DETAILED ACTION
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 .
Election/Restrictions
Applicants’ amendments to claims and specifications received on 12/18/2025 has been acknowledged. Claims 1, 3, 5, 7, 9, 11, 14, 19, 20, 24, 27, 28, 38, 42, 44-46, 51, and 56-60 are pending.
Claims 14 and 57 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/05/2024.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Therefore claims 1, 3, 5, 7, 9, 11, 19, 20, 24, 27, 28, 38, 42, 44-46, 51, and 56, 58-60 are examined in this Office Action.
For the following analysis the page number of Specification are from “Substitute Specification-Clean copy” submitted on 04/01/2024.
Rejection that are Withdrawn
35 USC § 102 rejection is withdrawn in light of applicant’s amendment of claim now requiring “wherein the non-endogenous gene is not adjacent to any genes that are naturally found adjacent to the non-endogenous gene” since the Dundas et al. disclose the plant that would comprise adjacent gene of SEQ ID NO:1.
35 USC § 103 rejection is withdrawn in light of applicant’s amendment of claim now requiring “wherein the non-endogenous gene is not adjacent to any genes that are naturally found adjacent to the non-endogenous gene” since the Dundas et al. does not teach the plant that would not comprise adjacent genes of SEQ ID NO:1.
Previous Double patenting rejection has been withdrawn in light of applicant’s deletion of claims 6-7 reciting Sr26 in copending Application No. 17554095 in in recent amendment.
Claim Rejections - 35 USC § 112 – Written Description Requirement
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.
Claims 1, 3, 5, 7, 9, 11, 19, 20, 24, 27, 28, 38, 42, 44-46, 51, 56, and 58-60 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.
Following analysis is added since applicant has amended claims to include the limitation of the method is in plant and it comprise “wherein the promoter of the first gene is a strong promoter, and the second gene is an herbicide resistance gene”.
Analysis of Breadth of Claims
Any genes that are naturally found adjacent to the nonendogenous gene (i.e. the gene encoding protein comprising an amino acid sequence which is at least 95% identical to SEQ ID N0:1) would comprise large number of gene (claims 1, 19, 27 and 56).
The term “adjacent” genes would encompass amu genes that are not in distant, or are near etc. (claims 1, 19, 27 and 56).
What is Described in the Specification
Applicant describes the following:
The inventors identified susceptible ethyl methanesulfonate-derived (EMS) mutants with point mutations and deletion from the Avocet+Lr46 background (page 55, lines 15-16).
The entire full sequence of Sr26 is 6,066bp consisting of two exons and an intron of 3,258bp wherein the encoded 935 amino acid protein contains a coiled coil (CC) domain at the N-terminus, followed by the NB-ARC domain and then the LRR motifs at the C-terminus (Figure lb) (page 55, lines 20-23).
Twenty one, 22 and 14 independent primary transgenic lines carrying the Fielder:Sr26:NativeRE, Fielder:Sr26:Sr22RE and Fielder:Sr26:Sr33RE, respectively were developed which showed resistance to stem rust pathotype 98-1,2,3,5,6, and Pgt pathotypes (PTKST, TTRTF, TKKTF, PCHSF) (page 56, lines 8-10).
the CC domains from Sr26 and Sr45 did not induce cell death in planta (page 60, lines 30-31).
Difference Between What was described and What is Claimed
Applicant has not described the term “adjacent”, does it mean any physical distance or genetic distance since it is not clear whether adjacent would mean next to or within certain centimorgan (cM) distance or within certain base pair distance from the non-endogenous gene? (claims 1, 19, 27 and 56).
Applicant has not described any genes that are naturally found adjacent to the nonendogenous gene (i.e. the gene encoding protein comprising an amino acid sequence which is at least 95% identical to SEQ ID N0:1) (claims 1, 19, 27 and 56).
Analysis
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
Applicant has not described any genes that are naturally found adjacent to the nonendogenous gene i.e. the gene encoding protein comprising an amino acid sequence which is at least 95% identical to SEQ ID N0:1 to differentiate it from the recited plant that has the non-endogenous gene wherein the gene would not be adjacent to any genes that are naturally found adjacent to the nonendogenous genes. A plant when comprise the non-endogenous gene comprising SEQ ID NO:1 would comprise many genes around it that would be inherited from historical evolution of the plants.
Many genes would be syntenic genes and would have homology across different chromosomes in any of the recited plant that comprise the non-endogenous gene. Since the meaning of adjacent is broad of being in various cM or any base pairs distance, there is dearth of description of plant that would not have any gene that would not be adjacent to any genes that are naturally found adjacent to the nonendogenous gene. For example Merriam Webster dictionary defines the term “adjacent” as “not distant, nearby, having common endpoint or border” (accessed at https://www.merriam-webster.com/dictionary/adjacent, accessed in 03/04/2026), therefore applicant has not described the genes comprised as the adjacent genes which are not distant or nearby etc.
Applicant describes stem rust resistance locus Sr26 is derived from tall wheat grass (Thinopyrum ponticum (Podp.) Barkworth & D.R. Dewey (Syn. Agropyron elongatum (Host) Beauvoir ssp. ruthenicum Beldie) (2n = l0x = 70)) (Spec, page 2, lines 12-13). Applicant describes the Sr26 locus was transferred to wheat chromosome 6A by Dr Doug Knott of the University of Saskatchewan (Spec, page 2, lines 17-19). Applicant describes Knott et al. (1961) used the wheat-Agropyron (now Thinopyrum) derivative previously developed by L.H. Shebeski and the translocation carrying Sr26 has been released in several Australian wheat cultivars (Spec, page 2, lines 21-23). Therefore, there would be specific genes that are naturally found adjacent to the nonendogenous gene as SEQ ID NO:1, applicant has not described the genes that are naturally found adjacent to SEQ ID NO:1.
