Opinion ID: 210965
Heading Depth: 2
Heading Rank: 3

Heading: The Patent Claims and Defenses

Text: 48 Loma Linda argues that the district court erred in holding that no issue of fact exists on the obviousness of the '287 patent over a neutron therapy facility at the University of Washington and a Conceptual Design Report reference (the CDR). Specifically, Loma Linda argues that modifying the University of Washington facility as described by the district court would result in a death ray and thus teaches away from an invention designed to treat patients; that there is no evidence supporting the court's conclusion that a motivation to combine references exists; and that no evidence supports that the CDR was publicly disseminated so as to qualify as prior art. Loma Linda also argues that the district court erred in applying the law by determining the obviousness of limitations, rather than the invention as a whole; by placing the burden of proving non-obviousness on Loma Linda; and by disregarding secondary considerations of non-obviousness. 49 IBA counters that the '287 patent is obvious over the University of Washington facility in view of the CDR, that the CDR provides an unquestionable motivation to combine the two references, and that Loma Linda and Optivus admitted that the CDR was a publication and thus qualifies as prior art. Loma Linda replies that it did not concede, but rather disputed, that the CDR qualified as prior art. 50 As an initial matter, we note that Loma Linda does not argue in its opening brief that the prior art combination utilized by the district court—the CDR and the University of Washington facility—fails to read on every limitation of the '287 patent. Although Loma Linda argues in its reply brief that IBA has not shown that the combination meets the gantry or controllable means limitations, we consider this argument waived because it was not raised in Loma Linda's opening brief. Becton Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 800 (Fed.Cir.1990) ([A]n issue not raised by an appellant in its opening brief . . . is waived.). We therefore focus on the issues raised by Loma Linda in its opening brief: (1) whether the University of Washington facility teaches away from modification; (2) whether the CDR qualifies as prior art; (3) whether evidence supports a motivation to combine; and (4) the propriety of the court's application of the law. 51 First, Loma Linda's argument that the University of Washington facility teaches away from modification is unpersuasive. The University of Washington facility uses neutrons, rather than protons, to treat cancer. The facility directs a proton beam at a beryllium plate to cause nuclear reactions that produce neutrons, which then travel towards the patient. Loma Linda makes much of the fact that the proton beam used in the University of Washington facility is of such high intensity that if it were modified by removing the beryllium plate, it would kill patients rather than cure them. A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. Kahn, 441 F.3d at 990 (quoting In re Gurley, 27 F.3d 551, 553 (Fed.Cir.1994)). As the district court noted, the common denominator among the individuals listed [by the parties as demonstrating ordinary skill] is a working familiarity with particle beam technology, particularly as it applies to cancer treatment. Patent Claims Order, slip op. at 10. Clearly, one of ordinary skill in the art would not simply remove the beryllium plate and direct the high intensity proton beam at a patient without further calculation or adjustment. Nothing about the University of Washington facility can be said to discourage a person having ordinary skill in the art from modifying it to enable proton therapy or to lead the skilled artisan in a path divergent from the path taken by Loma Linda. 52 Second, we decline Loma Linda's invitation to question the status of the CDR as prior art. Loma Linda is correct that neither the Transmittal of Publication submitted during prosecution of the '287 patent nor Optivus's Statement of Genuine Issues of Material Fact (Optivus's genuine issues statement) characterize the CDR in such a way as to qualify as an admission that the CDR was prior art. However, in IBA's motion for summary judgment of invalidity, it submitted argument and evidence identifying the CDR as a prior art reference and utilizing that prior art to demonstrate obviousness. Loma Linda's response to that motion did not dispute that the CDR was prior art; in fact, its response made no reference to the CDR at all. Optivus's response to IBA's motion likewise did not dispute that the CDR was prior art; indeed, its response referred to and discussed the teachings of the CDR in the context of discussing prior art and references. Optivus's genuine issues statement—the only record citation that Loma Linda points to as evidence of its position on the CDR's prior art status—notes only that the CDR was not characterized as prior art during prosecution of the patent; it does not dispute that the CDR was prior art. Here, IBA supported its motion for summary judgment of invalidity with evidence sufficient, if unopposed, to establish that the CDR was prior art; the burden of production then shifted to Loma Linda