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 Claims
Claims 2, 5-10, and 16-34 are canceled.
Claims 1, 3-4, 11-15, and 35-37 are pending.
Claims 11-15 are withdrawn from consideration.
Claims 1, 3-4, and 35-37 are examined herein.
Claims 1, 3-4, and 35-37 are rejected.
Priority
Application No. 17/786,117 filed on 04/15/2024 is a 371 of PCT Application No. PCT/US20/65472 filed on 12/17/2020, which claims benefit to provisional Application No. 62/949,574 filed on 12/18/2019.
Claim Interpretation
Claim 35 recites “The method of claim 30, wherein the targeted genetic modification is an expression modulating element (EME).” An expression modulation element (EME) is not explicitly defined in the instant disclosure. An EME is broadly reasonably interpreted as any targeted genetic modification that modulates gene expression.
Claim 36 recites “moderative constitutive promoter”. This term is not defined in the instant disclosure. A moderative constitutive promoter is broadly reasonably interpreted as any constitutive promoter.
Claim Objections
This is a new objection, necessitated by Applicant’s amendments.
Claims 1 and 4 are objected to because of the following informalities: The claims have been amended to recite “…comprising an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NO: 1”. However, because Applicant has deleted all other sequence identifiers from the group in the claims, there is only a single sequence identifier remaining and no longer a “group” to select from. Applicant should amend the claim more appropriately reflect this. For example, the claim(s) should recite “…comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 1”, or another equivalent. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-4, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US-20160251673-A1), and as evidenced by Cao (Cao, Y., Qu, J., Yu, H., Yang, Q., Li, W., & Fu, F. (2022). Genomic Characteristics of Elite Maize Inbred Line 18-599 and Its Transcriptional Response to Drought and Low-Temperature Stresses. Plants, 11(23), 3242.).
This is a modified rejection from the previous rejection set forth in the Office Action dated 12/16/2025, necessitated by Applicant’s amendments.
Claim 1 is drawn to a method for increasing grain yield in an elite maize plant, the method comprising: a. introducing in a regenerable plant cell a targeted genetic modification at a genomic locus that encodes a BG1 polypeptide comprising an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NO: 1; and b. generating the plant, wherein the level and/or activity of the encoded polypeptide is increased in the plant.
Claim 3 is drawn to the method of claim 1, wherein the targeted genetic modification is introduced using a genome modification technique selected from the group consisting of a polynucleotide-guided endonuclease, CRISPR-Cas endonucleases, base editing deaminases, a zinc finger nuclease, a transcription activator-like effector nuclease (TALEN), engineered site-specific meganucleases, or Argonaute.
Claim 4 is drawn to the method of claim 1, wherein the targeted genetic modification is present in (a) the coding region; (b) a non-coding region; (c) a regulatory sequence; (d) an untranslated region; or (e) any combination of (a)-(d) of the genomic locus that encodes a polypeptide comprising an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NO: 1.
Claim 35 is drawn to the method of claim 1, wherein the targeted genetic modification is introduction of an expression modulating element (EME).
Claim 36 is drawn to the method of claim 1, wherein the targeted genetic modification is insertion of a moderative constitutive promoter.
Claim 37 is drawn to the method of claim 1, wherein the targeted genetic modification is insertion of a moderative constitutive promoter designated maize GOS2.
Regarding claim 1, Chu teaches an invention related to BG1 compositions and methods to increase agronomic performance of plants (title), and teaches increased expression of BG1 results in increased grain size and yield (abstract). Chu teaches methods of improving yield of a plant include increasing the expression of a polynucleotide that encodes a polypeptide comprising the amino acid sequence selected from the group consisting of SEQ ID NOS: 1 or 4-27 (¶0011, 0032) which includes SEQ ID NO: 14, and SEQ ID NO: 14 of Chu originates from maize and has 100% identity to instant SEQ ID NO: 1 (see alignment below). Chu further teaches preferred plants containing the polynucleotides of the present disclosure include maize (¶0045, 0067, 0085).
