DING DONG, THE RULES ARE DEAD!* AND OTHER UPDATES ON US PATENT LAW

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DING DONG, THE RULES ARE DEAD!* AND OTHER UPDATES ON US PATENT LAW FOR: PIUG (Arlington, VA, May 21, 2008) RICHARD NEIFELD, Ph.D., PATENT ATTORNEY NEIFELD IP LAW, PC - www.neifeld.com EMAIL: rneifeld@neifeld.com 4813-B EISENHOWER AVE., ALEXANDRIA, VA 22304 *Credit to Dennis Kettleberger for Ding Dong,...! 1

OUTLINE 1. PIUG NEW BRUNSWICK UPDATE 2. THE RULES ARE DEAD! (WHY?) 3. RULE, RULES, AND MORE RULES! RICK N. - BPAI, IDS, MARKUSH 4. JUDICIAL DEVELOPMENTS 5. CONGRESS, WHITHER ART THOUGH? 2

1. PIUG NEW BRUNSWICK UPDATE REEXAM RESPONSE FILED CIRCA 9/2007 IRT KSR REJECTION NO SUBSTANTIVE ACTION YET (OLD REEXAM, IN GROUP) HOWEVER, NEW REEXAMS, 2 YEARS TO TERMINATION! 3

2. THE RULES ARE DEAD! Tafas v. Dudas and GSK v. Dudas (GSK)! FINAL RULES PACKAGE NULL AND VOID! WHY? - EXAMINE GSK OPINION TO FIND OUT 4

IN GSK, THE COURT DETERMINED THAT THE 5/25 AND 2+1 RULES EFFECTIVELY SHIFTED THE BURDEN OF EXAMINATION TO THE APPLICANT 5/25 CLAIMS LIMITATIONS 2+1 CONTINUATIONS LIMITATIONS ESD AND OTHER PENALTIES FOR VARIOUS ACTIONS; BURDENSOME 5

IN GSK, THE COURT STATED "After thorough examination..., the Court finds that the Final Rules are substantive in nature and exceed the scope of the USPTO s rulemaking authority under 35 U.S.C. 2(b)(2). Consequently, the Court will grant summary judgment to GSK and Tafas and void the Final Rules as otherwise not in accordance with law and in excess of statutory jurisdiction [and] authority. 5 U.S.C. 706(2). EMPHASIS ADDED. 6

WHAT DO THESE MEAN? A. the Final Rules are substantive in nature? B. exceed the scope of the USPTO s rulemaking authority under 35 U.S.C. 2(b)(2).? C. otherwise not in accordance with law and in excess of statutory jurisdiction [and] authority. 5 U.S.C. 706(2).? 7

A. the Final Rules are substantive in nature? Chrysler Corp. v. Brown, 441 U.S. 281, 302, 60 L. Ed. 2d 208, 99 S. Ct. 1705 (1979)( In order for a regulation to have the "force and effect of law," it must be a "substantive" or "legislativetype" rule affecting individual rights and obligations... ) EMPHASIS ADDED. SUBSTANTIVE RULE IS ONE THAT AFFECTS INDIVIDUAL RIGHTS AND OBLIGATIONS 8

IMPACT OF the Final Rules are substantive in nature THE FINAL RULES AFFECT INDIVIDUAL RIGHTS AND OBLIGATIONS BUT VIRTUALLY ALL RULES AFFECT INDIVIDUAL RIGHTS AND OBLIGATIONS CONSEQUENCE: USPTO MUST APPEAL TO CLARIFY WHAT RULES ARE SUBSTANTIVE! 9

B. the scope of the USPTO s rulemaking authority under 35 U.S.C. 2(b)(2).? 35 U.S.C. 2 Powers and duties. (b) SPECIFIC POWERS. The Office [THE USPTO] (2) may establish regulations, not inconsistent with law, which (A) shall govern the conduct of proceedings in the Office;... [and] (C) shall facilitate and expedite the processing of patent applications... INTERPOLATION AND EMPHASIS ADDED. 10

C. otherwise not in accordance with law and in excess of statutory jurisdiction [and] authority. 5 U.S.C. 706(2).? 5 U.S.C. 706(2) PROVIDES STATUTORY AUTHORITY FOR COURT TO REVIEW AND MODIFY IMPROPER AGENCY ACTION 11

5 U.S.C. 706(2) 5 USC 706(2): To the extent necessary to decision... [T]he reviewing court shall (2) hold unlawful and set aside agency action, findings, and conclusions found to be (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; (B) contrary to constitutional right, power, privilege, or immunity; (C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right;... EMPHASIS SUPPLIED. 12

5 U.S.C. 706(2) WHEN IS AGENCY ACTION in excess of statutory jurisdiction, authority? Chrysler Corp. v. Brown SUPREME COURT WAFFLES ON THIS ISSUE 13

in excess of statutory jurisdiction, authority Chrysler Corp. v. Brown, 441 U.S. 281, 302, 60 L. Ed. 2d 208, 99 S. Ct. 1705 (1979) The... exercise of quasi-legislative authority by governmental departments and agencies must be rooted in a grant of such power by the Congress and subject to limitations which that body imposes.... This is not to say that any grant of legislative authority to a federal agency by Congress must be specific before regulations promulgated pursuant to it can be binding... Emphasis supplied. 14

in excess of statutory jurisdiction, authority Chrysler Corp. v. Brown, CONCLUDES What is important is that the reviewing court reasonably be able to conclude that the grant of authority contemplates the regulations issued. [Emphasis added.] TALK ABOUT JUDICIAL DISCRETION! 15

