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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2026 has been entered.
Claim Status
Claims 1-5, 7, 9-11, 16-17, 20 and 22-34 are pending.
Claims 1-2, 7, 9-11, 17, 20, 27, 29 and 30 are newly amended.
Claims 31-34 are newly added.
Claims 12-15, 19 and 21 are newly cancelled.
Claims 1-5, 7, 9-11, 16-17, 20 and 22-34 are examined on the merits.
Response to Applicant Arguments - 35 USC § 112 (Indefiniteness)
Applicant’s cancellation of claims 12-15 dated 05/27/2026, renders the indefiniteness rejections of record against those claims moot and they are withdrawn. Additionally, in response to Applicant’s remarks and amendments to the claims dated 05/27/2026 the indefiniteness rejections of record against claims 29-30 are withdrawn.
Response to Applicant Arguments - 35 USC § 103)
In response to Applicant’s arguments and amendments to the claims dated 05/27/2026, the obviousness rejections of record have been withdrawn and new obviousness rejections are presented below.
Applicant’s arguments which remain relevant to the newly presented rejections are summarized and addressed below.
Slaymaker does not teach or suggest modification of the ACO genes themselves to generate a loss of function mutation, instead Slaymaker teaches the insertion of an antisense copy or truncated version for suppression (Remarks, Page 8, Middle Paragraph).
The Examiner has cherry-picked discrete disclosure from Slaymaker in order to arrive at the instantly claimed methods while disregarding the overall teachings of Slaymaker (Remarks, Page 2, Middle Paragraph).
Liu, post-dates Applicant’s effective filing date and therefore does not qualify as prior art and cannot be relied upon to supply teachings for a rejection unless it qualifies as prior art (Remarks, Page 12, Third Paragraph).
Applicant’s invention represents an unexpected result because as evidenced in the Pignocchi Declaration additional data shows banana plants having edits in both the ACO1 and ACO2 genes showed significantly extended green life in comparison to a commercial cultivar and an unedited control line (Remarks, Page 14, Last two paragraphs).
With respect to Applicant’s arguments summarized in 1. above, these arguments have been fully considered but are not found to be persuasive because Slaymaker is used in the new rejections to teach an effective and efficient method of targeting ACO genes to reduce their expression and the activity of the proteins they encode. The specific mechanism of reducing the expression and activity of these targets using the DNA editing system of Slaymaker represents a design choice and while Slaymaker teaches the use of a silencing construct to target ACO, Slaymaker also teaches the use of non-homologous end joining techniques to produce insertion-deletion mutations (indels) which result in premature stop codons and a non-functional protein product (Slaymaker, Paragraph 00188, Spanning Pages 49-50). Slaymaker teaches that this can be an effective method of gene disruption of an undesirable protein (Slaymaker, Page 49, Paragraph 0188). As such, given motivation provided by the other references to target banana ACO1 and the teachings of Slaymaker, it is clear that in combination the references teach generating loss of function mutations in the target banana ACO1 genes and therefore Applicant’s arguments summarized in 1. above are not found to be persuasive.
With respect to Applicant’s arguments summarized in 2. above, these arguments have been fully considered but are not found to be persuasive because in combination the references describe the importance of banana fruits at both the economic and human nutrition levels, present the problem of large post-harvest losses and the opportunity to increase the global supply of bananas by reducing these losses. The references describe the role of ethylene in post-harvest banana losses and describe the role of the ACO1 gene in ethylene production and state that recombinant DNA techniques should be used to target this gene to reduce ethylene production and lower post-harvest losses. Slaymaker teaches an effective system and effective methods for gene editing plants and provides several examples, one drawn to targeting ACO and another drawn to targeting undesirable proteins through the NHEJ mechanism to produce knockout alleles through the production of premature stop-codons. These references teach a clear pathway which leads to a banana plant comprising a loss of function mutation in the ACO1 genes that was introduced through a DNA editing agent.
Rather than picking through Slaymaker and arbitrarily combining teachings, the ordinary artisan upon viewing the teachings of Hailu, Pathak, Cheng and the evidence provided in Liu would have found it obvious to generate knock-out mutations in banana ACO1 and would have found that Slaymaker teaches efficient methods for generating this mutations in plants including two different methods that were readily applicable to the problem of excess ethylene production and large post-harvest losses in banana.
As such Applicant’s arguments summarized in 2. above, have been fully considered but are not found to be persuasive.
With respect to Applicant’s arguments summarized in 3. above, these arguments have been fully considered but are not found to be persuasive because Liu is used in the rejection to provide evidence of an inherent characteristic of a teaching of a thing taught by the primary reference. The use of the language “as evidenced by” in the rejection is not a semantic trick in order to provide teachings from a reference which post-dates the earliest effective filing date of the instant application, it is an indicator that this reference is used to provide evidence that a characteristic not disclosed in the reference is inherent.
The MPEP in 2131.01 describes the use of extra references in a 102 rejection, although this is a 103 rejection, this section of the MPEP provides the following information which is relevant. First, III of MPEP 2131.01 states the following in the final sentence:
“Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.”
Then MPEP 2141 states the following “In certain circumstances, references cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism.”
2141 also makes clear that “Post-effective-filing-date evidence offered to illuminate the post-effective-filing-date state of the art is improper”.
This is important because while Liu and new reference Wu post-date the effective filing date of the instant application these references are cited to show a universal fact:
The banana (Musa acuminata) ACO1 (MaACO1) gene has the inherent characteristic of another name, specifically, the gene ID number Ma01_g11540. Liu is not used to illuminate the post-effective-filing-date state of the art, nor to show that the claimed invention is enabled or described. Liu is used to show that a characteristic (alternative name of ACO1) which was not disclosed in the reference (Cheng) is inherent. ACO1 refers to a gene in the Musa acuminata genome, this gene can also be described by its position in the genome via a gene ID number in this case Ma01_g11540 or Ma07_g19730.
Therefore, Applicant’s arguments summarized in 3. above, have been fully considered but are not found to be persuasive.
