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 .
Election/Restrictions
Applicant’s election without traverse of Group IV in the reply filed on 7/25/2026 is acknowledged.
The requirement is deemed proper and is made FINAL.
Claim Status
Claims 1-3, 5, 8-14 and 16-24 are pending.
Claims 1-2, 5, 11 and 19 are withdrawn from examination as being part of non-elected inventions.
Claims 8-10, 12-14, 16-18, and 20-24 are being examined.
It is noted, however, that the amended claim 13 (as submitted on 7/25/2026), which is part of elected Group IV (as described in the Office action dated 6/1/2026), has been incorrectly indicated as “withdrawn” in the claim set filed 07/25/2026, instead of “Currently Amended”. Nonetheless, the Examiner examined claim 13 as being part of elected Group IV. Claim 20 was inadvertently omitted from the restriction requirement of 06/01/2026. Claim 20 reads on the invention of Group IV and is examined herein.
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 8-10, 12-14 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Independent claim 8 recites: A method for identifying a maize plant or germplasm that exhibits resistance to a 4-hydroxyphenylpyruvate dioxygenase inhibitor, the method comprising the steps of:
detecting in a maize plant the presence of a resistant SNP marker allele selected from the group consisting of: SNP 1 resistant allele which comprises an A to C nucleotide substitution at position no 141 in SEQ ID NO: 1 (TRLMZLD-1), SNP2 resistant allele which comprises a C to T substitution at position 115 in SEQ ID NO:3 (TRLMZLD-2); SNP3 resistant allele which comprises a G to A substitution at position 139 in SEQ ID NO:5 (TRLMZLD-3); SNP4 resistant allele which comprises G to A substitution at position 132 in SEQ ID NO:7 (TRLMZLD-4), SNP 5 resistant allele which comprises A to G substitution at position 122 in SEQ ID NO: 9 (TRLMZLD-7), and SNP6 resistant allele which comprises T to G substitution at position 126 in SEQ ID NO:11 (TRLMZLD-8).
The subject matter eligibility analysis is discussed in MPEP 2106.
Step 1: Does the claim fall into a statutory category of invention? Yes, the claim is drawn to a process.
Step 2A, Prong 1: Are the claims directed to law of nature, a natural phenomenom, or an abstract idea, i.e., a judicial exception (JE)? Yes, the SNP marker alleles in the maize plant or germplasm are naturally-occurring. The specification in Examples 1-3 describes how the SNP markers recited in the claims were determined, which involved crosses of maize inbred lines identified as resistant to HPPD inhibitors, with inbred lines identified as susceptible, and F2 populations were used for marker-trait association. While experiments were conducted to determine the SNP marker alleles, the Examples do not indicate that any man-made mutation(s) including genetic engineering was/were used to create the SNP markers recited in the claims. The SNP marker alleles recited in claim 8 are naturally occurring.
Step 2A, Prong 2: Are there any additional elements that integrate the JEs into a practical application? No, claim 8 does not recite any additional elements that integrate the JEs into a practical application. The claim recites a step of detecting the presence of a SNP marker allele but does not recite any further step.
Step 2B: Does the claim as a whole recite an inventive concept (something significantly more) than the JEs? No. The claim recites a single step, of detecting in a maize plant the presence of a resistant SNP marker allele, in a recited Markush group. The step is highly general, not limited to any methodology for detection. The instant specification also teaches that the SNPs can be detected by any method known in the art, and recites several such methods, including DNA sequencing, and PCR-based sequence specific amplification methods (spec, p. 15, 1st full paragraph). Such methods were well-understood, routine and conventional before the effective filing date. As such, the detection step does not add significantly more to the claim.
The claim 8 preamble also recites the method is “for identifying a maize plant or germplasm that exhibits resistance to a 4-hydroxyphenylpyruvate dioxygenase inhibitor” in lines 1-2. However, this is only the recited intended use or purpose of the method.
The claim is analogous to the claimed invention in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015), which was found patent ineligible. The claim in “Ariosa” was drawn to a method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female. The method comprises steps of amplifying a paternally inherited nucleic acid from the serum or sample and detecting its presence in the sample. The court in Ariosa found the existence of cell-free fetal DNA (cffDNA) in maternal blood to be an example of a law of nature or natural phenomenon. Also see MPEP ¶ 2106.04(b)(I). The court in Ariosa also found methods like PCR to amplify and detect cffDNA to be well-understood, routine, and conventional activity (see also MPEP 2106.05(d)(II)), and the only new subject matter was the discovery of the presence of cffDNA in maternal plasma or serum. The court noted that the claimed method began with a naturally-occurring phenomenon, cffDNA, and ended with a naturally occurring phenomenon, paternally inherited cffDNA. As with the claim in Ariosa, the new subject matter of the instant invention is the discovery of the presence of the recited SNP marker alleles in maize plant or germplasm. The instant method has only the step of detecting the SNP, using routine methods, and the claimed method also begins and ends with naturally occurring phenomenon- the SNP marker alleles.
