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, 3, 5, 7, 11, 14, 17-19 and 85, and the species of SEQ ID NOs: 90-98, 112, 114, 136 and 137 in the reply filed on February 02, 2026 and phone interview 03/12/2026 are acknowledged. The restriction is made FINAL.
Claim Status
Claims 1, 3, 5, 7, 11, 14, 17-19, 69, 72, 76-77, 83 and 85-87, are pending. Claims 2, 4, 6, 8-10, 12-13, 15-16, 20-68, 70-71, 73-75, 78-82, 84 and 88-103, are cancelled. Claims 69, 72, 76-77, 83 and 86-87, are withdrawn. Claims 1, 3, 5, 7, 11, 14, 17-19 and 85, are examined in the instant application.
Priority
This application is claiming the benefit of Provisional Application No.
63/297,070 filed January 06, 2022.
Information Disclosure Statement (IDS)
The IDS submitted on 07/03/2024 has been considered. Signed copy is attached.
Specification
The abstract of the disclosure is objected to because the abstract need to be on a separate document and not on WO 2023/133440 A1 cover page. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 18 and 85 are objected to because of the following informalities:
Claim 18 the recitation of “endogenous GL2 genes endogenous GL2 genes” is grammatically incorrect. Appropriate correction is required.
Claim 85 is objected to because it depends from a withdrawn claim. It is suggested claim 85 be amended to a product produced by the method claim format. To the extent that claim 85 depends from claim 69, the following objection would apply upon incorporation of the method claim into claim 85. In claim 69, “and” should be inserted before the second “wherein” clause.
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, 3, 5, 11, 14, 18-19 and 85, 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 “mutation” is not given patentable weight because there is nothing in the mutated gene that is structurally different to make it distinguishable from a product of nature, as the claims are directed to a Brassica plant or part thereof comprising at least on mutation in an endogenous wild-type GLABRA2 (GL2) gene (SEQ ID NOs: 112 or 114).
In regard to claim 1, it is directed to a Brassica plant or part thereof comprising at least on mutation in an endogenous wild-type GLABRA2 (GL2) gene (SEQ ID NOs: 112 or 114) is indistinguishable from a naturally occurring gene from a wild-type. The claim states at least one mutation however, Applicant does not claim the location of said mutation, the resulting phenotype or function and no comparative basis to distinguish the wild-type plant from the claimed invention. Additionally, naturally gene undergo genetic mutation leading to gene variations, so how is one skilled in the art supposed to distinguish between a plant that underwent natural genetic variation versus Applicants claimed invention. SEQ ID NO:112 encoding SEQ ID NO:114 was obtained from Brassica juncea, a naturally occurring plant. GL2 sequences within 80% sequence identity of SEQ ID NO:112, or 80% sequence identity to SEQ ID NO:s.90-98, or 80% sequence identity to a sequence encoding SEQ ID NO:114, naturally contain mutations that do not alter the plant phenotype, such as allelic variants. Therefore, there is nothing in the Brassica plant that is structurally different to make it distinguishable from a product of nature.
In regard to claims 3 and 5, is directed to a Brassica plant or part hereof of claim 1, wherein the mutation is a base substitution, a base deletion, and /or base insertion. However, as mentioned above plants undergo natural gene variation which include base substitutions, deletions, and/or insertions. So how is one skilled in the art supposed to distinguish between a plant that underwent natural genetic variation versus Applicants claimed invention. Therefore, there is nothing in the Brassica plant that is structurally different to make it distinguishable from a product of nature.
In regard to claim 11, because the 5’ region is not defined, a naturally-occurring GL2 gene contains a mutation in the 5’ region.
In claim 18, naturally occurring Brassica plants comprise at least one endogenous GL2 gene.
With regard to claims 14 and 19, William et al. (GenEmbl Database, Acc. No. OZ282448, Direct submission, 09 July 2025 (U), see Result 1) teaches a naturally occurring Brassica rapa narinosa that comprises a sequence having 97% sequence identity to SEQ ID NO:136.
Claim 85 is included because it is directed to a plant. The method used to produce the plant holds no patentable weight if said method does not structurally alter the claimed 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, 3, 5, 7, 11, 14, 17-19 and 85, 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 one skilled in the art can distinguish a GL2 sequence having 80% sequence identity to SEQ ID NO:112 from a mutated GL2 gene. No function or structure is recited for the mutated sequence. Does Applicant intend for the mutated sequence to be any sequence having less than 80% sequence identity? The same rejection applies to 80% sequence identity to SEQ ID NOs. 90-98 and 80% sequence identity to SEQ ID NO:114. See also claim 85 which depends from withdrawn claim 69.
