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 .
Election/Restrictions
Applicant's election without traverse of Group I claims 1-6, 13-14 and 18, and the species of SEQ ID NO: 40 and 58 in the reply filed on February 05, 2026 is acknowledged. The restriction is made FINAL.
Claim Status
Claims 1-6, 8-19 and 21, are pending. Claims 7 and 20, are canceled. Claims 9-12, 15-17, 19 and 21, are withdrawn. Claims 1-6, 8, 13-14 and 18, are examined in the instant application.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP22150603.3, filed on 01/07/2022.
Information Disclosure Statement (IDS)
The IDS submitted on 09/24/2024 and 06/24/2024 have been considered. Signed copies are attached.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Page 19: (https://en.novogene.com).
The sequences disclosed in the Specification do not comply with Sequence Rule 1.821(d) under 37 CFR 1.821-1.825. For example, the sequences on page 17, lines 13 and 14 do not have SEQ ID NO. identifiers.
Scientific names, such as Arabidopsis, should be italicized.
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.
Claims 1-6, 8, 13-14 and 18, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a product of nature. Claim interpretation: The limitations “vector” and “mobile genetic element” are not given patentable weight because there is nothing in the vector or mobile genetic element that is structurally different to make it distinguishable from a product of nature, since the claim states the vector only comprises the nucleic acid molecule that encodes a tonoplast proton-fructose symporter. The claimed invention is directed to a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.--(June 13, 2013).
In regard to claim 1, it is directed to a vector comprising a nucleic acid molecule that is claimed is indistinguishable from a naturally occurring gene from a wild-type. The claim states the vector only comprises the nucleic acid molecule that encodes a tonoplast proton-fructose symporter (SEQ ID NO: 40 and 58). SEQ ID NO:40 encoding SEQ ID NO:58 was obtained from Beta vulgaris, a naturally occurring plant. Therefore, there is nothing in the vector that is structurally different to make it distinguishable from a product of nature.
In regard to claim 2, a host cell encompasses a naturally occurring B. vulgaris cell.
In regard to claim 3, a host plant encompasses a naturally occurring B. vulgaris plant.
Claims 4, 5 and 18 are included because the claimed plant is compared to its parent plant, and is not compared to a control plant under the same environmental conditions.
In regard to claim 6, the limitation of “modified promoter” is not given any patentable weight because there is nothing in the promoter that is structurally different to make it “modified”.
In regard to claim 8, due to gene segregation during sexual hybridization, the claimed seed does not necessarily comprise the vector / mobile genetic element. Moreover, a naturally occurring B. vulgaris seed comprises SEQ ID NO: 40 encoding SEQ ID NO: 58.
In regard to claims 13-14, the naturally occurring B. vulgaris plant comprising SEQ ID NO: 40 encoding SEQ ID NO: 58 naturally increases the concentration of fructose in the cytosol of said plant.
Claim Rejections - 35 USC § 112
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.
Claims 1-6, 8, 13-14 and 18, are 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.
In claim 1, it is unclear how a “mobile genetic element” is defined. It is unclear what type of mobility the genetic element has. This is not an art-recognized term and is not clearly defined in Applicant’s disclosure. All subsequent recitations of “mobile genetic element” are rejected.
In claim 1, it is unclear whether there is an implied function or structure for the “tonoplast proton-fructose symporter” recitation. Does Applicant intend for all sequences within the 50% sequence identity to SEQ ID NO: 40 or to a sequence encoding SEQ ID NO:58 to be tonoplast proton-fructose symporters? If not, how does one skilled in the art distinguish tonoplast proton-fructose symporter sequences from non-tonoplast proton-fructose symporter sequences within the 50% sequence identity populations?
In claim 1(b), a nucleic acid molecule that is complementary or hybridizes to SEQ ID NO: 40 encompasses a 2-nucleotide sequence, which does not appear to be Applicant’s intention. Moreover, a sequence that is complementary or hybridizes to SEQ ID NO:40 would be a negative sense sequence and would not encode a protein.
In claim 1(b), the metes and bounds of “stringent conditions” are unclear because what is considered as “stringent” for one skilled in the art may not be “stringent” for another skilled in the art. It is suggested the stringency conditions be recited.
In claim 3 recites “at least one host cell according to claim 2”. Claim 2 does not recite “at least one host cell”. It is suggested “at least one host cell” be amended to “the host cell” for proper antecedence.
In claim 4, it is unclear whether the plant comprises elevated levels of fructose as a result of expressing the vector or mobile genetic element of claim 1, or the claimed plant independently comprises elevated levels of fructose regardless of the presence or absence of the vector or mobile genetic element of claim 1. Claim 4 implies the latter, which does not appear to be Applicant’s intention.
