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 .
Claims 1, 3, 5-6, 9-12, 15-48, 55-70 are pending.
Claims 20-41 and 59-70 are withdrawn.
Claims 1, 3, 5-6, 9-12, 15-19, 42-48 and 55-58 are examined in the present Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/3/2025 has been entered.
Withdrawn objections
The objection to claim 1 is withdrawn in light of amendments made by Applicant.
Withdrawn rejections
The rejection of claims 4, 8, 14 and 50-54 on the basis of containing an improper Markush group is withdrawn in light of amendments made by Applicant.
Claim Objections
Claim 19 is objected to because of the following informalities: the claim is dependent on a cancelled claim. Appropriate correction is required.
Improper Markush Group
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings of sequences are improper because the alternatives defined by the Markush groupings do not share both a single structural similarity and a common use for the following reasons: the claim encompasses a multitude of different and unique sequences which are biochemically divergent, have no conserved structure throughout the genus other than being WUS proteins, each of which is derived from a different plant species or is a unique WUS/WOX protein (Table 3).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Applicant’s arguments regarding rejection for having an improper Markush group
Applicant's arguments filed 7/3/2025 have been fully considered but they are not persuasive.
Applicant argues that claims 4, 8, 14 and 50-54 have been cancelled.
The basis for rejection of claim 1 having an improper Markush group is a new ground for rejection due to Applicant’s amendments.
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, 3, 5-6, 9-12, 15-19, 42-48 and 55-58 remain rejected under 35 U.S.C. 103 as being unpatentable over Gordon-Kamm (US 20110167516) in view of Nardmann (Nardmann et al. Mol Biol Evol. 26(8):1745-55. 2009. GenBank Accession No. CAT02932).
Due to Applicant's amendment of the claims, the rejection is modified from the rejection set forth in the Final Rejection filed 4/3/2025, as applied to claims 1, 3-13, 15-18, 42-49 and 56-57.
The claims are drawn to a method of producing a transgenic dicot plant that contains a heterologous polynucleotide comprising contacting the plant with a T-DNA containing a heterologous polynucleotide and a morphogenic gene expression cassette, selecting a plant cell containing the heterologous polynucleotide and no morphogenic gene expression cassette and regenerating a transgenic plant from the regenerable plant structure containing the heterologous polynucleotide and no morphogenic gene expression cassette. An embodiment of the method is that the expression cassette comprises a nucleotide sequence encoding a functional WUS/WOX polypeptide and optionally a BBM polypeptide wherein the WUS is SEQ ID NO: 128 and the plant is soybean (claim 1). Claim 3 specifies that the nucleotide sequence does not encode the BBM polypeptide or ODP2 polypeptide. Claim 5 specifies that the nucleotide sequence encodes the BBM polypeptide. An embodiment of claim 6 is the nucleotide sequence encoding the BBM polypeptide is BBM2. Claims 9 and 42-48 provide Markush groups of functions that the heterologous polynucleotide confers, including increased yield. Claims 10-12 provide Markush groups of tissue which the dicot plant of claim 1 may comprise. An embodiment of claims 15 and 55 is that the site-specific recombinase is FLP and operably linked to an inducible promoter. Claim 16 requires the method of claim 15 further comprising excising the morphogenic gene expression cassette. The claims further require a plant produced by the method (claims 17 and 56), a seed comprising the heterologous polynucleotide (claims 18 and 57). Embodiments of claims 19 and 58 are drawn to members of a Markush group of ranges of increased frequency that the regenerable plant structure is formed at, from 0.1% to 100%.
