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 .
Claim Status
Claims 5-9, 17-25, 27 and 30-31 are pending.
Claim 31 is new.
Claims 5-9, 17-19, 22-23 and 30 are withdrawn as drawn to an unelected invention.
Claims 20 and 27 are currently amended.
Claims 20-21, 24-25 and 31 are rejected.
Claim 27 is objected to as being drawn to allowable subject matter but being dependent on a rejected base claim.
Response to Arguments - Claim Interpretation
Applicant’s amendments to the claims to remove the phrase “expression cassette” renders the claim interpretation of record moot and it is withdrawn.
Response to Arguments- Written Description
Applicants arguments and amendments to the claims, dated 03/02/2026 have been fully considered. With respect to claim 27 and new claim 31 Applicant’s amendments to the claims and arguments are found to be persuasive, particularly the amendment to the independent claim that the expression of the BG1 be increased in at least one meristematic or reproductive tissue and the rejection of record is withdrawn. With respect to claims 20-21, 24-25 Applicant’s arguments have been fully considered but are not found to be persuasive and the rejections of record are maintained.
The overall theme of applicant’s arguments is that the written description rejection rests on a fundamentally flawed framework, with the following specific arguments which are addressed below:
The examiner relies on unsupported hypotheticals rather than evidence.
The examiner improperly shifts the burden to applicant.
The examiner applies and incorrect “structure-function” requirement.
The examiner disregards disclosed common structural features.
The examiner mischaracterized the claimed scope and conflates possession with universality.
The examiner improperly discounts representative species.
The claim amendments further clarify disclosed possession.
Applicant’s arguments with respect to A. above can be found on pages 5-6 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The office repeatedly relies on imagined BG1 variants and regulatory combinations that are not disclosed, not shown to exist and not shown to representative of the claimed genus. Applicant urges that this mode of analysis is legally improper because written description does not require an applicant to demonstrate operability or predictability for these hypothetical embodiments. Instead applicant states that “the governing inquiry is whether the specification, viewed as a whole reasonably conveys to a person of ordinary skill in the art that the inventors were in possession of the claimed genus, not whether every imagined edge-case would succeed.”
Applicant the describes the ways that the example presented by the examiner lacks evidence, stating that there is no evidence of the following:
That a 95% identical BG1 variant lacking conserved residues exists within the relevant biological space.
That such a variant would lack BG1 function.
That the hypothetical divergent/pairings invoked by the examiner are indeed representative of the claimed genus that a POSA would envision in light of the specification.
Applicant concludes that unsupported speculation cannot sustain a written description rejection and that while “applicants must do more than articulate a “wish or plant,” it does not impose a reciprocal requirement that applicants disprove every hypothetical failure scenario” and as such “The office’s reliance on such hypotheticals departs from the proper evidentiary inquiry under 112(a)”.
With respect to the arguments of A. above, these arguments have been fully considered but are not found to be persuasive. The Examiner agrees with Applicant that “to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed” (MPEP 2163.02).
However, the Examiner disagrees with Applicant’s statement that “the governing inquiry is whether the specification, viewed as a whole reasonably conveys to a person of ordinary skill in the art that the inventors were in possession of the claimed genus, not whether every imagined edge-case would succeed.” (Remarks, Page 6, First Complete Paragraph).
The MPEP in 2163 provides guidance on the Written Description requirement. Section II of 2163 is drawn to a methodology for determining adequacy of written description and provides the following guidance:
For each claim, determine what the claim as a whole covers. “Each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description” (MPEP 2163 (II)(A)(1)). In the instant case, the broadest reasonable interpretation (BRI) of claim 20 as presented in the claims dated 03/02/2026 includes a genus of elite maize plants.
With respect to claims drawn to a genus the MPEP in 2163 (II)(A)(3)(a)(ii) provides the following guidance on written description rejections:
“The written description 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).”
The MPEP continues quoting Ariad “[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”.
Rather than relying on hypothetical embodiments to demonstrate “hypothetical failure scenario[s]” the examiner demonstrates that given the description provided by applicant and an example of a species which falls inside the broadest reasonable interpretation of the genus claimed by applicant, the ordinary artisan would not be able to determine that applicant is in possession of that embodiment.
