throbber

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`FIRST NAMED INVENTOR
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`12/337,144
`
`12/17/2008
`
`An Vermeulen
`
`PRD2901USNP
`
`3172
`
`27177
`
`7590
`
`03/13/2015
`
`BERNARDF. PLANTZ
`JOHNSON & JOHNSON
`ONE JOHNSON& JOHNSON PLAZA
`NEW BRUNSWICK,NJ 08933-7003
`
`CLAYTOR, DEIRDRE RENEE
`
`1627
`
`DATE MAILED: 03/13/2015
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applicationsfiled on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`proL-8s (Rev. 02/11
`
`P
`
`Mylanv. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 629
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`3
`
`of 3
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 629
`
`

`

`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
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`1320.5(b).
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`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public whichis to file (and by the USPTO to process) an application. Confidentiality is
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`of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the
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`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency,if the USPTO becomesawareof a violation or potential violation of law or regulation.
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 630
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 630
`
`

`

`
`
`Applicant(s)
`VERMEULEN ETAL.
`i
`AIA (First Inventor to
`
`No
`
`
`
`Notice of Allowability treet|File) StatusRecsSlaytor
`
`.
`
`aye
`
`Application No.
`12/337,144
`i
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANTOF PATENT RIGHTS. This application is subject to withdrawal from issue atthe initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. KJ This communication is responsive to the RCEfiled on 11/17/2014.
`LIA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2. J An election was madeby the applicant in response to a restriction requirementset forth during the interview on
`requirement and election have been incorporatedinto this action.
`
`3. K] The allowed claim(s)is/are 1-5,13,15-20,22 and 24. As a result of the allowed claim(s), you may beeligible to benefit from the Patent
`dD
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information,
`
`please see hitp/www.usoio.gov/patenis/init events/oph/index.ise or send an inquiry to PPHieedback@uspto.doy .
`
`; the restriction
`
`4. 1] Acknowledgmentis madeof a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`
`Certified copies:
`‘*c) (J None ofthe:
`a)OJ All
`b)[)Some
`1. [] Certified copies of the priority documents have been received.
`2. [J Certified copies of the priority documents have been received in Application No.
`3. [J] Copiesof the certified copies of the priority documents have been receivedin this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE”of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT ofthis application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. [] CORRECTED DRAWINGS( as “replacement sheets”) must be submitted.
`C1
`including changes required by the attached Examiner's Amendment / Commentor in the Office action of
`Paper No./Mail Date
`.
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. [] DEPOSIT OF and/or INFORMATIONaboutthe deposit of BBOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. [J Notice of References Cited (PTO-892)
`2. [X] Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. [] Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [ Interview Summary (PTO-413),
`Paper No./Mail Date
`.
`
`5. Examiner's Amendment/Comment
`6. KJ Examiner's Statement of Reasons for Allowance
`
`7. Other
`
`.
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20150309
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 631
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 631
`
`

`

`Application/Control Number: 12/337,144
`Art Unit: 1627
`
`Page 2
`
`DETAILED ACTION
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`Requestfor Continued Examination
`
`A requestfor continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), wasfiled in this application after allowance or after an Office
`
`action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm’Pat. 1935). Since
`
`this application is eligible for continued examination under 37 CFR 1.114, and the fee
`
`set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has
`
`been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 11/17/2014
`
`has been entered.
`
`REASONS FOR ALLOWANCE
`
`The following is an examiner's statement of reasons for allowance: please see
`
`the original Notice for Allowance given on 6/25/2013.
`
`It is noted that Applicants have filed an IDS, which has been considered and no
`
`art was foundto be relevantto the present invention.
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the paymentof the issue fee and, to avoid processing delays, should preferably
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 632
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 632
`
`

`

`Application/Control Number: 12/337,144
`Art Unit: 1627
`
`Page 3
`
`accompanythe issue fee. Such submissions should beclearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`Conclusion
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Renee Claytor whose telephone numberis (571)272-
`
`8394. The examiner can normally be reached on M-F 8:00-4:30.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Sreeni Padmanabhan can be reached on 571-272-0629. The fax phone
`
`numberfor the organization wherethis application or proceeding is assigned is 571-
`
`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on accessto the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automatedinformation
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/Renee Claytor/
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 633
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 633
`
`