In claims 4 and 5, it is unclear whether the claimed plant is being compared to a wild type plant, or the claimed plant is derived (obtained) from the wild type plant. The recitation of “the wild type plant” suggests the latter, which does not appear to be Applicant’s intention. Also, it is unclear what part of the wild type plant is retained in the derived plant. If Applicant intends the latter interpretation, it is suggested “derived” be amended to “obtained”. Further, does “it” refer to the claimed plant?
In claim 5, it is unclear what level of expression constitutes “overexpresses”. How does one skilled in the art distinguishes “expresses” from “overexpresses”? All subsequent recitations of “overexpresses” or “overexpressed” are rejected.
In claims 6(i)-(ii), “the overexpressed tonoplast proton-fructose symporter” lacks antecedence. Claim 5 states that the plant overexpresses a tonoplast proton-fructose symporter, which is not the same as an endogenous gene or a nucleic acid encoding the overexpressed tonoplast proton-fructose symporter.
In claim 6(i)-(iii), it is unclear whether these embodiments replace the vector / mobile genetic element of claim 4 in the claimed plant, which are not further limiting, or these embodiments are in addition to the vector / mobile genetic element. If Applicant intends the latter, it is suggested “further” be inserted before “comprises”.
In claim 6(i), it is unclear how a modified promoter differs from other promoters. Does the modified promoter modify the “homologously”, the “overexpressed”, or the “homogenously overexpressed” limitation?
In claim 6(i)-(ii), it is unclear how “homologously overexpressed” is defined, and how one skilled in the art can distinguish “homologously overexpressed” from other “overexpressed” embodiments.
In claim 6(iii), it is unclear how “heterologously overexpressed” is defined, and how one skilled in the art can distinguish “heterologously overexpressed” from other “overexpressed” embodiments.
In claim 8, “a plant” should be amended to “the plant” for proper antecedence.
In claim 13, line 2, “the plant” should be amended to “a plant” because there is no antecedence for “the plant”.
In claim 13, it is unclear whether the starting product is a plant producing the storage compound, and the concentration of fructose is increased in said plant, or the plant expresses the vector / mobile genetic element, resulting in an increased concentration of fructose and storage compound.
In claim 13, “a plant of claim 4” should be amended to “the plant of claim 4” for proper antecedence.
In claims 14 and 18, it is unclear whether the “preferably” clause is intended to be a claim limitation. Preferable embodiments are not considered by the Office to be claim limitations.
In claim 14, “selected from” implies at least two embodiments. However, only “sugar” is recited. Starch, protein and lipid are not sugars.
In claim 18, it is unclear whether the recitations within the parentheses are intended to be claim limitations or a nonlimiting examples. It is suggested the parentheses be deleted.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)(Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8, 13-14 and 18, 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 written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Applicant’s disclosure is as follows.
Applicant describes over expressing AtERDL4 in Arabidopsis results in having “a bigger leaf rosette (Fig.4) as well as higher root biomass (Fig.5), the 1000 seed weight is higher (Fig.6) and the lipid content of seeds higher than in control plants (Fig. 7). In addition, sugar flux exported from leaves via the phloem is higher than in control plants (Fig.8)” (ex. 2). Additionally, determined that “ERDL4 over-expressing Arabidopsis thaliana plants fructose content is specifically increased in the cytosol (Fig.9)” (ex.1). Lastly, Applicant determines that overexpression ERDL4 in Arabidopsis to drought conditions results in “fresh weight biomass decreases. However, the decrease of biomass was less pronounced in overexpressor plants than in controls (Fig.12)”.
As for BvIMP2 (BvERDL4;SEQ ID NOs:40 and 58) the Applicant states that “Fructose content of BvlMP2 OX1 and OX2 does not reach the level of fructose in control plants, and it decreases earlier than in control plants” (p.21 ex. 7 lines 28-29). Suggesting that heterologous tonoplast proton-fructose symporters (e.g. SEQ ID NOs: 40 and 58) functionally did not reproduce the same phenotype as endogenous symporters, as seen above.
Claims encompass polynucleotides and polypeptides having as little as 50% sequence identity of SEQ ID NO: 40 and 58 resulting in elevated levels of fructose in the cytosol.
The claimed invention lacks adequate written description for the following reasons. Claims 1-6, 8, 13-14 and 18, are directed to a vector or a mobile genetic element that encodes a tonoplast proton-fructose symporter, wherein the polynucleotide is obtained from any source as long as it has at least 50% sequence identity to SEQ ID NOs: 40 and 58.
The specification does not describe the features of sequences having as little as 50% sequence identity to SEQ ID NOs: 40 and 58 which confer elevated levels of fructose in the cytosol. Therefore, one skilled in the art cannot identify whether the genus of structures as claimed would have functionality.
(1) Applicant has not described the polynucleotide and polypeptide of SEQ ID NOs: 40 and 58. (2) Applicant has not described the genus of structures (i.e., having at least 50% sequence identity to SEQ ID NOs: 40 and 58). (3) Applicant has not described how one would achieve complementary to or hybridizes under stringent conditions with sequences having only 50% sequence identity to SEQ ID NOs: 40 and 58.