Further, while applicant has reduced the invention to practice, applicant has described one species in the claimed genus rather than a representative number of species. Specifically, applicant described four distinct transgenic events in a single maize elite line. Importantly these events all used the same construct, which comprised the ZM-GOS2 promoter operatively linked to the ZM-BG1H1-A1 allele from the B73 maize line (Specification, Page 30, Paragraph 0104; Specification, Page 33, Table 4). As such given the breadth of the claim as demonstrated by the examiner’s hypothetical example and given the description provided in the specification, Applicant has not described the invention such that the ordinary artisan would understand that the inventor possessed the entire scope of the claimed invention.
Finally, applicants arguments that the example presented by the examiner lacks evidence are not persuasive. This example demonstrates the scope of the claim and the lack of clarity on whether or not this example was the claimed invention illustrates how applicant’s description does not demonstrate that applicant was in possession of the entire scope of the claimed invention.
The example provided by the Examiner exists within the genus of maize plants claimed by applicant and as such are clearly envisioned species within the broadest reasonable interpretation of the claimed genus.
With respect to ii.above, this argument is not persuasive because the relevant question is, would this variant when expressed at any level greater than that of an endogenous BG1 gene in the elite maize plant confer one of the claimed list of increased agronomic parameters as compared to a null control maize plant. The answer to this question is not yes. Without description of a representative number of species Applicant has not demonstrated possession of the claimed invention. While the answer to the above question may be yes in some instances, more information is required to draw this conclusion than is provided in the specification. As such, given the lack of description of a representative number of species of the claimed genus and given that the amount of expression of the ZmBG1 gene or variants required to increase one of the claimed agronomic parameters in any maize background under any growing conditions is not clear, applicant’s arguments drawn to A. above are not found to be persuasive.
Applicant’s arguments drawn to B. above can be found on pages 6-7 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The Office Action uses language including: “it is unclear whether,” “Applicant has not shown,” and “would the applicant be able to determine if”. This is improper because once applicant provides a disclosure that includes (i) a defined structural class, (ii) representative species, and (iii) a disclosed functional characteristic, the office must provide some evidence as to why a POSA would not recognize possession of the claimed genus. The Office Action does not articulate why a POSA would expect function to be lost within the claimed 95% identity window.
With respect to the arguments of B. above, these arguments have been fully considered but are not found to be persuasive. First, the Examiner cites Khaipho-Burch which describes the unpredictability of modifications to a single loci in plants with respect to the agronomic parameters of crop plants and as such the rejection of record includes evidence which demonstrates that the specifically claimed function of ZmBG1 to increase one of a series of agronomic parameters is not an implicit intrinsic characteristic of all sequences sharing at least 95% sequence identity with instant SEQ ID NO: 1. Further and importantly, the written description rejection was not made only due to the scope of the genus of sequences sharing 95% sequence identity with instant SEQ ID NO: 1. Rather the analysis as described in the rejection of record combines several factors.
These factors include the lack of description on what level of increased expression of the claimed genus of constructs is required to produce the claimed phenotype, which regions of the sequence of SEQ ID NO: 1 must be conserved in order to conserve the increased agronomic parameter phenotype and in which cultivars and under what conditions are these phenotypes attainable.
These questions are all reasonable in light of applicants specification which provides description on one example reduced to practice rather than description of a representative number of species of the claimed genus.
As such the office action does not use this language to shift the burden back to the applicant instead these phrases reflect the position of the ordinary artisan and highlight the areas of the specification which lack adequate description to demonstrate that applicant was in possession of the entire scope of the claimed invention.
Applicant’s arguments drawn to C. above can be found on page 7 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The office action demands a one-to-one predictive “structure function relationship” that the written description requirement does not require. Instead, applicant urges that genus claims are adequately described when the disclosure provides representative species and/or common structural features sufficient for an ordinary artisan to recognize members of the genus. Currently the examiner’s analysis improperly imports enablemet0style concerns into the written description inquiry, particularly those relating to predictability across all theoretical embodiments, in written description a lack of perfect predictability does not negate possession. The office action’s requirement that Applicant pre-map expression outcomes for all regulatory permutations exceeds what is required by the written description standard.
