`
`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
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`
`
`
`
`
`
`
`11/797,082
`
`04/30/2007
`
`Karnail S. Atwal
`
`2305.0330001/TJS/ASL
`
`2828
`
`26111
`
`7590
`
`06/09/2010
`
`stNE, KESSLER, Gomsmmmx 1311c.
`1100 NEW YORK AVENUE, N.W.
`WASHINGTON, DC 20005
`
`PIHONAK, SARAH
`PAPER NUMBER
`
`ART UNIT
`
`1 627
`
`MAIL DATE
`
`06/09/2010
`
`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)
`
`

`

`
`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/797,082
`
`Examiner
`
`SARAH PIHONAK
`
`ATWAL ET AL.
`
`Art Unit
`
`1627 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`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 (6) 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).
`
`Status
`
`1)IXI Responsive to communication(s) filed on 23 March 2010.
`
`2a)I:I This action is FINAL.
`
`2b)IZI This action is non-final.
`
`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`
`4)IXI Claim(s) 1-3 6 9-13 15 1718 27 28 54-56 59 62-73 and 214 is/are pending in the application.
`
`
`4a) Of the above Claim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I Claim(s) _ is/are allowed.
`
`6)IXI Claim(s) 1-3 6 9-13 15 1718 27 28 54-56 59 62-73 and 214 is/are rejected.
`
`7)I:I Claim(s) _ is/are objected to.
`
`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`
`10)I:I The drawing(s) filed on
`
`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)I:I All
`
`b)I:I Some * c)I:I None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No.
`
`
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`3.I:I 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)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`4) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date. _
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`5) I:I Notice of Informal Patent Application
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date 1/11/2008. 6) D Other:
`
`U.S. Patent and Trademark Office
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20100525
`
`

`

`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
`
`This application, filed on 4/30/2007, claims priority from Provisional Application No.
`
`60/796235, filed on 4/28/2006.
`
`Response to Species Election
`
`1.
`
`Applicant’s election without traverse of the species of formula I, in which
`
`Ar1=phenyl; Ar2=phenyl; Ar3=nitrophenyl; and R1=H in the reply filed on 3/23/2010 is
`
`acknowledged. This species reads on claims 1, 3, 6, 9, 10, 11, 12, 54, 55, 56, 59, and
`
`62-65. Claims 4-5, 7-8, 14, 16, 19-26, 29-53, 57, 58, 60, 61, and 74-213 have been
`
`cancelled by the Applicants.
`
`2.
`
`The elected species, 4,5-diphenyl-2-(4-nitrophenyl)-imidazole, was found to be
`
`free of the prior art. Therefore, the search was expanded to other claimed species of
`
`formula I.
`
`3.
`
`4.
`
`Claims 1-3, 6, 9-13, 15, 17-18, 27-28, 54-56, 59, 62-73, and 214 were examined.
`
`Claims 1-3, 6, 9-13, 15, 17-18, 27-28, 54-56, 59, 62-73, and 214 are rejected.
`
`Claim Rejections-35 USC § 112
`
`5.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it,
`in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
`
`6.
`
`Claims 1-3, 6, 9-12, 17-18, 27-28, 54-56, 59, 62-73, and 214 are rejected under
`
`35 U.S.C. 112, first paragraph, because the specification, while being enabling for
`
`

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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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`inhibition of some taste modulation proteins, such as TRPM5, does not reasonably
`
`provide enablement for inhibition of all taste modulation proteins, or inhibition of the
`
`depolarization of all taste receptor cells. The specification does not enable any person
`
`skilled in the art to which it pertains, or with which it is most nearly connected, to
`
`practice the invention commensurate in scope with these claims. See M.P.E.P. 2164.08.
`
`Nelson et. al., Nature, 416, pp. 199-202, (2002), and Zhang et. al., Cell, 112, pp. 293-
`
`301, (2003), are referenced in this rejection.
`
`The factors to be considered in determining whether a disclosure meets the
`
`enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In
`
`re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states,
`
`“Enablement is not precluded by the necessity for some experimentation, such as
`
`routine screening. However, experimentation needed to practice the invention must not
`
`be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8
`
`USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on
`
`the basis of quantity of experimentation required to make or use the invention.
`
`“Whether undue experimentation is needed is not a single, simple factual determination,
`
`but rather is a conclusion reached by weighing many factual considerations” (Wands, 8
`
`USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the
`
`breadth of the claims; (3) the state of the prior art; (4) the predictability or
`
`unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of
`
`direction or guidance presented; (7) the presence or absence of working examples; and
`
`(8) the quantity of experimentation necessary.
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`

