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1 Therasense, Inc., et al., Plaintiffs Appellants, v. Becton, Dickinson and Company, et al., Defendants- Appellees. (USPTO) USPTO 1.56 IDS(Information Disclosure Statement ) USPTO 1 CAFC 2 3 CAFC CAFC 2 CAFC 1 Therasense, Inc. v. Becton, Dickinson & Co., 560 F. Supp. 2d 835, 854, 880 (N.D. Cal. 2008). 2 Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1289 (Fed. Cir. 2010) 3 en banc: ( ) 1

2 (1) Therasense( ) U.S. Patent No. 5,820,551 ( 551 ) ( ) ( ) 2

3 1. (2) U.S. Patent No. 4,545,382 ( 382 ) 382 (EP ( EP 636 ) EP636 D A single use disposable electrode strip for attachment to the signal readout circuitry of a sensor to detect a current representative of the concentration of a compound in a drop of a whole blood sample comprising: a) an elongated support having a substantially flat, planar surface, adapted for releasable attachment to said readout circuitry; b) a first conductor extending along said surface and comprising a conductive element for connection to said readout circuitry; c) an active electrode on said strip in electrical contact with said first conductor and positioned to contact said whole blood sample; d) a second conductor extending along said surface comprising a conductive element for connection to said read out circuitry; and e) a reference counterelectrode in electrical contact with said second conductor and positioned to contact said whole blood sample, wherein said active electrode is configured to be exposed to said whole blood sample without an intervening membrane or other whole blood filtering member.... 3

4 D1 EP (Optionally, but preferably) ( ) Pope Sanghera Sanghera (3) 382 EP636 D

5 D1 D1 D1 D1 382 (4) Becton( ) EPO PTO 551 CAFC CAFC CAFC CAFC 5

6 CAFC (intent) materiality 2 5 USPTO 1.56 CAFC CAFC (1) (Unclean Hands) 3 5 Star Scientific Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008) 6

7 Keystone 6 Hazel 7 Precision 8 3 (i)keystone Keystone PTO 2 Byers General Excavator (ii)hazel Hazel Keystone USPTO William Clarke PTO Hazel-Atlas Glass Co. ( Hazel-Atlas ) Clarke Clarke Clarke Clarke 8 6 Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933) 7 Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944), (Standard Oil Co. v. United States, 429 U.S. 17 (1976) 8 Precision Instruments Manufacturing Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806 (1945) 7

8 9 PTO (iii)precision Precision PTO PTO 2 Larson Zimmerman Automotive Zimmerman Larson Automotive Larson PTO Automotive Automotive Larson Zimmerman Larson Automotive Automotive (2) 3 PTO PTO 9 United States v. Hartford-Empire Co., 46 F. Supp. 541 (N.D. Ohio 1942) 8

9 (3) 2 PTO PTO

10 800 PTO PTO the knowing and deliberate standard CAFC PTO 10

11 CAFC But for 1.56 (i)corona 11 But for Corona But for Corona PTO (ii)but for CAFC Corona But for PTO PTO PTO Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U.S. 358, (1928) 11

12 (iii) 1.56 CAFC 1.56 (i) (b) (1) (2) (i) (ii) 56 CAFC (ii) CAFC

13 CAFC 1.56 (i) EPO 551 PTO 1.56 EPO CAFC EPO PTO (ii) EPO (good faith explanation) should have known CAFC CAFC Sanghera Pope EPO PTO EPO CAFC 13

14 USPTO IDS 1.56 PTO [PDF ] (a) 14

15 1.97(b) (d) 1.98 (1) (2) (b) (1) (2) (i) (ii) (c) (1) (2) (3) (d) (e) (b) PCT 15

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