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 .
Second Non-Final Rejection
In order to present new art rejections a second non-final rejection is presented below.
Claim Status
Claims 1-8, 10, 28-35, 45-48 and 63-64 remain pending.
Claims 28-35 remain withdrawn from consideration.
Claims 1, 6,28, 32 and 64 are newly amended.
Claims 1-8, 10, 45-48 and 63-64 are examined on the merits.
Claim Objections
Claim 4 is objected to because of the following informalities: in the final two lines of the claim there is a space missing between “99%” and “sequence”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities:
In line three of the claim there is a “)” after “dichlorophenoxy” that does not have a matching “(“.
In line four of the claim there is a space missing between (2,4,5-trichlorophenoxy) and “acetic acid”.
In line ten of the claim there is a comma missing after “(dicamba)”.
Appropriate correction is required.
Claim 32 is objected to because of the following informalities:
In line two of the claim there is a “)” after “dichlorophenoxy” that does not have a matching “(“.
In line four of the claim there is a space missing between (2,4,5-trichlorophenoxy) and “acetic acid”.
In line ten of the claim there is a comma missing after “(dicamba)”.
Appropriate correction is required.
Response to Applicant Arguments - 35 USC § 112 (Indefiniteness)
Applicant’s arguments dated 03/24/2026 have been fully considered but are not found to be persuasive and as such the indefiniteness rejections of record are maintained. Applicant arguments are summarized and addressed below.
Applicant’s arguments are drawn to the following concept:
The claims do not require that every polynucleotide present in a product be intact and DNA fragmentation in oil is a matter of degree, not complete elimination. Costa provides no evidence that zero intact copies of a 1476 bp polynucleotide could remain, it is therefore clear to a person of ordinary skill in the art that products including oil can comprise at least one fully intact copy of the polynucleotide molecule recited in the claim (Applicant Remarks, 03/24/2026, Paragraph Spanning Pages 6-7).
This line of argument is not found to be persuasive because while applicant makes clear that the scope of the claim is drawn to products, including oils, that comprise at least one full intact copy of the polynucleotide molecule recited in the claim applicants arguments highlight an area of indefiniteness in the claim, the longevity and stability of DNA in oils.
Applicant states that “DNA fragmentation in oil is a matter of degree, not complete elimination. Oil derived from a transgenic crop plant would initially contain abundant copies of the heterologous polynucleotide and while it is possible that some degradation may reduce the number of intact copies over time, Costa provides no evidence that zero intact copies of a 1476 polynucleotide could remain.
Importantly, this argument acknowledges that polynucleotides degrade in oil over time. While applicant urges that there is no evidence in Costa that zero copies of the full length fragment could remain there is no evidence suggesting that due to “high degradation and minute amounts of DNA present in vegetable oils” that all full length copies of the polynucleotide of interest would not be degraded (Costa, Page 48, Column 2, Last Paragraph). Rather than a buffer like scenario the degradation of the polynucleotide in the oil represents a simple catabolic-like reaction where a larger molecule is broken down into smaller pieces by nucleases in the oil (Costa, Page 47, Column 1, Last Sentence of the First Paragraph).
As such, it appears that given enough time and the presence of nucleases in vegetable oils as taught by Costa that all full length copies of the polynucleotide of interest would be degraded and therefore it is not clear how these oils could comprise the polynucleotide of interest.
Applicant’s arguments raise another issue that is relevant to the indefiniteness rejections of record. Applicant states that “Oil derived from a transgenic crop plant would initially contain abundant copies of the heterologous polynucleotide” and that “some degradation may reduce the number of intact copies over time”. This introduces a scenario where due to instability of the polynucleotide in oil over time, oil which initially comprises at least one full length copy of the polynucleotide of interest after time no longer comprises that full length copy of the polynucleotide of interest. Would this oil be the oil claimed by applicant? This scenario appears to be similar to that of Schrodinger’s cat, in this instance before testing the aged oil it both is and is not the claimed oil while after testing the oil either is or is not the claimed depending on the presence of the full length polynucleotide. However, differently from Schrodinger’s cat, after testing if the oil tests negative it still both is and is not the claimed oil given that at one time it was and later is was not.
The above examples, demonstrate the unclear and indefinite scope of the claims and as such applicant’s arguments are not found to be persuasive and the rejections of record are maintained.
