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 .
Status of Claims
The amendments received on 11/21/2025 have been entered. Claims 1, 9-17, and 20 are pending.
Claims 12-17 remain withdrawn for being directed to a non-elected invention(s).
Claims 18-19 have been canceled.
Claims 1, 9-11, and 20 are examined in this Office Action.
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on 11/28/2025 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections/Rejections that are Withdrawn
All rejections to claims 18-19 have been rendered moot by Applicant’s cancelation of the claims.
The text of those sections of Title 35, U.S. Code, not included in this action, can be found in a
prior Office Action.
Claim Rejections - 35 USC § 103
Claims 1, 9-11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sammons (Sammons et al., EP2545182B1, Pub. Date: 03/05/2017; included on IDS dated 09/07/2022) in view of Paul (Paul et al., Pub. No.: US 2004/0154053 A1, Pub. Date: Aug. 5, 2004; included on List of references cited by examiner dated 08/14/2024) in further view of Roberts (Roberts et al., Patent Number: 6,096,946; Date of Patent: Aug. 1, 2000) as evidenced by Crop Science (https://www.cropscience.bayer.us/articles/dad/genetic-traits-improved-harvest-management-canola, Aug. 17, 2021; included on List of references cited by examiner dated 03/11/2025). This is a modified rejection necessitated by amendment.
Claim 1 recites “a composition comprising:
a dsRNA molecule that comprises at least 18 contiguous nucleotides that are essentially identical or essentially complementary to a portion of a sequence encoding an amino acid sequence as set forth in SEQ ID NO: 599 of an oilseed rape plant ARABIDOPSIS DEHISCENCE ZONE POLYGALACTURONASE 1 (ADPG1) gene or a transcript of the plant gene, wherein the dsRNA molecule comprises a polynucleotide sequence as set forth in SEQ ID NO: 729; and
a transfer agent configured to facilitate permeation of the dsRNA molecule into cells of a plant;
wherein permeation of the dsRNA molecule into cells of the plant causes a transient reduction in the expression of the ADPG1 gene, and
wherein the transient reduction in the expression of the ADPG1 gene causes a change in a yield-associated trait of the plant, the yield-associated trait of the plant is selected from the group consisting of increased oil content, increased seed size, increased seed weight, and any combination thereof, thereby resulting in an increased yield of the plant”.
Sammons teaches and claims a method for regulating expression of an endogenous target gene in a growing plant comprising: topically applying onto the surface of said growing plant:
(a) at least one double stranded RNA (dsRNA) polynucleotide comprising a sequence that is essentially identical to, or essentially complementary to, 18 or more contiguous nucleotides of said target gene or a nucleotide sequence of an RNA transcribed from said target gene (i.e., a dsRNA molecule that comprises at least 18 contiguous nucleotides that are essentially identical or essentially complementary to a portion of a sequence encoding an amino acid sequence or a transcript of the plant gene); and
(b) an effective amount of a transferring agent, wherein said transferring agent permits said at least one dsRNA polynucleotide to directly permeate the interior of said growing plant (i.e., a transfer agent configured to facilitate permeation of the dsRNA molecule into cells of a plant), whereby said at least one dsRNA polynucleotide induces suppression of said endogenous target gene in said growing plant (i.e., wherein permeation of the dsRNA molecule into cells of the plant causes a transient reduction in the expression of the gene) (Sammons, page 3, paragraph 0003 and claim 1).
Sammons teaches the compositions and methods of the invention are also useful for transiently silencing one or more genes (i.e., transient reduction in the expression of the gene) in a growing plant cell or whole plant to affect a desired phenotype (i.e., a change in a yield associated trait) in response to culture conditions, environmental or abiotic or biotic stress, or change in market demand during the growing season or in the post-harvest environment. For example, compositions and methods of the invention are useful for transiently suppressing a biosynthetic or catabolic gene in order to produce a plant or plant product with a desired phenotype, such as a desired nutritional composition of a crop plant product, e. g., suppressing a FAD2 gene to affect a desired fatty acid profile in soybean or canola or other oilseed (i.e., oilseed rape plant), or suppressing lignin biosynthetic genes such as COMT and CCOMT to provide more easily digestible forage plants (Sammons, page 11, paragraph 0033).
