DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
2. Claims 1-5 and 7-17 are pending.
3. Claims 15-17 remain withdrawn.
4. Claims 1-5 and 7-14 are examined.
5. The objection to the specificaiton is withdrawn in view of Applicant’s amendments to the disclosure.
6. The objections to the claims 1, 3, and 7-14 are withdrawn in view of Applicant’s amendments.
7. The rejection under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims. 8. The rejection under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s amendments to the claims and argument in the Remarks.
Election/Restrictions
9. Applicant’s election of Group I, claims 1-14, in the reply filed on September 22, 2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 22, 2025.
Claim Objection
10. In claim 2, the phrase “Brassica plants are harvested when 80% to 100% seed the further 80% to 100% seed color change has occurred” appear to contain a typographical error. The first instance of “80% to 100% seed” should be deleted. Appropriate correction is required.
Claim Interpretation
11. The following is noted with regard to claim interpretation.
Claim 1, as instantly amended, is read to encompass any plant expressing an enzyme or enzymes that result in the production of EPA, DHA or DPA. The term “first raceme” is read as being synonymous with the terms “main stem” or “primary raceme.” The terms “second,” “third,” and “fourth” racemes are understood to be synonymous with “secondary raceme” or “branches” (see Graham et al, below; page 1).
The newly added “wherein” clause, in claim 1, as well as the clauses that begin with “the method results”, in claims 7-14 are interpreted as recited the intended result of the active method steps. It is noted that the active steps of the method of claim 1 and dependent claims do not require selecting for a plant exhibiting a percentage of weight increase in EPA, DHA, and/or DPA. The method is, however, limited by the timing of the harvest as expressed by the percent seed color change on the first, second, third, and/or fourth racemes.
Claim Rejections - 35 USC § 103
12. 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.
13. 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.
14. Claims 1-6 and 7-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Andre (US Patent Publication 2019/0256862, published on August 22, 2019) in view of Graham et al (Re-evaluating seed colour change in canola to improve harvest management decisions; pages 1-4; Proceedings of the 18th Australian Society of Agronomy Conference, 24-28 September 2017, Ballarat, Australia. Available at http://agronomyaustraliaproceedings.org).
Andre teaches Brassica napus plants transgenically modified to produce long chain omega-3 fatty acids EPA, DHA and/or EPA, including wherein the plant comprise transgenic events LBFLFK and LBFDAU (paragraphs 15-16; 213; Example 1; Table 3). Andre teaches growing said plants in the field and evaluating their seed oil content (paragraphs 223-229). Andre teaches that the seeds of the plants produced oil having at least 12% (w/w of the total seed oil) of EPA; at least 1% (w/w) of DHA; and between 0.1% and 10% (w/w) of DPA (paragraphs 161-162; 204). Andre teaches a method of producing Brassica napus seeds having increased very long-chain polyunsaturated fatty acids, comprising EPA and/or DHA, by growing said genetically modified plants to obtain their seeds, wherein the content of said acids is increased by at least 30% by weight compared to the seeds from a wild-type Brassica napus plant; and teaches seeds produced by said method (claims 1, 5-7, 10-12, for example).
Andre does not expressly teach a step of harvesting Brassica seeds when 80-100% of the seeds on the first or other racemes change color.
Graham et al teach that windrowing, i.e. harvesting, canola when 40-60% of the seeds on the primary raceme change color resulted in significant yield and oil content penalty when compared to harvesting at later windows, including when 80-100% of the seeds on the primary stem changed color (Abstract; page 1; top paragraph on page 2; page 3 under “Seed Yield” and “Oil Concentration;” and Fig. 1;). Graham et al that the seeds on “branches” (i.e., “second, third, and/or fourth racemes” recited in the instant claims) matured later than the seeds on the main stem, but contributed substantially to the seed yield and oil concentration (see Conclusion on page 4; Fig. 1-4).
