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 .
Response to Amendment
Applicant’s amendment filed 10/31/2025 is acknowledged. Claims 1 and 15 are amended. Claims 1-3, 5-8 and 11-15 are under examination.
Objections/Rejections Withdrawn
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
The objection to claim 15 for minor informalities is withdrawn in response to Applicant’s deletion of the extra “and” in line 8 between “(SEQ ID NO: 6);” and “miR-199a-3p”.
Claim Rejections - 35 USC § 102
The rejection of claims 1-3, 5 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Onrat et al. Genet Test Mol Biomarkers. 2018 Nov;22(11):644-651. doi: 10.1089/gtmb.2018.0188. Epub 2018 Oct 26—on IDS filed 08/27/2024) is withdrawn in response to Applicant’s amendment of the claims to recite “wherein the expression level of the at least 3 miRNA markers is less than the expression level of the corresponding miRNA control samples”. According to Table 4 of Onrat et al., three of the four miRNAs recited in claim 1 had increased, rather than decreased levels compared to control.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3 and 5-7 under 35 U.S.C. 103 as being unpatentable over Onrat et al. Genet Test Mol Biomarkers. 2018 Nov;22(11):644-651. doi: 10.1089/gtmb.2018.0188. Epub 2018 Oct 26—on IDS filed 08/27/2024) in view of Chowdhury et al. (WO 2018129535) is withdrawn in response to Applicant’s amendment of the claims to recite “wherein the expression level of the at least 3 miRNA markers is less than the expression level of the corresponding miRNA control samples”. According to Table 4 of Onrat et al., three of the four miRNAs recited in claim 1 had increased, rather than decreased levels compared to control.
The rejection of claims 1-3, 6 and 7 under 35 U.S.C. 103 as being unpatentable over Chowdhury et al. (WO 2018129535) is withdrawn in response to Applicant’s amendment of the claims to recite “wherein the expression level of the at least 3 miRNA markers is less than the expression level of the corresponding miRNA control samples”, which Chowdhury et al. do not teach.
New Rejection
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This rejection was necessitated by Applicant’s amendment. The claims recite a method of detecting the expression levels of miRNA markers in a biological sample, and thus are drawn to the statutory category of a process. See Step 1 of the Guidelines.
The first step in determining whether a claim recites patent-eligible subject matter is to consider whether the claim recites an abstract idea, law of nature or natural phenomenon (see Prong One of Step 2A in the Revised Guidelines). Amended claim 1 recites a method of detecting the expression level of miRNA markers in a biological sample obtained from a mammal comprising: i) detecting the expression level of at least 3 miRNA markers selected from the group consisting of miR-199a-3p, miR-143-3p, miR-340-5p, let-7b-5p, miR-21-5p, miR-17-5p, miR-20a-5p and miR- 103a-3p, in the biological sample, wherein the expression level of the at least 3 miRNA markers is less than the expression level of corresponding miRNA control samples; and ii) detecting the expression level of at least one miRNA reference marker which is stable across biological samples and control samples. The added wherein clause implicitly requires comparing the miRNA marker expression levels to corresponding controls in order to determine that the expression level is less than that of control. Dependent claims 2-3, 5 and 6 provide more detail as to how the detection is performed and what markers are detected and claim 7 recites that the controls do not have endometriosis. The claims require the judicial exception of comparing miRNA biomarker levels to control. The mental step of comparing biomarker levels is similar to comparing information regarding a sample or test subject to a control or target data (see Univ. of Utah Research Found, v. Ambry Genetics Corp., 113 USPQ2d 1241 (Fed. Cir. 2014). In summary, the answer to Prong One of Step 2A is yes.
The second step in determining patent-eligibility of claimed subject matter is to consider whether the claims recite additional elements that integrate the judicial exception into a practical application. The methods require detecting miRNA expression samples obtained from mammals; however, sample collection is merely necessary data gathering required in order to perform the mental analysis of comparison and diagnosis. Claim 3 recites the detection is performed using RT-PCR and claim 6 recites the primers that are used to detect expression levels. The claims do not encompass any further steps beyond detection and comparison, thus the answer to Prong Two of Step 2A is no.
The final step in determining whether claims recite patent-eligible subject matter is to consider whether the claims recite additional elements that amount to significantly more than the judicial exception. The claims do not recite any particular assay or steps that amount to significantly more than the judicial exception. The instant specification discloses that “samples may be obtained from the mammal in a manner well-established in the art” (see p. 5, paragraph [0018]) and “[a]s one of skill in the art will appreciate, the expression level of each biomarker may be determined using one of several techniques established in the art, including methods of quantifying nucleic acids, such as PCR-based techniques, microarrays, gene expression systems, and Northern or Southern blotting techniques” (see p. 5, paragraph [0020]). In the instant case, the encompassed detecting steps are simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (see MPEP 2106.05(d)). Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Conclusion
Claims 1-3 and 5-7 are rejected and claims 8 and 11-15 are allowed.
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 CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675