UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`PO. Box I450
`Alexandria, VA 223 134450
`www.uspto.gov
`
`STERNE, KESSLER GOLDSTEIN & FOX PLLC
`1100 NEW YORK AVENUE NW
`
`WASHINGTON DC 20005
`
`In re
`Application No. 12/439,410
`Filing Date: November 9, 2009
`Patent No. 9,101,625
`
`Issue Date: August 11, 2015
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`A H
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`[L E
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`OFFICE OF PETITIONS
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`ON REDETERMINATION
`OF PATENT TERM ADJUSTMENT
`
`This is a redetermination of the patent term adjustment in response to application for patent term
`adjustment filed August 27, 2015, requesting that the patent term adjustment determination for
`the above-identified patent be changed from 407 days to 944 days.
`
`This redetermination of patent term adjustment is not the Director's decision on the
`applicant's request for reconsideration for purposes of seeking judicial review under
`35 U.S.C. §154(b)(4).
`
`Effective April 1, 20131, for any patent granted on or after January 14, 2013, 37 CFR 1.705(b)
`has been revised to no longer provide for a request for reconsideration of the Office’s patent term
`adjustment determination prior to the grant of a patent. Rather, 37 CFR 1.705(b)2 now provides:
`
`(b) Any request for reconsideration of the patent term adjustment indicated on the patent
`must be by way of an application for patent term adjustment filed no later than two ‘_
`months from the date the patent was granted. This two month time period may be
`extended under thc provisioris of § 1.136(a). An application for patent term adjustment
`under this section must be accompanied by3:
`
`Interim Final Rule, 78 FR 19416 (April
`
`' Revisions to Patent Term Adjustment,
`1, 2013).
`2 The former provisions of §§ 1.705(d) and (e) have been removed in View of
`the changes to 1.705(b).
`-
`3
`(1) The fee set forth in § 1.18(e); and (2) A statement of the facts
`involved, specifying:
`The correct patent term adjustment and the basis or
`
`bases under § 1.702 for the adjustment;
`The relevant dates as specified in
`§§ 1.703(a)
`through (e) for which an adjustment is sought and the adjustment
`as specified in § 1.703(f)
`to which the patent is entitled; Whether the
`patent is subject to a terminal disclaimer and any expiration date specified
`in the terminal disclaimer; and (A) Any circumstances during the prosecution
`
`

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`Patent No. 9,101,625
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`Page 2
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`On August 11, 2015, the instant application issued as Patent No. 9,101,625, with a patent term
`adjustment of 407 days, which consists of a 306 day period of delay under 37 C.F.R.
`§ 1.703(a)(l) (“A-1 Delay”), a 451 day period of delay under 37 C.F.R. § l.703(a)(2), and a 437
`day period of delay under 37 C.F.R. § 1.703(b) (“B Delay”), reduced by 787 days for five
`separate instances of Applicant delay.
`
`The petition asserts the correct period of A-l Delay is 311 days, and the correct period of B
`Delay is 443 days. The 451 day period of Office delay under 37 C.F.R. 1.703(a)(2) is not in
`dispute. Patentees also argue that the Office improperly calculated Applicant delay.
`
`Background
`
`The instant application is the national stage of International Application No.
`PCT/EP2007/05 8978, filed August 29, 2007, which claims priority to foreign application No.
`061198396, filed August 30, 2006.
`
`National stage papers were filed in this case on February 27, 2009. The papers did include an
`express request to begin national examination procedures. However, as set forth below, the
`application papers were not complete on filing.
`
`The Office mailed a Notification of Missing Requirements on September 9, 2009, requiring,
`inter alia, an inventor’s oath or declaration.
`
`Applicants filed the declaration on November 9, 2009.
`
`The Office issued a Notice of Acceptance of Application under 35 USC 371 on December 28,
`2009, which stated that the “Date of Completion of All 35 USC. 371 Requirements” (“Date of
`Completion”) is November 9, 2009.
`
`Patentees timely filed the application for patent term adjustment on August 27, 2015. Patentees
`assert that the Office used an incorrect Commencement Date when calculating A-l Delay and B
`Delay. According to the petition, the Commencement Date is February 27, 2009, the date the
`application papers were deposited. The petition asserts the correct period of A-l Delay is 311
`days, and the period of B Delay is 443 days.
`
`Discussion
`
`On January 14, 2013, President Obama signed into law HR. 6621, which makes technical
`corrections to the Leahy-Smith America Inventors Act and title 35 of the United States Code.
`
`of the application resulting in the patent that constitute a failure to
`engage in reasonable efforts to conclude processing or examination of such
`
`application as set forth in § 1.704; or (B) That there were no circumstances
`constituting a failure to engage in reasonable efforts to conclude processing
`
`or examination of such application as set forth in § 1.704.
`
`

