Prosecution Insights
Last updated: April 19, 2026
Application No. 18/722,389

LETTUCE PLANT RESISTANT TO DOWNY MILDEW AND RESISTANCE GENE

Non-Final OA §101§112
Filed
Jun 20, 2024
Examiner
ORDAZ, CHRISTIAN JOSE
Art Unit
1663
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Enzazaden Beheer B V
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
9 granted / 14 resolved
+4.3% vs TC avg
Strong +100% interview lift
Without
With
+100.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
29 currently pending
Career history
43
Total Applications
across all art units

Statute-Specific Performance

§101
9.1%
-30.9% vs TC avg
§103
32.2%
-7.8% vs TC avg
§102
18.2%
-21.8% vs TC avg
§112
35.2%
-4.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 14 resolved cases

Office Action

§101 §112
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 of Group I claims 1-8 and 14-17, and the species of SEQ ID NO: 7 in the reply filed on October 06, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Upon further consideration, the restriction requirement is withdrawn and claims 1-20 are being examined. Claim Status Claims 1-20 are pending. Claims 1-20 are examined in the instant application. Priority Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/EP2021/087080, filed on December 21, 2021. Information Disclosure Statement (IDS) The IDS submitted on 06/20/2024 has been considered. Signed copies is attached. Specification The disclosure is objected to because of the following: The Abstract should be on a sperate document. Additionally, Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. Currently the Abstract contains a total of 179 words. It is advised that Applicant amend the abstract with less than 150 words. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Appropriate correction is required. 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 1-6, 8-13 and 16-20, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product and a natural phenomenon without significantly more. The claim(s) recite(s) “A downy mildew resistance lettuce plant, wherein said lettuce plant comprises a V06 resistance gene”. This judicial exception is not integrated into a practical application because the V06 resistance gene is a naturally occurring protein. As described in MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68). The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: In regard to claims 1, 6, 9, 11 and 17-18, the claims are directed to a resistance gene present in a downy mildew resistant lettuce plant. Applicant states “[g]ene mapping experiments were done to identify a resistance gene that is involved in full spectrum Bremia (B. lactucae) resistance in lettuce (L. sativa). The resistance gene was originally isolated from L. virosa and was mapped on chromosome 8”, (see page 8 lines 19-21). For example, UniProt et al. (A0AAU9MS05_9ASTR GenBank: CAH1424770.1. 2024 (U)) having 100% sequence identity to Applicants SEQ ID NO: 3 is a naturally occurring protein, (see search result below). ID A0AAU9MS05_9ASTR Unreviewed; 1318 AA. AC A0AAU9MS05; DT 27-NOV-2024, integrated into UniProtKB/TrEMBL. DT 27-NOV-2024, sequence version 1. DT 08-OCT-2025, entry version 5. DE RecName: Full=TIR domain-containing protein {ECO:0000259|PROSITE:PS50104}; GN ORFNames=LVIROSA_LOCUS11951 {ECO:0000313|EMBL:CAH1424770.1}; OS Lactuca virosa. OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta; OC Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae; Pentapetalae; OC asterids; campanulids; Asterales; Asteraceae; Cichorioideae; Cichorieae; OC Lactucinae; Lactuca. OX NCBI_TaxID=75947 {ECO:0000313|EMBL:CAH1424770.1, ECO:0000313|Proteomes:UP001157418}; RN [1] {ECO:0000313|EMBL:CAH1424770.1, ECO:0000313|Proteomes:UP001157418} RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA]. RA Xiong W., Schranz E.; RL Submitted (JAN-2022) to the EMBL/GenBank/DDBJ databases. CC -!- CAUTION: The sequence shown here is derived from an EMBL/GenBank/DDBJ CC whole genome shotgun (WGS) entry which is preliminary data. CC {ECO:0000313|EMBL:CAH1424770.1}. CC --------------------------------------------------------------------------- CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms CC Distributed under the Creative Commons Attribution (CC BY 4.0) License CC --------------------------------------------------------------------------- DR EMBL; CAKMRJ010001889; CAH1424770.1; -; Genomic_DNA. DR Proteomes; UP001157418; Unassembled WGS sequence. DR GO; GO:0016020; C:membrane; IEA:UniProtKB-KW. DR GO; GO:0043531; F:ADP binding; IEA:InterPro. DR GO; GO:0006952; P:defense response; IEA:UniProtKB-KW. DR GO; GO:0051707; P:response to other organism; IEA:UniProtKB-ARBA. DR GO; GO:0007165; P:signal transduction; IEA:InterPro. DR FunFam; 3.40.50.10140:FF:000007; Disease resistance protein (TIR-NBS-LRR class); 1. DR Gene3D; 1.10.8.430; Helical domain of apoptotic protease-activating factors; 1. DR Gene3D; 3.40.50.300; P-loop containing nucleotide triphosphate hydrolases; 1. DR Gene3D; 3.80.10.10; Ribonuclease Inhibitor; 3. DR Gene3D; 3.40.50.10140; Toll/interleukin-1 receptor homology (TIR) domain; 1. DR InterPro; IPR042197; Apaf_helical. DR InterPro; IPR044974; Disease_R_plants. DR InterPro; IPR003591; Leu-rich_rpt_typical-subtyp. DR InterPro; IPR032675; LRR_dom_sf. DR InterPro; IPR055414; LRR_R13L4/SHOC2-like. DR InterPro; IPR002182; NB-ARC. DR InterPro; IPR027417; P-loop_NTPase. DR InterPro; IPR000157; TIR_dom. DR InterPro; IPR035897; Toll_tir_struct_dom_sf. DR InterPro; IPR036390; WH_DNA-bd_sf. DR PANTHER; PTHR11017:SF544; ADP-RIBOSYL CYCLASE_CYCLIC ADP-RIBOSE HYDROLASE; 1. DR PANTHER; PTHR11017; LEUCINE-RICH REPEAT-CONTAINING PROTEIN; 1. DR Pfam; PF23598; LRR_14; 2. DR Pfam; PF00931; NB-ARC; 1. DR Pfam; PF01582; TIR; 1. DR Pfam; PF23282; WHD_ROQ1; 1. DR PRINTS; PR00364; DISEASERSIST. DR SMART; SM00369; LRR_TYP; 5. DR SMART; SM00255; TIR; 1. DR SUPFAM; SSF52058; L domain-like; 