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 .
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finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/17/2026 has been entered.
Status of the Claims
Amendments dated 07/17/2026 have been entered.
Claims 1-11, 13-14, and 18-28 have been cancelled.
Claims 12 and 15-17 are pending.
Claims 15-17 have been withdrawn from consideration as being directed to a non-elected invention.
Claim 12 is examined herein.
The rejection of Claim 12 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter has been withdrawn in view of Applicant’s amendments to the claims dated 07/17/2026.
The rejection of Claim 12 under 35 U.S.C. 102(a)(1) as being anticipated by Heller et al. (Theoretical and Applied Genetics 92.8 (1996): 991-997) has been withdrawn in view of Applicant’s amendments to the claims dated 07/17/2026.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, step (ii) should be amended to recite “…selecting for the sugar beet plant comprising…”
Appropriate correction is required.
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.
---This is a new rejection from those set forth in the Office Action dated 05/19/2026 made in view of Applicant’s amendments to the claims dated 07/17/2026. Applicant’s Remarks dated 07/17/2026 have been reviewed but are deemed inapposite to the new rejection.---
Claim 12 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.
The claim is broadly directed to a method for identifying, and providing or selecting, a sugar beet plant that is resistant to a nematode of the genus Heterodera, wherein the method comprises:(i) detecting the presence of molecular markers in the sugar beet plant or a portion of the sugar beet plant; (ii) selecting the sugar beet plant comprising two or more molecular markers and having resistance to a nematode of the genus Heterodera, wherein the sugar beet plant is a Beta vulgaris subsp. vulgaris plant, wherein the molecular markers identify whether the sugar beet plant is resistant or susceptible to a nematode of the genus Heterodera, wherein the molecular markers indicating a sugar beet plant that is resistant to a nematode of the genus Heterodera comprise one or more of SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86, and wherein the molecular markers indicating a sugar beet plant that is susceptible to a nematode of the genus Heterodera comprise one or more of SEQ ID NOs: 11, 13, 14, 16, 18, 21, 23, 24, 27, 28, 30, 32, 35, 37, 38, 42, 44, 46, 48, 51, 53, 55, 57, 58, 60, 63, 65, 66, 69, 70, 72, 75, 76, 78, 81, 82, 85, and 87. The broad genus of Beta vulgaris subsp. vulgaris plants used in the methods and plants of the instant invention can be derived from any Beta vulgaris subsp. vulgaris germplasm, accession, or source.
Applicant describes a “resistance locus” located on chromosome 5 in relation to the reference physical map ZR_BPMv7 (monogerm sensitive sugar beet reference sequence) that was reduced to a target region between the flanking markers s5e5864s01 (Integrated genetic map: 9,17 cM) and s5e4503s02 (9,74 cM) enclosing a physical distance of 119341 bp in the reference physical map (ZRBPMv7 - monogerm sensitive reference sequence)(Specification, pg. 57, lines 3-6). Applicant describes the assembly of a gapless resistant sugar beet sequence to make comparisons between the “resistant” and “sensitive” reference genotype and to develop new markers in the target region described above (pg. 57, lines 12-14). Applicant discloses that the source of the resistance gene is Beta vulgaris subsp. maritima (pg. 17, lines 22-27; Applicant’s Remarks dated 07/17/2026, pg. 5). Applicant discloses that the sensitive parental genotype is a Beta vulgaris subsp. vulgaris plant (Example 3; Applicant’s Remarks dated 07/17/2026, pg. 5). Applicant describes a fine-mapping step, wherein the target region described above was reduced to two new flanking markers inclosing a stretch of 26484 bp in the resistant and 39587 bp in the sensitive genotype (pg. 57, lines 14-16). Applicant describes that the reduced target region contains only 9 annotated genes, comprising 3 tandemly repeated LRR (LRR1, LRR2, LRR3) genes that were identified as potential causal candidate genes for Heterodera resistance (pg. 57, lines 17-18). Applicant describes a population of ten plants (presumably sugar beet plants from an undefined germplasm or source) being used to detect the presence of markers developed for the 3 LRR genes, wherein Applicant asserts that all plants carrying the LRR1 genes are “resistant” (presumably resistant to Heterodera)(pg. 57, lines 26-30).
