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 7, 10, 13, 15, and 17 are canceled.
Claims 1-6, 8-9, 11-12, 14, 16, 18-56 and newly added claims 57-58 are pending.
Claims 1-6, 8-9, 11-12, 14, 16, 18-36, and 58 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 37-57 are examined herein.
The previous rejection under 35 USC 112(a) has been withdrawn in view of Applicant’s amendments.
Upon further consideration, claims 47-51 are no longer considered free of the prior art. As a result, a modified rejection has been made to claims 37-57 under 35 USC 103.
Claims 37-57 are rejected.
Priority
Application No. 17/999,358 filed on 11/18/2022 is a 371 of PCT Application No. PCT/GB2021/051195 filed on 05/18/2021, and also claims priority to United Kingdom Application No. GB2007526.3 filed on 05/20/2020.
Election/Restrictions
Newly submitted claim 58 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The currently examined invention is limited to a genetically engineered plant comprising an exogenous nucleic acid sequence comprising an expression regulatory element that specifically induces expression in bundle sheath cells, mestome cells, or vascular bundle sheath cells, and the expression regulatory element drives expression of a nucleic acid sequence encoding a phytochrome B protein. In sum, the instantly claimed invention is essentially drawn to a transformed plant comprising a vector comprising the tissue specific regulatory element as described above driving phyB gene expression.
Alternatively, claim 58 is drawn to a genetically engineered plant generated by contacting a cell of the plant with a gene- editing protein, wherein the gene-editing protein generates one or more mutations in an expression regulatory element of a gene encoding a phytochrome B protein, wherein the one or more mutations induce specific expression of the gene encoding the phytochrome B protein in bundle sheath cells, mestome sheath cell, or vascular cells of the genetically engineered plant, and wherein photosynthesis is enhanced in the genetically engineered plant as compared to a non-engineered plant of the same species. Thus, the new claim encompasses modification/ gene-editing of endogenous regulatory elements to alter expression patterns.
Therefore, the claims are drawn to non-overlapping subject matter and require different fields of search.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 58 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 37 is objected to because of the following informalities: In view of Applicant’s amendments and deletions, there are multiple instances of double spaces. See, e.g., at least lines 1, 3, 6, and 14 in claim set dated 1/30/2026. Applicant should delete one of the space characters. Applicant should also include a comma after “phytochrome B protein” in line 5/ before the term “wherein” in line 6.
Claim 47 is objected to because of the following informalities: In view of Applicant’s amendments and deletions, there is a double space between “wherein” and “one or more”. Applicant should delete one of the space characters.
Claim 53 is objected to because of the following informalities: In view of Applicant’s amendments and deletions, there are multiple instances of double spaces. See, e.g., at least lines 2 and 3 of claim 53 in claim set dated 1/30/2026. Applicant should delete one of the space characters.
Applicant should review all pending claims for minor errors.
Appropriate correction is required.
Claim 40 recites “wherein the exogenous nucleic acid sequence encoding the phytochrome B protein is different to the native…”. To improve clarity and grammar, Applicant should amend the claim to recite “wherein the exogenous nucleic acid sequence encoding the phytochrome B protein is different from the native…”.
Applicant should thoroughly review all pending claims for grammatical errors.
Claim 41 recites “The plant as claimed in claim 37 obtained by a process of CRISPR-Cas protein genetic modification”. Applicant should amend the claim to include a comma and wherein clause following “claim 37” and before “obtained…”. Additionally, “CRISPR-Cas protein genetic modification” should be amended to improve clarity of the claim. For example, Applicant should amend the claim to recite “The plant as claimed in claim 37, wherein the plant is obtained by a process of genetic modification using CRISPR-Cas protein.”
Claim 50 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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 52 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim(s) recite(s) “A pollen grain or seed derived or obtained from the plant of claim 37”. This judicial exception is not integrated into a practical application because the claims encompass pollen and seeds that are identical to those that would be found in nature because, for example, if the plant comprises only a single copy of the exogenous nucleic acid sequence in the plant’s genome, a subset of the pollen and seeds produced by the plant would be expected to be non-transgenic and identical to those found in nature as a result of segregation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are recited in the claims that would make the pollen or seed structurally different from a from naturally occurring pollen or seed."
