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 .
Priority
The instant application claims the benefit of priority to PCT/EP2021/069552 filed 07/14/2021 and European Application 20185759.6 filed 07/14/2020. Acknowledgment is made of Applicant's claim for foreign priority under 35 U.S.C. 119 (a)-(d) and domestic benefit under 35 U.S.C. 119(e). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. As such, the effective filing date of Claims 1-2, 4-5, 8-13, and 15-16 is 07/14/2020.
Status of the Claims
Amendments dated 03/20/2026 have been entered.
Claims 1-2, 4-5, 8-13, and 15-16 are pending.
Claims 5, 8-13, and 15-16 are withdrawn from consideration for being directed to non-elected inventions.
Claims 1-2 and 4 are examined herein.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
---The following is a new rejection from those set forth in the Office Action dated 12/22/2025 made in view of Applicant’s amendments to the claims dated 03/20/2026.---
Claim 4 is 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. Dependent claims are included in all rejections.
Claim 4 is rendered indefinite for indirectly relying on Table 1 of the instant specification (pg. 177) to define molecular markers “PZE-108092843”, “PZE-108094590”, “MA0043”, “MA0025”, “PZE-108096469”, “PZE-108096610”, and “PZA-003182005”. Claim 4 recites “PZE-108092843”, “PZE-108094590”, “MA0043”, “MA0025”, “PZE-108096469”, “PZE-108096610”, and “PZA-003182005” which have no meaning without referencing Table 1 in the instant specification. Additionally, “PZE-108092843”, “PZE-108094590”, “MA0043”, “MA0025”, “PZE-108096469”, “PZE-108096610”, and “PZA-003182005” have no art accepted meaning. The claims should recite the actual sequence identifier rather than indirectly relying on Table 1 of the instant specification to define the metes and bounds of “PZE-108092843”, “PZE-108094590”, “MA0043”, “MA0025”, “PZE-108096469”, “PZE-108096610”, and “PZA-003182005”. It should be noted that the current sequence listing does not comprise any sequences that are denoted as “PZE-108092843”, “PZE-108094590”, “MA0043”, “MA0025”, “PZE-108096469”, “PZE-108096610”, and “PZA-003182005”.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
--- Applicant’s Remarks have been reviewed and are acknowledged, but are deemed moot in light of the amendments to the claims. The following is a new rejection from those set forth in the Office Action dated 12/22/2025 made in view of Applicant’s amendments to the claims dated 03/20/2026. ---
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Dependent claims are included in all rejections.
Claim 1 is broadly directed a method for identifying a maize plant comprising a fragment from a donor A619HT2 maize plant and/or a donor A619HT3 maize plant, comprising screening for the presence of a polynucleotide comprising molecular marker allele MA0045, and optionally one or more of MA0062, MA0063, MA0070, MA0071, MA0064, PZE-108095339, and/or Affx-91328160, screening for the presence of one or more of the recited molecular marker alleles recited above, selecting the maize plant or plant part comprising the polynucleotide having the fragment from the donor A619HT2 maize plant and/or the donor A619HT3 maize plant on the basis of the screening step, wherein the maize plant or plant part has increased resistance to Northern corn leaf blight (NCLB) and/or Helminthosporium turcicum relative to a maize plant or plant part that does not comprise the polynucleotide.
In the instant specification, Applicant describes the identification of a RLK1 HT2 alleles in a QTL interval between positions 154,456,106 and 158,167,578 relative to the reference genome B73 AGPv4, wherein they narrowed down the QTL interval by identifying recombinant plants with presence of markers MA0035 and MA0045 (population RP6 x RP6HT3A) and PZE-108095325 and MA0045 (population RPS x RP5HT2A) that showed the resistant phenotype for NCLB in the field (pg. 176, Example 1, first paragraph). Applicant describes that marker-assisted selection for small donor introgression comprising HT2 from a donor A619HT2 maize plant and A619HT3 maize plant could be performed with marker combinations between Affx- 91328160 and MA0045 (pg. 176, lines 29-33; pg. 177, Table 1) in order to eliminate linkage drag positioned outside of the respective donor introgression.
