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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
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`11/797,082
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`04/30/2007
`
`Karnail S. Atwal
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`2305.0330001/TJS/ASL
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`2828
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`26111
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`7590
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`12/22/2010
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`stNE, KESSLER, Gomsmmmx 1311c.
`1100 NEW YORK AVENUE, N.W.
`WASHINGTON, DC 20005
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`PIHONAK, SARAH
`PAPER NUMBER
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`ART UNIT
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`1 627
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`MAIL DATE
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`12/22/2010
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 04/07)
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`

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`Application No.
`Applicant(s)
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`Office Action Summary
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`11/797,082
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`Examiner
`SARAH PIHONAK
`
`ATWAL ET AL.
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`Art Unit
`1627
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1. 136( a).
`In no event however may a reply be timely filed
`after SIX () MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`1)IZI Responsive to communication(s) filed on 08 October 2010.
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`a)I:l This action is FINAL.
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`2b)IZ| This action is non-final.
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`3)|:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IXI Claim(s) 13 9-13 151718 27 28 54 56 62-73 and 214-216 is/are pending in the application.
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`4a) Of the above claim(s) _ is/are withdrawn from consideration.
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`5)I:I Claim(s) _ is/are allowed.
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`6)|Zl Claim(s) 13 9-13151718 2728 54 56 62- 73 214-216is/are rejected.
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`7)I:l Claim(s) _ is/are objected to.
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`8)I:l Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`OH] The drawing(s) filed on _ is/are: a)|:l accepted or b)I:l objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`11)|:l The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)|:l AII
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`b)I:l Some * c)|:l None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.|:I Certified copies of the priority documents have been received in Application No. _
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`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) X Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) El Information Disclosure Statement(s) (PTO/SB/OS)
`Paper No(s)/Mai| Date _.
`US. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper N°(5 )/Mai| Date. _
`5)I:I Notice of Informal Patent Application
`)6|:| Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20101216
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`
`
`

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`Application/Control Number: 11/797,082
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`Page 2
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`Art Unit: 1627
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`DETAILED ACTION
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`Priority
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`This application, filed on 4/30/2007, claims priority from Provisional Application No.
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`60/796235, filed on 4/28/2006.
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`Response to Remarks
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`1.
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`As of the amendments filed on 10/8/2010, claims 1, 3, 9-13, 15, 17-18, 27-28, 54,
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`56, 62-73, and 214-216 are pending. Claims 2, 5-8, 14, 16, 19-26, 29-53, 55, 57-61, and
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`74-213 have been cancelled by the Applicants.
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`The claim amendments are sufficient to overcome the rejections under 35 USC
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`112, first paragraph, for lack of enablement. Therefore, the rejections under 35 USC
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`112, first paragraph are withdrawn.
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`In response to the rejection for obviousness type double patenting, Applicants
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`have requested that this rejection be held in abeyance until the instant claims are
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`allowable. The rejection for obviousness type double patenting is maintained, for
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`reasons of record, and will be reiterated in the office action.
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`In further consideration of the claims, a new rejection has been made, which will de
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`discussed in detail. Accordingly, this action is made NON-FINAL.
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`Claims 1, 3, 9-13, 15, 17-18, 27-28, 54, 56, 62-73, and 214-216 were examined.
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`Claims 1, 3, 9-13, 15, 17-18, 27-28, 54, 56, 62-73, and 214-216 are rejected.
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`Claim Rejections-35 USC § 102
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`Application/Control Number: 11/797,082
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`Page 3
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`Art Unit: 1627
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`2.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
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`3.
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`Claims 1, 3, 9-13, 15, 17-18, 27-28, 54, 56, 62-73, and 214-216 are rejected
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`under 35 U.S.C. 102(b) as being anticipated by Salassidis et. al., WO 2004/005264,
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`with Zhang et. al., Cell, 112, pp. 293-301, (2003), as an evidentiary reference. Zhang et.
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`al. was previously provided in the office action dated 6/9/2010.
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`The claims are directed to a method of inhibiting the taste modulating protein
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`TRPM5, comprising contacting TRPM5 with a compound of formula I, such as 4-(4,5-
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`diphenyl-1H-imidazol-2-yl)benzonitrile, and of inhibiting the depolarization of a taste
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`receptor cell expressing TRPM5 comprising contacting the taste receptor cell with the
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`compound.
