REGINA et al.v.Slade et al.Download PDFPatent Trial and Appeal BoardAug 14, 201813668177 (P.T.A.B. Aug. 14, 2018) Copy Citation BoxInterferences@uspto.gov Entered: August 14, 2018 Tel: 571-272-9797 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD AHMED REGINA, PIERRE GEORGES LOUIS BERBEZY, ELISABETH MARIE-ANNE IDA CHANLIAUD, BERNARD DUPERRIER, and MATTHEW KENNEDY MORELL, (Patent 9,357,722) v. ANN J. SLADE, DAYNA L. LOEFFLER, AARON M. HOLM, and JESSICA C. MULLENBERG, (Application 15/615,555). Patent Interference 106,094 (SGL) (Technology Center 1600) Before SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ, Administrative Patent Judges. LANE, Administrative Patent Judge. JUDGMENT - Bd. R. 127(a) A Decision granting Regina Motion 1 has been entered. (Decision, 1 Paper 107). As a result of that decision Slade lacks standing to continue in the 2 interference. Bd. R. 201. Accordingly it is appropriate to enter judgment against 1 Slade. 2 3 Order 4 It is 5 ORDERED that judgment on priority as to Count 1, the sole count of the 6 interference, is entered against senior party Slade (Declaration, Paper 1, 4); 7 FURTHER ORDERED that claim 19-21, corresponding to Count 1, of Slade 8 application 15/615,555, are FINALLY REFUSED, 35 U.S.C. § 135(a);1 9 FURTHER ORDERED that the parties are directed to 35 USC § 135(c) and 10 Bd. R. 205 regarding the filing of settlement agreements; 11 FURTHER ORDERED that a copy of this judgment be entered into the 12 administrative records of the involved Regina patent and Slade application; and 13 FURTHER ORDERED that, if a party seeks judicial review, the party must file 14 a notice with the Board within seven days of initiating judicial review. Bd. R. 41.8(b). 15 We direct the parties’ attention to Biogen Idec MA, Inc., v. Japanese Foundation for 16 Cancer Research, 785 F.3d 648, 657 (Fed. Cir. 2015). 17 18 19 20 21 cc (via email): 1 Any reference to a statute in this Judgment is to the statute that was in effect on March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat. 284, 293 (2011). Attorney for Regina: Christopher L. North, Ph.D., Esq. Todd R. Walters, Esq. BUCHANAN, INGERSOLL & ROONEY P.C. Christopher.north@bipc.com Todd.walters@bipc.com Gary J. Gershik, Esq. COOPER & DUNHAM LLP ggershik@cooperdunham.com Attorney for Slade: Michael L. Goldman, Esq. Edwin V. Merkel, Esq. Tate L. Tischner, Esq. LeClairRyan Michael.goldman@leclairryan.com Edwin.merkel@leclairryan.com Tate.tischner@leclairryan.com BoxInterferences@uspto.gov Entered: August 14, 2018 Tel: 571-272-979 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD AHMED REGINA, PIERRE GEORGES LOUIS BERBEZY, ELISABETH MARIE-ANNE IDA CHANLIAUD, BERNARD DUPERRIER, and MATTHEW KENNEDY MORELL, (Patent 9,357,722) v. ANN J. SLADE, DAYNA L. LOEFFLER, AARON M. HOLM, and JESSICA C. MULLENBERG, (Application 15/615,555). Patent Interference 106,094 (SGL) (Technology Center 1600) Before SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ, Administrative Patent Judges. LANE, Administrative Patent Judge. Decision –Motions – Bd. R. 121(a) Interference 106,094 2 I. Introduction 1 Junior party Regina1 filed a motion, Regina Motion 1, for judgment on the 2 basis that all the involved claims of senior party Slade2 are unpatentable for lacking 3 the written description support required by the first paragraph of 35 U.S.C. §112. 4 (Regina Motion 1, Paper 27). Slade filed an opposition to the Regina motion. 5 (Slade Opposition 1, Paper 58). Regina filed a reply. (Regina Reply 1, Paper 89). 6 Slade substantially coped claim 1 of the Regina involved patent and 7 suggested this interference after the issuance of the Regina involved patent. 8 (Regina Motion 1, Paper 27, SMF3 1, admitted by Slade at Slade Opposition 1, 9 Paper 58, Appendix 2). Thus Regina Motion 1 raises a threshold issue, i.e., an 10 issue that if resolved in favor of the movant would deprive the opponent of 11 standing in the interference. Bd. R. 201.4 12 We GRANT Regina Motion 1. 