Claim Rejections - 35 USC § 112 (Indefiniteness)
Claims 45-48 remain 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.
This rejection is maintained for the reasons of record, because the remarks by Applicants in response to Office Action mailed on January 12, 2026, have been fully considered but not deemed persuasive, see Response to Applicant Arguments - 35 USC § 112 (Indefiniteness) above.
Claims 45 and 47 are drawn to a product prepared from the plant, part thereof, or plant cell of claim 1 and methods for producing a plant product from the plant, part thereof, or plant cell of claim 1. These claims are further limited by claims 46 and 48, respectively, which limit the products to a group of products including oil. Given that claims 45 and 47 require that the product comprises the polynucleotide encoding the polypeptide of interest, it is not clear how the oil of claims 46 and 48 can further limit claims 45 and 47, respectively. Specifically, oil is a collection of lipid molecules and does not require DNA nor would DNA be able to remain intact in oil without some other undescribed structure, see Costa which reviews the state of the art with respect to the use of DNA based methods of plant seed oil authentication and analysis (Costa, Page 47, Column 1, Lines 5-13; Costa, Pages 52-53, Conclusion)( Costa, Trends in Food Science & Technology 26.1 (2012): 43-55.).
Costa discloses that due to “high degradation and minute amounts of DNA present in vegetable oils” that when authenticating oil, small fragments should be targeted (Costa, Page 48, Column 2, Last Paragraph). This statement makes clear that larger fragments are broken down to produce smaller ones and that in order to efficiently detect and amplify DNA of interest smaller fragments should be targeted because larger ones are present so rarely that the testing would not be efficient or possible at all. By this same logic, all full length copies of the polynucleotide of interest, given sufficient time, would be degraded. This is because rather than a buffer like scenario, the degradation of the polynucleotide in the oil represents a simple catabolic-like reaction where a larger molecule is broken down into smaller pieces by nucleases in the oil and absent any other undisclosed reason these nucleases would continue to function until all polynucleotide targets had been degraded(Costa, Page 47, Column 1, Last Sentence of the First Paragraph).
As such, it appears that given enough time that all full length copies of the polynucleotide of interest would be degraded and therefore it is not clear how these oils could comprise the polynucleotide of interest.
Additionally, given the instability and degradation of the polynucleotides in oil, there appears to exist a scenario in where oil comprising at least one full length copy of the polynucleotide of interest after time no longer comprises that full length copy of the polynucleotide of interest. Would this oil be the oil claimed by applicant? This scenario appears to be similar to that of Schrodinger’s cat, in this instance before testing the aged oil it both is and is not the claimed oil while after testing the oil either is or is not the claimed depending on the presence of the full length polynucleotide. However, differently from Schrodinger’s cat, after testing, if the oil tests negative, it still both is and is not the claimed oil, given that at one time it was and later is was not.
Therefore, the scope of claims 45-48 is indefinite because it is not clear how oil from the plant, plant part or plant cell can comprise the full undegraded polynucleotide encoding the polypeptide of interest because even if this DNA was found in the oil it would be broken down by nucleases in the oil, as described by Costa.
Response to Applicant Arguments - 35 USC § 112 (Enablement)
In response to Applicant’s arguments and amendments to the claims dated 03/24/2026 the enablement rejections of record are withdrawn.
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 1-8, 10, 45-48 and 63-64 are newly rejected under 35 U.S.C. 103 as being unpatentable over Kato in view of Shyam, Scientific Reports 9.1 (2019): 16695.
Claim 1 is drawn to a modified plant, or a progeny, plant part, or plant cell thereof, comprising a heterologous polynucleotide encoding a polypeptide having at least 98% to SEQ ID NO: 2 (CYP81E, see Specification, Page 13, Lines 26-29) and having tolerance to an auxin herbicide.
With respect to claim 1, Kato teaches a herbicide (Bentazon) susceptible soybean cultivar (Himeshirazu) which comprises a CYP81E gene having a specific sequence which differs from CYP81E in herbicide tolerant soybean cultivars (Fukuyutaka and Williams 82) by a frameshift mutation (Kato, Page 2106, Abstract; Kato, Page 2110, First Column, Last Paragraph; Kato, Page 2106, Figure 1d). Therefore, Kato discloses a modified plant (Plants of Soybean cultivars Fukuyutaka and Williams 82 comprise a modified CYP81E sequence compared to plants of Soybean cultivar Himeshirazu (Kato, Page 2110, Last Paragraph; Kato, Page 2108, Figure 1d)), having tolerance to an herbicide (Kato, Page 2109, Column 2, Lines 4-8), the modified plant comprising a polynucleotide encoding a CYP81E polypeptide.
