Tafas v. Dudas et al

Filing 127

Memorandum in Support re 126 MOTION for Summary Judgment Against the "GlaxoSmithKline" Plaintiffs, 125 MOTION for Summary Judgment Against Plaintiff Triantafyllos Tafas filed by Jon Dudas, The United States Patent and Trademark Office. (Attachments: # 1 Exhibit 1# 2 Exhibit 2 (Part 1 of 4)# 3 Exhibit 2 (part 2 of 4)# 4 Exhibit 2 (part 3 of 4)# 5 Exhibit 2 (part 4 of 4)# 6 Exhibit 3# 7 Exhibit 4a# 8 Exhibit 4b# 9 Exhibit 4c# 10 Exhibit 4d# 11 Exhibit 4e)(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 CORP., d/b/a GLAXOSMITHKLINE, et al., Plaintiffs, v. JON W. DUDAS, et al., Defendants. ) ) ) ) ) ) ) ) ) ) )

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

MEMORANDUM IN SUPPORT OF DEFENDANTS' MOTIONS 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv TABLE OF EXHIBITS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 STATUTORY BACKGROUND.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 STATEMENT OF MATERIAL UNDISPUTED FACTS.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 I. HIST O R Y OF THE RULES FOR CONTINUATION AND CLAIMS PRACTICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 OV ER V IEW OF FINAL RULES CONCERNING CLAIMS AND CONTINUATIONS PRACTICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 A. Final Rules 78 and 114 Permit An Applicant to File Two Continuation or Continuation-In-Part Applications and One Request for Continued Examination Without a Petition and Showing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Final Rule 75 Permits An Applicant to File Five Independent Claims and Twenty-five Total Claims in Any Application Without the Examination Support Document Described in Final Rule 265.. . . . . . . . . . . . . . . . . . . . . . . . . . 10 Additional Sections of Final Rules 78 and 75 Support the Main Provisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Final Rule 142 Provides Additional Flexibility for Applicants Claiming More than One Invention in a Single Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 The USPTO Structured the Final Rules to Ensure that Applicants with Pending Applications Could Receive the Patent Protection They Seek. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

II.

B.

C.

D.

E.

SUMMARY JUDGMENT STANDARD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 I. TH E FINAL RULES DO NOT VIOLATE THE PATENT ACT. . . . . . . . . . . . . . . . . . . . . 13 i

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A.

The USPTO's Exercise of Its Rulemaking Authority Qualifies for Chevron Deference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 The Final Rules Warrant Chevron Deference Whether They Are "Procedural" or "Substantive," Though They Are Procedural Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 The Final Rules are Consistent with the Patent Act. . . . . . . . . . . . . . . . . 20 1. Final Rule 78 Concerning Continuing Applications Comports With Section 120 of the Patent Act. . . . . . . . . . . . . . . . 20 Final Rule 114 Concerning RCEs Is Consistent with Section 132.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Final Rules 75 and 265 Concerning Claims and the Examination Support Document Are Consistent with Sections 111, 112, 131 and 151. . . . . . . . . . . . . . 27 Tafas's Remaining Challenges to Final Rules 75 and 78 Are Meritless.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 a. Final Rules 75(b)(2) and (b)(5)(c) Do Not Violate the Patent Act. . . . . . . . . . . . . . . . . . . . . . . . . 30 Tafas's Remaining Final Rule 78 Allegations Lack Merit. . . . . . . . . . . . . . . . . . . . . . . . . . . 31

B.

C.

2.

3.

4.

b.

II.

TH E USPTO DID NOT ACT IN AN ARBITRARY OR CAPRICIOUS MANNER IN PROMULGATING RULES THAT AIM TO IMPROVE QUALITY AND EFFICIENCY OF PATENT APPLICATION EXAMINATION. . . . . . . . . . 34 TH E FINAL RULES ARE NOT RETROACTIVE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 A. B. The Final Rules Do Not Implicate Vested Rights. . . . . . . . . . . . . . . . . . . 40 The Final Rules Impose No New Duties With Respect To Completed Transactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

III.

IV.

TH E FINAL RULES ARE CONSTITUTIONAL UNDER THE FIFTH AMENDMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 A. Plaintiffs Cannot Prevail Under the Fifth Amendment Claim in the Absence of a Cognizable Property Right. . . . . . . . . . . . . . . 45 ii

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B.

The Final Rules Satisfy Due Process Because They Are Not Arbitrary or Irrational. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 The Final Rules Do Not Effect an Unconstitutional Taking. . . . . . . . . . . 47

C. V. VI.

TA FA S CANNOT PREVAIL ON HIS PATENT CLAUSE CLAIM.. . . . . . . . . . . . . . . . . . 50 GSK DOES NOT RAISE AN ACTIONABLE CONSTITUTIONAL VAGUENESS CHALLENGE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 A. B. The Void-For-Vagueness Doctrine Is Inapplicable. . . . . . . . . . . . . . . . . . 52 The Final Rules Are Sufficiently Clear. . . . . . . . . . . . . . . . . . . . . . . . . . . 54 1. The Preexamination Search Requirement of Rule 265's ESD Provision is Sufficiently Clear to Meet Due Process Standards.. . . . . . . . . . . . . . . . . . . . . 55 Final Rule 75(b) Provides Sufficient Notice of What the Phrase "Not Unduly Multiplied" Means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

2.

