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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s response filed 07/30/2026 in reply to the office action of 05/01/2026 has been entered. Claims 1, 8, 19, 113-115, 121, and 123-124 are amended. New claims 125-126 are added. Therefore, claims 1, 8-9, 11-13, 19, 31-32, 34, 38, 40, 42, 45-46, 48-49, 113-117 and 120-126 are pending
Claims 1, 8-9, 11-13, 19, 31-32, 34, 38, 40, 42, 45-46, 48-49, 113-117 and 120-126, drawn to the elected species of Ms1 (SEQ ID NO: 183, 185, 186, 188, 189, 191, 214, 215 or encodes SEQ ID NO: 184, 187, , 190 or 216 -191 and 214-216) and PV3 (SEQ ID NO: 222, 224-225, 227, 230 or 257 or encodes SEQ ID NO: 223, 226 or 229) are examined.
Withdrawn Objections and Rejections
The 103 rejections to the claims have been withdrawn in view of Applicant’s amendment to the claims and/or upon further consideration.
All previous objections and rejections not set forth below have been withdrawn in view of Applicant’s amendment to the claims and/or upon further consideration.
Claim Rejections - 35 USC § 112
Claims 1, 8-9, 11-13, 19, 31-32, 34, 38, 40, 42, 45-46, 48-49, 113-117 and 120-124 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. This rejection is repeated for the reasons of record as set forth in the last Office action of 05/01/2026. Applicant’s arguments filed 07/30/2026 have been considered but are not all persuasive.
The rejection is maintained for claims 1, 8 and 121 in the recitation of “95% sequence identity” without reciting a specific sequence structure or SEQ ID NO: In addition, in the response filed 07/30/2026, Applicant states that the “MF gene” and “PV gene” refers to a genus. Therefore, it is unclear how to determine 95% sequence identity of multiple of sequences.
The rejection is maintained for claim 124 because the amended claim recites “Table 2”.
The MPEP 2173.05 (s) states the following:
[w]here possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Clarification is required to more clearly define the metes and bounds of the claims.
Improper Markush Grouping Rejection
Claims 1, 8, 13, 19, 121, and 123-126 are rejected under the judicially-created basis that they contain an improper Markush grouping of alternative species. See In re Harnisch, 631 F.2d 716,721-722 (CCPA 1980) and Exparte HozumL 3 USPQ2d 1059, 1060 (Bd. Pat. App. and Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or common use that flow from the substantial structural feature. This rejection is repeated for the reasons set forth in the last office action of 05/01/2026. Applicant’s arguments filed 07/30/2026 have been fully considered but are not deemed persuasive.
Applicant argues that the group members recited in the claims belong to the same art-recognized class of saprophytic male sterility genes, therefore, the "single structural similarity" requirement is satisfied. Applicant also argues that the members of the class are known in the prior art and behave the same way. These are not found persuasive because the genus of MF genus and the genus of PV genes do not behave the same way and do not belong to the same art-recognized class of genes. For example, in Table 1, the Mfw2 gene encodes a callose synthase while the Mfw3 is an Aborted microspore 1 like, the Ms1 gene encodes a phospholipid-binding protein, and the Mfw9 is a member of the sweet family. For examples, the genus of PV genes, it is noted that PV1, PV2 and PV3 are disclosed by different sequences, showing structural differences. Table 2 shows that the genus of PV genes lack a single structural similarity” and/or common use that flow from the substantial structural feature. For example, the PV1 gene is disclosed by SEQ ID NO: 174-182; PV2 gene is disclosed by SEQ ID NO: 157-165; and PV3 is disclosed by SEQ ID NO: 222-230 and 257. Other than the phosphodiester backbone, the species in the genus have no conserved structure. Further, none of the references listed on pages 2-3 of Applicant’s response appears to support Applicant’s arguments.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Claim Rejections - 35 USC § 112
Claims 1, 8-9, 11-13, 19, 31-32, 34, 38, 40, 42, 45-46, 48-49, 113-117 and 120-126 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. This rejection is repeated for the reasons set forth in the last office action of 05/01/2026. In response filed 07/30/2026, Applicant chose not to respond to this rejection.
