Further to our October 31, 2016 post, on November 28, 2016, ALJ David P. Shaw issued the public version of his Initial Determination (“ID”) finding a violation of Section 337 in Certain Radiotherapy Systems and Treatment Planning Software, and Components Thereof (Inv. No. 337-TA-968). Due to the size of the ID, we have split it into the following: part 1, part 2, part 3, and part 4.

By way of background, this investigation is based on a September 25, 2015 complaint filed by Varian Medical Systems, Inc. and Varian Medical Systems International AG (collectively, “Varian”) alleging violation of Section 337 by Respondents Elekta AB, Elekta Ltd., Elekta GmbH, Elekta Inc., IMPAC Medical Systems, Inc., Elekta Instrument (Shanghai) Ltd., and Elekta Beijing Medical Systems Co. Ltd. (collectively, “Elekta”) in the importation into the U.S. and sale of certain radiotherapy systems and treatment planning software and components thereof that infringe one or more claims of U.S. Patent Nos. 7,945,021 (“the ’021 patent”); 8,116,430 (“the ’430 patent”); 8,867,703 (“the ’703 patent”); 7,880,154 (“the ’154 patent”); 7,906,770 (“the ’770 patent”); and 8,696,538 (“the ’538 patent’). See our September 30, 2015 and November 3, 2015 posts for more details on the complaint and Notice of Investigation, respectively.

According to the ID, the technology at issue generally relates to radiation therapy used to treat cancer, and apparatuses and methods for planning and carrying out such treatment. The accused products include Elekta’s Versa HD, Infinity, Axesse, and Synergy/Synergy S linac systems with integrated imaging and control systems (the “Accused Linacs”), as well as Elekta’s Monaco treatment planning software, Active Breathing Coordinator, and Gamma Knife Icon radiosurgery system. The Accused Linacs share the same features and components, including the Integrity Treatment Control System (“TCS”), the MOSAIQ record and verify system, the Agility multi-leaf collimator, the Response MV Beam Gating system, the XVI kV cone-beam imaging system, and the Precise Treatment Table couch (that may include an adjustable couch top referred to as HexaPod). Varian’s domestic industry products include the Clinac iX and Trilogy linac systems when used with the On-Board Imager system, and the TrueBeam and Edge linac systems.

The ’021 Patent

After construing the disputed claim terms, ALJ Shaw determined that asserted claims 1, 4, 9, and 15 of the ’021 patent are infringed by the Accused Linacs, but not the Gamma Knife Icon. The ALJ also found that Varian’s arguments regarding the technical prong of domestic industry as to claims 1 and 4 of the ’021 patent were not disputed. With respect to invalidity, however, ALJ Shaw agreed with Elekta that the asserted claims are anticipated by WO 01/60236 (“Jaffray WIPO”), as well as the Jaffray 2000 and Jaffray 2001 references. The ALJ also found that Elekta made a prima facie showing that the asserted claims are obvious, but failed to perform a complete Graham analysis by not weighing secondary considerations of non-obviousness. Further, ALJ Shaw determined that the evidence does not show that the ’021 patent is unenforceable due to inequitable conduct.

The ’430 Patent

After construing the disputed claim terms, ALJ Shaw determined that the Accused Linacs infringe claim 6 of the ’430 patent, but not claim 18. The ALJ also found that Varian’s TrueBeam radiotherapy system and Edge radiosurgery system satisfy the technical prong of domestic industry with respect to claim 6. With respect to validity, ALJ Shaw found that claim 6 is anticipated by the Jaffray MICCAI 2001 reference as well as the Jaffray WIPO reference, but that neither reference anticipates claim 18. The ALJ also found that Elekta made a prima facie showing that claim 6 is obvious, but again failed to perform a complete Graham analysis by not weighing secondary considerations. The ALJ rejected Elekta’s obviousness argument regarding claim 18, as well as Elekta’s § 112 arguments regarding both claims. Further, ALJ Shaw determined that the evidence does not show that the ’430 patent is unenforceable due to inequitable conduct.

