Friday, 2 August 2013

Interpretative Spotlight: “Certified”

This is a revocation appeal.

Claim 1 of the main request before Board 3.3.04 read:
1. Use of a cross-linked matrix for promoting meningeal tissue growth to replace a damaged meningeal tissue, said matrix comprising:

certified collagen prepared by a process certified to provide physiologically compatible collagen which is free of effective amounts of active viruses and prions, and

pores having a diameter of 10-500 micrometers that permit growing meningeal tissue to infiltrate said matrix,

said matrix being substantially free of non-collagenous proteins and adapted to contact said damaged meningeal tissue to promote meningeal tissue growth through said matrix, and to be resorbed, wherein said certified process comprises:
  • cleaning extraneous matter from a native source of Type I collagen;
  • washing said cleaned collagen containing material;
  • comminuting said washed collagen containing material;
  • digesting said comminuted collagen containing material with a proteolytic enzyme to substantially remove elastin and non-collagenous impurities which can cause antigenic activity and to swell said collagen;
  • inactivating said proteolytic enzyme;
  • washing said enzymatically digested collagen containing material to substantially remove excess enzyme and non-collagenous protein impurities;
  • alkalinizing said collagen containing material to a pH of about 13 to about 14, at a temperature of about 25ºC to about 30ºC for a period of about 35 to about 48 hours, to substantially remove contaminating glycoproteins and lipids;
  • neutralizing said alkalinized collagen containing material with an acid;
  • washing said neutralized collagen containing material;
  • acidifying said washed and neutralized collagen containing material to a pH of about 2 to about 3 to further swell said material, wherein said acidifying does not employ an acid that causes substantial cross-linking of collagen;
  • homogenizing said acidified collagen containing material;
  • filtering said homogenized collagen containing material to remove unswollen, non-collagenous material from collagen fibers; and
  • collecting said filtered collagen fibers for use in said matrix,
in the manufacture of a medicament for promoting meningeal tissue growth to replace a damaged meningeal tissue. (my emphasis)
The interpretation of the term “certified” was decisive for the outcome of the appeal:

[5] It is not disputed by the [patent proprietor] that the application as filed does not contain the term “certified”, neither to qualify “collagen” nor to qualify a “process of preparation” therefor.

[6] The pivotal question in the present appeal is therefore what the technical information embodied in this feature in the context of claim 1 of both requests is and whether this technical information is clearly and unambiguously derivable from the application as filed, account being taken of matter which is implicit to a skilled person in what is expressly mentioned therein.

[7] The [patent proprietor] has referred to the dictionary definition of “certified” contained in document D27 which states: “certified (...) a. Made certain; assured; certainly informed; attested by certificate; furnished with a certificate. (...)”. The board is satisfied that the above dictionary definition reflects the common understanding of the term “certified” and also reflects the understanding of the person skilled in the relevant technical field.

[8] The [patent proprietor] argued that, in the context of the description of the patent and the invention claimed, the skilled person would understand the term “certified” to have the meaning “assured”.

[9] The board notes that the appropriate reference, in the context of A 123(2), is to the application as filed. The passages referred to in the patent are however identical to the corresponding passages in the application as filed. Therefore, for the sake of the [patent proprietor’s] argument in the present case, the board considers the reference to the patent as equivalent to a reference to the application as filed.

[10] It was argued by the [patent proprietor] that, whereas previously used collagen sponges posed health hazards, the invention ensured the elimination of such health hazards and assured the safety of the product […]. The patent provided a dural graft with suitable safety margin to allow for a mass-marketable product enabling commercial scale use. The patent […] stated that:
“(...) the method for producing the product of the present invention makes use of steps that are recognized as the most effective for inactivating viral and prion contamination. This gives the product a very high safety level while eliminating the inflammatory response. That is, the method for producing the product of the invention provides a product that is substantially free of viruses and prions without being physiologically incompatible” (emphasis added by the board).
The subsequent disclosure […] of the patent provided detailed information on two different processes for obtaining such collagen that was assured to be physiologically compatible and substantially free of viruses and prions. Accordingly, it was clear and unambiguous to the skilled person that following the steps of these methods was an assured way to achieve the desired result of obtaining a very high safety level collagen sponge with respect to physical compatibility and inactivation of viruses and prions without there necessarily being any actual certificate to that effect. The patent did furthermore not disclose an additional limitation requiring that some governing body issue a certificate.