With respect to claim 1, Kato does not explicitly teach crop plants comprising heterologous polynucleotide encoding CYP81E polypeptides having at least 98% sequence identity to SEQ ID NO: 2 which exhibit tolerance to auxin herbicides.
With respect to claim 1, Shyam teaches 2,4-D resistance in Amaranthus tuberculatus is conferred by rapid metabolism of the auxin herbicide by cytochrome P-450 monooxygenases (Shyam, Page 1, First Paragraph After Abstract).
At the time of filing it would have been obvious to the ordinary artisan to modify the crop plants of Kato in order to use the cytochrome P-450 monooxygenases from Amaranthus tuberculatus in order to confer tolerance to herbicides including the synthetic auxinic herbicide 2,4-D which is a valuable post-emergence option to control broadleaf weeds.
Applicant appears to agree with this statement. In the remarks dated 03/24/2026 on page 8, Applicant states the following:
“As is known in the art, the herbicide-metabolizing activity of a P450 enzyme depends on the structure of the enzyme and is independent of any species-specific factors of the host plant. Cytochrome P450 enzymes target structural features to metabolize herbicides, primarily through aromatic ring hydroxylation and side chain oxidation. Auxin herbicides are structurally related and may generally comprise an aromatic ring system with a carboxylic acid moiety and halogen substitutes. Any suggestion that crop species would require independent validation fails to account for the mechanistic basis of P450-mediated herbicide metabolism. There are numerous examples of P450 genes that confer herbicide tolerance when transferred into various crop plants known in the art including, as acknowledged in the Action, Kato, et al., 2020. A person of ordinary skill in the art viewing the specification would recognize CYP81E8 can be used to confer auxin herbicide tolerance to multiple crop species with a reasonable expectation of success.”
The Examiner accepts wholeheartedly this position and given the teachings of the prior art it would have been obvious for the ordinary artisan to modify the plants of Kato to arrive at a modified crop plant comprising a heterologous polynucleotide encoding a polypeptide having at least 98% sequence identity to instant SEQ ID NO: 2 where that crop plant comprises tolerance to an auxin herbicide.
This would have been obvious under the obvious to try rationale.
Under this rationale the MPEP (MPEP 2143.I.E) states that Examiner must articulate the following:
a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
whatever additional findings based on the Graham factual inquires may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
In the instant case, the Examiner presents the following findings:
As presented in Kato, in the year of the earliest effective filing date of the instant application before the instant priority date, stated the following “Weed control is needed in soybean (Glycine max [L.] Merr.) cultivation to avoid yield reductions caused by weed competition and to prevent degradation of seed quality”. Further, Kato states that “it is especially difficult to control weed growth only with pre-emergence treatments because soybean planting season coincides with the rainy season” (Kato, Page 2105, Column 2, First Paragraph).
As such Kato presents a finding at the relevant time that there was a relevant need in the art for crop plants having improved herbicide tolerance, particularly to post-emergence herbicides in order to allow for herbicide treatment during cultivation.
Kato also presents the finding that there were a number of identified, predictable potential solutions to the problem. Specifically, Kato states that “P450 helps plants to render harmful exogenous chemicals less phytotoxic” and that tobacco and Arabidopsis thaliana “both of which are sensitive to bentazon, displayed tolerance to this herbicide after they were transformed with rice CYP81A6” (Kato, Page 2112, Column 1, Second Paragraph of Discussion; Kato, Page 2106, Column 1, First Complete Paragraph). Shyam further narrows the list of options to cytochrome P450s from Amaranthus tuberculatus which confer resistance to the auxin herbicide 2,4-D.
As demonstrated in Kato and highlighted in Applicant’s remarks recited above, there is a high level of predictability in the art with respect to the use of exogenous CYP81 sequences to confer herbicide tolerance to a plant of interest. Therefore, the ordinary artisan could have transformed crop plants of interest with any CYP81 gene with a reasonable degree of success at producing such a plant and further that those plants would possess herbicide tolerance.
