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 .
This is a Final Office Action in response to amendment filed on January 26, 2026. Claims 3, 5, 6, 14, 15, 20, 22, 23 and 25 are amended. Claim 27 is canceled. Claims 1-3, 5-10, 13-16, 19-23, and 25 remain pending and are examined herein.
Response to Amendment
The objection to the Specification regarding missing deposit information is withdrawn in view of amendment removing the mentioning of deposit date and number. However, it does not relieve Applicant from the duty to disclose, should it be determined necessary hereinafter.
The objection to claim 3 is withdrawn in view of amendment of the claim.
The objection to claims 23, and 25 is withdrawn in view of amendment of the claim. Claim 23 and 25 are now dependent on a single claim and are examined herein.
The rejections of claims 5-6 and 20 under 35 U.S.C. 112(b) are withdrawn in view of amendment of the claims.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 7/24/2025. Applicant’s arguments filed on 1/26/2026 have been fully considered but they are not persuasive. See response to Applicant’s Remarks after this section of the rejection.
.
Claims 1-3, 5-10, 13-15, and 19-22 remain, and claim 23 is, rejected under 35 U.S.C. 102(a)(1) as being anticipated by WOOD, C. et al., “Seed-specific RNAi in safflower generates a superhigh oleic oil with extended oxidative stability, Plant Biotechnology Journal. 2018, Vol 16, No. 10 pages 178-1796, provided in the IDS filed on November 29, 2023 as Exhibit 3, with evidence from Exhibit 2 of the same IDS.
Claim 1 is drawn to a safflower plant cell comprising
(a) a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:13 and a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:14,
(b) a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:21 and a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:22,
(c) a T-DNA molecule, wherein the T-DNA molecule is inserted into a region of a chromosome of the cell, wherein the region has a nucleotide sequence provided as SEQ ID NO:11,
(d) a T-DNA molecule, wherein the T-DNA molecule is inserted into a region of a chromosome of the cell, wherein the region has a nucleotide sequence provided as SEQ ID NO:18, or
(e) any combination thereof.
Claim 2 is drawn to the safflower plant cell of claim 1 which comprises (a) and (c), or (b) and (d), and/or which is homozygous for the polynucleotide(s) and/or the T-DNA(s).
Claim 3 is drawn to a safflower plant cell comprising one or more of (a) a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:7, (b) a polynucleotide which comprises a sequence of nucleotides provided as nucleotides 296 to 8640 of SEQ ID NO:7, (c) a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:33, (d) a polynucleotide which comprises a sequence of nucleotides provided as SEQ ID NO:34, or (e) a polynucleotide having at least 95% identity with the full length of nucleotides 296 to 8640 of SEQ ID NO:7.
As disclosed, SEQ ID NO: 13 and 14 (claim 1, item a) is the nucleotide sequence of the Left border sequence inserted into GOR73226 (E26_LB); or a portion of the GOR73226 Right border junction sequence, respectively (for SEQ ID NO: 14, nucleotides 1-20 correspond to flanking safflower genomic DNA, nucleotides 21-40 correspond to inserted T-DNA sequence at the Right border) (Specification, p. 17, lines 29-33).
Similarly, SEQ ID NO:21 and 22 represents the Right and left border junction sequence of GOR73240;
SEQ ID NO: 11 represents where T-DNA of GOR73226 has inserted.
SEQ ID NO: 18 represents where T-DNA of GOR73240 has inserted.
As such, claim 1 is interpreted to encompass at least two embodiments: a specific transgenic event in which T-DNA of GOR73226 is inserted at the locus of SEQ ID NO: 11 and has the junction sequences of SEQ ID NO: 13-14; a specific transgenic event in which T-DNA of GOR73240 is inserted at the locus of SEQ ID NO: 18 and has the junction sequences of SEQ ID NO: 21-22, Those two events, as disclosed, are from transformation with the same T-DNA construct pCW732 into Safflower plants, and alternatively named “GOR73226 (732-26) and GOR73240 (732-40)”(p. 51, line 19).
Wood discloses transgenic safflower, transformed with the vector pCW732, and the resulted events pCW732-26, and pCW732-40 (p. 1789, and Fig. 1).
By virtue of disclosing the same transgenic events of the instantly claimed embodiments, Wood discloses the safflower seed, and plant, that comprises the SEQ ID NO: 13-14 (Event “732-26”) or SEQ ID NO: 21-22 (732-40).