Applicant does not describe common structures or motifs for the polynucleotide or polypeptide functionality that is shared by tonoplast proton-fructose symporters. For example, Slewinski, T. (“Diverse functional roles of monosaccharide transporters and their homologs in vascular plants: a physiological perspective” Molecular plant vol. 4,4 (2011): 641-62. doi:10.1093/mp/ssr051(U)), describes “majority of the proteins are considered to be non-specific transporters. For example, AtSTP1 transports glucose, but is also capable of transporting galactose, mannose, and xylose at; 70% the rate of glucose (Sauer et al., 1990; Bu¨ttner, 2010). Very few members of the MST(-like) superfamily have been shown to be single substrate-specific”, (p. 641). Slewinski suggest that these transporters vary in substrate specificity and does not guarantee which metabolite would be elevated in the cytosol, or if tonoplast proton-fructose symporters having at least 50% sequence identity to SEQ ID NOs: 40 and 58 would result in increased levels in the fructose in the cytosol. Therefore, the lack of such identifying characteristics is not sufficient to show the Applicant was in possession of the invention as claimed.
Furthermore, while one skilled in the art can generate a population of sequences having 50% sequence identity to SEQ ID NOs: 40 and 58, it is unpredictable which species within the population would also encode a tonoplast proton-fructose symporter. The disclosure of SEQ ID NOs: 40 and 58 is not representative of sequences having 50% sequence identity to SEQ ID NOs: 40 and 58 and encoding a tonoplast proton-fructose symporter. Especially, if the Applicant’s only example does not produce the desired phenotype (ex.7). No common structure or motif is disclosed.
Applicant has only described how one skilled in the art can readily identify these homologs using BLAST. However, the Applicant does not validate if any of them will produce the same increased fructose levels in the cytosol. Therefore, Applicant has not provided a representative number of sequences to show possession of sequences with as little as 50% sequence identity to SEQ ID NOs: 40 and 58, or allow one skilled in the art to identify sequences having at least 50% sequence identity that would produce increase fructose phenotype.
Lastly, Applicant does not adequately describe how one skilled in the art would achieve complementary to or hybridizes under stringent conditions with sequences having only 50% sequence identity to SEQ ID NOs: 40 and 58. The likelihood of sequences to adequately bind under stringent conditions is very low. For example, Nelson, D. (“Biology 335 molecular genetics Hybridization technology”, Thompson Rivers University, 2008 (V)), describes that under high stringent “conditions tolerate approximately 5% mismatch” (pg.1) and likely result in weak binding (pg.2). Additionally, Don describes that 95% sequence identity is required under high stringent conditions. Applicant has not even described how one skilled in the art to produce a plant using a sequence with at least 95% sequence identity, so how is one skilled in the art going to produce a plant with said phenotype having as little as 50% sequence identity to SEQ ID NOs: 40 and 58. Therefore, one skilled in the art would find it virtually impossible to adequately hybridize with a 50% identical sequence.
Claims 2-3, recites the host comprising said vector but does not address the structures, motifs, and domains that need to be retained in order to see increased fructose phenotype. If none of these are described how would one skilled in the art predictably identify the structures with said phenotype.
Claims 4-5 recites that “a tonoplast proton-fructose symporter relative to the wild type plant from which it is derived” however it is unclear. The Applicant does not clarify whether the heterologous sequences having at least 50% sequence identity to SEQ ID NOs: 40 and 58 of claim 3 will result with the same phenotype as those with endogenous structures of claim 4-5 having at least 50% sequence identity to SEQ ID NOs: 40 and 58.
Claim 6(a): a modified promoter for overexpressing a tonoplast proton-fructose symporter is not adequately described. No structure or modification for any promoter is disclosed to allow one skilled in the art to predict the modified promoter for an endogenous gene to overexpress said gene.
Claim 13, a plant storage compound is not adequately described. Claim 14 further states that the plant storage compound is a sugar, starch, protein or lipid. There is no disclosure as to the type of sugar, starch, protein or lipid yield that is increased by expressing SEQ ID NO: 40 or a nucleic acid molecule encoding SEQ ID NO: 58. For example, Fig. 7 discloses the seed lipid content of seeds from erdl4-knockout mutants and ERDL4-overexpressing Arabidopsis plants. However, the claims do not require any modification of other genes or substrates to achieve the increased lipid content. The same applies for the sugars, starches and proteins. It is highly unpredictable what type of sugar, starch, protein or lipid yield, if any, that is increased by expressing SEQ ID NO: 40 or a nucleic acid molecule encoding SEQ ID NO: 58 absent the modification of other genes and substrates in the target plant.