Dependent claims 9, 10 and 16 also do not recite additional elements that integrate the JEs into a practical application, or which add significantly more to the claim. Claim 9 further requires a step of selecting the maize plant or germplasm comprising a resistant SNP marker allele. However, this is also a judicial exception, since such selection step is a mental process. Claim 10 includes the step of obtaining DNA from the maize plant or germplasm and analyzing the DNA for the presence of the SNP marker alleles. This step is recited at a high level of generality and encompasses any manner of obtaining the DNA, encompassing routine methodology, as discussed above. Claim 16, which depends from claim 10, limits the method by reciting that the recited SNPs are located within a maize chromosomal interval flanked by SEQ ID NOs: 5 and 7. However, this merely marks the genomic location of the naturally-occurring SNP marker alleles.
Claim 12 is an independent claim also “for identifying a maize plant that exhibits resistance to a” 4-HPPD inhibitor. Claim 12 differs from claim 8 in that it does not limit the identity of the SNP marker allele, but does recite that “the at least one SNP marker locus is located within a chromosomal interval comprising and flanked by” SEQ ID NOs: 5 and 7. While the SNP marker allele is not identified in claim 12, the claim is directed to a JE without significantly more, as it encompasses naturally-occurring SNPs, and recites only the single detection step. Similar to claim 8, claim 12 also does not integrate the JE into a practical application, or recite an additional element that adds significantly more to the claim. Claims 13-14 depend from claim 12, and limits the SNPs to be the same naturally-occurring SNPs recited in claim 8.
Claim Rejections - 35 USC § 112(b)
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 8-10, 12-14, 16-18 and 20-24 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.
Claims 8-10, 12-14 and 16-18 recite “resistance” to a 4-hydroxyphenylpyruvate dioxygenase inhibitor or an HPPD inhibitor- in form of “resistance to a 4-hydroxyphenylpyruvate dioxygenase inhibitor”, “resistance to an HPPD inhibitor”, “resistant allele”, or “resistant SNP marker”.
It is known that maize plants inherently tolerate (i.e., resistant to) at least some HPPD inhibitors including triketone herbicides because CYP81A-family cytochrome P450s convert mesotrione and tembotrione to non-phytotoxic hydroxylated metabolites before significant carotenoid depletion occurs (Melo et al., Physiological and Biochemical Mitigation of Tembotrione-Induced Phytotoxicity in Sorghum by Ascophyllum nodosum Extracts, 2026, Agronomy, 16:889; p.21, para 4, line 3-5). Unlike plants like sorghum, maize has robust constitutive HPPD-inhibitor detoxification property (Melo et al.; p.22, para 2, line 5-6). Characterization of the maize and soybean HPPD proteins showed that maize HPPD enzyme is 40-fold less sensitive (in other words, 40-fold more resistant) to a HPPD inhibitor, mesotrione, than that of soybean and, thus, the maize enzyme, encoded by a single gene NM-001112312.1 (Siehl et al., Broad 4-Hydroxyphenylpyruvate Dioxygenase Inhibitor Herbicide Tolerance in Soybean with an Optimized Enzyme and Expression Cassette, 2014, Plant Physiology, 166:1162–1176; p.1164, left column, para 2, line 1-4) (located in chromosome 5 from position 85854248 to 85856368, data not shown), is used in soybean plants to improve resistance to HPPD inhibitors (Siehl et al.; p.1167, right column, para 2, line 6-10).
It is not clear to the Examiner what the Applicant imply by the word “resistance”. The Applicant does not define the word “resistance”. It is not clear what is the threshold level or dose of a 4-hydroxyphenylpyruvate dioxygenase inhibitor or an HPPD inhibitor to indicate resistance in a “a maize plant or germplasm that exhibits resistance to a 4-hydroxyphenyl pyruvate dioxygenase inhibitor”, given the HPPD inhibitor resistance that all maize plants possess.
Claims 20-24 depend on claim 18, which in turn depends from claim 8. Thus, claims 20-24 inherit the indefiniteness of claims 8 and 18.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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J.C.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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