VII.

TH E FINAL RULES DID NOT REQUIRE NOTICE UNDER THE APA, BUT EVEN IF THEY DID, THEY ARE A LOGICAL OUTGROWTH OF THE PROPOSED RULES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 A. B. The Logical Outgrowth Doctrine Is Inapplicable.. . . . . . . . . . . . . . . . . . . 59 The Final Rules Are a Logical Outgrowth of the Proposed Rules.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

VIII.

TH E USPTO COMPLIED WITH THE REGULATORY FLEXIBILITY ACT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 A. The USPTO Provided a Factual Basis For Its Certification and Reasonably Concluded that the Final Rules Would Not Have a Significant Impact on Small Entities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 The USPTO Substantially Provided a Full Regulatory Flexibility Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

B.

CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 CERTIFICATE OF SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 iii

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TABLE OF AUTHORITIES Page CASES Aaipharma, Inc. v. Thompson, 296 F.3d 227 (4th Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Aeronautical Repair Station Ass'n v. Fed. Aviation Admin., 494 F.3d 161 (D.C. Cir. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Alenco Commc'ns Inc. v. FCC, 201 F.3d 608 (5th Cir. 2000).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Am. Coke & Coal Chems. Inst. v. EPA, 452 F.3d 930 (D.C. Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Andrus v. Allard, 444 U.S. 51 (1979).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Animal Legal Defense Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 59 Application of Rubinfield, 270 F.2d 391 (CCPA 1959). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 17, 28, 29 Ariz. Pub. Serv. Co. v. EPA, 211 F.3d 1280 (D.C. Cir. 2000). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Associated Fisheries of Me., Inc. v. Daley, 127 F.3d 104 (1st Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Baltimore Gas & Elec. Co. v. Nat'l Res. Def. Council, Inc., 462 U.S. 87 (1983).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Bellsouth Telecomms., Inc. v. Southeast Telephone, Inc., 462 F.3d 650 (6th Cir. 2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40, 41, 42 Bergerco Canada v. U.S. Treasury Dep't, 129 F.3d 189 (D.C. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

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Bicycle Trails Council of Marin v. Babbitt, 82 F.3d 1445 (9th Cir. 1996).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Bd. of Regents of State Colleges v. Roth, 408 U.S. 564 (1972).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Bowen v. Georgetown Univ. Hosp., 488 U.S. 204 (1988).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Boyden v. Comm'r of Patents, 441 F.2d 1041 (D.C. Cir. 1971). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Brenner v. Ebbert, 398 F.2d 762 (D.C. Cir. 1968). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Bruno Independent Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28, 42 Camp v. Pitts, 411 U.S. 138 (1973).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Carlton v. Bokee, 84 U.S. 463 (1873).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Carpenter v. Sec'y of Veterans Affairs, 343 F.3d 1347 (Fed. Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66, 68 Cement Kiln Recycling Coal. v. EPA, 493 F.3d 207 (D.C. Cir. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Celtronix Telemetry, Inc. v. FCC, 272 F.3d 585 (D.C. Cir. 2001) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Centigram Commc'ns Corp. v. Lehman, 862 F. Supp. 113 (E.D. Va. 1994). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Central Texas Tel. Coop. v. FCC, 402 F.3d 205 (D.C. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Chadmore Commc'n v. FCC, 113 F.3d 235 (D.C. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41, 44 Chem. Waste Mgmt. v. EPA, 869 F.2d 1526 (D.C. Cir. 1989). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

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Chevron USA, Inc. v. NRDC, Inc., 467 U.S. 837 (1984).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim Chocolate Mfrs. Assoc. v. Block, 755 F.2d 1098 (4th Cir. 1985). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Cienega Gardens v. United States, 503 F.3d 1266 (Fed. Cir. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48, 49 Colten v. Kentucky, 407 U.S. 104 (1972).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Combs v. Comm'r of Soc. Sec., 459 F.3d 640 (6th Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39, 40, 59 Connolly v. Pension Benefit Guaranty Corp., 475 U.S. 211 (1986).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47, 48, 49 County of Sacramento v. Lewis, 523 U.S. 833 (1998).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253 (Fed. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 De Ferranti v. Lyndmark, 30 App. D.C. 417 (1908). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Dickinson v. Zurko, 527 U.S. 150 (1999).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Durr v. Nicholson, 400 F.3d 1375 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Eldred v. Ashcroft, 537 U.S. 186 (2003).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50, 51, 52 Eli Lilly & Co. v. Bd. of Regents of Univ. of Washington, 334 F.3d 1264 (Fed. Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Envt'l Defense Center v. EPA, 344 F.3d 832 (9th Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Envt'l Integrity Project v. Envt'l Prot. Agency, 425 F.3d 992 (D.C. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