Sammons does not explicitly teach a dsRNA molecule comprising a polynucleotide sequence as set forth in SEQ ID NO: 729.
Applicant describes the dsRNA molecule comprising a polynucleotide sequence as set forth in SEQ ID NO: 729 to target the BnADPG1 gene in oil seed rape plants. Applicant describes increasing the yield in plants by silencing/suppressing expression of this target gene. However, Applicant does not provide the criticality of the region of the BnADPG1 gene targeted by SEQ ID NO: 729 to disrupt expression of the gene. Therefore, any dsRNA that targets and disrupts expression of the BnADPG1 gene would lead to the same expected result; thus, the use of the dsRNA as recited in SEQ ID NO: 729 is merely a design choice. Furthermore, it is the Office’s position that every dsRNA that targets and disrupts expression of the BnADPG1 gene would be obvious.
Sammons does not explicitly teach an amino acid sequence as set forth in SEQ ID NO: 599 of an oilseed rape plant ARABIDOPSIS DEHISCENCE ZONE POLYGALACTURONASE 1 (ADPG1) gene.
However, Paul teaches that the production of seed is an important developmental process in all higher plants. In oilseed rape ( Brassica napus), following abscission of floral parts, pods or siliques are formed which contain 15-30 seeds. Around 50-70 days after anthesis (DAA) the pods become susceptible to shatter, a process that serves to expel the mature seeds into the surrounding environment. In the days leading to dehiscence, an array of anatomical, molecular and biochemical changes takes place, thus preparing both seed and pod for the event. Shatter eventually occurs as a result of a combination of factors including: the creation of tensions within the pod between the lignified valve edge cells of the endocarp and the unlignified dehiscence zone (DZ) cells, weakening of the DZ cell walls by hydrolytic enzyme activity, and ultimately due to physical forces such as strong winds or harvesting machinery (Paul, page 1, paragraph 0002).
Paul teaches that further and improved genetic elements to control plant processes in this area are constantly desired (Paul, page 1, paragraph 0008).
Paul teaches that molecular studies of the penultimate stage of pod development have revealed a spatial and temporal correlation between the up-regulation of a number of mRNAs and pod dehiscence in B. napus. These mRNAs encode a polygalacturonase (PG) and a proline-rich protein (SAC51). Further analysis of the expression of the PG following fusion of a pod-specific Arabidopsis thaliana PG promoter to GUS, has revealed that reporter gene expression is restricted precisely to the layer of cells comprising the pod DZ in transgenic B. napus (page 1, paragraph 0005).
Paul teaches that DZ-expressed genes have been previously isolated and individually downregulated to result in B. napus plants that have increased resistance to pod shatter; namely Sac66, DZ15, and OSR 7(9) (page 5, paragraph 0067).
Paul teaches Sac66 amino acid sequence (SEQ ID NO: 32; Figure 15) which shares 100% sequence identity with elected instant sequence SEQ ID NO: 599 (i.e., amino acid sequence as set forth in SEQ ID NO: 599 of an oilseed rape plant ARABIDOPSIS DEHISCENCE ZONE POLYGALACTURONASE 1 (ADPG1) gene) (see alignment below).
