Post-Issuance Practice: Reissue and Reexamination

1. Post-Issuance Practice:Reissue and Reexamination James F. McKeown Crowell & Moring LLP June 12, 2003

2. Introduction • Reissue and Reexamination as Post-Issuance Amendment Tools • Reissue has long existed to provide the patent owner (PO) an administrative remedy for correcting errors in issued patents made without deceptive intent • Ex parte Reexamination (EPR) is a much newer tool created for the purposes of improving patent quality and of serving as a lower cost alternative to civil litigation • Optional inter partes reexamination (IPR) is the most recent attempt to address perceived imbalances faced by third party requestors (TPRs) in EPR proceedings

3. Generally speaking, each of these procedures is primarily utilized for patents with actual economic value or a strong potential of economic value • Given the relatively more frequent use of reissue than reexamination as an amendment tool, as well as certain overlap between the two procedures, this discussion willinitially focus on and devote more time to reissue • A “dark side” is associated with each of these procedures • The patent prosecutor must be acutely aware of the limits and risks associated with these post-issuance patent amendment procedures in terms of their effects upon injunctive relief, enforceability and damages

4. “We made too many wrong mistakes.”Lawrence Peter Berraa/k/a Yogi • Reissue as a Tool to Correct Error • 35 U.S.C. § 251 provides the PTO Director with the statutory authority to regain jurisdiction over Letters Patents for reissue purposes where certain prerequisites exist, namely “error without any deceptive intention” “wholly or partly inoperative or invalid” • “by reason of a defective specification or drawing”, or • “by reason of the [PO] claiming more or less than [it] had a right to claim in the patent”

5. No new matter is permitted • No enlargement of the scope of the claims beyond two years from the grant of the original patent • 35 U.S.C. § Section 252 provides intervening rights as a quid pro quo for permitting correction in claim scope • Intervening rights are of two separate and distinct types • Absolute - Past and present making, using, etc. • Equitable - Continued making, using, etc.

6. Intervening rights may create the litigator’s trial strategy dilemma if there is a strong likelihood that a “substantially identical” original claim will not be infringed • The date when intervening rights arise create the prosecutor’s dilemma • Reissue can be initiated only by the PO • Reissue requires an oath or declaration admitting to the existence of at least one defect

7. A reissue patent cannot be issued after the original patent expires even though an enforceability period still remains • Reissue reopens prosecution and examination of all the claims, not merely those declared to be defective as being too broad or too narrow, or even where the error relates to something other than the claims • There is no presumption of validity of the originally issued claims during a reissue examination • There is no clear and convincing evidence requirement; the less strict “substantial evidence” standard is the appropriate one under Dickinson v. Zurko

8. Besides no enlargement in claim scope being permitted after two years, reissue cannot “recapture” subject matter previously disclaimed • Surrender can occur by argument alone; the recapture rule is analogous to prosecution history estoppel • * * * • In re Clement sets forth a three-step approach: • 1. Determine the broader aspect of the reissue claim • 2. Determine whether the PO surrendered subject matter and whether the reissue claim’s broader aspect relates to the surrendered subject matter, and • 3. Determine whether surrendered subject matter has “crept into” the broadened reissue claims • * * * • Application of the Clement test is not easy and involves more than just counting claim limitations • * * * • The scope of a claim may, in fact, be the same even if one limitation is broadened an another is narrowed so that it would not sweep in subject matter that was previously unclaimed

9. Even though reissue “error” is liberally construed, Section 251 does not allow for correction of every type of error • Errors of fact, law and judgment in the application resulting in the defective patent are, generally speaking, correctableClearly correctable errors include priority and inventorship except perhaps where inventorship may not also be correctable under 35 U.S.C. § 256

10. Inequitable conduct in the original patent is not correctable error • Inequitable conduct in the prosecution of the original patent renders the reissue patent unenforceableBristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc.(Fed. Cir. 2003) • Inequitable conduct in the prosecution of the reissue patent may render the original patent unenforceable • Kearney & Trecker Corp. v. Giddings & Lewis, Inc.(7th Cir. 1971) • The In re Orita divisional is a non-correctable error • Error must have occurred in prosecution of original patent, not in a divisional case where error only “relates back” to the original patent

11. Reissue also may not be employable to broaden claims to the extent once thought possible • The Section 112, ¶1 “written description” problemcreated by Gentry Gallery and Tronzo

12. When is resort to reissue most appropriate? • Where a claim of priority to an earlier filing date is likely to be necessaryWhere a category of invention, e.g., a method, has been overlooked • When is resort to reissue likely to be least appropriate? • Where use of claim construction arguments and/or the doctrine of equivalents may be a justifiable risk even when the PO can file a broadening reissue within the two-year broadening period • Avoids recapture, intervening rights and PTO inequitable conduct issues • Preserves the presumption of validity and need by an accused infringer to establish invalidity by clear and convincing evidence • Where defects in the disclosure and/or claims are trivial even if not merely typographical Reliance on the “one skilled in the art” standard

