In a decision from an appeal before the Patent Trial and Appeal Board following rejection of claims to an isolated nucleic acid apparently (to applicants) falling within the scope of U.S. Patent and Trademark Office Guidance setting forth Office policy for implementing the Supreme Court's decision in AMP v. Myriad Genetics is this assertion by the Board:
Appellants cite as support the USPTO's 2014 . . . ("Interim Guidance"). In particular, Appellants points to Claim 2 of Example 7 in the Interim Guidance . . . —"Isolated nucleic acid comprising a sequence that has at least 90% identity to SEQ ID No. 1 and contains at least one substitution modification relative to SEQ ID No. 1"—which was found in the Interim Guidance to be patent eligible. We are not persuaded. As an initial matter, we are not bound by the Interim Guidance. Furthermore, we find the instant claims distinguishable from the example in the Interim Guidance, which requires a specific type of mutation (substitution) and specifies that "[n]o substitution modifications of [the gene at issue] are known to occur in nature."
Ex parte Lukyanov, U.S. Appl. Ser. No. 11/607,828 (appeal decided 05/25/2017) (emphasis added).
In contrast, another panel of the Board found the following claim patent-eligible based on another Guidance:
1. A method for detecting and quantitating in a biological fluid sample from a human [a biomarker having a specific SEQ ID NO], comprising
(a) contacting the sample with a labeled monoclonal or polyclonal antibody which specifically binds to said [biomarker] and
(b) detecting and quantitating the resulting [biomarker]: antibody complex using an immunoassay, wherein said immunoassay
(i) is not a radioimmunoassay, and
(ii) has a limit of detection of about 50 pmol/L.
Ex parte Bergmann, U.S. Appl. Ser. No. 10/551,298 (appeal decided 07/10/2017):
It seems curious, and the source of inconsistent policy, for the PTAB to take the position that the Board can choose to ignore USPTO Guidances at its leisure (if not its whim) in view of the stance the Office has taken with regard to the importance of maintaining consistency in its policies in other situations. For example, in convening an expanded panel for deciding whether filing a lawsuit asserting a patent waives sovereign immunity as a grounds to dismiss an inter partes review before the Board (it does; see "PTAB Decides Patent Infringement Lawsuit Waives Eleventh Amendment Sovereign Immunity to Inter Partes Review"), the expanded panel, which comprised Deputy Chief Administrative Patent Judge Scott R. Boalick, Vice Chief Patent Judges Jacqueline Wright Bonilla and Scott C. Weidenfeller, and Administrative Patent Judges Jennifer S. Bisk, Robert J. Weinschenk, and Charles J. Boudreau, in addition to the Chief Administrative Patent Judge, expressly set forth its reliance on the Chief Judge's authority under 35 U.S.C. § 6 to expand panels when issues before the Board are of exceptional importance or are "necessary to secure and maintain uniformity of the Board's decisions." And a different Board panel excoriated counsel for the St. Regis Mohawk Tribe for filing a motion for discovery regarding whether there would be any attempt to "stack" the Board against it (see "The PTAB Strikes Back -- Issues Order Prohibiting St. Regis Mohawk Tribe from Filing Any Additional Papers in IPR"), despite there being concern before the Federal Circuit (see "Yissum Research Development Co. v. Sony Corp.") and, less directly, the Supreme Court regarding this policy. In the Tribe's motion that provoked the panel's vociferous response, the request cited portions of the Administrative Procedures Act (specifically, 5 U.S.C. § 554(d)) that others have alleged, and it seems reasonable to suspect, might be bruised if not violated by the enlarged panel practices employed by the PTAB, i.e., a prohibition on members of a PTAB panel from being "subject to the supervision or direction of an employee or agent engaged in the performance of investigative or prosecuting functions for an agency." In addition, the request cited the prohibition on ex parte communications under 5 U.S.C. § 557 or, if such communications have occurred, that they be included in the public record.
