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
Newly amended Claim 15, and dependents thereof (Claims 16-17) directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Newly amended Claims 15-17 are drawn to an oligonucleotide of 15 to 500 nucleotides in length, wherein the oligonucleotide specifically hybridizes with a nucleotide sequence comprising the sequence of one or more of SEQ ID NOs: 10-87, and wherein the oligonucleotide is directly or indirectly linked to a fluorochrome, wherein the fluorochrome is carboxyfluorescein (FAM) or hexachlorofluorescein (HEX) and a mixture of oligonucleotides, wherein the oligonucleotides are suitable for hybridization as forward primer and reverse primer which would have all been originally drawn to Group III as set forth in the Restriction Requirement dated 05/03/2024. As such, Applicant has amended Claims 15-17 so that they are consonant with the subject matter of Invention Group III (as set forth in the Restriction Requirement dated 05/03/2024). For that reason, Claims 15-17 as amended are withdrawn as being directed toward a non-elected invention
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 15-17 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
Acknowledgment is made of Applicant's claim for domestic benefit under 35 U.S.C. 119(e). As
such, the effective filing date of 12 and 15-17 is 12 November 2019.
Status of the Claims
Amendments dated 04/28/2026 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 Claims 1-2 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more is withdrawn in view of Applicant’s cancellation of the claims.
The rejection of Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Hijner (Mededelingen van het Instituut voor rationele Suikerproductie, 1951, Vol. 21, 1-13; 11; IDS Document) taken with evidence from the instant specification is withdrawn in view of Applicant’s cancellation of the claim.
The rejection of Claims 1-3 and 8-9 under 35 U.S.C. 103 as being unpatentable over Jung et al. (WO 2014/127835 A1, published 08/28/2014; IDS Document) is withdrawn in view of Applicant’s cancellation of the claims.
The rejection of Claims 4-7 and 13 under 35 U.S.C. 103 as being unpatentable over Jung et al. (WO 2014/127835 A1, published 08/28/2014; IDS Document) as applied to Claim 3 above, and further in view of Heijbroek et al. (Crop protection 14.5 (1995): 363-366; IDS Document) is withdrawn in view of Applicant’s cancellation of the claims.
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.
---This is a new rejection from those set forth in the Office Action dated 10/29/2025 made in view of Applicant’s amendments to the claims dated 04/28/2026. Applicant’s Remarks dated 04/28/2026 have been reviewed but are deemed inapposite to the new rejections.---
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one or the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are determined to be directed to a subject matter that is naturally occurring, or to a law of nature/natural principle or natural phenomenon. The rationale for this determination is explained below.
The instantly pending claim is a method claim. The judicial exception is the “selecting” step of a sugar beet plant which encompasses mental processes (abstract idea).
The claim is drawn to a method for “identifying, and providing or selecting” which apply the natural principle of a correlation between sugar beet genomic regions, or molecular markers (alleles) located therein, and Heterodera nematode resistance phenotype. This claim reads on thought processes, i.e., visually observing sugar beet plants already grown in a field. The instant claim does not encompass the limitation that the sugar beet plant that is selected has the claimed molecular markers indicating that a sugar beet plant is resistant or susceptible to a nematode of the genus Heterodera, just that it merely has some degree of Heterodera resistance that is not necessarily linked to the claimed molecular markers or the genomic region comprising the resistance QTL. The breadth of “selecting” encompasses non-transformative visual assessment of a sugar beet plant. This breadth does not impose a meaningful limit on the claim scope, such that all others are not precluded from using the natural principle. Furthermore, the instant claim does not encompass the limitation that the sugar beet plant has any claimed molecular marker that is linked to the nematode resistance, but rather just identifying the presence or absence of the genomic region that the molecular markers as associated with.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to naturally-occurring process(es), nucleotides, cells, and organisms. The claimed methods have the inherent property/ies that are recited in the claims. The instant method claims do not require any transformation event or any additional element to show a practical application or integration of the natural principle. A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289,101 USPQ2d 1961 (2012), at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. Although the claim recites the step of selecting a sugar beet plant, wherein the selected sugar beet plant happens to have some degree of resistance to Heterodera nematodes— the selected sugar beet plant is not even required to have the recited molecular markers; therefore, this step is not a substantial integration of the natural principle sufficient to confer patent eligibility. Encompassed in the claim is standard practices of sugar beet breeding and selection for improved traits, particularly Heterodera nematode resistance, and these methods are commonplace and routine in the art, as evidenced by Yu (Crop Science 21.5 (1981): 714-717; abstract), and therefore does not amount to significantly more. Additionally, although Claim 12 recites the step of detecting for specific molecular markers, encompassed by the claims are standard practices of plant molecular biology (i.e., DNA isolation, DNA amplification, fine-mapping markers to a sugar beet genome) and these methods are commonplace and routine in the art as evidenced by Stevanato et al. (Plant Molecular Biology Reporter 33.3 (2015): 474-479; IDS Document), and therefore, does not amount to significantly more. Furthermore, the preamble of Claim 12 is directed to an intended purpose of the judicial exception, which encompasses a known association between the recited markers/alleles, as evidence by Stevanato et al. (Plant Molecular Biology Reporter 33.3 (2015): 474-479; IDS Document), and therefore, does not amount of significantly more.
