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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
1.17(e), was filed in this application after final rejection. Since this application is eligible for continued
examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the
finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
submission filed on 12/12/2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged. As such, the effective filing date of Claims 1, 3-21, and 24-25 is 07/11/2019.
Status of the Claims
Amendments dated 11/17/2025 have been entered.
Claims 2 and 22-23 have been cancelled by Applicant.
Claims 1, 3-21, and 24-25 are pending.
Claims 9-14, 19-20, and 24 are withdrawn as being directed to a non-elected invention.
Claims 1, 3-8, 15-18, 21, and 25 are examined herein.
The rejections to Claims 1, 3-8, 15-18, 21, and 25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicant’s amendments to the claims.
The rejections of Claims 1, 3-8, 15-18, 21, and 25 under 35 U.S.C. 103 as being unpatentable over Kong et al. (WO 2020/260682 A1, effectively filed on 06/28/2019 [see MPEP 2154.01(b)]) in view of Frankard et al. (WO 2009/037338 A1, published 03/26/2009) and Kim et al. (Proceedings of the National Academy of Sciences 101.36 (2004): 13374-13379) and Schommer et al. (WO 2016/098027 A1, published 06/23/2016) are withdrawn in view of Applicant’s amendments to the claims.
Claim Interpretation
The term “elite plant” recited in Claim 17 is not defined in the instant specification and will therefore be interpreted broadly to include any plants that have properties or traits that are considered to be useful agro-economically.
If Applicant disagrees with these interpretations, an appropriate response should be made of record to that effect. No substantive reply will be taken as a confirmation by Applicant that the Office’s interpretation(s) are correct. Applicant is reminded that “the doctrine of prosecution disclaimer ensures that claims are not construed one way [by Applicant] in order to obtain their allowance and in a different way against accused infringers” (SandBox Logistics LLC v. Proppant Express Invs. LLC, 813 F. App'x 548, at 556 (Fed. Cir. 2020)) and, to that end, “[Applicant' s] failure to challenge the Examiner' s understanding amounts to a disclaimer” (SandBox v. Proppant infra at 554; citing Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, at 1096 (Fed. Cir. 2013)).
Claim Objections
Claims 1 and 5-8 are objected to because of the following informalities:
Claim 1, lines 1-2 and 8 should both be amended to recite “…regeneration efficiency of a plant regenerated from…”
Claims 5-8 should be amended to recite “SEQ ID NOs:”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
This is a new rejection is made in view of Applicant’s amendments to the claims dated 11/17/2025.
Claims 1, 3-8, 15-18, 21, and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has clarified the written description requirement. The court stated that a
written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
The court also concluded that "naming a type of material generally known to exist, in the absence of
knowledge as to what that material consists of, is not description of that material". Id. Further, the court
held that to adequately describe a claimed genus, Patent Owner must describe a representative number
of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
Claims 1, 3-8, 15-18, 21, and 25 are broadly directed to a method of increasing regeneration efficiency of a plant from one or more plant cells, the method comprising, in part, introducing into said one or more plant cells a nucleic acid molecule encoding or a polypeptide comprising a Growth Regulating Factor (GRF)-GRF-interacting Factor (GIF) chimera, from any diverse source known in the art.
Applicant describes SEQ ID NOs: 3-4, 40-42, 45-46, 48 and 140 as GRF-GIF chimeras useful in the methods of the invention (pgs. 60-61 and 63-65, “List of Sequence Identifiers”). Applicant discloses in the working examples of the instant disclosure that the plant cells comprising the TaGRF4-GIF1 chimera (SEQ ID NO: 5) and the constitutive promoter (Ubi) had greater generation efficiency than the Ubi::TaGRF4 plant cells, the Ubi::TaGIF1 plants cells, and the control (pg. 3, paragraph 0011; FIG 5). Applicant also discloses wheat transformations with GRF-GIF1 chimeras under the control of a constitutive promoter (ZmUbi), where all chimeric proteins had increased regeneration efficiency when compared to the control (pg. 5, paragraph 0026; FIG 20A and B). Applicant also discloses wheat transformations with GRF4-GIF chimeras under the control of a constitutive promoter (ZmUbi), where all chimeric proteins had increased regeneration efficiency when compared to the control (pg. 5, paragraph 0026; FIG 20C and D). As such, Applicant describes that the disclosed TaGRF-TaGIF chimeras have similar activity for increasing the regeneration efficiency of a wheat plant cell. Additionally, Applicant discloses pepper (Capsicum annuum cultivar R&C Cayenne) transformation with Capsicum annuum GRF4.1-GIF1.1 chimera (which are noted as homologs to wheat GRF4 and GIF1, respectively), where the pepper plant cells comprising the GRF4.1-GIF1.1 chimera had increased regeneration efficiency when compared to a plant cell transformed with an empty vector (pg. 7, paragraph 0034; FIG 28).
