United States: Trending At The PTAB: How Q1 Policymaking Affects Practice

The  U.S. Patent and Trademark Office has kicked off 2024 with several policymaking initiatives.

From updated guidance for making a proper determination of obviousness to a proposed rule on motion to amend practice and procedures in trial proceedings under the America Invents Act before the Patent Trial and Appeal Board, the USPTO is clarifying and updating its policies that affect the PTAB.

This article provides an overview of the policymaking we have seen this year and highlights how these policies may affect practice before the PTAB.

Notices of Proposed Rulemaking

So far this year the USPTO has published two notices of proposed rulemaking before the PTAB; 

• Expanding opportunities to appear;¹ and
• Practice and procedure in motions to amend during AIA trial proceedings.²

Expanding Opportunities Rule

Currently, to practice before the PTAB in AIA proceedings, you must either be a registered practitioner, i.e., have passed the registration exam; file a motion to appear pro hac vice as back-up counsel where lead counsel is a registered practitioner; or represent yourself.³

In particular, the proposed rule expanding appearance opportunities before the PTAB, issued on Feb. 21,⁴ makes four changes. First, it gives parties the option to designate nonregistered practitioners who are recognized pro hac vice as lead counsel.⁵ 

It permits parties to proceed without designating back-up counsel as long as lead counsel is a registered practitioner and upon a showing of good cause (e.g., such as a lack of resources to hire two counsel).⁶

For practitioners who have previously been admitted pro hac vice before the PTAB, the proposed rule allows a streamlined process for these PTAB-recognized practitioners to be automatically admitted in subsequent cases by filing a notice of intent to designate instead of having to file a pro hac vice motion for subsequent cases.⁷

Finally, the proposed rule clarifies the duty for those admitted pro hac vice to inform the board of subsequent events that render inaccurate or incomplete representations they made to obtain pro hac vice recognition.⁸

The USPTO is accepting comments on this proposed rule until May 21.⁹

Practice Tips

This policy provides parties more options in the counsel they choose to represent them in AIA proceedings.

The policy changes may also support a more diverse set of attorneys practicing before the PTAB by making it easier and less expensive for nonregistered attorneys to appear in multiple proceedings.

Motion to Amend Rule

Under the AIA, a patent owner has a statutory right to

The AIA also enables the director to prescribe rules related to these motions to amend.¹¹ Using this authority, the director implemented a motion to amend the pilot program in 2019.¹²

This pilot program enabled a patent owner to request preliminary, nonbinding guidance from the board when proposing substitute claims. After receiving the preliminary guidance or a petitioner's opposition, the patent owner had the opportunity to submit a revised motion.

On March 1, the USPTO issued a notice of proposed rulemaking relating to motions to amend during AIA proceedings at the PTAB.¹³

The proposed rule, if implemented, would make certain provisions of this pilot program permanent. For example, patent owners will still be able to request preliminary guidance and can file a revised MTA.¹⁴

Patent owners will also have the option to reply to the preliminary guidance.¹⁵ Likewise, petitioners will be able to oppose any motions to amend and be able to respond to the preliminary guidance.¹⁶

The proposed rule further specifies that the board would apply a preponderance of the evidence standard to any new ground of unpatentability that the board's preliminary guidance raises.¹⁷

The proposed rule also reminds practitioners that the board may conduct its own prior art search and receive help from an examiner.

The USPTO is accepting comments on this proposed rule until May 3.¹⁸

Practice Tips

Both patent owners and petitioners can make use of the potential new rule that effectively codifies the current pilot program. Patent owners should consider whether it makes sense to file a motion to amend on a case-by-case basis, but the pilot program has proven to be a helpful tool.

The new rule, as the pilot program has done in the past, would continue to effectively allow patent owners two opportunities to amend the challenged claims.

From a patent owner's perspective, if used effectively, motions to amend could serve as a safety net to ensure that the challenged patent not only survives a validity challenge but achieves the strongest claims possible.

From a petitioner's perspective, the preliminary guidance from the board and the opportunity to respond affords a critical opportunity to challenge any proposed amendments, introduce new prior art and evidence, and benefit from the board's guidance before a final decision is rendered.

Guidance Documents

The USPTO has published three guidance documents so far this year, including:

• Guidelines for assessing enablement in utility applications and patents in view of the May 18, 2023, U.S. Supreme Court decision in Amgen Inc. v. Sanofi;¹⁹
• Updated guidance for making a proper determination of obviousness;²⁰ and
• Inventorship guidance for AI-assisted inventions.²¹

Of these three, only the first two are discussed here because they directly apply to the PTAB.

Enablement Guidance

In Amgen v. Sanofi,²² the Supreme Court addressed the question of what satisfies the enablement requirement for a patent claim directed to a functional genus.

