Appendix 1 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 3 of 3
`
`Appendix 2
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`Statement of Material Facts Relied Upon in Motion.
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`Appendix 3
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`Claim chart comparing Adair claim 24 presented in 2005 and Adair
`involved claim 24.
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`1501 of 1849
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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 1 of 11
`
`Appendix 2
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`STATEMENT OF MATERIAL FACTS RELIED UPON IN MOTION
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`1.
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`On December 21, 1989, Adair filed Great Britain Application GB 8928874.0
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`(“the UK Application”). (Ex. 2036).
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`2.
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`On December 21, 1990, Adair filed PCT Application PCT/GB90/02017 (“the
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`PCT Application”). (Ex. 2005).
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`3.
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`Exhibit 2037 is a computer generated comparison (using WorkshareTM
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`Professional 5.2 SR2 software) of the typewritten text of the UK Application to the typewritten
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`text of the PCT Application. The last page of Exhibit 2037 contains a color-coded legend for
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`identifying deletions, additions, and movement of text.
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`4.
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`On September 17, 1991, Adair entered the U.S. national stage by filing U.S.
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`Patent Application No. 07/743,329 (“the ‘329 application”). (Ex. 2006).
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`5.
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`Adair’s ‘329 application contained claims 1-23, which are identical to claims 1-23
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`as originally filed with Adair’s PCT application. (Ex. 2005, pp. 67-70 and Ex. 2006, pp. 67-70).
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`6.
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`Original claim 1 of the Adair ‘329 application reads as follows:
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`A CDR-grafted antibody heavy chain having a variable region
`1.
`domain comprising acceptor framework and donor antigen binding regions
`wherein the framework comprises donor residues at at least one of positions 6, 23
`and/or 24, 48 and/or 49, 71 and/or 73, 75 and/or 76 and/or 78 and 88 and/or 91.
`[Ex. 2006, p. 67].
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`7.
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`At pages 4-6 of the specification, Adair provides a discussion of “recent”
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`disclosures by Queen (cid:73)(cid:88)(cid:4)(cid:69)(cid:80). relating to CDR-grafted antibodies and the substitution of acceptor
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`framework residues with donor residues. (Ex. 2002, pp. 4-6).
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`8.
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`At page 6, lines 22-28, the Adair specification states:
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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 2 of 11
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`This has enabled us to establish a protocol for obtaining satisfactory CDR-
`grafted products which may be applied very widely irrespective of the level of
`homology between the donor immunoglobulin and acceptor framework. The set
`of residues which we have identified as being of critical importance does not
`coincide with the residues identified by Queen….” [Ex. 2002, p. 6, lns. 22-28].
`
`9.
`
`The Abstract of Adair’s involved specification reads, in part, as follows:
`
`CDR-grafted antibody heavy and light chains comprise acceptor
`framework and donor antigen binding regions, the heavy chains comprising donor
`residues at at least one of positions (6, 23) and/or (24, 48) and/or (49, 71) and/or
`(73, 75) and/or (76) and/or (78) and (88) and/or (91). [Ex. 2002, Abstract].
`
`10.
`
`At page 6, lines 31-37, the Adair specification reads as follows:
`
`the invention provides a CDR-grafted
`in a first aspect
`Accordingly,
`antibody heavy chain having a variable region domain comprising acceptor
`framework and donor antigen binding regions wherein the framework comprises
`donor residues at at least one of positions 6, 23 and/or 24, 48 and/or 49, 71 and/or
`73, 75 and/or 76 and/or 78 and 88 and/or 91. [Ex. 2002, p. 6, lns. 31-37].
`
`11.
`
`At page 7, lines 1-5, the Adair specification reads as follows:
`
`In preferred embodiments, the heavy chain framework comprises donor
`residues at positions 23, 24, 49, 71, 73 and 78 or at positions 23, 24 and 49. The
`residues at positions 71, 73 and 78 of the heavy chain framework are preferably
`either all acceptor or all donor residues. [Ex. 2002, p. 7, lns. 1-5].
`
`12.
`
`At page 16, line 30 to page 19, line 9, Adair describes its “preferred protocol” for
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`obtaining CDR-grated antibodies. (Ex. 2002, p. 16, ln. 30 to p. 19, ln. 9).
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`13.
