Tafas v. Dudas et al

Filing 246

Memorandum in Opposition re 133 MOTION for Summary Judgment of GlaxoSmithKline filed by Jon Dudas, The United States Patent and Trademark Office. (Attachments: # 1 Exhibit 1 (Excerpts of Administrative Record))(Wetzler, Lauren)

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UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA Alexandria Division TRIANTAFYLLOS TAFAS, Plaintiff, v. JON W. DUDAS, et al., Defendants. ) ) ) ) ) ) ) ) ) )

Civil Action No. 1:07cv846(L) (JCC/TRJ)

CONSOLIDATED WITH SMITHKLINE BEECHAM CORPORATION, et al., Plaintiffs, v. JON W. DUDAS, et al., Defendants. ) ) ) ) ) ) ) ) ) ) )

Civil Action No. 1:07cv1008 (JCC/TRJ)

DEFENDANTS' MEMORANDUM IN OPPOSITION TO GLAXOSMITHKLINE'S MOTION FOR SUMMARY JUDGMENT Of Counsel: JAMES A. TOUPIN General Counsel STEPHEN WALSH Acting Deputy General Counsel and Solicitor WILLIAM COVEY Deputy General Counsel WILLIAM G. JENKS JANET A. GONGOLA NATHAN KELLEY WILLIAM LAMARCA Associate Solicitors JENNIFER M. MCDOWELL Associate Counsel United States Patent and Trademark Office CHUCK ROSENBERG UNITED STATES ATTORNEY LAUREN A. WETZLER RALPH ANDREW PRICE JR. R. JOSEPH SHER Assistant United States Attorneys Attorneys for All Defendants Justin W. Williams U.S. Attorney's Building 2100 Jamieson Avenue Alexandria, Virginia 22314 Tel: [phone] Fax: [phone] [e-mail]

Dockets.Justia.com

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TABLE OF CONTENTS Page TABLE OF AUTHORITIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 RESPONSE TO GSK'S STATEMENTS OF FACTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 I. TH E FINAL RULES ARE CONSISTENT WITH THE PATENT ACT. . . . . . . . . . . . . . . . . 4 A. The USPTO Had Authority to Promulgate Final Rules Governing The Conduct Of Proceedings In The Office and the Rules are Entitled to Chevron Deference. . . . . . . . . . . . . . . . . . . . 4 Final Rule 78 Places Reasonable Conditions on the Filing of Continuing Applications, Consistent with Section 120 of the Patent Act.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Final Rule 114's Reasonable Conditions on Requests for Continued Examinations ("RCEs") Are Consistent With Section 132. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Final Rules 78 and 114 Do Not Create a Mechanical Limit on Continuations and RCEs and Are Reasonable Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Final Rules 75 and 265 Comport With Section 112 In Reasonably Requiring Information From Applicants Who Present Large Numbers of Claims. . . . . . . . . . . . . . . . . . . . . . . . . . 18

B.

C.

D.

E.

II. III.

TH E FINAL RULES ARE NOT ARBITRARY OR CAPRICIOUS. . . . . . . . . . . . . . . . . . . 20 PLA IN T IFFS FAIL TO ESTABLISH THAT THE FINAL RULES ARE RETROACTIVE.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 A. The Final Rules Do Not Impose New Duties on Completed Transactions.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 The Final Rules Do Not Impair Rights a Party Possessed When It Acted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

B.

IV.

GSK'S TAKINGS CLAIM FAILS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 2

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A. B.

The USPTO Adequately Considered the Takings Issue. . . . . . . . . . . . . . 31 The Final Rules Do Not Effect a Taking. . . . . . . . . . . . . . . . . . . . . . . . . . 33 1. 2. Plaintiffs Lack Any Cognizable Property Right.. . . . . . . . . . . . . . 33 The Final Rules Do Not Effect a "Per Se" or Other Regulatory Taking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

V.

PLA IN T IFFS FAIL TO RAISE A COGNIZABLE VOID-FOR-VAGUENESS CHALLENGE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 A. B. The Void-for-Vagueness Doctrine Is Inapplicable. . . . . . . . . . . . . . . . . . 37 The Preexamination Search Requirement of Final Rule 265 Is Not Vague, and Determination of the Question is, in any Event, Premature.. . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 The Office Properly Relied on Guidance Clarifying any Putative Vagueness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

C.

VI.

THE APA'S NOTICE AND COMMENT PROVISIONS ARE INAPPLICABLE, AND, IN ANY EVENT, THE PROPOSED RULES PROVIDED SUFFICIENT NOTICE OF THE 5/25 RULE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 A. The APA's Notice and Comment Provisions Do Not Apply to Procedural Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 The Proposed Rules Provided Sufficient Notice of the "5/25 Rule". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

B.

CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 CERTIFICATE OF SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

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TABLE OF AUTHORITIES Page CASES A.T. Massey Coal Co. v. Holland, 472 F.3d 148 (4th Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Abbott Labs. v. Gardner, 387 U.S. 136 (1967).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15, 40 Adams Fruit Co. v. Barrett, 494 U.S. 638 (1990).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Aeronautical Repair Station Ass'n v. FAA, 494 F.3d 161 (D.C. Cir. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 AK Steel Corp. v. United States, 226 F.3d 1361 (Fed. Cir. 2000). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Am. Coke & Coal Chems. Inst. v. EPA, 452 F.3d 930 (D.C. Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Am. Hosp. Ass'n v. Bowen, 834 F.2d 1037 (D.C. Cir. 1987). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 15 Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Animal Legal Def. Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991)("ALDF"). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 42 Appalachian Power Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Application of Rubinfield, 270 F.2d 391 (C.C.P.A. 1959). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Aronson v. Quick Point, 440 U.S. 257 (1979).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 BASF Wyandotte Corp. v. Costle, 598 F.2d 637 (1st Cir. 1979). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 4