With respect to the arguments of C. above, these arguments have been fully considered but are not found to be persuasive. Examiner agrees with Applicant that the written description requirement for genus claims may be satisfied through sufficient description of a representative number of species. The MPEP in 2163 (II)(A)(3)(a)(i-ii) provides three ways that applicant can provide description for species. First, an application can describe a reduction to practice of a species of the invention. Second, an application can reduce to drawings or structural formulas the claimed invention. Third, an application can describe the invention including relevant, identifying characteristics, including structural properties or characteristics or by functional characteristics coupled with a known or disclosed correlation between function and structure.
This section of the MPEP continues, stating “A “representative number of species” means that the species which are adequately described are representative of the entire genus”.
Currently, applicant has provided description of one member of the claimed genus. As noted above, in response to the arguments summarized in B. the breadth and variation within the claimed genus is such that applicants reduction to practice is insufficient to adequately describe the entire genus. This is demonstrated in the hypothetical examples presented by the Examiner in the rejections of record.
Further, Applicant has not provided a reduction to drawings of a representative number of species to demonstrate possession of the claimed genus. As such, to describe the claimed genus there must be sufficient description in the specification either by structure or by function such that the ordinary artisan would understand that the inventor possessed the entire scope of the claimed invention.
In the instant case, applicant claims a genus of different elite corn plants having at least one member of a genus of recombinant DNA constructs that comprises a member of a genus of promoters operatively linked to a member of a genus of BG1 genes that confers increased expression of the BG1 gene. Importantly, the many claimed species produced through the different combinations of these elements are required to have a specific function of increasing an agronomic parameter selected from a list in the claims.
As such this claim requires description of the structure and the function, which the MPEP clarifies can come in the form of a “disclosed correlation between function and structure” (MPEP 2163 (II)(A)(3)(a)(ii)). Therefore, rather than improperly import enablement-style concerns, the rejections of record demonstrate that a representative number of species have not been described using any of the three methods of describing an invention including a disclosure of a structure-function relationship, which appears to be the most relevant to the instantly claimed invention, given the substance of the claim.
Therefore, Applicant’s arguments drawn to C. above are not found to be persuasive.
Applicant’s arguments drawn to D. above can be found on pages 7-8 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The Office Action acknowledges that the specification discloses that BG1 polypeptides from a plant-specific family with a conserved C-terminal region and that BG1 allelic variants share high sequence identity with conserved residues. The specification further identifies BG1 as a functional gene family with known biological activity. These are precisely the types of “identifying characteristics” that are recognized as sufficient to support genus possession.
With respect to the arguments of D. above, these arguments have been fully considered but are not found to be persuasive. Applicant’s arguments centers on description of the sequence of the BG1 gene/protein, however, this is only one aspect of the claim which must be described.
Given that applicant has provided one reduction to practice of a claimed species of the genus and that the claim is drawn to a genus of structures linked to a required function a structure-function relationship would describe the claimed genus. However, applicant has not described several aspects of the claimed invention by structure-function relationship or other description. This is illustrated by the following question which would be relevant to a person having ordinary skill in the art when attempting to determine if Applicant was in possession of the claimed invention. “How much must expression of BG1 be increased in any meristematic tissue or reproductive tissue in order to produce the claimed function of increased agronomic characteristics?” Given applicant’s description, the answer to this question is unclear and as such applicant has not adequately described the claimed genus.
Applicant’s arguments drawn to E. above can be found on page 8 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The Office Action repeatedly criticizes the claims as covering “any heterologous regulatory element whatsoever” and “all growing environments”, however the independent claim does not recite growing environments nor does it claim constructs in the abstract. Instead the claim recites an elite maize plant exhibiting (i) increased BG1 expression in at least one meristematic or reproductive tissue relative to endogenous BG1 and (ii) at least one increased agronomic parameter relative to a null control.
