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 .
Status of the Claims
Claims 1-17 are pending.
Claims 1-17 are examined herein.
Claims 1-17 are rejected.
Priority
Application No. 18/859,903 filed on 10/24/2024 is a 371 of Application No. PCT/CN2022/089505 filed on 04/27/2022.
Specification
The use of the term DNeasy® Plant Mini Kit and QIAGEN® (at least page 35, line 25, and page 36 ,line 2), NanoDrop™ 2000 and Thermo Scientific® (page 36, line 6), and TaqMan® (at least page 35, line 13, page 36, line 11, and page 44, line 14 and 17), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
In claims 1, 7, and 13-16, “PPO” is used as an abbreviation. It is suggested to
insert a definition for PPO without bringing in new matter, immediately before the first
appearance of “PPO” in independent claims 1, 7, and 13-16; and to enclose the appearance of “PPO” in parentheses (in claims 1, 7, and 13-16 only). Appropriate correction is required.
Claim 1 recites “A method for controlling weeds, characterized by comprising applying…” which is difficult to read and not grammatically proper. Applicant should amend the claim to read “A method for controlling weeds, wherein the method comprises applying…” or another grammatically appropriate equivalent to improve clarity of the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because claims 16-17 are drawn to a use. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid." See MPEP 2173.05(q). Claim 16 recites “preferably” applying the herbicide containing an effective dose of a PPO inhibitor to a field (lines 12-18). However, this step is merely preferable, not required, and no other steps are provided. Thus, claims 16-17 do not require any active, positive steps delimiting how this use is actually practiced.
Improper Markush Grouping
Claims 1-2, 7-8, and 13-17 are 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 grouping of:
SEQ ID NOs: 1-6
SEQ ID NOs: 7-24
is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Regarding group i, the SEQ ID NOs represent amino acid sequences encoding PPO proteins that originate from different species, and the sequences do not share a single structural similarity. An ABSS sequence search of, e.g., SEQ ID NO: 1 (see file wrapper 20260518_111308_us-18-859-903a-1.rapbm) returned results having as low as 57.8% identity to SEQ ID NO: 1. From the instant application, only SEQ ID NO: 3 appeared in the search results which has only 58.6% sequence identity. All other sequence identities did not appear in the results, meaning they had below 57.8% sequence identity. That is, none of the sequences in group i listed above are structurally similar to SEQ ID NO: 1 and therefore the species do not share both a substantial structural feature and a common function that flows from the substantial structural feature.
Regarding group ii, the SEQ ID NOs represent polynucleotide sequences encoding the PPO amino acid sequences as described above and are rejected for the same reasons.
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.
Claim Rejections - 35 USC § 112
Indefiniteness
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 1-17 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 7, and 13-16 recite the broad recitation “…wherein the protoporphyrinogen oxidase has at least 90% sequence identity…”, “…preferably, the transgenic plant comprises monocotyledonous plants and dicotyledonous plants…”, and “…preferably, the PPO-inhibitor herbicide comprises a PPO-inhibitor herbicide from the class of…”. The claim also recites “preferably…”, “more preferably…”, further preferably…” after these statements in reference to the PPO sequence identity, plant type, or PPO-inhibitor type above and further limits them, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-6, 8-12, and 17 are rejected as a function of their dependency.
Claims 1, 7, and 13-16 recite a plant or transgenic plant "comprises monocotyledonous plants and dicotyledonous plants". A singular plant cannot comprise both a monocotyledonous plant and a dicotyledonous plant, so it is unclear whether these claims are limited to interpretations where the plant is multiple plants that are both monocotyledonous and dicotyledonous or whether the claims should be interpreted to encompass embodiments where a single plant is either monocotyledonous or dicotyledonous.
Claims 2-6, 8-12, and 17 are rejected as a function of their dependency.
Claims 7 is indefinite in claiming both a planting combination (line 1) and a step in a method of making the planting combination (“the herbicide containing an effective dose of a PPO inhibitor is applied to a field” lines 2-3). When a claim mixes statutory classes, it is unclear when direct infringement occurs. See MPEP 2173.05(p) II.
Claims 8-12 are rejected as a function of their dependency.
Claims 16-17 are drawn to a “use” of a protoporphyrinogen oxidase. Claim 16 recites “preferably” applying the herbicide containing an effective dose of a PPO inhibitor to a field (lines 12-18). However, this step is merely preferable, not required, and no other steps are provided. Thus, claims 16-17 do not require any active, positive steps delimiting how this use is actually practiced and are therefore indefinite.
