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 .
DETAILED ACTION
Election/Restrictions
1. Applicant’s election without traverse of Group I (claims 1-3 and 6-16) and bHLH093 polypeptide as set forth in SEQ ID NO: 3 in the reply filed on May 5, 2026 is acknowledged. Claims 1-27 are pending. Claims 4, 5 and 17-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 5, 2026. It is noted that claim 25 was erroneously left out of Group II in the requirement for restriction mailed in papers of February 11, 2026. This is being corrected through this Office action.
Accordingly, claims 1-3 and 6-16 in conjunction with the elected bHLH093 polypeptide as set forth in SEQ ID NO: 3 (encoded by SEQ ID NO: 4) are examined on merits in the present Office action. This restriction is made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Information Disclosure Statement
2. The listing of references in the specification (pages 32-35) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
3. Claims 1, 3, 11, 12, 13 and 16 are objected to because of the following informalities:
Claim 1, 3, 12 and 16 are objected for objected for having non-elected subjected matter. Non-elected subject matter includes polypeptides MYBS2, ATHB25, DiV2, CESTA1, TGA4, SPL12, AGL18, including any combination thereof, and SEQ ID NOs: 1, 5, 7, 9, 11, 13 and 15, and including any combination thereof.
In claims 11 and 13, it is suggested to change the recitation “a cauliflower mosaic virus promoter (such as CaMV 35S or CaMV 19S)” in lines 2-3 to ---- a cauliflower mosaic virus promoter CaMV 35S, a cauliflower mosaic virus promoter CaMV 19S--- as a part of Murkush group for the clarity of the claimed subject matter. The recitation “(such as CaMV 35S or CaMV 19S)” can raise issues under 112(b), like whether recitation within parenthesis is part of claim limitation etc. Even the recitation “such as” can invoke issues under 112(b). That does not Appear to be Applicant’s intention.
In claims 11 and 13 , it is suggested to change the recitation “actin promoter (such as from rice)” in lines 3-4 to ---a rice actin promoter--- as a part of Murkush group for the clarity of the claimed subject matter. The recitation “(such as from rice)” can raise issues under 112(b), like whether recitation within parenthesis is part of claim limitation etc. Even the recitation “such as can invoke issues under 112(b). That does not Appear to be Applicant’s intention.
Appropriate correction is required.
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.
4. Claims 2, 9 and 14 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 pre-AIA the applicant regards as the invention.
Claims 9 and 14 are rejected under 35 U.S.C. 112(b), as being indefinite in their recitation “strong” because the term "strong" is a relative term which renders the claim indefinite. The term “strong" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the recitation “strong” are unclear as they not defined. The recitation lacks a comparative basis. Without defined thresholds or reference standards, one skilled in the art cannot determine the scope with reasonable certainty. See Nautilus v. Biosig, 572 U.S. 898. However, replacing “strong” by ---constitutive--- can overcome this rejection because a constitutive promoter is accepted to be a strong promoter in the art.
Claim 2 is rejected under 35 U.S.C. 112(b), as being indefinite for their recitation “approximately” because the phrase "approximately 10% to approximately 20% more seed lipid content” lacks clarity regarding measurement methodology reference baseline, and statistical variability. It is unclear whether the comparison is per seed, per weight, or per plant population. Additionally, the recitation “approximately” is a term of approximation. It is noted that the specification does not define “approximately”, does not identify an acceptable margin of error or variance around the recited 10% and 20% endpoints, and does not otherwise provide objective boundaries for determining what value fall within or outside the claimed range. Thus, it is unclear whether, for example, 9%, 9.5%, 20.5%, 21% , or other values are encompassed by the claim.
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.
5. Claims 1, 3 and 6-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1: Statutory category.Claims 1 is directed to a plant cell, plant seed, or plant. A plant, seed, or cell is a composition of matter or
manufacture and therefore falls within a statutory category under 35 U.S.C. § 101.
Step 2A, Prong One: Judicial exception.
Claim 1 recites an expression system comprising an expression cassette with a promoter operably linked to a nucleic acid segment encoding bHLH093. To the extent the claim encompasses a naturally occurring plant cell, seed, or plant, or naturally occurring genetic material, the claim is directed to a product of nature. The bHLH093 gene and corresponding polypeptide are naturally occurring. See for example, Tabata et al. (GenBank Sequence accession No. NM_125962.4, Published 2019) who teach naturally occurring Arabidopsis plant showing presence of naturally occurring bHLH093 gene having native expression cassette with native promoter and terminator sequences, and encoding bHLH093 polypeptide having 100% identity to instant SEQ ID NO: 3. The bHLH093 gene disclosed in the reference is located naturally on the chromosome 5 of the Arabidopsis genome as taught in the reference. The claims do not recite a structurally modified gene or non-natural sequence, but rather encompass naturally occurring sequences and variants with ≥95% identity. Likewise, instantly claimed bHLH093 gene is also present naturally in other plant species, such as but not limited to Brassica species as evident from genome sequencing results of naturally occurring plant genome.
Step 2A, Prong Two: Markedly different characteristics.
The claim does not require any structural or functional characteristic that is markedly different from what exists in nature. The claim broadly recites bHLH093 expression without limiting the plant to a non-natural transformation event, non-natural promoter/nucleic acid combination, or a defined engineered construct producing a changed phenotype. Therefore, the claim does not clearly establish markedly different characteristics. See Diamond v. Chakrabarty, 447 U.S. 303 (1980), patent eligibility requires markedly different characteristics from what exists in nature.
Step 2B: Inventive concept/significantly more.
The additional elements, including a promoter, expression cassette, and expression system, are recited generically and do not add significantly more than the natural product itself. The claim does not require a specific non-conventional promoter, transformation method, construct architecture, or engineered modification sufficient to transform the judicial exception into patent-eligible subject matter. See In re Roslin Institute, 750 F.3d 1333 (Fed. Cir. 2014) who describe that a biological product lacking meaningful structural or functional counterpart is not patent eligible.
