“We see no reason why BMI could not challenge the Examiner’s findings and conclusions in the re-examination proceedings of the 283 patent on appeal to this court. Indeed, we are not aware of any cases that would apply collateral estoppel in these circumstances, and BMI has not cited any. – CAFC Judge Stoll
On August 26, the United States Court of Appeals for the Federal Circuit (CAFC) issued a landmark decision in Best Medical International, Inc. v. Elekta Inc. upholding the decisions of the Patent Trial and Appeal Board (PTAB) invalidating patent claims covering a method and apparatus for radiotherapy of tumours. The Court of Appeal, which rendered an amended version of the notice today to correct some minor formatting issues, also determined that Best Medical International (BMI) lacked standing to appeal the PTAB’s invalidation of claim 1 of BMI’s patent.
Cancellation of claim 1 before notice of appeal cancels IMC Munsingwear Dispute
The patent at issue in this case is US Patent No. 6393096, Planning method and apparatus for radiation dosimetry. It claims a method and apparatus for determining an optimized radiation beam arrangement to apply radiation to a target tumor volume while minimizing radiation to a structural volume in a patient. As noted by the Federal Circuit, the technology covered by the ‘096 patent purported to improve upon the prior art by computationally determining an optimal beam of radiation to treat tumors, which are irregularly shaped, in a manner that minimizes the radiation from healthy tissue.
BMI filed lawsuits against Elekta and Varian Medical Systems in the Delaware District Court in 2018, after which the two companies filed multiple motions for inter partes review proceeding (IPR) challenging the claims of the ‘096 patent, leading to four final written decisions appealed by BMI. Varian has also launched ex parte re-examination proceedings on the ‘096 patent, leading to a rejection by the examiner of claim 1. BMI did not appeal this rejection by the examiner and canceled claim 1 without prejudice or waiver as a result of the review procedure. Because BMI did not file a disclaimer, the PTAB in the IPR proceeding held that claim 1 had not been voided by final action. The Board then assessed the merits of Elekta’s arguments and determined that claim 1 was obvious from the prior art. In a separate final action appealed by BMI, the PTAB also struck down claims 43, 44 and 46 of the ‘096 patent as obvious from the prior art.
On appeal to the Federal Circuit, BMI argued that the cancellation of claim 1 following the reconsideration proceeding raised the issue of patentability in the IPR proceeding. Citing the 1950 United States Supreme Court decision in United States vs. Munsingwear, BMI argued that courts are required to overrule underlying decisions where those decisions have been invoked during the pendency of the appeal. The Federal Circuit, however, rejected the argument under Munsingwear since the fictitious event, the cancellation of claim 1, occurred before BMI filed its notice of appeal in the IPR proceedings; thus, the underlying decision was not moot for the duration of BMI’s appeal.
Potential for collateral estoppel does not create standing for appeal of BMI claim 1
As to BMI’s jurisdictional argument that the PTAB had no authority to determine the patentability of claim 1 in a written final decision, the Federal Circuit noted that the Supreme Court’s decision in SAS Institute versus Iancu (2017) allowed the Board to reasonably conclude that it was required to assess the patentability of all of the claims challenged in Elekta’s petition in the absence of any final avoidance. Such cancellation would have occurred had BMI filed a statutory release of Claim 1 pursuant to 35 USC § 253(a) following the review procedure. Therefore, the Federal Circuit could not say that the PTAB erred in dealing with the patentability of claim 1 of the ‘096 patent.
Further, the Federal Circuit agreed with Elekta that BMI lacked standing to challenge the PTAB’s non-patentability ruling on claim 1 of the ‘096 patent. Although BMI filed a Notice of Appeal against the Examiner’s rejection on reconsideration, this appeal did not challenge the Examiner’s rejection of the double patenting of claim 1, so there was no case or controversy surrounding the patentability of claim 1. Although BMI argued that the PTAB decision created harm in fact through collateral estoppel effects, “we see no reason why BMI could not challenge the findings and Examiner’s Findings in the Reexamination Proceedings of the ‘283 Patent in an Appeal to this Court,” the Federal Circuit Opinion written by Circuit Judge Kara dit Farnandez Stoll. “Indeed, we are not aware of any cases that would apply collateral estoppel in these circumstances, and BMI has cited none.” Further, the Federal Circuit cited several of its prior decisions supporting the proposition that the potential for collateral estoppel itself cannot create standing for an appeal such as BMI’s.
Despite their status, IMC appeals for other evidence findings also fail
Although the Federal Circuit concluded that BMI clearly had standing to challenge the other non-patentability determinations from the IPR proceedings, it was not persuaded by any of the arguments raised by BMI on appeal. First, BMI had challenged the PTAB’s decision that a person of ordinary skill in the field would have “formal experience in computer programming, that is, designing and writing underlying computer code.” While the Elekta expert witness had such experience, the BMI witness did not, which led the PTAB to dismiss the evidence of non-obviousness offered by this witness.
The Federal Circuit recently considered the factors courts should consider in determining a craftsman’s ordinary level of skill in Daiichi Sankyo v. Apotex (2007). Although neither BMI nor Elekta presented much evidence regarding these factors, the PTAB relied on the entire trial record to determine that formal computer training was necessary in the face of conflicting testimony from both sides. As noted by the Federal Circuit, the claims and written description of the ‘096 patent establish that the invention is implemented using a computer and it was not unreasonable for the PTAB to conclude that formal computer experience was required.
The court then sent a series of other arguments for annulment raised by BMI. Although BMI argued that the PTAB erred in interpreting the claims of the ‘096 patent so that the stated steps of the patent claims could be performed using more than one computer, the plain language of the claims and the written description established that the stated steps could be completed by a set of computers. The Federal Circuit also found no reason to interpret the claimed “compliance check factors” as having mathematically defined parameters, since no such language in the patent established this limitation. The Federal Circuit found that the expert testimony supported the PTAB’s conclusion that an item of claimed prior art taught “provide a user with a range of values to indicate the importance of objects to be irradiated”, and that the PTAB had correctly found a motivation to combine artistic references leading to the findings of evidence.
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