UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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
`
`90/013,709
`
`04/29/2016
`
`RE38551
`
`34323-001 ReEXam
`
`7135
`
`COVINGTON & BURLING, LLP
`Attn: Patent Docketing
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001-4956
`
`RA1LEYa JOHNNYF
`
`3991
`
`MAIL DATE
`
`06/ 16/2016
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`ARGENTUM PHARMACEUTICALS LLC
`
`|PR2016—00204 - Exhibit 1047 p.1
`
`IPR2016-00204 - Exhibit 1047 p.1
`
`

`
` TJNI TED S '.['ATE'.~'_-1 PATEN T AND TRADEI1-‘IARK QFFI CE
`
`Cornrnis-sinner for Patents
`United States Patent and Tradernark Office
`F'.O. Elo;~c145I:i
`Alexaridria, VA 2231 3-1 450
`vuvu-wuspro.gmr
`
`DO NOT USE IN PALM PRINTER
`
`(THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS)
`
`ANDREWS KURTH LLP
`
`1350 I Street, NW
`
`Suite 1100
`
`Washington, DC 20005
`
`EX PARTE REEXAMINATION COMMUNICATION TRANSM|'|'|'AL FORM
`
`REEXAMINATION CONTROL NO. 90/013 709.
`
`PATENT NO. RE38551 ETAL..
`
`ART UNIT 3991.
`
`Enclosed is a copy of the latest communication from the United States Patent and Trademark
`Office in the above identified ex parte reexamination proceeding (37 CFR 1.550(f)).
`
`Where this copy is supplied after the reply by requester, 37 CFR 1.535, or the time for filing a
`reply has passed, no submission on behalf of the ex parte reexamination requester will be
`acknowledged or considered (37 CFR 1.550(g)).
`
`PTOL—465 (Rev.07—04)
`
`|PR2016—00204 - Exhibit 1047 p.2
`
`IPR2016-00204 - Exhibit 1047 p.2
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`The present application is being examined under the pre-AIA first to invent provisions.
`
`Procedural Posture
`
`The Third Party Request filed on 29 April 2016 for exparte reexamination of claims 1-13 of
`
`United States Reissued Patent No. RE38,551 E to Kohn is acknowledged. The current Request has been
`
`assigned Control No. 90/013,709.
`
`Decision Granting Ex Parte Reexamination
`
`A substantial new question of patentability (SNQ) affecting claims 1-13 of United States Reissued
`
`Patent No. RE38,551 E is raised by the request for reexamination.
`
`Claims 1-13 of United States Reissued Patent No. RE38,551 E are currently subject to
`
`reexamination proceedings hereinbelow.
`
`Status of Claims
`
`Priority
`
`The application Serial No. 10/058,634 that issued as United States Reissued Patent No. RE38,551
`
`E was filed on 28 January 2002 and is a reissue of United States Patent 5,773,475, issued on 30 June
`
`1998 from application Serial No. 08/818,688, filed on 17 March 1997. Application Serial No. 08/818,688
`
`claims benefit of provisional U.S. Application Serial No. 60/013,522, filed on 15 March 1996.
`
`Information Disclosure Statement
`
`The Information Disclosure Statement (Substitute for Form 1449/PTO) filed on 25 March 2016
`
`has been considered.
`
`Substantial New Question of Patentability (SNQ) Raised By the Request
`
`For "a substantial new question of patentability" to be present, it is only necessary that:
`
`A.
`
`The prior alt patents and/or printed publications raise a substantial question of patentability
`regarding at least one claim i.e. the prior art teaching is such that there is a substantial likelihood
`that a reasonable examiner would consider the teaching to be impoitant in deciding whether or
`not the claim is patentable; and it is not necessary that the prior alt establish a prima facie case
`of unpatentability and;
`
`|PR2016—00204 - Exhibit 1047 p.3
`
`IPR2016-00204 - Exhibit 1047 p.3
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 3
`
`B.
`
`The same question of patentability as to the claim has not been decided by the Office in a
`previous examination or pending reexamination of the patent or in a final holding of invalidity by
`the Federal Coults in a decision on the merits involving the claim. See MPEP 2242.
