Ex Parte Lang et alDownload PDFPatent Trial and Appeal BoardSep 16, 201312156515 (P.T.A.B. Sep. 16, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte BRUCE A. LANG, JAMES W. BING, JONATHAN M. BABCOCK, THOMAS MEADE, NICHOLAS P. STORER, BLAIR DAVID SIEGFRIED, and ELISEN JOSE GUEDES PEREIRA __________ Appeal 2012-002264 Application 12/156,515 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, ERICA A. FRANKLIN and ANNETTE R. REIMERS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a composition for controlling lepidopteran pests. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Agrigenetics, Inc. (see App. Br. 3). Appeal 2012-002264 Application 12/156,515 2 Statement of the Case Background The Specification teaches that “a European corn borer population selected for resistance to Cry1Fa is not resistant to CrylAb . . . plants expressing these 2 insecticidal proteins . . . will be useful in delaying or preventing the development of resistance to either of these insecticidal proteins alone” (Spec. 2-3 ¶ 0008). The Claims Claims 1-7 are on appeal. Claim 1 is representative and reads as follows: 1. A composition for controlling lepidopteran pests, said composition comprising cells that express effective amounts of both a Cry1Fa chimeric core toxin-containing protein and a CrylAb chimeric core toxin-containing protein. The issue The Examiner rejected claims 1-7 under 35 U.S.C. § 103(a) as obvious over Chen2 and Cao3 (Ans. 5-6). The Examiner finds that “Chen et al teach com seed transformed with trans genes encoding one or more proteins selected from the group consisting of crylAb, crylF” (Ans. 6). The Examiner finds that “Cao et al teach that transgenic broccoli plants carrying two trans genes that confer 2 Chen et al., US 2002/0177526 A1, published Nov. 28, 2002. 3 Cao et al., Broccoli plants with pyramided crylAc and crylC Bt genes control diamondback moths resistant to CrylA and CrylC proteins, 105 THEORETICAL APPLIED GENETICS 258-264 (2002). Appeal 2012-002264 Application 12/156,515 3 resistance to the same pest, the lepidopteran diamondback moth (DBM) (pg 261, right column, paragraph 2), resulted in rapid mortality of DBM, even those that were resistant to one of the cry endotoxins” (Ans. 6). The Examiner finds it obvious “to select two cry endotoxins toxic to the same pest, i.e., cry1Ab and cry1F, to use in the corn seed taught by Chen et al. One of ordinary skill in the art would have been motivated to do so because Cao et al show that pyramiding two or more insecticidal genes to the same pest overcomes resistance and can delay resistance development” (Ans. 6). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the cited prior art renders claim 1 obvious? Findings of Fact The following findings of fact (“FF”) are supported by a preponderance of the evidence of record. 1. Chen teaches that “the seed may also be genetically transformed, e.g., with genes coding for proteins having insecticide, herbicide and/or fungicide resistance properties. It is preferable to transform the seed to protect it from the indigenous pests that cause the greatest harm” (Chen 4 ¶ 0049). 2. Chen teaches the use of seed where the seed comprises “one or more transgenes expressing an insecticidal protein or combination of proteins, preferably a protein or proteins derived from or having the insecticidal activity of the insecticidal proteins from Photorhabdus or Appeal 2012-002264 Application 12/156,515 4 Bacillus, such as a delta endotoxin from Bacillus thuringiensis (especially cry lAb, cry1Ac, cry1F, cry9c, cry2A, or cry6A)” (Chen 4 ¶ 0052). 3. Chen teaches that Where both the seed coating and the transformed seed are active against the same target insect, the combination is useful (i) in a method for enhancing activity against the target insect and (ii) in a method for preventing development of resistance to a transgenic insecticidal protein by providing a second mechanism of action against the target insect. (Chen 4 ¶ 0050). 4. Chen teaches that the “most preferred seeds include corn and soybean” (Chen 3 ¶ 0039). 5. Cao teaches that “the hybrid plants analyzed all produced both CrylAc and CrylC protein” (Cao 261, col. 2). 6. Cao teaches that “crylA+cryl C hybrid plants showed little or no feeding damage from either DBM population . . . and caused 100% mortality of both types of larvae” (Cao 262, col. 1). 