2. DR SUPFAM; SSF52540; P-loop containing nucleoside triphosphate hydrolases; 1. DR SUPFAM; SSF52200; Toll/Interleukin receptor TIR domain; 1. DR SUPFAM; SSF46785; Winged helix' DNA-binding domain; 1. DR PROSITE; PS50104; TIR; 1. PE 4: Predicted; KW Leucine-rich repeat {ECO:0000256|ARBA:ARBA00022614}; KW Membrane {ECO:0000256|SAM:Phobius}; NAD {ECO:0000256|ARBA:ARBA00023027}; KW Plant defense {ECO:0000256|ARBA:ARBA00022821}; KW Reference proteome {ECO:0000313|Proteomes:UP001157418}; KW Repeat {ECO:0000256|ARBA:ARBA00022737}; KW Transmembrane {ECO:0000256|SAM:Phobius}; KW Transmembrane helix {ECO:0000256|SAM:Phobius}. FT TRANSMEM 1296..1316 FT /note="Helical" FT /evidence="ECO:0000256|SAM:Phobius" FT DOMAIN 13..176 FT /note="TIR" FT /evidence="ECO:0000259|PROSITE:PS50104" FT REGION 1201..1240 FT /note="Disordered" FT /evidence="ECO:0000256|SAM:MobiDB-lite" FT COMPBIAS 1204..1218 FT /note="Low complexity" FT /evidence="ECO:0000256|SAM:MobiDB-lite" FT COMPBIAS 1220..1234 FT /note="Polar residues" FT /evidence="ECO:0000256|SAM:MobiDB-lite" SQ SEQUENCE 1318 AA; 149817 MW; 2AA99AA511E185AF CRC64; MASSSSSSNQ KSFKYQVFLS FTGEDTRKTF VDHLYASLKQ KGIHTFRDNE ELEKGKRIDE LFKAIEESRF FIIVFSKNYA SSSWCLKEVT KIMECQDGNQ QIAYPLFYGV EPSDIRHQTG PVGRAIA KHK DNEQIKKWEK ALEDAGNLVG WDLKNIANGH EAEAITKIIE EISLKLGSIH LGNDEHLIGM ERRMQALEPS LGIGLNDKAR MIGIKGMGGI GKTTLAKAIF NKFSSHFEGS SFVADIREVS KKKGLESLQQ QILSDVLKDE RMRVGSVNEG ERIMRMRLPY KKVLLVLDDV DDTKQLEALA GDWFKNGSRI IITTRDENVL LSHEVKKKWI HDVDFLSDEE AIRLFLWFAF RRYIPDQGYE ELTARVVRYA AGLPLKIRVL GSHLCGENKD VWRDALKRLE KIPLQETLDV LEISYNSLED DHKEIFLDVA CFLNGLSHEF AIRILESCGF HATYGLRILE HKSLVTISDG RLGMHDTIQE LGKNIIRREH PRELNKHSRL WNTEEIVELL SDDEGTATST CTGMLLLLLL CELSPEIIIQ KLGNLKRLRY LCVLGIVSDC FPSDWKFDET KPSFPNSLQY LIWDKYPGFS LPHTFRAKNL VGLELTGSRI TQLWESSERK KLKFFLLGNS NLRTLRESGE RMVLEKLRFL NLKNSKVSIL DLGMTPNLER LDLEGCHDLK EIYAPAGCLK RLIYIDLRGC PWSVSFPFVK QLEPHVLLSL PVLAVKVDPM EAFPRDSTNN LRFTFVYYKE LPSSREGINF KSVFLDLQPC TKLESVSGSI CGLQHLREVK FQGCIPEVPK DIDQLKGLQQ LILLSTHVKR LPDSVCMLKH LKSLKLSDCQ HLEELPENLG LLENLEELSL STASIRRLPD SVCMLKHLKS LKLGDCQHLE ELPENLGWLG NLEELMFISI SIRRLPDSIC MLSHLKSLHL DSCGRLEKLP EDIGQLKSLE MLNLGQCESL RDIPNSICNM KSLTHLYLRE CRQVEKLPED LGNLKLLQGL NIGFTGISHL PHSISSMNGL LVFGSISLLQ SCAFATEIYT HEVLGPHCRI QAMDSTLAHT ELRSQSEQKY LTREGKEILI EDGDEGTLGG ESSDDVNKRM RVSHMGTNSE YLQNKELIRF FENLMSAADP EEFLKMLQVI TSLQGDNNGS SEMSEKETDM IIKMLAEELQ NRSEMASSFN TQNLVETNRS NIPQGQQSQR SGTSQGQGFL NRQPSFPNIQ SQLRNPDMRE MTPDIKFSRE DAERAQQVMS SLSPETIHRL IKLADLIKTA CEGAVKTKNW LLGRQGFVMV VCMLLFAIFL HWLGFIGN In regard to claims 2-3 and 10, the claims are directed to a V06 resistance gene comprising a nucleic sequence having at least 90% sequence identity with SEQ ID NO: 1. As mentioned by the Applicant said gene is found in resistant lettuce plant, (see page 8 lines 19-21). Therefore, the naturally occurring V06 nucleic acid is found in nature and not patent-eligible. For example, NCBI et al. (PREDICTED: Lactuca sativa TMV resistance protein N (LOC111911229), transcript variant X2, mRNA NCBI Reference Sequence: XM_023907009.3. 2022 (V)) having 95.07% sequence identity to Applicants SEQ ID NO: 1 is a naturally occurring protein, (see search result below). LOCUS XM_023907009 2327 bp mRNA linear PLN 22-DEC-2022 DEFINITION PREDICTED: Lactuca sativa TMV resistance protein N (LOC111911229), transcript variant X2, mRNA. ACCESSION XM_023907009 VERSION XM_023907009.3 DBLINK BioProject: PRJNA432228 KEYWORDS RefSeq. SOURCE Lactuca sativa (garden lettuce) ORGANISM Lactuca sativa Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta; Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae; Pentapetalae; asterids; campanulids; Asterales; Asteraceae; Cichorioideae; Cichorieae; Lactucinae; Lactuca. COMMENT MODEL REFSEQ: This record is predicted by automated computational analysis. This record is derived from a genomic sequence (NC_056630) annotated using gene prediction method: Gnomon, supported by EST evidence. Also see: Documentation of NCBI's Annotation Process On Dec 22, 2022 this sequence version replaced XM_023907009.2. ##Genome-Annotation-Data-START## Annotation Provider :: NCBI RefSeq Annotation Status :: Full annotation Annotation Name :: GCF_002870075.4-RS_2022_12 Annotation Pipeline :: NCBI eukaryotic genome annotation pipeline Annotation Software Version :: 10.1 Annotation Method :: Best-placed RefSeq; Gnomon; cmsearch; tRNAscan-SE Features Annotated :: Gene; mRNA; CDS; ncRNA ##Genome-Annotation-Data-END## FEATURES Location/Qualifiers source 1..2327 /organism="Lactuca sativa" /mol_type="mRNA" /cultivar="Salinas" /db_xref="taxon:4236" /chromosome="8" gene 1..2327 /gene="LOC111911229" /note="TMV resistance protein N; Derived by automated computational analysis using gene prediction method: Gnomon. Supporting evidence includes similarity to: 1 EST" /db_xref="GeneID:111911229" CDS 201..2069 /gene="LOC111911229" /codon_start=1 /product="disease resistance protein RPV1 isoform X2" /protein_id="XP_023762777.1" /db_xref="GeneID:111911229" /translation="MTPNLERLGLERCRDLEKIYAPAGCLKRLIYIDLRGCPWSVSFP FVKQLEPHVLLSLPVLAVKVDPLEDFPKDHTNNLRFTFVYYKEPPLSREGIDYKTVFL DLQPCTKLESVSGSICGLQHLREVKFQGCITEVPNDIDQLKSLEQLILLSTHVKRLPD SVCMLKHLKSLNISDCQHLEELPENLGLLENLMELSLSTTSIQRLPDSVCMLKNLKSL ELGDCQHLEELPENLGWLGNLEELVFISINIRRIPDSICMLSHLKSLHFDSCGGLEKL PEDIGQLESLEMLNLGKCESLRDIPNSLCNMKSLNHLYLRECRQVEKLPEDLGNLKLL QGLNIAFTGISHLPHSISSMNGLHVFGSISLLQSCAFATEIYTHEVLGPHCRIQAMDS TLARTELRSQSTQKYLTREGKEILIEDGDEGTPGEGILCFFFQVKFFIDQHVCILLLH LVCISESSEYLQNQELIRFLENFMPAPEPEDLENMLQVITSFQGDNNGSSEMSEKETD MIIMMLNEELQKRSEMASSFNTQNPMETNRSNIPQSQLTNPDMREEDAERAQQVMSSL SPETIDRLIKLADRIKTACEGAVKTKNWLLGRQGFLMVVFMLLFAIFLHWLGFIGN" polyA_site 2327 /gene="LOC111911229" /experiment="COORDINATES: polyA evidence [ECO:0006239]" ORIGIN 1 cgaattcgtt acagtatctg atataggata aataccctgg tttctcttta ccccacacat 61 ttcgagcaaa gaatcttgtt ggacttgaat tgactggaag caaaatcaca caactatggg 121 aaagtagaga