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 .
Response to Restriction Requirements
Applicant's election with traverse of Group I, claims 1-12, 30, 31, 34, 50, and 51 in the reply filed on 02/06/2026 is acknowledged.
Applicant’s election of species of the combination of an endogenous strong promoter and the gene coding region of the PPO gene as recited in claim 11. Applicant assert the elected species lead to one characteristic recited in claim 12, i.e., the level of the new gene expression is up-regulated relative to the plant's endogenous wild-type PPO gene in the reply filed on 02/06/2026 is acknowledged.
Claims 1-12, 18, 21-22, 24, 30-31, 34, 36-37, 41-42, 45, 47-48, 50-51 and 58 are pending.
Claims 18, 21-22, 24, 36-37, 41-42, 45, 47-48 and 58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 02/06/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Applicant argues on the arguments filed on response to restriction and election of species filed on 02/06/2026 that the office has not established the requirement of "[t]here would be a serious burden on the examiner if restriction is not required." Applicant argues specifically, the Office has made no showing that there would be an undue burden in examining the subject matter of Groups I-VIII together.” (response to restriction election, page 3, last two paragraphs).
Applicant’s arguments have been fully considered but they are not persuasive since the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function and each individual sequence from a different source, will require a separate search for the prior art and each species will raise separate issues with regard to 35 U.S.C. 101 and 112 (see restriction requirement office action sent on 12/09/2025). Therefore, the restriction requirement has been maintained.
Thus claims 1-12, 30, 31, 34, 50, and 51 along with the species of the combination of an endogenous strong promoter and the gene coding region of the PPO gene as recited in claim 11 and one characteristic recited in claim 12, i.e., the level of the new gene expression is up-regulated relative to the plant's endogenous wild-type PPO gene are examined in this office action.
For following analysis clean substitute specification submitted on 08/04/2025 has been used for referring to the page and paragraph numbers.
Specification
The disclosure is objected to because of the following informalities:
Spec, pages 126-133, 160-161, 163-164, 174-175, 177, 185, 191, 195-197, 201-219 comprises tables that does not have table numbers. Applicant are advised to add subsequent table numbers to the tables and make the table numbers continuous in orders to make the specification more legible.
Spec, page 179, first paragraph states the term “herbicideCompound”, Applicant are advised to separate two words with a space between them.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code for example in page 20, second paragraph; page 160, first, third and last paragraph, page 161, first paragraph; page 162, page 173, last paragraph; paragraph 4; page 174, second and last paragraph; page 184, last paragraph, paragraph 186, last paragraph; page 195, last two paragraphs; page 197; paragraph 5; page 200; last two paragraphs; page 208, last two paragraphs; page 209, second to last paragraph; page 220, last paragraph; page 2112, first paragraph; page 213, first two paragraphs; page 222, third paragraph; page 224, second and third paragraphs; page 225, last paragraph. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The amendment to the Specification on 08/04/2025 does not comply with 37 CFR 1.57(d).
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper see the second paragraph of the specification. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The use of the term “phytagel”, “Timetin” in pages 214-215, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 5 and 7 are objected to because of the following informalities:
Claims 5 and 7, line 1 recite the phrase “any claim 1” which is incorrect and applicants are advised to delete the term “any” since the claim only recite the method of claim 1.
Appropriate correction is required.
Claim Interpretation
In claim 1 lines 7 and 14, the recitation of term “combination” has been interpreted as the combination of genetic elements encompass both functional or structural combinations between promoter of first a gene and coding region of a second gene. Thus the first and second genes are located at any distance in single or different chromosomes in an organisms.
In claim 1 line 1, the recitation of “new gene” has been interpreted since applicant has not specifically described. It is interpreted broadly to encompass any genomic sequence that had at least one nucleotide changed by non-homologous end joining (NHEJ) or homologous repair.
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, 4-6 and 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to judicial exception (i.e., a law of nature, natural phenomenon, or an abstract idea) without significantly more.
The claims are drawn to a method for creating a new gene in an organism comprising steps of simultaneously generating DNA breaks at two or more different specific sites in the organism's genome, wherein the specific sites are genomic sites capable of separating different genetic elements or different protein domains, and the DNA breaks are ligated to each other by a non-homologous end joining (NHEJ) or homologous repair, generating a new combination of the different genetic elements or different protein domains different from the original genomic sequence, thereby creating the new gene. The claims are drawn wherein the method further characterized that the combination of different gene elements is a combination of adjacent gene elements of the same gene.
The method is a natural process. The method includes a natural process of DNA breaks that happened in nature and natural process of homologous repair of the DNA breaks that would create new combination of genetic elements or different protein domains which is happening in nature as natural evolutionary phenomenon.
Regarding claims 1 and 10, Rodriguez et al. (Published: 2011, Journal: Plant physiology, 156(1), 275-285) (Included in IDS submitted on 05/20/2025); teaches a tomato cultivar Orange Strawberry, which is an accession as Heirloom variety carrying large number of locule numbers of 14 (Rodriguez, Supplementary PDF). Furthermore, Huang et al. (Published: 2011, Journal: Theoretical and Applied Genetics, 123, 465-474) (Included in IDS submitted on 05/20/2025); teaches fascinated (fas) locus in tomato (Solanum lycopersicum) wherein the main function of fas is to control locule number which affects fruit mass and certain accessions carry fruit of many locules, some of which are controlled by the FAS gene mutation which also leads to floral organ number and fruit size (Huang, page 466, left paragraph 2).