With respect to Applicant’s arguments summarized in 4. above, these arguments have been fully considered but are not found to be persuasive because while Applicant urges that the data presented in the Pignocchi Declaration represents an unexpected result it is not clear what about these results is unexpected.
Specifically, Applicant urges that these results demonstrate that the CRISPR/Cas9 system could be used to introduce precise mutations in endogenous ACO target genes in banana with the expectation of achieving banana fruit characterized by an extended shelf life, while nowhere in any of the cited references is there anything to suggest that these results would be expected.
The examiner disagrees.
First, it is not clear how the results are unexpected because the evidence that Applicant points to as unexpected matches that which is expected giving the teachings of the prior art. Specifically, Cheng teaches that NO treatment of bananas inhibited the activity and transcription of ACO1 which resulted in decreased ethylene synthesis and the delay of ripening in bananas. Therefore, that modifications to the ACO1 target gene led to extended shelf life of bananas is the predicted result not an unexpected one.
Further, the CRISPR/Cas9 system is well known in the art and generating targeted mutations with this system is routine in a wide variety of targets. Slaymaker teaches the use of this system to make several different types of modifications to target different sequences including ACO genes in a variety of species which Slaymaker teaches can include banana. Therefore, that the CRISPR/Cas9 system could be used to make precise edits in a target sequence would appear to be the predicted result rather than an unexpected result.
Applicant’s argument that because the references do not teach that this result would be expected that it is unexpected is not persuasive because each of the reference used in this obviousness rejection teach that certain actions have corresponding expected results. When the teachings are combined the corresponding expected results are combined such that the expected result of the plants of Hailu, Pathak, Cheng as evidenced by Liu and Slaymaker is the production of banana fruits having delayed fruit ripening due to a targeted loss of function mutation in ACO1.
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.
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 1-5, 7, 9, 10-11, 16, 23-30 are newly rejected under 35 U.S.C. 103 as being unpatentable over Hailu, African Journal of Biotechnology 12.7 (2013): 635-647, in view of Pathak, Plant Growth Regulation 40.1 (2003): 11-19, Cheng, Journal of Agricultural and Food Chemistry 57.13 (2009): 5799-5804, as evidenced by Liu, Journal of experimental botany 72.20 (2021): 7078-7091 and in view of Slaymaker (WO 2016/205613 Al).
The obviousness rejections below are grouped based on shared fact pattern and analysis even though they all rely on the same prior art references.
Obviousness rejection against claim 1.
Claim 1 is drawn to a banana plant comprising a loss of function mutation in a Ma01_g11540 or Ma07_g19370 nucleic acid sequence encoding a 1-aminocyclopropane-1-carboxylate Oxidase (ACO).
Applicant defines two important terms in the specification.
First, applicant defines “plant” on page 25 in lines 18-22 as follows:
“As used herein “plant” refers to whole plant(s), a grafted plant, ancestors and progeny of the plants and plant parts, including seeds, fruits, shoots, stems, roots (including tubers), rootstock, scion, and plant cells, tissues and organs.
The plant may be in any form including suspension cultures, protoplasts, embryos, meristematic regions, callus tissue, leaves, gametophytes, sporophytes, pollen, and microspores”.
Applicant also defines “loss of function mutation” on page 27 in lines 8-10 as follows:
“As used herein “loss of function” mutation refers to a genomic aberration which results in reduced ability (i.e., impaired function) or inability of the component of the ethylene biosynthesis pathway to facilitate in the synthesis of ethylene or precursor thereof”.
Given these definitions, when viewing the claims in light of the specification the broadest reasonable interpretation of the claims is drawn to the following: any single banana cell, including a protoplast comprising any genomic aberration in a Ma01G11540 or Ma07_g19730 gene which results in reduced ability of ACO to facilitate in the synthesis of ethylene or a precursor thereof.
With respect to claim 1, Hailu teaches that Banana is an incredibly important food crop and the 4th largest food crop in the world (Hailu, Page 635, Columns-12). Hailu also teaches that bananas and plantains are important cash crops providing the sole source of income to some rural populations (Hailu, Page 635, Columns 1-2). Finally, Hailu teaches that banana is a major starch stable of considerable importance in the developing world which is consumed as an energy yielding food and as a dessert (Hailu, Page 635, Column 1). These teachings demonstrate the importance of bananas for human health, as an element in global trade and as a product with implications on the development of nations.
Hailu teaches that despite this importance, there is a key problem to be solved in the trade of fruits and vegetables and in particular of banana. Specifically, there is a large percentage of post-harvest loss due to lack of packaging, storage facilities and poor means of transportation, this can lead to up to 50% losses (Hailu, Page 636, Column 6, First Complete Paragraph).
Hailu then reviews characteristics of bananas, preharvest factors that influence banana quality and then postharvest characteristics of banana and factors affecting postharvest losses. This review includes approaches that work to delay the process of ripening, thereby extending the shelf-life of the produce and reducing post-harvest losses (Hailu, Page 643, Column 1, Last Paragraph).
As such Hailu teaches the importance of banana fruit, that banana fruits experience a high percentage of post-harvest losses and that there are many strategies to try and alleviate these losses including those which extend the shelf-life of the fruit by delaying fruit ripening.
With respect to claim 1, Hailu does not teach a banana plant comprising a genome comprising a loss of function mutation in Ma01_g11540 or Ma07_g19730 which are genes encoding ACC oxidases (ACO), a component in the ethylene biosynthesis pathway of banana.
With respect to claim 1, Pathak teaches motivation to target ACS or ACO in banana through recombinant DNA technology to delay ripening (Pathak, Page 17, Column 2, Last Paragraph).
With respect to claim 1, Cheng teaches that down regulation of banana ACO1 (MaACO1) was associated with reduced ethylene production which may account for the delay of softening of banana fruits (Cheng, Page 5799, Abstract). Cheng proposes that the inhibition of banana ACO1 transcription resulted in decreased ethylene synthesis and the delay of ripening of banana slices (Cheng, Page 5799, Abstract).
