DETAILED ACTION
Application Status
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
2. The Amendment filed on October 10, 2025, has been received and entered.
Claim Disposition
3. Claims 1-18 have been cancelled. Claims 19-25 are pending and are under examination.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
4. Claim(s) 19-25 is/are rejected under pre-AlA 35 U.S.C. 102(b) as being anticipated by WO2005/083093 (9/9/05, of record in the application, here after ‘83093), based on the filing receipt of record in the application with effective filing date of 2/21/06.
The present invention relates to oils, lipids and/or fatty acids produced by a transgenic Brassica plant species juncea and napus and comprise certain weight percent of C22 fatty acids in seed (see instant claim 1, for example). The ‘83093 document teach the plant such as Brassica juncea and Brassica napus. In addition, a method for producing polyunsaturated fatty acids in seeds of these transgenic plants are also taught. Accordingly, nucleic acids, coding for polypeptides with a ω-3-desaturase, Δ-12-desaturase, Δ-6-desaturase, Δ-6-elongase, Δ-5-desaturase, Δ-5-elongase and/or Δ-4-desaturase activity, preferably for polypeptides with a Δ-6-desaturase, Δ-6-elongase and Δ-5-desaturase activity, are introduced into the organism. The nucleic acid sequences can be expressed in the organism optionally together with other nucleic acid sequences that code for polypeptides of the biosynthesis of the fatty acid or lipid metabolism. Nucleic acid sequences coding for a Δ-6-desaturase, Δ-5-desaturase, Δ-4-desaturase, Δ-1 2-desaturase and/or Δ-6-elongase activity are especially advantageous. The desaturases and elongases originate from thalassiosira, euglena or ostreococcus. Further, disclosed is a method for producing oils and/or triacylglycerides with an increased content of long-chain polyunsaturated fatty acids (a method for producing arachidonic acid, eicosapentaenic acid or docosahexaenic acid, and to a method for producing triglycerides with an increased content of unsaturated fatty acids, especially arachidonic acid, eicosapentaenoic acid and/or docosahexaenoic acid, in transgenic plants, preferably in seeds of the transgenic plants). The seed of transgenic plants with a content of at least 20% by weight based on total lipid content. The secondary reference discloses C2 to C24 (see abstract and pages 1-5 and claims). In addition, it is disclosed that to increase yield in the preparation of oils/triglycerides (of EPA, ERA or DHA and mixtures) that starting materials was increased by introducing a nucleic acid encoding a polypeptide having the activity of a delta-12-desaturase and co-expressing it in the organism (i.e. Brassicaceae family such as the genus Brassica, for example rapeseed, turnip rape or sareptase). In addition, the reference teach the plant such as Brassica juncea and Brassica napus. Additionally, the reference discloses at least 20% by weight based on total lipid content (see abstract, pages 1-5, claims and the entire document). Therefore, the limitations of the claims are met by the reference.
5. Claim(s) 19-25 remains is/are rejected under pre-AlA 35 U.S.C. 102(a) as being anticipated by WO2005/083093 (9/9/05, of record in the application, here after ‘83093), based on the ADS of record in the application with a priority date of 2/21/06.
The present invention relates to oils, lipids and/or fatty acids produced by a transgenic Brassica plant species juncea and napus and comprise certain weight percent of C22 fatty acids in seed (see instant claim 1, for example). The ‘83093 document teach the plant such as Brassica juncea and Brassica napus. In addition, a method for producing polyunsaturated fatty acids in seeds of these transgenic plants are also taught. Accordingly, nucleic acids, coding for polypeptides with a ω-3-desaturase, Δ-12-desaturase, Δ-6-desaturase, Δ-6-elongase, Δ-5-desaturase, Δ-5-elongase and/or Δ-4-desaturase activity, preferably for polypeptides with a Δ-6-desaturase, Δ-6-elongase and Δ-5-desaturase activity, are introduced into the organism. The nucleic acid sequences can be expressed in the organism optionally together with other nucleic acid sequences that code for polypeptides of the biosynthesis of the fatty acid or lipid metabolism. Nucleic acid sequences coding for a Δ-6-desaturase, Δ-5-desaturase, Δ-4-desaturase, Δ-1 2-desaturase and/or Δ-6-elongase activity are especially advantageous. The desaturases and elongases originate from thalassiosira, euglena or ostreococcus. Further, disclosed is a method for producing oils and/or triacylglycerides with an increased content of long-chain polyunsaturated fatty acids (a method for producing arachidonic acid, eicosapentaenic acid or docosahexaenic acid, and to a method for producing triglycerides with an increased content of unsaturated fatty acids, especially arachidonic acid, eicosapentaenoic acid and/or docosahexaenoic acid, in transgenic plants, preferably in seeds of the transgenic plants). The seed of transgenic plants with a content of at least
20% by weight based on total lipid content. The secondary reference discloses C2 to C24 (see abstract and pages 1-5 and claims). In addition, it is disclosed that to increase yield in the preparation of oils/triglycerides (of EPA, ERA or DHA and mixtures) that starting materials was increased by introducing a nucleic acid encoding a polypeptide having the activity of a delta-12-desaturase and co-expressing it in the organism (i.e. Brassicaceae family such as the genus Brassica, for example rapeseed, turnip rape or sareptase). In addition, the reference teach the plant such as Brassica juncea and Brassica napus. Additionally, the reference discloses at least 20% by weight based on total lipid content (see abstract, pages 1-5, claims and the entire document). Therefore, the limitations of the claims are met by the reference.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
6. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
7. Claims 19-25 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO99/64614 (12/16/99, of record in the application, here after ‘64614) in view of WO2005/083093 (9/9/05, of record in the application, here after ‘83093).