For example, Dundas et al. Figure 1 (see figure below) showed the resistance fragment of 6Ae#1 from Th. ponticum is integrated in chromosome 6AL (WA-1) and (WA-5), or 6DL (WA-12). Furthermore, Liu et al. (Published:2024, Journal: BMC Plant Biology 24:40 https://doi.org/10.1186/s12870-023-04629-6) teaches in for example comparing NAC transcription factors in Tritipyrum comprising Triticum aestivum (AABBDD) and Th. elongatum (EE) wherein 732 TtNAC genes are widely distributed across 28 chromosomes and include 110 duplicated genes and the NAC gene family had common ancestor (page 1, Abstract). Figure 3 (see figure below) showed the duplicated and syntenic genes present across the chromosomes of Triticum aestivum (AABBDD) and Th. elongatum (EE). Therefore, there is dearth of description of any plant that would not have any genes that would be adjacent to any genes that are naturally found adjacent to the nonendogenous gene encoding SEQ ID NO:1, since applicant has not described the genes naturally found adjacent to SEQ ID NO:1.
It is known in the art that many genes would be syntenic genes and would have homology across different chromosomes in any of the recited plant that comprise the non-endogenous gene as compared to the plant that comprise the endogenous gene. Baker et al. (Published: 2020, Journal: Theoretical and Applied Genetics 133:2213–2226) teaches when Th. elongatum and T. estivum syntenic relationships were compared with 263 SNP markers, for example in Fig. 5 (see figure below) showed the genetic position in cM for Th. elongatum and the corresponding physical positions on the D genome of wheat wherein markers showed the same score for the top hit for more than one genome (page 2214, last paragraph, page 2215, left paragraph 1).
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Applicant has not described any genes that are naturally found adjacent to the nonendogenous gene i.e. the gene encoding protein comprising an amino acid sequence which is at least 95% identical to SEQ ID N0:1). Applicant describes their disclosed gene encoding SEQ ID NO:1 was identified creating mutation in line Avocet + Lr46 (Avocet carries Sr26) (page 51, lines 29-30). Therefore, it is not clear in any other plant other than Avocet how many common genes or syntenic genes are present as compared to the line Avocet to be considered them as not having the adjacent naturally found genes? Furthermore, applicant has not described which are the adjacent naturally occurring genes of the specific Th. ponticum strain in which SEQ ID NO:1 was discovered? Since applicant has not provided the complete genomic sequence or has deposited the lines to be readily available to public to determine the adjacent naturally occurring genes of SEQ ID NO:1, there is no description of genes naturally found adjacent to SEQ ID NO:1.
Therefore, there is dearth of description of the any genes that are naturally found adjacent to the nonendogenous gene i.e. the gene encoding protein comprising an amino acid sequence which is at least 95% identical to SEQ ID N0:1.
The above factual evidence provides a reasonable basis that the necessary written description for the naturally occurring genes adjacent to SEQ ID NO:1 are necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims (See MPEP 2163.04). Because the instant specification lacks the written description of the recited plant, the public will not be able to fully resolve questions of infringement.
Given the structural diversity associated with the claimed genus of any plant that has non-endogenous gene wherein the gene would not be adjacent to any genes that are naturally found adjacent to the nonendogenous gene, Applicant’s disclosure is not representative of the claimed genus as a whole. This point is particularly relevant because, as discussed above, the prior art speaks to the disconnection between the structure of the broadly claimed plant genome that require to not have any adjacent naturally occurring genes of the nucleotide encoding protein comprising SEQ ID NO:1.
"The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to one skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc, v EH Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, ina, 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). "An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPG2d at 1966". While the written description requirement does not demand either examples or an actual reduction, actual "possession" or reduction to practice outside of the specification is not enough. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F,3d 1336,1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time of the effective filing date of the claims.
Conclusion
No claim is allowed.
Claims 1, 3, 5, 7, 9, 11, 19, 20, 24, 27, 28, 38, 42, 44-46, 51, 56, and 58-60 are appear to be free of prior art. The closest prior art is Dundas et al. (Year: 2015, Journal: Crop Science, Vol. 55(2), pages: 648-657) (Included with IDS sent in 01/20/2022) which teaches wheat variety Eagle and lines 80, 1532, 1673, 1788 and 1804 of Figure 1 which are genetically modified by translocation of a polynucleotide comprising Sr26 gene that encodes protein SEQ ID NO: 1 (i.e. the gene is non endogenous to the wheat line) that confers resistance to stem rust (Puccinia grami graminis f. sp. tritici) pathotypes 21-2, 3, 7. The patentable distinction appears to be Dunda et al. does not teach the wherein the non- nonendogenous gene is not adjacent to any genes that are naturally found adjacent to the nonendogenous gene because the introgressed fragment would comprise other genes adjacent to the gene. However, a complete search at this time is not possible because applicant have not provided the description of the naturally occurring genes adjacent to SEQ ID NO:1 as to enable a complete and meaningful search of the prior art.
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.
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663