Claim 14 is directed to a plant storage compound is selected from a sugar, preferably sucrose, starch, a protein or a lipid. However, it depends from claim 13 and it states fructose and not any of the recited compounds. Therefore, it is unpredictable for one skilled in the art to identify the structure without adequately describing the function.
Claim 18 merely recites the plant species but does not address the structures of the polynucleotide and polypeptide having at least 50% sequence identity to SEQ ID NOs: 40 and 58.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 1-6, 8, 13-14 and 18, 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of a patent enable any person skilled in the art to which it pertains to make and use the claimed invention. Although the statute does not say so, enablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original); see also In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’”) “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Wands, supra.
Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. Factors to consider include “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons. To comply with 35 USC 112(a) enablement, one skilled in the art must be able to make and use the claimed invention.
(A) The breadth of the claims
The breadth of the claims encompasses are directed to a vector or a mobile genetic element that encodes a tonoplast proton-fructose symporter, wherein the polynucleotide and polypeptide are obtained from any source as long as it has at least 50% sequence identity to SEQ ID NOs: 40 and 58.
(B) The nature of the invention.
The nature of the claimed invention is directed to are directed to a vector or a mobile genetic element that encodes a tonoplast proton-fructose symporter, wherein the polynucleotide and polypeptide are obtained from any source as long as it has at least 50% sequence identity to SEQ ID NOs: 40 and 58, resulting in increased fructose levels in the cytosol.
(C) The state of the prior art
The state of the prior art does not teach the structures having at least 50% sequence identity to SEQ ID NOs: 40 and 58 that confer increased fructose levels in the cytosol.
(D) The level of one of ordinary skill
The level of one of ordinary skill in the art is high.
(E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claimed invention lacks adequate enabling guidance for the following reasons. Claims 1-6, 8, 13-14 and 18, are directed to a vector or a mobile genetic element that encodes a tonoplast proton-fructose symporter, wherein the polynucleotide is obtained from any source as long as it has at least 50% sequence identity to SEQ ID NOs: 40 and 58.
The specification does not provide the adequate amount of direction or guidance regarding the features of sequences having as little as 50% sequence identity to SEQ ID NOs: 40 and 58 which confer increased fructose activity. Applicant has not even provided one working example of sequences with at least 95% sequence identity, so how is one skilled in the art going to produce a plant with said phenotype having as little as 50% sequence identity to SEQ ID NOs: 40 and 58. From the disclosure of 50% sequence identity to SEQ ID NOs: 40 and 58, one skilled in the art cannot predict the structures that retain functional activity or produce a plant with desired activity.
For example, Slewinski, T. (“Diverse functional roles of monosaccharide transporters and their homologs in vascular plants: a physiological perspective” Molecular plant vol. 4,4 (2011): 641-62. doi:10.1093/mp/ssr051(U)), teaches that “majority of the proteins are considered to be non-specific transporters. For example, AtSTP1 transports glucose, but is also capable of transporting galactose, mannose, and xylose at; 70% the rate of glucose (Sauer et al., 1990; Bu¨ttner, 2010). Very few members of the MST(-like) superfamily have been shown to be single substrate-specific”, (p. 641). Slewinski suggests that these transporters vary in substrate specificity and does not guarantee which metabolite would be elevated in the cytosol, or if tonoplast proton-fructose symporters having at least 50% sequence identity to SEQ ID NOs: 40 and 58 would result in increased levels in the fructose in the cytosol.
Applicant does not teach common structures or motifs for the polynucleotide and polypeptide functionality that is shared by all tonoplast proton-fructose symporters having the same increased fructose activity that would allow one skilled in the art to predict their structures of symporters having as little as 50% sequence identity to SEQ ID NOs: 40 and 58 which confer increased fructose activity.
The specification fails to TEACH, or fails to provide GUIDANCE for making sequences having as little as 50% sequence identity to SEQ ID NOs: 40 and 58 which confer increased fructose activity rendering it unknown if the variants will have the same functional activity. The lack or guidance and the lack of working examples means one skilled in the cannot make and use a polynucleotide and polypeptides having as little as 50% sequence identity to SEQ ID NOs: 40 and 58.
The Applicant claims a genus of sequence defined by 50% sequence identity to SEQ ID NOs: 40 and 58 encompasses deletions, additions, substitutions, and any combination thereof anywhere within SEQ ID NOs: 40 and 58. Applicant provides no guidance as to which region(s) of SEQ ID NOs: 40 and 58.can be mutated and which regions(s) of SEQ ID NOs: 40 and 58 must be conserved for increased fructose activity. While one skilled in the art can make mutations to SEQ ID NOs: 40 and 58, further guidance is needed to readily identify operable embodiments, or readily eliminate inoperable embodiments, without resorting to random trial and error requiring undue experimentation. To require one skilled in the art to make each sequence mutation within said 50% sequence identity, introduce each sequence into a plant cell, grow each plant cell into a plant, and test each mutated sequence for increased fructose activity in all aspects of plant growth would not be routine experimentation.
