Case 1:16-cv-01208-AJT-MSN Document 4 Filed 09/23/16 Page 1 of 1 PagelD# 22
`
`AO 120 (Rev. 08/10 )
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`Eastern District - Virginia (cid:9)
`on the following
`filed in the U.S. District Court (cid:9)
`q Trademarks or (cid:9) 2 Patents. ( q the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`1:16-cv-1208
`PLAINTIFF
`
`Eli Lilly and Company, et al.
`
`DATE FILED
`9/22/2016
`
`U.S. DISTRICT COURT
`Eastern District - Virginia
`
`DEFENDANT
`
`Cipla Limited, et al.
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 (cid:9) 6,943,166
`
`9/13/2005
`
`Lilly ICOS, LLC
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`n Amendment (cid:9)
`DATE OF PATENT
`OR TRADEMARK
`
`n Answer (cid:9)
`
`n Cross Bill (cid:9) q Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`1
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`I
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`0001
`
`MYLAN - EXHIBIT 1006
`
`(cid:9)
`

`
`Case 1:16-cv-01120-GBL-IDD Document 4 Filed 09/07/16 Page 1 of 1 PagelD# 32
`
`AO 120 (Rev. 08/10
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`Eastern District of Virginia (cid:9)
`filed in the U.S. District Court
`on the following
`q Trademarks or
`Patents. ( q the patent action involves 35 U.S.C:. § 292.):
`
`DOCKET NO.
`1 :16cv1120
`PLAINTIFF
`
`DATE FILED
`9/2/2016
`
`U.S. DISTRICT COURT
`Eastern District of Virginia
`
`DEFENDANT
`
`Eli Lilly and Company, et al.
`
`Alembic Pharmarceuticals Ltd., et al.
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 (cid:9) 6,943,166
`
`9/13/2005
`
`Lily ICOS LLC.
`
`2
`
`4
`
`5
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`q Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`q Answer (cid:9)
`
`n Cross Bill (cid:9)
`
`n Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`2
`
`1
`
`4
`
`5
`
`In the above entitled case. the following decision has been rendered or judgemei
`
`DECISION/JUDGEMENT
`
`CI.FTK
`Fernando Galindo
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1----Upon initiation of action, mail this copy to Director Copy 3--Upon termination of action, mail this copy to Director
`Copy 2 (cid:9) Upon riling document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`0002
`
`(cid:9)
`

`
`Case 1:16-cv-01122-LO-TCB Document 4 Filed 09/02/16 Page 1 of 1 PagelD# 33
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`Eastern District Virginia - Alexandria (cid:9)
`on the following
`filed in the U.S. District Court (cid:9)
`0 Patents. ( 0 the patent action involves 35 U.S.C. § 292.):
`
`0 Trademarks or (cid:9)
`
`DOCKET NO.
`1:16-cv-1122
`PLAINTIFF
`
`DATE FILED
`9/2/2016
`
`U.S. DISTRICT COURT
`Eastern District Virginia - Alexandria
`DEFENDANT
`
`Eli Lilly and Company, et al.
`
`Mylan Pharmaceuticals Inc.
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`I (cid:9) 6,943,166
`
`9/13/2005
`
`Eli Lilly and Company
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`• Amendment (cid:9)
`DATE OF PATENT
`OR TRADEMARK
`
`MI Answer (cid:9)
`
`• Cross Bill (cid:9)
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`I
`
`2
`
`3
`
`4
`
`5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`0003
`
`

`
`Trials@uspto.gov (cid:9)
`Tel: 571-272-7822 (cid:9)
`
`Paper 13
`Entered: September 1, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INTELGENX CORPORATION,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`
`Case IPR2016-00678
`Patent 6,943,166 B1
`
`Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`0004
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`INTRODUCTION
`
`IntelGenX Corporation ("Petitioner") filed a Petition (Paper 1, "Pet.")
`
`to institute an inter partes review of claims 1-12 of U.S. Patent No.
`
`6,943,166 B1 (Ex. 1001, "the '166 patent"). ICOS Corporation ("Patent
`
`Owner") timely filed a Preliminary Response. Paper 11 ("Prelim. Resp.").
