DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-20 are pending.
Claims 1-20 are examined on the merits.
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 depends on claim 1 which recites “residue 383 relative to SEQ ID NO: 2”, however in the last line, claim 3 recites “a position corresponding to residue 383” without the reference sequence. Given that it is clear that claim 3 is referring to residue 383 relative to SEQ ID NO: 2 no indefiniteness rejection is being made, however in order to ensure consistency between claims claim 3 should be amended to match the language of claim 1.
Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the claim recites “a phenotype of tolerance to one or more PPO-inhibiting herbicides which tolerance is greater than that of a corresponding wild-type sunflower plant” which is awkward language. In order to improve syntax the office recommends amending the claim to replace “which tolerance” to “, where said tolerance”.
Appropriate correction is requested.
Claim 11 is objected to because of the following informalities: the claim recites “cafentrazone-ethyl, flumioxazin, saflufenacil and/or trifludimoxasin herbicides, and combinations thereof”. This is objected to because it includes “and/or” and “and combinations thereof” which are redundant and either “and/or” or “and combinations thereof” should be removed from the claim to improve syntax.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Indefiniteness)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-20 all recite “sunflower” which is indefinite. This is because the exact scope conferred by the use of this term is not clear. Specifically, sunflower can refer to Helianthus annuus, see specification paragraph 0018, however sunflower is also used to refer to the genus Helianthus (“Helianthus (Sunflower) .” North Carolina Extension Gardener Plant Toolbox, NCSU, Accessed 27 Feb. 2026). As such it is clear that the recitation of sunflower in the claims introduces two distinct scopes, one where this recitation refers to a specific species (Helianthus annuus” and a second where it refers to any member of the Helianthus genus. It is important that not only does the term sunflower have two different meanings and corresponding scopes but these different scopes also produces claims having different and distinct scopes. Finally, even with the recitation in paragraph 0018 of the specification which reads “Sunflower (Helianthus annuus)”, given that this is a single recitation in the specification which refers to a single oil crop and that there are many other recitations of sunflower in the claims that do not recite “Helianthus annuus” the exact scope imparted by the recitation of “sunflower” in the claims is not clear and claims 1-20 are rejected as indefinite.
Claim 2 recites “other than exclusively an essentially biological process”, which renders the claim indefinite. Specifically, the meaning of essentially biological process is not clear. For example, transformation of a plant cell with exogenous DNA occurs naturally during Agrobacterium pathogenesis of plant cells. Another example of a biological process could be radiation induced mutation of human DNA which results in skin cancer. As these two examples demonstrate process of inducing mutations which are generally thought of as relying on human intervention are simply humans taking advantage of naturally occurring biological processes. The specification provides no clarity on the scope of essentially biological process nor does the state of the art. Therefore, given that the scope of “essentially biological process” is not clear, claim 2 is rejected as indefinite.
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 1-2, 5-8 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hutzler (WO 2012/080975 A1) Published December 15, 2011.
With respect to claim 1, Hutzler teaches a non-transgenic sunflower plant (Hutzler teaches a broad list of plants which are particularly useful in the methods of Hutzler which includes sunflower plants, additionally, Hutzler teaches that the plants of the invention of Hutzler can be non-transgenic)(Hutzler, Pages 9-10, Paragraph Spanning Pages; Hutzler, Page 4, Line 32) comprising a mutated protoporphyinogen IX oxidase (PPO) gene (Hutzler teaches “mut-PPO nucleic acids” which are PPO nucleic acids which have sequences that have been mutated from a wild-type PPO nucleic acid and that confers increased benzoxazinone-derivative herbicide tolerance to a plant in which it is expressed)(Hutzler, Page 30, Lines 16-24) encoding a mutated sunflower protoporphyrinogen IX oxidase (Hutzler teaches the term “mutated protoporphyrinogen oxidase (mut-PPO) refers to the replacement of an amino acid of the wild type sequences with another amino acid”)(Hutzler, Page 30, Lines 16-24), wherein mutated sunflower protoporphyrinogen IX oxidase comprises a substitution of phenylalanine (F) to isoleucine (I) at a position corresponding to residue 383 relative to SEQ ID NO: 2 (F383I substitution)(Hutzler teaches F420I substitutions and alignment between the sunflower PPO polypeptide sequence and the Amaranthus PPO polypeptide sequence of Hutzler demonstrates that position 420 of the Amaranthus polypeptide sequence corresponds to position 383 of the Sunflower polypeptide sequence)(Hutzler, Page 64, Table 4a).