PAUL SEQUENCE SEQ ID NO: 32 ALIGNED WITH INSTANT SEQUENCE SEQ ID NO: 599
Qy 1 MARCHGSLAIFLCVLLMLACCQALSSNVDDGYGHEDGSFETDSLIKLNNDDDVLTLKSSD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MARCHGSLAIFLCVLLMLACCQALSSNVDDGYGHEDGSFETDSLIKLNNDDDVLTLKSSD 60
Qy 61 RPTTESSTVSVSNFGAKGDGKTDDTQAFKKAWKKACSTNGVTTFLIPKGKTYLLKSIRFR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RPTTESSTVSVSNFGAKGDGKTDDTQAFKKAWKKACSTNGVTTFLIPKGKTYLLKSIRFR 120
Qy 121 GPCKSLRSFQILGTLSASTKRSDYSNDKNHWLILEDVNNLSIDGGSAGIVDGNGKIWWQN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GPCKSLRSFQILGTLSASTKRSDYSNDKNHWLILEDVNNLSIDGGSAGIVDGNGKIWWQN 180
Qy 181 SCKIDKSKPCTKAPTALTLYNLNNLNVKNLRVRNAQQIQISIEKCNSVDVKNVKITAPGD 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SCKIDKSKPCTKAPTALTLYNLNNLNVKNLRVRNAQQIQISIEKCNSVDVKNVKITAPGD 240
Qy 241 SPNTDGIHIVATKNIRISNSDIGTGDDCISIEDGSQNVQINDLTCGPGHGISIGSLGDDN 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SPNTDGIHIVATKNIRISNSDIGTGDDCISIEDGSQNVQINDLTCGPGHGISIGSLGDDN 300
Qy 301 SKAYVSGINVDGATLSETDNGVRIKTYQGGSGTAKNIKFQNIRMDNVKNPIIIDQNYCDK 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SKAYVSGINVDGATLSETDNGVRIKTYQGGSGTAKNIKFQNIRMDNVKNPIIIDQNYCDK 360
Qy 361 DKCEQQESAVQVNNVVYRNIQGTSATDVAIMFNCSVKYPCQGIVLENVNIKGGKASCKNV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DKCEQQESAVQVNNVVYRNIQGTSATDVAIMFNCSVKYPCQGIVLENVNIKGGKASCKNV 420
Qy 421 NVKDKGTVSPKCP 433
|||||||||||||
Db 421 NVKDKGTVSPKCP 433
Furthermore, Roberts teaches that the process of pod dehiscence, or shatter as it is commonly termed, in oilseed rape (Brassica napus) and other crops shares a number of features with abscission. Degradation and separation of cell walls occurs along a discrete layer of cells, termed the dehiscence zone, and a localized increase in the activity of cellulase has been reported prior to the onset of dehiscence. This process is agronomically important because it may result in the premature shedding of seed before the crop can be harvested. Adverse weather conditions can exacerbate the process resulting in a greater than 50% loss of seed. This loss of seed not only has a dramatic effect on yield but also results in the emergence of the crop as a weed in the subsequent growing season (column 1, lines 18-33).
Roberts teaches and claims that polygalacturonase (PG) is implicated in dehiscence and that manipulation of this enzyme's activity can influence the timing of dehiscence. The gene coding for PG has a pattern of expression which is, spatially and/or temporally, specific or at least preferential for tissue involved in dehiscence. Roberts teaches that the exploitation of the gene and related DNA sequences in the manipulation of pod dehiscence including its reduction or prevention in particular (column 2, lines 22-31; claim 5).
Additionally, Roberts teaches nucleic acid (SEQ ID NO: 5) and corresponding amino acid (SEQ ID NO: 6) sequence of SAC66 which shares 100% sequence identity with instant sequence SEQ ID NO: 599 (see alignment below):
ROBERTS SEQUENCE SEQ ID NO: 6 ALIGNED WITH INSTANT SEQUENCE SEQ ID NO: 599
Qy 1 MARCHGSLAIFLCVLLMLACCQALSSNVDDGYGHEDGSFETDSLIKLNNDDDVLTLKSSD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MARCHGSLAIFLCVLLMLACCQALSSNVDDGYGHEDGSFETDSLIKLNNDDDVLTLKSSD 60
Qy 61 RPTTESSTVSVSNFGAKGDGKTDDTQAFKKAWKKACSTNGVTTFLIPKGKTYLLKSIRFR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RPTTESSTVSVSNFGAKGDGKTDDTQAFKKAWKKACSTNGVTTFLIPKGKTYLLKSIRFR 120
Qy 121 GPCKSLRSFQILGTLSASTKRSDYSNDKNHWLILEDVNNLSIDGGSAGIVDGNGKIWWQN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GPCKSLRSFQILGTLSASTKRSDYSNDKNHWLILEDVNNLSIDGGSAGIVDGNGKIWWQN 180
Qy 181 SCKIDKSKPCTKAPTALTLYNLNNLNVKNLRVRNAQQIQISIEKCNSVDVKNVKITAPGD 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SCKIDKSKPCTKAPTALTLYNLNNLNVKNLRVRNAQQIQISIEKCNSVDVKNVKITAPGD 240
Qy 241 SPNTDGIHIVATKNIRISNSDIGTGDDCISIEDGSQNVQINDLTCGPGHGISIGSLGDDN 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SPNTDGIHIVATKNIRISNSDIGTGDDCISIEDGSQNVQINDLTCGPGHGISIGSLGDDN 300
