Assuring Quality U.S. Patents: Patent Owners’ Perspective Part 1 of a 3 Part Series

Finnegan’s Prosecution First blog embarks on a three-part series that outlines considerations from a patent owners’ perspective for assuring quality patents. This series of blog posts addresses the interaction between attorney and inventor on quality and preparing a quality patent (Part 1), satisfying Section 112 (Part 2), and considerations for quality patent drafting to avoid inequitable conduct or unclean hand implications (Part 3). 

PART 1:  Interaction Between Attorney and Inventor on Quality and Preparing a Quality Patent

I. Interaction Between Patent Attorney and Inventor on Quality

A. Understand full scope of invention
B. Understand differences between invention and prior art
C. Explore alternatives for each element
D. Disclose all known and possible embodiments
E. Details needed to fulfill enablement, written description and best mode requirements
F. Discuss invention story

1. Unpredictability in art may be helpful; OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)
2. Balance arguments in favor of nonobviousness with satisfaction of written description and enablement requirements

II. Preparing a Quality Patent

A. Eliminate potential issues around subject matter eligibility

1. 35 U.S.C. § 101
2. Mayo/Alice Test
3. 2019 USPTO Guidance Revision to Step 2A
   

B. Specification

1. Important because disclosure may drive claim construction

a. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc)
b. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996)
c. Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244 (Fed. Cir. 2008)
d. Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328 (Fed. Cir. 2000)
e. Allen Engineering Corp. v. Bartell Indus., 299 F.3d 1336 (Fed. Cir. 2002)

2. Focus on objective of literal infringement (by single actor)

a. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003)
b. Osram GmbH v. ITC, 505 F.3d 1351 (Fed. Cir. 2007)
c. Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018)

3. Specification acts as a dictionary for the claim terminology

a) If broad meaning for a term intended, set forth a broad definition in the specification.
b) Alternatively, consider embodiments with narrower definitions; maybe patent profanity, mentioned below, could assist in construing alternative claims more narrowly.
c) Consider crafting definitions to address concerns about related prior art, but live by the sword, die by the sword; are the definitions broad enough; too broad?
d) Clearly define any intended special meaning.

(1) Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012)
(2) AIA Engineering Ltd. v. Magotteaux Intern. S/A, 657 F.3d 1264 (Fed. Cir. 2011)

e) Use specification to eliminate uncertainty.

(1) Athletic Alternatives, Inc. v. Prince Manufacturing, Inc. (Fed. Cir. 1996): when there is an equal choice between a broad and a narrow meaning of a claim, the public notice function is better served by interpreting the claim more narrowly.
(2) ACS, Inc. v. Medtronic, Inc. (Fed. Cir. 2001)
(3) SciMed Life Systems, Inc. v. ACS, Inc. (Fed. Cir. 2001)

f) Define and consistently use terms.

(1) Union Pacific Resources Co. v. Chesapeake Energy Corp., 236 F.3d 684 (Fed. Cir. 2001)
(2) Aqua-Aerobic Systems, Inc. v. Aerators Inc., 211 F.3d 1241 (Fed. Cir. 2000)
(3) Ortho-McNeil v. Caraco, 476 F.3d 1321(Fed. Cir. 2007)
(4) In re Abbott Diabetes Care Inc., 696 F.3d 1142 (Fed. Cir. 2012)

g) Patent profanity for some embodiments, none for others

(1) Inpro II Licensing, S.A.R.L. v. T-Mobile USA, Inc., 450 F.3d 1350 (Fed. Cir. 2006)
(2) Bayer AG v. Elan Pharmaceuticals Research Corp., 212 F.3d 1241 (Fed. Cir. 2000)
(3) Pharmacia & Upjohn Co. v. Mylan Pharmaceuticals, Inc., 170 F.3d 1373 (Fed. Cir. 1999)
(4) Atofina v. Great Lakes Chemical Corp., 441 F.3d 991 (Fed. Cir. 2006)
(5) C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858 (Fed. Cir. 2004)
(6) Forest Laboratories, LLC v. Sigmapharm Laboratories, LLC, 918 F.3d 928 (Fed. Cir. 2019)

h) Relevant prior art cited and addressed

i) Multiple embodiments providing §112 support for broad claims

(1) Drawings
(2) Actual and hypothetical examples

(a) A cautionary tale: Hoffmann-LaRoche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003)