In order to overcome this rejection, It is suggested to amend the claims by clearly reciting that plant cell, plant seed or plant are transgenic obtained by transforming said plant cell, plant seed or plant with an expression cassette comprising a heterologous promoter operably linked to a nucleotide sequence encoding instantly claimed bHLH093 polypeptide.
Claim Rejections - 35 USC § 112
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.
6. Claims 1-3 and 6-16 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to a plant cell, plant seed, or plant comprising an expression system comprising an expression cassette comprising a promoter operably linked to a nucleic acid segment encoding a polypeptide for bHLH093, or wherein the plant seed has approximately 10% to approximately 20% more seed lipid content than a corresponding wild- type plant seed, or wherein the polypeptide for bHLH093 has at least 95% sequence identity to SEQ ID NO: 3, or wherein the plant cell, plant seed, or plant is an oil crop plant cell, plant seed, or plant, or wherein the oil crop is a Brassica species, camelina, soybean, corn, sunflower, cotton, peanut, or avocado, or wherein the Brassica plant species is Brassica rapa, Brassica juncea, Brassica napus, or Brassica carinata, or wherein the promoter is a strong or inducible promoter, or wherein the promoter is a tissue- specific promoter, or wherein the promoter is selected from a cauliflower mosaic virus promoter (such as CaMV 35S or CaMV 19S), nos promoter, Adhl promoter, sucrose synthase promoter, a-tubulin promoter, ubiquitin promoter, actin promoter (such as from rice), cab promoter, PEPCase promoter, R gene complex promoter, poplar xylem-specific secondary cell wall specific cellulose synthase 8 promoter, Z10 promoter from a gene encoding a 10 kDa zein protein, Z27 promoter from a gene encoding a 27 kDa zein protein, pea rbcS gene, and phaseolin promoter, an expression cassette comprising a promoter operably linked to a nucleic acid segment encoding a polypeptide for bHLH093, or wherein the promoter is selected from a cauliflower mosaic virus promoter (such as CaMV 35S or CaMV 19S), nos promoter, Adhl promoter, sucrose synthase promoter, a-tubulin promoter, ubiquitin promoter, actin promoter (such as from rice), cab promoter, PEPCase promoter, R gene complex promoter, poplar xylem- specific secondary cell wall specific cellulose synthase 8 promoter, Z10 promoter from a gene encoding a 10 kDa zein protein, Z27 promoter from a gene encoding a 27 kDa zein protein, pea rbcS gene, and phaseolin promoter, or wherein the promoter is a strong or inducible promoter, or wherein the promoter is a tissue-specific promoter, or wherein the polypeptide for bHLH093 has at least 95% sequence identity to SEQ ID NO: 3.
Claims are directed a nucleic acid segment encoding a polypeptide for bHLH093 from any source, and/or whose expression in plant increases seed lipid by approximately 10% to approximately 20%. Claims are also directed to a nucleic acid segment encoding a polypeptide of bHLH093 having amino acid identity of 95% identity to instant SEQ ID NO: 3.
The breadth of claims encompasses a very large genus comprising diverse species which are derived from diverse sources. For example, the genus encompassed by the breadth and scope of the claims include but not limited to bHLH093 genes from lower eukaryotes, higher eukaryotes (animal and plant species) etc., and having the function of increasing seed lipid content in any plant species, or part thereof upon expression of said bHLH093 genes gene(s) derived from said diverse sources.
A 95% identity to SEQ ID NO: 3 would encompass unspecified 17 amino acid changes to the 351 amino acid long full-length bHLH093 polypeptide as set forth in instant SEQ ID NO: 3. This will encompass a genus having species with unknown structures, whose structure function cannot be reliably predicted.
The instant specification, however, only describes over-expression of bHLH093 polypeptide coding sequence as set forth in SEQ ID NO: 4 which is derived from Arabidopsis thaliana by transforming Arabidopsis plants with a nucleic acid sequence encoding of bHLH093 polypeptide protein coding sequences derived from Arabidopsis thaliana as set forth in SEQ ID NO: 4 and encoding the bHLH093 polypeptide of SEQ ID NO: 3. The transgenic plants overexpressing bHLH093 polypeptide of SEQ ID NO: 3 exhibited 11.33% to 18.80% increase in total seed oil of the transgenic plant. See in particular, example 6 at paragraphs [0099]-[0106] of the specification.
The specification does not describe the structure for representative members of bHLH093 genes of Applicant’s broadly claimed genus from diverse sources as encompassed by the breadth and scope of claims and thus their function of increasing seed lipid content upon overexpression in a plant is either unknown or unpredictable.
The specification does not correlate the structure of representative members of Applicant’s broadly claimed genus comprising bHLH093 genes and their variants from diverse sources as encompassed by the breadth and the scope of the claims to the function of increasing protein content upon overexpression in a diverse plant species.
State of the related art suggests that bHLH093 genes and their encoded proteins are involved in diverse functions. See for example, Cheng et al. (Front. Plant Sci., 13:1007895; doi: 10.3389/fpls.2022.1007895) who teach that VvibHLH93 from grapevine negatively regulates proanthocyanidin biosynthesis in grapevine. See in particular, abstract, Figs. 1-7.
This implies that members of bHLH093 transcription factor gene family isolated from diverse sources are implicated in diverse functions.
Thus one of skilled in the art would not expect all bHLH093 gene(s) and their encoded proteins would result increase in seed lipid content upon overexpression in a transgenic plant environment. The specification does not teach which bHLH093 gene(s) and their encoded proteins would confer this trait and which would not.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of a functional bHLH093 gene(s) and their encoded proteins. Applicant’s broadly claimed genus encompasses structures whose function is unrelated to bHLH093 protein as set forth in SEQ ID NO: 3. The specification fails to describe the function of increased oil content for a representative species of Applicant’s broadly claimed genus.
The only species whose structure and function is described in the specification is bHLH093 protein coding sequence as set forth in SEQ ID NO: 4 encoding the Arabidopsis bHLH093 polypeptide as set forth in SEQ ID NO: 4. Structure of nucleic acid sequences encoding bHLH093proteins from diverse sources are not described, and thus their function is unknown.