to identify genuine issues that preclude summary judgment. See Fed.R.Civ.P. 56(e); 10A C. Wright, A. Miller, & M. Kane, Federal Practice and Procedure § 2727 (3d ed. 1998) ([I]f the movant makes out a prima facie case that would entitle him to a judgment as a matter of law if uncontroverted at trial, summary judgment will be granted unless the opposing party offers some competent evidence that could be presented at trial showing that there is a genuine issue as to a material fact.). Because Loma Linda's submissions to the district court failed to identify a genuine issue regarding the publication status of the CDR, we decline to consider the merits of that argument on appeal. Singleton v. Wulff, 428 U.S. 106, 120, 96 S.Ct. 2868, 49 L.Ed.2d 826 (1976) (It is the general rule, of course, that a federal appellate court does not consider an issue not passed upon below.). 53 Third, Loma Linda's argument that there is an issue of fact regarding the motivation to combine is unpersuasive. The CDR provides an overview of proton beam cancer therapy from its first proposal in 1946 to the state of the art at the time of the study and notes that recent technological developments in diagnostic and alignment devices had reawakened interest in proton beam therapy. A stated design goal of the proposed facility in the CDR was to create a facility with more treatment rooms, more advanced beam control, and the availability of different energies to treat different tissue depths. The study discusses proton, neutron, and other particle therapy methods and specifically notes that a neutron therapy facility was in operation at the time of the study. However, the CDR argues that protons have important advantages over neutron and other particle therapy methods. In considering motivation in an obviousness analysis, we ask whether a person of ordinary skill in the art, possessed with the understandings and knowledge reflected in the prior art, and motivated by the general problem facing the inventor, would have been led to make the combination recited in the claims. Kahn, 441 F.3d at 988. Here, there is no question that the CDR establishes that a person having a working familiarity with particle beam technology as it relates to cancer treatment, motivated by the need for more effective and efficient proton therapy facilities, would have been led to combine the University of Washington's neutron therapy facility with the proton beam therapy design outlined in the CDR. We see no error in the district court's conclusion that a motivation to combine the two references exists as a matter of law. 54 Finally, the district court's application of the law does not warrant reversal. The court analyzed the level of skill in the art, the scope and content of the prior art, the differences between the claimed invention and the prior art, and the alleged secondary considerations of non-obviousness. See Patent Claims Order, slip op. at 9-32. The court determined that a motivation to combine the prior art references existed, id., slip op. at 17, and that the references did not teach away from combination or modification, id., slip op. at 30-32, thereby guarding against a hindsight reconstruction of the invention. See Kahn, 441 F.3d at 987 (holding that the motivation-suggestion-teaching test, much like the analogous-art test, is used to defend against hindsight). As discussed above, the combination of prior art references was proper, and Loma Linda's opening brief does not contest the district court's conclusion that the combination reads on every limitation in the '287 patent. 55 Loma Linda points to the court's statement that [t]here is no indication that the desire or ability to provide proton therapy, as opposed to neutron therapy, was nonobvious, Patent Claims Order, slip op. at 17, as a misallocation of the burden of proof. That statement reflected the court's determination that the prior art indicated the motivation and ability to develop proton therapy facilities; it in no way demonstrates a misallocation of the burden of proof. The whole of the district court's opinion indicates that, consistent with Federal Rule of Civil Procedure 56(e), it placed the burden on IBA to support its motion with credible evidence and, upon a prima facie showing, shifted the burden of production to Loma Linda to produce evidence demonstrating a genuine issue for trial. The district court also did not disregard secondary considerations of obviousness. Patent Claims Order, slip op. at 24-30. We find Loma Linda's arguments regarding skepticism in the art, commercial success, and long-felt need to be unpersuasive. Because the district court correctly allocated the burden of proof and made the relevant inquiries into obviousness law, and because [w]e sit to review judgments, not opinions, Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540 (Fed.Cir.1983), we see nothing in the district court's application of the law that warrants a reversal. 56 Accordingly, we affirm the district court's summary judgment holding the '287 patent invalid. Having affirmed the judgment of invalidity, we need not address the judgment of non-infringement. See id. at 1541 (The claims having been found invalid, the issue [of infringement] has been rendered moot.).