To overcome the rejection as it relates to the judicial exception, Examiner suggest that Applicant amend the claim, for example, to encompass a method step of “selecting for” a sugar beet plant comprising two or more of the molecular markers indicating a sugar beet plant that is resistant to a nematode of the genus Heterodera.
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 10/29/2025 made in view of Applicant’s amendments to the claims dated 04/28/2026. Applicant’s Remarks dated 04/28/2026 have been reviewed but are deemed inapposite to the new rejections.---
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 having resistance to a nematode of the genus Heterodera, 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 sugar beet plants used in the methods and plants of the instant invention can be derived from any sugar beet germplasm 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 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 sugar beet plants 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 sugar beet plants 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 sugar beet lines with a range of nematode resistance (Tables 1 and 2).
Applicant does not describe any sugar beet plants from any diverse source of germplasms 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 one 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 resistant parent name, germplasm, and source are not disclosed. Applicant does not describe the germplasm, source, or names of the “resistant” sugar beet 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” sugar beet plants used in the fine-mapping of the QTL region and discovery of the instant molecular markers. Applicant does not describe the germplasm or source for the original sugar beet parent plant or sugar beet 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 sugar beet plant or the sugar beet accession that created a population of ten sugar beet plants used in the identification of resistant germplasm and validation of the markers. Applicant does not even clearly define which of the parents is the Heterodera-resistant source in the recombinant plants. 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].
The instant application does not describe any of the sugar beet plants used in the methods of the invention by germplasm, source, or accession. The instant application does not describe a sufficient number of sugar beet 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 sugar beet plants from any germplasm or source comprising one 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 sugar beet plants derived from a wide range of different parental genotypes which comprise the required Heterodera-resistance and at least one or more the molecular markers that indicate a resistance phenotype. For these reasons, the undefined sugar beet plants recited in instant Example 2 are not sufficient to be representative across the broad genus of sugar beet plants that are encompassed by the claims.
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 sugar beet 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 sugar beet 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 and 39587 bp span in the sensitive genotype (wherein both genotypes are never described in the instant specification by germplasm, source, accession, or name), 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 sugar beet 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 sugar beet 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 sugar beet germplasm genome other than the ZRBPMv7 monogerm sensitive reference genome, which is not known in the prior or post-filing art.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
---This is a new rejection from those set forth in the Office Action dated 10/29/2025 made in view of Applicant’s amendments to the claims dated 04/28/2026. Applicant’s Remarks dated 04/28/2026 have been reviewed but are deemed inapposite to the new rejections.---
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heller et al. (Theoretical and Applied Genetics 92.8 (1996): 991-997).
As stated in the rejection to Claim 12 under U.S.C. 101 above, the broadest reasonable interpretation of Claim 12 encompasses a method of identifying, and providing or selecting a sugar beet plant that is resistance to a nematode of the genus Heterodera, wherein the selected sugar beet plant happens to have some degree of nematode resistance, further wherein, the sugar beet plant that undergoes “selecting” is not required to comprise any of the instantly claimed markers/alleles associated with Heterodera nematode resistance.
Regarding Clam 12, Heller et al. (herein referred to as Heller) discloses 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.
Conclusion
No claims are allowed.
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.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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