Huang et al. teach fine mapping and genome structure analysis of the fas locus wherein a presence of a ~294-kb inversion in the fas mutants (Fig. 2b, c) affected the expression of YABBY where the YABBY is knocked out (page 469, right paragraph 1). Huang Figure 2 showed that the left breakpoint of the inversion was between predicted gene PDE247 and R3aL the right breakpoint of the inversion was within the first intron of YABBY gene. Thus, it shows the new gene arrived from the method of inversion wherein the process of formation of the fas allele would involve generating DNA breaks to create inversion at two or more different specific sites in the tomato genome.
Wherein the specific sites are genomic sites capable of separating different genetic elements of PDE247, R3aL and YABBY gene, and the DNA breaks are ligated to each other by natural process of homologous repair, generating a new combination of the different genetic elements in the order of PDE247, YABBY, R3aL that created the high locule number natural mutant of fas gene in tomato.
YABBY family members are regulators of organ polarity and the establishment of proper boundaries in meristems (Huang, page 466, left paragraph 2).
Regarding claim 4, the specific sites are located on chromosome 11 (page 468, right paragraph 1).
Regarding claims 5-6 and 9, region would be one of the region described in claim 5 or any combination thereof.
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Thus the method anticipates the natural process.
Claim Rejections - 35 USC § 112 - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12, 30-31, 34, 50, and 51 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Regarding claim 1, claim recites “the specific sites are genomic sites capable of separating different genetic elements” renders claim indefinite since metes and bound of specific site cannot be determined. Since it is not clear what does a genetic element means? The genetic element that can be hereditary can be as small as a nucleotide. Thus the sites can be of any length and structure. The specific site can be a single nucleotide long to almost the whole DNA length in a chromosome located between two genetic elements residing in any distance. Furthermore, in recitation of “capable” it is not clear whether claim would require the genomic sites to separate the different genomic element or not.
Regarding claim 6, the claim recites term “CDS” that has not been described in the claim or dependent claim, hence the meets and bound of the term cannot be determined.
Regarding claim 11, the claim recites term “PPO” that has not been described in the claim or dependent claim, hence the meets and bound of the term cannot be determined.
Regarding claim 1, the claim recites a single method step, “generating DNA breaks” which does not appear to “creating a new gene in an organism” as required by the preamble. For example, Portin et al. (Published: 2017, Journal: Genetics, 205(4), 1353-1364) (Included in IDS submitted on 05/20/2025) defines gene as “A gene is a DNA sequence (whose component segments do not necessarily need to be physically contiguous) that specifies one or more sequence-related RNAs/proteins that are both evoked by genetic networks or genetic regulatory networks (GRNs) and participate as elements in GRNs, often with indirect effects, or as outputs of GRNs, the latter yielding more direct phenotypic effects.” (pages 1361 and 1362, last and first paragraph). Thus it is not clear whether the DNA breaks and combining the breaks would specifies one or more sequence-related RNAs/proteins which renders the claim indefinite.
Regarding claims 1, 5-6, 9, 11, 12 the claim recites the phrase “gene elements” renders claim indefinite since the metes and bound of the gene elements cannot be determined. It has been defined by the open-ended definition of “The "gene elements" comprise a promoter, a 5' untranslated region (5'UTR), a coding region (CDS) or non-coding RNA region (Non-coding RNA), a 3' untranslated region (3'UTR) and a terminator of the gene.” Therefore, it is not clear what does other components or feature of the genes are comprised in the phrase “gene element”.
Claims 2, 3 and 11 recite the limitation “strong promoter” renders claim indefinite since the metes and bound of strong cannot be determined. It is not further clear, strong as compared to which standard or control promoter? Furthermore, it is not clear what would be the structure and function of the strong endogenous promoter compared to normal or weak promoter? and how does an ordinary skill in art would differentiate strong promoter?
Claim 2, 3 and 6 recite the limitation "the non-coding region " in lines 4 and 5; line 5; line 3 respectively. There is insufficient antecedent basis for this limitation in the claim since the non-coding region is not required component of a gene described in independent claim 1.
Claim 6 recites the limitation "the CDS " in line 6. There is insufficient antecedent basis for this limitation in the claim since the CDS is not recited in independent claim 1.
Regarding claim 3, the claim recites the phrase “translocation editing events can be generated” renders claim indefinite since recitation of ambiguous phrase “can be” would mean it may not be a required step. If translocation is not a required step, then it is not clear how does a DNA fragment generated from specific cuts at three different sites would join together lading to the method of creating new gene?
Applicant are advised to recite instead “translocation editing events are generated” to ensure the translocation of the fragment from one position to other position after cutting the genome.
Claims 1 and 3 recite the phrase “capable of separating different gene elements or different protein domains” renders claim indefinite since it is not clear whether claim requires the specific site to separate the gene elements or it only requires it to be capable of separating or they are site that separates the gene elements or protein domains. For example Merriam Webster dictionary define the term “capable” to “having traits conducive to or features permitting something” or “having attributes (such as physical or mental power) required for performance or accomplishment” (accessed from https://www.merriam-webster.com/dictionary/capable, accessed on 10/03/2025). Since claims 1 and 3 require joining the breaks to generate new combination of different genetic elements or different protein domains different from original genomic sequence, then how the genomic sites only capable of separating different genetic elements or different protein domains would generate new combination of different genetic elements or different protein domains different from original genomic sequence?
Claim Rejections - 35 USC § 112 – Written Description Requirement
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 1-12, 30-31, 34, 50, and 51 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.
Analysis of Breadth of Claims
Claim broadly recite “genomic sites” with any structure that has to separate any of the two different genetic elements (i.e. any promoter, any 5’URR, any coding region etc.) (claim 1).
Claim recite a broad structure or function of any combination of any strong promoter of any gene as first gene and a coding region of any PPO gene as a second gene in any plant (claim 11).