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Exxon Chem. Patents, Inc. v. Lubrizol Corp., 935 F.2d 1263 (Fed. Cir. 1991). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41, 45 Fernandez-Vargas v. Gonzales, 126 S.Ct. 2422 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Figueroa v. United States, 466 F.3d 1023 (Fed. Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51, 52 Fleury v. Clayton, 847 F.2d 1229 (7th Cir.1988). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Folden v. United States, 56 Fed. Cl. 43 (2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Freeman United Coal Mining Co. v. Fed. Mine Safety & Health Rev. Comm., 108 F.3d 358 (D.C. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Freytag v. Commissioner, 501 U.S. 868 (1991).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Gen. Elec. Co. v. EPA, 53 F.3d 1324 (D.C. Cir. 1995). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Godfrey v. Eames, 68 U.S. 317 (1863).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22, 23 Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Grayned v. City of Rockford, 408 U.S. 104 (1972).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52, 53, 54 Guardian Fed. Sav. & Loan Ass'n v. Fed. Sav. & Loan Ins. Corp., 589 F.2d 658 (D.C. Cir. 1978). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Herndon v. Lowry, 301 U.S. 242 (1937).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

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Hutchinson Tel. Co. v. Fronteer Directory Co. of Minn., Inc., 770 F.2d 128 (8th Cir. 1985). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Hyatt v. Dudas, 492 F.3d 1365 (Fed. Cir. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Hyatt v. Town of Lake Lure, 114 Fed. Appx. 72 (4th Cir. 2004).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 In re Barnett, 155 F.2d 540 (CCPA 1946). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24, 25 In re Henriksen, 399 F.2d 253 (CCPA 1968). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24, 25 In re Leuders, 111 F.3d 1569 (Fed. Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 In re Tenney, 117 F.2d 377 (CCPA 1941). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 In re Van Ornum, 686 F.2d 937 (CCPA 1982). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19, 20 IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 JEM Broad. Co. v. Fed. Commun. Comm'n ("FCC"), 22 F.3d 320 (D.C. Cir. 1994). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Johnson & Johnston Assocs. v. R.E. Service Co., 285 F.3d 1046 (Fed. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Kelley v. Johnson, 425 U.S. 238 (1976).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Kolender v. Lawson, 461 U.S. 352 (1983).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53, 56 Kunz v. New York, 340 U.S. 290 (1951).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

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Lacavera v. Dudas, 441 F.3d 1380 (Fed. Cir. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15, 16, 34 Landgraf v. USI Film Prods., 511 U.S. 244 (1994).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim Lingle v. Chevron U.S.A., Inc., 544 U.S. 528 (2005).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45, 46, 47, 48 Long Island Care at Home, Ltd. v. Coke, -- U.S. --, 127 S. Ct. 2339 (2007).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Lucas v. South Carolina Coastal Council, 505 U.S. 1003 (1992).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Maritel Inc. v. Collins, 422 F. Supp. 2d. 188 (D.D.C. 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Marsh v. Nichols, Shepherd & Co., 128 U.S. 605 (1888).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41, 45 Marshall County Health Care Auth. v. Shalala, 988 F.2d 1221 (D.C. Cir. 1993). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Martin v. D.C. Court of Appeals, 506 U.S. 1 (1992).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Merck & Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17, 18, 19, 20 Morganroth v. Quigg, 885 F.2d 843 (Fed. Cir. 1989). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Motor Vehicle Manufacturers. Ass'n of the United States, Inc. v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34, 35 Mullins Mfg. Co. v. Booth, 125 F.2d 660 (6th Cir. 1942). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S. 967 (2005).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 14, 17, 25 Nat'l Coal. For Marine Conservation v. Evans, 231 F. Supp.2d 119 (D.D.C. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 ix

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Nat'l Endowment for the Arts v. Finley, 524 U.S. 569 (1998).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 N.L.R.B. v. United Food and Commercial Workers Union, Local 23, AFL-CIO, 484 U.S. 112 (1987).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Nyeholt v. Sec'y of the Veterans Affairs, 298 F.3d 1350 (Fed. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53, 54 Ohio v. U.S.E.P.A., 997 F.2d 1520 (1993).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Olim v. Wakinekona, 461 U.S. 238 (1983).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Omnipoint Corp. v. FCC, 78 F.3d 620 (D.C. Cir. 1996). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Papachristou v. City of Jacksonville, 405 U.S. 156 (1972).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Pauley v. BethEnergy Mines, Inc., 501 U.S. 680 (1991).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Penn Central Trans. Co. v. City of New York, 438 U.S. 104 (1978).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47, 48, 49 Pine Tree Med. Assocs. v. Sec. of Health & Human Servs., 127 F.3d 118 (1st Cir. 1997). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41, 43 Prometheus Radio Project v. F.C.C., 373 F.3d 372 (3d Cir. 2004).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Ranchers Cattlemen Action Legal Fund United Stockgrowers of Am. v. U.S. Dep't of Agric., 415 F.3d 1078 (9th Cir. 2005).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Regions Hosp. v. Shalala, 522 U.S. 448 (1998).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Ruckelshaus v. Monsanto Co., 467 U.S. 986 (1984).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Ryder Truck Lines, Inc. v. Brennan, 497 F.2d 230 (5th Cir. 1974). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 x