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Batterton v. Marshall, 648 F.2d 694 (D.C. Cir. 1980). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Bowen v. Georgetown University Hospital, 488 U.S. 204 (1988).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Boyden v. Comm'r of Patents, 441 F.2d 1041 (D.C. Cir. 1971). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs. Ltd., 394 F.3d 1348 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Califano v. Sanders, 430 U.S. 99 (1977).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Cathedral Candle Co. v. U.S. Int'l Trade Comm'n, 400 F.3d 1352 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Chadmore Commc'ns v. FCC, 113 F.3d 235 (D.C. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Chevron USA, Inc. v. NRDC, Inc., 467 U.S. 837 (1984).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim Chocolate Manufacturers Ass'n v. Block, 755 F.2d 1098 (4th Cir. 1985). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Cmty. Nutrition Inst. v. Block, 749 F.2d 50 (D.C. Cir. 1984). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Comm. for Fairly Traded Venezuelan Cement v. United States, 372 F.3d 1284 (Fed. Cir. 2004). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Comm'y Tel. of Utah, Inc. v. Wilkinson, 611 F. Supp. 1099 (D.C. Utah 1985). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Community TV, Inc. v. FCC, 216 F.3d 1133 (D.C. Cir. 2000). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Consumers Union of U.S., Inc. v. Fed. Trade Comm'n, 801 F.2d 417 (D.C. Cir. 1986). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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CropLife Am. v. EPA, 329 F.3d 876 (D.C. Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Diamond Roofing Co. v. OSHRC, 528 F.2d 645 (5th Cir. 1976). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Dickinson v. Zurko, 527 U.S. 150 (1999).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7, 8 Digital Equip. Corp. v. Diamond, 653 F.2d 701 (1st Cir. 1981). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 E.E.O.C. v. Seafarers Int'l Union, 394 F.3d 197 (4th Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Eli Lilly & Co. v. Bd. of Regents of Univ. of Washington, 334 F.3d 1264 (Fed. Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Exxon Chem. Patents, Inc. v. Lubrizol Corp., 935 F.2d 1263 (Fed. Cir. 1991). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Fabil Mfg. Co. v. United States, 237 F.3d 1335, 1341 (Fed. Cir. 2001). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 FCC v. Nat'l Citizens Comm'n for Broad., 436 U.S. 775 (1978).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 FCC v. Potsville Broad. Co., 309 U.S. 134 (1940).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Federal Communications Commission v. Schreiber, 381 U.S. 279 (1965).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Fleury v. Clayton, 847 F.2d 1229 (7th Cir. 1988). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Freeman United Coal Mining Co. v. Fed. Mine Safety & Health Rev. Comm'n, 108 F.3d 358 (D.C. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Go Leasing, Inc. v. Nat'l Transp. Safety Bd., 800 F.2d 1514 (9th Cir. 1986). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Gen. Elec. Co. v. EPA, 53 F.3d 1324 (D.C. Cir. 1995). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 6

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Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Grayned v. City of Rockford, 408 U.S. 104 (1972).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38, 39 In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 13 In re Chandler, 319 F.2d 211 (C.C.P.A. 1963). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 In re Clark, 97 F.2d 628 (C.C.P.A. 1938). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 In re Flint, 411 F.2d 1353 (C.C.P.A. 1969). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 In re Henriksen, 399 F.2d 253 (C.C.P.A. 1968). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 12 In re Hogan, 559 F.2d 595 (C.C.P.A. 1977). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 12 In re Makari, 708 F.2d 709 (Fed. Cir. 1983). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 In re Wakefield, 422 F.2d 897 (C.C.P.A. 1970). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 In re Lueders, 111 F.3d 1569 (Fed. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 JEM Broad. Co. v. FCC, 22 F.3d 320 (D.C. Cir. 1994). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 42 Jordan v. De George, 341 U.S. 223 (1951).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Kendall v. Winsor, 62 U.S. 322 (1858).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Khattak v. Ashcroft, 332 F.3d 250 (4th Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 7

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Lacavera v. Dudas, 441 F.3d 1380 (Fed. Cir. 2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 8 Landgraf v. USI Film Products, 511 U.S. 244 (1994).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26, 28, 29, 30 Leatherman v. Tarrant County Narcotics Intel. & Coordination, 507 U.S. 163 (1993).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Lingle v. Chevron U.S.A., Inc., 544 U.S. 528 (2005).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Long Island Care at Home, Ltd. v. Coke, -- U.S. --, 127 S. Ct. 2339 (2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Lucas v. South Carolina Coastal Council, 505 U.S. 1003 (2002).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35, 36 Marsh v. Nichols, Shepherd, & Co., 128 U.S. 605 (1888).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Marsh v. Oregon Natural Res. Council, 490 U.S. 360 (1989).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Merck & Co., Inc. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Mfr. Housing Inst. v. EPA, 467 F.3d 391 (4th Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Motor Vehicle Mfrs. Ass'n of the U.S., Inc. v. State Farm Mutual Auto. Ins. Co., 463 U.S. 29 (1983).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20, 25, 31, 32 Motorola, Inc. v. United States, 436 F.3d 1357 (Fed. Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S. 967 (2005).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 12, 19 Nat'l Indus. Contractors, Inc. v. OSHRC, 583 F.2d 1048 (8th Cir. 1978). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Nathan Katz Realty, LLC v. NLRB, 251 F.3d 981 (D.C. Cir. 2001). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 8

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National Wildlife Federation v. Interstate Commerce Comm'n, 850 F.2d 694 (D.C. Cir. 1988). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32, 33 Natural Res. Def. Council v. SEC, 606 F.2d 1031 (D.C. Cir. 1979). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 New Motor Vehicle Bd. of Ca. v. Orrin W. Fox Co., 439 U.S. 96 (1978).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25, 31, 37 Nyeholt v. Sec'y of Veterans Affairs, 298 F.3d 1350 (Fed. Cir. 2002), cert. denied, 537 U.S. 1109 (2003). . . . . . . . . . . . . . . . 38 Ohio Forestry Ass'n, Inc. v. Sierra Club, 523 U.S. 726 (1998).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15, 40 Olim v. Wakinekona, 461 U.S. 238 (1983).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Omnipoint Corp. v. FCC, 78 F.3d 620 (D.C. Cir. 1996). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Owner-Operator Independent Driver Ass'n, Inc. v. Fed. Motor Carrier Safety Admin., 494 F.3d 188 (D.C. Cir. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22, 25, 26 Paulsen v. Gotbaum, No. 90 CIV. 6252, 1992 WL 8361 (S.D.N.Y. Jan. 15, 1992).. . . . . . . . . . . . . . . . . . . . . . 3 Penn Central Transportation Co. v. City of New York, 438 U.S. 104 (1978).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36, 37 Pension Benefit Guar. Corp. v. LTV Corp., 496 U.S. 633 (1990).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Posely v. Eckerd Corp., 433 F. Supp. 2d 1287 (S.D. Fla. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Prill v. NLRB, 755 F.2d 941 (D.C. Cir. 1985). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Prometheus Radio Project v. F.C.C., 373 F.3d 372 (3d Cir. 2004).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29, 30 Puerto Rico Dep't of Consumer Affairs v. ISLA Petroleum Corp., 485 U.S. 495 (1988).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 9