13 14 II. Discussion 15 A. Legal Principles 16 To be sufficient, a motion must provide a showing, supported with 17 1 Regina indicates that its real party in interest is Arista Cereal Technologies Pty Limited (“Arista”). According to Regina, Bay State Milling Company holds an exclusive license agreement in the United States and Commonwealth Scientific and Industrial Research Organisation and Limagrain Cereales Ingredients SA have an ownership interest in Arista. (Regina real party notice, Paper 11). 2 Slade indicates that its real party in interest is Arcadia Biosciences, Inc. and that a confirmatory license is held by the U.S. Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (Slade real party notice, Paper 5). Interference 106,094 3 appropriate evidence, such that, if unrebutted, it would justify the relief sought. 1 The burden of proof is on the movant. Bd. R. 208(b). 2 In determining the scope of claims before us we give each claim its broadest 3 reasonable construction in view of the specification as it would be interpreted by 4 one of ordinary skill in the art. Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. 5 Cir. 2005); See also Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131, 6 2145 (Fed. Cir. 2016) citing Bamberger v. Cheruvu, 55 U.S.P.Q.2d 1523, 1527 7 (BPAI 1998) (for the proposition that the USPTO applies the broadest reasonable 8 construction standard to patent claims involved in interference proceedings). 9 Claim terms are given their ordinary and customary meaning unless the applicant 10 clearly sets forth a different definition of the term in the specification. In re 11 Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). 12 3 Statement of material fact. 4 Bd. R. 201 states (with relevant portion shown in italics): Threshold issue means an issue that, if resolved in favor of the movant, would deprive the opponent of standing in the interference. Threshold issues may include: (1) No interference-in-fact, and (2) In the case of an involved application claim first made after the publication of the movant’s application or issuance of the movant’s patent: (i) Repose under 35 U.S.C. 135(b) in view of the movant’s patent or published application, or (ii) Unpatentability for lack of written description under 35 U.S.C. 112 of an involved application claim where the applicant suggested, or could have suggested, an interference under § 41.202(a). Interference 106,094 4 The written description inquiry requires that we consider whether the 1 disclosure of the application reasonably conveys to those skilled in the art that the 2 inventor had possession of the claimed subject matter as of the filing date. Vas–3 Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed.Cir.1991). Our evaluation 4 “requires an objective inquiry into the four corners of the specification from the 5 perspective of a person of ordinary skill in the art” with the understanding that “the 6 level of detail required ... varies depending on the nature and scope of the claims 7 and on the complexity and predictability of the relevant technology.” Ariad 8 Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “[W]hile 9 the description requirement does not demand any particular form of disclosure…or 10 that the specification recite the claimed invention in haec verba, a description that 11 merely renders the invention obvious does not satisfy the requirement, Ariad, 698 12 F.3d 1352, citing Carnegie Mellon Univ. v. Hoffmann–La Roche Inc., 541 F.3d 13 1115, 1122 (Fed.Cir.2008) and Lockwood v. Am. Airlines, 107 F.3d 1565, 1571–72 14 (Fed.Cir.1997). 15 Slade substantially copied claim 1 of the Regina involved patent (as 16 claim 19 of the Slade involved application).5 (Slade Preliminary Amendment, 17 Ex. 2012, 4). Given the holding in Agilent Techs. Inc. v. Affymetrix, Inc., 567 F.3d 18 1366, 1375 (Fed. Cir. 2009), we must construe any “substantially copied” claim in 19 5 As noted in the record the Regina involved claims contain a printing error resulting in the issued claims reciting “amylase content” instead of “amylose content” as in the allowed claims. For purposes of this proceeding the claims are understood to recite “amylose content”. (Order Setting Times, Paper 19, 4; See also Regina clean copy of claims, Paper 13). Interference 106,094 5 view of its originating disclosure for purposes of evaluating written description. 