`
`Based on this record, we determine Petitioner has not established a
`
`reasonable likelihood that it would prevail in showing the unpatentability of
`
`at least one challenged claim. See 35 U.S.C. § 314(a). Therefore, we deny
`
`institution of an inter partes review.
`
`Related Proceedings
`
`According to the parties, there are no related matters that would affect
`
`or be affected by this proceeding. Pet. 59; Paper 8, 2.
`
`The '166 Patent
`
`The '166 patent relates to a highly selective phosphodiesterase (PDE)
`
`enzyme inhibitor and its use in a pharmaceutical unit dosage form.
`
`Ex. 1001, Abstract, 1:14-16.
`
`Type 5 cGMP-specific PDE (PDE5) is an attractive target in the
`
`treatment of sexual dysfunction. Id. at 1:34-39. Before the '166 patent
`
`invention, a pharmaceutical product, which provides a PDE5 inhibitor, was
`
`available and marketed for treating male erectile dysfunction ("ED") under
`
`the trademark VIAGRA®. Id. at 1:41-43. The active ingredient in
`
`VIAGRA® is sildenafil. Id. at 1:43-44. According to the '166 patent,
`
`however, "[w]hile sildenafil has obtained significant commercial success, it
`
`has fallen short due to its significant adverse side effects." Id. at 1:58-60.
`
`The '166 patent discloses a pharmaceutical unit dosage composition
`
`comprising about 1 to about 20 mg of compound tadalafil, which has the
`
`2
`
`0005
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`following structure: •
`
`0
`
`0
`
`Id. at 3:11-28. The '166 patent discloses that the pharmaceutical unit
`
`dosage is suitable for oral administration, and is useful for treating sexual
`
`dysfunction. Id. at 3:29-31.
`
`Illustrative Claim
`
`Claim 1 is the sole independent claim challenged in the Petition. It
`
`reads:
`
`1. A method of treating sexual dysfunction in a patient in need
`thereof comprising orally administering one or more unit dose
`containing about 1 to about 20 mg, up to a maximum total dose
`of 20 mg per day, of a compound having the structure [of formula
`(I)].
`
`Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds, each of which challenges the
`
`patentability of claims 1-12:
`
`Basis
`§ 103
`§ 103
`
`References
`Daugan'
`Daugan and SNDA2
`
`Daugan, WO 97/03675, published Feb. 6, 1997 (Ex. 1002, "Daugan").
`2 Center for Drug Evaluation and Research, Approval Package for
`VIAGRA®, Approval Date March 27, 1998 (Ex. 1003, "SNDA").
`
`3
`
`0006
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`In support of its patentability challenges, Petitioner relies on the
`
`Declaration of Drs. Wayne J.G. Hellstrom (Ex. 1005) and Douglas Reid
`
`Patterson (Ex. 1007).
`
`ANALYSIS
`
`Claim Construction
`
`In an inter partes review, the Board interprets a claim term in an
`
`unexpired patent according to its broadest reasonable construction in light of
`
`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b);
`
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144-46 (2016). Under
`
`that standard, and absent any special definitions, we assign claim terms their
`
`ordinary and customary meaning, as would be understood by one of ordinary
`
`skill in the art at the time of the invention, in the context of the entire patent
`
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007).
`
`Claim terms need only be construed to the extent necessary to resolve
`
`the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
`
`(Fed. Cir. 2011). On this record and for purposes of this Decision, we see no
`
`need to construe any term expressly.
`
`Prior Art Disclosures
`
`Daugan
`
`Daugan identifies (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methy1-6-
`
`(3,4-methylene-dioxyphenyl)pyrazino[2',1':6.1] pyrido[3,4-b]indole-1,4-
`
`dione, also known as compound (A), as a compound of the invention.
`
`Ex. 1002, 3:24-25. Compound (A) is the same as the compound of formula
`
`(I) in the '166 patent, i.e., tadalafil.