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Ranger v. Federal Communications Commission, 294 F.2d 240 (D.C. Cir. 1961). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Reg'l Mgmt. Corp. v. Legal Servs. Corp., 186 F.3d 457 (4th Cir.1999). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Ribis v. Mike Barnard Chevrolet-Cadillac, Inc., 468 F. Supp. 2d 489 W.D.N.Y. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25, 31, 37 Ricoh Co. v. Nashua Corp., No. 97-1344, 1999 WL 88969 (Fed. Cir. Feb. 18, 1999). . . . . . . . . . . . . . . . . . . . . . . . . 12 Rodriguez v. Peake, -- F.3d --, 2008 WL 60423 (Fed. Cir. Jan. 7, 2008). . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Ruckelshaus v. Monsanto Co., 467 U.S. 986 (1984).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29, 34, 35 Ryder Truck Lines, Inc. v. Brennan, 497 F.2d 230 (5th Cir. 1974). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 SEC v. Chenery Corp., 318 U.S. 80 (1943).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Skidmore v. Swift & Co., 323 U.S. 134 (1944).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Star Fruits S.N.C. v. United States, 393 F.3d 1277 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Stevens v. Tamai, 366 F.3d 1325 (Fed. Cir. 2004). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Symbol Techs., Inc. v. Lemelson Med. Educ. & Res. Found., L.P., 277 F.3d 1361 (Fed. Cir. 2002)("Symbol II"). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Symbol Technologies, Inc. v. Lemelson Medical, Education & Research Foundation, 422 F.3d 1378 (Fed. Cir. 2005)("Symbol IV"). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Tafas v. Dudas, 511 F. Supp. 2d 652, 660-61 (E.D. Va. 2007) ("Tafas I").. . . . . . . . . . . . . . . . . . . . . . . . . 2 Tafas v. Dudas, -- F. Supp. 2d --, 2008 WL 112043 (E.D. Va. Jan. 9, 2008) ("Tafas II"). . . . . . . . . . . . 20 10

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Tahoe-Sierra Pres. Council, Inc. v. Tahoe Reg'l Planning Agency, 535 U.S. 302 (2002).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35, 36, 37 U.S. Air Tour Ass'n v. Fed. Aviation Admin., 298 F.3d 997 (D.C. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 United States v. Lanier, 520 U.S. 259 (1997).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 United States v. Mead Corp., 533 U.S. 218 (2001).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 5 United States v. Powell, 423 U.S. 87 (1975).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 United States v. Wise, 370 U.S. 405 (1962).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Vill. of Hoffman Estates v. Flipside, Hoffman Estates, Inc., 455 U.S. 489 (1982).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Vt. Yankee Nuclear Power Corp. v. Natural Res. Def. Council, 435 U.S. 519 (1978).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Walker v. Bain, 65 F. Supp. 2d 591 (E.D. Mich. 1999), aff'd in part, vacated & rev'd in part, 257 F.3d 660 (6th Cir. 1999). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Woodbury Patent Planing Mach. Co. v. Keith, 101 U.S. 479 (1879).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 CONSTITUTION U.S. Const., Am. V. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31, 37 STATUTES 5 U.S.C. § 551(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5 U.S.C. § 553. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 25 5 U.S.C. § 553(b)(A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 5 U.S.C. § 553(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 11

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5 U.S.C. §§ 601-612. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 U.S.C. § 701. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 U.S.C. § 704. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 5 U.S.C. § 706. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33, 37 5 U.S.C. § 706(2)(A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20, 21, 25 35 U.S.C. § 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 35 U.S.C. § 2(b)(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 2(b)(2)(A).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 6, 11 35 U.S.C. § 2(b)(2)(B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 35 U.S.C. § 2(b)(2)(C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 35 U.S.C. § 2(b)(2)(D).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 35 U.S.C. § 41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 35 U.S.C. § 41(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 35 U.S.C. § 101. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 42 35 U.S.C. § 102. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 42 35 U.S.C. § 103. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 42 35 U.S.C. § 112. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 19, 30, 42 35 U.S.C. § 120. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 35 U.S.C. § 122(b)(2)(B)(I). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 35 U.S.C. § 132. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 35 U.S.C. § 132(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 35 U.S.C. § 132(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

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35 U.S.C. § 134. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 35 U.S.C. § 154(a)(2).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 35 U.S.C. § 261. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 LEGISLATIVE MATERIALS 145 Cong. Rec. S14,708-26 (1999) (daily ed. Nov. 17, 1999) . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 American Inventors Protection Act of 1990, Pub. L. No. 106-113, § 4405(b)(1), 113 Stat. 1501, 1501A-560 (1999) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 H.R. 1908, 110th Cong. § 14(b) (2007) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 RULES Fed. R. Civ. P. 56(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Local Civil Rule 56(B).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 REGULATIONS 37 C.F.R. § 1.53(b)-(d) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 37 C.F.R. § 1.78(b) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 37 C.F.R. § 1.105 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 37 C.F.R. § 1.183 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 37 C.F.R. § 1.431(b) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 37 C.F.R. § 1.154(b)(6) (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 37 C.F.R. § 10.18(b)(2)(i) (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 37 C.F.R. § 10.18(c) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 37 C.F.R § 10.77(b) (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

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FEDERAL REGISTER Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications; Final Rule, 72 Fed. Reg. 46716 (Aug. 21, 2007).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim

See Changes to Practice for Petitions in Patent Applications To Make Special and for Accelerated Examination, 71 Fed. Reg. 36323-01 (June 26, 2006). . . . . . . . . . . . . . . . . . . . 18, 31 Changes to Provisional Application Practice, 65 Fed. Reg. 50,092 (Aug. 16, 2000). . . . . . . . . . 15 Changes to Practice for the Examination of Claims in Patent Applications, 71 Fed. Reg. 61 (Jan. 3, 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Changes to Implement the Patent Business Goals, 63 Fed. Reg. 53497 (Oct. 5, 1998). . . . . . . . 43 MANUAL OF PATENT EXAMINATION PROCEDURE MPEP § 714 (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 MPEP § 1201. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 MISCELLANEOUS Kimberly A. Moore, Worthless Patents, 20 BERKELEY TECH. L. J. 1521, 1537-38 (Fall 2005)... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Thomas Schneck, The Duty to Search, 87 J. PAT. & TRADEMARK OFF. SOC'Y 689 (2005). . . . . 27 To Promote Innovation: The Proper Balance of Competition and Intellectual Property Law and Policy (Federal Trade Commission 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 To Promote the Progress of Useful Arts, Report of the President's Commission on the Patent System (1966). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 U.S. Patent and Trademark Office: Transforming To Meet the Challenges of the 21st Century (National Academy of Public Administration 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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Defendants Jon W. Dudas and the United States Patent and Trademark Office (collectively "USPTO" or "Office") respectfully oppose GlaxoSmithKline's ("GSK") crossmotion for summary judgment. To the extent that Plaintiff Triantafyllos Tafas ("Tafas") raises arguments that overlap with that of GSK, those arguments are also addressed in this memorandum. The USPTO addresses Tafas's unique arguments in a separate memorandum, which is intended to be read after this memorandum. INTRODUCTION The USPTO demonstrated in its opening summary judgment memorandum that the Final Rules concerning "claims and continuations" practice1 comply with the Patent Act, 35 U.S.C. § 1 et seq., the Administrative Procedure Act ("APA"), 5 U.S.C. § 701 et seq., the Regulatory Flexibility Act ("RFA"), 5 U.S.C. §§ 601-612, and the Constitution. The USPTO further explained how, by promoting more focused patent application prosecution and providing additional information to examiners, these procedural rules are critical to helping the agency keep pace with a burgeoning patent system and improve the quality of issued patents. The Court has now also had the benefit of hearing from a diverse group of amici who recognize the lawfulness of the Final Rules and appreciate their importance. Thirteen public interest organizations; intellectual property, administrative law, and public health professors from twelve law schools; and at least one of the top ten patent prosecuting corporations in the United States (Micron Technology, Inc.) have voiced their support for the Final Rules.2 Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications; Final Rule, 72 Fed. Reg. 46716 (Aug. 21, 2007) ("Final Rules") (Ex. 1 to Mem. in Supp. of Defs. Mots. for Summ. J. ("USPTO Mem."), Dkt. No. 127). See Br. for Amici Curiae Public Patent Foundation et al. ("Public Interest Br."), Dkt. No. 228; Br. Amici Curiae of Intellectual Prop., Admin. Law and Pub. Health Professors . . . ("Prof. Br."), Dkt. No. 232; Br. of Amicus Curiae Micron Tech., Inc. . . . ("Micron Br."), Dkt. 1
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Plaintiffs have nevertheless launched a scattershot facial challenge to the Final Rules, hoping that one of their many allegations will prevent the USPTO from achieving its critical reforms. Plaintiffs are joined by "the concentrated group of special interests that benefit from an enlarged patent system, namely patent holders and patent attorneys." Public Interest Br. at 8. The briefs of Plaintiffs and their supporting amici reflect their desire to cling to the status quo when new procedures are needed to improve the efficiency and quality of patent application examination. A desire for stasis in the face of reform does not justify enjoining lawful regulations.3 RESPONSE TO GSK'S STATEMENTS OF FACTS The USPTO does not contend that there are any genuine issues of material fact in dispute that would preclude summary judgment in these consolidated cases. See Fed. R. Civ. P. 56(c); Local Civil Rule 56(B). The USPTO objects, however, to GSK's "Statement of Undisputed Facts," which presents facts about GSK that are not "material" to a facial challenge to the Final Rules. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986) (explaining that a fact is material only if it could affect the outcome of the suit). Local Civil Rule 56(B) (calling for listing of disputed material facts); Mem. in Supp. of GSK's Mot. for Summ. J. ("GSK Mem."),

No. 229. A second top-ten corporation, Intel, also sought leave to participate as amicus curiae in support of Defendants' motions for summary judgment, but this Court denied Intel's motion on timeliness grounds. See Order, Dkt. No. 220, Jan. 8, 2007. Although the USPTO responds in this and its other opposition brief to some arguments by amici, the USPTO appropriately does not respond to issues and arguments that were not also raised by Plaintiffs. See Tafas v. Dudas, 511 F. Supp. 2d 652, 660-61 (E.D. Va. 2007) ("Tafas I") ("The Court agrees that it may not consider legal issues or arguments not raised by the parties."). It is worthy of reminder that all amici had an opportunity to express their views during the notice and comment period, and many did. The USPTO's 127-page Federal Register notice testifies to the agency's extraordinary efforts to consider and respond to the more than 500 comments it received. See 72 Fed. Reg. at 46744-830. This litigation may not serve as a "doover" of the administrative process. 2
3

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Dkt. No. 142, at 7-9 & Ex. 4. As Tafas recognizes, "[s]ince the issues for decision are primarily purely legal in nature and the Final Rules apply across the board to all patent applicants, a determination as to their validity should not turn on facts unique or peculiar to a particular plaintiff or, for that matter, any disputes that might subsequently become apparent as to such background facts." Pl. Triantafyllos Tafas' Mem. of Law in Supp. of Summ. J. Mot. ("Tafas Mem."), Dkt. No. 141, at 2. The material facts in this case are those set out in the USPTO's Statement of Material Undisputed Facts, which describes the regulatory history of the Final Rules and their key provisions, with reference to the certified administrative record. USPTO Mem. at 7-11; Paulsen v. Gotbaum, No. 90 CIV. 6252, 1992 WL 8361, at *3 (S.D.N.Y. Jan. 15, 1992) ("The material facts in the facial challenge are the existence and application of the regulations."); Comm'y Tel. of Utah, Inc. v. Wilkinson, 611 F. Supp. 1099, 1107 (D.C. Utah 1985) ("Few facts are relevant to a facial challenge, because the law at issue is not analyzed in a factual context."). Accordingly, GSK's "Statement of Undisputed Facts," as well as the declaration of Sherry M. Knowles upon which it relies, should be disregarded.4 GSK Mem., Ex. 4. Many of GSK's "factual" assertions about the Final Rules in other background sections are mischaracterizations of the rules and/or the accompanying Federal Register notice, which the USPTO will correct in the context of its legal arguments.

