UNITED ST ATES PATENT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313~1450
`www.usp10.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`09/750,022
`
`12/29/2000
`
`Indu J. Isaacs
`
`016777/0454
`
`6419
`
`06/08/2004
`
`7590
`Stephen A Bent
`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite 500
`Washington, DC 20007-5109
`
`EXAMINER
`
`KAM, CHIH MIN
`
`1653
`
`DA TE MAILED: 06/08/2004
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PT0-90C (Rev. 10/03)
`
`CFAD Exhibit 1013
`
`1
`
`

`

`Office Action Summary
`
`Application No.
`
`09/750,022
`
`Examiner
`
`Applicant(s)
`
`ISAACS, INDU J.
`
`Art Unit
`
`1653
`Chih-Min Kam
`-- 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
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1 )[8J Responsive to communication(s) filed on 16 March 2004.
`2a}i:8J This action is FINAL.
`2b)0 This action is non-final.
`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
`
`4}[8J Claim(s) 1-76 is/are pending in the application.
`4a) Of the above claim(s)
`is/are withdrawn from consideration.
`5)[8J Claim(s) 1.5-22.31-33.36.39.40.43.46.55.58.60-62.64 and 68-76 is/are allowed.
`6)[8J Claim(s) 2-4.23-30.34.35,37.38.41.42.44.45.47-54.56.57.59,63 and 65-67 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on
`is/are: a)O accepted or b)O 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 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)[8J Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)[8J All b)O Some* c)O None of:
`1.[8J Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`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.
`
`Attachment(s)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disdosure Statement(s) (PT0-1449 or PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application (PT0-152)
`6) 0 Other:
`.
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 1-04)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 0604
`
`2
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page2
`
`DETAILED ACTION
`
`Status of the Claims
`
`1.
`
`Claims 1-76 are pending.
`
`Applicants' amendment filed March 16, 2004 is acknowledged. Applicants'
`
`response has been fully considered. Claims 1, 25 and 52 have been amended, and new
`
`claims 56-76 have been added. Therefore, claims 1-76 are examined.
`
`Rejection Withdrawn
`
`Claim Rejections - 35USC§112
`
`2.
`
`The previous rejection of claim 17 under 35 U.S.C. 112, second paragraph, as
`
`being indefinite, is withdrawn in view of applicants' response at page 14 in the
`
`amendment filed March 16, 2004, and applicant's response at page 4 in Paper No. 8.
`
`Claim Rejections - 35USC§103
`
`3.
`
`The previous rejection of claims 1-10, 22, and 49-55 under 35 U.S.C. 103(a) as
`
`being unpatentable over Knudsen et al. (WO 99/43361) in view of Yamazaki et al. (U.S.
`
`Patent 6,120,761), is withdrawn in view of applicants' response at pages 14-18 in the
`
`amendment filed March 16, 2004.
`
`4.
`
`The previous rejection of claims 11, 12, 31 and 33 under 35 U.S.C. 103(a) as
`
`being unpatentable over Knudsen et al. (WO 99/43361) in view of Yamazaki et al. as
`
`applied to claims 1-10, further in view of Hora et al. (U.S. Patent 5,997,856), is
`
`withdrawn in view of applicants' response at pages 18-19 in the amendment filed March
`
`16, 2004.
`
`5.
`
`The previous rejection of claims 13-15, 17-20 and 32 under 35 U.S.C. 103(a) as
`
`being unpatentable over Knudsen et al. (WO 99/43361) in view of Yamazaki et al. and
`
`3
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page 3
`
`Hora et al., as applied to claim 1, further in view of Drucker et al. (WO 97/39031), is
`
`withdrawn in view of applicants' response at page 19 in the amendment filed March 16,
`
`2004.
`
`6.
`
`The previous rejection of claims 16 and 21under35 U.S.C. 103(a) as being
`
`unpatentable over Knudsen et al. (WO 99/43361) in view of Yamazaki et al. as applied to
`
`claim 1, further in view of Thim et al. (U.S. Patent 5,912,229), is withdrawn in view of
`
`applicants' response at pages 19-20 in the amendment filed March 16, 2004.
`
`7.
`
`The previous rejection of claims 43-46 under 35 U.S.C. 103( a) as being
`
`unpatentable over Knudsen et al. (WO 99/43361) in view of Yamazaki et al. as applied to
`
`claim 1, further in view of Drucker (U.S. Patent 5,952,301), is withdrawn in view of
`
`applicants' response at page 20 in the amendment filed March 16, 2004.
`
`Claim Objections
`
`8.