aagaaaggtt cttgagaaac tcaggttcct cgaccttaaa aattcgaagg 181 tgaggaccct tgaccttggg atgactccca atcttgagag gttaggtctt gaaagatgtc 241 gtgatttgga aaagatttat gcgcctgctg gatgtctaaa aaggcttatc tacatagatt 301 tacgtggttg cccatggtct gtatcttttc cttttgttaa acaattggaa ccacatgtgc 361 ttcttagtct acctgtgtta gctgtgaaag tggatccctt ggaggatttt ccaaaggacc 421 acacaaacaa tctacgattt acatttgtat attataaaga accacctttg tcaagagaag 481 gaattgatta taagactgtt tttctagatc ttcagccttg cacaaaactt gagagtgttt 541 caggaagcat ttgtggctta caacatctaa gagaagttaa atttcagggc tgtattacgg 601 aggttcctaa cgacattgac cagttgaaaa gcttggaaca actcattttg ttgtctacac 661 acgtcaaacg tcttcctgat agtgtttgta tgttgaaaca tttgaaatct ctcaacatta 721 gtgattgcca gcatcttgaa gagttgccgg agaatcttgg tttgttagaa aatttaatgg 781 agctgagttt atcgactaca agtattcagc gtcttcctga tagtgtttgt atgttgaaaa 841 atctgaaatc tctcgaactt ggagattgcc aacatcttga agagttaccg gagaaccttg 901 gctggttagg aaatttagag gagctggtgt tcatttctat aaatattaga cgtattccag 961 atagcatttg catgctgagt catctgaaat ctctacactt tgactcttgt ggaggcctcg 1021 agaagttacc cgaggatatt gggcaactag agagtttaga gatgctgaac ctaggaaagt 1081 gtgaatcttt acgagatatt ccaaacagcc tctgtaacat gaaatcttta aatcatctct 1141 atctccgcga atgtagacaa gttgagaaat tgccagagga tttgggaaac ctaaagcttt 1201 tacaagggtt aaatatagcg tttacaggaa taagtcatct tccacatagt atttcctcga 1261 tgaatggtct acatgttttc ggatccatat cacttcttca gtcttgtgct tttgcaaccg 1321 agatatatac ccatgaagta cttggacccc actgccgcat acaagccatg gatagcacac 1381 tggcacgcac agaattaagg agccagtcca ctcagaagta tcttaccagg gagggcaagg 1441 aaatattaat tgaagatggt gatgagggta caccaggaga aggtattttg tgtttttttt 1501 ttcaagtcaa gttttttatt gaccaacatg tatgtattct tttgttacat cttgtatgta 1561 tttcagaatc ttcagagtat ctgcagaacc aagaactcat cagattcttg gagaacttca 1621 tgcctgcacc agaaccagaa gatttagaaa atatgctcca agtgatcacc tcctttcaag 1681 gtgacaacaa tggttcttca gaaatgagtg aaaaggaaac tgacatgata attatgatgc 1741 taaatgaaga gctccaaaag aggtctgaaa tggcatcatc tttcaacact caaaatccaa 1801 tggaaacaaa taggagtaat attccacaaa gccaattgac gaatccagac atgcgtgagg 1861 aggatgcaga aagagcccaa caagtcatgt cgtctttgtc accggagacc atcgatagac 1921 tgataaagtt ggctgatcga ataaaaacag catgtgaagg tgctgtaaaa accaaaaatt 1981 ggcttctggg gaggcagggg tttcttatgg tcgtatttat gcttcttttt gcaatctttc 2041 tccattggct tggattcatt ggcaattaga aaaaaaaaaa gaaaaaaggt aatggaatga 2101 catgtaaaaa cagtcactta attaatgctc ttgaatttaa attttggata ggtaaatcat 2161 gggcatgcgt ggctggattt tatgaattat tttggaacaa tgagtcaaac tgtcaatgtt 2221 ttatatactt tcatgacctt atgtaaccta tatcaaaata tatttcaatt attgtatgat 2281 gcattatgat taaacataaa gatatttata cactacatct tggaatc In regard to claims 4, 8, and 16, the claims are drawn to a plant with said resistance gene not comprising SEQ ID NOs: 6 and 7, wherein the lettuce plant produces an average seed yield of at least 5 grams (g). Additionally, the specification states “[a] Bremia resistant lettuce plant which does not comprise both markers SEQ ID No.6 and SEQ ID No.7 and/or comprises markers 1 and 2 (SEQ IDs 4 and 5, respectively) provided the most reduced V06 introgression fragment, and therefore is expected to restore the seed production to wild type levels, i.e. average weight of 15.7 g per plant”, (see page 10 lines 11-14), suggesting that it is indistinguishable from the wild-type especially since said gene exist in the wild-type and produce the same amount of seed yield. Therefore, there is nothing that would distinguish said plant from the wild-type since crossing and natural selection happens in the wild. Furthermore, beside genotyping the gene the making of the plant had no hand of man to make such plant. In regard to claim 5, as stated above said gene is found in nature and therefore inherently is resistant to races B1:1-15EU. In regard to claims 12-13 and 19-20, the claims are drawn to a method of identifying a downy mildew resistant lettuce plant. Step 1 asks are the claims to a process, machine, manufacture, or compositions or matter. Here, the claims are drawn to a process/method. Step 2A asks are the claims directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea? In this case the judicial exception is the V06 resistance gene that naturally is resistant against downy mildew. Additionally, the step of establishing the presence of the V06 resistance gene in a genome of the lettuce plant involves a natural phenomenon; the gene inherently confers resistance. This also represents a naturally occurring correlation between the gene and resistance. Applicant has not claimed a practical application or use of said correlation. Step 2B asks does the claim recite additional elements that amount to significantly more that the judicial exception? Here, the claims do not recite additional elements that amount to “significantly more” than the judicial exception. The claims do 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 nucleic acid(s) and protein(s). The claimed nucleic acids, proteins, and plant(s) have the inherent property/ies that are recited in the claims. The judicial exception is not integrated into a practical application because the claimed invention is directed to naturally-occurring nucleotides, cells, organisms, and processes. 