It is also important to note the state of the art for inferring a structure function relationship based on sequence homology is highly unpredictable. The functional prediction of a protein based on structural comparison is not consistent with an empirical assessment of its function. See for example, Doerks et al., (TIG, 14:248-250, 1998) who teach that sequence homology is not sufficient to determine functionality of an uncharacterized protein. The homologs that scored best in PSI-BLAST analysis failed to share same catalytic activity. The reference clearly emphasizes that computer analysis of genome sequences is flawed, and overpredictions are common because the highest scoring database protein does not necessarily share the same or even similar functions. See in particular, page 248, 1st paragraph; page 248, right column, 2nd paragraph.
Also see Smith et al. (Nature Biotechnology, 15:1222-1223, 1997) who teach that there are numerous cases in which proteins of very different functions are homologous. See in particular, page 1222, last paragraph.
Also see Bork et al. (TIG, 12:425-427, 1996) who teach that homology search methods are stretched and spurious hits are taken as real. The reference further teaches that similarities determined by homology search might only be restricted to certain domains of the uncharacterized protein, whereas the whole protein is required for the functionality of the protein. See page 426, right column, 1st paragraph.
Thus one of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, bHLH093 coding sequence of SEQ ID NO: 4 encoding the bHLH093 protein as set forth in SEQ ID NO: 3 and derived from Arabidopsis thaliana are insufficient to describe the claimed genus.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
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.
7. Claims 1-3 and 6-16 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for transgenic plant having increased seed lipid content (11.33% to 18.80%) compared to a control plant, comprising transforming a plant with a nucleotide sequence encoding bHLH093protein as set forth in SEQ ID NO: 3, does not reasonably provide enablement for (a) any bHLH093 gene and its encoding polypeptide; (b) sequences having 95% identity to instant SEQ ID NO: 3; and (c) increasing total oil content in a plant by a method that does not involve transformation and selection of transgenic plants overexpressing transgenic bHLH093 protein as set forth in SEQ ID NO: 3. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claims are broadly drawn to a plant cell, plant seed, or plant comprising an expression system comprising an expression cassette comprising a promoter operably linked to a nucleic acid segment encoding a polypeptide for bHLH093, or wherein the plant seed has approximately 10% to approximately 20% more seed lipid content than a corresponding wild- type plant seed, or wherein the polypeptide for bHLH093 has at least 95% sequence identity to SEQ ID NO: 3, or wherein the plant cell, plant seed, or plant is an oil crop plant cell, plant seed, or plant, or wherein the oil crop is a Brassica species, camelina, soybean, corn, sunflower, cotton, peanut, or avocado, or wherein the Brassica plant species is Brassica rapa, Brassica juncea, Brassica napus, or Brassica carinata, or wherein the promoter is a strong or inducible promoter, or wherein the promoter is a tissue- specific promoter, or wherein the promoter is selected from a cauliflower mosaic virus promoter (such as CaMV 35S or CaMV 19S), nos promoter, Adhl promoter, sucrose synthase promoter, a-tubulin promoter, ubiquitin promoter, actin promoter (such as from rice), cab promoter, PEPCase promoter, R gene complex promoter, poplar xylem-specific secondary cell wall specific cellulose synthase 8 promoter, Z10 promoter from a gene encoding a 10 kDa zein protein, Z27 promoter from a gene encoding a 27 kDa zein protein, pea rbcS gene, and phaseolin promoter, an expression cassette comprising a promoter operably linked to a nucleic acid segment encoding a polypeptide for bHLH093, or wherein the promoter is selected from a cauliflower mosaic virus promoter (such as CaMV 35S or CaMV 19S), nos promoter, Adhl promoter, sucrose synthase promoter, a-tubulin promoter, ubiquitin promoter, actin promoter (such as from rice), cab promoter, PEPCase promoter, R gene complex promoter, poplar xylem- specific secondary cell wall specific cellulose synthase 8 promoter, Z10 promoter from a gene encoding a 10 kDa zein protein, Z27 promoter from a gene encoding a 27 kDa zein protein, pea rbcS gene, and phaseolin promoter, or wherein the promoter is a strong or inducible promoter, or wherein the promoter is a tissue-specific promoter, or wherein the polypeptide for bHLH093 has at least 95% sequence identity to SEQ ID NO: 3.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are directed a nucleic acid segment encoding a polypeptide for bHLH093 from any source, and/or whose expression in plant increases seed lipid by approximately 10% to approximately 20%. Claims are also directed to a nucleic acid segment encoding a polypeptide of bHLH093 having amino acid identity of 95% identity to instant SEQ ID NO: 3.
The breadth of claims encompasses bHLH093 gene sequences from diverse species which are derived from diverse sources. For example, the breadth and scope of the claims encompasses includes but not limited to bHLH093 gene(s) from lower eukaryotes, higher eukaryotes (animal and plant species) etc., and which produce a trait of increasing seed lipid content upon overexpression of said bHLH093 gene(s) derived from said diverse sources.
Furthermore, claims are also directed to a nucleotide sequence encoding a polypeptide having at least 95% sequence identity to instant SEQ ID NO: 3.
Making all possible single amino acid substitutions in an 351 amino acid long protein like that encoded by SEQ ID NO: 3 would require making and analyzing 19351 nucleic acid sequences; these proteins would have 99.71% identity to SEQ ID NO: 3. Because nucleic acid sequences encoding proteins with 95% sequence identity to the 351 amino acid long SEQ ID NO: 3 would encode proteins with at least 17 random amino acid substitutions relative to SEQ ID NO: 3, many more than 19351 nucleic acid sequences would need to be made and analyzed.