`
`Daugan teaches that tadalafil is useful for treating male or female
`
`4
`
`0007
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`sexual dysfunction. Id. at 4:25-28. According to Daugan, tadalafil may be
`
`administered orally to treat erectile dysfunction. Id. at 3:30-32. It also
`
`teaches that "for a typical adult patient, individual tablets or capsules contain
`
`from 0.2-400mg of active compound, in a suitable pharmaceutically
`
`acceptable vehicle or carrier, for administration in single or multiple doses,
`
`once or several times per day." Id at 5:4-7. Specifically, Daugan teaches
`
`preparing tablets with 50 mg active compound. Id. at 12:15-14:16.
`
`SNDA
`
`SNDA teaches sildenafil is a potent PDE5 inhibitor and is useful for
`
`treating ED. Ex. 1003, 35. Sildenafil is therapeutically effective for treating
`
`ED at doses of 25, 50, and 100 mg. Id. at 127-28, 215, 217-19. According
`
`to SNDA, in some patients, doses as low as 5 and 10 mg are therapeutically
`
`effective over placebo. Id. SNDA states that the "maximum recommended
`
`dosing frequency is once per day." Id. at 50.
`
`Obviousness Grounds
`
`Petitioner contends that claims 1-12 would have been obvious over
`
`the teachings of Daugan, either alone or in combination with SNDA.
`
`Pet. 20-46. In both obviousness grounds, Petitioner relies on both Daugan
`
`and SNDA for suggesting tadalafil dose recited in claim 1. Based on the
`
`current record, we determine Petitioner has not established a reasonable
`
`likelihood that it would prevail in this assertion.
`
`Specifically, Petitioner points to Daugan for teaching tadalafil
`
`formulations comprising individual tablets or capsules containing "from 0.2-
`
`400mg of active compound." Id. at 22, 25 (citing Ex. 1002, 5). According
`
`to Petitioner, while Daugan provides examples of 50 mg dosage forms for
`
`oral administration, it teaches that "other strengths" and "other doses" may
`
`5
`
`0008
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`be prepared, and that "lower dose ranges may be merited." Id. at 23, 25
`
`(citing Ex. 1002, 12-16). In addition, Petitioner refers to SNDA for
`
`teaching that sildenafil is therapeutically effective in treating ED at doses of
`
`25, 50, and 100 mg. Id. at 39 (citing Ex. 1003, 127-28, 215, 217-19). In
`
`some patients, Petitioner asserts, sildenafil is therapeutically effective in
`
`dosages as low as 5 to 10 mg. Id. at 26, 39 (citing Ex. 1003, 127-28, 215,
`
`217-19).
`
`According to Petitioner, because tadalafil is a more potent and highly
`
`selective PDES inhibitor, an ordinary artisan would have had a reason to use
`
`doses lower than the 50 mg dose exemplified in Daugan, including doses
`
`lower than the known effective doses of sildenafil, and would have had a
`
`reasonable expectation of success in doing so. Id. at 26-28, 42-44. As a
`
`result, Petitioner contends, one of ordinary skill in the art would have arrived
`
`at the method of claim 1 either by following the express teachings and
`
`guidance in Daugan, or through routine optimization. Id. at 29, 44.
`
`In its Preliminary Response, Patent Owner does not address the "unit
`
`dose containing about 1 to about 20 mg" limitation. Patent Owner, instead,
`
`emphasizes that Petitioner fails to account for another essential claim
`
`limitation—"a maximum total dose of 20 mg per day." Prelim. Resp. 13-22.
`
`We agree with Patent Owner.
`
`In an inter partes review, the petition must specify where each
`
`element of the claim is found in the prior art. 37 C.F.R. § 42.104(b)(4).
`
`Claim 1 recites "orally administering one or more unit dose containing about
`
`1 to about 20 mg, up to a maximum total dose of 20 mg per day." In
`
`general, all patent claim terms are presumed to have meaning. Bicon, Inc. v.
`
`Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006). Petitioner, however,
`
`6
`
`0009
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`paraphrases the claim as "recit[ing] a method of treating sexual dysfunction
`
`comprising administering a tadalafil dose range of 'about 1 to about 20
`
`mg.'" Pet. 21. In other words, Petitioner appears to ignore the maximum-
`
`total-dose requirement. Petitioner's analysis reflects this omission.
