T 0824/12 20-10-2015

Summary of Facts and Submissions

I. This decision concerns the appeal filed by the opponent against the decision of the opposition division to reject the opposition against European patent No. 1 102 549.

II. The patent was granted with twenty claims. Claims 1, 16 and 20 read as follows:

"1. A liquid nutritional product having a pH of from 3.0-4.6 comprising:

a) from 45-95% by weight water;

b) from 1.0-15% by weight of a source of protein;

c) from 0.1-3.3% by weight of a stabilizer system comprising high methoxy pectin in the amount of at least 0.1% by weight of the nutritional product;

d) from 1-30% by weight of a carbohydrate;

e) from 0.5-10% by weight of an edible oil; and

f) at least 800 mg/liter of calcium;

g) at least 40 mg/liter of vitamin C;

h) at least 100 myg/liter of folic acid;

i) at least 2.5 myg/liter of vitamin D;

j) at least 6 mg/liter of vitamin E;

k) at least 30 myg/liter of vitamin K;

said liquid nutritional product prepared by a method including a homogenization step prior to and another one subsequent to an acidification step."

"16. A nutritional product according to claim 1 wherein said pH is 4.0 to 4.4 and said nutritional comprises:

a) from 60-90% by weight water;

b) from 6-8% by weight of a source of protein, wherein said source of protein is a mixture of milk protein isolate and calcium caseinate;

c) from 0.8-2.0% by weight of a stabilizer system comprising high methoxy pectin;

d) from 0.1-1.0% by of a calcium source, wherein said calcium source comprises a mixture of calcium glycerophosphate and calcium citrate;

e) from 0.3-2.0% by weight of a feed grade acid;

f) from 0.1-5.0% by weight soy lecithin;

g) from 0.1-3% by weight of an antioxidant system comprising ascorbyl palmitate, mixed tocopherols and citrate;

h) from 10-25% by weight of a carbohydrate;

i) from 0.5-5% by weight of an edible oil; and

j) vitamins and minerals."

"20. A method for preparing a liquid nutritional composition, said method including the steps of:

a) preparing an oil blend wherein said oil blend comprises an edible oil, an emulsifier, vitamins A, D, E and K, ascorbyl palmitate and mixed tocopherols;

b) preparing a carbohydrate/mineral slurry by mixing high methoxy pectin with water at less than 10% by weight total solids under high shear at a temperature between 65°C and 71°C (150°F-170°F) for at least ten (10) minutes and thereafter adding a source of major minerals, trace/ultra trace minerals and carbohydrates;

c) preparing a protein slurry by combining protein with water, under agitation, to obtain an aqueous mixture of at least 8% by weight solids;

d) combining the protein slurry, carbohydrate/mineral slurry and the oil blend to form a protein/carbohydrate/mineral/oil mixture;

e) homogenizing the protein/carbohydrate/mineral/oil mixture through a homogenizer at a pressure of at least 17 MPa to form a homogenized blend;

f) acidifying the homogenized blend of step (e) with an edible acid to a pH ranging from 3.0-4.6;

g) adding to the homogenized mixture at least one component selected from the group consisting of flavors, colors, vitamins, fruit juice, water, folic acid, cysteine and ascorbic acid;

h) homogenizing the acidified mixture from step (g) by passing the mixture through a homogenizer at a pressure of at least 17 MPa to form an aqueous food solution; and

i) heating said aqueous food solution to a sterilization temperature for a time sufficient to kill or inactivate substantially all microorganisms in said food solution."

III. A notice of opposition was filed requesting revocation of the patent in its entirety under Article 100(a) (lack of novelty and inventive step), Article 100(b) and (c) EPC.

IV. The documents submitted before the opposition division included the following:

D10: US 5 409 725 A;

D11: US 5 614 241 A;

D13: US 5 690 975 A;

D16: EP 0 765 609 A2;

D19: WO 96/29880 A1;

D20: WO 96/25054 A1;

D23: A.C. Spork, Dairy Foods, July 1994, pp 34 and 36; and

D25: B.R. Thakur et al, Critical Reviews in Food Science and Nutrition, 1997,37(1), pp 47-73.

V. The decision of the opposition division rejecting the opposition may be summarised as follows:

The subject-matter of the claims as granted did not extend beyond the content of the application as filed, and the invention was disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Furthermore, novelty of the claimed subject-matter over the cited prior-art documents was acknowledged.

Regarding inventive step, the opposition division considered D10 to represent the closest prior art. It held that the claimed product differed from that of D10 in that it comprised only high methoxy pectin as stabiliser and that a homogenisation step was required prior to acidification. The technical problem underlying the claimed invention was seen in the provision of a storage-stable, retortable mineral and vitamin supplemented liquid formula comprising high methoxy pectin as stabiliser. Example V of the patent showed that the sole use of high methoxy pectin provided superior results. As the solution was not obvious from the prior art, inventive step was acknowledged.