The instant specification, however, only provides guidance on over-expression of bHLH093 polypeptide coding sequence as set forth in SEQ ID NO: 4 which is derived from Arabidopsis thaliana by transforming Arabidopsis plants with a nucleic acid sequence encoding of bHLH093 polypeptide protein coding sequences derived from Arabidopsis thaliana as set forth in SEQ ID NO: 4 and encoding the bHLH093 polypeptide of SEQ ID NO: 3. The transgenic plants overexpressing bHLH093 polypeptide of SEQ ID NO: 3 exhibited 11.33% to 18.80% increase in total seed oil of the transgenic plant. See in particular, example 6 at paragraphs [0099]-[0106] of the specification.
The instant specification fails to provide guidance on how to isolate nucleic acid sequences encoding bHLH093 protein encoding genes from diverse sources (e.g. lower eukaryotes, lower plants, monocot, dicots, animals etc.) as encompassed by the claims and use such diverse bHLH093 protein encoding genes in a method to increase seed lipid content in a plant.
State of the related art suggests that bHLH093 genes and their encoded proteins are involved in diverse functions. See for example, Cheng et al. (Front. Plant Sci., 13:1007895; doi: 10.3389/fpls.2022.1007895) who teach that VvibHLH93 from grapevine negatively regulates proanthocyanidin biosynthesis in grapevine (see in particular, abstract, Figs. 1-7).
This implies that members of bHLH093 transcription factor gene family isolated from diverse sources are implicated in diverse functions.
Thus one of skilled in the art would not expect all bHLH093 gene(s) and their encoded proteins would result increase in seed lipid content upon overexpression in a transgenic plant environment. The specification does not teach which bHLH093 gene(s) and their encoded proteins would confer this trait and which would not.
The state of the art for inferring a structure function relationship based on sequence homology is highly unpredictable. The functional prediction of a protein based on structural comparison is not consistent with an empirical assessment of its function. See for example, Doerks et al., (TIG, 14:248-250, 1998) who teach that sequence homology is not sufficient to determine functionality of an uncharacterized protein. The homologs that scored best in PSI-BLAST analysis failed to share same catalytic activity. The reference clearly emphasizes that computer analysis of genome sequences is flawed, and overpredictions are common because the highest scoring database protein does not necessarily share the same or even similar functions. See in particular, page 248, 1st paragraph; page 248, right column, 2nd paragraph.
Also see Smith et al. (Nature Biotechnology, 15:1222-1223, 1997) who teach that there are numerous cases in which proteins of very different functions are homologous. See in particular, page 1222, last paragraph.
Also see Bork et al. (TIG, 12:425-427, 1996) who teach that homology search methods are stretched and spurious hits are taken as real. The reference further teaches that similarities determined by homology search might only be restricted to certain domains of the uncharacterized protein, whereas the whole protein is required for the functionality of the protein. See page 426, right column, 1st paragraph.
Thus, in the absence of guidance, isolating and analyzing bHLH093 protein encoding genes from diverse sources that can be used in a method to increase seed lipid content in a plant or a part thereof would require undue experimentation.
Making amino acid substitutions in SEQ ID NO: 3 protein is unpredictable. While it is known that many amino acid substitutions, additions or deletions are generally possible in any given protein the positions within the protein's sequence where such amino acid changes can be made with a reasonable expectation of success (without altering protein function) are limited. Certain positions in the sequence are critical to the protein's structure/function relationship, e.g. such as various sites or regions directly involved in binding, activity and in providing the correct three-dimensional spatial orientation of binding and active sites. These regions can tolerate only relatively conservative substitutions or no substitutions (see for example, Wells, Biochemistry 29:8509-8517, 1990, see pages 8511-8512, tables 1-2; Ngo et al., pp. 492-495,1994, see page 491, 1st paragraph).
Also, see Guo et al. (PNAS, 101: 9205-9210, 2004, see page 9205, abstract; page 9206, table 1; page 9208, figure 1) who teach that there is a probability factor of 34% that a random amino acid replacement in a given protein will lead to its functional inactivation. In the instant case, such a probability factor will be much higher as the claim encompasses more than a single amino acid changes in the encoded protein of SEQ ID NO: 3.
Also see, Keskin et al. (Protein Science, 13:1043-1055, 2004, see page 1043, abstract) who teach that proteins with similar structure may have different functions. Furthermore, Thornton et al. (Nature structural Biology, structural genomics supplement, November 2000, page 992, 2nd paragraph bridging columns 1 and 2) teach that structural data may carry information about the biochemical function of the protein. Its biological role in the cell or organism is much more complex and actual experimentation is needed to elucidate actual biological function under in vivo conditions.
Also see McConnell et al. (Nature, 411:709-713, 2001; see in particular, abstract; figure 2) who teach that a single amino acid change (glycine to aspartic acid) in START domain of either PHABULOSA or PHAVOLUTA (homeodomain leucine zipper domain containing transcription factor) was sufficient to alter sterol/lipid binding domain activity.
Also see Hanzawa et al. (PNAS, 102:7748-7753, 2005; see in particular, abstract, Figures 1-5) who teach that a single amino acid change in Terminal Flower (TFL1) repressor protein converts its repressor function to an activator having FT (Flowering locus) function in flowering.
Additionally, also see Wishart et al. (JBC, 270:26782-26785, 1995; see in particular abstract; Figures 1-4) who teach that a single mutation converts a novel phosphotyrosine binding domain into a dual-specificity phosphatase.
Applicant is reminded that even in cases where a protein with a known function is expressed in a plant can produce unpredictable results. For example, Nishimura et al. (Plant Cell Physiol., 41(5):583-590, 2000; see in particular, abstract) describe over-expression of NTH15 and NTH20 proteins (transcription factors) in a transgenic plant resulted in abnormal leaf morphology. Also see Yang et al. (PNAS, 98:11438-11443, 2001; abstract; pages 11442-11443) who teach that transgenic rice plants constitutively overexpressing REB transcription factor resulted in sterile transgenic plants.
Thus, making and analyzing proteins with large amino acid changes that have a biological activity would require undue experimentation.
Thus, making and analyzing proteins with large amino acid changes that also have the activity of improving instantly claimed characteristics when overexpressed in a plant would require undue experimentation.
