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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-2, and the species elections of “suppressed product inhibition” in claim 1 and “at least 85% sequence identity to Seq ID No: 7, wherein a part of the sequence is LVKGGKP at positions 223 to 229” in claim 1, in the reply filed on 4/8/2026 are acknowledged.
Claims 3-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/8/2026.
In view of the prior art search, the species election has been expanded to include “at least 85% sequence identity to Seq ID No: 6” in claim 1.
Priority
This application is a 371 of PCT/EP2022/072839 (8/16/2022) which claims priority to EP21191447.8 (8/16/2021) as reflected in the filing receipt issued on 2/10/2025.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 3/4/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
Claim Objections
The claims are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
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 1 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding written description, 35 U.S.C. 112(a) and the first paragraph of pre-AlA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention (MPEP § 2163(I)).
MPEP 2163(II)(A)(3)(a)(i and ii) states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., .759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, claim 1 recites an amino acid sequence with at least 85% sequence identity to SEQ ID No: 6; or at least 85% sequence identity to SEQ ID No: 7, wherein a part of the sequence is LVKGGKP at positions 223 to 229. There is not sufficient written description support for a sequence having 85% identity to SEQ ID NOs: 6 or 7 and having the claimed functions. SEQ ID NOs: 6 and 7 have 306 amino acids. This means that up to 45 amino acids may differ within the range of 85% identity, or that there may be various insertions or deletions, encompassing a vast number of sequences. It is not clear which of these many sequences, aside from specifically disclosed SEQ ID NOs and regions (see instant specification Table V, for example), would have the required activity.
Regarding 85% identity, the specification states that “A person skilled in the art will understand that the remaining 15% or fewer amino acids along the length of the polypeptide of SEQ ID NO: 6, or SEQ ID NO: 7, or SEQ ID NO: 8, or SEQ ID NO: 9 according to the invention is variable due to, for example, synonymous or silent effects of particular amino acid residues exchanged at various sequence positions, compensation effects of amino acid residue pairs exchanged at various sequence positions, etc.” (see instant specification p. 9). However, it is not clear which 15% of amino acids can vary while maintaining any protein activity, or which 15% of amino acids may vary and result in improved properties as claimed. Regions disclosed as important for activity, for example positions 223-229 or 146-165, are modified in SEQ ID NOs: 6 and 7 relative to SEQ ID NO: 1 (see instant specification p. 4). However, it is not clear which additional residues could be modified in SEQ ID NOs: 6 and 7 to arrive at a sequence with 85% identity and having the claimed functional improvements.
Given the large number of potential sequences, the disclosed sequences are not representative of the entire genus of sequences that are 85% identical to SEQ ID NO: 6 with improved properties as claimed. For this reason, it is not clear that applicant was in possession of the full scope of the invention at the time of filing.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
The term “improved” in claim 1 is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how a polypeptide would be determined to have improved properties, particularly what the polypeptide is being compared to in order to determine an improvement. “Suppressed product inhibition” as set forth in the specification “denotes the ratio of the Michaelis constant (Km) and the product inhibition constant (Kp) that is decreased at least 10-fold or at least 1.6 fold” (see instant specification p. 8). However, it is not clear how this decrease is determined, i.e. a decrease in comparison to what? For this reason, the scope of claim 1 is unclear.
Claim 2 is included in this rejection because it depends on a rejected claim and does not clarify the issue.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schenkmayerova et al., Nature Communications. 2021 Jun 14; 12(1):3616, as evidenced by NCBI PDB ID 6S97.
Regarding claim 1, Schenkmayerova teaches a coelenterazine-utilizing luciferase polypeptide AncFT, which has a sequence that is 100% identical to residues 12-305 of SEQ ID NO: 6 (see NCBI ref. PDB ID 6S97; Fig. 4; see sequence alignment in OA appendix). Schenkmayerova teaches that the AncFT polypeptide, which is modified from the polypeptides RLuc8 and ancestral AncHLD-RLuc, has weaker product inhibition, i.e. suppressed product inhibition, compared to RLuc8 (p. 7 first partial para. and first full para.).
Regarding claim 2, Schenkmayerova teaches a coelenterazine-utilizing luciferase polypeptide AncFT, which has a sequence that is 100% identical to SEQ ID NO: 6 (see sequence alignment in OA appendix).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaloupkova et al., ACS Catalysis. 2019 Apr 15;9(6):4810-23, as evidenced by NCBI PDB ID 6G75.
Regarding claim 1, Chaloupkova teaches a coelenterazine-utilizing luciferase polypeptide AncHLD-RLuc, which has a sequence that is 94.3% identical to instant SEQ ID NO: 6 (see NCBI ref. PDB ID 6G75; p. 4817 para. 4; see sequence alignment in OA appendix). Regarding the limitation “exhibiting at least one improved property selected from suppressed product inhibition”, this is a functional limitation of the claimed polypeptide. Any polypeptide having the claimed structure, i.e. at least 85% identity to SEQ ID NO: 6, must necessarily have this same function, absent any unclaimed essential features. Therefore, it is considered that the polypeptide of Chaloupkova would have the function of suppressed product inhibition. Further, Chaloupkova teaches that AncHLD-RLuc has greater thermal stability than LinB and RLuc8 (Chaloupkova p. 4815 para. 2).
Conclusion
Claims 1-2 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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