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`At page 17, lines 27-30, the involved Adair specification reads as follows under a
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`section titled “Protocol”:
`
`Heavy Chain
`2.
`2.1 Choose donor residues at all of positions 23, 24, 49, 71, 73 and 78 of
`the heavy chain or all of positions 23, 24 and 49 (71, 73 and 78 are always either
`all donor or all acceptor). [Ex. 2002, p. 17, lns. 25-30; Emphasis added].
`
`14.
`
`At page 17, lines 32-35, the involved Adair specification states:
`
`Check that the following have the same amino acid in donor and
`2.2.
`acceptor sequences, and if not preferably choose the donor: 2, 4, 6, 25, 36, 37, 39,
`47, 48, 93, 94, 103, 104, 106 and 107. [Ex. 2002, p. 17, lns. 32-35].
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`1503 of 1849
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`

`

`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 3 of 11
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`15.
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`At pages 19-23 of its involved specification, Adair offers a “rationale” for its
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`protocol. (Ex. 2002, pp. 19-23).
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`16.
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`At page 20, line 27, the involved Adair specification states “Heavy Chain - Key
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`residues are 23, 71 and 73.” (Ex. 2002, p. 20, ln. 27).
`
`17.
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`At page 21, line 9, for the “packing residues near the CDRs,” the involved Adair
`
`specification states “Heavy Chain - Key residues are 24, 49 and 78.” (Ex. 2002, p. 21, ln. 9).
`
`18.
`
`At page 48, lines 25-27, the involved Adair specification explains: “the presence
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`of the 6, 23 and 24 changes are important to maintain a binding affinity similar to that of the
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`murine antibody.” (Ex. 2002, p. 48, lns. 25-27).
`
`19.
`
`At page 52, lines 25-29, the Adair involved specification states:
`
`These and other results lead us to the conclusion that of the 11 mouse
`framework residues used in the gH341A (JA185) construct, it is important to
`retain mouse residues at all of positions 6, 23, 24, 48 and 49, and possibly for
`maximum binding affinity at 71, 73 and 78. [Ex. 2002, p. 52, lns. 25-29].
`
`20.
`
`On November 18, 1992, the U.S. Patent and Trademark Office entered a non-final
`
`office action rejecting Adair’s original claims 1-23 on various grounds. (Ex. 2038).
`
`21.
`
`At page 5 of the November 1992 office action, the Examiner rejected claims 1-5
`
`under 35 U.S.C. § 112, first paragraph as not being enabled. In particular, the Examiner stated
`
`that practicing the invention as claimed would require undue experimentation relative to the
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`teachings of the Adair specification. (Ex. 2038, p. 5).
`
`22.
`
`At page 6 of the November 1992 office action, the Examiner rejected claims 1-5
`
`under 35 U.S.C. § 112, second paragraph, as being indefinite in their recitation of “at least one of
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`positions 6, 23 and/or 24, 48 and/or 49, 71 and/or 73, 75 and/or 76 and/or 78 and 88 and/or 91”
`
`because it was unclear whether the heavy chain,
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`1504 of 1849
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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 4 of 11
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`a.
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`b.
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`c.
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`had at least one of 6, 23, 24, 48, 49, 71, 73, 75, 76, 78, 88, or 91, or
`
`alternatively,
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`had at least one of (6) or (23 and/or 24) or (48 and/or 49) or (71 and/or 73)
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`or (75 and/or 76 and/or 78 and 88 and/or 91), or alternatively,
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`had at least one of (6, 23) and/or (24, 48) and/or (49, 71) and/or (73, 75)
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`and 76 and/or (78 and 88) and/or (91). (Ex. 2038, p. 6).
`
`23.
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`At pages 7-12 of the November 1992 office action, the Examiner rejected Adair’s
`
`claims under 102/103 in view of Riechmann (cid:73)(cid:88)(cid:4)(cid:69)(cid:80)., (cid:50)(cid:69)(cid:88)(cid:89)(cid:86)(cid:73), Vol. 332, pp. 323-327 (March 1988)
`
`and Queen (cid:73)(cid:88)(cid:4)(cid:69)(cid:80)., (cid:52)(cid:86)(cid:83)(cid:71)(cid:18)(cid:4)(cid:50)(cid:69)(cid:88)(cid:80)(cid:18)(cid:4)(cid:37)(cid:71)(cid:69)(cid:72)(cid:18)(cid:4)(cid:55)(cid:71)(cid:77)(cid:18)(cid:4)(cid:57)(cid:55)(cid:37), Vol. 86, pp. 10029-10033 (December 1989) . (Ex.