However, Chu does not explicitly teach in a single embodiment:
a targeted genetic modification is introduced at a genomic locus encoding a BG1 polypeptide comprising an amino acid sequence that is at least 95% identical to an amino acid sequence of SEQ ID NO: 1; and the maize plant is an elite maize plant (remaining limitation of claim 1)
wherein the targeted genetic modification is introduced using a genome modification technique selected from the group consisting of a polynucleotide-guided endonuclease, CRISPR-Cas endonucleases, base editing deaminases, a zinc finger nuclease, a transcription activator-like effector nuclease (TALEN), engineered site-specific meganucleases, or Argonaute (claim 3).
wherein the targeted genetic modification is present in (a) the coding region; (b) a non-coding region; (c) a regulatory sequence; (d) an untranslated region; or (e) any combination of (a)-(d) of the genomic locus that encodes a polypeptide comprising an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NO: 1 (claim 4)
wherein the targeted genetic modification is an expression modulating element (EME) (claim 35)
wherein the targeted genetic modification is insertion of a moderative constitutive promoter (claim 36)
wherein the targeted genetic modification is insertion of a moderative constitutive promoter designated maize GOS2 (claim 37)
Regarding the remaining limitations of claims 1 and 3, Chu teaches in an alternative embodiment the CRISPR/Cas system allows targeted cleavage of genomic DNA, and based on the disclosure of the BG1 coding sequences, polypeptide sequences of the orthologs/homologs and the genomic DNA sequences, site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the BG1 polypeptide or an ortholog thereof (¶0152).
Regarding claim 4, Chu also teaches in general, methods to modify or alter the host endogenous genomic DNA are available and includes altering the host native DNA sequence or a pre-existing transgenic sequence including regulatory elements, coding and non-coding sequences.
Regarding claim 35, because Chu teaches CRISPR site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the endogenous BG1 polypeptide or an ortholog thereof (¶0152), this targeted genetic modification described by Chu is broadly reasonably interpreted as an expression modulating element (see claim interpretation above).
Regarding claim 36, Chu teaches in an alternative embodiment overexpressing BG1 in rice using an expression vector that drives BG1 cDNA under the control of the rice ACTIN promoter, as well as overexpressing OsBG1 in Arabidopsis under control of the cauliflower mosaic virus 35S promoter (35S) (¶0175) (i.e. rice ACTIN1 and CaMV 35S are constitutive promoters). Chu teaches in both instances grain/seed size increased (¶0175). Chu also teaches in general, methods to modify or alter the host endogenous genomic DNA are available, and includes altering the host native DNA sequence or a pre-existing transgenic sequence including regulatory elements (i.e. the promoter) (¶0152).
Regarding claim 37, Chu teaches in an alternative embodiment suitable constitutive promoters include for example, Ubiquitin promoters, actin promoters, and GOS2 promoter (¶0095).
Chu teaches all of the limitations of the rejected claims in alternative embodiments, but does not disclose a single embodiment having all the limitations. As such, the claims are not rejected as anticipated under 35 USC §102 but are instead rejected as obvious under 35 USC §103. One of ordinary skill in the art would have been motivated to combine the limitations as taught by Chu into a single embodiment to arrive at Applicant’s claimed inventions because Chu explicitly teaches that increased expression of the identical maize-originated BG1 sequence increases yield in plants, and a preferred plant of interest to express the sequence(s) of Chu’s invention is maize (¶0011, 0032, 0045, 0067, 0085). Additionally, Chu explicitly teaches in working examples constitutive promoters can be used to increase BG1 expression in various plant species, and methods are known in the art to increase endogenous BG1 expression (¶0095, 0175, and 0152). Because each limitation is explicitly taught as an alternative embodiment of the invention, it would be prima facie obvious to combine the methods into a single embodiment for the purpose of expressing a higher level of the endogenous BG1 polypeptide in maize by using, e.g., CRISPR to insert a constitutive promoter such as those that are instantly claimed in a noncoding region upstream the endogenous and known BG1 sequence to increase yield in maize. One having ordinary skill in the art would have a reasonable expectation of success because Chu acknowledges using systems such as CRISPR to perform site-directed mutagenesis to increase endogenous BG1 expression can be readily performed based on the disclosure, as well as are available in general. That is, inserting known constitutive promoters upstream genes to increase expression is routine in the art and could be achieved by one of ordinary skill in the art without encountering any special technical difficulties. Furthermore, as evidenced by Cao, elite maize lines are termed elite because they have elite agronomic characteristics, wide adaptability, good quality, and high reproductive capacity (p. 1, ¶1). Because elite maize lines have these traits, it would have been both obvious and routine in the art to for Chu to specifically use elite maize plants in order to improve yield in an agronomically important and desirable plant such that this plant could be used as a parent plant for the development of hybrids having increased yield (Cao, Page 1, Introduction, First Full Paragraph).