`
`For a reexamination that was ordered on or after November 2, 2002 (the date of enactment of
`Public Law 107-273; see Section 13105, of the Patent and Trademark Office Authorization Act of 2002),
`reliance so/e/yon old alt (as the basis for a rejection) does not necessarily preclude the existence of a
`substantial new question of patentability (SNQ) that is based exclusively on that old alt. Determinations
`on whether a SNQ exists in such an instance shall be based upon a fact-specific inquiry done on a case-
`by-case basis. For example, a SNQ may be based solely on old alt where the old alt is being
`presented/viewed in a new light, or in a different way, as compared with its use in the earlier concluded
`examination(s), in view of a material new argument or interpretation presented in the request. MPEP
`2258.01.
`
`Patented claims - United States Reissued Patent No. RE38,551 E
`
`The patent consists of claims 1-13. Of the claims under reexamination, claim 1 is the only
`
`independent claim and is drawn to a compound:
`
`[1 ..Ava:s::s‘mgmté.§§;§. in
`
`R §£f:$£1‘§}j§IEil§;8ilisfm
`
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`
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`Documents Cited in the Ex Parte Reexamination Request
`
`U.S. Patent 5,654,301. (5 August 1997). Kohn. [“The ‘301 Patent”]
`
`U.S. Patent 5,378,729. (3 January 1995). Kohn et a/. [“The ‘729 Patent”]
`
`Kohn et a/. (1991). “Preparation and Anticonvulsant Activity of a Series of Functionalized o-
`Heteroatom-Substituted Amino Acids,”J. Med. Chem. 34:2444-2452. [“Kohn 1991”]
`
`LeGa|| (December 1987). “2-Substituted-2-acetamido-u-benzylacetamides. Synthesis,
`Spectroscopic and Anticonvulsant Propelties,” A Thesis Presented to the Faculty of the
`Depaltment of Chemistry. University of Houston-University Park. [“LeGa||”]
`
`|PR2016-00204 - Exhibit 1047 p.4
`
`IPR2016-00204 - Exhibit 1047 p.4
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 4
`
`Discussion of Documents Cited in the Ex Parte Reexamination Request
`
`The Requester considers that a substantial new question of patentability of claims 1-13 of the
`United States Reissued Patent No. RE38,551 E is raised by the combined teachings of The ‘301
`Patent, The ‘729 Patent, Kohn 1991, and LeGa||.
`
`The teachings of The ‘301 Patent, The‘729 Patent, Kohn 1991, and LeGa|| are discussed
`
`in the request at pages 37-66. The ‘301 Patent, The ‘729 Patent, and Kohn 1991 were each cited during
`
`the prosecution of the United States Reissued Patent No. RE38,551 E but were not applied in a ground of
`
`rejection. LeGa|| was not cited during that prosecution. Thus, the SNQ cited by the third paity requester
`
`is not solely based upon previously considered prior alt.
`
`The ‘301 Patent discloses amino acid derivative anticonvulsant compounds, compositions and
`
`methods of treating CNS disorders using these compounds. Claim 39 recites a general formula and claims
`
`40-47 recite specific designations as follows:
`
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`
`|PR2016—00204 - Exhibit 1047 p.5
`
`IPR2016-00204 - Exhibit 1047 p.5
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 5
`
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`The ‘729 Patent teaches amino acid derivative anticonvulsant compounds, compositions and
`
`methods of treating CNS disorders using these compounds. Claim 1 is illustrative:
`
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`
`|PR2016—00204 - Exhibit 1047 p.6
`
`IPR2016-00204 - Exhibit 1047 p.6
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 6
`
`The ‘729 patent teaches that R is benzyl, R1 is methyl, R2 is hydrogen, R3 is methyl and n is 1 or
`
`the D or L stereoisomer. The compounds tested in Table I all contain an unsubstituted methyl and 90%
`
`contain an unsubstituted benzyl at the R position. The R-isomers of similar compounds are ten times
`
`more active than their corresponding S-isomer. Stereoisomers are separated by recognized techniques
`
`known in the art, including fractional crystallization and chiral chromatography. The anti-convulsant
`
`composition contains an effective amount of the anti-convulsant with a pharmaceutically active carrier. It
`
`is used to treat epilepsy and central nervous system disorders. The oral dosage unit form is between
`
`about 5 and 1000 mg of the active compound. See the ‘729 patent claims 1, 18, and 132; column 3 lines
`
`9-17 and lines 35-40; column 5, lines 17-19; column 10, line 28; column 15, line 31 through column 16,
`
`line 47; column 17, line 13 and lines 53-58; column 18, lines 12-16; column 58, lines 1-3; and Table I.
