[8] 35 USC § 101.

[9] 35 USC § 100. Despite the reference to new uses in this definition, the USPTO will normally reject a claim in the form "use of X to do Y" as being directed to non-statutory subject matter citing Ex parte Dunki, 153 USPQ 678 (Bd of Apps. 1967).

[10] 447 U.S. 303, 206 USPQ 193 (1980).

[11] Mauer v. Dickerson, 113 F.2d 870 (3d Cir.) "the claim is not restricted to the product made by the described process, but covers the chemical individual, however produced."

[12] See, for example, In re Bergstrom and Sjovall, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970) and Parke Davis v. H. K. Mulford, 189 F 95 (S.D.N.Y. 1911) aff'd 196 F 496 (2d Cir. 1912). In the Parke Davis case, the claim was to [adrenaline] in a stable and concentrate form and practically free from inert and associated gland tissue. It was argued that this was simply a purified product and so was not patentable since no change had been effected in the material. The court disagreed:

[13] The USPTO’s view on the patentability of, for example, genes isolated from their natural environment is found for example in Comments 1 and 2 on the 2001 Utility Guidelines set out at Fed. Reg. 66 1092 (January 5, 2001).

[14] There was some question as to the propriety of medical method patents at one time. In the early 1900's two bills were introduced into Congress to ban the grant of patents for medical methods. However neither was enacted. The grant of such patents was uncommon before a USPTO Board of Appeals decision in 1954 in Ex parte Scherer, 103 USPQ 107. In 1996 Congress took steps to limit the rights of owners of certain types of patents relating to surgical uses of unpatented instruments. This change is discussed in Section 8.4.2 of this paper.

[15] Pioneer Hi-Bred International Inc. v. J.E.M. Ag Supply Inc., 53 USPQ2d 1440 (Fed. Cir. 2000), affirmed by the Supreme court in a 6-2 decision December 10, 2001. See also Ex parte Hibberd, 227 USPQ 443 (Bd of Apps. 1985).

[16] 18 USPQ2d 1677.

[17] The patenting of research tools remains controversial as is the patenting of products obtained by use of such tools by use of so-called “reach-through claims”. The National Institute of Health has adopted a position that the grant of such claims may have the effect of inhibiting rather than promoting research since the users of such tools may be placed in a position in which they have to pay royalty fees to several different patent owners for the same new product resulting from their research using multiple research tools. At present, however, as long as the normal requirements for patentability are met such inventions are patentable.

[18] See for example claim 1 of U.S. Patent 6,178,384, claim 1 of U.S. Patent 5,699,268 and claim 1 of U.S. Patent 5,684,711, all of which are set out in the appendix to this paper.

[19] See, for example U.S. Patents 6,078,360 (claim 5), 6,076,092 (claim 35) and 5,995,921 (claims 20 - 29).