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Schnapper v. Foley, 667 F.2d 102 (D.C. Cir. 1981). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Skidmore v. Swift & Co., 323 U.S. 134 (1944).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506 (D.C. Cir. 1983). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735 (1996).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 South Corp. v. United States, 690 F.2d 1368 (Fed. Cir. 1982). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Star Fruits S.N.C. v. United States, 393 F.3d 1277 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Stevens v. Tamai, 366 F.3d 1325 (Fed. Cir. 2004). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15, 16, 19 Symbol Techs., Inc. v. Lemelson Med. Educ. & Research Found., L.P., 277 F.3d 1361 (Fed. Cir. 2002). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Tafas v. Dudas, 511 F. Supp. 2d 652 (E.D.Va. 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34, 52 Tahoe-Sierra Preservation Council, Inc. v. Tahoe Regional Planning Agency, 535 U.S. 302 (2002).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Transmission Access Policy Study Grp. v. Fed. Eng. Reg. Comm'n, 225 F.3d 667 (D.C. Cir. 2000). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Tunik v. Merit Sys. Prot. Bd., 407 F.3d 1326 (Fed. Cir. 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59, 60 U.S. Cellular Corp. v. FCC, 254 F.3d 78 (D.C. Cir. 2001). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65, 69 United of Omaha Life Ins. Co. v. Solomon, 960 F.2d 31 (6th Cir. 1992). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 United Sav. Ass'n of Tex. v. Timbers of Inwood Forest Assocs., 484 U.S. 365 (1988).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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United States v. Lanier, 520 U.S. 259 (1997).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 United States v. Mead Corp., 533 U.S. 218 (2001).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 15 Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 529 (1978).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Village of Hoffman Estates v. Flipside, Hoffman Estates, Inc., 455 U.S. 489 (1982).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53, 54 Webster Elec. Co. v. Splitdorf Elec. Co., 264 U.S. 463 (1924).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Winchester v. Comm'r of Internal Revenue, 27 B.T.A. 783 WL 231 (Bd. Tax. App. 1933). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Woodruff v. U.S. Dep't of Labor, 954 F.2d 634 (11th Cir. 1992). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Woodbridge v. United States, 263 U.S. 50 (1923).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 CONSTITUTION U.S. Const. art. I, § 8, cl. 8.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 50, 51, 52 U.S. Const. amend. V.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 45 STATUTES 5 U.S.C. § 551(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39, 40 5 U.S.C. § 553. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 16, 20 5 U.S.C. § 553(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 20, 60 5 U.S.C. § 553(b)(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 5 U.S.C. § 553(b)(A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 5 U.S.C. §§ 601-612. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 64 5 U.S.C. §§ 601-604. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 xii

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5 U.S.C. § 604. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 5 U.S.C. § 604(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 5 U.S.C. § 605(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64, 65 5 U.S.C. § 611(a)(5).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 5 U.S.C. §§ 701-706. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 U.S.C. § 706(2)(A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13, 34 5 U.S.C. § 706(2)(C) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 28 U.S.C. § 358(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 28 U.S.C. § 2071(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 35 U.S.C. § 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 35 U.S.C. § 2(b)(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 2(b)(2)(A).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 2(b)(2)(B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 16, 20 35 U.S.C. § 2(b)(2)(C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 14, 29 35 U.S.C. § 2(b)(2)(D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 15 35 U.S.C. § 3(a)(2).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 35 U.S.C. § 3(a)(2)(A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 35 U.S.C. § 6(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 35 U.S.C. § 41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 35 U.S.C. § 41(a)(2).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 35 U.S.C. § 101. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 102. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 103. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim xiii

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35 U.S.C. § 111. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 27, 29 35 U.S.C. § 111(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 35 U.S.C. § 112. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 120. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 21, 22 35 U.S.C. § 121. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim 35 U.S.C. § 122. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 35 U.S.C. § 122(b)(2)(B)(I). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 35 U.S.C. § 131. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 5, 29 35 U.S.C. § 132. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 26 35 U.S.C. § 132(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 26 35 U.S.C. § 132(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 6, 13, 26 35 U.S.C. § 134. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 35 U.S.C. § 141. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 35 U.S.C. § 145. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 35 U.S.C. § 151. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 29, 44 35 U.S.C. § 200. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 35 U.S.C. § 203. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 35 U.S.C. § 251. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 23, 32 LEGISLATION Federal Courts Improvement Act, Pub. L. No. 97-164, 96 Stat. 25 (1982). . . . . . . . . . . . . . . . . . 16 Fiscal Year 2000 Consolidated Appropriations Act, Pub. L. No. 106-113, § 4403, 113 Stat. 1501, 1501A-560 (1999). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26, 27

