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, and 18-56 are pending.
Claims 1-6, 8-9, 11-12, 14, 16, and 18-36 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 37-56 are examined herein.
The objections to the specification are withdrawn in view of Applicant’s amendments to the specification and submission of SEQ ID NOs: 14-16.
The objection to claim 44 has been withdrawn in view of Applicant’s amendment to the claim.
The rejections to claims 52-53 under 35 USC §101 as being as being directed to a natural phenomenon without significantly more are withdrawn in view of Applicant’s amendments of the claims.
The rejection to claim 44 under 35 USC § 112(a) have been withdrawn in view of Applicant’s amendments to the claim.
The rejections to claims 38 and 43-46 under 35 USC § 112(b) have been withdrawn in view of Applicant’s amendments to the claims.
The previous rejections to claims 37-40, 42-43, 45, 47, and 51-53 under 35 USC §102 as being anticipated over Hu and as evidenced by Wang and Cornejo are withdrawn in view of Applicant’s amendments of the claims. However, new rejections have been made under 35 USC §102, necessitated by Applicant’s amendments.
The previous rejections to claims 41, 44, 46, and 48-50 under 35 USC §103 as being obvious are withdrawn in view of Applicant’s amendments of the claims. However, new rejections have been made under 35 USC §103, necessitated by Applicant’s amendments.
Claims 37-56 are rejected.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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.
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.
Claims 37-56 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.
Claims 37-56 are broadly drawn to a genetically modified or a genetically engineered plant which carries out C3 photosynthesis in at least a part thereof, wherein the plant has a genetic modification or is genetically engineered to additionally comprise at least one additional copy of a phytochrome B gene or functional fragment thereof, and wherein the plant is genetically altered compared to a genetically equivalent unaltered plant, wherein an expression regulatory element of at least one copy of a phytochrome B gene or functional fragment thereof in the altered plant causes an additional at least one phytochrome B gene, or functional fragment thereof, expression specifically in bundle sheath cells and/or mestome sheath cells and/or vascular cells of the plant compared to the unaltered plant, as recited in claim 37.
Specifically, the written description issue regards the claim to any functional fragment of a phytochrome B gene. Claims 45, 46, and 53 also recite the broad limitation of a “function fragment”, or a “sequence variant”.
The genus of functional fragments or active variants that also have the function of a phytochrome B gene and/or protein is subject matter that is essential to the claims.
Applicant describes a constitutively active variant of PHYB known as YHB which contains a single amino acid change from Y to H at site 276 in the Arabidopsis version of the PHYB gene. This appears to be represented by SEQ ID NO: 1 which is the domesticated Arabidopsis thaliana PHYB coding sequence containing the YHB mutation and encodes SEQ ID NO: 4 which is the domesticated Arabidopsis thaliana PHYB coding sequence containing the YHB mutation.
However, Applicant has not described any other active variant of phytochrome B, nor has Applicant described any functional fragment of phytochrome B.
The prior art fails to remedy this deficiency because there is a dearth of description in the prior art of the structural requirements of phytochrome B fragments and active variants that would be expected to have the required phytochrome B function.
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. The limited example of one active variant and no examples of functional fragments does not describe the claimed genus by virtue of example. Therefore, one of ordinary skill in the art would not have recognized the Applicant to be in possession of the claimed invention at the time the application was filed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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).
This is a new rejection necessitated by Applicant’s amendments to the claims.
Claim 37 is drawn to a genetically modified or a genetically engineered plant which carries out C3 photosynthesis in at least a part thereof, wherein the plant has a genetic modification or is genetically engineered to additionally comprise at least one additional copy of a phytochrome B gene or functional fragment thereof, and wherein the plant is genetically altered compared to a genetically equivalent unaltered plant, wherein an expression regulatory element of at least one copy of a phytochrome B gene or functional fragment thereof in the altered plant causes an additional at least one phytochrome B gene, or functional fragment thereof, expression specifically in bundle sheath cells and/or mestome sheath cells and/or vascular cells of the plant compared to the unaltered plant.
Claim 42 is drawn to the plant as claimed in claim 37, wherein the genetic modification is heritably stable.
Claim 43 is drawn to the plant as claimed in claim 37, wherein the plant is a C3 plant.
Regarding claim 37, Endo discloses a method of genetically engineering Arabidopsis to overexpress PHYB under control of a CaMV 35S minimal promoter to produce ‘PBT lines’ (Fig. 1), and discloses 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).
Regarding claim 42, Endo discloses 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 discloses the plant is Arabidopsis (i.e. a C3 plant) (title, whole document).
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 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 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).
This is a new rejection necessitated by Applicant’s amendments to the claims.
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 and/or vascular cells of a C3 plant
Regarding claim 38, Endo teaches the limitations of claim 37 as set forth in the previous anticipation rejection. The teachings of Endo as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo does not explicitly teach wherein the coding sequence of the additional at least one phytochrome B gene is the same as a native phytochrome B gene or genes in the plant.