Amici who speculate how the Final Rules might affect them likewise do not present material facts that may be considered on summary judgment in a facial challenge. 3

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ARGUMENT I. THE FINAL RULES ARE CONSISTENT WITH THE PATENT ACT A. The USPTO Had Authority to Promulgate Final Rules Governing The Conduct Of Proceedings In The Office and the Rules are Entitled to Chevron Deference

The USPTO is entitled to Chevron deference in its interpretation of the relevant Patent Act provisions because Congress has delegated to the USPTO authority to enact the Final Rules. See 35 U.S.C. § 2(b)(2); Chevron USA, Inc. v. NRDC, Inc., 467 U.S. 837 (1984). As the Amicus Professors make clear, whether the Final Rules warrant Chevron deference is a threshold issue, which must be resolved in the USPTO's favor because "[t]he Patent Act gives the PTO authority to make regulations governing its internal proceedings" and "[t]he rules at issue are unquestionably directed at the control of PTO procedures." Prof. Br. at 3-4. Plaintiffs err in arguing that the Final Rules exceed the USPTO's rulemaking authority and resist giving the USPTO the deference it is due. See GSK Memo at 17-20; Tafas Mem. at 8-10. Contrary to Plaintiffs' suggestion, the essential question in determining whether the USPTO had authority to issue the Final Rules and whether they are entitled to Chevron deference is not whether the rules may be labeled "substantive" or "procedural," but whether Congress has delegated to the USPTO rulemaking authority to promulgate the Final Rules.5 See United States
5

The USPTO has already explained why the Federal Circuit's dicta in Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1550-51 (Fed. Cir. 1996), repeated in dicta in Eli Lilly & Co. v. Bd. of Regents of Univ. of Washington, 334 F.3d 1264, 1269 n.1 (Fed. Cir. 2003), concerning whether the USPTO may enact "substantive rules," does not control whether the Final Rules were a proper exercise of the USPTO's rulemaking authority, or whether the agency is entitled to Chevron deference. USPTO Mem. at 17-18. As the USPTO has also explained, Congress has expressly authorized the USPTO to promulgate rules using APA notice and comment procedures­ a type of rulemaking that the APA requires only when an agency is enacting substantive rules. 35 U.S.C. § 2(b)(2)(B) (citing 5 U.S.C. § 553); see USPTO Mem. at 20. GSK thus errs in suggesting that there is "no dispute that the PTO lacks `any general substantive rulemaking authority.'" GSK Mem. at 17. The USPTO did not concede at the preliminary injunction stage that it lacks substantive rulemaking authority, see id., but simply argued that the 4

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v. Mead Corp., 533 U.S. 218, 229 (2001) (explaining that "express congressional authorizations to engage in the process of rulemaking" are "a very good indicator of delegation meriting Chevron treatment"). It clearly has. Each of the Final Rules falls squarely within the broad, express delegation of 35 U.S.C. § 2(b)(2)(A) to "govern the conduct of proceedings in the Office," and/or the additional grants of rulemaking authority in § 2(b)(2)(C) to "facilitate and expedite the processing of patent applications" and § 2(b)(2)(D) to "govern the . . . conduct of agents, attorneys, or other persons representing applicants or other parties before the Office." See USPTO Mem. at 15. Final Rules 78 and 114 (the "2+1 Rule") merely address how many times applicants may appear before the agency, continuing old applications, before they are required to justify further prosecution by submitting a petition to the Office. Final Rules 75 and 265 (the "5/25 Rule") concern when applicants who file a large number of claims must make a further evidentiary submission to assist the Office in examining those claims. The Amicus Professors agree that these rules are within the USPTO's authority: "The rules at issue are unquestionably directed at the control of PTO procedures ­ under what circumstances applicants can file continuation applications, and what information applicants must disclose along with those applications that are particularly large." Prof. Br. at 4. GSK errs in suggesting that the USPTO's authority under § 2(b)(2) is narrow or "limited," GSK Mem. at 17, as the Federal Circuit has recognized that "Congress has delegated plenary authority over PTO practice" to the Office under § 2(b)(2)(A). Stevens v. Tamai, 366 F.3d 1325, 1333 (Fed. Cir. 2004) (emphasis added); see also Lacavera v. Dudas, 441 F.3d 1380, 1383 (Fed. Cir. 2006) (describing the USPTO's § 2(b)(2)(A) powers as "broad" and conferring Chevron deference). The courts have thus upheld as proper exercises of USPTO rulemaking

Final Rules are procedural, see Defs.' Opp. To Pls.' Mot. TRO and Prelim. Inj., Dkt. No. 46 in 1:07cv1008, 21-23. 5

