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`UNITED STATES PATENT AND 'IRADEMARK OFFICE
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`UNITED S'l'A'I'ES Dt:PAR'l'MEN'l' OF COMMERCE
`United Stntett Patent. und 1.'radernurL. Offiue
`Address' COMMISSIONER OP PATENTS AND TRADEMARKS
`Wa11hingum, D.C. 20231
`WWW.U!llpto.gov
`
`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`09n50,022
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`12129/2000
`
`Indu J. Isaacs
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`016777/0454
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`6419
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`02/05/2003
`
`7590
`Stephen A. Bent
`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite 500
`Washington, DC 20007-5109
`
`EXAMINER
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`KAM, CHIH MIN
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`ART UNIT
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`1653
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`DA TE MAILED: 02/05/2003
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`PAPER NUMBER
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`ID
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`\
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`PT0-90C (Rev. 07-01)
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`CFAD Exhibit 1009
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`1
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`I
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`09/750,022
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`Examiner
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`ISAACS, INDU J.
`
`Art Unit
`
`Chih-Min Kam
`1653
`•• 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 J MONTH(S) 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 the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.
`-
`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
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`1 )[81 Responsive to communication(s) filed on 27 November 2002.
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`2a)0 This action is FINAL.
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`2b)r81 This action is non-final.
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`3)0 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 parle Quayle, 1935 C.D. 11, 453 O.G. 213.
`Disposition of Claims
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`4)[81 Claim(s) 1-54 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)[81 Claim(s) 36-42 is/are ellovved. r 'b fn·,-,,.,..~
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`6)[81 Claim(s) 1-22.31.43-46 and 49-54 is/are rejected.
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`7)[81 Claim(s) 23-30.32-35.47.48 is/are objected to.
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`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`Application Papers
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`9)0 The specification is objected to by the Examiner.
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`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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).
`11 )0 The proposed drawing correction filed on __ is: a)O approved b )0 disapproved by the Examiner.
`If approved, corrected drawings are required in reply to this Office action.
`12)0 The oath or declaration is objected to by the Examiner.
`
`Priority under 35 U.S.C. §§ 119 and 120
`13)[81 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d} or (f).
`a)O All b)O Some* c}O None of:
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`1.[81 Certified copies of the priority documents have been received.
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`2.0 Certified copies of the priority documents have been received in Application No. __ .
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`3.0 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.
`14)0 Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 119(e) (to a provisional application}.
`a) 0 The translation of the foreign language provisional application has been received.
`15)0 Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 and/or 121.
`Attachment(s)
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`1) [81 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PT0-1449) Paper No(s) __ .
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`4) 0 Interview Summary (PT0-413) Paper No(s). __ .
`5) 0 Notice of Informal Patent Application (PT0-152)
`6) 0 Other:
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`U.S. Patent and Trademark Office
`PT0-326 (Rev. 04-01)
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`Office Action Summary
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`Part of Paper No. 10
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`2
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`•
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`Page 2
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`DETAILED ACTION
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`Status of the Claims
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`1.
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`Claims 1-54 are pending.
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`Applicants' amendment filed November 27, 2002 (Paper No. 8) is acknowledged.
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`Applicants' response has been fully considered. Claims 1, 14, 15 and 32 have been amended,
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`and claims 1-54 are examined.
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`Priority Document
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`2.
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`The priority document (United Kingdom 9930882.7, filed December 30, 1999) is
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`acknowledged (Paper No. 9).
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`Objection Withdrawn
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`3.
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`The previous objection to claims 14, 15 and 32 is withdrawn in view of the amendment to
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`the claim, and applicants' response at page 3 in Paper No. 8.
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`Rejection Withdrawn
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`Claim Rejections-35USC§112
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`4.
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`The previous rejection of claims 1-54, under 35 U.S.C.112, second paragraph, is
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`withdrawn in view of applicants' amendment to the claims, and applicants' response at pages 3-5
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`in Paper No. 8.
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`Claim Rejections-35USC§103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness
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`rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the
`manner in which the invention was made.
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`3
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`Page3
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`5.
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`Claims 1-10; 22, and 49-54 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over Knudsen et al. (WO 99/43361) in view of Makino et al. (U. S. Patent 4,985,244).
