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 .
Restriction/Election
In response to the communication received on July 17, 2026, from Tracy M. Heims, the election with traverse of Group I, claims 1-4, is acknowledged.
The traversal is on the basis that, with respect to Groups I and III, although US2020048315A1 ("D1") generally teaches improving herbicide resistance using HSL proteins, D1 does not disclose or suggest the specifically claimed mutant HSL proteins recited in the present application. In particular, D1 neither teaches mutations at amino acid position 335 nor the specifically claimed mutation combinations involving position 335 together with one or more of positions 140, 204, and 298 (Remarks, section bridging pages 1-2).Applicant further argues “that the Examiner has identified the common technical feature at an impermissibly high level of generality”, and that “[t]he common feature shared by the pending claims is not merely an HSL protein or its use” (Id., page 2).
Applicants’ arguments have been carefully considered but they are not persuasive.
Shown below is a copy Applicants’ abstract of the invention/application:
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Shown below is a copy Applicants’ description of the Technical Field of the invention/application:
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Accordingly, as admitted by Applicants’ disclosure, and in contrast to Applicants’ arguments, the Examiner has not identified the common technical feature at an impermissibly high level of generality.
Briefly, mirroring the Applicants’ statements, and as stated on pages 3-4 in the Office action dated 06/01/2026, the technical feature common to Groups I-III appears to be HSL protein, gene, vector, cell, composition and use thereof, and method for improving herbicide resistance in crops. However, in the art, TOZAWA (Tozawa, U.S. Patent Application Publication No. 2020/048315 A1) teaches a method for producing HSL protein having improved catalytic activity for 2-oxoglutaric acid-dependently oxidizing 4-hppd inhibitor (entire document; see Title, Abstract, for example). TOZAWA further teaches producing a plant with increased resistance to a 4-HPPD inhibitor, where 4-HPPD inhibitors are herbicides (see Abstract and paragraph 0003). TOZAWA teaches that a gene (4-hydroxyphenylpyruvate dioxygenase inhibitor sensitive gene No. 1 (HIS1)), which rice has and codes for an oxidase (2-oxoglutarate-dependent dioxygenase) dependent on the divalent iron ion and 2-oxoglutarate, and a homologous gene thereof (i.e., HSL1 gene) contribute to the resistance or the susceptibility to the 4-HPPD inhibitors (paragraph 0005). TOZAWA teaches and claims a method for producing an HSL protein with increased catalytic activity to oxidize a 4-HPPD inhibitor (claim 1 of TOZAWA). Specifically, the plants of TOZAWA are more herbicide resistant through the use of the method for producing [a mutated] HSL protein [where] the catalytic activity of the protein to oxidize a 4-HPPD inhibitor in a 2-oxoglutarate-dependent manner can be increased, and an activity of the protein to decompose the inhibitor can be increased (see Abstract).
Thus, Groups I-III lack unity of invention because even though the inventions of these groups require the HSL protein, gene, vector, cell, composition and use thereof, and method for improving herbicide resistance in crops, this technical feature is not a special technical feature as it does not make a contribution over the teachings of TOZAWA.
. The requirement is still deemed proper and is therefore made FINAL.
Priority
This application is a 371 national phase of PCT International Application No. PCT/CN2023/112677, which designated the United States, and was filed on August 11, 2023, published in Chinese, which claims priority to Chinese Patent Application No. CN202210963026.0, filed August 11, 2022. However, the present application does not yet satisfy the formal requirements to establish entitlement to the benefit of the earlier foreign filing date(s). Specifically, the following items are required under 37 C.F.R. § 1.55 and MPEP § 214:
Certified Copy English Translation of Foreign Application: A certified copy of the foreign application (specification and drawings) upon which the priority claim is based must be submitted. If the foreign application is not in the English language, a verified English translation must also be provided.
Specification
The listed and cited reference(s) in the specification (e.g., at pages 5, 6, 10) are not a proper information disclosure statement. 37 CFR§ 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency – Sequences appearing in the specification (for example, at page 6, Table 1) are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR § 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR §§ 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Information Disclosure Statement
Initialed and dated copy of Applicants’ information disclosure statements (IDSs) filed on 02/06/2025 and 12/23/2025 are attached to the instant Office action. The submission is in compliance with the provisions of 37 C.F.R. § 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
Amendments dated 07/17/2026 are entered.
Claims 3-4, 7, and 17 have been canceled.
