It’s a common occurrence when you’re involved in technology transfer for a corporation or are a patent attorney – an inventor approaches you with an urgent deadline, perhaps there’s going to be a disclosure at a meeting, or the inventor fears that another entity is about to file an application, and you have to file an application right away. Right away as in, tonight. Common “wisdom” in such a situation is often to file a provisional application – after all, a provisional application doesn’t even have to have claims, and can be as simple as affixing a cover sheet on the inventor’s notes and filing them. How wise is that wisdom? In Storer v. Clark (Fed. Cir. June 21, 2017) the Federal Circuit’s decision suggests that just filing the barest bones of a provisional may well not be doing the applicant any favors.
The value of a provisional – if anything – is that it can provide a priority date that can be claimed by a regular US application, which of course is critically important in the first-to-file world of post-AIA law. As Storer shows, however, that lesson can be learned even from a first-to-invent case.
Storer’s patent was involved an interference with an application of Clark. Storer was awarded priority in the interference based on the filing date of his provisional application, which apparently would have been dispositive of the interference. However, Clark challenged that decision based on the argument that Storer’s provisional failed to provide priority in that it did not satisfy the enablement requirement of 35 USC §112.
The Federal Circuit began its decision by reminding that,
“When a party to an interference seeks the benefit of an earlier-filed United States patent application, the earlier application must meet the requirements of 35 U.S.C. § 120 and 35 U.S.C. §112 ¶ 1 for the subject matter of the count.” Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed. Cir. 1998) (footnotes omitted). Section 112 ¶ 1 requires:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In noting 35 USC §120, the Court reminds us that whenever priority is claimed (and indeed, the same is true for foreign priority under 35 USC§119) the priority application must both describe the later claims, but also enable them.
Storer’s application was directed to methods of treating hepatitis C, with compounds having specific stereochemistry. In the interference, claim 1 was selected as representative: 1. A method for the treatment of a host infected with a hepatitis C virus, comprising administering to the host infected with a hepatitis C virus an effective amount of a compound having the formula:
or a pharmaceutically acceptable salt thereof… (The definitions of the variables were unimportant for purposes of the interference, with Clark’s challenge centering around the ability to produce the compound having the fluorine atom in a downward orientation.) The provisional application was generic to the fluorine configuration, but did not exemplify the structure with down configuration.
The Board held that the provisional, taken together with the prior art, did not enable the specific compounds having the identified structure. Storer argued on appeal, that a person of ordinary skill would have been able to make this class of compounds having the requisite stereochemistry, based on information in the provisional application and the prior art.
Noting that enablement would be present only where one of ordinary skill in the art could practice the invention without undue experimentation, the Court turned to the seminal decision of In re Wands, 858 F.2d 731, (Fed. Cir. 1988), establishing that factors relevant to enablement include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. The majority of the Wands factors were not disputed, with Storer admitting that there were no examples detailing preparation of the isomer in the provisional. For the fourth Wands factor—the nature of the invention – the Board found that as of the time of filing of the provisional application, although organic fluoridation mechanisms were generally well-known in the art a 2′- fluoro-2′-methyl nucleoside with the fluoro substituent in the “down” position had not yet been synthesized. Moreover, the Court noted that the specific reagent used to effect such a synthesis was not known in the art to be useful to produce a fluorine in the down position. Thus, despite the parties’ agreement that the level of skill in the art would be high – a PhD. in synthetic organic chemistry – that level of skill would not have been sufficient to negate undue experimentation as considerable effort and consultation with other experts would have been necessary.
Despite Storer’s argument that a well-known precursor compound was disclosed in the provisional, the court based its decision in upholding the Board particularly upon the unpredictability in the art, coupled with the lack of specific direction and identification of relevant chemical syntheses in the provisional.
Setting aside correctness of the decision – the important message here, beyond the obvious that a provisional must comply with §112 to provide any value as a priority application – is that when a provisional application is prepared in haste, it is necessary to, in the cold light of day and after a good night’s sleep, revisit the application and as quickly as possible put in any additional effort needed to ensure that the application is complete and solid. In addition, the message from Storer is that, even when a sound effort is put in at the provisional stage, in situations – such as presumably the case in Storer – where research continues even after filing, it is advisable to touch base with the inventors and where additional discoveries made or gaps in the provisional filled in, to file multiple provisionals if not yet ready to file a regular application. In provisionals – you definitely get what you pay for.