The examiner urges incorrectly that because some agronomic parameters may vary applicant lacks possession of the claimed genus. This argument fails to look at the claim as a whole which does not require improvements in all of the agronomic parameters and while the claim may read on some inoperative embodiments, this does not necessarily invalidate the claim if the necessary information to limit the claims to operative embodiments is known to a person of ordinary skill in the art.
With respect to the arguments of E. above, these arguments have been fully considered but are not found to be persuasive. To begin, the Examiner agrees in part with Applicant’s final point that “although claims may read on some inoperative embodiments, this does not necessarily invalidate the claim if the necessary information to limit the claims to operative embodiments is known to a person of ordinary skill in the art”.
This standard is applied to the enablement requirement, however the theme appears relevant to the written description rejections of record. In keeping with this line of thought, the Examiner urges that given the genus claimed, the description provided by applicant and the state of the art, that the ordinary artisan would not be able to limit the claims to operative embodiments. Stated differently, when presented with an elite maize plant having a non-statistically significant level of increased expression of BG1 in at least one meristematic or reproductive tissue, the ordinary artisan would not be able to determine if that plant would exhibit one of the required phenotypes and therefore the ordinary artisan would not be able to limit the claimed genus to operative embodiments.
For completeness the examiner agrees that the claim does not recite a specific set of growing conditions, rather the claim is drawn more broadly to elite maize plants which have a modification and exhibit a specific phenotype. The recitation of growing conditions are intended to demonstrate that given the structure of the claim any elite maize plant comprising the claimed construct and exhibiting the claimed phenotype falls within the scope of the claim, even if that phenotype is only demonstrated under specific conditions at a specific time.
Applicant’s arguments drawn to F. above can be found on pages 8-9 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The office repeatedly faults Applicant for having “reduced to practice a single example”, however a single example may support a genus claim when coupled with a structural definition that allows a POSA to recognize the genus. Therefore, Applicant’s disclosure represents adequate written description of the claimed genus.
With respect to the arguments of F. above, these arguments have been fully considered but are not found to be persuasive. The examiner agrees that a single example may support a genus claim, however in the instant fact pattern, the one working example is not sufficient to adequately the genus because the “defined identity-based structural class” is required to have a specific function. Applicant’s argument does not sufficiently weight the overall breadth of the claimed genus in combination with the requisite phenotype which must be demonstrated by the elite maize plants. While the ordinary artisan may be able to identify an elite maize plant comprising the claimed genus of constructs, the ordinary artisan would not have been able to determine if these plants would produce the claimed phenotype, given that applicant has not described the relationship between the amount of increased expression of ZmBG1 and the claimed phenotypes. It is this disconnect that is rejected in the written description rejections of record.
With respect to the arguments of G. above, the examiner notes that applicant’s amendment to claim 20 to clarify gene expression characteristics narrows the scope of the claim. However, as noted in the response to the arguments of A-F above, despite the newly narrowed scope the claims
Applicant’s arguments have been fully considered but are not found to be persuasive and the rejections of record are maintained.
Claim Rejections - 35 USC § 112(a) (Written Description)
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 10/01/2025 as applied to claims 20-21 and 24-25 and 27. Applicant’s arguments filed on 03/02/2026 have been fully considered but they are not found to be persuasive.
Claims 20-21 and 24-25 remain rejected and claim 31 is newly 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 recites an elite maize plant comprising a recombinant DNA construct comprising a polynucleotide encoding a BG1 polypeptide operably linked to a heterologous promoter that confers increased expression of BG1 in at least one meristematic or reproductive tissue relative to expression of an endogenous BG1 gene, wherein the elite maize plant exhibits increased plant height, ear height, ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume and total kernel number. The increased expression of the target polynucleotide and the link between this expression and the claimed improved agronomic parameters are thus a central element of claim 20.
The claim is drawn to plants exhibiting increased expression in a meristematic or reproductive tissue. In maize this includes the shoot apical meristem and the inflorescence meristem but also the root apical meristem and intercalary meristem (Wang, Page 526, References to each meristem is found spread throughout the page)(Wang, Plant biotechnology journal 20.3 (2022): 526-537).