Qy 301 SKAYVSGINVDGATLSETDNGVRIKTYQGGSGTAKNIKFQNIRMDNVKNPIIIDQNYCDK 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SKAYVSGINVDGATLSETDNGVRIKTYQGGSGTAKNIKFQNIRMDNVKNPIIIDQNYCDK 360
Qy 361 DKCEQQESAVQVNNVVYRNIQGTSATDVAIMFNCSVKYPCQGIVLENVNIKGGKASCKNV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DKCEQQESAVQVNNVVYRNIQGTSATDVAIMFNCSVKYPCQGIVLENVNIKGGKASCKNV 420
Qy 421 NVKDKGTVSPKCP 433
|||||||||||||
Db 421 NVKDKGTVSPKCP 433
In regard to a yield-associated trait selected from those recited in the claim, according to Crop Science (https://www.cropscience.bayer.us/articles/dad/genetic-traits-improved-harvest-management-canola, Aug. 17, 2021) increased pod shatter resistance has a direct impact on the yield-associated traits recited in the claim. Pod shatter resistant canola products offer growers greater flexibility in their harvest management options. Instead of a single reliance on swathing, growers with pod shatter resistant canola products can opt for straight combining. Straight cutting canola allows the crop to mature longer in the field which can result in more seed production and increased seed size. Products have shown not only to be more resistant to shattering during harvest but are also less impacted by adverse weather before shattering occurs. This trait can help increase yield potential.
At the time the instant application was filed, it would have been obvious and within the scope of one of ordinary skill in the art to apply the teachings of Sammons, to the Sac66 (SEQ ID NO: 32) amino acid sequence as taught by Paul or to the Sac66 (SEQ ID NO: 6) amino acid sequence as taught by Roberts which both share 100% sequence identity with elected instant sequence SEQ ID NO: 599, in order to change a yield-associated trait in a plant as evidenced by Crop Science. One would have been motivated to combine the method for transiently silencing the expression of an endogenous target gene in an oilseed plant as taught by Sammons knowing that reducing the expression of the Sac66 (i.e., ADPG1) gene would have an effect on pod shatter, leading to a change in a yield-associated trait as taught by Paul and Roberts (and evidenced by Crop Science). Thus, one of ordinary skill in the art would have a high expectation of success by combining the teachings of Sammons, Paul, and Roberts.
The method of reducing the expression of a gene using dsRNA is a technique that was routine in the art at the time the application was filed, as taught by the cited references and the state of the art in general.
In regard to claims 9 and 10, Sammons teaches and claims a method for regulating expression of an endogenous target gene in a growing plant comprising: topically applying onto the surface of said growing plant:
(a) at least one double stranded RNA (dsRNA) polynucleotide comprising a sequence that is essentially identical to, or essentially complementary to, 18 or more contiguous nucleotides of said target gene or a nucleotide sequence of an RNA transcribed from said target gene (i.e., wherein said dsRNA molecule is at least about 50 bases in length; wherein said dsRNA molecule is at least about 200 bases in length) (Sammons claim 1; page 3, paragraph 0003).
In regard to claim 11, Sammons teaches the compositions and methods of this invention can comprise transferring agents or permeability-enhancing agents such as a silicone polyether copolymer such as a copolymer of polyalkylene oxide (i.e., Polyalkyleneoxide Copolymer) modified heptamethyl trisiloxane and allyloxypolypropylene glycol methylether (commercially available as Silwet® L-77 surfactant) (Sammons, page 9, paragraph 0022).
In regard to claim 20, Paul teaches that DZ-expressed genes have been previously isolated and individually downregulated to result in B. napus plants that have increased resistance to pod shatter. As evidenced by Crop Science, increased pod shatter resistance can result in more seed production and increased seed size, which can help increase yield potential. Thus, increased pod shatter resistance can result in an increase in seed size, seed weight, and/or oil content in the amounts as recited by the claim.
