Applicant:
`
`Indu J. ISAACS
`
`Title:
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`GLP-2 Formulations
`
`Appl. No.:
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`09nS0,022
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`Filing Date: December 29, 2000
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`Examiner:
`
`C.Kam
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`Art Unit:
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`1653
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`Atty. Dkt. No. 016777/0454
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`f\E.CE\VEO
`JUN 1 2 ?.002.
`1EC\i CEN1ER ~ 60012.9~0
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`AMENDMENT AND REPLY UNDER 37 C.F.R. §1.111
`
`Commissioner for Patents
`Washington, D.C. 20231
`
`Sir:
`
`In reply to the non-final Office Action dated March 8, 2002, Applicant submits the
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`following Amendment and Reply under 37 C.F.R. § 1.111.
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`If additional fees are necessary to prevent abandonment of this application, the
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`Commissioner is hereby authorized to charge Deposit Account No. 19-0741.
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`IN THE CLAIMS:
`
`In accordance with 37 C.F.R. § 1.121, please substitute for claims 1, 14, 15, and 32
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`the following rewritten version of the same claims, as amended. The changes are shown
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`explicitly in the attached "Version with Markings to Show Changes Made".
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`1.
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`(Amended) A GLP-2 formulation comprising:
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`(a)
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`a medically useful amount of a naturally occurring glucagon-like
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`peptide-2 (GLP-2) or an analog thereof;
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`(b)
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`a phosphate buffer in an amount sufficient to adjust the pH of the
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`formulation to a physiologically tolerable level;
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`(c)
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`L-histidine; and
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`CFAD Exhibit 1008
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`1
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`Atty. Dkt. No. 01677710454
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`Indu J. ISAACS
`Serial No. 09/750,022
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`(d)
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`a bulking agent selected from the group consisting of mannitol and
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`sucrose.
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`14.
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`(Amended) The GLP-2 formulation of claim 13, wherein the GLP-2 peptide
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`has the sequence of a GLP-2 species from an animal selected from the group consisting of a
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`primate, rat, mouse, porcine species, oxine species, bovine species, degu, hamster, guinea pig,
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`fish, chicken, and human.
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`15.
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`(Amended) The GLP-2 formulation of claim 14, wherein the GLP-2 peptide is
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`h(Gly2)GLP-2.
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`32.
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`(Amended) The GLP-2 formulation of claim 31, wherein the GLP-2 is
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`h(Gly2)GLP-2.
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`I.
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`Status of the Claims
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`REMARKS
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`By this amendment, claims 1, 14, 15, and 32 are amended. Upon entry of this
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`Amendment, claims 1-54 will remain pending in the application.
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`Claim 1 has been amended to recite a "glucagon-like peptide-2 (GLP-2)'', rather than
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`"GLP-2;" claim 14 has been amended to correct a spelling error; and claims 15 and 32 have
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`been amended to replace the recited brackets with parentheses. Because the foregoing
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`amendments do not introduce new matter, entry thereof by the Examiner is respectfully
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`requested.
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`II.
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`Issues Regarding Perfection of the Claimed Foreign Priority
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`The examiner asserted that applicant claims foreign priority; however, the priority
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`document (United Kingdom 993-882.7) has not been submitted. Submitted herewith, as
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`Exhibit 1, is a certified copy of the priority document.
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`002.810030.1
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`Atty. Dkt. No. 016777/0454
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`III.
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`Claim Objections
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`Indu J. ISAACS
`Serial No. 09/750,022
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`Claim 14 was objected to for the recitation of "n animal". Applicant has amended
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`claim 14 to recite "an animal". Therefore, withdrawal of the rejection is respectfully
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`requested.
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`Claims 15 and 32 were objected to for the use of brackets. Applicant has amended
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`claims 15 and 32 by changing the brackets to parentheses. Therefore, withdrawal of the
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`rejection is respectfully requested.
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`IV.
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`Claim Rejections - 35 U.S.C. § 112, Second Paragraph
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`Claims 1-54 were rejected under 35 U.S.C. § 112, second paragraph, because the
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`claims are allegedly indefinite. Applicant respectfully requests reconsideration and
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`withdrawal of the rejection.
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`Claims 1-54 were rejected because the term "GLP-2" is allegedly indefinite.
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`Applicant has amended claim 1 to recite "glucagon-like peptide-2 (GLP-2)".
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`Claims 1-14, 17, and 22-54 were rejected because the term "an analog" is allegedly
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`indefinite. Applicant respectfully disagrees. A person of ordinary skill in the art would
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`understand the meaning of the term "an analog" in the context of the present application. For
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`example, applicant directs the Examiner's attention to page 5, line 24, through page 6, line
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`28, where GLP-2 analogs are clearly described. As the present specification provides a
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`detailed description of the term "analog", the term "an analog" as used in claims 1-14, 17, and
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`22-54 is not indefinite.
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`Claims 2 and 3 were rejected because the phrases "greater than about 6.0" and "from
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`about 6.9 to 7.9" are allegedly indefinite. The examiner applied the same rejections to claims
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`4, 34, 35, 37-41, 44, 45, 50, and 51. Claims 23 and 25 were rejected by the examiner because
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`the phrases "less than about 5%'', "for up to at least 6 months'', and "less than about 3 to
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`about 4%" are allegedly indefinite. The examiner extended this rejection for the same
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`reasons to claims 26-30, 41, and 47. Finally, claim 48 was rejected by the examiner because
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`002.810030.1
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`Indu J. ISAACS
`Serial No. 09nso,022
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`the phrase "up to about 24 hours" is allegedly indefinite. Applicant respectfully disagrees and
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`asserts that these terms do not render the claims indefinite. See W.L. Gore & Associates, Inc.