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 49 is rejected 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.
Applicant uses the term “leaf photosynthetic efficiency” in claim 49. This term is not defined and traits that result from greater leaf photosynthetic efficiency are not provided. It is unclear what the term means and how one would determine if a plant of the invention has leaf photosynthetic efficiency that is greater than in the equivalent leaf or leaves of a non-engineered plant of the same species, as claimed in claim 49. For purposes of examination, the term is interpreted to mean leaf photosynthesis is enhanced, and may be determined by the plant producing the same traits as observed with plants of the invention that have enhanced photosynthesis (see spec. p. 23, lines 3-7).
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.
Claim(s) 37-39, 42-43, and 47-51 are rejected under 35 U.S.C. 103 as being unpatentable over Endo (Endo, M., Nakamura, S., Araki, T., Mochizuki, N., & Nagatani, A. (2005). Phytochrome B in the mesophyll delays flowering by suppressing FLOWERING LOCUS T expression in Arabidopsis vascular bundles. The Plant Cell, 17(7), 1941-1952) and Suzuki (Suzuki, S., & Burnell, J. N. (2003). The pck1 promoter from Urochloa panicoides (a C4 plant) directs expression differently in rice (a C3 plant) and maize (a C4 plant). Plant Science, 165(3), 603-611), and as evidenced by Yamaguchi (Yamaguchi, R., Nakamura, M., Mochizuki, N., Kay, S. A., & Nagatani, A. (1999). Light-dependent translocation of a phytochrome B-GFP fusion protein to the nucleus in transgenic Arabidopsis. The Journal of cell biology, 145(3), 437-445.).
Claim 37 is drawn to a genetically engineered plant which carries out C3 photosynthesis in at least a part thereof, wherein the genetically engineered plant comprises an exogenous nucleic acid sequence encoding a phytochrome B protein, wherein the exogenous nucleic acid sequence further comprises an expression regulatory element, wherein the expression regulatory element specifically induces expression of the exogenous nucleic acid sequence in bundle sheath cells, mestome sheath cells, or vascular cells of the genetically engineered plant, and wherein photosynthesis is enhanced in the genetically engineered plant as compared to a non-engineered plant of the same species.
Claim 38 is drawn to the plant as claimed in claim 37, wherein the expression regulatory element is a promoter which is active specifically in the bundle sheath cells or vascular cells of a C3 plant.
Claim 39 is drawn to the plant as claimed in claim 37, wherein the coding sequence of the exogenous nucleic acid sequence encoding the phytochrome B protein comprises a sequence from a native phytochrome B gene or genes in the plant.
Claim 42 is drawn to the plant as claimed in claim 37, wherein the exogenous nucleic acid sequence is heritably stable.
Claim 43 is drawn to the plant as claimed in claim 37, wherein the plant is a C3 plant.
Claim 47 is drawn to the plant as claimed in claim 37, wherein one or more chloroplasts present in bundle sheath or vascular cells are developmentally enhanced, in terms of size or photosynthetic capacity, compared to chloroplasts in equivalent bundle sheath or vascular cells of a non-engineered plant of the same species.
Claim 48 is drawn to the plant as claimed in claim 37, wherein photosynthesis is enhanced compared to a control unmodified plant grown under the same conditions.
Claim 49 is drawn to the plant as claimed in claim 37, wherein leaf photosynthetic efficiency is greater than in the equivalent leaf or leaves of a non-engineered plant of the same species.
Claim 50 is drawn to the plant as claimed in claim 37, wherein water use efficiency is greater than in a non-engineered plant of the same species.
Claim 51 is drawn to the plant as claimed in claim 47, wherein the enhanced photosynthetic capacity results in one or more of the following traits: enhanced growth rate, reduced time to flowering, faster maturation, enhanced seed yield, enhanced biomass, increased plant height, and enhanced leaf canopy area, when compared to a non- engineered plant of the same species.