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authority rules that are closely analogous to the Final Rules. For example, it is well-established that the USPTO may, by rule, require applicants to submit additional information under its § 2(b)(2) powers. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281-82 (Fed. Cir. 2005) (discussing 37 C.F.R. § 1.105 (2004)); Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs. Ltd., 394 F.3d 1348, 1351 (Fed. Cir. 2005) (discussing 37 C.F.R. § 1.56 (2004) ("Rule 56")); Digital Equip. Corp. v. Diamond, 653 F.2d 701, 708 (1st Cir. 1981) (holding that Rule 56 constitutes "a valid exercise of the Commissioner's rulemaking powers" under § 2(b)(2)(A)). Furthermore, the Supreme Court has frequently emphasized that delegations of rulemaking authority like § 2(b)(2) must be construed broadly. See Vt. Yankee Nuclear Power Corp. v. Natural Res. Def. Council, 435 U.S. 519, 524 (1978) ("Even apart from the Administrative Procedure Act this Court has for more than four decades emphasized that the formulation of procedures was basically to be left within the discretion of the agencies to which Congress had confided the responsibility for substantive judgments."). Thus, in Federal Communications Commission v. Schreiber, 381 U.S. 279 (1965), the Court discussed the broad authority conferred on the FCC by a statutory provision authorizing it to "`conduct its proceedings in such manner as will best conduce to the proper dispatch of business and to the ends of justice.'" Id. at 289-90 (quoting § 4(j) of the Communications Act of 1934, as amended). The Court remarked that it is an "established principle that administrative agencies `should be free to fashion their own rules of procedure and to pursue methods of inquiry capable of permitting them to discharge their multitudinous duties.'" Id. at 290 (quoting FCC v. Potsville Broad. Co., 309 U.S. 134, 138 (1940)). "This principle, which has been upheld in a variety of applications, is an outgrowth of the congressional determination that administrative agencies and administrators will be familiar with the industries which they regulate and will be in a better position than federal courts or Congress itself to design procedural rules adapted to the 6

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peculiarities of the industry and the tasks of the agency involved." Id. (footnote omitted). The cases on which GSK relies in trying to diminish the USPTO's rulemaking authority under § 2(b)(2) are readily distinguishable. GSK Mem. at 18-20. Adams Fruit Co. v. Barrett, 494 U.S. 638 (1990), involved an attempt by the Department of Labor to regulate "the scope of judicial power" by finding that state workers compensation laws prevented workers from receiving additional benefits under federal law. Id. at 650. Holding that "Congress has expressly established the Judiciary and not the Department of Labor as the adjudicator of private rights of action arising under the [federal] statute," the Court found it inappropriate to consult executive interpretations of the statute. Id. Similarly, Fabil Mfg. Co. v. United States, 237 F.3d 1335, 1341 (Fed. Cir. 2001), concerned whether a Customs Service decision relating to the burden of proof in an administrative proceeding applied when the case reached the Court of International Trade. Not surprisingly, the Court concluded that it was up to the courts, not an agency, to set burdens of proof in judicial proceedings. Id. Here, by contrast, Congress has delegated to the USPTO, not the courts, the power to enact regulations governing proceedings in the Office, and the Final Rules affect proceedings before the USPTO, not the courts. See 35 U.S.C. § 2(b)(2). A.T. Massey Coal Co. v. Holland, 472 F.3d 148 (4th Cir. 2006), is likewise inapposite. There, the court declined to afford Chevron deference to the Commissioner of Social Security's interpretation of the term "reimbursement" in the Coal Act because Congress had only delegated the Commissioner authority to perform the ministerial task of making reimbursement calculations. Id. at 167. Here, by contrast, Congress has expressly given the USPTO broad authority to establish regulations, not just perform a ministerial task. See 35 U.S.C. § 2(b)(2). The creation of the Federal Circuit through the Federal Courts Improvement Act of 1982 is similarly irrelevant. GSK Mem. at 19. In Dickinson v. Zurko, 527 U.S. 150 (1999), the Supreme Court held that notwithstanding that enactment, the USPTO was entitled to the same 7

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deference from the Courts as any other agency. Id. at 152; see Professor's Br. at 1-2. In doing so, the Court abrogated the contrary holding of In re Lueders, 111 F.3d 1569, 1577 (Fed. Cir. 1997), cited by GSK. Since Zurko, the Federal Circuit has given Chevron deference to USPTO rules promulgated under § 2(b)(2), see, e.g., Lacavera, 441 F.3d at 1383, as well as to rules involving other areas of law over which the Federal Circuit has exclusive jurisdiction. See, e.g., Motorola, Inc. v. United States, 436 F.3d 1357 (Fed. Cir. 2006) (review of Customs tariff classifications); Comm. for Fairly Traded Venezuelan Cement v. United States, 372 F.3d 1284 (Fed. Cir. 2004) (review of International Trade Commission decision). GSK's attempt to read the tea leaves of unenacted legislation is a red herring. GSK Mem. at 18. "Unenacted approvals, beliefs, and desires are not laws" and should not distract this Court from the authority conferred by § 2(b)(2). Puerto Rico Dep't of Consumer Affairs v. ISLA Petroleum Corp., 485 U.S. 495, 501 (1988). Moreover, mere non-adoption of legislation is not probative of congressional intent, as "`several equally tenable inferences' may be drawn from such inaction, `including the inference that the existing legislation already incorporated the offered change.'" Pension Benefit Guar. Corp. v. LTV Corp., 496 U.S. 633, 650 (1990) (quoting United States v. Wise, 370 U.S. 405, 411 (1962)). Thus, to the extent the bills GSK cites would have ­ as it contends ­ expanded the USPTO's rulemaking authority, one could readily conclude that Congress did not enact that legislation because § 2(b)(2) already gave the USPTO the authority it needed and the legislation was thus unnecessary. In fact, the most recent legislation would not have expanded the USPTO's authority, but simply "clarifies the scope of power granted to [it] by paragraph (2) of section 2(b) of title 35." H.R. 1908, 110th Cong. § 14(b) (2007) (emphasis added). The Final Rules are merely an exercise of that already-granted power. Finally, even if this Court were to accept Plaintiffs' view that the USPTO's rules must be

