatic cancer based on IL-7R expression level. Descriptions of treating a subject, by curative resection, wherein the subject is determined to have pancreatic cancer based on IL-7R expression level are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
In the Reply of 11/13/25, Applicant indicates support for the method is found at [0088] and [0003] of the specification. However, [0088] and [0003] of the specification do not disclose treating a subject, by curative resection, wherein the subject is determined to have pancreatic cancer based on IL-7R expression level. At [0003], the specification discloses “80% to 90% of pancreatic cancer patients are diagnosed in a state in which curative resection enabling a complete cure is impossible.” There is no mention of “curative resection” anywhere else in the specification and [0003] doe not disclose treating a subject, by curative resection, wherein the subject is determined to have pancreatic cancer based on IL-7R expression level. At [0088], the specification discloses a step of subjecting a subject to “appropriate treatment such as administration of a drug for the disease (such as an anticancer drug for pancreatic cancer), gene therapy, radiotherapy or immunotherapy” when likelihood of developing pancreatic cancer is predicted or diagnosed to be high based on IL-7R expression level. However, [0088] makes no mention of curative resection.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642