Applicant does not describe the structural features of the broadly claimed genus of GRF-GIF chimeras from any diverse source known in the art. The claims are drawn to an exceedingly vast genus of chimeric proteins due to the ambiguity of the term “chimera”, wherein neither the specification nor the claims define the structural components of the broad genus of chimeras. As such, the range of chimeric structures encompassed by the recitation of Claim 1 includes GRF-GIF chimeras from any diverse source that comprise two-full length polypeptides which are fused, two partial length polypeptides that are fused, and one full length polypeptide and one partial polypeptide that are fused; most of which were not in Applicant’s possession at the time of filing (only SEQ ID NOs: 3-4, 40-42, 45-46, 48 and 140). Additionally, Applicant does not provide any description or guidance to elucidate the order in which the GRF and GIF polypeptides can be fused. As such, these factors related to the recitation of “chimera” do not appear to have been adequately considered in the instant application.
The state of the art regarding the creation of artificial, “non-natural”, or “unnaturally linked” chimeric proteins teaches that the genetic fusion of protein-encoding genes of interest can be unpredictable. Witte et al. (2013) discloses that genetic fusion of protein-encoding genes of interest is the most common method for the production of chimeric proteins. Witte et al. (2013) discloses that although the genetic engineering required to produce such fusions is straightforward, the resulting product may not express or fold properly, with consequent loss of function (pg. 1808, left column, second paragraph).
In view of the teachings of the prior art and the instant specification, Applicant does not describe the artificial, “non-natural”, or “unnaturally linked” GRF-GIF chimeric proteins required by the claims in such a way (through a representative number of species or a clearly defined structure-function relationship) that one of ordinary skill in the art could reasonably identify members of the broadly claimed genus comprising GRF and GIF sequences from any diverse source that have retained their recited function of increasing the regeneration efficiency of plants regenerated from plant cells comprising the claimed chimeric proteins. Applicant does not describe the design of the chimeric proteins or experimental steps one of ordinary skill in the art must take to ensure that the artificially fused proteins, comprising any GRF and GIF sequence known in the art (from any diverse source), retain their structure-function relationship in such a way as to avoid total loss of function, or decreased function. Applicant has not described a representative number of species of the broadly claimed genus of chimeric proteins that have the broadly claimed range of chimeric structures without loss of function of the fused protein. Applicant has not described the structure-function relationship of the broad genus of chimeric protein structures encompassed by the claims in such a way that one of ordinary skill in the art would be able to identify GRF-GIF chimeric proteins comprising the broadly claimed range of chimeric structures that have the recited function from GRF-GIF chimeric proteins structures that do not have the recited function.
When looking at the broadest scope of Claim 1, which includes any GRF-GIF chimera known in the art from any diverse species of plant, Kim et al. (2004) teaches that when AtGRF1 and AtGIF1 are transformed into plant cells and expressed in the same vector, they form a functional complex (pg. 13374, right column, first paragraph) and increase cell proliferation involved in the growth of leaf tissue in plants (pg. 13379, right column, second paragraph). Applicant’s own remarks dated 11/17/2025 (pg. 8) disparage the disclosure of Kim, in that it would not implicitly flow that a GRF-GIF polypeptide functional complex in a plant cell that results in increased plant cell proliferation would lead to increased regeneration efficiency of plants that are regenerated from said plant cells. In light of Applicant’s own remarks, it is clear that not all GRF-GIF chimeras known in the art would be able to perform the recited function of increased regeneration efficiency, and as such, it is unclear how one of ordinary skill in the art would be able to identify which GRF-GIF chimeras could perform the recited function. As such, Applicant has not adequately described the structure of the instantly claimed GRF-GIF chimeras, or the chimeric proteins disclosed in SEQ ID NOs: 3-4, 40-42, 45-46, 48 and 140, in such a way as to differentiate which GRF and GIF polypeptides from any plant source known in the art could be fused or functionally linked into a chimeric protein, that is introduced into a plant cell, that is subsequently regenerated into a plant, that would perform the recited function of increasing the regeneration efficiency of said plant. Essentially, the question is— what structural components of SEQ ID NOs: 3-4, 40-42, 45-46, 48 and 140 allows these chimeras to have the recited function of increased regeneration efficiency, versus a functional complex of AtGRF-AtGIF that would purportedly not have the recited function of increased regeneration efficiency?
The number of species described by Applicant are insufficient to describe the recited genus by virtue of example, given the vast size of the recited genus and the lack of written description in the instant specification with regard to the structural and functional characteristics of the claimed compositions.
Hence, Applicant has not, in fact, described the claimed compositions used in the methods of the invention within the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Closest Prior Art
Claims 1, 3-8, 15-18, 21, and 25 appear to be free of the prior art, given the failure of the prior art to reasonably teach a regenerated plant from a plant cell comprising a GRF-GIF chimera, wherein the regenerated plant has increased regeneration efficiency relative to an appropriate control. The closest prior art regarding Claims 1, 3-8, 15-18, 21, and 25 can be found in the combination of Kong et al. (WO 2020/260682 A1, effectively filed on 06/28/2019) in view of Frankard et al. (WO 2009/037338 A1, published 03/26/2009) and Kim et al. (Proceedings of the National Academy of Sciences 101.36 (2004): 13374-13379) and Schommer et al. (WO 2016/098027 A1, published 06/23/2016).