Claim 20 is thus directed to a genus of plants comprising a recombinant DNA construct comprising a nucleic acid encoding a BG1 protein that is operably linked to a promoter that drives increased expression in a meristematic or reproductive tissue including at least the shoot and root apical meristems, the inflorescence meristem and the intercalary meristem, a meristem located between mature tissues in the stem (Wang, Page 526, Paragraph Spanning Columns 1-2). This genus of plants is required to display an increase in plant height, ear height, ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume or total kernel number.
The level of skill and knowledge in the art at the time of filing was such that a large number of agronomic parameters in crops, including maize, have been examined, but that these parameters are underpinned by activities of genes and proteins having unrelated structures, all of which interact with environmental variables and management practices in unforeseen ways
(Khaipho-Burch et al. Nature 621.7979 (2023): 470-473; Pg. 471, ¶1-5).
The specification gives some descriptions the expression pattern of BG1 genes. Applicant observed that Zm-BG1H1 had highest expression in stalks, immature ear, silk and tassel. The maize eFP browser confirmed that ZM-BG1H1 has its highest expression in stems and shoot apical meristem, cob, tassel and silks (Instant Specification, Pages 29-30, Paragraphs 101-102). Importantly this description is drawn to native expression of the gene of interest and does not describe specific overexpression patterns.
In paragraph 0105 on page 31 of the specification Applicant describes the relative expression of the ZM-BG1H1 transgene linked to the GOS2 promoter in seedling leaves and mature ear leaves, which each demonstrated elevated expression. Further, Applicant provides a comparison between the native expression of ZM-GOS2 and its promoter to ZM-BG1H1 and its promoter in 11 different tissue types and found that GOS2 had higher expression in most tissues (Specification, Page 31, Paragraph 0105).
Finally, Applicant provides some description of the promoters of native ZM-BG1H1 homologs. Specifically the promoters of BG1 homologs from maize, rice, sorghum, Brachypodium and Setaria, although this analysis does not describe amount or location of expression throughout the plants or link this expression to the claimed phenotypes (Specification, Pages 35-37, Paragraphs 0114-0115).
The specification does not describe the expression/increased expression of BG1 and any link to the claimed phenotypes such that there is a clear structure function relationship between the structure of a certain level of expression of BG1 in a meristematic or reproductive tissue and the function of producing one of the claimed phenotypes.
Furthermore, the specification states that there are structural elements pertaining to recombinant DNA constructs comprising nucleic acids encoding BG1 that are unknown. For example, six conserved motifs were identified in the promoter of the nucleic acid encoding BG1 in maize that had unknown functions (Specification, Pages 35-36, Paragraph 0114; Specification, Page 38, Paragraph 0118). The specification also describes that relatively few regions in the BG1 gene were associated with agronomic parameters of interest (Specification, Page 39, Paragraph 0121).
Further, the specific amount of expression and timing of that expression in any of the claimed tissues within the maize plant that is required to produce the claimed phenotype is not clear (Emphasis added). As noted above, Applicant has reduced to practice the use of the ZmGOS2 promoter which confers “moderate constitutive expression” to drive expression of a gene encoding the exact polypeptide of SEQ ID NO: 11 which was capable of increasing total kernel mass in hybrid plants produced by outcrossing the transformed maize plants comprising the recombinant DNA construct comprising the ZmGOS2 promoter linked to the ZmBG1H1 gene (Specification, Pages 30-31, Paragraph 0104). This is not enough for the ordinary artisan to understand the relationship between the amount, timing and location of BG1H1 expression and the claimed increased yield phenotype.
To summarize, while applicant has reduced to practice an example of the claimed invention, given the breadth of the claim and the unpredictability with respect to the claimed agronomic parameters, the applicant has not produced a structure-function relationship between the structure of any elite maize plant comprising an recombinant DNA construct comprising any heterologous regulatory element operatively linked to a polynucleotide sequence encoding BG1 polypeptide and the function of increasing plant height, ear height, ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume and/or total kernel number. Nor has applicant provided any other description which demonstrates possession of the full scope of the claimed invention. Therefore, it does not appear that applicant is in possession of the full scope of the claimed invention.