`

`Application/Control Number: 12/337,144
`Art Unit: 1627
`
`Primary Examiner, Art Unit 1627
`
`Page 4
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 634
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 634
`
`

`

`PTO/SB/08A (08-00)
`Approved for use through 10/31/2002. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respond to a collection of information unlessit displays a valid OMB control number.
`Substitute for form 1449A/PTO
`
`INFORMATION DISCLOSURE
`Claytor, Deirdre
`Examiner Name
`STATEM ENT BY APPLICANT
`
`{use as many sheets as necessary) Attorney Docket Number|PRD2901USNP
`
`Sheet 1 of 1
`
`First NamedInventor
`
` 03/09/2015
`
`
`Examiner’s
`Initials*
`
`.
`
`OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS
`
`Include nameof the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published
`Kazuo YAMADAetal., Future Potentiality of Pharmacotherapy for
`Schizophrenia in Acute Phase, Clinical Psychopharmacology, Vo. 8, No. 10
`(2005), pp.1563-1568
`
`Examiner
`Signature
`
`|
`
`Date
`Considered
`
`*EXAMINER: Initial if reference considered, whetheror notcitation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /R.C,/
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 635
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 635
`
`

`

`
`
`Application/Control No.
`
`Search Notes
`
`12337144
`
`Applicant(s)/Patent Under
`Reexamination
`VERMEULEN ET AL.
`
`
`
`il Ml |
`Art Unit
`ll _—
`
`
`Renee Claytor
`
`1627
`
`3/9/2015
`
`REISSOF31/519
`
`—aoeee
`
`CPC- SEARCHED
`
`CPC COMBINATION SETS - SEARCHED
`
`Search Notes|Date|_——sExaminer_|
`PALM Inventor Search
`3/9/2015
`EAST(updated)
`3/9/2015
`
`SEARCH NOTES
`
`INTERFERENCE SEARCH
`
`
`
`US Class/ US Subclass / CPC Group|Date|Examiner
`
`CPC Symbol
`A61K
`
`31/519
`
`US: Ratent and Trademark Office
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part’Spo636°"
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 636
`
`

`

`PTO/SB/08A (08-00)
`Approved for use through 10/31/2002. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respond to a collection of information unlessit displays a valid OMB control number.
`Substitute for form 1449A/PTO
`Application Number
`12/337,144
`
`INFORMATION DISCLOSURE
`Claytor, Deirdre
`Examiner Name
`STATEM ENT BY APPLICANT
`
`{use as many sheets as necessary) Attorney Docket Number|PRD2901USNP
`
`Sheet 1 of 1
`
`OTHERPRIOR ART - NON PATENT LITERATURE DOCUMENTS
`
`Examiner’s
`Initials*
`
`Include nameof the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published
`Kazuo YAMADAetal., Future Potentiality of Pharmacotherapy for
`Schizophrenia in Acute Phase, Clinical Psychopharmacology, Vo. 8, No. 10
`(2005), pp.1563-1568
`Takashi YOSHIO, Sustained-release Antipsychotic Drugs (depot drugs),
`Psychiatric Nursing, Vol. 33, No.4 (2006), pp.64-67
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Examiner
`
`i
`.
`Renee Claytor/
`
`Date
`
`.
`03/09/2015
`
`*EXAMINER: Initial if reference considered, whetheror notcitation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /R.C./
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 637
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 637
`
`

`

`EAST Search History
`
`EAST Search History
`
`EAST Search History (Prior Art)
`
`‘Plurals Time
`{Search Query
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`3JPO; DERWENT
`
`
`
`%US-PGPUB; USPAT; EPO
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`uJPO; DERWENT
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`uJPO; DERWENT
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`
`
`;
`%JPO; DERWENT
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`
`
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`;
`%JPO; DERWENT
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`4JPO; DERWENT
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`yJPO; DERWENT
`
`(usPGPUB; USPAT; EPO;
`
`file:///Cl/Users/dclaytor/Documents/e-Red% 20Folder/12337 144/EASTSearchHistory.12337144_AccessibleVersion.htm[3/9/2015 11:58:48 AM]
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 638
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 638
`
`

`

`EAST Search History
`
`
`(2013/06/14:
`
`4US-PGPUB; USPAT; EPO;
`
`|US-PGPUB; USPAT; EPO;
`dJPO; DERWENT
`%US-PGPUB; USPAT; EPO;
`uJPO; DERWENT
`%US-PGPUB; USPAT; EPO;
`%JPO; DERWENT
`%US-PGPUB; USPAT; EPO;
`4JPO; DERWENT
`%US-PGPUB; USPAT; EPO;
`4JPO; DERWENT
`¥US-PGPUB; USPAT; EPO;
`yJPO; DERWENT
`JUS-PGPUB; USPAT; EPO;
`|JPO; DERWENT
`
`2014/08/11.
`(13:55
`5
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`3/9/2015 11:58:46 AM
`C:\ Users\ dclaytor\ Documents\ EAST\ Workspaces\ 337144.wsp
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 639
`file:///Cl/Users/dclaytor/Documents/e-Red% 20Folder/12337 144/EASTSearchHistory.12337144_AccessibleVersion.htm[3/9/2015 11:58:48 AM]
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 639
`
`

`

`Application/Control No.
`
`Index of Claims
`
`12337144
`
`Examiner
`
`RENEE CLAYTOR
`
`= Allowed | Restricted
`
`Applicant(s)/Patent Under
`Reexamination
`VERMEULEN ETAL.
`
`.D.
`
`1.
`
`Rejected | Cancelled
`
` (1 Claims renumberedin the sameorderas presented by applicant
`
`CLAIM
`Final|Original_[07/01/2010|12/03/201006/28/2011]06/14/2013[os/tv/2o14|osiosizo15|||
`to
`20|2|
`sf st
`of 4teTPwe
`sf 5| Ewee
`PoefeTE
`Po?ww
`Poets
`eeeeeeee Po
`Pte
`Poe
`Pr]NN
`SR|=| a
`a a
`Ptstw
`Potsts
`90ofa
`tof te
`moot tePe
`maf 2fe
`Se a
`woofer
`posteTN
`woofet
`PetEw
`PoetEw
`Poem
`Poet
`PoetEw
`PposoteENEN
`PostteEw
`PsatEN
`st oe|weTEwe
`
`U.S. Patent and TrademarkOffice
`
`Part of Paper No.
`
`: 20150309
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 640
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 640
`
`

`

`PTO/SB/30EFS (07-09)
`Doc code: RCEX
`Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Request for Continued Examination (RCE)
`U.S. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`
`
`
`REQUEST FOR CONTINUED EXAMINATION(RCE)TRANSMITTAL
`(Submitted Only via EFS-Web)
`
`Application|49/337,144 2008-12-17 Docket Number| 5 2n2901USNP
`
`
`Number (if applicable)
`
`First Named An Vermeulen
`Examiner
`Claytor, D. Renee
`
`Inventor Name
`
`This is a Request for Continued Examination (RCE) under 37 CFR 1.114 of the above-identified application.
`Request for Continued Examination (RCE) practice under 37 CFR 1.114 does not apply to any utility or plant application filed prior to June 8,
`1995, or to any design application. The Instruction Sheet for this form is located at WWW.USPTO.GOV
`
`SUBMISSION REQUIRED UNDER 37 CFR 1.114
`
`
`Note: If the RCE is proper, any previously filed unentered amendments and amendments enclosed with the RCE will be entered in the order
`in which they werefiled unless applicant instructs otherwise. If applicant does not wish to have any previously filed unentered amendment(s)
`entered, applicant must request non-entry of such amendmenit(s).
`Cc Previously submitted. If a final Office action is outstanding, any amendmentsfiled after the final Office action may be considered as a
`submission evenif this box is not checked.
`
`[_] Consider the arguments in the Appeal Brief or Reply Brief previously filed on
`
`[|] Other
`
`[X] Enclosed
`
`Amendment/Reply
`
`Information Disclosure Statement (IDS)
`
`Affidavit(s)/ Declaration(s}
`
`Other
`
`Application Data Sheet
`
`MISCELLANEOUS
`
`O Suspension of action on the above-identified application is requested under 37 CFR 1.103(c) fora period of months
`(Period of suspension shall not exceed 3 months; Fee under 37 CFR 1.1 7{i) required)
`
`[|] Other
`
`
`
`[] Applicant Signature
`
`The RCE fee under 37 CFR 1.17(e) is required by 37 CFR 1.114 when the RCE is filed.
`The Director is hereby authorized to charge any underpaymentof fees, or credit any overpayments, to
`Deposit Account No
`100750
`
`FEES
`
`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT REQUIRED
`
`Patent Practitioner Signature
`
`EFS - Web 2.1.15
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 641
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 641
`
`