Regarding claim 37, Endo teaches a method of genetically engineering Arabidopsis to overexpress PHYB under control of a CaMV 35S minimal promoter to produce ‘PBT lines’ (Fig. 1), and teaches two PBT lines expressed phyB in vascular-bundle-specific manner (p. 1943, section titled PhyB-GFP in Cotyledons Complements phyB-Deficient Early Flowering Phenotype, Table 1). Endo teaches the two PBT lines (PBT6 and PBT239) that expressed phyB in vascular-bundle-specific manner flowered early compared to wild type Arabidopsis plant (p. 1943, section titled PhyB-GFP in Mesophyll Cells Delays Flowering, ¶1). As described in the specification, plants with enhanced photosynthesis result in one or more traits including reduced time to flowering (see spec., p. 23). Therefore, photosynthesis is reasonably interpreted to be enhanced in the genetically engineered plants compared to non-genetically engineered plants of the same species.
Regarding claim 39, Endo teaches the nucleic acid sequence encoding the PhyB protein in the transformation vector was derived from the pBI-Hyg/35S-PHYB-sGFP-nosT vector of Yamaguchi (p. 1950, section titled Plasmid Construction and Plant Transformation). Yamaguchi evidences the PHYB cDNA for this vector was isolated from an Arabidopsis cDNA library (p. 438, section titled Plasmid Construction and Transformation), therefore the coding sequence of the exogenous nucleic acid sequence encoding the phytochrome B protein as taught by Endo comprises a sequence from a native phytochrome B gene in the plant.
Regarding claim 42, Endo teaches the plant is transformed by Agrobacterium-mediated floral dip method (i.e. a stable transformation method that results in modifications that are heritably stable) (p. 1950, section titled Plasmid Construction and Plant Transformation).
Regarding claim 43, Endo teaches the plant is Arabidopsis (i.e. a C3 plant) (title, whole document).
Regarding claims 47-49 and 51, Endo teaches the two PBT lines (PBT6 and PBT239) that expressed phyB in vascular-bundle-specific manner flowered early compared to wild type Arabidopsis plant (p. 1943, section titled PhyB-GFP in Mesophyll Cells Delays Flowering, ¶1). As described in the specification, plants with enhanced photosynthesis result in one or more traits including reduced time to flowering (see spec., p. 23). Based on this description in the instant specification, the limitations of claims 47-49 and 51 are therefore taught by Endo.
However, Endo does not explicitly teach:
wherein the exogenous nucleic acid sequence further comprises an expression regulatory element, wherein the expression regulatory element specifically induces expression of the exogenous nucleic acid sequence in bundle sheath cells, mestome sheath cells, or vascular cells of the genetically engineered plant (remaining limitation of claim 37). This is because the regulatory element taught by Endo that allows for the tissue-specific expression is an enhancer in the genome of the plant, not in the exogenous nucleic acid sequence.
wherein the expression regulatory element is a promoter which is active specifically in the bundle sheath cells or vascular cells of a C3 plant (claim 38).
In analogous art, Suzuki teaches the pck1 promoter from Urochloa panicoides is localized to bundle sheath cells and vascular bundle cells in rice (abstract).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Endo to include the limitations of Suzuki to arrive at the instantly claimed method with a reasonable expectation of success because Endo teaches a method of expressing phyB specifically in vascular bundle cells using an enhancer trap system, Suzuki teaches a vascular bundle-specific promoter, and one having ordinary skill in the art could have incorporated the pck1 promoter into the transformation construct rather than the minimal 35S promoter (used in the enhancer trap system) for the purpose of producing transgenic lines that express phyB in vascular bundle cells as taught by Endo. One having ordinary skill in the art would have been motivated to do so because it would be prima facie obvious to substitute one method for another for the same purpose of obtaining transformants that express specifically in vascular bundle cells to promote early flowering in the plants. Additionally, the method taught by Endo is reliant on random integration near an enhancer that will cause the specified expression pattern, whereas the use of the pck1 promoter taught by Suzuki is not random and would be expected to express in vascular bundle cells of all transformants.