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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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`While all of these factors are considered, a sufficient amount for a prima facie
`case is discussed below.
`
`(1) The nature of the invention and (2) the breadth of the claims:
`
`The claims are drawn to a method of inhibiting a taste modulating protein,
`
`comprising contacting the protein with a compound of formula I, as well as inhibiting
`
`the depolarization of a taste receptor cell. Thus, the claims taken together with the
`
`specification imply that compounds of formula lwill inhibit all taste modulating
`
`proteins, or that all taste receptor cells will be inhibited from depolarization. The
`
`Applicants have provided support which shows that the taste modulating protein,
`
`TRPM5, is inhibited by compounds of formula I. However, the prior art teaches that
`
`there may exist other taste modulating proteins which are responsible for other taste
`
`sensations. Therefore, as the claims are drawn to inhibiting all taste modulating
`
`proteins, and inhibiting the depolarization of all taste receptor cells, the breadth of
`
`the claims is extensive.
`
`(3) The state of the prior art and (4) the predictability or unpredictability of the art:
`
`The protein expressed by the TRPM5 gene is responsible for the sensation of sweet,
`
`amino acid, and bitter tastes, as taught by Zhang et. al. (Abstract; p. 294, left
`
`column, last paragraph-right column, top paragraph). However, TRPM5 is expressed
`
`in only about 50% of mammalian taste receptor cells (p. p. 294, left column, last
`
`paragraph-right column, top paragraph). Zhang et. al. teaches that T1 R and T2R
`
`cells are co-expressed with TRPM5 (p. 294, right column, top paragraph), and that
`
`the G-protein, gustducin, is co-expressed with T2R receptors (p. 293, right column,
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`

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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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`last paragraph, first sentence). Nonetheless, a gustducin knockout animal model
`
`was still responsive to bitter taste (p. 293, right column, last paragraph). Therefore,
`
`while the TRPM5 protein, which is associated with sweet, amino acid, and bitter
`
`tastes, is co-expressed with T1 R and T2R, and T2R is co-expressed with gustducin,
`
`gustducin knockout models are still responsive to bitter taste. Animal model
`
`knockouts of TRPM5 are not perceptive of sweet, bitter, or amino acid tastes, but
`
`still experience sour and salty tastes (p. 296, left column; p. 299, left column, 1St
`
`paragraph). As such, it is believed that the taste proteins and/or signaling pathways
`
`responsible for the experience of sour and salty tastes are different from that of
`
`sweet, amino acid, and bitter tastes, or TRPM5 (p. 296, left column). Additionally,
`
`Zhang et. al. teaches that sweet, amino acid, and bitter taste receptors are found in
`
`distinct taste cell populations (p. 299, left column, bottom paragraph).
`
`Nelson et. al. teaches that mammalian taste receptors T1 R1 and T1 R3 act in
`
`combination for the taste sensation of most of the 20 standard amino acids (p. 199,
`
`left column, 1st paragraph; right column, 2nd full paragraph). Additionally, T1R1 and
`
`T1 R2 in combination function as a sweet taste receptor (p. 199, left column, bottom
`
`paragraph). Moreover, only L-amino acids activate the T1 R1 and T1 R3 combination,
`
`as D-amino acids and others sweeteners are not able to do so (p. 199, right column,
`
`2nd full paragraph). Nelson et. al. teaches that there exist differences between and
`
`within species of the sequences of T1 R, and that polymorphism of one of the
`
`receptor units results in an alteration of receptor function (p. 200, left column, last
`
`sentence-right column, full paragraph). Human and rodent T1 Rs are about 70%
`
`