Alignments
Alignment of instant SEQ ID NO: 1 (Qy) with SEQ ID NO: 14 taught by Chu (Db):
ALIGNMENT:
Query Match 100.0%; Score 1605; Length 316;
Best Local Similarity 100.0%;
Matches 316; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
Qy 61 HQDLHYSYYYKTSLAGSYRGSRAAAAAHAATTTSSSSECSSYGGFSSSEAESSQHRRLRP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HQDLHYSYYYKTSLAGSYRGSRAAAAAHAATTTSSSSECSSYGGFSSSEAESSQHRRLRP 120
Qy 121 IRTSVGAAASPAPAPEKKKKAGANIRAKLRDLRKPASPGARLAGFLNTIFSGRRAPATPP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IRTSVGAAASPAPAPEKKKKAGANIRAKLRDLRKPASPGARLAGFLNTIFSGRRAPATPP 180
Qy 181 SRGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAAAAAPGGERRRVQVGV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SRGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAAAAAPGGERRRVQVGV 240
Qy 241 AELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPDAAAAYRDELPVYETTRV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPDAAAAYRDELPVYETTRV 300
Qy 301 VLGHRAIGHGRSARVV 316
||||||||||||||||
Db 301 VLGHRAIGHGRSARVV 316
DUPLICATES:
US-14-910-437B-14
Filing date in PALM: 2016-02-05
Sequence 14, US/14910437B
Publication No. US20160251673A1
GENERAL INFORMATION
APPLICANT: INSTITUTE OF GENETICS AND DEVELOPMENTAL BIOLOGY CHINESE
APPLICANT: ACADEMY OF SCIENCES
TITLE OF INVENTION: BG1 COMPOSITIONS AND METHODS TO INCREASE AGRONOMIC PERFORMANCE OF
TITLE OF INVENTION: PLANTS
FILE REFERENCE: RTS16139C
CURRENT APPLICATION NUMBER: US/14/910,437B
CURRENT FILING DATE: 2016-05-17
PRIOR APPLICATION NUMBER: CN201310343713.3
PRIOR FILING DATE: 2013-08-08
NUMBER OF SEQ ID NOS: 75
SEQ ID NO 14
LENGTH: 316
TYPE: PRT
ORGANISM: Zea mays
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4, and 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8, 17-19,and 30 of copending Application No. 17/786,137 in view of Chu (US-20160251673-A1).
This is a modified rejection from the previous rejection set forth in the Office Action dated 12/16/2025, necessitated by Applicant’s amendments.
The copending application is drawn to a method of increasing yield of a plant, the method comprising increasing the expression of a polynucleotide encoding an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51 ,53, and 55 in a plant, wherein the polynucleotide is operably linked to a heterologous regulatory element; and growing the plant in a crop growing environment. The copending application is further drawn to the same instantly claimed plants, and also wherein the regulatory element is a moderative constitutive heterologous promoter including a maize GOS2 promoter. The copending application also teaches the plants are maize plants.
However, the copending application is not explicitly drawn to a targeted modification in the genomic locus encoding a BG1 polypeptide.
