DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-2, 8, 15, 29-30, 32, 42, 47, 50, 52, 55, 57-62 and 68 are pending.
Claims 57-62 remain withdrawn as drawn to an unelected invention.
Claim 68 is newly added.
Claim 21 is newly cancelled.
Claims 1-2, 8, 15, 29-30, 32, 42, 47 and 55 are newly amended.
Claims 1-2, 8, 15, 29-30, 32, 42, 47, 50, 52, 55 and 68 are rejected.
Response to Applicant Arguments – Specification
In response to applicant’s arguments and amendments to the specification dated 04/13/2026, the specification objections of record are withdrawn.
Response to Applicant Arguments – Claim Objections
In response to applicant’s arguments and amendments to the claims the claim objections of record are withdrawn. Applicant’s amendments to the claims require a new claim objection.
Claim Objections
Claim 47 is objected to because of the following informalities: “increased omega-3 long chain polyunsaturated fatty acids (LC-PUFAs) content” has contradictory grammatical number, with “long chain polyunsaturated fatty acids” being plural while “content” is singular. Appropriate correction is required.
Response to Applicant Arguments – Indefiniteness Rejections
In response to applicant’s arguments and amendments to the claims the indefiniteness rejections of record are withdrawn.
Response to Applicant Arguments – Obviousness
In response to Applicant’s arguments and amendments to the claims the obviousness rejections of record are withdrawn. However, Applicant’s amendments require new obviousness rejections to address newly introduced limitations.
Applicant’s arguments which remain relevant to the newly presented rejections are summarized and addressed below.
Applicant urges that the combined teachings of the references in the rejections of record do not teach or suggest the use of a ∆15-desaturase, the new obviousness rejections of record address this issue.
Applicant also urges the following:
The effects on EPA production as a result of selecting new enzyme and/or modifying the combinations of enzymes cannot be predicted by one of skill in the art because the newly claimed present invention which uses an additional introduced gene produced a higher level of EPA than produced using the methods of Usher.
The newly claimed invention has superior and unexpected properties compared to the prior art. Specifically, the present invention significantly increases the level of EPA in recombinant plants or parts thereof.
These two arguments are not found to be persuasive. Essentially these arguments appear to compare the EPA values of Usher to those of the presently claimed invention and then urge that because the values differ that the results are unexpected. This amounts to piecemeal analysis where the invention of Usher in view of Ozseyhan is not considered. The combined teachings of these references make clear that it would have been obvious to try different combinations of fatty acid biosynthetic enzymes and that the introduction of exogenous fatty acid metabolic enzymes into plants having a fae1 mutant background would lead to further elevated levels of EPA. As such, rather than being unexpected or unobvious these results are obvious because the result of combining these features of the prior art have a predictable outcome with a reasonable chance of success and the enhanced accumulation of EPA is the obvious motivation to combine these teachings as presented in the prior art.
Therefore, Applicant’s arguments are not found to be persuasive.
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.
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.
Claims 1, 8, 15, 29-30, 32, 42, 47, 50, 52, 55 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Usher, in view of Ozseyhan and Ruiz-López, Transgenic research 21.6 (2012): 1233-1243.
With respect to claim 1, Usher teaches recombinant Camelina sativa plants comprising expression constructs made up of exogenous promoters and terminators operably linked to Physcomitrella patens ∆6-elongase, Thraustochytrium sp. ∆5-desaturase, Ostreococcus tauri ∆6-desaturase and Phytophthora infestans ω3-desaturase and therefore, Usher teaches recombinant plants which contain tissues from another tissue or species (Usher, Page 1, Abstract; Usher, Page 3, Figure 1B, DHA5_33_13 Vector Map; Usher, Page 2, Third Paragraph). Further, Usher teaches that these enzymes are responsible for catalyzing the ETA-EPA, RPA-DPA, DPA-DHA and DPAn-6-DHA reactions, respectively, which convert the stearidonic acid produced from α-linolenic acid into EPA and DHA (Usher, Page 3, Figure 1a). Usher provides motivation to produce EPA and DHA in plants stating that these fatty acids are important in human nutrition and aquaculture and further that these have a proven role in reducing human risk of cardiovascular disease (Usher, Page 1, Abstract; Usher, Page 1, Last Paragraph, First Sentence). Usher continues noting that farmed fish appear to contain significantly less EPA and DHA than they did ten years ago and suggests that using plants to produce these compounds would represent a potentially more sustainable and less environmentally-intrusive production route for these compounds (Usher, Page 1, Last Paragraph). Finally, Usher teaches the concept of “tailor[ing] seed oil profile to reduce” less desirable fatty acids and enhance the presence of desirable fatty acids. Usher teaches that this can be accomplished by using different combinations of fatty acid biosynthetic enzymes (Usher, Page 1, Abstract; Usher, Page 2, Third Paragraph).