`
`Kohn 1991 teaches anticonvulsant compounds. “Potent protection against maximal electroshock
`
`seizures (MES) in mice was observed for functionalized amino acid racemates containing both an IV-
`
`benzylamide moiety and an acetylated amino group.” See page 2444, first column. See the compound
`
`shown:
`
`‘F
`9
`GH:.Cb!§i-l:|l-iiiii-ECH;-®
`
`H C:
`
`‘
`
`ea, 3*. -Di-I,
`H Hit Pill
`: R’- 2-piwoiyl
`;1 Fl’: E-luranyl
`
`The potent activity is achieved when a benzyl is on one end of the functionalized amino acid and a
`
`methyl is on the other end. All 26 compounds found in Table 1 on page 2445 show an unsubstituted
`
`benzyl at R and an unsubstituted methyl at R1. Comparison of enantiomers 2a, b, and d revealed that in
`
`each case the anticonvulsant activity resided primarily in the R stereoisomer. See page 2444, first
`
`column.
`
`LeGa|| discloses compound 107e, which contains a methoxymethyl (-CHZOCH3) at the R position.
`
`See page 133, Table 35 and page 137, Table 36. This position corresponds to the R3 position of the
`
`compound of The '301 Patent. Compound 107e has a more lipophilic methoxy ether and its close
`
`structural analogy to compound 86b suggests that this adduct may have good anticonvulsant activity.
`
`See page 155, lines 10-13. Compounds are selected and tested to delineate the structure-activity
`
`relationship of this novel class of antiepileptic compounds. See page 43.
`
`|PR2016-00204 - Exhibit 1047 p.7
`
`IPR2016-00204 - Exhibit 1047 p.7
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 7
`
`There is a substantial likelihood that a reasonable examiner would consider the teachings of The
`
`‘301 Patent, The ‘729 Patent, Kohn 1991, and LeGa|| important in deciding the patentability of claims 1-
`
`13 of United States Reissued Patent No. RE38,551 E, which question had not been decided in a previous
`
`examination of this patent.
`
`Conclusion
`
`In view of the above, the Request for expa/Te Reexamination is GRANTED.
`
`Claims 1-13 of United States Reissued Patent No. RE38,551 E will be reexamined.
`
`Extensions of Time
`
`Extensions of time under 37 CFR 1.136(a) will not be permitted in these proceedings because the
`provisions of 37 CFR 1.136 apply only to "an applicant" and not to parties in a reexamination proceeding.
`Additionally, 35 U.S.C. 305 requires that expa/Te reexamination proceedings "will be conducted with
`special dispatch" (37 CFR 1.550(a)). Extensions of time in exparte reexamination proceedings are
`provided for in 37 CFR 1.550(c).
`
`Duty to Disclose
`
`The patent owner is reminded of the continuing responsibility under 37 CFR 1.565(a) to apprise
`the Office of any litigation activity, or other prior or concurrent proceeding, involving United States
`Reissued Patent No. RE38,551 E throughout the course of this reexamination proceeding. The third party
`requester is also reminded of the ability to similarly apprise the Office of any such activity or proceeding
`throughout the course of this reexamination proceeding. See MPEP §§ 2207, 2282 and 2286.
`
`Waiver of Right to File Patent Owner Statement
`
`During a telephone conversation held with patent owner's representative Andrea G. Reister on 9
`May 2016, the patent owner did not agree to waive the right to file a patent owner's statement under 35
`USC 304 in the event reexamination is ordered for the above identified patent. See the paper mailed 18
`May 2016. An action on the merits will follow the order.
`
`Amendment in Reexamination Proceedings
`
`Patent owner is notified that any proposed amendment to the specification and/or claims in this
`reexamination proceeding must comply with 37 CFR 1.530(d)-(j), must be formally presented pursuant to
`37 CFR 1.52(a) and (b), and must contain any fees required by 37 CFR 1.20(c).