8

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labeled "procedural" to fall within the agency's rulemaking authority, they are.6 See USPTO Mem. at 18-20. What qualifies as a "procedural" rule is far broader than Plaintiffs acknowledge. Procedural rules "`ensure that agencies retain latitude in organizing their internal operations'" and "`do not themselves alter the rights or interests of parties, although [they] may alter the manner in which parties present themselves or their viewpoints to the agency.'" Am. Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1047 (D.C. Cir. 1987) (emphasis added) (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980)). Thus, in JEM Broad. Co. v. FCC, 22 F.3d 320 (D.C. Cir. 1994), the court concluded that "stringent application processing rules designed to streamline the agency's review process and to weed out hastily prepared, incomplete applications" were procedural. Id. at 322. The court looked to an earlier, "almost identical" case, Ranger v. Federal Communications Commission, 294 F.2d 240 (D.C. Cir. 1961), in which the FCC established, without notice and comment, a "cut-off" date by which all applications had to be filed. JEM, 22 F.3d at 327. Like JEM, the appellant in Ranger filed an incomplete application and did not have sufficient time to amend and refile before the "cut-off." Id. Ranger held that the rule was procedural, even though "failure to observe it might cause the loss of substantive rights," and that cut-off was a reasonable method of dealing with the Commission's need to establish a terminal point beyond which applicants would not be entitled to a comparative hearing. Id. (quoting Ranger, 294 F.2d at 244). Here, too, the Final Rules expedite and focus the patent application examination process by establishing benchmarks for the timely submission of continuation applications and requiring additional information about large numbers of claims. JEM further underscores that the fact of rules having an impact on those they regulate ­

As the USPTO stated in the Federal Register, "these rules changes involve interpretive rules, or rules of agency practice and procedure." 72 Fed. Reg. at 46830 (emphasis added). The USPTO does not separately address in its opposition to Tafas's memorandum the cases he cites because they focus on the meaning of "interpretative," not procedural rules. Tafas Mem. at 8-10. 9

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even to the point of "caus[ing] the loss of substantive rights" ­ does not render the rules substantive. Id.; see also USPTO Mem. at 19-20. In any event, the Final Rules do not cause the loss of substantive rights because they do not alter the eligibility criteria for obtaining a patent set out in 35 U.S.C. §§ 101, 102, 103, and 112. See Animal Legal Def. Fund v. Quigg, 932 F.2d 920, 930 (Fed. Cir. 1991) ("ALDF"). Any invention that would have met these criteria before the Final Rules will still meet these criteria after them, and Plaintiffs do not contend otherwise. In sum, the USPTO had authority to enact the Final Rules, and they thus are entitled to Chevron deference. Even if the Court does not afford Chevron deference, however, Plaintiffs err in suggesting that no deference is appropriate. "[E]ven if Chevron deference does not apply, an agency's construction of a statue that it is charged with administering is still subject to some deference under the standard set forth by the Supreme Court in Skidmore v. Swift & Co.," 323 U.S. 134 (1944). Cathedral Candle Co. v. U.S. Int'l Trade Comm'n, 400 F.3d 1352, 1365 (Fed. Cir. 2005). The USPTO certainly has the "expertise" and "the specialized experience" that make deference to its understanding of patent law and procedures particularly appropriate. See id. at 1366 (quoting Mead, 533 U.S. at 228); see also Professors Br. at 5 n.4. B. Final Rule 78 Places Reasonable Conditions on the Filing of Continuing Applications, Consistent with Section 120 of the Patent Act

Plaintiffs err in arguing that because 35 U.S.C. § 120 does not affirmatively "authorize" the USPTO to place conditions on continuing applications, Final Rule 78 is invalid. Tafas Mem. at 5; see GSK Mem. at 20. Plaintiffs' quest for an affirmative grant of authority turns Chevron on its head. To prevail, Plaintiffs must instead show that the Patent Act unambiguously guarantees unlimited applications regardless of how delayed or abusive they may be. See Chevron, 467 U.S. at 843. To the contrary, "Section 120 does not compel the PTO to give applicants an unlimited numbers [sic] of bites at the apple. Far from it." Prof. Br. at 6.

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Plaintiffs focus on the "shall have" language of § 120, but, as the USPTO explained in its opening brief, this language does not compel the USPTO to accept for filing an unlimited number of continuation applications absent a petition and showing. USPTO Mem. at 21-22. The "shall have" language merely assures applicants that the USPTO will not reject a later, properlyfiled continuation application on the ground that art published between the filing date of the prior-filed application and the filing date of the later-filed application renders the invention claimed in the later-filed application unpatentable. See id. The section says nothing about whether the USPTO, exercising its authority to "govern the conduct of proceedings before the Office," 35 U.S.C. § 2(b)(2)(A), may place reasonable conditions upon whether the later-filed application may be considered properly filed. Where a statute is silent, the agency may promulgate reasonable regulations. See Chevron, 467 U.S. at 842-43. The USPTO has already explained why In re Henriksen, 399 F.2d 253 (C.C.P.A. 1968), does not preclude Final Rule 78. USPTO Mem. at 24-26. In re Hogan, 559 F.2d 595 (C.C.P.A. 1977), is inapposite for many of the same reasons. These cases did not involve USPTO rulemaking, nor did they involve anything like the petition and showing requirement. Instead, the Office, without prior notice, simply rejected applications for exceeding an ad hoc, absolute limit on the number of continuations that the plaintiff applicants could file. In reversing, the Court of Customs and Patent Appeals ("C.C.P.A.") did not read § 120 as unambiguously precluding the USPTO from imposing reasonable conditions on when continuations may be considered properly filed. See Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S. 967, 982 (2005) ("Brand X") (holding that an agency's construction of a statute is still entitled to Chevron deference even in light of a court's prior judicial construction of a statute so long as the prior court decision does not hold that the statute unambiguously mandates only the court's construction and leaves no room for agency 11

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interpretation); Prof. Br. at 10 (observing, with reference to Henriksen, that "the Brand X Court's declaration that agencies can not, and should not, be precluded from `revising unwise judicial constructions' of ambiguous statutes . . . is entirely apt"). Nor did either case address the conditions on filing that the USPTO may apply using notice and comment rulemaking. Indeed, Henriksen cites the lack of rulemaking as a critical flaw in the agency decision. 399 F.2d at 262 ("Nothing appears in the Patent Office Rules of Practice or the Manual of Patent Examining Procedure which sanctions such a result."). Accordingly, neither case is controlling.7 See id. Plaintiffs selectively quote dicta in Hogan to suggest that only Congress may regulate in this area. GSK Mem. at 21; Tafas Mem. at 6. The full quotation states, "[A] limit upon continuing applications is a matter of policy for the Congress, not for us." Hogan, 559 F.2d at 604 n. 13 (emphasis added). What the court said, therefore, was that it could not judicially impose "limit[s]" on continuing applications, not that the USPTO ­ to which Congress has delegated rulemaking authority ­ may not set reasonable conditions on filing by regulation. In re Bogese makes clear that Final Rule 78 is lawful. See In re Bogese, 303 F.3d 1362, 1368 (Fed. Cir. 2002); USPTO Mem. at 24-25; see also Symbol II, 277 F.3d at 1365-66. Tafas attacks Bogese merely with reference to the dissent. Tafas Mem. at 7. GSK attempts to read into