In claim 5, the metes and bounds of “about 1” and “about 100” are unclear. The term “about” is not clearly defined in Applicant’s disclosure. The claim recites a range but “about” encompasses values above and below the range. It is unclear what those values are. Does “about 1” encompass zero?
In claim 7, “an out-of-frame insertion” is not a base deletion.
In claim 11, it is unclear where the 5’ region begins and ends. Additionally, is Exon 2 the 5’ region, or is Applicant referring to the 5’ region in Exon 2? It is further unclear where Exon 2 is located in SEQ ID NO:112.
In claim 17, the recitation “modified trichomes” is unclear. Applicant does not define how the trichomes are modified. For example, does that include increase trichome density? Size? Or function?
In claim 19, there is an overlap in sequences between the 90% sequence identity to SEQ ID NO:136 (mutated sequence) and the 80% sequence identity to SEQ ID NO:112 (wildtype sequence). It is unclear how the overlapping sequences can be distinguished.
To the extent claim 85 depends from claim 69, the “and/or” recitation before (c) in claim 69 is unclear. It is unclear whether the claim encompasses three embodiments, i.e., three separate sequences in the same plant, or (a), (b) and (c) are alternates of each other.
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, 3, 5, 7, 11, 14, 17-19 and 85, 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 mutating the Brassica juncea plant by knocking out two wild-type GL2 sequences. Specifically, SEQ ID NO: 112 was modified via a “1 bp insertion of nucleotide "A" at position 2170 AND a 9 bp (GAGGATCAA) deletion starting at position 2250”. Additionally, wild-type SEQ ID NO: 115, a second GL2 sequence, was modified via an “11 bp (TGACGATGAGG) (SEQ ID NO:186) deletion starting at position 2215”. These modifications result in a “[o]ut-of-frame mutation which leads to an early stop codon” in the resulting nucleotide sequences (SEQ ID NOs: 136 and 138) and their corresponding amino acid sequences (SEQ ID NOs: 137 and 139) as described in (pg. 79 table 3). Additionally, the knockout of both SEQ ID NO:112 and SEQ ID NO:115 results in “a statistically significant (P value< .05) reduction in the number of trichomes on both sides of the leaf as well as a reduction in trichome presence on the leaf margin was observed” (pg. 83 lines 3-5). The only plants with the desired phenotype was found in only 6 plants which required both GL2 alleles knocked out (i.e. wildtype GL2 sequences having SEQ ID NOs: 112 and 115).
Claims encompass polynucleotides and polypeptides having as little as 80% sequence identity of SEQ ID NO: 90-98, 112 or 114 having an undescribed function and mutated structure.
The claimed invention lacks adequate written description for the following reasons. While one skilled in the art can generate a population of sequences having at least 80% sequence identity to SEQ ID NO:112, 80% sequence identity to SEQ ID NOs. 90-98, and 80% sequence identity to SEQ ID NO:114, one skilled in the art cannot predictably determine which are endogenous GL2 sequences and which are mutated GL2 sequences. The claims do not recite a structure / function for the endogenous GL2 genes, or a structure / function for the mutated GL2 sequences, to distinguish one from the other.
The instant claims recite endogenous Brassica GL2 sequences based on an 80% sequence identity threshold to SEQ ID NOs: 90-98, 112, or 114. However, the Applicant fails to disclose the specific structures of the naturally occurring mutants and allelic variants claims to encompass. Because the disclosure of a single Brassica juncea sequence is not representative of the diverse GL2 sequence across the entire Brassica genus, there are insufficient identifying characteristics to identify these variants without undue experimentation. Consequently, the Applicant has failed to provide either a representative number of species or common structural features necessary to support the claimed genus.
With regard to 80% sequence identity to SEQ ID NOs. 90-98, these are partial gene sequences of the endogenous GL2 gene sequence of SEQ ID NO:112. The “comprises” language encompasses the full-length sequences. One skilled in the art cannot predict the structure of the full-length endogenous GL2 sequences from the disclosure of the partial gene sequences, even at 100% sequence identity, let alone at 80% sequence identity.
With regard to claim 17, claim 1 only recites the endogenous GL2 gene. There are virtually an ad infinitum number of possible mutations to the recited sequences of the endogenous GL2 genes. It is highly unpredictable from said ad infinitum number of possible mutations predict which mutation or combination of mutations would produce the claimed phenotypes. The mutations shown in SEQ ID NO:136 (a 1 bp insertion of the nucleotide “A” at position 2170 and a 9 bp deletion beginning at position 2250) does not allow one skilled in the art to predictably determine other mutations for producing the claimed phenotypes.