Even, new claim 31, which limits the scope of BG1 sequences to those that are at least 99% identical to SEQ ID NO: 1 does not limit the scope to subject matter having adequate written description because the specification does not link any level of increased expression of the claimed sequence in a meristematic tissue, such as the root apical meristem to the claimed agronomic phenotypes.
Hence, Applicant has not, in fact, described maize plants comprising recombinant DNA constructs comprising nucleic acids encoding BG1 that have improvements to all agronomic parameters within the full scope of the claims. The specification instead describes maize plants comprising a recombinant construct with one specific promoter with some agronomic parameters improved, which is an insufficient number of species within the claimed genus to be representative of the entire breadth of the genus. Thus, the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments - Scope of Enablement
Applicants arguments and amendments to the claims, dated 03/02/2026 have been fully considered. With respect to claim 27 Applicant’s arguments are found to be persuasive and the rejections of record are withdrawn. With respect to claims 20-21, 24-25 and new claim 31, Applicant’s arguments have been fully considered but are not found to be persuasive and the rejections of record are maintained.
The overall theme of applicant’s arguments is that the enablement rejection rests on the same fundamentally flawed framework as the written description rejections, with the following specific arguments which are addressed below:
The examiner applies an incorrect legal standard by requiring universal predictability.
The Wands Factors, as applied to the amended claims, confirm enablement.
The Examiner improperly applies hypothetical inoperative features and treats those as enablement failures.
The enablement rejection is not supported by substantial evidence.
Claim amendments further clarify enablement of the claimed invention.
Applicant’s arguments with respect to A. above can be found on pages 10-12 of the remarks dated 03/02/2026. These arguments are summarized as follows:
Enablement does not require that a specification eliminate all experimentation, however the Examiner faults the specification for not enabling any heterologous regulatory element whatsoever. The enablement requirement does not require this, rather enablement requires that the invention be practiced with reasonable experimentation.
With respect to the arguments of A. above, these arguments are not found to be persuasive because while Examiner agrees with Applicant that the enablement requirement does not require that the description provide such guidance that no experimentation is required to make or use the invention, in light of the guidance provided by applicant the experimentation that would be required a person skilled in the art to use the full scope of the claimed invention would be undue. This experimentation would be undue because the relationship between the claimed genus of sequences, their expression in a meristematic or reproductive tissue, which includes root apical meristems and the claimed group of agronomic parameters is unclear given the guidance from the specification and the state of the art.
As such the ordinary artisan in order to make and use the full scope of the claimed invention would be required to fill in this gap of information. The experimentation required to do so would include producing a series of constructs producing varied levels of a representative group of the genus of BG1 sequences claimed, transforming a series of elite maize cultivars with all of these constructs, assaying the expression of the BG1 sequence at each of the meristematic or reproductive structures and then assessing agronomic parameters of the plants for improved plant height, ear height, ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume and total kernel number.
This would involve meristem tissue specific expression analysis of several elite maize cultivars which were transformed with a representative number of species from the genus of claimed BG1 sequences. These experiments may require cell sorting or another approach to generating meristem tissue specific expression patterns, as well as other genetic and agronomic testing requiring a field trial. As such this experimentation which would be necessary to enable the full scope of the claimed invention is undue.
Applicant’s arguments with respect to B. above can be found on pages 12-13 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The amended claims now expressly recite the operative features taught in the specification and therefore the specification enables the claimed invention commensurate with this scope.
With respect to the arguments of B. above, these arguments are not found to be persuasive with respect to claims 20-21 and 24-25. The examiner agrees with Applicant that the new amendments, particularly the amendment that expression be increased in the meristematic and reproductive tissues in combination with the recitation of the specific phenotypes and the exact promoter of the reduction to practice limits the scope of claim 27 and the limiting of BG1 sequences to those having 99% sequence identity to the reference as described in claim 31 limits the scope to enabled subject matter, this does not apply to the scope of the other claims.