`
`Assuming, without deciding, that tadalafil would have been expected to be
`
`therapeutically effective at doses from "about 1 to about 20 mg," Petitioner
`
`does not point to the asserted prior art or otherwise explain why an ordinary
`
`artisan would limit the tadalafil dose to 20 mg per day.
`
`As a result, based on the current record, we conclude Petitioner has
`
`not established a reasonable likelihood it would prevail in showing that
`
`claim 1 would have been obvious over Daugan, either alone or in
`
`combination with SNDA.
`
`CONCLUSION
`
`On this record, Petitioner has not demonstrated a reasonable
`
`likelihood of prevailing on its challenges to the patentability of any
`
`challenged claim of the '166 patent on the grounds asserted in the Petition.
`
`Accordingly, it is
`
`ORDER
`
`ORDERED that Petitioner's request for an inter partes review of
`
`claims 1-12 of the '166 patent is denied and no inter partes review is
`
`instituted.
`
`7
`
`0010
`
`

`
`IPR2016-00678
`Patent 6,943,166 B1
`
`PETITIONER:
`
`Patrick A. Doody
`Bryan P. Collins
`Pillsbury Winthrop Shaw Pittman, LLP
`patrick.doody@pillsburylaw.com
`bryan.collins@pillsburylaw.com
`
`PATENT OWNER:
`
`Mark J. Feldstein
`Joshua L. Goldberg
`Yieyie Yang
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`mark.feldstein@finnegan.com
`joshua.goldberg@finnegan.com
`yieyie.yang@finnegan.com
`
`Mark J. Stewart
`Dan L. Wood
`Eli Lilly and Company
`stewart_mark@lilly.com
`wood_dan_l@lilly.com
`
`8
`
`0011
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`: 6,943,166 B1
`APPLICATION NO. : 10/031556
`DATED (cid:9)
`: September 13, 2005
`INVENTOR(S) (cid:9)
`: Pullman et al.
`
`Page 1 of 2
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is
`hereby corrected as shown below:
`
`First page, line 54, in the title, "INHABITORS" should be --INHIBITORS-- and
`"DISFUNCTION" should be --DYSFUNCTION--
`
`Column 1, lines 1-4, in the title, "INHABITORS" should be --INHIBITORS-- and
`"DISFUNCTION" should be --DYSFUNCTION--
`
`Column 1, line 35, "CGMP" should be -- cGMP --
`
`Column 1, line 35, delete "lyzing"
`
`Column 1, line 38, "PDES" should be -- PDE5 --
`
`Column 1, line 51, "3 rM" should be -- 3 nM --
`
`Column 1 line 62, "vison" should be --vision --
`
`Column 2, line 14, "PDES" should be -- PDE5 --
`
`Column 2, line 36, delete "in" between "the" and "product"
`
`Column 2, line 44, "for-sexual" should be -- for sexual --
`
`Column 3, line 45, "in vitro" should be italicized
`
`Column 4, line 45, "Iarts." should be -- arts. --
`
`Column 5, lines 53-54, "VIAGRA" should be -- VIAGRA° --
`
`Column 6, line 15, "2xSC-leu" should be -- 2X SC-leu --
`
`Column 6, line 17, "2xYEP/" should be -- 2X YEP/ --
`
`Column 6, line 19, "-700C." should be -- -70°C. --
`
`Column 6, line 41, "ZnSO,)." should be -- ZnSO4).
`
`0012
`
`(cid:9)
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`: 6,943,166 B1
`APPLICATION NO. : 10/031556
`DATED (cid:9)
`: September 13, 2005
`INVENTOR(S) (cid:9)
`: Pullman et al.