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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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`identical, and human cells expressing T1 R1 have greater than one order of
`
`magnitude increased sensitivity towards glutamate than to other amino acids (p.
`
`200, right column, full paragraph). Additionally, Nelson et. al. teaches that sequence
`
`differences in T1 Rs within a single species can have a significant affect on taste
`
`perception (p. 200, right column).
`
`The Applicants have provided data which show that the claimed compounds of
`
`formula I inhibit the taste modulation protein, TRPM5, and therefore, inhibit the
`
`depolarization of taste receptor cells expressing TRPM5. However, Zhang et. al.
`
`teaches that there are other signaling pathways and possibly taste modulating
`
`proteins which are responsible for salty and sour tastes, which are not modulated by
`
`the TRPM5 protein. Additionally, Nelson et. al. teaches there are sequence
`
`differences among and within species for T1 Rs, which can significantly affect taste
`
`perception. As the T1 Rs, T1 R and T2R are co-expressed with TRPM5, it would have
`
`been expected that alterations in the sequence of T1 Rs could alter taste. TRPM5 is
`
`expressed in about 50% of taste receptor cells. While the Applicants have provided
`
`data which show that some compounds of formula I are effective in inhibiting
`
`TRPM5, and hence, inhibiting the depolarization of the 50% of taste receptor cells
`
`which express TRPM5, it is unlikely that the depolarization of all taste receptor cells
`
`can be inhibited by compounds of formula I.
`
`(5) The relative skill of those in the art:
`
`The relative skill of one in the art is expected to be high, such as a person with an
`
`advanced degree in molecular biology or biochemistry.
`
`

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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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`(6) The amount of direction or guidance presented and (7) the presence or absence of
`
`working examples:
`
`The specification has provided guidance for the inhibition of the taste modulating
`
`protein, TRPM5, with some compounds of formula I, and hence, inhibition of the
`
`depolarization of taste receptor cells expressing TRPM5.
`
`However, the specification does not provide data or support for the inhibition of all
`
`taste modulating proteins, or inhibiting the depolarization of all taste receptor cells.
`
`(8) The quantity of experimentation necessary:
`
`Considering the state of the art as discussed by the references above, particularly
`
`with regards to the teachings of the prior art and the high unpredictability in the art
`
`as evidenced therein, and the lack ofguidance provided in the specification, one of
`
`ordinary skill in the art would be burdened with undue experimentation to practice
`
`the invention commensurate in the scope of the claims.
`
`Claim Rejections-35 USC § 112
`
`7.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it,
`in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
`
`8.
`
`Claims 1-3, 6, 9, 13, 15, 17-18, 27-28, 54-56, 59, 62, 66, 67-73, and 214 are
`
`rejected under 35 U.S.C. 112, first paragraph, because the specification, while being
`
`enabling for inhibition of the taste modulating protein TRPM5 and inhibition of the
`
`depolarization of a taste receptor cell expressing TRPM5 with some compounds of
`
`

`

`Application/Control Number: 11/797,082
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`Page 8
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`Art Unit: 1627
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`formula I, in which Ar1, Ar2, and Ar3 are optionally substituted phenyl, does not
`
`reasonably provide enablement for all claimed compounds of formula I, in which Ar1,
`
`Ar2, and Ar3 may be heteroaryl. The specification does not enable any person skilled in
`
`the art to which it pertains, or with which it is most nearly connected, to practice the
`
`invention commensurate in scope with these claims. See M.P.E.P. 2164.08. Chou et.
`
`al., Bioorganic and Medicinal Chemistry Letters, 13, pp. 507-511, (2003), and
`
`Mortensen et. al., J. Med. Chem, 44, pp. 3838-3848, (2001), are referenced in this
`
`rejection.
`
`The factors to be considered in determining whether a disclosure meets the
`
`enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In
`
`re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states,
`
`“Enablement is not precluded by the necessity for some experimentation, such as
`
`routine screening. However, experimentation needed to practice the invention must not
`
`be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8
`
`USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on
`
`the basis of quantity of experimentation required to make or use the invention.
`
`“Whether undue experimentation is needed is not a single, simple factual determination,
`
`but rather is a conclusion reached by weighing many factual considerations” (Wands, 8
`
`USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the
`
`breadth of the claims; (3) the state of the prior art; (4) the predictability or
`
`unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of
`
`