GSK also cites Ex Parte Hull, 191 U.S.P.Q. 147, 159-60 (Pat. & Tr. Office Bd. App. 1975), but the Office did not "concede" in that distinguishable case that it lacks the power to issue Final Rule 78. GSK Mem. at 21. Even if it had, an agency may change its interpretation of a statute without losing its entitlement to Chevron deference. See AK Steel Corp. v. United States, 226 F.3d 1361, 1375 n.11 (Fed. Cir. 2000) (quoting Chevron, 467 U.S. at 863 (initial agency interpretation is not "carved in stone")); E.E.O.C. v. Seafarers Int'l Union, 394 F.3d 197, 201 (4th Cir. 2005). Ricoh Co. v. Nashua Corp., No. 97-1344, 1999 WL 88969 (Fed. Cir. Feb. 18, 1999), cited by Tafas, is a nonprecedential case with no binding authority on this Court or the Federal Circuit. The Federal Circuit has declined to follow it for this reason. See Symbol Techs., Inc. v. Lemelson Med. Educ. & Res. Found., L.P., 277 F.3d 1361, 1367-69 (Fed. Cir. 2002) ("Symbol II"); id. at 1370 (Newman, J. dissenting) (criticizing majority's refusal to follow Ricoh). In any event, Ricoh does not unambiguously interpret § 120. 12

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the case a non-existent limit on the USPTO's rulemaking authority by arguing that the "factual underpinnings" of Symbol II and Bogese limit the USPTO "to rejecting claims on a case-by-case basis in light of the doctrine of prosecution laches." GSK Mem. at 23. This argument contradicts what the Federal Circuit actually said in Bogese: Indeed, we think the PTO's authority to sanction undue delay is even broader than the authority of a district court to hold a patent unenforceable. The PTO is the administrative agency that is "responsible for the granting and issuing of patents. ..." 35 U.S.C. § 2 (2000). Like other administrative agencies, the PTO may impose reasonable deadlines and requirements on parties that appear before it. The PTO has inherent authority to govern procedure before the PTO, and that authority allows it to set reasonable deadlines and requirements for the prosecution of applications. Bogese, 303 F.3d at 1367-68 (emphases added). Thus, although the court in Symbol Technologies, Inc. v. Lemelson Medical, Education & Research Foundation, 422 F.3d 1378 (Fed. Cir. 2005) ("Symbol IV"), may have cautioned that the courts should be sparing in the use of an equitable doctrine, the Bogese court plainly recognized that the USPTO's inherent authority to regulate the prosecution of applications goes beyond the "factual underpinnings" of any given case. Indeed, in noting that the USPTO could "set reasonable deadlines and requirements for the prosecution of applications," the Federal Circuit implicitly invited the USPTO to exercise its rulemaking authority, for it is rarely, if ever, practical to set deadlines via post-hoc adjudication. As the Amicus Professors observe, "[i]t would be perverse to conclude that the PTO has the power to individually reject each one of the plaintiffs' pending applications because they have filed too many continuation applications ­ something Bogese makes clear they can do ­ but no power to set general rules that provide guidance and certainty to applicants." Prof. Br. at 7. C. Final Rule 114's Reasonable Conditions on Requests for Continued Examinations ("RCEs") Are Consistent With Section 132

Plaintiffs likewise err in arguing that 35 U.S.C. § 132 authorizes applicants to file unlimited, unconditional RCEs. Plaintiffs argue that because § 132(b) reads, "[t]he Director

13

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shall prescribe regulations to provide for the continued examination of applications for patent at the request of the applicant," the Director must grant every RCE. Plaintiffs cite no authority for this reading, which is incorrect even on the face of the statute. See USPTO Mem. at 26-27. The command to "prescribe regulations" is not a command to "grant every request for continued examination." 35 U.S.C. § 132(b). Instead, the statute authorizes the promulgation of regulations. Final Rule 114 is such a regulation, reasonably providing that an applicant who has received a final Office action may, as a matter of right, file one RCE. After that, the applicant must file a petition and make a showing as to why they could not have previously presented the argument, evidence, or amendment. See 72 Fed. Reg. at 46841, 37 C.F.R. § 1.114(f), (g). GSK argues from an unremarkable "effective date" provision that because § 132(b) applied to "all applications" filed after June 8, 1995, the USPTO may not place conditions on whether second or subsequent RCEs may be filed. GSK Mem. at 24. The cited section is far less significant.8 It does not require unlimited RCEs, but simply limits RCEs to those applications that are subject to the 20-year patent term provisions of 35 U.S.C. § 154(a)(2), namely patent applications, other than applications for design patents, that were filed on or after June 8, 1995. The USPTO applied the "Effective Date" provision accordingly when it published final

8

SEC. 4405. EFFECTIVE DATE (b) AMENDMENTS MADE BY SECTION 4403.--The amendments made by section 4403-(1) shall take effect on the date that is 6 months after the date of the enactment of this Act, and shall apply to all applications filed under section 111(a) of title 35, United States Code, on or after June 8, 1995, and all applications complying with section 371 of title 35, United States Code, that resulted from international applications filed on or after June 8, 1995; and (2) do not apply to applications for design patents under chapter 16 of title 35, United States Code. American Inventors Protection Act of 1990, Pub. L. No. 106-113, § 4405(b)(1), 113 Stat. 1501, 1501A-560 (1999). 14

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rules implementing § 132(b) in 2000. See Request for Continued Examination Practice and Changes to Provisional Application Practice, 65 Fed. Reg. 50,092, 50,095 (Aug. 16, 2000). Contrary to GSK's suggestion, the USPTO did not state in those rules t