The application as filed contained the following claims:
1. A method for treating acute myelogenous leukemia in a human comprising administering to a human with acute myelogenous leukemia a therapeutically effective amount of arsenic trioxide.
2. A method for treating chronic myelogenous leukemia in a human comprising administering to a human with chronic myelogenous leukemia a therapeutically effective amount of arsenic trioxide.
3. A method for treating solid cancer in a human comprising administering to a human with a solid cancer a therapeutically effective amount of arsenic trioxide.
4. The method of claim 3 in which the solid cancer is cancer of the digestive tract, soft tissues, oesophagus, liver, stomach, colon, lung, skin, brain, bone, breast, or prostate gland.
5. A method for treating leukemia resistant to treatment with retinoids in a human comprising administering to a human in need thereof a therapeutically effective amount of arsenic trioxide or melarsoprol.
6. A method for treating leukemia, lymphoma, or solid tumors in a human, comprising administering to a human in need thereof a therapeutically effective amount of melarsoprol.
7. The method of claim 1, 2, 3, 4, or 5, wherein about 2.5 to 4.5 mg of arsenic trioxide is administered per day .
8. The method of claim 1, 2, 3, 4, or 5, wherein about 0.15 mg of arsenic trioxide per kg body weight of the human is administered per day. […]
Claim 1 of the main request before the Examining Division read as follows:
The use of arsenic trioxide for manufacturing a medicament for the treatment of acute myelogenous leukaemia by administering to a human a therapeutically effective amount of about 0.15 mg of arsenic trioxide per kg body weight of the human per day.
This claim was rejected for lack of novelty. The applicant filed an appeal and presented a new main request claim 1 of which read:
Arsenic trioxide for use in a method of treating acute myelogenous leukaemia in a human, wherein said treatment comprises administering about 0.15 mg of arsenic per kg per day to said human.
The Board finds this claim unallowable under A 123(2), for the following reasons:
Claims as originally filed as a source of original disclosure
[3.1.1] Claims 1 to 5 as originally filed relate to four different diseases to be treated by means of arsenic trioxide since claims 2 to 5 after claim 1 do not concern particular embodiments of the subject-matter of claim 1 but independent alternatives having equal weights without any preference, namely
− acute myelogenous leukaemia (claim 1)
− chronic myelogenous leukaemia (claim 2)
− solid cancer (claim 3)
− leukaemia resistant to treatment with retinoids (claim 5).
In addition, also claims 7 and 8 - both claims referring to claims 1,2,3,4, or 5 in unison - concern two independent alternatives, namely
− administration of about 2.5 to 4.5 mg of arsenic trioxide per day (claim 7) and
− administration of about 0.15 mg of arsenic trioxide per kg body weight of the human per day (claim 8).
[3.1.2] Claim 1 of the main request essentially relates to
− arsenic trioxide
− for treating acute myelogenous leukaemia by way of
− administering about 0.15 mg … per kg per day to said human.
[3.1.3] Nothing in the wording of the claims as originally filed links the regimen “administering about 0.15 mg … per kg per day” (original claim 8) specifically to the disease “acute myelogenous leukaemia” (original claim 1). Accordingly, the teaching of claim 1 of the main request cannot be regarded as individualised in the set of claims as originally filed.
The description as originally filed per se
or in context with the claims
as the source of the original disclosure
[3.2.1] There is no teaching in the description as originally filed that “acute myelogenous leukaemia” was the preferred disease or the preferred leukaemia to be treated.
[3.2.2] On page 20, lines 14 to 20 of the application as originally filed, the following statement can be found:
“An exemplary course of treatment of a patient with leukemia, lymphoma, or solid cancer can involve daily administration by intravenous infusion of arsenic trioxide in an aqueous solution …. Preferably, about 0.15 mg arsenic trioxide per kg body weight per day is used.”
This means at the utmost a clear and unambiguous disclosure that
− either leukaemia
− or lymphoma
− or solid cancer is to be treated by way of a dose regimen of
− 0.15 mg arsenic trioxide per kg body weight per day.
But the teaching that this dose regimen is linked to “acute myelogenous leukaemia” is missing and cannot be derived from claim 1 as originally filed either because that claim itself only represents one of four alternatives without any preference.
[3.2.3] Thus, there is no suggestion anywhere in the application as originally filed that the regimen “administering about 0.15 mg … per kg per day” relates specifically to the disease “acute myelogenous leukaemia”.
As a consequence, the teaching of claim 1 of the main request is not individualised in the application as originally filed and represents an unallowable extension of its content (A 123(2)).
In my opinion this decision went well “over the top.” The Board appears to suggest that by limiting the application to a combination of claims 1 and 8 as filed, the applicant has unduly singled out one of the treatments proposed in the application. I have some understanding for prohibiting singling out of alternatives within a claim, but to extend this prohibition to the application as a whole is simply “too much”.
To download the whole decision, you may click here.
NB: Laurent Teyssèdre was probably the first to report this decision; you can find his post here.
1 comments:
I wonder if the presence of claim 7 is relevant here. One could maybe see the amended claim as a selection from two lists, the first list being claims 1, 2, 3, 4, 5 and the second list being claims 7, 8... Not that I find this very convincing, though.
If this decision is followed, it will become very hard to add more than one feature to an independent originally filed claim, even if the dependent claims are drafted as "method according to any one of the previous claims, further comprising ...".
The reason for being strict about Art. 123(2) is obviously that it should be prevented that an applicant obtains a patent for something that he only invented after filing the application, e.g. by patching together a suitable combination of features disclosed throughout the application as filed that might be said to solve some problem over the cited prior art even though the inventors never considered that problem.
Instead of being extremely strict on Art. 123(2) it might make more sense for the Boards to put greater emphasis on the requirement that the technical effect of a feature combination that the applicant relies on for inventive step should be derivable from the application as filed. Decisions like this one might simply prompt applicants to apply some kind of automatic claim expansion macro to their application and fill hundreds of pages of description with arbitrary feature combinations, one of which might turn out to be the perfect combination for a new independent claim. That would completely defeat the purpose of the strict application of Art. 123(2). Such a circumvention is not possible if the Boards instead strictly require that any technical effect relied upon is derivable from the application as filed (and otherwise conclude that the claim is a mere aggregation of individually obvious features).
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