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 .
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 05, 2026 has been entered.
Claim Status
2. Claims 1-2, 4-6, 17, and 19 are pending and under examination to the extent of the elected species of oats.
Claims 3, 7-16, 18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 13, 2025. The restriction requirement was made FINAL in the Office Action dated 04/28/2025.
Response to Arguments – Claim Objections
3. Applicant’s amendments filed January 05, 2026 have been carefully considered but are not persuasive and do not overcome the objections of record. Furthermore, said amendments have necessitated new grounds for objections to the claims.
Though Applicant has amended the recitation in claim 2 wherein a “native unmutated hydroxyphenylpyruvate dioxygenase polypeptide is HPPDs of plants or microorganisms”, the amended claim retains grammatical and/or typographical errors. Therefore, the objection is maintained.
Claim Objections
4. Claims 1-2, 4-6, 17, and 19 are objected to because of the following:
Regarding claim 1, Applicant has not defined the acronym HPPD before its introduction in ln. 3. It is recommended Applicant amend ln. 1 to recite “A mutant hydroxyphenylpyruvate dioxygenase polypeptide (HPPD)” so that the full name of the protein is introduced prior to its acronym.
Claim 2, lns. 2-3 contain grammatical errors. Regarding the recitation of wherein the “native unmutated hydroxyphenylpyruvate dioxygenase polypeptide is one of plant or microorganism HPPDs”, Applicant is required to amend the claim to correct the improper grammar. It is suggested Applicant amend “native unmutated hydroxyphenylpyruvate dioxygenase polypeptide is one of plant or microorganism HPPDs” to “native unmutated hydroxyphenylpyruvate dioxygenase polypeptide is a plant or microorganism HPPD”, if appropriate.
Claim 2, lns. 5-9 contain typographical errors. “Brachypodium distachyon”, “cicer arietinum”, “Arabidopsis thaliana”, “Cyanophyta”, “Pseudomonas fluorescens”, “Sphingobium”, and “Burkholderia” should be italicized. It is standard nomenclature in the biological arts to italicize the proper names of genera. Additionally, “cicer” should be capitalized.
Claim 2, ln. 9 contains a grammatical error; “genus” should be amended to “genera” for correct subject-verb agreement because more than one genus is recited.
Dependent claims are included, and appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
5. Applicant’s arguments and amendments filed January 05, 2026 have overcome the rejections of record. However, said amendments have necessitated new grounds of rejection under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112(b)
6. 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.
7. Claims 1-2, 4-6, 17, and 19 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.
The metes and bounds of claim 1 are indefinite because it is unclear what is intended by the recitation of “high-resistant tolerance” because this is not an art-recognized term or phrase and Applicant provides no definition or parameters for the phrase. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Does Applicant intend to recite a specific type of tolerance? Applicant is required to clarify the intended recitation and is reminded no new matter may be added.
The scope of claim 1 is indefinite because it is unclear what is intended by the recitation of “one-fold field concentration” and “four-fold field concentration” because these are not art-recognized terms of phrases and Applicant has provided no definition for these phrases in the specification or claims. Though Applicant recites the terms “one-fold field concentration” and “four-fold field concentration” (p. 53, lns. 8-15), these recitations are examples, not definitions, and therefore, the recitations do not provide further limitations to the claim. It is unclear how these recitations are intended to provide further structure or limitations to the claimed mutant HPPD polypeptide. Does Applicant intend for the invention to be limited to a particular concentration of the recited polypeptide? Applicant is required to clarify the intended recitation and is reminded that no new matter may be added.
The scope of claim 1 is indefinite because it is unclear what is encompassed by and how one would assess a “degree of damage of less than 50%”. The claims do not describe the parameters by which said plant damage is to be assessed. The specification provides no definition for the term “plant damage” and this term is not standard or recognized in the art. Though Applicant provides examples of “plant damage” in the specification, the claims are not limited to these embodiments (p. 21, lns. 4-19; p. 26, lns. 31-44). It is recommended Applicant amend the claim to describe the parameters by which a “degree of damage of less than 50%” may be assessed, if appropriate. Applicant is required to clarify the intended recitation and is reminded that no new matter may be added.
