General Mills, Inc.Download PDFPatent Trials and Appeals BoardJul 20, 202014886238 - (D) (P.T.A.B. Jul. 20, 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. 14/886,238 10/19/2015 Eric Wayne Jackson 7729US01 7999 106306 7590 07/20/2020 DIEDERIKS &WHITELAW, PLC 13885 Hedgewood Dr., Suite 317 Woodbridge, VA 22193-7932 EXAMINER DEVEAU ROSEN, JASON ART UNIT PAPER NUMBER 1662 NOTIFICATION DATE DELIVERY MODE 07/20/2020 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): gmi.mail@dwpatentlaw.com mail@dwpatentlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ERIC WAYNE JACKSON __________ Appeal 2020-000110 Application 14/886,238 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC B. GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to an Avena magna (oat) variety. The Examiner rejected the claims as failing to comply with the written description requirement and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 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 General Mills, Inc. (see Appeal Br. 3). 2 We have considered and refer to the Specification of Oct. 19, 2015 (“Spec.”); Final Action of Oct. 11, 2018 (“Final Act.”); Appeal Brief of May 23, 2019 (“Appeal Br.”); Examiner’s Answer of Aug. 8, 2019 (“Ans.”); and Reply Brief of Oct. 4, 2019 (“Reply Br.”). An oral hearing was held on July 7, 2020. Appeal 2020-000110 Application 14/886,238 2 Statement of the Case Background “Common cultivated oat (Avena sativa) has long been a healthy food and ingredient primarily due to favorable levels of grain beta glucan (soluble fiber), antioxidants, and a beneficial fatty acid profile” (Spec. ¶ 2). “Unfortunately, these grains have modest levels of grain protein (~10%) and few contain all the amino acids required in the human diet” (id.). “Avena magna, a wild relative of cultivated oat, is a promising source of protein. However, the lack of favorable agronomic characteristics (e.g., cultivation and harvestability) have limited the use of A. magna as a crop” (id. ¶ 3). “Prior attempts to domesticate this wild species . . . have failed to produce a cultivatable oat plant that retains the favorable nutritional qualities of wild A. magna” (id.). The Claims Claims 1, 4–7, 13–16, 33, 41–44, and 47–52 are on appeal. Independent claim 1 is representative and reads as follows: 1. An Avena magna variety that is: a. cultivatable using one or more standard farming practices, including mechanical planting and/or mechanical harvesting, as exhibited by the following traits: i. a semi-dwarf height, ii. a comparable or superior lodging resistance compared to Avena sativa variety ‘Leggett’ when grown under the same environment under the same conditions, iii. a comparable or superior shattering resistance compared to Avena sativa variety ‘Leggett’ when grown under the same environment under the same conditions, and iv. a statistically significant increase in seed protein content as compared to Avena sativa variety ‘Leggett’ when grown under the same environment under the same conditions Appeal 2020-000110 Application 14/886,238 3 wherein the semi-dwarf height, the comparable or superior lodging resistance compared to Avena sativa variety ‘Leggett’, the comparable or superior shattering resistance compared to Avena sativa variety ‘Leggett’, and the statistically significant increase in seed protein content compared to Avena sativa variety ‘Leggett’ are heritable from one or more of an Avena magna variety selected from 96.5.6 (American Type Culture Collection accession PTA-122534), 96.5.34 (American Type Culture Collection accession PTA-122532), and 100.2.235 (American Type Culture Collection accession PTA- 122533). The Issues A. The Examiner rejected claims 1, 4–7, 13–16, 33, 41–44, and 47–52 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement (Final Act. 2–14; cf. Ans. 3–8). B. The Examiner rejected claims 1, 4–7, 13–16, 33, 41–44, and 47–52 under 35 U.S.C. § 103 as obvious over Ladizinsky3 and Oliver4 (Final Act. 15–21; cf. Ans. 9–12). A. 35 U.S.C. § 112(a), written description We begin our analysis of this rejection with claim interpretation, because before we can determine whether the claims satisfy the written description requirement, we must determine the meaning of the phrases: “are heritable from” in independent claims 1, 13, 14, 16, 43, and 50; “having 3 Ladizinsky, G., Development of protein rich tetraploid oat- current state and prospects, Hebrew University 1–12 (2014). 4 Oliver et al., New Diversity Arrays Technology (DArT) markers for tetraploid oat (Avena magna Murphy et Terrell) provide the first complete oat linkage map and markers linked to domestication genes from hexaploid A. sativa L., 123 Theor. Appl. Genet. 