1 See Agilent at 1375. (“To be clear, as the court explained in Rowe, when a party 2 challenges written description support for an interference count or the copied claim 3 in an interference, the originating disclosure provides the meaning of the pertinent 4 claim language.”).6 5 B. Slade involved claims 6 All of Slade’s involved claims, claims 19-21, are reproduced below with 7 relevant language emphasized: 8 19. A process for producing a milled product, comprising the 9 steps of 10 (i) obtaining wheat grain (Triticum aestivum)[7] comprising an 11 embryo and starch, wherein the embryo comprises two identical null 12 alleles of an SBEIIa-A gene, two identical null alleles of an SBEIIa-B 13 gene and two identical null alleles of an SBEIIa-D gene, wherein 14 either the two identical null alleles of the SBEIIa-A gene, or of the 15 SBEIIa-B gene or of the SBEIIa-D gene are point mutations, wherein 16 SBEIIa protein is undetectable in the wheat grain, and wherein 17 6 For purposes of evaluating other challenges to patentability, e.g., prior art under 35 U.S.C. § 102 or § 103, it is appropriate to construe the claims in view of the specification in which they appear. (See Agilent at 1375). 7 We understand Triticum aestivum (bread wheat) to be a hexaploid having pairs of homologous chromosomes in each of three genomes designated as A, B, and D genomes. Each of these genomes comprises two variants of an SBEIIa gene. (Regina Statement of Material Facts 4 and 5; Ex. 2001, 1:59-61; Ex. 2021, ¶ 26). Interference 106,094 6 (a) the starch comprises amylose such that the grain has an 1 amylose content[8] of between 50-60% (w/w) as a proportion of the 2 starch in the grain; and 3 (b) the wheat grain germinates, and 4 (ii) milling the grain, thereby producing the milled product. 5 6 20. The process of claim 19, wherein the amylose content of 7 between 50-60% (w/w) is as measured by the K-AMYL kit from 8 Megazyme. 9 10 21. The process of claim 19, wherein the wheat grain is free of 11 any exogenous nucleic acid that encodes an RNA which reduces 12 expression of an SBEIIa gene. 13 14 (Slade clean copy of claims, Paper 8). 15 16 1. “Either/or/or” limitation 17 Summary of parties’ positions 18 The method of Slade claim 19 requires wheat grain comprising an embryo 19 that comprises two identical null alleles9 of an SBEIIa-A gene, two identical null 20 alleles of an SBEIIa-B gene and two identical null alleles of an SBEIIa-D gene. 21 8 High amylose content is said to be of interest because of the health benefits it may bring. (Regina involved patent, Ex. 2001, 1; Tetflow Declaration, Ex. 2021, ¶ 21). 9 We understand a “null allele” of an SBEIIa gene to be a variant of the gene on one chromosome that either encodes an SBEIIa protein that is inactive or encodes no protein at all. (Tetflow Declaration, Ex. 2021, ¶ 27). Interference 106,094 7 Claim 19 also requires that: 1 either the two identical null alleles of the SBEIIa-A gene, or of the SBEIIa-B gene or of the SBEIIa-D gene are point mutations The parties dispute what meaning “either/or/or” (shown in italics above) 2 should be given in the claim. Regina argues that properly construed in view of the 3 Regina involved patent specification, “either/or/or” means that only one pair of 4 identical null alleles of either the SBEIIa-A gene, the SBEIIa-B gene, or the 5 SBEIIa-D gene can be a point mutation. Thus, Regina argues alleles of the other 6 two genomes must have some type of mutation other than a point mutatation. 7 (Regina Motion 1, Paper 27, 4:12-24). Slade argues that, in view of the lack of 8 clarity in the claim language, we should consider the Regina prosecution history10 9 in construing “either/or/or” and conclude, based on statements made by Regina, 10 that it means “at least one” allowing null alleles resulting from point mutations in 11 more than one of the listed SBEIIa genes (A, B, or D). (Slade Opposition 1, 12 Paper 58, 3:9-4:4). 