The claims are broadly drawn to a genus of male fertile maintainer plant species for a genus of male-sterile polyploid plant species comprising a first genome comprising on a first chromosome of a pair of homologous chromosomes, at a single target locus, at least one functional ectopic allele of a MF gene and at least of a seed color; on a second chromosome of the pair of homologous chromosomes, at the target locus
corresponding to the target locus of the first chromosome of the pair of homologous
chromosomes, at least one functional ectopic allele of a PV gene; loss-of-function alleles of the endogenous MF genes at the native MF gene loci and loss-of-function alleles of the endogenous PV genes at the native PV gene loci; and at least one further genome, each of the further genomes comprising loss-of-function alleles of the MF gene at the native MF gene loci and loss-of-function alleles of the PV gene at the native PV gene loci; wherein the at least one functional allele of a MF gene and the at least one allele of a seed color gene are part of single construct. The claims are also drawn a method of providing a male sterile plant seed, the method comprising selecting, from seed produced by selfing a plant of claim 8, seed not displaying a phenotype provided by the seed endosperm gene that is the male sterile plant seed; a method of providing a F1 hybrid seed for crop production, the method comprising collecting the seed produced by a male-sterile plant pollinated by a male-fertile plant, wherein the male-sterile plant is a plant grown from male sterile plant seed obtained by the method of claim 114; and a method of producing F1 and further generation seed by said male sterile plant and pollinated by a male-fertile plant.
The specification describes a method of producing a maintainer line and cognate male sterile line using wheat plants, male fertility Mfw gene, seed/grain color gene (BA), and a pollen vital gene (PV), all from Triticum/wheat; the method comprising engineering knock-out and knock-in mutations of one or more alleles of said Mfw and PV genes at MFw and PV loci. Resultant wheat plants are used in wheat breeding and production of wheat hybrid seed. The specification also describes wild type elite wheat line selected for transformation with wild type genes in all three wheat genomes.
The specification, however, fails to describe a representative species of the genus of male fertile maintainer plant species for a genus of male-sterile polyploid plant species comprising a genus of Ms1, a genus of PV3 and genus of seed color genus from any source, and a genus of methods including targeted gene modification, conventional transformation of crops with multiple transgenes, transgene or trait stacking and mutation breeding methods of producing said genus of male fertile maintainer plant species from all types polyploids. The office interprets that Ms1 genes, PV3 genes of the claims to encompass any male fertility/sterility genes from all natural sources. The specification describes some of these genes from wheat or from Triticum (Tables 1-2) and its use in wheat or Triticum plants. The specification does not describe other Ms1 and PV3 genes from other plant species and their use in non-native plants. The specification fails to provide conserved structure (genetic) among the Ms1 and PV3 genes that is responsible for the male fertility phenotype. Note, claims 125-126 are included in the rejection because the specification fails to describe a representative number of plant species of the genus male-fertile maintainer plant species for a genus of male-sterile polyploid plant species.
The state of the prior art, as evidenced by Ainley et al ((US 11, 198, 883) is that each of the processes of targeted gene modification, conventional transformation of crops with transgenes, transgene or trait stacking and mutation breeding methods of producing said genus of male fertile maintainer polyploid plant species, presents difficulties and unpredictability. Ainley et al teach, for example, the conventional transformation of crops with transgenes and mutation breeding are relatively inefficient and random nature. For transgene (trait) stacking, Ainley et al state regarding polyploid plants “…..polyploidy, where the organism has two or more duplicated (autoploidy) or related (alloploid) paired sets of chromosomes, occurs more often in plant species than in animals” has proven difficulty. Regarding conventional transformation of crops with transgenes, Ainley et al point to the “ difficulty for predicting whether pleiotropic effects due to unintended genome disruption have occurred; and difficulty for comparing the impact of different regulatory elements and transgene designs within a single transgene candidate, because such comparisons are complicated by random integration into the genome…….As a result, conventional plant trait engineering is laborious and cost intensive process with a low probability of success.”
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id. See MPEP 2163.
Further, the specification has neither provided a representative number of the genus of male-fertile maintainer plants for male sterile polyploid plants, nor did that Applicant describe a common structural feature that would allow to recognize the identity of the members of the genus of Ms1 and PV3 and BA genes from all natural sources. In addition, the Ms1 genes and PV3 genes are described by function ( or loss-of-function) and not by both function and structure. Therefore, one of skill in the art would not know that applicants are in possession of the invention as broadly claimed.
Therefore, for all the reasons discussed above, the claimed invention is not adequately described.
Conclusion
No claim is 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 MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
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