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`•
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`UNITED STATES PATENT AND 1RADEMARK OFFICE
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`• UNITED STATES DEPARTMENT OF COMMERCE.·
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`United Stotos P.otont und Trodom.ork OMco
`AddrcH: COMMISSIONER OF PATENTS ANO TRADEMARKS
`Washington, D.C. 20231
`WWW.\18pto.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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`09/750,022
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`12/29/2000
`
`Jndu J. Isaacs
`
`016777/0454
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`6419
`
`03/08/2002
`
`7590
`Stephen A. Bent
`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite 500
`Washington, DC 20007-5109
`
`EXAMINER
`
`KAM, CHIH MIN
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`ART UNIT
`
`PAPER NUMBER
`
`1653
`
`DA TE MAILED: 03/08/2002
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PT0-90C (Rev. 07-01)
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`CFAD Exhibit 1007
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`1
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`

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`,.j'---_...:;.~------------1
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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
`
`Examiner
`
`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~ 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
`ea med patent term adjustment. See 37 CFR 1. 704(b ).
`Status
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`1 )rg] Responsive to communication(s) filed on 01 February 2002.
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`2a)0 This action is FINAL.
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`2b)rg] 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 parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`Disposition of Claims
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`4)rg) 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)0 Claim(s) __ is/are allowed.
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`6)rg] Claim(s) 1-54 is/are rejected.
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`7)0 Claim(s) __ 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)0 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)O disapproved by the Examiner.
`If approved, corrected drawings ar~ 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)rg] 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)rg) None of:
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`1.rg] 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)
`
`1) rg] Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) rg] lnfonnation Disclosure Statement(s) (PT0-1449) Paper No(s) !1..
`
`Interview Summary (PT0-413) Paper No(s). __ .
`4) 0
`5) 0 Notice of lnfonnal Patent Application (PT0-152)
`6) 0 Other:
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`U.S. Patent and Trademark Office
`PT0-326 (Rev. 04-01)
`
`Office Action Summary
`
`Part of Paper No. 7
`
`2
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`

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`•
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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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`1.
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`Applicants claim foreign priority, however, the priority document (United Kingdom 993-
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`882.7) has not been submitted. Therefore, the priority date is not perfected.
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`Election/Restrictions
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`2.
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`Applicant's election with traverse of Group II, claims 49-54 along with the product
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`claims 1-35 and 43-48 in Paper No. 6 is acknowledged. Applicants traverse on the ground(s)
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`that claims 36-42 of Group I can be examined with Group II without serious search burden. The
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`argument is found persuasive. Upon reconsideration, Group I is rejoined with Group II. Thus,
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`claims 1-54 are examined.
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`Claim Objections
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`3.
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`Claim 14 is objected to because of the use of the term "n animal". Appropriate correction
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`is required.
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`4.
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`Bracketing or underlining are commonly used to indicate amendments or changes in the
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`claims as provided in 37 CFR 1.121(a)(2)(ii) and are normally not intended to be printed in the
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`published patent. For example, in claims 15 and 32, applicant has used "h[Gly2]GLP-2" in such
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`a manner that appears that the instant brackets would indicate deleted material and is thus,
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`confusing as to whether the h[Gly2]GLP-2 in claims 15 and 32 would include "Gly2" or not.
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`The applicant can only amend by cancellation and presentation of a new claim. See also changes
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`to 37 CFR 1.121 in Amendment rules package (Final Rule published on 8 Sep. 2000 (65 Fed.
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`--
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`Reg. 54603), see also 0. G. of 19 Sep. 2000 (1238 Off. Gaz. Pat. Office 77)).
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`Claim Rejections-35USC§112
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`3
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`•
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`•
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`Page 3
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`The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the
`subject matter which the applicant regards as his invention.
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`5.
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`Claims 1-54 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for
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`failing to particularly point out and distinctly claim the subject matter which applicant regards as
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`the invention.
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`Claims 1-54 are indefinite because of the use of the term "GLP-2. The term "GLP-2"
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`renders the claim indefinite, it is not clear what the term means. A full spelled out word should
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`precede the term at the first occurrence. Claims 2-30, 32-35, 37-42, 44-48 and 50-54 are
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`included in this rejection for being dependent on rejected claims and not correcting the
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`deficiency of the claims from which they depend.
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`6.