The scope of claim 1 is indefinite because the term “can” in the recitation, “can confer high-resistant tolerance to HPPD-inhibitor herbicide upon a plant” makes it unclear what conditions are required for the mutant HPPD polypeptide to confer high tolerance or resistance to an HPPD-inhibitor herbicide. Are there conditions/situations in which the polypeptide would not confer resistance/tolerance to a plant comprising the polypeptide? If the mutant HPPD polypeptide constitutively confers HPPD inhibitor tolerance to a plant expressing said polypeptide, it is suggested Applicant amend “can confer” to “confers”. As currently recited, the claim does not require the mutant HPPD polypeptide confer increased HPPD inhibitor tolerance; such a polypeptide may be subject to analysis for utility under 35 U.S.C. 101. Applicant is required to clarify the intended recitation and is reminded that no new matter may be added.
Dependent claims are included, and appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 102
8. Applicant’s arguments and amendments filed January 05, 2026 have been carefully considered but are not persuasive and do not overcome the rejections of record.
In the remarks dated January 05, 2026, Applicant argues primarily that claim 1 has been amended to recite specific traits of the mutant peptide (p. 10, “Rejections Under 35 U.S.C. 102”, second paragraph) and that Hawkes’ teachings regarding F372 are speculative (pp. 10-11, “Rejections Under 35 U.S.C. 102”, paragraphs 3-5).
Applicant’s arguments are not considered persuasive because the traits of the mutant peptide are inherent to said polypeptide regardless of the disclosure of said traits at the time of the disclosure of the structure of the polypeptide. Hawkes explicitly teaches mutating position 372 of an amino acid sequence that is identical to Applicant’s SEQ ID NO:1 to provide HPPD-inhibitor herbicide resistance to a plant and further suggests that said position may be substituted with any amino acid. The function and/or activity of a polypeptide is inherent to its structure/sequence regardless of explicit validation or invalidation of said activity. Thus, regardless of whether Hawkes validated the functionality of a substitution at position 372 of a sequence identical to SEQ ID NO:1, said functionality (e.g., the reaction of transforming 4-hydroxyphenylpyruvic acid into homogentisic acid or homogentisate) would be inherent to said protein. Even if an inherent feature was not recognized at the time of discovery, said polypeptide does not become patentable upon the discovery of a new property. See MPEP 2112. Therefore, even if Hawkes is silent to any particular trait of the mutant HPPD polypeptide as recited in the claims, such a trait is inherent to the protein taught by Hawkes. Therefore, the claims are anticipated by the teachings of Hawkes.
Accordingly, claims 1-2, 5-6, and 17 remain rejected under 35 U.S.C. 102.
Claim Rejections - 35 USC § 102
9. 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.
10. Claims 1-2, 5-6, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkes et al. (US-2010/0197503-A1, published 09/24/2014 (previously cited)).
Hawkes discloses a mutant HPPD, which retains the HPPD catalytic activity and is less sensitive to an HPPD-inhibitor herbicide than the native, unmutated HPPD[0006]. Hawkes discloses the mutation may comprise any substitution at position F372 of SEQ ID NO:27[0039], which is identical to the instant SEQ ID NO:1, and may further comprise a substitution at position 413[0082]. Hawkes also discloses a polynucleotide sequence and expression vector encoding the mutant HPPD and a method for co-expressing the HPPD with another protein to produce an HDDP inhibitor-resistant plant[0085], [0101], [0117], [0146].