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`Knudsen et al. teach a pharmaceutical composition comprising a GLP-2 derivative or
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`analog, an isotonic agent such as mannitol, a buffer of histidine or sodium phosphate, a
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`pharmaceutical acceptable carrier, a preservative and a surfactant, where the solubility and
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`stability of GLP-2 is improved and the pharmaceutical formulation has pH 6.9 if phosphate
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`buffer is used (page 4, line 19-29; page 3, lines 24-25; claims 1-4 and 10). The reference also
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`indicates the concentration of the GLP-2 derivative is more than 0.5 mg and less than 100 mg/ml
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`(page 4, lines 9-12; page 13, lines 16-19; claims 5-8), the formulation can be obtained in
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`lyophilized form (page 13, line 10; claim 22), and the pharmaceutical composition can be
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`administered by injection or means of infusion pump to treat small bowl syndrome or intestinal
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`inflammation (page 12, lines 13-16; page 13, 16-24, claims 49-54). However, Knudsen et al. do
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`not disclose using histidine as a stabilizing agent. Makino et al. disclose using 5% (w/v%) of
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`histidine as a stabilizing agent in a vaccine composition (column 1, lines 15-20), which is about
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`1 % (claim 9). At the time the invention was made, it would have been obvious to a person of
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`ordinary skill in the art to use the pharmaceutical composition of GLP-2 analogs as indicated by
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`Knudsen et al. with the addition of a stabilizing agent taught by Makino et al. to treat a
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`gastrointestinal disease because the addition of histidine can further improve the stability of the
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`pharmaceutical formulation. Thus, the combined references result in the claimed invention and
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`was, as a whole, prima facie obvious at the time the claimed invention was made.
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`4
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`Application/Control Number: 091750,022
`Art Unit: 1653
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`Page4
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`7.
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`Claims 11, 12 and 31 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Knudsen et al. in view of Makino et al. as applied to claims 1-10 above, further in view of Hora
`
`et al. (U. S. Patent 5,997 ,856).
`
`Knudsen et al. teach a pharmaceutical composition comprising a GLP-2 derivative or
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`analog, an isotonic agent such as mannitol, a buffer of histidine or sodium phosphate, a
`
`pharmaceutical acceptable carrier, a preservative and a surfactant, where the solubility and
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`stability of GLP-2 is improved and the pharmaceutical formulation has pH 6.9 if phosphate
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`buffer is used (page 4, line 19-29; page 3, lines 24-25; claims 1-4 and 10), the concentration of
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`the GLP-2 derivative is more than 0.5 mg and less than 100 mg/ml (page 4, lines 9-12; page 13,
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`lines 16-19; claims 5-8), and Makino et al. disclose using 5% (w/v%) of histidine as a stabilizing
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`agent in a vaccine composition (column 1, lines 15-20), which is about 1%(claim9). However,
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`Knudsen et al. and Makino et al. do not disclose the concentration of mannitol in the
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`pharmaceutical composition. Hora et al. disclose 1-5% mannitol is used as a bulking agent in a
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`protein preparation (column 25, lines 7-14). At the time the invention was made, it would have
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`been obvious to a person of ordinary skill in the art using the pharmaceutical formulation of
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`GLP-2 analogs as indicated by Knudsen et al. and Makino et al. with a known concentration of
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`mannitol taught by Hora et al. (claims 11, 12 and 31) to treat a gastrointestinal disease because
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`the addition of a known concentration of mannitol can further improve the stability of the
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`pharmaceutical composition. Thus, the combined references result in the claimed invention and
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`was, as a whole, prima facie obvious at the time the claimed invention was made.
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`5
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`Page 5
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`7.
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`Claims 13-15 and 17-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Knudsen et al. in view of Makino et al. as applied to claim 1 above, further in view of Drucker et
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`al. (WO 97/39031).
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`Knudsen et al. teach a pharmaceutical composition comprising a GLP-2 derivative or
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`analog, an isotonic agent such as mannitol, a buffer of histidine or sodium phosphate, a
`
`pharmaceutical acceptable carrier, a preservative and a surfactant, where the solubility and
`
`stability of GLP-2 is improved and the pharmaceutical formulation has pH 6.9 if phosphate
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`buffer is used (page 4, line 19-29; page 3, lines 24-25; claim 1), and Makino et al. disclose using
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`histidine as a stabilizing agent in a vaccine composition (column 1, lines 15-20). However,
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`Knudsen et al. and Makino et al. do not disclose the source and the sequences of GLP-2, the
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`h[Gly2]GLP-2 analog, and OPP-IV-resistant GLP-2 analogs. Drucker et al. disclose the
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`sequence of human GLP-2, h[Gly2]GLP-2 analog, and OPP-IV-resistant GLP-2 analogs, where
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`the Ala at position 2 has been modified (page 7, lines 8-20; page 9, lines 11-22, Table 1). At the
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`time the invention was made, it would have been obvious to a person of ordinary skill in the art
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`using the GLP-2 analogs taught by Drucker et al. to prepare the pharmaceutical composition as
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`indicated by Knudsen et al. and Makino et al. (claims 13-15 and 17-20) to treat a gastrointestinal
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`disease because the use ofDPP-IV resistant GLP-2 analogs in the pharmaceutical composition
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`would result in a more stable pharmaceutical composition in vivo, where the GLP-2 analogs are
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`degraded more slowly in vivo condition. Thus, the combined references result in the claimed
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`invention and was, as a whole, prima facie obvious at the time the claimed invention was made.