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`v. Garlock, Inc., 721F.2d1540, (Fed. Cir. 1983) and Ex parte Eastwood, 163 USPQ 316 (Bd.
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`App. 1968). A person of ordinary skill in the art would know that the phrases refer to
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`measurement variability.
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`Claim 17 was rejected by the examiner because the phrases "one or more amino acid
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`substitutions, additions, deletions or modifications" and "biological activity" are allegedly
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`indefinite. Applicant respectfully disagrees.
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`With respect to "one or more amino acid substitutions, additions, deletions, or
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`modifications", a person of ordinary skill in the art would know the meaning of this term
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`within the context of the specification. For example, applicant directs the Examiner's
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`attention to page 6, lines 4-23, of the specification where specific amino acid substitutions,
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`additions, deletions or modifications are described. As the present specification provides a
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`detailed description of specific amino acid substitutions, additions, deletions, or
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`modifications in the context of the present specification, the phrases "one or more amino acid
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`substitutions, additions, deletions, or modifications" is not indefinite.
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`Turning to "biological activity", applicant asserts that a person of ordinary skill in the
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`art would know the meaning of this term within the context of the specification. For
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`example, the Examiner's attention is directed to page 1, lines 21-23, of the specification
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`where it is stated that "GLP-2 and analogs thereof act as trophic agents to enhance and
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`maintain the functioning of the gastrointestinal tract and to promote growth of intestinal
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`tissue." As the present specification clearly describes the biological activity of GLP-2 and
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`analogs thereof, the phrase "biological activity" is not indefinite.
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`Claims 49-54 were rejected because the terms "a disorder, disease, or condition" and
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`"gastrointestinal disease" are allegedly indefinite. Applicant respectfully disagrees. A person
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`of ordinary skill in the art would know the disorders, diseases, and conditions, including
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`gastrointestinal diseases, for which treatment with GLP-2 is indicated. For example, on page
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`7, lines 27-33, of the specification, it states "[t]herapeutically useful amounts of GLP-2
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`Atty. Dkt. No. 016777/0454
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`Indu J. ISAACS
`Serial No. 09/750,022
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`include those unit dosage amounts useful in a regimen to treat a subject that would benefit
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`from GLP-2 administration, as described more fully in U.S. Patent Nos. 5,834,428;
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`5,789,379; 5,990,077; and 5,952,301, and in International Publication No. WO 98/52600." A
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`person of ordinary skill in the art would refer to these documents to determine disorders,
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`diseases, or conditions for which treatment with GLP-2 is indicated. Therefore, the terms "a
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`disorder, disease or condition" and "gastrointestinal disease" are not indefinite within the
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`context of the present specification.
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`Claims 49-54 were rejected because the claims allegedly lack essential steps in the
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`method of treating a human or an animal having a disease using the GLP-2 formulation.
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`Applicant respectfully disagrees. Claim 49 is a proper method claim. The "steps" that the
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`Examiner states are missing from the claims are not steps, but instead, are details about the
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`method that are not necessary to make the claim a proper method claim. The method of
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`administration and the effective amount of formulation are factors that can easily be
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`determined by a person of ordinary skill in the art and are described in the specification at, for
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`example, page 7, lines 27-33. A person of ordinary skill in the art would also know that the
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`outcome of the treatment is to treat the disorder, disease, or condition for which treatment
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`with GLP-2 is indicated.
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`Atty. Dkt. No. 01677710454
`
`Indu J. ISAACS
`Serial No. 091750,022
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`CONCLUSION
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`As the above-presented amendments and remarks address and overcome all of the
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`rejections presented by the Examiner, withdrawal of the rejections and allowance of the
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`claims are respectfully requested.
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`If the Examiner has any questions concerning this application, he or she is requested
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`to contact the undersigned.
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`Respectfully submitted,
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`Date June 10. 2002 (Monday)
`
`By
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`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite 500
`Washington, D.C. 20007-5109
`Telephone:
`(202) 672-5538
`Facsimile:
`(202) 672-5399
`
`Michele M. Simkin
`Attorney for Applicant
`Registration No. 34,717
`
`Should additional fees be necessary in connection with the filing of this paper, or if a petition for extension of
`time is required for timely acceptance of same, the Commissioner is hereby authorized to charge Deposit
`Account No. 19-0741 for any such fees; and applicant(s) hereby petition for any needed extension of time.
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`002.810030.1
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`Atty. Dkt. No. 016777/0454
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`VERSION WITH MARKINGS TO SHOW CHANGES MADE
`
`1.
`
`(Amended) A GLP-2 formulation comprising:
`
`(a)
`
`a medically useful amount of a naturally occurring [GLP-2 peptide]
`
`glucagon-like peptide-2 CGLP-2) or an analog thereof;
`
`(b)
`
`a phosphate buffer in an amount sufficient to adjust the pH of the
`
`formulation to a physiologically tolerable level;
`
`L-histidine; and
`
`a bulking agent selected from the group consisting of mannitol and
`
`(c)
`
`(d)
`
`sucrose.
`
`14.
`
`(Amended) The GLP-2 formulation of claim 13, wherein the GLP-2 peptide
`
`has the sequence of a GLP-2 species from [n animal] an animal selected from the group
`
`consisting of a primate, rat, mouse, porcine species, oxine species, bovine species, degu,
`
`hamster, guinea pig, fish, chicken, and human.
`
`15.
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`(Amended) The GLP-2 formulation of claim 14, wherein the GLP-2 peptide is
`
`h[[]f G 1 y2[]]}GLP-2.
`
`32.
`
`(Amended) The GLP-2 formulation of claim 31, wherein the GLP-2 is
`
`h[[]f G 1 y2[]]}GLP-2.
`
`7
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