Claims 1-2, 5-6, 8-16, and 18-20 are pending.
Claims 5-6, 8-16, and 18-20 are withdrawn from consideration for being directed to non-elected invention(s).
Claims 1-2 are examined in this Office action.
Claim Objections
In claims 1 and 2, “HSL” is used as abbreviation. It is suggested to insert a definition for HSL without bringing in new matter, immediately before the first appearance of “HSL” in claim 1; and to enclose the appearance of “HSL” in parentheses (in claim 1 only).
Claim 1 is also objected to for the following informalities:
In line 3, the phrase “wherein having” should be replaced with ---having---, as it is grammatically awkward.
Appropriate correction is required.
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 1-2 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 the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are determined to be directed to subject matter that is naturally occurring, or to a law of nature/natural principle or natural phenomenon. The rationale for this determination is explained below.
Claims 1-2 read on naturally occurring His 1-like, i.e., HSL, proteins (for example, naturally present in rice), with naturally occurring mutations; see the art rejections under 35 USAC 102, infra. The recited naturally occurring HSL proteins are compositions that are not linked to any recited structural features that would distinguish them from ones that are naturally occurring. The claimed products and methods are found in nature, and thus are unpatentable to the Applicants. The products as claimed have the same characteristics as those found naturally, and therefore do not constitute patentable subject matter.
Show below is an excerpt from the sequence listing of LA ROSA (La Rosa et al., U.S. Patent Application Publication No. 2010/0269213 A1). LA ROSA’s SEQ ID NO:120388 is a naturally occurring protein from Oryza sativa, which reads on the instantly claimed HSL protein(s), including the claimed mutations. See also the amino acid alignment infra., in the 35 U.S.C. § 102 rejections.
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The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to naturally-occurring process(es), cells, and organisms, with naturally occurring protein(s). The claimed plants and the claimed naturally-occurring protein(s) have the inherent property/ies of conferring drought tolerance that are recited in the claims.
The claimed products not patent-eligible pursuant to the Supreme Court decision in Ass'n. for Molecular Pathology v. Myriad Genetics (formerly v. USPTO), 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011), cert. granted, judgment vacated and remanded to the Court of Appeals for the Federal Circuit, No. 11-725, 80 U.S.L.W. 3380, 2012 BL 72224 (U.S. Mar. 26, 2012), reversed, ---- S.Ct. ----, 106 USPQ2d 1972, 1974-75 (2013). The claimed invention does not rise to a level that is markedly different in structure from what exists in nature. See “2014 Interim Guidance On Patent Subject Matter Eligibility”, December, 2014, available at http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf.
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LA ROSA (La Rosa et al., U.S. Patent Application Publication No. 2010/0269213 A1, published October 21, 2010).
The claims are drawn to an HSL protein having an amino acid sequence derived from the mutation of site 335 and of site 298 in the amino acid sequence shown in SEQ ID NO: 1; and further wherein the isoleucine at site 335 is mutated into phenylalanine shown in SEQ ID NO:1.
LA ROSA teaches rice nucleic acid molecules and other molecules associated with plants and uses thereof for plant improvement. Polypeptides encoded by the polynucleotide sequences are also provided. The disclosed polynucleotides and polypeptides find use in production of transgenic plants to produce plants having improved properties (entire document; see Title, Abstract, for example).
LA ROSA teaches functional homologs of the provided polypeptides, which have the same function, but with increased or decreased activity or altered specificity. Such variations in protein activity may exist naturally in polypeptides encoded by related genes, for example in a related polypeptide encodes by a different allele or in a different species, or can be achieved by mutagenesis. Naturally occurring variant polypeptides may be obtained by well known nucleic acid or protein screening methods using DNA or antibody probes, for example by screening libraries for genes encoding related polypeptides, or in the case of expression libraries, by screening directly for variant polypeptides. An alternative approach to the generation of variants uses random recombination techniques such as “DNA shuffling”. An alternative method of molecular evolution involves a staggered extension process (StEP) for in vitro mutagenesis and recombination of nucleic acid molecule sequences (paragraph 0064).
LA ROSA teaches insertion mutations, obtaining mutant plants, and teaches site-directed mutagenesis. Site-directed mutagenesis may be utilized to modify nucleic acid sequences, particularly as it is a technique that allows one or more of the amino acids encoded by a nucleic acid molecule to be altered (e.g., a threonine to be replaced by a methionine) (paragraphs 0090-0091).
