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 .
This Office Action is in reply to Applicants’ correspondence of 07/24/2026.
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: 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
In the reply filed on 08/11/2025 Applicants elected the particular gene that is SH3BGRL3 and the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 2 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as set forth on page 2 of the Office Action of 03/24/2026.
Priority
Applicant cannot rely upon the certified copy of the foreign priority application (JP2020-077036) to overcome any rejection set forth in this Office Action 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.
Withdrawn Claim Rejections - 35 USC § 112 - Indefiniteness
The rejection of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth on pages 3-4 of the Office Action of 03/24/2026, is withdrawn on light of the amendments to the claims.
Withdrawn Claim Rejection - Improper Markush Grouping
The rejection of claims for containing an improper Markush grouping of alternatives, as set forth on pages 4-7 of the Office Action of 03/24/2026, is withdrawn on light of the amendments to the claims.
Maintained Claim Rejections - 35 USC § 101
Modified As Necessitated by Claim Amendments
Claims 1 and 4-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The claim(s) are directed to methods of detecting severe premenstrual syndrome in a subject where the prediction is based on comparison of a measured level of mRNA to a control level. The claims are thus directed to an abstract idea which is a mental process in which premenstrual syndrome is deduced from a measure of gene expression (see MPEP 21106.04(a)(2)). Where claims include using a comparison of expression to detect severity, such a concept may be performed in the human mind (e.g.: observations, evaluations, judgments, and opinions; see MPEP 21106.04(a)(2) III). Additionally, claim 5 recites a limitation related to analyzing data using a prediction model with principal component analysis, where this step of data manipulation is directed to mathematical calculations that also are interpreted as being abstract ideas (e.g.: see MPEP 21106.04(a)(2) I). Furthermore, it is noted that where the subject matter of the claims is directed to the use of gene expression values associated with premenstrual syndrome severity, such an association is a natural aspect of the biological organism function (i.e.: a gene expression:phenotype relationship), and as such the claims are directed to a judicial exception that is a law of nature and/or a natural phenomenon (e.g.: MPEP 2106.04(b). With regard to claim 5, it is noted that claims can be directed to a mental process even if they are claimed as being performed on a computer (e.g.: MPEP 2106.04(a)(2)(III)(C)).
This judicial exception(s), as identified above, are not integrated into a practical application because the claims do not require any active process step that is performed based on a particular result of the abstract ideas of the claims. The claims are directed to the analysis of an mRNA biomarker level, but the methods end with the abstract idea of using the levels detect severe premenstrual syndrome.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the data collection of the claims uses well understood, routine and conventional methods that are properly considered insignificant extra-solution activity (e.g.: see MPEP 2106.05(g)). The data gathering steps themselves (e.g.: measuring an expression level of SH3BGRL3, as consonant with the election) were known in the art. The instant application teaches that the data collection of the instantly claimed methods may be performed using well known technologies (e.g.: p.2). And the prior art demonstrates that collection of the required data was routinely practiced in the art; Singla et al (2016) provides examples of using Affymetrix GeneChip Human Exon 1.0 ST arrays (e.g.: p.466 - RNA isolation and microarray hybridization; Microarray data preprocessing) to provide quantitative measures of gene expression levels including the level of SH3BGRL3 (e.g.: Table 2). Further relevant to the practical steps of the claimed methods, the prior art of EP-3372693 (cited on the IDS of 06/11/2024) and WO 2018/008319 (cited on the IDS of 10/21/2022) teach a comprehensive analysis of gene expression from skin surface lipid samples that is performed using a next-generation sequencing, which provides a measure of expression levels of every transcript in the transcriptome.
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 101 as maintained above. Applicants’ arguments (p.5-6 of the Remarks of 07/24/2026) have been fully considered but are not persuasive to withdraw the rejection. Applicants have argued that the amended claims recite steps of providing an SSL sample, detecting a level of SH3BGRL3 mRNA in the sample, comparing the level to a control, and determining the presence of severe premenstrual syndrome. Applicants assert the amended claims have additional steps that add meaningful limitations and therefore add significantly more to the claim than a mental process. The argument is not persuasive because as set forth in the rejection the aspects of the claims related to comparing a level to a control, and a determination based on the compared level, are judicial exceptions (as detailed in the rejection). The practical steps of the claims which require the providing of a sample and the detection of an expression level are routine and conventional activity when considering the teachings of the related art as cited in the rejection.
Withdrawn Claim Rejections - 35 USC § 112 – Scope of Enablement
The rejection of claims under 35 USC 112 as set forth on pages 9-13 of the Office Action of 03/24/2026, is withdrawn on light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 102 and 103
The rejections of claims under 35 USC 102 and 103 as set forth on pages 14-16 of the Office Action of 03/24/2026, are withdrawn on light of the amendments to the claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated any 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 STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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