57 Loma Linda argues that the district court erred in holding that no issue of fact exists on the obviousness of the '581 patent over the Fermilab National Accelerator Laboratory Neutron Facility (the Fermilab facility). Specifically, Loma Linda argues that there is no evidence indicating that the Fermilab facility employed a safety system with the verifying step or the beam path configuration signal limitation as required by claims of the '581 patent. 3 58 IBA responds that the Fermilab facility possesses all of the claimed steps and limitations. IBA also responds that Loma Linda did not argue in the district court that the Fermilab facility lacked the beam path configuration signal limitation and should not be permitted to do so on appeal. 59 The verifying step in claim 1 of the '581 patent requires verifying the authenticity of one of the beam request signals. '581 patent, col. 9, ll. 9-10. Loma Linda does not dispute the court's construction of this step, which was interpreted to mean to confirm or establish the genuine or trustworthy nature of one of the beam request signals from one of the treatment rooms. Claim Construction Order, slip op. at 31. IBA presented evidence demonstrating that the Fermilab facility authenticated a beam request signal before sending the signal. Loma Linda's arguments and expert testimony assert that the verifying step requires authentication after the signal has been sent, focusing on the proposition that a signal cannot be confirmed as genuine until it has been made. Such an analysis, however, ignores that the court interpreted the verifying step as to confirm or establish authentication. Authenticating a signal before it is sent establishes the genuine nature of the signal. As the district court noted in response to the same argument below: The word `after' appears nowhere in claim 1. There are no such limitations on the terminology in the '581 patent. The patent at issue is written with expansive and highly inclusive language. Patent Claims Order, slip op. at 43 n. 31. Because Loma Linda's evidence failed to address the entirety of the court's construction, it did not properly rebut IBA's evidence demonstrating that the Fermilab facility possessed the verifying step. We therefore conclude that the district court did not err in holding that the Fermilab facility employed a safety system with the verifying step. 60 This court does not need to reach the merits of whether the Fermilab facility employed a safety system with the beam path configuration signal limitation because Loma Linda waived this argument by failing to raise it below. Loma Linda argues that the signals used in the Fermilab facility fail to include information about the physical properties of the proton beam, as required by the court's construction. IBA submitted evidence to demonstrate that the Fermilab facility possessed the beam path configuration signal limitation. Loma Linda fails to identify—and we fail to find—any support in the record to indicate that it contested this evidence before the district court. We therefore decline Loma Linda's invitation to consider its arguments based on the beam path configuration signal limitation for the first time on appeal. Singleton, 428 U.S. at 120, 96 S.Ct. 2868. Accordingly, we affirm the district court's summary judgment holding the '581 patent invalid.
61 On cross-appeal, IBA argues that the district court abused its discretion in denying IBA's motion to amend the pleadings to add a defense of patent unenforceability due to inequitable conduct after the motion cut-off date had expired. Loma Linda counters that the court's denial was proper because IBA was not diligent and had filed the motion for dilatory purposes. 62 After a scheduling order has been entered, a party must show good cause for not having amended [its complaint] before the time specified in the scheduling order expired. Coleman v. Quaker Oats Co., 232 F.3d 1271, 1294 (9th Cir.2000). This standard `primarily considers the diligence of the party seeking the amendment.' Id. (quoting Johnson v. Mammoth Recreations, Inc., 975 F.2d 604 (9th Cir. 1992)). The district court determined that IBA's motion was not supported by any evidence, was inexcusably delayed, would result in prejudice to Loma Linda and Optivus, and was likely filed in bad faith. Motion to Amend Order, slip op. at 5-7. We are not persuaded that these determinations were in error. Accordingly, we conclude that the district court did not abuse its discretion in denying IBA's motion to amend.