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`2038, pp. 7-12; Ex. 2011, and Ex. 2023).
`
`24.
`
`On January 19, 1993, Adair responded to the November 1992 Office action. (Ex.
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`2007).
`
`25.
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`In the January 1993 amendment, Adair responded to the rejection of claims under
`
`35 U.S.C. § 112, second paragraph, by cancelling claims 1-12. (Ex. 2007, pp. 29-32).
`
`26.
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`In the January 19, 1993, amendment, Adair responded to the rejection of claims
`
`under 35 U.S.C. § 102(b) in view of Riechmann (cid:73)(cid:88)(cid:4)(cid:69)(cid:80)(cid:18) as follows:
`
`In Part A of this rejection, claims 1, 5, 6-8, and 12-22 were rejected as
`anticipated by Riechmann et al. The Examiner stated that claim 1 and claim 6
`were interpreted to mean that the framework has donor residues in at least one of
`any of positions 6, 23, 24, 48, 49, 71, 73, 75, 76, 78, 88, or 91 in the heavy chain
`and (1, 3, 46, or 47) or 46, 48, 58, or 71) in the light chain, and thus, the teachings
`of Riechmann et al. anticipate the invention as claimed.
`
`the original claims lacked novelty over
`The Examiner contends that
`Riechmann et al. Claims 1, 5, 6-8, 12 and 22 have been cancelled without
`prejudice and submitted as new claims that more distinctly point out certain
`aspects of the present invention.
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`1505 of 1849
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`

`

`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 5 of 11
`
`In present claims 24 and 25, it is specified that residues 23 and 24 in the
`heavy chain should be donor residues. However, as can be seen from Fig. 1,
`panel (a) in Riechmann et al., in the recombinant antibody shown there, residues
`23 and 24 are acceptor residues. [Ex. 2007, p. 32-33].
`
`27.
`
`In the January 19, 1993, response, Adair responded to the rejection of claims
`
`under 35 U.S.C. § 102(b) in view of Queen (cid:73)(cid:88)(cid:4)(cid:69)(cid:80)(cid:18) as follows:
`
`In Part B of the rejection, the Examiner rejected claims 1-6 and 12-22 as
`anticipated by Queen et al.
`
`Claims 1-6, 12-20 and 22 have been cancelled without prejudice and
`submitted as new claims that more distinctly point out certain aspects of the
`present invention.
`
`In present claims 24 and 25, it is specified that residues 48, 66, 67, 68, 93,
`103 to 108 and 110 should all be acceptor residues. However, in Queen et al., as
`can be seen from Fig. 2B, in these positions Queen et al. uses donor, rather than
`acceptor, residues. It should again be borne in mind that Queen et al. does not use
`the Kabat numbering and it
`is therefore necessary to look carefully at
`the
`disclosure in Queen et al. before it is possible to come to any final conclusion.
`[Emphasis by Adair].
`
`In present claim 38, it is specified that residue 71 should be a donor
`residue. However, as can be seen from Fig. 2A of Queen et al., in that position
`Queen et al. uses an acceptor, rather than a donor residue.
`
`Applicants’ claimed antigen-binding molecules are thus not anticipated by
`Queen et al. Withdrawal of this entire 35 USC § 102 (b) rejection is respectfully
`requested. [Ex. 2007, pp. 33-34].
`
`28.
`
`At pages 26-28 of its January 19, 1993, response, Adair responded to the § 112,
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`first paragraph rejection by arguing, (cid:77)(cid:82)(cid:88)(cid:73)(cid:86)(cid:4)(cid:69)(cid:80)(cid:77)(cid:69), as follows:
`
`In contrast, the teaching in the present application can be applied without
`undue experimentation to any antibody. All that is required is experimentation
`following a protocol which is clearly set out in the description, in particular at
`page 16, line 30 to page 19, line 9. In order to follow this protocol, as a first step,
`it is necessary to determine the amino acid sequence of the donor chain. The
`sequence of the acceptor chain will already be known, for instance from a
`sequence data base.
`
`There is then no need to carry out computer modeling to determine which
`donor residues to substitute into the acceptor sequence. The protocol in the
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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 6 of 11
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`It instructs the skilled person
`present application provides the teaching directly.