In analogous art, Suzuki teaches the pck1 promoter from Urochloa panicoides was localized to bundle sheath cells and vascular bundles of 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. 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.
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).
This is a new rejection necessitated by Applicant’s amendments to the claims.
Claim 39 is drawn to the plant as claimed in claim 37, wherein the coding sequence of the additional at least one phytochrome B gene is the same as a native phytochrome B gene or genes in the plant.
Claim 40 is drawn to the plant as claimed in claim 37, wherein the additional at least one phytochrome B gene 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 additional at least one phytochrome B gene or the functional fragment thereof 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 additional at least one phytochrome B gene is a light insensitive sequence variant.
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 processed product pollen grain or seed comprises a detectable nucleic acid sequence of (i) a phytochrome B or active fragment thereof downstream of a gene expression regulatory element active specifically inthe bundle sheath and/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 39-40, 45,46, and 52-54, Endo teaches the limitations of claim 37 as set forth in the previous anticipation rejection. The teachings of Endo as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo does not explicitly teach the limitations of claims 39-40, 45-46, and 52-54, as recited above.
Regarding claim 39, in analogous art, Hu teaches generating transgenic rice lines by transforming rice plants with a transformation construct comprising the full length rice phytochrome B (OsPHYB) cDNA and a functional variant (OsYHB) constitutively expressed (p. 3, section 2.1).
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 additional at least one phytochrome B gene 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 additional at least one phytochrome B gene or the functional fragment thereof has phytochrome signaling activity but lacks light sensitivity and wherein a protein encoded by the additional at least one phytochrome B gene is a light insensitive sequence variant).
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.
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 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 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 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).
This is a new rejection necessitated by Applicant’s amendments to the claims.
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 teaches the limitations of claim 37 as set forth in the previous anticipation rejection. The teachings of Endo as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo does 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 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 as applied to claim 37 above, and further in view of Aasen (US20120005773A1).
This is a new rejection necessitated by Applicant’s amendments to the claims.
Claim 44 is drawn to the plant as claimed in claim 37, wherein a protein encoded by the additional at least one phytochrome B gene 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 teaches the limitations of claim 37 as set forth in the previous anticipation rejection. The teachings of Endo as they are applied to claim 37 are set forth previously herein and are incorporated by reference.
However, Endo does not explicitly teach wherein a protein encoded by the additional at least one phytochrome B gene 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 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.
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).
This is a new rejection necessitated by Applicant’s amendments to the claims.
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 and Hu teach the limitations of claims 37, 45, and 46 as set forth in the previous obviousness rejection. The teachings of Endo 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 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 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.
Closest Prior Art
Claims 47-51 appear free of the prior art.
Regarding claims 47-51, the closest prior art is 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).
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 discloses 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).
However, Endo does not disclose, teach, or otherwise render obvious plants defined by claim 37 will also have the limitations as recited in claims 47-51.
Response to Arguments
Applicant argues beginning on p. 17 of remarks dated 07/07/2025 the
following arguments:
Claims 37-39 and 42-43 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Hu (Hu, W., et al. (2020). Regulation of monocot and dicot plant development with constitutively active alleles of phytochrome B. Plant Direct, 4(4), e00210), and as evidenced by Wang (Wang, P., et al. (2016). Finding the genes to build C4 rice. Current Opinion in Plant Biology, 31, 44-50) and Cornejo (Cornejo, M. J., et al. (1993). Activity of a maize ubiquitin promoter in transgenic rice. Plant molecular biology, 23, 567-581). Applicant respectfully disagrees.
However, without acquiescing and solely facilitate prosecution, Applicant has amended claim 37 to recite, in part, that expression is "specifically in at least some bundle sheath cells and/or mestome sheath cells and/or vascular cells of the plant compared to the unaltered plant." Applicant submits that the promoters used in Hu are ubiquitous promoters which would result in overexpression without any cell specificity as required by the instant claims. For at least these reasons, Applicant submits that claim 37, and therefore claims 38, 39, 42, and 43 depending therefrom, are novel over the cited references. Applicant respectfully requests withdrawal of the rejections under 35 U.S.C. §102.
This argument has been fully considered and is found not persuasive for
the following reason(s):
Applicant’s arguments regarding the previous 102 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues beginning on p. 17 of remarks dated 07/07/2025 the
following arguments:
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Hu as applied to claim 1 above, and further in view of Dong (Dong, O. X., et al. (2020). Marker-free carotenoid- enriched rice generated through targeted gene insertion using CRISPR-Cas9. Nature communications, 11(1), 1178).
Claims 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Hu as applied to claim 1 above, and further in view of Thiele (Thiele, A., et al. (1999). Heterologous expression of Arabidopsis phytochrome B in transgenic potato influences photosynthetic performance and tuber development. Plant Physiology, 120(1), 73-82).
Claims 44, 46, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Hu as applied to claim 37 above, and further in view of Aasen (US20120005773A1).