1159–71 (2011). Appeal 2020-000110 Application 14/886,238 4 greater than 50% allele sharing similarity” in independent claim 42 (that Appellant grouped with claim 48); “essentially derived from” in independent claim 44; and “are inherited from” in independent claim 52. We will then assess whether these claims, as interpreted, comply with the written description requirement. “inherited from,” “descended from,” and “essentially derived from” Appellant asserts that for the phrases “essentially derived from” and “inherited from,” “the phenotypic traits are required to be inherited from one or more of the deposited lines” (Appeal Br. 8). We understand Appellant’s position to be that the plants recited in claims 44 and 52 must have the same alleles as those in the deposited lines. Consequently, we understand Appellant to be asserting that the underlying genetic basis for the traits in these plants is identical, and the claimed plants share identical nucleic acid sequences with the nucleic acid sequences controlling the trait in the deposited lines. The Examiner finds that the genetic makeup of plants with traits either “inherited from,” “descended from,” or “essentially derived from” “the deposited lines will differ from the instantly deposited/described varieties with each subsequent filial generation” (Final Act. 7). We agree with Appellant’s view and interpret “inherited from” and “essentially derived from” as requiring the genus of plants in claims 44 and 52 to those plants that both share all of the functional recitations required by the claims and share identical nucleic acid sequences with the nucleic acid sequences in the deposited lines that result in semi-dwarf height and seed protein content. That is, these claims impose two separate limitations. First, the plants must be the result of breeding of the deposited lines, with the Appeal 2020-000110 Application 14/886,238 5 deposited lines in their parentage as in claim 44. Second, the two recited traits in claim 52 must share the same underlying nucleic acid sequences in the genes that cause these traits as those found in the deposited lines. “are heritable from” and “having greater than 50% allele sharing similarity” Appellant asserts that the phrases “are heritable from” and “having greater than 50% allele sharing similarity” “require the claimed phenotypic traits to be those that are heritable from the deposited lines” (Appeal Br. 8). Appellant further asserts these plants “have the same genetic basis for the claimed phenotypes as the deposited lines and cannot be of any conceivable genotype” (id.). The Examiner finds “the specification fails to describe the genetic structure of these A. magna lines that confers the semi-dwarf height, superior shattering resistance and other traits” (Final Act. 5). The Examiner points out that without describing the genes/structures required for heritability, the skilled artisan would be unable to distinguish between oat varieties having the claimed traits which are heritable from the deposited varieties and other oat varieties that have the claimed traits arising from different genes or combinations of genes not present in the deposited variety. (Ans. 19). In analyzing these opposing views, we note that the Specification does not define the claim phrases at issue. However, the Specification does state “mutation induction, or transgene introduction, can be used for introducing genetic variability . . . Such methods can be used to introduce new traits . . . or improve existing traits” (Spec. ¶ 41). The Specification further notes that “varieties may be obtained for example by the selection of a natural or Appeal 2020-000110 Application 14/886,238 6 induced mutant, or of a somaclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering” (id. ¶ 46). The Specification explains that “[e]xamples of single locus conversions include mutant genes, transgenes and native traits finely mapped to a single locus. One or more locus conversion traits may be introduced into a single oat variety” (id.). Thus, the Specification recognizes that different mutations may result in either new traits or improvements in existing traits, demonstrating that a trait may be shared by two plants but the underlying genetic basis may differ. That the same phenotypic trait may result from different genetic bases is supported by Mr. Richter’s5 statement that “variety 100.2.235 (ATCC designation PTA-122533) exhibits a genotype that confers semi-dwarf height that is different than the genotypes of variety 96.5.6 (ATCC designation PTA-122534) and variety 96.5.34 (ATCC designation PTA- 122532)” (Richter Decl. ¶ 9). Mr. Richter further notes that “the high seed protein content phenotype varies in each of the deposited lines, suggesting potential genotypical variance conferring that trait between the deposited lines” (id. ¶ 11). Therefore, we find that a reasonable interpretation of the phrases “are heritable from” and “having greater than 50% allele sharing similarity” does not require the genetic basis of the phenotypic trait to be identical to the genetic basis in the deposited lines, but rather that the phenotypic trait is one 5 Declaration of Paul Richter, dated July 18, 2018. Appeal 2020-000110 Application 14/886,238 7 of the traits found in the deposited lines and is a phenotypic trait that may be inherited from that line or that shares alleles with that line. Written Description analysis The written description requirement can be met by disclosing “complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (emphasis omitted). The Examiner finds the claims of the instant invention are considered “reach through” claims in which Applicant has only described a starting material and at least one method step, but has not described the resulting product such that the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art would not readily envision the members of the claimed genus (Ans. 8). Appellant contends that the “biological deposits, description in the application, and declaratory evidence, especially in light of the Examiner’s own statement that ‘that the deposited varieties comprise whatever genetic material is necessary to yield a plant with the claimed phenotypes’ substantively support the sufficiency of Applicant’s written description” (Appeal Br. 19). Appellant contends the “declaratory evidence of record by Dr. McMullen and Mr. Richter supports Applicant’s possession of not only the deposited varieties, but of an entire class of A. magna plants with the claimed combination of heritable traits” (id. at 18). Appellant also contends “there is no requirement to disclose an underlying causal genetic element for Appeal 2020-000110 Application 14/886,238 8 the claimed genus, particularly on a nucleotide-by-nucleotide basis, in order to comply with the written description requirement” (id. at 21) We find that Appellant is persuasive with regard to claims 44 and 52 that recite the phrases “essentially derived from,” “descended from,” and “are inherited from.” As discussed in our claim interpretation above, these phrases require the claimed plants both share all of the functional recitations required by the claims and share identical nucleic acid sequences with the nucleic acid sequences in the deposited lines that result in semi-dwarf height and seed protein content (claim 52). Thus, the recited functional characteristics are linked to specific physical properties of the deposited plants, and indeed necessarily share the identical nucleic acid sequences responsible for these properties. We agree with Dr. McMullen6 that given this identity of sequence required by the “derived from,” “descended from,” or “inherited from” language, “[a]dditional Avena magna varieties having the claimed traits can be readily produced by breeding one or more of the deposited Avena magna varieties to other oat varieties, or to each other, and selecting for the desired traits” (McMullen Decl. ¶ 27). We agree with Appellant that the three deposited species represent a reasonable number of species relative to the scope of a claim to plants that necessarily incorporate genetic material bred from those three deposited species. We find that the Examiner is persuasive with regard to claims 1, 13, 14, 16, 42, 43, and 50 that recite the phrases “are heritable from” or “having greater than 50% allele sharing similarity.” As discussed in our claim 6 Declaration of Michael S. McMullen, dated July 18, 2018. Appeal 2020-000110 Application 14/886,238 9 interpretation above, these phrases do not require the claimed plants to share identical sequences with the deposited lines, but rather encompass mutations or other alterations in the genes for the recited functional properties like semi-dwarf height or increased protein content that differ from the genes necessarily present in the deposited lines.7 No such mutations or gene alterations were disclosed in the Specification. These claims are not limited to either the deposited plants or plants whose traits are directly inherited from those deposited plants. The Supreme Court stated: “To obtain utility patent protection, . . . the plant must meet the specifications of § 112, which require a written description of the plant and a deposit of seed that is publicly accessible.” J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Intern., Inc., 534 U.S. 124, 131 (2001). Thus, the claims with the “are heritable from” or “having greater than 50% allele sharing similarity” language do not fall into the safe harbor of the deposit regulations. Dr. McMullen recognizes that lack of possession of other sequences is a concern, noting “[i]n my opinion, in the absence of further information about how semi-dwarf height could be introduced into the lines described in Ladizinsky AOWC,[8] there would be no reason for the person of ordinary skill to expect that the trait could be introduced into the lines described by Ladizinsky” (McMullen Decl. ¶ 20). The same concern applies to the 7 See Oral Hearing Transcript at 8:25 to 9:1 (“[W]e can’t be certain that any mutations would be identical when you are able to distinguish between different genes”). 