Assuring Quality U.S. Patents: Patent Owners’ Perspective Part 2 of a 3 Part Series

In the second part of this series, Assuring Quality U.S. Patents: Patent Owners’ Perspective, satisfying Section 112 is examined. The first part of the series can be found here. The series will end with considerations for quality patent drafting to avoid inequitable conduct or unclean hand implications (Part 3). 

PART 2:  Satisfying 35 U.S.C. § 112

III.    Satisfying 35 U.S.C. § 112

A. M.P.E.P. §§ 2171-2174

B. Best mode

1. 35 U.S.C. § 282(b): no penalty post-AIA
2. But remains requirement, so disclose
3. Ateliers de la Haute–Garonne v. Broetje Automation USA Inc., 717 F.3d 1351 (Fed. Cir. 2013)

C. Indefiniteness

1. Standard in courts (Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120 (U.S. 2014)
2. Standard in USPTO (In re Packard, 751 F.3d 1307 (Fed. Cir. 2014); Ex parte McAward, Appeal 2015-006416 (P.T.A.B. Aug. 25, 2017), precedential)
3. Consider including definitions in specification!
4. Words of degree in the specification and claims can be risky and require special attention.
5. Try to avoid providing more than one way to measure while simultaneously providing no direction as to which measure to use (Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003)).
6. BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360 (Fed. Cir. 2017)
7. Eli Lilly and Company v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017)
8. Dow Chemical Co. v. Nova Chemicals Corp., 803 F.3d 620 (Fed. Cir. 2015), cert. denied (U.S., May 23, 2016)
9. Presidio Components, Inc. v. American Technical Ceramics Corp., 875 F.3d 1369 (Fed. Cir. 2017)

D. Description

1. Standard in courts (AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014))
2. Standard in USPTO (M.P.E.P. § 2163.02)
3. Ariad Pharmaceuticals v. Eli Lilly, 598 F.3d 1336 (Fed. Cir. 2010) (en banc)
4. University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir.), cert. denied, 125 S.Ct. 629 (U.S. Nov 29, 2004)
5. Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed. Cir. 2011)
6. Amgen Inc. v. Sanofi, 872 F.3d 136(Fed. Cir. 2017)
7. Gen. Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368 (Fed. Cir. 2018)
8. Nuvo Pharm. v. Dr. Reddy's Labs. Inc., 923 F.3d 1368 (Fed. Cir. 2019)

E. Enablement

1. Standard in courts (MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377 (Fed. Cir. 2012))
2. Standard in USPTO (M.P.E.P. § 2164.01; In re Wands, 858 F.2d 731 (Fed. Cir. 1988)
3. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)
4. In re Fisher, 427 F.2d 833 (C.C.P.A. 1970)
5. Enzo LIfe Sciences v. Roche Molecular Sys., 928 F.3d 1340 (Fed. Cir. 2019)
6. Lack of enablement may mean loss of priority date; Storer v. Clark, 860 F.3d 1340 (Fed. Cir. 2017)

F. More than one type of claim may be used in an application

G. No matter what type, the claim should be supported in the specification, self-contained in the body of the claim, and, most importantly, complete (Allen Eng’g v. Bartell Indus. (Fed. Cir. 2002))