T 1000/12 17-12-2013

Summary of Facts and Submissions

I. European patent application No. 08168252.8, filed on 4 November 2008 in the name of Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory, and claiming priority from CN 200710301265 (18 December 2007), was refused by decision of the examining division which was announced orally on 27 October 2011 and issued in writing on 2 December 2011.

II. In the examination proceedings, the following documents were cited:

D3: |US 6,296,877 B1; and|

D4: |EP 1 460 060 A1. |

III. The decision of the examining division was based on a main and first auxiliary request. Independent claims 1 and 5 of the main request read as follows:

"1. Microcapsules powders or beadlets for supplementing animals with carotenoids, comprising a yellow pigment and a red pigment, wherein: [...]

- said microcapsules powders or beadlets are dispersed in water [...]."

"5. A pigment dispersion containing the microcapsules powders or beadlets according to any one of claims 1 to 4 and water [...]."

Claim 1 of the first auxiliary request read as follows:

"1. Use of water soluble microencapsulated dry powders or beadlets for the coloration of poultry skin, meat or yolk eggs, said water soluble microencapsulated dry powders or beadlets comprising at least one yellow pigment and at least one red pigment, wherein the weight ratio of the yellow pigment to the red pigment is 6:1 to 0.1:1, comprising

- dissolving in water the microencapsulated powders or beadlets, to obtain a yellow and red pigments solution and

- administering the solution of yellow and red pigments to animals by drinking [...]."

IV. In its decision, the examining division essentially held that the main request did not meet the requirements of Articles 56, 84 and 123(2) EPC and Rule 139 EPC.

It also held that the invention defined by the main and first auxiliary requests was insufficiently disclosed. The invention as defined by these requests related to a solution of microencapsulated carotenoids (according to the examining division, the dispersion in claims 1 and 5 of the main request had to be understood as a solution). This solution state could only be achieved with nanoparticles, ie with particles having a diameter lower than 1 micron. However, this was nowhere disclosed in the application as filed. Moreover, the nature of the microcapsules was not disclosed at all. Thus the skilled person was not presented with the information that was required to achieve the solution required by the invention. Since the present application failed to disclose that essential feature, it did not meet the requirements of Article 83 EPC.

The following additional reasoning in relation to Article 83 EPC was presented in an obiter dictum:

According to the present application, the microcapsules provided a higher efficiency than those of the prior art when administered to chickens in the form of a solution in drinking water. Thus, the fact that the microcapsules were solubilised when put into water was an essential feature of the invention. However, for being solubilised, the particles had to be nanoparticles. Therefore, the inventive effect, if any, was linked to a feature that was not disclosed. Also for this reason the present application did not meet the requirements of Article 83 EPC.

V. On 2 February 2012, the applicant (hereinafter "the appellant") filed a notice of appeal against the above decision. The prescribed fee had been paid on 1 February 2012.

VI. The statement setting out the grounds of appeal was filed on 2 April 2012 together with the following attachments:

Attachment 1: |Product information on redivivo**(®)(Lycopene) and OPTISHARP**(®)(ZEAXANTHIN) of DSM;|

Attachment 2: |Experimental report on the solubility of microencapsulated powders and beadlets;|

Attachment 3: |Measurement data on the volume distribution of lutein; |

Attachment 4: |Measurement data on the volume distribution of canthaxanthin; and |

Attachment 5: |CN 101177540 B; |

as well as a main request, claim 1 of which read as follows:

"1. Use of microencapsulated dry powders or beadlets for supplementing poultry with carotenoids by drinking water, comprising the following steps:

(1) making yellow and/or red pigments into microencapsulated dry powders or beadlets; wherein the content of the component of carotenoids in the microencapsulated dry powders or beadlets is 5~25% (w/w);

(2) mixing the aforementioned microencapsulated dry powders or beadlets in a certain proportion and dissolving them in water to prepare for a pigment solution; ...".

VII. By its communication of 6 May 2013, the board issued its preliminary opinion on all relevant issues. Regarding sufficiency of disclosure, it expressed the preliminary opinion that the invention underlying the main request was insufficiently disclosed for the following reasons:

Firstly, it appeared to be an essential feature of the invention as defined by the main request that the microencapsulated dry powders or beadlets contained carotenoids in an amorphous form. The application as filed did however not contain any teaching as to how such powders or beadlets could be obtained. Furthermore, such a teaching seemed not to be part of the skilled person's common general knowledge.

Secondly, claim 1 of the main request contained the step of dissolving microencapsulated dry carotenoid-containing powders or beadlets in water. In order to perform this step, the microencapsulated dry powders or beadlets had to be water-soluble. The present application did not contain any teaching as to how normally non-water-soluble carotenoid powders or beadlets could be made water-soluble. There was furthermore no evidence that such a teaching belonged to the common general knowledge at the priority date of the present application.

Concerning attachment 5, this was a Chinese patent that was published after the priority date of the present application and thus attachment 5 could not constitute any evidence of what was common general knowledge at the priority date of the present patent application. An English language machine translation of attachment 5 was annexed to the board's communication and any reference to this attachment hereinafter will relate to this translation.