With respect to claim 1, while Hutzler provides general teachings of all of the limitations of the instantly claimed non-transgenic sunflower plant, Hutzler does not teach a single embodiment which teaches all of the limitations of the claimed invention.
At the time of filing it would have been obvious to the ordinary artisan to combine the teachings of Hutzler to arrive at the instantly claimed invention. Specifically, given that Hutzler teaches motivation to generate the claimed mutations in PPO genes in order to produce herbicide tolerant plants and suggests that these methods are applicable to crop plants and explicitly references sunflower it would have been obvious to generate this mutation in sunflower PPO to generate herbicide tolerant sunflower plants. This would have been obvious it is simply combining prior art elements according to known methods to produce predictable results. Additionally, the ordinary artisan would have been motivated to produce herbicide tolerant sunflower plants because Hutzler teaches advantageous methods of controlling undesired vegetation at a plant cultivation site which rely on PPO resistant crop plants. These methods allow for the rapid and efficient removal of undesired plants in an agricultural setting which may reduce yield, contaminate crop plants and otherwise inhibit optimal production of crop plants. As such the ordinary artisan would have both found it obvious to combine the teachings of Hutzler to arrive at the invention of instant claim 1 and would have been motivated to combine these teachings.
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Figure 1: Alignment of instant SEQ ID NO: 4 drawn to wild type sunflower PPO and Amaranthus PPO demonstrates that position 383 of sunflower PPO corresponds to position 420 of Amaranthus PPO.
With respect to claim 2, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches the non-transgenic plant has been obtained by means other than exclusively an essentially biological process (Hutzler, teaches that the plants of the invention of Hutzler can be non-transgenic and further teaches the use of EMS to mutagenize Arabidopsis thaliana plants to produce and identify plants with mutations in PPO genes)(Hutzler, Page 4, Line 32; Hutzler, Page 66, Lines 12-32).
With respect to claim 5, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches plants which encode a mutated PPO which is resistant or tolerant to PPO-inhibiting herbicides (Hutzler, Abstract). Additionally, Hutzler teaches that expression of the mutated PPO genes produces plants which have increased resistance or tolerance to a benzoxazinone-derivative herbicide as compared to a wild type variety of the plant (Hutzler, Page 4, Lines 21-25). Finally, Hutzler makes clear that benzoxazinone-derivative herbicides target PPO and therefore, benzoxazinone-derivative herbicides are PPO-inhibiting herbicides (Hutzler, Page 3, Lines 1-12).
With respect to claim 6, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches self-crossing T1 plants comprising the modified PPO gene in order to produce homozygous T2 plants that are homozygous for the mutated PPO gene (Hutzler, Page 46, Lines 18-35).
With respect to claim 7, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches the non-transgenic plant has been obtained by EMS mutagenesis (Hutzler, teaches that the plants of the invention of Hutzler can be non-transgenic and further teaches the use of EMS to mutagenize Arabidopsis thaliana plants to produce and identify plants with mutations in PPO genes)(Hutzler, Page 4, Line 32; Hutzler, Page 66, Lines 12-32).
With respect to claim 8, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches the non-transgenic plant can be obtained by methods other than EMS mutagenesis including radiation induced mutagenesis (Hutzler, Page 48, Lines 26-39).
With respect to claim 10, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches the plant comprising applying an effective amount of a benzoxazinone-derivative herbicide (Hutzler, Page 3, Lines 1-7).