(3) Possession and enablement
(4) MSM Investments Co., LLC v. Carolwood Corp., 259 F.3d 1335 (Fed. Cir. 2001)

j) Numerical ranges

(1) Broad - middle - narrow
(2) Alternative functional definition
(3) Use of “about”

k) Guard against admissions of prior art

(1) In re Nomiya, 509 F.2d 566 (CCPA 1975)

l) Claim subject matter disclosed to avoid disclosure-dedication rule

(1) Johnson & Johnston Assocs., Inc. v. R.E. Serv. Co., 285 F.3d 1046 (Fed. Cir. 2002)
(2) PSC Computer Products Inc. v. Foxconn Int’l Inc., 355 F.3d 1353 (Fed. Cir. 2004)
(3) Amgen, Inc. v. Coherus Biosciences, Inc., 2018 WL 1517689 (D. Del. Mar. 26, 2018), aff’d on other grounds, 931 F.3d 1154 (Fed. Cir. 2019)
(4) Eagle Pharm., Inc. v. Slayback Pharma LLC, 958 F.3d 1171 (Fed. Cir. 2020)

m) Incorporation by reference

(1) Chain of priority

(a) Droplets, Inc. v. E*Trade Bank, 887 F.3d 1309 (Fed. Cir. 2018)
(b) Medtronic Corevalve, LLC v. Edwards Lifesciences Corp., 741 F.3d 1359 (Fed. Cir. 2014)
(c) ButamaxTM Advanced Biofuels LLC v. Gevo, Inc., IPR2013-00539
(d) Baxter Healthcare Corp. v. Millenium Biologix, LLC, IPR2013-00591, Paper 8 (P.T.A.B. March 21, 2014) and IPR2013-00583, Paper 9 (P.T.A.B. March 21, 2014).
(e) Mylan Pharms. Inc. v. Yeda Research & Development Co. Ltd., 2016-00010, Paper 9 (P.T.A.B. Aug. 16, 2016).
(f) Aradigm Corp. v. Insmed Inc., PGR2017-00021, Paper 10 (P.T.A.B. Nov. 15, 2017).

(2) Unwanted disclosure

(a) Zenon Environmental, Inc. v. U.S. Filter Corp., 506 F.3d 1370 (Fed. Cir. 2007)
(b) Cisco Sys., Inc. v. C-Cation Techs., LLC, IPR2014-00454, Paper 12 (P.T.A.B. Aug. 29, 2014) (“informative”)
(c) Harari v. Hollmer, 602 F.3d 1348 (Fed. Cir. 2010) and Harari v. Lee, 656 F.3d 1331 (Fed. Cir. 2011)

n) Be diligent about trying to draft the patent so that the claim terms will be construed as desired, whether broadly or narrowly.

o) Guard against “clear disavowal”

(1) Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367 (Fed. Cir. 2014)
(2) Tanabe Seiyaku Co., Ltd. v. U.S. ITC, 109 F.3d 726 (Fed. Cir. 1997)
(3) Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d 1420 (Fed. Cir. 1997)
(4) Kinik Co. v. ITC, 362 F.3d 1359 (Fed. Cir. 2004)
(5) Alza v. Mylan, 391 F.3d 1365 (Fed. Cir. 2004)
(6) Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharms. Ltd., 887 F.3d 1153 (Fed. Cir. 2018)
(7) Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)
(8) “claims are construed in light of the specification and are not limited to a designated ‘preferred embodiment’," the practitioner should be cautioned, “unless that embodiment is in fact the entire invention presented.”

(a) (Vulcan Eng'g Co. v. Fata Aluminum, Inc. (Fed. Cir. 2002)

(9) “[A] court may not read into a claim a limitation from a preferred embodiment, if that limitation is not present in the claim itself.”

(a) Bayer AG v. Biovail Corp., 279 F.3d 1340, 1348 (Fed. Cir. 2002)

(10) "When the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment."