Combination of different gene elements would encompass combination of any of the elements of gene such as intron, exons, 5’UTR, 3’UTR, promoter, terminator, enhancer or any other fragment of a gene etc. (claim 1).
Claim recite a broad structure or function of any combination of a promoter of any gene as first gene and a coding region of any gene as second gene.
The genomic site capable of separating different genetic elements could be of any size from a nucleotide to almost whole chromosome (claim 1).
A gene would encompass both coding and non-coding genes.
What is Described in the Specification
Applicant describes the following:
guide RNA1 and guide RNA2 located between the promoter and the CDS region of the rice PPO1 gene, close to the PPO1 start codon, and the guide RNA3 and guide RNA4 located between the promoter and the CDS region of the CP12 gene, close to the CP12 start codon (page 174, paragraph 3).
resistance test results were shown in Figure 18. 3-5 days after the application of herbicide, the wildtype control rice seedlings began to wither from tip of leaf, necrotic spots appeared on the leaves, and gradually weathered while PPO 1 inversion event maintained normal growth wherein after two weeks wildtype rice seedlings died and the inverted line grew normally (page 177, second paragraph)
the expression levels of CP12 in the experimental groups all showed a tendency of decrease, while the expression levels of PPO 1 for 252L and 329M increased significantly (page 178, first paragraph).
the inversion of chromosome fragments generated new genes on both sides (page 178, first paragraph).
EPSPS gene (as shown in SEQ ID NO: 4, in which l-1897bp was the promoter, and the rest was the expression region) was located on chromosome 6 in rice wherein the gene upstream was transketolase (TKT, as shown in SEQ ID NO: 3, in which l-2091bp was the promoter, and the rest was the expression region) with an opposite direction, where in the expression intensity of TKT gen was 20-50 times higher than EPSPS, the inversion results into rice plants resistant to glyphosate herbicide (Example 7, pages 183-184).
HPPD-gene duplicated lines created by chromosome segment duplication QY2091-12 and QY2091-21 in rice were normally growing on herbicide treatment (page 192, last two paragraphs and page 193 first paragraph).
the chloroplast signal peptide domain of LOC4331514 and LOC4337056 gene was fused with the coding region of OsCATC gene to create a new gene wherein the protoplast test results in gene combined from new protein domains could be created through the deletion of chromosome segments between different protein domains by using the method of the present invention (page 199, second to last paragraph, page 200, paragraph 3).
the SAMDC promoter-driven high expression of PPO2 protein enables rice to resist PPO inhibitor herbicides (page 203, second paragraph).
OsZFF promoter fused with OsPPO2 CDS obtained a positive TO plant with desired inversion. (page 205 paragraph 1, page 206, first paragraph).
OsNPP promoter fused to OSPPO2 CDS wherein one of the events was obtained to have a positive TO plant with desired inversion (page 206, first paragraph).
Ubi2pro+PPO2-CDS genotype of rice could survive a rate of 4 g a.i./mu, wherein wildtype rice was killed at the rate of 2 g a.i./mu (page 228, second to last paragraph).
Difference Between What was described and What is Claimed
Applicant has not described a method of creating new genes other than shuffling promoter or regulatory region to enhance expression of a gene.
Applicant has not described a method for creating a new gene in an organism characterized by comprising, generating a new combination of the different genetic elements or different protein domains different from the original genomic sequence wherein the combination of different gene elements is a combination of the promoter of one of the two genes with different expression patterns and the non-coding RNA region of the other gene since it would require coding region for a gene and applicant has not described non-coding RNA encoding genes (claims 5 and 6).
Application has not described combination of any promoter of a first gene and a coding region of any second gene would create new gene (claim 1).
Applicant has not described combination of any strong promoter would have effect on any PPO gene found in any organisms (claims 11 and 12)
Applicant has not described the method of producing a plant with an increased resistance or tolerance to an herbicide as compared to what control or standard? (claim 31).
Applicant has not described the method of controlling a weed in a cultivation site as compared to what control or standard? (claim 34).
Analysis
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
Combination of different gene elements would encompass combination of any of the elements of gene such as intron, exons, 5’UTR, 3’UTR, promoter, terminator, enhancer or any other fragments of the gene etc. Applicant has not described a method of creating new genes other than shuffling promoter or regulatory region to enhance expression of a gene. Applicant has described creation of new genes by structure only or by combining genetic element which would not require any function of the gene to be changed. For example, Portin et al. defines gene as “A gene is a DNA sequence (whose component segments do not necessarily need to be physically contiguous) that specifies one or more sequence-related RNAs/proteins that are both evoked by genetic networks or genetic regulatory networks (GRNs) and participate as elements in GRNs, often with indirect effects, or as outputs of GRNs, the latter yielding more direct phenotypic effects.” (pages 1361 and 1362, last and first paragraph). Thus, it is not clear whether the DNA breaks and combining the breaks would specify one or more sequence-related RNAs/proteins that are both produced by GRN. Wherein applicant has only showed promoter swapping for PPO1 and CP12; and the HPPD gene and the UBI2 gene. There is dearth of description of combination of other gene and genetic elements that would create new genes by the method of simultaneously creating DNA breaks. For example, Leal et al. (Published: 2017, Journal: Cell, 171(2), 470-480); teaches many of simultaneous deletion and ligation causing combination of gene or genetic elements would not have change in expression of SlCLV3 gene for example in mutant m7 and m9 (see Figure 4 below from Leal et al.). Since there is no effect on the gene’s expression or function, there is dearth of description of new genes whether it is only described by structure of combination or their change in functions. Thus there is dearth of description of creating new genes by simultaneously causing DNA breaks and ligating them to create new gene or genetic element combination to create new genes.