Claim 50 is also obvious as a function of inherency. Endo teaches Arabidopsis plants overexpressing phyB in a vascular-bundle-specific manner (p. 1943, section titled PhyB-GFP in Cotyledons Complements phyB-Deficient Early Flowering Phenotype, Table 1). Endo teaches using a 35S promoter in an enhancer trap system to achieve the tissue-specific overexpression, and the use of a promoter that expresses specifically in bundle sheath cells and vascular bundle cells over the trap system taught by Endo would be obvious to achieve the same expression pattern result (see analysis above). Thus, an Arabidopsis plant expressing phyB specifically in a vascular-bundle-specific manner is obvious in view of Endo (and also Endo + Suzuki). Because the instant specification provides evidence that Arabidopsis plants overexpressing the phyB functional variant have enhanced water use efficiency (spec., p 45, Example 3), seemingly attributing the WUE result to expression pattern, and not the functional variant compared to phyB since Applicant claims these gene sequences as interchangeable in the invention, the structurally identical/ obvious plant taught by Endo that expresses phyB in the same pattern and cell/ tissue type would be reasonably interpreted to have the same recited function that is increased water use efficiency.
Claims 40, 45-46, and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Endo and Suzuki as applied to claims 37 and 43 above, and further in view of Hu (Hu, W., Figueroa-Balderas, R.. Chi-Ham, C.. & Lagarias, J.C. (2020). Regulation of monocot and dicot plant development with constitutively active alleles of phytochrome B. Plant Direct, 4(4), e00210).
Claim 40 is drawn to the plant as claimed in claim 37, wherein the exogenous nucleic acid sequence encoding the phytochrome B protein is different to the native phytochrome B gene or genes in the plant.
Claim 45 is drawn to the plant as claimed in claim 37, wherein a protein encoded by the exogenous nucleic acid sequence has phytochrome signaling activity but lacks light sensitivity.
Claim 46 is drawn to the plant as claimed in claim 37, wherein a protein encoded by the exogenous nucleic acid is light insensitive.
Claim 52 is drawn to a pollen grain or seed derived or obtained from the plant of claim 37.
Claim 53 is drawn to the pollen grain or seed of claim 52, wherein the pollen grain or seed comprises a detectable nucleic acid sequence encoding a phytochrome B protein downstream of a gene expression regulatory element active specifically in the bundle sheath or vascular cells of a plant.
Claim 54 is drawn to the plant as claimed in claim 43, wherein the C3 plant is a crop plant selected from the group consisting of a cereal crop plant, an oilseed crop plant, and a legume.
Regarding claims 40, 45,46, and 52-54, Endo and Suzaki teach the limitations of claims 37 and 43 as set forth in the previous obviousness rejection. The teachings of Endo and Suzaki as they are applied to claims 37 and 43 are set forth previously herein and are incorporated by reference.
However, Endo and Suzaki do not explicitly teach the limitations of claims 40, 45-46, and 52-54, as recited above.
Regarding claim 40, Hu teaches overexpressing the Arabidopsis thaliana PHYB functional variant, AtYHB, in transgenic rice (p. 3, section 2.1) (i.e. wherein the exogenous nucleic acid sequence encoding the phytochrome B protein is different to the native phytochrome B gene or genes in the plant).
Regarding claims 45 and 46, Hu teaches YHB is a functional variant of phyB and encodes a light-insensitive “signal-active” protein (p. 11, section 4, ¶1) (i.e. wherein a protein encoded by the exogenous nucleic acid sequence has phytochrome signaling activity but lacks light sensitivity, and wherein a protein encoded by the exogenous nucleic acid is light insensitive).
Regarding claims 52 and 53, Hu teaches the plants overexpressing phyB and YHB produced seed (Table 1, section 4.2). Because the plants taught by Hu are transformed via Agrobacterium-mediated transformation which is a stable, genomic DNA transformation method (meaning the genetic modification is heritably stable) and the plants have a detectable nucleic acid sequence of phyB or YHB by PCR (p. 3, section 2.1), at least some seeds produced by the plants are reasonably expected to inherit the expression construct, express similarly to the parent transformant, and also comprise a detectable nucleic acid sequence of phyB and YHB. Therefore, the combination of Endo and Suzaki, who make obvious the combination of a nucleic acid sequence encoding PHYB downstream a gene expression regulatory element active specifically in the bundle sheath or vascular cells of a plant, with Hu would produce seed comprising the instantly claimed limitations.