`
`Page 2 of 2
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is
`hereby corrected as shown below:
`
`Column 6, line 53, "[32p] cGMP to [32p]5'GMP" should be -- [32P] cGMP to
`[32p] 5'GMP --
`
`Signed and Sealed this
`
`Eighth Day of August, 2006
`
`JON W. DUDAS
`Director of the United States Patent and Trademark Office
`
`0013
`
`(cid:9)
`

`
`SPE RESPONSE FOR CERTIFICATE OF CORRECTION
`
`Paper No.: (cid:9)
`
`
`
`DATE (cid:9)
`
`June 2. 2006
`
`TO SPE OF : ART UNIT (cid:9)
`
`3724
`
`SUBJECT (cid:9)
`
`: Request for Certificate (cid:9) of Correction for Appl. No.: 10/031556
`
`(cid:9) Patent No.: 7,024,776 B2
`
`Please respond to this request for a certificate of correction within 7 days.
`
`Please review the requested changes/corrections as shown in the COCIN document(s) in
`the IFW application image. No new matter should be introduced, nor should the scope or
`meaning of the claims be changed.
`
`Please complete the response (see below) and forward the completed response to scanning
`using document code COCX.
`
`Magdalene Talley
`
`Certificates of Correction Branch
`
`703-308-9390 ext. 116
`
`Thank You For Your Assistance
`
`The request for issuing the above-identified correction(s) is hereby:
`Note your decision on the appropriate box.
`
`q Approved (cid:9)
`
`All changes apply.
`
`q Approved in Part (cid:9)
`
`Specify below which changes do not apply.
`
`q Denied (cid:9)
`
`State the reasons for denial below.
`
`Comments: (cid:9)
`
`
`
`PTOL-306 (REV. 7/03) (cid:9)
`
`SPE (cid:9)
`Art Unit
`U.S. DEPARTMENT OF COMMERCE Patent and Trademark Office
`
`0014
`
`

`
`Cl
`
`PATENT--FEE
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Issued: September 13, 2005 (cid:9)
`
`Serial No. 10/031,556 (cid:9)
`
`Filed: October 19, 2001 (cid:9)
`
`Application of: (cid:9)
`
`WILLIAM E. PULLMAN ET AL. (cid:9)
`
`Patent No. 6,943,166 (cid:9)
`
`) (cid:9)
`) (cid:9)
`) (cid:9)
`) (cid:9)
`) (cid:9)
`) (cid:9)
`) (cid:9)
`)
`) (cid:9)
`) (cid:9)
`) (cid:9)
`)
`) (cid:9)
`For: COMPOSITIONS COMPRISING (cid:9)
`PHOSPHODIESTERASE INHIBITORS FOR )
`)
`THE TREATMENT OF SEXUAL (cid:9)
`)
`DYSFUNCTION (cid:9)
`)
`Attorney Docket No. 29342/36206A )
`) (cid:9)
`) (cid:9)
`) (cid:9)
`) (cid:9)
`
`I hereby certify that this
`paper is being deposited
`with the United States
`Postal Service with suffi-
`dent postage, as first
`class mail, in an envelope
`addressed to:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450.
`
`Dated: May 16, 2006
`
`412
`
`James J. Napoli
`Registration No. 32,361
`Attorney for Applicants
`
`REQUEST FOR CERTIFICATE OF
`CORRECTION UNDER RULES 3 22 (a) & 323
`05/22/2006 BABRO081 00000013 6943166
`100.00 OP
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`01 FC:1811
`
`Sir:
`
`Patentees respectfully request a Certificate
`
`of Correction to be issued for the above-identified
`
`U.S. Patent correcting the patent as noted in the
`
`attached "Certificate of Correction" form PTO 1050.
`
`Duplicate copies of the form are attached hereto.
`
`Errors in the patent can be verified by
`
`reference to the application as follows:
`
`MAY
`
`!,2073
`
`Of Con ecriu;
`
`MAY 2 4 ZON
`
`0015
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`
`First Page
`
`1
`
`1
`1
`1
`1
`1
`2
`2
`2
`3
`4
`5
`6
`6
`6
`6
`
`Appin. Page # Appin. Line # Column #
`Notice of
`Allowance
`Notice of
`Allowance
`2
`2
`2
`2
`2
`3
`4
`4
`7
`9
`11
`12
`12
`12
`13
`14
`14
`17
`18
`21
`26
`
`2
`2,3
`6
`20
`last line
`22
`15
`24
`1
`14
`30
`29-30
`32
`34
`24
`6
`14
`10-11
`26
`2
`26
`
`6
`6
`8
`8
`9
`12
`
`Line #
`
`Error by
`
`54
`
`1-4
`
`35
`35
`38
`51
`62
`14
`36
`44
`
`45
`45
`53-54
`15
`17
`19
`41
`53
`61
`7
`48
`43-44
`11
`
`PTO
`
`PTO
`
`PTO
`PTO
`PTO
`PTO
`applicants
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`PTO
`
`Our check in the amount of $100.00 to correct
`
`the error(s) by patentee(s) is submitted herewith.