Applicant describes introducing an LRR gene of interest (SEQ ID NOs: 2 and 5) into a Beta vulgaris subsp. vulgaris plant denoted as “genotype 04E05BIDH5” to produce Heterodera-resistant sugar beet plants, for the purpose of validating the LRR gene as the resistance conferring gene and to produce transgenic resistance events that confer a novel Heterodera resistance or improve already existing Heterodera resistances (pg. 58, lines 10-13). Applicant describes transforming Beta vulgaris subsp. vulgaris plant denoted as “genotype 04E05BIDH5” with either SEQ ID NO: 2 or SEQ ID NO: 5 and then subjecting the transformants with nematode assays to determine resistance or susceptibility (pgs. 60-61, Table 1). Applicant describes a panel of 25 Beta vulgaris subsp. vulgaris “genotype 04E05BIDH5” lines with a range of nematode resistance (Tables 1 and 2).
Applicant does not describe any Beta vulgaris subsp. vulgaris plants from any diverse source of germplasms known in the art that are actually screened for the presence or absence of all the molecular markers denoted as SEQ ID NOs: 10-87, or more specifically, the presence of two or more molecular markers denoted as SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86 (resistance markers). The only plants that appear to have been screened are undefined recombinant plants with undefined markers described as “specific dominant markers” for the three LRR genes, wherein the Beta vulgaris subsp. maritima germplasm/accession and source are not disclosed. Applicant does not describe the germplasm, source, or accession of the “resistant” Beta vulgaris subsp. maritima plants used in the fine-mapping of the QTL region and discovery of the instant molecular markers. Applicant does not describe the germplasm, source, or names of the “susceptible” Beta vulgaris subsp. vulgaris plants used in the fine-mapping step of the QTL region and discovery of the instant molecular markers. Applicant does not describe the germplasm or source for the original Beta vulgaris subsp. maritima accession in the original cross that created a population of sugar beet plants used in the identification of the QTL interval on chromosome 5, which led to gene predictions and fine-mapping to a ZR_BPMv7 (monogerm sensitive sugar beet reference sequence) reference genome. When looking at the sample of ten plants analyzed with specific dominant markers to determine the resistance or susceptibility phenotype of said plants, Applicant does not describe the germplasm or source of the original Beta vulgaris subsp. vulgaris plant or the Beta vulgaris subsp. vulgaris accession that created a population of ten sugar beet plants used in the identification of resistant germplasm and validation of the markers. A search of the prior art does not cure these deficiencies.
It is known in the art that “there is no guarantee that DNA markers identified in one population will be useful in different populations, especially when the populations originate from distantly related germplasm.” [Collard et al. (2005), pg. 186; cited in the PTO-892 dated 05/19/2026].
The instant application does not describe any of the Beta vulgaris subsp. vulgaris plants used in the methods of the invention by germplasm, source, or accession. The instant application does not describe a sufficient number of Beta vulgaris subsp. vulgaris plants from any germplasm known in the art that have been screened for the presence of all the molecular markers denoted as SEQ ID NOs: 10-87, a sufficient number of Beta vulgaris subsp. vulgaris plants from any germplasm or source comprising two or more of the molecular markers denoted as SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86, a sufficient number of Heterodera-resistant Beta vulgaris subsp. vulgaris plants derived from a wide range of different parental genotypes which comprise the required Heterodera-resistance and at least two or more the molecular markers that indicate a resistance phenotype. For these reasons, the undefined Beta vulgaris subsp. vulgaris plants recited in instant Example 2 are not sufficient to be representative across the broad genus of Beta vulgaris subsp. vulgaris plants that are encompassed by the claims. Was the sensitive genotype (“genotype 04E05BIDH5”) used in Example 3 the source of the sensitive genotype in Example 2?
