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
Applicant elected Group II (claims 7-17, 19-22, 33-34, and 38-39) without traverse. Therefore, the present Office action is limited to the elected claims. The nonelected claims remain withdrawn from consideration.
Claim Status
Claims 1-17, 19-25, 30-34, and 38-39 are pending.
Claims 1-6, 23-25, and 30-32 are withdrawn from consideration as being directed to a nonelected invention.
Claims 7-17, 19-22, 33-34, and 38-39 are examined on the merits.
Claim Objections
Claim 33 is objected to because of informalities. The phrase “(a) expressing, one or more gametophytic cell” should be amended to read “one or more gametophytic cells”.
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.
Claim 34 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.
Claim 34 depends from claim 33, which recites obtaining a clonal apomictic plant from “one or more gametophytic cells”. however, claim 34 recites that “the embryo is formed from an unreduced plant cell, wherein the unreduced plant cell is an egg cell or formed from a somatic cell”. It is unclear how an unreduced plant cell “formed from a somatic cell” corresponds to the gametophytic cell recited in claim 33, because a somatic cell is not a gametophytic cell. Accordingly, the scope of claim 34 is unclear.
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.
Scope of Enablement
Claims 7-17, 19-22, 33-34, and 38-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specifications, while being enabling for the disclosed embodiments in which selected full-length exogenous BBM polynucleotides from wheat, maize, rice, and Seteria Virdis are expressed in a wheat female gametophyte under an egg cell-specific promoter to induce maternal haploid embryo formation without pollination; does not reasonably provide enablement for the full scope of the claimed invention, which encompasses BBM polynucleotides having broad sequence variation, expression in plant species beyond the specifically demonstrated wheat system, and increasing expression of an endogenous BBM gene in a wheat female gametophyte by any mechanism, including gene editing, promoter modification, transcriptional activation, or other regulatory approaches, to induce maternal haploid embryo formation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
Claims 7 and 33 broadly encompass the use of a BBM polypeptide or a fragment thereof that retains haploid-induction activity to induce embryo formation without fertilization. Claims 8 and 11-13 depend from claim 7 but do not limit the BBM polypeptide or functional-fragment scope in a manner that resolves the enablement deficiency. Claims 21-22 add chromosome-doubling, regeneration, pollination, and embryo-rescue steps performed after induction of the haploid embryo, but do not limit the BBM polypeptide or functional-fragment scope responsible for the underlying enablement deficiency. Claims 34 depends from claim 33 and further encompasses embryo formation from an unreduced egg cell or a cell formed from a somatic cell, but does not otherwise limit the BBM polypeptide or functional-fragment. Accordingly, these claims retain the enablement deficiency discussed below.
Claims 9, 10, 38, and 39 broadly encompass BBM nucleotide and amino acid sequences having as low as 85% sequence identity to numerous disclosed BBM sequences, as well as fragments of such sequences that retain haploid induction activity. The claims further encompass fragments comprising an A motif, a B motif, an AP2 DNA-binding domain, or combinations thereof.
The breadth of the claimed fragment genus is extensive. The claims are not limited to a particular fragment length, fragment boundary, combination of domains, or location of a fragment within a BBM polypeptide. Rather, the claims encompass fragments derived from each of the numerous expressly recited BBM sequences. Thus, the claims encompass numerous possible contiguous and nonidentical portions of each full-length BBM polypeptide, including fragment containing an A motif alone, a B motif alone, an AP2 DNA-binding domain alone, or any combination thereof, provided only that the fragment ultimately possesses the claimed haploid-induction activity. Because an 85%-identity sequence may contain substitutions at many different position, and fragments may begin and end at numerous different residues, the claims encompass a vast number of structurally distinct polypeptides rather than a limited class of specifically identified functional fragments.