Lastly, Applicant does not adequately teach how one skilled in the art would achieve complementary to or hybridizes under stringent conditions with sequences having only 50% sequence identity to SEQ ID NOs: 40 and 58. The likelihood of sequences to adequately bind under stringent conditions is very low. For example, Nelson, D. (“Biology 335 molecular genetics Hybridization technology”, Thompson Rivers University, 2008) (V)), teaches that under high stringent “conditions tolerate approximately 5% mismatch” (pg.1) and likely result in weak binding (pg.2). Additionally, Don teaches that 95% sequence identity is required under high stringent conditions. Therefore, one skilled in the art would find it impossible to adequately hybridize with a 50% identical sequence and the Applicant has not provided working examples of how one would achieve this limitation.
Given the breadth of the claims, the lack of sufficient guidance, the absence of working examples regarding the structure of polynucleotide sequences having at least 50% sequence identity to SEQ ID NOs: 40 and 58 which confer functional activity, the state of the prior art, and unpredictability in the art, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without excessive burden and undue experimentation.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
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.
Claims 1-6, 8, 13-14 and 18, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rimon Knopf et al. (US 20190352661 A1 (A)).
In regard to claims 1-3, Rimon Knopf discloses over expressing SEQ ID NOs: 1499 and 2632 (i.e. SEQ ID NOs: 40 and 58,respectively) to increase yield, biomass, and seed yield (see claims 1 and 18). Additionally, SEQ ID NOs: 1499 and 2632 have 52.8% and 76% sequence identity to Applicants SEQ ID NOs: 40 and 58,respectively (see alignments below).
RESULT 5
US-16-466-045-1499
Sequence 1499, US/16466045
Publication No. US20190352661A1
GENERAL INFORMATION
APPLICANT: Evogene Ltd.
APPLICANT: RIMON KNOPF, Ronit
APPLICANT: BROG, Yaacov Micha
APPLICANT: DANGOOR, Inbal Nurith
APPLICANT: DAYAN GLICK, Cathy
APPLICANT: GOREN, Shlomo Zev
APPLICANT: MATARASSO, Noa
APPLICANT: VAN-OSS PINHASI, Ruth
APPLICANT: PORATY GAVRA, Limor
APPLICANT: SHORESH, Michal
APPLICANT: WEISSHAUS, Oori
APPLICANT: GALON WOLFENSON, Yael
APPLICANT: KARCHI, Hagai
TITLE OF INVENTION: METHODS OF INCREASING SPECIFIC PLANTS TRAITS BY
TITLE OF INVENTION: OVER-EXPRESSING POLYPEPTIDES IN A PLANT
FILE REFERENCE: 71283
CURRENT APPLICATION NUMBER: US/16/466,045
CURRENT FILING DATE: 2019-06-03
PRIOR APPLICATION NUMBER: US 62/436,500
PRIOR FILING DATE: 2016-12-20
PRIOR APPLICATION NUMBER: US 62/522,765
PRIOR FILING DATE: 2017-06-21
NUMBER OF SEQ ID NOS: 3156
SEQ ID NO 1499
LENGTH: 1808
TYPE: DNA
ORGANISM: Vitis vinifera
Query Match 52.8%; Score 796.4; Length 1808;
Best Local Similarity 73.8%;
Matches 1026; Conservative 0; Mismatches 361; Indels 3; Gaps 1;
Qy 123 GATGGGTTCAAGACAATCTAGTATTTTCGGGTCTATTGC---TAATATGCGTGAATCCGC 179
|||||| || | ||||| || ||| | || || || | || || || | |
