The United States Patent & Trademark Office ("USPTO") issues Examination Guidance "for use by USPTO personnel in evaluating" patent applications during prosecution.2 Patent examiners, as well as Patent Trial and Appeal Board ("PTAB") Administrative Patent Judges, are trained on published Examination Guidance and are expected to properly administer their teachings.3 A Guidance may, for example, guide an examiner to reject a pending claim or be cited by a defendant in federal court in challenging patentability of an issued patent.
As such, practitioners may wonder: what is the binding effect, if any, of a Guidance in various scenarios: (1) an appeal to the PTAB from an examiner rejection; (2) an appeal to the PTAB from a reexamination proceeding; (3) a post-grant review proceeding at the PTAB; and (4) a patent case in federal court. A review of existing cases is informative on the point.
Q: Binding in Appeals from an Examiner Rejection? A: No
A patent applicant may appeal an examiner's final rejection to the PTAB. The PTAB has noted that Guidance do not establish legal requirements and, therefore, the PTAB is not bound by them. This does not mean that the PTAB will avoid mentioning a Guidance in its decisions. Instead, the PTAB may refer to a Guidance and, through it, cite and rely upon the underlying case law to inform its decision.
A. Where PTAB Found a Guidance Not Binding
- Ex parte Rama, 2017 WL 6816891 (Dec. 15, 2017): PTAB "note[d] that the guidelines are not legal requirements, and regardless of how closely the Examiner adheres to such guidelines (or not), we must still heed the precedent set by our controlling courts."
- Ex parte Yadav, 2017 WL 4861527 (Oct. 24, 2017): PTAB stated that "reliance on examples in USPTO guidance is problematic at best. The Board decides cases in accordance with the law, not in accordance with the hypothetical examples intended to be illustrative only."
- Ex parte Lukyanov, 2017 WL 2297971 (May 23, 2017): Appellants argued that pending claims were patent eligible because they were similar to an example in a published Guidance, but the PTAB disagreed because it "is not bound by the Guidance."
- Ex parte Pirlet, 2018 WL 1378092 (Mar. 8, 2018): PTAB agreed with an examiner's comment that "the guidelines are not legal requirements."
- Ex parte Park, 2017 WL 745073 (Feb. 21, 2017): PTAB stated that a Guidance "is not law[.]"
B Where PTAB Cited to a Guidance
- Ex parte Tryggvason, 2017 WL 394203 (Jan. 26, 2017): PTAB observed that the pending claims were similar to an example in a published Guidance, but relied upon U.S. Supreme Court precedent, not the Guidance, to "agree with Appellants that the claimed combination results in something 'significantly more' than the naturally occurring products."
- Ex parte Chen, 2015 WL 3919788 (Jun. 24, 2015): PTAB cited to a Guidance to find that an examiner's arguments and application of the machine-or-transformation test were "too rigid" in view of recent U.S. Supreme Court precedent.
Q: Binding in Appeals from Reexamination-Type Proceedings (inter partes, ex parte, Interferences)? A: No
Determinations in reexamination-type proceedings may also be appealed to the PTAB. The PTAB's predecessor, the Board of Patent Appeals and Interferences ("BPAI"), like the PTAB, had concluded that a Guidance does not bind its decision on appeal. Decisions on point may refer to a Guidance but the ultimate conclusion is based on the underlying case law.
- Ex parte Reiffin, 2007 WL 2814119 (Sept. 25, 2007): BPAI noted that a Guidance cannot cover every circumstance that may arise, therefore demonstrating one reason why it is imperative to look at the case law underlying a Guidance as the primary source of authority.
- Ex parte TBKS, 2006 WL 3101728 (Sept. 11, 2006): BPAI determined, relying on a Guidance and corresponding Federal Circuit case law, the proper scope of a reexamination proceeding.
Q: Binding in Post-Grant Review Proceedings (IPR, PGR, CBMR, Derivation)? A: No.
The underlying premise that a Guidance is not binding on the PTAB continues into post-grant review proceedings conducted at the PTAB as a first instance. The PTAB has noted, however, that it requires persuasive reasons to depart from a Guidance as the Guidance is the USPTO's interpretation of controlling case law. The PTAB has also allowed additional briefing in some post-grant review proceedings for parties to address a newly published Guidance.
A. Where PTAB Found a Guidance Not Binding
- Google Inc. v. Zuili, 2017 WL 2116956 (May 5, 2017): PTAB noted that a Guidance "is applicable to Examiners who are of the view that a claim clearly does not have a subject matter eligibility problem. It is inapplicable to either Petitioner or Patent Owner. The controlling law in this proceeding on patent eligibility is the two-step test under Alice/Mayo[.]"
- TradeStation Grp, Inc. v. Trading Techs. Int'l, Inc., 2017 WL 1215637 (Mar. 31, 2017): PTAB held, based on a Guidance and U.S. Supreme Court precedent cited therein, that "although the guidance [is] not binding upon the Board, Patent Owner provides no persuasive reason for the Board to depart from this guidance. Like in a pre-issuance context, during covered business method patent review, claims are given their broadest reasonable interpretation in light of the specification."
