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 I, species marker allele M1 in the reply filed on 7/3/2025 is acknowledged. This application is a 371. Rejoinder of additional species will be governed by Lack of Unit practice.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/9/2026 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of copending Application No. 18/569441 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims, including teaching detection of instant M1.
The copending claims teach obtaining a nucleic acid sample from a maize plant or plant part, detecting the presence of a QTL, wherein detecting the presence of the QTL allele comprises detecting the presence of marker alleles A and B. See copending claim 1, where the marker alleles A and B are identical to those set forth in instant claim 1, although different language is used to describe the alleles.
The copending claims also teach wherein detecting the presence of the QTL allele comprises detecting the marker allele M1 and selecting the maize plant. See claim 5.
The copending claims also teach selecting the plant or plant part comprising the QTL allele or marker allele, see claim 5.
The copending claims do not state that the plant part has increased resistance to NCLB, however, this is an inherent property associated with the presence of the allele and does not distinguish the action of the instantly claimed method from that set forth in the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In the response filed 4/9/26 applicant argued that the amendments overcame the rejection of record but did not explain further. The examiner does not agree and the rejection is maintained for the reasons stated in the rejection.
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, 3-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and/or a natural phenomenon without significantly more.
The claim(s) recite(s) “identifying a maize plant or plant part” and “selecting the maize plant or plant part” which are a mental process judicial exception.
Furthermore, claim 1 recites that the plant or plant part an association between the QTL allele and increased resistance to Exserohilum turcicum. This sets forth a relationship between genomic content and a phenotype, which is a naturally occurring correlation that has been recognized by the courts as a law of nature.
This judicial exception is not integrated into a practical application because the only steps in addition to the judicial exceptions are obtaining a sample and detecting the presence of a QTL allele, which is presolution data gathering that does not apply or use the judicial exception in any way. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because steps in addition to the judicial exceptions are obtaining a sample and detecting the presence of a QTL allele in a chromosomal interval. This extra-solution data gathering step is recited at such a high level of generality that it encompasses any possible method for determining if a QTL allele is present in a maize plant or plant part, including many well-known molecular biology techniques like sequencing or hybridization analysis with allele-specific probes. See specification p. 54, lines 10-11.
The response filed 4/9/2026 traverses the rejection stating the method requires cannot be practiced in the mind. It is not disputed that the totality of the method cannot be completed in the mind; nor does the rejection assert as much. The rejection explains how the method sets forth or describes judicial exceptions, why these are not integrated by the additional steps and why the additional steps do not amount to significantly more than the exceptions.
Applicant argues that the identifying and selecting are not abstract evaluations, but the examiner does not agree because these steps can be practiced by thinking about the results of the detecting. They are separate from the detecting. concrete, physical steps of obtaining a sample and subjecting it to “a specific molecular analysis.” No “specific” analysis is required; the claims are sufficiently broad so as to encompass any possible analysis that could determine the presence of the QTL. The reasons why the additional steps neither integrate the judicial exceptions nor amount to significantly more than the judicial exceptions are given previously in the rejection. The rejection is modified and maintained.
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, 3, and 4 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 language “wherein the one or more of marker alleles comprise markers M1 to M56” is indefinite.” First, it is unclear if the claim is attempting to require detecting all 56 marker alleles. Second, it is unclear what the “and/or” recited at the end of the list of marker alleles on page numbered 6 of the claims is means. Third, it is unclear what the phrase “one or more of marker alleles” means. Fourth, if the language is meant to set forth alternatives, the use of “comprise” renders the claim indefinite because this sets forth an open set of alternatives and leaves a question as to what other alternatives are included. MPEP § 2173.05(h)(I). Since the clause which defines the detecting refers to detecting the presence of “one or more marker alleles located within the QTL allele” the claim is interpreted as being sufficiently broad so as to encompass that the detecting of step(b) is detecting the presence of marker alleles A and B OR is detecting one or mor marker alleles located within the QTL allele, wherein the one or more marker allele is selected from the group consisting of M1 to M56. The claim language should be clarified.
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.
Claim(s) 1, 3, and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by European Variation Archive, Variant Summary for rs726321403, at least entry ss635105293, dated 26 November 2012, accessed from www.ebi.ac.uk/ on 8/5/2026.
Further search identified a reference teaching detecting the SNP M1 which is a thymine at position 1071 of SEQ ID NO: 11.
The reference teaches a SNP on chromosome 4 of maize, namely at position 16735918, as numbered in the B73 RefGen V4 genome, which is a G/C allele and was disclosed 26 November 2012. This reference is evidence that the claimed method was available to the public.
The instant SNP is at position 16735918, inherently, thus this reference evidences the practice of a method that inherently includes obtaining a nucleic acid sample from a maize plant, detecting the presence of the M1 allele, and thus the presence of the QTL. By identifying the allele, the plant was “selected” as having the allele.
Further, in alternative interpretation, the step of selecting a plant is extremely broad, and is not limited to occurring after the obtaining a nucleic acid sample and detecting the M1 marker allele (consonant with the election). Thus, it is also true that each maize plant that was sampled and genotyped was “selected” and the ones that had the “T” allele carried the QTL, inherently. There is no requirement of knowledge of the presence of the allele during the selecting step, just that such a plant is “selected.”
The “wherein” clause in the claim that teaches the relationship between the QTL and resistance does not require any action that distinguishes from the reference, it is merely a statement of an inherent property of the plant.
Furthermore, claim 4 is even broader than claims 1 and 4 and only requires “screening” for the presence of the marker, which the SNP record clearly evidences had been done at the time of the invention.
The portion of B73 RefGen V4 genome from 16735900-16736000 is as follows:
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149
609
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The arrow indicates position 16735918 which is the position of the variant in ss635105293, which is listed under rs726321403. This is identical to position 1071 of SEQ ID NO: 11.
The inherent position of the SNP is given on the maizegdb.org website and was accessed by the examiner on 8/5/2026:
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415
475
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Claims 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank AC217259.4 (Zea mays cultivar B73 chromosome 4 clone ZMMBBb-114K20, ***SEQUENCING IN PROGRESS***, 3 unordered pieces; 21 Sept 2013, 25 pages; retrieved from NCBI 8/19/25).
The claim requires screening for the presence of one or more marker alleles, with M1 being the elected species.
The GenBank record teaches the sequence chromosome 4 from Zea mays, thus evidencing that the chromosome had been sequenced. The portion of the genome that contains M1 is contained within the sequenced genome, see nucleotides 4156-4256 of the disclosed sequence as compared to nucleotides 1050-1150 of instant SEQ ID NO: 11; the two sequences are identical. By sequencing this portion of the genome, the reference teaches “screening” for the M1 allele as defined in claim 1. The claim does not require detecting the T allele.
Regarding the 112a rejections:
The rejection for lack of Written Description was overcome by amendment of the claims. The rejection for lack of Enablement was overcome in part by amendment, and with regard to the functionality of M1 as a marker by the arguments presented on p. 14-15 of the remarks.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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