7. Cao teaches that “[s]election of parental plants for crosses allowed us to produce hybrid lines producing Bt proteins at desirable and co- ordinate levels for effectiveness in insect resistance management. Growth and development of the crylAc+crylC hybrid plants were normal, as was seed production” (Cao 263, col. 1). 8. Cao teaches that “[p]yramiding two or more insecticidal genes in the same plant is a promising long-term strategy for delaying resistance, and one that is more forgiving on refuge size” (Cao 263, col. 1). Appeal 2012-002264 Application 12/156,515 5 Principles of Law “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex lnc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Analysis Chen teaches a composition of corn seed cells genetically transformed with genes encoding proteins having insecticide resistance properties (FF 1, 4) where the seed cell may comprise “one or more transgenes expressing an insecticidal protein or combination of proteins . . . such as a delta endotoxin from Bacillus thuringiensis (especially cry lAb, cry1Ac, cry1F, cry9c, cry2A, or cry6A)” (Chen 4 ¶ 0052; FF 2). Chen teaches the advantage of combining two different components to provide “a second mechanism of action against the target insect” (Chen 4 ¶ 0050; FF 3). Cao experimentally demonstrates that when two insecticide genes were expressed in a single plant, the “crylA+crylC hybrid plants showed little or no feeding damage from either DBM population . . . and caused 100% mortality of both types of larvae” (Cao 262, col. 1; FF 6). Cao teaches that “[g]rowth and development of the crylAc+crylC hybrid plants were normal, as was seed production” (Cao 263, col. 1; FF 7). Appeal 2012-002264 Application 12/156,515 6 Applying the KSR standard of obviousness to the findings of fact, we conclude that the person of ordinary skill would have reasonably followed the guidance of Chen and Cao to incorporate two known genes for insecticidal proteins into seeds in order to provide a second mechanism of action against a target insect (FF 3) and since Cao teaches that “[p]yramiding two or more insecticidal genes in the same plant is a promising long-term strategy for delaying resistance, and one that is more forgiving on refuge size” (Cao 263, col. 1; FF 8). Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appellants contend that “Cry1F, Cry1Ab, Cry1C, and CrylAc are completely different proteins with different spectrums of activity (against different insects) with different levels of activity . . . Cao targeted diamondback moths (DBM) in broccoli. European cornborer (ECB) was the main pest targeted in the subject application - with corn/maize being exemplified” (App. Br. 7). We are not persuaded. None of the pending claims are limited to control of the European cornborer. Indeed, claim 1 broadly encompasses lepidopteran pests, which would reasonably include the diamondback moth taught by Cao. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Appellants contend that “[m]any other combinations were possible, and there were reasons to make other combinations. For example, Figure 11 of van Frankenhuyzen shows that even among a group of 12 toxins selected for testing against ECB (non-resistant), other Cry proteins (such as CrylAc, Appeal 2012-002264 Application 12/156,515 7 CrylBb, and Cry2Aa) could be more active than the ones now claimed for controlling ECB. Thus, these bioassay results teach away from the combination now claimed” (App. Br. 8). We are not persuaded. Chen teaches the specific list of delta endotoxins as preferred, listing only six different proteins. Even including the two VIP proteins identified by Chen as well, the prior art provides specific direction to this small set of proteins. See Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (The disclosure in the prior art of “a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art”). Here, there is no argument that the other combinations would be ineffective, only different. Further, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). See also In re Crockett, 279 F.2d 274, 276-77 (CCPA 1960); Ex parte Quadranti, 25 USPQ2d 1071, 1072 (BPAI 1992) (mixture of two known herbicides held prima facie obvious). Appellants contend that “[t]here was no reasonable expectation of successfully using crylAb and crylF together in corn / to control resistant ECB. In addition, no other reason to