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. The claimed products are not patent-eligible pursuant to the Supreme Court decision in Ass'n. for Molecular Pathology v. Myriad Genetics (formerly v. USPTO), 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011), cert. granted, judgment vacated and remanded to the Court of Appeals for the Federal Circuit, No. 11-725, 80 U.S.L.W. 3380, 2012 BL 72224 (U.S. Mar. 26, 2012), reversed, ---- S.Ct. ----, 106 USPQ2d 1972, 1974-75 (2013). The claimed invention does not rise to a level that is markedly different in structure from what exists in nature. See “The 2019 Revised Patent Subject Matter Eligibility Guidance”, issued January 7, 2019, available from the USPTO website at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Claim Rejections - 35 USC § 112(a)(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. Claims 1-20, are 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 written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406. Applicant’s disclosure is as follows. Applicant has described identifying V06 resistance gene (SEQ ID NOs: 1-3), in a resistance in Lactuca sativa (lettuce) plant under the seed deposit number NCIMB 43827, (see page 13 lines 3-5). Furthermore, said resistance and unaffected seed production was only seen when sequences did not have the marker 3 (SEQ ID NO: 6) and marker 4 (SEQ ID NO: 7), (see page 10 lines 14-17). Lastly, the specification validated that said gene is resistant to Bermia lactucae, specifically races B1: 1-37EU, (see figure 2 and page 13 lines 1-2). Claims encompass any V06 gene – the specification only describes a single V06 gene from in L. sativa (seed deposit NCIMB 43827). The claimed invention lacks adequate written description for the following reasons. Claims 1-20, are directed to downy mildew resistant lettuce plant comprising V06 gene wherein the plant is resistant to B. lactucae, specifically races B1:1-37EU and/or B1:1-9US, obtained from any source having any nucleic acid structure. Additionally, the claims encompass an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 3, a coding sequence having at least 90% sequence identity to SEQ ID NO: 2, a genomic sequence having at least 90% sequence identity to SEQ ID NO: 1. Furthermore, the scope of the claims encompasses V06 resistance genes and encoding sequences obtained from sources other than L. sativa so long as they share at least 90% sequence identity to SEQ ID NOs: 1-3. The only V06 gene disclosed is from L. sativa (seed deposit NCIMB 43827) being SEQ ID NO: 2-3. From the disclosure of SEQ ID NO: 1-3, one skilled in the art cannot predict gene structures that confer functional activity from other sources and their allelic variants. Applicant does not describe common structures or motifs for V06 resistance gene functionality that is shared by L. sativa (seed deposit NCIMB 43827) plants and other lettuce plants having the same resistance. The specification describes that SEQ ID NOs: 1-3 was isolated solely from a specific wild-type L. sativa and that is not found in other wild-type sources. The specification does not describe that these sequences are representative of other V06 sequences from other wild-type sources. Moreover, the claimed L. sativa V06 gene (SEQ ID NOs: 1-3), exist exclusively in deposit accession number NCIMB 43827 and is absent from other sources or known wild-types. This required resistance is unique to this single plant having deposit accession number NCIMB 43827. The specification fails to describe that variants with at least 90% sequence identity will behave conferring resistance against B. lactucae across different lettuce lines, crosses, or wild-types rendering it unknown if the variants will retain functional activity and confer resistance to the claimed races. The resistance observed is tied to this singular, isolated genetic material. The issue is that the functional activity of variants of SEQ ID NO: 1-3 (i.e., sequences with as little as 90% identity to SEQ ID NO: 1-3) are not predictable because the specification does not describe functional domains or motifs such that one would have no idea if the variants possess the necessary structures to be functionally active and confer resistance. Furthermore, claims 1-20 encompass a nucleic acid sequence having at least 90% identity to SEQ ID NO: 1, or encoding a V06 polypeptide with at least 90% identity to SEQ ID NO: 3. This requires the specification to describe nucleic acid sequences encoding such polypeptides. However, the specification does not describe a nucleic acid sequence having at least 90% identity to SEQ ID NO: 1, or a polynucleotide encoding a V06 polypeptide with at least 90% identity to SEQ ID NO: 3, which leads to a functional V06 polypeptide. A nucleic acid sequence having at least 90% identity to SEQ ID NO: 1 would have 543 nucleic acid substitutions relative to SEQ ID NO:1, while a polynucleotide encoding a polypeptide with at least 90% identity to SEQ ID NO: 3 would have 131 amino acid substitutions relative to SEQ ID NO: 3. These polynucleotide and polypeptides would encompass 3543 and 19131 distinct gene and protein variants, respectively. In the absence of describing where in the sequence of SEQ ID NO: 1 such variations can be sustained, one of skill in the art would not be led to believe that Applicant possesses this vast genus of nucleic and amino acid sequences that retain functional activity , or to the make the polypeptide which would retain the activity of SEQ ID NO: 3, and lead to resistance to B. lactucae Therefore, while the examples describe that certain specific V06 SEQ ID NOs: 1-3 can confer resistance with lettuce, the specification fails to provide adequate description on the motifs, catalytic domains, etc. in these sequences that confers the specifically claimed function of resistance. Applicant has shown one structure/sequence which is not deemed to be a representative number of structures/sequences from the genus of sequences having 90% sequence identity to SEQ ID NO: 1-3 that retain function and thus confer resistance. For example, a blast search of the top ten results shows proteins as unnamed, predicted, and hypothetical genes. PNG media_image1.png 316 1206 media_image1.png Greyscale (1) here are the alignments none of which have high sequence similarity (2) these search results do not describe structures that confer functionality. Therefore, based on the state of the art the skilled artisan would not know the structures found within sequence having as little as 90% sequence identity to SEQ ID NO: 1-3 that confer resistance to the claimed races. The lack of a description of a representative