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
Applicant’s election of Group I, claims 1, 8-9, 11-13, 19, 31-32, 34, 40, 42, 45-46, 48-49, 113-117 and 120 with the species of Ms1B (from MF genes on Table 1) and PV3D (from PV genes on Table 2) in the reply filed on 01/16/2026 is acknowledged. However, neither the claims nor the specification refers to Ms1B or PVD3. The office will consider Ms1 and PV3 as the elected species.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
New claims 121-124 are added. Therefore, claims 1, 8-9, 11-13, 19, 31-32, 34, 38, 40, 42, 45-46, 48-49, 113-117 and 120-124 are pending.
Claims 1, 8-9, 11-13, 19, 31-32, 34, 38, 40, 42, 45-46, 48-49, 113-117 and 120-124, pending in this application, are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
Claims 1, 8, 115-117 and 120-121 are rejected in the recitation of a “ MF gene”, “MF genes” a “PV gene”, and “PV genes” as it is unclear as to whether the names refer to a single gene or gene families. Further, the use of the names do not carry art recognized limitation as to the specific characteristics or essential characteristics that are associated with the denomination. The claims are also indefinite because “ectopic allele of a MF gene” and “ectopic allele of a PV gene”, “ loss-of function alleles of a MF gene”, “loss-of-function alleles of a PV gene” “ectopic functional allele”, “functional ectopic alleles”, “ectopic copy of the MF gene” which are neither defined in the specification nor are recognized in the art. While Tables 1 and 2 of the specification refer to exemplary MF and PV genes, the specification does not provide definition of the phrases as recited in the claims and one would not be able to determine the metes and bounds of the claims. Dependent claims 9, 12-13, 19, 31, 32, 34, 38, 40, 42, 45-46, 48-49, 113-114 and 122-124 are included in the rejection.
Amending the claims to replace MF, Ms1 and PV3 genes with SEQ ID NO: would obviate the above the rejection.
Claim 11 is indefinite for depending upon cancelled claim 10. For the interest of compact prosecution, claim 11 is considered to depend from claim 1.
Claim 115 is indefinite for depending upon cancelled claim 60. For the interest of compact prosecution, the claim is considered to depend from claim 114.
Claims 13, 19 and 123-124 are indefinite in the recitation of “Table 1” and “Table 2” because a claim is to be complete in itself. 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).
Claims 123 and 124 are indefinite in the recitation of “same type of activity” as it is unclear what activity is being referred to. The claims are also indefinite in the recitation of “95% sequence identity” without reciting a specific sequence or SEQ ID NO:
Claims 13 and 123 recite Mfw2 and Ms1 and Table 1, that also listed Mfw2 and Ms1. Therefore, the claims recite twice each of Mfw2 and Ms1.
Claims 19 and 124 recite PV3 and Table 2, which also listed PV3. Therefore, the claims recite twice PV3.
Clarification is required to more clearly define the metes and bounds of the claims.
Improper Markush Grouping Rejection
Claims 13, 19 and 123-124 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 and/or common use that flow from the substantial structural feature for the following reasons:
The sequences and corresponding loci on Tables 1 and 2 of the Markush group are structurally different and encode structurally different proteins. 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. At Table 2, different PV sequences are disclosed by different SEQ ID NO:, showing structural differences. Additionally, the sequences are from different loci on each chromosome. Other than the phosphodiester backbone, the species in the genus have no conserved structure. 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 § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 8-9, 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. 103 as being unpatentable over Keeling et al WO 2019/165199 A) in view of Feldman et al (US 6, 407, 311 B1; Applicant’s IDS).