Thus Cheng provides motivation to knock-out the MaACO1 gene in banana plants in order to reduce ethylene production and delay fruit ripening in banana.
With respect to claim 1, Liu provides evidence that an inherent characteristic of MaACO1 is that it has the gene ID number Ma01_g11540 (Liu, Page 7083, Column 1, After reference to supplementary table S3). Importantly, in this rejection Liu is not being used to teach any limitations of the claimed invention, rather Liu is describing an inherent characteristic of banana ACO1; the gene ID number Ma01_g11540.
With respect to claim 1, Slaymaker teaches methods of introducing genomic modifications into plant cells and modified plants. Specifically, Slaymaker teaches modified Cas9 enzymes for use in the CRISPR/Cas9 gene editing system which have increased efficiency and reduced off target effects (Slaymaker, Page 2, Paragraph 0008). This system allows for the targeted and efficient generation of different types of specific genomic modifications (aberrations) in plant cells (Slaymaker, Page 411, Paragraph 1192).
These modifications can be simple and drawn to disrupting an undesirable gene (Slaymaker, Paragraph 0188) or more complicated, like inserting an antisense sequence for a target gene in order to suppress expression of that target gene (Slaymaker, Paragraph 001191). Further, Slaymaker states that “the specific type of genome editing therapy depends on the nature of the mutation causing the disease” and would also depend on the desired outcome. As such, Slaymaker indicates that the type of gene-editing approach used represents a design choice based on the target and the desired outcome.
Slaymaker provides many examples of specific uses for this improved gene editing system including using gene editing to modify the expression and therefore activity of ACO genes in tomato plants to reduce expression of the enzyme and delay fruit ripening (Slaymaker, Page 410, Paragraph 1191; Slaymaker, Page 411, Paragraph 1191).
Further, Slaymaker teaches the generation, transformation and gene editing of protoplast cells and generating protoplasts and further teaches that these methods are well known and routine practice in the art (Slaymaker, Page 376, Paragraph 1103; Slaymaker, Page 386, Paragraph 1130; Slaymaker, Page 386, Paragraph 1131; Slaymaker, Page 391, Paragraph 1147; and Slaymaker, Page 391, Paragraph 1150).
Finally, Slaymaker teaches that the methods described by Slaymaker use the CRISPR/Cas9 system and can be used to confer desired traits on essentially any plant including those from the Musa family and in the previous paragraph Slaymaker makes clear that the term plants refers to a variety of different species including Banana (Slaymaker, Pages 380-381, Paragraphs 1111-1112; Slaymaker, Page 379, Paragraph 1110).
Given the above teachings of the prior art, it would have been obvious to the ordinary artisan at the time of filing to use recombinant DNA technology to target banana ACO1 which is also known as Ma01_g11540 in order to generate a knock-out mutant which is not transcribed or translated in order to produce banana plants having fruits without ACO1 transcription. This would have been obvious because the references are all drawn towards Banana plants and effects and strategies of preventing post-harvest losses in crops. Hailu teaches the importance of banana plants, the high level of post-harvest fruit loss, and a desire for methods or products which reduce these losses. The other references teach the role of ACO in fruit ripening and Slaymaker teaches a method of efficiently generating mutations which reduce ethylene production by reducing the expression and activity of ACO.
Given this the ordinary artisan would have found it obvious to use the gene editing system of Slaymaker which suggests targeting ACO to delay fruit ripening to target the banana ACO genes as taught in the other references in order to reduce post-harvest losses. Stated differently, this would have been obvious because it is simply combining prior art elements according to known methods to yield predictable results.
The ordinary artisan would have been motivated to combine these teachings because this would allow for the rapid and efficient production of a banana ACO1 mutant having reduced ACO activity, reduced ethylene synthesis and delayed ripening. Delayed ripening of the banana fruit has been proposed as a method to alleviate the high post-harvest losses in banana crops and as such the ordinary artisan would have been motivated to produce banana plants having fruits with delayed ripening in order to produce banana crops having increased shelf-life and reduced post-harvest losses. This would lead to a larger banana supply which would mean more food for those that rely on bananas as an energy source as well as higher profits for those selling bananas to retailers as more fruit would be available for sale due to reduced losses. As such the ordinary artisan would have been motivated to combine the teachings of the prior art to produce a banana plant having delayed fruit ripening because of the economic benefits of reduced post-harvest losses in banana crops and the ability to deliver a larger and more stable food supply to those who rely on banana as an energy source.
As such claim 1 is newly rejected as obvious given the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker.
Obviousness rejection against claim 2.
Claim 2 is drawn to a method of increasing the shelf-life of banana comprising:
subjecting any banana plant cell including protoplasts to a DNA editing agent directed at a Ma-1_g11540 or Ma07_g19730 nucleic acid sequence encoding an ACO enzyme to produce a mutation which results in impaired function of the ACO and regenerating a plant from said plant cell.
This broad genus of methods includes the introduction of mutations which reduce the expression of ACO, as lack of expression would impair the function of the gene/enzyme in producing ethylene, see applicant definitions of plant and loss of function mutation at the beginning of the anticipation rejections above.
With respect to claim 2, Hailu teaches that Banana is an incredibly important food crop and the 4th largest food crop in the world (Hailu, Page 635, Columns-12). Hailu also teaches that bananas and plantains are important cash crops providing the sole source of income to some rural populations (Hailu, Page 635, Columns 1-2). Finally, Hailu teaches that banana is a major starch stable of considerable importance in the developing world which is consumed as an energy yielding food and as a dessert (Hailu, Page 635, Column 1). These teachings demonstrate the importance of bananas for human health, as an element in global trade and as a product with implications on the development of nations.
Hailu teaches that despite this importance, there is a key problem to be solved in the trade of fruits and vegetables and in particular of banana. Specifically, there is a large percentage of post-harvest loss due to lack of packaging, storage facilities and poor means of transportation, this can lead to up to 50% losses (Hailu, Page 636, Column 6, First Complete Paragraph).