Specifically, while the claims have been limited the skilled artisan would still be required to use the trial and error experimentation described in the response to A. above in order to make and use the full scope of the claimed invention and this experimentation is undue.
Applicant’s arguments with respect to C. above can be found on page 13 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The office action asserts that enablement is lacking because some agronomic parameters may worsen (kernel density) even when others improve, this is the incorrect standard given that claim 20 limits the agronomic parameters to a specific set.
With respect to the arguments of C. above, these arguments are not found to be persuasive. While, the Examiner agrees with Applicant that not all metrics, across all configurations must show an improvement given the guidance of the specification the ordinary artisan would still be required to use undue experimentation to make and use the claimed invention, see response to A. above.
Applicant’s arguments with respect to D. above can be found on pages 13-14 of the remarks dated 03/02/2026. These arguments are summarized as follows:
The office provides no concrete obstacle that would prevent a skilled artisan from making and using plants falling within the claims, such as any demonstrated inability to select regulatory elements to achieve the claimed increased expression, or to assess agronomic parameters.
With respect to the arguments of D. above, these arguments are not found to be persuasive. In response the examiner urges that the amount of experimentation required to use the full scope of the claims appears remains undue, this experimentation is summarized in the response to A. above.
Applicant’s arguments with respect to E. above can be found on page 14 of the remarks dated 03/02/2026. These arguments are summarized as follows:
Applicant’s amendments to the claims limit the scope to subject matter having adequate enabled guidance in the specification.
With respect to the arguments of E. above, these arguments are not found to be persuasive. In response the examiner notes that the rejections against claims 27 and 31 have been withdrawn but urges that the amount of experimentation required to use the full scope of the other claims appears remains undue, this experimentation is summarized in the response to A. above.
As such claims 20-21 and 24-25 remain rejected and a rejection against new claim 31 is presented below.
Claim Rejections - 35 USC § 112 – Scope of Enablement
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 10/01/2025 as applied to claims 20-21 and 24-25 and 27. Applicant’s arguments filed on 03/02/2026 have been fully considered but they are not found to be persuasive.
Claims 20-21 and 24-25 remain rejected and claim 31 is newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a maize plant comprising a recombinant expression cassette comprising a nucleic acid encoding a sequence having at least 100% sequence identity to SEQ ID NO: 11 which has been operatively linked to the ZmGOS2 moderately constitutive promoter, wherein the maize plant exhibits improved traits of agronomic significance including ear length, ear diameter, and total kernel volume, does not reasonably provide enablement for a maize plant comprising a cassette comprising a BG1 operatively linked to a promoter which increases expression in a reproductive or meristematic tissue by any amount and which exhibits increases in any of the claimed agronomic parameters. Therefore, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 20 recites an elite maize plant comprising a recombinant DNA construct comprising a polynucleotide encoding a BG1 polypeptide operably linked to a heterologous promoter that confers increased expression of BG1 in at least one meristematic or reproductive tissue relative to expression of an endogenous BG1 gene, wherein the elite maize plant exhibits increased plant height, ear height, ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume and total kernel number. The increased expression of the target polynucleotide and the link between this expression and the claimed improved agronomic parameters are thus a central element of claim 20.
The claim is drawn to plants exhibiting increased expression in a meristematic or reproductive tissue. In maize this includes the shoot apical meristem and the inflorescence meristem but also the root apical meristem and intercalary meristem (Wang, Page 526, References to each meristem is found spread throughout the page)(Wang, Plant biotechnology journal 20.3 (2022): 526-537).
Claim 20 is thus directed to a genus of plants comprising a recombinant DNA construct comprising a nucleic acid encoding a BG1 protein that is operably linked to a promoter that drives increased expression in a meristematic or reproductive tissue including at least the shoot and root apical meristems, the inflorescence meristem and the intercalary meristem, a meristem located between mature tissues in the stem (Wang, Page 526, Paragraph Spanning Columns 1-2). This genus of plants is required to display an increase in plant height, ear height, ear length, ear fill length, ear diameter, ear kernel row number, total kernel weight, total kernel volume or total kernel number.
