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 1-17 are pending.
3. Claims 15-17 are withdrawn.
4. Claims 1-14 are examined.
Election/Restrictions
5. 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Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Objections
6. Claims 1-3 and 6-14 are objected to because of the following informalities.
In claims 1 and 6, the term “omega-3 fatty acid” should be amended to recite “omega-3 fatty acids.” In claim 1, the phrase “at least one of EPA, DHA, and DPA” should be amended to recite “at least one of EPA, DHA, or DPA” to clearly indicate that individual members as well as their combination are encompassed and recited in the alternative.
In claims 1-3 and 6, the term “color change” should be amended to recite “seed color change,” in order to reflect the art-accepted reference to the change of seed color as an indicator of canola’s maturity (see the obviousness rejection below) and in view of the reading of the specification (see Example 4, page 26). In claims 7-14, the term “maturity” should be changed to “seed color change,” for consistency throughout the claims.
In claims 2 and 3, the limitation “color change has further occurred on 80% to 100% of” appears to refer to the “racemes,” and should be amended to clearly indicate that the color change refers the color change of the seeds.
In claim 6, the term “identically” should be amended to recite “identical,” to reflect proper grammar. Appropriate correction is required.
Specification
7. On page 2, paragraph 7, the term “substantially identical” is misspelled as “substantially identically. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 1-14 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.
In claim 1, the term “increase” renders the claim indefinite. The term is a relative term of degree that requires a clear point of comparison. Neither the claims nor the specificaiton provide such a reference point. It is thus unclear relative to what control the proportion of the omega-3 fatty acids is meant to “increase.” See MPEP 2173.05(b).
While the term “increase” is recited in the preamble of claim 1, in the instant case, the preamble has been determined to limit the claim because it requires that the plant used in the claimed method be “modified to produce seed oil with at least one of EPA, DHA, and DPA.” See MPEP 2111.02.
The term “modified” introduces further ambiguity in the language of claim 1. It is unclear how the recited plants have been modified or relative to what control. If Applicant intended to require that the plants express transgenes that result in the production of EPA, DHA or DPA, this should be clearly reflected in the claim language.
In claim 6, the recitation “wherein the proportion of omega-3 fatty acid [sic] in the seed oil is increased in comparison to control Brassica oilseed plants grown under substantially identically [sic] conditions except the control plants were harvested before a color change” renders the claim indefinite. First, it is unclear what conditions are encompassed by the term “substantially identical.” The specification does not define the term and one of ordinary skill would not be readily apprised of its metes and bounds. Second, it is unclear whether the control plants are meant to be “modified” in the same way as the plants of claim 1. Third, it is unclear what point of reference the term “proportion” refers to, and which of the three omega-3 amino acids recited in claim are meant to be encompassed.
In claims 7-14, the term “percent increase” followed by the recitation of the numerical values for the percentages, renders the claims indefinite. First, it is unclear on what basis the “percent increase” is estimated, such as, for example, whether it is based on the total seed oil or the total omega-3 fatty acid content. Second, it is unclear what are the measurement units used to estimate the percentages, such as, for example, whether the values are meant to refer to weigh/volume or weight/weight.
Given that claims 2-5 depend from claim 1 and fail to recite any additional limitations overcoming its indefiniteness, they are indefinite as well.
Claim Interpretation
10. The claims have been found indefinite for the reasons set forth above. The following is noted with regard to claim interpretation.
Claim 1 is read to encompass any plant expressing an enzyme or enzymes that result in the production of EPA, DHA or DPA. The term “color change” is understood to mean “seed color change,” and 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 term “increase” or “increased,” in claims 1 and 6-10, is interpreted as referring to a control plant whose seed is harvested prior to 80% seed color change on the first raceme. In claims 11-14, the term “increase” is interpreted to refer to a change to the seed maturation on the secondary racemes, in addition to an “increase” due to the later harvest, as required by claim 1 from which these claims depend.
In claims 7-14, the term “maturity” is understood to mean “seed color change.”
Claim Rejections - 35 USC § 112(a)
11. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
12. Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant claims a method of increasing a proportion of long chain omega-3 fatty acids in a Brassica plant that has been modified to produce seed oil with at least one of EPA, DHA, and DPA, comprising growing said plant and harvesting it when 80% to 100% of the seeds on the main raceme, or on the second, third or fourth racemes, change color. Applicant claims said method wherein the percentages of the increase in EPA, DHA, or DPA are as recited in the dependent claims 6-14.
Applicant describes growing Brassica napus plants of the transgenic event LBFLFK, and harvested via swathing when the percentage of seeds on the main raceme that changed color was 60%, 80% or 100%. Applicant states that the plants harvested at 80% and 100% color change “showed an increase in EPA, DPA and DHA over swath60 samples. This increase was surprisingly large in EPA, up to a 1.2% increase in amount of EPA” (Example 2, page 24).