(a) SciMed Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d 1337 (Fed. Cir. 2001)
(b) Honeywell Int’l, Inc. v. ITT Industrials, Inc., 452 F.3d 1312 (Fed. Cir. 2006)
(c) Techtronic Indus. Co. v. ITC, 944 F.3d 901 (Fed. Cir. 2019)

C. Claims

1. Consider claim variety

a) Compound
b) Composition/formulation
c) Product-by-process
d) Method of making
e) Method of using
f) Method of treatment
g) Means-plus-function

2. Draft complete, self-contained claims that fully define the intended invention in the body of the claim, but be prepared to have preamble construed as limitation, so avoid preamble language unless you desire to rely on it.

a) MBO Laboratories, Inc. v. Becton, Dickinson & Co., 474 F.3d 1323 (Fed. Cir. 2007).
b) Kropa v. Robie, 187 F.2d 150, 152 (CCPA 1951).
c) Marrin v. Griffin, 599 F.3d 1290 (Fed. Cir. 2010).

3. Use transition terms deliberately (comprising, consisting of, consisting essentially of)

4. Watch ordinary words and relative terms – try to avoid ambiguity.

a) “to”

(1) Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371 (Fed. Cir. 2004)

b) “at least one”

(1) Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870 (Fed. Cir. 2004)

c) “and/or”

d) “about”

(1) Jeneric/Pentron, Inc. v. Dillon Co., Inc., 205 F.3d 1377 (Fed. Cir. 2000)

(2) Cohesive Technologies, Inc. v. Waters Corp., 543 F.3d 1351 (Fed. Cir. 2008)

(3) Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014)

e) “very high”

(1) ArcelorMittal France v. AK Steel Corp., 700 F.3d 1314 (Fed. Cir. 2012)

f) “essentially free”

(1) Sunovion Pharmaceuticals, Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271(Fed. Cir. 2013)

5. Watch for ambiguity from functional language

a) Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244 (Fed. Cir. 2008)

6. Be cautious about leaving information out of the specification.

7. Test by analyzing “design around” possibilities from viewpoint of infringer.

8. Determine necessity of each term.

9. Make sure that each independent claim recites clearly ONLY that which is required. 

10. Identify where each term is defined in specification.

11. Identify ambiguity and eliminate it!

12. Ascertain whether an infringer could “misconstrue” the applicant’s intended meaning of any term.

13. Is every term used consistently?

14. The mantra:  Necessary, clearly defined, and consistently used.

D. Prosecution history

1. In claim construction

a) Viskase Corp. v. American National Can Co., (Fed. Cir. 2001)
b) Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995).
c) Spectrum Int'l, Inc. v. Sterilite Corp., 164 F.3d 1372, 1378 (Fed. Cir. 1998) 
d) Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1347 (Fed. Cir. 1998).
e) MBO Laboratories, Inc. v. Becton, Dickinson & Co., 474 F.3d 1323 (Fed. Cir. 2007))
f) Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328 (Fed. Cir. 2000)

In infringement: prosecution history estoppel

a) Amendments

(1) Hughes Aircraft Co. v. U.S., 717 F.2d 1351 (Fed. Cir. 1983)
(2) Pharma Tech Solutions Inc. v. Lifescan Inc., 942 F.3d 1372  (Fed. Cir. 2019)
(3) Intendis v. Glenmark, 822 F.3d 1355 (Fed. Cir. 2016)

b) Arguments

(1) Andersen Corp. v. Fiber Composites LLC, 474 F.3d 1361 (Fed. Cir. 2007)
(2) Amgen v. Coherus Biosciences, 931 F.3d 1154 (Fed. Cir. 2019)
(3) Galderma v. Amneal, 2020 U.S. App. LEXIS 9341 (Fed. Cir. 2020)

c) Festo v. SMC, 493 F.3d 1368 (Fed. Cir. 2007)

(1) Criteria for showing no surrender
(2) Operation of presumptions

(a) Eli Lilly and Co. v. Hospira, Inc., 933 F.3d 1320 (Fed. Cir. 2019)
(b) Ajinomoto Co., Inc. v. ITC, 932 F.3d 1342 (Fed. Cir. 2019)

d) All-limitations rule

(1) Amgen v. Sandoz, 923 F.3d 1023 (Fed. Cir. 2019)