In analogous art, Chu teaches an invention related to BG1 compositions and methods to increase agronomic performance of plants (title), and teaches increased expression of BG1 results in increased grain size and yield (abstract). Chu teaches methods of improving yield of a plant include increasing the expression of a polynucleotide that encodes a polypeptide comprising the amino acid sequence selected from the group consisting of SEQ ID NOS: 1 or 4-27 (¶0011, 0032) which includes SEQ ID NO: 14, and SEQ ID NO: 14 of Chu has 100% identity to instant SEQ ID NO: 1 and SEQ ID NO: 1 of the copending application. Chu teaches in an alternative embodiment overexpressing BG1 in rice using an expression vector that drives BG1 cDNA under the control of the rice ACTIN promoter, as well as overexpressing OsBG1 in Arabidopsis under control of the cauliflower mosaic virus 35S promoter (35S) (¶0175) (i.e. rice ACTIN1 and CaMV 35S are constitutive promoters). Chu teaches in both instances grain/seed size increased (¶0175). Chu also teaches in general, methods to modify or alter the host endogenous genomic DNA are available, and includes altering the host native DNA sequence or a pre-existing transgenic sequence including regulatory elements (i.e. the promoter) (¶0152). Chu teaches the CRISPR/Cas system allows targeted cleavage of genomic DNA, and based on the disclosure of the BG1 coding sequences, polypeptide sequences of the orthologs/homologs and the genomic DNA sequences, site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the endogenous BG1 polypeptide or an ortholog thereof (¶0152).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention taught by Chu to combine the limitations to arrive at the instantly claimed method of inserting a constitutive promoter at a genomic locus encoding a BG1 polypeptide with a reasonable expectation of success because Chu teaches in one embodiment using a recombinant expression vector that overexpressed BG1 driven by a constitutive promoter increased grain size, and teaches in an alternative embodiment CRISPR can be used to alter endogenous DNA sequences including regulatory sequences (i.e. promoter sequences), and insertion of the constitutive promoters, including a maize GOS2 promoter, taught by Chu upstream the endogenous BG1 sequence using targeted modification methods such as CRISPR could be achieved by one of ordinary skill in the art without encountering any special technical difficulties. One having ordinary skill in the art would have been motivated to combine the teachings into a single embodiment for the same purpose of overexpressing BG1 to increase grain size and yield (abstract).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues beginning on p. 4 of remarks dated 05/12/2026 the
following arguments:
Claim Interpretation
The Office Action states at page 3, that an expression modulation element (EME) is not explicitly defined in the instant disclosure. Support for claim 35 is found in the specification in at least Figure 10 and Example 8. Claim 35 is amended to read on a method wherein the targeted genetic modification of claim 30 is introduction of an EME. For example, the Application (as filed and published), states:
[0182] In an embodiment, the gene edit design for the 2x ZM-AS2 EME elements are expected to be inserted at -20 and -46 from the TATA box. In an embodiment, the gene edit design for the 2x ZM-AS2 EME elements are expected to be inserted at -46 and
-72 from the TATA box of the ZM-BG1H1 Locus.
[0183] The ZM-BG1H1 promoter was modified to include 1, 2 or 3 copies of an EME (Expression Modulating Element) (insertion of an expression modulating element (EME), such as an EME described in PCT/US2018/025446, in operable linkage with the BG1 gene, incorporated herein by reference), that has been shown to increase the net transcriptional expression of various genes when placed in the proximal promoter.
Three separate locations, at -20, -46 and -72 nts relative to the TATA box were used.
[0184] Gene editing design map for engineering promoter motifs were developed.
Design of the gene editing experiment on the ZM-BG1H1 promoter region to emplace two 'EME' (expression modulating element) motifs, one at -20 nts and one at -46 nts
relative to the TATA box.
The claim phrase expression modulating element (EME) has adequate support and provides clarity for a POSA as to the meets and bounds. Therefore, Applicant requests the Examiner to adopt an interpretation that is consistent with the disclosure and withdraw any applicable objection.
Examiners response:
An “expression modulation element (EME)” is not explicitly defined in the specification. It is clear throughout the specification that the EME referenced above and in ¶0182-0186 is one example of an EME, however what may be considered an “expression modulation element” is not limited by this singular example. For this reason, the broad, reasonable interpretation is maintained. If Applicant does not intend for the term “expression modulation element (EME)” to include any targeted genetic modification that modulates gene expression, Applicant should amend the claim to more clearly define what is meant by or encompassed by an EME, without inserting new matter.
Applicant argues beginning on p. 4 of remarks dated 05/12/2026 the
following arguments:
Claim Objections
The Office Action states at page 3 that should claims 1-5 be found allowable, claims 30- 34 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Claims 30- 34 are canceled and claims 35-37 are amended to depend from claim 1.
Examiners response:
In view of Applicant’s cancellation of claims 30-34 and amendments to claims 35-37, the previous objection to the claims have been withdrawn.
Applicant argues beginning on p. 4 of remarks dated 05/12/2026 the
following arguments:
Claim Rejections- 35 USC 112
Claims 1-6 and 30-37 are rejected under 35 U.S.C. § 112(a) as allegedly failing to comply with the written description requirement. Claims 2, 5-6, and 30-34 are canceled rendering the rejections moot for these claims. Applicant respectfully traverses this rejection in its entirety. As demonstrated below, the specification satisfies the written description requirement through both (1) the disclosure of a representative number of species falling within the scope of the claimed genus, and (2) the disclosure of common structural features that allow a person of ordinary skill in the art ("POSA") to visualize and recognize the members of the claimed genus. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc).