The level of skill and knowledge in the art at the time of filing was such that a large number of agronomic parameters in crops, including maize, have been examined, but that these parameters are underpinned by activities of genes and proteins having unrelated structures, all of which interact with environmental variables and management practices in unforeseen ways
(Khaipho-Burch et al. Nature 621.7979 (2023): 470-473; Pg. 471, ¶1-5).
The specification does not provide guidance on the expression/increased expression of BG1 and any link to the claimed phenotypes such that there is a clear structure function relationship between the structure of a certain level of expression of BG1 in a meristematic or reproductive tissue and the function of producing one of the claimed phenotypes.
The specification gives some guidance on the expression pattern of BG1 genes. Applicant observed that Zm-BG1H1 had highest expression in stalks, immature ear, silk and tassel. The maize eFP browser confirmed that ZM-BG1H1 has its highest expression in stems and shoot apical meristem, cob, tassel and silks (Instant Specification, Pages 29-30, Paragraphs 101-102). Importantly, this guidance is drawn to native expression of the gene of interest and does not describe specific overexpression patterns.
In paragraph 0105 on page 31 of the specification Applicant provides guidance on the relative expression of the ZM-BG1H1 transgene linked to the GOS2 promoter in seedling leaves and mature ear leaves, which each demonstrated elevated expression. Further, Applicant provides a comparison between the native expression of ZM-GOS2 and its promoter to ZM-BG1H1 and its promoter in 11 different tissue types and found that GOS2 had higher expression in most tissues (Specification, Page 31, Paragraph 0105).
Finally, Applicant provides some guidance on the promoters of native ZM-BG1H1 homologs. Specifically the promoters of BG1 homologs from maize, rice, sorghum, Brachypodium and Setaria, although this analysis does not describe amount or location of expression throughout the plants or link this expression to the claimed phenotypes (Specification, Pages 35-37, Paragraphs 0114-0115).
The specification does not contain guidance for how to make maize plants with improvements to each of the claimed agronomic parameters using any heterologous promoter operatively linked to any of the claimed BG1 polynucleotides, where the BG1 polynucleotide has increased expression in meristematic or reproductive tissue. By extension, the specification does not provide guidance on how make a maize plant having improvements to these agronomic parameters that also comprises a recombinant expression cassette comprising a nucleic acid encoding BG1.
Thus, from the guidance in the specification, it would appear that one of skill in the art would need to make a plurality of maize plants comprising expression cassettes including various heterologous promoters operatively linked to a nucleic acid encoding the claimed BG1 polypeptides.
Making plants with improved agronomic parameters is unpredictable. Even after the filing date of the instant invention, it is understood that plants having a controlled modification to a single locus can display improvements to some agronomic parameters under some environments but not others, and that the interaction between the effects of the manipulated locus with environmental variables cause different effects to agronomic parameters through mechanisms that are poorly understood (Khaipho-Burch et al. Nature 621.7979 (2023): 470-473; Page 470, Middle column, Paragraphs 1-5; Page 472, Paragraphs 1-9). Assaying all maize plants comprising all types of expression cassettes comprising a nucleic acid encoding BG1 under all environments for improvements to all agronomic parameters would thus entail undue experimentation.
Thus, extensive guidance is required for making a maize plant having improvements to these agronomic parameters that comprises a recombinant expression cassette comprising a nucleic acid encoding BG1. As the specification does not provide guidance for a maize plant comprising a recombinant expression cassette comprising a nucleic acid encoding BG1 that has improvements to each of the yield parameters in any environment, undue trial and error experimentation would be required to screen through the myriad of possible expression cassettes, environments, agronomic parameters, and possible genetic backgrounds in maize that could comprise said expression cassette to identify those with improvements to all agronomic parameters generally, if such plants are even obtainable.
Given the claim breath, unpredictability in the art, undue experimentation, and lack of guidance in the specification as discussed above, the instant invention is not enabled throughout the full scope of the claims. Claims 21, 24-25 and 31, which depend on claim 20, do not recite limitations that overcome the rejection stated above.
Conclusion
Claims 20-21, 24-25 and 31 are rejected.
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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