A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

Intra-Cellular Therapies, Inc. v. Iancu, No. 2018-1849 (Fed. Cir. (E.D. Va.) Sept. 18, 2019). Opinion by Chen, joined by Wallach and Hughes.

The Federal Circuit affirmed a district court’s summary judgment decision affirming a patent term adjustment (PTA) determination by the Patent Office.

During prosecution of Intra-Cellular’s patent, the Patent Office issued a final Office action rejecting some claims and objecting to the others. On the three-month deadline for responding, Intra-Cellular filed a response that failed to comply with the Patent Office’s regulatory requirements for a proper “reply” to a final Office action. Twenty-one days later, Intra-Cellular filed a second response that adopted the examiner’s suggestions and successfully overcame all outstanding rejections and objections. The patent then issued, and the Patent Office calculated a PTA of 264 days. As part of that calculation, the Patent Office determined that the extra 21 days it took Intra-Cellular to file a proper “reply” constituted applicant delay. Intra-Cellular filed a district court complaint seeking review of the PTA determination, but the district court affirmed, prompting Intra-Cellular to appeal.

The Federal Circuit addressed whether the disputed period of 21 days, following the three-month deadline for responding to a final Office action, counts as applicant delay. The issue “hinged in part on an interpretation of statutory text” by the Patent Office, and therefore was subject to Chevron deference. At Step 1 of Chevron, the Federal Circuit determined that the PTA statute’s plain terms do not directly address the question at issue. The court thus turned to Step 2 of Chevron, which considers whether the Patent Office’s interpretation is based on a “permissible construction of the statute.” The Federal Circuit ruled that the agency’s determination “is supported by a permissible construction of the PTA statute.” An applicant can properly respond to a final Office action in limited ways set forth in 37 C.F.R. § 1.113(a). Here, Intra-Cellular’s first after-final response did not comply with § 1.113(a), while the second response filed 21 days later did. “Until a compliant reply was filed, Intra-Cellular began accruing ‘applicant delay’ once the three-month deadline passed for responding to the final Office action.”

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Mayo Foundation for Medical Education & Research v. Iancu, No. 2018-2031 (Fed. Cir. (E.D. Va.) Sept. 16, 2019). Opinion by Lourie, joined by Dyk. Dissenting opinion by Newman.

The Federal Circuit affirmed a district court’s decision affirming a patent term adjustment (PTA) determination by the Patent Office.

During prosecution, the Patent Office rejected Mayo’s claims as anticipated by a prior art patent. In response, Mayo filed a request for continued examination (RCE), argued that it had priority over the patent, and suggested an interference. An interference was declared and proceeded for two years, resulting in priority being awarded to Mayo. Following termination of the interference, the examiner issued a new Office Action rejecting the claims. Mayo replied to the Office Action, and the examiner withdrew the rejection and issued a Notice of Allowance. 

The Patent Office then calculated PTA for Mayo’s patent. Under 35 U.S.C. § 154(b)(1)(B), an applicant generally is entitled to PTA for each day the application is pending beyond three years. The provision excludes “any time consumed by continued examination of the application requested by the applicant under section 132(b).” The Patent Office applied that exclusion, concluding that the period of examination that occurred after termination of the interference is excluded from the PTA for Mayo’s patent. The district court affirmed the Patent Office’s PTA calculation, and Mayo appealed.

On appeal, Mayo argued that it never “requested” any examination after the interference concluded and that, under Patent Office regulations, “an interference cannot be declared unless at least some of the claims, and in this case all of the claims, are deemed allowable but for the outcome of the interference.” Thus, Mayo argued, the post-interference examination delay was attributable to the Patent Office and not to Mayo. The Federal Circuit rejected this argument, explaining: “While the PTO’s regulations do indicate that at least one claim in an application should be in condition for allowance before an interference is declared, the regulations also explicitly contemplate that the Board may recommend further action by the examiner, including issuing a rejection.” The Federal Circuit therefore held that, “where an RCE has previously been filed, the time between termination of an interference and the date of mailing of the Notice of Allowance is ‘time consumed by continued examination of the application requested by the applicant under section 132(b).’” The court therefore affirmed.

Judge Newman dissented, explaining that the post-interference examination was PTO activity that “plainly is examination delay due to PTO procedures” and “plainly is within the purpose of the term adjustment statute.” Therefore, in her view, “the calculation of PTA includes the period of examination after termination of the interference.”

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