`
`Respectfully submitted,
`
`MARSHALL, GERSTEIN & BORUN LLP
`
`By
`
`James J. Napoli
`(Registration No. 32,361)
`Attorneys for Applicants
`6300 Sears Tower
`233 South Wacker Drive
`Chicago, Illinois 60606
`(312) 474-6300
`
`Chicago, Illinois
`May 16, 2006
`
`- 2
`
`MAY 24 :4y%
`
`0016
`
`(cid:9)
`

`
`PTO/SB/44 (02-01)
`Approved for use through 01/31/2004. OMB 0651-0033
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`(Also Form PTO-1050)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`
`DATED (cid:9)
`
`6,943,166
`
`09/13/2005
`
`INVENTOR(S) (cid:9)
`
`PULLMAN ET AL.
`
`It is certified that error appears in the above-identified patent and that said Letters
`Patent is hereby corrected as shown below:
`
`First page, line 54, in the title, "INHABITORS"
`should be --INHIBITORS-- and "DISFUNCTION" should be
`--DYSFUNCTION--
`
`Column 1, lines 1-4, in the title, "INHABITORS"
`should be --INHIBITORS-- and "DISFUNCTION" should be
`--DYSFUNCTION--
`
`Column 1, line 35, "CGMP" should be -- cGMP --
`
`Column 1, line 35, delete "lyzing"
`
`Column 1, line 38, "PDES" should be -- PDE5 --
`
`Column 1, line 51, "3 rM" should be -- 3 nM --
`
`Column 1 line 62, "vison" should be -- vision --
`
`Column 2, line 14, "PDES" should be -- PDE5 --
`
`MAILING ADDRESS OF SENDER:
`James J. Napoli, Ph.D.
`MARSHALL, GERSTEIN & BORUN LLP
`233 S. Wacker Drive, Suite 6300
`Sears Tower
`Chicago, Illinois 60606-6357
`
`PATENT NO.: 6,943,166
`
`No. of additional copies: 1
`
`HAY 2 4 ZOOU
`
`0017
`
`

`
`PTO/SB/44 (02-01)
`Approved for use through 01/31/2004. OMB 0651-0033
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`(Also Form PTO-1050)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`
`DATED (cid:9)
`
`6,943,166
`
`09/13/2005
`
`INVENTOR(S) (cid:9)
`
`PULLMAN ET AL.
`
`It is certified that error appears in the above-identified patent and that said Letters
`Patent is hereby corrected as shown below:
`
`Column 2, line 36, delete "in" between "the" and "product"
`
`Column 2, line 44, "for-sexual" should be -- for sexual --
`
`Column 3, line 45, "in vitro" should be italicized
`
`Column 4, line 45, "Iarts." should be -- arts. -
`
`Column 5, lines 53-54, "VIAGRA" should be -- VIAGRA® -
`
`Column 6, line 15, "2xSC-leu" should be -- 2X SC-leu --
`
`Column 6, line 17, "2xYEP/" should be -- 2X YEP/ --
`
`Column 6, line 19, "-700C." should be -- -70°C. -
`
`Column 6, line 41, "ZnS0,)." should be -- ZnSO4 ). --
`
`Column 6, line 53, "[32p]cGMP to [32p]5'GMP" should be
`-- (cid:9) [32P] cGMP to [32P] 5 ' GMP - -
`
`MAILING ADDRESS OF SENDER:
`James J. Napoli, Ph.D.