As stated above, in the rejection of the claims under 35 U.S.C. 112(b), the recitations regarding “high-tolerant resistant”, “one-fold field concentration to four-fold field concentration”, and a “degree of damage of less than 50%” are indefinite. Thus, for the purpose of compact prosecution, claim 1 is herein interpreted to recite a mutant HPPD polypeptide, which retains the activity of catalyzing the reaction of transforming 4-hydroxyphenylpyruvic acid into homogentisic acid or homogentisate and is less sensitive to an HPPD-inhibitor herbicide than the native, unmutated HPPD, wherein the mutant HPPD further comprises a mutation at position 372 of SEQ ID NO:1, wherein F372 is either deleted or substituted with alanine, glycine, valine, proline, serine, threonine, cytosine, methionine, glutamine, or aspartate, wherein the mutant HPPD polypeptide confers high resistance and/or tolerance to an HPPD-inhibitor herbicide upon a plant expressing the polynucleotide, wherein the HPPD-inhibitor herbicide is at some concentration, and wherein the plant has no or reduced plant damage caused by the HPPD-inhibitor herbicide. Applicant is required to clarify the intended recitation and is reminded no new matter may be added.
Regarding claim 1, Hawkes teaches a mutant HPPD polypeptide, which retains the activity of catalyzing the reaction of transforming 4-hydroxyphenylpyruvic acid into homogentisic acid or homogentisate and is less sensitive to an HPPD-inhibitor herbicide than the native, unmutated HPPD of SEQ ID NO:27 (which is identical to the instant SEQ ID NO:1), wherein the mutant HPPD further comprises a mutation at position 372, wherein F372 is substituted with any other amino acid[0006], [0039], wherein the mutant HPPD polypeptide confers high resistance and/or tolerance to an HPPD-inhibitor herbicide upon a plant expressing the polynucleotide, wherein the HPPD-inhibitor herbicide is at various fold concentrations including those typically employed in the field[0101], [0191], [0259], and wherein the plant has no or reduced plant damage caused by the HPPD-inhibitor herbicide[0101], [0191], [0244], [0322-0323], [0598], [0600] (see also: Abstract; claims). The amino acid sequence of SEQ ID NO:63 is comprised within SEQ ID NO:27 of Hawkes, and the F residue of Hawkes’ SEQ ID NO:63 corresponds to F372 of Applicant’s SEQ ID NO:1[0039].
Hawkes explicitly teaches mutating position 372 of an amino acid sequence that is identical to Applicant’s SEQ ID NO:1 to provide HPPD-inhibitor herbicide resistance to a plant and further suggests that said position may be substituted with any amino acid; thus, the teachings of Hawkes anticipate a mutation at position 372 of the recited HPPD polypeptide. The function and/or activity of a polypeptide is inherent to its structure/sequence regardless of explicit validation or invalidation of said activity. Thus, regardless of whether Hawkes validated the functionality of a substitution at position 372 of a sequence identical to SEQ ID NO:1, said functionality (e.g., the reaction of transforming 4-hydroxyphenylpyruvic acid into homogentisic acid or homogentisate) would be inherent to said protein. Even if an inherent feature was not recognized at the time of discovery, said polypeptide does not become patentable upon the discovery of a new property. See MPEP 2112.
Regarding claim 2, in addition to the teachings discussed above, Hawkes teaches an HPPD polypeptide obtained from Avena sativa (oats)[0116].
Regarding claims 5 and 17, proteins are inherently encoded in polynucleotides. Therefore, in teaching mutant HPPD polypeptides, Hawkes also teaches polynucleotide sequences encoding said polypeptides[0039]. Furthermore, in addition to the teachings discussed above, Hawkes teaches polynucleotides encoding mutant HPPDs[0085], [0146].
Regarding claim 6, in addition to the teachings discussed above, Hawkes teaches an expression cassette comprising a mutant HPPD under the regulation of effectively-linked regulatory sequences[0085], [0146].
Accordingly, the claimed invention is anticipated by the prior art.
Response to Arguments – Claim Rejections - 35 USC § 103
11. Applicant’s arguments and amendments filed January 05, 2026 have been carefully considered but are not persuasive and do not overcome the rejections of record.
In traversing the rejection of claims 4 and 19 under 35 U.S.C. 103, Applicant reasserts the arguments presented in the traversal of the rejection of the claims under 35 U.S.C. 102. Accordingly, Applicant’s argument is not persuasive for the reasons discussed above in the rejection of the claims under 35 U.S.C. 102 and the rationale explaining the maintenance of said rejections.
