09895019 (B.P.A.I. Apr. 14, 2010)

Ex Parte Plank et al

Board of Patent Appeals and InterferencesApr 14, 2010

09895019 (B.P.A.I. Apr. 14, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte CHRISTIAN PLANK and CHRISTIAN BERGEMANN __________ Appeal 2008-002329 Application 09/895,019 Technology Center 1600 __________ Decided: April 15, 2010 __________ Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants have requested rehearing of the decision entered November 20, 2009 (“Decision”), affirming the rejection of claims 1-5, 8- 10, 19-21, 23, and 24 for obviousness. The request for rehearing is denied. Appeal 2008-002329 Application 09/895,019 DISCUSSION Appellants contend that a rehearing is appropriate because our Decision misapprehended the principles of obviousness set out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), as elaborated by the Federal Circuit in two decisions in the biotechnology/chemical arts issued after briefing was required in the instant appeal (Req. Reh’g 2-3 (citing Eisai Co. Ltd. v. Dr. Reddy's Laboratories, Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008) and Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989, 997 (Fed. Cir. 2009))). Appellants specifically urge that, as evidenced by KSR when viewed in light of Eisai and Procter & Gamble v. Teva, a conclusion of obviousness requires a showing that potential solutions to a prior art problem would have been considered predictable (Req. Reh’g 4). In contrast, Appellants urge, the “only argument that [the] Board Decision makes concerning predictability of delivering Taylor’s virus using Lübbe’s magnetic particles, is a general statement by Lübbe that its methods would be applicable to a variety of therapeutic agents including drugs, cells, and gene products” (id. (citing Decision 11)). Appellants’ arguments do not persuade us that our original Decision misapprehended any point of fact or law, nor are we persuaded that the decisions in Eisai or Procter & Gamble v. Teva change the law of obviousness in any way significant enough to alter the outcome of our original Decision. Moreover, we do not agree with Appellants’ characterization of our Decision’s treatment of this issue. We acknowledge that, in considering the obviousness of a chemical compound based on its similarity to a prior art compound, Eisai cautioned 2 Appeal 2008-002329 Application 09/895,019 that “[t]o the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these ‘identified, predictable solutions’ may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.” Eisai, 533 F.3d at 1359 (quoting KSR, 550 U.S. at 421). In Procter & Gamble v. Teva the Federal Circuit again considered whether a chemical compound would have been obvious based on the similarity of its structure to prior art compounds, and advised that “patents are not barred just because it was obvious ‘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.’” Procter & Gamble Co. v. Teva Pharmaceuticals, 566 F.3d at 997 (quoting In re O’Farrell, 853 F.2d, 894, 903 (Fed. Cir. 1988)). Thus, these cases make it clear that, in requiring predictability in prior art solutions to art-recognized problems, the Federal Circuit views KSR as endorsing the well settled principle that a legal conclusion of obviousness requires a finding that an ordinary artisan would have had a reasonable expectation of successfully practicing the claimed subject based on the teachings in the prior art. See In re O’Farrell, 853 F.2d at 903-04 (“Obviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.”). As our Decision explicitly addressed the requirement for a reasonable expectation of success (Decision 11-12), we are not persuaded that the holdings in Eisai and Procter & Gamble v. Teva demonstrate that we misapprehended the principles of obviousness advanced in KSR. Nor are we persuaded that an ordinary artisan viewing the cited prior art would have 3 Appeal 2008-002329 Application 09/895,019 lacked a reasonable expectation that a therapeutic viral vector like Taylor’s would be deliverable to a desired location in a subject’s body using Lübbe’s coated magnetic beads. Appellants contend that the Decision’s finding of a reasonable expectation of success is based only on “a general statement by Lübbe that its methods would be applicable to a variety of therapeutic agents including drugs, cells, and gene products” (Req. Reh’g 4). We disagree. In addressing this argument in the Decision, we noted not only Lübbe’s statement regarding the general applicability of its drug delivery methods, but also the fact that the magnetic particles were provided with an ion exchange coating to allow the drug to adhere to the particles (Decision 11). In view of these teachings, we found that given Lübbe’s disclosure that its techniques were amenable to delivery of a variety of therapeutics, such as cells, which have properties much different than epirubicin, it appears on the current record that an ordinary artisan seeking to deliver Taylor’s virus by Lübbe’s targeting methods would have expected that adapting Lübbe’s particles in the desired manner would be routine. (Id.) Thus, in agreeing with the Examiner that the prior art provided a reasonable expectation of success, we based that finding on the fact that, given the wide variety of properties possessed by the different substances disclosed by Lübbe as being deliverable by its methods, an ordinary artisan would have reasoned that therapeutic viruses would be predictably deliverable in the same manner. Appellants, in contrast, seek to limit the ordinary artisan’s understanding of Lübbe to teaching delivery of only those substances 4 Appeal 2008-002329 Application 09/895,019 specifically named in the reference. As the Supreme Court pointed out in KSR, this is error. See KSR, 550 U.S. at 418 (the obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”); see also id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an automaton.”). As also pointed out in the Decision, Appellants did not provide any specific evidence of unpredictability controverting the Examiner’s finding of a reasonable expectation of success. Decision 11 (“Appellants point to no evidence of record suggesting that an ordinary artisan would have been unable to determine, through routine experimentation, ion exchange-type binding moieties suitable for delivering therapeutic agents other than epirubicin.”). In contrast, the Examiner provided evidence, in addition to Lübbe, that in methods of delivering therapeutic agents in vivo and in vitro, viruses as well as naked nucleic acids were known to be releasably adhered to magnetic particles using appropriate ion exchange coatings (Decision 16 (FF 17) (citing Chan, col. 6, ll. 33-38)). Thus, the evidence of record does not support Appellants’ assertion that an ordinary artisan would have considered it an unpredictable undertaking to apply Lübbe’s teachings to the delivery of therapeutic viruses. In sum, Appellants’ arguments do not demonstrate that rehearing is proper in this appeal. While Appellants disagree with the Decision’s finding on the issue of predictability, Appellants have not shown that the Decision failed to adequately appreciate or address the arguments presented in the 5 Appeal 2008-002329 Application 09/895,019 Appeal Brief and Reply Brief on that issue, or any other issue. Moreover, as discussed above, we are not persuaded that the opinions in Eisai and Procter & Gamble v. Teva demonstrate that our Decision misapprehended the obviousness principles outlined in KSR. Accordingly, we decline to modify our original decision entered November 20, 2009. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). REHEARING DENIED cdc FULBRIGHT & JAWORSKI L.L.P. 600 CONGRESS AVE. SUITE 2400 AUSTIN TX 78701 6