`
`Bracketing or underlining are commonly used to indicate amendments or changes
`
`in the claims as provided in 37 CFR l.121(a)(2)(ii) and are normally not intended to be
`
`printed in the published patent. For example, in claims 56 and 57, applicant has used
`
`"h[Gly2]GLP-2" in such a manner that appears that the instant brackets would indicate
`
`deleted material and is thus, confusing as to whether the GLP-2 peptide in claims 56 and
`
`57 would include "Gly2" or not. The applicant can only amend by cancellation and
`
`presentation of a new claim. See also changes to 37 CFR 1.121 in Amendment rules
`
`package (Final Rule published on 8 Sep. 2000 (65 Fed. Reg. 54603), see also 0. G. of 19
`
`Sep. 2000 (1238 Off. Gaz. Pat. Office 77)).
`
`9.
`
`Claim 59 is objected to because of the use of terms "glu" and "P03-Tyr2
`". Use of
`
`"Glu" and "P03-Tyr" is suggested.
`
`4
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page4
`
`Claim Rejections- 35USC§112
`
`The following is a quotation of the second paragraph of 35 U.S.C. 112:
`
`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.
`
`10.
`
`Claims 2-4, 23-30, 34, 35, 37, 38, 41, 42, 44, 45, 47-54, 56, 57, 59, 63, 65-67 are
`
`rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to
`
`particularly point out and distinctly claim the subject matter which applicant regards as
`
`the invention.
`
`11.
`
`Claims 2-4, 34, 35, 37, 38, 44, 45, 50, 51, 56, 57, 65-67 are indefinite because of
`
`the use of the term "greater than about 6.0" or "greater than about 5.5''. The term
`
`"greater than about 6.0" or "greater than about 5.5'' renders the claim indefinite, it is
`
`unclear whether the pH of the formulation is higher than pH 6.0 (or 5.5) as to "greater
`
`than", or, is less than pH 6.0 (5.5) as to "about". Claims 3, 4, 35, 38, 45, 50, 51, 56, 57
`
`and 65-67 are included in this rejection for being dependent on rejected claims and not
`
`correcting the deficiency of the claims from which they depend.
`
`12.
`
`Claims 23-25, for example, are indefinite because of the use of the term "less than
`
`about 5%'', "for up to at least 6 months" or "less than about 3 to about 4%". The term
`
`"less than about 5%", "for up to at least 6 months" or "less than about 3 to about 4%"
`
`renders the claim indefinite, it is unclear whether the water content in the lyophilized
`
`formulation is less than 5% as to "less than'', or is greater than 5% as to "about", whether
`
`the GLP-2 formulation is stable less than 6 months as to "up to'', or, is greater than 6
`
`months as to "about", and the percentage of degradation of GLP-2 is in the range of 3 to
`
`4% as to "about. .. to about", or, is less than 3% as to "less than". See also claims 26-30,
`
`41, 42 and 47.
`
`5
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page 5
`
`13.
`
`Claim 42 is indefinite because of the use of the term "no more than about 2%".
`
`The term "no more than about 2%" renders the claim indefinite, it is unclear whether the
`
`water content is less than 2% as to "no more than'', or is greater than 2% as to "about".
`
`14.
`
`Claim 48 is indefinite because of the use of the term "up to about 24 hours". The
`
`term "up to about 24 hours" renders the claim indefinite, it is unclear the GLP-2
`
`formulation is stable less than 24 hours as to "up to'', or, is more than 24 hours as to
`
`"about".
`
`In response to the rejections in paragraphs 11-14, applicants indicate the same
`
`type of rejection has been withdrawn in the previous Office Action (Paper No. 10) in
`
`response to the argument presented in Paper No. 8 (page 14 of the response in the
`
`amendment March 16, 2004 ), which indicates a person of ordinary skill in the art would
`
`know the phrases refer to measurement variability (pages 3-4 of the response in Paper
`
`No. 8). The response has been considered, however, the argument is not found
`
`persuasive because the phrase, e.g., "the pH of the formulation is greater than about 6.0"
`
`indicates the pH can be less than, equal to, or greater than 6.0 as to the term "about",
`
`however, the term "greater than" indicates the pH is higher than 6.0, thus it is not clear
`
`whether the pH is greater or less than 6.0 as to the term "greater than about". Use of the
`
`term "the pH of the formulation is about 6.0 or greater" is suggested.
`
`15.
`
`Claims 49-54, 57 and 63 are indefinite because the claims lack an essential step in
`
`the method of treating a disease using the GLP-2 formulation. The omitted step is the
`
`outcome for the treatment. Claims 49-54, 57 and 63 are also indefinite because of the use
`
`of the term "a disorder, disease or condition for which treatment with GLP-2 is treated".