The ‘64614 document teach transgenes and the production of plant oils such as from seeds (polyunsaturated long chain fatty acids such as docosahexaenoic acid, eicosapentaenoic acid, alpha-linolenic acid, arachidonic acid and modifications). The reference teaches seed oil producing LCPUFAs in percentages as claimed (see pages 1-19). In Example 1 of the document Brassica napus is used to produce increased expression of gamma-3-desaturase (see page 21). Binary vector pCGN8623 is employed and introduced into B. napus, (see page 22, Table 5 on pages 45-46 and claims). The primary document does not disclose B. juncea.
The ‘83093 document teach the plant such as Brassica juncea and Brassica napus. In addition, a method for producing polyunsaturated fatty acids in seeds of these transgenic plants are also taught. Accordingly, nucleic acids, coding for polypeptides with a ω-3-desaturase, Δ-12-desaturase, Δ-6-desaturase, Δ-6-elongase, Δ-5-desaturase, Δ-5-elongase and/or Δ-4-desaturase activity, preferably for polypeptides with a Δ-6-desaturase, Δ-6-elongase and Δ-5-desaturase activity, are introduced into the organism. The nucleic acid sequences can be expressed in the organism optionally together with other nucleic acid sequences that code for polypeptides of the biosynthesis of the fatty acid or lipid metabolism. Nucleic acid sequences coding for a Δ-6-desaturase, Δ-5-desaturase, Δ-4-desaturase, Δ-1 2-desaturase and/or Δ-6-elongase activity are especially advantageous. The desaturases and elongases originate from thalassiosira, euglena or ostreococcus. Further, disclosed is a method for producing oils and/or triacylglycerides with an increased content of long-chain polyunsaturated fatty acids (a method for producing arachidonic acid, eicosapentaenic acid or docosahexaenic acid, and to a method for producing triglycerides with an increased content of unsaturated fatty acids, especially arachidonic acid, eicosapentaenoic acid and/or docosahexaenoic acid, in transgenic plants, preferably in seeds of the transgenic plants). The seed of transgenic plants with a content of at least 20% by weight based on total lipid content. The secondary reference discloses C2 to C24 (see abstract and pages 1-5 and claims). In addition, it is disclosed that to increase yield in the preparation of oils/triglycerides (of EPA, ERA or DHA and mixtures) that starting materials was increased by introducing a nucleic acids coding for polypeptides having the activity of a delta-12-desaturase and co-expressing it in the organism (i.e. Brassicaceae family such as the genus Brassica, for example rapeseed, turnip rape or sareptase). In addition, the primary reference teach the plant such as Brassica juncea and Brassica napus (see abstract, pages 1-5, claims and the entire document).
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention as a whole because the combined teaching of the references renders the claimed invention as obvious. The invention as claimed is directed to obtaining seed oil from transgenic Brassica species napus and juncea plant seed comprising polyunsaturated C22 fatty acids in amounts of 5-10% (see claims 19-25). The prior art of record is similarly directed to altering the production of LCPUFAs in a host plant (see the Examples provided in both documents).
One of ordinary skill in the art having the results shown in other plant seed such as O. violaceous, a close relative of B. juncea and napus and plants such as A. thaliana would be able to construct and produce the same results in B. juncea/napus.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn rejections/objections will not be discussed herein as applicant’s comments are moot. Note that the art rejections of record are being maintained for the reasons stated above and herein.
Applicant traverses the anticipation rejections in a combined fashion by stating that the WO2005/083093 reference does not disclose a seed oil obtained from a transgenic Brassica juncea plant seed comprising polyunsaturated C22 fatty acids in an amount of 5-10% by weight as recited in claim 19. This argument is not persuasive because the percentage of C22 in a Brassica juncea plant seed with a total lipid content of 20% is approximately 9% by seed weight (based on the art disclosure that a typical erucic acid content is 45% of the total oil and some sources report a range of 40%). As DHA is not naturally present in these seeds in any significant amount would be expected to be less than 20%. Note that the WO document in the abstract discloses a method to producing and increasing the content of DHA in plant seed, specifically a transgenic plant. Applicant argues that only DHA is a C22 fatty acid which is not accurate in the art.