Thus, extensive teachings are required for making nucleic acids encoding a protein with unspecified amino acid substitutions relative to SEQ ID NO: 3 (encoded by SEQ ID NO: 4), as encompassed by the claimed product. These teachings are not provided for by the specification. The specification also fails to overcome the unpredictability of making large numbers of amino acid substitutions in SEQ ID NO: 3 protein as it provides no working examples of proteins with unspecified amino acid substitutions relative to SEQ ID NO: 3.
Given the claim breath, unpredictability, and lack of guidance as discussed above, undue experimentation would have been required by one skilled in the art to develop and evaluate bHLH093 protein encoding genes, including sequences having 95% identity to SEQ ID NO: 3, from diverse sources to increase seed lipid content in a plant or a part thereof as instantly claimed.
In the absence of guidance, undue trial and error experimentation would be required to screen through the myriad of nucleic acids encompassed by the claims and plants transformed therewith, to identify those that can increase seed lipid content when over-expressed in a plant or a part (seed) thereof. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 at page 1027, where it is taught that the disclosure of a few gene sequences did not enable claims broadly drawn to any analog thereof.
Claims also encompass over-expressing in a plant or part thereof any bHLH093 gene using any method. The instant specification, however, only provides guidance on over-expression of bHLH093 polypeptide coding sequence as set forth in SEQ ID NO: 4 which is derived from Arabidopsis thaliana by transforming Arabidopsis plants with a nucleic acid sequence encoding of bHLH093 polypeptide protein coding sequences derived from Arabidopsis thaliana as set forth in SEQ ID NO: 4 and encoding the bHLH093 polypeptide of SEQ ID NO: 3. The transgenic plants overexpressing bHLH093 polypeptide of SEQ ID NO: 3 exhibited 11.33% to 18.80% increase in total seed oil of the transgenic plant. See in particular, example 6 at paragraphs [0099]-[0106] of the specification.
However, specification does not provide guidance on making said plant or parts thereof, comprising overexpressing said bHLH093 protein encoding genes from Arabidopsis as set forth of SEQ ID NO: 4 encoding SEQ ID NO: 3, in any manner other than a method that comprises transforming a plant with a nucleic acid sequence which encode said bHLH093 protein encoding genes. The specification does not provide guidance on co-factors, or positive regulators of said bHLH093 protein encoding genes from Arabidopsis as set forth of SEQ ID NO: 4 encoding SEQ ID NO: 3, for example that makes the endogenous genes to overexpress to increase seed lipid content in a plant. The specification provides no guidance on up-stream regulatory factors, for example, that may be necessary in stimulating the overexpression of said endogenous genes.
In the absence of adequate guidance, undue experimentation would have been required by a skilled artisan to determine how to practice a method that comprises over-expression of said bHLH093 protein encoding genes, without transforming the plant with said bHLH093 protein encoding genes.
Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
Claim Rejections - 35 USC § 102
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.
8. Claim(s) 1-3, 6 and 9-16 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Ohashi-Ito et al. (The Plant Cell, 18:2493-2505, 2006).
Ohashi-Ito et al. disclose a method of producing a transgenic plant cell comprising transformation of said plant cell with a plant transformation vector comprising an expression cassette which comprises a nucleic acid sequence ( At5g65640 gene) encoding a bHLH093 polypeptide which has 100% amino acid sequence identity to instant SEQ ID NO: 3. The reference further discloses that the vector comprising said nucleic acid sequence is operably linked to a promoter (strong constitutive CaMV 35S promoter or inducible promoter), which is capable of causing transcription in a plant cell, and wherein said promoter is either native or heterologous (non-native) to the nucleic acid sequence disclosed in the reference. The reference further discloses regenerating a transgenic plant from said transformed plant cell. The reference also discloses transgenic plants over-expressing the nucleic acid sequence encoding the polypeptide disclosed in the reference. The reference further discloses that said transgenic plant is Arabidopsis. The reference also discloses producing transgenic seeds from said transgenic plant. See in particular, abstract, Figures 1-7; methods at pages 2503-2504; results & discussion at pages 2495-2503.
Although Ohashi-Ito et al. do not explicitly disclose 10% to 20% increase in seed lipid content in their transgenic plant expressing Ohashi-Ito et al. bHLH093 polypeptide, such property would be inherent to the method of making a transgenic plant comprising over-expressing Ohashi-Ito et al. bHLH093 polypeptide (100% identity with instant SEQ ID NO: 3, emphasis added) in Ohashi-Ito et al. transgenic plant, unless the Applicant provides evidence to the contrary.
It is important to note that Ohashi-Ito et al. transgenic plant is structurally identical to the instantly claimed plant.
Accordingly, Ohashi-Ito et al. anticipated the claimed invention.
It may be emphasized that something which is old does not become patentable upon the discovery of a new property. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. See also In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also MPEP § 2112.01.
The sequence homology results are as follows:
RESULT 1
BH093_ARATH
ID BH093_ARATH Reviewed; 351 AA.
AC Q9LSL1; Q0WPP5; Q8LEZ5;
DT 16-DEC-2008, integrated into UniProtKB/Swiss-Prot.
DT 01-OCT-2000, sequence version 1.
DT 28-JAN-2026, entry version 137.
DE RecName: Full=Transcription factor bHLH93;
DE AltName: Full=Basic helix-loop-helix protein 93;
DE Short=AtbHLH93;
DE Short=bHLH 93;
DE AltName: Full=Transcription factor EN 47;
DE AltName: Full=bHLH transcription factor bHLH093;
GN Name=BHLH93; Synonyms=EN47; OrderedLocusNames=At5g65640;
GN ORFNames=K21L13.16;
OS Arabidopsis thaliana (Mouse-ear cress).
OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
OC Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae; Pentapetalae;
OC rosids; malvids; Brassicales; Brassicaceae; Camelineae; Arabidopsis.
OX NCBI_TaxID=3702;
RN [1]
RP NUCLEOTIDE SEQUENCE [MRNA], GENE FAMILY, AND NOMENCLATURE.