Article I courts, and the PTAB in particular, have a legitimate goal of providing consistent application of the law to applicants and, in the case of implementing the adversarial avenues the AIA created, developing a consistent body of procedural and substantive law. To this end, for example, the PTAB has designated some (albeit few) cases precedential, thus providing notice to the public regarding how the Office can be expected to conduct the "trials" mandated by the statute.
But the Board's efforts are a larger part of, and expressly dependent on, the authority of the Office through the Director (as Under Secretary of Commerce) "for providing policy direction and management supervision for the Office and for the issuance of patents and the registration of trademarks [] in a fair, impartial, and equitable manner." 35 U.S.C. § 3(2)(A). Those duties include the powers to "establish regulations, not inconsistent with law" for "govern[ing] the conduct of proceedings in the Office." 35 U.S.C. § 2(2)(A). However, those activities "shall be made in accordance with section 553 of title 5," 35 U.S.C. § 2(2)(A), which govern administrative rulemaking. More fundamentally, the Office is established under statute so that while being "subject to the policy direction of the Secretary of Commerce" it "otherwise shall retain responsibility for decisions regarding the management and administration of its operations and shall exercise independent control of its budget allocations and expenditures, personnel decisions and processes, procurements, and other administrative and management functions in accordance with this title and applicable provisions of law." 35 U.S.C. § 1. Finally, nothing in the enabling statute for establishing the PTAB arrogates to that body any powers or authority independent of or superior to the powers vested in the Director over operation of the Office. 35 U.S.C. § 6.
Which brings us to the source of the Interim Guidance ignored by the PTAB in the Lukyanov case, the Office of Legal Administration, which operates within the Office of Patent Examination Policy. According to the USPTO website, the OPLA has the following functions:
The Office of Patent Legal Administration (OPLA) drafts regulations and develops practices for the examination of patent applications, as well as assists in the implementation of these new regulations and practices. In addition, OPLA staff author rule packages published in the Federal Register, create Official Gazette notices, monitor public comments, and formulate Frequently Asked Questions (FAQs). To reflect changes in law, rules, procedures, and policies, OPLA recommends updates to the Manual of Patent Examining Procedure (MPEP) as well as the forms used by the Patent Examining Corps (Corps) and external customers. Lastly, OPLA prepares and delivers training to the Corps.
Other OPLA staff duties include supporting post grant instruments such as reexamination proceedings and reissue applications, and treating applications for patent term extension and patent term adjustment. OPLA has the authority to decide various petitions which have been delegated for consideration. Legal advisors also deliver training on specialized subjects and patent law and procedure for the Office of Patent Training.
Additionally, in its representative capacity of the USPTO, OPLA responds to inquiries about patent law and Office policies and procedures via letters, phone calls, lectures, presentations, and other contacts with members of the public and the patent bar. OPLA also assists in the efforts to negotiate the harmonization of patent laws and other international matters.
What is unclear is the statutory basis for the PTAB's evident conviction that it has the authority to ignore USPTO policies, as evinced by Guidances from the OPLA. As an adjudicatory body it is reasonable for the Board to take the position that is needs the authority to decide how to apply such Guidances from the OPLA a particular case. But in the language of the Lukyanov decision lingers a flavor of an assertion of a higher authority, along the lines of the Board having the responsibility to decide what the law is independent from and superior to the Office's administration. This is consistent with the impression created by the chimerical nature of IPR and other adversarial review procedures established by the AIA, which are sometimes characterized as being in the nature of a trial and other times (when the characterization suits) are analogized to any other administrative procedure. These various roles may have had the effect of engendering a belief that the Board has an obligation greater than its statutory brief, and this reasonably calls into question the legitimacy of its decisions. Many have opined in the wake of new Director Iancu's confirmation on the matters requiring his attention. The proper role of the PTAB in the policy-making hierarchy of the USPTO appears to be one of them.
