AIA Strategies First-To-File • Changes take effect March 16, 2013 • Apply to any application having a priority claim falling on or after March 16, 2013 • Significantly expands the scope of applicable prior art First-To-File • Critical date for any application is its “effective filing date” • The effective filing date of a US nonprovisional application is the earlier of: (a) the actual US filing date; or (b) the filing date of any earlier application from which the US nonprovisional application claims priority benefits (German, European, US provisional, etc.) First-To-File Effective Filing Date Appl. A US Non-Prov Filing Date Effective Filing Date Appl. B German Priority Date US Non-Prov Filing Date First-to-File New § 102 defines lack of novelty: The invention lacks novelty if: (a) the invention was “available to the public” before the effective filing date; or (b) the invention was described in a US patent or published US patent application that names another inventor and has an earlier effective filing date. First-To-File New § 102 Appl. A US Non-Prov Filing Date Effective Filing Date Literature Pub Date Literature published prior to the effective filing date will be prior art First-To-File New § 102 Appl. A German Priority Date US Non-Prov Filing Date Effective Filing Date Literature Pub Date Literature published prior to the effective filing date will be prior art First-To-File New § 102 Appl. A German Priority Date US Non-Prov Filing Date Effective Filing Date PCT Pub Date A PCT or other patent published prior to the effective filing date will be prior art First-To-File New § 102 Appl. A US Non-Prov Filing Date Effective Filing Date A US application claiming a priority date prior to the effective filing date will be prior art Appl. B German Priority Date US Non-Prov Filing Date First-To-File New § 102 Appl. A German Priority Date US Non-Prov Filing Date Effective Filing Date A US application claiming a priority date prior to the effective filing date will be prior art Appl. B German Priority Date US Non-Prov Filing Date First-To-File New § 102 Appl. A German Priority Date US Non-Prov Filing Date Effective Filing Date A US application claiming a priority date prior to the effective filing date will be prior art Appl. B German Priority Date PCT Nationalized in US Filing Date First-To-File The new definition of lack of novelty in new §102 significantly expands the applicable prior art: – Publications published less than a year before the actual US filing date and published before any priority date claimed cannot be antedated (old: can antedate) – PCT applications designating the US but not published in English will be prior art as of their earliest priority dates (old: prior art upon publication) – US applications claiming priority to non-US applications will be prior art as of their earliest non-US priority dates (old: prior art as of earliest US filing date) First-To-File Potential Gaps in New § 102: The following would appear according to present understanding not to be prior art until publication: – A PCT application that is not nationalized and published in the US – A non-US application for which no corresponding application is filed in the US First-To-File Grace Periods: New §102 contains two exceptions: (1) A rejection based on a disclosure less than one year before the effective filing date can be overcome by: – (A) showing the disclosure was that of the inventor or someone who derived from the inventor; or – (B) showing the inventor or someone who derived from the inventor publicly made the same disclosure previously. First-To-File Grace Period Appl. A US Non-Prov Filing Date Effective Filing Date < 1 year before EFD A/Deriv Literature Pub Date Earlier disclosure can be overcome by showing disclosure was by A or Deriv First-To-File Grace Period Appl. A US Non-Prov Filing Date Effective Filing Date < 1 year before EFD B Literature Pub Date A/Deriv Literature Pub Date Earlier disclosure by B can be overcome by showing A or Deriv prepublished First-To-File Exceptions continued: (2) A rejection based on a disclosure in a US patent or published US patent application can be overcome by: – (A) showing the disclosure is that of the inventor or someone who derived from the inventor; – (B) showing the inventor or someone who derived from the inventor had publicly disclosed before the effective filing date of the cited reference; or – (C) showing the reference and the application being examined were commonly owned or subject to assignment to the same person/entity. First-To-File Grace Period Appl. A German Priority Date US Non-Prov Filing Date Second US application with priority date less than one