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`Salassidis et. al. teaches 4,5-diaryl-1H-imidazole compounds which are effective
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`against the hepatitis C virus (Abstract). The compounds act as inhibitors of the human
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`cellular proteins casein kinase l alpha, delta, and epsilon, which are associated with
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`cytoplasmic and nuclear processes, including DNA replication and repair, and as such
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`are active in treating hepatitis C (p. 1, lines 9-20; p. 31, lines 25-32; p. 33, lines 24-33).
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`Treatment of mammals is taught, along with compositions comprised of a
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`pharmaceutically effective amount of the compounds (p. 34, lines 16-31 ; p. 36, line 23-
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`p. 37, line 21; p. 38, lines 20-33). The composition can further comprise additional
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`Application/Control Number: 11/797,082
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`Page 4
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`Art Unit: 1627
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`antiviral agents (p. 39, lines 1-5). The compounds taught by Salassidis et. al. are of the
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`formula shown below (p. 4, line 1-p. 20, line 17):
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`‘22?
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`Where R1, R1'=aryl groups such as phenyl substituted by R6, R7, R8, and R8; R3, R4=R1,
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`or pyridyl groups substituted by R8, R8; RT; R2=H, CH3, etc.; R6, R7, R8, and
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`R8'=independently H, -Nog; -R5, etc.; R5=F, Cl, Br, CN, etc.
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`In particular, Salassidis et. al. teaches the specific compound, 4-(5-phenyl-4-pyridine-4-
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`yl-1H-imidazole-2—yl)-benzonitrile, which is shown below, as a preferred compound (p.
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`20, line 19; p. 26, line 13, compound 108; p. 64, claim 10, with specific reference to this
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`claim on p. 70, compound 108):
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`Application/Control Number: 11/797,082
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`Page 5
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`Art Unit: 1627
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`4-(5 -pheny1-4-pyridine-4-yl— 1 H—imidazole—2-y1)-benzonitrile
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`This compound is structurally very similar to the compound of the claimed method, 4-
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`(4,5-diphenyl-1H-imidazol-2-yl)benzonitrile, which is shown immediately below:
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`
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`4-(4,5-dipheny1— lH—imidazol—Z-yl)benzonitrile
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`The only difference between the compound of the claimed method and the compound
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`taught by Salassidis et. al. is that for the compound of the claimed method, the
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`imidazole ring has a phenyl ring substituent at the 4-position instead of a pyridine ring.
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`However, Salassidis et. al. teaches that the equivalent position (position R4 for the
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`compounds taught by Salassidis et. al.) can be substituted by phenyl as well (see pg. 4,
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`Application/Control Number: 11/797,082
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`Page 6
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`Art Unit: 1627
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`where R4=R1, in which R1 is the first phenyl ring shown to the top left, and variables R6,
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`R7, R8, and R8=H; see pages 9, beginning with line 5-p. 10, line 34). Therefore, the
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`compound of the instantly claimed method, 4-(4,5-diphenyl-1H-imidazol-2-
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`yl)benzonitrile, and the compound taught by Salassidis et. al. are obvious variants of
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`each other. As Salassidis et. al. teaches that the compounds have pharmaceutical
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`utility, it would have been expected that 4-(4,5-diphenyl-1 H-imidazol-2-yl)benzonitrile
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`would have similar utility. Salassidis et. al. teaches that the compound is administered
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`by a variety of routes, including orally, parenterally, intravenously, transdermally, in the
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`form of pills, tablets, capsules, powders, and deposits (p. 38, lines 20-33).
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`Therapeutically effective dosages in the range of 0.05 to 30 (M are taught (p. 37, lines
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`4-21), which corresponds to a dosage ranging from .016 to 3.2 mg. for the compound 4-
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`(4,5-diphenyl-1H-imidazol-2-yl)benzonitrile (M.W. 321.37 g/mol; 0.05 *10'6 moles = .016
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`mg; 10 * 10'6 moles=3.2 mg.), which is within the dosage range as claimed. While
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`Salassidis et. al. does not explicitly teach that the compound inhibits the taste
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`modulating protein TRPMS, or inhibits the depolarization of the taste receptor cell
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`expressing TRPMS, such characteristics are properties of the compounds. The TRPMS
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`protein is present in mammals, as evidenced by Zhang et. al., where it is disclosed that
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`TRPM5 is a taste TRP ion channel which is responsible for the sensation of bitter and
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`sweet tastes in mice and humans (Abstract; p. 294, left column, last paragraph-right
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`column, top paragraph; p. 295, right column, lower paragraph-p. 296, left column, full
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`paragraph). A compound and its properties are not patentably distinct; see M.P.E.P.
