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 .
Claim Status
Claims 1, 4 & 6 are under examination on the merits.
Claims 2-3, 5 & 7 are cancelled.
Priority
Claims 1, 4 & 6 receive the U.S. effective filing date of 11/23/2022. Foreign priority to CN202211470272.9 is claimed and acknowledged.
Previous objection to the drawings is withdrawn in view of Applicant’s amendment to the specification.
Previous objection to the specification is withdrawn in view of Applicant’s amendment to the specification.
Previous rejection of claim 7 under 35 U.S.C. 112(d) is withdrawn due to Applicant’s cancelation of the claim.
Previous rejection of claims 1-2 & 7 under 35 U.S.C. 112(b) for failing to define what method steps comprise ‘use of’ is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 1-2 & 7 under 35 U.S.C. 101 as directed to detection of a natural phenomenon is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 1-2 & 7 under 35 U.S.C. 101 because the claimed invention is directed to a ‘use’ is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of Claims 1-2, 4 & 7 under 35 U.S.C. 103 is withdrawn due to Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112
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 & 6 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.
Due to Applicant’s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 9 Feb 2026 as applied to claim 6. Applicant’s arguments filed 11 May 2026 have been fully considered but are not persuasive.
Claims 1 & 6 recite applicant’s designated ‘OsRNR10’ gene, and/or its promoter sequences. The gene designation ‘OsRNR10’ is a descriptive term coined by the Applicant that has no precedent in prior art which would unambiguously specify the genetic sequence it consists of. Newly amended claim 1 recites that the gDNA of OsRNR10 is SEQ ID NO.2. Newly amended claim 6 recites that the gDNA of OsRNR10 is SEQ ID NO.6.
Referring to the sequence information provided, SEQ ID NO.2 is a nucleic acid of 1,489bp and SEQ ID NO.6 is a nucleic acid of 885bp. Average gene length in rice is 2,853—3,223 bp [see NPL_RiceGenomeAnnotation_NSF_8June26]. Applicant indicates OsRNR10 ‘has a sequence of’ either of these molecules, which could be interpreted as open language, implying the genes merely comprise either of the provided sequences.
This discrepancy between sequences both being described as the OsRNR10 gene, when combined with Applicant’s language stating the gene ‘has a sequence of’, creates reasonable doubt as to whether the sequences presented are representative of the entire gene being claimed, fragments or marker sequence within a larger gene, or alternate alleles thereof. Notably Applicant does not refer to the recited sequences as alleles, but to both as the OsRNR10 gene.
Without clarifying information from Applicant regarding the discrepancies between the two sequences referencing the same gene, their small size relative to average rice genes, and whether the phrase ‘has a sequence’ is intended as open language, it is unclear if these are smaller sequences comprising markers, or the OsRNR10 gene itself. If they are intended to be the native OsRNR10 gene sequence, it is also unclear which of these two sequences is the wild-type allele (i.e. native OsRNR10). Because of this, the complete identifying DNA sequence of Applicant’s newly named OsRNR10 gene is unclear.
Because there is no definition of the genetic architecture or sequence of OsRNR10 in the prior art, it is particularly unclear what is being limited to in claims 1 & 6. Therefore, it would be unclear to one what the specific metes and bounds of the claim limitations are, or how one would avoid infringing such claims when working with allelic variants of OsRNR10. Because of this, as currently written, claims 1 & 6 are rejected.
Response to Arguments
Applicant urges that previous rejection of claim 6 under 112(b) for indefiniteness is improper due to details of the specification [Remarks, p.7, ¶1] and due to amendment of claims that now recite the OsRNR10 gene “has a gDNA nucleotide sequence of SEQ ID NO: 6” [id].
This is unconvincing in that the specification states, “…a gDNA nucleotide sequence [of OsRNR10] is shown in SEQ ID NO: 6…” [Specification, p.3, ¶2], and amended claims use language of ‘has a sequence of…’. Statements of ‘has a sequence of’, rather than ‘is’, could be interpreted as open, or indicating recited sequences are a smaller portion of (i.e. comprising) the OsRNR10 gene. This potentially variable interpretation is emphasized by the fact that claims recite two different sequences as representing the OsRNR10 gene (rather than alleles).
Furthermore, if the recited ‘gene’ is interpreted to be a description of a species-specific allele, then amended language of claim 6 would potentially introduce an issue of lack of proper antecedent basis, as the claim first refers to “an OsRNR10 gene in rice” (i.e. a gene) followed by reference to “the japonica rice OsRNR10 gene” (i.e. a species-specific allelic variant). These are different. Additionally, if Applicant is referring to species-specific alleles in amended claim language, claim 1 makes reference to “an OsRNR10 knockout vector” which does not specify which recited OsRNR10 sequence the knockout vector is specific to targeting, either SEQ ID NO.2 or 6, or both.
