The Testimony of an Expert Without the Requisite Experience Would Be Discounted in the Obviousness Determination
| October 21, 2022
Best Medical International, Inc., v. Elekta Inc.
Before HUGHES, LINN, and STOLL, Circuit Judges. STOLL, Circuit Judge.
Summary
The Federal Circuit affirmed the Patent Trial and Appeal Board’s determination that challenged claims are unpatentable as obvious over the prior art.
Background
Best Medical International, Inc (BMI) owns the patent at issue, U.S. Patent No. 6,393,096 (‘096). Patent ‘096 is directed to a medical device and method for applying conformal radiation therapy to tumors using a pre-determined radiation dose. The device and the method are intended to improve radiation therapy by computing an optimal radiation beam arrangement that maximizes radiation of a tumor while minimizing radiation of healthy tissue. Claim 43 is listed below as representative of the claims:
43. A method of determining an optimized radiation beam arrangement for applying radiation to at least one tumor target volume while minimizing radiation to at least one structure volume in a patient, comprising the steps of:
distinguishing each of the at least one tumor target volume and each of the at least one structure volume by target or structure type;
determining desired partial volume data for each of the at least one target volume and structure volume associated with a desired dose prescription;
entering the desired partial volume data into a computer;
providing a user with a range of values to indicate the importance of objects to be irradiated;
providing the user with a range of conformality control factors; and
using the computer to computationally calculate an optimized radiation beam arrangement.
Varian Medical Systems, Inc. filed two IPR petitions challenging some claims of the ’096 patent. Soon after the Board instituted both IPRs, Elekta Inc. filed petitions to join Varian’s instituted IPR proceedings. The Board issued the final written decisions that determined the challenged claims 1, 43, 44, and 46 were unpatentable as obvious.
Prior to the Board’s final decisions, BMI canceled claim 1 in an ex parte reexamination where the Examiner rejected claim 1 based on the finding of statutory and obviousness-type double patenting. Although BMI had canceled claim 1, the Board still considered the merits of Elekta’s patentability challenge for claim 1 and concluded that claim 1 was unpatentable in its final decision. The Board explained that claim 1 had not been canceled by final action as BMI had “not filed a statutory disclaimer.” BMI appealed the Board’s final written decisions. Varian later withdrew from the appeal.
Discussion
The Federal Circuit first addressed the threshold question of jurisdiction. BMI asked for a vacatur of the Board’s patentability determination by arguing “the Board lacked authority to consider claim 1’s patentability because that claim was canceled before the Board issued its final written decision, rendering the patentability question moot.” The Federal Circuit found that it was proper for the Board to address every challenged claim during the IPR under the Supreme Court’s decision in SAS Institute Inc. v. Iancu in which the Supreme Court held that the Board in its final written decision “must address every claim the petitioner has challenged.” 138 S. Ct. 1348, 1354 (2018) (citing 35 U.S.C. § 318(a)). Furthermore, the Federal Circuit supported Elekta’s argument that BMI lacked standing to appeal the Board’s unpatentability determination. The Federal Circuit explained that BMI admitted during oral argument that claim 1 was canceled prior to filing its notice of appeal without challenging the rejections. Thus, the Federal Circuit found that there was no longer a case or controversy regarding claim 1’s patentability at that time. Accordingly, the Federal Circuit dismissed BMI’s appeal regarding claim 1 for lack of standing.
The Federal Circuit later moved to consider BMI’s challenges to the Board’s findings regarding the level of skill in the art, motivation to combine, and reasonable expectation of success. The Board’s finding put a requirement on the level of skill in the art that a person of ordinary skill in the art would have had “formal computer programming experience, i.e., designing and writing underlying computer code.” BMI’s expert did not have such requisite computer programming experience. Thus, BMI’s expert testimony was discounted in the Board’s obviousness analysis.
The Federal Circuit stated that there is a non-exhaustive list of factors in finding the appropriate level of skill in the art, these factoring including: “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those
problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” The Federal Circuit found that both parties did not provide sufficient evidence relating to these factors. Elekta principally relied on its expert Dr. Kenneth Gall’s declaration, whereas BMI relied on Mr. Chase’s declaration. In Dr. Gall opinion, a person of ordinary skill in the art would have had “two or more years of experience in . . . computer programming associated with treatment plan optimization.” Mr. Chase only disagreed with “the requirement,” but did not provide any explanation as to why “the requirement of ‘two or more years of . . . computer programming associated with treatment plan optimization’” was “inappropriate.”
Despite competing expert testimony on a person of ordinary skill, the Federal Circuit took the Board’s side and held that the Board relied on “the entire trial record,” including the patent’s teachings as a whole, to conclude the level of skill in the art. The Federal Circuit cited several sentences from the specification of the ‘096 patent to explain why the Board was reasonable to conclude that a skilled artisan would have had formal computer programming experience. For example, representative claim 43 was cited, which recites “using the computer to computationally calculate an optimized radiation beam arrangement.” The written description in ‘096 patent also recites “optimization method may be carried out using . . . a conventional computer or set of computers, and plan optimization software, which utilizes the optimization method of the present invention.”
The Federal Circuit found that BMI’s additional arguments were unpersuasive. BMI argued that the claims require that one specific step must be accomplished using a single computer and the claimed “conformality control factors” are “mathematically defined parameter[s].” The Federal Circuit concluded that there is no error in the Board’s determination based on the plain claim language and written description. BMI also argued that the Board’s finding that the prior teaches “providing a user with a range of values to indicate the importance of objects to be irradiated” is unsupported by substantial evidence. The Federal Circuit was not persuaded, because Dr. Gall’s testimony provide the support that a skilled artisan would have found the feature obvious.
BMI also challenged the Board’s findings as to whether there would have been a motivation to combine the prior art of Carol-1995 with Viggars and whether a skilled artisan would have had a reasonable expectation of success. But the Federal Circuit found that the Board relied on the teachings of the references themselves to support both findings. Thus, it was concluded that the Board’s well-reasoned analysis was supported by substantial evidence.
Takeaway
- The level of skill in the art could be defined in the specification for determining obviousness.
- The testimony of an expert without the requisite experience would be discounted in the obviousness arguments.