With regard to claim 18, no structure is recited for the second GL2 gene. The specification does not disclose the location of the second GL2 gene in the Brassica genome. One skilled in the art cannot predict the structure of the second GL2 gene from the disclosure of the first GL2 gene. It is not known if they are structurally identical or distinct.
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, 3, 5, 7, 11, 14, 17-19 and 85, 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, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(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. 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 a Brassica plant comprising at least one mutation in an endogenous GLABRA2 gene having at least 80% sequence identity to SEQ ID NOs: 112 or 114.
(B) The nature of the invention.
The nature of the invention is a Brassica plant comprising at least one mutation in an endogenous GLABRA2 gene having SEQ ID NOs: 112 or 114 and reducing leaf trichomes of plant.
(C) The state of the prior art
The state of the prior art does not teach particular structures or mutations that can be correlated with a functional activity, nor does it disclose modified or reduced trichome function in a plant expressing phenotype with at least 80% sequence identity.
(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. With regard to claim 1, it should be noted that the 80% sequence identity is over the entire sequence and not limited to any particular region of SEQ ID NOs:90-98, 112 or 114. Again, no functional activity is recited for population of sequences having at least 80% sequence identity to SEQ ID NO:112, 80% sequence identity to SEQ ID NOs. 90-98, and 80% sequence identity to SEQ ID NO:114. No resulting objective is recited for the sequence having at least 80% sequence identity to SEQ ID NOs: 90-98, 112 or 114. While one skilled in the art can readily produce a population of sequences having at least 80% sequence identity to SEQ ID NOs: 90-98, 112 or 114, one skilled in the art cannot readily determine which of the 80% variant structures are endogenous GL2 genes having an undisclosed function, as seen in claim 1. No guidance or working examples are provided to allow one skilled in the art predict which identity genus are endogenous GL2 sequences or which region(s) of SEQ ID NOs: 90-98, 112 or 114 can be altered, and which region(s) must be conserved. No structure and function is recited for the endogenous GL2 gene or for the mutated GL2 sequences. The state of the art teaches that some mutations will retain sequence functional activity while others do not. The claims do not indicate whether the sequence(s) having the 80% sequence identity is required to have a particular functional activity or produce a plant having a particular phenotype. Thus, for these reasons, one skilled in the art cannot make and use a sequence having 80% sequence identity to SEQ ID NOs: 90-98, 112 or 114 as commensurate in scope with the claims without undue experimentation. See also claim 19 with regard to 90% sequence identity to SEQ ID NOs: 136 or 137. Applicant’s disclosure must teach how a person skilled in the art can “make and use” the claimed invention. There is no evidence that all sequences having 90% sequence identity to SEQ ID NO:136 or 90% sequence identity to SEQ ID NO:137 have a useful function. While one skilled in the art can produce sequences having 90% sequence identity to SEQ ID NO:136 or encoding a polypeptide having 90% sequence identity to SEQ ID NO:137, because no useful function is recited for the 90% sequence identity sequences, one skilled in the art cannot use the claimed invention without undue experimentation.
With regard to claims 3, 5, 7, and 11, while one skilled in the art can readily construct polynucleotides or polypeptides such as SEQ ID NOs: 112 or 114, respectively, one skilled in the art cannot construct the polynucleotide or polypeptide without the location, and conserved regions to maintain, without undue experimentation. Additionally, as mentioned above there is a lack of disclosed functional activity which makes it highly unpredictable to determine the unknown function without undue experimentation. Furthermore, the lack of clear guidance on the resulting objective of said polypeptide one skilled in the art would find it impossible to know what to do with the polynucleotide or the polypeptide, or what is the purpose of the sequences? Therefore, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without undue experimentation.
In regards to claim 14, even though Applicant further clarifies what species of plant to use the nucleic acid sequence or a nucleotide sequence that encodes an amino acid with at least 80% sequence identity to SEQ ID NOs: 90-98, 112 or 114, it is still lacking guidance on the phenotype that is required for one skilled in the art should produce. Therefore, the lack of phenotype makes it unpredictable for one skilled in the art to produce a plant or part of a plant with a particular unknown phenotype without undue experimentation. See also claim 85, in regards to producing a plant.