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`Patent No. 9,101,625
`
`Page 3
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`The Office recently amended several regulations in order to implement changes made by the
`AIA Technical Corrections Act (HR. 6621). E Revisions to Patent Term Adjustment (Interim
`Final Rule), 78 Fed. Reg. 19416 (April 1, 2013).
`
`'
`
`The Office amended 37 C.F.R. § 1.703(a) to read as follows, with emphasis added:
`
`The period of adjustment under § 1.702(a) is the sum of the following periods:
`
`(1)
`
`The number of days, if any, in the period beginning on the day
`after the date that is fourteen months after the date on which the
`
`application was filed under 35 U.S.C. 111(a) or the date the
`national stage commenced under 35 U.S.C. 371(b) or (f) in an
`international application and ending on the date of mailing of
`either an action under 35 U.S.C. 132, or a notice of allowance
`under 35 U.S.C. 151, whichever occurs first[.]4
`
`The changes made to 37 C.F.R. § 1.703(a) apply to all patents issued on or after
`January 14, 2013, and the instant application issued as a patent on August 11, 2015. Therefore,
`the changes made to 37 C.F.R. § 1.703(a) apply to this case.
`
`In view of the prior discussion, the Office agrees the period of A-1 delay should be based on the
`date the national stage commenced (“Commencement Date”) instead of the Date of Completion.
`
`The date the national stage of an international application commences is addressed in MPEP §
`1893.01, which states, with emphasis added,
`
`Subject to 35 U.S.C. 371(f), commencement of the national stage occurs upon
`expiration of the applicable time limit under PCT Article 22(1) or (2), or under
`PCT Article 39(1)(a). See 35 U.S.C. 371(b) and 37 CFR 1.491(a). PCT
`Articles 22(1), 22(2), and 39(1)(a) provide for a time limit of not later than
`the expiration of 30 months from the priority date. Thus, in the absence ofan
`express requestfor early processing of an international application under
`35 U.S.C. 371(f) and compliance with the conditions provided therein, the U. S.
`national stage will commence upon expiration of30 months flom the priority
`date ofthe international application.
`
`The February 27, 2009 papers do include a request for early processing. However, the
`application papers were not complete. Therefore, the national stage commenced upon the
`expiration of 30 months from the priority date of the international application.
`
`The date '30 months after August 30, 2006, which is the priority date of the international
`application, is March 1, 2009. As March 1, 2009 fell on a Sunday, the commencement date
`began on the next succeeding business day. §e_e PCT Rule 80.5. Therefore, the Commencement
`Date is Monday, March 2, 2009.
`
`4 & Revisions to Patent Term Adjustment (Interim Final Rule), 78 Fed. Reg. 19416, 19420 (April 1, 2013).
`
`