B. Where PTAB Cited to a Guidance
- Amneal Pharms. LLC v. Alkermes Phara Ire. Ltd., 2018 WL 5862297 (Nov. 7, 2018): PTAB instituted an IPR trial on all challenged claims after citing both U.S. Supreme Court precedent and a Guidance describing the impact of that precedent on the PTAB.
- Inv'rs. Exch. v. Nasdaq, Inc., 2019 WL 258636 (Jan. 17, 2019): PTAB allowed both parties to submit additional briefing on the impact of a newly published Guidance, stating that the Guidance "set out agency policy with respect to the USPTO's interpretation of the subject matter eligibility requirements of 35 U.S.C. § 101 in view of decisions by the Supreme Court and the Federal Circuit."
- Wells Fargo Bank, N.A. v. United Servs. Auto. Ass'n., 2019 WL 262957 (Jan. 18, 2019): PTAB instructed both parties "to present argument as to the patent eligibility under [a newly published Guidance] in their respective papers."
- Schul Int'l Comp., LLC v. Emseal Joint Sys., Ltd., 2018 WL 4043186 (Aug. 22, 2018): PTAB instituted a PGR trial on all challenged claims after citing both U.S. Supreme Court precedent and a Guidance describing the correct claim construction standard.
Q: Binding at the Federal Circuit and/or Federal Court? A: No.
The Federal Circuit has held that, just like the PTAB, Guidance are not binding authority. A Guidance may be cited but it is the underlying case law that governs the ultimate outcome for a case. Even where cited, a Guidance is merely a "cite-through" to the controlling case law. Indeed, on April 1, 2019, the Federal Circuit confirmed in its non-precedential decision in Cleveland Clinic Found. v. True Health Diagnostics LLC that it is not bound by the USPTO's Guidances.
A. Where Federal Courts Found a Guidance Not Binding
- Cleveland Clinic Found. v. True Health Diagnostics LLC, 760 Fed. Appx. 1013 (Fed. Cir. 2019) (non-precedential): Federal Circuit held that "[w]hile we greatly respect the PTO's expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance."
- Intellectual Ventures LLC v. Erie Indemnity Co., 711 Fed. Appx. 1012 (Fed. Cir. 2017): Federal Circuit stated that a Guidance is "not binding authority on this court" such that the Guidance "and accompanying explanatory example sets do not have the force and effect of law."
- In re Smith, 815 F.3d 816 (Fed. Cir. 2016): Federal Circuit held that a "Guidance is not binding on this Court" and rejections must "continue to be based upon the substantive law, and it's these rejections that are appealable."
- Nat. Alts. Int'l., Inc. v. Creative Compounds, LLC, 2017 WL 3877808 (S.D. Cal. Sept. 5, 2017): Court rejected Plaintiff's invitation to consider and apply a Guidance, noting first "that PTO Guidance is not binding on this Court," and second that the Court did "not find [the Guidance] persuasive."
B. Where Federal Courts Cited to a Guidance
- In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005): Federal Circuit concluded that, even though a Guidance "govern[s] [the USPTO's] internal practice[s]" and the USPTO "incorporated these guidelines into the [MPEP]," "[t]he MPEP and Guidelines are not binding on this court" but they "may be given judicial notice to the extent they do not conflict with the statute."
- In re Biogen '755 Patent Litigation, 335 F. Supp. 3d 668 (D.N.J. 2018): Court concluded that "[w]hile not binding on this Court, the PTO's guidance is nevertheless persuasive."
USPTO Examination Guidance are not binding on the PTAB or on federal courts. They are useful training materials but do not have the force of law. It is not uncommon for both the PTAB and federal courts to reference a Guidance for additional support. Such references, however, are "cite-through" references to the case law underlying the Guidance. Guidance may, under proper circumstances, be informative to the extent that they do not conflict with controlling case law. Practitioners would be well-advised to consider USPTO Guidance in their practice but remember to rely on the controlling case law to support their positions before a tribunal.
- This article reflects only the present considerations and views of the authors, which should not be attributed to Kirkland & Ellis LLP, or to any of its or their former or present clients.
- 35 U.S.C. § 3(a)(2)(A) (Director of USPTO has authority to “provid[e] policy direction and management supervision for the Office[.]”); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019). The FDA issues similar guidance documents “prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue.” 21 C.F.R. § 10.115 (2018). The FDA “[g]uidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.” Id.
- Examiner Training Materials, available at: https://www.uspto.gov/learning-and-resources/examiner-training-materials (last visited Feb. 26, 2019); USPTO Announcement, available at: https://www.uspto.gov/about-us/news-updates/us-patent-and-trademark-office-announces-revised-guidance-determining-subject (last visited Feb. 26, 2019) (USPTO Director Andrei Iancu stating that the “USPTO will provide training to examiners and administrative patent judges on [Examination Guidance] to ensure that guidance is being properly administered.")