`to compare the two sequences and change certain specified residues in the
`acceptor sequence to donor residues.
`
`Moreover, the present application provides a hierarchical structure of
`residues which can be considered. Thus, if changing the residues at the top of the
`structure does not provide adequate affinity, then a lower level of residues are
`considered, and so on until acceptable affinity is obtained.
`
`[…]
`
`It is submitted that this identifies where the present invention makes a
`significant departure from the prior art. The prior art indicates that each antibody
`has to be treated individually. In contrast, the present invention teaches that, by
`following the protocol set forth in the present application, it is possible to reshape
`any antibody.
`[Ex. 2007, pp. 26-28].
`
`29.
`
`An Examiner Interview Summary Record dated January 27, 1993, states
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`“applicant suggests that the ‘comprising’ in eg clm 24 is not to be taken as ‘comprising’ more
`
`residues than those in clm, i.e. claimed residues are not to be considered open ended. Applicant
`
`indicated they would clarify the latter issue. Queen does not teach changing residues: 73HC;
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`38HC; 71 on LC # 1 on LC + #4 on LC, 36 on LC 46 on LC.” (Ex. 2039, p. 4; Emphasis by
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`Examiner).
`
`30.
`
`On April 7, 1993, Adair made the following statements in an amendment:
`
`Having considered the Examiner’s concerns that the language of the
`claims might be indefinite, because it was not clear whether the specified residues
`were the only or the minimum number of residues to be donor residues, the
`Applicants have amended the claims. In all the claims it is made clear that there
`is a minimum number of residues which have to be donor residues and a
`minimum number which have to be acceptor residues. Those residues which are
`not specified in the claims may be either donor or acceptor.
`[Ex. 2008, p. 13;
`Emphasis by Adair].
`
`In claim 67, it has been specified that residues 71, 73 and 78 are all donor
`residues in order to ensure that claim 67 is novel over the anti-TAC antibody
`disclosed by Queen. This anti-TAC antibody has an acceptor residue at residue
`73. However, as can be seen from page 7, lines 1 to 5, the Applicant considers
`that in general, residues 71, 73 and 78 can be either all donor or all acceptor. [Ex.
`2008, p. 14].
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`1507 of 1849
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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 7 of 11
`
`It is stated on page 7, lines 1 to 5, that residues 71, 73 and 78 should all be
`either acceptor or donor. Claims 73, 80, 87, 94 and 101 cover the first alternative
`and claims 74, 81, 88, 95 and 102 cover the second alternative. [Ex. 2008, p. 15].
`
`31.
`
`On September 9, 1993, in the Adair PCT/EP Patent Application 91901433.2,
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`Adair filed an amendment deleting original claims 1-23 and replacing them with new claims 1-
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`20 and made the following statements:
`
`2.10. In new claim 1, it has been specified that residues 71, 73 and 78 are
`all donor residues in order to ensure that new claim 1 is novel over the anti-TAC
`antibody disclosed in PNAS-USA, 86, 10029-10033, 1989 (Queen) (cited in the
`International Search Report). This anti-TAC antibody has an acceptor residue at
`residue 73. However, as can be seen from page 7, lines 1 to 5, the Applicant
`considers that in general, residues 71, 73 and 78 can be either all donor or all
`acceptor. [Ex. 2009, p. 3].
`
`32.
`
`On February 7, 1994, Adair filed an amendment in the ‘329 application
`
`responding to the office action mailed on September 7, 1993 (Ex. 2028), wherein Adair stated:
`
`the present protocol
`is specifically stated in the application that
`It
`represents a departure from the procedures of Reichmann [sic] and Queen, at
`least. Thus, the skilled person would not rely on Reichmann [sic] and Queen as
`teachings relevant to whether the present description is enabling.
`
`It is submitted that the skilled person would rely on the clear teaching
`given in the application and find that it is enabling. The specification plainly sets
`out what actions need to be taken.
`It is presumed that the Examiner agrees that
`the skilled person could have taken those actions. The application also sets out
`that, contrary to the teachings of Reichmann and Queen, the protocol is generally
`applicable.
`The application further shows that
`it had been successfully
`implemented. Thus, it is submitted that the skilled person would find that the
`present application is properly enabled the full extent of the claims.
