In season 5, episode 3, of the TV show "Die Höhle der Löwen" (German version of the US show Shark Tank and the UK show Dragon's Den), a young company, Smart Sleep GmbH, presents a nutritional supplement called "smartsleep". smartsleep is an innovative mix of nutrients for the night, which is intended to make sleep more efficient. Unlike conventional sleep aids, smartsleep does not promote fatigue, but is intended to support recovery processes during sleep. The target group for smartsleep is athletes and business people. Likewise, smartsleep is intended to help with short nights, e.g. when traveling through time zones, or after days of heavy physical or mental stress.
Two different European patents have been granted for smartsleep. Using smartsleep as an example, it will be shown how a new use of a known active complex can be used to achieve an effective differentiation from the prior art.
The first European patent – EP2918177B1 (EP'77)
Subject-Matter
Originally, an attempt was made to protect the food supplement smartsleep in an independent claim. Claim 1 of the original patent application to EP'77 defines the following features:
N1: A food supplement containing:
N1.1: Creatine,
N1.2: Glutamine
N2: to use in sleep optimization, vigilance and/or cognitive performance, sleep specific regeneration, daytime sleepiness, and/or as a natural sleeping aid.
Prior Art
In the European Search Report, the Search Division cited eight documents each describing foods or supplements containing at least creatine and glutamine and provided for the various uses according to feature N2 of claim 1.
Thus, original claim 1 of the patent application to EP'77 is not novel over the cited prior art.
Effective delineation from the prior art
Claim 1 (EP'77) was amended during the examination proceedings as follows:
N1: A food supplement containing:
N1.1: Creatine,
N1.2: Glutamine
N1.3: Glycine
N2: to use in sleep optimization, vigilance and/or cognitive enhancement, sleep-specific regeneration, daytime sleepiness, and/or as a natural sleeping aid.
D3 (CN 103 371 317 A) discloses a functional food containing creatine, glutamine, glycine, calcium, magnesium, selenium, etc., for this purpose, but does not provide for specific use as a sleeping aid.
Note: It should be pointed out at this point that, for the sake of clarity, only D3 is discussed herein as prior art.
Claim 1 is considered novel over the cited prior art, e.g., D3, having the same substance composition according to features N1, N1.1, N1.2, and N1.3, but relating to a different use.
Note: According to Art. 54(5) EPC, substances/mixtures, such as a food supplement, may be patentable if the specific application thereof does not belong to the prior art. This also applies to substances/mixtures which relate to use in a process excluded from patentability (cf. Art. 53(c) EPC, see below).
The above-mentioned limitation of claim 1 according to EP'77 thus leads to novelty over the prior art.
As a result, a relatively broad active complex comprising the three essential components creatine, glutamine and glycine was patented, ultimately restricted to the intended form of use, namely as a sleeping aid.
The second European Patent – EP3056096B1 (EP'96)
Subject-Matter
The second patent application, on which EP'96 is based, sought to protect smartsleep but again as a food supplement in an independent claim. Claim 1 thereof originally defined the following features:
M1: Food supplement,
M1.1: containing creatine
M2: to reduce the natural need for sleep / sleep pressure and/or to support sleep specific regeneration processes.
Prior Art
In the European Search Report, the Search Division cited six documents, each disclosing foods or supplements containing creatine, some of which are contemplated for various uses, such as treating insomnia, sleep disorders, or sleep deprivation, according to feature M2 of claim 1.
Thus, the original claim 1 of the EP'96 patent application is not novel over the cited prior art.
Effective delineation from the prior art
Claim 1 (EP'96) was amended to a use claim during the examination proceedings.
Note: A claim to a product, e.g. the food supplement, may be replaced by a claim to a use of that product if the use is directed exclusively to the achievement of an effect and not to the manufacture of the product (see G 2/88), as is also the case here with respect to the food supplement (see below).
Amended claim 1 reads as follows:
M1: Use of a food supplement
M1.1: containing creatine
M2: to reduce natural sleep need / sleep pressure and/or to support sleep specific regeneration processes.
Note: Therapeutic treatments are excluded from patentability under Art. 53(c) EPC. The administration of food supplements, which relates to the reduction of the natural need for sleep/ sleep pressure, does not involve a medical indication, and is thus to be regarded as non-therapeutic and consequently eligible for protection.
In the prior art, there are functional food supplements containing creatine, which is nowadays popular in weight training, but not for reducing the natural sleep need / sleep pressure according to M2, as defined in amended claim 1.
Note: It should be noted at this point that, again for the sake of clarity, the rest of the examination proceedings are not discussed herein.
The above-mentioned limitation of claim 1 according to EP'96 thus leads to novelty over the prior art.
As a result, a relatively broad use of a food supplement containing creatine as an active ingredient was patented. The targeted use to reduce the natural sleep need / sleep pressure ultimately also appears to correspond to the intended form of use.
Conclusion
It was briefly shown how the prior art in terms of novelty can be overcome by a specific use of a food supplement known per se or a composition thereof. The borderline between lack of novelty and inventive step is thereby vanishingly small, whereby in the case of smartsleep a patent grant was achieved by this specific use. Specifically, it was shown for the case of smartsleep that by defining the type of use, both the product claim and the use claim can be effectively delimited from the cited prior art to achieve a patent grant.
In view of both patents granted, Smart Sleep GmbH has, in our view, a very broad scope of protection for its food supplement smartsleep, in which both product and use are protected alongside each other. Based on this scope of protection, potential competitors can be effectively prevented from imitating the innovative food supplement in the future and, if necessary, forced out of the market.
Author: Julian Graf
German and European Patent Attorney
Disclaimer: The above contribution reflects the personal opinion of the author. The assessments and statements made in the article do not constitute legal advice and are provided under exclusion of any liability. If you need an assessment of an individual case, please contact the author and/or the law firm KUHNEN & WACKER.