I. Legal Standard
Written description "requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." AriadPharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc) (quoting Regents of the Univ. of Cahfornia v. Eli Lilly & Co., 119 F.3d 1559, 1568-69 (Fed. Cir. 1997)). As Ariad explains, the law only requires disclosure of either representative examples (e.g., species) or common structure-not both. 598 F.3d at 1350; Ajinomoto Co., Inc. v. Int'l Trade Comm'n, 932 F.3d 1342, 1359-60 (Fed. Cir. 2019). The disclosure of "four examples of potent promoters" in Ajinomoto as a distinguishing feature because they provided guidance on methods for evaluation and strength of promoter performance, relative data, and a methodology for determining promoter strength. Id.
Furthermore, Ajinomoto held that "[a]dequate written description does not require a perfect correspondence between the members of the genus and the asserted common structural feature." Id. at 1360. The Federal Circuit in Ajinomoto rejected arguments that similarity to a consensus sequence is "not enough to predict the site and strength of a promoter from a given sequence" and found adequate written description. Ajinomoto, 932 F.3d at 1360 (explaining that the challenger's prediction-based argument assumed "too strict a legal standard"); Lifescan, PGR2019-00032, Paper 11 at 30 (rejecting argument that it would be impossible to "predict the behavior" of 5x1076 protein sequences covered by the claims because such arguments derived solely from the size of the genus rather than the factors informing a written-description analysis, including the state of the art). As the Supreme Court has explained, the "certainty which the law requires in patents is not greater than is reasonable." Amgen Inc. v. Sanofi, 598 U.S. 594, 611 (2023). Disclosed species are representative when they reflect the diversity of a claimed genus. AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014). Ajinomoto, 932 F.3d at 1359 (finding disclosure of four exemplary promoters and "background knowledge in the art" sufficient to support claims with no promoter sequence limitations). Ariad, 598 F.3d at 1352 ("[T]he written description requirement does not demand either examples or an actual reduction to practice ...."); Sandoz, PGR2022-00037, Paper 11 at 17-18, 23-24, 29 ("there is no legal requirement that a patent specification must include test results or working examples").
Applicant respectfully submits that the specification satisfies the written description requirement.
II. The Examiner's Identity Gap Argument Does Not Adequately Support the Rejection
A central basis for the Examiner's rejection is the observation that the next most similar sequence to elected SEQ ID NO: 1 found in the USPTO sequence database shares only 72.6% identity, a sequence derived from Setaria italica (foxtail millet), which is a distinct taxonomic species. The Examiner appears to use this cross-species identity gap to suggest that sequences with less than 100% identity to SEQ ID NO: 1 are insufficiently described.
Applicant respectfully submits that this reasoning does not accurately characterize the relevant comparison. The identity gap cited by the Examiner reflects the normal evolutionary divergence between maize and foxtail millet; it is not a gap within the claimed genus. The Setaria italica BG1 sequence at 72.6% identity does not fall within the claimed 95% identity threshold and is not a member of the claimed genus. Accordingly, this cross-species comparison does not speak to whether the specification adequately describes the sequences that are within the claimed genus.
The relevant question for written description purposes is whether the specification describes sequences within the 95% identity threshold in sufficient detail that a POSA can recognize the members of the claimed genus. As demonstrated below, the specification provides exactly this.
III. The Specification Discloses a Representative Number of Species
Applicant has described SEQ ID NOs: 3, 5, 7, 9, and 11 in Table 1 of the specification and in the sequence listing. Example 1 describes the BG1 gene family identification and characterization. Example 5 describes promoter analysis among the native ZM-BGH1 homologs, including a conserved TATA box context in all the genes, a conserved motif in the 5' UTRs, and 5 additional upstream conserved motifs. Example 6 describes global amino acid identity (AAID) of each of the five maize allelic ZM-BG1H1 variants which were compared to the rice BG1 homologs and showed 65.1-66.9% AAID. Simmons et al. ("Maize BIG GRAIN1 homolog overexpression increases maize grain yield." Plant Biotechnology Journal 18.11 (2020): 2304-2315) describes the five allelic variants of ZM-BG1H1 (Al-AS) of the instant application and continues their characterizations. "All five alleles presented include a complete open reading frame, with no premature truncations or obviously defective incomplete proteins. The nucleotide identities range from 94.8% to 99.3% in the CDS. The encoded proteins are all distinct, ranging from 95.4% to 99.4% ID among themselves, and to OSBG1 (65.1%-66.9% ID) and to sorghum SB-BG1 (XP_021314015.1; 77.5%-80.3% AAID; Table S5)." (Simmons et al. pg 7; Simmons et al. Suppl Data, Table S5). "...no ZMBG1H1 presence-absence and copy number variations in the maize germplasm, and that while the ZM-BG1H1 locus harbours multiple (at least 5 major) allelic structural variations, there are no apparent large functional differences among these alleles in either protein function, promoter structure or gene expression." (pg 8-9) The ZM-BG1H1A1-A5 alleles of the instant application are all within 95% sequence identity of SEQ ID NO: 1 and represent a distinct class of sequences which is disclosed in the specification and summarized in Table 1 below.