With respect to claim 11, Hutzler teaches all of the limitations of claim 5, see above. Further, Hutzler teaches plants which show herbicide-tolerance to the saflufenacil herbicide (Hutzler, Page 71, Example 10, Lines 12-21).
With respect to claims 12-13, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches plants which encode a mutated PPO which is resistant or tolerant to PPO-inhibiting herbicides (Hutzler, Abstract). Additionally, Hutzler teaches that expression of the mutated PPO genes produces plants which have increased resistance or tolerance to a benzoxazinone-derivative herbicide as compared to a wild type variety of the plant (Hutzler, Page 4, Lines 21-25). Finally, Hutzler teaches the use of the herbicide Saflufenacil (Hutzler, Page 71, Example 10, Lines 12-21).
With respect to claim 14, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches the use of the native promoter to express the mutant PPO genes (Hutzler, Page 52, Lines 11-14).
With respect to claim 15, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches that the plants of Hutzler can be transgenic or non-transgenic (Hutzler, Page 4, Line 32). Finally, Hutzler teaches seeds produced from plants of the invention wherein the seeds are true-breeding for increased resistance to herbicides.
With respect to claims 16 and 17, Hutzler teaches all of the limitations of claim 1, see above. Further, Hutzler teaches a method for controlling undesired vegetation at a plant cultivation site, comprising providing a plant comprising at least one nucleic acid encoding a resistant PPO gene wherein that plant is resistant or tolerant to herbicides and applying to that site an effective amount of the herbicide (Hutzler, Page 72, Claim 1).
With respect to claims 2, 5-8 and 10-17, while Hutzler provides general teachings of all of the limitations of the instantly claimed non-transgenic sunflower plant, Hutzler does not teach a single embodiment which teaches all of the limitations of the claimed invention. Further, Hutzler does not explicitly teach the specifically claimed concentrations of herbicides or application stages described in claim 13 not does Hutzler explicitly teach seeds from non-transgenic herbicide resistant plants.
At the time of filing it would have been obvious to the ordinary artisan to combine the teachings of Hutzler to arrive at the instantly claimed invention. Specifically, given that Hutzler teaches motivation to generate the claimed mutations in PPO genes in order to produce herbicide tolerant plants and suggests that these methods are applicable to crop plants and explicitly references sunflower it would have been obvious to generate this mutation in sunflower PPO to generate herbicide tolerant sunflower plants. This would have been obvious it is simply combining prior art elements according to known methods to produce predictable results. Additionally, the ordinary artisan would have been motivated to produce herbicide tolerant sunflower plants because Hutzler teaches advantageous methods of controlling undesired vegetation at a plant cultivation site which rely on PPO resistant crop plants. These methods allow for the rapid and efficient removal of undesired plants in an agricultural setting which may reduce yield, contaminate crop plants and otherwise inhibit optimal production of crop plants.
Additionally, arriving at the specific concentration of herbicide and timing of treatment is simple optimization of experimental conditions and as such would have been obvious. Finally, given that Hutzler, teaches the non-transgenic sunflower plants of claim 1 and additionally teaches progeny seed which carries the herbicide tolerance trait it would have been obvious to produce seed from the non-transgenic sunflower plants and to select for seeds having the desirable herbicide tolerance phenotype.
As such the ordinary artisan would have both found it obvious to combine the teachings of Hutzler to arrive at the claimed inventions and would have been motivated to combine these teachings and therefore claims 2, 5-8 and 10-17 are rejected as obvious under Hutzler.
With respect to claim 18, Hutzler teaches all of the limitations of claim 1, see above.
With respect to claim 19, Hutzler teaches all of the limitations of claim 15, see above.
With respect to claim 20, Hutzler teaches all of the limitations of claim 15, see above.
With respect to claims 18-20, Hutzler does not teach methods for producing oil from the plants and seeds of claims 1 and 15.
