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 .
This is a Final Office Action in response to amendment filed on 07/072026.
Claim Status
Claims 1-2, 4, 6, 9, 14-15, 18, 20-21, 23, 25-28, 32, 34-37, 39, and 42 are pending. Claims 1-2, 4, 6, 9, 14-15, 20-21, 23, 25, 27-28, 32, and 39 are currently amended. Claims 1-2, 4, 6, 9, 14-15, 18, 20-21, 23, 25-28, 32, 34-37, 39, and 42 are examined on the merits.
Response to applicant’s Remarks Regarding the Restriction Requirement
Applicant states that it understands the restriction requirement mailed November 24, 2025 to have been withdrawn because all pending claims were examined on the merits.
Applicant’s understanding is correct. The restriction requirement mailed November 24, 2025 is hereby withdrawn.
Response to Amendment
The rejection of Claims 1-2, 4, 6, 9, 14-15, 18, 20-21, 23, 25-28, 32, 34-37, 39, and 42 rejected under 35 U.S.C. 112(b) are withdrawn in view of amendment to the claims.
The rejection of Claims 1-2, 4, 6, 9, 14-15, 18, 20-21, 23, 25-27, 32, 34-37, 39, and 42 rejected under 35 USC § 102(a)(1) is withdrawn in view of amendment to the claims.
The rejection of Claim 28 rejected under 35 USC § 103 is withdrawn in view of amendment to the claims.
The rejection under 35 U.S.C. 112(a) is maintained and modified in view of Applicant’s amendment to the claims.
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.
Written Descriptions
Claim 1-2, 4, 6, 9, 14-15, 18, 20-21, 23, 25-28, 32, 34-37, 39, and 42 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 Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
Claims 1-2, 4, 6, 9, 14-15, 18, 20-21, 23, 28, 32, 35, 39, and 42, and dependent claims 25-27, 34, 36, and 37 are directed to a modified plant LysM receptor polypeptide. Under The broadest reasonable interpretation consistent with the specification, the recited term “plant LysM receptor polypeptide” encompasses plant receptor-like kinases having extracellular LysM motifs together with transmembrane and juxtamembrane (JM) domains and is not limited to the particular NFR1 and CERK6 receptor constructs exemplified in the specification. The claims therefore encompass numerous LysM receptor subclasses from different plant species, including receptors having different sequence backgrounds and biological functions, unless otherwise limited by the claimed language. As described in the specification (paragraph 0005-0006), plant LysM receptors are receptor-like kinase comprising an extracellular domain containing LysM motifs, a transmembrane domain, a juxtamembrane (JM) domain.
Applicant amended the claims to require one or more insertion, deletion, or substitutions at amino acid residues corresponding to M306, A308, or K320 of SEQ ID NO: 1, or T304, D306, or T318 of SEQ ID NO: 8. These amendments narrow the claimed modifications to one or more aamino acid residues corresponding to spedified positions withing JM zone 4. However, the amendments do not limit the identity of the underlying plant LysM receptor polypeptide or otherwise restrict the claims to the specific receptor constructs disclosed in the specification.
However, the claims continue to encompass modification of those corresponding positions across a broad genus of plant LysM receptor polypeptides, including numerous receptor subclasses, numerous receptor sequence backgrounds, multiple plant species, conservative substitutions, and numerous modified receptors beyond the specifically exemplified embodiments.
The specification provides specific and limited examples of modified LysM receptors, inducing: chimeric receptor constructs involving domain swaps between NFR1 and CERK6 transmembrane JM regions (example 1); identification of JM zone 4 as a determinant of symbiotic signaling (example 1); individual amino acid substitutions within JM zone 4, such as M306, A308, K320 and related residues, and their effects on nodulation (example 3); combinatorial substitutions, such as M306T/A308D/K320T, affecting signaling outcomes (example 4); and limited gain-of-function substitutions showing partial restoration of signaling (examples 5-6).
Although the amendments now identify specific residue positions, the functional disclosure remains centered primarily on NFR1, CERK6, and closely related receptor constructs.
The specification does not provide a representative number of species spanning the structural diversity encompassed by the claimed genus, nor does it identify common structural features or a structure-function correlation that would distinguish the claimed functional receptors form other members of the claimed genus.
Under the above claim construction, the claims continue to encompass: any second LysM receptor as a source of amino acids for JM zone 4 modification; and numerous possible modifications across JM zone 4, including sing-residue, multi-residue, insertion, deletion, and substitution variants, tied to multiple functional outcomes.