Db 178 GATGGGCTCCCGGCAATCCAGCATTATGGGATCCTCCGCGCAGATCATCCGCGACAACTC 237
Qy 180 CATTTCCATTGTTTTCTGTGTTTTTGTTGTTGCTTTGGGTCCCATCCAATTTGGTTTCAC 239
| | ||| | | | || || | | |||||| |||||||||| || || || |||||
Db 238 CGTCTCCGTCCTCCTATGCGTCCTCATCGTTGCTCTGGGTCCCATTCAGTTCGGCTTCAC 297
Qy 240 CTGTGGGTATTCATCCCCAACTCAATCCGACATCATTAAGGATCTTGACCTTAAAGTTTC 299
|||||||||||| || || || ||||| || ||||| | ||||||| ||| ||||
Db 298 CTGTGGGTATTCTTCTCCTACGCAATCTGAGATCATCAGTGATCTTGGACTTTCCCTTTC 357
Qy 300 CGAGTTCTCATTGTTTGGATCATTGGCTAATGTGGGAGCAATGGTGGGGGCAATTGCGAG 359
|||||||| | ||||| || ||| | |||||||| || ||||| |||||||| || ||
Db 358 AGAGTTCTCTATTTTTGGTTCGTTGTCAAATGTGGGGGCCATGGTTGGGGCAATAGCCAG 417
Qy 360 TGGACAGATTTCTGAATACATTGGAAGAAAAGGGTCATTAATGATCGCCTCAATCCCTAA 419
||| |||||| | |||||||| || || ||||||||| ||||||| || || || |||||
Db 418 TGGTCAGATTGCGGAATACATCGGCAGGAAAGGGTCACTAATGATTGCTTCGATTCCTAA 477
Qy 420 CATTATAGGATGGCTTGTCGTTTCATTTGCGAGGGATGTCTCGTTTCTTTACATGGGACG 479
|| ||||||||||||| | |||||||| ||| || |||||||| |||||| |
Db 478 TATAATAGGATGGCTTGCAATATCATTTGCCCAAGATTCATCATTTCTTTATATGGGAAG 537
Qy 480 CCTGCTGGAAGGTTTTGGTGTTGGCATTATTTCCTACACGGTGCCTGTTTATATAGCCGA 539
|| ||||||| ||||| ||||| | || || ||||| |||||||| |||||||| ||
Db 538 ATTGTTGGAAGGGTTTGGCGTTGGTGTAATCTCTTACACAGTGCCTGTATATATAGCTGA 597
Qy 540 AATAGCACCTCAAAACATGAGGGGAATGCTTGGATCAGTGAACCAGCTTGCTGTTACCAT 599
||| | |||||||| ||||||||| | ||||| || |||||||| | ||||| |
Db 598 GATATCGCCTCAAAATATGAGGGGAGGCTTAGGATCTGTTAACCAGCTCTCAGTTACTCT 657
Qy 600 TGGCATAATGATCGTTTACCTGTTGGGAATTTTTGTTGAGTGGAGAGCACTTGCAATCAT 659
||| ||| | | | || |||||||| |||||||| | ||||| | ||||||| | |
Db 658 TGGAATACTATTGGCATATGTGTTGGGACTTTTTGTTAATTGGAGGGTACTTGCAGTTTT 717
Qy 660 TGGAATCCTACCTTGCGCTGCGTTGATACCTGGATTGTTTTTCATACCAGAATCTCCTCG 719
||||| | || ||| | ||||||||||| | |||||||||||||||||||||||
Db 718 AGGAATTTTGCCATGCACAATATTGATACCTGGTCTATTTTTCATACCAGAATCTCCTCG 777
Qy 720 CTGGCTGGCAAAAATGGGGATGATGGAAGAATGTGAAGCGTCTTTGCAAGTTCTGAGAGG 779
|||||||| |||||||| |||| ||||| | |||||| |||||||||||||| | ||
Db 778 GTGGCTGGCCAAAATGGGAATGACAGAAGATTTTGAAGCATCTTTGCAAGTTCTACGGGG 837
Qy 780 ATTCGATACAGATATCTCGATTGAAATGAATGAAATCAAAAAATCTGTGGGATCATCCAG 839
||| ||||| || || || |||| ||| ||||||||| | |||||||| |||| | |
Db 838 ATTTGATACCGACATTTCTGTTGAGGTGACTGAAATCAAGAGATCTGTGGCATCAACAGG 897
Qy 840 CAAAAGAACAACAATTAGCATTTCACATCTCAAGAGAAAAAGATATTGGTTCCCATTGAT 899
||| ||||| || || ||||| ||||||| | |||||||||||||| || |||||
Db 898 CAAGAGAACTACCATCCAGTTTTCAGATCTCAAACGGAAAAGATATTGGTTTCCTTTGAT 957
Qy 900 GTTAGGAATCGGATTACTTTTGCTTCAGCAGCTCTGTGGTATTAATGGAATATTGTTCTA 959
| |||| || |||||||| |||| ||||| ||| ||||||| ||||| | | |||||
Db 958 GGTAGGGATTGGATTACTCATGCTCCAGCAACTCAGTGGTATCAATGGTGTTCTATTCTA 1017
Qy 960 CTCCCGCACCATATTTGAAATGGCAGGAATATCTGAGGGTGCTGTCGCCACATTTGGTCT 1019
||| | | || |||||| || || || || | ||| | | || ||| |||| ||
Db 1018 TTCCAGTAATATCTTTGAAGCTGCTGGGATTTCATCGAGTGATATTGCAACAGTTGGACT 1077
Qy 1020 TGGAAGCATTCAGGTGGTTGCTACTGGAGTTGCCACTTGGCTGATGGACAGGGCTGGCCG 1079
||| |||||||| |||| ||||| || | |||||| || |||||| ||||| ||
