IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`First Inventor: Steven A. FISCHKOFF
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`Docket No:
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`381493-093C4 (130717)
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`Appl. No.:
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`14/256,886
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`April18, 2014
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`Filing or
`371(c) date:
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`Title:
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`Conf. No.:
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`3521
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`Group Art Unit: 1644
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`METHODS OF ADMINISTERING ANTI- Examiner:
`TNFa ANTIBODIES
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`Zachary S. SKELDING
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`PRELIMINARY AMENDMENT UNDER 37 CFR § 1.115
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`AND
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`CORRECTION OF TIMELY PRIORITY CLAIM UNDER 37 CFR § 1. 78(a)(l)
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`ViaEFS
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Madam:
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`Prior to examination of the above-identified application, please enter the following amendments and
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`consider the accompanying remarks.
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`Amendments of the Specification begins at page 2 of this paper.
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`Amendments of the Claims begin at page 3 of this paper.
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`Amendments of the Drawings begin at page 4 of this paper.
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`Remarks begin on page 5 of this paper.
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`- 1 -
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`AMENDMENTS TO THE SPECIFICATION
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`In the Specification
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`Please replace the paragraphs as detailed below (deleted text appears strnek throagh and inserted text appears
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`underlined):
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`At page 1, replace the paragraph beginning at line 3:
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`The present application is a eontinaation divisional under 35 U.S.C. § 121 ofU.S. Application No.
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`10/163,657, filed on June 5, 2002, which claims the benefit of U.S. Provisional Application No. 60/296,961,
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`filed June 8, 2001. Each of these applications is hereby incorporated by reference in its entirety.
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`At page 6, replace the paragraph beginning at line 27:
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`F'igu:re 4 e:le}'liets Figures 4A and 4B depict results from a short form health survey (SF-36) from
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`patients suffering from RA after subcutaneous dosing with the antibody D2E7 and methotrexate every other
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`week at twenty-four weeks. RP, role physical; PF, physical function; BP, bodily pain; GH, general health; V,
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`vitality; SF, social functioning; RE, role emotional; and ME, mental health.
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`- 2-
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`In the Claims
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`AMENDMENTSTOTHECL~S
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`The following Listing of Claims, in which deleted text appears IJelded stFaek thFOagh or bolded in
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`double brackets (e.g., [[deleted text]]) and inserted text appears bolded underlined, will replace all prior
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`versions, and listings, of claims in the application.
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`Listing of Claims
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`(Currently amended) A method for treating Crohn's disease in a human subject, comprising
`1.
`administering subcutaneously to a human subject having Crohn's disease a total body dose of 40 mg of a
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`human anti-1NFa antibody once every etheF weell at an ioteFValef 13-15 days for a time period sufficient
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`to treat Crohn's disease, wherein the anti-1NFa antibody comprises an lgG1 heavy chain constant region; a
`variable light ("VL") chain region comprising a CDR1 having the amino acid sequence of SEQ ID N0:7, a
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`CDR2 having the amino acid sequence of SEQ ID N0:5, and a CDR3 having the amino acid sequence of
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`SEQ ID N0:3; and a variable heavy ("Vn") chain region comprising a CDR1 having the amino acid
`sequence of SEQ ID N0:8, a CDR2 having the amino acid sequence of SEQ ID N0:6 and a CDR3 having
`the amino acid sequence of SEQ ID N0:4.
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`2.
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`(Original) The method of claim 1, wherein the VL chain region of the anti-1NFa antibody
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`has the amino acid sequence of SEQ ID N0:1 and the Vn chain region of the anti-1NFa antibody has the
`amino acid sequence of SEQ ID N0:2.
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`(Original) The method of claim 1, wherein the human subject has had an unwanted immune
`3.
`response to a chimeric or humanized anti-1NFa antibody.
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`(Original) The method of claim 3, wherein the human anti-1NFa antibody is administered
`4.
`for a period of at least 24 weeks.
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`(Original) The method of claim 2, wherein the anti-1NFa antibody is administered for a
`5.
`period of at least 24 weeks.
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`(Original) The method of claim 1, wherein the anti-1NFa antibody is administered for a
`6.
`period of at least 24 weeks.
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`- 3-
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`AMENDMENTS TO THE DRAWINGS
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`In the Drawings
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`Please replace drawing sheets 3-5 with the attached replacement drawing sheets 3-5.
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`-4-
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`REMARKS
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`Claims 1-6 are pending and under consideration. With this Amendment, claim 1 is being amended.
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`Thus, after entry of this Amendment, claims 1-6 are pending and under consideration. This Track One
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`application remains compliant with 37 C.F.R. § 1.102(e), having four or fewer independent claims and 30 or
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`fewer total claims after entry of the instant amendments.
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`The Amendments of the Drawings
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`Replacement sheets have been submitted for Figures 3 and 4 in order to comply with technical
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`requirements for drawings.