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LEGISLATIVE MATERIALS S. Rep. No. 82-1979 (1952), as reprinted in 1952 U.S.C.C.A.N. 2394.. . . . . . . . . . . . . . . . . 23, 50 RULES Fed. Cir. R. 1(f). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Fed. R. Civ. P. 56(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Sup. Ct. R. 39.8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 REGULATIONS 37 C.F.R. § 1.53(b) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 37 C.F.R. § 1.56 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28, 49 37 C.F.R. § 1.75(b) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 37 C.F.R. § 1.75(c) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 37 C.F.R. § 1.104(a) (2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 37 C.F.R. § 1.105 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28, 49 37 C.F.R. § 1.111 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 37 C.F.R. § 1.114 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 37 C.F.R. § 1.154(b)(6) (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 37 C.F.R. § 1.176 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 37 C.F.R. § 1.183 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 25 37 C.F.R. § 1.213 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 37 C.F.R. § 10.18 (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 49 37 C.F.R. § 10.18(b)(2) (2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

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FEDERAL REGISTER Board of Veterans' Appeals: Rules of Practice-Attorney Fee Matters, 67 Fed. Reg. 36102 (May 23, 2002).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Changes to Implement the Patent Business Goals, 63 Fed. Reg. 53497 (Oct. 5, 1998). . . . . . . . 61 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 Changes to Practice for Continuing Applications, Requests for Continuing Applications, Requests for Continued Examination Practice, and Applications Concerning Patentably Indistinct Claims, 71 Fed. Reg. 48 (Jan. 3, 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 63 Changes to Practice for the Examination of Claims in Patent Applications, 71 Fed. Reg. 61 (Jan. 3, 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 61, 64 Changes to Practice for Petitions in Patent Applications to Make Special and for Accelerated Examination, 71 Fed. Reg. 36323 (June 26, 2006). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Changes to Information Disclosure Requirements and Other Related Matters, 71 Fed. Reg. 38808 (July 10, 2006).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Examination of Patent Applications That Include Claims Containing Alternative Language, 72 Fed. Reg. 44992 (Aug. 10, 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 MANUAL OF PATENT EXAMINATION PROCEDURE U.S. Pat. & Trademark Off., Manual of Patent Examining Procedure ("MPEP") § 201.06 (8th ed. 2001, rev. Aug. 2006) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 MPEP § 706.03(l) (1st ed. Nov. 15, 1949). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 MPEP § 804.01 (8th ed. 2001, rev. Aug. 2006) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 MPEP §§ 904-904.03 (8th ed. 2001, rev. Aug. 2006) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 MPEP § 1450 (8th ed. 2001, rev. Aug. 2006) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 MPEP § 1865 (8th ed. 2001, rev. Aug. 2006) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

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TABLE OF EXHIBITS Description No.

Final Rules: 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).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Excerpts of Administrative Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Proposed Rules: Changes to Practice for Continuing Applications, Requests for Continuing Applications, Requests for Continued Examination Practice, and Applications Concerning Patentably Indistinct Claims, 71 Fed. Reg. 48 (Jan. 3, 2006); Changes to Practice for the Examination of Claims in Patent Applications, 71 Fed. Reg. 61 (Jan. 3, 2006). . . . . . . . . . . . . . . 3 "Guidelines for Applicants under the New Accelerated Examination Procedure". . . . . . . . . . . . 4a "Basic Search Strategy" Slide Show... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4b "Frequently Asked Questions".. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4c "Examination Support Document Guidelines (ESD) under 37 Fed. Reg. 1.265". . . . . . . . . . . . . 4d Sample Search Templates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4e

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Defendants Jon W. Dudas and the United States Patent and Trademark Office (collectively "USPTO" or "Office") respectfully submit this memorandum in support of their motions for summary judgment against Plaintiff Triantafyllos Tafas ("Tafas") and the "GlaxoSmithKline" Plaintiffs ("GSK"). INTRODUCTION The USPTO promulgated the procedural rules under attack in these consolidated cases to improve the timeliness, efficiency, and quality of patent application examination. Facing a backlog of more than 700,000 unexamined patent applications in 2006, the agency had no choice but to act if it was to keep pace with the burgeoning patent system. The USPTO identified two key problems contributing to the mounting pile of applications: (1) applicants flooding the agency with repetitive and otherwise vexatious "continuing" applications, often for the purpose of strategic delay; and (2) applicants presenting increasingly large numbers of claims for examination. Without rules in place to address these issues, the USPTO faced an increasing backlog and a threat to the quality of its issued patents. The Office thus developed procedural rules that would continue to allow applicants to pursue patent protection for their inventions to the full extent allowed by law, while also making the patent system more efficient. The USPTO published its proposed rules in January 2006, voluntarily provided a notice and comment period, and, after careful consideration, published final rules in August 2007. The final rules redress the identified problems by: (1) establishing a benchmark for applicants to promptly present claims and arguments for patent examination rather than using limitless continuation applications to do so; and (2) ensuring that the agency will receive greater assistance from applicants through prior art searches and analysis when their applications impose disproportionate burdens on examination by presenting large numbers of