A gene would encompass both coding and non-coding genes. Applicant has not described their method would have any effect to the non-coding genes. For example, Eddy et al. (Published: 2001, Journal: Nature Reviews Genetics, 2(12), 919-929) teaches Non-coding RNA (ncRNA) genes produce functional RNA molecules rather than encoding proteins which has roles of highly specific nucleic acid recognition without complex catalysis, such as in directing post-transcriptional regulation of gene expression or in guiding RNA modifications (page 919, Abstract). However, applicant has not described any non-coding RNA genes can be produced by the method of simultaneous DNA breaks and ligation using homologous recombination or NHEJ.
Application has not described combination of any promoter of a first gene and a coding region of a second gene would create new gene other than specific strong promoter and coding region of the gene as showed in specification. A combination of any promoter of any gene to the coding region of any second gene would not always lead to the transcription of other gene. For example, Zheng et al. (Published: 2008, Journal: Methods Mol Biol. 2008; 434: 205–219. doi:10.1007/978-1-60327-248-3_13) teaches each gene has its own promoter, and some promoters can only be activated in a specific cell type wherein the promoter is specific genetic region involved in the binding of a RNA polymerase to initiate transcription, and is located 5′ from the transcription start site (page 1, last paragraph). Furthermore, Brazda et al. (Published: 2021, Journal: Trends in Genetics, August 2021, Vol. 37, No. 8, pages:730-743) teaches in eukaryotic promoters comprises diversity in downstream promoter elements CAAT box, GC box and more specific ‘TATA-like’, the ‘motif ten element (MTE)’, and the ‘downstream core element’ (DCE) which have different variation in the consensus sequences for different genes (page 731, last paragraph). Bradza et al. taches in eukaryotes the complexity of promoter variation in its architecture increases for example with tissue-specificity of many of the promoters (page 732, first paragraph). Bradza et al. teaches although all living organisms share the same basic types of genes to support fundamental basic cellular processes, there are important differences in their regulatory sequences 9page 739, second paragraph). For this reason, since many of the gene would have specific promoters there is dearth of description of any combination of a promoter of a first gene and a coding region of a second gene would create new gene by driving the expression of the combined coding region.
Applicant has not described combination of any promoter would have effect on any PPO gene found in any organisms. For example, Yoon et al. (Published: 2019, Journal: Plant Molecular Biology 101:561–574) teaches Protoporphyrinogen IX oxidase (PPO) is a universal enzyme of the tetrapyrrole biosynthetic pathway (page 561, right paragraph 1). There is various diversity of the PPO genes and amino acid sequences found in different organisms (page 565, Figure 1, see figure below, page 566, Figure 2).
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Furthermore, Applicant has not described the method of producing a plant with an increased resistance or tolerance to an herbicide or method of controlling a weed as compared to what control or standard? (claim 31 and 34). The increase would mean any increase in tolerance or resistance and controlling weed means any level of control. Instead, applicant has not described increase or controlling weed other than compared to wildtype control plant.
Given the structural diversity associated with the claimed genus any combination of any of the gene or genetic elements that would create gene and genus of any combination of any of the gene or any PPO gene or genetic elements of the genes that would create gene, Applicant’s disclosure is not representative of the claimed genus as a whole. This point is particularly relevant because, as discussed above, the prior art speaks to the disconnection between the structure of the broadly claimed method that would include combination of any genetic or gene elements to create a new gene.
"The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to one skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc, v EH Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, ina, 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). "An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPG2d at 1966". While the written description requirement does not demand either examples or an actual reduction, actual "possession" or reduction to practice outside of the specification is not enough. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F,3d 1336,1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time of the effective filing date of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Anticipated by Li et al.
Claims 1-2, 4-6, 9-10 and 50-51 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Li et al. (Published Year: 2015, Journal: Journal of molecular cell biology, Vol. 7(4), pages: 284-298) (Reference included in IDS submitted on 05/12/2022).
Claim 1 is drawn to a method of creating new gene in an organism by simultaneously generating DNA breaks at two or more different genomic sites and ligating the DNA breaks to generate new combinations of different genetic elements. Claim 2 is further drawn wherein the combination is between promoter of one gene and coding region of another gene.
Regarding claims 1-2, Applicant teaches “The term "gene" comprises a nucleic acid fragment expressing a functional molecule (such as, but not limited to, specific protein), including regulatory sequences before (5' non-coding sequences) and after (3' non-coding sequences) a coding sequence.” (page 19, paragraph 2).
New genes only have been described by structure of combination of the different genetic elements or different protein domains different from the original genomic sequence and it has not been described whether such genetic combination would have any effect on function of the gene.
The claims are drawn to a method for creating a new gene in an organism, characterized by comprising steps of simultaneously generating DNA breaks at two or more different specific sites in the organism's genome, wherein the specific sites are genomic sites capable of separating different genetic elements or different protein domains, and the DNA breaks are ligated to each other by a non-homologous end joining (NHEJ) or homologous repair, generating a new combination of the different genetic elements or different protein domains different from the original genomic sequence, thereby creating the new gene.
Li et al. discloses a method to design seven pairs of sgRNAs to invert DNA fragments by DNA breaks on three different human chromosomes ranging in size from as small as 35 bp to as large as 807480 bp in the HEK293T cell line (Figure 2F–L and Supplementary Table S2) which included regulatory DNA elements of 35 bp in the Pcdh locus (RE2: regulatory element 2) (Figure 2F and Supplementary Figure S6A) and of 709 bp (Figure 2G and Supplementary Figure S6B) and 6277 bp (Figure 2H and Supplementary Figure S6C) in the b-globin locus, as well as large gene clusters of HoxD (18142 bp), b-globin (80732 bp), and Pcdh (256744 and 807480 bp) (Figure 2I–L and Supplementary Figure S6D–G) (page 288, right last paragraph, and page 289, first left paragraph).