Kong et al. (herein referred to as Kong) teaches methods for improving plant regeneration especially from transformed or genetically modified plant cells using GRF1 booster genes (Abstract). Kong teaches a method for transforming a plant cell, comprising the steps of introducing into a plant cell in parallel or sequentially at least one nucleotide sequence of interest; and an expression cassette comprising a polynucleotide encoding a GRF1 polypeptide, mRNA encoding a GRF1 polypeptide, or GRF1 polypeptide(s) and cultivating the plant cell or a plant cell derived from the plant cell under conditions where in the plant cell the GRF1 polypeptide is expressed from the expression cassette, GRF1 polypeptide is translated from introduced mRNA, GRF1 polypeptide is enhanced expressed from the endogenous gene, or GRF1 polypeptide(s) are present (pg. 37, Claim 1), wherein the method yields a modified or transformed plant cell having an improved ability of regeneration due to the presence of GRF1 or the presence of GRF1 in an enhanced amount (pg. 7, lines 5-7).
Frankard et al. (herein referred to as Frankard) teaches a method for increasing various plant yield-related traits by increasing expression in a plant of: (i) a nucleic acid sequence encoding a Growth-Regulating Factor (GRF) polypeptide; and of (ii) a nucleic acid sequence encoding a synovial sarcoma translocation (SYT) polypeptide, wherein said yield-related traits are increased relative to plants having increased expression of one of: (i) a nucleic acid sequence encoding a GRF polypeptide, or (ii) a nucleic acid sequence encoding a SYT polypeptide (Abstract; pg. pg. 97, Claim 1), and wherein said increased expression is effected by introducing and expressing in a plant: (i) a nucleic acid sequence encoding a GRF polypeptide; and (ii) a nucleic acid sequence encoding a SYT polypeptide (pg. 99, Claim 17), and plants, parts thereof (including seeds), or plant cells obtainable by a method according to any preceding claim, wherein said plant, part or cell thereof comprises (i) an isolated nucleic acid transgene encoding a GRF polypeptide and (ii) an isolated nucleic acid transgene encoding a SYT polypeptide (pg. 100, Claim 25); wherein SYT polypeptides are also called GIF or GRF-interacting factors (pg. 88, Example 6, lines 24-25).
Kim et al. teaches that when GRF1 and GIF1 are transformed into plant cells and expressed in the same vector, they form a functional complex (pg. 13374, right column, first paragraph) and increase cell proliferation involved in the growth of leaf tissue in plants (pg. 13379, right column, second paragraph). Applicant’s Remarks dated 11/17/2025 explicitly state that the GRF-GIF functional complex disclosed by Kim would not have the unexpected results of increased regeneration efficiency of plants that could be derived from the plant cells taught by Kim comprising the GRF-GIF functional complex (Applicant’s Remarks, pg. 8).
Schommer et al. teaches that when a GIF domain or fragment thereof and a GRF transcription factor are fused into a single, chimeric protein, both moieties keep their functional properties intact and the activity of the transcription factor is enhanced (pg. 14, last paragraph). Schommer et al. also teaches that normally the interaction between GIFs and GRFs might be subjected to regulation in vivo and formation of the GRF/GIF complex will depend on the concentration of each protein; however, the issues seem to be avoided in the chimera, which surprisingly keeps the biologic function of the complex formed between GRF and GIF when these are expressed as separate proteins, free to interact without the constrains posed by their incorporation into a fusion protein (pg. 14, last paragraph).
However, the combination of Kong, Frankard, Kim, and Schommer do not teach or suggest the limitation of Claim 1 wherein the plant that is regenerated from the plant cells comprising the GRF-GIF chimera has increased regeneration efficiency relative to the appropriate control. Applicant defines “regeneration efficiency” on pg. 10 as “increasing the number of plant cells, tissue or plants regenerated from the one or more cells having introduced the GRF, GIF or GRF/GIF chimera.” As such, the teachings of Kim, which are drawn to increased cell proliferation, teach increasing the number of plant cells from plant cells comprising the GRF and GIF polypeptides—meaning Kim teaches increased regeneration efficiency of plant cells, not increased regeneration efficiency in plants regenerated from the one or more cells having introduced the GRF-GIF chimera. Additionally, increased cell proliferation in the non-differentiated cells comprising the GRF1 and GIF1 complex taught by Kim would not be predicative of the regeneration efficiency of a plant that is regenerated from the non-differentiated cells, as other factors in the cell differentiation stage play a role in the regeneration efficiency of a plant regenerated from callus tissue.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD ABRAHAM can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663