Hailu then reviews characteristics of bananas, preharvest factors that influence banana quality and then postharvest characteristics of banana and factors affecting postharvest losses. This review includes approaches that work to delay the process of ripening, thereby extending the shelf-life of the produce and reducing post-harvest losses (Hailu, Page 643, Column 1, Last Paragraph).
As such Hailu teaches the importance of banana fruit, that banana fruits experience a high percentage of post-harvest losses and that there are many strategies to try and alleviate these losses including those which extend the shelf-life of the fruit by delaying fruit ripening.
With respect to claim 2, Hailu does not teach methods of increasing shelf-life of banana comprising; subjecting a banana plant cell to a DNA editing agent directed at Ma01_g11540 or Ma07_g19730 which are genes encoding ACC oxidases (ACO), a component in the ethylene biosynthesis pathway of banana and regenerating a plant from said plant cell.
With respect to claim 2, Pathak teaches motivation to target ACS or ACO in banana through recombinant DNA technology to delay ripening (Pathak, Page 17, Column 2, Last Paragraph).
With respect to claim 2, Cheng teaches methods of down-regulating the expression of banana ACO1 (MaACO1) which was associated with reduced ethylene production and may account for the delay of softening of banana fruits (Cheng, Page 5799, Abstract). Cheng proposes that the inhibition of banana ACO1 transcription resulted in decreased ethylene synthesis and the delay of ripening of banana slices (Cheng, Page 5799, Abstract).
Thus, Cheng provides motivation to develop methods of delaying banana fruit ripening (increasing the shelf-life) by knocking out the MaACO1 gene in banana plants in order to reduce ethylene production.
With respect to claim 2, Liu provides evidence that an inherent characteristic of MaACO1 is that it has the gene ID number Ma01_g11540 (Liu, Page 7083, Column 1, After reference to supplementary table S3). Importantly, in this rejection Liu is not being used to teach any limitations of the claimed invention, rather Liu is describing an inherent characteristic of banana ACO1; the gene ID number Ma01_g11540.
With respect to claim 2, Slaymaker teaches methods of introducing genomic modifications into plant cells. Specifically, Slaymaker teaches modified Cas9 enzymes for use in the CRISPR/Cas9 gene editing system which have increased efficiency and reduced off target effects (Slaymaker, Page 2, Paragraph 0008). This system allows for the targeted and efficient generation of specific genomic modifications (aberrations) in plant cells (Slaymaker, Page 411, Paragraph 1192).
These modifications can be simple and drawn to disrupting an undesirable gene (Slaymaker, Paragraph 0188) or more complicated, like inserting an antisense sequence for a target gene in order to suppress expression of that target gene (Slaymaker, Paragraph 001191). Further, Slaymaker states that “the specific type of genome editing therapy depends on the nature of the mutation causing the disease” and would also depend on the desired outcome. As such, Slaymaker indicates that the type of gene-editing approach used represents a design choice based on the target and the desired outcome.
Slaymaker provides many examples of specific uses for this improved gene editing system including using gene editing to modify the expression and therefore activity of ACO genes in tomato plants to reduce expression of the enzyme and delay fruit ripening (Slaymaker, Page 410, Paragraph 1191; Slaymaker, Page 411, Paragraph 1191).
Further, Slaymaker teaches the generation, transformation and gene editing of protoplast cells and generating protoplasts and further teaches that these methods are well known and routine practice in the art (Slaymaker, Page 376, Paragraph 1103; Slaymaker, Page 386, Paragraph 1130; Slaymaker, Page 386, Paragraph 1131; Slaymaker, Page 391, Paragraph 1147; and Slaymaker, Page 391, Paragraph 1150).
Finally, Slaymaker teaches that the methods described by Slaymaker use the CRISPR/Cas9 system and can be used to confer desired traits on essentially any plant including those from the Musa family and in the previous paragraph Slaymaker makes clear that the term plants refers to a variety of different species including Banana (Slaymaker, Pages 380-381, Paragraphs 1111-1112; Slaymaker, Page 379, Paragraph 1110).
Given the above teachings of the prior art, it would have been obvious to the ordinary artisan at the time of filing to produce a method of using recombinant DNA technology including DNA editing agents, to target banana ACO1 (Ma01_g11540) in banana cells and then regenerating banana plants from these cells in order to generate banana plants comprising a loss of function mutation in ACO1 to produce banana plants having fruits without ACO1 transcription. This would have been obvious because the references are all drawn towards Banana plants and effects and strategies of preventing post-harvest losses in crops. Hailu teaches the importance of banana plants, the high level of post-harvest fruit loss, and a desire for methods or products which reduce these losses. The other references teach the role of ACO in fruit ripening and Slaymaker teaches a method of efficiently generating mutations which reduce ethylene production by reducing the expression and activity of ACO.
Given this the ordinary artisan would have found it obvious to use the gene editing system of Slaymaker which suggests targeting ACO to delay fruit ripening to target the banana ACO genes as taught in the other references in order to reduce post-harvest losses. Stated differently, this would have been obvious because it is simply combining prior art elements according to known methods to yield predictable results.
The ordinary artisan would have been motivated to combine these teachings to arrive at the claimed method because this method would allow for the rapid and efficient production of a banana ACO1 mutant having reduced ACO activity, reduced ethylene synthesis and delayed ripening. Delayed ripening of the banana fruit has been proposed as a method to alleviate the high post-harvest losses in banana crops and as such the ordinary artisan would have been motivated to produce banana plants having fruits with delayed ripening in order to produce banana crops having increased shelf-life and reduced post-harvest losses.
This would lead to a larger banana supply which would mean more food for those that rely on bananas as an energy source as well as higher profits for those selling bananas to retailers as more fruit would be available for sale due to reduced losses. As such the ordinary artisan would have been motivated to combine the teachings of the prior art to produce a method of increasing the shelf life of bananas because of the economic benefits of reduced post-harvest losses in banana crops and the ability to deliver a larger and more stable food supply to those who rely on banana as an energy source.
As such claim 2 is newly rejected as obvious given the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker.
Obviousness rejections against claims 3-5, 7, 10-11, 16, 23-26 and 28.