Sequencing of both upstream and downstream junctions for each inverted DNA fragment demonstrated that all of the inversion junctions contain precise ligations except those of the Pcdh RE2 (Figure 2F and Supplementary Figure S6A) and the upstream junction of the b-globin locus (Figure 2J and Supplementary Figure S6E). Li discloses NHEJ mechanism created some imprecise junctions in these loci (page 289, first left paragraph).
Li discloses results showed precise double strands breaks, deletions and tandem segmental duplications (page 289, left paragraph 2).
Li et al. further discloses a method of combinatorial inversions and duplications generated by CRISPR with four sgRNAs, targeting specific sites at the boundaries of the Pcdh α, β, and γ gene clusters (Figure 4A). Li detected inversion junctions of individual α (Figure 4B), β (Figure 4C), or γ(Figure 4D) gene cluster as well as of combinations of these clusters, such as the Pcdh α/β (Figure 4E), β/γ (Figure 4F), or the entire Pcdh α/β/γ gene clusters (Figure 4G) (page 289, right second last paragraph). Li discloses, In addition, segmental duplications junctions of the α/β or β/γ gene clusters were also detected generated by NHEJ (page 291, left first paragraph).
Li et al. discloses Quantitative real-time RT–PCR experiments revealed a significant decrease of their expression levels compared with the wild-type (WT) control wherein the expression analysis showed in the edited cell lines, expression levels of two isoforms of Pcdhα genes were significantly decreased compared to wild type (see Figure 5B below). Furthermore, wherein the expression of two ubiquitous isoforms of the Pcdhα cluster is significantly increased when target element contained a NRSF/REST suppressor binding site which was discovered to also regulates the expression of the Pcdh β and γ clusters (Figure 5B) (page 291, right paragraph 1). Thus, the method of Li et al. found a new role of the Pcdhα regulatory element in the regulation of the Pcdh γ cluster that was not found before.
Li et al. discloses variation of expression of the Pcdh α, β, and γ gene clusters in wild type mice (see Figure 5B below). Hence there was variation in expression of the Pcdh α, β, and γ genes.
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Thus, Li discloses a method for creating a new gene in an organism, characterized by comprising steps of:
simultaneously generating DNA breaks at two or more different specific sites in the organism's genome, wherein the specific sites are genomic sites capable of separating different genetic elements or a promoter or the 5’ UTR region of different Pcdhs loci.
the DNA breaks are ligated to each other by a non-homologous end joining (NHEJ) or homologous repair, generating a new combination of the different genetic elements as different combinatorial genomic inversions from different sections of the Pcdhs loci different from the original genomic sequence, thereby creating the new gene.
Li discloses the method further characterized the combination of different gene elements is a combination of the region from the promoter to 5'UTR of one of the two genes with different expression patterns and the CDS or non-coding RNA region of the other gene, or a combination of adjacent gene elements of the same gene.
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Regarding claim 4, the specific site would have been in same chromosome.
Regarding claims 5, 6 and 9, the Li et al. discloses different gene elements is a combination of the region from the promoter to 5'UTR of one of the two genes with different expression patterns and the CDS or non-coding RNA region of the other gene (see Figure 5B above).
Regarding claim 10, Li et al. discloses their inversions were in non-human mice (page 284, Abstract).
Regarding claim 50, Li et al. discloses the method of combinatorial inversions and duplications generated by CRISPR with four sgRNAs, targeting specific sites at the boundaries of the Pcdh α, β, and γ gene clusters (Figure 4A).
Regarding claim 51, the nuclease was delivered into the cell by Lipofectamine 2000 (i.e. a liposome mediated cell transfection method) (page 294, last paragraph).
Therefore, Li et al. anticipates the claims.
Anticipated by Shi et al.’16 or Shi et al. ‘17
Claims 1-2, 4-10, 50, and 51 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Shi et al.’17 (Published: 2017, Journal: Plant Biotechnology Journal 15, pp. 207–216) (reference included with IDS filed on 09/16/2022) or Shi et al., 16 (WIPO International Publication Number: WO 2016/007948 Al, Publication Date: 01/14/2016)) (reference included with IDS filed on 05/20/2025). For the following analysis the Publication in the Shi et al.’17 has been used below for reference to page numbers for rationale of obviousness analysis.
The claims are drawn to a method for creating a new gene in an organism, comprising steps of simultaneously generating DNA breaks at two or more different specific sites in the organism's genome by delivering a CRISPR-based gene editing system into a cell of the organism, and detecting a new combination of the different genetic elements, wherein the combination of different genetic elements is a combination of a promoter of a first gene and a coding region of a second gene, wherein the two genes have different expression patterns, wherein the transcription of the second gene is driven by the promoter of the first gene.
Regarding claims 1 and 10, Shi et al. discloses a method for creating a new gene in maize plants, comprising the following steps:
simultaneously generating DNA breaks at two or more different specific sites in the organism's genome by delivering a CRISPR-based gene editing systemin to a cell of the maize plant which targets the two or more different specific sites of the genomic DNA (i.e. around ARGOS8 PRO promoter that separates the promoter from 5’URT, CDS and other CDS), wherein the CRISPR-based gene editing system comprises a nuclease (i.e. Cas 9 nuclease) or a polynucleotide encoding thereof, and two or more guide RNAs which target the two or more different specific sites respectively or one or more polynucleotide encoding the guide RNAs (i.e. two sgRNAs (CR2 and CR3) in the GOS2 PRO swap (Figure S3)) (Shi et al., page 208, right last paragraph).