At the time of filing it would have been obvious to the ordinary artisan to produce oil from the sunflower plants and seeds of Hutzler. This would be obvious because, Hutzler teaches methods of weed control of unwanted plants in an agricultural setting and further teaches the use of plants having a modified PPO gene including sunflower plants. Given that Hutzler teaches these plants, seeds and methods it would have been obvious to use these seeds and plants to efficiently produce high yields of desirable sunflower seeds. It would then have been obvious to produce oil from these seeds. This would have been obvious because producing oil from sunflower seeds is well known in the art. Further, this would have been extremely motivating to the ordinary artisan given the value of sunflower oil. As such the ordinary artisan being in possession of efficient methods of producing sunflower plants and seeds would then have found it obvious to produce oil from these seeds and would have been motivated to do so due to the economic value of sunflower oil. As such claims 18-20 are rejected as obvious under Hutzler.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hutzler in view of A0A251TWC2, UniProt, European Bioinformatics Institute, 22 Nov. 2017.
With respect to claim 3, Hutzler teaches all of the limitations of claim 1, see above. This includes a mutated PPO protein comprising a substitution of phenylalanine (F) to isoleucine (I) at a position corresponding to residue 383 relative to SEQ ID NO: 2, see above.
With respect to claim 3, Hutzler does not explicitly teach that the mutated PPO has a sequence that is at least 98% identical to instant SEQ ID NO: 2.
With respect to claim 3, Accession A0A251TWC2 in UniProt teaches the wild-type sunflower PPO protein which shares 99.8% sequence identity with instant SEQ ID NO: 2 and lacks complete identity with instant SEQ ID NO: 2 due only to the lack of the F to I substitution at position 383 (See Figure 2 below for a description of the alignment of the two sequences).
Given that Hutzler teaches a non-transgenic mutated sunflower plant having a PPO gene which has the specific substitution required of the claimed invention but is silent on the exact sequence of the PPO protein outside of this substitution and that AOA251TWC2 teaches the sequence of wild-type sunflower PPO protein which differs from the instantly claimed sequence only in the lack of the claimed substitution it would have been obvious to use the PPO protein of AOA251TWC2 as the starting material to generate the substitution described in Hutzler to produce the instantly claimed sunflower plant.
This would have been obvious because Hutzler teaches all of the critical elements of the claim but is silent on the specific sequence of the starting material and AOA251TWC2 makes clear that this was known in the art at the time of filing. As such producing this specific plant is simply combining known teachings in the art to arrive at a predictable results and is therefore obvious. Further, as noted above in the obviousness rejection against claim 1, the ordinary artisan would have been motivated to produce herbicide tolerant sunflower plants because Hutzler teaches advantageous methods of controlling undesired vegetation at a plant cultivation site which rely on PPO resistant crop plants. These methods allow for the rapid and efficient removal of undesired plants in an agricultural setting which may reduce yield, contaminate crop plants and otherwise inhibit optimal production of crop plants.
Given these teachings and motivations claim 3 is rejected as obvious under Hutzler in view of A0A251TWC2.
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Figure 2: Description of the alignment of the sequence of UniPRot Accession: A0A251TWC2 and instant SEQ ID NO: 2 which differ only due to a single mismatch.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hutzler in view of XM_022126722.2 “PREDICTED: Helianthus Annuus Protoporphyrinogen Oxidase, Mitochondrial - Nucleotide - NCBI.” Nih.gov, NCBI, 1 Sept. 2020.
With respect to claim 4, Hutzler teaches all of the limitations of claim 1, see above. This includes a mutated PPO gene comprising a mutation which produces a substitution of phenylalanine (F) to isoleucine (I) at a position corresponding to residue 383 relative to SEQ ID NO: 2 in the protein encoded by the nucleic acid sequence, see above.
With respect to claim 4, Hutzler does not explicitly teach that the mutated PPO gene has a sequence that is at least 98% identical to instant SEQ ID NO: 1.
With respect to claim 4, Accession XM_022126722.2 teaches the wild-type sunflower PPO gene which shares 99.86% sequence identity with instant SEQ ID NO: 1 (See Figure 3 below for a description of the alignment of the two sequences).