`MARSHALL, GERSTEIN & BORUN LLP
`233 S. Wacker Drive, Suite 6300
`Sears Tower
`Chicago, Illinois 60606-6357
`
`PATENT NO.: 6,943,166
`
`No. of additional copies: 1
`
`MAY g 2000
`
`0018
`
`

`
`PTO/SB/44 (02-01)
`Approved for use through 01/31/2004. OMB 0651-0033
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`(Also Form PTO-1050)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`
`DATED (cid:9)
`
`6,943,166
`
`09/13/2005
`
`INVENTOR(S) (cid:9)
`
`PULLMAN ET AL.
`
`It is certified that error appears in the above-identified patent and that said Letters
`Patent is hereby corrected as shown below:
`
`Column 6, line 61, "MgCl," should be -- MgC12 ,
`
`Column 8, line 7, "polyvinylpurrolidine" should be
`polyvinylpyrrolidine --
`
`Column 8, line 48, "ICS„" should be -- IC50 , -
`
`Column 9, lines 43-44, "scintillatio n" should be
`-- scintillation --
`
`Column 12, line 11, "PDES" should be -- PDE5 --
`
`MAILING ADDRESS OF SENDER:
`James J. Napoli, Ph.D.
`MARSHALL, GERSTEIN & BORUN LLP
`233 S. Wacker Drive, Suite 6300
`Sears Tower
`Chicago, Illinois 60606-6357
`
`PATENT NO.: 6,943,166
`
`No. of additional copies: 1
`
`MAY 2.4 2005
`
`0019
`
`

`
`PTO/SB/44 (02-01)
`Approved for use through 01/31/2004. OMB 0651-0033
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`(Also Form PTO-1050)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`
`DATED (cid:9)
`
`6,943,166
`
`09/13/2005
`
`INVENTOR(S) (cid:9)
`
`PULLMAN ET AL.
`
`It is certified that error appears in the above-identified patent and that said Letters
`
`Patent is hereby corrected as shown below:
`
`First page, line 54, in the title, "INHABITORS"
`should be --INHIBITORS-- and "DISFUNCTION" should be
`--DYSFUNCTION--
`
`Column 1, lines 1-4, in the title, "INHABITORS"
`should be --INHIBITORS-- and "DISFUNCTION" should be
`--DYSFUNCTION--
`
`Column 1, line 35, "CGMP" should be (cid:9)
`
`cGMP --
`
`Column 1, line 35, delete "lyzing"
`
`Column 1, line 38, "PDES" should be -- PDE5 --
`
`Column 1, line 51, "3 rM" should be -- 3 nM --
`
`ColuMn 1 line 62, "vison" should be -- vision --
`
`Column 2, line 14, "PDES" should be -- PDE5 --
`
`MAILING ADDRESS OF SENDER:
`James J. Napoli, Ph.D.
`MARSHALL, GERSTEIN & BORUN LLP
`233 S. Wacker Drive, Suite 6300
`Sears Tower
`Chicago, Illinois 60606-6357
`
`PATENT NO • 6,943,166
`
`No. of additional copies: 1
`
`tlAY 2 4 LUIJO
`
`0020
`
`

`
`PTO/S13/44 (02-01)
`Approved for use through 01/31/2004. OMB 0651-0033
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`(Also Form PTO-1050)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`
`DATED (cid:9)
`
`6,943,166
`
`09/13/2005
`
`INVENTOR(S) (cid:9)
`
`PULLMAN ET AL.
`
`It is certified that error appears in the above-identified patent and that said Letters
`
`Patent is hereby corrected as shown below:
`
`Column 2, line 36, delete "in" between "the" and "product"
`
`Column 2, line 44, "for-sexual" should be -- for sexual --
`
`Column 3, line 45, "in vitro" should be italicized
`
`Column 4, line 45, "Iarts." should be -- arts. -
`
`Column 5, lines 53-54, "VIAGRA" should be -- VIAGRA() -
`
`Column 6, line 15, "2xSC-leu" should be -- 2X SC-leu --
`
`Column 6, line 17, "2xYEP/" should be -- 2X YEP/ --
`
`Column 6, line 19, "-700C." should be -- -70°C. -
`
`Column 6, line 41, "ZnS°,)." should be -- ZnSO4). -
`
`Column 6, line 53, "[32p]cGMP to [32p)5'GMP" should be
`[32PlcGMP to [32P] 5 ' GMP - -
`
`MAILINGADDRESSOFSENDER
`James J. Napoli, Ph.D.