With respect to claim 3, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Importantly, Slaymaker teaches regenerating an edited plant cell to produce a plant therefrom and Hailu teaches harvesting bananas from banana plants (Slaymaker, Page 411, Paragraph 1192; Hailu, Page 638, Column 1, First Paragraph).
With respect to claim 4, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Further, Slaymaker teaches that CRISPR systems can be self-cleaving in that cleavage of both ends of a CRISPR/Cas cassette can be used to generate transgene-free T0 plants with biallelic mutations without having to perform a crossing or segregating step in T1 plants, this would be beneficial in plants like banana which are not normally sexually propagated (Slaymaker, Page 425, Paragraph 1228).
With respect to claim 5, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Importantly, Slaymaker teaches that the CRISPR/Cas9 system produces homozygous mutations in plants (Slaymaker, Page 376, Paragraph 1104).
With respect to claim 7, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Importantly, as noted above, Slaymaker teaches the insertion of antisense or truncated copies of the target genes (Slaymaker, Page 410, Paragraph 1191).
With respect to claims 10-11 Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Importantly, Slaymaker teaches the use of the CRISPR/Cas9 system (Slaymaker, Pages 410-411, Paragraphs 1191-1192).
With respect to claim 16, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Importantly, Slaymaker teaches that not only can CRISPR be used to insert antisense or truncated copies of target genes for gene silencing approaches, CRISPR can be used to induce insertion, deletion or substitution mutations of a target polynucleotide (Slaymaker, Page 115, Paragraph 416).
Additionally, Slaymaker teaches that Cas9CRISPR complexes can be designed to allow targeted mutation of multiple genes in plants (Slaymaker, Pages 408-409, Paragraph 1187).
Finally, Slaymaker teaches that in some cases, a single control element could therefore be used to control the transcription of multiple genes simultaneously (Slaymaker, Page 368, Paragraph 1083).
Therefore, Slaymaker teaches DNA editing agents which are directed at multiple target genes either directly or by targeting specific coordinates that then regulate multiple secondary targets.
With respect to claims 23-25, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 1, see above. Further, Pathak teaches banana plant parts including fruits (Pathak, Page 12, Column 1, Last Complete Paragraph). Additionally, Cheng teaches air-dried banana fruits (Cheng, Page 5799, Column 2, Last line).
With respect to claim 26, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 1, see above. Importantly, Slaymaker teaches that the CRISPR/Cas9 system can be introduced into plant protoplasts which are then regenerated to plant cells which are then grown and regenerated into plants (Slaymaker, Page 392, Paragraph 1152). Further, Hailu teaches harvesting banana fruits from banana plants (Hailu, Page 638, Column 1, First Paragraph).
With respect to claim 28, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 1, see above. Importantly, Slaymaker teaches the use of the CRISPR/Cas9 system to make genetically modified non-transgenic plants by transiently expressing the CRISPR/Cas9 components in plant protoplasts where the DNA encoding the gene editing system is not integrated into the genome (Slaymaker, Pages 392-393, Paragraphs 1153-1155).
With respect to claim 29, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 1, see above. Further, Slaymaker teaches the generation of mutations in the first exon of the codon sequence or with 500 base pairs (bp) of the transcription start site (Slaymaker, Page 324, Paragraph 00960).
With respect to claim 30, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Further, Slaymaker teaches the generation of mutations in the first exon of the codon sequence or with 500 base pairs (bp) of the transcription start site (Slaymaker, Page 324, Paragraph 00960).
Given the teachings of the cited prior art and the rationale and motivation to combine these references, see obviousness rejections against claims 1 and 2 from which claims 3-5, 7, 10-11, 16, 23-26 and 28 depend, claims 3-5, 7, 10-11, 16, 23-26 and 28-30 are newly rejected as obvious given the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker.
Obviousness rejection against claim 9.
With respect to claim 9, Hailu teaches that Banana is an incredibly important food crop and the 4th largest food crop in the world (Hailu, Page 635, Columns-12). Hailu also teaches that bananas and plantains are important cash crops providing the sole source of income to some rural populations (Hailu, Page 635, Columns 1-2). Finally, Hailu teaches that banana is a major starch stable of considerable importance in the developing world which is consumed as an energy yielding food and as a dessert (Hailu, Page 635, Column 1). These teachings demonstrate the importance of bananas for human health, as an element in global trade and as a product with implications on the development of nations.
Hailu teaches that despite this importance, there is a key problem to be solved in the trade of fruits and vegetables and in particular of banana. Specifically, there is a large percentage of post-harvest loss due to lack of packaging, storage facilities and poor means of transportation, this can lead to up to 50% losses (Hailu, Page 636, Column 6, First Complete Paragraph).
Hailu then reviews characteristics of bananas, preharvest factors that influence banana quality and then postharvest characteristics of banana and factors affecting postharvest losses. This review includes approaches that work to delay the process of ripening, thereby extending the shelf-life of the produce and reducing post-harvest losses (Hailu, Page 643, Column 1, Last Paragraph).
As such Hailu teaches the importance of banana fruit, that banana fruits experience a high percentage of post-harvest losses and that there are many strategies to try and alleviate these losses including those which extend the shelf-life of the fruit by delaying fruit ripening.
With respect to claim 9, Hailu does not teach a nucleic acid construct comprising a sequence encoding a DNA editing agent directed as a Ma01_g11540 or Ma07_g19730 ACO gene operably linked to a plant promoter.
With respect to claim 9, Pathak teaches motivation to target ACS or ACO in banana through recombinant DNA technology to delay ripening (Pathak, Page 17, Column 2, Last Paragraph).
With respect to claim 9, Cheng teaches methods of down-regulating the expression of banana ACO1 (MaACO1) which was associated with reduced ethylene production and may account for the delay of softening of banana fruits (Cheng, Page 5799, Abstract). Cheng proposes that the inhibition of banana ACO1 transcription resulted in decreased ethylene synthesis and the delay of ripening of banana slices (Cheng, Page 5799, Abstract).