LA ROSA teaches polypeptides of the invention (paragraphs 0035-0037), and also teaches variants of the polypeptides provided, and which variants generally demonstrate significant identity with the polypeptides provided (paragraph 0065).
One of the polypeptide sequences from rice, taught and claimed by LA ROSA (cl. 2 of LA ROSA), is described as SEQ ID NO:120388. The protein sequence set forth in SEQ ID NO:120388, taught by LA ROSA, is 99.1% identical to instant SEQ ID NO:1. It also includes (i) the instantly recited mutation at site 335; where the isoleucine (I) at site 335 is mutated into phenylalanine (F), and (ii) the mutation at site 298, where the phenylalanine (F) is mutated into leucine (L). See alignment below; and see in particular the positions of F298L and of I335S.
ALIGNMENT OF INSTANT SEQ ID NO:1 WITH SEQ ID NO: 120388 FROM LA ROSA
RESULT 3
US-10-437-963-120388
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
Sequence 120388, US/10437963
Publication No. US20100269213A2
GENERAL INFORMATION
APPLICANT: La Rosa, Thomas J.
APPLICANT: Kovalic, David K.
APPLICANT: Zhou, Yihua
APPLICANT: Cao, Yongwei
APPLICANT: Wu, Wei
APPLICANT: Boukharov, Andrey A.
APPLICANT: Barbazuk, Brad
APPLICANT: Li, Ping
TITLE OF INVENTION: Rice Nucleic Acid Molecules and Other Molecules Associated With
TITLE OF INVENTION: Plants and Uses Thereof for Plant Improvement
FILE REFERENCE: 38-21(53221)B
CURRENT APPLICATION NUMBER: US/10/437,963
CURRENT FILING DATE: 2003-05-14
NUMBER OF SEQ ID NOS: 204966
SEQ ID NO 120388
LENGTH: 350
TYPE: PRT
ORGANISM: Oryza sativa
FEATURE:
OTHER INFORMATION: Clone ID: PAT_MRT4530_23512C.1.pep
Query Match 99.0%; Score 1802; Length 350;
Best Local Similarity 99.1%;
Matches 347; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 MADESWRTPAIVQELAAAGVEEPPSRYVLGEKDRSDELVAAELPEPIPVVDLSRLAGADE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MADESWRTPAIVQELAAAGVEEPPSRYVLGEKDRSDELVAAELPEPIPVVDLSRLAGADE 60
Qy 61 AAKLRAALQNWGFFLLTNHGVETSLMDDVLNLAREFFNQPIERKRKFSNLIDGKNFQVEG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AAKLRAALQNWGFFLLTNHGVETSLMDDVLNLAREFFNQPIERKRKFSNLIDGKNFQVEG 120
Qy 121 YGTDRVVTQDQILDWSDRLFLRVEPKEERNLAFWPDHPESFRDVLNEYASRTKRIRDDIV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YGTDRVVTQDQILDWSDRLFLRVEPKEERNLAFWPDHPESFRDVLNEYASRTKRIRDDIV 180
Qy 181 QAMSKLLGLDEDYFFDRLNKAPALARFNYYPPCPRPDLVFGVRPHSDGSLFTILLVDEDV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QAMSKLLGLDEDYFFDRLNKAPALARFNYYPPCPRPDLVFGVRPHSDGSLFTILLVDEDV 240
Qy 241 GGLQIQRDGKWYNVQVTPNTLLINLGDTMEVLCNGIFRSPVHRVVTNAERERISLAMFYS 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||
Db 241 GGLQIQRDGKWYNVQVTPNTLLINLGDTMEVLCNGIFRSPVHRVVTNAERERISLAMLYS 300
Qy 301 VNDEKDIGPAAGLLDENRPARYRKVSVGEFRAGIIGKFSRRERYIDSLKI 350
||||||| |||||||||||||||||||||||||| |||||||||||||||
Db 301 VNDEKDIEPAAGLLDENRPARYRKVSVGEFRAGIFGKFSRRERYIDSLKI 350
Accordingly, LA ROSA anticipated the claimed invention.
Summary
No claim is allowed.
Examiner’s Contact Information
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BRATISLAV STANKOVIC, JD, PhD
Supervisory Patent Examiner
Art Units 1661 & 1662
/BRATISLAV STANKOVIC/SPE, Art Units 1661 & 1662
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