Whether a particular member of this broad genus retains haploid-induction activity would have been unpredictable because sequence identity or the presence of an A motif, B motif, or AP2 DNA-binding domain does not establish that the resulting fragment will retain the complete structural and regulatory properties necessary to induce parthenogenesis. BBM-mediated embryo induction requires more than DNA binding alone and may depend on the preservation, spacing, and interaction of the AP2 DNA-binding domains and BBM-specific motifs, the overall folding and stability of the polypeptide, nuclear localization, interaction with transcriptional cofactors, and appropriate transcriptional activation of downstream embryogenic pathways. Deletions or substitutions outside a conserved motif may therefore alter folding, motif spacing, protein stability, cofactor interaction, or transcriptional activity even when the motif itself remains present. Further, the functional result depends on expression levels and timing and on the cellular and plant-species context in which the variant or fragment is expressed. Consistent with this unpredictability, Ouakfaoui (Souad El Ouakfaoui et. al., Plant Molecular Biology (2010) 74:313–326) demonstrate that deletion or alteration of conserved BBM regions affects BBM-mediated embryogenesis and embryo development (p319-323; Fig. 4-6). Accordingly, a person of ordinary skill in the art could not determine from sequence identity, fragment length, or motif presence alone which of the claimed variants and fragments would retain haploid-induction activity; each candidate would need to be constructed, expressed in an appropriate female gametophyte, and experimentally evaluated for embryo induction.
The specification identifies BBM sequences, conserved motifs, and AP2 domains, and states that variants and fragments may retain haploid induction activity. However, the specification does not provide representative working examples showing that BBM sequences having 85% identity to the listed sequences retain haploid induction activity, nor does it provide working examples demonstrating which fragments, motif-containing fragments, or AP2-domain-containing fragments are sufficient to induce haploid embryo formation in a female gametophyte.
Claims 14-17 further encompass methods in which BBM expression is obtained by modifying an endogenous BBM regulatory region, expressing BBM from a modified endogenous genomic BBM locus, expressing BBM from a modified endogenous genomic egg-cell locus, or using a gene-editing technique. The specification describes these endogenous-locus editing embodiments only generally. The specification states that an endogenous BBM regulatory region may be modified so that BBM is expressed in a female gametophyte, and that a BBM-encoding sequence may be introduced into or expressed from an endogenous egg-cell locus. However, the specification does not provide a working example of an edited endogenous BBM regulatory region, an edited endogenous genomic BBM locus, or an edited endogenous genomic egg-cell locus that successfully expresses BBM in a female gametophyte and induces haploid embryo formation. Achieving the claimed result would require successful editing at the endogenous locus, appropriate regulatory configuration, proper egg-cell or female-gametophyte expression, appropriate regulatory configuration, proper egg-cell or female-gametophyte expression, appropriate expression timing, and level, and successful induction and recovery of haploid embryos. The specification does not provide sufficient guidance to practice the full scope of these endogenous editing embodiments without undue experimentation.
Claims 19-20 further broaden the method to monocot and dicot female gametophytes, including wheat, cotton, sunflower, safflower, tobacco, Arabidopsis, cannabis, canola, sugarcane, soy, barley, oats, rice, maize, triticale, sorghum, turf grass, rye, millet, and flax. The working disclosure is primarily directed to use of selected BBM constructs in wheat female gametophytes. Although the specification lists additional monocot and dicot species, it does not provide working examples showing that BBM expression in the female gametophyte induced parthenogenesis or haploid embryo formation across the full range of claimed plant species. The ability to induce parthenogenesis by ectopic BBM expression is expected to depend on species-specific transformation methods, egg-cell promoter activity, BBM ortholog function, timing and level of expression embryo rescue, and plant regeneration conditions.
Accordingly, undue experimentation would be required to practice the full scope of claims 7-17, 19-22, 33-34, and 38-39.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 7, 8, 13, 19-22, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ozias-Akins (Peggy Ozias-Akins et.al., US20160304901A1, Application of 2014-10-21, Publication of 2016-10-20).