At the time of filing, it would have been prima facie obvious to one of ordinary skill in the art to use the Brassica napus plants genetically modified to produce EPA, DHA and/or DPA, as taught by Andre, including those of the transgenic event LBFLFK, in a method comprising growing said plants in a field, and harvesting the seeds when at least 80% and up to 100% of the seeds on the main raceme change color from green to red, brown or black, as taught by Graham et al. The resultant method would read on the active steps of the method of claim 1. It would have been obvious to also harvest the seed of said canola wherein the color change occurred on the “branches,” which include the “second, third, and/or fourth raceme” (instant claims 2 and 3).
Given that delaying harvest increases seed yield and oil content, as taught by Graham et al, and given the teachings of Andre regarding the increased omega-3 content in the plants of the two Brassica napus transgenic events, one would have expected an increase in the DHA, EPA, or DPA content in the plants harvested at the later stages. The specific percentage of the color change at which the canola is harvested, as well as any resultant change in long chain omega-3 content, would have been a matter of routine optimization of conditions given that Graham et al teach a range of seed color change percentages at which the harvest occurs, and teach said range for both, the main raceme and the branches (see Fig. 1). MPEP 2144.05(II).
Graham et al teach that from the earliest harvest window timing to the latest (100% color change), as estimated for the primary stem only, the total seed oil percentage varied from approximately 39 to over 44, which represents at least a 14% increase (see Fig. 4 of Graham et al). In view of this, one would have also reasonably expected a corresponding increase of at least 14% in the DHA, EPA, or DPA content in the late harvested seeds.
Moreover, Graham et al teach harvesting at 100% color change on the main stem and the “branches” (page 2, first paragraph). When the seeds are harvested at that latest possible maturity point (doing so would have been obvious and is encompassed by the instant claim 1), any percent increase in the EPA, DHA, or DPA (however that percentage is estimated) would have necessarily flowed. It is noted that the Brassica napus plants of Andre comprise the same transgenic event as the plants described in the instant specification (see Example 1).
One would have been motivated to combine the above teachings and delay the harvest until at least 80% and up to 100% of the seeds on either the main stem and/or the “branches” of said Brassica napus plant change color given the express suggestion of Graham et al and the advantages of doing so taught by Graham as well.
Response to Arguments
Applicant argues as follows: “The claimed method is directed to a specific component of the seed oil (i.e., EPA, DPA, or DHA), while Graham is directed to "seed size, oil concentration and seed yield". Graham at p. 1, Abstract. Graham does not provide any teaching or suggestion to use seed color change to optimize a specific component of seed oil, let alone for optimizing EPA, DHA, or DPA in a transgenic Brassica plant. In addition, there is no motivation from Graham to harvest "when 80% to 100% seed color change has occurred as recited in claim 1. As stated above, Graham teaches yield is "optimised at the higher end of current industry guidelines (i.e. ~60% SCC)." Graham at p. 4, Conclusion. Moreover, there is no motivation from Graham to base seed color change on the "first raceme of the plants" as recited in claim 1. Graham teaches that harvest should be based on seed color change of the entire plant (and not just the primary stem) ("This study indicates that SCC should be measured on a whole plant basis not based solely on the primary stem, as branches contribute a large proportion of seed yield." Graham at p. 1, Abstract).” (page 9 of the Remarks).
Applicant’s argument is not found to be persuasive. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Applicant’s argument is directed to the teachings of Graham et al. In the above rejection, Graham is the secondary reference and there is no dispute that it does not teach all of the limitations of the claimed invention. However, the claimed invention would have been obvious in view of the combined teachings of Andre and those of Graham et al.
Moreover, contrary to Applicant’s position, Graham et al does provide motivation to harvest seeds at 80% to 100% color change and, specifically, when the color change occurs on the “first raceme” - Graham et al teach that harvesting, canola when 40-60% of the seeds on the primary raceme (synonymous with “first raceme”) change color resulted in significant yield and oil content penalty when compared to harvesting at later windows, including when 80-100% of the seeds on the primary stem changed color (Abstract; page 1; top paragraph on page 2; page 3 under “Seed Yield” and “Oil Concentration;” and Fig. 1;). Applicant’s argument fails to address this express teaching of Graham et al or reconcile it with Applicant’s position. The rejection is maintained.
Conclusion
15. No claims are allowed.
16. THIS ACTION IS MADE FINAL. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662
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