Ex Parte Dan et alDownload PDFPatent Trial and Appeal BoardJan 30, 201410715910 (P.T.A.B. Jan. 30, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte YINGHUI DAN, TICHAFA R. I. MUNYIKWA, KIMBERLY A. RAYFORD, and CAIUS M. T. ROMMENS ____________ Appeal 2012-008847 Application1 10/715,910 Technology Center 1600 ____________ Before ERICA A. FRANKLIN, ULRIKE W. JENKS, and ZHENYU YANG, Administrative Patent Judges. JENKS, Administrative Patent Judge DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to introducing nucleic acid sequences into plant cells. The Examiner has rejected the claims as being indefinite and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Monsanto Company as the Real Party in Interest (App. Br. 2). Appeal 2012-008847 Application 10/715,910 2 STATEMENT OF THE CASE The Specification discloses “transforming dicotyledonous and monocotyledonous plant tissue and regenerating fertile transgenic plants therefrom comprising the inclusion of an effective amount of lipoic acid or an analog thereof in at least one of the plant transformation media during the transformation and/or regeneration process.” (Spec. 4, ll. 3-7.) Claims 1-4, 15-18, and 22 are on appeal, and can be found in the Claims Appendix Appeal Brief. Claim 1 is representative of the claims on appeal and reads as follows: 1. A method for introducing a nucleic acid sequence into the genome of a plant cell and regenerating a transformed plant therefrom, said method comprising: a) transforming a plant cell; and b) regenerating a transformed plant therefrom, wherein the transforming and/or regenerating comprises culturing said plant cell on at least one plant transformation media, said at least one plant transformation media comprising an amount of lipoic acid or an analog thereof effective for increasing the efficiency of the transformation and/or regeneration of a plant therefrom, relative to a plant transformed and/or regenerated in the absence of lipoic acid or an analog thereof. The following grounds of rejection are before us for review: A. Claim 15 stands rejected under 35 U.S.C. § 112, second paragraph as being indefinite (Ans. 5). B. Claims 1-4 and 17 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Enríquez-Obregón2 in view of Packer3 (Ans. 5). 2 Gil A Enríquez-Obregón et al., Genetic Transformation of Sugarcane by Agrobacterium tumefaciens using antioxidant compounds, 14 BIOTECNOLOGIA APLICADA 169-174 (1997). 3 Lester Packer et al., Alpha-Lipoic Acid as a Biological Antioxidant, 19 Appeal 2012-008847 Application 10/715,910 3 C. Claims 1-4 and 16 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Peri4 in view of Packer (Ans. 6). D. Claims 1-3 and 17 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Cai5 in view of Packer (Ans. 7). E. Claim 1-3, 15-16, 18, and 22 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Olhoft6 in view of Packer (Ans. 8). F. Claim 1-4 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Ciccarone7 (Ans. 9). A. Indefiniteness The Examiner takes the position that claim 15 is indefinite because the “explant” is transformed and not the “plant cell” as recited in parent claim 1 (Ans. 5). Appellants contend that “[e]xplants inherently and necessarily are comprised of cells (a feature of claim 1).” (Reply Br. 5; see also App. Br. 6). Accordingly, “[t]ransforming an explant thus necessarily and inherently includes transformation of a cell” (App. Br. 6). We find that Appellants have the better position. “The standard of indefiniteness is somewhat high; a claim is not indefinite merely because its scope is not ascertainable from the face of the claims.” Amgen, Inc. v. FREE RADICAL BIOLOGY & MEDICINE 227-250 (1995). 4 Avihai Peri et al., Establishment of an Agrobacterium-mediated transformation system for grape (Vitis vinifera L.): The role of antioxidants during grape- Agrobacterium interactions, 14 NATURE BIOTECHNOLOGY 624-628 (1996). 5 Tishu Cai et al., US 6,369,298 B1, issued Apr. 9, 2002. 6 Paula Olhoft et al., US 2001/0034888 Al, published Oct. 25, 2001. 