Based on the disclosure of the instant specification, it appears that one of ordinary skill in the art would need to screen the claimed plant for a combination of molecular markers, not a singular marker such as MA0045, in the method of marker-assisted selection of a plant for the desired trait (disease resistance) (See pg. 176, Example 1, first paragraph; pg. 176, lines 29-33; pg. 177, Table 1).
Applicant asserts that maize plants comprising the donor introgression with HT2 are characterized as having the marker haplotype comprising MA0064, MA0063, MA0062 and MA0045, optionally comprising additionally Affx-91328160 and PZE-108095339, as indicated in Table 1,
wherein the donor introgression is located between the markers PZE-108092843 and PZA-003182005 (length: ~3.72 Mb, calculated on basis of B73 AGPv4), preferably between the markers PZE-108094590 and PZE-108096610 (length: ~1.52 Mb) or between the markers PZE-108094590 and PZE-108096469 (length: ~ 1.41 Mb), more preferably between the markers MA0043 and MA0025 (length: ~0.97 Mb) (paragraph bridging pgs. 176-177). Based on these assertions, Applicant describes the position of the HT2 gene as being located between positions 156,763,311 to 156,774,071 of the B73 AGPv4 reference genome (pg. 177, lines 8-9).
Again, based on the disclosure of the instant specification, it appears that one of ordinary skill in the art would need to screen the claimed plant for a combination of molecular markers, not a singular marker such as MA0045, in the method of marker-assisted selection of a plant for the desired trait (disease resistance) and to determine if there was donor introgression of HT2.
Applicant describes that the diagnostic markers contributing to the HT2 halotype for the HT2 donor line A619HT2 and A619HT3 were markers Affx-91328160, PZE-108095339, MA0064, MA0063, MA0062 and MA0045 (See Table 2). Applicant also states that each of the listed diagnostic markers can be used to follow a small donor introgression of at least HT2 (and HT3) in breeding processes, wherein each marker is diagnostic and closely linked to the causative gene conferring HT2 resistance. Further, individual markers of Table 1 can be used in combination and/or in combination with other markers in the region from PZE-108092843 to PZA-003182005, preferably from PZE-108094590 to PZE- 108096610 or PZE-108094590 to PZE-108096469, more preferably from MA0043 to MA0025 (pg. 178, lines 14-20).
Based on the instant specification, it appears that Applicant is asserting that singular molecular markers could be used to determine donor introgression of HT2 and HT3 in breeding processes— however, Applicant does not provide evidence in the form of assays or experimentation that supports a statement that an individual marker (such as MA0045) could not only provide evidence of HT2 or HT3 introgression, but also comprise the claimed increased disease resistance. Without further evidence or results from experimentation, these statements appear speculative rather than factual, as QTL markers such as those described in the instant specification are typically only correlative and not causative in relation to the trait in question. Applicant does not provide any experimental evidence that each marker, by itself, is diagnostic and closely linked to the causative gene conferring HT2 resistance, much less, evidence that disease resistance is conferred to the claimed plants by a single marker that comprises only a single SNP.
It is unclear based on Applicant’s instant disclosure and currently amended claims if a maize plant must only comprise the SNP of MA0045 recited in Claims 1 to have the phenotype of increased resistance to Northern corn leaf blight (NCLB) and/or Helminthosporium turcicum relative to a maize plant or plant part that does not comprise the polynucleotide, or if a maize plant only needs to comprise MA0045 and one of the other recited SNPs to have the phenotype of increased resistance to Northern corn leaf blight (NCLB) and/or Helminthosporium turcicum relative to a maize plant or plant part that does not comprise the polynucleotide.
Applicant teaches in their singular working example that recombinant plants with presence of markers MA0035 and MA0045 (population RP6 x RP6HT3A) and PZE-108095325 and MA0045 (population RPS x RP5HT2A) showed the resistant phenotype for NCLB in the field (pg. 176, Example 1, first paragraph). It appears, based on Applicant’s own disclosure, that the resistant phenotype for NCLB in the field requires that a maize plant have, at minimum, at least two of the instantly claimed SNPs to confer a resistant phenotype to NCLB. However, Claim 1 only requires the presence of MA0045.