Written Description
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 1-17 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 is a Written Description rejection.
Claims 1-17 require a polynucleotide sequence encoding a protoporphyrinogen oxidase (PPO) that has at least 90% identity to an amino acid sequence of instant SEQ ID NOs: 1-6.
SEQ ID NO: 1 is used below to exemplify and prove a lack of written description of the claimed subject matter, however the rejection applied to SEQ ID NOs: 2-5 for the same reasons.
Nucleic acids encoding protoporphyrinogen oxidases with 90% identity to, e.g., 177 amino acid long SEQ ID NO: 1 encompass those encoding proteins with 17 amino acid substitutions relative to SEQ ID NO: 1.
The only species of PPO amino acids described in the specification are SEQ ID NOs: 1-6 encoding proteins with at most 58.6% identity to SEQ ID NO: 1. See alignment below. The only species of nucleotide encoding a PPO described in the specification are SEQ ID NOs: 7-24, of which SEQ ID NOs: 7, 13, and 19 encode a PPO with the amino acid sequence of SEQ ID NO: 1. Thus, the specification does not describe species over the full scope of the claimed proteins and accordingly does not describe species over the full scope of the nucleic acids encoding them.
US-18-859-903A-3
Sequence 3, US/18859903A
Publication No. US20250275540A1
GENERAL INFORMATION
APPLICANT: BEIJING DABEINONG BIOTECHNOLOGY CO., LTD.
TITLE OF INVENTION: USE OF PROTOPORPHYRINOGEN OXIDASE
FILE REFERENCE: FP1220438P
CURRENT APPLICATION NUMBER: US/18/859,903A
CURRENT FILING DATE: 2024-10-24
NUMBER OF SEQ ID NOS: 57
SEQ ID NO 3
LENGTH: 176
TYPE: PRT
ORGANISM: Proteus
FEATURE:
OTHER INFORMATION: The amino acid sequence of PPOC
Query Match 58.6%; Score 535.5; Length 176;
Best Local Similarity 57.7%;
Matches 101; Conservative 31; Mismatches 42; Indels 1; Gaps 1;
Qy 1 MKALLIYSSREGQTKTIVTRIADELQEKGIQVDLYNVDDVPQ-VNFADYSGILVGAAIRY 59
| |||:| | :|||| |:|:||:||:: | : |: :: | | :| : |: :||||:|||
Db 1 MSALLLYCSTDGQTKKIMTQIANELRQHGYECDVRDLTSVQQSLNLSAYNKVLVGASIRY 60
Qy 60 GHFHKKFRMFVERHYQALNQVPSAFVSVSLIARKAEKQTVETNSYTRKYLAATPWHPTLC 119
|:|:| |: || || :|:|| |:| ||| || | |||:| ||:| ||| |||
Db 61 GYFNKALDKFITRHLAQLNSMPTAFFGVNLTARKEEKNTPETNAYMRKFLDKTPWKPTLT 120
Qy 120 GVFAGALRYPRYTWLDRIMIQLIMKMTKGETDSSKEVEYTDWVKVRQFAEEFERL 174
||||||| |||| |:||:|||||||||||||| :||:||||| || :|| | ::
Db 121 GVFAGALFYPRYKWIDRVMIQLIMKMTKGETDPTKEIEYTDWNKVSEFASHFAKI 175
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species.
Hence, Applicant has not, in fact, described nucleic acids that encode a PPO with at least 90% sequence identity to SEQ ID NOs: 1-6 over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention. Because the nucleic acids that encode a PPO with at least 90% sequence identity to SEQ ID NOs: 1-6 are not described over the full scope of the claims, the method of using the sequences to control weeds, generate or cultivate a plant which is tolerant to a PPO-inhibitor herbicide, protect a plant from damages caused by a PPO-inhibitor herbicide or use said PPO is likewise not described, and the specification fails to provide an adequate written description of the claimed invention. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Claim Rejections - 35 USC § 102
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 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 1-13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larue (US-20190185873-A1).
Claim 1 is drawn to, in the broadest embodiment, a method for controlling weeds comprising applying a herbicide containing an effective dose of a PPO inhibitor to a field where at least one transgenic plant is present, wherein the transgenic plant comprises in its genome a polynucleotide sequence encoding a protoporphyrinogen oxidase having at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6, and the transgenic plant has a reduced plant damage and/or increased plant yield compared with other plants without the polynucleotide sequence encoding the protoporphyrinogen oxidase.
