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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because page 69, line 25 of the specification contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction filed on April 08, 2026. No claims amendment are made in the response filed on 04/08/2026.
Claims 1-16 are currently pending, with claims 4, 7-9 and 14-15 withdrawn.
Claims 1-3, 5-6, 10-13 and 16 are under examination. This is the first action on the merits.
Election/Restrictions
The requirement for species election for "Species of aptamer sequence having at least 85% identity with" and "Species of Kd(F)", set forth in the office action mailed on February 20, 2026 has been withdrawn.
Applicant’s election without traverse of the following species in the reply filed on April 08, 2026 is acknowledged:
Species of additional aptamer sequence :
K) a modified RNA sequence having at least 85% identity with a sequence selected from the group consisting of SEQ ID NO: 34, SEQ ID NO: 35, SEQ ID NO: 36, SEQ ID NO: 37, SEQ ID NO: 38, SEQ ID NO: 39, and SEQ ID NO: 40 (claim 5)1.
Species of kit comprising additional aptamer sequence having at least 85% identity with:
M) the kit in claim 10 comprising a total of 13 aptamers2.
Species of aptamer composition:
N) all in one composition (claim 11).
Species of method of using aptamer:
P) method for screening compounds/molecules capable of detecting and/or recognizing a conformer of F-type a-Syn fibers, preferably screening compounds/molecules capable of discriminating the conformers of F-type a-Syn fibers from conformers of R-type a-Syn fibers (claim 13) 3;
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 § 818.01(a)).
Claims 4, 7-9 and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention 4.
Examination on the merits commences on claims 1-3, 5-6, 10-13 and 16.
Priority
The effective filling date of the instant claims 1-3, 5-6, 10-13 and 16 is November 27, 2023, the filling date of the instant U.S. nonprovisional application.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Specifically, Applicant's claim to domestic priority is acknowledged as a 371 national stage entry of PCT/FR2022/050993. Applicant's claim to foreign priority to FRANCE Application 2105529 is also acknowledged. However, neither of the submitted document is in English, and English translations have not been submitted.
The domestic benefit date may be the effective filing date of the claimed invention if:
• the earlier application to which domestic benefit is claimed supports the claimed invention under 35 U.S.C. 112(a).
The foreign priority date may be the effective filing date of the claimed invention if:
• the foreign application supports the claimed invention under 35 U.S.C. 112(a), AND
• the applicant has perfected the right of priority by providing a certified copy of the priority application, and a translation of the certified copy (if not in English) along with a statement that the translation of the certified copy is accurate.
See MPEP 213.04 and 216; See also MPEP 2304.01(c)
In this instant case, the priority documents submitted are not in English, without a translation; without a English translation, the examiner is unable to verify whether the earlier applications provide written description support for the claimed invention under 35 U.S.C. 112(a). Thus, since an English translation of the priority application has not been filed, the effective filing date (EFD) of the claimed invention is the filing date of the application.
However, if applicant perfects the right of priority by providing an certified English translation of the priority application that supports the claimed invention under 35 U.S.C. 112(a), the effective filing date will be the filing date of the foreign application.
Claim Objections
Claim 12 is objected to because of the following informalities:
- In claim 12, lines 2-3, "the RNA of the aptamer was modified " should read "the RNA of the aptamer is modified."
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
Claim 1 recites the term "aptamer," which is defined in the specification as follows:
“Aptamer” means an oligonucleotide (that is to say a segment of a nucleic acid chain) which adopts a three-dimensional structure giving it the ability to bind specifically to a given ligand (the ligand is called “target”), particularly of a protein nature. An aptamer is said to bind specifically to a target when it has essentially no affinity for a compound structurally unrelated to the target. (specification, page 14)
Claim 1 recites the term "modified RN," which is defined in the specification as follows:
“Modified RNA” means an RNA including at least one modified nucleotide. A modified RNA may in particular be an RNA in which the backbone of the nucleic acid is modified, in whole or in part, in particular to make it resistant to hydrolytic degradation, in particular due to the action of nucleases. RNA can be modified in its entirety (that is to say each nucleotide which constitutes it is modified) or in part (that is to say only part of the nucleotides which constitute it is modified). When the RNA is partially modified, it is possible to choose to modify all or part of the purines and/or all or part of the pyrimidines. (specification, page 15)
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3, 5-6, 10-13 and 16 are rejected under 35 U.S.C. 112(b), 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.