VI. On 26 March 2012 the opponent (in the following the appellant) filed an appeal against the decision of the opposition division. The statement setting out the grounds of appeal was filed on 1 June 2012 and included the following new documents:

D37':Brochure of USAID and DSM entitled "Fortification Basics, Milk" comprising four pages (disclosing on Table 2 "Micronutrient Content of Cow's Whole Milk (3.3% Fat)" from Genesis 6.01, ESHA Research, 1997); and

D38':"High-shear mixer", from Wikipedia, http://en.wikipedia.org/wiki/High-shear_mixer; 11 May 2012.

The appellant requested that the decision under appeal be set aside and that the patent be revoked. The appellant maintained all the objections raised before the opposition division.

VII. By letter dated 17 October 2012, the patent proprietor (in the following the respondent) filed observations on the appeal, including auxiliary request I. The respondent requested that the appeal be dismissed or that the patent be maintained on the basis of the claims of auxiliary request I.

It is noted that the claims of auxiliary request I differed from the claims as granted only in that claims 16-18 as granted had been deleted.

VIII. By letter dated 6 March 2013, the appellant submitted the following new documents and requested that they be admitted into the proceedings:

D37: EP 0 449 354 A1;

D38: WO 97/03574 A1;

D39: EP 0 664 300 A1;

D40: WO 94/14329 A1; and

D41: N. Amice-Quemeneur et al, J Dairy Sci, 1995 (78), pp 2683-2690.

The appellant repeated the previously raised objections. Regarding inventive step, it developed a new line of argumentation, starting from D37 as the closest prior-art document.

These arguments were repeated in the letter dated 21 August 2015.

IX. By letter dated 17 September 2015, the respondent objected to the admission of the late-filed documents into the proceedings.

X. On 20 October 2015, oral proceedings were held before the board. During these proceedings the board decided to admit late-filed document D37. The respondent reacted by filing auxiliary request II, consisting of one claim, namely claim 20 as granted. The appellant stated that he did not object to the admissibility of auxiliary request II.

XI. The arguments put forward by the appellant in its written submissions and at the oral proceedings may be summarised as follows:

- Claim 1 as granted extended beyond the content of the application as filed (Article 100(c) EPC). Firstly, there was no clear and unambiguous teaching in the application as filed that ingredients (g)-(k) as disclosed in table 2 could be combined with ingredients (a)-(e) in claim 1. Secondly, the reference to "vitamins and minerals" in claim 1 as filed was no longer present in claim 1 as granted, which now recited only one mineral, calcium. Lastly there was no basis in the application as filed for the process feature in granted claim 1 in these general terms ("said liquid product prepared by a method including a homogenization step prior to and another one subsequent to an acidification step").

The range of "6-8% by weight of a protein source" in claim 16 as granted was not disclosed in the application as filed in combination with the specific amounts of the vitamins and minerals. In this regard, claim 18 as filed was not a proper basis, because it required for the composition "at least 25% of the RDI for protein".

- The invention disclosed in the patent lacked sufficiency because three out of the four high methoxy pectins of example II were found to be physically unstable. Furthermore, the stable one was only defined by its trade name, and its chemical structure may have changed over time.

- The subject-matter of claim 1 as granted lacked novelty in view of D10, D10/D21, D13 and D16. The subject-matter of claim 20 as granted lacked novelty over at least D10.

- Late-filed documents D37 to D41 should be admitted into the proceedings in view of their prima facie relevance, their submission being early enough to allow them to be considered by the respondent and not to complicate the proceedings.

- The subject-matter of claim 1 as granted lacked inventive step in view of the obvious combination of D37 with D23 or D25, or with one of D38 to D41.

- The subject-matter of claim 1 of auxiliary request II (identical to claim 20 as granted) lacked an inventive step in view of the obvious combination of D37 with D23/25 and D19. The method of claim 20 compared with that of D37 provided an alternative method for the preparation of a liquid nutritional composition. The technical differences over the method of D37 did not provide any technical effect and were either disclosed in D23/D25 (replace pectin by high methoxy pectin) and D19 (use an edible acid in order to reduce pH) or within the capabilities of the skilled person.

- The appellant objected to the description as adapted to auxiliary request II, in particular to paragraph [0001] and any formulation ("example") raising doubts as to whether or not the product would still be understood to be part of the claimed invention, which now related to a method only.

XII. The arguments put forward by the respondent in its written submissions and at the oral proceedings may be summarised as follows:

- The opposition division was correct to conclude that the introduction of ingredients (f)-(k) based on the complete set of lower German RDI values from table 2 was permissible. The claim was merely limited to one of the individual embodiments disclosed in the application as filed. As to the alleged omission of "minerals", it was clear from page 23, lines 20-21, that "Vitamins, minerals and other trace elements could be used to supplement the food composition ...", i.e. they were optional. Regarding the two homogenisation steps, one before and another after acidification, this was also disclosed on page 13, lines 3-5.