PUTTING IT ALL TOGETHER GSK COURT CONCLUDED: THE RULES PLACED BURDEN OF EXAMINATION ON THE APPLICANT CONGRESS HAD NO INTENT TO PLACE THE BURDEN OF EXAMINATION ON THE APPLICANT THEREFORE... 16

UNANSWERED QUESTION WILL GSK STAND ON APPEAL? WHAT PTO RULES ARE NOT SUBSTANTIVE? PROPOSED IDS RULES PROBABLY DEAD PROPOSED MARKUSH RULES PROBABLY DEAD PROPOSED BPAI RULES IN EX PARTE APPEALS ARE NOT DEAD 17

3. RULE, RULES, AND MORE RULES! PROPOSED BPAI RULES IN EX PARTE APPEALS FINAL RULES TO BE PROMULGATED VERY SOON 18

PROPOSED BPAI RULES IN EX PARTE APPEALS CURRENT APPEALS SITUATION IS AWFUL! AS PUBLISHED, PROPOSED APPEALS RULES TO COMPLICATED! CAPJ RECENTLY SAW THE LIGHT CURRENTLY PROPOSING TO SIMPLY LIMIT APPEALS TO (1) APPEAL BRIEF, (1) ANSWER, AND (1) REPLY BRIEF 19

PROPOSED BPAI RULES IN EX PARTE APPEALS IMPACT OF REVISED RULES PROPOSAL: APPEAL BRIEF BURDEN - SUBSTANTIALLY MORE COMPLICATED (CLAIM CHARTS, FORMATTING, PAGE LIMITS, ETC) INSTEAD OF REQUIREMENT TO CORRECT THE BRIEF, A DEFECTIVE BRIEF MAY RESULT IN A LOSS ON THE MERITS AND/OR SANCTIONS 20

PROPOSED BPAI RULES IN EX PARTE APPEALS IMPACT OF REVISED RULES PROPOSAL: BUT REVISED PROPOSED RULES WILL RESULT REDUCE THE DURATION OF PING PONG BEFORE AN APPEALED CASE GETS TO THE BOARD, TO WELL UNDER 2 YEARS 21

PROPOSED BPAI RULES IN EX PARTE APPEALS PATENT TERM ADJUSTMENT ISSUE PTA DURATION OF APPEAL 37 CFR1.704(c)(7) PTA REDUCTION FOR REFLING PAPER TO CORRECT AN OMISSION IN ORIGINAL 37 CFR1.704(c)(7) APPLIES TO APPEALS USPTO CURRENTLY NOT APPLYING 22

4. JUDICIAL DEVELOPMENTS SUPREME COURT Quanta Computer, Inc. v. LG Elecs., Inc., pending, (Did sale of licensed product by licensee exhaust patent right, when license required licensee to notify third parties that the license did not extend to them? First sale exhaustion doctrine/license/conditional sale doctrine are downstream users liable?) 23

4. JUDICIAL DEVELOPMENTS SUPREME COURT Biomedical Patent Mgmt. Corp. v. Cal. Dep't of Health Servs., pending, (State 11th amendment immunity from a patent in which it intervened in a prior suit on the same patent?) Medelllin v. Texas, decided, (When are treaty obligations self implementing/ provide Court jurisdiction?) - Relevant to PCT, Paris, Madrid) 24

4. JUDICIAL DEVELOPMENTS CAFC GSK, pending In re Bilski, pending, argued 5/8, (scope of 101 patent eligible subject matter)(question 5, whether to overrule State Street and AT&T?) 25

4. JUDICIAL DEVELOPMENTS CAFC In re Kubin, pending, appeal from Ex parte Kubin, pending, (does a functional claim without disclosed correlation of function to structure that performs the function fail the written description requirement) Miller v. Brand, decided, (BPAI cannot substitute its own knowledge for evidence of record; interference case.) 26

4. JUDICIAL DEVELOPMENTS BPAI (PRECEDENTIAL DECISIONS) Ex parte Fu, (species of disclosed genus not per se patentable) (not new law) Ex parte Letts, (generally, procedural failure of appeals that provides a basis for affirmance of merits of a rejection will result in affirmance) 27

4. JUDICIAL DEVELOPMENTS BPAI (PRECEDENTIAL DECISIONS) Ex parte Nehls, (101/112 and 103 issues relating to biotech and computers) Held 1: Claims to a computer system for identifying nucleic acid fragments homologous to other sequences that fails to demonstrate substantial and specific utility unpatentable Held 2: Data processed by that computer system is non functional descriptive material if it does not functionally affect the process performed by the computer system; such data does not provide patentable non obviousness 28

5. CONGRESS, WHITHER ART THOUGH? CONGRESSIONAL ACTION STILL PENDING MAY LEGISLATIVELY OVERRULE GSK MAY AUTHORIZE USPTO TO REQUIRE PRE FILING SEARCH AND ANALYSIS HOST OF OTHER CHANGES PENDING, INCLUDING FIRST TO FILE, POST GRANT OPPOSITIONS 29

THE END THANK YOU! RICHARD NEIFELD, PH.D., PATENT ATTY. NEIFELD IP LAW, PC - www.neifeld.com StockPricePredictor.com, LLC - www.patentvaluepredictor.com EMAIL: rneifeld@neifeld.com TEL: 703-415-0012 EXT. 21 30