Keeling et al teach Keeling et al teach a male fertile maintainer plant for a male-sterile polyploid plant comprising a first, a second and further genomes, and modifications of a Mf gene, a PV gene and OV gene. Fig. 1C shows that Mfw and PV genes on chromosomes A, B or D are within 10cM. Keeling et al specifically teach wheat male-fertile maintainer plant for a male sterile polyploid, the maintainer line comprising: a first genome comprising, in the first chromosome of a homologous pair, an endogenous wild type functional allele of a male-fertile gene (MF gene); an engineered knock-out modification at the allele of a pollen-vital gene (PV gene); an endogenous, wild-type functional allele of ovule-vital gene (OV gene); and modification comprising a deletion of endogenous intervening sequence between the Mf, the PV and/or OV loci; and in the second chromosome and any subsequent genome with an endogenous wild type functional allele of the PV gene; an engineered knock-out modification at each allele of the MF gene and OV gene; and an engineered modification comprising a deletion of endogenous intervening sequence between the Mf, PV, and OV loci; wherein these modifications result in viable, germinating pollen grains produced by the male-fertile maintainer plant; and wherein the knock-out modifications are engineered by contacting a plant cell with a site-specific guided nuclease from Crispr-Cas or with a Cas enzyme and one or more multi-guide constructs that target each allele of Mf, OV, and PV ([00137]-[00139]); wherein the plant cell is a tetraploid wheat, hexaploidy wheat, or Triticum aestivum or Triticum durum, or canola or oat. Keeling et al also teach a method of producing said male-fertile maintainer plant comprising engineering the knock-out modifications in each allele of Mf, OV, and PV in the second and subsequent genomes, producing a fertile plant; engineering modifications in the first chromosome of the first genome; and engineering the modifications in the second chromosome of the first genome; the resultant plants are crossed, selfing the F1 generation to produce F2 generation, selecting plants homozygous from the F2 generation, and crossing the selected homozygous plants with third, wild type elite plant of the same cultivar, and repeating this process until the crossed plants are substantially isogenic with the wild type cultivar. At paragraph [0063], Keeling et al teach that endogenous Mf and PV are located on the same arms of the same homologous pair of chromosomes in the wild-type genome. Figs 1-3 of Keeling et al show chromosomes from each of the three genomes of wheat plant, in the wild type (Fig. 1A) and in multiple of modifications of all three genes (Fig. 1B-1C). Table 1 of Keeling lists post meiosis PV genes while Table 3 lists pre-meiosis Mf genes including Mfw2 and Ms1. Keeling et al teach that Mf gene produced a male sterile phenotype when modified to knock-out allele, while deactivated PV gene eliminated development of mature pollen. Therefore, the claims of the instant application and the prior art both teach targeting of Mfw and PV genes for knockout/knock-in modification at the Mfw and PV loci, for the production of male fertile maintainer plants for male sterile polyploid plants. At paragraph [0068], Keeling et al cite Wang et al (PNAS (2017) which describes the Ms genes including the Ms1 gene.
While instant claims are substantially disclosed by Keeling et al (see at least claims 1-30), Keeling et al do not explicitly teach the use of BA (blue aleurone) layer selectable marker gene of the instant claims. However, the use of BA gene that confers coloration on the progeny seed as a selectable marker gene is known in the prior art as evidenced by Feldman et al. Feldman et al provide the use of seed endosperm coloration gene as a selectable marker in methods of improving seed hybrid production in cereals such as wheat with alien chromosome or chromosome segment carrying dominant male-fertility gene homoallelic to the male -sterility mutant allele and a color marker gene such as the BA. At paragraph bridging columns 4 and 5, Feldman et al state “[t]he maintenance of the male-sterile (female) parental line is accomplished by physically separating the progeny seeds by color sorting”. Therefore, the use of BA seed color as a selectable marker is known in the prior art. With respect to claim 34, one of skill in the art would expect that the allele of the seed color gene and the allele of the PV gene are located within 10 cM to the Mf gene loci, since the alleles are expected to be segregated with the Mf gene at the Mf loci.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of producing a male-fertile maintainer plant of a male-sterile polyploid plant by engineering knock-out/knock-in modifications to alleles of the male-fertile MF and PV genes at MF and PV loci on one or more wheat polyploid genomes, and using the resultant plants in methods of hybrid seed production by breeding or by genetic transformation as taught by Keeling et al, and to modify that method by incorporating the use of BA gene taught by Feldman et al, for selection of transgene free plants, with a reasonable expectation of success as taught by Feldman et al. One would have been motivated to produce a male-fertile maintainer plant for a male-sterile polyploid plant because maintainer lines are used for the propagation of male-sterile lines , given that male-sterile lines are essential for hybrid seed production and cannot propagate by itself as taught by Keeling et al. One would also have been motivated to target endogenous/wild type male fertility Mf and PV genes for knock-out/knock-in modifications to induce male sterile/fertile phenotype for use in polyploid plant breeding and hybrid seed production methods as taught by Keeling et al.
Claim Rejections - 35 USC § 112
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, 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(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.
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 Mfw, a genus of PV 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 MF genes, PV genes of the claims to encompass any male fertility genes from all natural sources. The specification describes some of these genes from wheat or from Triticum (Tables 1-2). The specification does not describe any other MF and PV genes. The specification fails to provide conserved structure (genetic) among the MF and PV genes that is responsible for the male fertility phenotype.
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 Mf, PV and BA genes from all natural sources. In addition, the MF genes, PV genes, and BA genes are described by function ( and 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.
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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