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 .
Status of the Application
Applicants’ entry into the TrackOne program as of 18 March 2026 is acknowledged.
The claims of 9 September 2025 are entered.
The election of 16 June 2026 is acknowledged.
Claims 1-20 are pending. Claims 11-14 and 16-20 are withdrawn without traverse. Claims 1-10 and 15 are being examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10 and 15) and SEQ ID NO: 19 in the reply filed on 16 June 2026 is acknowledged.
Claims 11-14 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 16 June 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection 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.
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.
Claims 1-10 and 15 are 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.
The claims are directed to a light-activated channel comprising a channelrhodopsin comprising SEQ ID NO: 1. This compound has adequate written description. However, the claim also encompasses variants, including where 1-23 residues are truncated at the N-terminus, 90-189 residues are truncated at the C-terminus, a combination of the N- and C-terminal truncations, and a protein where 70-99% sequence identity is present to any of the N, C-, and N- and C-terminal truncations. These options lead to questions of written description.
SEQ ID NO: 1 is a 432 amino-acid long protein. The truncations allow for significant variability. Claim 1 still contains language that implies function in that the resulting variant still must be light-activated. It is not clear that any deletion up to residue 23 of the N-terminus, up to 198 residues at the C-terminus, or combinations of both of those still allow for light-activation. The 70-99% sequence identity adds in further variability with no clear indication that any alterations still maintain light-activation. For instance, a 70% identity to a 1 residue truncation to SEQ ID NO: 1 at the N-terminus allows for 128 alterations. Collectively, the possibilities encompassed by the 70-99% identity threshold allows for many millions of possible variants to read upon the claims.
The disclosure offers four N-terminal truncations: deletions of 5, 10, 15, and 24 residues (NCR1 e1, e2, e3, and e4). Six c-terminal truncations are disclosed: deletions of 102, 126, 149, 159, 179, and 190 residues (NCR e5, e6, e7, e8, e9, and 10). Nine combinations were produced (NCR1 e11, e12, e13, e14, e15, e16, e17, e18, and e19).
In total, this covers a tiny fraction of the possible variants as claimed, not even considering the options for proteins with variable identity to the truncated proteins.
There is no clear understanding of protein structure/function relationship that allows one of ordinary skill in the art to alter protein sequences with a knowledge of resulting function outside of physical experimentation on the altered protein. Fenton et al. Med. Chem. Res. 29:1133-1146 indicate that while it is known that alterations at conserved positions generally abolish protein function, alterations at non-conserved positions can equally impact protein function. Fenton discuses that these so-called rheostat positions have unpredictable outcomes on activities and specificities of protein-based drugs. Introduction of multiple mutations in a single protein is generally less predictable such as discussed in Guo et al Proc. Nat. Acad. Sci. 101:9205-9210, which indicates that effects of mutations on proteins are largely additive in nature (see e.g. p.9207).
In the instant application the Applicants have shown possession of a limited number of species from a wide genus. The genus is extensive, and the art indicates that alteration of protein sequences is unpredictable with respect to retaining function post-mutation.
MPEP 2163 II. A. 3. (a) ii) states for written description of a genus:
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 (see i)(A) above), reduction to drawings (see i)(B) above), 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 inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
MPEP 2163 also states:
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
In this case, the skilled artisan is presented with a very large genus of compounds in claim 1. As noted above, the skilled artisan would only recognize possession of a limited number of N-terminal, C-terminal, and N- and C-terminal truncations. There is no clear possession of any variants with alterations in the 70-99% identity range. There is no clear structure-function relationship established that reasonably allows one of ordinary skill in the art to alter amino acids in the sequence without potentially disrupting the light-activation required of the protein. The art casts doubt on altering protein sequences without significant structure-function data in hand. Collectively, the skilled artisan would not determine that the Applicants were in possession of sufficient representative species to justify the genus as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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