number of structures/sequences, the absence of information in the art on conserved regions required for activity, or the impact of 10% variation of the sequence, one skilled in the art would not know the structures conferring claimed resistance. The examples are specific examples tied to a specific starting material, and not reasonably reproducible description to predictably produce downy mildew resistant lettuce plants. The claims encompass any lettuce plant having any V06 resistance gene – the specification only describes silencing the V06 resistance gene in L. sativa already having resistance and not actually transiently expressed a heterologous gene in another lettuce species. The claimed invention lacks adequate written description with regard to the genus of plants that comprise V06 resistance gene whereby the plant confers resistance to downy mildew races B1:1-37EU and/or B1:1-9US. The scope of the claims any species of lettuce plant. However, Applicant’s working example is only on silencing the V06 (SEQ ID NO: 1-3) in L. sativa (seed deposit NCIMB 43827), a plant that inherently comprises the V06 resistance gene which results in conferring resistance to downy mildew. Applicant has not shown transiently expressing SEQ ID NOs: 1-3 into another lettuce species and conferring said phenotype. Additionally, for claim 14 that is directed to crossing any lettuce plant to get said plant with said resistance phenotype, the Applicant has not described if the crossing of all lettuce plants would successfully confer said gene or function. For example, Xiong, et al (The genome of Lactuca saligna, a wild relative of lettuce, provides insight into non-host resistance to the downy mildew Bremia lactucae. 2023. Plant J, 115: 108-126. (W)), describes that using Pfam models PF00931.23 (Nucleotide-binding (NB) domain) and PF01582.20 (Toll/Interleukin-1 Receptor (TIR) domain) to identify for nucleotide-binding leucine-rich repeat (NLR) in lettuce, (see page 120 right column last paragraph), which are the same Pfam identifiers that were used to identify Applicants resistance gene, (see UniProt alignment above), suggesting that both Xiong’s protein (A0AAU9MS05_9ASTR) and the Applicants V06 resistance protein are the same gene. Moreover, Applicant describes that the V06 resistance gene comprises both the NB and TIR domain, (see page 3 lines 3-11). Xiong further describes that “L. saligna is crossable with L. sativa, the F1 plants are nearly sterile, and the resulting inbred offspring (F2 generation) show severely reduced fertility and transmission ratio distortion (TRD) due to hybrid incompatibility (HI)”, (see page 109 left column middle paragraph), and “If the HI/TRD locus indeed resides in the inversion, then further fine-mapping and introgression of loci associated with HI, and potential immune genes underlying NHR for that matter, will not be feasible due to the lack of recombination caused by inversion.”, (see page 117 right column middle paragraph last sentence and figure 3). Xiong also describes that “the inversion on chromosome 8 co-segregated with an HI region”, (see page 117 right column middle paragraph last sentence and figure 3), suggesting that hybrid incompatibility mainly occurs in chromosome 8. Overall, Xiong describes that not all crosses will result in a successfully transfer desired resistance NLR genes (i.e. V06 resistance gene) and phenotype. Xiong’s description also suggest that not all plants are compatible for crossing. Specifically, because the Applicant’s resistance gene is found on chromosome 8, (see page 8 line 21), and producing at least 5 grams of seed can be hindered by HI. Additionally, Applicant has described that SEQ ID NOs: 6 and 7 are required to see seed yield unaffected. However, Applicant has not described if HI would successfully omit SEQ ID NOs:6 and 7 to see the same function. Therefore, and in light of the state of the art, the skilled artisan would not be of the opinion that Applicant was in possession of the claimed methods as viable seed is not produced. Furthermore, in regard to claims 9-10, being directed to a resistance gene that confers resistance to all downy mildew races in all lettuce plants. However, Applicant has only described races B1:1 to 37EU and/or B1:1 to 9US. Neither the Applicant or the art has described V06 resistance gene as seen in the blast results above or that V06 gene confers resistance to all downy mildew races. Therefore, the V06 resistance gene has not been adequately described for providing resistance to all downy mildew species. Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111 Claim Rejections - 35 USC § 112(a)(Enablement) Claims 1-20, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the lettuce plant deposited under NCIMB 43827, does not reasonably provide enablement for any species of lettuce plant comprising a protein having as little as 90% sequence identity to SEQ ID NO: 3 or a coding sequence having as little as 90% sequence identity to SEQ ID NO: 2 or a genomic sequence having as little as 90% sequence identity to SEQ ID NO:1, or methods of using said protein. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. “The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of a patent enable any person skilled in the art to which it pertains to make and use the claimed invention. Although the statute does not say so, enablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original); see also In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’”) “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Wands, supra. Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. Factors to consider include “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id. Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons. To comply with 35 USC 112(a) enablement, one skilled in the art must be able to make and use the claimed invention. (A) The breadth of the claims The breadth of the claims encompasses any lettuce plant comprising V06 resistance gene having any structure within 90% sequence identity to SEQ ID NOs: 1-3 providing resistance against Bremia lactucae races B1:1-37EU and/or B1:1-9US. However, the specification has only taught silencing said gene in L. sativa (seed deposit NCIMB 43827) already comprising downy mildew resistance to B1:1-37EU and/or B1:1-9US and SEQ ID NOs: 1-3. (B) The nature of the invention. The nature of the claimed invention is directed to any lettuce plant comprising the V06 resistance gene having at least 90% sequence identity to SEQ ID NOs: 1-3, whether achieved by hybridization or gene construction, to provide downy mildew resistance. Additionally, said plant needs to produce at least 5 grams of seed yield. (C) The state of the prior art The state of the prior art does not teach the V06 resistance gene having structure, or function. Additionally, the art does not teach conserved regions or alignments of said gene. Furthermore, there is a lack of guidance whether said gene is compatible in other lettuce plants. (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. The claimed invention lacks adequate enabling guidance for the following reasons. Claims 1-20, are directed to downy mildew resistant lettuce plant comprising V06 resistance gene wherein the plant is resistant to B. lactucae, specifically races B1:1-37EU and/or B1:1-9US, obtained from any source having any nucleic acid structure. Additionally, the claims encompass an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 3, a coding sequence having at least 90% sequence identity to SEQ ID NO: 2, a genomic sequence having at least 90% sequence identity to SEQ ID NO: 1. Furthermore, the scope of the claims encompasses V06 resistance genes and encoding sequences obtained from sources other than L. sativa so long as they share at least 90% sequence identity to SEQ ID NOs: 1-3. The only V06 resistance gene taught is from L. sativa (seed deposit NCIMB 43827) being SEQ ID NOs: 1-3. From the disclosure of SEQ ID NOs: 1-3, one skilled in the art cannot predict the structures of other V06 genes from other sources and their allelic variants. Applicant does not teach common structures or motifs for V06 resistance genes shared by L. sativa (seed deposit NCIMB 43827) plants or any lettuce plant that would allow one skilled in the art to predict their structures of V06 resistance genes. The teaching of SEQ ID NOs: 1-3 was isolated solely from a specific wild-type L. sativa deposit and is not found in other wild-type sources, and lacks the presence or absence of working examples and guidance of V06 resistance sequences from other wild-type sources having at least 90% sequence identity. Moreover, the claimed L. sativa V06 resistance gene (SEQ ID NOs: 1-3), exist exclusively under deposit accession numbers NCIMB 43827 and is absent from other sources, crosses, or known wild-types. This required resistance is unique to this single isolate under deposit accession numbers NCIMB 43827. The specification fails to TEACH, or fails to provide GUIDANCE variants with at least 90% sequence identity will behave predictably across different lettuce lines, crosses, or wild-types. The resistance observed is tied to this singular, isolated genetic material. The lack or guidance and the lack of working examples suggests that other wild-types L. sativa plants or variants would be unpredictable to have the same function or structure. Furthermore, claims 1-20 encompass a nucleic acid sequence having at least 90% identity to SEQ ID NO: 1, or encoding a V06 polypeptide having an amino acid sequence with at least 90% identity to SEQ ID NO: 3. This requires the specification to teach nucleic acid sequences encoding such polypeptides. However, the specification does not teach or provide guidance for making a nucleic acid sequence having at least 90% identity to SEQ ID NO: 1, or a polynucleotide encoding a V06 polypeptide with at least 90% identity to SEQ ID NO: 3, which leads to a functional V06 polypeptide. A nucleic acid sequence having at least 90% identity to SEQ ID NO: 1 would have 543 nucleic acid substitutions relative to SEQ ID NO:1, while a polynucleotide encoding a polypeptide with at least 90% identity to SEQ ID NO: 3 would have 131 amino acid substitutions relative to SEQ ID NO: 3. These polynucleotide and polypeptides would encompass 3543 and 19131 distinct gene and protein variants, respectively. In the absence of guidance indicating where in the sequence of SEQ ID NO: 1 such variations can be sustained, undue trial and error experimentation would be required to make the claimed polynucleotides of SEQ ID NO: 1, or to the make the polypeptide which would retain the activity of SEQ ID NO: 3, and lead to resistance to B. lactucae Therefore, while the examples teach that certain specific V06 SEQ ID NOs: 1-3 can confer resistance with lettuce, the specification fails to teach motifs, catalytic domains, etc. in these sequences that confers the specifically claimed function of resistance. Applicant has not shown one structure/sequence having 90% sequence identity that retain function and thus confer resistance. For example, a blast search of the top ten results shows proteins as unnamed, predicted, and hypothetical lacking adequate enabling guidance of other V06 resistance genes. PNG media_image1.png 316 1206 media_image1.png Greyscale Therefore, because the art fails to teach the structures required for V06 functional activity, a person skilled in the art would be unable to predictably make, and thus use, the claimed amino and nucleic acid sequences as the specification fails to teach the critical domains and motifs that are required for functional activity. The lack of representative sequences, information on conserved regions required for activity, or the impact of 10% variation of the sequence, shows