Claim 2 is drawn to the method for controlling weeds according to claim 1, characterized in that the polynucleotide sequence of the protoporphyrinogen oxidase comprises: (a) a polynucleotide sequence encoding an amino acid sequence having at least 90% sequence identity to a sequence selected from SEQ ID NOs: 1-6, wherein the polynucleotide sequence does not include SEQ ID NOs: 7-12; or (b) a polynucleotide sequence as shown in any one of SEQ ID NOs: 13-24.
Claim 3 is drawn to the method for controlling weeds according to claim 1, characterized in that the transgenic plant further comprises at least one second polynucleotide encoding a second herbicide-tolerant protein, which is different from the polynucleotide sequence encoding the protoporphyrinogen oxidase.
Claim 4 is drawn to the method for controlling weeds according to claim 3, characterized in that the second polynucleotide encodes a selectable marker protein, a protein with synthetic activity, a protein with degradation activity, a biotic stress-resistant protein, an abiotic stress-resistant protein, a male sterility protein, a protein that affects plant yield and/or a protein that affects plant quality.
Claim 5 is drawn to the method for controlling weeds according to claim 4, characterized in that the second polynucleotide encodes 5-enolpyruvylshikimate-3-phosphate synthase, glyphosate oxidoreductase, glyphosate-N-acetyltransferase, glyphosate decarboxylase, glufosinate acetyltransferase, alpha-ketoglutarate-dependent dioxygenase, dicamba monooxygenase, 4- hydroxy phenyl pyruvate dioxygenase, acetolactate synthase, and/or cytochrome-like protein.
Claim 6 is drawn to the method for controlling weeds according to any one of claims1--5,characterized in that the herbicide containing an effective dose of a PPO inhibitor further includes a glyphosate herbicide, glufosinate herbicide, auxin-like herbicide, graminicide, pre- emergence selective herbicide and/or post-emergence selective herbicide.
Claim 7 is drawn to, in the broadest embodiment, a planting combination for controlling the growth of weeds, comprising a PPO- inhibitor herbicide and at least one transgenic plant, wherein the herbicide containing an effective dose of a PPO inhibitor is applied to a field where the at least one transgenic plant is present, wherein the transgenic plant comprises in its genome a polynucleotide sequence encoding a protoporphyrinogen oxidase, and the transgenic plant has a reduced plant damage and/or increased plant yield compared with other plants without the polynucleotide sequence encoding the protoporphyrinogen oxidase; wherein the protoporphyrinogen oxidase has at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6.
Claim 8 is drawn to the planting combination for controlling the growth of weeds according to claim 7, characterized in that the polynucleotide sequence of the protoporphyrinogen oxidase comprises: (a) a polynucleotide sequence encoding an amino acid sequence having at least 90% sequence identity to a sequence selected from SEQ ID NOs: 1-6, wherein the polynucleotide sequence does not include SEQ ID NOs: 7-12; or (b) a polynucleotide sequence as shown in any one of SEQ ID NOs: 13-24.
Claim 9 is drawn to the planting combination for controlling the growth of weeds according to claim 7, characterized in that the transgenic plant further comprises at least one second polynucleotide encoding a second herbicide-tolerant protein, which is different from the polynucleotide sequence encoding the protoporphyrinogen oxidase.
Claim 10 is drawn to the planting combination for controlling the growth of weeds according to claim 9, characterized in that the second polynucleotide encodes a selectable marker protein, a protein with synthetic activity, a protein with degradation activity, a biotic stress-resistant protein, an abiotic stress-resistant protein, a male sterility protein, a protein that affects plant yield and/or a protein that affects plant quality.
Claim 11 is drawn to the planting combination for controlling the growth of weeds according to claim 10, characterized in that the second polynucleotide encodes 5-enolpyruvylshikimate-3-phosphate synthase, glyphosate oxidoreductase, glyphosate-N-acetyltransferase, glyphosate decarboxylase, glufosinate acetyltransferase, alpha-ketoglutarate-dependent dioxygenase, dicamba monooxygenase, 4-hydroxy phenyl pyruvate dioxygenase, acetolactate synthase, and/or cytochrome-like protein.