Claim 7 recites a method of inducing parthenogenesis, the method comprising: expressing, in a female gametophyte, a Babyboom (BBM) polynucleotide operably linked to a promoter that expresses in a plant egg cell, wherein the Babyboom (BBM) polynucleotide comprises a nucleotide sequence encoding a Babyboom (BBM) polypeptide or a fragment thereof, wherein the female gametophyte is rendered parthenogenic and forms a haploid embryo without pollination, and wherein the Babyboom (BBM) polynucleotide is not naturally expressed in a female gametophyte.
Under the broadest reasonable interpretation, the recited “Babyboom (BBM) polynucleotide” encompasses BBML polynucleotides because dependent claim 8 expressly identifies BBM1, BBM2, BMN2, BMN3, ODP2, and BBML as one of the nucleotide sequences encoding the BBM polypeptide recited in claim 7.
Ozias-Akins discloses methods of propagating from one or more gametophytic or sporophytic cells in an ovule in the absence of egg-cell fertilization by transforming a plant with an ASGR-BBML gene construct operably linked to a promoter (Abstract; claim 1). Ozias-Akins discloses that ASGR-BBML is a BBM-like gene and was evaluated for use as an apomixis gene due to its protein similarity to BBM (pa 0073).
Ozias-Akins further disclosed that the PsASGR-BBML promoter directs expression in female reproductive tissues, including egg cells and ovaries. Expression is observed in egg cells and young embryos, and promoter-driven expression is detected in egg cells of unfertilized sexual embryo sacs (pa 0027, 0028, 0032, and 0036). Thus, Ozias-Akins discloses expressing an ASGR-BBML polynucleotide in a female gametophyte under the control of a promoter that expressed in a plant egg cell.
Ozias-Akins discloses that apomixis includes parthenogenesis, namely development of an unreduced egg into an embryo, and that ASGR-BBML induces parthenogenesis in the absence of fertilization (pa0004-0005; pa0073-0074). Ozias-Akins additionally discloses transforming a diploid plant to produce a haploid progeny plant and transforming a heterozygous flowering plant to produce haploid offspring (claims 12 and 20). Accordingly, the ASGR-BBML-expressing female gametophyte is rendered parthenogenic and forms a haploid embryo without pollination.
The ASGR-BBML polynucleotide introduced by transformation is a heterologous polynucleotide expressed in the female gametophyte and therefore is not naturally expressed in that female gametophyte in the claim.
Accordingly, Ozias-Akins discloses each and every limitation of claim 7. Claim 7 is anticipated by Ozias-Akins.
Claim 8 recites the method of claim 7, wherein the nucleotide sequence encoding the Babyboom (BBM) polypeptide or fragment thereof is selected from the group consisting of: BBM1, BBM2, BMN2, BMN3, ODP2, and BBML.
For the same reasons set forth above with respect to claim 7, Ozias-Akins discloses ASGR-BBM-LIKE (ASGR-BBML) gene (claim 1). Accordingly, claim 8 is anticipated by Ozias-Akins.
Claim 13 recites the method of claim 7, wherein the female gametophyte has not been fertilized prior to or during expression of the Babyboom (BBM) polynucleotide in an egg cell.
For the same reasons set forth above with respect to claim 7, Ozias-Akins discloses embryo/progeny seed production from gametophytic or sporophytic cells in an ovule in the absence of egg cell fertilization (claims 1). Accordingly , claim 13 is anticipated.
Claim 19 recites the method of claim 7, wherein the female gametophyte is a monocot or dicot female gametophyte. Claim 20 recites the method of claim 7, wherein the female gametophyte is a wheat, cotton, sunflower, safflower, tobacco, Arabidopsis, cannabis, canola, sugarcane, soy, barley, oats, rice, maize, triticale, sorghum, turf grass, rye, millet, or a flax female gametophyte.
For the same reasons set forth above with respect to claim 7, Ozias-Akins also discloses monocots and dicots, including grasses such as millet, rice, maize, wheat, sorghum, and switchgrass (claims 15-18).