`[Ex. 2010,
`pp. 11-12].
`
`33.
`
`In the February 7, 1994, amendment, Adair made the following statements:
`
`At a very helpful interview held at the beginning of 1993, there was some
`discussion of the word “comprising” as used in the claims under consideration at
`that time.
`In those claims, it was only specified that certain residues should be
`donor residues.
`[Emphasis by Adair].
`It was considered that it was not clear
`whether these were the only residues which could be donor residues. The
`alternative view was that these were only the minimum number of residues which
`must be donor but that any of the other residues could also be donor.
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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 8 of 11
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`If the second line of interpretation were taken, the claims could be read to
`cover a situation in which all except one of the residues in the variable domain
`were donor residues. [Emphasis by Adair]. In this case, the claims could then be
`interpreted to cover a structure similar to a “chimeric” antibody comprising a
`donor variable domain and a human constant region. Such chimeric antibodies
`were already well known at the priority date.
`
`the intention of the Applicants to claim chimeric
`It plainly is not
`antibodies or any similar structures. As can be seen from the description, the
`superhumanised antibodies of the present invention are compared to the prior art
`chimeric antibodies. Moreover, the present invention was intended to deal with
`the problem of chimeric antibodies in that chimeric antibodies were believed to be
`too “foreign” because of the presence of the complete donor variable domain.
`
`For the above reasons, it is clear that the wording of the claims needed to
`be changed so that the Applicants’ intention of excluding chimeric antibodies was
`made effective. The language now present in the claims puts this intention clearly
`into effect.
`
`As to support for this wording, the Examiner is referred firstly to page 16,
`under the heading "Protocol". It can be seen from this paragraph that the first step
`in the process involves the choice of an appropriate acceptor chain variable
`domain. This acceptor domain must be of known sequence. Thus, the protocol
`starts with a variable domain in which all the residues are acceptor residues. In the
`sentence bridging pages 16 and 17, it is stated that:
`
`“The CDR-grafted chain is then designed starting from the
`basis of the acceptor sequence”. [Emphasis by Adair].
`
`On page 17, in the middle paragraph, it is stated that:
`
`“The positions at which donor residues are to be substituted
`for acceptor in the framework are then chosen as follows ....”
`
`This again shows that, unless a residue is chosen for substitution, it will remain as
`in the acceptor sequence.
`
`It must also be borne in mind that the purpose of the invention is to
`obviate some of the disadvantages of prior art proposals. The proposal of using
`chimeric antibodies had the disadvantage that they were more “foreign” than
`desirable.
`The problem of making CDR-grafted antibodies was that
`they
`generally did not provide good recovery of affinity. Thus, the aim of the present
`invention was to minimise as far as possible the “foreign” nature of the antibody
`while maximising as far as possible its affinity.
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`1509 of 1849
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`

`

`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 9 of 11
`
`Bearing the passages referred to above and the aim of the invention in
`mind, it would have been abundantly clear to the skilled person reading the
`application that as many residues as possible should remain as acceptor residues.
`If this were not the case, it could hardly be said that the composite chain is based
`on the acceptor sequence.
`
`The skilled person reading the application can plainly see that certain
`residues have been considered for changing from acceptor to donor. These are
`clearly set out in the description. It would be plain to the skilled person that all
`other residues should not be considered for changing at all. It would therefore be
`obvious that any residue which is not specified as being under consideration for
`changing must remain as in the acceptor chain.
`
`It may be that there is no explicit statement in the description that the
`specified residues should remain as in the acceptor chain. However,
`the
`disclosure in a specification is not limited to the explicit disclosure but also
`includes that which is implicit.
`It is implicit, in the recitation that the chain is
`based on the acceptor and that only certain residues are considered for changing,
`that all non-specified residues must remain as acceptor residues. Subject matter
`which might be fairly deduced from the disclosure is not new matter. (cid:37)(cid:71)(cid:81)(cid:73)
`(cid:44)(cid:77)(cid:75)(cid:76)(cid:91)(cid:69)(cid:93)(cid:4)(cid:52)(cid:86)(cid:83)(cid:72)(cid:89)(cid:71)(cid:88)(cid:87)(cid:4)(cid:39)(cid:83)(cid:86)(cid:84)(cid:18)(cid:4)(cid:90)(cid:18)(cid:4)(cid:40)(cid:18)(cid:55)(cid:18)(cid:4)(cid:38)(cid:86)(cid:83)(cid:91)(cid:82)(cid:4)(cid:39)(cid:83)(cid:18), 431 F.2d 1074, 1080, 167 U.S.P.Q.
