Nationalizing PCT Applications in the US Which is Better, 371 Route or Bypass CON Route? 371 Nationalization v. Bypass Continuation Let’s get ready to…

…Training- Review of Some of the Basics

PCT Applications- Nationalization Routes PCT Applications that designate the US are considered US applications, so... Can Nationalize under 35 USC 371- traditional nationalization- a 371 nationalization is technically the same application as the PCT application Can file a “Bypass CON”- a continuation application that claims priority under 35 USC 120 to the PCT application as a continuation application of the PCT application 35 U.S.C. 363 provides that "[a]n international application designating the United States shall have the effect, from its international filing date under article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office....“ --See, MPEP 1895

PCT Applications- 371 Nationalization Route International Phase Transmittal National Phase PCT Application US National Stage -Same Int'l App. No. -Assigned New US App. No. (for tracking) -Claims & Spec. amendments are based on those during international phase. -Generally, do not need a new IDS for Refs. cited in Search Report/Written Opinion (as long as transmitted to USPTO). -Generally, do not need to resubmit certified copies of foreign priority documents as long as transmitted to the USPTO (but may need to submit verified translation). Treated as if the Same Application

PCT Applications- Bypass Continuation Route International Phase PCT Application “This application is a continuation of International Application No. PCT/... CON. Continuation Application Treated as a New Application -New US App. No. -Claims & Spec. amendments are based on what is filed- amendments during international phase do not count. -Need a new IDS for Refs. cited in Search Report/Written Opinion. -Need to resubmit certified copies of foreign priority documents and may need to submit verified translation.

The Match- Let’ s Get Ready to…. Compare

…Filing Requirements Round 1

PCT Applications- Filing Requirements 371 Nationalization Transmittal (PTO-1390) Filing Fees- Filing, Search, and Examination fees, etc. May also need.. Preliminary Amendment - to remove multiple dependent claims Bypass CON Application- specification, claims, abstract & drawings Need priority claim Filing Fees- not required

371 Transmittal

…Practical Issues Round 2

PCT Applications- Practical Issues Filing Bypass CON Standard practice Allows addition of new matter (CIP) –see, MPEP 1895 371 Nationalization Sometimes, not sure which claims are pending due to amendments during the international phase Have to deal with multiple dependencies Not familiar with transmittal Do not need to submit copy of the application and other paper work- just makes USPTO file messy No new matter allowed (i.e., no CIP’s)

…Foreign Certified Copies Round 3

Certified Foreign Priority Documents Easily missed- need to check PAIR If Examiner comes across intervening reference, they may request foreign priority documents (to show entitled to earlier date) Otherwise, no notice! To Perfect a Foreign Priority Claim USPTO Needs a Certified Copy 1. Paper Certified Copy, OR 2. Patent Document Exchange (PDX) Request- Electronic Transfer to USPTO (automatic now)- but some countries not yet participating. Verified English Translation- for non-English foreign priority documents

PCT Applications- Foreign Certified Copies 371 Nationalization Certified copies of foreign priority applications are not required so long as the International Bureau transmits the copies to the USPTO. If priority application is not in English, you will still need to transmit a verified translation. Bypass CON You will need to submit a certified copy of foreign priority application BUT now have Patent Document Exchange (PDX) program with a majority of countries USPTO will now automatically request If priority application is not in English, you will still need to transmit a verified translation.

…After Filing Formalities Round 4

PCT Applications- After Filing Formalities 371 Nationalization Filing Receipt takes a long time to receive Signed Declaration- will not receive a filing date until a signed declaration is filed (hurts patent term as well) Bypass CON Filing Receipt- processed relatively fast Signed Declaration- filing date is not based on when declaration is filed Filing Fees- can file later

PCT Applications- After Filing Formalities 371 Nationalization Publication Claim amendments made at the time of nationalization via a Preliminary Amendment might be published (or not) at the discretion of the USPTO. Normally, the application is published without the amended claims from the Preliminary Amendment. This is a BIG problem because you might time from your damages calculation for provisional rights. Bypass CON Publication As long as the amended claims are incorporated into the body of the application (i.e., not via a Preliminary Amendment), they will be published. -Any new matter questions- you can submit remarks. Eliminates the problem with damages calculations.