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wherein the nuclease and the guide RNAs contact the two or more different specific sites and creates cleavage at the two or more different specific sites (see figure above for two cleavages around the ARGOS9 promoter), and wherein the specific sites are genomic sites separating different genetic elements (i.e. CDS and ARGOS8 promoter and any other gene from ARGOS8 promoter), wherein the genetic element consisting of a promoter, a 5' untranslated region, a coding region (CDS) (Figure 1).
Shi et al. discloses a pair of junction PCR assays was designed to detect native maize GOS2 PRO swaps at CTS due to homologous recombination (i.e. HR) (page 210, left paragraph 1) (Figure 2c, see image below) wherein P1 and P2 for the HR1 junction; P5 and P4 for the HR2 junction (page 209, Figure 2)
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Shi et al. discloses detecting new combination of the different genetic elements (i.e. a native GOS2 PRO promoter attached to the ARGOS8 genomic sequence which is different from the original genomic sequence)
wherein the combination of different genetic elements is a combination of a promoter of a first gene and a coding region of a second gene,
wherein the two genes have different expression patterns, wherein the transcription of the second gene is driven by the promoter of the first gene,
Shi et al. discloses for the GOS2 promoter swapped three plants were positive for both junctions (Figure 2d and Table S1), and from these eight plantlets were regenerated. Shi et al. discloses one of the lines is referred to as ARGOS8-variant2 (ARGOS8v2) (page 210, left paragraphs 2-3) wherein the expression of the ARGOS8 is increased in ARGOS8-variant2 relative to the wildtype (see Figure 3b and 4a, see image below).
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Shi et al. discloses Significant differences among entries were observed for grain yield in the FS location group, with the ARGOS8-v1 and ARGOS8-v2 entries yielding approximately five bushel per acre more than the control (Table 1) (page 210, right paragraph 3).
Shi et al. discloses in a diverse set of over 400 maize inbreds the expression levels were less than in the original ARGOS8 transgenic events wherein native maize GOS2 promoter confers a moderate level of constitutive expression (page 207, Abstract). For this reason the genes have different expression patterns.
Regarding claims 2 and 5, the specific sites are genomic sites separating different genetic elements (i.e. CDS and ARGOS8 promoter and any other gene from ARGOS8 promoter), wherein the genetic element consisting of a promoter, a 5' untranslated region, a coding region (CDS) (Figure 1).
Regarding claim 4, Shi et al. the two or more specific sites are in same chromosome (Figure 1).
Regarding claim 6, Shi et al teaches the combination is combination of maize GOS2 gene promoter replaced with the promoter of the ARGOS8 gene leading to change in the ARGOS8 gene expression pattern and grain yield under stress condition in maize (page212, left paragraph 1).
Regarding claims 7-9, the combination would have combined the promoter of GOS2 gene and any of a DNA binding domain, a transcription activation domain, a receptor activation domain or an enzyme catalytic center of the ARGOS8 gene leading to change in the ARGOS8 gene expression pattern and grain yield under stress condition.
Shi et al. teaches ARGOS8 proteins physically interact with the ethylene receptor signaling complex, modulating ethylene perception and the early stages of the ethylene signal transduction (page212, left last paragraph) wherein overexpression of the ARGOS8 gene exhibit reduced sensitivity to ethylene (page 212, right paragraph).
Regarding claim 50, Shi et al. DNA breaks are created by delivering CRISPR/Cas system (page 207, Abstract).
Regarding claim 51, Shi et al. teaches the maize transformation was biolistic mediated using a Helium Gun bombardment (page 213, right first paragraph).
Therefore, method disclosed by Shi et al. anticipates the claim.
Anticipated by Aponte et al.
Claims 12, 30-31 and 34 are rejected under 35 U.S.C. 102 (a)(1) and/or (a)(2) as being anticipated by Aponte et al. (US Patent No.: US 10,392,630 B2, Date of Patent: Aug. 27, 2019).
Claims are drawn to a gene created by method of claim 1, characterized that the level of new gene expression is upregulated relative to the plant endogenous wild type PPO gene that causes herbicide tolerance.
Following analysis based on the In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) which teaches “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Thus, a product-by-process claim may be properly rejectable over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Regarding claims 12 and 30-31, Aponte et al. discloses a corn plant with a PPO gene fused to a ZmUbi promoter and Figure 5 showed a corn plant comprising the construct (col. 228, lines 60-67). The plant comprising the construct showed increased herbicide tolerance (1 is wildtype) (see Figure 5 below).
Claim 11 that depend on claim 1 is only directed to a product of a gene that would require to have combination of genetic element of one gene to other gene. A corn plant with a PPO gene fused to a ZmUbi promoter comprise the gene with combination of a promoter of one gene and coding region of other gene.
Regarding claim 34, Aponte et al. teaches method of applying to the cultivation site of the maize PPO inhibiting herbicide: flumioxazin, butafenacil, acifluorfen etc. wherein top survivors were transplanted into gallon pots wherein the results are showing in figure 5 below (col.234, lines 45-67 and col. 235, lines 1-21).
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Therefore Aponte et al. anticipate the claim.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 non-obviousness.
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.
Obvious over Li, and further in view of Cigan and Lermontova
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Published Year: 2015, Journal: Journal of molecular cell biology, Vol. 7(4), pages: 284-298) (Reference included in IDS submitted on 05/20/2025), and further in view of Cigan et al. (WIPO International Publication Number: WO 2015/026883 A1, Publication Date: 02/26/2015) (Reference included in IDS submitted on 05/20/2025), and further in view of Lermontova et al. (Published Year: 2000; Journal: Plant Physiology, Vol. 122(1), pages: 75-84) (Reference included in IDS submitted on 05/20/2025).