`

`PTO/SB/30EFS (07-09)
`Doc code: RCEX
`Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Request for Continued Examination (RCE)
`U.S. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`
`
`Signature of Registered U.S. Patent Practitioner
`
`
`
`This collection of information is required by 37 CFR 1.114. The information is required to obtain or retain a benefit by the public whichis to
`file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is
`estimated to take 12 minutes to complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time
`will vary depending uponthe individual case. Any comments on the amountof time you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce,
`P.O. Box 1450, Alexandria, VA 22313-1450.
`if you need assistance in completing the form, calif 1-800-PTO-9199 and select option 2.
`
`EFS - Web 2.1.15
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 642
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 642
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be
`advised that:
`(1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information
`solicited is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office
`is to process and/or examine your submission related to a patent application or patent.
`If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonmentof the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information
`Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Departmentof Justice to determine whether the Freedom of Information Act requires disclosure of these records.
`
`enforcement agency, if the USPTO becomesaware of a violation or potential violation of law or regulation.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`requestinvolving an individual, to whom the record pertains, when the individual has requested assistance from the
`Memberwith respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need
`for the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization,
`pursuant to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services,
`or his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may
`be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record wasfiled in an
`application which became abandonedorin which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`
`EFS - Web 2.1.15
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 643
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 643
`
`

`

`CERTIFICATE OF EFS TRANSMISSION
`I hereby certify that this paper
`(along with any paper referred to as being attached
`or enclosed)
`is being transmitted to the United States Patent and Trademark Office on
`
`the date shown below via the “Electronic Filing System” in accordance with 37 C.F.R.
`§ 1.6(a) (4).
`
`Docket No. PRD2901USNP
`
`Signature
`
`Kristin Miele
`
`Type or print name
`
`/Kristin Miele/
`
`June 12, 2015
`
`IN THE UNITED STATES PATENT AND TRADEMARKOFFICE
`
`Applicants:
`
`An Vermeulen etal.
`
`Art Unit:
`
`1627
`
`Serial No.:
`
`12/337,144
`
`Examiner:
`
`Claytor, D.
`
`Filed:
`
`12/17/2008
`
`Confirmation Number: 3172
`
`For:
`
`DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE PALIPERIDONE
`ESTERS
`
`IDS
`Mail Stop:
`Commissioner for Patents
`P. O. Box 1450
`Alexandria, VA 22313-1450
`
`SUPPLEMENTAL INFORMATION DISCLOSURE STATEMENT
`
`Dear Sir:
`
`This copy is supplemental to the Information Disclosure Statementsfiled on April
`
`11, 2011, December 12, 2011, September 18, 2013, November 17, 2014 and December5,
`
`2014.
`
`Pursuant to 37 C.F.R. §1.56 and in accordancewith 37 C.F.R. §§1.97-1.98,
`
`information relating to the above-identified application is hereby disclosed.
`
`Inclusion of
`
`information in this statement is not to be construed as an admission that this information is
`
`material as that term is defined in 37 C.F.R. §1.56(b).
`
`Applicant(s) reserve(s) the right to establish the patentability of the claimed
`
`invention over anyof the information provided herewith, and/or to prove that this
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 644
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1019 Part 3, p. 644
`
`

`

`information may not beprior art, and/or to provethatthis information may not be enabling
`
`for the teachings purportedly offered.
`
`Docket Number: PRD2901USNP
`
`This statement should not be construed as a representation that a search has been
`
`made, orthat information more material to the examination of the present patent
`
`application does notexist.
`
`Xx
`
`In accordance with §1.97(b), since this Information Disclosure Statementis
`
`being filed either within three months ofthe filing date of the above-identified national
`
`application (other than a continued prosecution application under §1.53(d)), within three
`
`months of the date of ent

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