Editing Utility (patentability requirement) (section)

==History and development==
The very first US [[Patent Act of 1790]] required patentable inventions to be "sufficiently useful and important".<ref>{{Cite web |url=http://www.ipmall.info/hosted_resources/lipa/patents/Patent_Act_of_1790.pdf |archive-url=https://web.archive.org/web/20110722040111/http://www.ipmall.info/hosted_resources/lipa/patents/Patent_Act_of_1790.pdf |archive-date=2011-07-22 |website=[[University of New Hampshire]] |language=en |access-date=4 August 2023 |title=Sec. 1. |year=1790 |page=1}}</ref> An 1817 case ''Lowell v. Lewis'' (Circuit Court, D. Massachusetts) proclaimed that: ''the word "useful," therefore, is incorporated into the [Patent] act in contradistinction to mischievous or immoral.'' This very broad definition survived well into the Twentieth Century. It was the basis for the ''beneficial utility'' doctrine, which excludes from patentability anything immoral or deceitful.<ref name="juicy">Juicy Whip v. Orange Bang, 185 F.3d 1364 (Fed. Cir. 1990)</ref> 
However, in the 1970's after cases establishing patentability of a [[slot machine]] in 1977,<ref>Ex parte Murphy, 200 U.S.P.Q. 801 (Bd. Pat. App. & Int. 1977)</ref> and drink machines with decorative reservoirs that did not contain the drink actually dispensed,<ref name="juicy"/> the [[United States Patent and Trademark Office]] and federal courts no longer consider beneficial utility nor the deceitful or immoral qualities of inventions. 

However, it is not only "mischievous or immoral" inventions, that fase{{Clarify|date=June 2023|reason=fase?}} the utility challenge. Oftentimes new chemicals, which are known to be useful as a class, but have not demonstrated a "specific, substantial and credible utility" <ref>{{cite web|url=https://www.uspto.gov/sites/default/files/web/menu/utility.pdf|title=REVISED INTERIM UTILITY GUIDELINES TRAINING MATERIALS|access-date=2023-08-14}}</ref> are denied a patent. The [[landmark decision]] in this area is 1966 [[Brenner v. Manson]]. In this case, the [[SCOTUS]] concluded that a new [[steroid]] was not "useful" in the meaning of the patent law, because it had no defined use at the time of the application. "A patent is not a hunting license," the Court stated. It is "not a reward for the search, but compensation for [the search's] successful conclusion." This standard for utility cannot be met until a "specific benefit exists in currently available form."<ref name="brenner-1966"/> 

On the same day as [[Brenner v. Manson]], the Court decided two other cases [[In re Kirk]] and [[In re Joly]]. These cases denied patentability to chemical intermediates for products, which had no known use.

In 1955 [[United States Court of Appeals for the Federal Circuit]] in ''[[In re Brana]] ''clarified, that ''utility'' requirement for pharmaceutical inventions does not require formal approval by the [[Food and Drug Administration]].<ref name="brana-1955">[http://www.leagle.com/xmlResult.aspx?page=1&xmldoc=1995161151F3d1560_11390.xml&docbase=CSLWAR2-1986-2006&SizeDisp=7 In re Brana, 51 F.3d 1560 (Fed. Cir. 1995)].</ref> Instead an [[in vitro]] proof of efficacy, using a known test is sufficient. 

In 1995, the USPTO published new utility guidelines, which eliminated the "substantial", but retained  “specific” and “credible” requirements.<ref>Utility Examination Guidelines, 60 Fed. Reg. 36,263, 36,264 (July 14, 1995)</ref> In the case of a process of making chemicals, the utility of the process can be established only if a product of this process has a utility. Thus, a process resulting only in products, which have no known use, is not patentable.

Another landmark decision related to utility of biological inventions was 2005 case [[In re Fisher]].<ref>In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005)</ref> It denied patentability of [[express sequence tags]] (which are “tiny portion[s] of an entire gene that can be used to help identify unknown genes and to map their positions within a genome”), because their only known use at the time of patent application was as a research tool.<ref>In re Fisher: Denial of Patents for ESTs Signals Deeper Problems in the Utility Prong for Patentability. 2007. Minnesota journal of law, science & technology. 8/2, 645. L. Ewing. [https://scholarship.law.umn.edu/mjlst/vol8/iss2/15/ In Re Fisher: Denial of Patents for ESTs Signals Deeper Problems in the Utility Prong for Patentability]</ref>

The utility of invention must be demonstrated in the patent application itself. Post application activities cannot be used to prove utility.<ref>Newmann v. Quigg, 877 F.2d 1575 (Fed. Cir. 1989).</ref>