there is not enough guidance to predictably make and/or use the claimed sequences. The examples are specific examples tied to a specific starting material, and not reasonably reproducible teachings to predictably produce downy mildew resistant lettuce plants. The claimed invention lacks adequate enabling guidance with regard to the genus of plants that comprise V06 gene whereby the plant confers resistance to downy mildew races B1:1-37EU and/or B1:1-9US. The scope of the claims encompass any species of lettuce plant. However, Applicant’s working example is only silencing the V06 resistance gene in L. sativa (seed deposit NCIMB 43827), a plant that inherently comprises the V06 resistance gene which results in conferring resistance to downy mildew races B1:1-37EU and/or B1:1-9US. Applicant has not taught transiently expressing SEQ ID NOs: 1-3 into another lettuce species and conferring said phenotype. Additionally, for claim 14 that is directed to crossing any lettuce plant to get said resistance phenotype, the Applicant has not enabled if the crossing of all lettuce plants would successfully confer said gene or function. For example, Xiong, et al (The genome of Lactuca saligna, a wild relative of lettuce, provides insight into non-host resistance to the downy mildew Bremia lactucae. 2023. Plant J, 115: 108-126. (W)), teaches that using Pfam models PF00931.23 (Nucleotide-binding (NB) domain) and PF01582.20 (Toll/Interleukin-1 Receptor (TIR) domain) to identify for nucleotide-binding leucine-rich repeat (NLR) in lettuce, (see page 120 right column last paragraph), which are the same Pfam identifiers that were used to identify Applicants resistance gene, (see UniProt alignment above). The Applicant discloses that the V06 resistance gene comprises both the NB and TIR domain, (see page 3 lines 3-11), suggesting that both Xiong’s protein (A0AAU9MS05_9ASTR) and the Applicants V06 resistance protein are the same gene. Xiong further teaches that “L. saligna is crossable with L. sativa, the F1 plants are nearly sterile, and the resulting inbred offspring (F2 generation) show severely reduced fertility and transmission ratio distortion (TRD) due to hybrid incompatibility (HI)”, (see page 109 left column middle paragraph), and “If the HI/TRD locus indeed resides in the inversion, then further fine-mapping and introgression of loci associated with HI, and potential immune genes underlying NHR for that matter, will not be feasible due to the lack of recombination caused by inversion.”, (see page 117 right column middle paragraph last sentence and figure 3). Lastly, Xiong teaches that “the inversion on chromosome 8 co-segregated with an HI region”, (see page 117 right column middle paragraph last sentence and figure 3), suggesting that hybrid incompatibility mainly occurs in chromosome 8. Overall, Xiong teaches that not all crosses will result in a successfully transfer desired resistance NLR genes (i.e. V06 resistance gene) and phenotype. Xiong teaching also suggest that not all plants are compatible for crossing. Specifically, because the Applicant’s resistance gene is found on chromosome 8, (see page 8 line 21), and producing at least 5 grams of seed can be hindered by HI. Additionally, Applicant has taught that SEQ ID NOs: 6 and 7 are required to see seed yield unaffected. However, Applicant has not taught if HI would successfully omit SEQ ID NOs:6 and 7 to see the same function. Therefore, it would be unpredictable for one skilled in the art to successfully produce a lettuce plant with the specific phenotype. Furthermore, in regard to claims 9-10, being directed to a resistance gene that confers resistance to all downy mildew races in all lettuce plants. However, Applicant has only taught races B1:1 to 37EU and/or B1:1 to 9US. Neither the Applicant or the art has taught V06 resistance gene as evidenced by the blast results above or that V06 gene is resistant to all downy mildew races. Therefore, the V06 resistance gene as claimed has not been adequately enabled for all downy mildew species. Neither the Applicant nor the prior art teach that the V06 resistance gene successfully confer said phenotype in other lettuce species other than L. sativa (seed deposit NCIMB 43827). Furthermore, the Applicant failed to teach adequate guidance within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus having said phenotype. Given the breadth of the claims, the lack of sufficient guidance, the absence of working examples regarding the structure of V06 having at least 90% sequence identity to SEQ ID NOs:1-3 which confer functional activity, the state of the prior art, and unpredictability in the art, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without excessive burden and undue experimentation. For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims. Claim Rejections - 35 USC § 112(b) Indefiniteness Claim 15 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. Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: how to introduce the construct or plasmid to confer resistance. The essential steps are required for one skilled in the art to know how to use it and what to select for. Applicant is advised to properly amend claim. Subject matter free of prior art Instant claims 1-20 appear to be free of the prior art. The closest prior art US Pub. No. 2014/0259212 A1 which teaches SEQ ID NO: 102,236 having 23% sequence identity to SEQ ID NO: 3 as shown below. RESULT 2 US-13-510-783A-102326 Sequence 102326, US/13510783A Publication No. US20140259212A1 GENERAL INFORMATION APPLICANT: Plesch, Gunnar APPLICANT: Blau, Astrid APPLICANT: Herold, Michael M. APPLICANT: Kamlage, Beate APPLICANT: Wendel, Birgit APPLICANT: Puzio, Piotr APPLICANT: Henkes, Stefan APPLICANT: Haake, Volker APPLICANT: Van Camp, Wim APPLICANT: Fahnenstich, Holger APPLICANT: McKersie, Bryan APPLICANT: Bruce, Wesley APPLICANT: Christiansen, Nicole TITLE OF INVENTION: PROCESS