With regard to claim 17, the nature of the invention is a mutation in a Brassica GL2 gene for producing reduced trichomes. The scope of the claims encompasses deletions, insertions, substitutions, and any combination thereof in any region of the endogenous GL2 genes having at least 80% sequence identity to SEQ ID NO:112, 80% sequence identity to SEQ ID NOs. 90-98, or 80% sequence identity to SEQ ID NO:114. Applicant’s working examples are deletions in two positions of SEQ ID NO:112 and a deletion in a second GL2 gene comprising SEQ ID NO:115 to produce the claimed phenotype of reduced trichomes. Applicant has no working example of a mutation of SEQ ID NO:112 alone for producing reduced trichomes. It is unpredictable whether a mutation in SEQ ID NO:112 alone would produce the claimed phenotypes, and if so, it is not known which mutation(s) in what location(s) of SEQ ID NO:112 would do so.
The phenotype of “modified trichomes”, this phenotype is not fully enabled because the breadth of “modified” encompasses all features and characteristics of a trichome including but not limited to length, width, functionality, etc. Because all aspects of modification to the trichomes, one skilled in the art cannot determine the Brassica plant phenotype of without excessive burden. Absent a recitation of a phenotype that can be readily identified and correlated with a plant comprising a polypeptide comprising an amino acid sequence that has at least 80% sequence identity to SEQ ID NOs: 112 or 114, one skilled in the art cannot make and use a polypeptide having the phenotype of “modified trichomes” as commensurate in scope with the claims without undue experimentation.
See also claim 18, Applicant does not teach any guidance on the more than one endogenous GL2 genes having at least 80% sequence identity to SEQ ID NOs: 112 and 114, and where to mutate. Additionally, Applicant does not disclose the phenotype of these endogenous GL2 genes or the resulting phenotype of said gene with at least one mutation, which can be as simple as a conservative substitution resulting in a silent mutation. Thus, for these reasons, one skilled in the art cannot make and use a sequence having 80% sequence identity to SEQ ID NOs: 112 or 114 as commensurate in scope with the claims without undue experimentation.
It is unpredictable which variant would control trichome activity. Applicant’s working examples are deletions in two positions of SEQ ID NO:112 and a deletion in a second GL2 gene comprising SEQ ID NO:115 to produce the claimed phenotype of reduced trichomes. Applicant has no working example of a mutation of SEQ ID NO:112 alone for producing reduced trichomes. It is unpredictable whether a mutation in SEQ ID NO:112 alone would produce the claimed phenotypes, and if so, it is not known which mutation(s) in what location(s) of SEQ ID NO:112 would do so. The 80% sequence identity recited in claim 1 indicates there are many naturally occurring wildtype GL2 genes having mutations that do not produce the claimed phenotypes. Other than the two specific mutated GL2 genes (SEQ ID NO:136 encoding SEQ ID NO:137, and SEQ ID NO:138 encoding SEQ ID NO:139), no guidance is provided for one skilled in the art to predictably determine other combinations of mutations to produce the claimed phenotypes without resorting to random trial and error requiring undue experimentation. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
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, 3, 5, 7, 11, 14, 18-19 and 85, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by William, W. (GenEmbl Database, Acc. No. LR031574, Direct submission, 16 Nov 2018 (V), See Result 2)
In regard to claims 1 and 14, William discloses a Brassica rapa plant comprising a sequence having 97% sequence identity to Applicant SEQ ID NO: 112 (see alignment).
In regard to claims 3, 5, 7, 11 and 19, since William disclose accession number LR031574 having 97% sequence identity to Applicant’s SEQ ID NO: 136 coding region. One could clearly see there is many differences (i.e. mutations) in the nucleic acid sequence that involve base substitutions and deletions. Because the 5’ region is not identified, the sequence of William has a mutation in the 5’ region.
In regard to claim 18, since William discloses a Brassica rapa LR031574 having 97% sequence identity to Applicant SEQ ID NO: 112, then the gene GL2 is inherent to the structure.
Claim 85 is included because it is directed to a plant. The recited method used to produce the plant does not impart a structural change to the plant; therefore, the product-by-method limitation lacks patentable weight against the structurally identical prior art.
Therefore, the claims are anticipated by the art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5,7, 11, 14, 17-19 and 85, are rejected under 35 U.S.C. 103 as being obvious over Nayidu et al., “Comparison of Five Major Trichome Regulatory Genes in Brassica villosa with Orthologues within the Brassicaceae”, 22 Apr. 2014, PLOS ONE 9(4): e95877 (W) in light of Nayidu et al., Supplemental, "Comparison of Five Major Trichome Regulatory Genes in Brassica villosa with Orthologues within the Brassicaceae", 22 Apr 2014, PLOS ONE 9(4): e95877, 10 pages (Year: 2014) (X) and Chai et al. (UniProt Database, Accession No. D0PSG2, 15 Dec 2009, "Brassica GLABRA2 genes: Analysis of Function Related to Seed Oil Content and Development of Functional Markers", Theor. Appl. Genet., 120:1597-1610, 2010, (Y)), and in view of De Veylder et al. (US 2016/0272992 A1(A)).