Further evidence for the class is shown in Fig 1 which shows a dendrogram of the ZM- BG1 sequences disclosed in the instant application. SEQ ID NOs: 1, 3, 5, 7, 9, and 11 are represented in their own grouping in the dendrogram.
Accordingly, the six disclosed species provide an adequate representative sampling of the claimed genus. This type of disclosure is consistent with the guidance in Ajinomoto, 932 F.3d at 1359, where the Federal Circuit found that disclosure of four exemplary promoters and background knowledge in the art was sufficient to support claims with no promoter sequence limitations.
IV. The Specification Discloses Common Structural Features
Beyond the representative species, the specification independently satisfies the written description requirement through disclosure of common structural features that enable a POSA to visualize and recognize members of the claimed genus.
As noted above, the specification, in conjunction with Simmons et al. Supplemental Fig. 8, discloses the amino acid alignment of the ZM-BG1H1 Al-AS alleles with conserved residues identified. Simmons et al. further characterized the seven variant peptide regions among the five alleles and compared each variant region against Poaceae BG1 homolog representatives, concluding that these variant regions are similarly variable across species. This analysis identifies both the conserved structural core of the ZM-BG1H1 proteins and the regions where variation is tolerated without loss of function.
In addition, the dendrogram demonstrates that SEQ ID NOs: 1, 3, 5, 7, 9, 11, and related sequences occupy a discrete, phylogenetically defined cluster that is clearly distinguished from the rice OsBG1 proteins (65.1-66.9% AAID), sorghum SbBG1 proteins (77.5-80.3% AAID), and other more distantly related sequences. A POSA skilled in plant molecular biology is readily able to use this clustering, combined with the conserved structural features identified in the specification and in Simmons et al., to identify whether a given sequence is a member of the claimed ZM-BG1H1 genus. The Office Action has not pointed any evidence to the contrary as to why a POSA would not be able to do so.
Furthermore, the specification describes conserved promoter motifs, including a well- defined TATA box (CTATATCTTC) and six additional conserved elements, that are shared across all five alleles and across multiple species' BG1 homologs, suggesting these features are relevant for conserved function. The specification's disclosure of these conserved features, at both the protein and regulatory levels, further supports a POSA's ability to recognize members of the claimed genus.
This type of structural feature disclosure is consistent with the standard articulated in Ajinomoto, 932 F.3d at 1360, which held that identification of common structural features common to genus members is sufficient for written description, even without perfect correspondence among all members.
V. The Amended Claim 1 Aligns the Claims with the Described Genus
Applicant notes that claim 1 has been amended to require at least 95% amino acid identity to SEQ ID NO: 1. ZM-BG1H1 alleles share 95.4-99.4% amino acid identity among themselves (see e.g., Fig. 1 and accompanying description in paragraph [0176] and other sections). At 95% identity, the claimed genus corresponds are well-supported by the sequences that are disclosed, characterized, and functionally described in the specification and supporting literature.
For all of the foregoing reasons, Applicant respectfully submits that the specification satisfies the written description requirement of 35 U.S.C. § 112(a) for amended claims 1, 3, 4, and 35-37 and respectfully requests that the written description rejection be withdrawn.
Examiners response:
In view of Applicant’s amendments that narrow the claims (from at least 90%) to require a least 95% sequence identity to SEQ ID NO: 1, and also in view of Zm-BG1 variants in the instant disclosure that have at least 95% identity to SEQ ID NO: 1, the rejection under 35 USC 112(a) has been withdrawn.
Applicant argues beginning on p. 4 of remarks dated 05/12/2026 the
following arguments:
Claim Rejections- 35 USC 103
Claims 1-6 and 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US-20160251673-A1). Claims 2, 5-6, and 30-34 are canceled.