`

`Application/Control Number: 11/797,082
`
`Page 9
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`Art Unit: 1627
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`direction or guidance presented; (7) the presence or absence of working examples; and
`
`(8) the quantity of experimentation necessary.
`
`While all of these factors are considered, a sufficient amount for a prima facie
`case is discussed below.
`
`(1) The nature of the invention and (2) the breadth of the claims:
`
`The claims are drawn to the inhibition of a taste modulating protein, and inhibition of
`
`the depolarization of a taste receptor cells comprising contact with a compound of
`
`formula I. Thus, the claims taken together with the specification imply that all
`
`compounds of formula I would be effective in the claimed invention. It is noted that
`
`Ar1, Ar2, and Ar3 of the compounds of formula I can be independently phenyl or
`
`heteroaryl. There are a vast number of heteroaryl groups, of different chemical and
`
`physical properties. Due to the considerable number of different compounds of
`
`formula I which are defined by Ar1, Ar2, and Ar3 being either phenyl or heteroaryl, the
`
`claims are considerably broad in scope.
`
`(3) The state of the prior art and (4) the predictability or unpredictability of the art:
`
`The Applicants have provided data that some compounds of formula I, in which Ar1,
`
`Ar2, and Ar3 = optionally substituted phenyl, express activity at inhibiting the taste
`
`modulation protein TRPM5. However, the claims are drawn to the claimed methods,
`
`in which Ar1, Ar2, and Ar3 are independently selected from optionally substituted
`
`phenyl or heteroaryl. Bioisosteric replacements, in which a functional group is
`
`replaced with another which has similar chemical and physical properties, are well
`
`known in the art. There exist bioisosteric relationships among different aromatic
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`

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`Page 10
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`Art Unit: 1627
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`groups; however, such relationships are usually generalized, and in some instances
`
`do not apply for individual situations. For example, pyridine is a commonly applied
`
`bioisosteric replacement for a phenyl group; however, there are many instances in
`
`which pyridine and phenyl do not function as equivalent replacements of each other.
`
`Chou et. al. compares structure-activity relationships of benzothiophene factor Xa
`
`inhibitors (Abstract). Factor Xa inhibitors prevent thrombin formation and have
`
`pharmaceutical utility as anti-coagulants (p. 507, left column, 1st paragraph). Chou
`
`et. al. compared the potencies of compounds in which a benzene group was
`
`replaced by pyridine and thiophene. The replacement of benzene with 2—pyridyl
`
`resulted in very similar potencies; however, the replacement of benzene with 3-
`
`pyridyl lead to a decrease in activity by a factor of ten (p. 508, right column, middle
`
`paragraph and Table 2). Additionally, even though 2—pyridyl and 2—thiazole are
`
`considered in general to be isosteric, the 2—thiazole compound was inactive (p. 508,
`
`right column, middle paragraph and Table 2). For other compounds, Chou et. al.
`
`replaced the benzothiophene group with phenyl, pyridine, naphthyl, and thiophene
`
`groups (p. 509, Table 4). The pyridyl and pyrimidyl substituted compounds were
`
`inactive, while variable potencies were observed for substituted benzothiophene and
`
`thiophene compounds (p. 509, Table 4; p. 510, left column, 1St paragraph). 3-Cl-
`
`benzothiophen-2-yl and 3-methoxy-benzothiophen-2-yl were the most potent, while
`
`3-thiophen-2-yl and 3-methoxy-thiophen-2-yl were considerably less active (p. 509,
`
`Table 4; p. 510, left column, 1St paragraph). The 2—naphthyl analog exhibited greater
`
`