Additionally, the structural features that distinguish the intervals between SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86 resistant markers from other DNAs in any Beta vulgaris subsp. vulgaris germplasm known in the art are not described in the specification. Indeed, such structural features may not even exist; as QTL markers such as those described by the instant specification are typically only correlative and causative in relation to the trait in question. By Applicant’s own admission (pg. 57, lines 17-18), the 3 tandemly repeated LRR (LRR1, LRR2, LRR3) genes were only described as “potential causal candidate genes for Heterodera resistance”.
Applicant fails to sufficiently describe the vast genus of genetic determinants in the intervals between the claimed markers associated with the Heterodera-resistant QTL on chromosome 5 in any Beta vulgaris subsp. vulgaris germplasm known in the art. The chromosomal regions that lie between these diagnostic markers in any sugar beet germplasm known in the art, encompass a myriad of genes, motifs, loci, and alleles, and other genetic determinates having unknown structural across the 26484 bp span in the resistant (Beta vulgaris subsp. maritima) and 39587 bp span in the sensitive genotype (Beta vulgaris subsp. vulgaris) (wherein both genotypes are never described in the instant specification by germplasm, source, or accession), which Applicant is clearly not in possession of. Applicant has not provided a description regarding the identity or any other distinguishing characteristics of the intervals between the claimed marks in any Beta vulgaris subsp. vulgaris germplasm known in the art that would allow one of ordinary skill in the art to recognize the identity of members of the genus of markers between the region or in proximity to the exemplified Heterodera-resistant QTL on chromosome 5 of any Beta vulgaris subsp. vulgaris germplasm known in the art. Applicant has not described the position/location of SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86 relative to any other Beta vulgaris subsp. vulgaris germplasm genome other than the ZRBPMv7 monogerm sensitive reference genome, which is not known in the prior or post-filing art.
Furthermore, it is unclear based on Applicant’s instant disclosure and currently amended claims if a Beta vulgaris subsp. vulgaris plant must comprise all of the recited resistance molecular markers (i.e., SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86) to have the phenotype of resistance to a nematode of the genus Heterodera , or if a Beta vulgaris subsp. vulgaris plant only needs to comprise two or more of the recited markers to have the phenotype of resistance to a nematode of the genus Heterodera.
Applicant describes a fine mapping step in Example 2, wherein using the available recombinants the target region was reduced to two new flanking markers enclose a sequence stretch of 26484 bp in the resistant and 39587 bp in the sensitive genotype. Applicant discloses that the reduced target region contains only 9 annotated genes. Among these genes, 3 tandemly repeated LRR genes were identified as potential causal candidate genes for the NRBMH resistance (LRR1, LRR2 and LRR3 (Figure 1)). The target region shows a high degree of complexity: a) the resistant sequence contains a large sequence duplication; b) the LRR genes are showing sequence-similarity; c) in sensitive genotypes several retrotransposons are embedded in the target region. Applicant discloses that because of the sequence complexity, the assembly of the RR and ss sequences was a highly demanding and very complex procedure. Applicant discloses that within the reduced targeted region, 5 recombinations were detected and 180 descendants of these recombinants were phenotyped. The phenotypes were determined with intensive statistical methods (t-Test, Power analysis). From these 5 recombinants, a sample of 10 plants per Ident were analyzed with specific dominant markers developed for the 3 LRR genes. It was possible to test the 3 LRR genes for functionality. Applicant discloses that the LRR1 gene shows in none of the recombinants any conflicting data, i.e. all recombinants carrying the LRR1 gene are resistant (pg. 57, Example 2).
Applicant does not describe a representative number of Beta vulgaris subsp. vulgaris plants that are screened and selected for only comprising two or more of the recited resistance molecular markers (i.e., SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86). In fact, Applicant does not describe the number of markers used in the identification process of plants comprising the LRR resistance gene at all. Applicant does not describe a representative number of Beta vulgaris subsp. vulgaris plants that are screened and selected for only comprising two of the recited resistance molecular markers (i.e., SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86) and have resistance to a nematode of the genus Heterodera. Additionally Applicant does not describe any Beta vulgaris subsp. vulgaris nematode assays, wherein a plant comprising any two of the recited resistance molecular markers (i.e., SEQ ID NOs: 10, 12, 15, 17, 19, 20, 22, 25, 26, 29, 31, 33, 34, 36, 39, 41, 43, 45, 47, 49, 50, 52, 54, 56, 59, 61, 62, 64, 67, 68, 71, 73, 74, 77, 79, 80, 83, 84, and 86) shows evidence of resistance to a nematode of the genus Heterodera.