Claims 1 is amended to read as a method for increasing grain yield in an elite maize plant, the method comprising: introducing in a regenerable plant cell a targeted genetic modification at a genomic locus that encodes a BG1 polypeptide comprising an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NO: 1.
The specification lists several agronomic traits that showed increased values. See e.g., paragraphs [0108], [0109], Table 4, and Figures 3, 4, and 5. Furthermore, Chu does not disclose an elite plant comprising a targeted genetic modification in a nucleic acid encoding BG1. Support for this amendment can be found in Example 8 of the specification.
Global amino acid identity (AAID) of each of the five most common maize allelic ZM-BG1H1 variants were compared to the rice BG1 homologs and showed 65.1-66.9% AAID (Example 6, page 38). Chu does not demonstrate any experimental data for increase expression of BG1 resulting in increased agronomic parameters in maize. Chu is limited to recombinant overexpression of BG1 driven by the rice ACTIN1 promoter in a transgenic rice plant. To further prosecution, Applicant has amended claim 1 with the specific agronomic traits. Support can be found at least in paragraphs [0108], [0109], Table 4, and Figures 3, 4, and 5 of the specification. Given the % amino acid identity of the pending claims are focused for a specific genus, Examiner's primary reliance on Chu (whose rice BG1 is only about 66% identical to the claimed maize genus) is overcome by applicant.
Example 5 of Chu describes the rice BG1 as a primary auxin response gene, showing that rice BG1 can be induced by 3 auxin compounds. Chu further states that these results were consistent with two auxin responsive element (TGTCTC) found within 1500 nts upstream of the rice BG1 translational start site. In contrast to this observation in rice, Example 5 of the instant application states "furthermore, the 5 auxin response motifs are not among or overlapping any of these 7 conserved motifs: ACTTTA, TGACG, CATATG were found in only some promoters; TGTGNN and NNGACA were found in multiple locations suggesting non-specificity; and CACGCAAT and KGTCCCAT were not found at all." (Example 5).
"Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination." Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (citing KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). "Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention." Unigene, 66 F.3d at 1360 (citing KSR 550 U.S. at 421). In this case, the Office Action has not articulated some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of skill in the art, to make the modification or combinations alleged in the rejection. See M.P.E.P § 2143(1)(G).
Chu does not teach or suggest that a targeted genetic modification at a genomic locus that encodes SEQ ID NO: 1 results in improved agronomic traits such as increased ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume, or total kernel number. Thus, Chu does not teach or suggest the claimed invention. One of ordinary skill in the art would therefore not have expected the results yielded by the claimed invention, which further demonstrates that the claims are non-obvious. Applicant respectfully requests that the obviousness rejection be withdrawn.
Examiners response:
Applicant’s argument has been fully considered and is not found persuasive.
Applicant first argues Chu does not disclose an elite plant comprising a targeted genetic modification in a nucleic acid encoding BG1. It is first highlighted that the claim does not require a targeted genetic modification in a nucleic acid encoding BG1, but rather requires a targeted genetic modification at a genomic locus that encodes a BG1 polypeptide of which is obvious in view of Chu (see 103 above). Regarding Applicants argument the plant is not “elite”, as addressed in the modified rejection under 35 USC 103, Cao evidences elite maize lines are termed elite because they have elite agronomic characteristics, wide adaptability, good quality, and high reproductive capacity (p. 1, ¶1). Because elite maize lines have these traits, it would have been obvious and, moreover, it would have been routine in the art to for Chu to specifically use elite maize plants in order to improve yield in an agronomically important and desirable plant such that this plant could be used as a parent plant for the development of hybrids having increased yield (Cao, Page 1, Introduction, First Full Paragraph). This particular argument is not persuasive for this reason.
Next, Applicant argues:
Global amino acid identity (AAID) of each of the five most common maize allelic ZM-BG1H1 variants were compared to the rice BG1 homologs and showed 65.1-66.9% AAID (Example 6, page 38). Chu does not demonstrate any experimental data for increase expression of BG1 resulting in increased agronomic parameters in maize. Chu is limited to recombinant overexpression of BG1 driven by the rice ACTIN1 promoter in a transgenic rice plant. To further prosecution, Applicant has amended claim 1 with the specific agronomic traits. Support can be found at least in paragraphs [0108], [0109], Table 4, and Figures 3, 4, and 5 of the specification. Given the % amino acid identity of the pending claims are focused for a specific genus, Examiner's primary reliance on Chu (whose rice BG1 is only about 66% identical to the claimed maize genus) is overcome by applicant.