`
`Future Correspondence
`
`Any inquiry concerning this communication or earlier communications from the examiner should
`be directed to Johnny F. Railey II whose telephone number is (571) 272-0985. The examiner can
`normally be reached on Monday through Thursday from 9:00 a.m. to 6:30 p.m. The examiner can also
`be reached on alternate Fridays.
`
`|PR2016—00204 - Exhibit 1047 p.8
`
`IPR2016-00204 - Exhibit 1047 p.8
`
`

`
`Application/Control Number: 90/013,709
`
`Art Unit: 3991
`
`Page 8
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor,
`Jean C. Witz, can be reached on (571) 272-0927. The fax phone number for the organization where this
`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://poitaI.uspto.gov/external/poital. Should you have questions on access to the Private PAIR system,
`contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
`
`All correspondence relating to this expa/Te reexamination proceeding should be directed to:
`
`By EFS:
`
`Registered users may submit via the electronic filing system EFS-Web at:
`
`.bags;fieis._u§9:g..g.@y1s:fi_i§.{_n1v..m:2fia_Mef§_:_::§gi§ir:e:§gi.
`
`By mail to:
`
`Mail Stop EX Parte Reexam
`Central Reexamination Unit
`Commissioner for Patents
`United States Patent & Trademark Office
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`By hand:
`
`Customer Service Window
`Randolph Building
`401 Dulany Street
`Alexandria, VA 22314
`
`/Johnny F. Railey II/
`Patent Reexamination Specialist
`CRU - Art Unit 3991
`
`/Jean C. Witz/
`Supervisory Patent Reexamination Specialist
`CRU - Alt Unit 3991
`
`/Stephen Stein/
`Supervisory Patent Reexamination Specialist
`CRU - Alt Unit 3991
`
`|PR2016-00204 - Exhibit 1047 p.9
`
`IPR2016-00204 - Exhibit 1047 p.9
`
`

`
`Control No.
`
`Patent Under Reexamination
`
`.
`Order Granting Request For
`Ex Parte Reexamination
`
`9o/013,709
`E
`_
`"""“'"°'
`JOHNNY F. RAILEY II
`
`RE38551 ET AL.
`A U _
`" ""
`3991
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`
`The request for ex parte reexamination filed 29 April 2016 has been considered and a determination has
`been made. An identification of the claims, the references relied upon, and the rationale supporting the
`determination are attached.
`
`Attachments: a)I:I PTO-892,
`
`b)I:I PTO/SB/O8,
`
`c)X| Other: PTO 1449 substitute
`
`1. IX] The request for exparte reexamination is GRANTED.
`
`RESPONSE TIMES ARE SET AS FOLLOWS:
`
`For Patent Owner's Statement (Optional): TWO MONTHS from the mailing date of this communication
`(37 CFR 1.530 (b)). EXTENSIONS OF TIME ARE GOVERNED BY 37 CFR 1.550(c).
`
`For Requester's Reply (optional): TWO MONTHS from the date of service of any timely filed
`Patent Owner's Statement (37 CFR 1.535). NO EXTENSION OF THIS TIME PERIOD IS PERMITTED.
`If Patent Owner does not file a timely statement under 37 CFR 1.530(b), then no reply by requester
`is permitted.
`
`if third art
`cc:Reuester
`U.S. Patent and Trademark Office
`
`reuester
`
`PTOL-471G(Rev. 01-13)
`
`Office Action in Ex Parte Reexamination
`
`Part of Paper No. 20160520
`
`|PR2016—00204 - Exhibit 1047 p.10
`
`IPR2016-00204 - Exhibit 1047 p.10
`
`

`
`Search NOTES
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`90013709
`
`RE38551 ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under
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`IPR2016-00204 - Exhibit 1047 p.11
`
`

`
`Reexamination
`
`Application/Control No.
`
`90013709
`
`App|icant(s)/Patent Under
`Reexamination
`RE38551 ET AL.