Thus, Cheng provides motivation to develop methods of delaying banana fruit ripening (increasing the shelf-life) by knocking out the MaACO1 gene in banana plants in order to reduce ethylene production.
With respect to claim 9, Liu provides evidence that an inherent characteristic of MaACO1 is that it has the gene ID number Ma01_g11540 (Liu, Page 7083, Column 1, After reference to supplementary table S3). Importantly, in this rejection Liu is not being used to teach any limitations of the claimed invention, rather Liu is describing an inherent characteristic of banana ACO1; the gene ID number Ma01_g11540.
With respect to claim 9, Slaymaker teaches nucleic acid construct comprising sequences encoding DNA editing agents. Specifically, Slaymaker teaches modified Cas9 enzymes for use in the CRISPR/Cas9 gene editing system which have increased efficiency and reduced off target effects (Slaymaker, Page 2, Paragraph 0008). Slaymaker teaches vectors comprising sequences encoding the components of the CRISPR/Cas9 gene editing system (Slaymaker, Page 1, Paragraph 0004). This system allows for the targeted and efficient generation of specific genomic modifications (aberrations) in plant cells (Slaymaker, Page 411, Paragraph 1192).
These modifications can be simple and drawn to disrupting an undesirable gene (Slaymaker, Paragraph 0188) or more complicated, like inserting an antisense sequence for a target gene in order to suppress expression of that target gene (Slaymaker, Paragraph 001191). Further, Slaymaker states that “the specific type of genome editing therapy depends on the nature of the mutation causing the disease” and would also depend on the desired outcome. As such, Slaymaker indicates that the type of gene-editing approach used represents a design choice based on the target and the desired outcome.
Slaymaker, provides many examples of specific uses for this improved gene editing system including using gene editing to modify the expression and therefore activity of ACO genes in tomato plants to reduce expression of the enzyme and delay fruit ripening (Slaymaker, Page 410, Paragraph 1191; Slaymaker, Page 411, Paragraph 1191).
Further, Slaymaker teaches the generation, transformation and gene editing of protoplast cells and generating protoplasts and further teaches that these methods are well known and routine practice in the art (Slaymaker, Page 376, Paragraph 1103; Slaymaker, Page 386, Paragraph 1130; Slaymaker, Page 386, Paragraph 1131; Slaymaker, Page 391, Paragraph 1147; and Slaymaker, Page 391, Paragraph 1150).
Finally, Slaymaker teaches that the methods described by Slaymaker use the CRISPR/Cas9 system and can be used to confer desired traits on essentially any plant including those from the Musa family and in the previous paragraph Slaymaker makes clear that the term plants refers to a variety of different species including Banana (Slaymaker, Pages 380-381, Paragraphs 1111-1112; Slaymaker, Page 379, Paragraph 1110).
Given the above teachings of the prior art, it would have been obvious to the ordinary artisan at the time of filing to produce a method of using recombinant DNA technology including DNA editing agents, to target banana ACO1 (Ma01_g11540) in banana cells and then regenerating banana plants from these cells in order to generate banana plants comprising a loss of function mutation in ACO1 to produce banana plants having fruits without ACO1 transcription. This would require modifying the gene editing vectors of Slaymaker to produce a nucleic acid construct encoding a gRNA directed at the ACO gene Ma01_g11540. This would have been obvious because the references are all drawn towards Banana plants and effects and strategies of preventing post-harvest losses in crops. Hailu teaches the importance of banana plants, the high level of post-harvest fruit loss, and a desire for methods or products which reduce these losses. The other references teach the role of ACO in fruit ripening and Slaymaker teaches a method of efficiently generating mutations which reduce ethylene production by reducing the expression and activity of ACO.
Given this the ordinary artisan would have found it obvious to use the gene editing system of Slaymaker which suggests targeting ACO to delay fruit ripening to target the banana ACO genes as taught in the other references in order to reduce post-harvest losses. Stated differently, this would have been obvious because it is simply combining prior art elements according to known methods to yield predictable results.
The ordinary artisan would have been motivated to combine these teachings to arrive at the claimed construct this construct can be used in a method which would allow for the rapid and efficient production of a banana ACO1 mutant having reduced ACO activity, reduced ethylene synthesis and delayed ripening. Delayed ripening of the banana fruit has been proposed as a method to alleviate the high post-harvest losses in banana crops and as such the ordinary artisan would have been motivated to produced banana plants having fruits with delayed ripening in order to produce banana crops having increased shelf-life and reduced post-harvest losses.
This would lead to a larger banana supply which would mean more food for those that rely on bananas as an energy source as well as higher profits for those selling bananas to retailers as more fruit would be available for sale due to reduced losses. As such the ordinary artisan would have been motivated to combine the teachings of the prior art to produce a construct comprising a DNA editing agent targeted at ACO1 (Ma01_g11540) bananas because of the economic benefits of reduced post-harvest losses in banana crops and the ability to deliver a larger and more stable food supply to those who rely on banana as an energy source.
As such claim 9 is newly rejected as obvious given the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker.
Obviousness rejection against claim 27.
With respect to claim 27, Hailu teaches that Banana is an incredibly important food crop and the 4th largest food crop in the world (Hailu, Page 635, Columns-12). Hailu also teaches that bananas and plantains are important cash crops providing the sole source of income to some rural populations (Hailu, Page 635, Columns 1-2). Finally, Hailu teaches that banana is a major starch stable of considerable importance in the developing world which is consumed as an energy yielding food and as a dessert (Hailu, Page 635, Column 1). These teachings demonstrate the importance of bananas for human health, as an element in global trade and as a product with implications on the development of nations.
Hailu teaches that despite this importance, there is a key problem to be solved in the trade of fruits and vegetables and in particular of banana. Specifically, there is a large percentage of post-harvest loss due to lack of packaging, storage facilities and poor means of transportation, this can lead to up to 50% losses (Hailu, Page 636, Column 6, First Complete Paragraph).
Hailu then reviews characteristics of bananas, preharvest factors that influence banana quality and then postharvest characteristics of banana and factors affecting postharvest losses. This review includes approaches that work to delay the process of ripening, thereby extending the shelf-life of the produce and reducing post-harvest losses (Hailu, Page 643, Column 1, Last Paragraph).