Applicant describes an experiment where the seeds were harvested at 100% color change on the main raceme or on the third raceme, and states as follows: “Surprisingly, the largest increase is seen in EPA at an average of 0.4%, with DPA following at 0.06% and DHA at 0.03%. This percent increase for swathing at 100% maturity on the third branch compared to 100% maturity on the main raceme is 4.8% for EPA+DPA+DHA, 5.1% for EPA, and 2.8% for DPA and 5.3% for DHA” (Example 3, page 25). Applicant describes an additional experiment where the seeds were harvested “at 95% physiological maturity of the whole plant” and the increases were as follows: “In dryland locations the EPA+DPA+DHA increased 1.03% overall — when moving from Harvest 1 to Harvest 2 timing. The largest component of this increase was from an increase in EPA of 0.874%. By further delaying harvest in the dryland environment the overall EPA+DPA+DHA increased another 0.350%, with the largest component of that also coming from the EPA contributing 0.260% of that increase. In irrigated locations Harvest time 2 showed the EPA+DPA+DHA increased 1.720% compared to that achieved from harvest time 1 with the largest component of this also coming from the increase in EPA of 1.378%. By further delaying the harvest to harvest 3 time the overall EPA+DPA+DHA declined 0.246% (not significant) however this was still 1.473% greater than the EPA+DPA+DHA level achieved in harvest 1 time” (Experiment 4; paragraphs 82 and 83).
Applicant does not describe the invention as broadly claimed, for the following reasons. First, Applicant does not describe the claimed method wherein the percent increase in the individual omega-3 fatty acids or their combination encompass the higher values of the claimed ranges. For example, Applicant has not described the method, as claimed in claim 6, wherein the “percent increase in combined EPA, DPA, and DHA” is between 14% and 19.7%. Similarly, the described method and the resultant values of EPA, DPA or DHA increase relative to the seeds harvested at earlier stages are not sufficiently representative of the ranges recited in the dependent claims 7-14. For example, Applicant has not described a method wherein the seeds are harvested at 80% maturity on the first raceme and the increase in the DHA is 13.3% as recited in claim 10.
On page 3, in paragraphs 8 and 9, the specificaiton does provide literal support for the percentages recited in claims 7-14. However, the specification does not appear to have reduced to practice any methods reflecting those values, and it is unclear how od whether said values were derived from the teachings of the rest of the specification, including Examples 1-4.
Next, while the claims encompass any Brassica oilseed plants that have been modified in any way “to produce seed oil with at least one EPA, DHA, and DPA,” Applicant has only described a method that uses the Brassica napus plants of the transgenic event LBFLFK and two of their apparent hybrids (see Examples 1-4). As evident form the instant specification and confirmed by the state of the art, this is not sufficiently representative of the claimed genus.
With regard to the instant specification, none of the methods that Applicant described and reduced to practice in Examples 1-4 resulted in the percent increase in the individual or combined EPA, DHA, and DPA that would encompass or approach the upper limit of the values recited in the ranges included in claims 7-14. In view of this deficiencies in the specificaiton, one would also not be able to conclude that the specificaiton has set forth sufficient structure-function relationship for the genus of plants that can be used in the claimed methods: the transgenes of event LBFLFK do not appear to be sufficient to produce said values.
The prior art reference Petrie et al (Frontiers in Plant Science (2020) Vol. 11, Article 727, pages 1-15) teaches that the Brassica napus event NS-B50027-4, which was comprises transgenes resulting in high levels of DHA, showed substantial variability in the DHA percentage: from 13.8% to 8.9% in individual generations under varying growth conditions (see Table 3). Petrie et al also teaches that earlier studies indicated that “co-production of EPA and DHA in seed tended to result in reduced accumulation of at least one of those fatty acids” (page 10, right col.). The latter teaching is particularly relevant given that the instant claims encompass a plant that has been modified to produce, specifically, all three of EPA, DHA, and DPA.
In view of these teachings of the prior art, the limited teachings of the specificaiton, and the variability and the breadth of the genus of methods encompassed by the claims, one of ordinary skill in the art would not be able to conclude that the subject matter described in the disclosure is sufficient to describe the claimed invention. It is thus unclear whether at the time of filing, Applicant was in possession of the instant invention as broadly claimed.
Claim Rejections - 35 USC § 103
13. 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.
14. 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.
15. Claims 1-14 are 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).
As set forth in the indefiniteness rejection above, the control for the “increase” recited in the dependent claims 6-14 is unclear. However, in view of the wording of claim 6, it appears that the control would encompass seeds harvested at an stage “before” the color change of “80% to 100%” on the main raceme and the branches. 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.
Conclusion
16. No claims are allowed.
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