Claim 1 is drawn to a method of creating new gene in an organism by simultaneously generating DNA breaks at two or more different genomic sites and ligating the DNA breaks to generate new combinations of different genetic elements. Claim 11 is furthermore drawn to wherein one genetic element is an endogenous strong promoter and another gene is a PPO gene.
Regarding claim 1, Li et al. teaches a method to design seven pairs of sgRNAs to invert DNA fragments by DNA breaks on three different human chromosomes ranging in size from as small as 35 bp to as large as 807480 bp in the HEK293T cell line (Figure 2F–L and Supplementary Table S2) which included regulatory DNA elements of 35 bp in the Pcdh locus (RE2: regulatory element 2) (Figure 2F and Supplementary Figure S6A) and of 709 bp (Figure 2G and Supplementary Figure S6B) and 6277 bp (Figure 2H and Supplementary Figure S6C) in the b-globin locus, as well as large gene clusters of HoxD (18142 bp), b-globin (80732 bp), and Pcdh (256744 and 807480 bp) (Figure 2I–L and Supplementary Figure S6D–G) (page 288, right last paragraph, and page 289, first left paragraph).
Li et al. teaches sequencing of both upstream and downstream junctions for each inverted DNA fragment demonstrated that all of the inversion junctions contain precise ligations except those of the Pcdh RE2 (Figure 2F and Supplementary Figure S6A) and the upstream junction of the b-globin locus (Figure 2J and Supplementary Figure S6E). Li teaches NHEJ mechanism created some imprecise junctions in these loci (page 289, first left paragraph).
Li et al. teaches results showed precise double strands breaks, deletions and tandem segmental duplications (page 289, left paragraph 2).
Li et al. further teaches a method of combinatorial inversions and duplications generated by CRISPR with four sgRNAs, targeting specific sites at the boundaries of the Pcdh α, β, and γ gene clusters (Figure 4A). Li et al. teaches detection of inversion junctions of individual α (Figure 4B), β (Figure 4C), or γ(Figure 4D) gene cluster as well as of combinations of these clusters, such as the Pcdh α/β (Figure 4E), β/γ (Figure 4F), or the entire Pcdh α/β/γ gene clusters (Figure 4G) (page 289, right second last paragraph, see figure 4 above). Li teaches, in addition, segmental duplications junctions of the α/β or β/γ gene clusters were also detected generated by NHEJ (page 291, left first paragraph).
Li et al. teaches Quantitative real-time RT–PCR experiments revealed a significant decrease of their expression levels compared with the wild-type (WT) control wherein the expression analysis showed in the edited cell lines, expression levels of two isoforms of Pcdhα genes were significantly decreased compared to wild type (see Figure 5B below). Furthermore, wherein the expression of two ubiquitous isoforms of the Pcdhα cluster is significantly increased when target element contained a NRSF/REST suppressor binding site which was discovered to also regulates the expression of the Pcdh β and γ clusters (Figure 5B) (page 291, right paragraph 1). Hence the method of Li et al. found a new role of the Pcdhα regulatory element in the regulation of the Pcdh γ cluster that was not found before.
Li et al. teaches variation of expression of the Pcdh α, β, and γ gene clusters in wild type mice (see Figure 5B above). Hence there was variation in expression of the Pcdh α, β, and γ genes.
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Li et al. teaches their data demonstrated the usefulness of CRISPR technology in manipulating genomes to study gene regulatory elements as well as gene clusters (page 293, right first paragraph). Li et al. discloses they have showed precise inversion and duplication of DNA fragments with defined length ranging in size from tens of bp to hundreds of kb could be easily achieved (page 294, left paragraph 2).
Cigan et al. teaches a method of replacement of a EPSPS1 promoter in soybean with the soybean UBQ promoter using the guide RNA/Cas9 endonuclease system wherein two guideRNA expression vectors were used in soybean transformation. Cigan et al. teaches Homologous recombination between the polynucleotide modification template and the genomic DNA resulted in the replacement of EPSPS1 promoter/5'UTR with the soybean UBQ promoter/5'UTR/lntron1 and the desired amino acid modifications evidenced by PCR analysis (page 185, lines 421).
Cigan et al. teaches endogenous wild type enolpyruvylshikimate-3-phosphate synthase (page 11, lines 6-7). Cigan et al. teaches altering the EPSPS target can result in the production of plants that are tolerant and/or resistant against glyphosate based herbicides (page 123, lines 15-16).
Cigan et al. teaches promoter swap causes increased promoter activity, a new promoter activity, an inducible promoter activity, an extended window of gene expression etc., wherein the promoter can be endogenous promoter or preexisting promoter to the cell that is being edited (page 53, lines 1-5).
Regarding claim 76, Li et al. and Cigan et al. does not specifically teach the one promoter is endogenous promoter of the plant and other is the coding region of protoporphyrinogen oxidase (PPO) gene.
Lermontova et al. teaches transformation of a tobacco plants with PPO gene under the control of cauliflower mosaic virus 35S promoter. Lermontova et al. teaches the resistance to herbicide acifluorfen is conferred by overexpression of the plastidic isoform of protoporphyrinogen oxidase (PPO) wherein overproduction of PPO oxidase neutralizes the herbicidal action prevents the accumulation of the substrate protoporphyrinogen IX, and consequently abolishes the light-dependent phytotoxicity of acifluorfen (page 75, Abstract). Thus, someone skilled in art would increase expression of PPO as taught by Li et al. and further showed in plant by Cigan et al. for using specific promoter to overexpress the gene which could be effective for herbicide tolerance wherein Lermontova et al. teaches herbicides to control undesirable vegetation is important practice and for the broad application of herbicides the risk of damage to crop plants has to be limited (page 75, Abstract).