…Information Disclosure Statements Round 5

PCT Applications- IDS Comparison 371 Nationalization Do not need to submit IDS for references cited during international phase (e.g., in the search report) so long as USPTO Form PCT/DO/EO/903 indicates search results transmitted to national file. Still probably good practice to submit IDS because references will not be listed on the face of the patent unless cited on IDS. --see, MPEP 609.03 Will need to submit IDS for new references Bypass CON Need to submit an IDS “When filing a continuing application that claims benefit under 35 U.S.C. 120 to an international application that designated the U.S. (see MPEP § 1895), it will be necessary for the applicant to submit an information disclosure statement complying with 37 CFR 1.97 and 1.98 in the continuing application listing the documents cited in the international search report and/or the international preliminary examination report of the international application if applicant wishes to ensure that the information be considered by the examiner in the continuing application.<“ --MPEP 609.02 Will need to submit IDS for new references

…Restriction Practice Round 6

PCT Applications- Restriction 371 Nationalization Relies on PCT unity of invention standard Usually results in less independent claims This can cause problems because US examiners may not be familiar with the standard and incorrectly use US standard restriction practice Bypass CON Uses US standard restriction practice (independent & distinct) On average, more independent claims- more permissive US Examiners are familiar with the standard

…Prosecution & Fees Round 7

PCT Applications- Prosecution & Fees 371 Nationalization Totally clean search report/opinion (i.e., all claims are patentable)- very unlikely May receive marginal filing fee discount if have clean Search Report/Written Opinion by US as ISA $320 Savings US/ISA $650 Savings other normal ISA’s New- May use PCT-PPH to speed up examination when originating application is filed in certain countries (JPO, EPO, etc.) No fee now required Bypass CON Bypass route is the only way to use traditional accelerated examination (371 will not work) --See, USPTO’s Accelerated Examination FAQs Clean written opinion- still pay the same fees (Rare) PCT-PPH available for bypass applications as well

…Patent Term Adjustment Round 8

PCT Applications- Patent Term Adjustment 371 Nationalization Will lose patent term if: Do not request expedited examination (check the right box on transmittal). File signed declaration after nationalization date. Bypass CON Will only lose patent term if file signed declaration more than 3 months after mail date of missing parts.

Quick Patent Term Adjustment Refresher 35 USC §154(b)(1) Periods (A) Guarantee of prompt USPTO responses- 14 months for USPTO to send an Office Action or Notice of Allowance (plus various 4 month periods)- Examination Delays (B) Guarantee of no more than 3-year application pendency- USPTO fails to issue patent 3 years after actual filing date No Double Counting When Periods Overlap § 154(b)(2)(A) "[t]o the extent that periods of delay attributable to grounds specified in paragraph (1) overlap, the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed."

Wyeth v. Kappos (Fed. Cir. 2009) Issue: When does the overlap occur? USPTO 37 CFR § 1.703(f)- B guarantee period starts at the time of the filing of the application, not 3 years after the filing date. You only get the greater of the A or B periods USPTO – 3 Years PTA Overlap Here Overlap Here B Delay A Delay A Delay Filing date 14 mo. date Office Action issued 3 year date Issue fee paid 4 mos. from issue fee payment, patent should issue Issue date

Wyeth v. Kappos (Fed. Cir. 2009) Federal Circuit A & B overlap only occurs after 3 years from the filing date. (A+B Formula) 1 Year USPTO – 3 Years PTA Overlap Here B Delay A Delay A Delay Filing date 14 mo. date 26 mo. Office Action issued 3 year date Issue fee paid 4 mos. from issue fee payment, patent should issue 6 years issue date

Wyeth v. Kappos (Fed. Cir. 2009) USPTO Response USPTO will be processing recalculation requests under an interim procedure that is available to a patentee whose patent issues prior to March 2, 2010, and who requests it no later than 180 days after the issue date. This procedure is available only for alleged errors in calculation that are specifically identified in Wyeth. Information on requesting a recalculation of patent term is on the USPTO Web site at http://www.uspto.gov/patents/announce/pta_wyeth.pdf.

Wyeth v. Kappos (Fed. Cir. 2009) USPTO Wyeth PTA Form PTO/SB/131

Novartis Challenges Interim Procedure "[t]hese interim procedures included an expedited, informal procedure for seeking recalculation of PTA solely on the basis of Wyeth, but extended that remedy only to patents issued on or after September 2, 2009." … it would “deny as untimely any request for recalculation of patent term adjustment indicated on a patent that is not filed within 180 days of the day the patent was granted."