Despite Applicant’s argument above, Applicant has not amended claim 1 with the specific agronomic traits and the claims only generally require “increasing grain yield”. Further, this recitation of “increasing grain yield” is merely an intended use since it is only recited in the preamble, and the only limiting steps of the method are those recited in parts a) and b). Thus, all that is required by claim 1 is introducing SEQ ID NO: 1 into an elite maize plant cell, and generating the plant wherein the polypeptide encoded by SEQ ID NO: 1 is increased. These limitations are obvious in view of Chu. Chu teaches BG1 overexpression increases grain yield in various plants (title, abstract, ¶0175). Chu also teaches a maize BG1 amino acid sequence 100% identical to claimed SEQ ID NO: 1, and teaches preferred plants to express the sequences include maize, and further teaches increasing endogenous BG1 expression to achieve the aim of Chu’s invention which is increased grain size and yield (abstract). Therefore, the concept of the claimed invention is obvious in view of Chu whether or not Chu used maize in working examples.
Next, Applicant argues:
Example 5 of Chu describes the rice BG1 as a primary auxin response gene, showing that rice BG1 can be induced by 3 auxin compounds. Chu further states that these results were consistent with two auxin responsive element (TGTCTC) found within 1500 nts upstream ofthe rice BG1 translational start site. In contrast to this observation in rice, Example 5 of the instant application states "furthermore, the 5 auxin response motifs are not among or overlapping any of these 7 conserved motifs: ACTTTA, TGACG, CATATG were found in only some promoters; TGTGNN and NNGACA were found in multiple locations suggesting non-specificity; and CACGCAAT and KGTCCCAT were not found at all." (Example 5).
Regardless of the presence of auxin response elements in the native promoter of the rice and maize BG1 genes, the rice and maize BG1 polypeptides were known homologs both taught/ suggested to increase grain yield when overexpressed, and therefore overexpression of the known homologs would reasonably be expected to produce similar results. For this reason, this argument is not persuasive.
Next, Applicant argues:
Chu does not teach or suggest that a targeted genetic modification at a genomic locus that encodes SEQ ID NO: 1 results in improved agronomic traits such as increased ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume, or total kernel number. Thus, Chu does not teach or suggest the claimed invention. One of ordinary skill in the art would therefore not have expected the results yielded by the claimed invention, which further demonstrates that the claims are non-obvious.
As described in the previous response, Applicant has not amended claim 1 with the specific agronomic traits and the claims only generally require “increasing grain yield”. Further, this recitation of “increasing grain yield” is merely an intended use since it is only recited in the preamble, and the only limiting steps of the method are those recited in parts a) and b). Thus, all that is required by claim 1 is introducing SEQ ID NO: 1 into an elite maize plant cell, and generating the plant wherein the polypeptide encoded by SEQ ID NO: 1 is increased. These limitations are obvious in view of Chu. Chu teaches BG1 overexpression increases grain yield in various plants (title, abstract, ¶0175). Chu also teaches a maize BG1 amino acid sequence 100% identical to claimed SEQ ID NO: 1, and teaches preferred plants to express the sequences include maize, and further teaches increasing endogenous BG1 expression to achieve the aim of Chu’s invention which is increased grain size and yield (abstract). Therefore, the concept and limitations of the claimed invention is/are obvious in view of Chu. For this reason, Applicant’s argument that Chu does not teach or suggest that a targeted genetic modification at a genomic locus that encodes SEQ ID NO: 1 results in improved agronomic traits such as increased ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume, or total kernel number is not found persuasive.
Applicant argues beginning on p. 11 of remarks dated 05/12/2026 the
following arguments:
Double Patenting
Claims 1-6 and 30-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8, 17-19, and 30 of copending Application No. 17/786,137 in view of Chu (US-20160251673-A1). The Office stated that although the claims at issue are not identical, they are not patentably distinct from each other because the above claims of the instant application are obvious over those of the reference applications.
Given applicant's amendments are directed to the maize specific genus, applicant kindly request the Examiner to withdraw the double patenting rejection.
Examiners response:
This is not persuasive because the claims in the co-pending application are also drawn to maize plants. The secondary reference, Chu, teaches a similar invention and teaches preferred plants include maize plants. Therefore, maize plants are also obvious in view of Chu. The double patenting rejection is maintained.
Conclusion and Inquiries
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 JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
Prosecution Insights