Because the scope of both amended claims still varies depending on the readers interpretation of the exact sequence of OsRNR10, as currently written, both claims are rejected.
Applicant is advised to clarify if recited sequences are the exact identity of the gene being claimed or only portions thereof, as well as specify when allelic variants of sequence(s) are being referenced if and where appropriate.
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.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to detection of a natural phenomenon without significantly more. Claims recite methods of detecting a naturally occurring allele, OsRNR10, based on native DNA sequence. This judicial exception is not integrated into a practical application because the claims simply recite a method of diagnosing the naturally occurring allele without substantially more.
Due to Applicant’s amendment of the claims, the rejection is modified fom that set forth in the Office action mailed 9 Feb 2026 as applied to claims 1-2, 4 & 7. Applicant’s arguments filed 11 May 2026 have been fully considered but are not persuasive.
The OsRNR gene and promoter are naturally occurring in rice. Prior art demonstrates that two auxin-responsive alleles, one of which is the claimed OsRNR10, differentiate the subspecies of cultivated rice [See Zhang 2020; p.573, col.2, par.2]. Applicants’ specification provides further evidence of this, in their statement that screening of 3,000 rice accessions indicates the claimed allele clearly differentiates indica or japonica backgrounds [See Instant Application; p.13, par.2; p.14, par.2].
Rice plants in the indica subgroup of rice have low/no expression of the OsRNR10 gene which results in their generally ‘less compact’ roots and higher NUE than rice in the japonica subgroup. Japonica rice has high expression of OsRNR10 due to action of the promoter, which leads to ‘more compact’ roots and lower NUE [Specification, p.3, par.4]. Claimed methods consist of detecting the allelic state OsRNR10 allele and/or its promoter and selecting these corresponding phenotypes. These are one and the same as the naturally occurring, primary differentiator of the indica subspecies of cultivated rice, its root architecture and agronomic characteristics. The presence of this functioning or null allele for OsRNR10 would be visibly detectable or diagnosable based on phenotype in addition to genetic diagnosis.
Claim 4 recites the additional element of detecting OsRNR10 using molecular markers. The claim recites, “detecting that a rice OsRNR10 gene promoter is present” to determine “control of rice root system development” (i.e. root phenotype). The variant of the OsRNR10 promoter being referenced is the naturally occurring allelic variant associated with the specific phenotype, as discussed above.
The detection of the natural allelic variant that differentiates the major subpopulations of cultivated rice is presented as a ‘method for determining’ the phenotypic effect of OsRNR10 alleles. However, this does not differentiate the claim from natural phenomenon; this is merely a diagnosis of which form of the naturally occurring gene or alleles is present in a given rice plant. Similar differentiation could reasonably be made by examination of the root architecture of a given plant. Applicant recites the diagnostic sequence but this is simply a characterization and does not constitute any type of active step beyond diagnosis. Therefore, this claim is not directed to significantly more than describing a natural phenomenon.
These are adaptive characteristics which already phenotypically differentiate particular genetic groups in rice, and known to be the result of different allelic states of OsRNR10 and/or its promoter(s).
Because this claim is merely directed to the detection of a naturally occurring allele (i.e. genetic diagnosis of a natural trait) using molecular diagnosis, this is a claim to a natural phenomenon. As such, claim 4 is rejected.
Response to Arguments
Applicant urges rejection of claim 4 under 101 is improper due to the requirement that a listed category of judicial exception is recited in the claim [Remarks, p.9, ¶2]. Applicant argues guidance in MPEP directed to abstract ideas is relevant regarding eligibility [p.9, ¶3-5].
This is unconvincing with respect to claim 4 because as stated in the previous Office rejection, the claim is directed to a natural phenomenon, being that of detecting or diagnosing natural genetic state [Office action mailed 9 Feb 2026, p.8, ¶1-2]. The claim is not a product claim directed to the allele in question, which Applicant admits is naturally occurring [Remarks, p.10, ¶4—p.11, ¶1], but to merely genotyping and diagnosis (i.e. detecting OsRNR10) to determine the genetic predisposition of a living organism. Applicant’s claim diagnoses but does not include method steps beyond identification.
Argument directed to examples refuting abstract ideas, in the context of additional active steps that go beyond diagnosis or identification, are similarly not persuasive because rejection of this claim is not grounded in Applicant claiming an abstract idea, but rather is because Applicant is claiming a natural phenomenon via mere genetic diagnosis.
Applicant is advised to add a selection step or action that is based on, but follows after, the isolation of DNA and detection of the marker from isolated DNA to diagnose or identify a particular plant.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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