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 .
Election/Restriction
Applicant's election with traverse of Group II, claims 19, 24, 27, 28 and 41 in the reply filed on 24 April 2026 is acknowledged. The traversal is on the ground(s) that the newly amended claims now relate to a green tissue preferred expression of both an oil-synthesizing enzyme and an oil-encapsulating protein and that the reference does not teach a green tissue-preferred expression. This is not found persuasive because the originally filed claims dated 16 January 2026 were used to establish lack of unity of invention.
The restriction requirement is maintained with the understanding that should any claim be found allowable, then all claims that require all limitations of the allowable claim with be rejoined.
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
The status of the claims filed 24 April 2026 is as follows:
Claims 2-3, 5, 7, 11, 15, 19, 22-28 and 30-41 are pending.
Claims 2, 3, 5, 11, 19, 24, 32, 33, 35 and 36 have been amended.
Claims 15, 22 and 23 have been cancelled.
Claims 2-3, 5, 7, 11, 15, 25-26, and 30-40 have been withdrawn.
Claims 19, 24 ,27-28 and 41 have been hereby examined.
Priority
The present application filed on 4 November 2024, is the national phase of PCT application PCT/IB2023/054626 having an international filing date of 4 May 2023. Acknowledgment is made of applicant’s foreign priority which claims the benefits of AU2022901207 filed on 6 May 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 19, 24 ,27-28 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Izadi-Darbandi et al (2020. Metabolically engineered rice biomass and grain using genes associated with lipid pathway show high level of oil content. Molecular Biology Reports 47: 7917-7927) and Dean, E.A. (2018. Characterization of strong and tissue-specific promoters of soybean (Glycine max (L.) Merr.) using multiple systems. Master’s Thesis. Ohio State University. etd.ohiolink.edu/acprod/odb_etd/ws/send_file/send?accession=osu1524052611288602&disposition=inline. 95 pages)
The claims are broadly drawn to a plant with a seed, a seed or seed produced by a method comprising ectopically expressing an oil-synthesizing enzyme in a plant, wherein expression of the oil-synthesizing enzyme is green tissue-preferred expression, and ectopically expressing an oil-encapsulating protein in the plant, wherein expression of the oil-encapsulating protein is green tissue preferred expression, wherein the ectopic expression of the oil-synthesizing enzyme and the oil-encapsulating protein leads to the production of seed with increased oil content, without significantly reduced protein content wherein the polynucleotide encoding the oil-synthesizing enzyme and the oil-encapsulating protein is operably linked to a promoter that drives green tissue-preferred expression. The claims are further drawn to a plant, plant part, propagule, progeny or seed of the plant with increased production or content of oil in its seed relative to that in a control plant without significantly decreased production or content of protein in its seed relative to that in the control plant, wherein the plant ectopically expresses the oil-synthesizing enzyme and ectopically expresses the oil-encapsulating protein , wherein expression of the oil-synthesizing enzyme and encapsulating protein is green tissue-preferred expression, and wherein the ectopic expression leads to the increased production or content of oil in the seed, without the significantly decreased production or content of protein in the seed, wherein the production or content of oil in the seeds of the plant is increased by at least 1% and wherein the production or content of protein in the seeds of the plant is increased by at least 0.1%.
Izadi-Darbandi et al teach increasing lipid content using metabolic engineering methods in different parts of plant, including leaves and stem (i.e., green tissue) can be considered as an innovative platform for achieving more energy and biofuel in more green habits [abstract]. Izadi-Darbandi et al states global demand for food, feed and energy is rising to meet the diverse requirements, however, the use of non-renewable energy resources, such as petroleum, is not only costly, but also harmful to the environment [page 7917, rt. col., para. 1]. Izadi-Darbandi et al teach that triacylglycerides (TAGs) play vital roles in vegetative and reproductive parts. Izadi-Darbandi et al teach that in addition to elevating seed oil content in oilseed crops, increasing the lipid content by using metabolic engineering methods in non-seed parts including, leaves and stem can be considered an innovative platform for achieving more energy and biofuel in more green habits [para. Bridging pages 7917-7918]. The enzyme diacylglycerol (DAG) and diacylglycerol acyltransferase (DGAT) are involved in the Kennedy pathway [para. Bridging paras. 