13 Regina argues further that Slade’s specification does not support the 14 “either/or/or” language of claim 19,11 since Slade’s specification describes only 15 combinations of point mutations and does not describe combining point mutations 16 with another type of mutation such that only the alleles of one genome are point 17 10 Slade refers to the prosecution history of Regina application 13/668,177 (’177) which issued as involved Regina patent 9,357,722 (’722). 11 The only other Slade involved claims, claims 20 and 21, are dependent claims and thus also contain the “either/or/or” limitation that Regina argues is not described in the Slade involved application. Interference 106,094 8 mutations.12 (Regina Motion 1, Paper 27, 9:22-14:3). Slade does not point to 1 description in its specification that only one pair of identical null alleles of either 2 the SBEIIa-A gene, the SBEIIa-B gene, or the SBEIIa-D gene can be a point 3 mutation. Slade instead asserts that its specification supports “at least one” pair of 4 identical null alleles resulting from point mutations. (Slade Opposition 1, Paper 57, 5 13:1-16:19). Slade also asserts that because single and double null deletion 6 mutations were already known, one skilled in the art would have known that it 7 would have been useful to combine these other mutations with the point mutation 8 taught by the Slade involved specification. (Slade Opposition 1, Paper 57, 16:21-9 17:21). 10 Either/or/or construction 11 Regina first directs us to language of Slade claim 19. Regina argues that, 12 giving the “either/or/or” limitation its ordinary meaning, only one of the listed 13 options may be selected. (Regina Motion 1, Paper 27, 5:1-19). 14 As Regina urges we first consider the “widely accepted meaning of [these] 15 commonly understood words”. Phillips, 415 F.3d at 1314. Under such a 16 construction we understand that the “either/or/or” language used in Slade claim 19 17 allows for only one option to be chosen from those provided. We do not 18 understand “either/or/or” to be a term that has a particular meaning in the relevant 19 field of art and we have not been directed to evidence indicating such a meaning. 20 12 We understand a point mutation to be a mutation that affects a single base pair of a gene. (Genes, second edition (Benjamin Lewin, ed., John Wiley and Sons 1985), Ex. 2019, 45, 48; Tetflow Declaration, Ex. 2021, ¶¶ 28, 65.) Interference 106,094 9 We do not construe claims “solely on the basis of the claim language, but 1 upon giving claims their broadest reasonable construction ‘in light of the 2 specification as it would be interpreted by one of ordinary skill in the art.’” Phillips 3 415 F.3d at 1316, citing In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 4 (Fed. Cir. 2004). Where, as here, there is a disputed claim term “the specification 5 ‘is the single best guide to the meaning’ of [that] disputed term’” Agilent at 567 6 F.3d 1376-77, citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 7 (Fed.Cir.1996). 8 Regina asserts that its specification supports a construction of “either/or/or” 9 where the null alleles of just one gene pair result from point mutations. Regina 10 points to, inter alia, the portion of its specification stating: 11 In another embodiment, the grain embryo comprises null alleles 12 which are deletion mutations in the B and D genomes which delete at 13 least part of the SBEIIa-B and SBEIIa-D genes, respectively and 14 wherein the SBEIIa-A gene comprises the point mutation; or having 15 null alleles which are deletion mutations in the A and D genomes 16 which delete at least part of the SBEIIa-A and SBEIIa-D genes, 17 respectively and wherein the SBEIIa-B gene comprises the point 18 mutation; or having null alleles which are deletion mutations in the A 19 and B genomes which delete at least part of the SBEIIa-A and SBEIIa-20 B genes, respectively and wherein the SBEIIa-D gene comprises the 21 point mutation. 