Claim 12 is drawn to the planting combination for controlling the growth of weeds according to claim 7, characterized in that the herbicide containing an effective dose of a PPO inhibitor further includes a glyphosate herbicide, glufosinate herbicide, auxin-like herbicide, graminicide, pre-emergence selective herbicide and/or post-emergence selective herbicide.
Claim 13 is drawn to, in the broadest embodiment, a method for producing a plant which is tolerant to a PPO-inhibitor herbicide, characterized in that the method comprises introducing a polynucleotide sequence encoding a protoporphyrinogen oxidase into the genome of the plant, and when the herbicide containing an effective dose of a PPO inhibitor is applied to a field where at least the plant is present, the plant has a reduced plant damage and/or increased plant yield compared with other plants without the polynucleotide sequence encoding the protoporphyrinogen oxidase, wherein the protoporphyrinogen oxidase has at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6.
Claim 15 is drawn to, in the broadest embodiment, a method for protecting a plant from damages caused by a PPO-inhibitor herbicide or for conferring tolerance to the PPO-inhibitor herbicide upon a plant, characterized by comprising applying the herbicide comprising an effective dose of a PPO inhibitor to a field where at least one transgenic plant is present, wherein the transgenic plant comprises in its genome a polynucleotide sequence encoding a protoporphyrinogen oxidase, and the transgenic plant has a reduced plant damage and/or increased plant yield compared with other plants without the polynucleotide sequence encoding the protoporphyrinogen oxidase, wherein the protoporphyrinogen oxidase has at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6.
Claim 16 is drawn to, in the broadest embodiment, a use of a protoporphyrinogen oxidase for conferring tolerance to a PPO-inhibitor herbicide upon a plant, wherein the protoporphyrinogen oxidase has at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6.
Claim 17 is drawn to the use of a protoporphyrinogen oxidase for conferring tolerance to a PPO- inhibitor herbicide upon a plant according to claim 16, characterized in that the polynucleotide sequence of the protoporphyrinogen oxidase comprises: (a) a polynucleotide sequence encoding an amino acid sequence having at least 90% sequence identity to a sequence selected from SEQ ID NOs: 1-6, wherein the polynucleotide sequence does not include SEQ ID NOs:7-12; or (b) a polynucleotide sequence as shown in any one of SEQ ID NOs: 13-24.
Regarding claims 1, 7, and 15 Larue discloses a method for controlling or preventing weed growth in a plant growth area, comprising applying an effective amount of at least one PPO herbicide to a plant growth area that comprises the transgenic plant or seed of claim 11, wherein the transgenic plant or seed is tolerant to the PPO herbicide (claim 20 of Larue). Larue discloses the transgenic plant or seed of claim 11 comprises the recombinant DNA molecule of claim 1 (claim 11 of Larue), which comprises a heterologous promoter operably linked to a nucleic acid molecule encoding a protein with herbicide-tolerant protoporphyrinogen oxidase activity, wherein the protein has at least 50% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs:1-23 and comprises at least a first amino acid substitution at a position corresponding to residues 125 through 146 of SEQ ID NO:1, wherein the substitution is selected from the group that includes Q139K (claim 1 of Larue). Of the sequences disclosed by Larue, SEQ ID NO: 13 is 92.4% identical to instant SEQ ID NO: 6 (see alignment below), and instant SEQ ID NO: 6 also comprises the Q139K substitution disclosed by Larue. Furthermore, Larue discloses the invention is for the purpose of providing new herbicide tolerance traits in the field (¶0004), and a weed is any undesired plant and may be considered undesirable in a particular situation, for example a crop plant of one species in a field of a different species, also known as a volunteer plant (¶0072). Additionally, Larue discloses the transgenic plant comprises the recombinant DNA molecule of claim 1, and discloses recombinant DNA may be used in vectors for transformation (i.e. introducing the heterologous DNA into plastid or genomic DNA) to produce transgenic plants (¶0047). Therefore the polynucleotide sequence encoding the PPO must have been introduced into the genome of the plant as required by claim 13. Lastly, because weed growth is prevented, the PPO herbicide dose is effective, and the transgenic plants were tolerant to the PPO herbicide as disclosed in claim 1, the transgenic plant is reasonably interpreted to have reduced damage and/ or increased yield compared to the weed. Therefore, the disclosure of Larue anticipates claims 1, 7, 13, and 15.