`MARSHALL, GERSTEIN & BORUN LLP
`233 S. Wacker Drive, Suite 6300
`Sears Tower
`Chicago, Illinois 60606-6357
`
`PATENT NO.: 6,943,166
`
`No. of additional copies: 1
`
`MAY 24 k941:1
`
`0021
`
`

`
`PTO/SB/44 (02-01)
`Approved for use through 01/31/2004. OMB 0651-0033
`Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`(Also Form PTO-1050)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`
`DATED (cid:9)
`
`6,943,166
`
`09/13/2005
`
`INVENTOR(S) (cid:9)
`
`PULLMAN ET AL.
`
`It is certified that error appears in the above-identified patent and that said Letters
`Patent is hereby corrected as shown below:
`
`Column 6, line 61, "MgCl," should be -- MgC12, -
`
`Column 8, line 7, "polyvinylpurrolidine" should be
`- polyvinylpyrrolidine --
`
`Column 8, line 48, "ICS„" should be -- IC50, -
`
`Column 9, lines 43-44, "scintillatio n" should be
`-- scintillation --
`
`Column 12, line 11, "PDES" should be -- PDE5 --
`
`MAILING ADDRESS OF SENDER:
`James J. Napoli, Ph.D.
`MARSHALL, GERSTEIN & BORUN LLP
`233 S. Wacker Drive, Suite 6300
`Sears Tower
`Chicago, Illinois 60606-6357
`
`PATENT NO.: 6,943,166
`
`No. of additional copies: 1
`
`MAY s4 4 —4-A6
`
`0022
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark 0111cc
`Add= COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO. (cid:9)
`
`10/031,556
`
`FILING DATE
`
`10/19/2001
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. (cid:9)
`
`CONFIRMATION NO.
`
`William Ernest Pullman
`
`29342/36206A
`
`6526
`
`03/02/2005
`7590 (cid:9)
`4743 (cid:9)
`MARSHALL, GERSTEIN & BORUN LLP
`6300 SEARS TOWER
`233 S. WACKER DRIVE
`CHICAGO, IL 60606
`
`EXAMINER
`
`COOK, REBECCA
`
`ART UNIT
`
`PAPER NUMBER
`
`1614
`
`DATE MAILED: 03/02/2005
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PTO-90C (Rev. 10/03)
`
`0023
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`
`Notice of Allowability
`
`Application No.
`
`Applicant(s)
`
`10/031,556
`Examiner
`
`PULLMAN ET AL.
`Art Unit
`
`Rebecca Cook
`
`1614
`
`-- The MAILING DATE of 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 GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. q This communication is responsive to (cid:9)
`
`
`
`2. q The allowed claim(s) is/are (cid:9)
`
`
`
`3. q The drawings filed on (cid:9)
`
`are accepted by the Examiner.
`
`4. q Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`b) q Some* c) q None of the:
`a) q All (cid:9)
`1. q Certified copies of the priority documents have been received.
`.
`2. q Certified copies of the priority documents have been received in Application No. (cid:9)
`3. q Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`* Certified copies not received: (cid:9)
`
`
`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 of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. q A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`
`6. q CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
`(a) q including changes required by the Notice of Draftsperson's Patent Drawing Review ( PTO-948) attached
`1) q hereto or 2) q to Paper No./Mail Date (cid:9)
`.
`(b) q including changes required by the attached Examiner's Amendment / Comment or in the Office action of
`Paper No./Mail Date (cid:9)
`
`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).
`
`7. q DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. q Notice of References Cited (PTO-892)
`2. q Notice of Draftperson's Patent Drawing Review (P10-948)
`
`3.
`
`Information Disclosure Statements (PTO-1449 or PTO/SB/08),
`Paper No./Mail Date 5/24/04
`4. q Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`1