22 23 (Regina Reply 1, Paper 89, 4:1-20 citing Regina involved patent, Ex. 2001, 9:5-16; 24 ’177 application, Ex. 2002, 12, ¶ 51). 25 Interference 106,094 10 In further support of its position Regina points to the testimony of Dr. Ian J. 1 Tetflow. (Tetflow Declaration, Ex. 2021).13 2 Dr. Tetflow testified: 3 [I]t is my opinion that a person of ordinary skill in the art would 4 understand that the meaning of the “either . . . or” limitation of Slade 5 Claim 19 is that while all three of the SBEIIa genes comprise identical 6 pairs of null alleles, only one pair of identical null alleles of the 7 SBEIIa-A gene, or SBEIIa-B gene or SBEIIa-D gene are point 8 mutations, and the other pairs of identical null alleles are not point 9 mutations. 10 11 (Tetflow Declaration, Ex. 2021, ¶ 74, original emphasis). 12 Dr. Tetflow points to, inter alia, examples 11, 17 and 18 of the Regina 13 involved patent. According to Dr. Tetflow: 14 [These examples] describe additional crossing of wheat plants having 15 deletions in two genomes with plants having null point mutations in 16 the other genome. Id. at cols. 87-88. The crosses described in 17 Examples 11, 17, and 18 produced wheat grain in which the identical 18 SBEIIa null alleles in one genome are point mutations and the SBEIIa 19 alleles of the other two genomes are deletion mutations in accordance 20 with the plain and ordinary meaning of Claim 1 of the ‘772 Patent. 21 22 (Tetflow Declaration, Ex. 2021, ¶ 73, examples discussed at ¶¶ 30, 32, 40-43, 72). 23 13 Based on Dr. Tetflow’s background and qualifications as discussed in his declaration testimony and curriculum vitae, we find Dr. Tetflow to be qualified to testify about the technical issues presented in Regina Motion 1. (Tetflow Declaration, Ex. 1007, ¶¶ 11-16; Tetflow curriculum vitae (Ex. 2022). Interference 106,094 11 We credit the testimony of Dr. Tetflow and find it convincing to show that 1 one skilled in the art would understand Slade claim 19, when read in view of the 2 Regina specification, to require that all three of the SBEIIa genes comprise 3 identical pairs of null alleles, with only one pair of identical null alleles of the 4 SBEIIa-A gene, or SBEIIa-B gene or SBEIIa-D gene as point mutations, and the 5 other pairs of identical null alleles not being point mutations. 6 In opposition to Regina’s proposed claim construction, Slade points to 7 evidence, a grammar reference manual, which Slade argues shows the ordinary 8 language of claim 19 to be unclear because “either/or/or” is not used in the most 9 acceptable way. That text states that “[m]ost properly either…or can frame only 10 two alternatives and no more” and that “the better practice, for the time being, is to 11 rely on the disjunctive or for a list of many – not either…or.” (original emphasis) 12 (Garner14, Ex. 2014, 296-297, discussed in Slade Opposition 1, Paper 58, 12:13-13 22). In Reply Regina points to other evidence, also a grammar reference manual, 14 indicating that it is “acceptable” to use “either” when more than two alternatives 15 are present. (Gregg15, Ex. 2028, 257, discussed in Regina Reply 1, Paper 89, 3:7-16 14). Regardless of whether it is less acceptable to use more than one “or” with 17 “either”, the evidence Slade presents does not show that the “either/or/or” language 18 14 GARNER’S MODERN AMERICAN USAGE, THE AUTHORITY ON GRAMMAR, USAGE, AND STYLE, Quick Editorial Guide (inside cover), 296- 297 (3d ed., 2009); 15 The Gregg Reference Manual: A Manual of Style, Grammar Usage and Formatting by William A. Sabin, (10th ed. 2005). Interference 106,094 12 of Slade claim 19 is unclear in its meaning or is commonly understood to mean “at 1 least one”. 