`
`Requester Correspondence Address:
`
`|:|
`
`Patent Owner
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`IXI Third Party
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`Washington, DC 20005
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`ANDREWS KURTH LLP
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`1350 I Street, NW
`Suite 1100
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`LITIGATION REVIEW XI
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`
`/J.R./
`(examiner initials)
`
`05/20/2016
`(date)
`Director Initials
`
`1:14cv834 (open); 1:13cv5514 (closed)
`
`1:13ov1206 (open); 1:13ov1207 (open); 1:13ov1208 (open)
`
`1:13ov1209 (open); 1:13ov1210 (open); 1:13ov1211 (open)
`
`1:13ov1212 (closed); 1:13ov1213 (closed); 1:13ov1214 (open)
`
`1 :13cv1215 (closed); 1 :13cv1216 (closed); 1 :13ov1217 (closed)
`
`1:13ov1218 (closed); 1:13ov1219 (open); 1:13ov1220 (open)
`
`1:13cv1148(c|osed);1:13ov4021 (closed); 3:13ov4021 (open)
`
`TYPE OF PROCEEDING
`
` COPENDING OFFICE PROCEEDINGS
`
`|PR2014-01 126 (open)
`
`|PR2016-00204 (open)
`
`2.
`
`IPR
`
`U.S. Patent and Trademark Office
`
`|PR2016—00204 - Exhibit 1047 p.12
`DOC. CODE RXFILJKT
`
`IPR2016-00204 - Exhibit 1047 p.12
`
`

`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.R../’
`
`90013709 - GAU: 3991
`
`Substitute for form 1449lPTO
`INFORMATION DISCLOSURE
`
`smremeur av APPLICANT
`.
`_
`Date Submitted. March 25 2016
`(use as many sheets as necessary)
`
`A Iication Number
`
`Filing Date
`First Named Inventor
`
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`New ReExam A Iication
`
`Kohn
`Central Reexam Unit
`Railey
`Unassined
`34323-001 ReExam (226355)
`
`A. A‘
`
`Document Number
`
`Number-Kind code? (if known)
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant of
`Cited Document
`
`u.s. Patent No. RE3B,551
`u.s. Patent No. 5,773,475
`U.S. Patent Application No. 08/818,688
`U.S. Patent No. 5,373,729
`US. Patent No. 5.654.301
`
`Jul. 6, 2004
`Jun. 30, 1998
`Kohn
`Jun 30, 1998
`Kohn et al.
`Jan. 3, 1995
`Au. 5. 1997 I
`
`Sheet
`
`Examiner
`
`'”“ia'5*
`
`FOREIGN PATENT DOCUMENTS
`
`Foreign Patent Document
`
`Examiner
`
`-
`
`'
`
`L
`3
`Country Code Number Kind Code
`(if known)
`
`5
`
`Pnl;'|:i|i_°SgE’,'(1Y|2(a;t(e
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns,
`Lines, Where
`Relevant
`Passages Or
`Relevant Figures
`Appear
`
`Examiner
`
`Include name of the author (in CAPITAL LE'|'l'ERS), 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 andior country where
`published.
`
`NON PATENT LITERATURE DOCUMENTS
`
`Declaration of Dr. Binghe Wang from |PR2016—00204
`
`Declaration of Dr. Clayton Heathcock from |PR2D14—01126
`
`Joint Statement of Uncontested Facts, UCB, Inc. v. Accord Heaithcare inc., 1:13—cv—01206 (D. Del. Oct. 26,
`2015)
`
`District Court Claim Construction Opinion, , UCB, inc. v. Accord Healthcare lnc., 1:13-cv-01206 (D. Del. May
`14, 2015)
`
`Philippe LeGal|, 2-Substituted-2-acetamido-N-benzylacetamides. Synthesis, Spectroscopic and
`Anticorrvulsant Properties (Dec. 1987)
`
`Choi et al., Trimethyisilyl Haiides: Effective Reagents for the Synthesis of[3-Halo Amino Acid Derivatives,
`Tet. Lett., Vol. 36(39), pg. 7011 (1995)
`
`1007
`
`1008
`
`1010
`
`1011
`
`Purdie et a.l., The Aikylation of Sugars, J.A.C.S.Vo|. 83, pg. 1021 (1903)
`
`Examiner
`
`Date
`
`..