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`Figure 3 (drawing sheet 3) has been amended to more clearly identify parts "A" and "B." The
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`replacement drawing now replaces the label "A" with "FIGURE 3A" and replaces the label "B" with
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`"FIGURE 3B." The figure labels correspond to the Brief Description of the Drawings section of the
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`specification.
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`Figure 4 (drawing sheets 4 and 5) was not labeled "A" and "B" for drawing sheets 4 and 5,
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`respectively. The replacement drawing sheets correct the drawings by placing an "A" and "B" after
`"FIGURE 4" on the relevant drawing sheets. See 37 C.F.R. § 1.84(u)(1).
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`No new matter is added by virtue of the amendments to the drawings.
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`The Amendments of the Specification
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`The priority claim in the first sentence of the specification has been corrected to specify that the
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`instant application is a divisional under 35 U.S.C. § 121, rather than a continuation, of Application
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`No. I 0/163,657 ("the '657 Application") .
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`Figure 4, as amended herein, now includes labels "FIGURE 4A" and "FIGURE 4B" to comply with
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`37 C.F.R. § 1.84(u)(l). The specification has been amended accordingly to note that Figure 4 is now labeled
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`"FIGURE 4A" and "FIGURE 4B" across two drawing sheets. Each figure part was labeled on its axis in the
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`drawings as filed, and was described in the specification as filed in the description for Figure 4.
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`No new matter is added by virtue of the amendment to the specification.
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`The Amendments of the Claims
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`Claim 1 has been amended to clarify the dosing schedule. No new matter is added by virtue of the
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`amendments to the claims.
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`Correction of the Priority Claim
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`Applicant hereby corrects the priority claim to designate this application a divisional under
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`35 U.S.C. § 121, rather than a continuation, ofthe '657 Application.
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`The Office mailed three restriction requirements during examination of the '657 application. The
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`second and third restriction requirements each explicitly superseded the immediately preceding restriction
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`requirement. In the third restriction requirement, mailed on May 31, 2006, Applicant was required to "elect a
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`'disorder' from the species of disorders recited in claims 58-69 and 70 or in the instant specification at pages
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`28-32." Among the disorders separately recited in claims 58-69 and 70 were "rheumatoid arthritis"
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`(claim 60) and "intestinal disorder" (claim 68); as set forth in the '657 specification, Crohn's Disease is a
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`species of "intestinal disorder."
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`In the response filed June 29, 2006, Applicant timely elected the species of"autoimmune disease" or
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`in the alternative, "rheumatoid arthritis". The Examiner accepted the election of"rheumatoid arthritis" in an
`Office Action mailed September 21, 2006.1 The claims allowed by the Examiner in the '657 Application are
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`directed exclusively to "rheumatoid arthritis."
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`The requirement for species election further stated, in accordance with 37 C.P.R.§ 1.146, that
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`"Applicant is required under 35 USC 121 to elect a single disclosed species for prosecution on the merits to
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`which the claims shall be restricted if no generic claim is finally held allowable." No claim generic to
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`rheumatoid arthritis and the other "disorders recited in claims 58-69 and 70 or in the instant specification at
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`pages 28-32" was allowed in the '657 application. Absent such a generic claim, the species requirement
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`became a final restriction requirement, permitting divisional applications drawn to nonelected species of
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`disorder to be filed under 35 U.S.C. § 121. St. Jude Med, Inc. v. Access Closure, Inc., 729 F.3d 1369, 1379
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`(Fed. Cir. 2013).
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`The claims in the instant application are drawn exclusively to treatment of Crohn's disease, a species
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`of disorder not elected for prosecution in the '657 Application, and are thus consonant with the final
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`restriction requirement in the '657 Application. The instant application is, therefore, properly a divisional
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`under 35 USC§ 121.
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`A Supplemental Application Data Sheet providing the updated priority information is attached to this
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`Request. See 37 C.P.R.§ 1.76(c)(1). The first sentence of the specification has also been amended to reflect
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`1 and sua sponte expanded the search to include an intestinal disorder.
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`this change. A change in the relationship between related applications in a timely filed priority claim does
`not require the petition and fee under 37 C.F.R. § 1.78(a)(3). See MPEP § 211.03.
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`Conclusion
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`This application is now correctly stated to be a divisional under 35 U.S.C. § 121 of the '657
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`Application. Claims 1-6 are believed to satisfy all of the criteria for patentability and are believed to be in
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`condition for allowance. An early indication of the same is therefore kindly requested.
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`Although no fees are believed due, the Director is authorized to charge any fees that may be
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`required, or credit any overpayment, to Dechert LLP Deposit Account 50-2778 (Order No. 381493-093C4
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`(130717)).
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`DECHERTLLP
`Customer No. 37509
`Tel: 650.813.4800
`Fax: 650.813.4848
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`Reg. No. 69,158
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