Thus, the rejection of claims 4 and 19 under 35 U.S.C. 103 is maintained.
Claim Rejections - 35 USC § 103
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
13. Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkes et al. (US-2010/0197503-A1, published 09/24/2014 (previously cited)) as applied to claims 1-2, 5-6, and 17 above.
The teachings of Hawkes are as discussed above in the rejection of the claims under 35 U.S.C. 102(a)(1).
Regarding claim 4, in addition to the teachings discussed above, Hawkes teaches a second mutation at position 413, wherein G413 is substituted with any other amino acid[0082]. The sequence of SEQ ID NO:68 of Hawkes is comprised within SEQ ID NO:27 of Hawkes[0069]. The sixth G of SEQ ID NO:68 of Hawkes corresponds to G413 of instant SEQ ID NO:1.
The level of ordinary skill in the plant biotechnology art is high. It would have been prima facie obvious to one of ordinary skill in the art to combine the F372 substitution taught by Hawkes[0039] with the G413 substitution taught by Hawkes[0082] to generate a mutant HPPD protein comprising an F372 substitution and G413 substitution.
Hawkes explicitly teaches mutating positions 372 and 413 of an amino acid sequence that is identical to Applicant’s SEQ ID NO:1 to provide HPPD-inhibitor herbicide resistance to a plant and further suggests that said position may be substituted with any amino acid; thus, Hawkes provides a clear teaching, suggestion, and motivation to mutate positions 372 and 413 of the recited HPPD polypeptide. The function and/or activity of a polypeptide is inherent to its structure/sequence regardless of explicit validation or invalidation of said activity. Thus, regardless of whether Hawkes validated the functionality of a substitution at positions 372 and 413 of sequence identical to SEQ ID NO:1, said functionality (e.g., the reaction of transforming 4-hydroxypehnylpyruvic acid into homogentisic acid or homogentisate) would be inherent to said protein. Even if an inherent feature was not recognized at the time of discovery, said polypeptide does not become patentable upon the discovery of a new property. See MPEP 2112. One of ordinary skill in the art would have been motivated to produce variants of SEQ ID NO:1 wherein positions 372 and 413 were substituted with each of the other 19 amino acids because this is a small and finite number of substitutions, which would be routine for one of ordinary skill in the art to design and produce. Furthermore, Hawkes teaches that substituting positions 372 and 413 with any other amino acid results in increased HPPD-inhibitor herbicide resistance, that plants with increased HPPD-inhibitor herbicide resistance are useful for methods for selectively controlling weeds in a field of crops, and that mutations may be used in combination with other mutations (Abstract)[0002], [0004], [0117]. Given that Hawkes provides a limited number of HPPD mutations (i.e., 52 mutations) for conferring increased resistance to inhibitor herbicides and suggests combining said mutations, it would be obvious for one of ordinary skill to try combining a mutation at positions 372 and 413 regardless of Hawkes’ alleged silence with regard to the validation of the activity of a protein comprising said mutations. Those of skill in the art could reasonably survey 52 mutations (a finite number of identified, predictable potential solutions) for combinatorial effects in a protein using standard tools and reasonable experimentation, with a reasonable expectation of success, given the teachings Hawkes. See MPEP 2143(I)(E). Accordingly, one of ordinary skill in the art would be motivated to produce a protein comprising both mutations to further increase herbicide tolerance in a plant comprising the double mutant HPPD.
Regarding claim 19, proteins are inherently encoded in polynucleotides. Therefore, in teaching a mutant HPPD polypeptides, Hawkes also teaches polynucleotide sequences encoding said polypeptides[0039]. Furthermore, in addition to the teachings discussed above, Hawkes teaches polynucleotides encoding mutant HPPDs[0085], [0146].
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Response to Arguments – Double Patenting
14. The terminal disclaimer filed by Applicant on January 05, 2026 is approved and renders moot the provisional double patenting rejections of record.
Conclusion
15. No claim is allowed.
Examiner’s Contact Information
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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