DETAILED CORRESPONDENCE
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 action is in response to the papers filed September 15, 2026. Currently, claims 1-6, 11-20 are pending. Claims 11-18 have been withdrawn as drawn to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant's election of Group I in the paper filed February 17, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application is a 371 of PCT/EP2021/087806, filed December 29, 2021 and claims priority to EPO 20217509.7, filed December 29, 2020.
Drawings
The drawings are acceptable.
Information Disclosure Statement
The listing of references in the specification 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, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The list of references on pages 30-37 has not been considered as an IDS.
Claim Rejections - 35 USC § 102
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.
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 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.
Claim(s) 1-6, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hornstein et al. (WO2020/230133, November 19, 2020).
Hornstein teaches cell-free miRNA markers for prognosis and diagnosis of neurodegenerative diseases. In particular Hornstein teaches the neurodegenerative disease is frontotermal dementia or FTD (abstract). Hornstein teaches analysis of level of miR-181a-5p (see Figure 7, 8, 10, 14, for example). Hornstein further teaches specific embodiments with miR-181a-5p, miR-146a-5p (page 20, lines 25), miR-148a-3p (page 21, lines 12-13). Hornstein teaches combination of any two or more of the above described miRNAs is considered (page 21, lines 21-23).
With respect to Claim 2, the collection of blood, plasma or serum is not a surgical method (page 21, lines 23-25).
With respect to Claim 3, Hornstein teaches the subject is a human being (page 6, line 27).
With respect to Claim 4, Hornstein teaches the biological sample is a fluid such as blood, plasma, serum, cerebrospinal fluid (page 21, lines 23-25).
With respect to Claims 5-6, Hornstein teaches performing quantification using next generation sequencing (page 39).
Response to Arguments
The response traverses the rejection. The response asserts Hornstein does not describe a method to detected the presence of miR-181a-5p (see Figure 7, 8, 10, 14, for example), miR-146a-5p (page 20, lines 25), and miR-148a-3p (page 21, lines 12-13). This argument has been considered but is not convincing because the Hornstein teaches methods comprising analyzing each of these three miRNA in addition to other miRNA.
The response further argues the three enumerated miRNA are included in a laundry list of at least 55 options. This argument has been reviewed but is not persuasive. There are numerous places throughout the disclosure of Hornstein that lists miR-146 and miR-148 in a list of four alternative miRNA molecules. Selection from a very limited genus would anticipate the claimed invention, even if the claims were amended to require the group consisting of miR-181a-5p, miR-146a-5p and miR-148a-3p. As provided in MPEP 2131.02,
The Federal Circuit stated that the reference’s “express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required.” Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017) (“Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would “at once envisage” the missing limitation. Rather, Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations.”).
Therefore, the limited number of possible combinations anticipates the claimed invention. Thus, for the reasons above and those already of record, the rejection is maintained.
Claim(s) 1-6, 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hill et al. (US 2022/0017962, January 20, 2022, PCT filed December 2019).
Hill teaches methods of diagnosing a disease, where the disease is a neurodegenerative disorder such as Parkinson’s disease, Alzheimer’s disease and prion disease. Hill analyzes each of miR-181a-5p, miR-146a-5p, miR-148a-3p in neurodegenerative diseases. Table 10 provides has-miR-181a-5p is significantly downregulated in in PD patients (page 27). Table 10 provides has-miR-146a-5p is significantly upregulated in Creutzfeldt-Jakob disease/CJD patients. Table 11 provides has-miR-148a-3p is differentially expressed in AD vs Healthy controls (page 27).
With respect to Claim 2, the collection of blood, plasma or serum is not a surgical method (par 51).
With respect to Claim 3, Hill teaches the subject is a human being (para 66).
With respect to Claim 4, Hill teaches the biological sample is a fluid such as blood, plasma, serum (para 51).
With respect to Claims 5-6, Hill teaches performing quantification of level of expression of the small non-coding RNA compared to a reference level (para 17, 23, 53). Hill teaches the levels are detected using qRT-PCR.
Response to Arguments
The response traverses the rejection. The response asserts Hill does not describe a method to detected the presence of miR-181a-5p, miR-146a-5p, miR-148a-3p. This argument has been considered but is not convincing because Hill teaches methods comprising analyzing each of these three miRNA in addition to other miRNA (see para 146, for example).
The response further argues the three enumerated miRNA are included in a laundry list of Table 10. Table 10 includes 19 miRNA. This argument has been reviewed but is not persuasive. Selection from a very limited genus would anticipate the claimed invention, even if the claims were amended to require the group consisting of miR-181a-5p, miR-146a-5p and miR-148a-3p. As provided in MPEP 2131.02,
The Federal Circuit stated that the reference’s “express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required.” Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017) (“Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would “at once envisage” the missing limitation. Rather, Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations.”).
Thus, the limited number of possible combinations anticipates the claimed invention.
The response further argues each miRNA was related to different diseases. The response argues it is unclear why one of skill int eh art would combine these miRNA. This argument has been reviewed but is not persuasive. Each of these miRNA are taught in Hill to be associated with neurodegenerative disorders. The ordinary artisan would be motivated to distinguish and differentiate neurodegenerative disorders using known miRNA that are differentially expressed. Thus for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable over the art.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bianco et al. (WO 2017/085287, May 26, 2017) teaches analysis of miRNAs for monitoring neurological, neurogdegenerative and inflammation-based diseases (abstract). Bianco lists each of miR-181a, miR146a-5p and 148a-3p.
Xu (US 2015/0275299, October 1, 2015) teaches miRNAs as markers for Parkinson’s disease. Each of the miRNA claimed are recited in Table 39, page 3, as differentially expressed and/or correlated with clinical/pathological findings.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
October 1, 2026