Gordon-Kamm teaches a method of producing a transgenic plant by introducing polynucleotides into plants [0013]. Gordon-Kamm teaches a vector for transformation of plants comprising a promoter operably linked to a site-specific recombinase, a second promoter operably linked to a cell proliferation factor (e.g., a babyboom polypeptide); and a third promoter operably linked to a polynucleotide of interest or multiple polynucleotides of interest operably linked to one or more promoters and a fourth promoter operably linked to a WUS gene [0078]. Gordon-Kamm teaches the expression cassettes for the site-specific recombinase, the cell proliferation factor, and the Wuschel polypeptide are all flanked by site-specific recombination sites that are directly repeated and are recognized by the site-specific recombinase, such that expression of the site-specific recombinase results in the excision of the three expression cassettes, leaving the polynucleotides of interest behind [0078]. Gordon-Kamm teaches introducing the vector with at least one cell proliferation factor, such as Wuschel, which is an embodiment which excludes BBM (reading on instant claim 3) [0078]. Gordon-Kamm teaches that the term plant reads on embodiments of plant cells and tissue that can be regenerated [0129]. These teachings read on the method of claims 1, 3, 5-6, 9-12, 15-19, 42-48 and 55-58.
Gordon-Kamm teaches the individual use of a WUS gene or BBM gene which also reads on claim 1 [0078]. Gordon-Kamm teaches that the BBM polypeptide can be BBM2 [0053] (claim 6). Gordon-Kamm teaches that the method results in increased yield [0065] (claims 9, 42-48). Gordon-Kamm teaches that the method may be used with plant meristem [0111] (claim 10) and leaf tissue [0110] (claim 11), which is interpreted as including a petiole (claim 12) because a petiole is a portion of a leaf. Gordon-Kamm teaches that FLP can be used as a site-specific recombinase in the method [0036]; Gordon-Kamm teaches that the vector comprises a promoter Rab17 [0078] (Claims 15 and 55). Rab17 is being interpreted as an inducible promoter because Gordon-Kamm teaches that it induces expression under desiccation conditions [0184]. Applicant does not provide a definition which excludes Rab17 from being interpreted as an inducible promoter. Gordon-Kamm teaches that the method may be used with soybean [0125].
Gordon-Kamm teaches an embodiment of the method resulted in 45% of transformants recovered from treated embryos. This is interpreted as reading on the requirement of claims 19 and 58 that the regenerable plant cell is formed at an increased frequency between 0.1-100% compared to the frequency of regenerable plant structures formed when the dicot is not contacted with the morphogenic gene expression cassette.
Gordon-Kamm does not teach a method wherein the morphogenic gene expression cassette comprises a polynucleotide comprising SEQ ID NO: 128 (claims 14, 50-55).
Nardmann teaches Genbank Locus FM882154, which shares 100% identity with SEQ ID NO: 128 (see alignment below). Nardmann teaches Genbank Locus CAT02932 is a WUS gene.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Gordon-Kamm with the teachings of Nardmann to practice a method of producing transgenic plants by introducing polynucleotides comprising a BBM2 and a nucleotide encoding a WUS protein because Gordon-Kamm teaches a method of producing transgenic plants by introducing polynucleotides comprising a BBM2 and a WUS protein, which would encompass the WUS protein of Nardmann. One of ordinary skill in the art would have recognized a WUS protein as taught by Nardmann to have the same function as a WUS gene as taught by Gordon-Kamm because the WUS of Nardmann is a species of the genus taught by Gordon-Kamm.
Alignment of SEQ ID NO: 128 to Genbank Locus CAT02932 taught by Nardmann (100%)):
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Applicant’s arguments regarding rejection under 35 USC 103
Applicant's arguments filed 12/4/2024 have been fully considered but they are not persuasive.
Applicant argues that claim 1 has been amended to require the WUS polypeptide is from a Markush group of amino acids, which Applicant argues is not taught, suggested or motivated by the cited references.
This argument has been fully considered but it is not persuasive. Due to applicant’s amendment, a new ground for rejection has been made of record.
Applicant argues that the present application reports only 4 of 13 orthologs tested showed functionality in the claimed method in soybean. Therefore, Applicant argues, it would not have been predictable to practice the instantly claimed method.
This argument has been fully considered but it is not persuasive. One of ordinary skill in the art would have been motivated, in view of the teachings of Gordon-Kamm, to transform a soybean plant to produce a transgenic plant as claimed by Applicant encoding a WUS polypeptide such as that taught by Nardmann.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662