Accordingly, claims 19 and 20 are anticipated by Ozias-Akins.
Claim 21 recites the method of claim 7, further comprising:(a) contacting the haploid embryo with a chromosome doubling agent for a period sufficient to generate a doubled haploid embryo;(b) isolating the doubled haploid embryo; and(c) regenerating a doubled haploid plant from the doubled haploid embryo of step (b).
For the same reasons set forth above with respect to claim 7, Ozias-Akins discloses producing haploid progeny from a diploid plant and treat the haploid progeny to achieve chromosome doubling and production of a homozygous plant (Claim 13; pa0009, and pa0074). Accordingly, claim 21 is anticipated by Ozias-Akins.
Claim 22 recites the method of claim 7, further comprising:(a) regenerating a parthenogenic plant from a haploid embryo comprising the Babyboom (BBM) polynucleotide operably linked to the promoter that expresses in an egg cell;(b) pollinating the parthenogenic plant of (a) with pollen from a non-haploid inducer; and(c) rescuing a haploid embryo from the parthenogenic plant of (b).
For the same reasons set forth above with respect to claim 7, Ozias-Akins discloses obtaining progeny plants and seeds from gametophytic or sporophytic cells in an ovule in the absence of egg cell fertilization (claims 1). Claim 22 is anticipated by Ozias-Akins.
Claim 33 recites a method of obtaining a clonal apomictic plant by expressing a BBM polynucleotide in one or more gametophytic cells using an egg cell-expressing promoter, developing an embryo without egg cell fertilization, and obtaining progeny containing chromosomes from the gametophytic cell.
Ozias-Akins discloses a method of propagating from one or more gametophytic or sporophytic cells in an ovule of a plant in the absence of egg cell fertilization, comprising transforming a plant with an ASGR-BBML gene construct comprising a nucleic acid encoding a BBML polypeptide operably linked to a promoter and growing/selecting a progeny plant containing chromosomes from the transformed plant (claim 1).
Accordingly, claim 33 is anticipated by Ozias-Akins.
Claim 34 recites the method of claim 33, wherein the embryo is formed from an unreduced plant cell, wherein the unreduced plant cell is an egg cell or formed from a somatic cell.
For the same reasons set forth above with respect to claim 33, Ozias-Akins discloses that the embryo may be formed from an unreduced egg, reduced egg, or somatic cell (claims 8- 10). Accordingly, claim 34 is anticipated by Ozias-Akins.
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.
Claims 9-10 and 38-39 are rejected under 35 U.S.C. §103 as being unpatentable over Ozias-Akins (US20160304901A1) as apply to claim 7 and 33, in view of Gordon-Kamm (William J. Gordon-Kamm et.al., US20050257289A1, Application of 2005-01-28, Publication of 2005-11-17).
Claims 7 and 33 as the teachings of Ozias-Akins are discussed above.
Claims 9-10 are interpreted as dependent of claim 7.
Claims 38-39 are interpreted as dependent of claim 33.
Claim 9 recites the method of claim 7, wherein the BBM polynucleotide is selected from specified nucleotide sequence, nucleotide sequences having at least 95% or 85% sequence identity thereto, or fragments thereof having haploid induction activity. Claim 10 recites the method of claim 7, wherein the BBM polypeptide is selected from specified amino acid sequence, amino acid sequences having at least 95% or 85% sequence identity thereto, or fragments thereof having haploid induction activity.
For the same reasons set forth above with respect to claim 7, Ozias-Akins teaches expressing an ASGR-BBML polynucleotide in a female gametophyte under the control of a promoter that expressed in a plant egg cell.
Ozias-Akins does not expressly teaches expressing the specific BBM nucleotide or amino acid sequences, or the recited sequence identity ranges.
Gordon-Kamm teaches ODP2 (Zm-ODP2), wherein SEQ ID NO: 2 (Fig. 1 and 2) is 100% identical to SEQ ID NO: 14 of the instant application (see below), thereby, Gordon-Kamm teaches at least one claimed BBM polynucleotide/polypeptide within the recited sequence and identity ranges.