`
`
`
`‘EXAMINER: Initial if reference considered, whether or not citation 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. ‘Applicant's unique citation designation number (optional). 2See Kinds Codes of
`USPTO Patent Documents at www.usgto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two—|etter code (WIPO Standard ST.3). 4 For
`Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document. 5Kind of document
`by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. E-‘Applicant is to place a check mark here if English language
`Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by
`the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments
`on the amount of time you require to complete this form andior suggestions for reducing this burden, should be sent to the Chief Information Oflicer, U.S. Patent
`and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO:
`Commissioner for Patents, P.0. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1«S0O—PTO—9199 (1—800—786—9199) and select option |PR20 1 6—0O204 - Exhibit 1 047 p. 1 3
`
`IPR2016-00204 - Exhibit 1047 p.13
`
`

`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`90013709 - GAU: 3991
`
`Sheet
`
`Examiner
`Initials‘
`
`Substitute for form 1449lPTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`.
`_
`Date Submitted. March 25 2016
`(use as many sheets as necessary)
`
`A Iication Number
`Filing Date
`First Named Inventor
`
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`New ReExam A Iication
`Herewith
`Kohn
`3-931
`Central Reexam Unit
`Ra ilgy
`Unassined
`34323-001 ReExam (226355)
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of 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 andlor country where
`published.
`
`Kohn et al., Preparation and Anticonvulsant/tctivity of a Series of Functionalized a-Heteroatom-Substituted
`Amino Acids, J. Med. Chem. Vol. 34, pg. 2444 (1991)
`
`Silverman, R. B., The Organic Chemistry of Drug Design and Drug Action, Academic Press (1992)
`
`Development of New Stereoisomeric Drugs, U.S. F.D.A., May 1, 1992
`
`Cortes et al., Effect of Structural Modification of the Hydantoin Ring on AnticonvulsantActivity, J. Med.
`Chem., Vol. 28, pg. 601 (1985)
`
`LeGal| et al., Synthesis of Functionalized Non-Natural Amino Acid Derivatives via Amidoalkylation
`Transformations, Int. J. Peptide Protein Res. Vol. 32, pg. 279 (1988)
`
`Kohn et al., Synthesis and AnticonvulsantActivities of a-Heterocyclic a-Acetamido-N-benzylacetamide
`Derivatives, J. Med. Chem. Vol. 36, pg. 3350 (1993)
`
`Kohn et al., Preparation and Anticonvulsant/tctivity of a Series of Functionalized a—Aromatic and a-
`Heteroaromatic Amino Acids, J. Med. Chem. Vol. 33, pg. 919 (1990)
`
`Patent Term Extension Request in U.S. Patent No. 5,654,301 filed on December 23, 2008
`
`FDA Guideline for Industry, November 1994
`
`Schmidt, R., Dose-Finding Studies in Clinical Drug Development, Eur. J. Clin. Pharmacol, Vol. 34, pg. 15
`(1988)
`
`lsbell, H. S., The Optical Rotation of the Various Asymmetric Carbon Atoms in the Hexose and Pentose
`Sugars, B. S. Jour. Research, Vol. 5, pg. 1041 (1929)
`
`Wilson and Gisvold’s Textbook of Organic Medicinal Chemistry, Physicochemical Properties in Relation to
`Biologic Action, (Delgado J. N. 8. Remers W. A., eds. 1991)
`
`Thornber, C. W., lsosterism and Molecular Modification in Drug Design, Chem. Soc. Rev., Vol. 8(4) (1979)
`
`Reissue Declaration in Reissue of U.S. Patent No. 5,773,475 executed on Jan. 7, 2002
`
`
`
`.
`Date
`Examiner
`05.1’ 2 0 /2 0 I 5
`Considered
`I" JOHNNY F RAILEY I: /
`Signature
`‘EXAMINER: Initial if reference considered, whether or not citation 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. ‘Applicant's unique citation designation number (optional). 2See Kinds Codes of
`USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two—|etter code (WIPO Standard ST.3). 4 For
`Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document. 5Kind of document
`by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. E-‘Applicant is to place a check mark here if English language
`Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by
`the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments
`on the amount of time you require to complete this form andlor suggestions for reducing this burden, should be sent to the Chief Information Oflicer, U.S. Patent
`and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1«S0O—PTO—9199 (1—800—786—9199) and select option IPRZO 1 6—0O204 - Exhibit 1 047 p. 1 4
`
`IPR2016-00204 - Exhibit 1047 p.14
`
`

`
`90013709 - GAU: 3991
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`Substitute for form 1449lPTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`.