Finally, Hailu teaches processed banana fruit products (Hailu, Page 636, Column 1, Last Paragraph).
As such Hailu teaches the importance of banana fruit, that banana fruits experience a high percentage of post-harvest losses, that there are many strategies to try and alleviate these losses including those which extend the shelf-life of the fruit by delaying fruit ripening and that banana fruits can be processed.
With respect to claim 27, Hailu does not teach a processed banana product comprising a genomic loss of function mutation in a nucleic acid sequence encoding a component in a Ma01_g11540 or Ma07_g19730sequence of an ACO gene.
With respect to claim 27, Pathak teaches motivation to target ACS or ACO in banana through recombinant DNA technology to delay ripening (Pathak, Page 17, Column 2, Last Paragraph).
With respect to claim 27, Cheng teaches that down regulation of banana ACO1 (MaACO1) was associated with reduced ethylene production which may account for the delay of softening of banana fruits (Cheng, Page 5799, Abstract). Cheng proposes that the inhibition of banana ACO1 transcription resulted in decreased ethylene synthesis and the delay of ripening of banana slices (Cheng, Page 5799, Abstract).
Thus Cheng provides motivation to knock-out the MaACO1 gene in banana plants in order to reduce ethylene production and delay fruit ripening in banana.
With respect to claim 27, Liu provides evidence that an inherent characteristic of MaACO1 is that it has the gene ID number Ma01_g11540 (Liu, Page 7083, Column 1, After reference to supplementary table S3). Importantly, in this rejection Liu is not being used to teach any limitations of the claimed invention, rather Liu is describing an inherent characteristic of banana ACO1; the gene ID number Ma01_g11540.
With respect to claim 27, Slaymaker teaches methods of introducing genomic modifications into plant cells. Specifically, Slaymaker teaches modified Cas9 enzymes for use in the CRISPR/Cas9 gene editing system which have increased efficiency and reduced off target effects (Slaymaker, Page 2, Paragraph 0008). Slaymaker teaches vectors comprising sequences encoding the components of the CRISPR/Cas9 gene editing system (Slaymaker, Page 1, Paragraph 0004). This system allows for the targeted and efficient generation of specific genomic modifications (aberrations) in plant cells (Slaymaker, Page 411, Paragraph 1192).
These modifications can be simple and drawn to disrupting an undesirable gene (Slaymaker, Paragraph 0188) or more complicated, like inserting an antisense sequence for a target gene in order to suppress expression of that target gene (Slaymaker, Paragraph 001191). Further, Slaymaker states that “the specific type of genome editing therapy depends on the nature of the mutation causing the disease” and would also depend on the desired outcome. As such, Slaymaker indicates that the type of gene-editing approach used represents a design choice based on the target and the desired outcome.
Slaymaker, provides many examples of specific uses for this improved gene editing system including using gene editing to modify the expression and therefore activity of ACO genes in tomato plants to reduce expression of the enzyme and delay fruit ripening (Slaymaker, Page 410, Paragraph 1191; Slaymaker, Page 411, Paragraph 1191).
Further, Slaymaker teaches the generation, transformation and gene editing of protoplast cells and generating protoplasts and further teaches that these methods are well known and routine practice in the art (Slaymaker, Page 376, Paragraph 1103; Slaymaker, Page 386, Paragraph 1130; Slaymaker, Page 386, Paragraph 1131; Slaymaker, Page 391, Paragraph 1147; and Slaymaker, Page 391, Paragraph 1150).
Finally, Slaymaker teaches that the methods described by Slaymaker use the CRISPR/Cas9 system and can be used to confer desired traits on essentially any plant including those from the Musa family and in the previous paragraph Slaymaker makes clear that the term plants refers to a variety of different species including Banana (Slaymaker, Pages 380-381, Paragraphs 1111-1112; Slaymaker, Page 379, Paragraph 1110).
Given the above teachings of the prior art, it would have been obvious to the ordinary artisan at the time of filing to use recombinant DNA technology to target banana ACO1 which is also known as Ma01_g11540 in order to generate a knock-out mutant which is not transcribed or translated in order to produce banana plants having fruits without ACO1 transcription which can be processed into banana fruit products. This would have been obvious because the references are all drawn towards Banana plants and effects and strategies of preventing post-harvest losses in crops. Hailu teaches the importance of banana plants, the high level of post-harvest fruit loss, and a desire for methods or products which reduce these losses. The other references teach the role of ACO in fruit ripening and Slaymaker teaches a method of efficiently generating mutations which reduce ethylene production by reducing the expression and activity of ACO.
Given this the ordinary artisan would have found it obvious to use the gene editing system of Slaymaker which suggests targeting ACO to delay fruit ripening to target the banana ACO genes as taught in the other references in order to reduce post-harvest losses. Stated differently, this would have been obvious because it is simply combining prior art elements according to known methods to yield predictable results.
The ordinary artisan would have been motivated to combine these teachings because this would allow for the rapid and efficient production of a banana ACO1 mutant having reduced ACO activity, reduced ethylene synthesis and delayed ripening. Delayed ripening of the banana fruit has been proposed as a method to alleviate the high post-harvest losses in banana crops and as such the ordinary artisan would have been motivated to produced banana plants having fruits with delayed ripening in order to produce banana crops having increased shelf-life and reduced post-harvest losses and to produce processed fruit products from these fruits. This would lead to a larger banana supply which would mean more food for those that rely on bananas as an energy source as well as higher profits for those selling bananas to retailers as more fruit would be available for sale due to reduced losses. Further, the processed fruit products, originating from the modified banana fruits would comprise increased shelf life. As such the ordinary artisan would have been motivated to combine the teachings of the prior art to produce a processed banana fruit product from banana plants having delayed fruit ripening because of the economic benefits of reduced post-harvest losses in banana crops and the ability to deliver a larger and more stable food supply to those who rely on banana as an energy source.
As such claim 27 is newly rejected as obvious given the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker.
