Best Medical International, Inc. v. Elekta Inc.

Court of Appeals for the Federal Circuit·Decided August 26, 2022·No. 21-2099·Published

Opinion

Case: 21-2099 Document: 57 Page: 1 Filed: 08/26/2022

United States Court of Appeals for the Federal Circuit ______________________

BEST MEDICAL INTERNATIONAL, INC., Appellant

v.

ELEKTA INC., Appellee ______________________

2021-2099, 2021-2100 ______________________

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2020- 00071, IPR2020-00072, IPR2020-00970, IPR2020-00971. ______________________

Decided: August 26, 2022 ______________________

BARRY J. COYNE, The Webb Law Firm, Pittsburgh, PA, argued for appellant. Also represented by KENT E. BALDAUF, JR., BRYAN P. CLARK.

RONALD S. LEMIEUX, Squire Patton Boggs LLP, Palo Alto, CA, argued for appellee. Also represented by TAMARA FRAIZER. ______________________

Before HUGHES, LINN, and STOLL, Circuit Judges. STOLL, Circuit Judge. Case: 21-2099 Document: 57 Page: 2 Filed: 08/26/2022

This is an obviousness case where the disputed level of skill in the art impacted the Patent Trial and Appeal Board’s unpatentability determination in two inter partes reviews. In its final written decisions addressing various claims of U.S. Patent No. 6,393,096, the Board found that a person having ordinary skill in the art would have had formal computer programming experience. Petitioner El- ekta Inc.’s expert had that experience; Patent Owner Best Medical International Inc.’s (BMI) did not. The Board ac- cordingly discounted BMI’s expert testimony and deter- mined Elekta had proven that challenged claims 1, 43, 44, and 46 were unpatentable as obvious. BMI appeals the Board’s unpatentability determina- tions. Prior to filing this appeal, BMI finally canceled claim 1 during an ex parte reexamination. Because there is no longer a case or controversy regarding the patentabil- ity of claim 1, we dismiss-in-part BMI’s appeal for lack of jurisdiction and therefore do not reach the merits of the Board’s unpatentability determination for claim 1. For claims 43, 44, and 46, substantial evidence supports the Board’s findings regarding the level of skill in the art and each of the remaining Graham factors. We therefore affirm the Board’s unpatentability determination for those claims. BACKGROUND I The ’096 patent is generally directed to a method and apparatus for conformal radiation therapy of tumors using a pre-determined radiation dose. ’096 patent, Abstract; id. at col. 1 ll. 10–12. Tumors are three-dimensional and typically irregu- larly shaped. To account for the three-dimensionality, the gantry of a radiation machine—which houses the radiation beam—rotates around a patient to irradiate the tumor from different angles. The gantry uses a multileaf Case: 21-2099 Document: 57 Page: 3 Filed: 08/26/2022

BEST MEDICAL INTERNATIONAL, INC. v. ELEKTA INC. 3

collimator to narrow the radiation beam and conform it to the shape of the tumor. According to the written descrip- tion, collimator leaves “can be programmed to follow the spatial contour of the tumor” by moving the leaves “indi- vidually into and out of the path of the radiation beam,” “thus block[ing] the transmission of radiation to tissue dis- posed outside the tumor’s spatial outline.” Id. at col. 1 ll. 35–49. The ’096 patent purports to improve upon prior art ap- proaches to radiation therapy by computing an optimal ra- diation beam arrangement that maximizes radiation of a tumor while minimizing radiation of healthy tissue. Ac- cording to the written description, the “optimal beam ar- rangement is arrived at by computationally increasing the proposed beam weight [or beam intensity] iteratively, in- corporating cost functions to ensure that an iterative change in the beam weight would not result in unaccepta- ble exposure to the volumes of tissue or other structures being subjected to the proposed [radiation] dose.” Id. at col. 5 ll. 39–44. The “dose distribution resulting from the proposed beam selection is compared to a . . . desired[] dose for the tumor volume and surrounding tissue struc- tures.” Id. at col. 5 ll. 44–47. The written description ex- plains that if a change in the proposed beam weight (i.e., intensity) results in a radiation dose that more closely matches the desired prescription than the previous beam weight, the proposed beam weight is accepted. Id. at col. 5 ll. 47–49. Claim 43 is representative of the claims on ap- peal and recites: 43. A method of determining an optimized radia- tion beam arrangement for applying radiation to at least one tumor target volume while minimizing radiation to at least one structure volume in a pa- tient, comprising the steps of: Case: 21-2099 Document: 57 Page: 4 Filed: 08/26/2022

distinguishing each of the at least one tumor tar- get 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 prescrip- tion; 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. Id. at col. 21 l. 19–col. 22 l. 10. II Varian Medical Systems, Inc. filed two IPR petitions, one challenging claims 1 and 18 of the ’096 patent (IPR2020-00071) and the other challenging claims 43, 44, and 46 (IPR2020-00072). The Board instituted review in both IPRs on May 1, 2020. Soon thereafter, Elekta filed copycat petitions requesting institution and joinder to Var- ian’s instituted IPR proceedings. The Board granted insti- tution on June 24, 2020 (IPR2020-00971 and IPR2020- 00970) and joined Elekta as a party to Varian’s proceed- ings. 1

1 Varian withdrew from this appeal on April 22, 2022. Because of this procedural posture, certain filings were made only in the Varian IPR proceedings, and thus we cite to those proceedings when needed. Case: 21-2099 Document: 57 Page: 5 Filed: 08/26/2022

BEST MEDICAL INTERNATIONAL, INC. v. ELEKTA INC. 5

While these IPRs were underway, a parallel ex parte reexamination (initiated by Varian in December 2019) was ongoing. That reexamination included review of claims 1 and 18. In August 2020 (after institution of the IPRs), the Examiner in the reexamination rejected claim 1 based on statutory and obviousness-type double patenting. Rather than arguing the merits of the Examiner’s rejection, BMI canceled claim 1 “without prejudice or disclaimer” in No- vember 2020. Mot. to Dismiss Appeal, Ex. I at 10, Best Med. Int’l Inc. v. Elekta Inc., No. 21-2099 (Fed. Cir. Aug. 16, 2021), ECF No. 17. The Examiner noted BMI’s cancelation of claim 1 in their final rejection on Febru- ary 10, 2021. Id. Ex. J. Meanwhile, the Board issued its final written decisions in the IPRs in April 2021. See Varian Med. Sys., Inc. v. Best Med. Int’l, Inc., No. IPR2020-00071, 2021 WL 1599184 (P.T.A.B. Apr. 23, 2021) (’071 Final Written Decision); Var- ian Med. Sys., Inc. v. Best Med. Int’l, Inc., No. IPR2020- 00072, 2021 WL 1595724 (P.T.A.B. Apr. 23, 2021) (’072 Fi- nal Written Decision). In the ’071 IPR, the Board noted that BMI canceled claim 1 during reexamination but con- cluded that claim 1 had “not yet been canceled by any final action” because BMI had “not filed a statutory disclaimer of claim 1.” ’071 Final Written Decision, 2021 WL 1599184, at *2. The Board therefore considered the merits of El- ekta’s patentability challenge for claim 1. See id. The Board determined that Elekta had proven that claim 1 was unpatentable as obvious but had not done so for claim 18. Id. at *25. In the ’072 IPR, the Board determined that El- ekta had proven that claims 43, 44, and 46 were Case: 21-2099 Document: 57 Page: 6 Filed: 08/26/2022

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