With respect to claim 8, Usher teaches all of the limitations of claim 1 taught above, see above.
With respect to claim 15, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches that the expression constructs include a ∆5-elongase (Usher, Page 3, Figure 1B Legend).
With respect to claim 29, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches that the Physcomitrella patens ∆6-elongase gene is operably linked to the unknown seed protein seed-specific promoter, the Thraustochytrium sp. ∆5-desaturase gene is operably linked to the Conlinin 1 promoter and the Ostreococcus tauri ∆6-desaturase is operably linked to the sucrose binding protein 1800 promoter (Usher, Page 3, Figure 1B Legend).
With respect to claim 30, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches that in the field trial that the transgenic Camelina plants, once established were treated with a grass specific herbicide (Usher, Page 2, Last Paragraph). This herbicide did not kill the Camelina plants, therefore compared to grass species which possess a susceptible allele conferring herbicide susceptibility to this herbicide, the Camelina plants comprise a nucleic acid which confers resistance to this herbicide. Even though this is an endogenous allele which is not explicitly described as being a resistance allele to grass specific herbicide, the language of the claim is clear: “resistance to at least one herbicide” as the resistance of the Camelina plants to the grass specific herbicide as such it is clear that the Camelina plants of Usher possess as an inherent characteristic a nucleic acid sequence which encodes resistance to this herbicide, even if the nucleic acid sequence in Camelina is the nucleic acid which makes up a chromosome which lacks the gene targeted in grass species.
With respect to claim 32, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches the recombinant plants comprise increased EPA percentages and reduced GA (20:1 (n-9)) content (Usher, Page 4, Figure 2C and Figure 2D; Usher, Page 3, Figure 1B; Usher, Page 5, First Paragraph, Line 3).
With respect to claim 42, Usher teaches all of the limitations of claim 1, see above.
With respect to claim 47, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches growing the recombinant plants and obtaining fatty acids from the seeds of transgenic plants which comprised the expression construct as confirmed by detecting the DsRed selectable marker(Usher, Page 10, Paragraphs 2-3; Usher, Page 10, Paragraph 5). Further, Usher teaches that when plants were transformed omega-3 fatty acid concentration was increased, see Usher, page 7, Last Paragraph for an example.
With respect to claims 50 and 52, Usher teaches all of the limitations of claim 47 taught above, see above. Further, Usher teaches that in the transformed Camelina plants that TAG levels were increased compared to wild type plants, these increased TAG species include C56:8-56:11 and 58:8-58:12 (Usher, Page 7, Figure 5a)
With respect to claim 55, Usher teaches all of the limitations of claim 1, see above. Further, Usher teaches growing the recombinant plants and obtaining fatty acids from the seeds of transgenic plants which comprised the expression construct as confirmed by detecting the DsRed selectable marker which demonstrates expression of the transformed sequences (Usher, Page 10, Paragraphs 2-3; Usher, Page 10, Paragraph 5).
With respect to claim 68, Usher teaches all of the limitations of claim 15, see above. Further, Usher teaches the recombinant plants comprise increased EPA percentages and reduced GA (20:1 (n-9)) content (Usher, Page 4, Figure 2C and Figure 2D; Usher, Page 3, Figure 1B; Usher, Page 5, First Paragraph, Line 3).
With respect to claims 1, 8, 15, 29-30, 32, 42, 47, 50, 52, 55 and 68 Usher does not explicitly teach recombinant plants having reduced expression or activity of a gene encoding an enzyme involved in the synthesis of very long chain fatty acids (VLCFAs), recombinant plants comprising a ∆15-desaturase or recombinant plants having a GA content of below 10% based on the total fatty acid content of the seed.
With respect to claims 1, 8, 15, 29-30, 32, 42, 47, 50, 52, 55 and 68 Ozseyhan teaches that Camelina sativa is a re-emerging low input oilseed crop that has great potential but that this crop should be modified to produce optimized fatty acid composition and that this plant produces significant amounts of very long chain fatty acids that may not be desirable (Ozseyhan, Page 1, Abstract). As a solution to this problem Ozseyhan teaches homozygous knockout mutants of the FAE1 genes in Camelina using CRISPR technology. In these plants VLCFAs were reduced to less than 2% of total fatty acids compared to over 22% in wild type seeds. Correspondingly Ozseyhan found that in these mutant plants that 18 carbon fatty acids were concomitantly increased, including α-linolenic acid (18:3) (Ozseyhan, Page 1, Abstract; Ozseyhan, Page 6, Column 1, First Paragraph). Finally, Ozseyhan teaches that FAE1 elongates oleic, acid a precursor to α-linolenic acid (18:3), into 20:1 or 22:1 (Ozseyhan, Page 2, Column 1, First Complete Paragraph).