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claims. These are modest steps, which the USPTO has the authority and responsibility to take. The Court should deny Plaintiffs' efforts to derail these crucial reforms. First, the USPTO had authority to enact the challenged rules by virtue of Congress's express grants of power to the USPTO to, inter alia, "govern the conduct of proceedings in the Office" and "facilitate and expedite the processing of patent applications." 35 U.S.C. § 2(b)(2). Because the USPTO had authority to enact these rules, they are entitled to Chevron deference, irrespective of whether they may be considered "substantive" or "procedural." Moreover, the Federal Circuit decisions that GSK relied on to obtain a preliminary injunction cannot stand in the way of this Court affording Chevron deference to these rules. See Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S. 967, 982 (2005). Properly viewed in light of these principles, each of the challenged rules is clearly consistent with the Patent Act. Second, as this Court indicated at the preliminary injunction stage, the rules are not "arbitrary" or "capricious" under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701706. In its 127-page Federal Register notice announcing the final rules, the USPTO articulated the rationale for its rules, showed how data supported them, and addressed proposed alternatives. The voluminous administrative record further evidences the USPTO's careful and lawful efforts. Third, the Final Rules are not retroactive. The rules could not impair vested rights because patent applicants do not have such rights. Patent applicants have not sacrificed any "trade secrets" in applying for patents because the USPTO would be willing to keep their applications in confidence; it is the applicants who choose to make their applications public in order to pursue patent protection from other countries. The rules also do not impose new duties on completed transactions, as the mere act of filing an application does not complete any "transaction," and, in any event, the Final Rules do not render invalid any action taken in past applications. 2

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Fourth, the rules do not run afoul of the Fifth Amendment by violating the Due Process Clause or the Takings Clause. Here again, Plaintiffs' claims fail for lack of a cognizable property right. Moreover, these economic regulations are not so "irrational" as to violate due process. The rules also do not effect a taking under the Supreme Court's regulatory takings framework. Fifth, the Patent Clause of the Constitution, art. I, § 8, cl. 8, simply authorizes Congress to establish a patent system and presents no obstacle to the final rules. The preambular language of the Patent Clause does not constitute an independent factor for the USPTO to "weigh," and even if it did, the USPTO satisfied the interests underlying the Patent Clause. Sixth, Plaintiffs fail to assert a cognizable challenge under the void-for-vagueness doctrine because that doctrine relates only to regulations or statutes prohibiting conduct, whereas these rules concern the procedures by which an applicant seeks a government benefit. In any event, the rules are sufficiently clear to satisfy due process. Seventh, the final rules here need not be a "logical outgrowth" of the proposed rules because, as procedural rules, they did not require the agency to undertake APA notice and comment procedures. Even if they did, however, the final rules were reasonably foreseeable and are a logical outgrowth of the proposed rules, addressing concerns raised in the public comments. Eighth, the USPTO complied with the procedural requirements of the Regulatory Flexibility Act ("RFA"), 5 U.S.C. §§ 601-612, in promulgating the final rules. The Office properly certified that the final rules would not have a significant impact on small entities and thus did not require a full RFA analysis. Even if the Office had been required to undertake a full RFA analysis, its initial and final certifications fulfill that requirement. With the USPTO's position now fully briefed for the first time, the Court should grant the USPTO's motions for summary judgment and allow it to implement its crucial reforms. 3

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STATUTORY BACKGROUND Title 35 of the United States Code ­ commonly known as the Patent Act ­ provides the statutory framework for the examination of patents by the USPTO. Sections 111 and 112 of the Patent Act set out the formal requirements for submitting a patent application to the Office. See 35 U.S.C. §§ 111, 112. Section 111 mandates that the application be in writing, describes the required contents of a patent application in general terms, and calls for application fees and an oath. See id. § 111. Section 112 requires an application to contain two primary parts: (1) a "specification," which generally describes the invention and how to make and use it; and (2) one or more "claims,"which identify the scope of legal protection to which the applicant believes the invention is entitled. Id. § 112. A claim may be in "independent" or "dependent" form.1 See id., ¶ 5. The first application an applicant files for a given invention is known as the "parent" or "initial" application. After receiving an application, a patent examiner will determine whether the claimed invention meets the substantive patentability requirements set forth in Sections 101, 102, 103, and 112 of the Patent Act. See id. §§ 101 (requirement that invention be "new and useful"), 102 (novelty requirement), 103 (nonobviousness requirement), & 112 (written description, enablement, definiteness, and best mode requirements). Section 131 requires the Office to "cause an examination" of each patent application and to grant a patent if the applicant is entitled to one by law. Id. § 131. If an application does not comply with the patent eligibility requirements, Section 132(a) For example, Claims 1 and 2 below are independent claims; Claim 3 is a dependent claim; and Claim 4 is a "multiple dependent claim." 1. An automobile comprising: a chassis; an engine; and four wheels. 2. An automobile comprising: a chassis; an engine; four wheels; and four doors. 3. The automobile of claim 1 wherein the engine is an internal-combustion engine. 4. The automobile of claims 1 or 2 wherein the engine has eight cylinders. 4
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requires the examiner to issue a notice of rejection, known as an "Office action," which sets forth the grounds for rejection. 35 U.S.C. §§ 131, 132(a); see also 37 C.F.R. § 1.104(a) (2006). In response, the applicant may (i) amend his or her claims; (ii) argue against the rejection; or (iii) present evidence to show why the claimed invention is believed to be patentable. 37 C.F.R. § 1.111 (2006). The examiner may then "allow"--that is, authorize for patenting--some or all of the claims and issue a patent pursuant to Section 151. 35 U.S.C. § 151. Alternatively, the examiner may issue another rejection. The exchange between an applicant and an examiner is commonly referred to as the "prosecution" of an application. The Patent Act affords an applicant several choices upon receiving a final rejection. First, the applicant may appeal to the Board of Patent Appeals and Interferences ("Board") and from there to a federal court. 35 U.S.C. §§ 134, 141, & 145. Second, Section 132(b) authorizes the applicant to file a "request for continued examination" ("RCE") of the application, which typically extends examination for two more rounds. Id. § 132(b); 37 C.F.R. § 1.114 (2006). Third, under Section 120, the applicant may file a "continuation" (or a "continuation-inpart") application of the initial application. 35 U.S.C. § 120. Continuation applications allow applicants to enjoy the benefit of the filing date (a.k.a. "priority date") of the parent application while amending claims or offering further evidence or arguments as to patentability of the claimed invention. Id. An applicant will only receive the benefit of the earlier filing date, however, if the new application meets certain statutory requirements. See 35 U.S.C. § 120 (allowing application earlier priority date "if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application."). Significantly, although applicants may await a final rejection before filing a continuation application, Section 120 does not require them to do so, and applicants regularly file 5

