RECENT BIOTECH CASE LAW. Stephen Walsh, Ph.D., J.D. Associate Solicitor Prepared for Biotech/Chem/Pharm Customer Partnership Meeting, November 10, 2005. Today’s topics. WRITTEN DESCRIPTION UTILITY DISCLOSING INFORMATION TO THE PTO OBVIOUSNESS CLAIM CONSTRUCTION. WRITTEN DESCRIPTION.
Stephen Walsh, Ph.D., J.D.
Prepared for Biotech/Chem/Pharm Customer
Partnership Meeting, November 10, 2005
Case law includes several tests for written description, including possession, but two themes are re-emerging in recent decisions.
Is the Federal Circuit’s written description jurisprudence converging?
Variety of ways disclosure could show possession such as:
Inverse correlation between level of skill and knowledge in the art and the amount of description needed – what is already known does not have to be repeated in the specification
Predictability in genus/species cases – representative number inverse function of level of skill and knowledge in the art
(Fed. Cir. 2003)
Claims directed to chimeric genes to be made from known DNA sequences of known function using known procedures
The Board found that “persons having ordinary skill would not have been able to visualize and recognize the identity of the claimed genetic material without considering additional knowledge in the art, performing additional experimentation, and testing to confirm results”
The Court explained:
Loom Co. v. Higgins, 105 U.S. 580, 586 (1881)
The inventor “may begin at the point where his invention begins, and describe what he has made that is new, and what it replaces of the old. That which is common and well known is as if it were written out in the patent and delineated in the drawings.”
In re Lukach, 442 F.2d 967, 968 (CCPA 1971)
“[W]here an applicant claims, as here, a class of compositions, he must describe that class in order to meet the description requirement of the statute.”
Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256 (1928)
“an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions”
Paraphrased claim: A method of selectively inhibiting an enzyme comprising administering a selective inhibitor.
Claim: Dental floss “having a coating of at least one material capable of increasing the coefficient of friction.”
Claim: Isolated DNA encoding TBP-II.
Section 101: “any new and useful . . . .”
“Useful” means that a specific and substantial utility is currently available.
Office may require applicant to submit information reasonably necessary to examine or treat a matter
Rule 105 authorizes PTO to require applicants to provide:
(nickel-base superalloy comprising nickel plus percentages of 12 other elements)
Issue: extent to which specification is used for finding proper scope of claims
Why extrinsic evidence is less reliable than intrinsic evidence:
Problems arise if a dictionary is given more weight than the specification:
Pre-Phillips decision (dictionary meaning + no scope disclaimer) withdrawn !
Post-Phillips decision turns on context of written description and prosecution history