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`2141.02, In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963). A method
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`Application/Control Number: 11/797,082
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`Page 7
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`Art Unit: 1627
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`involving an inherent property of a known compound is not novel over the prior art; see
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`M.P.E.P. 2112.02, Exparte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993).
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`Therefore, as this protein is present in the mammalian population, it would have been
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`expected to have been present in the patient population being treated for hepatitis, from
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`the method taught by Salassidis et. al. Salassidis et. al. teaches administration of the
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`compounds orally, intravenously, and by other routes, and thus it would have been
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`expected that the compounds would have been distributed systemically to the taste
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`receptor cells expressing TRPM5, and in effect, would have inhibited the taste
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`modulating protein TRPM5 by about 10 to 95%, and inhibited by depolarization of the
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`taste receptor cells expressing TRPM5 by about 10 to 95% in the patient population
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`being treated. As it is evidenced by Zhang et. al. that TRPM5 is associated with the
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`sensation of a bitter taste, it would have been expected that by inhibiting the
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`depolarization of the taste receptor cell expressing TRPM5, the bitter taste associated
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`with the pharmaceutical composition and other antiviral agents present would have
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`been inhibited. While Salassidis et. al. does not explicitly teach that the compound is
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`administered in a concentration from 0.01 to 50% by weight of the composition, the
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`therapeutic dosage taught by Salassidis is within the dosage range claimed; therefore, it
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`would have been expected that the concentration of the compound in the composition
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`would have been within the claimed range from 0.01 to 50% by weight.
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`Claim Rejections-Obviousness Type Double Patenting
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`Application/Control Number: 11/797,082
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`Page 8
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`Art Unit: 1627
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`4.
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory
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`obviousness-type double patenting rejection is appropriate where the conflicting claims
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`are not identical, but at least one examined application claim is not patentably distinct
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`from the reference claim(s) because the examined application claim is either anticipated
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`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
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`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
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`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
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`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422
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`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
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`USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the conflicting application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement.
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`Effective January 1, 1994, a registered attorney or agent of record may sign a
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`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
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`37 CFR 3.73(b).
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`Application/Control Number: 11/797,082
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`Page 9
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`Art Unit: 1627
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`1.
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`Claims 1, 3, 9-13, 15, 17-18, 27-28, 54, 56, 62-73, and 214-216 are provisionally
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`rejected on the ground of nonstatutory obviousness-type double patenting as being
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`unpatentable over claims 1-7 of copending Application No. 12/212508. Although the
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`conflicting claims are not identical, they are not patentably distinct from each other
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`because both sets of claims are drawn to methods of modulating TRPM5 activity. The
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`instant claims are drawn to a method of inhibiting a taste modulating protein comprising
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`contacting the taste modulating protein with a compound of formula I, and in particular
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`inhibition of TRPM5. The copending claims are drawn broadly to administration of a
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`modulator of TRPM5 activity, which includes the claimed compounds. It would have
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`been obvious that modulation of TRPM5 activity would also include inhibition of the
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`protein of TRPM5. As such, the claims are not patentably distinct from each other.
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`This is a provisional obviousness-type double patenting rejection because the
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`conflicting claims have not in fact been patented.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to SARAH PIHONAK whose telephone number is
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`(571 )270—771 0. The examiner can normally be reached on Monday-Thursday 8:00 AM
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`- 6:30 PM EST.
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`lf attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Sreeni Padmanabhan can be reached on (571)272-0629. The fax phone
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`Application/Control Number: 11/797,082
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`Page 10
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`Art Unit: 1627
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1 000.
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`/Shengjun Wang/
`Primary Examiner, Art Unit 1627
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`S.P.
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`