13. Ex Parte Reexamination (EPR) • EPR as a Tool to Improve Patent Quality • Can only be based upon “prior art consisting of patents or printed publications” per Section 301 • The Director must find the existence of “a substantial new question of patentability” raised by the prior art cited in the request, with or without consideration of other patents or printed publications, and must designate the claims subject to the reexamination procedure; any other prior art (e.g., on sale or public use) established in the record or in court cannot be used in combination with Section 301 prior art in rejecting those claims that are the subject of the reexamination

14. Refusal to institute EPR is final and non-appealable • But a refusal is petitionable and subject to a district court writ of mandamus if there has been an abuse of discretion • Section 305 governs the conduct of EPR • Prosecution and appeals are conducted with “special dispatch” at least in theory

15. Like reissue, EPR has advantages and disadvantages for POs but more so for TPRs • POs are subject to reissue’s Section 252 intervening rights arising prior to issuance of the reexamination certificate • Like reissue, there is no presumption of validity of any claim subject to reexamination and only substantial, not clear and convincing evidence, is required

16. The PO’s major disadvantage is that claim scope cannot be enlarged • One of the several disadvantages of EPR to TPRs is that the TPR’s input is considered only at the front end, not during the conduct of the reexamination process itself • Although any person can seek EPR, only the PO can appeal

17. On balance, EPR is perceived to be a PO’s tool, and available statistics appear to support that perception • Only less than 6% of the reexamination requests granted in 1994 (about 89% of the total filed) were completely rejected • The number of reexamination requests appears to have dwindled

18. Under 2002 legislation, TPRs at least now have the opportunity to use prior art previously cited by or to the PTO or even considered by the examiner to establish the existence of “a substantial new question of patentability” • Like reissue, EPR cannot be used by the PO as a tool to correct inequitable conduct in obtaining the original patent • Also like reissue, the “duty to disclose” clock is once again reset • Unlike reissue, however, EPR can be instituted after expiration of the patent during the remaining period of its enforceability

19. “When we walk to the edge of all the light we have and take the step into the darkness of the unknown, we must believe that one of two things will happen. There will be something solid for us to stand onor we will be taught to fly.”-- Frank Outlaw • Optional Inter Partes Examination (IPR) • The newer form of reexamination was generated in 1999 as a response to the complaints about the lack of “a level playing field” with EPR • There has been no rush toward IPR as a litigation alternative • As with EPR, IPR is supposed to be conducted with “special dispatch”

20. Optional Inter Partes Examination (IPR) • IPR adds the following safeguards to EPR procedures: • Although any person can file a written request for IPR at any time, Section 311 requires the identity of the real party in interest • The TPR can now file written responses during the conduct of the reexamination proceeding as well as when seeking to initiate the IPR • Neither the PO nor the TPR can have an interview • The proceeding is conducted before a different examiner

21. Section 315 estops the TPR in a civil litigation with regard to any ground of invalidity that the TPR raised or could have raised during the IPR proceedings • As with EPR, the 2002 legislation allows the TPR to rely upon prior art previously considered, thereby eliminating theIn re Portola Packaging problem • The same legislation also provides TPR appeal rights to the Federal Circuit but not to the U.S. District Court for the District of Columbia for either the PO or the TPR • The PTO has issued proposed rules to implement the 2002 legislation

22. Reissue -- Revisited • Depending upon the nature of the defect, other alternatives should be considered • Those alternatives would include doing nothing at all or the minimum such as a Certificate of Correction • Claim broadening, assuming compliance with the 2-year rule and the absence of Gentry Gallery andrecapture problems, as well as correcting technical defects such as priority claims, are among reissue’s most important uses • Only a PO, not a third party or perhaps even a court, can decide whether and when a reissue proceeding should be initiated

23. To avoid intervening rights issues, consideration must be given to broadening of claims through other techniques • Markman claim construction determinations • Doctrine of equivalents in the absence of Festo estoppel issues

24. EPR and IPR -- Revisited • Only a TPR can decide whether and when an IPR proceeding should be initiated • Notwithstanding the expanded appeal rights and additional prior art that will be considered as well as an additional level of review, inherent limitations in the conduct of reexamination, not the least of which is the examiner’s training, experience and reputation, and the estoppel that will flow from the proceedings may well confine the use of IPR to a handful of cases

25. Conclusion • There is no substitute for crafting and prosecuting patent applications for state-of-the-art technologies usingstate-of-the-art case law