`129, 132-133(6th Cir. 1970), (cid:71)(cid:73)(cid:86)(cid:88)(cid:4)(cid:72)(cid:73)(cid:82)(cid:77)(cid:73)(cid:72), 401 U.S. 956 (1971).
`
`Another way to look at it is to consider a different way in which the claim
`could be drafted.
`It could be specified that in the composite chain, at least a
`certain minimum number of residues are donor residues (as in the present claims)
`and at most a certain maximum number of residues are donor residues. The
`maximum number would be derived by listing all
`the residues which are
`considered for changing. Such an amendment would have clear explicit basis in
`the description because all those residues are mentioned as such. However, the
`effect of such an amendment would be to produce claims of exactly the same
`scope as the present claims. It can thus be seen that the present claims do not add
`subject matter but are plainly properly based on the disclosure in the description.
`
`the claims are fully supported by the
`is therefore submitted that
`It
`description, are commensurate in scope with the disclosure in the description, and
`are properly delimited over the prior art. [Ex. 2010, pp. 3-7].
`
`34.
`
`Adair did not present a newly executed declaration at the time of filing the ‘261
`
`application but, rather, relied on the inventor declaration from the parent application to satisfy
`
`the requirements of 37 C.F.R. § 1.63. (Ex. 2002).
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`

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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 10 of 11
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`35.
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`On November 21, 2005, Adair filed its involved application, (cid:77)(cid:18)(cid:73)(cid:18), U.S. Patent
`
`Application No. 11/284,261 (“the ‘261 Application”). (Ex. 2002).
`
`36.
`
`On November 21, 2005, Adair presented new claim 24 as follows:
`
`Claim 24 (new) A humanised antibody heavy chain variable domain
`comprising non-human complementarity determining region amino acid residues
`which bind an antigen and a human framework region wherein said framework
`region comprises an amino acid substitution at a residue selected from the group
`consisting of 23, 24, 49, 71, 73, and 78, and combinations thereof, as numbered
`according to Kabat. [Ex. 2003, p. 3].
`
`37.
`
`On September 9, 2009, Adair presented its involved claim 24 in the ‘261
`
`application, which reads as follows:
`
`Claim 24 (currently amended): A humanised antibody comprising a heavy
`chain variable domain comprising non-human complementarity determining
`region amino acid residues which bind an antigen and a human framework region
`wherein said framework region comprises a non-human amino acid substitution at
`a residue selected from the group consisting of 23, 24, 49, 71, 73, and 78, and
`combinations thereof, as numbered according to Kabat.
`[Ex. 2004, p. 2; Adair
`Clean Copy of Claims, Paper No. 5, p. 4].
`
`38.
`
`Appendix 3 is a claim chart comparing Adair claim 24 as originally filed in 2005
`
`and Adair involved claim 24.
`
`39.
`
`Adair involved claim 24 encompasses a humanized antibody wherein the heavy
`
`chain variable domain framework region has any combination of human and non-human amino
`
`acid residues at positions 23, 24, 49, 71, 73 and 78. (Adair Clean Copy of Claims, Paper No. 5,
`
`p. 4).
`
`40.
`
`Adair involved claim 24 encompasses a humanized antibody wherein the heavy
`
`claim variable domain framework region has non-human amino acids at positions 71, 73 and 78
`
`and human amino acids at positions 23, 24, and 49. (Adair Clean Copy of Claims, Paper No. 5,
`
`p. 4).
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`1511 of 1849
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`

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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 11 of 11
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`1
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`41.
`
`Adair involved claim 24 encompasses a humanized antibody wherein the heavy
`
`claim variable domain framework region has non-human amino acids at positions 23 and 71 and
`
`human amino acids at positions 24, 49, 73 and 78. (Adair Clean Copy of Claims, Paper No. 5, p.
`
`4).
`
`42.
`
`Adair involved claim 24 encompasses a humanized antibody wherein the heavy
`
`claim variable domain framework region has non-human amino acids at position 23 and human
`
`amino acids at positions 24, 49, 71, 73 and 78. (Adair Clean Copy of Claims, Paper No. 5, p. 4).