RC STRAIN=cv. Columbia;
RX PubMed=12679534; DOI=10.1093/molbev/msg088;
RA Heim M.A., Jakoby M., Werber M., Martin C., Weisshaar B., Bailey P.C.;
RT "The basic helix-loop-helix transcription factor family in plants: a
RT genome-wide study of protein structure and functional diversity.";
RL Mol. Biol. Evol. 20:735-747(2003).
RN [2]
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=cv. Columbia;
RA Kaneko T., Katoh T., Asamizu E., Sato S., Nakamura Y., Kotani H.,
RA Tabata S.;
RT "Structural analysis of Arabidopsis thaliana chromosome 5. XI.";
RL Submitted (APR-1999) to the EMBL/GenBank/DDBJ databases.
RN [3]
RP GENOME REANNOTATION.
RC STRAIN=cv. Columbia;
RX PubMed=27862469; DOI=10.1111/tpj.13415;
RA Cheng C.Y., Krishnakumar V., Chan A.P., Thibaud-Nissen F., Schobel S.,
RA Town C.D.;
RT "Araport11: a complete reannotation of the Arabidopsis thaliana reference
RT genome.";
RL Plant J. 89:789-804(2017).
RN [4]
RP NUCLEOTIDE SEQUENCE [LARGE SCALE MRNA] (ISOFORM 1).
RC STRAIN=cv. Columbia;
RA Shinn P., Chen H., Kim C.J., Quinitio C., Ecker J.R.;
RT "Arabidopsis ORF clones.";
RL Submitted (JUN-2006) to the EMBL/GenBank/DDBJ databases.
RN [5]
RP NUCLEOTIDE SEQUENCE [LARGE SCALE MRNA] (ISOFORM 2).
RC STRAIN=cv. Columbia;
RA Totoki Y., Seki M., Ishida J., Nakajima M., Enju A., Kamiya A.,
RA Narusaka M., Shin-i T., Nakagawa M., Sakamoto N., Oishi K., Kohara Y.,
RA Kobayashi M., Toyoda A., Sakaki Y., Sakurai T., Iida K., Akiyama K.,
RA Satou M., Toyoda T., Konagaya A., Carninci P., Kawai J., Hayashizaki Y.,
RA Shinozaki K.;
RT "Large-scale analysis of RIKEN Arabidopsis full-length (RAFL) cDNAs.";
RL Submitted (JUL-2006) to the EMBL/GenBank/DDBJ databases.
RN [6]
RP NUCLEOTIDE SEQUENCE [LARGE SCALE MRNA] (ISOFORM 1).
RA Brover V.V., Troukhan M.E., Alexandrov N.A., Lu Y.-P., Flavell R.B.,
RA Feldmann K.A.;
RT "Full-length cDNA from Arabidopsis thaliana.";
RL Submitted (MAR-2002) to the EMBL/GenBank/DDBJ databases.
RN [7]
RP GENE FAMILY.
RX PubMed=12897250; DOI=10.1105/tpc.013839;
RA Toledo-Ortiz G., Huq E., Quail P.H.;
RT "The Arabidopsis basic/helix-loop-helix transcription factor family.";
RL Plant Cell 15:1749-1770(2003).
RN [8]
RP GENE FAMILY, AND NOMENCLATURE.
RX PubMed=14600211; DOI=10.1105/tpc.151140;
RA Bailey P.C., Martin C., Toledo-Ortiz G., Quail P.H., Huq E., Heim M.A.,
RA Jakoby M., Werber M., Weisshaar B.;
RT "Update on the basic helix-loop-helix transcription factor gene family in
RT Arabidopsis thaliana.";
RL Plant Cell 15:2497-2502(2003).
RN [9]
RP FUNCTION, INTERACTION WITH FAMA, AND TISSUE SPECIFICITY.
RX PubMed=17088607; DOI=10.1105/tpc.106.046136;
RA Ohashi-Ito K., Bergmann D.C.;
RT "Arabidopsis FAMA controls the final proliferation/differentiation switch
RT during stomatal development.";
RL Plant Cell 18:2493-2505(2006).
CC -!- FUNCTION: Transcription factor. May be involved in the differentiation
CC of stomatal guard cells. {ECO:0000269|PubMed:17088607}.
CC -!- SUBUNIT: Homodimer (Probable). Interacts with FAMA.
CC {ECO:0000269|PubMed:17088607, ECO:0000305}.
CC -!- SUBCELLULAR LOCATION: Nucleus {ECO:0000305}.
CC -!- ALTERNATIVE PRODUCTS:
CC Event=Alternative splicing; Named isoforms=2;
CC Name=1;
CC IsoId=Q9LSL1-1; Sequence=Displayed;
CC Name=2;
CC IsoId=Q9LSL1-2; Sequence=VSP_036094;
CC -!- TISSUE SPECIFICITY: Broadly expressed. {ECO:0000269|PubMed:17088607}.
CC -!- SEQUENCE CAUTION:
CC Sequence=AF488621; Type=Miscellaneous discrepancy; Note=Sequencing errors.; Evidence={ECO:0000305};
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DR EMBL; AF488621; -; NOT_ANNOTATED_CDS; mRNA.
DR EMBL; AB026639; BAA98183.1; -; Genomic_DNA.
DR EMBL; CP002688; AED98080.1; -; Genomic_DNA.
DR EMBL; CP002688; AED98081.1; -; Genomic_DNA.
DR EMBL; BT025665; ABF74726.1; -; mRNA.
DR EMBL; AK229018; BAF00904.1; -; mRNA.
DR EMBL; AY085134; AAM61687.1; -; mRNA.
DR RefSeq; NP_001078801.1; NM_001085332.2. [Q9LSL1-2]
DR RefSeq; NP_569014.1; NM_125962.4. [Q9LSL1-1]
DR AlphaFoldDB; Q9LSL1; -.
DR SMR; Q9LSL1; -.
DR BioGRID; 21932; 1.
DR FunCoup; Q9LSL1; 184.