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continuation applications before receiving final rejections. When an application claims more than one independent or distinct invention, Section 121 of the Patent Act authorizes the patent examiner to issue a "restriction requirement," which requires the applicant to choose one of the claimed inventions to prosecute in the initial application and allows the applicant to file separate "divisional applications" to protect each of the applicant's other inventions. 35 U.S.C. § 121. Like a continuation application, a divisional application claims the priority date of the parent application. See id. Collectively, "continuation," "continuation-in-part," and "divisional" applications are commonly referred to as "continuing applications." See 37 C.F.R. § 1.53(b) (2006). Once a patent issues, Section 251 of the Patent Act provides for the "reissue" of a defective patent. 35 U.S.C. § 251. Under this section, a patentee who mistakenly claims more or less than it has a right to claim in a patent may surrender that patent and obtain a reissued patent that corrects the error. See id. A reissue patent may expand the scope of the claims, however, only if it is applied for within two years of the original patent's issuance. While the Patent Act sets out the general framework for the patent examination process, Congress has delegated the USPTO broad authority to "establish regulations, not inconsistent with law," which "(A) shall govern the conduct of proceedings in the Office;" "(C) shall facilitate and expedite the processing of patent applications;" and "(D) may govern the . . . conduct of agents, attorneys, or other persons representing applicants or other parties before the Office." 35 U.S.C. § 2(b)(2). The Patent Act also authorizes the USPTO to promulgate regulations pursuant to APA rulemaking procedures. See id. § 2(b)(2)(B) (citing 5 U.S.C. § 553). In Section 3, Congress expressly charged the Director with "providing policy direction" for the Office by, among other things, engaging in rulemaking. Id. § 3(a)(2). The Patent Act also provides more specific delegations of authority. See, e.g., id. § 132(b) (requiring the Director to "prescribe regulations 6

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for the continued examination of applicants for patent at the request of the applicant"). The USPTO relied on these broad delegations of authority in promulgating its final rules. STATEMENT OF MATERIAL UNDISPUTED FACTS I. HIST OR Y OF THE RULES FOR CONTINUATION AND CLAIMS PRACTICE Over the past decade, applicants have been filing increasing numbers of continuing applications, as well as applications containing a greater number of claims and more complex claims. See 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, 46718 (Aug. 21, 2007) ("Final Rules").2 The number of continuing applications (other than divisional applications) as a percentage of overall filings has skyrocketed, from about 11.4 percent in fiscal year 1980 to 29.4 percent in fiscal year 2006. Id.; see also A05072.3 Likewise, the number of claims per application has grown, from an average of about 14.4 claims in fiscal year 1990 to about 21 claims in fiscal year 2005. A07099. These filings are hindering the Office's ability to examine newly-filed applications and maintain quality examination. See 72 Fed. Reg. at 46716-18. Consequently, as of 2006, the Office's backlog of unexamined applications stood at 701,147 applications. Id. at 46790. A substantial portion of this backlog is attributable to practices employed by applicants ­ some negligent, some deliberate ­ that unnecessarily prolong prosecution through the use of repetitive and vexatious continuing applications. For example, some applicants file deficient initial applications, relying on the availability of an endless stream of continuing applications to work out issues of patentability. See id. at 46719. Other applicants deliberately use the

The final Federal Register notice is attached hereto as Exhibit 1 and included in the administrative record at A09390-A09518.
3