2 Slade further argues that, given what it asserts to be a lack of clarity, we 3 should turn to the prosecution history to understand the meaning of the 4 “either/or/or” limitation. Slade asserts that “Regina repeatedly asserted during 5 prosecution that claim 70 of the Regina ’177 Application, which matured into 6 claim 1 of the Regina ’722 Patent [copied by Slade as claim 19]” …. “requires ‘at 7 least one’ of the listed pairs of null SBEIIa alleles be a point mutation. (Slade 8 Opposition 1, Paper 58, 5:19-24 citing Giroux Declaration, Ex. 1007, ¶¶ 67-78; 9 ’177 amendment, Ex. 2016, 9, 14; ’177 communication, Ex. 1004, 2-5; 10 ’177 amendment, Ex. 1005, 3, 6 (emphasis added by Slade)). For example Slade 11 points out that, during prosecution, Regina stated that “[w]ith respect to new claim 12 70, Example 18[16] discloses the actual reduction to practice of SBEIIa triple null 13 grain comprising at least one SBEIIa point mutation and ‘amylose levels up to 14 158% higher than the control grain.’” (Slade Opposition 1, 7:13-8:4 citing 15 ’177 amendment, Ex. 2016, 17 (emphasis added by Slade)). 16 Slade also directs us to the testimony of Dr. Michel J. Gioroux17 regarding 17 his opinion that the “either/or/or” language of Slade claim 19 should be construed 18 16 Example 18 shows wheat grain having deletion mutations in two genomes and point mutations in only one genome. (Tetflow Declaration, Ex. 2021, ¶¶ 30(c), 32). 17 Based on Dr. Giroux’s background and qualifications as discussed in his declaration testimony and curriculum vitae, we find Dr. Giroux to be qualified to testify about the technical issues presented in Regina Motion 1. (Giroux Declaration, Ex. 1007, ¶¶ 7-12; Giroux curriculum vitae (Ex. 1008). Interference 106,094 13 as “at least one”. Dr. Giroux relies “primarily” upon the prosecution history to 1 support his opinion. On cross-examination Dr. Giroux acknowledges that he gave 2 little consideration to the specification of the Regina involved patent in construing 3 Slade claim 19. (Giroux Deposition Transcript, Ex. 1030, 54:2 -56:13; see also 4 Giroux Declaration, Ex. 1007, ¶ 69). 5 In its Reply 1 Regina points out that it argued claim 70 and the claims 6 containing the “at least one” limitation separately. (Regina Reply 1, Paper 89, 7 6:18-7:7). Regina further points to an interview with the Examiner conducted 8 during prosecution of the ’177 application where, in discussing claim 70 9 specifically, counsel for Regina asserted that claim 70 was adequately described by 10 directing the Examiner “to crosses in Example 11 wherein plants were triple null 11 for the SBEIIa genes wherein two of the alleles were deletion mutants and one of 12 the alleles was a null allele comprising a point mutation.” (Regina Reply 1, 6:18-13 7:15, citing Examiner Interview Summary, Ex. 2029, 4, emphasis added). 14 We have considered the above as well as all other portions of the 15 ’177 prosecution history, and those portions of the testimony of Dr. Giroux, 16 pointed out to us by Slade in its Opposition 1 in determining the construction of 17 Slade claim 19 and in particular the “either/or/or” limitation. We recognize that 18 “because the prosecution history represents an ongoing negotiation between the 19 PTO and the applicant, rather than the final product of that negotiation, it often 20 lacks the clarity of the specification and thus is less useful for claim construction 21 purposes.” Phillips, 415 F.3d at 1317. We agree that portions of the prosecution 22 history show that Regina, at times, broadly characterized its claims, including 23 claim 70, as containing “at least one” point mutation. At the time though some of 24 Interference 106,094 14 the ’177 claims (e.g., claim 50 and 67) 18 did, in fact, contain the “at least one” 1 limitation. (’177 amendment, Ex. 2016, 4, 8). Slade does not direct us to any 2 remarks by Regina during prosecution of the ’177 application that convince us that 3 Regina made a clear statement or other clear indication that the “either/or/or” 4 limitation found in ’177 claim 70 (and thus in Regina claim 1 and Slade claim 19) 5 was intended to mean “at least one”. 