DR IntAct; Q9LSL1; 2.
DR STRING; 3702.Q9LSL1; -.
DR PaxDb; 3702-AT5G65640.1; -.
DR ProteomicsDB; 240835; -. [Q9LSL1-1]
DR GeneID; 836690; -.
DR Gramene; AT5G65640.1; AT5G65640.1; AT5G65640.
DR Gramene; AT5G65640.2; AT5G65640.2; AT5G65640.
DR KEGG; ath:AT5G65640; -.
DR Araport; AT5G65640; -.
DR TAIR; AT5G65640; BHLH093.
DR eggNOG; ENOG502QQHH; Eukaryota.
DR HOGENOM; CLU_035660_1_0_1; -.
DR InParanoid; Q9LSL1; -.
DR OMA; DTRVDIC; -.
DR PhylomeDB; Q9LSL1; -.
DR PRO; PR:Q9LSL1; -.
DR Proteomes; UP000006548; Chromosome 5.
DR ExpressionAtlas; Q9LSL1; baseline and differential.
DR GO; GO:0005634; C:nucleus; IDA:TAIR.
DR GO; GO:0003700; F:DNA-binding transcription factor activity; ISS:TAIR.
DR GO; GO:0046983; F:protein dimerization activity; IEA:InterPro.
DR GO; GO:0043565; F:sequence-specific DNA binding; IBA:GO_Central.
DR GO; GO:0045487; P:gibberellin catabolic process; IMP:TAIR.
DR GO; GO:0006355; P:regulation of DNA-templated transcription; IBA:GO_Central.
DR GO; GO:0010371; P:regulation of gibberellin biosynthetic process; IMP:TAIR.
DR CDD; cd11443; bHLH_AtAMS_like; 1.
DR FunFam; 4.10.280.10:FF:000066; BHLH transcription factor; 1.
DR Gene3D; 4.10.280.10; Helix-loop-helix DNA-binding domain; 1.
DR InterPro; IPR054502; bHLH-TF_ACT-like_plant.
DR InterPro; IPR011598; bHLH_dom.
DR InterPro; IPR036638; HLH_DNA-bd_sf.
DR InterPro; IPR051358; TF_AMS/ICE1/BHLH6-like.
DR PANTHER; PTHR31945:SF15; TRANSCRIPTION FACTOR BHLH61-RELATED; 1.
DR PANTHER; PTHR31945; TRANSCRIPTION FACTOR SCREAM2-RELATED; 1.
DR Pfam; PF22754; bHLH-TF_ACT-like_plant; 1.
DR Pfam; PF00010; HLH; 1.
DR SMART; SM00353; HLH; 1.
DR SUPFAM; SSF47459; HLH, helix-loop-helix DNA-binding domain; 1.
DR PROSITE; PS50888; BHLH; 1.
PE 1: Evidence at protein level;
KW Alternative splicing; Developmental protein; DNA-binding; Nucleus;
KW Reference proteome; Transcription; Transcription regulation.
FT CHAIN 1..351
FT /note="Transcription factor bHLH93"
FT /id="PRO_0000358784"
FT DOMAIN 174..223
FT /note="bHLH"
FT /evidence="ECO:0000255|PROSITE-ProRule:PRU00981"
FT VAR_SEQ 268..350
FT /note="FEIDRRDEDTRVDICCSPKPGLLLSTVNTLETLGLEIEQCVISCFSDFSLQA
FT SCSEGAEQRDFITSEDIKQALFRNAGYGGSC -> IVETRILELIYAARQNRDCYYL
FT (in isoform 2)"
FT /evidence="ECO:0000303|Ref.5"
FT /id="VSP_036094"
SQ SEQUENCE 351 AA; 39484 MW; A28579226445A459 CRC64;
Query Match 100.0%; Score 1840; Length 351;
Best Local Similarity 100.0%;
Matches 351; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MELSTQMNVFEELLVPTKQETTDNNINNLSFNGGFDHHHHQFFPNGYNIDYLCFNNEEED 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MELSTQMNVFEELLVPTKQETTDNNINNLSFNGGFDHHHHQFFPNGYNIDYLCFNNEEED 60
Qy 61 ENTLLYPSSFMDLISQPPPLLLHQPPPLQPLSPPLSSSATAGATFDYPFLEALQEIIDSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ENTLLYPSSFMDLISQPPPLLLHQPPPLQPLSPPLSSSATAGATFDYPFLEALQEIIDSS 120
Qy 121 SSSPPLILQNGQEENFNNPMSYPSPLMESDQSKSFSVGYCGGETNKKKSKKLEGQPSKNL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSSPPLILQNGQEENFNNPMSYPSPLMESDQSKSFSVGYCGGETNKKKSKKLEGQPSKNL 180
Qy 181 MAERRRRKRLNDRLSMLRSIVPKISKMDRTSILGDAIDYMKELLDKINKLQDEEQELGNS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MAERRRRKRLNDRLSMLRSIVPKISKMDRTSILGDAIDYMKELLDKINKLQDEEQELGNS 240
Qy 241 NNSHHSKLFGDLKDLNANEPLVRNSPKFEIDRRDEDTRVDICCSPKPGLLLSTVNTLETL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 NNSHHSKLFGDLKDLNANEPLVRNSPKFEIDRRDEDTRVDICCSPKPGLLLSTVNTLETL 300
Qy 301 GLEIEQCVISCFSDFSLQASCSEGAEQRDFITSEDIKQALFRNAGYGGSCL 351
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GLEIEQCVISCFSDFSLQASCSEGAEQRDFITSEDIKQALFRNAGYGGSCL 351
Accordingly, Ohashi-Ito et al. anticipated the claimed invention.
9. Claim(s) 1-3 and 6-16 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Alexandrov et al. (US Patent Publication No. US 2006/0150283 A1, Published July 6, 2006, Filed February 14, 2005, Provisional filed February 13, 2004).