2

Cited excerpts of the administrative record are provided at Exhibit 2. 7

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availability of continuing applications to delay presenting claims for examination, despite current USPTO rules that prohibit filings that intentionally prolong prosecution. See 37 C.F.R. § 10.18 (2006). Such applicants often delay submitting continuing applications to figure out what the most commercially viable form of their invention is or to obtain a competitive advantage over rivals by monitoring marketplace developments for similar inventions which may fall within the scope of yet-to-be-presented claims. See 72 Fed. Reg. at 46719. The growing number of such continuation filings are hobbling the Office's efforts to examine new filings. Without regulations that set a benchmark for the prompt presentation of claims, argument, and evidence in the application process, the USPTO risks being swamped by continuation filings. Applications containing large numbers of claims also present difficulties for the Office; they absorb an inordinate amount of patent examining resources because they are extremely difficult to properly process and examine. See id. at 46721. The USPTO reasonably concluded that it needed to elicit assistance from applicants who impose such burdens on the Office. Accordingly, in January 2006, the USPTO proposed new procedural rules to effect more focused and efficient examination. See Changes to Practice for Continuing Applications, Requests for Continuing Applications, Requests for Continued Examination Practice, and Applications Concerning Patentably Indistinct Claims, 71 Fed. Reg. 48 (Jan. 3, 2006); Changes to Practice for the Examination of Claims in Patent Applications, 71 Fed. Reg. 61 (Jan. 3, 2006) (collectively "Proposed Rules").4 Among other rules, "Proposed Rule 78" would have restricted applicants to only one continuation application as a matter of right. See 71 Fed. Reg. at 58-59. "Proposed Rule 75" would have required applicants to provide an examination support document ("ESD") for any application that included more than ten representative claims when the applicant

The initial Federal Register notices are attached hereto as Exhibit 3 and contained in the administrative record at A00001-A00023. 8

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wanted the Office to examine every claim in the application from the outset. See id. at 67-68. The USPTO solicited public comments on the Proposed Rules over a four month period. 72 Fed. Reg. at 46717. It received more than 500 comments and spent more than a year analyzing and considering the feedback. Id. Responding to the public's concerns, the USPTO modified the Proposed Rules and published Final Rules on August 21, 2007. See generally 72 Fed. Reg. at 46716-843 (Ex. 1). II. OV ER V IEW OF FINAL RULES CONCERNING CLAIMS AND CONTINUATIONS PRACTICE A. Final Rules 78 and 114 Permit An Applicant to File Two Continuation or Continuation-In-Part Applications and One Request for Continued Examination Without a Petition and Showing

Seeking to encourage applicants to timely claim their inventions rather than using endless continuing applications and RCEs to do so, Final Rules 78 and 114 allow an applicant to file two continuation or continuation-in-part applications, plus a single RCE, after an initial application as a matter of right. See 72 Fed. Reg. at 46718; see also 37 C.F.R. § 1.78(d)(1)(i), (ii), & (iii) ("Final Rule 78"); 37 C.F.R. § 1.114(f) ("Final Rule 114") (collectively "2+1 Rule"). If an applicant seeks to further continue prosecution at the examiner level beyond a second continuation or continuation-in-part application and an RCE, it must file a "petition and showing" of need. See 72 Fed. Reg. at 46719; 37 C.F.R. §§ 1.78(d)(1)(vi), 1.114(g). That petition and showing must explain why the claims, argument, or evidence could not have been presented previously.5 If, in an extraordinary situation, an applicant believes that the petition and showing requirement would work an injustice, it may petition for waiver of the rule under 37 C.F.R. § 1.183 (2006). See 72 Fed. Reg. at 46769.

Final Rules 78(d) and 114(g) originally were to apply to all initial and continuing applications filed on or after November 1, 2007. See 72 Fed. Reg. at 46716, 46736. In light of the Court's preliminary injunction, the original effective date will have to be revised. 9

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B.

Final Rule 75 Permits An Applicant to File Five Independent Claims and Twenty-five Total Claims in Any Application Without the Examination Support Document Described in Final Rule 265

Final Rules 75 and 265 require applicants who submit an unusually large number of claims to help expedite the Office's examination by aiding its prior art search efforts. Final Rule 75 permits an applicant to present a total of five independent claims and twenty-five total claims for examination without providing any further information about the claims. See 72 Fed. Reg. at 46721; 37 C.F.R. § 1.75(b)(1) ("Final Rule 75," a.k.a "5/25 Rule"). If an applicant wants to present more than five independent claims or twenty-five total claims, Final Rule 75 requires the applicant to provide an examination support document ("ESD"), which must contain information about the claims, before the Office issues a first Office action on the merits. 72 Fed. Reg. at 46721; 37 C.F.R. § 1.75(b)(1). An ESD is designed to assist the examiner in determining patentability of the claimed invention. 72 Fed. Reg. at 46721. The requirements for an ESD are set out in 37 C.F.R. § 1.265 ("Final Rule 265"), see 72 Fed. Reg. at 46842, and in supplemental guidance issued by USPTO.6 See Ex. 4. In light of the two continuation or continuation-in-part applications that an applicant may file as of right after the initial application, an applicant may ultimately present fifteen independent claims and seventy-five total claims for each invention without an ESD. Id. at 46718, 46721. C. Additional Sections of Final Rules 78 and 75 Support the Main Provisions

Other sections of Final Rules 75 and 78 buttress the USPTO's efforts to better focus examination through the 5/25 Rule and the 2+1 Rule. Final Rules 75(b)(2) and (b)(5)(c) define

Final Rule 75 originally was to apply to all applications filed on or after November 1, 2007, and all pending applications for which a first Office