The court noted that "[a] specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art."²³

Applying this rule to the facts of the case, the court determined that Amgen's patent specification did not enable the broad claim at issue.²⁴

In response to the Supreme Court's decision in Amgen Inc. v. Sanofi,²⁵ the USPTO issued this guidance to assist examiners and administrative patent judges in assessing enablement and supporting findings of enablement.²⁶

The guidance seeks to help USPTO personnel understand what reasonable experimentation entails by summarizing the  U.S. Court of Appeals for the Federal Circuit's 2021 Amgen v. Sanofi decision,²⁷ which the Supreme Court affirmed, as well as three post-Amgen cases that were appealed to the Federal Circuit.²⁸

The guidance explains that prior to Amgen, the Federal Circuit developed a framework of factors, referred to as the Wands factors.²⁹

And that although the Supreme Court did not explicitly address the Wands factors in Amgen, based on the Sanofi-Aventis decision and the Federal Circuit's post-Amgen enablement decisions, the guidance instructs USPTO personnel to continue applying the Wands factors.³⁰

The Wands factors include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (4) the level of predictability in the art, (5) the amount of direction provided by the inventor, (6) the existence of working examples, and (7) the quantity of experimentation needed to make and use the invention based on the content of the disclosure.³¹

Obviousness Guidance

Since the Supreme Court's 2007 decision in KSR International Co. v. Teleflex Inc., the USPTO has released three guidance documents related to obviousness.³²

In the third installment, published on Feb. 27, the USPTO highlights "the requirement for a flexible approach to the obviousness determination" and emphasizes that USPTO personnel must provide sufficient reasoning when finding that a claim is obvious.³³

This guidance does not appear to change the USPTO's approach to determining obviousness. It acknowledges how the AIA shifted the obviousness inquiry from "at the time the invention was made" to "before the effective filing date of the claimed invention."³⁴

The guidance reaffirms that the inquiry under the Supreme Court's 1966 Graham v. John Deere Co. decision still controls obviousness, and summarizes recent Federal Circuit cases that demonstrate how flexible this inquiry is.³⁵

For example, the USPTO highlights that flexibility is needed to understand the scope of prior art, credit the knowledge of a skilled artisan, determine analogous art, and explain a rationale for combining or modifying prior art.³⁶

This flexibility, however, does not negate USPTO personnel's requirement to consider all relevant evidence and sufficiently articulate the reasoning behind their decisions.³⁷

Practice Tips

Guidance documents apply only to USPTO personnel and are not binding on the public.

Although guidance documents do not have the full force or effect of law, practitioners can look to them for instructions on best practices. For example, in light of the enablement guidance, PTAB practitioners should continue to address the Wands factors whenever they are presented with enablement issues in post-grant reviews or ex parte appeals.

Similarly, in light of the obviousness guidance, practitioners should address the Graham factors based on the effective filing date of the claimed invention in their petitions, responses and appeal briefs.

Footnotes

1. Expanding Opportunities To Appear Before the Patent Trial and Appeal Board, 89 Fed. Reg. 13017-21 (proposed Feb. 21, 2024) ("Expanding Opportunities Rule").

2. Motion To Amend Practice and Procedures in Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board, 89 Fed. Reg. 15531 (Mar. 4, 2024) ("MTA Rule").

3. See 37 CFR 42.10; see also 37 CFR 11.7.

4. Expanding Opportunities Rule, 89 Fed. Reg. 13020 (proposed Feb. 21, 2024).

5. Id.

6. Id.

7. Id.

8. Id.

9. Expanding Opportunities Rule, 89 Fed. Reg. 13017 (proposed Feb. 21, 2024).

10. 35 U.S.C. § 316(d)(1).

11. Id. at § 316(a)(9).

12. Notice Regarding a New Pilot Program Concerning MTA Practice and Procedures in Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board, 84 Fed. Reg. 9497 (March 15, 2019).

13. MTA Rule, 89 Fed. Reg. 15531 (Mar. 4, 2024).

14. Id. at 15538-40.

15. Id.

16. Id.

17. Id. at 15540.

18. Id. at 15531.

19. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 Fed. Reg. 1563-1566 (Jan. 10, 2024) ("Enablement Guidance").

20. Updated Guidance for Making a Proper Determination of Obviousness, 89 Fed. Reg. 14449-14453 (Feb. 27, 2024) ("Obviousness Guidance").

21. Inventorship Guidance for AI-Assisted Inventions, 89 Fed. Reg. 10043-10051 (Feb. 13, 2024).

22. Amgen Inc. v. Sanofi, 143 S. Ct. 1243 (2023).

23. Id. at 1256.

24. Id. at 1258.

25. Id.

26. Enablement Guidance, 89 Fed. Reg. 1563-64 (Jan. 10, 2024).

27.  Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021).

28. Id. at 1565-56.

29.  In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

30. Amgen, 987 F.3d at 1566.

31. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

32. Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc, 72 Fed. Reg. 57526 (Oct. 10, 2007); Examination Guidelines Update: Developments in the Obviousness Inquiry After KSR v.Teleflex, 75 Fed. Reg. 53643 (Sep. 1, 2010); Updated Guidance for Making a Proper Determination of Obviousness, 89 Fed. Reg. 14449 (Feb. 27, 2024).

33. Obviousness Guidance, 89 Fed. Reg. 14449 (Feb. 27, 2024).

34. Id. at 14450.

35. Id. at 14450-53.

36. Id.

37. Id. at 14452-53.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.