Therefore a known work in mice model as showed by Li et al. for the usefulness of CRISPR technology in manipulating genomes to study gene regulatory elements as well as gene clusters by precise inversion and duplication of DNA fragments with defined length and also further showed by Cigan et al. in plants to carry out a promoter swap of a native soybean promoter with the promoter of native EPSP gene in soybean effecting herbicide resistance, would have prompted variations of it for use for example for increasing expression of a PPO gene as motivated by Lermontova et al. that would increase herbicide resistance in a plant based on the value of herbicide resistant products in plant sciences since the variation were predictable to one of ordinary skill in the art.
Obvious over Shi et al. and further in view of Vanoli et al.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al.’17 (Published: 2017, Journal: Plant Biotechnology Journal 15, pp. 207–216) (reference included with IDS filed on 09/16/2022) or Shi et al., 16 (WIPO International Publication Number: WO 2016/007948 Al, Publication Date: 01/14/2016) ) (reference included with IDS filed on 05/20/2025) and further in view of Vanoli et al.(Published: 2017, Journal PNAS 114(14), pages: 1-6).
Claim 1 is drawn to a method of creating new gene in an organism by simultaneously generating DNA breaks at two or more different genomic sites and ligating the DNA breaks to generate new combinations of different genetic elements. Claim 3 is drawn to creating DNA breaks in three specific sites wherein the translocation editing events is generated when the genomic site of a promoter of highly expressing gene and coding region of other gene is combined.
Regarding claim 3, Shi et al. teaches three target sites (see part of figure 2 below) in the genome of the corn plant, Shi et al. teaches their ARGOS8 editing process can be summarized as a two-step procedure: duplication of the GOS2 promoter and translocation to the ARGOS8 locus (page 212, right last paragraph). Therefore, someone skilled in the art would create such fragment by cutting of the promoter region of GOS2 gene and translocating it to the promoter of ARGOS8 gene CDS.
Furthermore, the event of duplication and translocation of DNA fragment is found naturally in maize and other genome (page 212, right last paragraph).
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Shi et al. specifically does not teach simultaneously generating breaks at three different specific sites to create translocation editing events.
Vanoli et al. teaches generating translocation EWSR1–WT1 created by using two gRNA and CRISPR-cas9 system that led to translocation and fusion transcript under the control of the endogenous EWSR1 promoter (page 1, Abstract, page 5, right first paragraph).
Vanoli et al. teaches a translocation can either fuse two genes within intronic sequences to result in expression of a novel fusion protein (page 1, left first paragraph).
Therefore, it would have been obvious from teaching, suggestion, or motivation in Shi et al. to create translocation of DNA fragment in maize genome and modify the prior art so that the specific translocation is created by cutting and rejoining the DNA fragment comprising the promoter of one gene to the CDS of other gene as taught by Vanoli et al. to arrive at the claimed invention of the method of creating a new gene.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Nonstatutory Double Patenting as being unpatentable over Copending Application No. 17264367
Claims 1-12, 30, 31, 34, 50, and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 76, and 83-84 of copending Application No. 17264367 (reference application) Hereafter referenced as ‘367). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 10, Copending Application ‘367 claim 1 discloses a method for creating a new gene in a plant, characterized by comprising the following steps: simultaneously generating DNA breaks at two or more different specific sites in the plant, wherein the specific sites are genomic sites separating different genetic elements or different protein domains, and the DNA breaks are ligated to each other by a non-homologous end joining (NHEJ) or homologous repair, generating a new combination of the different genetic elements or different protein domains different from the original genomic sequence, thereby creating the new gene.
Regarding claims 2, 5-6, 7-9, Copending Application ‘367 claim 1 discloses the combination is promoter of one gene and coding region of other gene with different expression patterns.
Regarding claim 3, simultaneously generating DNA breaks at two or more different specific sites in claim 1 would mean three sites.
Regarding claim 4, the genomic site would have been either in same or different chromosomes.
Regarding claims 11-12, 30-31, and 34, the Copending Application ‘367 claims 1 and 76 discloses coding region of the gene is from PPO gene.
Copending Application ‘367 claims 83 recite method of producing herbicide resistance plant that comprise regenerating the modified plant cell.
Copending Application ‘367 claims 84 discloses the method comprise applying PPO inhibitory herbicides to effectively control the weed.
Regarding claim 50, copending Application ‘367 claim 1 discloses delivering CRISPR-based system.
Regarding claim 51, Copending Application ‘367 claim 9 discloses PEG-mediated cell transfection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Nonstatutory Double Patenting as being unpatentable over Copending Application No. 17058261
Claim 1, 3-5, 9-10 and 50-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 103, 113, 136 and 142 of copending Application No. 17058261 (reference application) (Hereafter referenced as ‘261). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1, 4 and 50, copending Application No. ‘261 claim 103 and 136 discloses a method which comprise sequentially generating two or more breaks at specific site in a genome of the organism and spontaneously repairing them to create new sequence using CRISPR /Cas system.
Since the genomic sites and genetic elements are not defined the breaks would comprise any genomic sites and genetic.
Regarding claims 3-5 and 9, the breaks would have been in either same or different chromosome and in one of the region of claim 5 for example any coding or non-coding region.
Regarding claim 10, copending Application No. ‘261 claim 142 recites the method is in plant.
Regarding claim 51, copending Application No. ‘261 claim 113 recite PEG mediated cell transfection used to deliver nuclease.
Conclusion
No claim is allowed.
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/SANTOSH SHARMA/ Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663