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 .
Applicant’s Reply, filed on 07/29/2025 is hereby acknowledged. Applicant’s arguments, when taken together with the claim amendments have overcome the rejection of the claims under 35 USC 102 as being anticipated.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 13-14 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (2019 Mol Breeding 39:17 pages 1-12).
The claims are drawn to soybean plants, parts or cells comprising one or more mutations modulating the expression of a SACPD-C gene, a FATB-1A gene or both wherein the plant, plant part or plant cell produces oil with increased saturated fatty acid content compared to plants, plant part, or plant cells lacking said mutation wherein the mutations comprise a targeted mutation induced by a rare-cutting endonuclease wherein the mutation results in a reduced expression of SACPD-C wherein the mutation is a knock-out mutation wherein the mutation is in a sequence set forth in SEQ ID NO:21 and methods for generating a soybean plant comprising a mutation modulating the expression of the gene or genes above comprising contacting a population of soybean plant cells producing an oil with a saturated fatty acid content of about 15% with one more nucleic acid sequences and selecting from the population plants wherein the gene expression has been altered.
Kim et al teach the identification of a new soybean SCAPD-C allele in high steric acid derived from gamma-ray irradiation and detail several other mutants from the prior art including a knock out which deletes the entire gene including SEQ ID NO:21, meeting the limitation of claim 7 (see page 2 1st full paragraph spanning columns 1 and 2, for example) wherein the total saturated fatty acid content of the unaltered plant was about 15% (see Table 2). With respect to the targeted mutation, it is noted that particularly in product claims or even in method claims wherein the limitation is passive, the method of mutation does not impart a structural change such that the plant would be patentably distinct from the plants taught by Kim et al, and accordingly, Kim et al meets all the limitations of the claims.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (2019 Mol Breeding 39:17 pages 1-12), in view of Sun et al (2014 Plant Biotechnology Journal 12:624-637).
The claims are drawn to soybean plants, parts or cells comprising one or more mutations modulating the expression of a SACPD-C gene, and a FATB-1A gene wherein the plant, plant part or plant cell produces oil with increased saturated fatty acid content compared to plants, plant part, or plant cells lacking said mutation wherein the mutations comprise a targeted mutation induced by a rare-cutting endonuclease wherein the mutation results in a reduced expression of SACPD-C wherein the SACPD-C gene is knocked out in a seed-specific manner and wherein the FATB gene is overexpressed in a seed-specific manner and wherein the promoters are switched with seed-specific promoters in the case of FATB1 and non-seed specific in the case of SACPD-C and methods for generating a soybean plant comprising a mutation modulating the expression of the gene or genes above comprising contacting a population of soybean plant cells producing an oil with a saturated fatty acid content of about 15% with one more nucleic acid sequences and selecting from the population plants wherein the gene expression has been altered wherein the genes are altered by seed-specific knockout in the case of SACPD-C and knock-in in the case of FATB1.
Kim et al teach the identification of a new soybean SCAPD-C allele in high steric acid derived from gamma-ray irradiation and detail several other mutants from the prior art including a knock out which deletes the entire gene including SEQ ID NO:21, meeting the limitation of claim 7 (see page 2 1st full paragraph spanning columns 1 and 2, for example) wherein the total saturated fatty acid content of the unaltered plant was about 15% (see Table 2). With respect to the targeted mutation, it is noted that particularly in product claims or even in method claims wherein the limitation is passive, the method of mutation does not impart a structural change such that the plant would be patentably distinct from the plants taught by Kim et al, and accordingly, Kim et al meets these limitations of the claims as well as the oil compositions (see Table 2 at least).
Kim et al do not teach knocking out or in in a seed-specific manner by changing the promoters for either of the two claimed genes, nor does Kim et al teach both the SCAPD-C and FATB gene simultaneously being altered.
Sun et al teach the simultaneous overexpression of FATB in a seed-specific manner using a brassica napus FatB gene with a seed-specific promoter while simultaneously knocking out the expression of SACPD wherein total fatty acid content was increased (see abstract at least). Although Neither reference specifically teaches the method of replacing the native promoter with a seed-specific promoter, the overexpression of the FATB gene with a seed-specific promoter achieves the same result.
Given the state of the art, the disclosures by Kim et al and Sun et al, it would have been obvious when understanding the teachings of the impact of both knocking out SACPD-C and overexpressing FATB1A would result in increased saturated fatty acid levels as taught by Kim et al and Sun et al, to modify the soybean by mutating the SACPD-C gene as taught by Kim et al and overexpress the native FATB1a gene similarly to the increased FATB gene in brassica napus as taught by Sun et al, and one of ordinary skill in the art would have been motivated to do so based on the teaching of Kim et al as to the importance of vegetable oil in nutrition (see page 1-2 introduction 1st paragraph).
Response to Arguments
Applicant's arguments filed 07/29/2025 have been fully considered but they are not persuasive.
Applicant’s urge that Kim alone or in combination with Sun et al does not teach or suggest the claimed invention as a whole. That neither Kim nor Sun et al teach a targeted mutation in a soybean plant in the recited genes (see Response pages 7-8).
This is not persuasive because as a first matter, the claims are directed to products and as products, the method by which they are made (targeted mutation vs non-targeted) cannot be distinguished without a discernable structural difference. As a second matter, Kim et al is recited to demonstrate that the SACPD-C had already been identified in soybean, the effect of down-regulating said gene taught and known in the prior art, while Sun et al is cited to demonstrate that simultaneous down-regulation of SACPD-C and up regulation of FATB were known in the prior art and as such, especially in the same plant family, it would have been obvious to practice the instant invention in soybean given the combined teachings of Kim et al and Sun et al.
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).
Applicant’s urge that neither reference teaches replacing the native promoter as a means to knockout the gene.
This is not persuasive because the method for knocking out the gene does not impact the result and aim of the knockout absent evidence to the contrary.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRENT T PAGE/Primary Examiner, Art Unit 1663