make this combination in corn is alleged by the examiner” (Reply Br. 3). Appeal 2012-002264 Application 12/156,515 8 We are not persuaded. With regard to corn, Chen teaches that the “most preferred seeds include corn and soybean” (Chen 3 ¶ 0039; FF 4). This provides a specific reason to apply the combination taught by Chen to corn (FF 1-3). We also do not find the “expectation of success” argument persuasive. In O’Farrell, the court found that The admonition that “obvious to try” is not the standard under § 103 has been directed mainly at 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). This is not a case where the prior art gave no direction or indication of the critical parameters. Indeed, Chen provided a specific list of six specific proteins which might be genetically expressed in seeds (FF 2) where corn was a preferred seed (FF 4), and where Chen taught that “one or more transgenes” might be employed (FF 2). Cao specifically demonstrated the efficacy of using two of the six transgenes taught by Chen in a single seed for inhibiting the growth of a lepidopteran insect pest (FF 5-7) and provides a specific reason to combine such genes, noting that “[p]yramiding two or more insecticidal genes in the same plant is a promising long-term strategy for delaying resistance, and one that is more forgiving on refuge size” (Cao 263, col. 1; FF 8). Here, there Appeal 2012-002264 Application 12/156,515 9 were explicit directions suggesting ways to proceed provided by both Chen and Cao (FF 1-8), and direct evidence that combinations of insecticidal genes were successful (FF 8). Appellants contend that “other knowledge in the art would have lead one away from making the claimed combination of cry1Ab and cry1F as called for claim 1” (App. Br. 10). We are not persuaded. Neither Chen nor Cao teach away from the combination of genes. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”). Here, neither Chen nor Cao discourage or criticize any particular gene combination (FF 1-8). Appellants appear to be relying for the teaching away upon several references including van Frankenhuyzen4, a document published after the instant filing date and several years after the priority date of March 5, 2004. However, publications dated after the filing date providing information publicly first disclosed after the filing date generally cannot be used to show what was known at the time of filing. See In re Gunn, 537 F.2d 1123, 1128 (CCPA 1976). With regard to the other publications, Appellants did not refer to the Tabashnick or Marcon references in either the Appeal Brief or in 4 Van Frankenhuyzen, K., Insecticidal activity of Bacillus thuringiensis crystal proteins, 101 J. INVERTEBRATE PATHOLOGY 1-16 (2009). Appeal 2012-002264 Application 12/156,515 10 Appellants’ response filed Aug. 13, 2010 prior to the Examiner’s Final Rejection. These are therefore new arguments that the Examiner did not have the opportunity to respond to in the Answer, and for which no good cause has been presented explaining why they should be considered. Therefore, we do not consider these arguments. In re Hyatt, 211 F.3d 1367, 1373 (Fed. Cir. 2000) (noting that an argument not first raised in the brief to the Board is waived on appeal); Ex parte Nakashima, 93 USPQ2d 1834 (BPAI 2010) (explaining that arguments and evidence not timely presented in the principal Brief, will not be considered when filed in a Reply Brief, absent a showing of good cause explaining why the argument could not have been presented in the Principal Brief); Ex parte Borden, 93 USPQ2d 1473, 1477 (BPAI 2010) (informative) ( “Properly interpreted, the Rules do not require the Board to take up a belated argument that has not been addressed by the Examiner, absent a showing of good cause.”). Claims 2-7 Merely pointing out what these claims recite without explaining why the references do not render them obvious is not considered a separate argument for patentability. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). Conclusion of Law The evidence of record supports the Examiner’s conclusion that the cited prior art renders claim 1 obvious. SUMMARY In summary, we affirm the rejection of claim 1-7 under 35 U.S.C. § 103(a) as obvious over Chen and Cao. Appeal 2012-002264 Application 12/156,515 11 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 lp Copy with citationCopy as parenthetical citation