year earlier can be overcome by showing disclosure was by A or Deriv Effective Filing Date Appl. A/Deriv < 1 year before EFD German Priority Date US Non-Prov Filing Date First-To-File Grace Period Appl. A German Priority Date US Non-Prov Filing Date Effective Filing Date < 1 year before EFD German Priority Date A/Deriv Literature Pub Date Appl. B US Non-Prov Filing Date US application by B with priority date less than one year earlier can be overcome by showing A or Deriv prepublished First-To-File Grace Period Appl. A German Priority Date US Non-Prov Filing Date Effective Filing Date < 1 year before EFD German Priority Date Appl. B PCT Filing Date US application by B with priority date less than one year earlier can be overcome by showing common ownership First-To-File All of the prior art available to show lack of novelty under new §102 will also be available to show lack of inventive step/obviousness under §103 This includes even prior US patent applications that were unpublished at the time of your filing Recommendations • File new German/European priority applications if practicable before March 16, 2013 (to avoid First-To-File provisions) • Nationalize and publish even unimportant applications in the US to establish prior art • Avoid the use of continuations-in-part that “straddle” the March 16, 2013 date (combination claims of old + new matter will be subject to First-To-File provisions) Recommendations • Retain Laboratory Notebooks/Records – Detail cooperations with third-parties: • To support a derivation claim: – What exactly was disclosed? – Exactly to whom was it disclosed? – When was it disclosed? • To defend a derivation claim: – Record inventor’s individual/group efforts – Unexpected results Third-Party Submissions • Takes effect on September 16, 2012, and applies to any application pending on that date or filed thereafter • Third-party can submit patents, published patent applications or other printed publications • Submission can be electronic; USPTO will not list in PAIR until compliance with applicable rules is confirmed Third-Party Submissions Must be made before earlier of: (a) Mailing of Notice of Allowance; or (b) Later of: (i) 6 months from first publication of the application by USPTO; or (ii) Mailing of First Office Action on the Merits (FOAM) Third-Party Submissions 6 months from publication FOAM Third-party submission will be timely if filed by this later date (unless in the situation below the Notice of Allowance has issued) FOAM 6 months from publication Third Party Submissions • Proposed fees are €139 ($180) for every 10 documents submitted or fraction thereof • An exemption from fees is proposed for: – A submission of 3 or fewer documents – Where the submission is the third-party’s first submission Supplemental Examination • Takes effect on September 16, 2012 • Applies to any patent in force on or after September 16, 2012 Supplemental Examination • Requested by Patentee • To consider, reconsider or correct information believed to be relevant to the patent • The information that may be presented is not limited to patents and printed publications • Information includes, for example, also patentability under §§ 101 and 112 Supplemental Examination • Instituted by Patentee’s filing of Request for Supplemental Examination • Within 3 months, USPTO will determine whether there is a “substantial new question of patentability” • If a substantial new question of patentability is raised, the USPTO will order ex parte reexamination Supplemental Examination • With two exceptions, a patent that cures a defect through supplemental examination will not be held unenforceable in subsequent litigation • Exception 1: Cure will not apply if the defect had been pleaded in a civil action before the Request was filed • Exception 2: Cure will not apply if the defect is defense raised in a civil action and supplemental examination and any ex parte reexamination are not concluded before the action is brought Supplemental Examination Examples of Defects that Can be Cured by Supplemental Examination: – A prior art reference that was not submitted during the original prosecution or, if submitted, was inadequately considered – Comparison data later found to be erroneous – An erroneous priority benefit claim Supplemental Examination • As with most cures, Supplemental Examination will be expensive • USPTO proposes: – Fee for filing Request €3 916 ($5180) – Conducting Reexam subsequent to Request €12 188 ($16,120) – For each document over 20 pages long to be considered €125+ ($166+) Trial Proceedings: Litigation Alternatives • Post-Grant Review • Inter Partes Review • Derivation Post-Grant Review • Takes effect on September 16, 2012 • Applies to patents that issue from applications subject to First-To-File provisions • First-To-File provisions take effect on March 16, 2013, and apply to any patent application having a priority date after March 16, 2013 Post-Grant Review • Provides a vehicle for challenging the validity of any patent on any prosecution grounds (utility, enablement, indefiniteness, anticipation, obviousness) • Petition to institute Post-Grant review can be by anyone other than the patentee • Petition must be filed within 9 months of the issue date of the patent Inter Partes Review • Takes effect on September 16, 2012 • Applies to any patent in force on or after September 16, 2012 • Converts present inter partes reexamination from an examination to an adjudication Inter Partes Review • Challenge is limited to lack of novelty (§102) and obviousness (§103) grounds • Challenge is based on patents and printed publications only • Petition to institute Inter Partes review can be by anyone other than the patentee • Petition may be filed upon issuance of the patent. Derivation • Takes effect on March 16, 2013 • Applies to patents that issue from applications subject to First-To-File provisions • First-To-File provisions take effect on March 16, 2013, and apply to any patent application having a priority date after March 16, 2013 Derivation • Provides a vehicle to challenge any person who has derived/stolen the invention from you and attempted to patent it him/herself • Must be filed on the earlier of 1) within one year after grant of the derived claim or 2) within one year after publication of the earlier application containing a claim to the same or substantially the same invention (US PGPub or PCT designating US) Trial Proceedings: Overview Petition Filed 2 months PO Preliminary Response Decision on Petition 5 months PO Response & Motion to Amend Claims Petitioner Reply to PO Response & Opposition to Amendment PO Reply to Opposition to Amendment 4 months 2 months 1 month Hearing Set On Request PO Discovery Period Petitioner Discovery Period PO Discovery Period Period for Observations & Motions to Exclude Evidence No more than 12 months PO = Patent Owner Oral Hearing Final Written Decision Trial Proceedings: Common Attributes • Quick: • • Final Written Decision issued within one year of instituting trial, which can be extended once for 6 months on good cause Expensive: For example, USPTO proposed filing fee for PGR petition of 20 or fewer claims is €27 068 ($35,800); estimated cost to prepare that PGR petition is €46 373 ($61,333) Estoppel: Petitioner is barred from later raising in the USPTO, any district court action or any ITC proceeding, any ground that was raised or reasonably could have been raised Trial Proceedings: The Petition • Filed on time • Identifies claims challenged and the grounds for challenge • Includes the evidence the Petitioner intends to rely upon • Shows how the requisite standard for instituting the trial are met Trial Proceedings: Institution of Trial • Once the Petition is filed, Patentee has 2 months to file optional Preliminary Response • Within 3 months of the date such Preliminary Response was due, the Board will determine whether to institute trial • Board will narrow the issues for final determination by authorizing the trial to proceed as to specific claims and on specific grounds for which the threshold requirements for proceeding have been met Trial Proceedings: Discovery • Direct examination proceeds in the form of Declarations • Cross-examination will be live • Discovery is in Sequenced Fashion: – Patentee can begin deposing Petitioner’s declarants as soon as trial is instituted – Petitioner can depose Patentee’s declarants as soon as Patentee files a response including declarations Best Mode • Took effect on September 16, 2011 • Applies to litigation proceedings commenced on our after that date Best Mode • Best mode will cease to be a litigation defense • This does not affect examination practice • USPTO has indicated that best mode will continue to be evaluated as set forth in MPEP § 2165 Best Mode • Compliance with the best mode requirement is a two-pronged test: – (1) Did the inventor have a best mode at the time the application was filed? – (2) If so, does the specification disclose the best mode such that persons skilled in the art can practice it? • Under the MPEP, the examiner will presume the best mode is disclosed until evidence of concealment is submitted, which is rare Thank You! If you have questions or need further information, please contact Kurt Briscoe at kgbriscoe@nmmlaw.com; or Dr. Christa Hildebrand at childebrand@nmmlaw.com.