`
`1512 of 1849
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`

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`Appendix 3 to Carter Substantive Motion 2
`Interference No. 105,744
`Page 1 of 1
`
`Appendix 3
`
`CLAIM CHART COMPARING
`ADAIR CLAIM 24 PRESENTED IN 2005 AND ADAIR INVOLVED CLAIM 24
`
`Adair Claim 24 Presented in 2005
`A humanised antibody heavy
`chain variable domain comprising
`non-human complementarity determining
`region amino acid residues which bind an
`antigen and a human framework region
`wherein said framework region comprises an
`amino acid substitution at a residue
`selected from the group consisting of 23, 24,
`49, 71, 73, and 78, and combinations thereof,
`as numbered according to Kabat.
`
`Adair Involved Claim 24
`A humanised antibody comprising a heavy
`chain variable domain comprising
`non-human complementarity determining
`region amino acid residues which bind an
`antigen and a human framework region
`wherein said framework region comprises a
`non-human amino acid substitution at a residue
`selected from the group consisting of 23, 24,
`49, 71, 73, and 78, and combinations thereof,
`as numbered according to Kabat.
`
`1513 of 1849
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`BI Exhibit 1095
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`

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`Mail Stop Interference
`P.O. Box 1450
`Alexandria Va 22313-1450
`Tel: 571-272-9797
`Fax: 571-273-0042
`
`Paper 73
`Filed: 16 June 2010
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`PAUL J. CARTER AND LEONARD G. PRESTIA
`Junior Party
`(Patent 6,407,213),
`
`v.
`
`JOHN ROBERT ADAIR, DILGEET SINGH ATHWAL, and JOHN SPENCER EMTAGE
`Senior Party
`(Application No. 11/284,261),
`
`Patent Interference No. 105,744
`(Technology Center 1600)
`
`ORDER –Authorizing Oppositions – 125(a)
`
`A conference call was held on 15 June 2010 at approximately 2:00 pm.
`
`Participating in the call were:
`
`(1) Oliver Ashe for Carter,
`
`(2) Doreen Trujillo for Adair, and
`
`(3) Sally Gardner Lane, Administrative Patent Judge.
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`Adair oppositions
`
`Carter has filed two motions (Paper 71 and 72). The motions address threshold
`
`issues. Adair oppositions were not previously authorized. (Paper 23 at 3). After review
`
`of the motions, the Board has determined that it is appropriate to authorize Adair
`
`oppositions to the Carter motions. As requested by Adair, a four week time period is set
`
`for the filing of the Adair oppositions.1 ,2
`
`As discussed during the call and as agreed to by the parties, Carter will be given
`
`a small amount of time in addition to that set out in Bd. R. 155(b)(1) to make any
`
`objections to evidence relied upon in the Adair oppositions.
`
`No Carter reply to either of the Adair oppositions is authorized at this time.
`
`Settlement conference
`
`Adair noted that it has neglected to initiate the settlement conference required by
`
`the Standing Order at ¶ 126. 2. Adair indicated that it is awaiting a response from its
`
`real party in interest regarding plans for a settlement conference, however it is unlikely
`
`that settlement will occur.
`
`It is
`
`Order
`
`ORDERED that Adair oppositions to Carter Motions 1 and 2 shall be filed
`
`on or before 14 July 2010;
`
`Due to a health issue affecting Adair lead counsel, Adair has requested, and
`1
`Carter has agreed to the request for, additional time than would ordinarily be authorized.
`2
`Adair indicated that it does not wish to file a responsive motion and none is
`authorized. Adair should contact the Board and arrange a conference call immediately
`if Adair determines that it wishes to seek authorization to file a responsive motion.
`
`2
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`1515 of 1849
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`FURTHER ORDERED that any Carter objections to evidence relied upon
`
`in the Adair opposition under Bd. R. 155(b) (1) shall be filed on or before 28 July 2010;
`
`and
`
`FURTHER ORDERED that Adair shall, within a reasonable time from the
`
`date of this Order, initiate the settlement negotiations required by the Standing Order
`
`(SO at ¶ 126.2).
`
`/Sally Gardner Lane/
`Administrative Patent Judge
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`cc (via electronic delivery):
`
`Attorney for Carter:
`
`Oliver R. Ashe, Jr., Esq.