7918-7919]. Izadi-Darbandi et al state that manipulation of DGAT enzyme would be more effective in promoting the TAG content of plants and it was shown that lipid content of leaves of transgenic plants is 1.5 to twice that of controls [page 7919, left col. para. 1]. Izadi-Darbandi et al teach that following TAGs assembling, they can be protected from degradation and coalescence by packing into oil bodies surrounded by oleosin and that plants possessing a high TAG content can be achieved by overexpressing oleosin encoding genes (OLE), to more stabilization of oil bodies (i.e., oil-encapsulating protein) [page 7919, rt. col., para. 2]. Izadi-Darbandi et al state that co-overexpression of three genes caused significant improvement in TAG content of leaves and seeds up to 71% and 25%, respectively and that seeds and leaves of metabolically engineered corn showed more oil bodies in their cells, in compared with [sic] nontransformed plants [page. 7919, rt. col., para. 3] (which reads on a plant, a seed or a plant part that is transgenic for a polynucleotide or construct encoding the oil-synthesizing enzyme and a polynucleotide or construct encoding the oil-encapsulating protein). Izadi-Darbandi et al state that in addition to seeds abundant straw also is created annually in rice harvest and usually remains unused [page 7920, left col., para. 1]. The objective of this study is to increase lipid content of rice seeds and leaves thereby increasing the biomass would play a critical role in producing not only rice for food but biomass for oil or fuel production [page 7920, left col. para. 1]. Izadi-Darbandi et al overexpressed 4 genes involved in TAG assembly and protection (AtDGAT1 and AtPDAT, AtWRI1, and AtOle) under a constitutive promoter (35S) in rice crop [Fig. 2] (which reads on ectopically expressing an oil-synthesizing enzyme in a plant and ectopically expressing an oil-encapsulating protein in the plant). Izadi-Darbandi et al found TAG content of transgenic seeds increased significantly by 26% in compared with those of control plants (which reads on production or content of oil in the seeds of the plant in increased by at least 1%), that Oleosin (which reads on a protein) and palmitic acid contents were significantly increased by 28% in seeds of transgenic plants (which reads on without the significantly decrease production or content of protein in the seed and which reads on production or content of protein in the seeds of the plant increased by at least 0.1% relative to a control plant) compared with controls and that total grain and leaf oil content increase by 70% and 22.5%, respectively showing an increase in oil content in both seeds and plants [para. Bridging pages 7924-7925; page 7926, left col., para 2; Fig. 5.]. Izadi-Darbandi et al teach also found that important agronomic traits including plant height, fertile tiller/plant and number of grains per panicle increase significantly in transgenic plants in compared with controls [page 7925, rt. col., para. 3].
Izadi-Darbandi et al do not explicitly teach green tissue-preferred expression of an oil-synthesizing enzyme and an oil-encapsulating protein.
However, Dean teaches that for generation of transgenics for both basic research and for commercial production, transgenes are often placed under the control of various promoters such as the Cauliflower Mosaic Virus 35S (35S) promoter and that several native soybean promoters provide higher transgene expression than the 35S promoter [page 16, para. 1]. The Dean study focuses on four rbcS promoters from soybean (which reads on a green tissue preferred expression), two of which have not been previously evaluated and compared rbcS promoter strength to a commonly used viral promoter [para. Bridging pages 16-17]. Expression of the native rbcS1-3 was high in young leaf tissues as well as in seed and pod shell tissues, with rbcS1 (which reads on green tissue-preferred expression) driving the highest expression of all promoters evaluated [page 23, para. 3]. It is noted that, paralleling the teaching of Dean, the instant disclosure also contemplates the use of the rbcs promoter for green tissue-preferred expression.
It would have been obvious to one of ordinary skill in the art before the effective filing date, to employ the methodologies of Izadi-Darbandi et al and replace the constitutive promoter (35S) with a green tissue-preferred promoter to obtain green tissue-preferred expression of an oil encapsulated oil body. Izadi-Darbandi et al teach a plant, seed or plant part that ectopically expresses an oil-synthesizing enzyme and oil-encapsulating protein under the control of the 35S promoter and found an increase in both oil and protein content in the plant. Dean teaches that native soybean promoters, such as rbcS, provide higher transgene expression than the 35S promoter. Dean teaches that using a green tissue-preferred promoter (rbcS1) resulted in higher oil expression in young leaf tissues as well as in seed and pod shell tissues than those found in the control. One would have had a reasonable expectation of success given that Izadi-Darbandi et al show increase in oil and protein production in plants and that swapping out one promoter for another promoter is routine in the art, commonly practiced by the skilled artesian and merely a design choice. Furthermore, one would expect an even higher production of oil than that obtained using the 35S promoter. One would have been motivated to ectopically express an oil-synthesizing enzyme and an oil-encapsulating protein under the control of a green tissue promoter such as rbcS1 to achieve even higher oil and protein expression, both in seeds and in other parts of a plant (leaves, stem, etc.). Such a high oil producing transgenic plant would provide an alternative and sustainable source of energy and nutrition at affordable costs and low risk to human health and the environment [Izadi-Darbandi et al teach; pate 7917; right col. para. 1].
Conclusion
No claim is allowable.
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/KAREN M REDDEN/Primary Examiner, Art Unit 1661
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