Regarding claim 54, Hu teaches the plant is rice (abstract, p. 3, section 2.1) (i.e. a cereal crop plant).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Endo and Suzaki to include the limitations of Hu to arrive at the instantly claimed method with a reasonable expectation of success because Hu teaches a similar method, but teaches transforming a plant with a phytochrome b gene that is identical to the endogenous phytochrome b and also a light-insensitive sequence variant YHB, and one having ordinary skill in the art could incorporate the teachings of Hu and Suzaki into the method of Endo without encountering any special technical obstacles. One having ordinary skill in the art would have been motivated combine the method of Endo with the rice plants and specified genes of Hu because Hu teaches a similar method of phyB overexpression in rice crops (whole document) and Endo teaches vascular bundle-specific expression of phyB resulted in earlier flowering than wild-type controls (p. 1943, section titled PhyB-GFP in Mesophyll Cells Delays Flowering) which is a known desirable trait in rice crops,. Additionally, it would be prima facie obvious to substitute a phytochrome B gene with another known phytochrome B gene, or a known active variant, for the same purpose.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Endo and Suzaki as applied to claim 37 above, and further in view of Dong (Dong, O. X., Yu, S., Jain, R., Zhang, N., Duong, P. Q., Butler, C., ... & Ronald, P. C. (2020). Marker-free carotenoid- enriched rice generated through targeted gene insertion using CRISPR-Cas9. Nature communications, 11(1), 1178).
Claim 41 is drawn to the plant as claimed in claim 37 obtained by a process of CRISPR-Cas protein genetic modification.
Regarding claim 41, Endo and Suzaki teach the limitations of claim 37 as set forth in the previous obviousness rejection. The teachings of Endo and Suzaki as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo and Suzaki do not explicitly teach the plant as claimed in claim 37 obtained by a process of CRISPR-Cas protein genetic modification.
In analogous art, Dong teaches targeted gene insertion using CRISPR-Cas9 (title).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Endo and Suzaki to include the limitations of Dong to arrive at the instantly claimed method with a reasonable expectation of success because Dong teaches an alternative method of introducing transgenes, which could substitute the transformation of Endo without any special technical obstacles. One having ordinary skill in the art would have been motivated to do so because Dong teaches the method uses targeted insertion of transgenes rather than random site integration, and the method may also be free of selectable markers (abstract).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Endo and Suzaki as applied to claim 37 above, and further in view of Aasen (US-20120005773-A1).
Claim 44 is drawn to the plant as claimed in claim 37, wherein a protein encoded by the exogenous nucleic acid sequence has an amino acid sequence of at least 97% identity to any of SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 10.
Regarding claim 44, Endo and Suzaki teach the limitations of claim 37 as set forth in the previous obviousness rejection. The teachings of Endo and Suzaki as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo and Suzaki do not explicitly teach wherein a protein encoded by the exogenous nucleic acid sequence has an amino acid sequence of at least 97% identity to any of SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 10.
In analogous art, Aasen teaches transgenic plants comprising the Arabidopsis-derived polypeptide sequence (SEQ ID NO: 432 of Aasen) which has 100% identity to instant SEQ ID NO: 4 (p. 66, Table 9, claim 3 of Aasen).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Endo and Suzaki to include the limitations of Aasen to arrive at the instantly claimed method with a reasonable expectation of success because the phytochrome polypeptide sequence taught Aasen by was a known and readily obtainable sequence. One having ordinary skill in the art would have been motivated to combine the teachings because it would have been prima facie obvious to search for known sequences of the protein and use one in place of another for the same purpose.
Claims 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Endo, Suzaki, and Hu as applied to claim 37, 54, and 46 above, and further in view of Aasen (US-20120005773-A1).
Claim 55 is drawn to the plant as claimed in claim 45, wherein the protein consists of the PAS and GAF domains.
Claim 56 is drawn to the plant as claimed in claim 46, wherein the protein is a YHB with an amino acid sequence of SEQ ID NO: 4.