7 Valentina C. Ciccarone et al., US 2003/0096414 Al, published May 22, 2003. Appeal 2012-008847 Application 10/715,910 4 Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003). Rather, “[a] claim is indefinite if, when read in light of the specification, it does not reasonably apprise those skilled in the art of the scope of the invention.” Id. Here, the Specification provides that the disclosed method is suitable for “transforming a plant cell, tissue or other suitable explant [material] and regenerating a transformed plant therefrom.” (Spec. 3, ll. 12- 13.) Thus, the Specification refers to cells or tissues in relation to explant material, which is consistent with the use of the term explant in the art. Accordingly, we agree with Appellants that explants are essentially a collection of cells. As such, the transformation of an explant would involve transforming the underlying cells. We reverse the rejection of claim 15 as being indefinite. B-F. Obviousness For the obviousness rejections, the Examiner takes the position that “the antioxidants in the prior art [e.g., each of Enríquez-Obregón, Peri, Cai, Olhoft] increased explant viability and transformation efficiencies at the same concentrations” as those claimed for lipoic acid (Ans. 13; see also id. at 10, 17). The Examiner combined this teaching of each of the references with Packer, a reference that teaches lipoic acid is not only an antioxidant but is considered an ideal antioxidant (id. at. 6-8). The Examiner reasoned that “[s]ubstitution of one antioxidant for another is obvious.” (id. at 14.) With regard to the rejection based on Ciccarone, the Examiner finds that the reference discloses the transformation of plant cells using lipoic acid in the culture media and reasons that regeneration of the transformed cells into a whole plant would have been obvious (id. at 9). Appeal 2012-008847 Application 10/715,910 5 The issue is: Does the preponderance of evidence support the Examiner’s conclusion that the combination of references renders the claims obvious, and if so, have Appellants provided sufficient rebuttal or evidence of unexpected results to overcome the Examiner’s prima facie case? Appellants argued all of the obviousness rejections together, contending that the claimed invention provides unexpected results not related to antioxidant activity (App. Br. 7-13). According to Appellants, “[t]he claimed method has been demonstrated to yield substantially improved plant transformation efficiencies at lipoic acid concentrations at which no appreciable antioxidant activity is observed. Thus, the results of the cited references and the claimed method are not similar.” (Reply Br. 7.) Specifically, Appellants contend that: [T]he claimed methods provide for enhanced transformation efficiency using lipoic acid at levels below that at which appreciable antioxidant activity is detected. Specifically, Dr. Duncan explains that no to negligible antioxidant activity was detected at lipoic acid concentrations up to 100μM in an assay to detect antioxidant activity, and concluded that “...the significant benefits provided by use of lipoic acid for plant transformation are not based on antioxidant activity of lipoic acid.” (Reply Br. 8-9.) After considering the evidence and the arguments, we conclude the evidence favors the Examiner’s conclusion of obviousness. Accordingly, we adopt the Examiner’s reasoning (see Grounds of Rejection, Ans. 5-10), and agree that the Examiner properly found Appellants’ arguments unpersuasive (see Response to Argument, Ans. 10-17). We provide the following points for emphasis. Appeal 2012-008847 Application 10/715,910 6 “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Indeed, an “[e]xpress suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997) (“Because the applicants merely substituted one element known in the art for a known equivalent, this court affirms [the rejection for obviousness].”). The Examiner finds that the art showed: [T]hat antioxidants increased explant viability and transformation efficiencies. The prior art also taught [that] lipoic acid is the ideal antioxidant (Packer et al, pg 228, right column, paragraph 2). One of skill in the art would be motivated to substitute an ideal antioxidant for another antioxidant in plant transformation. The actual mechanism of action of lipoic acid is not relevant. (Ans. 16.) We agree with the Examiner’s conclusion that it would have been obvious to substitute one antioxidant for another (id. at 14). Because the Examiner presents a prima facie case of obviousness, we consider whether Appellants submit sufficient evidence or argument in rebuttal. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). Appellants contend that the invention provides unexpected results not related to antioxidant activity (App. Br. 7-13). Appellants refer to the Duncan8 declaration in support of this contention. In the declaration, Dr. Duncan discusses the results of an antioxidant assay in the presence of 8 Declaration of Dr. David Duncan, submitted March 9, 2011. Appeal 2012-008847 Application 10/715,910 7 increasing concentrations of lipoic acid (Decl. ¶ 7). According to Dr. Duncan, “[t]hese results demonstrate that the substantial benefits observed from use of lipoic acid during plant transformation are not based on antioxidant activity” (Id.). According to the Examiner, the evidence presented by Appellants is not persuasive (Ans. 10-17). With respect to Dr. Duncan’s declaration, the Examiner notes that the declaration does not “show that other antioxidants had antioxidant activity at the level normally incorporated in plant tissue culture compared to lipoic acid at the same amounts” (Ans. 10). We agree with the Examiner’s position that without comparing other antioxidants next to lipoic acid in the same assay system, it is not possible to determine whether the lack of antioxidant activity at the lower concentrations is merely an artifact of the assay. Even if the effect of lipoic acid on transformation efficiency acts by some mechanism other than through antioxidant activity, as asserted by Appellants, the Duncan declaration does not undermine the Examiner’s reason for combining the references, namely, that it would have been obvious to substitute one known antioxidant for another. The declaration shows that lipoic acid above 100 μM possess antioxidant activity (Dec. ¶ 7; see also Reply Br. 11). The Examiner reiterates that the prior art disclosed using antioxidants at concentrations ranging from “85 and 170 μM ascorbic acid, 330 and 740 μM cysteine, and/or 12 and 29 μM silver nitrate increased the percent sugarcane explant viability 5-9 fold relative to the antioxidant control” (Ans. 16-17). As such, we agree with the Examiner’s position that it would have been obvious to substitute lipoic acid at the same concentrations as those shown effective for other antioxidants. KSR Int’l Appeal 2012-008847 Application 10/715,910 8 Co. v. Teleflex Inc., 550 U.S. at 416. We agree with the Examiner that Appellants have not provided sufficient evidentiary basis to overcome the Examiner’s prima facie case. We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness, for each of the obviousness rejections, with respect to claim 1, and Appellants have not provided sufficient evidence of secondary considerations that outweighs the evidence supporting the prima facie case. As Appellants do not argue separately claims 15-18, and 22, these claims fall with claim 1 (App. Br. 1-12). 37 C.F.R. § 41.37 (c)(1). Regarding claims 2-4, Appellants additionally assert that the claimed concentration of lipoic acid “is well below the level at which 100% activity is observed” (App. Br. 16) or below the level at “which any antioxidant activity above background is observed” (id. at 17). We find Appellants’ argument with respect to antioxidant activities unpersuasive because the claims do not recite a particular antioxidant activity level. Accordingly, we affirm the rejection of claims 2-4. SUMMARY We reverse the rejection of claim 15 under 35 U.S.C. § 112, second paragraph as being indefinite. We affirm the rejection of claims 1-4 and 17 under 35 U.S.C. § 103(a) as being unpatentable over Enríquez-Obregón in view of Packer. We affirm the rejection of claims 1-4 and 16 under 35 U.S.C. § 103(a) as being unpatentable over Peri in view of Packer. We affirm the rejection of claims 1-3 and 17 under 35 U.S.C. § 103(a) as being unpatentable over Cai in view of Packer. Appeal 2012-008847 Application 10/715,910 9 We affirm the rejection of claims 1-3, 15-16, 18, and 22 under 35 U.S.C. § 103(a) as being unpatentable over Olhoft in view of Packer. We affirm the rejection of rejected claims 1-4 under 35 U.S.C. § 103(a) as being unpatentable over Ciccarone. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation