TOYOTA JIDOSHA KABUSHIKI KAISHADownload PDFPatent Trials and Appeals BoardNov 23, 20202020001969 (P.T.A.B. Nov. 23, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/917,045 03/07/2016 Hiroyuki ENOKI Q225572 6350 23373 7590 11/23/2020 SUGHRUE MION, PLLC 2000 PENNSYLVANIA AVENUE, N.W. SUITE 900 WASHINGTON, DC 20006 EXAMINER STANKOVIC, BRATISLAV ART UNIT PAPER NUMBER 1663 NOTIFICATION DATE DELIVERY MODE 11/23/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PPROCESSING@SUGHRUE.COM USPTO@sughrue.com sughrue@sughrue.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte HIROYUKI ENOKI, SATORU NISHIMURA, MOMOE SUITO, TSUKASA NUNOME, and YUJI NOGUCHI, ____________ Appeal 2020-001969 Application 14/917,045 Technology Center 1600 ____________ BEFORE DONALD E. ADAMS, RICHARD M. LEBOVITZ, and FRANCISCO C. PRATS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 4–7 and 10. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “TOYOTA JIDOSHA KABUSHIKI KAISHA” (Appellant’s August 13, 2019 Appeal Brief (Appeal Br.) 2). Appeal 2020-001969 Application 14/917,045 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to a marker associated with anthracnose resistance that enables selection of a plant line of the genus Fragaria exhibiting resistance against strawberry anthracnose and use thereof” (Spec.2 1). Appellant’s claim 4 is reproduced below: 4. A method for producing a Fragaria x ananassa plant line with improved anthracnose resistance, said method comprising: producing progeny plants by crossing, wherein at least one parent of said progeny plants is a Fragaria x ananassa plant, and wherein said crossing is a sibling cross, a backcross, or a cross to produce a hybrid line; extracting genomic DNA from at least one of said progeny plants; and analyzing said genomic DNA to detect the presence of a marker associated with anthracnose resistance in the extracted genomic DNA, and selecting a progeny line with the marker in its genome, thereby producing a Fragaria x ananassa plant line with improved anthracnose resistance, wherein said marker comprises at least 30 continuous nucleotides of the nucleotide sequence of SEQ ID NO: 8. (Appeal Br. 17.) Claims 4–7 and 10 stand rejected under the written description provision of 35 U.S.C. § 112(a). 2 Appellant’s March 7, 2016 Specification. Appeal 2020-001969 Application 14/917,045 3 ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention? FACTUAL FINDINGS (FF) FF 1. Appellant discloses: It is particularly preferable that the presence or absence of the marker associated with anthracnose resistance in the plant of the genus Fragaria be determined in strawberry cultivars (F. x ananassa). In addition, it is preferable that the presence or absence of the marker associated with anthracnose resistance in the plant of the genus Fragaria be determined in improved lines resulting from various varieties and lines of the strawberry cultivars described above. In such a case, strawberry anthracnose resistance can be evaluated in produced new varieties. Accordingly, it is preferable that a new variety be derived from a line having strawberry anthracnose resistance as either the mother plant or father plant. More specifically, for example, the presence or absence of the marker associated with anthracnose resistance in a plant of the genus Fragaria in a new variety produced from the Strawberry Parental Line Nou - 2 as a parent may be determined, so as to evaluate its resistance to strawberry anthracnose. The marker associated with anthracnose resistance in plants of the genus Fragaria according to the present invention has been newly identified by QTL (Quantitative Trait Loci) analysis using a genetic linkage map containing 1,502 markers acquired from the strawberry cultivar Sachinoka and 2,162 markers acquired from the Strawberry Parental Line Nou - 2 and data concerning strawberry anthracnose resistance. Many genes are considered to be associated with strawberry anthracnose resistance, which is a quantitative trait exhibiting a continuous distribution. Specifically, strawberry anthracnose resistance is evaluated based on rates of affection [sic, infection] with strawberry anthracnose, which exhibits a continuous distribution. QTL analysis is carried out with the Appeal 2020-001969 Application 14/917,045 4 use of the gene analysis software of QTL Cartographer (Wang S., C. J. Basten and Z.-B. Zeng, 2010, Windows QTL Cartographer 2.5. Department of Statistics, North Carolina State University, Raleigh, NC) in accordance with the composite interval mapping (CIM) method. (Spec. 8; see generally Ans. 4.) FF 2. Table 1 of Appellant’s Specification is reproduced below: Appeal 2020-001969 Application 14/917,045 5 Appellant discloses that “[t]he 29.0-cM region comprises the 10 types of markers shown in Table 1 in the order show in Table 1” (Spec. 9; see generally Ans. 4). FF 3. Appellant discloses that a region of “approximately 29.0 cM (centimorgan)” that includes a peak that “implies the presence of causal gene(s) that improve anthracnose resistance in plants of the genus Fragaria at such peak or in the vicinity thereof” (id. at 8–9; see generally Ans. 4). FF 4. Appellant discloses that the marker associated with anthracnose resistance in plants of the genus Fragaria according to the present invention is continuous nucleic acid region sandwiched between the nucleotide sequence as shown in SEQ ID NO: 1 and the nucleotide sequence as shown in SEQ ID NO: 10 in the chromosome of the plant of the genus Fragaria. The peak in the 29.0-cM region located in a region sandwiched between the marker consisting of the nucleotide sequence as shown in SEQ ID NO: 4 (IA200064) and the marker consisting of the nucleotide sequence as shown in SEQ ID NO: 8 (IA202631). (Spec. 10–11; see id. at 11 (Because the peak is located in the region sandwiched between SEQ ID NO: 4 and SEQ ID NO: 8, “the marker associated with anthracnose resistance in plants of the genus Fragaria is preferably selected from a region sandwiched between the nucleotide sequence as shown in SEQ ID NO: 4 and the nucleotide sequence as shown