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.
Response to Arguments
Applicant’s Remarks on pgs. of the reply filed on 07/17/2026 have been acknowledged but do not overcome the new rejection above. In particular, Applicant’s arguments to withdraw the rejection under 35 U.S.C. 112(a) rely on the premise that the amended claims are directed to a Beta vulgaris subsp. vulgaris plant, the parent source of the recombinant plants is a Beta vulgaris subsp. vulgaris plant, and the source of Heterodera resistance is from Beta vulgaris subsp. maritima (Remarks, pg. 5).
This is not found persuasive for the reasons given in the new 35 U.S.C. 112(a) rejection above.
Claim Rejections - 35 USC § 112
Enablement
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.
---This is a new rejection from those set forth in the Office Action dated 05/19/2026 made in view of Applicant’s amendments to the claims dated 07/17/2026. Applicant’s Remarks dated 07/17/2026 have been reviewed but are deemed inapposite to the new rejection.---
Claim 12 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding the Beta vulgaris subsp. vulgaris plant recited in Claim 12, Applicant has not provided adequate disclosure regarding the source of the genetic material from which the claimed molecular markers for resistance to a nematode of the genus Heterodera are derived from, or from which the claimed molecular markers indicating susceptibility to a nematode of the genus Heterodera are derived from. Without knowing the germplasm, source, or accession of the starting material for this method, one of ordinary skill in the art would be unable to use the claimed molecular markers to detect resistance or susceptibility of the claimed sugar beet plant to a nematode of the genus Heterodera . Essentially, the only way one of ordinary skill in the art could use the claimed markers, is if one of ordinary skill in the art had access to the starting sugar beet plants that the molecular markers were derived from.
To practice the method recited by the Applicant, the claimed molecular markers disclosed by Applicant cannot just be broadly applied to any species of sugar beet, the genes must actually be present in a specific plant/germplasm/accession for the molecular markers to achieve amplification in a detection step for identifying a plant’s resistance or susceptibility to a nematode of the genus Heterodera. Therefore, Applicant must provide evidence that the source of the genetic material is publicly available, or they must deposit the genome used to provide the source of the genetic material.
Therefore, given the deficiencies of the Applicant’s disclosure discussed above, the present invention encompassed by Claim 12 was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which is most nearly connected, to use the invention.
Closest Prior Art
Claim 12 appears to be free of the prior art. The closest prior art in regard to Claim 12 can be found in Heller et al. (Theoretical and Applied Genetics 92.8 (1996): 991-997; cited in the PTO-892 dated 05/19/2026) which teaches four different F2 sugar beet populations that underwent genomic DNA isolation (pg. 992, paragraph bridging left and right columns; Table 1) wherein a portion of each of the four different F2 sugar beet populations were found to be resistant to Heterodera nematodes (pg. 993, Table 2). By extracting genomic DNA from the four different F2 sugar beet populations, the disclosure of Heller has inherently detected the presence or absence of the molecular markers denoted as SEQ ID NOs: 10-87, specifically, the SEQ ID NOs associated with nematode resistance, in the four different F2 sugar beet populations used in the methods disclosed by Heller. However, Heller does not teach a step wherein particular sugar beet plants were selected from the F2 population due to the identification of two or more of the molecular markers denoted as SEQ ID NOs: 10-87, wherein the selected plant has resistance to Heterodera nematodes. Heller does not teach a rationale or motivation for selecting sugar beet plants with the specific molecular markers denoted as SEQ ID NOs: 10-87 which are linked to resistance alleles from Beta vulgaris subsp. maritima, that indicate an individual plants resistance to Heterodera nematodes. In fact, the F2 population of plants used in the method of Heller were not related by descent with respect to an introduced wild beet (Beta vulgaris subsp. maritima) segment because they originated from different alien addition lines.
Conclusion
No claims are allowed.
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
