DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Claims 1-20 are pending.
3. Claims 2-19 are withdrawn from consideration.
4. Claims 1 and 20 are examined.
Election/Restrictions
5. Applicant’s election of Group I, claims 1 and 20, and SEQ ID NO: 1 and 2 as species, in the reply filed on June 2, 2026 is acknowledged. 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)).
Claims 2-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 2, 2026.
Claim Objections
6. Claim 1 is objected to because of the following informalities: the abbreviation “PPO” should be spelled out at its first use. The term “tolerance of resistance” should be amended to recite either “tolerance” or “resistance,” as the terms are synonymous in the context of the claimed method.
In part (d), the term “identity with” should be replaced with --identity to-- in order to reflect conventional usage. Appropriate correction is required.
Claim Interpretation
8. Claim 1 is given its broadest reasonable interpretation as encompassing any nucleic acid molecule that encodes any homolog of SEQ ID NO: 2. The claim does not set forth any structural information for said homolog.
The specificaiton teaches that SEQ ID NO: 1 and 2 are a nucleic acid and protein of the wild-type PPO from blackgrass, Alopecurus myosuroides (Table 1 on pg. 9), which is a common and naturally-occurring weed (see, for example, US Patent 4,047,932, col. 1, lines 35-37). It is noted that besides reciting the PPO from blackgrass, the claims would encompass any homolog of the PPO of SEQ ID NO: 2 or the encoding nucleic acid of claim 1, not limited by a specific sequence.
Claim Rejections - 35 USC § 112 - First Paragraph
9. 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.
Written Description
10. Claims 1 and 20 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.
Applicant claims a method of producing a transgenic plant with increased herbicide tolerance or resistance, comprising transforming said plant with a nucleic acid molecule encoding the PPO polypeptide having the amino acid sequence of SEQ ID NO: 2 or any homolog thereof. Applicant claims said method wherein the nucleic acid encoding a PPO polypeptide has at least 30% identity to SEQ ID NO: 2, wherein the polypeptide confers herbicide tolerance. Applicant claims said method comprising transforming a plant with any polynucleotide that hybridizes under stringent conditions with SEQ ID NO: 1 or with any homolog thereof. Applicant claims a plant produced by said method.
Applicant describes the full-length SEQ ID NO: 1 and 2 as a wild-type nucleic acid sequence and the encoded amino acid sequence of the PPO from Alopecurus myosuroides (see Sequence Listing; Table 1; Fig. 1) Applicant describes a number of variants of SEQ ID NO: 2 that differ from it at one or two positions and confer herbicide tolerance (Tables 3a and 3b; Tables 6a and 6b).
Applicant does not describe the genus of nucleic acid molecules as broadly recited in the claimed method. The Federal Circuit has clarified 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; 48 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 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.
In the instant case, Applicant described neither a representative number of species nor set forth the required structure-function relationship. Applicant does not describe the genus of isolated nucleic acids encoding a PPO polypeptide, wherein the polypeptide is any homolog of SEQ ID NO: 2, or wherein the encoding nucleic acid is any homolog of SEQ ID NO: 1. Applicant does not describe the genus of nucleic acids encoding a PPO having 30% sequence identity to SEQ ID NO: 2, wherein the PPO confers increased herbicide tolerance. Nor does Applicant describe the genus of any polynucleotide that hybridizes under stringent conditions with any of the nucleic acids recited in parts (a)-(c) of claim 1.
The genus of homologs encompassed by the claims is recited solely by its function and is therefore much broader than the genus of the described species. Similarly, the genus of nucleic acids encoding a protein with at least 30% identity to SEQ ID NO: 2 would encompass a number of species that is infinite in practical term.
Moreover, part (e) of claim 1 recites the claimed nucleic acid solely by its ability to hybridize under stringent conditions to any of the other nucleic acids recited in the claim (apparently, including any homolog of SEQ ID NO: 1), and to confer “increased herbicide tolerance or resistance.” Fourgoux-Nicol et al provide evidence that a probe having less than 50% sequence identity to a polynucleotide fragment could hybridize with that polynucleotide under stringent conditions that include three consecutive 30 min washes in 2X, 1X, and 0.1X SSC with 0.1% SDS at 650C. (Plant Mol. Biol. (1999) 40: 857-872; see page 859, left col., 2nd paragraph; page 862, Fig. 2). In view of this evidence, a nucleic acid that has only 50% sequence identity to SEQ ID NO: 1 would be encompassed by the claims. And since a single nucleotide substitution could translate to a single amino acid substitution, such a nucleic acid would encode a protein with little or no identity to SEQ ID NO: 2.
Therefore, given the breadth of the genus encompassed by the claims, the single and double mutants of SEQ ID NO: 2, described in Table 3a and the variants set forth in Table 6 are not sufficiently representative. It is also noted that a definition by function alone “does not suffice” to sufficiently describe a coding sequence “because it is only an indication of what the gene does, rather than what it is.” Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)).
For these reasons, it is unclear whether at the time of filing Applicant was in possession of the invention as broadly claimed.
Claim Rejections - 35 USC § 102
11. 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.
12. Claims 1 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (Plant Physiol. (2003) 133:736-747).
As set forth above, the method of claim 1 is not limited to the use of the PPO polynucleotide comprising SEQ ID NO: 1 or encoding SEQ ID NO: 2, but will encompass a nucleic acid encoding homolog of SEQ ID NO: 2. The specificaiton does not limit nor define the term “homolog” and one of ordinary skill in the art would reasonably interpret the term as encompassing any PPO enzyme, including from a species other than Alopecurus myosuroides (from which SEQ ID NO’s 1 and 2 are obtained), and including any mutants thereof, wherein the exogenous expression of said PPO in a plant results in an increase in herbicide tolerance to a PPO inhibitor relative to a wild-type plant.
Li et al disclose a PPO gene from herbicide-resistant Arabidopsis plants, wherein the gene encodes a PPO enzyme comprising two substitutions: at positions Y426 and S305 (pg. 738, bottom of right col.). Li et al disclose that the Y426M mutation alone was sufficient to confer high levels of tolerance to butafenacil (pg. 739, left col., first paragraph).
Li et al disclose a method of making herbicide-tolerant Arabidopsis and maize plants by expressing a vector encoding the double mutated PPO in their cells and regenerating herbicide tolerant plants from said cells (pg. 739, both col. - pg. 740, left col.). Li et al disclose plants produced by said method and that that the transgenic plants expressing the double mutant PPO showed cross-resistance to a number of PPO inhibitors (Table I on pg. 739 and bottom of left col. of pg. 739).
Given the above claim interpretation, the disclosure of Li et anticipates the limitations of the instant claims.
Relevant Prior Art
13. While the following prior art was not relied upon in the anticipation rejection, above, the Examiner notes that it is relevant to Applicant’s disclosure.
Rousonelos (Master’s Thesis, University of Illinois, published August 2010), which teaches identifying, in the PPO of naturally occurring herbicide resistant population of ragweed plants, the presence of the R98L polymorphism (pg. iii; 63; 67, top paragraph; and beginning on pg. 76, bottom paragraph). Rousonelos also teaches that arginine R98 is highly conserved in plants and is involved in substrate coordination within the active site (Fig. 3.4 and paragraph spanning pg. 76-77; pg. 77, first full paragraph).
Conclusion
14. No claims are allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662
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