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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/15/2026 has been entered.
Claim Status
Claims 1-4, 6-12 and 14-23 are pending and being examined.
The Applicant added 3 new claims (21-23) which are entered and being examined.
All previous objections and rejections not set forth below have been withdrawn in view of applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b)
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 14 and 23 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
It is not clear to the Examiner what the Applicant imply by the terms “Rubus plant or plant part” in claim 14 and “Prunus family” in claim 23.
The Applicant describes, “In some embodiments, the plant material is from a plant in the Rubus family. In some embodiments, the plant material is from a plant in the Prunus family” (spec, p.36. para 1, last 3 lines). However, the plants (species) of the Rubus and Prunus genus belongs to “Rosaceae family.” A “Rubus family” and “Prunus family” do not exist. The terms are indefinite because the specification does not clearly redefine the terms. It is unclear what plants belong to a “Rubus family” and “Prunus family”.
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.
Claims 1-4, 6-12, 15-17 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbertson et al. (CA 3120571 A1, published 2020/04/09) in view of Sidorov et al. (Heritable DNA-free genome editing of canola (Brassica napus L.) using PEG-mediated transfection of isolated protoplasts, 2022, In Vitro Cellular & Developmental Biology - Plant, 58:447–456; published online on 8 November 2021).
Gilbertson et al. describes that many plant species and/or varieties are difficult to transform, culture, and/or regenerate from an explant or plant material (page 1, para 0003, line 4-5). The method comprises preparing plant tissues to regenerate (transgenic/mutant) plants from wounded recipient cells (abstract) from a callus (page 13, para 0027, line 3) (as recited in claim 3) that create openings or pores in the plant cell wall and/or plasma membrane of the plant cell(s) allowing biomolecules present in the environment or surroundings of the plant cell(s) (e.g., media, solution, or mixture) to enter, delivered or transferred into the plant cell(s) from the environment or surroundings to form a product cell having the biomolecule(s) within its cytoplasm, cytosol, organelle or nucleus (page 13, para 0027, line 4-9). Gilbertson et al. describes that the recombinant DNA construct can be introduced into plants by Agrobacterium-mediated transformation or particle-bombardment (p.20, para 0040, line 7-9; p.20, para 0041, line 1-2).
Gilbertson et al. teaches that wounding the plant tissues and the cells therein can be done by several methods including chopping or cutting of cells with a razor blade, knife or other sharp instrument, and also by vortexing, shaking blending, electroporation, or other mechanical means (p. 17, para 0032); and blending at high for 9-10 seconds (page 39, para 0077, line 2-5).
Wounding the cells in a tissue disrupts or create openings or pores in the plant cell walls and/or plasma membrane which allow biomolecules present in the medium to enter into cytoplasm, cytosol, organelle, or nucleus (page 14, para 0027, line 6-9; page 17, para 0032). Gilbertson et al. describes collecting (about 1.5 grams of) cultured callus cells (page 37, para 0073, line 12-13) as recited in claim 16, before wounding the tissues/cells.
Although Gilbertson et al. teaches the process of “blending” at a “high speed” but does not explicitly describe a blender or using a blender.
Sidorov et al. describes a plant transformation and regeneration protocol (abstract) where the seedlings (reads on to “whole plant”) of canola (Brassica napus) (p.448, right column, para 3, line 1-2) containing the shoot (as recited in claims 1-3) with (cotyledonary) leaves (as recited in claim 1) were cut and transferred into a sterile blender (Waring 7010G blender) and blended (as recited in claim 9) for 4-5 second (as recited in claims 6) at the high-speed position of the blender at ~20,000 rpm (p.448, right column, para 4, line 3-8), which translates into about 333 Hz (rpm ÷ 60=Hz), i.e., within 1 to 380 Hz, as recited in claim 1. The product description of the Waring 7010G blender shows that it comprises a single chopping blade (as recited in claim 1) with a central rotating axis. The process (of blending to prepare the wounded tissue) is devoid of “hand manipulation” (as recited in claim 8) and without “cutting plant tissue by hand”, as defined by the Applicant (instant specification, paragraph bridging p. 32-33, which teaches that the step of preparing wounded tissue is devoid of cutting plant tissue by hand other than a step of providing, e.g., harvesting and/or collecting the plant tissue). The process comprises collecting the plants (seedlings with shoots) prior to wounding the plant or plant part, as recited in claim 16. Sidorov et al. teaches blending the explants (seedlings with the shoots) at a high speed for 4-5 seconds (p.448, right column, para 4, line 3-8).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to modify the method described by Gilbertson et al. by explicitly using a blender to prepare the wounded plant tissue, as described by Sidorov et al. Gilbertson teaches that plant cells or tissues can be wounded by blending or other mechanical means, and disclosed an example in which callus was “blended at high speed”. It would have been obvious to conduct this step with a blender, as blenders have been used in the prior art to wound plants and plant parts, as taught by Sidorov et al.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to use a blender with single chopping blade for about 4-5 seconds at a speed of about 333 Hz for preparing the wounded plant tissue (as described by Sidorov et al.) to transform the plant tissue using Agrobacterium-mediated transformation or particle-bombardment, as taught by Gilbertson et al. and Sidorov et al. Using a blender for the blending process would make the process faster and more efficient than preparing the wounded plant tissue.