RESULT 2
US-16-218-822-13
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 13, US/16218822
Publication No. US20190185873A1
GENERAL INFORMATION
APPLICANT: Monsanto Technology LLC
TITLE OF INVENTION: Methods and Compositions for PPO Herbicide Tolerance
FILE REFERENCE: MONS:429US
CURRENT APPLICATION NUMBER: US/16/218,822
CURRENT FILING DATE: 2018-12-13
PRIOR APPLICATION NUMBER: US 62/599,386
PRIOR FILING DATE: 2017-12-15
NUMBER OF SEQ ID NOS: 278
SEQ ID NO 13
LENGTH: 179
TYPE: PRT
ORGANISM: Rahnella aquatilis
Query Match 92.4%; Score 879; Length 179;
Best Local Similarity 92.2%;
Matches 165; Conservative 7; Mismatches 7; Indels 0; Gaps 0;
Qy 1 MKALILYSSRDGQTHAIA SFIANELKEKCNCDVVDLAHAGHVDLKHYDQVMIGASIRYGH 60
|||||||||||||||||||:|||||||||:||||||||| |||| ||||||||||||||
Db 1 MKALILYSSRDGQTHAIA SYIANELKEKCSCDVVDLAHAERVDLKSYDQVMIGASIRYGH 60
Qy 61 FNAVLDKFVKTHSETLNQMPSAFFGVNLTARKPEKRTPQTNAYVRKFLLTSPWEPAICGV 120
|| ||||||| |:||||:||||||||||||||||||||||||||||||| ||||||:|||
Db 61 FNPVLDKFVKKHAETLNRMPSAFFGVNLTARKPEKRTPQTNAYVRKFLLASPWEPAMCGV 120
Qy 121 FAGALRYPRYRWFDKVMIKLIMRMTGGETDTSKEVEYTDWQQVAKFAKDFGQISYKKSH 179
||||||||||||||||||:|||||||||||| |||||||||||||||:|||||||||||
Db 121 FAGALRYPRYRWFDKVMIQLIMRMTGGETDTRKEVEYTDWQQVAKFAEDFGQISYKKSH 179
Regarding claims 2 and 8, which requires the polynucleotide sequence encoding the PPO amino acid sequence have 90% identity to an of SEQ ID NOs: 1-6 and the polynucleotide sequence does not include SEQ ID NOs: 7-12, Larue discloses SEQ ID NO: 13 which is 92.4% identical to instant SEQ ID NO: 6. Because the amino acid sequence of SEQ ID NO: 13 is 92.4% identical to instant SEQ ID NO: 6, the polynucleotide sequence encoding SEQ ID NO: 13 cannot have the polynucleotide sequence of SEQ ID NO: 12 (which encodes SEQ ID NO: 6 at 100% identity).
Regarding claims 3 and 9, Larue discloses a method for reducing the development of herbicide-tolerant weeds comprising: a) cultivating in a crop growing environment a plant according to claim 11; and b) applying a PPO herbicide and at least one other herbicide to the crop growing environment, wherein the crop plant is tolerant to the PPO herbicide and the at least one other herbicide (claim 25 of Larue). Because the crop is tolerant to at least one other herbicide, the plant is reasonably interpreted to comprise a second polynucleotide encoding a second herbicide-tolerant protein.
Regarding claims 4-5 and 10-11, Larue discloses the at least one other herbicide that the crop is also resistant to is a HPPD inhibitor (claim 27 of Larue). Because the crop is resistant to HPPD inhibitor, the crop is reasonably interpreted to comprise a second polynucleotide encoding hydroxy phenyl pyruvate dioxygenase (HPPD))
Regarding claims 6 and 12, Larue discloses Larue discloses a method for reducing the development of herbicide-tolerant weeds comprising: a) cultivating in a crop growing environment a plant according to claim 11; and b) applying a PPO herbicide and at least one other herbicide to the crop growing environment, wherein the crop plant is tolerant to the PPO herbicide and the at least one other herbicide (claim 25 of Larue). Larue further discloses wherein the at least one other herbicide is selected from a group including an EPSPS inhibitor (claims 27-28 of Larue) (i.e. the herbicide containing an effective dose of a PPO inhibitor further includes a glyphosate herbicide).
Regarding claim 16, Larue discloses transgenic plants comprising a heterologous polynucleotide sequence encoding a PPO amino acid sequence of SEQ ID NO: 13 and is 92.4% identical to instant SEQ ID NO: 6 (claims 1 and 11 of Larue). Larue discloses the transgenic plant expressing SEQ ID NO: 13 is tolerant to a PPO herbicide (i.e. the protoporphyrinogen oxidase has at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6 and confers tolerance to a PPO-inhibitor herbicide).
