The new petition for certiorari in Samaranayake v. Iancu (Supreme Court 2021) has little chance of being granted, but it does offer some insight on USPTO procedure. I mentioned 35 U.S.C. § 144 in a prior post this week. This case also focuses on Section 144 and asks whether the Federal Circuit exceeded its statutory jurisdiction by creating its own record rather than relying solely on the record before the USPTO. The statute:
[T]he Federal Circuit shall review the decision from which an appeal is taken on the record before the Patent and Trademark Office. . . .
35 U.S.C. § 144. The question presented to the Supreme Court stems directly from the statute:
Whether, in creating the required evidentiary record de novo rather than merely reviewing the agency Record below, … the Federal Circuit exceeded its statutory jurisdiction under 35 U.S.C. § 144.
Haritha Samaranayake is the first listed inventor on U.S. Patent Application No. 13/877,246 along with several other Finland-based inventors who were apparently working under Prof. Seppo Ylä-Herttuala. The application claims a 2011 UKIPO priority filing date and is now owned by a Gliotherapy Limited. As the company-name suggests, the patent here claims a method for treating malignant gliomas.
1. A method of treating cancer in a human patient, said method comprising:
diagnosing a cancer in a human patient,
administering to said human patient a viral gene therapy vector having a transgene, and
within about 30 days of said administration of said viral gene therapy vector, administering to said human patient a cytotoxic agent other than gancylovir.
The basic procedural setup in the case:
- Examiner twice rejected claims as obvious and Applicant appealed to PTAB.
- In her Answering Brief, Examiner conceded that the Evidence of Record did not support the rejection, but offered a new rejection based upon new prior art (not previously of record in the case). Of note, the Examiner provided a citation to the cited non-patent-literature, but did not actually provide a copy of the references in the record.
- The PTAB agreed with the examiner and found the claims obvious.
- On appeal to the Federal Circuit, and now before the Supreme Court, the Applicant argued/argues that those references were never made of-record, and thus cannot serve as the basis for Affirmance on Appeal. For its part, the Federal Circuit affirmed the rejection without opinion (R.36); and denied the en banc rehearing petition without opinion.
This case comes down to the basic question of what counts as the USPTO’s “record” when handling an appeal. Although we lack a decision from the Federal Circuit, the USPTO Solicitor’s Office makes the simple argument that prior art becomes “of record” if the full scientific citation is provided by the examiner and the reference is reasonably (or actually) available to the applicant. Likewise, the PTAB concluded in its rehearing decision that the reference “was made of record in the Examiner’s Answer because the Examiner provided a full citation to it.”
Not mentioned here, the patentee did not properly raise the full record issue until after-the-fact and also clearly had the references in-hand when drafting its reply brief.