Db 1078 TGGGGTTATTCAGGTCATTGCCACTGGGGTCACTACTTGGTTGGTGGACAAAGCTGGGCG 1137
Qy 1080 AAGGGTTCTTCTTATAGTATCCTCTGTTGGAATGACTGCTAGCCTCCTCCTAGTTTCAGT 1139
||| ||||||| ||||||||||| |||||||||| |||||||||||| || |||||
Db 1138 CAGGCTTCTTCTCATAGTATCCTCCTCTGGAATGACTCTTAGCCTCCTCCTTGTCTCAGT 1197
Qy 1140 CGCATTTTATCTGGAGACCATCGTACCAAAAGACTCGGCATTGCACAGCACGTTGGGCAT 1199
|||||||| ||| || || | || ||||||| ||| | |||| ||||| ||
Db 1198 TGCATTTTACCTGAAGGATGTCATTTCAGAAGACTCTCGATTTTATAGCATATTGGGAAT 1257
Qy 1200 TCTCTCTGTCGTAGGCCTCGTGGCAATGGTGGTTTCCTTTTCTTTGGGAATGGGACCCAT 1259
|| || | || || || ||||| |||| || |||| ||| | ||| | ||| ||||
Db 1258 CCTTTCACTTGTTGGGCTTGTGGCTTTGGTAATTACCTTCTCTCTAGGAGTTGGAGCCAT 1317
Qy 1260 TCCTTGGCTTATAATGTCTGAGATACTTCCAGCTAGTATAAAAGGCCTTGCTGGCAGTGT 1319
||||||| |||||||||| ||||||||||||| ||||| ||||| ||||| ||||| |
Db 1318 TCCTTGGGTTATAATGTCCGAGATACTTCCAGTGAGTATTAAAGGACTTGCAGGCAGCAT 1377
Qy 1320 AGCAACAATGGCGAACTTTCTAACTTCCTGGGGTGTCACTATGACTGCAAACTTGCTGCT 1379
|||||| |||| || | ||||| || |||| || || |||||||||||| | || ||
Db 1378 CGCAACATTGGCAAATTGGCTAACATCATGGGCAGTTACAATGACTGCAAACCTACTCCT 1437
Qy 1380 CGGCTGGAGTAGCGGAGGAACCTTTACAATTTACACATTTTTTGCTGCTTTTACTGTGAT 1439
| ||||| | ||||| ||||| | ||||||||||| | |||||||||| | |
Db 1438 GAGTTGGAGCAAAGGAGGGACCTTCGCTATTTACACATTAATGACTGCTTTTACCATAGT 1497
Qy 1440 ATTTGTGGCTGCATGGCTTCCGGAGACAAAAGGAAAGACGCTCGAGGAGATTCAAGCATA 1499
|||||| | ||| | || || || ||||||| || || || || ||||| |
Db 1498 GTTTGTGACACTTTGGGTCCCTGAAACCAAAGGAAGAACCCTGGAAGAAATTCAGCGGTC 1557
Qy 1500 CTTCAGATAA 1509
|||||||| |
Db 1558 CTTCAGATGA 1567
RESULT 4
US-16-466-045-2632
Sequence 2632, US/16466045
Publication No. US20190352661A1
GENERAL INFORMATION
APPLICANT: Evogene Ltd.
APPLICANT: RIMON KNOPF, Ronit
APPLICANT: BROG, Yaacov Micha
APPLICANT: DANGOOR, Inbal Nurith
APPLICANT: DAYAN GLICK, Cathy
APPLICANT: GOREN, Shlomo Zev
APPLICANT: MATARASSO, Noa
APPLICANT: VAN-OSS PINHASI, Ruth
APPLICANT: PORATY GAVRA, Limor
APPLICANT: SHORESH, Michal
APPLICANT: WEISSHAUS, Oori
APPLICANT: GALON WOLFENSON, Yael
APPLICANT: KARCHI, Hagai
TITLE OF INVENTION: METHODS OF INCREASING SPECIFIC PLANTS TRAITS BY
TITLE OF INVENTION: OVER-EXPRESSING POLYPEPTIDES IN A PLANT
FILE REFERENCE: 71283
CURRENT APPLICATION NUMBER: US/16/466,045
CURRENT FILING DATE: 2019-06-03
PRIOR APPLICATION NUMBER: US 62/436,500
PRIOR FILING DATE: 2016-12-20
PRIOR APPLICATION NUMBER: US 62/522,765
PRIOR FILING DATE: 2017-06-21
NUMBER OF SEQ ID NOS: 3156
SEQ ID NO 2632
LENGTH: 486
TYPE: PRT
ORGANISM: Vitis vinifera
Query Match 76.0%; Score 1915; Length 486;
Best Local Similarity 73.4%;
Matches 369; Conservative 58; Mismatches 58; Indels 18; Gaps 3;
Qy 1 MSSSDAEDARAELRKPFLHTGSWYRMSTGGGKDPISSGSMMMGSRQSSIFGSIAN-MRES 59
|| : || | :||||||||||||| |||||||| || | :|::
Db 1 MSFREEEDGR-DLRKPFLHTGSWYR----------------MGSRQSSIMGSSAQIIRDN 43
Qy 60 AISIVFCVFVVALGPIQFGFTCGYSSPTQSDIIKDLDLKVSEFSLFGSLANVGAMVGAIA 119
::|:: || :||||||||||||||||||||:|| || | :||||:||||:||||||||||
Db 44 SVSVLLCVLIVALGPIQFGFTCGYSSPTQSEIISDLGLSLSEFSIFGSLSNVGAMVGAIA 103