`
`The term "a disorder, disease or condition for which treatment with GLP-2 is treated"
`
`6
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page 6
`
`renders the claim indefinite, it is unclear what disease is treated. Claims 50-54, 57 and 63
`
`are included in this rejection for being dependent on a rejected claim and not correcting
`
`the deficiency of the claim from which they depend.
`
`In response, applicants indicate the same type of rejection has been withdrawn in
`
`the previous Office Action (Paper No. 10) in response to the argument presented in Paper
`
`No. 8 (page 14 of the response in the amendment March 16, 2004), which indicates claim
`
`49 is a proper method claim, the "outcome of the treatment" is not a step, but is details
`
`about the method that is not necessary to make the claim a proper method claim, and the
`
`method of administration and the effective amount of formulation are factors that easily
`
`be determined by a person of ordinary skill in the art and are described in the
`
`specification (page 7, lines 27-33); and a person of ordinary skill in the art would also
`
`know the outcome of the treatment is to treat disorder, disease or condition for which
`
`treatment with GLP-2 is indicated (page 5 of the response in Paper No. 8). The response
`
`has been considered, however, the argument is not found persuasive because without
`
`citing the endpoint in a method claim, it is not clear whether the treatment is effective or
`
`not, and "to treat disorder" is not the endpoint of the treatment. Regarding the terms "a
`
`disorder, disease, or condition" and "gastrointestinal disease'', applicants indicate a
`
`person of ordinary skill in the art would know the disorders, diseases and conditions,
`
`including gastrointestinal diseases, for which treatment with GLP-2 is indicated because
`
`the specification indicates a therapeutically useful amount of GLP-2 is administered to
`
`treat a subject, which is described more fully in severa] cited patents and international
`
`documents, thus a person of ordinary skill in the art would refer to these documents to
`
`determine disorders, diseases, or conditions for which treatment with GLP-2 is indicated
`
`7
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page 7
`
`(pages 4-5 of the response in Paper No. 8). The response has been considered, however,
`
`the argument is not fully persuasive because these patents and international documents
`
`describe specific gastrointestinal diseases are treated with amounts of GLP-2 compounds,
`
`which are effective to reduce the pathology or symptom of these diseases, while the
`
`claims of the present invention do not identify the diseases being effectively treated, but
`
`cite the disorders, diseases, or conditions for which treatment with GLP-2 is indicated,
`
`thus it is not clear what disorders, diseases, or conditions are being treated in the claims.
`
`17.
`
`Claim 59 is indefinite because of the use of the term "and/or". The term "and/or"
`
`renders the claim indefinite, it is unclear whether the limitation after "and/or" is included
`
`or not, and if included is to be read as an alternative "or" or the conjunctive "and". Claim
`
`59 is also indefinite as to the claim recites amino acid substitutions at various positions
`
`without indicating "SEQ ID NO:" of the reference sequence, it is not clear what amino
`
`acid sequence these positions are referring to.
`
`Conclusion
`
`18.
`
`Claims 2-4, 23-30, 34, 35, 37, 38, 41, 42, 44, 45, 47-54, 56, 57, 59, 63, 65-67 are
`
`rejected. It appears that claims 1, 5-22, 31-33, 36, 39, 40, 43, 46, 55, 58, 60-62, 64 and
`
`68-~6 are free of prior art.
`
`Applicant's amendment necessitated the new ground(s) ofrejection presented in
`
`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR l.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action. In the event a first reply is filed within
`
`8
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page 8
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`shortened statutory period will expire on the date the advisory action is mailed, and any
`
`extension fee pursuant to 37 CFR l.136(a) will be calculated from the mailing date of the
`
`advisory action. In no event, however, will the statutory period for reply expire later than
`
`SIX MONTHS from the date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Chih-Min Kam whose telephone number is (571) 272-
`
`0948. The examiner can normally be reached on 8.00-4:30, Mon-Fri.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Christopher Low can be reached on (571) 272-0951. The fax phone numbers
`
`for the organization where this application or proceeding is assigned are (703) 872-9306
`
`for regular communications and (703) 308-4227 for After Final communications.
`
`Any inquiry of a general nature or relating to the status of this application or
`
`proceeding should be directed to the receptionist whose telephone number is (703) 308-
`
`0196.
`
`Chih-Min Kam, Ph. D. C/-1 K
`Patent Examiner
`
`***
`June 4, 2004
`
`~~
`
`$UPERVISOl'tY PATENT EXAMINER
`TEC .. NOLOGY CENTER 1$00
`
`9
`
`