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`Patent No. 9,101,625
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`Page 4
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`The correct period of A-l Delay is 306 days, which is the number of days beginning
`May 3, 2010, the day after the date 14 months after the Commencement Date, and ending
`March 4, 2011, the date the Office mailed the first Office action.
`
`As for the amount of “B” delay, the Federal Circuit reviewed the statutory interpretation of
`35 U.S.C. § 154(b)(l)(B)(i) and issued a decision regarding the effects of a Request for
`Continued Examination (“RCE”) on “B” delay in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir.
`2014). In Novartis, the Federal Circuit agreed with the Office that “no [“B” delay] adjustment
`time is available for any time in continued examination, even if the continued examination was
`initiated more than three calendar years after the application’s filing.” Novartis, 740 F .3d at 601.
`However, the Novartis court found that if the Office issues a notice of allowance after an RCE is
`filed, the period after the notice of allowance should not be excluded from the “B” delay period
`but should be counted as “B” delay. Id. at 602. The Federal Circuit issued its mandate in the
`Novartis appeal on March 10, 2014.
`
`Pursuant to the Novartis decision, the USPTO has determined that the patentee is entitled to 437
`days of “B” delay. In this case, the application commenced on March 2, 2009 (30 months after
`the priority date of August 30, 2006) and the patent issued on August 11, 2015; thus, the
`application was pending for 2354 days. During this time, Applicants filed an RCE on March 21,
`2013, and the Office mailed a Notice of Allowance on June 18, 2015. Under 35 U.S.C. §
`154(b)(1)(B)(i), there was one time period consumed by continued examination (“RCE period”)
`— from March 21 , 2013 until the Notice of Allowance was issued on June 18, 2015 — i. e. 820
`days. Subtracting the RCE period from the total number of days the application was pending
`results in 23 54 — 820 = 1534 days. Thus, for purposes of “B” delay, the application was pending
`for 1534 — 1097 [i.e., the 3 year delay period] = 437 days beyond the 3-year anniversary of the
`filing date.
`
`Put it differently, the “B” delay period spanned March 3, 2012 — March 20, 2013 (383 days), and
`from June 19, 2015 to August 11, 2015 (54 days), or a total of 437 days. As such, there is no
`overlap between “A” delay and “B” delay.
`
`With respect to Applicant delay, Patentees argue that they should not have been assessed 557
`days for the filing of a Track 1 Request for Prioritized Examination on September 29, 2014,
`supplemental to an RCE filed March 21, 2013. The Office agrees that in this instance, the filing
`of a Track 1 Request is not a “failure to engage in efforts to conclude prosecution”, and as such,
`the 557 days assessed under 37 CFR 1.704(c)(8) is not warranted.
`
`Lastly, Patentees also point the Office’s attention to the fact that they were not assessed
`Applicant delay for the filing of a supplemental IDS on February 20, 2015, after an Amendment
`had been filed on January 5, 2015. The Office agrees that Applicant delay should have been
`assessed with respect to this filing. However, the number of days calculated by the Office under
`37 CFR 1.704(c)(8) is 46 days, not 47 days as asserted by Patentees. The number of days
`beginning January 6, 2015 (the date after the initial reply was filed) and ending on February 20,
`2015 (the date Applicants filed the IDS) is 46 days.
`
`

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`Patent No. 9,101,625
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`Page 5
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`Overall PTA Calculation
`
`Formula:
`
`“A” delay + “B” delay + “C” delay - Overlap - applicant delay = X
`
`USPTO’s Calculation:
`
`757+437+0—0—260=934
`
`Patentees’ Calculation:
`
`762+443 +0—0—261=944
`
`2mm
`
`Patentees are entitled to PTA of nine hundred thirty-four (934) days. Using the formula “A”
`delay + “B” delay + “C” delay - overlap - applicant delay = X, the amount of PTA is calculated
`as following: 757 + 437 + 0 — 0 — 260 = 934 days.
`
`Patentee is given TWO (2) MONTHS from the mail date of this decision to respond to this
`redetermination. Extensions of time under 37 CFR 1.136(a) are permitted. This is not final
`agency action within the meaning of 5 U.S.C. § 704.
`
`The application is being forwarded to the Certificate of Corrections Branch for issuance of a
`certificate of correction. The Office will issue a certificate of correction indicating that the term
`of the above-identified patent is extended or adjusted by nine hundred thirty-four (934) days.
`
`Telephone inquiries specific to this matter should be directed to the undersigned at (571) 272-
`3207.
`
`/C1iff Congo/
`
`Cliff Congo
`Attorney Advisor
`Office of Petitions
`
`Enc: draft Certificate of Correction
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`

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`PATENT
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`: 9,101,625
`
`DATED
`
`: August 11,2015
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`INVENTOR(S): Oksche et a1.
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`On the cover page,
`
`DRAFT COPY
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`[*] Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under
`35 USC 154(b) by 407 days.
`
`Delete the phrase “by 407 days” and insert — by 934 days—-
`
`