Qy 120 SGQISEYIGRKGSLMIASIPNIIGWLVVSFARDVSFLYMGRLLEGFGVGIISYTVPVYIA 179
||||:||||||||||||||||||||| :|||:| |||||||||||||||:||||||||||
Db 104 SGQIAEYIGRKGSLMIASIPNIIGWLAISFAQDSSFLYMGRLLEGFGVGVISYTVPVYIA 163
Qy 180 EIAPQNMRGMLGSVNQLAVTIGIMIVYLLGIFVEWRALAIIGILPCAALIPGLFFIPESP 239
||:|||||| |||||||:||:||:: |:||:|| || ||::||||| ||||||||||||
Db 164 EISPQNMRGGLGSVNQLSVTLGILLAYVLGLFVNWRVLAVLGILPCTILIPGLFFIPESP 223
Qy 240 RWLAKMGMMEECEASLQVLRGFDTDISIEMNEIKKSVGSSSKRTTISISHLKRKRYWFPL 299
|||||||| |: |||||||||||||||:|: |||:|| |: ||||| | ||||||||||
Db 224 RWLAKMGMTEDFEASLQVLRGFDTDISVEVTEIKRSVASTGKRTTIQFSDLKRKRYWFPL 283
Qy 300 MLGIGLLLLQQLCGINGILFYSRTIFEMAGISEGAVATFGLGSIQVVATGVATWLMDRAG 359
|:|||||:|||| ||||:|||| ||| |||| :|| ||| |||:|||| |||:|:||
Db 284 MVGIGLLMLQQLSGINGVLFYSSNIFEAAGISSSDIATVGLGVIQVIATGVTTWLVDKAG 343
Qy 360 RRVLLIVSSVGMTASLLLVSVAFYLETIVPKDSALHSTLGILSVVGLVAMVVSFSLGMGP 419
||:|||||| ||| |||||||||||: :: :|| :| |||||:|||||:|::||||:|
Db 344 RRLLLIVSSSGMTLSLLLVSVAFYLKDVISEDSRFYSILGILSLVGLVALVITFSLGVGA 403
Qy 420 IPWLIMSEILPASIKGLAGSVATMANFLTSWGVTMTANLLLGWSSGGTFTIYTFFAAFTV 479
|||:||||||| ||||||||:||:||:|||| ||||||||| || |||| ||| |||:
Db 404 IPWVIMSEILPVSIKGLAGSIATLANWLTSWAVTMTANLLLSWSKGGTFAIYTLMTAFTI 463
Qy 480 IFVAAWLPETKGKTLEEIQAYFR 502
:|| |:|||||:|||||| ||
Db 464 VFVTLWVPETKGRTLEEIQRSFR 486
Furthermore, Rimon Knopf discloses that these sequences are delivered to a plant cell (see claim 14) via a nucleic construct (i.e. vector) (see claim 11). As for the limitation of hybridizing under stringent conditions the claims only require 50% sequence identity so as long as it meets these conditions.
In regard to claim 4, the limitation of “elevated levels of fructose in the cytosol” is an inherent property of overexpressing SEQ ID NOs: 40 and 58, resulting in increased seed yield and biomass.
In regard to claim 6, since SEQ ID NOs: 1499 and 2632 meet the limitation of 50% sequence identity to Applicants SEQ ID NOs: 40 and 58, then they qualify as tonoplast proton-fructose symporter as defined in Applicant’s claims. Additionally, as these sequences originate from Vitis vinifera, they represent heterologous nucleic acid encoding a heterologous tonoplast proton-fructose symporter.
In regard to claim 8, since Rimon Knopf discloses increasing seed yield, that reads on “a seed of a plant according to claim 4”.
In regard to claims 13-14, Rimon Knopf discloses a method of increasing yield (see claim 1) and since both the prior art and the Applicant disclose overexpressing SEQ ID NOs: 40 and 58 it would inherently increase fructose in the cytosol of the plant. Additionally, Rimon Knopf discloses increasing storage compounds such as seed oil (i.e. lipid) (see claim 24).
In regard to claim 18, Rimon Knopf discloses the potential plants to be used with said construct such as sugar beet (paragraph [0436]).
Therefore, the claims are anticipated by the art.
Conclusion
No claims are allowed.
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/C.J.O./Examiner, Art Unit 1663 /PHUONG T BUI/Primary Examiner, Art Unit 1663