in SEQ ID NO: 8.”).) FF 5. Appellant discloses the “use of a nucleic acid region including a marker consisting of the nucleotide sequence as shown in SEQ ID NO: 8 (IA20263 l), which is located in a position nearest to the peak as the marker associated with anthracnose resistance in plants of the genus Fragaria is preferable” (Spec. 12). Appeal 2020-001969 Application 14/917,045 6 FF 6. Examiner interprets Appellant’s claimed invention to recite a “marker associated with improved anthracnose resistance comprises any 30 continuous nucleotides of the 112-nucleotide[]-long” sequence set forth in Appellant’s SEQ ID NO: 8 (Ans. 3). ANALYSIS Examiner finds that Appellant’s Specification fails to provide written descriptive support for Appellant’s claimed invention (see Ans. 3–4). Examiner asserts “that significant recombination frequency would be expected to occur in th[e] large 29.0 cM-long regions described by Appellant[]” (Ans. 4). Examiner fails, however, to establish an evidentiary basis on this record to support this assertion. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). Appellant discloses “that the presence or absence of the marker associated with anthracnose resistance in the plant of the genus Fragaria be determined in strawberry cultivars (F. x ananassa)” and exemplifies that “the presence or absence of the marker associated with anthracnose resistance in a plant of the genus Fragaria in a new variety produced from the Strawberry Parental Line Nou - 2 as a parent may be determined, so as to evaluate its resistance to strawberry anthracnose” (see FF 1). Thus, we are not persuaded by Examiner’s intimation that Appellant’s Specification fails to provide written descriptive support for Appellant’s claimed invention because Appellant’s “claims do not require that the new (claimed) variety is produced from the strawberry parental line Nou-2 as a parent” (Ans. 5). Appeal 2020-001969 Application 14/917,045 7 We are not persuaded by Examiner’s contention that Appellant’s Specification fails to provide written descriptive support for Appellant’s claimed invention because Appellants do not claim the necessary causative gene(s) or allele(s) associated with the particular markers associated with improved anthracnose resistance such that, Appellants do not disclose a conserved structure responsible with respect to the genes, markers, and alleles as to accomplish the instantly claimed function of producing a Fragaria x ananassa plant comprising in its genome an introgressed improved anthracnose resistance locus. The claims are not limited to genes or alleles indicative of the claimed phenotype of producing a Fragaria x ananassa plant with improved anthracnose resistance. The Specification makes it clear that a group of genes is causative of the claimed phenotype of improved anthracnose resistance, however no such genes have been identified, nor do the claims require any such genes. (Ans. 5.) We are also not persuaded by Examiner’s assertion that Appellant does “not describe the necessary structural features of these claimed markers as to ensure the intended function of producing Fragaria x ananassa plants with improved anthracnose resistance” (id. at 6). As Appellant explains “it is not critical which 30 continuous nucleotides within SEQ ID NO: 8 are used; the salient point is that 30 continuous nucleotides is sufficiently long to realistically exclude the possibility of inadvertently detecting a different locus” and “with the aid of a basic and rudimentary computer algorithm, persons of skill in the art could readily output each and every nucleotide sequence of SEQ ID NO: 8 that has at least 30 consecutive nucleotides,” thus, “persons of skill in the art could instantly envision the structure (the sequence) of each and every fragment of SEQ ID NO: 8 that is 30 Appeal 2020-001969 Application 14/917,045 8 nucleotides or greater” (Appeal Br. 11–12). We further agree with Appellant’s explanation that [p]ersons of skill in the art reading the present specification would readily recognize that the sequence of SEQ ID NO: 8 is tightly linked to (i.e., inherited in linkage with) the causative gene(s) for anthracnose resistance – and thus can be used as a surrogate for the presence of the causative gene(s) (and therefore as an expedient to select for plants having improved anthracnose resistance). Hence, it is wholly unnecessary for persons of skill in the art - either to practice, or to envision the identity of, the claimed subject matter – to know what the causative gene(s) are. Rather, it is entirely sufficient that the claimed markers are tightly linked with them, so that the presence of the claimed markers in progeny plant(s) can be used as a surrogate for the presence of the causative gene(s). Indeed, . . . Examiner’s demand in this regard – for Appellant to have identified the particular causative gene(s) within the 29.0 cM QTL that produces the improved anthracnose resistance – is fundamentally at odds with the entire reason why QTL markers are advantageous for selective breeding (because they allow selection for a particular trait without having to ultimately characterize the specific gene(s) in the locus that are responsible for the trait). Additionally, to the extent that the Examiner appears to require some sort of structure-function correlation between the marker sequence and anthracnose resistance . . . Appellant notes that the relevant structural feature is, as described above, that the marker has at least 30 continuous nucleotides of SEQ ID NO: 8 – which as a practical matter ensures that the detection will be specific for the target locus. (Appeal Br. 14–15.) CONCLUSION The preponderance of evidence on this record fails to support Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention. The rejection of claims 4–7 Appeal 2020-001969 Application 14/917,045 9 and 10 under the written description provision of 35 U.S.C. § 112, first paragraph is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 4–7, 10 112(a) Written Description 4–7, 10 REVERSED Copy with citationCopy as parenthetical citation