Tuesday, May 19, 2015 T 1164/11 - Use the force

This Examination appeal concerns a medical apparatus for cutaneous administration of medicaments, i.e., through the skin. The main claim in the appeal reads:

 
"A medical apparatus for cutaneous administration of medicaments comprising:
- a supporting frame (100);
- an energy emitter (9) in engagement with the frame (100) and active on the molecules of at least one medicament to cause penetration of same into a skin region to be treated (10); (...) said energy emitter (9) being an electromagnetic wave generator (11) emitting a laser light of a wavelength comprised in the range of 600 to 650 nm."

The board has its doubts whether such a electromagnetic wave generator can really  be  active on the molecules of a medicament to cause penetration into a skin region. The board  evaluates if there is a plausible explanation of the claimed effect and, in the absence thereof, the available evidence.
Reasons for the Decision

1. The appeal is admissible.

2. Sufficiency of disclosure

Claim 1 relates to a medical apparatus comprising a number of components. The Board agrees that the skilled person would be able to assemble the claimed apparatus. However, this does not necessarily imply that the claimed invention is sufficiently disclosed within the meaning of Article 83 EPC.

The requirement of sufficiency of disclosure in Article 83 EPC is based on the consideration that the grant of a patent is only justified if the information comprised in the patent application and generally available technical knowledge enable the skilled person successfully to put into practice the subject-matter of the claimed invention. It is not the purpose of the patent system to grant a monopoly for technical speculations that cannot be realised at the time of filing.

In addition to the components of the claimed device, the subject-matter of claim 1 also comprises the feature of "an energy emitter (9) [...] active on the molecules of at least one medicament to cause penetration of same into a skin region to be treated (10)". At the end of the claim it is further defined that the energy emitter is "an electromagnetic wave generator (11) emitting a laser light of a wavelength comprised in the range of 600 to 650 nm". The application is silent with regard to the power or intensity of the laser beam and the duration of its delivery.

The Board does not accept the appellant's view that this feature "should be interpreted in terms of 'intended use' and not in terms of coherence with one or more scientific theories". The feature relates to the function of the claimed energy transmitter, describing its interaction with the molecules of the medicament contained in the matrix of a solidified medicamentous solution which also forms part of the claim. Accordingly, this feature of the claim has to be taken into consideration when assessing whether the claimed invention is sufficiency disclosed.

The feature requires that the laser light must be "active" on the molecules to cause their penetration into the skin. In the Board's view, this must be understood as a direct interaction between the light and the molecules, and not as a possible effect of the light on the skin which has an indirect influence on the molecules that would somehow enhance their penetration through the skin (e.g. inhibition of receptors in channels in the skin, widening of inter-cellular pathways, change in cellular membrane permeability, ablation of the stratum corneum). The wording of the claim clearly states "active on the molecules" and not "active on the skin" or something similar. The direct interaction is also emphasised in the corresponding paragraph [0052] of the description, where it is stated that "the laser light will only act on the molecule crystals constituting the medicament" [emphasis added]. On the other hand, the description is silent on any influence on the skin resulting in an indirect interaction of the above-mentioned kind.

Accordingly, the question arises of what nature this interaction between the laser light and the molecules is and how it could effect the penetration of the molecules into the skin. In the cited paragraph of the description (which is the only one dealing with this interaction) it is further stated that the "molecules are therefore pushed and introduced through the epidermis into the skin region 10 to be treated". However, in line with what is stated in the impugned decision, the Board is not aware of a known physical mechanism according to which light is able to push molecules of a medicament, contained in the matrix of a solidified medicamentous solution, into the skin. The well-established effect of "radiation pressure" is not applicable to the present situation, as convincingly explained in point 2.3 of the Reasons of the impugned decision. This is not contested by the appellant, who does not rely on this effect as a possible explanation. Instead, the appellant referred to "energization of outer electronic orbitals or whatever else". It is indeed known that (laser) light, i.e. photons, can interact with the electrons of a molecule, resulting in their elevation to a higher energy level, but only if the incident wavelength corresponds to the available energy states, resulting in absorption. Consequently, this kind of interaction would not occur if the respective molecules do not have absorption bands in the claimed range of wavelengths of 600 to 650 nm. According to the established jurisprudence ("Case Law of the Boards of Appeal of the EPO", 7**(th) edition (2013), II.C.4.4), the disclosure is only sufficient if it allows the invention to be performed in the whole range claimed. Since claim 1 is directed to molecules of medicaments of any kind, this criterion is not fulfilled. In the application only one single example of a medicament is indicated ("escina-based medicamentous solution" in paragraph [0053]).

But even if absorption occurs, it remains entirely unresolved how the excited energy state of the molecules could result in their penetration into the skin, which would imply the directional movement of the molecules on a macroscopic scale. Accordingly, the Board has serious doubts regarding the claimed interaction of the (laser light) energy emitter with the molecules and the claimed result of penetration of the molecules into the skin.

The appellant admitted that there might be a lack of scientific explanation, but stated that nevertheless a "surprising effect" was achievable with the claimed device "without knowing the real phenomena occurring in the skin". The Board accepts that it may not be possible to provide a scientifically sound explanation and that the invention may still be sufficiently disclosed if such an unexpected effect is convincingly demonstrated. However, the original application is devoid of any test results or experimental evidence that could give an indication of light-induced enhancement of penetration of medicament molecules into the skin.

