Hester v. Allgeier

646 F.2d 513, 209 U.S.P.Q. (BNA) 370, 1981 CCPA LEXIS 236
Court of Customs and Patent Appeals·Decided March 19, 1981·No. Appeal No. 80-535·Published·Cited by 3 cases

Opinions

MILLER, Judge.

This is an appeal from the decision of the Patent and Trademark Office (“PTO”) Board of Patent Interferences (“board”) which awarded priority of count 2 to senior party Allgeier et al. (“Allgeier”). We vacate and remand.

BACKGROUND

Count 1

The applications in interference1 relate to central nervous system tranquilizers in a class known as triazolo benzodiazepines (“triazolos”). The generic triazolo known in the prior art is represented by the structural formula shown below:

H3C-C1 N

[514] The interference was declared on only count l,2 drawn to a triazolo genus. The compounds of genus count 1 differ from the prior art triazolos only in the attachment of hydroxymethyl-, alkoxymethyl-, or alkonoyloxymethyl- instead of methyl- at the 1-po-sition on the triazolo ring. Priority on count 1 was eventually awarded by the board to Hester based on his reduction to practice of ethoxymethyltriazolo (“ether”),3 an ether compound of genus count 1, prior to the effective filing date of Allgeier. All-Se^er does not appeal this award of priority,

Count 2&emdash;Primary Examiner’s Sua Sponte Motion On June

On June 19, 1975, during the motion period, Allgeier moved to substitute two sub- genus counts for count 1.4 In support of R3 R4 [515] the motion to substitute, Allgeier filed a declaration by Alexandra Delini-Stula, physician and pharmacologist, a citizen of Yugoslavia and resident of Switzerland, which compared the anticonvulsive action of three compounds:

I. 6-Phenyl-8-chloro-4H-s-triazolo [4,3-a][l,4] benzodiazepine-1-methanol described in [Allgeier’s] US Patent Application Serial No. 199,770
II. 1-(Methoxymethyl)-phenyl-8-chloro4H-s-triazolo [4,3-a][l,4] benzodiazepine
III. 1-(Ethoxymethyl)-6-phenyl-8-chloro4H-s-triazolo [4,3-a][1,4] benzodiazepine described in [Hester’s] US Patent Application Serial No. 138,276

Three anticonvulsive tests were described in the declaration as follows:

a) Anticonvulsive action.
Pentetrazole convulsion test on the mouse
The test substance is administered orally in increasing doses to male white mice weighing 17-25 g. Ten Animals are used for each dose of test substance. Sixty minutes after administration of the test substance, 80 mg/kg of 0.8% solution of pentetrazole is injected intraperitoneally. An assessment by observation is made of the occurrence of clonic and tonic convulsions, as well as of a Straub’s tail position. The observation time extends over two hours after administration of the pentetrazole.
The dose of the test substance is determined in mg per kg which, in the case of 50% of the animals, inhibits the clonic seizures produced by the intraperitoneal injection of 80 mg/kg of pentetrazole.
b) Anticonvulsive action
Strychnine survival rest [sic] on the mouse
The anticonvulsive action is determined in white mice weighing 17-25 g. The test substance is administered to the animals per os in different increasing doses. After 60 minutes, 2,5 mg/kg of strychnine is administered intraperitoneally in the form of a 0,025% aqueous solution of strychnine nitrate.
The dose of the test substance in mg per kg body weight is determined whith [sic] which 50% of the animals survive the time of 10 minutes (DE50). The time is arbitrarily chosen but it is an invariable feature of the test method,
c) Anticonvulsive action,
Electro shock test on the mouse
The substance to be tested is administered per os in different increasing doses to male albino mice weighing 18 to 22 g. Ten mice are used per dosis. 60 minutes after administration of the test substance, the mice are shocked by an alternating current of 50 Hz, 16 mA during 0.2 seconds through electrodes placed on the corneae. This treatment provokes a tonic extension cramp of the hind legs which is estimated as being significant if it lasts longer than 4 seconds.
The dose of the test substance is determined in mg per kg bodyweight which, in the case of 50% of the animals, inhibits the tonic extension cramp.

The test results were set forth in tabular form:

1) Results with 3 doses:
0,5 mg/kg 0% inhibition
2.0 mg/kg 50% inhibition
5.0 mg/kg 100% inhibition
2) The following results of the 4 tests series do not enable the determination of the DE5o to be made:
10 mg/kg 30% survivals
100 mg/kg 90% survivals
200 mg/kg 30% survivals
200 mg/kg 40% survivals
3) with 25 mg/kg 40% inhibition.

[516] The conclusion reached was:

Substance I, 6-phenyl-8-chloro-4H-s-triazolo[4,3-a][l,4]benzodiazepine-l-methanol containing a free hydroxy group, shows higher activity than the corresponding low alkyl ethers, compounds II and III in all three tests which provide conclusive evidence of anticonvulsive properties. In two of the three tests the activity of compound I is at least ten times higher than that of compounds II and III.

After consideration of Hester’s opposition to Allgeier’s motion to substitute counts and Allgeier’s reply to Hester’s opposition, the primary examiner, ip a decision dated February 5, 1976, denied" Allgeier’s motion. He noted that “Allgeier has failed to comply with the requirements of 37 C.F.R. 1.231(a)(2) 5 that he demonstrate the patentability of the counts to all parties and apply the counts to all involved applications.” He went on to say:

The Delini-Stula declaration does not establish that all of the alcohol compounds of Proposed Count A are patentably distinct from the remaining members of the present count or Proposed Count B, although it does indicate that the single specific compound discussed therein is patentably distinct from the genus of the present count. Compare In re Wetterau, 356 F.2d 556; 148 USPQ 499.

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Hester v. Allgeier, 646 F.2d 513, 209 U.S.P.Q. (BNA) 370, 1981 CCPA LEXIS 236 (ccpa 1981).

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