Thus, Wood discloses the safflower plant cell of claims 1-3, and inherently the plant parts claimed in claims 13-14.
Claim 5 is drawn to the safflower plant cell according to claim 1, wherein one or more or all of the following apply: (a) oleic acid comprises at least 90% by weight of the total fatty acids in the cell, preferably between 90% and 95% by weight of the total fatty acids in the cell, (b) at least 95% by weight of the lipid in the cell is triacylglycerol (TAG), (c) palmitic acid comprises less than 2.7% by weight of the total fatty acids in the cell, preferably between 2.5% and 2.7% by weight of the total fatty acids in the cell, (d) linoleic acid comprises less than 1.7% by weight of the total fatty acids in the cell, preferably between 1.2% and 1.6% by weight of the total fatty acids in the cell, (e) a-linolenic acid is absent from the total fatty acids in the cell or is present at less than 0.2% by weight of the total fatty acids in the cell, (f) the cell comprises a hygromycin phosphotransferase polypeptide, (g) the cell has reduced CtFAD2-2 activity and reduced CtFATB-3 activity relative to a corresponding safflower cell lacking the polynucleotide(s) and/or the T-DNA(s), (h) the cell comprises an ol allele of the CtFAD2-1 gene or an oll allele of the CtFAD2-1 gene, or both alleles, preferably is homozygous for the ol allele.
Regarding claim 5, and claim 23, Wood discloses oleic acid (C18:1) contents of more than 90% of the total fatty acid in Event 732-26 (Fig. 1, and Fig. 4).
Regarding claims 6-9, Wood discloses the seed, seed cell, plant (see above and the full document).
Regarding Claim 10, Exhibition 2 of the IDS provides evidence that including Event 26, there is no significant change in at least crude protein content (Exhibit 2, p. 72). Thus, the plant and seed of Wood, i.e., Event 26, reads on the claim.
Regarding claim 15, Wood discloses that “Events 21, 26, 33 and 40 were then backcrossed into HO safflower and the resulting F2 seed” (p. 1790, left, top)
Regarding claim 19, Wood discloses PCR-based screening (p. 1794, left, para. 4).
Regarding claim 20-22, Wood discloses growing the plant and harvesting the seed (see above), and processing the seed for oil (p. 1794, rigt, para. 3, for example).
Therefore, the claimed invention is anticipated by the prior art.
Response to Applicant’s Remarks:
Applicant traverses this rejection. Applicant argued that “the mere naming of transgenic safflower and the resulting events pCW732-26, and pCW732-40 in Wood did not put the public in possession of the claimed invention because neither the transgenic safflower, nor the specific insertion region recited in the pending claims, were available to the public based on the publication of Wood.” (Remarks, p. 10, emphasis added by Examiner).
This argument has been fully considered but not deemed persuasive.
Firstly, it is acknowledged that Applicant does not dispute that transgenic safflower events pCW732-26, and pCW732-40 in Wood are the same safflower plant of the instant claims, as discussed in the rejection above. It is acknowledged that Applicant is disputing whether the disclosure by Wood constitute anticipatory prior art.
Secondly, as support and basis for Applicant’s traversal argument, Applicant cited MPEP § 2121.01. However, it should be noted that in the very section of MPEP, it states:
“Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.”
In re Antor Media Corp., 689 F.3d at 1289, 103 USPQ2d at 1559. (emphasis added)
While the examiner has made a proper prima facie case of anticipation, Applicant, however, has not met the burden of proffering evidence of nonenablement.
Wood published in Plant Biotechnology Journal (“PBJ”), which, as Author Guidelines, specifically instructed:
Availability of biological and chemical material
Publication of a paper in PBJ explicitly requires that authors will provide, for non-profit research, all the biological and chemical materials not commercially available, including all plant cultivars, cell lines, DNA, antibodies, and other similar materials, that are used for the experiments reported. Seeds of mutants described must be deposited at the appropriate stock centre and accession numbers provided. PBJ expects that all authors will conform to the National Science Advisory Board for Biosecurity (NSABB) guidelines for Dual Use Life Sciences Research.
To ensure complete transparency of this requirement, PBJ requires authors to state that these materials will be available on request. Requests must be reasonable with regard to the amount of material that can be provided and the sharing of costs, particularly when materials have required substantial effort for their production.
It is understood as a prerequisite for acceptance of publication, Wood has agreed to promise that the material will be “available on request”. Thus, this is at least a piece of evidence shown that not only the claimed safflower plants have been published, but also have been publicly available, or at least have been offered to public (by agreeing to the above requirement for publication. Applicant is put on further notice to meet their share of burden.