Japan Tobacco Petition USPTO Miscalculating Period B for PCT 371 National Stage Applications Originally, USPTO considered the B Period filing date= when an international applications fulfilled the requirements of 35 U.S.C. § 371 (e.g., filed signed Oath/Dec.). BUT, 37 C.F.R. § 1.702(b) states that "the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to issue a patent within three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application.” Section 371(b) states that subject to § 371(f), "the national stage shall commence with the expiration of the applicable time limit under article 22 (1) or (2), or under article 39 (1)(a) of the [PCT].“ = 30 Month Chapter II Deadline So the B-Period filing date for 371 national stages should be the 30-Month Chapter II deadline (if filed under 371(b)-- more later)

Japan Tobacco Petition USPTO USPTO relents- B-delay should be calculated based on the date on which the national stage commenced, not the date on which the requirements of § 371(c) were fulfilled. 3-Year B-Period Chap II Deadline (30 Months) File Signed Declaration- satisfy 371(c)

Japan Tobacco Petition PCT Patent Term Landmines B-Period Delay Landmine- Early 371 Nationalization If Nationalize under 371 before 30-month chapter II deadline and satisfy 371(c) requirements (e.g., pay fees, signed Declaration, etc.), you still need to expressly request early processing under 371(f) to get the nationalization date for B-Delay filing date. If not, B-Delay filing date will be based on the Chapter II (30-month) deadline & not the earlier nationalization date. Contrast regular utility or bypass CON- B-Period filing date is the actual filing date of the application.

Japan Tobacco Petition B-Delay Period Landmine Nationalize PCT Application before the Chapter II Deadline Satisfy 371(c)- file signed declaration, etc. Expressly request early processing (check the box on form) 3-Year B-Period B-Delay filing date starts before Chapter II Deadline Nationalize Chap II Deadline (30 Months)

Japan Tobacco Petition B-Delay Period Landmine Nationalize PCT Application before the Chapter II Deadline BUT Fail to satisfy 371(c) OR Fail to expressly request early examination 3-Year B-Period B-Delay filing date starts on Chapter II Deadline Nationalize Chap II Deadline (30 Months) File Signed Declaration- satisfy 371(c)

Japan Tobacco Petition B-Delay Period Landmine- COMPARE Instead file via the bypass CON route BUT Fail to file signed declaration OR Fail to expressly request early examination B-Delay filing date starts before Chapter II Deadline 3-Year B-Period Bypass CON Filing Date Chap II Deadline (30 Months) File Signed Declaration

PCT- Patent Term Adjustment PCT Patent Term A-Delay Landmines A-Delay Date is still based on fulfillment of national requirements under 371(c). For example, if you do not file a signed declaration when the PCT application is nationalized, you lose A-term until you file the signed declaration. Contrast to a regular utility or bypass CON- where you do not lose A-term so long as you file the signed declaration within 3-months of Notice to File Missing Parts

PCT- Patent Term Adjustment A-Delay Period Landmine Nationalize PCT application under 371 Fail to file signed declaration with nationalization A-Period A-Delay- lose term- until file signed Declaration Lose Term Nationalize Chap II Deadline (30 Months) File Signed Declaration

PCT- Patent Term Adjustment A-Delay Period Landmine- COMPARE Instead file via the bypass CON route Fail to file signed declaration when application filed File signed declaration 1-month after missing parts deadline A-Period 2 Month Deadline For Missing Parts DO NOT LOSE ANY A-TERM! Bypass CON Filing Date Chap II Deadline (30 Months) File Signed Declaration w/ 1-Month EOT + surcharge

…And the Winner is…

PCT- 371 Nationalization or Bypass CON? What is the best way to nationalize a PCT ? Answer: Generally, bypass CON!!! Patent Term PDX Bypass CON Simplicity 371 Nationalization US Restriction...

Woodard, Emhardt, Moriarty, McNett & Henry LLP Want to know more? Chuck Schmal Patent Attorney Woodard, Emhardt, Moriarty, McNett & Henry LLP Chase Tower 111 Monument Circle, Suite 3700 Indianapolis, IN 46204 317.634.3456 cps@uspatent.com www.uspatent.com