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`Page 11
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`Art Unit: 1627
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`potency over the 2-bromo-phenyl analog, by more than a factor of 10 (p. 509, Table
`
`4; p. 510, left column, 1St paragraph).
`
`Mortensen et. al. compared the activity of analogs of pyrrole active agents which
`
`have affinity for the estrogen receptor (Abstract; p. 3838, Figure 1). Slight alterations
`
`in structure between the pyrazoles resulted in differences in ERd binding and
`
`selectivity (p. 3838, Figure 1 and right column, bottom paragraph). Analogs of the
`
`pyrazole compounds, such as oxazoles, thiazoles, and imidazoles, were inactive (p.
`
`3838, right column, last paragraph). Furanyl, thienyl, and pyrrole analogs of the
`
`parent pyrazoles were prepared, and analyzed for ER binding and selectivity p.
`
`3840, Table 2, and Scheme 3; p. 3841, Table 4). Several of the furanyl analogs
`
`displayed good binding affinity and selectivity for the ERd receptor (p. 3841, left
`
`column, lower paragraph), while the thiophene analogs were inactive as ER ligands
`
`(p. 3841, bottom paragraph). Additionally, despite structural similarity to the parent
`
`pyrazole compound, the pyrrole analog was inactive (p. 3841, left column, bottom
`
`paragraph-right column, top sentence).
`
`Chou et. al. and Mortensen et. al. have demonstrated that marked differences can
`
`exist among various aromatic compounds regarding biological activity. Even slight
`
`changes in structure can result in significant changes in potency, binding affinity, and
`
`selectivity. The Applicants have provided data which indicates that the taste
`
`modulating protein, TRPM5, is inhibited by contact with compounds of formula I, in
`
`which Ar1, Ar2, and Ar3 are all optionally substituted phenyl. However, there is no
`
`data to support that all compounds of formula I, wherein Ar1, Ar2, and Ar3 can also
`
`

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`Application/Control Number: 11/797,082
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`Page 12
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`Art Unit: 1627
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`be heteroaryl, also exhibit this activity. In view of the examples of Chou et. al. and
`
`Mortensen et. al., it is unlikely that all claimed compounds of formula I would be
`
`effective at inhibiting TRPM5 or inhibiting a taste receptor cell which expresses
`
`TRPM5.
`
`(5) The relative skill of those in the art:
`
`The relative skill of one in the art is expected to be high, such as that of a person
`
`with an advanced degree in medicinal chemistry or biochemistry.
`
`(6) The amount of direction or guidance presented and (7) the presence or absence of
`
`working examples:
`
`The specification has provided guidance for the preparation and activity of some
`
`compounds of formula I, in which Ar1, Ar2, and Ar3 are optionally substituted phenyls.
`
`However, the specification does not provide support that all claimed compounds of
`
`formula I are effective at inhibiting the taste modulating protein, TRPM5.
`
`(8) The quantity of experimentation necessary:
`
`Considering the state of the art as discussed by the references above, particularly
`
`with regards to the examples provided by the prior art and the high unpredictability in
`
`the art as evidenced therein, and the lack of guidance provided in the specification,
`
`one of ordinary skill in the art would be burdened with undue experimentation to
`
`practice the invention commensurate in the scope of the claims.
`
`

`

`Application/Control Number: 11/797,082
`
`Page 13
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`Art Unit: 1627
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`Claim Rejections-Obviousness Type Double Patenting
`
`9.
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory
`
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`
`are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference c|aim(s) because the examined application claim is either anticipated
`
`by, or would have been obvious over, the reference c|aim(s). See, e.g., In re Berg, 140
`
`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 14
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`Art Unit: 1627
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`10.
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`Claims 1-3, 6, 9-13, 15, 17-18, 27-28, 54-56, 59, 62-73, and 214 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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`Information Disclosure Statement
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`11.
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`The information disclosure statement (IDS) submitted on 1/11/2008 was filed.
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`The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the
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`information disclosure statement has been considered by the examiner.
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`Conclusion
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`

`

`Application/Control Number: 11/797,082
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`Page 15
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`Art Unit: 1627
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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 )270-7710. The examiner can normally be reached on Monday-Thursday 8:00 AM
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`- 6:30 PM EST.
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`If 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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`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.
`
`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—1000.
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`S.P.
`
`/SREENI PADMANABHAN/
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`Supervisory Patent Examiner, Art Unit 1627
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`