The ’703 Patent

After construing the disputed claim terms, ALJ Shaw determined that the Accused Linacs and the Gamme Knife Icon do not infringe claim 1 of the ’703 patent. The ALJ also found that Varian’s Clinac iX, Trilogy, TrueBeam, and Edge systems do not satisfy the technical prong of domestic industry with respect to claim 1. As to validity, the ALJ rejected Elekta’s anticipation and obviousness arguments regarding claim 1. Further, ALJ Shaw determined that the evidence does not show that the ’703 patent is unenforceable due to inequitable conduct.

The ’154 Patent

After construing the disputed claim terms, ALJ Shaw determined that claims 23 and 26 of the ’154 patent are infringed by the Accused Linacs used in combination with a treatment planning system such as Elekta’s Monaco software. The ALJ also found that Elekta did not dispute that Varian’s domestic industry products practice claim 23. Regarding validity, ALJ Shaw rejected Elekta’s arguments that the Earl article anticipates claim 23, and that claims 23 and 26 are rendered obvious by five combinations of between two and three prior art references.

The ’538 Patent

After construing the disputed claim terms, ALJ Shaw determined that claims 26 and 41 of the ’538 patent are infringed by the combination of the Accused Linacs and Monaco software. The ALJ also found that Varian’s domestic industry products practice claims 26 and 41. As to validity, ALJ Shaw rejected Elekta’s arguments that: (1) claim 26 is anticipated by U.S. Patent Appl. No. 86,530 (“Otto ’530”); (2) claims 26 and 41 are rendered obvious by five references, in six combinations of between two and four references each; and (3) claims 26 and 41 do not claim patentable subject matter under 35 U.S.C. § 101.

The ’770 Patent

After construing the disputed claim terms, ALJ Shaw determined that the combination of treatment planning software such as Monaco, the Accused Linacs, and XVI with kV infringes claim 61 of the ’770 patent. The ALJ also determined that the combination of the Monaco software, the Accused Linacs, Response MV Beam Gating, and one or both of XVI with kV imaging and Active Breathing Coordinator infringes claim 67. Further, ALJ Shaw determined that Varian’s domestic industry products practice claims 61 and 68. With respect to validity, the ALJ rejected Elekta’s arguments that: (1) claim 68 is anticipated by Otto ’530; (2) claims 67 and 68 are rendered obvious by various combinations of prior art; and (3) claims 61 and 67 are indefinite under § 112. ALJ Shaw determined, however, that claim 61 is obvious over a certain combination of prior art.

Economic Prong of Domestic Industry

ALJ Shaw found that for each asserted patent, the evidence shows that Varian satisfied the economic prong of the domestic industry requirement under Section 337 (a)(3)(A) and (B).

Public Interest

ALJ Shaw was particularly interested in the first and fourth public interest factors (i.e., the effects that a remedy might have on public health and welfare, and on domestic consumers). Specifically, questions were raised as to whether the quality of treatment that patients receive depends on whether the accused or other products are used, and whether the issuance and implementation of Commission remedial orders would disrupt patients’ treatment. The ALJ determined that the of record does not show that the accused devices must be imported in order for patients to receive the same level of care. In fact, in the case of the Gamma Knife Icon, ALJ Shaw noted that Elekta itself has available a substitute, non-accused product. The ALJ further found that the evidence does not show that there would be disruption in patients’ treatment, provided that certain exceptions, or “carve outs,” are present in the remedial orders.

Remedy and Bonding

ALJ Shaw recommended issuance of a limited exclusion order covering all of the infringing articles imported, sold for importation, or sold after importation by Elekta and any affiliated companies, parents, subsidiaries or other related business entities, or their successors or assigns. The ALJ also found that cease-and-desist orders aimed at Elekta’s domestic inventory is appropriate. Finally, ALJ Shaw recommended that no bond be imposed during the Presidential review period.