With its letter of 9 February 2015, i.e. after submitting its statement of grounds of appeal, the appellant presented three documents relating to experimental testing in order to demonstrate the effects achievable with the claimed device. All these documents were established well after the priority date of the present application. Even though sufficiency of disclosure must, in principle, be established at the priority date, post-published documents can be used as evidence that the claimed concept can be put in practice ("Case Law of the Boards of Appeal of the EPO", 7**(th) edition (2013), II.C.5.8). Accordingly, the Board decided to consider these documents (in spite of their late filing).

"Group 1)":
The penultimate paragraph of page 2 of this document refers to a technique "called Cryo Laser Phoresis (CLP) ... developed by CIRCE. Srl, Italy", i.e. the present appellant. It is further stated that it "consists in a device that emits radiation on the polar or apolar molecules of an active ingredient [...]" without, however, indicating any further details about this device. The cited reference at the end of this paragraph does not reveal anything in this regard either. Section 3 ("Materials and Methods") at pages 3 to 4 mentions a "cryoapplicator", a frozen gel and a laser, again without indicating any further details. Accordingly, in the absence of a description of further details about the features of the device used in this document, it cannot be established that the results described therein can be attributed to the device as claimed.

"Group 2)":
This is a colour copy of a piece of evidence already submitted in the first instance examination proceedings and dealt with in point 4.1 of the Reasons of the impugned decision. It refers to "the Cryopass Therapy Method" performed with a "gel in the LASERICEMED tube", the gel comprising 50mg/ml of porcine ganglioside GM1. Since further details of the device are not revealed, it again cannot be established that the results described in this document can be attributed to the device as claimed. Even if this were to be the case, the three test groups defined in the first paragraph of page 2 of this document are not suitable as proof that laser radiation has contributed to the active delivery of the medicine (which would have required a comparison of the application of the medicine in a test group with laser radiation and another one without, as correctly observed in the impugned decision).

"Group 3)":
This document comprises more than 100 pages and appears to be a manuscript of a doctoral thesis about melatonin (MLT).

The apparatus ("Lasericemed-cryoRx") depicted in Figure 14 at page 50 looks similar to that of the "medical machine" shown Figure 1 of the present patent application, but the photograph fails to reveal any details about the claimed apparatus (corresponding to what is shown in Figures 2A and 2B of the application). Paragraph 3 of page 51 mentions a low power laser "(source 635 nm, power 50 mW, laser safety class 3R)", apparently forming part of a "the cryo-applicator". In this context it is mentioned that skin lesions are avoided due to the laser, an effect unrelated to what is stated in the present application. The following paragraph merely mentions that "active principles" penetrated into certain tissues in 15-20 min, "with a maximum observed in the genital muscle of 6 cm (± 4 mm) (n=6 patients)" including a reference to "Criopass terapia" and the appellant's and the inventor's names, dated 8 June 2012. No further information is revealed in this passage with respect to the claimed device and effect.

In the cited passage at pages 66 and 67 it is stated that 15 ml of a suspension comprising a certain amount of melatonin were transferred into the cryo-applicator, frozen to -20°C, and the frozen stick connected to "a laser source", which gave the energy to penetrate the cutaneous barrier and deliver the active principle to the target area, was rubbed on the back of an animal, where tumors were xenografted, for 2.5 min. Due to the use of the indefinite article "a", it remains unclear whether the laser previously mentioned in the passage of pages 50 and 51 was used.

The results on tumour growth presented in the cited passage at pages 80 to 84 relate to a comparison of an untreated control group ("Ctrl") with a group "treated with laser alone" and a group "treated with topical MLT", apparently also termed as "transdermal MLT by cryolaser". Again these results are not adequate to prove that laser radiation has contributed to the active delivery of melatonin (which would have required a comparison of the application of medicine in a test group with laser radiation and another one without, as mentioned above).

Finally, the lower half of page 97 refers to a "novel and patented technique named cryoRx" (without, however, indicating any patent number). A meaningful comparison of results relating to the claimed effect is again missing. Instead, an increase in the systemic circulation is mentioned.

Accordingly, the results presented in this document do not demonstrate the claimed effect and it is not even certain that these results can be attributed to the device as claimed.

It follows that none of the three documents presented by the appellant demonstrate that the claimed device was able to achieve the alleged surprising effect of penetration into the skin achieved by laser irradiation active on the molecules of a medicament.

In the absence of a plausible explanation of the claimed effect and without any test results or experimental evidence demonstrating that this effect is achievable with the claimed device, the Board must conclude that the claimed invention is not disclosed in a manner sufficiently clear for it to be carried out by the person skilled in the art, in breach of Article 83 EPC.

Order
For these reasons it is decided that:
The appeal is dismissed.

This decision has European Case Law Identifier: ECLI:EP:BA:2015:T116411.20150218. The whole decision can be found here (pdf). The file wrapper can be found here. Photo "Meow Wars" by Kevin Dooley obtained via Flickr under CC BY 2.0 license (no changes made).