With respect to claims 1, 8, 15, 29-30, 32, 42, 47, 50, 52-55 and 68 Ruiz-López teaches introducing different combinations of genes encoding enzymes involved in fatty acid biosynthesis into plants in order to modulate the fatty acid profiles of those plants (Ruiz-López, Page 1234, Paragraph Spanning Columns 1-2). In one instance, Ruiz-López teaches the use of ∆15-desaturases to enhance levels of omega-3 substrates for conversion to long chain polyunsaturated fatty acids (Ruiz-López, Page 1234, Column 2, Third Sentence). Finally, Ruiz-López teaches enhancing accumulation of omega-3 long chain polyunsaturated fatty acids including DHA and EPA (Ruiz-López, Page 1233, Title; Ruiz-López, Page 1234, Column 1, First Paragraph).
At the time of filing it would have been obvious to modify the plants and methods of Usher by providing different combinations of exogenous genes and mutations in order to produce plants and plant parts having an optimal fatty acid profile which include seeds having optimal seed oils. These modifications include introducing an exogenous ∆15-desaturase as taught by Ruiz-López and generating a mutant FAE1 gene in these plants as taught by Ozseyhan and the specific fatty acid profile would include reduced GA content as taught by Usher. This would have been obvious because the method of Usher is drawn to Camelina sativa plants having elevated levels of EPA and DHA, two fatty acids which are produced from the 18 carbon α-linolenic acid precursor, Ruiz-López is drawn to Arabidopsis thaliana plants having enhanced accumulation of omega-3 long chain polyunsaturated acids including EPA and DHA, while Ozseyhan is also drawn to Camelina sativa plants having improved oil characteristics. Specifically, Ozseyhan teaches that fae1 mutant plants have decreased levels of VLCFAs which are undesirable and increased levels of 18 carbon fatty acids including α-linolenic acid. As such it would have been obvious to introduce the ∆15-desaturase of Ruiz-López and to generate fae1 mutants in the transgenic plants of Usher in order to decrease undesirable VLCFAs to below 10% and to increase the pool of α-linolenic acid in these plants.
This would have been motivating to the ordinary artisan because as taught by Ozseyhan VLCFAs are undesirable and as taught by Usher α-linolenic acid is the precursor to EPA and DHA biosynthesis. Therefore, introducing an exogenous ∆15-desaturase and generating fae1 mutants in the transgenic plants of Usher would reduce the content of undesirable fatty acids and allow for the production of higher levels of EPA and DHA by increasing the concentration of the precursor that the enzymes that where transformed into these plants use to produce EPA and DHA. Additionally, Usher makes clear that producing EPA and DHA in plants represents a potentially more sustainable and less environmentally-intrusive production route for these compounds which have significant heart health benefits for humans.
Claims 1, 8, 15, 29-30, 32, 42, 47, 50, 52, 55 and 68 are rejected as obvious under Usher in view of Ruiz-López and Ozseyhan.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Usher as evidenced by Gomez-Cano, CamRegBase: a gene regulation database for the biofuel crop, Camelina sativa, 2020 Dec 11 in view of Ruiz-López and Ozseyhan.
With respect to claim 2, Usher, Ruiz-López and Ozseyhan collectively teach all of the limitations of claim 1, see above.
With respect to claim 2, Usher, Ruiz-López and Ozseyhan do not explicitly teach the Camelina sativa cell further comprising a nucleic acid sequence encoding a phytoene synthase gene.
With respect to claim 2, Gomez-Cano provides evidence that Camelina sativa possesses a gene Csa13g019990.1 which is the Camelina ortholog of Arabidopsis thaliana phytoene synthase. Therefore, Gomez-Cano provides evidence that possessing a nucleic acid encoding a phytoene synthase gene is an intrinsic characteristic of Camelina sativa cells.
In light of this evidence it is clear that Usher as evidenced by Gomez-Cano in view of Ruiz-López and Ozseyhan collectively teach all of the limitations of claim 2.
Conclusion
No examined 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad 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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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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