Alexandrov et al. disclose a method of producing a transgenic plant cell comprising transformation of said plant cell with a plant transformation vector comprising an expression cassette which comprises a nucleic acid sequence encoding a polypeptide of SEQ ID NO: 100093 (bHLH093 protein) which has 100% amino acid sequence identity to instant SEQ ID NO: 3. The reference further discloses that the vector comprising said nucleic acid sequence is operably linked to a promoter (strong constitutive CaMV 35S promoter, inducible promoter etc.), which is inherently capable of causing transcription in a plant cell, and wherein said promoter is either native or heterologous (non-native) to the nucleic acid sequence disclosed in the reference. The reference further discloses regenerating a transgenic plant from said transformed plant cell. The reference also discloses transgenic plants over-expressing the nucleic acid sequence encoding the polypeptide disclosed in the reference. The reference further discloses that said transgenic plant is soybean, Arabidopsis or Brassica species. The reference also discloses producing transgenic seeds from said transgenic plant and growing them under stress or non-stress conditions. See in particular, claims 1-18; paragraphs 0746-0752, 0756; sequence tables in paragraphs 0106-0111.
Although Alexandrov et al. do not explicitly disclose 10% to 20% increase in seed lipid content in their transgenic plant expressing SEQ ID NOs: 88584/92340, such property would be inherent to the method of making a transgenic plant comprising over-expressing SEQ ID NO: 100093 protein (100% identity with instant SEQ ID NO: 3, emphasis added) in Alexandrov et al. transgenic plant, unless the Applicant provides evidence to the contrary.
It is important to note that Alexandrov et al. transgenic plant is structurally identical to the instantly claimed plant.
It may be emphasized that something which is old does not become patentable upon the discovery of a new property. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. See also In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also MPEP § 2112.01.
The sequence homology results are as follows:
RESULT 2
US-11-056-355B-100093
See complete list at the end of this report)
Sequence 100093, US/11056355B
Publication No. US20060150283A1
GENERAL INFORMATION
APPLICANT: Brover, Vyacheslav
APPLICANT: Alexandrov, Nickolai
TITLE OF INVENTION: Sequence Determined DNA Fragments and Corresponding
TITLE OF INVENTION: Polypeptides Encoded Thereby
FILE REFERENCE: 2750-1590PUS2
CURRENT APPLICATION NUMBER: US/11/056,355B
CURRENT FILING DATE: 2005-02-14
PRIOR APPLICATION NUMBER: 60/544,190
PRIOR FILING DATE: 2004-02-13
NUMBER OF SEQ ID NOS: 119966
SEQ ID NO 100093
LENGTH: 376
TYPE: PRT
ORGANISM: Arabidopsis thaliana
FEATURE:
NAME/KEY: peptide
LOCATION: (1)..(376)
OTHER INFORMATION: Ceres Seq. ID no. 13604336
Query Match 100.0%; Score 1840; Length 376;
Best Local Similarity 100.0%;
Matches 351; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MELSTQMNVFEELLVPTKQETTDNNINNLSFNGGFDHHHHQFFPNGYNIDYLCFNNEEED 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 26 MELSTQMNVFEELLVPTKQETTDNNINNLSFNGGFDHHHHQFFPNGYNIDYLCFNNEEED 85
Qy 61 ENTLLYPSSFMDLISQPPPLLLHQPPPLQPLSPPLSSSATAGATFDYPFLEALQEIIDSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 86 ENTLLYPSSFMDLISQPPPLLLHQPPPLQPLSPPLSSSATAGATFDYPFLEALQEIIDSS 145
Qy 121 SSSPPLILQNGQEENFNNPMSYPSPLMESDQSKSFSVGYCGGETNKKKSKKLEGQPSKNL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 146 SSSPPLILQNGQEENFNNPMSYPSPLMESDQSKSFSVGYCGGETNKKKSKKLEGQPSKNL 205
Qy 181 MAERRRRKRLNDRLSMLRSIVPKISKMDRTSILGDAIDYMKELLDKINKLQDEEQELGNS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 206 MAERRRRKRLNDRLSMLRSIVPKISKMDRTSILGDAIDYMKELLDKINKLQDEEQELGNS 265
Qy 241 NNSHHSKLFGDLKDLNANEPLVRNSPKFEIDRRDEDTRVDICCSPKPGLLLSTVNTLETL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 266 NNSHHSKLFGDLKDLNANEPLVRNSPKFEIDRRDEDTRVDICCSPKPGLLLSTVNTLETL 325
Qy 301 GLEIEQCVISCFSDFSLQASCSEGAEQRDFITSEDIKQALFRNAGYGGSCL 351
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 326 GLEIEQCVISCFSDFSLQASCSEGAEQRDFITSEDIKQALFRNAGYGGSCL 376
Accordingly, Alexandrov et al. anticipated the claimed invention.
10. Claim(s) 1, 6, 9 and 11-14 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Jia et al. (CN 113388622 A, Published September 14, 2021; English Translation attached).
Jia et al. disclose a method of producing a transgenic plant cell comprising transformation of said plant cell with a plant transformation vector comprising an expression cassette which comprises a nucleic acid sequence encoding a bHLH093 polypeptide. The reference further discloses that the vector comprising said nucleic acid sequence is operably linked to a promoter (strong constitutive CaMV 35S promoter present in pCAMBIA1302 vector) which is inherently capable of causing transcription in a plant cell, and wherein said promoter is either native or heterologous (non-native) to the nucleic acid sequence disclosed in the reference. The reference further discloses regenerating a transgenic plant from said transformed plant cell. The reference also discloses transgenic plants over-expressing the nucleic acid sequence encoding the polypeptide disclosed in the reference. The reference also discloses producing transgenic seeds from said transgenic plant and transgenic plants and seeds obtained thereof exhibited salt stress tolerance. See in particular, abstract, Figs. 1-5; claims
Accordingly, Jia et al. anticipated the claimed invention.
Conclusions
11. Claims 1-3 and 6-16 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (571) 270-7058 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/VINOD KUMAR/Primary Examiner, Art Unit 1663
Prosecution Insights