6 The construction proposed by Regina is consistent with the ordinary 7 meaning of “either/or/or” and aligns with the Regina description of the invention 8 found in the portions of the specification pointed out to us by Regina. The Regina 9 specification does not provide any special definition to the claim term 10 “either/or/or” so we see insufficient reason to we give the term a different meaning 11 than its ordinary one, which we find to be supported within the specification. 12 Further Regina’s statements during prosecution do not provide sufficient 13 reason to cause us to assign a meaning of “at least one” to the language 14 “either/or/or” where, as here, the specification comports with the ordinary meaning 15 of the claim language. Dr. Gioroux’s testimony regarding the meaning to be 16 assigned the “either/or/or” limitation relies heavily upon the prosecution history 17 with little discussion of the Regina involved specification. 18 As we noted above, “the specification ‘is the single best guide to the 19 meaning’ of [a] disputed term.’” Agilent 567 F.3d at 1376-77. Thus we conclude 20 that Slade claim 19 requires that all three of the SBEIIa genes comprise identical 21 18 These claims were cancelled in response to a rejection and prior to allowance. (’177 amendment, Ex. 2017, 3-5). Interference 106,094 15 pairs of null alleles, but that only one pair of identical null alleles of the SBEIIa-A 1 gene, or SBEIIa-B gene or SBEIIa-D gene are point mutations, and the other pairs 2 of identical null alleles are not point mutations. 3 4 Slade ’555 description 5 Regina argues that, under its proposed construction of the “either/or/or” 6 limitation Slade’s involved specification does not provide written description 7 support for Slade claim 19. (Regina Motion 1, Paper 27, 9:22-14:3). 8 According to Dr. Tetflow “[t]he ‘555 Application does not propose to cross 9 a wheat plant having identical point mutations in either the A, or B, or D genome 10 with a plant having another type of null mutation in the other two genomes.” 11 (Tetflow Declaration, Ex. 2021, ¶ 51). Dr. Tetflow’s testimony indicates that he 12 considered the Slade involved specification to show the two identical null alleles of 13 the SBEIIa-A, SBEIIa-B, SBEIIa-D genes as required by claim 19. However, 14 according to Dr. Tetflow, all of these null alleles, rather than just one as required 15 by Slade claim 19, result from point mutations. In particular Dr. Tetflow testified: 16 By contrast, a person of ordinary skill in the art would understand that 17 the methods of making mutants and the cross breeding described in 18 the ‘555 Application would produce wheat grain in which each of the 19 two identical null alleles of the SBEIIa-A gene, and of the SBEIIa-B 20 gene and of the SBEIIa-D gene are point mutations 21 22 (Tetflow Declaration, Ex. 2021, ¶ 56). 23 Dr. Tetflow acknowledges that “[i]n some places, the ‘555 Application 24 describes combining mutations on different Genomes” [but] “these descriptions do 25 not describe or even suggest combining point mutations on one genome with 26 Interference 106,094 16 another kind of mutation on another.” (Tetflow Declaration, Ex. 2021, ¶ 81). 1 According to Dr. Tetflow “[a]ll of the specific crosses of this kind that Slade 2 proposed are listed in Tables 8, and 10-12 of the ‘555 Application” [and] “[a]ll of 3 these crosses are designed to produce wheat grain having point mutations in more 4 than one genome.” (Id. at ¶ 82). Dr. Tetflow testified that “[t]here is no discussion 5 in the ‘555 Application that would lead a person of ordinary skill in the art to 6 conclude that Slade contemplated crossing a plant having a point mutation in one 7 genome with a plant having a different kind of mutation, such as a deletion of the 8 SBEIIa gene, in the other two genomes, which is how Regina made the invention 9 that is claimed in the claims of the ‘722 Patent that Slade copied.” (Id. at ¶ 53). 10 Slade does not direct us to a portion of its specification describing all three of 11 the SBEIIa genes comprising identical pairs of null alleles, where only one pair of 12 identical null alleles of the SBEIIa-A gene, or SBEIIa-B gene or SBEIIa-D gene are 13 point mutations, and the other pairs of identical null alleles are not point mutations. 