`_
`
`Date Submitted. March 25 2016
`
`(use as many sheets as necessary)
`
`A Iication Number
`Filing Date
`First Named Inventor
`
`Complete if Known
`New ReExam A Iication
`Herewith
`Kohn
`
`Central Reexam Unit
`
`I it?‘
`
`Examiner Name
`Attorney Docket Number
`
`Railey
`Unassined
`34323-001 ReExam (226355)
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials‘
`
`Include name of 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 andlor country where
`published.
`
`Subpoena directed to The University of Houston, UCB, inc. v. Accord Healthcare lnc., 1:13-cv-01206
`
`Texas Public Information Act Requests and Responses
`
`Zhou et al., Decisions under Uncertainty: the Fuzzy Compromise Decision Support Problem, Eng. Opt. Vol.
`20, pg. 21 (1992)
`
`Mistree et al., A Decsion—Based Perspective for the Design of Methods for Systems Design, (1989)
`
`Mistree et al., A Decision-based Approach to Concurrent Design, Concurrent Engineering: Contemporary
`Issues and Modern Design Tools, (Parsaei, H. R. & Sullivan W. G. Eds. 1993)
`
`Ingram W. T., Concerning Periodic Points in Mappings of Continua, J. Am. Math. Soc, Vol. 104(2) (1938)
`
`Mattson, Current Challenges in the Treatment of Epilepsy, Neurology, Vol. 44(supp|. 5), pg. 84 (1994)
`
`Loscher et al., New Avenues for Anti-Epileptic Drug Discovery and Development, Nature Reviews: Drug
`Discovery, Vol. 12, pg. 12 (2013)
`
`Cohen authorized amendment in U.S. Patent Application No. 08/818,688
`
`File History of U.S. Patent Appl. No. 08/818,683
`
`FDA Orange Book for Vimpat®
`
`Excerpts from Trial Transcript of Dr. Harold Kohn Testimony, UCB, inc. v. Accord Healthcare Inc, 1:13-cv-
`01206 (D. Del. Nov. 10, 2015)
`
`Excerpts from Trial Transcript of Dr. William Roush Testimony, UCB, lnc. V. Accord Healtl1carelnc., 1:13—cv—
`01206 (D. Del. Nov. 10 and 12,2015)
`
`Excerpts from Trial Transcript of Defendants’ Opening Statement, UCB, inc. V. Accord Healthcare Inc., 1:13-
`cv-01206 (D. Del. Nov. 9, 2015)
`
`Date
`Examiner
`0
`9 5
`considered
`I I /I
`F
`/1
`Signatufe
`‘EXAMINER: Initial if reference considered, whether or not citation 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. ‘Applicant's unique citation designation number (optional). 2See Kinds Codes of
`USPTO Patent Documents at www.uspto.gov or MPEP 901.04. 3 Enter Office that issued the document, by the two—|etter code (WIPO Standard ST.3). 4 For
`Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document. 5Kind of document
`by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. I-‘Applicant is to place a check mark here if English language
`Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by
`the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments
`on the amount of time you require to complete this form andlor suggestions for reducing this burden, should be sent to the Chief Information Oflicer, U.S. Patent
`and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1«S0O—PTO—9199 (1—800—786—9199) and select option IPRZO I 6—0O204 - Exhibit I 047 p. I 5
`
`O
`
`,
`
`IPR2016-00204 - Exhibit 1047 p.15
`
`

`
`ALL REFERENCES CONSIDERED EXCEFT WHERE LINED THROUGH.
`
`/J..R./’
`
`90013709 - GAU: 3991
`
`Substitute for form 1449lPTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`.
`_
`Date Submitted. March 25 2016
`(use as many sheets as necessary)
`
`A Iication Number
`Filing Date
`First Named Inventor
`
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`New ReExam A Iication
`Herewith
`Kohn
`Central Reexam Unit
`Ra -1-lav
`Unassined
`34323-001 ReExam (226355)
`
`I it
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of 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 andlor country where
`published.
`
`Trial Transcript of Dr. Clayton Heathcock, Argentum Pharm. V. Research Corp. Techs, 13-1206-LPS (D.
`Del. Nov. 9, 2015).
`
`Sheet
`
`Examiner
`
`
`
`.
`D