In regard to claims 1, 3, 5, 7, 11, 14, 17 and 19, Nayidu et al. (W), teaches Brassica napus GL2 (GLABRA2) nucleotide sequence, identified under Embl accession number EU826520.1 (pg.3 table 1), as well as the corresponding amino acid sequence (Nayidu et al. (X), Supplemental, fig. S1). Nayidu et al. (W) teaches that GL2 is a major regulator for trichome synthesis in Brassica spp. (pg.1 Abstract and p.9 col.2 second paragraph) and that inhibiting GL2 expression “prevents trichome initiation in neighbouring cells” (p.2 col.1 1st sentence). Moreover, “RNA seq showed that the single-copy BvGL2 gene … have very high transcript levels in hairy B. villosa leaves” and that “[t]ranscripts of the single BoGL2 were undetectable in glabrous [smooth] B. oleracea leaves” (pg. 5 col.1 and fig. 2). Meaning that when the GL2 gene expression is off or reduced it results in smoother leaves. Nayidu et al. (W) discloses that "[i]n the future, it will be particularly useful to express these B. villosa genes in a range of other Brassica species and to develop knock-out RNAi lines in B. villosa to solve the mystery of their true function" (p.10 col.1). The reference further identifies "high transcript levels for BvGL2, BvTTG1, BvTRY-1, and BvCPC-1 in B. villosa leaves with densely covered trichomes” (p.10 col.1). Taken together, these teachings suggest knocking out the identified genes to reduce expression.
Nayidu et al. (W) teaches nucleotide sequence having accession number EU826520 and provides the alignment of the amino acid sequence of Nayidu et al. (X) Supplemental figure 1 (EU826520).
Chai et al. identifies that the nucleotide sequence of Nayidu et al. (X) having Embl accession number EU826520 encodes the amino acid sequence having accession number ACJ54443 (see Chai 2010 Embl EU826520 attachment). The amino acid sequence (ACJ54443) of Chai shows 99% sequence identity to Applicant’s SEQ ID NO:114 (see Result 8) and 99% sequence identity to Applicant’s SEQ ID NO:137 (the mutated GL2 protein sequence, see Result 10).
An examination of these sequence alignments discloses several amino acid differences (i.e. mutations) and deletions, indicating their corresponding nucleotide sequences contain mutations and deletions. With regard to claim 11, because the 5’ region is not identified, the sequence of Nayidu et al.(X), has a mutation in the 5’ region of the endogenous GL2 gene.
While Nayidu et al. (W) teaches using RNAi to reduce GL2 gene expression, Nayidu et al. (W) does not teach mutation to the GL2 gene to reduce gene expression.
De Veylder et al. teaches “Methods for down-regulation are known to the person skilled in the art, and include, but are not limited to, mutations, insertions or deletions in the gene and/or its promoter, the use of anti-sense RNA or RNAi and gene silencing methods.” (pg. 2 para. [0008]). Therefore, De Veylder et al. teaches mutations, insertions, deletions (i.e. out-of-frame mutations) or RNAi can be used to reduce gene expression.
Therefore, prior to the effective filing date, it would have been prima facie
obvious to one of ordinary skill in the art to substitute the RNAi molecule of Nayidu et al. (W) with the deletion mutation of De Veylder et al. to reduce expression of the endogenous GL2 gene in a Brassica plant. The reduced GL2 gene expression would reduce the number of trichomes, as taught by Nayidu et al (W). The choice of using RNAi or a deletion mutation is an experimental design choice well within the means of one skilled in the art without any surprising or unexpected results and with a reasonable expectation of success.
MPEP 2143 (b) states that “Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious." Id. at 301, 213 USPQ at 536” and “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007)”
In regard to claim 18, Nayidu et al., discloses a Brassica plant with an endogenous GL2 gene (see fig. 3).
In claim 85 is included because it is directed to a plant. The recited method used to produce the plant does not impart a structural change to the plant; therefore, the product-by-method limitation lacks patentable weight against the structurally identical prior art.
Accordingly, the claimed invention is prima facie obvious in view of the prior 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