Given that Hutzler teaches a non-transgenic mutated sunflower plant having a PPO gene which has the specific substitution required of the claimed invention but is silent on the exact sequence of the modified PPO gene outside of this substitution and that XM_022126722.2 appears to teach the sequence of the wild-type sunflower PPO gene which shares 99.86% sequence identity with instant SEQ ID NO:1 it would have been obvious to use the PPO gene of XM_022126722.2 as the starting material to generate the substitution described in Hutzler to produce the instantly claimed sunflower plant.
This would have been obvious because Hutzler teaches all of the critical elements of the claim but is silent on the specific sequence of the starting material and XM_022126722.2 makes clear that this was known in the art at the time of filing. As such producing this specific plant is simply combining known teachings in the art to arrive at a predictable results and is therefore obvious. Further, as noted above in the obviousness rejection against claim 1, the ordinary artisan would have been motivated to produce herbicide tolerant sunflower plants because Hutzler teaches advantageous methods of controlling undesired vegetation at a plant cultivation site which rely on PPO resistant crop plants. These methods allow for the rapid and efficient removal of undesired plants in an agricultural setting which may reduce yield, contaminate crop plants and otherwise inhibit optimal production of crop plants.
Given these teachings and motivations claim 4 is rejected as obvious under Hutzler in view of XM_022126722.2.
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Figure 3: Description of the alignment of the sequence of Accession: XM_022126722.2 and instant SEQ ID NO: 1.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hutzler in view of Rauf, Advances in Plant Breeding Strategies: Industrial and Food Crops: Volume 6. 2019 and Han, Plant Biotechnology Reports 13.5 (2019): 447-457.
With respect to claim 9, Hutzler teaches all of the limitations of claim 1, see above. This includes teaching non-transgenic plants that were produced using a variety of methods including EMS mutagenesis and radiation treatment.
With respect to claim 9, Hutzler does not teach generating the mutated PPO gene using genome editing.
With respect to claim 9, Rauf teaches that sunflower breeding will be greatly facilitated by new molecular techniques including genome editing using the CRISPR/Cas9 system (Rauf, Page 665, Second Paragraph). As such Rauf demonstrates that there existed at the time of filing motivation to use gene editing to improve Sunflower varieties.
With respect to claim 9, Han teaches the use of the CRISPR/Cas9 system to produce herbicide-resistant plants by editing endogenous genes (Han, Page 447, Abstract). Additionally, Han teaches that herbicide resistance is one of the most important traits for plant biotechnology because it can widely used to improve agricultural efficiency by controlling weeds while also being used as a valuable selectable marker during genetic engineering (Han, Page 447, Abstract). Finally, Han teaches the advantages of CRISPR/Cas9 in producing herbicide resistant plants, stating that gene editing methods enable precise modification s of DNA sequences and offer great promise for the improvement of crops (Han, Page 447, Abstract).
At the time of filing it would have been obvious to modify the plant of Hutzler to produce the mutation in the PPO gene using gene editing as taught in Han given that Rauf teaches motivation to use these techniques and systems in sunflower plants.
Combining these teachings would have been obvious because it is simply substituting one known element (EMS mutagenesis or Radiation Treatment) for another known element (CRISPR/Cas9 Gene Editing) to obtain predictable results. Evidence for the predictability of this result can be found in Han which teaches the wide use of these methods to improve crop plants and in Rauf which teaches the benefits and motivations for applying this technique to Sunflower plants. As such it would have been obvious to combine these teachings. Further, as noted above in the obviousness rejection against claim 1, the ordinary artisan would have been motivated to produce herbicide tolerant sunflower plants because Hutzler teaches advantageous methods of controlling undesired vegetation at a plant cultivation site which rely on PPO resistant crop plants. These methods allow for the rapid and efficient removal of undesired plants in an agricultural setting which may reduce yield, contaminate crop plants and otherwise inhibit optimal production of crop plants and combined with the efficiency provided by the CRISPR/Cas9 system these plants could be produced more rapidly and efficiently than using other methods.
Given these teachings and motivations claim 9 is rejected as obvious under Hutzler in view of Rauf and Han.
Conclusion
All 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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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663