It would have been obvious to substitute the BBM polynucleotide/polypeptide taught by Gordon-Kamm for the BBML polynucleotide of Ozias-Akins because both arts teach BBM family proteins that induce parthenogenesis/haploid induction, with a reasonable expectation of success.
Accordingly, claims 9 and 10 are prima facie obvious over Ozias-Akins and Gordon-Kamm.
Claim 38 recites the method of 33, wherein the BBM polynucleotide to specified SEQ ID NOs, nucleotide sequences having at least 95% or 85% sequence identity thereto, or functional fragments having haploid induction activity. Claim 39 recites the method of 33, wherein the BBM polypeptide to specified SEQ ID NOs, amino acid sequences having at least 95% or 85% sequence identity thereto, or functional fragments having haploid induction activity.
For the same reasons set forth above with respect to claims 1 and 33, Gordon-Kamm teaches ODP2 SEQ ID NO: 2 and variants/fragments thereof retaining ODP2 activity (Fig. 1 and 2; claims 1, 22-24). Gordon-Kamm teaches SEQ ID NO: 2 is 100% identical to SEQ ID NO: 14 of the instant application, and therefore, teaches at least one claimed BBM polynucleotide /polypeptide within the recited sequence and identity ranges.
Accordingly, claims 38 and 39 are prima facie obvious over Ozias-Akins and Gordon-Kamm.
Claims 11-12 are rejected under 35 U.S.C. §103 as being unpatentable over Ozias-Akins (US20160304901A1) as apply to claim 7, in view of Cigan (Andrew Mark Cigan et. al., US20130180006A1, Application of 2012-04-12, Publication of 2013-07-11).
Claim 11 recites the method of claim 7, wherein the promoter that expresses in the plant egg cell is an egg cell-specific promoter or an egg cell-preferred promoter. Claim 12 recites the method of claim 7, wherein the promoter to specified egg cell-preferred promoter sequence, nucleotide sequence having at least 90% sequence identity thereto, or functional fragments thereof that retain the ability to drive expression in an egg cell.
Claim 7 as the teachings of Ozias-Akins are discussed above.
Claims 11-12 are interpreted as dependent of claim 7.
For the same reasons set forth above with respect to claim 7, Cigan teaches plant promoters for tissue-preferred expression of heterologous nucleotide sequences, including egg cell-preferred promoters (pa0003-0010, 0032-0033, Table 1). Cigan specifically identify AT-DD45 PRO as an egg cell-preferred promoter, EASE PRO as an egg cell-preferred promoter, and ZmDD45 PRO as SEQ ID NO:34 as an egg cell-preferred promoter (Table 1). Sequence analysis demonstrate that SEQ ID NO: 34 is 99.8% identical to SEQ ID NO: 15 of the instant application (see below).
It would have been obvious to use the egg cell-preferred promoter taught by Cigan to express the BBM polynucleotide of Ozias-Akins because both references concern expression of heterologous polynucleotides in plant egg cell expression. A person of ordinary skill would have had a reasonable expectation that the promoter would drive BBM expression in the egg cell and thereby induce parthenogenesis.
Accordingly , claims 11 and 12 are obvious.
Claims 14-15 and 17 are rejected under 35 U.S.C. §103 as being unpatentable over Ozias-Akins (US20160304901A1) as apply to claim 7, and further in view of Khanday (Imtiyaz Khanday et. al., WO2018098420A1, Application of 2017-11-27, Publication of 2018-05-31).
Claim 7 as the teachings of Ozias-Akins are discussed above.
Claims 14, 15 and 17 are interpreted as dependent of claim 7.
Claim 14 recites the method of claim 7, further comprising: modifying a regulatory region of an endogenous Babyboom (BBM) polynucleotide so that the Babyboom (BBM) polynucleotide expresses in a female gametophyte.