Regarding claim 55 and 56, Endo, Suzaki, and Hu teach the limitations of claims 37, 54, and 46 as set forth in the previous obviousness rejection. The teachings of Endo, Suzaki, and Hu as they are applied to claims 37, 45, and 46 are set forth previously herein and are incorporated by reference. Additionally, Hu teaches plant PHY apoproteins comprise an N-terminal photosensory “light input” module consisting of highly conserved PAS, GAF, and PHY domains, and a more diverged C-terminal regulatory “signal output” module with two PAS domains and a histidine kinase-related domain (HKRD) (p.2, ¶1).
However, Endo, Suzaki, and Hu do not explicitly teach wherein the protein consists of the PAS and GAF domains as recited in claim 55, nor wherein the protein is a YHB with an amino acid sequence of SEQ ID NO: 4 as recited in claim 56.
In analogous art, Aasen teaches a polypeptide sequence of a phytochrome protein, including defining the various GAF, PAS, PHY, and Histidine-kinase related domains described by Hu. Aasen further teaches transgenic plants comprising the Arabidopsis-derived polypeptide sequence (SEQ ID NO: 432 of Aasen) which has 100% identity to instant SEQ ID NO: 4 (p. 66, Table 9, claim 3 of Aasen).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Endo, Suzaki, to include the limitations of Aasen to arrive at the instantly claimed method with a reasonable expectation of success because the phytochrome polypeptide sequence taught Aasen by was a known and readily obtainable sequence. One having ordinary skill in the art would have been motivated to combine the teachings because it would have been prima facie obvious to search for known sequences of the protein and use one in place of another for the same purpose.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Endo and Suzaki as applied to claim 37 above, and further in view of Oka (Oka, Y., Matsushita, T., Mochizuki, N., Suzuki, T., Tokutomi, S., & Nagatani, A. (2004). Functional analysis of a 450–amino acid N-terminal fragment of phytochrome B in Arabidopsis. The Plant Cell, 16(8), 2104-2116.).
Claim 57 is drawn to the plant as claimed in claim 37, wherein the phytochrome B protein is a truncated phytochrome B protein.
Regarding claim 57, Endo and Suzaki teach the limitations of claim 37 as set forth in the previous obviousness rejection. The teachings of Endo and Suzaki as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo and Suzaki do not explicitly teach the plant as claimed in claim 37, wherein the phytochrome B protein is a truncated phytochrome B protein.
In analogous art, Oka teaches a known 450 amino-acid phytochrome B fragment (title) (i.e. a truncated phyB).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Endo and Suzaki to include the limitations of Oka to arrive at the instantly claimed method with a reasonable expectation of success because the truncated phytochrome polypeptide sequence taught Oka by was a known and readily obtainable sequence. One having ordinary skill in the art would have been motivated to combine the teachings because it would have been prima facie obvious to search for known sequences, including truncated sequence, of the protein and use one in place of another for the same purpose.
Response to Arguments
Applicant argues beginning on p. 11 of remarks dated 01/30/2026 the
following arguments:
Claims 37-56 rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. Specifically, the Office alleges that "the specification fails to provide an adequate written description to support any functional fragment or active variant recited in claims 37, 45, 46, and/or 53 that are able to effectively confer the functions of a phytochrome B gene and/or protein and produce the recited phenotypes" (See Office Action at pg. 5). Applicant respectfully disagrees.
However, without acquiescing and solely to facilitate prosecution, Applicant has
amended claims 37, 45, 46, and 53 to remove the recitation of "functional fragment thereof' or "sequence variant," thereby rendering the rejections under 35 U.S.C. §112 moot.
Applicant respectfully requests withdrawal of the rejection of claims 37-56 under 35 U.S.C. §112.
Examiner’s Response:
In view of Applicant’s amendments, the rejection under 35 USC 112(a) has been withdrawn.
Applicant argues beginning on p. 12 of remarks dated 01/30/2026 the
following arguments:
Claims 37, and 42-43 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Endo (Endo, M., Nakamura, S., Araki, T., Mochizuki, N., & Nagatani, A. (2005). Phytochrome B in the mesophyll delays flowering by suppressing FLOWERING LOCUS T expression in Arabidopsis vascular bundles. The Plant Cell, 17(7), 1941-1952).