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`Claims 1-14, 17 and 22-54 are indefinite because of the use of the term "an analog". The
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`term "an analog" renders the claim indefinite, it is unclear what amino acid sequence the analog
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`has as compared to the parent peptide. Claims 2-14, 17, 22-30, 32-35, 37-42, 44-48 and 50-54
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`are included in this rejection for being dependent on rejected claims and not correcting the
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`deficiency of the claims from which they depend.
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`7.
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`Claims 2 and 3, for example, are indefinite because of the use of the term "greater than
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`about 6.0" or "from about 6.9 to about 7.9". The term "greater than about 6.0" or "from about
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`6.9 to about 7.9" renders the claim indefinite, it is unclear the pH of the formulation is greater or
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`less than pH 6.0, and the pH is in the range of pH 6.9 to 7.9 or outside the range. Deletion of the
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`7
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`term "about" is suggested. See also claims 4, 34, 35, 37-41, 44, 45, 50 and 51.
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`8.
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`Claims 23 and 25, for example, are indefinite because of the use of the term "less than
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`about 5%", "for up to at least 6 months" or "less than about 3 to about 4%". The term "less than
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`about 5%", "for up to at least 6 months" or "less than about 3 to about 4%" renders the claim
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`4
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`•
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`Page4
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`indefinite, it is unclear the water content in the lyopholized formulation is greater or less than
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`5%, how many months the GLP-2 formulation is being stable, and the percentage of degradation
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`of GLP-2 is in the range of 3 to 4% or outside the range. See also claims 26-30, 41and47.
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`9.
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`Claim 17 is indefinite because of the use of the term "one or more amino acid
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`substitutions, additions, deletions or modifications" or "biological activity". The term "one or
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`more amino acid substitutions, additions, deletions or modifications" or "biological activity"
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`renders the claim indefinite, it is unclear how many and which amino acids are modified, and
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`what amino acids are used for modifications, and what the biological activity is because the
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`biological activity is not specified in the claim.
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`10.
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`Claim 48 is indefinite because of the use of the term "up to about 24 hours". The term
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`1
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`"up to about 24 hours" renders the claim indefinite, it is unclear the GLP-2 formulation is stable
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`less than or more than 24 hours.
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`11.
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`Claim 49-54 are indefinite because of the use of the term "a disorder, disease or
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`condition" or "gastrointestinal disease". The term "a disorder, disease or condition" or
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`"gastrointestinal disease" renders the claim indefinite, it is unclear what disease a human or
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`animal has. Claims 50-54 are included in this rejection for being dependent on rejected claims
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`and not correcting the deficiency of the claims from which they depend.
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`12.
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`Claims 49-54 are indefinite because the claims lack essential steps in the method of
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`treating a human or an animal having a disease using the GLP-2 formulation. The omitted steps
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`are: the method of administration, the effective amount of formulation and the outcome for the
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`treatment. Claims 50-54 are included in this rejection for being dependent on a rejected claim
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`and not correcting the deficiency of the claim from which they depend.
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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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`13.
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`No claims are allowed.
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`Conclusion
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`Art of Record
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`Knudsen et al. (WO 99/43361) teach a pharmaceutical composition comprising a GLP-2
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`derivative or analog, an isotonic agent such as mannitol, a buffer of histidine or sodium
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`phosphate, a pharmaceutical acceptable carrier, a preservative and a surfactant, where the
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`solubility and stability of GLP-2 is improved (page 4, line 19-29; page 3, lines 24-25). The
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`reference also indicates the concentration of the GLP-2 derivative is more than 0.5 mg and less
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`than 100 mg/ml (page 4, lines 9-12; page 13, lines 16-19), the formulation can be obtained in
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`lyopholized form (page 13, line 10), and the pharmaceutical composition can be administered by
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`~·
`injection or means of infusion pump to treat small bo~l syndrome or intestinal inflammation
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`(page 12, lines 13-16; page 13, 16-24, for claims 49-54). However, Knudsen et al. does not
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`disclose using histidine as a stabilizing agent. Makino et al. (U. S. Patent 4,985,244) disclose
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`using histidine as a stabilizing agent in a vaccine composition (column 1, lines 15-20), however,
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`it is not known whether histidine can stabilize GLP-2 or its analogs in the GLP-2 formulation.
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`Thus, the references do not teach the claimed invention.
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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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`6
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`Application/Control Number: 09/750,022
`Art Unit: 1653
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`•
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`Page6
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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.
`Patent Examiner
`
`March 3, 2002
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`r--&)--~~
`
`KAREN COCHRANE CARLSON, PH.D
`PRIMARY EXAMINER
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`7
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