Regarding claim 4, It is axiomatic that the blending process at a high speed (of about 333 Hz) would increase the amount of wounded tissue and wounded plants/seedlings/shoots/leaves prepared within a specific time (4-5 seconds) compared to the amount of wounded tissue prepared without blending using a blender in the same period of time for the same plant or plant tissue, as recited in claim 4.
Regarding claim 7, Sidorov et al. teaches blending about 800 to 1000 canola seedlings (approximately 200 seedlings per PhytatrayTM, and 4-5 PhytatrayTM used) (p.448, right column, para 4, line 1-3) to provide the wounded tissue for transformation. Weight of about 200 canola seedlings would vary depending on growth stage and other factors. It is noted that the amount or number of ‘clumps’ of wounded tissue obtained from blending, would depend on the amount of plant or plant part being blended and can be adjusted accordingly.
Regarding claims 8-9, the method described by Gilbertson et al. discusses blending the plant tissue (i.e., plant part) at a high speed (page 39, para 0077, line 2-3) implying using a blender, and Sidorov et al. teach the use of a blender to wound a plant, part or tissue, as recited in claim 9, and is devoid of “hand manipulation” (as recited in claim 8) and without “cutting plant tissue by hand” to prepare the wounded tissue, as defined by the Applicant (specification, page 32, last para).
Regarding claims 15 and 17, Gilbertson et al. describes plant (growth) medium 1074 comprising sucrose, MS basal salt, and plant hormones like IBA and NAA (page 37, Table 1); and medium 1796 comprising sucrose, MS basal salt, plant hormones (2, 4-D), vitamins, casamino acids, and proline; as recited in claim 15 (i.e., culturing the plant tissue in a growth media). The media, as described by Gilbertson et al., are made using water (Table 1 and Table 2), as recited in claim 17 (i.e., in the presence of water).
Regarding claim 15, Sidorov et al. describes using culture medium (p.449, right column, last para, line 9-10) (reads on to “growth media”) comprising carbon sources, Vit B5, casamino acids, growth hormones including IBA, 2,4-D, BAP, NAA, IAA, Zea (zeatin) (p.449, Table 1).
Regarding claim 17, Sidorov et al. describes covering all (plant) material using 25 to 50 ml of W-5 solution (p.448, right column, para 4, line 6-7; p.449, Table 2), which is interpreted as an aqueous solution.
Regarding claims 21-22, Sidorov et al. describes several T0 and T1 generations of the transformed (genome edited) plants (canola, Brassica napus) (abstract, line 7-10; p.452, left column, para 3, line 3-4) and shoots therein comprising a modified nucleic acid with specific indel mutations (p.454, left column, para 2, line 4-9), and wherein the method further comprises regenerating a modified shoot from the transformed plant tissue. Gilbertson et al. also teach producing transgenic plant cells, tissues, plants and seeds comprising a transgene or recombinant nucleic acid (p. 19, para 0039, and as discussed above).
Regarding claims 4 and 10-12; the “wherein” clause in claims is interpreted as an intended result of the recited method steps and thus not given weightage in terms of patentability as the intended step does not add to or change the process in any way or further restrict the method in any way. See MPEP 2111.04.