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`6
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`Application/Control Number: 091750,022
`Art Unit: 1653
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`Page 6
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`8.
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`Claims 16 and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Knudsen et al. in view of Makino et al. as applied to claim 1 above, further in view of Thim et
`
`al. (U.S. Patent 5,912,229).
`
`Knudsen et al. teach a pharmaceutical composition comprising a GLP-2 derivative or
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`analog, an isotonic agent such as mannitol, a buffer of histidine or sodium phosphate, a
`
`pharmaceutical acceptable carrier, a preservative and a surfactant, where the solubility and
`
`stability of GLP-2 is improved and the pharmaceutical formulation has pH 6.9 if phosphate
`
`buffer is used (page 4, line 19-29; page 3, lines 24-25; claim 1), and Makino et al. disclose using
`
`histidine as a stabilizing agent in a vaccine composition (column 1, lines 15-20). However,
`
`Knudsen et al. and Makino et al. do not disclose the use of GLP-2 receptor to identify peptides
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`that bind GLP-2 receptor or as GLP-2 receptor antagonist. Thim et al. disclose a GLP-2 receptor
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`is identified and cloned, and a cell line stably expressing the receptor is used in a screening assay
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`to identify the antagonist of GLP-2 receptor (column 10, lines 43-59). At the time the invention
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`was made, it would have been obvious to a person of ordinary skill in the art using the GLP-2
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`analogs taught by Thim et al. to prepare the pharmaceutical composition as indicated by
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`Knudsen et al. and Makino et al. (claims 16 and 21) to treat a GLP-2 receptor-associated disease
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`because the GLP-2 receptor antagonist can be used to treat GLP-2 receptor-associated diseases.
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`Thus, the combined references result in the claimed invention and was, as a whole, prima facie
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`obvious at the time the claimed invention was made.
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`9.
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`Claims 43-46 are rejected under 35 U.S.C. 103(a) as being unpatentable over Knudsen et
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`al. in view of Makino et al. as applied to claim 1 above, further in view of Drucker (U.S. Patent
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`5,952,301).
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`7
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`Application/Control Number: 091750,022
`Art Unit: 1653
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`Page 7
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`Knudsen et al. teach a pharmaceutical composition comprising a GLP-2 derivative or
`
`analog, an isotonic agent such as mannitol, a buffer of histidine or sodium phosphate, a
`
`pharmaceutical acceptable carrier, a preservative and a surfactant, where the solubility and
`
`stability of GLP-2 is improved and the pharmaceutical formulation has pH 6.9 if phosphate
`
`buffer is used (page 4, line 19-29; page 3, lines 24-25; claim 1), and Makino et al. disclose using
`
`histidine as a stabilizing agent in a vaccine composition (column 1, lines 15-20). However,
`
`Knudsen et al. and Makino et al. do not disclose a kit comprising a lyophilized GLP-2
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`formulation. Drucker disclose a kit comprising GLP-2 or GLP-2 analogs (column 2, lines 56-
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`61 ). At the time the invention was made, it would have been obvious to a person of ordinary
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`skill in the art using the pharmaceutical composition as indicated by Knudsen et al. and Makino
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`et al. to prepare a kit as taught by Drucker (claims 43-46) to treat a gastrointestinal disease
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`because the kit containing the pharmaceutical composition can be used more conveniently in the
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`treatment. Thus, the combined references result in the claimed invention and was, as a whole,
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`prima facie obvious at the time the claimed invention was made.
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`10.
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`Claims 23-30, 32-35, 47 and 48 are objected to as being dependent upon a rejected base
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`claim, but would be allowable ifrewritten in independent form including all of the limitations of
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`the base claim and any intervening claims.
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`8
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`Page 8
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`Conclusion
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`11.
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`Claims 1-22, 31, 43-46 and 49-54 are rejected, and claims 23-30, 32-35, 47 and 48 are
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`objected. It appears that claims 36-42 are free of prior art.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Chih-Min Kam whose telephone number is (703) 308-9437. The
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`examiner can normally be reached on 8.00-4:30, Mon-Fri.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Christopher Low can be reached on (703) 308-2923. The fax phone numbers for the
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`organization where this application or proceeding is assigned are (703) 308-0294 for regular
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`communications and (703) 308-4227 for After Final communications.
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`Any inquiry of a general nature or relating to the status of this application or proceeding
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`should be directed to the receptionist whose telephone number is (703) 308-0196.
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`Chih-Min Kam, Ph. D. {A--f /(
`Patent Examiner
`
`February 1, 2002
`
`CHRISTOPHER S. F. LOW
`SUPERVISORY PATENT EXAMINER
`TECHHOl.OGYCEHTER1to0
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`9
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