Lastly, it should be noted that the statue under 35 U.S.C. 102 requires the prior art to be “Patented, Described in a Printed Publication, or in Public Use, on Sale, or Otherwise Available to the Public”. Note that a description in a printed publication (of which Wood is) is besides the requirement of “otherwise Available to the Public”. Thus, Applicant’s insistence of that “public” having actual “possession” of the claimed safflower is unfounded legally.
At least for these reasons, the rejection is maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 7/24/2025. Applicant’s arguments filed on 1/26/2026 have been fully considered but they are not persuasive. See response to Applicant’s Remarks after this section of the rejection.
Claim 16 remain rejected under 35 U.S.C. 103 as being unpatentable over WOOD, (Plant Biotechnology Journal. 2018, Vol 16, No. 10 pages 178-1796, provided in the IDS filed on November 29, 2023) as applied to claims 1, 8, and 15 as discussed above, in view of Wood (US20130288318A1, 2013).
Claim 16 is drawn to the method of claim 15, further comprising:
(d) backcrossing one or more progeny plants from step (b) with plants of the same genotype as the second safflower plant for a sufficient number of times to produce a plant having at least 75% of the genotype of the second safflower plant.
As discussed above, Wood, inherently, taught the transgenic event “732-26” which is the instantly disclosed Event which inherently has the listed sequences in claim 1; and backcrossing of the event with another plant.
Wood did not explicitly teach the limitations of claim 16.
However, Wood-2013 taught high oleic acid safflower seed of plant transformed with RNAi-TDNA constructs silencing FATB and FAD2 genes (same as the instant invention); further backcrossing for introgressing a desirable trait ([0363]); or more specifically, a method of introducing an allele of a CtFAD2-1, CtFAD2-2 or CtFAD2-10 gene into a safflower plant lacking the allele, the method comprising crossing a first parent safflower plant with a second parent safflower plant, wherein the second plant comprises said allele of a CtFAD2-1, CtFAD2-2 or CtFAD2-10 gene, and backcrossing the progeny of the first cross with plants of the same genotype as the first parent plant for a sufficient number of times to produce a plant with a majority of the genotype of the first parent but comprising said allele (para. [0193]-[0195]).
Therefore, it would have been prima facie obvious for a person skilled in the art to use the conventional breeding technique and the basic principles of genetics to introgress the high oleic acid trait from the RNAi-event (such as the instant “Event 26” which is disclosed in Wood) with any other desired agronomic traits and arriving at the instantly claimed method. The number of crosses to reach sufficient trait introgressing is understood as basic principles for any ordinary skills in the field, and the level of expectation of success is high because method is conventional.
Therefore, the claimed invention is prima facie obvious over the combined teachings of the prior art.
Response to Applicant Remarks:
Applicant traverses the rejection above based on the same argument regarding Wood as prior art anticipating claim 15 as discussed above. The rejection is maintained for the reasons stated above following the 102 rejection.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over WOOD, (Plant Biotechnology Journal. 2018, Vol 16, No. 10 pages 178-1796, provided in the IDS filed on November 29, 2023) as applied to claims 1, 7, and 22 as discussed above, and in view of Napolitano (US PGPUB US 20170273330 A1, published 2017).
Claim 25 is drawn to a method of producing a feedstuff, comprising admixing the oil of claim 22, with at least one other food ingredient.
As discussed above, Wood, inherently, taught the oil of claim 22.
Wood did not explicitly teach the method of producing a feedstuff, comprising admixing the oil of claim 22, with at least one other food ingredient.
Napolitano taught a method of making a food product (e.g., a creamer which is a composition that is intended to be added to a food composition, [0023]), comprising mixing a high oleic oil, with at least another ingredient, e.g., a protein, ([0020]), wherein the high oleic oil is high oleic safflower oil ([0029]) which is high in oleic acid (>60% of total fatty acids) ([0026]).
Therefore, it would have been prima facie obvious for a person skilled in the art to use the high oleic safflower oil of Wood in the foodstuff making method of Napolitano and arriving at the instantly claimed method. The PHOSITA would have been motivated to do so given the teachings of the advantage and benefit of high oleic safflower oil by both Wood and Napolitano. The PHOSITA would have had reasonable expectation of success given the teachings and success of Napolitano.
Therefore, the claimed invention is prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (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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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663