Claims 14 and 23 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbertson et al. in view Sidorov et al. as applied to claims 1-4, 6-12, 15-17 and 21-22 above, and further in view of Liu et al. (Agrobacterium tumefaciens-mediated transformation of modern rose (Rosa hybrida) using leaf-derived embryogenic callus, 2021, Horticultural Plant Journal, 7: 359–366).
Gilbertson et al. in view Sidorov et al. describe a method of preparing a plant tissue for transformation and regeneration by wounding a plant tissue (callus) in a blender with a single chopping blade at a speed from 1 Hz to 380 HZ for 4-5 seconds, as discussed above.
However, Gilbertson et al. in view Sidorov et al. do not describe any “Rubus plant or plant part” or plants belonging to Rubus and Prunus genus. (See the claim interpretation as part of 112(b) rejection).
Liu et al. describes Agrobacterium tumefaciens-mediated transformation of modern rose which is a “Rubus plant” (Rosa hybrida) (abstract) (reads on to “Rubus plant”, as recited in claim 14). Claim 23 requires the plant to belong to a “Prunus family”. The term “Prunus family” is unclear, as explained in the indefinite rejection above. Plants of the genus Prunus, and Rosa hyrbrida, belong to the Rosaceae family. For purposes of compact prosecution, Rosa hybrida is also being interpreted as a plant of the “Prunus family”.
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to wound an explant in a blender (as described by Gilbertson et al. in view of Sidorov et al.) belonging to the Rosaceae family, as described by Liu et al., for preparing the plant tissue for transformation with a realistic goal to increase transformation rate in rose, which is a commercially important flower crop throughout the world, as described by Liu et al. (page 359, left column, para 1, line 1-2).
Before the effective filing date, it would have been obvious to an ordinarily skilled artisan to wound a rose explant, or any other economically important plant, including a Prunus plant, to increase transformation rate while using Agrobacterium mediated transformation.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbertson et al. in view of Sidorov et al. as applied to claims 1-4, 6-12, 15-17 and 21-22 above, and further in view of Gurel et al. (Sand-Wounding of Shoot and Petiole Explants Enhances Transformation Efficiency in Sugar Beet (Beta vulgaris L.) by Agrobacterium-mediated Transformation, 2021, Sugar Tech., 23:415–427).
Gilbertson et al. in view of Sidorov et al. describe a method of preparing a plant tissue for transformation and regeneration by wounding a plant tissue (callus) in a blender at a speed from 1 Hz to 380 HZ for 1 to 10 seconds, as discussed above.
However, Gilbertson et al. in view of Sidorov et al. do not describe blending the plant or plant part in a blender in presence of a bacteria.
Gurel et al. describes wounding of plant tissues (e.g. shoot and petiole) of sugar beet increases Agrobacterium mediated transformation efficiency (title and abstract). It describes wounding the explant in presence of Agrobacterium (page 421, Fig. 3) (as recited in claim 18) and silver sand (p.417, left column, para 4, line 3-4) wherein the sand is used to create wounds in the explant. The effect of wounding was more prominent when stable transformation efficiencies are compared- achieving almost a 60% increase (1.38% vs. 2.16%) using petiole explants while that from the shoot explants is doubled (0.98% vs. 1.97%) (Abstract, line 22-27). Transformation rate or transformation efficiency increased further to 53% with sonication followed by 9 min of mixing in presence of Agrobacterium (p.425, right column, para 1, line 4-6). Transformation efficiencies are measured in terms of introducing a polynucleotide (as recited in claim 19) such as a binary vector (e.g., pPZP201-GFP-PMI) (p.417, left column, para 1, line -1-4). Gurel et al. describes culturing the wounded tissue in growth/growing media (p.417, left column, para 4, line 5-11), as recited in claim 20.
Gilbertson et al. teaches that wounding creates pores that can allow biomolecules present in the surrounding medium to be transferred into the cells (page 13, para 0027; page 14, para 0032, 0033).
Gurel et al. demonstrate wounding and transforming of plant tissue in the same step. Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to wound the explant in a blender, as described by Gilbertson et al. in view of Sidorov et al., in presence of Agrobacterium to transform the wounded plant tissue.
Before the effective filing date, it would have been obvious to an ordinarily skilled artisan to wound the explant (plant tissue including protoplasts) using a blender to increase transformation efficiency even further (e.g., to about 53%, as described by Gurel et al., compared to 30%, as described by Sidorov) in commercially important plant plants including sugar beet, as described by Gurel et al.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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J.C.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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