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Post-Amgen Claiming Techniques in Focus

Last year’s landmark decision in Amgen V. Sanofi emphasized that “the more a party claims, the broader the monopoly it demands, the more it must enable.” That is, particularly when claiming a broad genus of antibodies, the specification cannot be a research assignment to engage in trial and error as to the recited claim scope.

Since that time and perhaps dealing with inadequate specifications filed prior to Amgen, prosecutors have considered whether fallback claiming techniques such as Jepson format claiming or mean-plus-function formatted claims can at least secure some protection in the case where broader claims fail.

The USPTO is now committed to providing clarity on these topics in In re Xencor.Continue Reading USPTO Appeals Panel to Clarify Antibody Claiming in MPF & Jepson Format

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Leveraging Written Description Vulnerabilities in IPR

Bio/pharma patents are rarely targeted in IPR proceedings because their technical vulnerabilities often relate to written description and/or enablement. IPR, of course, is restricted in scope to only grounds of unpatentability that are based on patents and printed publications. And claims in the unpredictable arts, even when challenged in IPR, can be relatively tougher to invalidate as compared to patents in the predictable arts.

That is not to say that 112 issues cannot be litigated in an IPR—only that 112 cannot be a stand-alone trial ground. For example, where a subject patent claims priority to one or more prior filings, the 112 support of those filings is properly litigated in IPR if the claims of the subject patent are argued as lacking support in the earlier filings. The distinction is that 112 is not being assessed as a stand-alone challenge, but rather, as part of the priority assessment to determine the applicability of intervening prior art under 102/103.

The above IPR strategy is not new. However, it might be significantly more valuable to Bio/Pharma patent challengers as a mechanism to force an Amgen analysis on older patent portfolios via IPR.Continue Reading Amgen Analysis: An Emerging PTAB Threat For Bio/Pharma

Virtual CLE Program January 24 – 27th

IPWatchdog’s PTAB Masters 2022 (PTAB-palooza if you prefer), is coming next week!

The free, 4-day CLE program is virtual, and will focus on the PTAB from the viewpoint of both the patent owner and petitioners challenging patents.  Topics will explore political and legislative developments impacting the agency in…

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Photo Boards, Unsplash
Bill Released – Iancu Era Rebuked

Well, the wait was not that long after all.  Senator Leahy -VT (D) (with co-sponsor Senator Cornyn – Tx (R)) has today released the draft bill entitled “Restoring the America Invents Act.”  The bill includes most of what I expected, with a handful of additional tweaks.

Below is a brief overview of all of the proposed changes.
Continue Reading Restoring the America Invents Act – What You Need to Know

The Return of In-Person IP Conferences

In the words of princess Elsa…for the first time in forever.…there are a number of in-person IP conferences slated for this fall. (I’ve been cooped up with kids, I make Frozen references now)

First up is IPWatchdog Live 2021 September 12-14 in Dallas, Texas. The multi-day IPWatchdog…

First Boardside Chat of the Year

This Thursday the Patent Trial & Appeal Board (PTAB) will offer its first Boardside Chat of 2021, from noon to 1 p.m. (EST).

Several administrative patent judges of the PTAB will cover:

  • Final rules related to institution of trials, including elimination of the presumption at institution that a genuine

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Director Memo Decides Against Standard of In Re Packard

Back in 2018 I noted the current PTO administration had backed away from a dispute on the appropriate 112 standard to apply in AIA trials (after intervention by the previous PTO administration). That is, the initial intervention sought to support the application of the standard enunciated by In re Packard to AIA trial proceedings.  After Director Iancu came on board, that Intervenor Brief was withdrawn.

Today, the PTO formally announced (via memorandum) that the Nautilus standard applies to AIA trials – settling an open question….at least for the time being.Continue Reading PTAB Applies Nautilus 112 Standard to AIA Trials…For Now

Deciding Between PTAB & District Court Venues for 112 Challenges

With an increasing number of issued patents eligible for Post Grant Review (PGR), patent challengers find themselves assessing whether PGR is worth the added estoppel risk.  That is, where a first-inventor-to-file patent is still within 9-months of issuance (PGR window), should a challenger opt for PGR, or await the availability of IPR after the 9th month?

As with many legal questions, the answer is —”it depends.”
Continue Reading PGR May Be The Place For Your 112 Case

CAFC Implies PTO Might Overlook Some 112 Issues

The Patent Trial & Appeal Board (PTAB) does not accept trial grounds under 35 U.S.C § 112 in Inter Partes Review.  This is because the IPR statutes only authorize trial grounds based on patents and printed publications.  The same has been true of patent reexamination for decades.

Last week, in Samsung Elec. Am., Inc. v. Prisua Eng’g Corp., the Federal Circuit considered whether the Board may cancel claims under 112 when such issues arise during trial.  The Court held that the PTAB may not cancel claims under 112, but instead, might, for certain types of claims, proceed to decide the prior art grounds.
Continue Reading Should the PTAB Determine Patentability of Unsupported Means-Plus-Function Claims?

101 Guidance To Relax Patentability Standard?

Today, the USPTO announced revised guidance for subject matter eligibility under 35 U.S.C. § 101 (here). The USPTO also announced guidance on the application of 35 U.S.C. § 112 to computer-implemented inventions (here). The documents will be published in the Federal Register on Monday, January…