The state of the prior art in regards to mapping molecular markers to disease resistance QTL’s in maize plants for the purpose of determining disease resistance to Northern corn leaf blight teaches that high-resolution map-based cloning approach (like that used in the instant invention) requires using six microsatellite markers and two single nucleotide polymorphism (SNP) markers to map donor introgression. The prior art teaches that in parallel to mapping the donor introgression of the resistance allele, it was necessary to establish a NCLB greenhouse seedling infection assay and phenotyping for F2 progeny of the same cross to determine if the presence of the donor allele resulted in disease resistance (Hurni et al. (2015); pg. 8781, Results and discussion, High-Resolution Genetic Mapping of Htn1).
In view of the instant specification and the prior art, Applicant does not describe a representative number of maize plants comprising donor A619HT2 or A619HT3 alleles that are screened and selected for only comprising MA0045. Applicant does not describe a representative number of maize plants comprising donor A619HT2 or A619HT3 alleles that are screened and selected for only comprising MA0045 and have increased resistance to Northern corn leaf blight (NCLB) and/or Helminthosporium turcicum relative to a maize plant or plant part that does not comprise the polynucleotide. Applicant does not describe how many of the recited SNPs need to present in the selected maize plant, other than MA0045, so a person of ordinary skill in the art would know that the whole “fragment” of A619HT2 or A619HT3 is present in the selected maize plant (i.e., if the selected maize plant only requires having the presence of SEQ ID NO: 57, does that mean the whole fragment from HT2 or HT3 is present?). Additionally, Applicant does not describe any maize plant disease assays, wherein a plant comprising donor A619HT2 or A619HT3 alleles and only MA0045 shows evidence of increased resistance to Northern corn leaf blight (NCLB) and/or Helminthosporium turcicum relative to a maize plant or plant part that does not comprise the polynucleotide.
One of ordinary skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the broadly claimed genus in view of the disclosed species. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the compositions used in the claimed methods, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
To overcome this aspect of the written description rejection, Examiner suggests that Applicant amends Claim 1 to remove the term “optionally” from line 5, wherein the amended claim would require screening the claimed plant for the presence of MA0045 and at least one other molecular marker allele in the claimed maize plant.
Closest Prior Art
Claims 1-2 and 4 appear to be free of the prior art in regard to the presence of molecular marker MA0045, which is a SNP which is A at a position corresponding to position 156,789,751 of chromosome 8 of the B73 reference genome AGPv4. The closest prior art in regard to Claims 1-2 and 4 can be found in Jiao et al. (Nature 546.7659 (2017): 524-528) which discloses B73 maize plant seedlings that underwent a method of genomic DNA isolation and subsequent sequencing for de novo assembly of the B73 AGPv4 reference genome, denoted as BioProject PRJNA10769 and BioSample SAMN04296295 in Jiao et al. (pg. 528, Methods) and NCBI (See attached NCBI_ B73 RefGen_v4 in file wrapper). The resulting genome assembly B73 RefGen_v4 comprises sequencing and annotations of all 10 chromosomes of the B73 maize plant genome. As such, the plant and method of genome sequencing disclosed by Jiao et al. identified the presence or absence of polynucleotides comprising of all of the recited molecular markers MA0045, MA0062, MA0063, MA0070, MA0071, MA0064, PZE-108095339, and Affx-91328160. However, in the case of the molecular marker denoted as MA0045, Jiao discloses a B73 maize plant with a genome sequence that contains a cytosine nucleic acid at position 156,789,751 in chromosome 8 rather than an adenine as required by Claim 1. Neither the disclosure of Jiao et al. nor the prior art teach or suggest a motivation to target position 156,789,751 of chromosome 8 of the B73 maize plant to detect the presence or absence of the SNP, or to specifically mutate the C at position 156,789,751 of chromosome 8 of the B73 maize plant to be an adenine.
Conclusion
Claims 1 and 4 remain rejected.
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD ABRAHAM can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663