FOR THE PRODUCTION OF FINE CHEMICALS FILE REFERENCE: 13311-00084-US CURRENT APPLICATION NUMBER: US/13/510,783A CURRENT FILING DATE: 2012-05-18 PRIOR APPLICATION NUMBER: PCT/EP2010/006988 PRIOR FILING DATE: 2010-11-18 PRIOR APPLICATION NUMBER: EP 09014472.6 PRIOR FILING DATE: 2009-11-18 PRIOR APPLICATION NUMBER: EP 09176396.1 PRIOR FILING DATE: 2009-11-18 PRIOR APPLICATION NUMBER: EP 09181052.3 PRIOR FILING DATE: 2009-12-22 PRIOR APPLICATION NUMBER: EP 10186930.3 PRIOR FILING DATE: 2010-10-08 PRIOR APPLICATION NUMBER: EP 10188863.4 PRIOR FILING DATE: 2010-10-26 PRIOR APPLICATION NUMBER: EP 10189169.5 PRIOR FILING DATE: 2010-10-28 PRIOR APPLICATION NUMBER: EP 10189358.4 PRIOR FILING DATE: 2010-10-29 PRIOR APPLICATION NUMBER: EP 10189943.3 PRIOR FILING DATE: 2010-11-04 PRIOR APPLICATION NUMBER: EP 10190115.5 PRIOR FILING DATE: 2010-11-05 Remaining Prior Application data removed - See File Wrapper or PALM. NUMBER OF SEQ ID NOS: 158060 SEQ ID NO 102326 LENGTH: 1136 TYPE: PRT ORGANISM: Solanum tuberosum Query Match 23.7%; Score 1610.5; Length 1136; Best Local Similarity 36.9%; Matches 390; Conservative 184; Mismatches 315; Indels 169; Gaps 27; Qy 9 NQKS----------FKYQVFLSFTGEDTRKTFVDHLYASLKQKGIHTFRDNEELEKGKRI 58 ||:| : | ||||| ||| ||||||||| :|:|| |:||:|:|:||||| | Db 2 NQESSLLPSPEIIRWSYDVFLSFRGEDVRKTFVDHLYLALQQKCINTFKDDEKLEKGKFI 61 Qy 59 D-ELFKAIEESRFFIIVFSKNYASSSWCLKEVTKIMECQDGNQQIAYPLFYGVEPSDIRH 117 || :||||| :|:||||||:|:||| |:||||||:: || |:|| |:|| :| Db 62 SPELVSSIEESRIALIIFSKNYANSTWCLDELTKIMECKNVKGQIVVPVFYDVDPSTVRK 121 Qy 118 QTGPVGRAIA KHK---DNEQIKKWEKALEDAGNLVGWDLKNIANGHEAEAITKIIEEISL 174 | | | :||: ::::|| |||:| |: |||| | :||||| : || |:| Db 122 QKSIFGEAFSKHEARFQEDKVQKWRAALEEAANISGWDLPNTSNGHEARVMEKIAEDIMA 181 Qy 175 KLGS-IHLGNDEHLIGMERRMQALEPSLGIGLNDKARMIGIKGMGGIGKTTLAKAIFNKF 233 :||| | | :|:||| | : |||| : :|| || |:||||||: |:: Db 182 RLGSQRHASNARNLVGMESHMHQVYKMLGIG-SGGVHFLGILGMSGVGKTTLARVIYDNI 240 Qy 234 SSHFEGSSFVADIREVSKKKGLESLQQQILSDVLKDERMRVGSVNEGERIMRMRLPYKKV 293 | |:|: |: ::|: | |:||| ||: :||::| :::|: || : : || |||| Db 241 RSQFQGACFLHEVRDRSAKQGLERLQEILLSEILVVKKLRINDSFEGANMQKQRLQYKKV 300 Qy 294 LLVLDDVDDTKQLEALAG--DWFKNGSRIIITTRDENVLLSHEVKKKWIHDVDFLSDEEA 351 |||||||| || |||| :|| :||||||||:|:::|: :| :| |: : |:: |: Db 301 LLVLDDVDHIDQLNALAGEREWFGDGSRIIITTKDKHLLVKYETEK--IYRMKTLNNYES 358 Qy 352 IRLFLWFAFRRYIPDQGYEELTARVVRYAAGLPLKIRVLGSHLCGENKDVWRDALKRLEK 411 ::|| ||:: | : :|:|:|:|::: |||| ::|||| | | | | ::||:: Db 359 LQLFKQHAFKKNRPTKEFEDLSAQVIKHTDGLPLALKVLGSFLYGRGLDEWISEVERLKQ 418 Qy 412 IPLQETLDVLEISYNSLEDDHKEIFLDVACFLNGLSHEFAIRILESCGFHATYGLRILEH 471 || | | || |: | : ::||||:||| :| : ||||| | |:::| Db 419 IPENEILKKLEQSFTGLHNTEQKIFLDIACFFSGKKKDSVTRILESFHFCPVIGIKVLME 478 Qy 472 KSLVTISDGRLGMHDTIQELGKNIIRREHPRELNKHSRLWNTEEIVELLSDDEGTATSTC 531 | |:| ||: :| ||::| :|:||| : |||| |:| :| : | | Db 479 KCLITTLQGRITIHQLIQDMGWHIVRREATDDPRMCSRLWKREDICPVLERNLG--TDKI 536 Qy 532 TGMLLLLLLCELSPEIIIQKLG----NLKRLRYLCVLGIVSDCFPSDWKFDET----KPS 583 || | |: | : | : |||:| || | Db 537 EGMSL-----HLTNEEEVNFGGKAFMQMTRLRFL--------------KFQNAYVCQGPE 577 Qy 584 F-PNSLQYLIWDKYPGFSLPHTFRAKNLVGLELTGSRITQLWESSERKKLKFFLLGNSNL 642 | |: |::| | || |||::|: || |:| ||| |||::|: Db 578 FLPDELRWLDWHGYPSKSLPNSFKGDQLVSLKLKKSRIIQLWKTSKD------------- 624 Qy 643 RTLRESGERMVLEKLRFLNLKNSK--VSILDLGMTPNLERLDLEGCHDLKEIYAPAGCLK 700 | ||:::|| :|: : : | :||||||| || | | || | Db 625 -----------LGKLKYMNLSHSQKLIRMPDFSVTPNLERLVLEECTSLVEINFSIENLG 673 Qy 701 RLIYIDLRGCPWSVSFPFVKQLEPHVLLSLPVLAVKVDPMEAFPRDSTNNLRFTFVYYKE 760 :|: ::|: | | :|| :::: :| : || || Db 674 KLVLLNLKNC--------------RNLKTLP-KRIRLEKLEILVLTGCSKLR-TF----- 712 Qy 761 LPSSREGIN-FKSVFLDLQPCTKLESVSGSICGLQHLREVKFQGCIPEVPKDIDQLKGLQ 819 | | :| ::|| | | |:| :: | |: Db 713 -PEIEEKMNCLAELYLD---ATSLS----------------------ELPASVENLSGVG 746 Qy 820 QLIL-LSTHVKRLPDSVCMLKHLKSLKLSDCQHLEELPENLGLLENLEELSLSTASIRRL 878 : | |:: || |: || ||:| :| | |: ||::|||| ||:| : :|: : Db 747 VINLSYCKHLESLPSSIFRLKCLKTLDVSGCSKLKNLPDDLGLLVGLEQLHCTHTAIQTI 806 Qy 879 PDSVCMLKHLKSLKLGDCQHLEE------------------------------------- 901 | |: :||:|| | | | | Db 807 PSSMSLLKNLKRLSLSGCNALSSQVSSSSHGQKSMGVNFQNLSGLCSLIMLDLSDCNISD 866 Qy 902 --LPENLGWLGNLEELMFISISIRRLP-DSICMLSHLKSLHLDSCGRLEKLPEDIGQLKS 958 : |||:| :|| |: : :| || |: ||:| | ||||| ||| | Db 867 GGILSNLGFLPSLERLILDGNNFSNIPAASISRLTRLKTLKLLGCGRLESLPE---LPPS 923 Qy 959 LEMLNLGQCESLRDIPNSICNMKSLTHLYLRECRQVEK 996 :: : :| || | : : |: | |||: | Db 924 IKGIYANECTSLMSI-DQLTKYPMLSDASFRNCRQLVK 960 Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JOSE ORDAZ whose telephone number is (703)756-1967. The examiner can normally be reached 8:30 am-5:00 pm. 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 A Abraham can be reached on (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. /C.J.O./Examiner, Art Unit 1663 /JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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Prosecution Timeline

Jun 20, 2024
Application Filed
Jan 20, 2026
Non-Final Rejection — §101, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12588644
ROOT-KNOT NEMATODE RESISTANCE CONFERRING GENE
2y 5m to grant Granted Mar 31, 2026
Patent 12565662
PLANT PATHOGEN EFFECTOR AND DISEASE RESISTANCE GENE IDENTIFICATION, COMPOSITIONS, AND METHODS OF USE
2y 5m to grant Granted Mar 03, 2026
Patent 12507651
METHODS FOR IMPROVING SEED PRODUCTION IN MAIZE
2y 5m to grant Granted Dec 30, 2025
Patent 12501868
HAPLOID INDUCTION COMPONDS AND METHODS FOR USE THEREOF
2y 5m to grant Granted Dec 23, 2025
Patent 12446504
METHOD FOR ACTIVATING CROP SEED BY HIGH-VOLTAGE ELECTRIC FIELD COLD PLASMA (HVCP), AND USE THEREOF
2y 5m to grant Granted Oct 21, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
99%
With Interview (+100.0%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 14 resolved cases by this examiner. Grant probability derived from career allow rate.

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