14 Slade’s arguments that it describes the “either/or/or” limitation depend 15 almost entirely upon our construing its claim 19 where at least one pair of 16 identical null alleles of the SBEIIa-A gene, or SBEIIa-B gene or SBEIIa-D gene 17 are point mutations. (Slade Opposition 1, Paper 58, at, e.g., 17:11-21). 18 Dr. Giroux’s testimony also depends on such a construction. (Giroux Declaration, 19 Ex. 1007, ¶ 89, original emphasis) (“As discussed above, I interpret the 20 “either...or...or” limitation in claim 19 of the Slade ’555 Application to mean that 21 at least one of the two identical null alleles of the SBEIIa-A gene, or of the 22 SBEIIa-B gene or of the SBEIIa-D gene are point mutations [and] [f]or the 23 following reasons, it is my opinion that the Slade ’555 Application conveyed to a 24 Interference 106,094 17 person of ordinary skill in that art as of October 2, 2012, that that the inventors 1 had possession of a wheat grain having three homozygous null SBEIIa mutations, 2 at least one of which was a point mutation.”). 3 Slade also asserts that a person of ordinary skill in the art would have 4 understood that previously known double mutants would be useful to combine with 5 the point mutations taught in the ’555 Application. (Slade Opposition 1, 16:20-6 17:21, citing inter alia, Giorux Declaration, Ex. 1007, ¶¶ 86-102). We need not, 7 and do not, decide if we agree with Slade’s position. Whether the claimed subject 8 matter would have been obvious is not the standard for written description. Ariad, 9 698 F.3d at 1352. 10 Regina has met its burden to show that Slade does not describe the limitation 11 of the Slade involved claim requiring that only one pair of identical null alleles of 12 the SBEIIa-A gene, or SBEIIa-B gene or SBEIIa-D gene are point mutations, and 13 the other pairs of identical null alleles are not point mutations. We do not find any 14 of the arguments presented in Slade Opposition 1 convincing to show that the 15 Slade specification describes this limitation. 16 17 2. “Undetectable” limitation 18 Regina also contends that the Slade specification does not describe an 19 embodiment where the SBEIIa protein is undetectable in the wheat grain. Regina 20 argues that when we construe the Slade claims in view of the Regina specification 21 “undetectable” requires description of a method of detection, e.g., Western blot 22 analysis. Regina argues that Slade does not describe such a method and thus does 23 not describe the “undetectable” limitation. (Regina Motion 1, Paper 27, 14:9-24 Interference 106,094 18 15:9). 1 Slade argues that its disclosure that expression levels of SBEIIa protein with 2 one or more mutations disclosed therein is reduced to 0% of the expression level of 3 wild type SBEIIa protein would have conveyed possession of the contested 4 limitation to one skilled in the art. (Slade Opposition 1, Paper 58, 18:11-17). 5 Because we find that Slade’s involved specification does not support the 6 “either/or/or” limitation discussed above we need not and do not reach the 7 arguments of the parties regarding the “undetectable” limitation. 8 9 III. Conclusion 10 Regina has shown the involved Slade claims to be unpatentable for lack of 11 written description support. Accordingly Slade lacks standing of continue in the 12 interference. Bd. R. 201. 13 14 IV. Order 15 It is 16 ORDERED that Regina Motion 1 is GRANTED; and 17 FURTHER ORDERED that judgment shall be entered against Slade in a 18 separate paper. 19 20 21 22 23 24 Interference 106,094 19 cc (via email): Attorney for Regina: Christopher L. North, Ph.D., Esq. Todd R. Walters, Esq. BUCHANAN, INGERSOLL & ROONEY P.C. Christopher.north@bipc.com Todd.walters@bipc.com Gary J. Gershik, Esq. COOPER & DUNHAM LLP ggershik@cooperdunham.com Attorney for Slade: Michael L. Goldman, Esq. Edwin V. Merkel, Esq. Tate L. Tischner, Esq. LeClairRyan Michael.goldman@leclairryan.com Edwin.merkel@leclairryan.com Tate.tischner@leclairryan.com Copy with citationCopy as parenthetical citation