[11] The board agrees with the [patent proprietor] that the methods as disclosed in the application as filed (and the patent) may “assure” the skilled person that the collagen produced conforms certain safety (e.g. substantially free of viruses and prions) and physiological (e.g. free of inflammatory response) criteria […].

However, it has not been contested by the [patent proprietor] that the technical field of pharmaceutical products and their production methods - also in the field of neural surgery - is highly regulated and that these products and methods are subject to a multitude of prescribed “good manufacturing practices” and certification schemes ensuring technical compliance. The board therefore considers that a skilled person when confronted with the feature “certified” in the context of the claimed invention would, rather than interpreting the term in the restrictive manner advocated by the [patent proprietor], also consider the two meanings disclosed in document D27 involving a certificate (“attested by certificate” and “furnished with a certificate”).

[12] It is for the present decision irrelevant what the precise nature of a certification is. However, it is evident, as the respondent has argued that a variety of additional parameters can be considered for certification such as those mentioned in […] the patent, i.e. degree of purity, amount of endotoxins, fat content, hydroxyproline content or ash content or e.g. concerning the nitrogen content, the amide content, the amino acid analysis, the particular amino acid content (such as glycine or hydroxylysine content), the heavy metal content, the source of the collagen, the age of the source, the content of non-collagenous proteins etc.

[13] The board concludes that, in the context of claim 1 and with reference to point 7, above, the feature “certified” conveys in itself technical information to the skilled person, including the reference to a certificate, which goes beyond what results from operating the “recognized” methods referred to in the description and which information is not derivable in a clear and unambiguous manner from the application as filed.

[14] In the present circumstances, the board follows the rationale of decision T 1082/02 [3.8] [sic, this should read T 1018/02] that “[a]lthough a claim must not be interpreted in a way which is illogical or does not make any sense, the description cannot be used to give a different meaning to a claim feature which in itself imparts a clear credible technical teaching to the skilled reader. This also applies if the feature has not been initially disclosed in the form appearing in the claim.”.

[15] Accordingly, the term “certified” introduces into the claims information which the skilled person could not derive directly and unambiguously from the application as filed. Hence, the amendment constitutes added matter (A 123(2) EPC; A 100(c) EPC).

[16] The [patent proprietor] has furthermore argued, with reference to A 69, that a skilled person should try, with synthetical propensity, i.e. “building up rather than tearing down”, to arrive at an interpretation of the claim which was technically sensible and took into account the whole disclosure of the patent (see Case Law of the Boards of Appeal, 6th Edition, Section II.B.5.1). The board agrees that the claims must be interpreted by a “mind willing to understand” and not by “a mind desirous of misunderstanding”. However, this is understood to mean only that technically illogical interpretations should be excluded (see e.g. T 190/99 and T 1408/04). The board furthermore considers that a “mind willing to understand” does not require that a broad term needs to be interpreted more narrowly, but instead that a broad term should be understood to include all technically logical meanings, which for the present case includes those set out in points [12] and [13], above.

[17] In view of the foregoing finding also the [patent proprietor’s] argument that the addition of the term “certified”, as properly construed, did not provide a technical contribution to the invention because it merely referred to a limitation that was otherwise expressly set forth in the claims, i.e. that a process be utilized to ensure physiological compatibility and substantial inactivation of viruses and prions, must fail.

[18] In view of the foregoing considerations the board decided that claim 1 of both the main request and auxiliary request 1 do not comply with the requirements of A 123(2) EPC (A 100(c) EPC).

Should you wish to download the whole decision (T 1582/08), just click here.

The file wrapper can be found here.

Z 3.3.04, Spotlight, Claim Interpretation, A 123(2)