`ASHE, P.C.
`11440 Isaac Newton Square North
`Suite 210
`Reston, VA 20190
`
`Tel:
`Email:
`
`703-467-9001
`oashe@ashepc.com
`
`Jeffrey P. Kushan, Esq.
`SIDLEY AUSTIN LLP
`1501 K Street, NW
`Washington, DC 20005
`
`Tel:
`Email:
`
`202-736-8914
`jkushan@sidley.com
`
`Attorney for Adair:
`
`Doreen Yatko Trujillo, Esq.
`Michael B. Fein, Esq
`COZEN O’CONNOR P.C.
`1900 Market Street
`Philadelphia, PA 19103
`
`Tel:
`Email:
`
`215-665-5593
`dtrujillo@cozen.com
`
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`(cid:4)
`
`(cid:4)
`
`(cid:52)(cid:69)(cid:84)(cid:73)(cid:86)(cid:4)(cid:50)(cid:83)(cid:30)(cid:67)(cid:67)(cid:67)(cid:67)(cid:67)(cid:67)(cid:4)
`(cid:4)
`(cid:40)(cid:69)(cid:88)(cid:73)(cid:4)(cid:42)(cid:77)(cid:80)(cid:73)(cid:72)(cid:30)(cid:4)(cid:46)(cid:89)(cid:82)(cid:73)(cid:4)(cid:22)(cid:28)(cid:16)(cid:4)(cid:22)(cid:20)(cid:21)(cid:20)(cid:4)
`
`(cid:42)(cid:77)(cid:80)(cid:73)(cid:72)(cid:4)(cid:83)(cid:82)(cid:4)(cid:70)(cid:73)(cid:76)(cid:69)(cid:80)(cid:74)(cid:4)(cid:83)(cid:74)(cid:30)(cid:4)(cid:4)(cid:4)(cid:4)(cid:4)(cid:4)(cid:37)(cid:72)(cid:69)(cid:77)(cid:86)(cid:4)
`(cid:38)(cid:93)(cid:30)(cid:4)
`(cid:4)
`(cid:4)
`(cid:40)(cid:83)(cid:86)(cid:73)(cid:73)(cid:82)(cid:4)(cid:61)(cid:69)(cid:88)(cid:79)(cid:83)(cid:4)(cid:56)(cid:86)(cid:89)(cid:78)(cid:77)(cid:80)(cid:80)(cid:83)(cid:4)(cid:4)
`(cid:4)
`(cid:4)
`(cid:49)(cid:77)(cid:71)(cid:76)(cid:69)(cid:73)(cid:80)(cid:4)(cid:38)(cid:18)(cid:4)(cid:42)(cid:73)(cid:77)(cid:82)(cid:4)
`(cid:4)
`(cid:4)
`(cid:39)(cid:83)(cid:94)(cid:73)(cid:82)(cid:4)(cid:51)(cid:118)(cid:39)(cid:83)(cid:82)(cid:82)(cid:83)(cid:86)(cid:4)(cid:52)(cid:18)(cid:39)(cid:18)(cid:4)
`(cid:4)
`(cid:4)
`(cid:21)(cid:29)(cid:20)(cid:20)(cid:4)(cid:49)(cid:69)(cid:86)(cid:79)(cid:73)(cid:88)(cid:4)(cid:55)(cid:88)(cid:18)(cid:4)
`(cid:4)
`(cid:4)
`(cid:52)(cid:76)(cid:77)(cid:80)(cid:69)(cid:72)(cid:73)(cid:80)(cid:84)(cid:76)(cid:77)(cid:69)(cid:16)(cid:4)(cid:52)(cid:37)(cid:4)(cid:21)(cid:29)(cid:21)(cid:20)(cid:23)(cid:4)
`(cid:4)
`(cid:4)
`(cid:56)(cid:73)(cid:80)(cid:73)(cid:84)(cid:76)(cid:83)(cid:82)(cid:73)(cid:30)(cid:4)(cid:12)(cid:22)(cid:21)(cid:25)(cid:13)(cid:4)(cid:26)(cid:26)(cid:25)(cid:17)(cid:25)(cid:25)(cid:29)(cid:23)(cid:4)
`(cid:4)
`(cid:4)
`(cid:42)(cid:69)(cid:71)(cid:87)(cid:77)(cid:81)(cid:77