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Mayo Clinic Foundation v. Iancu

United States District Court, E.D. Virginia, Alexandria Division

April 23, 2018

ANDREI IANCU, [1] Defendant.



         This is an appeal from a decision by the United States Patent & Trademark Office (“PTO”), calculating the patent term adjustment for United States Patent No. 8, 981, 063, owned by plaintiff, the Mayo Foundation for Medical Education and Research (“Mayo”). Specifically, the PTO determined that the six-month period extending from the conclusion of the interference proceeding until the PTO's mailing of the notice of allowance constituted “time consumed by continued examination requested by the applicant” pursuant to 35 U.S.C. § 154(b)(1)(B). Accordingly, the PTO excluded this period from the patent term adjustment calculation. Mayo argues that the PTO erred in excluding this time period from its adjustment calculation because the applicant's requested “continued examination” ended when the interference was declared. This dispute has been fully briefed and argued and is now ripe for disposition.


         Because Congress has relatively recently altered the patent law landscape in a manner particularly pertinent to this appeal, a brief description of this new landscape provides necessary context for resolution of the issues here.

         The patent process begins when an applicant seeking a United States patent files an application with the PTO. See 35 U.S.C. § 111. The PTO then conducts an examination of that application, reviewing the application first for procedural requirements and then referring the application to an examiner to determine whether the claimed invention meets substantive patentability requirements. Id. §§ 101, 112, 103, 131. If the examiner determines that an applicant is entitled to a patent, a written notice of allowance is given or mailed to the applicant. Id. § 151. If, on the other hand, the examiner determines that the application does not meet patentability requirements, the examiner sends the applicant a notice rejecting the application and explaining the reasons for the rejection. See Id. § 132(a). The applicant may then appeal the determination to the Patent Trial and Appeal Board (“PTAB”) or file a request for continued examination (“RCE”) of the application pursuant to 35 U.S.C. § 132(b). See 37 C.F.R. § 1.114. When an applicant files an RCE, the PTO withdraws the finality of the rejection, and an examiner continues examination of the application. See Id. § 1.114(d).

         Throughout this process, the examiner or the applicant can also recommend an application for an “interference” proceeding. See 35 U.S.C. § 135(a); see also 37 C.F.R. § 41.202(a).[2] Where two parties claim the same patentable invention, an interference proceeding serves to determine which party is entitled to priority of invention. See Rolls Royce, PLC v. United Techs. Corp., 603 F.3d 1325, 1330 (Fed. Cir. 2010). Because interference proceedings are costly and time-consuming, examiners generally must complete examination or reexamination of the application before an interference is declared, and there must be at least one claim that “(1) [i]s patentable but for judgment in the contested case, and (2) [w]ould be involved in the contested case.” 37 C.F.R. § 41.102.[3]

         Once an interference is declared, the PTAB takes evidence and “enters final judgment on questions of priority and patentability arising in an interference.” Manual of Patent Examining Procedure (“MPEP”) § 2301.[4] Generally, the examiner will not examine the application again until after the interference concludes.[5] At that point, the application returns to the examiner, who then takes action, depending on the judgment in the interference proceeding. See Id. If the PTAB's judgment contains a recommendation for further action, the examiner must reopen prosecution to consider the recommendation. See Id. § 2308. Specifically, the PTAB may recommend rejection of a claim in which case the examiner generally must issue the recommended rejection. See 37 C.F.R. § 41.127(c). If, on the other hand, the PTAB determines that the applicant has priority with respect to a claim, the examiner “should update the search and may, but is not required to, reopen prosecution for any claim not disposed of in the judgment.” See MPEP § 2308; see Id. § 2301.

         If, at the end of this process, a patent issues, the patent term will last for twenty years from the date the initial patent application was filed. Prior to 1994, patent terms were seventeen years from the date the patent issued. In 1994, Congress changed the patent term to twenty years from the date the application was first filed. In changing the start date of the patent term to the date when the application was first filed, Congress acknowledged that PTO delays in the processing of applications would now consume some portion of the patent term. Accordingly, to account for certain of these delays, Congress passed the American Inventors Protection (“AIPA”) of 1999, requiring the PTO to grant several patent term adjustments based on delays in the application processing attributable to the PTO. See 35 U.S.C. § 154(b). Specifically, there are three types of delays for which patentees are entitled to term adjustments: A Delay; B Delay; and C Delay. A Delay extends the patent term one day for each day the PTO fails to meet prescribed deadlines for certain events during the processing and prosecution of the patent application, including deadlines for mailing notices of allowance, responding to replies under § 132, and issuing the patent after payment of the required fees. See Id. § 154(b)(1)(A). B Delay extends the patent term one day for each day beyond three years that the application remains pending. Id. § 154(b)(1)(B). C Delay extends the patent term one day for each day of the pendency of an interference proceeding, a secrecy order, or successful appellate review by the Board, or a Federal court. Id. § 154(b)(1)(C).

         Most relevant to this case is the PTO's calculation of B Delay. As described above, B Delay accounts for delays “due to the failure of the [PTO] to issue a patent within [three] years after the actual filing date of the application … .” Id. § 154(b)(1)(B). The statute excludes certain time periods from the calculation of this three-year period of time, including “any time consumed by continued examination of the application requested by the applicant under section 132(b)” and “any time consumed by a proceeding under section 135(a), ” which includes an interference proceeding. Id. § 154(b)(1)(B)(i)-(ii). In essence, the patent term adjustment provisions limit the time the PTO may take in considering patent applications, but provide for exceptions where the delay is attributable to the applicant or outside the PTO's control.

         In addition to establishing these categories of delay, the statute delegates to the PTO Director the authority to “prescribe regulations establishing procedures for the application for and determination of patent term adjustments … .” Id. § 154(b)(3)(A). Pursuant to this authority, the PTO promulgated a rule calculating the “time consumed by continued examination of the application requested by the applicant” in 35 U.S.C. § 154(b)(1)(B)(i) to include:

(1) The number of days, if any, in the period beginning on the date on which any request for continued examination of the application under 35 U.S.C. 132(b) was filed and ending on the date of mailing of the notice of allowance under 35 U.S.C. 151 … .

37 C.F.R. § 1.703(b)(1).

         Given this description of the patent application examination process and given the changes Congress implemented, it is appropriate to consider the parties' dispute.

         II. ...

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