Given these findings, which echo Applicant’s arguments recited above, it would have been obvious to the ordinary artisan to modify the crop plants of Kato in order to introduce heterologous CYP81 sequences from Amaranthus tuberculatus in order to produce modified crop plants having herbicide tolerance to post emergence herbicides auxin herbicides including 2,4-D as taught by Shyam.
Further, the ordinary artisan would have been motivated to make these modifications in order to produce crop plants (soybeans) which could be treated with post emergence herbicides, which include auxin herbicides, thereby preventing yield reductions caused by weed competition and to prevent degradation of seed quality resulting from weed contamination in machine harvesting. This would have been motivating because of the agronomic and economic benefits of cultivating soybeans without losses due to weeds or reduced productivity of plants due to herbicide treatment.
With respect to claim 2, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
With respect to claim 3, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
With respect to claim 4, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
With respect to claim 5, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
With respect to claim 6, Kato in view of Shyam collectively teach all of the limitations of claim 1 including conferred tolerance to 2,4-D, see above.
With respect to claim 7, Kato in view of Shyam collectively teach all of the limitations of claim 6 including conferred tolerance to 2,4-D, see above.
With respect to claim 8, Kato in view of Shyam collectively teach all of the limitations of claim 1 including modified soybean plants which are dicots, see above.
With respect to claim 10, Kato in view of Shyam collectively teach all of the limitations of claim 1 including modified soybean plants, see above.
With respect to claim 45, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
Further, Kato teaches soybean seeds (products) prepared from soybean plants comprising the herbicide tolerance gene (Kato, Page 2105, Column 2, First Paragraph).
With respect to claim 46, Kato in view of Shyam collectively teach all of the limitations of claim 45 including modified soybean plants which are dicots, see above.
With respect to claim 47, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
Further, Kato teaches soybean seeds comprising the herbicide tolerance gene (products) prepared by processing soybean plants (Kato, Page 2105, Column 2, First Paragraph).
With respect to claim 48, Kato in view of Shyam collectively teach all of the limitations of claim 47, see above.
With respect to claim 63, Kato in view of Shyam collectively teach all of the limitations of claim 1, see above.
Further, Kato teaches soybean seeds comprising the herbicide tolerance gene (products) prepared by processing soybean plants (Kato, Page 2105, Column 2, First Paragraph).
Further, Kato conducted RT-PCR experiments which convert the CYP81E transcripts in the susceptible and tolerant cultivars to cDNAs and allow the expression of CYP81E in each cultivar to be compared (Kato, Page 2108, Figure 1c-ii). In Figure 1c-ii the brighter bands present in the columns for the herbicide tolerant cultivars show that the expression of CYP81e is higher in these cultivars which are modified at the CYP81E locus compared to the herbicide susceptible cultivar.
With respect to claim 64, Kato in view of Shyam collectively teach all of the limitations of claim 63 taught above, see above.
Further, Shyam teaches that CYP81 proteins can confer tolerance to 2,4-D (Shyam, Page 1, Abstract).
With respect to claims Kato and Shyam do not explicitly teach heterologous promoters linked to the herbicide tolerance nucleotide nor do they explicitly teach soybean oil, seed meal, fodder or seed-treatment-coated seed.
At the time of filing it would have been obvious to modify the plants of Kato in view of Shyam to operatively link the heterologous polynucleotide conferring herbicide tolerance to a promoter and further to process the soybean seeds into oil.
These modifications would have been obvious, first because Kato demonstrates that CYP81 expression was increased in plants having tolerance to herbicides and therefore this gene was linked to a promoter. Further, soybean seeds are commonly used to make soybean oil and soybean plants are commonly used to for fodder. This are commercially significant uses of these materials and therefore it would have been obvious to the ordinary artisan to process the soybean seeds and soybean plants for these uses.
The ordinary artisan would have been motivated to make these modifications because the first would ensure that the plants expressed high levels of the tolerance polynucleotide which would lead to the tolerant phenotype in the plant which would lead to higher yields. Further, the ordinary artisan would then have been motivated to process the soybean seeds and plants into soybean oil and fodder because of the commercial value of these produces.
Therefore, claims 2-8, 10, 45-48 and 63-64 are rejected as obvious under Kato in view of Shyam.
Conclusion
All examined claims are rejected.
Contact Information
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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