8 Ladizinsky AOWC (Exhibit F attached to the McMullen Declaration) is the same reference that the Examiner cites in the § 103 rejection. Appeal 2020-000110 Application 14/886,238 10 instant claims at issue, which encompass genetic material not described in the Specification, not in the possession of the inventors, and for which no sequence, structure, or even parentage information is provided. These claims are entirely functional, requiring semi-dwarf height or elevated protein content, but lacking any description of the components necessary to obtain those functions. And unlike the previously discussed claims 44 and 52, that require the same parental nucleic acid for the trait, albeit undisclosed, claims 1, 13, 14, 16, 42, 43, and 50 are reasonably interpreted to encompass any type of mutation or alteration in the gene that results in traits like semi-dwarf height and elevated protein content. Therefore, the instant “claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad’s claims, cover any [plant] later actually invented and determined to fall within the claim’s functional boundaries—leaving it to the [plant breeding] industry to complete an unfinished invention.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353 (Fed. Cir. 2010). We do agree with Appellant that “there is no requirement to disclose an underlying causal genetic element for the claimed genus, particularly on a nucleotide-by-nucleotide basis, in order to comply with the written description requirement” (Appeal Br. 21). However, if the claims are written in substantially functional language, as here, where the limitations “are heritable from” or “having greater than 50% allele sharing similarity” encompass alleles and sequences not necessarily found in the deposited lines, a reasonable number of species of such alleles, sequences, or plants must be provided to demonstrate possession of such an extensive genus. No Appeal 2020-000110 Application 14/886,238 11 example of a single species that differs from the deposited lines has been provided. Conclusion of Law A preponderance of the evidence of record does not support the Examiner’s conclusion that claims 44 and 52 fail to comply with the written description requirement. A preponderance of the evidence of record does support the Examiner’s conclusion that claims 1, 4–7, 13–16, 41–43, 47, 49–50, and 51 fail to comply with the written description requirement. B. 35 U.S.C. § 103 as obvious over Ladizinsky and Oliver The Examiner finds “Ladizinsky teaches the transfer of the domestication syndrome (i.e., seed nonshattering and reduced size) of A. sativa to A. magna” (Final Act. 17). The Examiner finds Ladizinsky teaches “[e]ach of these traits shows monogenic inheritance (i.e., the trait is controlled by a single gene) with some of the characteristics being linked to each other” (id.). The Examiner finds “Ladizinsky teaches that backcross A. magna plants derived from this cross are morphologically indistinguishable from A. sativa common oat and that protein content was as high as 23% (p. 7; see also p. 9). Ladizinsky suggests a desire that semi-dwarf stature be introduced into the A. magna domesticated variety” (id.). The Examiner asserts that because Ladizinsky’s plants “are morphologically indistinguishable from A. sativa it . . . necessarily follows that the A. magna plants as taught by Ladizinsky have comparable shattering resistance and lodging resistance” (Final Act. 17). Appeal 2020-000110 Application 14/886,238 12 The Examiner finds Oliver teaches “A. magna is a potentially valuable resource for protein content that could be commercialized via direct domestication following the model of tetraploid wheat and because it carries resistance to crown rust and powdery mildew” (Final Act. 18). The Examiner finds it obvious to make the claimed oat variety because Oliver et al teaches the importance of the A. magna: it is higher in essential amino acids making it a superior crop and a potentially valuable resource for protein content that could be commercialized via direct domestication following the model of tetraploid wheat and because it carries resistance to crown rust and powdery mildew. (Final Act. 19). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that the combination of Ladizinsky and Oliver renders the claims obvious? Findings of Fact 1. Ladizinsky teaches a “[n]ew approach to exploit A. magna protein content” by: “Domestication: transferring the domestication syndrome of A. sativa to A. magna” (Ladizinsky 3). 2. Ladizinsky teaches that “domestication syndrome” is a “small number of traits that makes the difference between wild and domesticated state” (Ladizinsky 3). 3. Ladizinsky teaches that in oats, these traits include “seed non- shattering at maturity, accompanied by glabrous and yellow lemmas and reduction of awns number and size and erect growth” (Ladizinsky 3). 4. Ladizinsky teaches for the domestication syndrome traits that “[e]ach of these traits shows mono-genic inheritance”; “[s]ome of the Appeal 2020-000110 Application 14/886,238 13 characters are linked to each other”; and “the domestication syndrome can be transferred” (Ladizinsky 4). 5. Ladizinsky teaches that after hybridizing A. sativa and A. magna through five cycles, the outcome resulted in “28 plants [that] are morphologically indistinguishable from the common oat” (Ladizinsky 5–7). 6. Ladizinsky teaches the resultant plants were fertile and contained 16–23% protein content (Ladizinsky 9). 