A) Regarding claim 1, it recites an aptamer comprising:
"a sequence specific for modified ribonucleic acid (RNA) having at least 85% identity with a sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7."
This limitation is indefinite because the phrase "a sequence specific for modified ribonucleic acid (RNA)" fails to clearly define the structure of the claimed aptamer.
Specifically, it is unclear what structural features are required for a sequence to be "specific for modified RNA," and what "specific for" means in the context of the claim. It is unclear whether this requires a sequence capable of interacting with a modified RNA, or a sequence that itself comprises modified ribonucleotides.
Thus, it is also unclear what "modified RNA" refers to in the claim ꟷ whether it refers to a part of the aptamer itself or to an unrecited, separate element. SEQ ID Nos: 1-7 are described in the sequence listing as RNA sequences, but they are not described as comprising any modifications.
Accordingly, the scope of the claim is indefinite.
Claims 2-3, 5-6, 10-13 and 16 are rejected for depending from claim 1 and not remedying the indefiniteness.
B) Regarding claim 13, it recites "preferably", which suggests subjectivity and does not clearly delineate whether the feature is a requirement of the claim or merely an illustrative example. This uncertainly prevents determination of the scope with reasonable certainly.
C) Regarding claim 16, which depends from claim 6/1, it recites "the RNA of all the aptamers of the kit was modified." This limitation is indefinite because it is unclear what "the RNA" refers to. It is ambiguous whether it refers to the "modified RNA" recited in claim 1, which is not clearly required of the aptamer as discussed above; or to the sequence defined as having at least 85% identity with a sequence selected from SEQ ID Nos: 1-7, which is required by the claimed aptamer. Accordingly, the scope of the claimed aptamer(s) cannot be determined with reasonable certainty.
Additionally, the use of past tense ("was modified") is improper, as it does not clearly define a present structural limitation of the claimed kit.
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter.
Regarding claim 13, the claimed invention is directed to nonstatutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because claim 13 is directed to a use of the aptamer product described in claim 1. Specifically, claim 13 recites a method for applications a), b), c) or d): "using at least one aptamer according to claim 1, or at least one kit comprising at least one aptamer according to claim 1, or any combination thereof."
Therefore, claim 13 is a "use claim" of the aptamer of claim 1 for a specific application, without setting forth any active, positive steps that define how the method is used for the stated purpose. Therefore, claim 13 is directed to an intended use for the aptamer in claim 1, and is not patent eligible. See MPEP 2173.05(q) " 'Use' claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)('one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101')."
In conclusion, the claim is not patent eligible under 35 U.S.C. 101. Applicant is advised to cancel the patent ineligible claim to overcome this rejection.
Subject Matter Not Taught/Suggested in Prior Art
No references were found teaching or suggesting claim 1 and its dependent claims, but they are rejected for reasons given above.
No prior art teach of suggest an aptamer comprising sequence having at least 85% identity with a sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7, as required by claim 1.
In addition, no naturally occurring sequence meets this limitation.
Conclusion
Claim 12 is objected to; claims 1-3, 5-6, 10-13 and 16 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIAN NMN YU whose telephone number is (703)756-4694. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIAN NMN YU/Examiner , Art Unit 1681 /AARON A PRIEST/Primary Examiner, Art Unit 1681
1 Claim 4 is withdrawn as being drawn to non-elected species H-J.
2 Claims 7-9 are withdrawn as being drawn to non-elected species L.
3 Claims 14-15 are withdrawn as being drawn to non-elected species Q-T.
4 Applicant is reminded that when all the claims directed to the elected invention are in condition for allowance, the nonelected invention(s) will be considered for rejoinder.
In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim. A withdrawn claim that does not require all the limitations of an allowable claim will not be rejoined. Furthermore, where restriction was required between a product and a process of making and/or using the product, and the product invention was elected and subsequently found allowable, all claims to a nonelected process invention must depend from or otherwise require all the limitations of an allowable claim for the claims directed to that process invention to be eligible for rejoinder. See MPEP § 821.04(b). In order to retain the right to rejoinder, applicant is advised that the claims to the nonelected invention(s) should be amended during prosecution to require the limitations of the elected invention. Failure to do so may result in a loss of the right to rejoinder.
Rejoined claims must be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. See MPEP 821.04
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