The instant specification discloses
“The LCPUFAs produced in the process of the invention are produced with a content of at least 4% by weight, advantageously of at least 5, 6, 7, 8, 9 or 10% by weight, preferably of at least 11, 12, 13, 14 or 15% by weight, particularly preferably of at least 16, 17, 18, 19, or 20% by weight, very particularly preferably of at least 25, 30, 35 or 40% by weight based on the total fatty acids in the transgenic plant. The fatty acids EPA, DPA and/or DHA produced in the process of the invention are moreover present with a content of in each case at least 5% by weight, preferably of in each case at least 6, 7, 8 or 9% by weight, particularly preferably of in each case at least 10, 11 or 12% by weight, most preferably of in each case at least 13, 14, 15, 16, 17, 18, 19 or 20% by weight based on the total fatty acids in the transgenic plant”. The cited art meets the claimed embodiment and the disclosure in the specification.
Applicant provides an excerpt from US Patent No. 9458436 stating that the combined weight percentages of C20 and C22 fatty acids in the seeds of transgenic plants could be from 5-10% by weight of the seed oil (as disclosed in WO2005083093); and having this in hand applicant argues that it is unlikely the same amount as claimed, however, this argument is not persuasive. The total combined of C20 +C22 means that C22 is T-C20, so if T is 10 and C20 is 5 then C22 can be 5, based on this combination it falls within the recited range (see also Figure 33 of the cited patent (9458436) that shows DHA in transgenic seeds of Brassica juncea).
The language in claim 19 is directed to C22 which is broad and does not further define it as for example, C22:1 (Oleic Acid/Erucic Acid) or C22:6 (DHA), see paragraph [0089] of the specification. Thus applicant is arguing a limitation not present in the claims in implying only DHA is being claimed and applicant’s arguments that only DHA is C22 is certainly not accurate. The cited patent also discloses at paragraph [(59)], “This is especially advantageously in oil-producing organisms such as the family Brassicaceae, such as the genus Brassica, for example oilseed rape, turnip rape or Indian mustard; the family Elaeagnaceae, such as the genus Elaeagnus, for example the genus and species Olea europaea or the family Fabaceae, such as the genus Glycine, for example the genus and species Glycine max, which has a high oleic acid content, but only a low linoleic acid content (Mikoklajczak et al., Journal of the American Oil Chemical Society, 38, 1961, 678-681)”.
Furthermore, the instant specification discloses the following at paragraph [0382] “Extraction of seeds of transgenic Brassica juncea plants transformed with pSUN-9G, and the gas chromatography analysis was carried out as described in example 8. Table 6 shows the results of the analyses. The various fatty acids are indicated in percent area. As in Wu et al. 2005 it was possible to show the synthesis of long-chain polyunsaturated fatty acids (PUFA). Surprisingly, the use of the modified elongase sequence OtELO2.2 such as the nucleic acid sequence described by SEQ ID NO: 64 resulted in a drastic increase in the content of C22 fatty acids. In total, the seed oil contained about 8% by weight % polyunsaturated C22 fatty acids. Specifically, the content of the fatty acid docosahexaenoic acid (DHA) in the seed oil was 1.9% by weight %, representing an increase by a factor of 10 compared with Wu et al. 2005. Thus, DHA is not 5-10% as applicant appears to be arguing. In addition, the cited 9458436 Patent discloses at paragraph [(82)] that, “ In the method(s) according to the invention (for the purposes of the invention and the disclosure shown herein, the singular is to comprise the plural and vice versa), the LCPUFAs produced are produced in a content of at least 3, 5, 6, 7 or 8% by weight, advantageously at least 9, 10, 11, 12, 13, 14 or 15% by weight, preferably at least 16, 17, 18, 19 or 20% by weight, especially preferably at least 21, 22, 23, 24 or 25% by weight, very especially preferably at least 26, 27, 28, 29 or 30% by weight based on the total fatty acids in the transgenic organisms, advantageously in the seeds of the transgenic plants. Here, C.sub.18- and/or C.sub.20-fatty acids which are present in the host organisms are advantageously converted into the corresponding products such as ARA, EPA, DPA or DHA, to mention but a few by way of example, at the rate of at least 10%, advantageously at least 20%, especially advantageously at least 30%, very especially advantageously at least 40%. The fatty acids are advantageously produced in bound form”. Thus, the art remains meritorious over the claimed invention.
Applicant traverses the art rejections under 103 by separately attacking the references when the combined teaching renders the claimed invention as obvious. Applicant present the same argument in the 103 as provided for the 102 rejection regarding the usage of the WO document. However, the document is still regarded as prior art thus, these arguments are not deemed persuasive and the rejection of record remains relevant. The recited C22 can involve C22:0, C22:1, C22:6 and C22:5 which are recognized in the art and the disclosure in the specification, thus the recited 8-10% is not to a specific one and can be construed as a combined lipid content.
Therefore, the rejections of record under the cited art are being maintained. It is suggested that applicant claims the expressed amount of DHA (i.e.”….. comprising polyunsaturated C22 fatty acids in an amount of….., wherein the amount has DHA in a range of….).
Conclusion
9. No claims are presently allowable.
10. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652