Laundry Lists of Elements are Inadequate Written Description for a Explicit Mixture

by Dennis Crouch

The pending Supreme Court docket case of Amgen v. Sanofi focuses on a broadly claimed genus and asks whether or not the disclosure is sufficiently detailed.  The Federal Circuit’s latest UMN v. Gilead is the flip-side.  Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023).  UNM’s authentic disclosure is extraordinarily broad with “laundry lists” of elements that could be included in numerous combos;  whereas the later-added declare is directed to a extra specific sub-genus mixture.  The court docket seemed in useless for some indication within the specification as to why the claimed mixture is necessary or significantly urged.  Right here, they disclosed a big forest, however didn’t disclose the tree that turned out to be beneficial.

Going ahead, a patentee may keep away from this specific downside with some patent lawyer methods.  Moderately than itemizing all potential elements for every purposeful group and usually suggesting their mixture, an early-stage patentee might need its AI assistant present a hypothetical instance of every attainable mixture, one after the other.  That state of affairs would supply clear ipsis verbis disclosure and thus extra seemingly survive a written description problem.

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Most U.S. patents assert precedence to a minimum of one prior patent software submitting.  The early submitting date helps keep away from would-be intervening and invalidating prior artwork.  However, the suitable to precedence will not be computerized. Along with the formal paperwork, the unique software should sufficiently disclose the invention as claimed within the later patent.  Sufficiency of disclosure is mostly judged beneath 35 U.S.C. §112(a) with the doctrines of enablement and written description.

A patent that improperly claims precedence will not be mechanically invalid.  Moderately, the precedence submitting date is rendered void after which we think about whether or not the  invention was nonetheless novel and nonobvious as-of the later submitting date.  This setup additionally permits these disclosure points to be thought of throughout Inter Partes Overview  (IPR) proceedings which might be statutorily restricted to anticipation and obviousness grounds.

In Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023), the Federal Circuit confronted the problem of whether or not the  written description present in UMN’s precedence functions supported the claims within the ensuing US8815830 patent.  Right here, the ‘830 patent covers the drug sofosbuvir that has FDA approval for Hep-C therapy.  Declare 1 doesn’t merely cowl sofosbuvir, however as an alternative a whole genus of molecules that match the final construction proven above and the place purposeful teams R1 – R7 are additional outlined throughout the declare.  For example, “R3 is hydroxy … R5 is an amino acid …”

UMN’s preliminary patent software was a provisional filed again in 2004, adopted by a PCT software in 2005, adopted by a non-provisional software in 2007 and at last by one other non-provisional software in 2013 that led to the ‘830 patent. In 2010, a Gilead patent software printed (“Sofia”) that discloses the claimed invention.  On this setup, UMN’s can disregard Sofia as long as it correctly claimed precedence to a minimum of a kind of earlier functions.  However, if precedence fails then the ‘830 patent is anticipated.

Through the IPR, the Board sided with Gilead — concluding that the precedence filings lacked ample written description and thus that the claims had been invalid as anticipated. On attraction, the Federal Circuit has affirmed in an opinion by Decide Lourie and joined by Judges Dyk and Stoll.

The patent act requires a “written description of the invention” be submitted within the type of a patent specification.  “Judicial gloss” explains this requirement has proving that the inventor “possessed the invention as claimed” on the time of submitting.  Written description points most frequently come up in conditions like this one the place the patented claims weren’t discovered within the authentic submitting paperwork; however slightly had been added later throughout prosecution.

The courts have been significantly onerous on patentees in search of to say protection for a big genus of compounds.  In that state of affairs, it’s usually a troublesome endeavor for the patentee to actually enumerate all operable compounds coated by the claims.  That degree of disclosure will not be required, however the patentee should describe “the outer limits of the genus” in addition to “both a consultant variety of members of the genus or structural options frequent to the members of the genus, in both case with sufficient precision {that a} related artisan can visualize or acknowledge the members of the genus.”  The court docket will even think about “blaze marks throughout the disclosure that information consideration to the claimed species or subgenus.” Slip Op., citing In re Ruschig, 379 F.2nd 990 (CCPA 1967).