For the same reasons set forth above with respect to claim 7, Khanday teaches expressing Babyboom in egg cells/female gametophyte to induce haploid progeny, and teaches that mutations can be introduced into the native Babyboom promoter such that Babyboom is expressed in egg cells (pa0038, 0043). Khanday further teaches that genome editing methods, including CRISPR/Cas9, can be used to target mutations in the Babyboom promoter, and that Babyboom promoter mutations can be introduced into plants using the CRISPR/Cas9 system (pa0048-0050). Accordingly, claim 14 is obvious over Ozias-Akins and Khanday.
Claim 15 recites the method of claim 7, the method comprising: expressing the Babyboom (BBM) polynucleotide from a modified endogenous genomic BBM locus, wherein the modified endogenous genomic BBM locus comprises a modified regulatory region of an endogenous polynucleotide encoding a BBM polypeptide, wherein one or more nucleotides in the regulatory region have been modified so that the BBM polypeptide expresses in a female gametophyte.
For the same reasons set forth above with respect to claim 7, Khanday teaches that, instead of generating a transgenic plant, a Babyboom promoter sequence in a plant or plant cell can be altered in situ to generate a plant or plant cell carrying a modified Babyboom promoter linked to the native Babyboom coding sequence (claim 16-17; pa0050). Thus, Khanday teaches expressing BBM from a modified endogenous genomic BBM locus comprising a modified regulatory region of an endogenous BBM polynucleotide, wherein one of more nucleotides in the regulatory region are modified so that BBM is expressed in egg cells/female gametophyte (pa0043, 0050). Therefore, claim 15 is obvious over Ozias-Akins and Khanday.
Claim 17 recites the method of claim 7, wherein the Babyboom (BBM) polynucleotide has been modified from its native form using a gene editing technique.
For the same reasons set forth above with respect to claim 7, Khanday teaches that the Babyboom promoter mutations can be introduced into plants using the CRISPR/Cas9 system, and further teaches guide RNA-directed Cas9 genome editing in plants (pa0048-0050). Therefore, claim 17 is obvious over Ozias-Akins and Khanday.
Claim 16 are rejected under 35 U.S.C. §103 as being unpatentable over Ozias-Akins (US20160304901A1) as apply to claim 7, and in view of Khanday (WO2018098420A1), and further in view of Zhao (Yongping Zhao et. al., Scientific Reports (2016) 6:23890, pp1-11).
Claim 7 as the teachings of Ozias-Akins are discussed above.
Claim 16 is interpreted as dependent of claim 7.
Claim 16 recites the method of claim 7, the method comprising: expressing the Babyboom (BBM) polynucleotide from a modified endogenous genomic egg cell locus, wherein the egg cell's coding or genomic sequence in the endogenous genomic egg cell locus has been modified so that it encodes a BBM polypeptide, wherein the BBM polypeptide expresses in a female gametophyte.
For the same reasons set forth above with respect to claims 7 and 15, Khanday teaches expressing a Babyboom polynucleotide in an egg/cell/ female gametophyte to induce haploid embryo development (pa0038-0043, 0050, 0070-0072).
Zhao teaches CRISPR/Cas9-mediated targeted gene replacement in plants using dual sgRNAs and a donor repair template, wherein an endogenous genomic locus is modified by replacing an endogenous target region with a gene of interest through homology-directed repair(Title, Abstract). Zhao further teaches that HDR-mediated genome editing permits targeted knock-in or replacement of desired DNA sequences into endogenous plan loci (p1, pa3; Fig 1).
It would have been obvious to one of ordinary skill in the art to modify an endogenous egg-cell genomic locus so that the locus encodes a Babyboom polypeptide, as taught by Zhao’s targeted gene replacement methodology, in order to implement the egg-cell-specific BBM expression taught by Khanday and thereby obtain the expected haploid embryo formation.
Therefore, claim 16 is obvious over Ozias-Akins, Khanday and Zhao.
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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/YANXIN SHEN/ Examiner, Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663
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