As to claim 16 as granted, the amount of protein derived from the disclosure on page 9, line 33. For a nutritional product delivering at least 25% of the RDI for protein (also required in this embodiment), the lower limit must be 6% by weight. The only "selection" that had to be made in arriving at the subject-matter of claim 16 as granted was the selection of the minimum RDI values for Germany, which was entirely permissible.

- The invention of the patent was sufficiently disclosed. The patent set out in detail:

i) suitable components for use in a liquid nutritional composition according to the invention (sections A-J of the description);

ii) suitable high methoxy pectins in section B, such as GENU, JMJ, GEN, JM manufactured by Hercules Food ingredients;

iii) at least one process for producing a liquid nutritional composition according to the invention (paragraphs [0096]-[0104] and example IV); and

iv) liquid nutritional compositions according to the invention (examples IV and IX-XII).

- The subject-matter of claim 1 as granted (identical to claim 1 of auxiliary request I) was novel over D10, D11/D21, D13 and D16.

D10 did not disclose a nutritional composition with a pH of 3.0-4.6, with 0.5-10 wt% of an edible oil (the list of ingredients in the single example of D10 did not contain fat, since skim milk was involved), or with vitamins and minerals at the quantities specified in features (f) to (k) of claim 1 as granted.

D11/D20 concerned powdered food compositions and did not disclose that after water addition the reconstituted liquid nutritional product had the claimed pH or contained a high methoxy pectin (the disclosed pectin-citric was not necessarily a high methoxy pectin), an edible oil, vitamins and calcium in the claimed amounts. Furthermore, D11/D20 did not disclose the homogenisation of the composition.

D13 did not disclose compositions which included an edible oil or the vitamins of features (f)-(k) of claim 1 as granted. Only skim milk powder was involved in the composition, so the list of D37', relating to the whole cow's milk, could not be used to supplement the disclosure of D13. Regarding homogenisation, it occurred only after acid acidification.

D16 did not disclose the vitamins and minerals of features (f)-(k) of claim 1 as granted. If homogenisation had to be used, it should be carried out after acidification.

- The subject-matter of claim 20 as granted (identical to claim 1 of auxiliary request II) was also novel over the stated prior art. The appellant failed to point out a single prior-art document which clearly and unambiguously disclosed steps (a) to (i) of the claim.

- Late-filed documents D37-D41, used against the inventive step, should not be admitted into the proceedings. D37, allegedly being the closest prior art, was not more relevant than D10, considered as such by the opposition division. In fact, D37 did not belong to the technical field of the patent in suit. Regarding the secondary documents D38-D41, they were not more relevant than the secondary documents submitted before the opposition division.

- The subject-matter of claim 1 as granted (identical to claim 1 of auxiliary request I) also involved an inventive step if D37 was taken as the closest prior-art document. D37 did not disclose a high methoxy pectin or the claimed vitamins and mineral in the claimed amounts. Furthermore, D37, in its general disclosure, did not describe an homogenisation step before acidification of the composition. The role of pectin in D37 was to stabilise the composition during the pasteurisation heat-treatment. The technical problem in view of D37 was the provision of a liquid nutritional composition with an extended shelf life and excellent physical stability. This was shown by the examples of the patent. The skilled person starting from D37 would have no reason to replace the pectin of D37 by a high methoxy pectin. The high methoxy pectins disclosed in D23 improved the mouthfeel, viscosity and stability of dairy drinks which were not complete nutritional products. The high methoxy pectins disclosed in D25 were used as gelling agents in the presence of calcium ions. The stability in D23 and D25 concerned stability during pasteurisation in order to avoid micro-organisms' spoilage; it had nothing to do with physical stability over a long shelf life. The arguments of the appellant were based on an ex post facto analysis.

- The subject-matter of claim 1 of auxiliary request II (identical to claim 20 as granted) also involved an inventive step. The combination of the specific method steps provided a physically stable product with a long shelf life which was not disclosed or derivable from the cited prior art.

- The description adapted to auxiliary request II fulfilled the requirements of the EPC. In particular, the contested term "example", which replaced the previous term "embodiment", was used to describe the products derived from the claimed method; it did serve to disclose embodiments of the invention.

XIII. The appellant requested that the decision under appeal be set aside and that the patent be revoked.

XIV. The respondent requested that the appeal be dismissed, or, alternatively, that the patent be maintained on the basis of auxiliary request I submitted with letter dated 17 October 2012, or on the basis of claim 1 of auxiliary request II, including the adapted description pages 2 to 33, as submitted during the oral proceedings of 20 October 2015.