Response to Applicant’s Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
In their reply to the rejections under 35 USC 103, Applicant argues that the combined teachings of the cited references fail to suggest currently amended claim 1 (Remarks, page 6, last paragraph).
The Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091,231 USPQ 375 (Fed. Cir. 1986).
Sammons teaches and claims a method for regulating expression of an endogenous target gene in a growing plant comprising: topically applying onto the surface of said growing plant:
(a) at least one double stranded RNA (dsRNA) polynucleotide comprising a sequence that is essentially identical to, or essentially complementary to, 18 or more contiguous nucleotides of said target gene or a nucleotide sequence of an RNA transcribed from said target gene; and
(b) an effective amount of a transferring agent, wherein said transferring agent permits said at least one dsRNA polynucleotide to directly permeate the interior of said growing plant, whereby said at least one dsRNA polynucleotide induces suppression of said endogenous target gene in said growing plant. Sammons further teaches the compositions and methods of the invention are also useful for transiently silencing one or more genes in a growing plant cell or whole plant to affect a desired phenotype in soybean or canola or other oilseed.
Both Paul and Roberts teach the Sac66 amino acid which shares 100% identity with instant amino acid sequence SEQ ID NO: 599. Both Paul and Roberts teach that the downregulation of Sac66 delays pod dehiscence, which in turn can lead to a change in a yield associated trait as evidenced by Crop Science.
It is noted that the invention of claim 1 is directed to a composition comprising a dsRNA molecule and a transfer agent. The wherein clauses of the claim regarding transient reduction in expression of the ADPG1 gene and a change in a yield-related trait are an intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, the claim does not actually require the composition to be applied to a plant, it merely recites what can happen in a plant if the composition were to be applied.
Thus, the combination of the teachings of Sammons, Paul, Roberts, and Crop Science teach all the limitations as required by claim 1 except a dsRNA molecule comprising a polynucleotide sequence as set forth in SEQ ID NO: 729. However, as outlined in the 35 USC 103 rejection above, any dsRNA that targets and disrupts expression of the BnADPG1 gene would lead to the same expected result, and it is the Office’s position that every dsRNA that targets and disrupts expression of the BnADPG1 gene would be obvious.
Applicant argues that the currently claimed composition achieves a positive biological effect (increased seed metrics) beyond merely preventing the negative mechanical event (pod shatter).
However, it is stated several times in the instant Specification that the positive biological effect (increased seed metrics) is directly affected by preventing the negative mechanical event (pod shatter). For example: yield is affected by various factors, such as the number and size of the plant organs, plant architecture (for example, the number of branches), seed filling, seed number, drought resistance, shattering, flowering and number of tillers, etc. (instant Specification, page 1, lines 12-14); the different target genes may be directed to a same yield associated trait (e.g., decreased shattering) (instant Specification, page 20, lines 6-7); and, in Table 2 (instant Specification, page 40) the “Desired Trait” of the downregulation of both BnADPG1 and BnADPG2 is “Decreased Shattering”. Thus, it is evident from the teachings of Paul, Roberts, and Crop Science that preventing the negative mechanical event (pod shatter) can lead to the positive biological effect (increased seed metrics), as stated in the instant Specification.
Applicant argues that use of a specific dsRNA is not “merely a design choice”, and not “any dsRNA” to ADPG1 would lead to the same result.
The Examiner respectfully disagrees. It is stated in the Non-Final Rejection dated 07/22/2025 that “any dsRNA that targets and disrupts expression of the BnADPG1 gene would lead to the same expected result; thus, the use of the dsRNA as recited in SEQ ID NO: 729 is merely a design choice. Furthermore, it is the Office’s position that every dsRNA that targets and disrupts expression of the BnADPG1 gene would be obvious” (page 10, last paragraph). This statement is not intended to imply that just any dsRNA to ADPG1 would lead to the same result; the dsRNA must target and disrupt expression of the ADPG1 gene. Applicant does not disclose the criticality of the region of the BnADPG1 gene targeted by SEQ ID NO: 729. Therefore, any other dsRNA that targets and disrupts expression of the BnADPG1 gene would represent a separate, but equal, design of the instant invention.
Summary
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663