Regarding claim 17, which requires the polynucleotide sequence encoding the PPO amino acid sequence have 90% identity to an of SEQ ID NOs: 1-6 and the polynucleotide sequence does not include SEQ ID NOs: 7-12, Larue discloses SEQ ID NO: 13 which is 92.4% identical to instant SEQ ID NO: 6. Because the amino acid sequence of SEQ ID NO: 13 is 92.4% identical to instant SEQ ID NO: 6, the polynucleotide sequence encoding SEQ ID NO: 13 cannot have the polynucleotide sequence of SEQ ID NO: 12 (which encodes SEQ ID NO: 6 at 100% identity). That is, the polynucleotide sequence must be different than SEQ ID NO: 12 because different amino acid sequences cannot be encoded by the same polynucleotide sequence.
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Larue (US-20190185873-A1).
Claim 14 is drawn to, in the broadest embodiment, a method for cultivating a plant which is tolerant to a PPO-inhibitor herbicide, characterized by comprising: planting at least one plant propagule, the genome of which contains a polynucleotide encoding a protoporphyrinogen oxidase, wherein the protoporphyrinogen oxidase has at least 90% sequence identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6; growing the plant propagule into a plant; and applying the herbicide comprising an effective dose of a PPO inhibitor to a field comprising at least the plant, and harvesting the plant having a reduced plant damage and/or increased plant yield compared with other plants without the polynucleotide sequence encoding the protoporphyrinogen oxidase.
Regarding claim 14, Larue teaches transforming soybean cells with vectors, one of which comprised HemG003/ SEQ ID NO: 13 of Larue which is 92.4% identical to instant SEQ ID NO: 6. Larue teaches regenerating transgenic plantlets from the cells and growing them in the greenhouse (¶0089-0090). Larue also teaches the plants were sprayed at approximately V2 to V4 growth stage with the PPO herbicide at a rate of 80 or 20 g/ha to evaluate tolerance (i.e. reasonably interpreted as growing the plantlet (i.e. a propagule) comprising a PPO having at least 90% sequence identity to SEQ ID NO: 6 into a plant and applying the herbicide comprising an effective dose of PPO inhibitor) (¶0089-0090).
However, Larue does not explicitly teach the herbicide was applied in a field comprising the plant, nor harvesting the plant having reduced plant damage and/or increased yield compared to other plants without the polynucleotide encoding the PPO.
In an alternative embodiment, Larue teaches the invention is for the purpose of providing new herbicide tolerance traits in the field (¶0004), and a weed is any undesired plant and may be considered undesirable in a particular situation, for example a crop plant of one species in a field of a different species, also known as a volunteer plant (¶0072). Larue also teaches in an alternative embodiment, expressing a different PPO in soybean, applying the herbicide, and selfing transgenic plants that passed the herbicide spray testing to produce R1 seed, then planting and growing the R1 seed (¶0108). Because the seed was collected from the selfed plants that passed the herbicide sprat tests, this is reasonably interpreted as a step of harvesting the plant with reduced plant damage.
Larue teaches all of the limitations of the rejected claims in alternative embodiments, but does not disclose a single embodiment having all the limitations. As such, the claims are not rejected as anticipated under 35 USC §102 but are instead rejected as obvious under 35 USC §103. One of ordinary skill in the art would have been motivated to combine the limitations as taught by Larue into a single embodiment to arrive at Applicant’s claimed inventions because each limitation is explicitly taught as an alternative embodiment of the invention. It would therefore be obvious to combine the methods taught by Larue for the purpose of growing the new herbicide tolerant plants in the field where herbicide-resistant weeds also grow, and collecting the seed produced by the transgenic plants (i.e. harvesting the plant) to obtain seed comprising the PPO having at least 90% identity to SEQ ID NO: 6 that confers reduced damage compared to weeds when the PPO herbicide is applied as explicitly taught by Larue (¶0004, 0072, 0089-0090, and 0108). One having ordinary skill in the art would have a reasonable expectation of success because the method Larue teaches was functional and successful and the application to the alternative embodiments present no special technical obstacles.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/557,777 (reference application). The considered claims in the copending application are dated 10/20/2025. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the copending application, specifically with respect to instant SEQ ID NO: 3 which has 94.8% sequence identity to SEQ ID NO: 3 in the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
Prosecution Insights