Claims 17 and 20-22 are newly rejected under 35 U.S.C. 103 as being unpatentable over Hailu, in view of Pathak, Cheng as evidenced by Liu, Slaymaker and Jourda, New Phytologist (2014).
Claims 17 and 20-22 are drawn to method of claim 2 wherein the DNA editing agent comprises a nucleic acid sequence of one or more of SEQ ID NOs: 51-54 in certain specific combinations. The specification describes these sequences as guide RNAs in lines 25-28 on page 9.
With respect to claims 17 and 20-22, , Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claim 2, see above. Further, Slaymaker teaches direct targeted mutagenesis of target genes in plants (Slaymaker, Page 409, Paragraph 1188). Later, Slaymaker teaches that the use of multiple guide RNAs may increase the cutting frequency and hinder the evolution of drive resistant alleles in some target species (Slaymaker, 431, Paragraph 1248).
Slaymaker also teaches the use of multiple guide RNAs to target a target locus (Slaymaker, Page 86, Paragraph 312).
Finally, Slaymaker teaches that the guide RNAs which target the Cas9 enzyme to the target cut site have intrinsic design parameters which limit the structure of these molecules and also the sites within the genome which they can target (Slaymaker, Pages 139-140, Paragraph 484).
With respect to claims 17 and 20-22, Slaymaker does not teach the use of the exact guide RNAs of SEQ ID NOs: 51-54.
With respect to claims 17 and 20-22, Jourda teaches that there are 12 ACO genes in banana and that several ACO genes are expressed in the fruits including MaACO1 which is the most highly expressed (Jourda, Page 993, Column 1, Last Paragraph). Jourda also states that MaACO1 is a previously known ethylene- and ripening-induced genes and that there are 12 ACO genes in banana (Jourda, Page 993, Column 2; Jourda, Page 994, Figure 4).
Given the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker and Jourda, at the time of filing it would have been obvious to one of ordinary skill in the art to arrive at the claimed methods. At the time of filing it would have been obvious to try the method of the combined teachings of, Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker with all of the ACO genes in banana taught by Jourda.
Further it would have been obvious to target sites early in the coding region of these target genes and given that the method of Slaymaker uses the CRISPR/Cas9 system and that the gRNAs from that system have certain design limitations it would have been obvious to generate gRNAs having the sequences of SEQ ID NOs: 51-54 and to use more than one gRNA to target a specific locus in the target genes given that Slaymaker teaches that multiple the use of gRNAs may improve cutting efficiency.
This would have been obvious because of the following:
Hailu and Slaymaker demonstrate at the time of filing that there was a need to modify fruit ripening in order to delay that process. This is because fruit ripening renders fruits or vegetables inedible only a few days after it starts and brings significant losses to both farmers and consumers (Slaymaker, Page 410, Paragraph 1191)
The combined teachings of , Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker (See 103 analysis against claim 2 above), teach targeting ACO genes in banana to delay fruit ripening and Jourda teaches that there are 12 ACO genes in banana. Therefore, there is a finding that there had been a number of finite predictable solutions to the recognized problem.
Given the teachings of Slaymaker, it appears that one of ordinary skill in the art could have made gRNAs to target all of the ACO genes in banana protoplasts with a reasonable chance of success given the versatility and ease of use of the CRISPR/Cas9 system.
Given the above factual inquiries it is clear that it would have been obvious to try to use the method of the combined teachings of , Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker, see above, to target all of the ACO and ACS genes taught by Jourda including MaACS7 and MaACO1.
Given these teachings the ordinary artisan would naturally have arrived at the claimed gRNA sequences and given the motivation in Slaymaker to use multiple gRNAs the claimed methods are obvious.
Therefore claims 17 and 20-22 are newly rejected as obvious given the combined teachings of , Hailu in view of Pathak, Cheng as evidenced by Liu, Slaymaker and Jourda.
Claims 31-34 are newly rejected under 35 U.S.C. 103 as being unpatentable over Hailu, African Journal of Biotechnology 12.7 (2013): 635-647, in view of Pathak, Plant Growth Regulation 40.1 (2003): 11-19, Cheng, Journal of Agricultural and Food Chemistry 57.13 (2009): 5799-5804, as evidenced by Liu, Journal of experimental botany 72.20 (2021): 7078-7091 and Wu, Postharvest Biology and Technology 194 (2022): 112087 and in view of Slaymaker (WO 2016/205613 Al).
With respect to claims 31-34, Hailu, in view of Pathak, Cheng as evidenced by Liu and Slaymaker collectively teach all of the limitations of claims 1-2, 9 and 27, see above. Importantly, the combined teachings of these references teach plants, methods, nucleic acid constructs and banana products all rely on the use of DNA editing agents to generate mutations in all of the ACO genes in banana.
With respect to claims 31-34, Hailu, in view of Pathak, Cheng as evidenced by Liu and Slaymaker are silent on the gene accession number Ma07_g19730.
With respect to claims 31-34, Wu provides evidence that an inherent characteristic of MaACO1 is that it has the gene ID number Ma07_g19730 (Wu, Page 3, Column 1, Section 2.10 Accession Numbers). Importantly, in this rejection Wu is not being used to teach any limitations of the claimed invention, rather Wu is describing an inherent characteristic of banana ACO1; the gene ID number Ma07_g19730.
At the time of filing it would have been obvious to the ordinary artisan to combine the teachings of Hailu in view of Pathak, Cheng as evidenced by Liu and Slaymaker, see obviousness analysis with respect to claims 1, 2, 9 and 27 above. This combination of teachings would lead the ordinary artisan to produce banana plants having mutations in banana ACO1. Given the evidence of Wu, it is clear that this includes genes having the ID number Ma07_g19730. Therefore, claims 31-34 are rejected as being obvious given the teachings of Hailu in view of Pathak, Slaymaker and Cheng as evidenced by Liu and Wu.
Conclusion
1-5, 7, 9-11, 16-17, 20 and 22-34 are rejected.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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/BRIAN JAMES SULLIVAN/ Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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