Applicant respectfully disagrees. While the Office has not commented on the obviousness of claim 37, Applicant submits that claim 37 is inventive over the cited art for at least the following reasons.
As discussed previously, currently amended claim 37 recites specific expression of the gene constructs in bundle sheath cells and/or mestome sheath cells and/or vascular cells of the plant. The gene constructs utilized in Hu comprise ubiquitous promoters like the maize ubiquitin promoter or the 35S promoter. These promoters drive ubiquitous and constitutively active expression across cell types without specificity, and therefore Hu does not teach the limitations of claim 37. Neither Dong, Thiele, nor Aasen cure the deficiencies of Hu.
Further, Hu notes a number of negative effects associated with such constructs. In section 4.2, Hu describes the results of an experiment which demonstrated that the ubiquitous constructs resulted in reduced "tiller number in both rice cultivars regardless of the photoperiod [...] the panicle number and total grain yield of transgenics will inevitably be lessened" and that "reduced seed yield was also noted for 35S:AtYHB/N. sylvestris plants". See pg. 13 of Hu.
Similarly, Thiele describes results with overexpressing PHYB in potato plants. When transgenic plants were harvested at the same time, that "tuber yields were lower than in wild-type plants". See, pg, 80 of Thiele.
In contrast, the inventors of the instant application noted a surprising discovery using the specifically expressed constructs described in claim 37. For example, as noted in Example 7 of the instant application, "the transgenic plants of the inventors show surprisingly a much greater seed yield than controls when harvested at the same time, regardless of the stage which they are harvested". See pg. 50, In. 34 of the Specification. Accordingly, the present inventors have demonstrated unexpected results associated with the specific expression as claimed. See also pg 30, In. 5-8 of the Specification ("The unexpected finding of the inventors is that combined improvements are achievable separately from the disruptive aspects of PHYB expression by expressing PHYB additionally only in the vascular bundle or component cells thereof of plants.").
For at least these reasons, Applicant submits that claim 37 and therefore any claims depending therefrom (including, for example, claims 41, 44, 46, 48-49, and 50) are inventive in view of the cited art.
This argument has been fully considered and is found not persuasive for
the following reason(s):
This is not found persuasive. With regard to Applicant’s argument that Applicant has offered evidence of unexpected and unobvious results, pursuant to MPEP 716.02(b), the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). In the instant case, Applicant alleges the transgenic plants of the inventors show surprisingly a much greater seed yield than controls when harvested at the same time, regardless of the stage which they are harvested. In the prior art, Endo teaches phyb mutants that have been modified to overexpress phyB specifically in vascular bundles, and teaches this results in an early flowering compared to wild-type controls (p. 1439, section titled PhyB-GFP in Mesophyll Cells Delays Flowering) as well as morphology indistinguishable from phyB mutants. The prior art does not teach any effect on seed yield, therefore it is unclear how vascular bundle-specific expression of phyB would affect seed yield, and the alleged unexpected results appear statistically and practically significant.
Further, even if Applicant can make such a showing, MPEP 716.02(c) provides that the evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. MPEP 716.02(c) directs the examiner to MPEP 716.01(d), which establishes that although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989); Richardson-Vicks, Inc., v. The Upjohn Co., 122 F.3d 1476, 1484, 44 USPQ2d 1181, 1187 (Fed. Cir. 1997) (showing of unexpected results and commercial success of claimed ibuprofen and pseudoephedrine combination in single tablet form, while supported by substantial evidence, held not to overcome strong prima facie case of obviousness). The showing, when made, must outweigh the rationale in support of a finding of prima facie obviousness provided in the 103 rejection(s). Here, in the prior art, Endo teaches about phyb mutants that have been modified to overexpress phyB specifically in vascular bundles, and teaches this results in an early flowering compared to wild-type controls (p. 1439, section titled PhyB-GFP in Mesophyll Cells Delays Flowering) as well as morphology indistinguishable from phyB mutants. The prior art does not teach any effect on seed yield, therefore it is unclear how vascular bundle-specific expression of phyB would affect seed yield. However, the unexpected result is not a required limitation of any claim and is listed as an alternative limitation in depending claim 51. Therefore, because Endo teaches vascular bundle-specific expression of phyB in phyb mutants that results in early flowering compared to wild-type controls (p. 1439, section titled PhyB-GFP in Mesophyll Cells Delays Flowering) as well as morphology indistinguishable from phyB mutants, the unexpected results do not outweigh the 103 rejections set forth previously herein.
Finally, MPEP 716.02(d) provides that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In this case, the scope of the claims appears commensurate with the evidence. However, because claim 37 is drawn to a genetically modified plant but no observed trait, result, or phenotype is required by claim 37, there is no nexus between the unexpected results and the independent claim. Additionally, although claim 51 recites the trait of enhanced seed yield, it is not a required limitation because it is one of many traits that may result from the plant as claimed in claim 47. For these reasons, Applicant’s argument is not found persuasive.
Conclusion and Inquiries
Claims 47-51 appear free of the prior art.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
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