Ipsis verbis: I discussed above that written description challenges are most frequently profitable in conditions the place the declare scope has modified throughout prosecution.  Claims which might be discovered word-for-word within the authentic software (ipsis verbis) can nonetheless fail the written description requirement, however that result’s a lot much less seemingly.  Right here, UMN argued that the unique provisional submitting disclosed the eventual declare in ipsis verbis type — pointing to a mix of parts of provisional claims 1, 2, 13, 21, 22, 45, and 47 that collectively forming a considerable word-for-word recitation of declare 1 within the ‘830 patent.  On attraction although the Federal Circuit discovered that mixture of this disparate set of claims required a bit an excessive amount of cleverness.

Following this maze-like path, every step offering a number of various paths, will not be a written description of what might need been described if every of the non-obligatory steps had been set forth as the one possibility. This argument calls to thoughts what Yogi Berra, the Yankee catcher, was reported to have mentioned: “when one involves a fork within the highway, take it.” That remark was notable due to its indeterminacy, its lack of path. Equally, right here, all these non-obligatory selections don’t outline the meant end result that’s declare 1 of the ’830 patent.

Furthermore, Minnesota’s argument is akin to that rejected in Fujikawa, the place the applicant “persist[ed] in arguing that its proposed depend [wa]s disclosed ipsis verbis in Wattanasin’s software.” Fujikawa v. Wattanasin, 93 F.3d 1559 (Fed. Cir. 1996). Because the court docket defined in Fujikawa: “simply because a moiety is listed as one attainable selection for one place doesn’t imply there’s ipsis verbis help for each species or sub-genus that chooses that moiety. Had been this the case, a ‘laundry listing’ disclosure of each attainable moiety for each attainable place would represent a written description of each species within the genus. This can’t be as a result of such a disclosure wouldn’t ‘fairly lead’ these expert within the artwork to any specific species.”

Slip Op.  I might argue that the Federal Circuit erred on this level. The UMN provisional software’s Declare 1 is directed to the identical normal molecule, however with a lot broader definitions for every of the purposeful group. Then, the following provisional dependent claims (2, 13, 21, 22, 45, and 47) refine the scope of these purposeful teams in a way that’s an identical to that finally claimed within the ‘380 patent.  Right here, every of those dependent claims are outlined as being dependent upon any of the prior claims.  Thus, provisional dependent declare 47  seemingly consists of the an identical limitations discovered within the ‘830 patent declare 1. Sure, it’s a little bit sophisticated, however so is chemistry.

It’s not clear that my quibble would change the result of the case since ipsis verbis help doesn’t essentially end in ample written description.

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The absence of ipsis verbis help will not be deadly, as long as the unique filings sufficiently present possession of the total scope of the claimed invention.  In circumstances involving very broad disclosure (a forest), the courts look rigorously for indications that for disclosure of the actual timber really claimed.  However, lengthy lists of elements will not be ample. Moderately, the ideas – the “blaze marks” — have to be clear.  Right here, the PTAB discovered the patentee had failed to supply that roadmap and, on attraction, the Federal Circuit affirmed on substantial proof.

[T]he constructions [disclosed in the provisional] are so in depth and various that [they] encompasses a considerably bigger genus than that claimed within the ’830 patent, will not be sufficiently frequent to that of declare 1 of the ’830 patent to supply written description help.

Slip Op.

UMN made different arguments that had been all rejected:

1. The PTAB ought to have made a credibility dedication or different reality discovering concerning skilled testimony.  On attraction although the Federal Circuit concluded that the PTAB will not be required to deal with every  facet competition inside its resolution.
2. The PTAB beforehand issued a choice that’s facially inconsistent with this case, and thus is appearing in an arbitrary and capricious method.  On attraction, the court docket discovered no downside because the Board will not be sure by prior panels.
3. As a state establishment, UMN is immune from IPR challenges.  UMN acknowledged that this argument was beforehand determined by the Federal Circuit.  Additional, UMN has already misplaced a case on this argument and so is not only sure by precedent but additionally collateral estoppel.

Cancellation affirmed.