Applicant respectfully disagrees. However, without acquiescing and solely to facilitate prosecution, applicant has amended claim 37 to recite, in part, that "the expression regulatory element specifically induces expression of the exogenous nucleic acid sequence in bundle sheath cells, mestome sheath cells, or vascular cells." The constructs described in Endo utilize a CaMV 35S minimal promoter in a promoter-based enhancer trap approach. The CaMV 35S minimal promoter is not active specifically in bundle sheath cells and/or mestome sheath cells and/or vascular cells. The results observed by Endo are a result of the position in which the transgene is randomly inserted into the genome. As noted by the Office, "the method taught by Endo is reliant on random integration near an enhancer that will cause the specified expression pattern" (See, Office Action at pg. 9). There is no disclosure in Endo of a gene regulatory element that is specifically active in bundle sheath cells, mestome sheath cells, or vascular cells.
For at least this reason, Applicant submits that claim 37 and therefore claims 42-43 depending therefrom are novel over Endo. Applicant respectfully requests withdrawal of the rejections under 35 U.S.C. §102.
Examiner’s Response:
In view of Applicant’s amendments, the rejections under 35 USC 102 have been withdrawn. However, in view of Applicant’s amendments the claims are now rejected under 35 USC 103 (see new rejection above).
Applicant argues beginning on p. 12 of remarks dated 01/30/2026 the
following arguments:
Claim 38 is rejected under 35 U.S.C. §103 as being unpatentable over Endo as applied to claim 37 above, and further in view of Suzuki (Suzuki, S., & Burnell, J. N. (2003). The pckl promoter from Urochloa panicoides (a C4 plant) directs expression differently in rice (a C3 plant) and maize (a C4 plant). Plant Science, 165(3), 603-611).
Claims 39-40, 45-46, and 52-54 are rejected under 35 U.S.C. §103 as being unpatentable over Endo as applied to claim 37 above, and further in view of Hu (Hu, W., Figueroa-Balderas, R.. Chi-Ham, C.. & Lagarias, J.C. (2020). Regulation of monocot and dicot plant development with constitutively active alleles of phytochrome B. Plant Direct, 4(4), e00210).
Claim 41 is rejected under 35 U.S.C. §103 as being unpatentable over Endo as applied to claim 37 above, and further in view of Dong (Dong, O. X., Yu, S., Jain, R., Zhang, N., Duong, P. Q., Butler, C., ... & Ronald, P. C. (2020). Marker-free carotenoid- enriched rice generated through targeted gene insertion using CRISPR-Cas9. Nature communications, 11(1), 1178).
Claim 44 is rejected under 35 U.S.C. §103 as being unpatentable over Endo as applied to claim 37 above, and further in view of Aasen (US20120005773A1).
Claims 55-56 are rejected under 35 U.S.C. §103 as being unpatentable over Endo and Hu as applied to claim 37, 45, and 46 above, and further in view of Aasen (US20120005773A1).
Applicant respectfully disagrees. However, without acquiescing and solely to facilitate prosecution, Applicant has amended claim 37 to recite, in part, "wherein photosynthesis is enhanced in the genetically modified plant." This amendment incorporates the subject matter of claim 48, which the Office has kindly noted is free of the cited art. For at least this reason, Applicant submits that claim 37 and claims 38-47 and 49-57 depending therefrom are inventive over the cited references. Applicant respectfully requests withdrawal of the rejections under 35 U.S.C. §103.
Examiner’s Response:
Upon further consideration, the limitation of previous claim 48 that has been amended into claim 37 is no longer considered free of the prior art. This determination is based on the teaching of Endo that the plants expressing phyB specifically in vascular-bundle cells flowered early compared to controls, which Applicant has noted as a trait of enhanced photosynthesis (see 103 rejection above). As such, a modified rejection has been made to claim 37 and depending claims under 35 USC 103.
Conclusion and Inquiries
No claims are allowed.
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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
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