On June 29, 2021, Chief ALJ Charles E. Bullock issued the public version (Part I, Part II, Part III) of his final initial determination (“ID”) finding a violation of section 337 in Certain Laparoscopic Surgical Staplers, Reload Cartridges, and Components Thereof (Inv. No. 337-TA-1167).

By way of background, this investigation was instituted based on complaint filed on May 30, 2019 by Ethicon LLC; Ethicon Endo-Surgery, Inc.; and Ethicon US, LLC (collectively, “Ethicon”) alleging violations of section 337 by Respondents Intuitive Surgical, Inc.; Intuitive Surgical Operations, Inc.; Intuitive Surgical Holdings, LLC; and Intuitive Surgical S. De R.L. De C.V. (collectively, “Intuitive”) through the importation and/or sale of certain laparoscopic surgical staplers, reload cartridges, and components thereof that infringed one or more claims of U.S. Patent Nos. 9,844,379 (“the ’379 patent”); 9,844,369 (“the ’379 patent”); 7,490,749 (“the ’749 patent”); 8,479,969 (“the ’969 patent”); and 9,113,874 (“the ’874 patent”).

According to the ID, Chief ALJ Bullock determined there was a violation of section 337 with respect to infringement of the ’369 and ’379 patents based on the following conclusions of law:

  • Intuitive does not infringe claim 24 of the ’969 patent;
  • The technical prong of the domestic industry requirement for the ’969 patent has been satisfied;
  • Claim 24 of the ’969 patent is not invalid under 35 U.S.C. § 102;
  • Claim 24 of the ’969 patent is invalid under 35 U.S.C. § 103;
  • Claim 24of the ’969 patent is not invalid based on 35 U.S.C. § 112, ¶ 2;
  • Claim 24 of the ’969 patent is not unenforceable based on an error;
  • Intuitive does not infringe claim 19 of the ’874 patent;
  • The technical prong of the domestic industry requirement for the ’874 patent has been satisfied;
  • Claim 19 of the ’874 patent is not invalid under 35 U.S.C. § 102;
  • Claim 19 of the ’874 patent is invalid under 35 U.S.C. § 103;
  • Intuitive infringes claims 22 and 23 of the ’369 patent;
  • Intuitive does not induce infringement of claims 22 and 23 of the ’369 patent;
  • Intuitive contributorily infringes claims 22 and 23 of the ’369 patent;
  • The technical prong of the domestic industry requirement for the ’369 patent has been satisfied;
  • Claims 22 and 23 of the ’369 patent are not invalid under 35 U.S.C. § 103;
  • Intuitive infringes claims 2 and 3 of the ’379 patent;
  • Intuitive does not induce infringement of claims 2 and 3 of the ’379 patent;
  • Intuitive contributorily infringes claims 2 and 3 of the ’379 patent;
  • The technical prong of the domestic industry requirement for the ’379 patent has been satisfied;
  • Intuitive is estopped under 35 U.S.C. § 315(e)(2) from asserting that the ’379 patent is invalid under §§ 102 and 103;
  • The ’379 patent is not unenforceable based on inequitable conduct; and
  • The economic prong of the domestic industry requirement has been satisfied.

As a result of his finding a violation of section 337 with respect to the ’369 and ’379 patents, Chief ALJ Bullock recommended issuance of a limited exclusion order (“LEO”) and cease-and-desist order directed to Intuitive. The Chief ALJ did not recommend that the LEO include Intuitive’s requested carve-outs for unaccused components, or that the LEO be limited to only those articles named as accused products in the complaint. Finally, Chief ALJ Bullock recommended that the Commission set the bond at zero percent.