Although the claims are narrower than previously examined, the structural diversity of modified receptors encompassed by the claims remains substantially broader than the limited embodiments actually described and functionally characterized in the specification.
Plant LysM receptors comprise a structurally related but functionally diverse class of receptor-like kinases, including symbiotic receptors (e.g., NFR1/NFR5) and immune receptors (e. g., CERK-type receptors), which mediate distinct signaling pathways (e.g., Cyril Zipfel et. al., NATURE (2017|) VOL 543 pp328-336) (page 331-332, Fig. 3, The formation of ligand-induced receptor kinase complexes and the role of regulatory receptor kinases). Antolín-Llovera (Meritxell Antolín-Llovera et. al., New Phytologist (2014) 204: 791–80) (Abstract, and page 796 left column) and Bigeard (Jean Bigeard et. al., Molecular Plant (2015) 8, 521–539) (page 528, left column paragraph 2) further demonstrates that receptor signaling depends on domain context and specific residue interactions, and that domain swaps or mutations may alter, abolish, or fail to confer signaling.
Accordingly, although the specification identifies particular residues as important within the disclosed NFR1/CERK6 receptor system, it does not establish a common structural principle demonstrating that corresponding modifications at those positions across the numerous claimed receptor backgrounds constitute a common structural feature correlated with the claimed signaling activities throughout the claimed genus.
While the specification identifies certain residues as important in the particular context of the exemplified receptors, such as M306, A308, and K320, it does not establish a general structural principle applicable across: some substitutions impair signaling; some combinations are required; some constructs fail to restore signaling; receptor background affects function.
These disclosed experimental results demonstrate that signaling depends upon the particular receptor sequence, the identity of the substituted amino acids, and the combination of substitutions. The amendments identifying M306, A308, K320, T304, D306, and T318 do not establish that the inventors possessed modifications of the corresponding residues throughout the full breadth of the claimed receptor genus.
Accordingly, the specification does not establish that modification of the recited corresponding residues will identify a common structural characteristic linking the claimed signaling activity throughout the full scope of the claimed genus.
Accordingly, although Applicant amended the claims to recite specific corresponding amino acid positions, the claims continue to encompass numerous plant LysM receptor polypeptides, receptor subclasses, sequence backgrounds, conservative substitutions, and modified receptors beyond those specifically described.
The speciation provides functional characterization primarily for NFR1/CERK6-based constructs. These disclosed embodiments do not constitute a representative number of species for the claimed genus, nor does the specification identify structural characteristics common to the claimed members that would reasonably convey possession of the entire claimed genus.
Therefore, when the claims are construed under their broadest reasonable interpretation, the specification does not reasonably convey to one of ordinary skill in the art that the inventors were in possession of the full scope of the claimed invention as amended.
Response to Applicant’s Remarks Regarding Written Description
Applicant argues that paragraph 0166, Figures 5A, 14C, 17B, and 23A-23L provide sufficient structural criteria and sequence conservation to demonstrate possession of the claimed genus of modified plant LysM receptor polypeptides. Applicant further argues that the amendments requiring modification of residues correspond to M306, A308, or K320 of SEQ ID NO: 1, or T304, D306, or T318 of SEQ ID NO: 8, overcome the written-description rejection.
The arguments has been considered but are not persuasive. The examiner acknowledge that paragraph 0116 describes general LysM receptor architecture and that the cited figures provide sequence alignments and identify conserved residues. However, identification of receptor architecture, sequence correspondence, or conservation does not, by itself, demonstrate possession of the full genus of modified receptors encompassed by the claims.
Although the amendments narrow the positions at which JM zone 4 is modified, the claims continue to encompass modification of those corresponding positions in numerous plant LysM receptor sequence backgrounds, receptor subclasses, plant species, and conservatively substituted variants. The specification provides functional data primarily for NFR1, CERK6, and a limited member of related constructs, but does not provide a representative number of functionally characterized species across the breadth of the claimed genus.
Further, the disclosed results demonstrate that signaling depends on the particular receptor background, the identity of the substituted residue, and the combination of substitution. Thus, the specification does not establish a common structural principle or structure-function correlation showing that modification of the recited corresponding positions will provide the claimed signaling properties across the full scope of the claims.
Accordingly, the amendments and cited disclosure do not overcome the written-description rejection, which is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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/YANXIN SHEN/ Examiner, Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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