VIII. By its letter of 13 November 2013, the appellant filed a new main and an auxiliary request together with the following attachments:

Attachment RF1: |X-ray diffraction pattern of a microencapsulated canthaxanthin; |

Attachment RF2: |Particle size distribution of a microencapsulated powder; |

Attachment RF3: |"Microencapsulation: its application in nutrition", P. M. M. Schrooyen et al, Proceedings of the Nutrition Society, volume 60, 2001 pages 475 to 479; |

Attachment RF4: |PhD thesis "Studies on the preparations and its characterizations of microcapsule powder / beadlets with high content carotenoids", published in August 2007 (in Chinese language);|

Attachment RF4.1: |German translation of chapters 2 and 6 of RF4; and |

Attachment RF5: |Experiments on chickens intake of carotenoids through drinking. |

Claims 1, 5 and 6 of the main request read as follows:

"1. Microencapsulated dry powders or beadlets for supplementing animals with carotenoids by drinking water, wherein:

a) the microencapsulated dry powders or beadlets contain yellow and red pigments;

b) the yellow pigment comprises at least one selected from the group consisting of ß-apo-8'-carotene aldehyde, ß-apo-8’-carotene acetate, lutein and zeaxanthin;

c) the red pigment comprises at least one selected from the group consisting of canthaxanthin, citranaxanthin, and capsanthin

d) the content of the active component of amorphous carotenoids in the microencapsulated dry powders or beadlets is 5~25% (w/w); and

e) the weight ratio of the effective component of the yellow to red pigments mixed is 6:1 to 0.1:1."

"5. A water solution of the microencapsulated dry powders or beadlets according to claims 1-4, wherein the concentration of carotenoids in the pigment solution is 30 mg/kg ~ 400 mg/kg."

"6. A water solution of the microencapsulated dry powders or beadlets according to claims 1-4 for use in treating respiratory diseases of poultry, wherein the concentration of carotenoids in the pigment solution is 30 mg/kg ~ 400 mg/kg."

Claim 1 of the auxiliary request reads as follows:

"1. A water solution of microencapsulated dry powders or beadlets for use in treating respiratory diseases of poultry, wherein the microencapsulated dry powders or beadlets are directly obtained by:

making yellow and red pigments into the microencapsulated dry powders or beadlets; wherein

a) |the yellow pigment comprises at least one selected from the group consisting of ß-apo-8’-carotene aldehyde, ß-apo-8’-carotene acetate, lutein and zeaxanthin;|

b) |the red pigment comprises at least one selected from the group consisting of canthaxanthin, citranaxanthin, and capsanthin |

c) |the content of the active component of amorphous carotenoids in the microencapsulated dry powders or beadlets is 5~25% (w/w); and |

d) |the weight ratio of the effective component of the yellow to red pigments mixed is 6:1 to 0.1:1; |

and making a water solution of the microencapsulated dry powders or beadlets according to step a) to d), wherein the concentration of carotenoids in the pigment solution is 30 mg/kg ~ 400 mg/kg."

IX. On 17 December 2013, oral proceedings were held before the board. The appellant maintained its requests filed with the letter of 13 November 2013.

X. The appellant's position in the written and oral proceedings, in as far as relevant to the present decision, can be summarised as follows:

Water-solubility in terms of the present claims actually meant that the microencapsulated carotenoid particles formed a homogeneous dispersion in water that had the appearance of a solution. Water-solubility and amorphicity of the carotenoids were very important and, to obtain these properties, the diameter of the microencapsulated particles had to be in the range of 150 to 250 nanometers.

According to the application as filed, the carotenoid particles had to be prepared by the microcapsule technique. Even though rather silent about how microencapsulation had to be carried out, the application as filed still provided sufficient information about how to transform non-water soluble crystalline carotenoids into water-soluble and amorphous ones. More specifically, the skilled person simply had to rework example 1 of the application as filed in order to obtain the required water-solubility and amorphicity.

Furthermore, the skilled person would also have been able to obtain water-soluble amorphous carotenoids on the basis of his common general knowledge.

Firstly, as shown by RF3, spray drying was a commonly known method to obtain microencapsulated carotenoids and it was proven by the PhD thesis RF4 and its partial translation RF4.1 that by way of this method, water-soluble amorphous carotenoids were obtained. So all that the skilled person needed to do was to prepare microencapsulated carotenoids by the commonly known spray drying process.

Secondly, RF4.1 itself proved that it was commonly known at the priority date of the present application how the microencapsulation had to be carried out to obtain water-soluble amorphous carotenoids.

Thirdly, D3 disclosed a microencapsulation process that led to water-soluble amorphous carotenoids.

Fourthly, attachment 5 taught the skilled person how to obtain water-soluble amorphous carotenoids. The particles obtained in examples 1 to 5 of this document all had particle diameters in the range of 179 to 298 nm and thus were water-soluble.

Hence the method of preparing the microencapsulated dry powders or beadlets of the present application by the microcapsule technique belonged to the prior art. The skilled person was thus able to perform the invention on the basis of the application as filed and the common general knowledge available at the priority date of the present application.

XI. During the oral proceedings, the board made the following additional observations:

- Attachment 5 did not disclose microencapsulated amorphous carotenoids but it could be assumed that these were crystalline.

- Contrary to the appellant's assertions, not all spray drying methods led to water-soluble amorphous carotenoids. RF4.1 proved that it was necessary to control several parameters during spray drying and thus microencapsulation in order to obtain the required water-solubility and amorphicity.

XII. The appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of the main request, alternatively the auxiliary request, both filed with the letter of 13 November 2013.