7. Oliver teaches “increasing protein content has been an important breeding objective in oat for at least three decades . . . oat is higher in essential amino acids, making oat a nutritionally superior crop and an excellent target for increased seed protein content” (Oliver 1160, col. 1). 8. Oliver teaches “wild Moroccan oat species A. magna Murphy et Terrell . . . is a potentially valuable resource for protein content, with a measured value of 31% protein in the grain” but “has several undesirable characteristics that need to be addressed before cultivation, including lack of domestication and susceptibility to barley yellow dwarf virus” (Oliver 1160, col. 1). 9. Oliver teaches “Ladizinsky (1995) described the sexual transfer of the domestication syndrome, including genes for reduced awn size (A), yellow lemma color (Lc), glabrous lemma (Lp), and non-shattering spikelet (Ba), from A. sativa to A. magna through two successive backcrosses” (Oliver 1160, col. 1). Principles of Law A prima facie case for obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, Appeal 2020-000110 Application 14/886,238 14 1342 (Fed. Cir. 2003). In addition, while obviousness does not require absolute predictability of success, O’Farrell identifies two kinds of error. In some cases, what would have been “obvious to try” would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. . . . In others, what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it. In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Analysis Appellant contends “[i]t is the Examiner’s duty to demonstrate that one skilled in the art would have had a reasonable expectation of success flowing from the purported obviousness combination” (Appeal Br. 29–30). Appellant contends: Ladizinsky, arguably the leader in A. magna breeding, failed for almost 20 years to achieve A. magna plants combining high protein and other agronomic traits, particularly semi-dwarf height. Nobody before Applicant, including Ladizinsky, was able to achieve the balance of increased nutritional value and functional agronomic properties, because increasing one variable (e.g., protein content) would in turn lessen another variable (i.e., render a plant’s agronomic traits unworkable for large-scale growing). For example, Ladizinsky, summarizing about 20 years of work, teaches that the protein content he achieved was in the 16–23% range (page 9), but he did not consider that sufficient, or indicate it was successfully combined with semi-dwarf stature. Appeal 2020-000110 Application 14/886,238 15 (Appeal Br. 30). Appellant’s position is supported by Dr. McMullen, who states “[i]n my opinion, in the absence of further information about how semi-dwarf height could be introduced into the lines described in Ladizinsky AOWC, there would be no reason for the person of ordinary skill to expect that the trait could be introduced into the lines described by Ladizinsky” (McMullen Decl. ¶ 20). The Examiner responds that the “Office need not establish a reasonable expectation of success for combining the prior art references because Ladizinsky teaches one of ordinary skill in the art everything they need to know to arrive at the instantly claimed oat variety while Oliver provides the motivation for following the teachings of Ladizinsky” (Ans. 31). We agree with Appellant. While there is no doubt that Ladizinsky provides motivation to generate a variety of oat plant with both high protein content and semi-dwarf height, as well as the other traits recited in the claims (FF 3, 6) and Oliver is also interested in improved oat plants with these traits (FF 7, 9), neither reference actually provides a reasonable expectation of success in generating these oat plants. We credit Dr. McMullen’s statement that there would be no expectation of success in adding the semi-dwarf height into Ladizinsky’s oat plants with the other traits (see McMullen Decl. ¶ 20). In addition, we are also persuaded that the 20 year period between Dr. Ladizinsky’s 1995 publication9 and the later presentation in 2014 relied upon in the rejection (FF 1–6), where there was no disclosure of an oat plant with all of the features required by the claims, 9 Ladizinsky, Domestication via hybridization of the wild tetraploid oats Avena magna and A. murphyi, 91 Theor. Appl. Genet. 639–46 (1995). Appeal 2020-000110 Application 14/886,238 16 supports Appellant’s position that it may have been obvious to explore oat plant breeding technology, but the art did not provide sufficient guidance as to how to obtain an oat plant with both increased protein content and semi- dwarf height. Conclusion of Law A preponderance of the evidence of record does not support the Examiner’s conclusion that the combination of Ladizinsky and Oliver render the claims obvious. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1, 4–7, 13–16, 33, 41–44, 47– 52 112(a) Written Description 1, 4–7, 13– 16, 33, 41– 43, 47–49, 50, 51 44, 52 1, 4–7, 13–16, 33, 41–44, 47– 52 103 Ladizinsky, Oliver 1, 4–7, 13– 16, 33, 41– 44, 47–52 Overall Outcome 1, 4–7, 13– 16, 33, 41– 43, 47–49, 50, 51 44, 52 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART Copy with citationCopy as parenthetical citation